D500 User Manual

OPERATOR’S MANUAL
Defibrillator/Monitor D500
EU representative
OBELIS S.A
Bd. Général Wahis, 53, 1030 Brussels, Belgium
Manufacturer
Mediana Co., Ltd.
132, Donghwagongdan-ro, Munmak-eup,
Wonju-si, Gangwon-do, Korea
Tel: (82) 2 542 3375 (82) 33 742 5400
Fax: (82) 2 542 7447 (82) 33 742 5483
Part Number: A7226-10

Revised Date: 2019-02
Copyright © 2019 All rights reserved.

Directive
 Copyright law allows no part of this instruction manual to be reproduced without

permission.
 The content of this manual are subject to change without notice.
 The contents of this manual should be correct. If for some reason, there are any
questionable points, please do not hesitate to contact our service center.
 The manual will be replaced if any pages are missing or collation is incorrect.
Warranty
 Please contact your local distributor about the warranty period.

 Device failure or damage related to the following situations during the guarantee period
is not covered by this warranty:
 Installation, transfer installation, maintenance and repairs by any person other
than an authorized employee or technician by Mediana.
 Damage sustained to the Mediana product(s) caused by product(s) from another
company excluding products delivered by Mediana.
 Damage – caused by mishandling and/or misuse – is the responsibility of the
user.
 Maintenance and repairs utilizing maintenance components that are not specified
by Mediana.
 Device modifications or use of accessories not recommended by Mediana.
 Damage caused by accidents or natural disasters (earthquakes, flooding, etc.).
 Damage resulting from usage where caution statements and operating
instructions shown in this manual have not been followed.
 Damage due to neglect of specified maintenance checks.
 This warranty only covers the hardware of the D500. The warranty does not cover the
following selections:
 Whatever damage or loss results from the attachment of accessories or their
operation.
 In the event of a defect in the product, contact our sales outlet or EU
representative as noted on the back cover.
 The D500 conforms to the EMC standard IEC60601-1-2.
Note that mobile phones should not be used in the vicinity of the D500.
Note, however, any device not complying to the EMC standard that is used with the D500
renders the D500 as non-compliable to the EMC standard.
Trademark
Product brand names shown in this manual are likely to be the trademark or registered
trademark of the company concerned.
This defibrillator/monitor is equipped with epoch-making ECG monitoring

function incorporating the cutting edge software for analysis of
electrocardiograms developed by the University of Glasgow in UK, which
includes signal processing, diagnostic interpretation of electrocardiograms from individuals of
all ages and analysis of cardiac rhythm.
CONTENTS
CONTENTS .................................................................................................................................................... i
SAFETY INFORMATION .............................................................................................................................. 7
General Safety Information ................................................................................................................... 7
Warning ................................................................................................................................................. 7
Cautions .............................................................................................................................................. 12
INTRODUCTION ......................................................................................................................................... 13
Intended Use for the D500 .................................................................................................................. 13
Indications for Use ............................................................................................................................... 13
About This Manual ............................................................................................................................... 15
Identifying the D500 Configurations .................................................................................................... 15
DESCRIPTION OF THE DEFIBRILLATOR/MONITOR .............................................................................. 17
Front Panel Components..................................................................................................................... 17
Top Panel Components ....................................................................................................................... 19
Rear Panel Components ..................................................................................................................... 20
Left Panel Components ....................................................................................................................... 21
Right Panel Components..................................................................................................................... 21
Displays ............................................................................................................................................... 23
SETTING UP THE DEFIBRILLATOR/MONITOR ....................................................................................... 27
Unpacking and Inspection ................................................................................................................... 27
List of Components .............................................................................................................................. 28
Power Cable Connections ................................................................................................................... 30
Measurement Cable Connections ....................................................................................................... 32
BATTERY OPERATION .............................................................................................................................. 35
Operating the defibrillator/monitor on Battery Power .......................................................................... 36
Battery Status Indication ...................................................................................................................... 37
USING THE DEFIBRILLATOR/MONITOR ................................................................................................. 39
Turning On and Off the defibrillator/monitor ........................................................................................ 40
Setting Date and Time ......................................................................................................................... 41
Continued use ..................................................................................................................................... 42
Setting the Main Screen ...................................................................................................................... 42
ALARMS AND LIMITS................................................................................................................................ 45
General ................................................................................................................................................ 45
Alarm Priority and Messages .............................................................................................................. 46
Visual Alarm Indication ........................................................................................................................ 51
Audible Alarm Indication ...................................................................................................................... 51
Verifying Audible Alarm Indication ....................................................................................................... 52
Changing Alarm Limits......................................................................................................................... 52
Audio Paused and OFF ....................................................................................................................... 54
ECG MONITORING .................................................................................................................................... 57
General ................................................................................................................................................ 58
Setup Connections .............................................................................................................................. 58
12-lead ECG ........................................................................................................................................ 60
Preparing the 12 Lead ......................................................................................................................... 64
Calculation Feature ............................................................................................................................. 65
Description of HR/PR Menu Functions................................................................................................ 69
HR/PR Source ..................................................................................................................................... 70
AED(Automated External Defibrillator) MODE ....................................................................................... 71
AHA/ERC guidelines (Rescue protocol) .............................................................................................. 74
Summary of CPR Guidelines .............................................................................................................. 75
Performing CPR .................................................................................................................................. 78
Description of AED Mode Menu Functions ......................................................................................... 79
MANUAL MODE ......................................................................................................................................... 81
General ................................................................................................................................................ 81
i
Preparing for Defibrillation ................................................................................................................... 82
Operating the Manual Mode of defibrillator/monitor ............................................................................ 82
Defibrillating (async mode) .................................................................................................................. 83
Synchronized Cardioversion (sync mode) .......................................................................................... 84
Description of Manual Mode Menu Functions ..................................................................................... 86
MONITOR MODE ........................................................................................................................................ 93
General ................................................................................................................................................ 93
Description of Pacing Mode Menu Functions ...................................................................................... 93
PACING MODE ........................................................................................................................................... 99
General ................................................................................................................................................ 99
Demand Mode and Fixed Mode ........................................................................................................ 100
Operating the Pacing Mode of defibrillator/monitor ........................................................................... 100
Demand mode Pacing ....................................................................................................................... 100
Fixed Mode Pacing ............................................................................................................................ 101
Description of Pacing Mode Menu Functions .................................................................................... 102
NIBP MONITORING.................................................................................................................................. 107
General .............................................................................................................................................. 108
Setup Connections ............................................................................................................................ 108
Description of NIBP Menu Functions ................................................................................................ 110
Theory of Operation........................................................................................................................... 112
SpO2 MONITORING.................................................................................................................................. 115
General .............................................................................................................................................. 116
Clinical Studies .................................................................................................................................. 121
RESPIRATION MONITORING .................................................................................................................. 123
General .............................................................................................................................................. 123
Description of Respiration Menu Functions ...................................................................................... 124
CAPNOGRAPHY MONITORING .............................................................................................................. 127
General .............................................................................................................................................. 128
Calibrating the CO2 Sensor ............................................................................................................... 129
Description of EtCO2 Menu Functions ............................................................................................... 131
TEMPERATURE MONITORING ............................................................................................................... 135
General .............................................................................................................................................. 135
Description of Temperature Menu Functions..................................................................................... 135
IBP MONITORING .................................................................................................................................... 137
General .............................................................................................................................................. 138
Description of IBP 1 Menu Functions ................................................................................................ 139
Description of IBP 2 Menu Functions ................................................................................................ 140
SELF-TEST FUNCTION ........................................................................................................................... 143
General .............................................................................................................................................. 143
Functions to be tested in Self-test ..................................................................................................... 144
Self-test result transmission (if configured with Wireless module option) ......................................... 144
Self-test result printing ....................................................................................................................... 144
External shock test ............................................................................................................................ 145
Trouble shooting ................................................................................................................................ 146
EVENT ....................................................................................................................................................... 147
General .............................................................................................................................................. 147
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Event Data List Display ..................................................................................................................... 147
Event Review Display ........................................................................................................................ 148
12 Lead Record Display .................................................................................................................... 149
ID# ..................................................................................................................................................... 149
REAL-TIME DATA .................................................................................................................................... 151
General .............................................................................................................................................. 151
Real-time data menu ......................................................................................................................... 151
Real-time data recording ................................................................................................................... 152
Header recording ............................................................................................................................... 152
Event messages recording ................................................................................................................ 152
Waveform recording .......................................................................................................................... 153
Shock information recording .............................................................................................................. 153
Trend recording auto print. ................................................................................................................ 153
Download ........................................................................................................................................... 153
Print Setting ....................................................................................................................................... 153
MENU STRUCTURE ................................................................................................................................. 155
PRINTING ................................................................................................................................................. 165
General .............................................................................................................................................. 165
Printer Settings .................................................................................................................................. 165
Print-Out ............................................................................................................................................ 167
EXTERNAL INTERFACE .......................................................................................................................... 171
General .............................................................................................................................................. 171
SD Memory Card ............................................................................................................................... 171
Central System Communication ........................................................................................................ 172
MAINTENANCE ........................................................................................................................................ 173
Recycling and Disposal ..................................................................................................................... 173
Returning the defibrillator/monitor and System Components............................................................ 174
Service ............................................................................................................................................... 174
Periodic Safety Checks ..................................................................................................................... 174
Cleaning ............................................................................................................................................ 174
Battery Maintenance.......................................................................................................................... 175
Loading Printer Paper ....................................................................................................................... 176
TROUBLESHOOTING .............................................................................................................................. 177
General .............................................................................................................................................. 177
Obtaining Technical Assistance ......................................................................................................... 177
EMI (Electromagnetic Interference)................................................................................................... 178
FACTORY DEFAULTS .............................................................................................................................. 181
General .............................................................................................................................................. 181
Parameter Ranges and Default Settings ........................................................................................... 181
SPECIFICATION ....................................................................................................................................... 189
Display ............................................................................................................................................... 189
Controls ............................................................................................................................................. 189
Alarms ............................................................................................................................................... 189
Physical Characteristics and Printer .................................................................................................. 190
Electrical ............................................................................................................................................ 190
Environmental Conditions.................................................................................................................. 191
Tone Definition ................................................................................................................................... 192
Measurement Parameters ................................................................................................................. 193
Event ................................................................................................................................................. 199
Defibrillator (Technical Specification)................................................................................................. 200
Compliance ........................................................................................................................................ 215
Manufacturer’s EMC Declaration ...................................................................................................... 219
iii
Figures
Figure 1. Front panel components ............................................................................................................................... 17
Figure 2. Top panel components .................................................................................................................................. 19
Figure 3. Rear panel components ................................................................................................................................ 20
Figure 4. Left panel components ................................................................................................................................. 21
Figure 5. Right panel components ............................................................................................................................... 21
Figure 6. Displays ........................................................................................................................................................ 23
Figure 7. AC Power Connection .................................................................................................................................. 30
Figure 8. DC Power Connection .................................................................................................................................. 31
Figure 9. Battery Placement ........................................................................................................................................ 36
Figure 10. Mode Select Knob ...................................................................................................................................... 40
Figure 11. Select Date/Time Menu .............................................................................................................................. 41
Figure 12. Setup: Display mode Menu ......................................................................................................................... 42
Figure 13. Normal Screen (4 waveform, Defibrillation mode, Full option) .................................................................... 43
Figure 14. Large Numeric Screen (2 waveform, Monitor mode, Full option)................................................................ 43
Figure 15. Black-white Screen (4 waveform, Defibrillation mode, Full option) ............................................................. 44
Figure 16. Volume Menu Display ................................................................................................................................. 46
Figure 17. Alarm Limit Menu ........................................................................................................................................ 53
Figure 18. Standard 3 Electrode Placement ................................................................................................................ 58
Figure 19. 5 Electrode Placement................................................................................................................................ 59
Figure 20. Varying choice of baselines. ....................................................................................................................... 62
Figure 21. Baseline at the level of QRS onset as used by the Glasgow program. ....................................................... 62
Figure 22. Illustration of isoelectric segments I and K.................................................................................................. 62
Figure 23. Definitions for QRS end / ST junction ......................................................................................................... 63
Figure 24. 12 lead Placement ...................................................................................................................................... 64
Figure 25. Measurement Reference ............................................................................................................................ 65
Figure 26. 12-Lead ECG Preview Screen.................................................................................................................... 68
Figure 27. HR/PR Display ............................................................................................................................................ 69
Figure 28. ECG Waveform Display .............................................................................................................................. 69
Figure 29. HR/PR Menu .............................................................................................................................................. 69
Figure 30. AED Mode Menu ........................................................................................................................................ 79
Figure 31. ECG waveform display – ECG signal saturation (AED mode, Pads) .......................................................... 79
Figure 32. Patient Info: ID Menu .................................................................................................................................. 80
Figure 33. Manual Mode Screen.................................................................................................................................. 82
Figure 34. Shock Soft Key ........................................................................................................................................... 84
Figure 35. Manual Mode Menu .................................................................................................................................... 86
Figure 36. Setup Menu ................................................................................................................................................ 89
Figure 39. Monitor Mode Menu .................................................................................................................................... 93
Figure 40. Setup Menu ................................................................................................................................................ 96
Figure 43. Pacing mode screen ................................................................................................................................. 100
Figure 44. Pacing Mode Menu ................................................................................................................................... 102
Figure 45. Setup Menu .............................................................................................................................................. 104
Figure 46. Alarm Limit Menu ...................................................................................................................................... 106
Figure 47. Patient Info: ID Menu ................................................................................................................................ 106
Figure 48. NIBP Display............................................................................................................................................. 110
Figure 49. NIBP Menu Display ................................................................................................................................... 110
Figure 50. SpO2 Display ............................................................................................................................................ 118
Figure 51. SpO2 Waveform Display .......................................................................................................................... 118
Figure 52. SpO2 Menu Display .................................................................................................................................. 118
Figure 53. Oxyhemoglobin Dissociation Curve .......................................................................................................... 120
Figure 54. Modified Bland-Altman Plot ...................................................................................................................... 122
Figure 55. Respiration Display ................................................................................................................................... 124
iv
Figure 56. Respiration Waveform Display ................................................................................................................. 124
Figure 57. Respiration Menu Display ......................................................................................................................... 124
Figure 58. Connection for mainstream....................................................................................................................... 129
Figure 59. Connection for sidestream ........................................................................................................................ 130
Figure 60. EtCO2 Display .......................................................................................................................................... 131
Figure 61. EtCO2 Waveform Display ......................................................................................................................... 131
Figure 62. EtCO2 Menu Display ................................................................................................................................ 131
Figure 63. Temperature Display ................................................................................................................................. 135
Figure 64. Temperature Menu Display ....................................................................................................................... 135
Figure 65. IBP connections ........................................................................................................................................ 138
Figure 66. IBP 1 Display ............................................................................................................................................ 139
Figure 67. IBP 1 Waveform Display ........................................................................................................................... 139
Figure 68. IBP 1 Menu Display .................................................................................................................................. 139
Figure 69. IBP 2 Display ............................................................................................................................................ 140
Figure 70. IBP 2 Waveform Display ........................................................................................................................... 140
Figure 71. IBP 2 Menu Display .................................................................................................................................. 140
Figure 72. Auto Self-test display ................................................................................................................................ 144
Figure 73. External shock test ................................................................................................................................... 145
Figure 74. Event Data List Display............................................................................................................................. 147
Figure 75. Event Review Display ............................................................................................................................... 148
Figure 76. 12 Lead Record Display ........................................................................................................................... 149
Figure 77. Patient Info Menu ..................................................................................................................................... 149
Figure 78. Real-time data Menu ................................................................................................................................ 151
Figure 79. Real-time print (Header and Event messages) ......................................................................................... 152
Figure 80. Real-time print (Waveform, Shock info and Trend) ................................................................................... 153
Figure 81. Printer setting Menu ................................................................................................................................. 165
Figure 82. Print-out .................................................................................................................................................... 167
Figure 83. Print-out on shock ..................................................................................................................................... 167
Figure 84. Print-out on 12 lead ECG data .................................................................................................................. 168
Figure 85. Print-out on self-test result ........................................................................................................................ 168
Figure 86. Print-out on setting information ................................................................................................................. 169
Figure 87. Printer Paper Replacement ...................................................................................................................... 176
Figure 88. Biphasic Waveforms at 300 Joules and 360 Joules ................................................................................. 204
Figure 89. Biphasic Waveforms at 200 Joules ........................................................................................................... 204
Figure 94. Biphasic Waveforms at 75 Joules ............................................................................................................. 207
Figure 96: Biphasic Waveforms at 40 Joules ............................................................................................................. 208
v
Tables
Table 1. The defibrillator/monitor controls .................................................................................................................... 18
Table 2. The defibrillator/monitor controls on paddle ................................................................................................... 19
Table 3. Panel and Label Symbols .............................................................................................................................. 22
Table 4. Display Symbols............................................................................................................................................. 24
Table 5. Display Colors Factory Defaults ..................................................................................................................... 25
Table 6. Standard Accessories..................................................................................................................................... 28
Table 7. Optional Accessories...................................................................................................................................... 29
Table 8. Front Panel Indications for Power Source ...................................................................................................... 36
Table 9. The defibrillator/monitor Battery Status Icon .................................................................................................. 37
Table 10. Date/Time Menu ........................................................................................................................................... 41
Table 11. High Priority Alarm........................................................................................................................................ 46
Table 12. Medium Priority Alarm .................................................................................................................................. 47
Table 13. Low Priority Alarm ........................................................................................................................................ 48
Table 14. Informative Messages .................................................................................................................................. 49
Table 15. Defibrillator Messages .................................................................................................................................. 49
Table 16. Visual Alarm Characteristics......................................................................................................................... 51
Table 17. Audible Alarm Characteristics ...................................................................................................................... 51
Table 18. Alarm Limits Ranges .................................................................................................................................... 53
Table 19. Bell Icon ....................................................................................................................................................... 55
Table 20. ECG Lead Colors ......................................................................................................................................... 59
Table 21. ECG Lead Pairs ........................................................................................................................................... 59
Table 22. Measurement Matrix .................................................................................................................................... 67
Table 23. HR/PR Menu ................................................................................................................................................ 69
Table 24. AED Mode Menu .......................................................................................................................................... 80
Table 25. Manual Mode Menu ..................................................................................................................................... 86
Table 26. Monitor Mode Menu ..................................................................................................................................... 93
Table 27. Pacing Mode Menu .................................................................................................................................... 102
Table 28. Cuff Size..................................................................................................................................................... 109
Table 29. NIBP Menu ................................................................................................................................................. 110
Table 30. SpO2 Sensors ............................................................................................................................................ 117
Table 31. SpO2 Menu ................................................................................................................................................ 118
Table 32. Demographic Data ..................................................................................................................................... 121
Table 33. SpO2 Accuracy for Nellcor™ Sensors ....................................................................................................... 122
Table 34. Respiration Menu ....................................................................................................................................... 125
Table 35. EtCO2 Menu .............................................................................................................................................. 131
Table 36. Temperature Sensors ................................................................................................................................. 135
Table 37. Temperature Menu ..................................................................................................................................... 136
Table 38. IBP 1 Menu ................................................................................................................................................ 139
Table 39. IBP 2 Menu ................................................................................................................................................ 141
Table 40. Self-test functions....................................................................................................................................... 144
Table 41. Trouble shooting of Self-test....................................................................................................................... 146
Table 42. Wireless Status Icon and Bed Number Icon ............................................................................................... 171
Table 43. Parameter Ranges and Factory Defaults ................................................................................................... 181
Table 44. Delivered Energy at Every Defibrillator Settings into a Range of Loads ..................................................... 203
Table 45. Electromagnetic Emissions (IEC60601-1-2)............................................................................................... 219
Table 46. Electromagnetic Immunity (IEC60601-1-2) ................................................................................................ 219
Table 47. Electromagnetic Immunity (IEC60601-2-4) ................................................................................................ 221
Table 48. Electro-surgical Unit Interference (IEC 60601-2-27, IEC 60601-2-30) ....................................................... 222
Table 49. Recommended Separation Distances ........................................................................................................ 222
Table 50. Immunity to proximity fields from RF wireless communications equipment (IEC 60601-1-2) ..................... 223
Table 51. Cables (IEC60601-1-2) .............................................................................................................................. 223
vi
SAFETY INFORMATION
General Safety Information
This section contains important safety information related to general use of the D500
defibrillator/monitor. Other important safety information appears throughout the manual.
The D500 defibrillator/monitor will be referred to as the defibrillator/monitor throughout
this manual.
Important! Before use, read carefully the manual, accessory directions for use, all
precautionary information and specifications.
Warning
Warnings alert you to potential serious outcomes (death, injury, or adverse events)
to the patient or user.
Do not take or use the defibrillator/monitor in locations where highly

combustible anesthetics or flammable gases are used or in high-
pressure oxygen rooms or inside oxygen tents, as this may cause a
flammable explosion. Turn off the gas source or move the source away
from patient during defibrillation.
When using the defibrillator/monitor with anesthetics, nitrous oxide or
high concentrations of oxygen, connect the gas outlet to a scavenger
system.
When using the defibrillator/monitor with a commercial electric power
source, use the defibrillator/monitor with an electric power wall socket
with a grounding wire for medical use. Not doing so could cause
electric shock.
Do not connect grounding wire to gas pipes. This could cause fire.
Only doctors and officially certified personnel should use this
defibrillator/monitor. Do not allow patients to touch the
defibrillator/monitor. Allowing patients to touch the defibrillator/monitor
could cause accidents.
The defibrillator/monitor cannot be used when MRI is in progress. If MRI
is in use, keep patient attachments away from patients to prevent
accidents.
The defibrillator/monitor conforms to the requirements of the EMC
standard (IEC60601-1-2), and may therefore be used simultaneously
with pacemakers and other electrical simulators. It should, however, be
noted that the defibrillator/monitor may be affected by electrical
scalpels and microwave therapeutic apparatus. Please check operation
of the defibrillator/monitor during and after use of such equipment.
Do not take mobile phones or transceivers into a room where this
defibrillator/monitor is installed, as such devices may cause accidents.
In order to avoid accidents, do not use any unauthorized accessories or
options.
Thoroughly read the instruction manuals supplied with accessories and
options to ensure correct use. This instruction manual does not carry
the caution selections for such equipment.
7
Do not open cover or disassemble this defibrillator/monitor. Doing so
could cause electric shock or fire. It is prohibited by law to modify the
defibrillator/monitor without authorization.
Do not use power source other than the specified voltage, (100-
240V~50/60Hz) as this may cause fire or electric shock.
Pre-use inspection and preventive maintenance must be performed for
safe use.
The defibrillator/monitor may be used with electrical surgical
equipment.
Follow the instruction manuals for medical instruments – notably
electrosurgical and diathermy instruments – when used, as their high–
frequency energy units may cause burns to patients via attachments.
This defibrillator/monitor is protected against the discharge of a
defibrillator. However, do not touch the defibrillator/monitor when a
defibrillator is being discharged (electrified), as doing so may cause
electric shock.
The following cautions apply when connecting the defibrillator/monitor
with other equipment.
1. Ensure that the connected equipment is in accordance with the
IEC60601-1 or IEC safety standards, so that the system complies
with IEC60601-1.
2. Employ additional protective measures (e.g. additional protective
earthing) as necessary.
Do not connect devices that do not meet medical safety standards
(such as commercial PCs), as they may cause electric shock. This
defibrillator/monitor meets the restricted level of leakage current
required for medical devices. Therefore, this defibrillator/monitor
cannot be connected to a device that would give a combined total of
leakage current beyond the restricted level.
Avoid connecting the patient to several devices at once. Leakage
current limits may be exceeded. Do not use a second defibrillator on the
patient while pacing with the defibrillator/monitor.
Do not place anything on top of this defibrillator/monitor. If something
is spilled over the defibrillator/monitor or gets into it, such spillage may
cause fire or electric shock. If fluid spills on the defibrillator/monitor
accidentally, disconnect power cord, wipe dry immediately, and have
the defibrillator/monitor serviced to make sure that no hazard exists.
Do not place heavy objects on the power cord, as doing so may cause
fire or electric shock.
Before conducting maintenance work, turn the power off and unplug
the power cord from the wall socket to prevent electric shock.
When the following occur, turn the power off immediately and unplug
the power cord from the wall socket. Continued use in such situations
may cause fire or electric shock.
 There is smoke or a strange odor leaking out of the
defibrillator/monitor.
 The defibrillator/monitor has been dropped or impacted by an
object.
 Liquid or foreign matter gets inside the defibrillator/monitor.
 Defibrillator/monitor failure has occurred.
Also, when any of the above occurs, promptly do the following:
1. Check to see that the power cord has been unplugged from the
8
wall socket.
2. Place an “Out of Order” sign on the defibrillator/monitor and do
not use it.
3. Have the defibrillator/monitor serviced to make sure that no hazard
exists.
Do not connect more than one patient to the defibrillator/monitor. Do
not connect more than one defibrillator/monitor to a patient.
The defibrillator/monitor is a prescription device and is to be operated
by qualified personnel only.
As with any medical equipment, carefully route patient cabling to
reduce the possibility of patient entanglement or strangulation.
Never lift the defibrillator/monitor by the sensor cable, blood pressure
hose, power cord, or any other accessory. Such accessories could
detach, causing the defibrillator/monitor to fall on the patient.
Do not make any clinical judgments based on this
defibrillator/monitor’s measurement only.
Emergency defibrillation should be performed only by appropriately
trained, skilled and qualified personnel who are aware of the protocol
for handling a patient in medical emergency such as cardiac arrest and
have been certified in Advanced Cardiac Life Support (ACLS) or Basic
Life Support (BLS).
Synchronized electrical cardioversion should be performed only by
skilled personnel trained in Advanced Cardiac Life Support (ACLS) and
practiced in equipment operation. The precise cardiac arrhythmia must
be determined prior to performing defibrillation.
The defibrillator delivers up to 360 joules of electrical energy. Unless
properly used as described in this manual, this electrical energy may
cause serious injury or death. Do not attempt to operate this
defibrillator/monitor unless thoroughly familiar with this manual and the
function of all controls, indicators, connectors and accessories.
Do not discharge standard paddles on top of pads or ECG electrodes.
Do not allow standard paddles (or pads) to touch each other, ECG
electrodes, lead wires, dressings, transdermal patches, etc. Such
contact can cause electrical arcing and patient skin burns during
defibrillation and may divert defibrillating energy away from the heart
muscle.
Discharging the defibrillator/monitor with the standard paddle surfaces
shorted together can pit or damage the paddle electrode surface. Pitted
or damaged paddle surfaces may cause patient skin burns during
defibrillation. Discharge the defibrillator only as described in theses
operating instructions.
If a person is touching the patient, bed, or any conductive material in
contact with the patient during defibrillation, the delivered energy may
be partially discharged through that person. Clear everything away from
contact with the patient, bed, and other conductive material before
discharging the defibrillator/monitor.
Do not discharge the defibrillator into the open air. To remove an
unwanted charge, change the energy selection, or change the mode, or
turn off the defibrillator/monitor.
Conductive gel on the paddle handles can allow the electrical energy to
be discharged through the operator during defibrillation. Completely
9
clean the paddle electrode surfaces, handles, and storage area after
defibrillation.
A gel pathway on the skin between the standard paddles will cause
defibrillating energy to arc between paddles and delivery energy away
from the heart muscle. Do not allow conductive gel (wet or dry) to
become continuous between paddle sites.
During defibrillation checks, the discharged energy passes through the
cable connectors. Securely attach cable connectors to the simulator.
Do not touch the patient or any equipment connected to the patient
during defibrillation. Warn all persons around patient to DO NOT
TOUCH THE PATIENT prior to defibrillation.
The defibrillator/monitor should be out of contact with water (puddles
or water spray). It may cause electrical shocks and defibrillator/monitor
failure. Electrical safety of the defibrillator/monitor may not work
properly when wet.
Defibrillation may cause implanted devices to malfunction. Place
standard paddles or pads away from implanted devices if possible.
Check implanted device function after defibrillation.
Implanted pacemakers may cause the heart rate meter to count the
pacemaker rate during incidents of cardiac arrest or other arrhythmias.
Pacemaker patients should be carefully observed. Check the patient’s
pulse; do not rely solely on heart rate meters. Dedicated pacemaker
detection circuitry may not detect all implanted pacemaker spikes.
Patient history and physical exam are important in determining the
presence of an implanted pacemaker.
To ensure patient electrical isolation, connect only to other equipment
with circuits that are electrically isolated.
To avoid risk of electric shock, the defibrillator/monitor must only be
connected to a supply mains with protective earth.
The use of ACCESSORY equipment not complying with the equivalent
safety requirements of this equipment may lead to a reduced level of
safety of the resulting system. Consideration relating to the choice shall
include: Use of the accessory in the PATIENT VICINITY. Evidence that
the safety certification of the ACCESSORY has been performed in
accordance with the appropriate IEC (EN) 60601-1 and/or IEC (EN)
60601-1-1 harmonized national standards.
The defibrillator/monitor is equipped with RF telemetry module which
transmits with 50dBm power in the 2.5GHz. The module has been tested
and certified to be equipped safely.
Check leakage levels prior to use. Leakage current may be excessive if
more than one defibrillator/monitor or other piece of equipment is
connected to the patient.
Do not place or use the defibrillator/monitor when flammable gas
presents in atmospheres or other flammable material exist near/around.
Eg. Oxygenrich area, flammable anesthetic gases, gasoline and any
flammable material or gas. Do not use the defibrillator/monitor near the
place of a gasoline or other volatile substances spill may cause an
explosion.
Do not disassemble the defibrillator. It contains no operator serviceable
components and dangerous high voltages may be present. Contact
authorized service personnel for repair.
10
Do not immerse any portion of this defibrillator in water or other fluids.
Avoid spilling any fluids on defibrillator or accessories. Spilled liquids
may cause the defibrillator and accessories to perform inaccurately or
fail. Do not clean with ketones or other flammable agents. Do not
autoclave or sterilize this defibrillator or accessories unless otherwise
specified.
Use care when operating this device close to oxygen sources (such as
bag-valve-mask devices or ventilator tubing). Turn off gas source or
move source away from patient during defibrillation.
Check leakage levels prior to use. Leakage current may be excessive if
more than one defibrillator/monitor or other piece of equipment is
connected to the patient.
If you are monitoring a patient and using the system connector, all
equipment connected to the system connector must be battery powered
or electrically isolated from AC power according to EN 60601-1. If in
doubt, disconnect the patient from the defibrillator before using the
system connector. Only use Mediana recommended data transmission
cables. For more information, contact Mediana Technical Support.
The defibrillator/monitor delivers up to 360 joules of electrical energy.
When discharging the defibrillator, do not touch the paddle electrode
surfaces or disposable paddle/pads electrodes. Do not attempt to
perform this test unless you are qualified by training and experience
and are thoroughly familiar with these operating instructions.
Electric shock hazards exist internally. Do not remove assembly
screws. Refer servicing to qualified personnel.
Monitors, defibrillators, and their accessories (including electrodes and
cables) contain ferromagnetic materials. As with all ferromagnetic
equipment, these products must not be used in the presence of the
high magnetic field created by a Magnetic Resonance Imaging (MRI)
device. The high magnetic field created by an MRI device will attract the
equipment with a force sufficient to cause death or serious personal
injury to persons between the equipment and the MRI device. This
magnetic attraction may also damage the equipment. Skin burns will
also occur due to heating of electrically conductive materials, such as
patient leads and pulse oximeter sensors. Consult the MRI
manufacturer for more information.
Medical electrical equipment which does not incorporate defibrillator
protection should be disconnected during defibrillation.
Operating the defibrillator/monitor or its accessories in conditions
outside the environmental specifications can result in device or
accessory malfunction. The defibrillator/monitor should be allowed to
stabilize within the operating temperature range prior to operation.
11
Cautions
Caution statements identify conditions or practices that could result in damage to
the equipment or other property.
Always check that the defibrillator/monitor functions properly and is in

proper condition before use.
Federal law restricts this device to sale by or on the order of a physician.
The defibrillator/monitor may not operate properly if it is operated or
stored at conditions outside the ranges stated in this manual, or
subjected to excessive shock or dropping.
When connecting the defibrillator/monitor to any instrument, verify
proper operation before clinical use. Both the defibrillator/monitor and
the instrument connected to it must be connected to a grounded outlet.
Accessory equipment connected to the defibrillator/monitor’s data
interface must be certified according to IEC60950 for data-processing
equipment or IEC60601-1 for electromedical equipment. All combinations
of equipment must be in compliance with IEC60601-1-1 system
requirements. Anyone who connects additional equipment to the signal
input or signal output port configures a medical system and is therefore
responsible that the system complies with the requirements of IEC
60601-1-1 and the electromagnetic compatibility system standard
IEC60601-1-2. If in doubt, consult Mediana Technical Support
Representative.
Where the integrity of the external protective conductor in the installation
or its arrangement is in doubt, equipment shall be operated from its
internal electrical power source.
Risk of explosion if battery is replaced by an incorrect type.
12
INTRODUCTION
Patient conditions may result in erroneous readings. If the

measurements are suspect, verify the reading using another clinically
accepted measurement method.
Intended Use for the D500
The defibrillator/monitor is intended for use by trained medical technician, doctor, nurse or
medical specialist in outdoor and indoor emergency care settings including air and ground
ambulances within the environmental conditions specified. Manual and Automated
external defibrillation, External pacing, Diagnostic electrocardiography (12-lead ECG) are
intended for use on adult and pediatric patients.
The other monitoring functions (Electrocardiography (ECG, Heart Rate), Non-invasive

blood pressure (NIBP), functional arterial oxygen saturation (SpO2), respiration (RESP),
temperature (TEMP) and invasive blood pressure (IBP)) are intended for use on adult,
pediatric and neonatal patients. End tidal CO 2 (EtCO2) are intended for use on adult,
pediatric and infant patients.
Indications for Use
Indications Contraindications
Manual Manual defibrillation is Defibrillation is contraindicated
Defibrillation indicated for the termination of in the treatment of Pulseless
certain potentially fatal Electrical Activity (PEA), such
arrhythmias, such as as idioventricular or ventricular
ventricular fibrillation and escape rhythms, and in the
ventricular tachycardia. treatment if asystole.
Delivery of this energy in the Defibrillation is not intended for
synchronized mode is a patient who is conscious and
method for treating atrial has a palpable pulse and is
fibrillation, atrial flutter. contraindicated for use on
neonates.
Automated External AED mode is to be used only AED is not intended for patient
Defibrillation on patients in cardiopulmonary who is conscious and has a
arrest. The patient who must palpable pulse and is
be unconscious, pulseless and contraindicated for use on
not breathing normally before neonates.
using the defibrillator to
analyze the patient’s ECG
rhythm.
External Pacing External pacing is indicated for External pacing is

symptomatic bradycardia in contraindicated for the
patients with a pulse. treatment of ventricular
Increased heart rates in fibrillation and asystole.
response to external pacing External pacing in the
often suppress ventricular presence of severe
13
Indications Contraindications
ectopic activity and may hypothermia may be
prevent tachycardia. contraindicated and is
contraindicated for use on
neonates.
Electrocardiography The 12-lead electrocardiogram No known contraindications

is used to identify, diagnose
and treat patients with cardiac
disorders and is useful in the
early detection.
Noninvasive Blood Noninvasive blood pressure Noninvasive Blood Pressure is

Pressure monitoring is intended for not intended for use with
detection of hypertension or severe arrhythmia.
hypotension and monitoring Noninvasive Blood Pressure is
BP trends in patient conditions not intended for patients who
such as, but not limited to, are experiencing convulsion or
shock, acute dysrhythmia, or tremors.
major fluid imbalance.
Pulse Oximetry Pulse oximetry monitoring is Pulse Oximetry is not intended

intended to be used to monitor for use with severe peripheral
functional arterial oxygen vascular disease and severe
saturation and pulse rate. anemia (decreased
Hemoglobin).
Invasive Blood Invasive pressure monitor is No known contraindications

Pressure indicated for use in measuring
arterial, venous, intracranial
and other physiological
pressures using and invasive
catheter system with a
compatible transducer.
End-Tidal CO2 EtCO2 monitoring is indicated No known contraindications

for detection of trends in the
level of expired CO2. It is used
for monitoring breathing
efficacy and treatment
effectiveness in acute
cardiopulmonary care.
Temperature Temperature monitoring is No known contraindications

indicated for use in patients
who require continuous
monitoring of body
temperature.
14
About This Manual
This manual explains how to set up and use the defibrillator/monitor.
Read the entire manual including the Safety Information section, before you operate the
Identifying the D500 Configurations

The following table identifies D500 defibrillator/monitor configurations and how they are
indicated. The reference number and serial number are located on the back of the product.
All information in this manual, including the illustrations, is based on a device configured
with the 12 lead ECG, SpO2 module, Temperature(TEMP) module, Capnography(EtCO2
and InCO2) (Mainstream or Sidestream) module, IBP module and Printer module.
Product Code Description
D500M-0 Basic (Manual Defibrillation, Automated External Defibrillation,
Pacing, ECG (3 lead, 5 lead), Respiration, Printer)
D500M-S Basic + SpO2
D500M-L Basic + 12 lead ECG
D500M-LS Basic + 12 lead ECG + SpO2
D500M-LSNT Basic + 12 lead ECG + SpO2 + NIBP/TEMP
D500M-LSNTB Basic + 12 lead ECG + SpO2 + NIBP/TEMP + 2CH IBP
D500M-SNTEM Basic + SpO2 + NIBP/TEMP + Capnography (Mainstream)
D500M-SNTES Basic + SpO2 + NIBP/TEMP + Capnography (Sidestream)
D500M-LSNTEM Basic + 12 lead ECG + SpO2 + NIBP/TEMP + Capnography
(Mainstream)
D500M-LSNTES Basic + 12 lead ECG + SpO2 + NIBP/TEMP + Capnography
(Sidestream)
D500M-LSNTBEM Basic + 12 lead ECG + SpO2 + NIBP/TEMP + 2CH IBP +
Capnography (Mainstream)
D500M-LSNTBES Basic + 12 lead ECG + SpO2 + NIBP/TEMP + 2CH IBP +
Capnography (Sidestream)
15
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16
DESCRIPTION OF THE DEFIBRILLATOR/MONITOR
Front Panel Components 1
12
13 - 16
17
18
2
3 19 - 21
4 22
5
6 23
24 - 25
7
8 26 - 30
9
10
11
31 32
Figure 1. Front panel components
1 Paddle 17 MIC
2 NIBP connector 18 Mode select knob
3 LCD 19 ANALYZE button
4 Temperature1 connector 20 CHARGE button
5 Temperature2 connector 21 Energy Level button
6 IBP1 connector 22 SHOCK button
7 IBP2 connector 23 Multi function knob
8 Soft key 24 RATE button
9 EtCO2 Connector 25 mA button
10 SpO2 connector 26 NIBP button
11 Printer 27 PRINT button
12 Handle 28 ALARM button
13 AC/DC in LED 29 LEAD button
14 Battery A charging status LED 30 SIZE button
15 Battery B charging status LED 31 ECG connector
16 Service LED 32 Paddle/Pads connector
17
Table 1. The defibrillator/monitor controls
Symbols Description
Mode select knob

selects five modes of operation. (Pacing, Manual, Monitor, OFF
and AED)
ANALYZE button
analyzes the patient’s ECG to determine whether or not to
deliver a shock.
CHARGE button
charges to the desired energy level automatically.
Energy Level button

selects the defibrillation energy level.
SHOCK button
delivers a shock.
Multi function knob

provides user interaction with the defibrillator/monitor to control
the functions.
RATE button
adjusts the rate of pacing waveform.
mA button
adjusts the current of pacing waveform.
NIBP button
toggles between starting and stopping NIBP measurements.
PRINT button
prints measured data.
Alarm button
pauses the audible alarm temporarily.
turns off the audible alarm by pressing over 2 seconds.
LEAD button
selects to display the desired ECG lead on the screen.
SIZE button
adjusts and selects the amplitude of an ECG waveform.
18
Top Panel Components
1 2 3 4 5 6
Figure 2. Top panel components
1 Paddle 4 SHOCK button

2 Energy level button 5 CHARGE button
3 REC button 6 Charge Indicator
Table 2. The defibrillator/monitor controls on paddle

Symbols Description
CHARGE button
charges to the desired energy level automatically.
Charge Indicator
lights up red when charging is completed.
Energy Level button

selects the defibrillation energy level.
REC button
prints the measured data.
19
Rear Panel Components
3 4 5 6 7
Figure 3. Rear panel components
1 SMPS/battery push button 5 AC power supply (SMPS)
2 DC input connector 6 Speaker
3 AC power inlet 7 Li-ion battery
4 GND terminal
20
Left Panel Components
1 Side Option Case
Figure 4. Left panel components
Right Panel Components
1 Wireless(3G, Wi-Fi) module

2 USB/SD Card Slot
Figure 5. Right panel components
21
Table 3. Panel and Label Symbols
Symbols Description Symbols Description
AC indicator Dust and water resistance
Direct current CE mark
Battery charging status

Prescription only device
indicator
Service indicator Follow instructions for use
Type BF- Defibrillator Proof Separate Collection
Type CF- Defibrillator Proof EU representative
NIBP connector Manufacturer
Temperature 1 connector Date of manufacture
Temperature 2 connector Reference number
IBP 1 connector Serial number
Environmental shipping/storage
IBP 2 connector
altitude limitations
EtCO2 connector
humidity limitations
SpO2 connector
temperature limitations
ECG connector Fragile
AC power input rating Keep dry
Equipotential terminal This way up
Class II equipment Single patient use only
22
Displays
1 2 3 4 5 6
7
12
8
9
10
11 13
14
Figure 6. Displays
1 Shock count number/icon 8 Title of waveform parameter

2 Defibrillator message area 9 Waveform area
3 Battery status icon 10 Waveform
4 Elapsed time (Power on) 11 Alarm/Informative message area
5 Wi-Fi/3G icon 12 Numerical area
6 Title of numeric area 13 Date/Time
7 ECG waveform message area 14 Soft key menu
23
Table 4. Display Symbols
Symbols Description Symbols Description
ECG source: Paddle Temperature unit: Celsius
Temperature unit:
ECG source: Lead l
Fahrenheit
ECG source: Lead ll SpO2 unit or EtCO2 unit: %
ECG source: Lead lll Respiration Icon

NIBP or IBP or EtCO2 unit:
ECG source: Lead aVL
mmHg
NIBP or IBP or EtCO2 unit:
ECG source: Lead aVR
kPa
ECG source: Lead aVF Pulse amplitude indicator
ECG source: Lead V EtCO2 respiration: AW
ECG source: Lead V1 Thoracic impedance respiration: IM
ECG source: Lead V2 NIBP auto mode interval
ECG source: Lead V3 NIBP elapsed time
ECG source: Lead V4 HR/PR icon & unit
ECG source: Lead V5 Communication source: 3G
ECG source: Lead V6 Communication source: Wi-Fi
ECG source: Pads Bed number icon

NIBP icon : Noninvasive
Shock count number / icon
Blood Pressure
SpO2 waveform icon Elapsed time (Power on) icon
Impedance respiration
Neonatal icon
waveform icon
EtCO2 icon : End-tidal
carbon dioxide DC power input icon
concentration
InCO2 icon: Inspired carbon
Battery status icon
dioxide concentration
AC power input icon
(Note: AC power input icon is
IBP1 waveform icon
displayed if the battery has been
inserted.)
IBP1 waveform icon Time display
IBP2 waveform icon Alarm active
IBP2 waveform icon Audio pause
IBP2 waveform icon Audio off or Limit alarm pause
IBP2 waveform icon Pacer pulse detection icon
Temperature 1 icon ECG gain
Temperature 2 icon Wi-Fi communication icon
24
Table 5. Display Colors Factory Defaults
Function Color
ECG Waveform Green
SpO2 Waveform Cyan
Respiration Waveform Light Blue
EtCO2 Waveform Light Purple
ECG Green
NIBP White
SpO2 Cyan
Respiration Rate Light Blue
EtCO2 Light Purple
Temperature1 Pink
Temperature2 Pink
IBP 1 Red
IBP 2 Yellow
General background Black
Alarm/Informative message Black background, Green font
Defibrillator message Black background, White font
Low priority alarm message Black background, Yellow font
Medium priority alarm message Black background, Yellow font
High priority alarm message Black background, Red font
ECG alarm waveform message Green
Battery status icon (normal) Green (refer to Table 9)
Battery status icon (low battery) Yellow (refer to Table 9)
Battery status icon (critically low battery) Red (refer to Table 9)
Note: The display colors can only be changed by authorized personnel via the Service
Menu. The detailed information is described in the service manual.
25
26
SETTING UP THE DEFIBRILLATOR/MONITOR
To ensure accurate performance and prevent defibrillator/monitor

failure, do not expose the defibrillator/monitor to extreme moisture,
including direct exposure to rain. Such exposure may cause inaccurate
performance or device failure. Refer to Specification section.
The defibrillator/monitor should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the
defibrillator/monitor should be observed to verify normal operation in
the configuration it is to be used.
Make sure that the defibrillator/monitor speaker is not obstructed.
Failure to do so could result in an inaudible alarm tone.
Recharging the battery is strongly recommended when the battery has
not been recharged for 6 or more months.
Follow local government ordinances and recycling instructions
regarding disposal or recycling of defibrillator/monitor components,
including batteries.
The use of accessories, cables, transducers and sensors sourced from
manufacturers, which Mediana has not recommended may cause
incorrect analysis.
Electrical installation of the room or the building in which the
defibrillator/monitor is to be used must comply with regulations
specified by the country in which the equipment is to be used.
Unpacking and Inspection

The defibrillator/monitor is shipped in one carton. Examine the carton carefully for
evidence of damage. Contact Mediana Technical Support Representative immediately if
any damage is discovered. Refer to the Maintenance section for instructions on
returning damaged items.
Note: Refer to the Performance Verification section in the service manual for detailed
information.
Set the defibrillator/monitor to the user’s intended position where the user can easily
recognize the visual and audible monitoring conditions. Normally it is recommended to
set at a distance of 1m from the user. Also the viewpoint is at any point within the base of
a cone by an angle of 30° to the center of the monitoring display.
27
List of Components
The following items are standard in the package.
Table 6. Standard Accessories

Items Qty
D500 defibrillator/monitor 1
Operator’s manual 1
AC power cord 1
Printer paper 2
Defibrillation pads for adult 1
Defibrillation pads for pediatric 1
Pads extension cable 1
ECG 3 leads cable (SNAP) 1
SpO2 sensor 1
*Only when SpO2 option is installed.
SpO2 extension cable 1
*Only when SpO2 option is installed.
NIBP cuff for adult 1
*Only when NIBP option is installed.
NIBP cuff for pediatric 1
NIBP cuff hose for adult and pediatric 1
CAPNOSTAT 5 mainstream CO2 sensor 1
*Only when CO2 option is installed.
LoFlo airway adapter w/nafion, pediatric/adult box/10ea
Single patient use adult airway adapter box/1ea
Single patient use neonatal airway adapter box/1ea
Cable holding clips box/5ea
SMPS 1
Li-ion battery 1
28
Optional items may be ordered if needed. Contact your local supplier for pricing and
ordering information.
Table 7. Optional Accessories

Items Qty
Paddle -
Defibrillation / external pacing pads for adult -
Defibrillation / external pacing pads for pediatric -
NIBP cuff for neonate -
NIBP cuff hose for neonate -
ECG 3 leads cable (GRAB) -
ECG 5 leads cable (SNAP) -
ECG 12 leads cable (SNAP) -
SpO2 disposable sensor -
LoFlo CO2 cannula-adult box/10ea
LoFlo CO2 nasal cannula-pediatric box/10ea
LoFlo CO2 nasal cannula-infant box/10ea
LoFlo CO2 nasal cannula w/O2-adult box/10ea
LoFlo CO2 nasal cannula w/O2-pediatric box/10ea
LoFlo CO2 nasal cannula w/O2-infant box/10ea
LoFlo CO2 oral/nasal cannula-adult box/10ea
LoFlo CO2 oral/nasal cannula-pediatric box/10ea
LoFlo CO2 oral/nasal cannula w/O2-adult box/10ea
LoFlo CO2 oral/nasal cannula w/O2-pediatric box/10ea
LoFlo airway adapter-pediatric/adult box/10ea
LoFlo airway adapter-pediatric/infant box/10ea
LoFlo airway adapter w/nafion, pediatric/infant box/10ea
Straight sampling line box/10ea
Straight sampling line w/nafion box/10ea
Module mounting bracket 1
Single patient use adult airway adapter w/mouthpiece box/10ea
CAPNO2 mask-pediatric box/10ea
CAPNO2 mask-adult standard box/10ea
CAPNO2 mask-adult large box/10ea
Cable management straps box/10ea
Service manual (English) -
External DC-DC adaptor -
Carry bag -
Earth cable for ambulance -
29
Power Cable Connections
Do not connect to an electrical outlet controlled by a wall switch or

dimmer because the defibrillator/monitor may be accidentally turned off.
If the integrity of the AC power source is in doubt, the
defibrillator/monitor must be operated from its internal battery.
AC Power
Make sure that the AC outlet is properly grounded and supplies the specified voltage and
frequency (100-240V~ 50/60 Hz).
Figure 7. AC Power Connection
1. Connect the female type connector end of the AC power cord to mains connector
on the defibrillator/monitor’s rear panel.
2. Plug the male type connector end of the AC power cord into a properly grounded
mains outlet.
3. If necessary, connect grounding wire. Connect the grounding wire connector to the
equipotential terminal on the rear panel. Now attach the clip end of the grounding
wire to the medical equipment grounding terminal on the wall.
4. Verify that the Battery charging status LED and AC/DC in LED on the
defibrillator/monitor’s front panel is lit.
Note: Battery A charging status LED indicates battery A is installed and being charged
by the AC power.
Note: Even if the defibrillator/monitor is not turned on, the Battery charging status LED
is lit when the AC power cord is connected into a mains outlet.
Note: Do not place the defibrillator/monitor so that it is difficult to disconnect the AC power
cord.
30
DC Power
The external DC power source can be used, when the defibrillator/monitor is used for the
emergency condition in the moving car.
Figure 8. DC Power Connection
1. Connect an external DC-DC adaptor (input: 12-16 Vdc output: 18Vdc) to

defibrillator/monitor rear panel connecter identified with the DC power symbol.
2. Verify that the DC power input icon appears on the screen, Battery charging
status LED and AC/DC in LED on the defibrillator/monitor’s front panel is lit.
Note: Battery A charging status LED indicates battery A is installed and being charged
by the AC power and Battery B charging status LED indicates battery B is
installed and being charged by the AC or DC power.
Note: Even if the defibrillator/monitor is not turned on, the Battery charging status LED
is lit when the External DC-DC adaptor is connected into a DC input connector.
Note: If the Battery charging status LED is not lit, check:

 the power cord
 the external DC-DC power cable
 the AC input connector
 the DC input connector
 the power/ mains outlet
 No Battery
Note: If the Battery charging status LED still is not lit although no problem is found,
contact qualified service personnel or your local supplier for assistance.
Note: Do not connect the External DC-DC adapter and an AC power supply (SMPS) to
the defibrillator/monitor together.
31
Measurement Cable Connections
For best product performance and measurement accuracy, use only

accessories supplied or recommended by Mediana. Use accessories
according to the manufacturer’s directions for use and your facility’s
standards. Use only accessories that have passed the recommended
biocompatibility testing in compliance with ISO10993-1.
Connect the sensor, probe, cuff/hose or transducer firmly into socket
and do not use a damaged sensor, probe or cuff/hose.
To avoid damage to the cable, always hold by the connector rather than
the cable, when connecting or disconnecting either end.
The sensor connector should not be connected to anything other than a
sensor.
Note: Both frequent checks by the operator on a daily basis and more comprehensive
technical checks less frequently are covered by this requirement in order to detect
mechanical damage and damage to cables, etc.
ECG Cables and Leads
1. Connect an ECG cable to the ECG connector making sure that the connector arrow
is pointing panel (see Figure 1)
Defibrillator Paddle and Pads
1. Connect a paddle or pads to paddle / pads connector on the defibrillator/monitor’s

front panel. (see Figure 1)
2. Use LEAD button to select pads. (If paddle is connected, the mode is automatically
changed to paddle.)
3. Apply conductive material to paddles.
4. Apply paddles or pads to patient’s bare skin.
NIBP Hoses and Cuffs (if configured with NIBP option)
1. Select an appropriate size cuff for the patient. (Refer to the NIBP Monitoring
section.)
2. Connect the hose to the NIBP connector making sure to tighten the connector in
the clockwise direction. (see Figure 1)
3. Attach the cuff to the end of the hose.
SpO2 Cables and Sensors (if configured with SpO2 option)
1. Select an appropriate sensor for the patient and desired application. (Refer to the
SpO2 Monitoring section.)
2. Connect the extension cable to the SpO2 connector on the defibrillator/monitor’s
front panel. (see Figure 1)
3. Attach the sensor to the end of the cable.
32
Temperature Probes (if configured with Temperature option)
1. Select the appropriate probe(s) for the desired application. (Refer to the
Temperature Monitoring section.)
2. Connect the temperature probes to the Temperature connector on the
defibrillator/monitor’s side option case. (see Figure 1)
CO2 Sensor (if configured with CO2 option)
1. Select the appropriate CO2 sensor according to the operational mode. (Refer to the
Capnography Monitoring section.)
2. Connect Mainstream or Sidestream sensor to the CO 2 connector on the
defibrillator/monitor’s side option case. (see Figure 1)
IBP Transducers (if configured with IBP option)
1. Connect the interface cable(s) for the transducer(s) to the “IBP” connector on the
monitor’s side option case. An interface cable for the transducer has to be selected
correctly as it depends on the transducer type. (see Figure 1, IBP Monitoring
section)
2. Set up the patient circuit according to the directions for use of the transducer,
monitoring kit and IV set (6pin, red round connector).
Note: If leadwire cable, cuff/hose cable, sensor, probe and transducer are not connected
firmly, the defibrillator/monitor could lose signal from patient.
33
34
BATTERY OPERATION
Do not disassemble, puncture, crush, heat above 100°C (212°F), or
incinerate the battery. Be careful not to short the battery terminals
because this could result in a fire hazard.
Mediana has no information regarding the performance or effectiveness
of its Mediana defibrillator/monitors if other manufacturers’ batteries or
battery chargers are used. Using other manufacturers’ batteries or
battery chargers may cause the defibrillator/monitor to perform
improperly and invalidate the safety agency certifications. Use only
Mediana’s battery or battery charger.
Grounding reliability can only be achieved when the equipment is
connected to an equivalent receptacle marked “HOSPITAL ONLY” or
“HOSPITAL GRADE”. If the grounding integrity of the line cord or AC
receptacle is in doubt, operate on battery only.
Recharging the battery is strongly recommended when it has not been
fully recharged for 6 or more months.
Do not install the battery into the defibrillator/monitor when storage
may exceed 90 days. Battery damage may occur.
When the voltage of the battery is very low, it is a possibility of not
operating.
Check for the battery-in-use indication when the defibrillator/monitor is
operating on mains and apply corrective action.
Do not operate the defibrillator/monitor without a battery. Keep a fully
charged spare battery pack with the defibrillator/monitor at all times.
Partial charge of battery results in a shortened service life.
Storing at temperatures above 40°C (104°F) for extended periods of
time will significantly reduce a battery’s life-expectancy.
Using an improperly maintained battery to power the
defibrillator/monitor may cause power failure without warning. Use the
appropriate battery charger to charge batteries.
Battery pins in the defibrillator/monitor may be damaged if batteries are
dropped or forced into battery wells. Inspect pins routinely for signs of
damage. Keep batteries installed at all times except when
defibrillator/monitor is removed from service for storage.
When storing the defibrillator/monitor for an extended period of time,
the battery should be removed from the defibrillator/monitor.
Stored batteries lose charge. Failure to charge a stored battery before
use may cause device power failure without warning. Always charge a
stored battery before placing it in active use.
Note: It is recommended that keep AC power source connected to the defibrillator/monitor

when not in use. This will ensure a fully charged battery whenever it is needed.
Note: As the battery is used and recharged over a period of time, the amount of time
between the onset of the low battery alarm and the defibrillator/monitor shut-off may
become shorter. It is recommended for service personnel to check periodically or
replace the battery if necessary.
35
Operating the defibrillator/monitor on Battery Power
The defibrillator/monitor has the rechargeable battery that can be used to power the
defibrillator/monitor when AC power source or external DC-DC adaptor is not available.
The battery status icon appears on the screen when the defibrillator/monitor is on battery
power.
Note: The defibrillator/monitor can be powered with two batteries when a battery is
inserted instead of AC power supply (SMPS). When the defibrillator/monitor is
equipped with two batteries, two battery status icons appear on the screen.
Figure 9. Battery Placement
1. Turn off the defibrillator/monitor.

2. Push the AC power supply (SMPS)/battery push button.
3. Insert the battery into the defibrillator/monitor carefully.
Table 8. Front Panel Indications for Power Source

Power Connections Front Panel Indications
Battery charge icon is displayed on the screen.
AC source
AC/DC in LED is lit.
DC power input icon appears on the screen.
DC source
AC/DC in LED is lit.
Battery Battery status icon appears on the screen.
The defibrillator/monitor cannot operate with a completely discharged battery. Before

turning on the defibrillator/monitor with a battery that has been completely discharged,
plug the defibrillator/monitor into an AC outlet to charge the battery for a minimum of 3
minutes. The defibrillator/monitor may then be powered on.
A new, fully charged battery will provide 5 hours monitoring operation under the
following conditions:
 Operation of ECG monitoring or in defibrillation mode (Standard option)

 No audible alarm condition
 No external communication operating
 No recording
 Ambient temperature at 25°C±5°C
Note: If there is the combination of battery A and B in the defibrillator/monitor, two new,
fully charged batteries will provide 10 hours monitoring operation.
36
Battery Status Indication
When operating on batteries, the battery status icon in the lower part of the display
indicates the battery charge condition. See Table 9.
Table 9. The defibrillator/monitor Battery Status Icon

Battery Status Icons Battery Status Icon Color
Green (normal condition)
Yellow (low battery)
Red (critically low battery)
White (charging)
A low priority alarm occurs when the remaining battery power is only enough for 15
minutes of operation. The “Low battery” message is displayed on the screen. Connect the
AC power or replace the battery with a fully charged battery immediately when alarm
occurs.
This alarm cannot be paused while running on battery power. Connecting the
defibrillator/monitor to AC power will stop the alarm.
A high priority alarm occurs for about 5 minutes before the defibrillator/monitor shuts off.
The “SYSTEM: Critically low-battery condition” message is displayed on the screen.
Connect the defibrillator/monitor to an AC power source immediately to avoid any loss of
trend data or settings.
Note: The battery will not be charged for safety if the operating temperature exceeds 40°C.
37
38
USING THE DEFIBRILLATOR/MONITOR
Each time the defibrillator/monitor is used, check alarm limits to make
sure that they are appropriate for the patient being monitored.
If different alarm presets are used for the same or similar equipment in
any single area, e.g. an intensive care unit or cardiac operating room, a
potential hazard can exist.
Keep patients under close surveillance when monitoring. It is possible,
although unlikely, that radiated electromagnetic signals from sources
external to the patient and the defibrillator/monitor can cause inaccurate
measurement readings. Do not rely entirely on the defibrillator/monitor
readings for patient assessment.
Be aware of patient cables, including ECG monitoring equipment when
used with high frequency surgical equipment.
When inaccurate analysis is suspected because of motion artifact do
not analyze in a moving vehicle. Motion artifact may affect the ECG
signal resulting in an inappropriate SHOCK or NO SHOCK ADVISED
message. Motion detection may delay analysis. Stop vehicle and stand
clear of patient during analysis.
To avoid risk of electrical shock, do not touch gelled area of the pads
while pacing or shock. When defibrillating with paddles use your
thumbs to operate the SHOCK button in order to avoid inadvertent
operator shock. No portion of the hand should be near the paddle
plates.
Pediatric defibrillation energy levels should be set based on site-
specific clinical protocols.
The metronome sounds do not indicate information regarding the
patient’s condition. Because patient status can change in a short time,
the patient should be assessed at all times. Do not perform CPR on a
patient who is responsive or is breathing normally.
Place the patient on a firm surface before performing CPR.
Ventricular fibrillation may be induced with improper synchronization.
Do not use the ECG from another monitor (slaving) to synchronize the
defibrillator/monitor’s discharge. Always monitor the patient’s ECG
directly through the defibrillator/monitor’s ECG cable or pad cable.
Pitted or damaged paddles may cause patient skin burns during
defibrillation.
The ECG rhythm analysis function does not warn the operator of patient
asystole, as it is not a shockable rhythm.
Determination of electrical capture should only be performed by viewing
the ECG on the screen with its ECG cable directly attached to the
patient.
Connect the device only to a three-wire, grounded, hospital grade
receptacle. The three-conductor plug must be inserted into a properly
wired three-wire receptacle; if a three-wire receptacle is not available, a
qualified electrician must install one in accordance with the governing
electrical code. Do not under any circumstances remove the grounding
connector from the power plug. Do not use extension cords or adapters
of any type. The power cord and plug must be intact and undamaged.
The defibrillator/monitor does not automatically adjust energy when
using pediatric electrodes. Manually select the appropriate energy prior
to defibrillating the patient.
39
Only use thumbs to depress the paddle SHOCK button. Failure to do so
could result in the inadvertent depression of the energy select buttons,
causing the defibrillator/monitor to disarm itself.
Do not discharge the defibrillator/monitor except as indicated in the
instructions.
Do not permit gel to accumulate between the paddle electrodes on the
chest wall (gel bridge). This could cause burns and reduce the amount
of energy delivered to the heart.
Changing the selected energy while the defibrillator/monitor is charging
or charged will cause the defibrillator/monitor to disarm itself. Press the
CHARGE button again to charge the defibrillator/monitor.
If using defibrillation pads, make sure that the size of the pad is large
enough to cover the entire paddle electrode area.
Pads should be replaced after 8 hours of continuous pacing to ensure
maximum patient benefit.
Be sure to safely discharge external paddles.
Turning On and Off the defibrillator/monitor

Before using the defibrillator/monitor, confirm that the defibrillator/monitor is working
properly and is safe to use as described below.
Look for display motion before accepting any displayed data as a

current measurement.
Note: If unusable sound like buzzer can be heard, do not use the defibrillator/monitor.
Instead, please contact qualified service personnel or your local supplier.
1. Rotate Mode select knob to select one mode from AED, manual, monitor or pacing
mode.
2. The defibrillator/monitor is turned on in select mode.
Figure 10. Mode Select Knob
 AED mode - to enable AED mode for semi-automated external defibrillation.

 Manual mode - to enable manual mode for asynchronous or synchronous defibrillation.
 Monitor mode - to enable monitor mode for 3- or 5-lead ECG monitoring, 12-lead ECG
acquisition and vital signs trending, or monitoring of optional parameters.
 Pacing mode - to enable pacing mode for Demand or Fixed mode pacing.
Note: Monitor mode can be used in each mode.
3. To turn off the defibrillator/monitor, rotate Mode select knob to select Off mode.
After selecting Off mode, the settings will be stored and the defibrillator/monitor will
be turned off.
40
Setting Date and Time
You may set the date and time displayed on the screen and printed on the reports.
1. Rotate the Multi function knob to highlight Date/Time, and then press the Multi
function knob to select Date/Time Menu.
Figure 11. Select Date/Time Menu
2. Soft key Menu will be changed to Date Format, Set Date, Set Time and Return.
Rotate the Multi function knob to the desired format or number and then press the
Multi function knob to select the desired format or number. When the soft key is
pressed, the relevant Menu will appear.
Table 10. Date/Time Menu

Level 1 Menu Level 2 Menu or Response
DATE/TIME MENU
Date Format YY/MM/DD (Year/Month/Day)
MM/DD/YY (Month/Day/Year)
DD/MM/YY (Day/Month/Year)
Return
Set Date Year
Month
Day
Return
Set Time Hour
Minute
Second
Return
Return
41
Continued use
This defibrillator/monitor retains the previous settings when the defibrillator/monitor is

turned off for less than 10 seconds. And if the defibrillator/monitor was not turned off and
less than 10 minutes have elapsed since the operation mode was last used, the
defibrillator/monitor retains the previous settings of last operation mode.
Setting the Main Screen

You may select the main screen to be displayed; 4 waveform screen, large numeric
screen or Black-white invert screen.
1. Press Setup soft key to change main screen (4 waveform screen) to large numeric
screen or black-white invert screen.
2. Select Display mode menu. Display mode menu will be displayed on screen.
3. Rotate the Multi function knob to the desired display mode and then press the
Multi function knob to select the desired display mode.
Note: Large numeric screen can only be selected in monitor mode.
Figure 12. Setup: Display mode Menu
42
 4-ch Wave Screen: ECG + SpO2 + ABP + EtCO2
Figure 13. Normal Screen (4 waveform, Defibrillation mode, Full option)
 Large Numeric Screen
Figure 14. Large Numeric Screen (2 waveform, Monitor mode, Full option)
43
 Black-white Invert Screen (Mono-color screen)
Figure 15. Black-white Screen (4 waveform, Defibrillation mode, Full option)
44
ALARMS AND LIMITS

Always respond immediately to a system alarm since the patient may
not be monitored during certain alarm conditions.
Do not to cover the holes for the speaker which allows the alarm sound
to exit the defibrillator/monitor. Also do not disable audible alarms when
it is not appropriate to do so.
General
When the defibrillator/monitor detects certain conditions that require user attention, the
defibrillator/monitor enters an alarm state. The defibrillator/monitor response is indicated
by:
 Audible alarm indication
 Physiological alarms including identification of out-of-limit vital signs
 Technical alarms
Note: The audible and visual alarms on the defibrillator/monitor, used in conjunction with
clinical signs and symptoms, are the primary source for notifying medical
personnel that a patient alarm condition exists.
Note: Each key-control should result in some audible tone and that invalid key-controls
are ignored. Have the defibrillator/monitor serviced if the key-controls fail.
Changing Alarm Volume

User can select an alarm volume level of 1 to 8.
1. Select the Setup soft key and then the Setup menu will be displayed.
2. Rotate the Multi function knob to highlight Volume and then press the Multi
function knob to select Volume Menu.
3. Rotate the Multi function knob to highlight desired menu.
4. Selected menu is activated by pressing the Multi function knob.
5. Rotate the Multi function knob to adjust the volume.
6. Press the Multi function knob to save the desired volume and to select the other
menu.
7. Press the Return soft key. Then the current menu returns to the previous menu.
45
Figure 16. Volume Menu Display
Alarm Priority and Messages

There are three possible priorities for visual and audible alarms: High, Medium, and Low.
The high, medium, low priority messages and informative messages are displayed in the
alarm/informative message area and the defibrillator messages are displayed in the
defibrillator message area. A message is displayed alternatively every 2 seconds when
the defibrillator/monitor is in multiple alarm conditions. Refer to the Troubleshooting
section for the recommended actions.
High Priority
High priority alarm indicates that immediate operator response is required.
Table 11. High Priority Alarm

Parameter Condition Messages
Asystole ECG: Asystole
ECG
V-FIB ECG: V-FIB
Loss of Pulse from SpO2 or No valid ECG SpO2: Loss of Pulse
%SpO2
and no motion artifact
Loss of pulse from IBP {label}: Loss of pulse.
IBP
(ex. {label}: P1, P2, ABP, CVP, PAP, LAP)
EtCO2 APNEA EtCO2: APNEA
Resp Loss of Respiration Signal RESP : Loss of respiration signal
SYSTEM Critically Low-Battery condition SYSTEM : Critically low-battery condition
46
Medium Priority
Medium priority alarm indicates that prompt operator response is required.
Table 12. Medium Priority Alarm

High Heart Rate/Pulse Rate limits violated High Heart Rate/Pulse Rate limits violated
HR/PR
Low Heart Rate/Pulse Rate limits violated Low Heart Rate/Pulse Rate limits violated
ECG ECG Signal Saturation ECG Signal Saturation
High SpO2 limits violated High SpO2 limits violated
%SpO2
Low SpO2 limits violated Low SpO2 limits violated
High Systolic blood pressure limits violated NIBP-High Systolic blood pressure limits
violated
High Diastolic blood pressure limits violated NIBP-High Diastolic blood pressure limits
violated
High MAP blood pressure limits violated NIBP-High MAP blood pressure limits
violated
NIBP
Low Systolic blood pressure limits violated NIBP-Low Systolic blood pressure limits
violated
Low Diastolic blood pressure limits violated NIBP-Low Diastolic blood pressure limits
violated
Low MAP blood pressure limits violated NIBP-Low MAP blood pressure limits
violated
High Respiration Rate limits violated High Respiration Rate limits violated
Resp
Low Respiration Rate limits violated Low Respiration Rate limits violated
IBP Over the systolic upper limit {label}: High systolic blood pressure limit
violated.
IBP Under the systolic lower limit {label}: Low systolic blood pressure limit
violated.
IBP Over the diastolic upper limit {label}: High diastolic blood pressure limit
violated.
IBP Under the diastolic lower limit {label}: Low diastolic blood pressure
IBP
violated.
IBP Over the mean upper limit {label}: High MEAN blood pressure limit
violated.
IBP Under the mean lower limit {label}: Low MEAN blood pressure limit
violated.
Cable/Sensor disconnected. {label}: Cable/Sensor disconnected.
High EtCO2 limits violated EtCO2 : High EtCO2 Limits violated
Low EtCO2 limits violated EtCO2 : Low EtCO2 Limits violated
EtCO2
High InCO2 limits violated EtCO2 : High InCO2 Limits violated
Low InCO2 limits violated EtCO2 : Low InCO2 Limits violated
High Temperature limits violated TEMP1 : High temperature limits violated
TEMP2 : High temperature limits violated
Temp
Low Temperature limits violated TEMP1 : Low temperature limits violated
TEMP2: Low temperature limits violated
47
Low Priority
Low priority alarm indicates that operator awareness is required.
Table 13. Low Priority Alarm

ECG Leads Off ECG : Leads off
ECG
Chest Lead off ECG : Chest lead off
Temperature Probe Disconnect TEMP1 : Probe disconnect
TEMP2 : Probe disconnect
Temp
Temperature – Out of range TEMP1 : Out of range
TEMP2 : Out of range
Abnormal Cuff NIBP : Abnormal cuff / EEE 11
NIBP : Abnormal cuff / EEE 21
Measurement Fail NIBP : Measurement fail / EEE 12
NIBP : Measurement fail / EEE 14
NIBP
Overpressure NIBP : Overpressure / EEE 19
Artifact NIBP : Artifact / EEE 13
Artifact NIBP : Artifact / EEE 16
Time-Out NIBP : Time-out / EEE 17
Out of range NIBP : Out of range.
Failed in zero calibration {label}: Unable to zero calibration.
IBP
Out of range {label}: Out of range.
SpO2 - Technical Error SpO2 Error – EEE001
~ SpO2 Error:EEE511
SpO2 : Module reset
SpO2 : Reconnect / Replace SpO2 sensor
%SpO2
SpO2 : Reposition / Replace SpO2 sensor
SpO2 : Replace SpO2 Sensor
SpO2 Cable/Sensor Disconnect SpO2 : Cable/Sensor disconnect
Sensor Off from SpO2 Sensor SpO2 : Sensor off
Resp Respiration Leads Off RESP : Leads off
Adapter Calibration Failed EtCO2 : Adapter Calibration Failed
Check Adapter EtCO2 : Check Adapter
Faulty Sensor EtCO2 : Faulty Sensor
EtCO2 Occlusion or Leak EtCO2 : Occlusion or Leak
Out of Range EtCO2 : Out of Range
Sample Line Disconnected EtCO2 : Sample Line Disconnected
Sensor Disconnected EtCO2 : Sensor Disconnected
Printer out of paper SYSTEM : Printer out of paper
Low Battery SYSTEM : Low Battery
System
CMS disconnected SYSTEM : Connection to the CMS was
disconnected
48
Informative Messages
Informative messages indicate a system condition that needs operator’s acknowledgement

and action if needed.
Table 14. Informative Messages

Condition Messages
ECG offset control ECG: Signal calibration
SpO2 Pulse search SpO2 : Pulse search
SpO2 Motion interference SpO2 : Motion interference
IBP No zero reading {label}: No zero reading
IBP Zero cal in progress {label}: Zero cal in progress
EtCO2 - Pressure Not Zeroed EtCO2 : Pressure Not Zeroed
EtCO2 - Pressure Zero in Progress EtCO2 : Pressure Zero in Progress
EtCO2 - Sensor Too Warm EtCO2 : Sensor Too Warm
EtCO2 - Sensor Warming-up EtCO2 : Sensor Warming-up
Copyright ⓒ 2011 All rights reserved Copyright ⓒ 2011 All rights reserved.
Abnormally shut down last time SYSTEM : Abnormally shut down last time
Audio Off SYSTEM : Audio off
Audio Pause SYSTEM : Audio pause
Demo Mode SYSTEM : Demo Mode
Printer is not available SYSTEM : Printer is not available
Not Enough Memory – Event records SYSTEM : Not enough memory (Event records)
Not Enough Memory – 12 lead records SYSTEM : Not enough memory (12 lead records)
Not Enough Memory – Internal Memory SYSTEM : Not enough memory (Internal memory)
Transmission – 12 lead records SYSTEM : Transmission (12 lead records)
Note: There may be other informative messages that are not listed above.
Defibrillator message
Defibrillator messages indicate a condition related to manual mode, AED mode and pacing
mode.
Note: Defibrillator messages are not displayed in monitor mode.
Table 15. Defibrillator Messages

Condition Messages
Check for response Check response
(Voice prompt: Check for response. Are you all right?)
Call for help Call for help
(Voice prompt: Call for help.)
Open the airway Open airway
(Voice prompt: Open the airway.)
Check breathing Check breathing
(Voice prompt: Check breathing.)
Attach pads to bare chest Attach pads to bare chest
(Voice prompt: Remove clothes from the patient's chest.
Place pad exactly as shown in the picture.
Press pads firmly to patient's bare chest.)
Check Pads Check Pads
49
Condition Messages
Analyzing ECG Analyzing heart rhythm
(Voice prompt: Analyzing heart rhythm. Do not touch the
patient.)
Do not touch the patient Do not touch the patient
No Shock Advised No Shock Advised
(Voice prompt: Non Shock advised.)
Shock Advised Shock Advised
(Voice prompt: Shock advised.)
Press Shock button Press Shock button
(Voice prompt: Press the red flashing button now.
Deliver shock now.)
Press Paddle Shock button Press Paddle Shock Button
Shock button not pressed Shock button not pressed
(Voice prompt: Shock button not pressed.)
Shock Canceled Shock canceled
(Voice prompt: Shock Cancelled.)
Impedance is out of range Impedance is out of range
(Voice prompt: Poor pads contact.)
Shock Delivered Shock Delivered
(Voice prompt: Shock Delivered.)
Shock not delivered Shock not delivered
(Voice prompt: Shock not delivered.)
It is Safe to touch the patient It is Safe to touch the patient
(Voice prompt: It is Safe to touch the patient.)
Begin CPR Begin CPR
(Voice prompt: Begin CPR.)
If needed, Begin CPR If needed, Begin CPR
(Voice prompt: If needed, Begin CPR)
Press Charge button Press Charge button
Remove Paddle Remove Paddle
Poor Pads Contact Poor Pads Contact
Poor Paddles Contact Poor Paddle Contact
DEFIB Pads short DEFIB Pads short
DEFIB Paddles short DEFIB Paddle short
Release shock Release shock
Remove Sync to Analyze Remove Sync to Analyze
Analysis Halted Analysis Halted
ECG Lead Off ECG Lead Off
ECG 12 Lead Acquiring ECG 12 Lead Acquiring
Select BPM Select BPM
Select mA Select mA
Pacing Paused Pacing Paused
Pacing out Pacer out ‘___’ mA
50
Visual Alarm Indication
Table 16. Visual Alarm Characteristics
Alarm Category Color Flashing Period Duty Cycle
High priority Red 700ms (about 1.43Hz) 57% (On: 400ms / Off: 300ms)
Medium priority Yellow 2000ms (about 0.5Hz) 60% (On: 1200ms / Off: 800ms)
Low priority Yellow - 100% (Always On)
When a high priority alarm is activated, a non-flashing alarm message is displayed. The
numerical area will flash red.
When a medium priority alarm is activated, a non-flashing alarm message is displayed.

The numerical area will flash yellow.
When a low priority alarm is activated, a non-flashing alarm message is displayed. The
numerical area will change to yellow.
Audible Alarm Indication
Do not turn off the audible alarm or decrease its volume if patient safety
could be compromised.
Make sure that the defibrillator/monitor speaker is not obstructed.
Failure to do so could result in an inaudible alarm tone.
Table 17. Audible Alarm Characteristics

Alarm Category Tone Pitch (IEC60601-1-8) Beep Rate (IEC60601-1-8)
High priority ~976 Hz 10 beeps in 15 sec
Medium priority ~697 Hz 3 beeps in 15 sec
Low priority ~488 Hz 1 beeps in 30 sec
Note: Audible alarms may be decreased in volume or temporarily paused.
51
Verifying Audible Alarm Indication
If the defibrillator/monitor fails to perform as specified in this test, contact qualified service
personnel or your local supplier for assistance. You can verify the alarm operation for all
parameters like ECG, SpO2, NIBP, Temperature, EtCO2, IBP and Respiration by following
the below procedures.
1. Connect the defibrillator/monitor to an AC power source.

2. Rotate the Mode select knob to turn on the defibrillator/monitor.
3. Connect the simulator to the sensor input cable and connect cable to
4. Set the simulator to a smaller value than the lower alarm limit on the
5. Verify the following defibrillator/monitor reaction:
a. The defibrillator/monitor begins to track the physiological signal from the simulator.
b. After about 10 to 20 seconds, the defibrillator/monitor displays the value measured
as specified by the simulator. Verify values are within the tolerances specified in
the Specification section for each parameter.
c. Audible alarm sounds.
d. “Low limits violated” message is displayed.
e. The numerical area flashes, indicating the parameter has violated default alarm
limits.
Note: The maximum mean time of the alarm delay is less than 10 seconds unless
otherwise specified in this manual.
Changing Alarm Limits

Do not set the alarm limits to extreme values that can cause the alarm to
become useless.
You can change alarm limits from default values, if necessary. Alarm limits or Limit Alarm
Pause may be set in two ways:
 Via interaction with HR/PR, SpO2, NIBP, Respiration, EtCO2, IBP and Temperature
Menu or
 Via interaction with the Alarm Limits Menu that presents the limits in all the
parameters at one time.
Setting Alarm Limit via Alarm Limit Menu
1. Soft key is displayed on the lower of the normal screen. (Refer to figure 13.)
2. Press the Alarm Limit soft key located lower right corner of the screen.
3. Select the parameter menu to be changed by pressing the Multi function knob.
52
Figure 17. Alarm Limit Menu
4. Change the alarm limit by rotating the Multi function knob.

5. Selected parameter menu is returned to normal screen by pressing the Return soft
key.
6. When the menu is returned, the other menu can be selected.
Alarm Limits Ranges
Table 18 describes the possible alarm limits. The defibrillator/monitor is shipped with
factory default settings.
Note: Authorized personnel can define the way to save the power default. The detailed
information is described in the service manual.
Table 18. Alarm Limits Ranges

Parameters Upper Limit, Default Lower Limit, Default Resolution
HR/PR (BPM)
Adult/Pediatric 25 ~ 300 BPM, 120 BPM 20 ~ 295 BPM, 50 BPM 5 BPM
NIBP Systolic (mmHg, kPa)
35 ~ 270 mmHg, 160 mmHg 30 ~ 265 mmHg, 90 mmHg 5 mmHg
Adult/Pediatric
(4.7 ~ 36.0 kPa, 21.3 kPa) (4.0 ~ 35.3 kPa, 12.0 kPa) (0.6 or 0.7 kPa)
Neonatal
NIBP Diastolic (mmHg, kPa)
Adult/Pediatric
Neonatal
NIBP MAP (mmHg, kPa)
Adult/Pediatric
Neonatal
SpO2 (%)
53
Parameters Upper Limit, Default Lower Limit, Default Resolution
Adult/Pediatric 21 ~ 100 %, 100 % 20 ~ 99 %, 90 % 1%
Respiration (BPM)
Adult/Pediatric 4 ~ 120 BPM, 30 BPM 3 ~ 119 BPM, 8 BPM 1 BPM
Temperature1 (°C, °F)
0.1 ~ 50.0°C, 39.0 °C 0.0 ~ 49.9 °C, 36.0 °C 0.1°C
Adult/Pediatric
(32.1 ~ 122.0°F, 102.2°F) (32.0 ~ 121.8°F, 96.8°F ) (0.1°F or 0.2°F)
Temperature2 (°C, °F)
0.1 ~ 50.0°C, 39.0 °C 0.0 ~ 49.9 °C, 36.0 °C 0.1°C
Adult/Pediatric
(32.2 ~ 122.0°F, 102.2°F) (32.0 ~ 121.8°F, 96.8°F ) (0.1°F or 0.2°F)
EtCO2 (mmHg, kPa, %)
Adult/Pediatric (0.1 ~ 10.7 kPa, 10.7 kPa) (0 ~ 10.5 kPa, 0 kPa) (0.13 kPa)
(0.1 ~ 10.5 %, 10.5%) (0 ~ 10.4%, 0%) (0.13%)
InCO2 (mmHg, kPa, %)
Adult/Pediatric (0.1 ~ 2.7 kPa, 2.7 kPa) (0 ~ 2.5 kPa, 0 kPa) (0.13 kPa)
(0.1 ~ 2.6 %, 2.6 %) (0 ~ 2.5 %, 0%) (0.13%)
P1 Systolic (mmHg, kPa)
-45 ~ 300 mmHg, 120mmHg -50 ~ 295 mmHg, 70 mmHg 5 mmHg
Adult/Pediatric
(-6.0 ~ 40.0 kPa, 16.0 kPa) (-6.7 ~ 39.3 kPa, 9.3 kPa) (0.6 or 0.7 kPa)
P1 MEAN (mmHg, kPa)
-45 ~ 300 mmHg, 90 mmHg -50 ~ 295 mmHg, 50 mmHg 5 mmHg
Adult/Pediatric
P1 Diastolic (mmHg, kPa)
Adult/Pediatric
P2 Systolic (mmHg, kPa)
-45 ~ 300 mmHg, 120mmHg -50 ~ 295 mmHg, 70 mmHg 5 mmHg
Adult/Pediatric
P2 MEAN (mmHg, kPa)
Adult/Pediatric
P2 Diastolic (mmHg, kPa)
Adult/Pediatric
Audio Paused and OFF

Do not pause the audio or decrease its volume if patient safety could be
compromised.
If an alarm condition occurs while in the Audio Off state, the only alarm
indication on the defibrillator/monitor will be visual displays related to
the alarm condition.
Default startup setup is with Audio off on Power ON. If Audio Alarms are
required, make sure to activate audio alarm ON for the patient being
monitored.
Check the audible alarm silence duration before temporarily silencing
the audible alarms.
When an alarm occurs, you can pause the audio for the audio pause time (30 sec, 60 sec,
90 sec, 120 sec) selected via Service menu. However, visual alarms continue during this
time. The factory default for audio pause time is 30 seconds.
54
Table 19. Bell Icon
Limit
Alarm Active Audio paused Audio Off
alarm pause
To pause an audio:
1. Press the Alarm button to immediately pause the alarm tone. The alarm resumes
after the audio paused period if the alarm condition has not been corrected.
2. Check the patient and provide appropriate care.
During the audio paused period, you can press the Alarm button again to re-enable the
audio tones. Also, if another alarm occurs during the audio paused period, the audio tones
will be automatically re-enabled. You can pause the audio tones for that another alarm by
pressing the Alarm button.
Note: The audio paused by some technical errors may be canceled by pressing the Alarm
button. However, battery failure and physiological alarms cannot be canceled until
the alarm condition is corrected.
To off an audio:
1. To initiate an audible alarm off, press the Alarm button and hold it for at least 2
seconds.
2. To cancel an audible alarm off condition, press the Alarm button for 2 seconds
again.
This action disables audible alarms for a user-defined audio off period (3 min, 5 min, 10
min or Indefinite) selected via the Service menu.
If audio off period is set to 3, 5 or 10 minutes, the audible alarm is not activated for the
specified time interval and the Audio Off icon is displayed.
Note: You may disable limit violation alarms of each vital sign via the HR/PR, SpO2, NIBP,
Respiration, EtCO2, IBP, Temperature or Alarm limit menus.
Note: The periods can only be changed by authorized personnel via the Service menu.
Note: Alarm Off may disable the visual alarm manifestation if sensors, probes, or modules
are intentionally disconnected by operator.
55
56
ECG MONITORING

standards. It may cause burns to the patients or defibrillator/monitor
failure to use of pacing/defibrillation pads or adapters from sources
other than Mediana.
Line isolation defibrillator/monitor transients may resemble actual
cardiac waveforms and thus inhibit heart rate alarms. Such transients
may be minimized by proper electrode and cable placement, as
specified in this manual and electrode directions for use.
Do not use damaged ECG leads. Do not immerse ECG leads completely
in water, solvents, or cleaning solutions. Do not sterilize ECG leads by
irradiation, steam, or ethylene oxide. Follow the manufacturer’s
directions for use.
Do not use ECG electrodes with expired dates. Do not use defective
ECG electrodes. These might cause improper performance.
ECG cables may be damaged if they are connected to a patient during
defibrillation. Cables that have been connected to a patient during
defibrillation should be checked for functionality before using again.
It is possible for the patient to receive a burn due to an improperly
connected electrosurgical unit. Additionally, the defibrillator/monitor
could be damaged or measurement errors could occur. Place the ECG
cable and leads as far as possible from the site of the electrosurgical
unit and from the electrosurgical cables. This will minimize interference
and the risk of burns to the patient.
For pacemaker patients, the defibrillator/monitor may continue to count
pacemaker rate during occurrences of cardiac arrest or some
arrhythmias. To reduce the likelihood of this, ensure that the Pacer
Detect setting is On in the ECG waveform Menu when monitoring such
patients. Do not rely entirely upon the defibrillator/monitor alarms. Keep
pacemaker patients under close surveillance.
To ensure patient safety, the conductive parts of the ECG electrodes
(including associated connectors) and other patient-applied parts
should not contact other conductive parts, including earth ground, at
any time.
Correct the electrode placement. Improper electrode placement may
cause incorrect result. User must be aware of proper
defibrillator/monitor operation.
Use only high quality ECG electrodes. ECG electrodes are for rhythm
acquisition only. Do not attempt to defibrillate or pace through ECG
electrodes.
Precordial lead electrodes and lead wires may interfere with the
placement of standard paddles or pads. Before defibrillation, remove
any interfering precordial lead electrodes and lead wires.
The defibrillator/monitor may be used in conjunction with and must not
be damaged by typical electrosurgical equipment operation.
The defibrillator/monitor is not suitable for direct cardiac application.
57
General
The process of depolarization and repolarization of the myocardium generates electric
potentials that are sensed by ECG electrodes on the skin surface. These electrodes are
typically attached to the patient’s right arm, left arm, and left leg. The defibrillator/monitor
processes and amplifies these signals and presents the ECG waveform on the screen.
Also, the defibrillator/monitor computes the minute heart rate at least every second by
moving average. In addition to the acquisition of the QRS complex, the circuitry performs
a number of other functions. The defibrillator/monitor can display:
 Heart rate in beats per minute

 Detection of a “lead off” condition if an electrode is disconnected or poorly connected
 Detection of the presence of pacemaker signals within the ECG waveform complex
Note: Occasionally, electromagnetic interference beyond the range guaranteed from the
manufacturer’s EMC declaration may cause the defibrillator/monitor to display a
"Check ECG Leads & Electrodes" alarm. This occurrence is rare, and duration
should be short. When the interference ceases, the defibrillator/monitor removes
the "Check ECG Leads & Electrodes" alarm. Refer to the Specification section.
Setup Connections
Note: Mediana recommends the use of silver/silver chloride electrodes (Ag/AgCl). When
dissimilar metals are used for different electrodes, the electrodes may be subject to
large offset potentials due to polarization, which may be severe enough to prevent
obtaining an ECG trace. Using dissimilar metals may also increase recovery time
after defibrillation.
1. Select the electrodes to be used. Use only one type of electrode on the same
patient to avoid variations in electrical resistance. Prepare the electrode sites
according to the electrode manufacturer’s instructions. See Figure 18 and 19 for
electrode placement configurations.
Figure 18. Standard 3 Electrode Placement
58
Figure 19. 5 Electrode Placement
Note: One of 5-1 to 5-6 Lead electrode placement sites for the fifth lead.
2. Connect the ECG lead.

3. Connect the ECG lead to the ECG connector on the defibrillator/monitor’s front
panel.
4. Attach the leads to the electrodes, and then apply the electrodes to the patient,
using the color-code guide in Table 17. Verify that the desired Lead Selection is
active in the ECG waveform area. Refer to Table 18. Lead II is best suited for most
monitoring situations.
Table 20. ECG Lead Colors

Lead AAMI IEC
1. Right arm White (RA) Red (R)
2. Left arm Black (LA) Yellow (L)
3. Left leg Red (LL) Green (F)
4. Right leg Green (RL) Black (N)
5-1 to 5-6. V (Chest) Brown (V) White (C)
Table 21. ECG Lead Pairs

Lead-Selection Electrode Differential (AAMI) Electrode Differential (IEC)
I RA LA R L
II RA LL R F
III LA LL L F
V (Chest) (RA+LA+LL)/3 Chest (V) (R+L+F)/3 Chest (C)
aVR – (Lead I + Lead III/2) – (Lead I + Lead III/2)
aVL (Lead I – Lead III)/2 (Lead I – Lead III)/2
aVF (Lead II + Lead III)/2 (Lead II + Lead III)/2
59
12-lead ECG
Using previously unpackaged electrodes or electrodes past the Use by

date may impair ECG signal quality. Remove electrodes from a sealed
package immediately before use and follow the procedure for applying
the electrodes.
Computerized ECG interpretive statements should not be used
withholds or prescribes patient treatment without review of the ECG
data by qualified medical personnel. Always confirm interpretive
statements by over-reading the ECG data.
General
The optional 12 lead ECG function, using the GLA algorithm, is available in Monitor Mode
and allows you to Acquire, Setup, 12 lead On and Patient Info. In addition, the 12 lead
function provides computerized ECG analysis. A report with measurements and
interpretive statements from the analysis is displayed, stored and printed, as configured.
Patient age and gender are used to define normal limits for heart rate, axis deviation, time
intervals, and voltage values, for interpretation accuracy in tachycardia, bradycardia,
prolongation or shortening of PR and QT intervals, hypertrophy, early repolarization,
myocardial infarction and culprit artery detection.
In a 12-lead ECG using 10 electrodes, an electrode is placed on the right arm, left arm,
right leg and left leg. Six V/C electrodes are placed on the chest as shown in Figure 24.
The right leg electrode is the standard.
This defibrillator/monitor is equipped with epoch-making ECG

monitoring function incorporating the cutting edge software for
analysis of electrocardiograms developed by the University of
Glasgow in UK, which includes signal processing, diagnostic interpretation of
electrocardiograms from individuals of all ages and analysis of cardiac rhythm.
ECG Wave Recognition
The methodology for ECG waveform measurement is described in general terms in an

earlier publication from the Glasgow Laboratory. 10s of ECG data is input to the software
for analysis and all leads require to have been acquired simultaneously.
Processing
Initially, a 50Hz or 60Hz notch filter is applied to remove any AC interference, if such a
filter has not already been applied within the acquiring device. The first stage of the
analysis is to compute any missing limb leads from the minimum of two leads that need to
be provided. The ECG data is then filtered to minimize the effects of noise. The next step
in the analysis is to calculate a form of spatial velocity combining the first difference of
each lead. From this function, the approximate locations of all the QRS complexes are
derived. Allowance has to be made for pacemaker stimuli, which are ideally detected by
the front end equipment and passed to the program in the form of a list of “spike” locations.
Given the QRS locations, it is then possible to check the quality of the recording for noise
and baseline drift. If the drift is excessive, it is removed by using a cubic spline technique
to obtain, for each lead affected, the baseline trend, which is then subtracted from the
original data. If the noise is excessive, it is possible to remove a whole lead from the
analysis or alternatively, 5 seconds of all leads are removed either from the first or second
half of the recording.
60
QRS typing
Thereafter, the various QRS complexes are typed according to their morphology. An
iterative process is used. Effectively, the first complex in lead I is compared with the
second using first differences of each cycle. The comparison takes the form of moving
one beat over the other and when the difference is minimal, optimal alignment is present.
This alignment point is used for averaging as discussed below. If the difference between
beats is less than a threshold value, they are deemed to belong to the same class. The
procedure is repeated with the third beat being compared with the second and so on. If a
new morphology is detected, i.e. if the threshold is exceeded, a new class is established.
The procedure continues with five leads being used in the typing process.
Selection of Required QRS Class
If more than one class of beat is present, then a decision has to be made as to which
morphology will be used for the averaging procedure, i.e. the cycle to be interpreted has
to be selected. A complex logic is used for this purpose. It has to allow for a single
normally conducted beat in the midst of demand pacemaker beats for example. It also
needs to take account of the QRS durations of different beat classes, RR intervals to
exclude extrasystoles, and to a limited extent, the number of beats in each morphological
class. The net effect is to choose one class of beats, of a similar morphology, that are
regarded as being conducted in the normal sequence through the ventricles.
Averaging
All beats in the selected class are averaged so that 12 such beats, one from each lead,
are then available. The “average” beat can be computed in several ways. Common to this
are the alignment points detected when wave typing was undertaken. They are used as
reference points in the averaging process. The average beat can be a straight average of
all corresponding aligned points, it can be a median calculated from the same points or it
can be a weighted average – the so called modal beat introduced into the program in
1977. In practice, the program forms the straight average, which is compared to individual
beats in the same class. If there is a significant difference at any point, then the median
beat is used. The modal beat is regarded as being computationally excessive, though it is
undoubtedly the best approach to use.
61
Wave Measurement
From the 12 average beats, a single combined function is formed and a provisional overall
QRS onset and termination is determined by thresholding techniques. The provisional
onset and termination are then used as starting points for a search for QRS onset and
termination within each individual lead. Basically the approach conforms to the
recommendations of the CSE working party (of which one of the Glasgow team was a
member), which were published in 1985.
Figure 20. Varying choice of baselines. Figure 21. Baseline at the level of QRS
onset as used by the Glasgow program.
In each individual lead, the QRS onset is taken as the baseline and hence Q, R, S, R'
waves are measured with respect to the QRS onset as shown in the accompanying
figures from the CSE paper (see Figures 30-33).
Figure 22. Illustration of isoelectric segments I and K.
Isoelectric segments at the beginning of a QRS complex, i.e. a flat segment between the
provisional overall onset and the onset of an individual lead are excluded from the first
component (Q or R) of the QRS complex as recommended by the CSE group. Similar
considerations apply at the end of the QRS complex (see Figure 32). A sorting algorithm
is then applied to all 12 onsets to determine the global QRS onset as follows. The earliest
onset is excluded and the next onset that also lies within 20 ms of the next again is then
selected as the overall onset. This ensures that any true outliers are excluded. The
reverse process is used to find the overall QRS termination.
62
QRS Components
Within the QRS complex, the amplitude and duration of the various Q, R, S, R’ waves are
then measured. In keeping with the CSE recommendations, the minimum wave
acceptable has to have a duration >8 ms and an amplitude >20 V. With respect to global
QRS duration, the Glasgow program measures QRS duration from the global QRS onset
to the global QRS termination. This means that an isoelectric segment within one
particular QRS complex by definition will lead to a shorter QRS duration for that lead
compared to the global QRS duration.
Figure 23. Definitions for QRS end / ST junction
ST segment
The ST segment has several measurements made. Figure 19 shows the J point as used
in the diagnosis of ST elevation myocardial infarction. However, measurements are also
made at equal intervals throughout the ST segment, e.g. 1/8 ST-T, 2/8 ST-T etc.
P and T waves
A search for the P wave is made in the interval preceding the QRS complex. A P wave
may not always be found in certain arrhythmias. P onset and termination are found using
a method involving second differences but the same P onset and termination is used over
all 12 leads in view of the difficulty in detecting low amplitude P waves in many leads. P
wave amplitude is determined with respect to the same baseline as for Q, R, S
amplitudes, namely the QRS onset. This was found to be more reliable than fitting a
straight line between P onset and P termination even in cases where the P wave was
superimposed on the T wave in the case of a tachycardia.
T end is determined for each lead using a template method. The global T end is derived
in a similar fashion to the global QRS offset. The other components of the ECG waveform,
namely the ST and T wave amplitudes, are also measured with respect to QRS onset.
Thus, the ST junction and the various ST amplitude measurements, such as ST 60 and
ST 80 as well as the positive and negative components of the T wave, are all measured
with respect to the QRS onset. The reason for this is that it is the most straightforward
approach to measurement.
63
Interval Measurement
With respect to intervals, the global QT interval is measured from the global QRS onset to
the global T end. On the other hand, because the P onset is taken as being simultaneous
in all 12 leads, the global PR interval measurement is from the P onset to the global QRS
onset.
Normal Limits
The above methods were used to determine the normal limits of QRS waveforms from an
adult database of over 1,500 normal, published in Comprehensive Electrocardiology,
1989 and a pediatric database derived from 1750 neonates, infants and children,
published in part in 1989 and 1998 and which will be published in much more detail in the
next edition of Comprehensive Electrocardiology. These normal limits are essentially an
integral part of the diagnostic software.
Figure 24. 12 lead Placement
Preparing the 12 Lead

Proper skin preparation and electrode placement are the most important elements in
producing a high quality 12 lead ECG. The patient should be supine and relaxed when an
ECG is acquired. In preparation for acquiring the ECG:
1. Attach the electrodes to the patient as above Figure 24.

2. Attach the 12 lead cable lead wires to the electrodes on the patient.
3. Attach the 12 lead cable to the defibrillator/monitor’s front panel.
4. Turn on the manual mode of defibrillator/monitor by rotating the Mode select knob
to Manual Mode.
5. Enter patient information.
6. Check the patient’s pulse.
64
Calculation Feature
Figure 25. Measurement Reference
Figure 25 shows the parameters obtained in ECG waveform to analyze the ECG. Overall
P onset, P offset, QRS onset, QRS offset and T termination are determined from all 12
leads. Individual lead wave amplitudes are then obtained. P+, P-, Q, R, S, R’, S’, T+ and
T- amplitudes are measured with respect to a horizontal line through the lead QRS onset.
Durations are measured between relevant points. Areas are measured in units of millivolts
x milliseconds (mV x ms). Units of measure are not specified when an area measurement
appears in the criteria. Isoelectric components between the overall QRS onset and an
individual lead onset are not included in a Q or R duration.
ECG analysis results were categorized and categories include: PRELIMINARY

COMMENTS, measurement, Results on QRS wave analysis, Results on ST and T wave
analysis, MISCELLANEOUS, RHYTHM STATEMENTS. And the results in diagnosis will
be printed.
Preliminary Comments
Preliminary comments includes the effects to the statement of ECG input signal and
diagnosis.
 LEAD REVERSAL/DEXTROCARDIA
 RESTRICTED ANALYSIS
 MISCELLANEOUS PRELIMINARY STATEMENTS
Measurement Parameter
Measurement parameters are fundamentally obtained after ECG analysis.

 HEART RATE
 INTERVALS
 ATRIAL ABNORMALITIES
 QRS AXIS DEVIATION
65
Results on QRS Wave Analysis
Results on QRS wave analysis shows diagnosis results of QRS waveform and
measurement values.
 CONDUCTION DEFECTS
- WOLFF-PARKINSON-WHITE PATTERN
- BRUGADA PATTERN
 HYPERTROPHY
- LEFT VENTRICULAR HYPERTROPHY
- RIGHT VENTRICULAR HYPERTROPHY
- BIVENTRICULAR HYPERTROPHY
Results on ST And T Wave Analysis
Results on ST and T wave analysis shows diagnosis results of ST and T waveform and
measurement values.
 MYOCARDIAL INFARCTION
- INFERIOR INFARCTION
- LATERAL INFARCTION
- ANTEROSEPTAL INFARCTION
- ANTERIOR INFARCTION
- SEPTAL INFARCTION
- POSTERIOR INFARCTION
- ANTEROLATERAL INFARCTION
- EXTENSIVE INFARCTION
 ST ABNORMALITIES
 ST-T ABNORMALITIES (ISCHAEMIA ETC).
Rhythm Statements
Rhythm statements includes diagnosis results according to occurrence of beats, etc.

 DOMINANT RHYTHM
 SUPPLEMENTARY RHYTHM
66
Measurement Matrix
The electrocardiographs can be programmed so that the Measurement Matrix is written

out after the analysis report. The Measurement Matrix consists of 12 columns which
contain measurements for the twelve standard leads. These columns are labelled I, II, III,
aVR, aVL, aVF, V1, V2, V3, V4, V5, V6.
Table 22. Measurement Matrix

Measurement Meaning
PON Time in milliseconds from the beginning of recording to the
beginning of the first P wave.
PDUR P wave duration in milliseconds.
QRSON Time in milliseconds from the beginning of recording to the
beginning of the QRS complex.
QRSDUR QRS duration in milliseconds.
QDUR Q wave duration in milliseconds.
RDUR R wave duration in milliseconds.
SDUR S wave duration in milliseconds.
RPDUR R' wave duration in milliseconds.
SPDUR S' wave duration in milliseconds.
P+DUR P+ wave duration in milliseconds.
QRSDEF Intrinsicoid deflection time.
P+AMP P+ wave amplitude in microvolts.
P-AMP P- wave amplitude in microvolts.
QRSP2P Peak to peak amplitude of the QRS complex.
QAMP Q wave amplitude in microvolts.
RAMP R wave amplitude in microvolts.
SAMP S wave amplitude in microvolts.
RPAMP R' wave amplitude in microvolts.
SPAMP S' wave amplitude in microvolts.
STAMP ST wave amplitude in microvolts.
1/8STT Amplitude in microvolts at a point which is 1/8 of the ST-T
interval.
interval.
interval.
T+AMP T+ wave amplitude in microvolts.
T-AMP T- wave amplitude in microvolts.
QRSAR Total area of the QRS complex in microvolts/millisecond.
TMORPH T wave morphology.
RWNCH R wave notch count.
DWCON Probability (in %) of the presence of a delta wave.
STSLOP ST slope in degrees.
TON Time in milliseconds from the beginning of the recording to the
beginning of the T wave.
67
12 Lead Display
The 12 lead display allows you to see real-time 12 lead ECG data and verify signal quality
before acquiring the ECG. As shown in Figure 21, it displays patient information and
approximately 2.5 seconds of each of the 12 leads acquired. Waveforms are presented at a
rate of 25mm/sec and the configured wave size. A dashed line is displayed if a lead cannot
be derived. The message (Lead-Wire) Lead Off is displayed if an electrode is not making
adequate contact with the patient.
The Patient info menu of 12 lead mode includes ID, name, age and gender. The Event ID is
displayed until you enter the patient’s ID. Age and sex are displayed once entered.
Although waveforms for monitored parameters such as ECG, SpO 2, Invasive Pressures and
EtCO2 are not visible on the Preview Screen, related alarms, measurements and alarm
messages remain active and are reported in Parameter Blocks 1 and 2 and the general
status area.
Figure 26. 12-Lead ECG Preview Screen
68
Description of HR/PR Menu Functions
The calculated Heart Rate/Pulse Rate may be derived from different sources (ECG,
SpO2, NIBP or IBP) as shown by the icon in the HR/PR numerical area.
1
2
3
4
5 6 7
1 HR/PR icon 5 HR/PR unit

2 HR/PR source icon 6 HR/PR value
3 Pacer pulse detection icon 7 Bell icon
4 ECG size
Figure 27. HR/PR Display
1 ECG waveform icon 3 ECG lead pair

2 ECG waveform
Figure 28. ECG Waveform Display
HR/PR source Pacer Detect Filter Select Alarm Limit Return
Figure 29. HR/PR Menu
Table 23. HR/PR Menu

HR/PR MENU
HR/PR Source Auto
HR
PR
Return
Pacer Detect Enable
Disable
Return
Filter Select 0.5Hz ~ 21Hz
0.05Hz ~ 40Hz
1Hz ~ 21Hz
Return
HR/PR Upper Limit adjust
Alarm Limit
HR/PR Lower Limit adjust
Limit Alarm Pause On, Off
Return
69
HR/PR Source
You may select Auto, HR, PR to decide the source of the heart rate or pulse rate. The
HR/PR tone volume can be adjusted in the Setup menu.
Auto
If you select Auto, the defibrillator/monitor automatically derives the heart rate or pulse
rate from one of the monitoring parameters in this order of priority: ECG, IBP, SpO2 or
NIBP.
Note: When ECG lead off occurs, HR becomes “zero”. In this case, HR display is
automatically switched to PR from SpO2, if SpO2 is being measured.
HR
When HR is selected, the heart rate (HR) is measured from ECG.
PR
When PR is selected, the pulse rate (PR) is measured from IBP, SpO 2 or NIBP. The
color of the HR/PR icon and HR/PR source icon will be changed according to the current
source. If the pulse rate is derived from NIBP, the value will be displayed for only 180
minutes after the NIBP measurement, then the value will be changed to “---”.
Note: If the ECG signal is in saturation state or the normal QRS is not detected due to
noise, ‘---’ shall be displayed in heart rate measurement value.
Pacer Detect
Pacer detect should always be Enable for patients with pacemakers (refer to the warning
in this section). When Pacer detect is Enable, the defibrillator/monitor detects and filters
pacemaker-generated signals so that they will not be calculated in determining a
patient’s heart rate. When monitoring patients without pacemakers, Pacer detect should
be set to Disable to avoid misdiagnosis.
Filter Select
The defibrillator/monitor can filter ECG waveform noise with different ranges of
frequency response:
0.5 Hz to 21 Hz: Expands the range to display very low frequencies down to 0.05 Hz.
0.05 Hz to 40 Hz: Choose this mode to see just the ECG waveform monitoring.
1 Hz to 21 Hz: Generally called a filter mode, it reduces ECG waveform noise.
Note: The sub-clause 50.102.8 Frequency and impulse response and sub-clause
50.102.15 Heart rate range, accuracy and QRS detection range of IE60601-2-27
are tested only for Monitor (0.05Hz to 40Hz) of ECG filter.
Limit Alarm Pause
When the Limit Alarm Pause is set to On, the audible alarm for HR/PR limit violation is
paused.
Note: When the measurement value is an invalid, ‘---’ shall be displayed.
70
AED(Automated External Defibrillator) MODE
The defibrillator/monitor will only administer a shock if it is needed. A

voice prompt will tell you when to press the SHOCK button to
administer defibrillation therapy.
The defibrillator/monitor should not be used on someone who is
responsive when shaken or breathing normally.
Do not use pads if the adhesive gel is dried or damaged. Pads that are
dried out or damaged may cause electrical arcing and patient skin burns
during defibrillation. Do not use pads that have been removed from foil
package for more than 24 hours. Do not use electrodes beyond
expiration date. Check that pads adhesive is intact and undamaged. Do
not reuse disposable pads that are labeled for single patient use.
Do not use pediatric pads on adults or larger children. Delivery of
defibrillation energies equal to or greater than 100 joules (typically used
on adults) through these smaller pads increases the possibility of skin
burns.
Do not use paddles for AED mode. AED mode is enabled only with pads.
Disconnect non-defibrillation proof electronic devices or equipment
from patient before defibrillation.
Do not administer a shock using the electrode monitoring cable.
Do not place adult pads in the anterior-posterior position when
operating this defibrillator/monitor in AED mode. A shock or no shock
advised decision may be inappropriately advised. The shock advisory
algorithm requires the electrodes to be placed in the anterior-lateral
(Lead II) position.
The adult pads must be used on patients older than 8 years old. The
pediatric pads must be used on patients between 1 and 8 years old or
less than 25 kg (55lb). Do not use the defibrillator/monitor in AED mode
on patient younger than 1 years old. Do not delay therapy to determine
patient’s exact age or weight.
Be sure that the electrodes do not come in contact with other
conductive materials, especially when connecting or disconnecting the
electrodes to or from the patient.
Heart rate alarms are temporarily paused in AED Mode. Heart rate
alarms are also paused while the defibrillator/monitor is charging for
defibrillation and delivering a shock.
The AED Mode of defibrillator/monitor is designed for the treatment of sudden cardiac
arrest (SCA). It should only be used to treat someone who may be a victim of a SCA and
is:
 unresponsive to stimulus,
 not breathing,
 exhibiting no signs of life.
If the person is unresponsive but you are unsure that they have suffered from a SCA
begin CPR. When it is appropriate to treat, apply the defibrillator/monitor and follow the
audible instructions.
71
General
Defibrillation therapy is the definitive method for termination of a variety of potentially
fatal arrhythmias. The defibrillator/monitor’s Automated External Defibrillation (AED)
Mode is designed to guide you through standard treatment algorithms for cardiac arrest.
The defibrillator/monitor provides therapy through the application of a brief biphasic
pulse of electricity to the cardiac muscle. This electrical energy is transferred through
disposable multifunction pads applied to the patient’s bare chest.
Configuration choices allow you to customize AED Mode to better meet the unique
needs of your organization or resuscitation team. This chapter describes how to use
AED Mode. It explains the prompts that guide you through the defibrillation process and
describes how prompts vary depending upon the condition of the patient and the
configuration of your device.
Sudden Cardiac Arrest (SCA)
Sudden cardiac arrest is a condition in which the heart suddenly stops pumping
effectively due to a malfunction of the heart's electrical system. Often victims of SCA have
no prior warning signs or symptoms. SCA can also occur in people with previously
diagnosed heart conditions. Survival for an SCA victim depends on immediate cardio-
pulmonary resuscitation (CPR). The use of an external defibrillator within the first few
minutes of collapse can greatly improve the patients' chances of survival. Heart attack
and SCA are not the same, though sometimes a heart attack can lead to a SCA. If you
are experiencing symptoms of a heart attack (pain, pressure, shortness of breath,
squeezing feeling in chest or elsewhere in the body) seek emergency medical attention
immediately.
Heart Rhythm
The normal electrical rhythm by which the heart muscle contracts to create blood flow
around the body is known as Normal Sinus Rhythm (NSR). Ventricular Fibrillation (VF)
caused by chaotic electrical signals in the heart is often the cause of SCA, but a shock
can be administered to re-establish normal sinus rhythm. This treatment is called
defibrillation. The AED Mode is designed to automatically detect ventricular fibrillation
(VF) and perform defibrillation on victims of sudden cardiac arrest.
Detecting Fibrillation
The electrical rhythm by which the heart muscle contracts can be detected and used for
medical diagnosis and the resulting reading is called an Electrocardiogram (ECG). The
AED Mode is designed to analyze a patient’s ECG in order to detect ventricular fibrillation
(VF) in the heart. If ventricular fibrillation (VF) is detected, the defibrillator/monitor will
deliver a carefully engineered electrical shock designed to stop the chaotic electrical
activity experienced within the heart muscle during SCA. This may allow the victim's
heart to return to a normal sinus rhythm.
Rhythm Recognition Performance
The ECG database for validation of rhythm recognition performance includes ventricular
fibrillation (VF) rhythms of varying amplitudes, ventricular tachycardia (VT) rhythms of
varying rates and QRS width, various sinus rhythms including supraventricular
tachycardias, atrial fibrillation and atrial flutter, sinus rhythms with PVC (premature
ventricular contraction), asystole, and pacemaker rhythms.
72
Preparing for Defibrillation
The AED algorithm is not designed to handle erratic spiking problems

caused by a properly or improperly functioning pacemaker. In patients
with cardiac pacemakers, the defibrillator/monitor may have reduced
sensitivity and not detect all shockable rhythms.
1. Confirm that the patient is:

 unresponsive to stimulus,
 not breathing,
 exhibiting no signs of life.
2. Remove clothing to expose the patient’s chest. Wipe moisture from the patient’s
chest and if the patient has an excessively hairy chest, shave the area where the
electrodes are about to be applied.
3. Make sure the pads packaging is intact and within the expiration date shown.
4. Apply pads to the patient as directed on the pads package. Use the anterior-
anterior (anterior-lateral) pads placement.
5. If not pre-connected, insert the pads cable into paddle/pads connector located on
the front panel of the device. Push until you hear it click into place.
Note: Successful resuscitation is dependent on many variables specific to the patient’s

physiological state and the circumstances surrounding the patient incident. Failure
to have a successful patient outcome is not a reliable indicator of
defibrillator/monitor performance. The presence or absence of a muscular response
to the transfer of energy during electrical therapy is not a reliable indicator of energy
delivery or device performance.
73
Operating the AED Mode of defibrillator/monitor
Do not let the multifunction pads touch each other or other monitoring
electrodes, lead wires, dressings, transdermal patches, etc. Such
contact can cause electrical arcing and patient skin burns during
defibrillation and may divert defibrillation current away from the heart.
During defibrillation, air pockets between the skin and multifunction
pads can cause patient skin burns. To help prevent air pockets, make
sure defibrillation pads completely adhere to the skin. Do not use dried-
out multifunction pads.
Aggressive handling of multifunction pads in storage or prior to use can
damage the pads. Discard the pads if they become damaged.
Note: Impedance is the resistance between the defibrillator’s pads or paddles that the
defibrillator must overcome to deliver an effective discharge of energy. The degree
of impedance differs from patient to patient and is affected by several factors
including the presence of chest hair, moisture, and lotions or powders on the skin.
The low-energy biphasic waveform is an impedance-compensating waveform that is
designed to be effective across a wide range of patients. However, if you receive a
"Poor Pads Contact" message, check that the patient’s skin has been washed and
dried and that any chest hair has been clipped. If the message persists, change the
pads and/or the pads cable.
AHA/ERC guidelines (Rescue protocol)
The AED rescue protocol is consistent with the guidelines recommended by the
AHA/ERC 2015 Guidelines for Resuscitation and Emergency Cardiac Care. The AED
rescue protocol is subject to be upgradeable in order to be consistent with and optimized
for the guidelines recommended by the latest version of AHA/ERC Guidelines for
Resuscitation and Emergency Cardiac Care. Please contact your Mediana service
representative for more information.
Note: AHA is the abbreviation for ‘American Heart Association’ and ERC is the
abbreviation for ‘European Resuscitation Council’.
Note: This section is described in accordance with ERC Guidelines. Differences for ERC
Guidelines and AHA Guidelines are described with Note format.
74
Summary of CPR Guidelines
This “Guidelines Highlights” publication summarizes the AHA/ERC 2015 Guidelines.
This is easy reference material for both lay rescuer and healthcare provider. Before
installing the defibrillator/monitor, it is recommended that the expected AED user should
be trained to provide CPR and use the AED.
Note: The recommended procedure in below table is intended for the trained user. It is
recommended that the untrained user calls the emergency service and follows the
instruction directed by dispatcher.
Ensure scene safety. Make sure you, the victim and any bystanders are safe.
Gently shake victim’s shoulders and ask loudly: “Are you all
Check the victim for a response.
right?”
Open the airway.
Look, listen and feel for normal breathing.
Open the airway, Check for Note: AHA 2015 Guidelines recommends that untrained user
breathing. should call for help before checking for breathing and
trained rescuers are encouraged to simultaneously
perform ‘checking for pulse’ step.
Person not responsive?
Not breathing normally?
Ask a helper to call the emergency services if possible
otherwise call them yourself.
After call for help, Send for AED. Stay with the victim when making the call if possible.
Send someone to find and bring an AED if available.
If you are on your own, do not leave the victim, start CPR.
Note: AHA 2015 Guidelines indicates that helper gets AED if
there is an AED nearby.
Start chest compressions.
30 Compressions 2 Breaths After 30 compressions open the airway again and deliver two
rescue breaths.
UNTIL EMC ARRIVE.
Note: If untrained or unable to do rescue breaths, give chest
compressions only CPR.
Continue CPR until an AED is available or arrival of
emergency physician.
If the AED available, turn on and follow instructions.
ANALYSIS SHOCK DECISION
YES NO
Repeat every 2 minutes. DELIVER SHOCK.
Continue CPR for about 5 cycles.

(approximately 2minutes)
75
Using AED Mode
1. Turn on the AED Mode of defibrillator/monitor by rotating the Mode select knob.
2. Verify the AED Mode of defibrillator/monitor is activated normally and follow audio
guidance and STEP icon.
Note: It will take about 4 seconds to initialize AED mode.
STEP 1
Check for response.
Are you all right?
Call for help.
If pads are connected to
defibrillator/monitor during STEP1,
defibrillator/monitor will go on to
STEP4 directly.
STEP 2
Open the airway.

Check Breathing.
STEP4 directly.
STEP 3
Begin CPR [Beep]
Give two breaths.
Stop CPR.
STEP4 directly.
STEP 4
Remove clothes from the

patient’s chest. Place pads
exactly as shown in the picture.
Press pads firmly to patient’s
bare chest.
76
STEP 5
Analyzing heart rhythm.

Do not touch the patient.
Shock advised. Charging.
or No shock advised.
Note: The Step 5 should be performed at first when the AED Mode of defibrillator/monitor is
turned on and the pads are attached correctly to the patient.
STEP 6
Press the SHOCK button now.

Shock delivered.
Note: The SHOCK button on the third soft key as shown in Figure 34 appears only when
SHOCK button on the front side is not pressed within 10 seconds in fully charged state.
This button is just an auxiliary function. If there is a fail of the SHOCK button on the front
side, it should be repaired.
STEP 7
It is safe to touch the patient.

Begin CPR [Beep] or
If needed, Begin CPR [Beep]
Give two breaths.
Stop CPR.
Note: If you hear following voice while the AED Mode of defibrillator/monitor is analyzing
you should perform the following actions:
 SHOCK button not pressed or Shock cancelled:

Move to Step 7 → ECG analyzing again → non-shockable rhythm → move to
Step 7
or
 Critically low battery, Replace new battery:
Move to Step 1 after replace the new battery or connect AC power, External DC-
DC adaptor.
 Resume analyzing:
Pressing the Resume analyzing button at the bottom of the defibrillator/monitor,
CPR will be stopped. → Move to Step 5.
77
Performing CPR
After the electric shock is delivered, the following voice prompt would be emitted.
 It is safe to touch the patient.

 Begin CPR.
Follow the voice prompts to properly perform the CPR.

When performing CPR, use the metronome sound from the defibrillator/monitor in AED
mode for compression rate – the defibrillator/monitor emits a tone at a rate of 100 beats
per minute. Also, action icon of the defibrillator/monitor will be flashing at a same rate of
metronome sound.
Rescuer performs 5 cycles of CPR, each cycle include 30 times of chest compression
and 2 times of rescue breaths. Or perform the chest compression without rescue breath,
if untrained or unable to do rescue breaths. The defibrillator/monitor will remain in CPR
mode for 5 cycles (approximately 2 minutes). After CPR mode you will hear the following
voice prompt:
 Stop CPR.
The defibrillator/monitor in AED mode will then return to analyzing procedure. Continue to
follow this instruction until emergency physician arrives and the hand over patient to
emergency physician.
Note: In accordance with AHA/ERC 2015 Guidelines,

- the recommended compression rate is 100 ~ 120 beats per minute,
- the recommended compression depth is at least 2 inches (5 cm), but not more
than 2.4 inches (6 cm),
- the recommended compression ventilation ratio is 30:2,
- the recommended duration is 5 cycles (30:2 x 5 cycles).
Note: Your Mediana dealer will have trained you in the particular SCA treatment protocol
you have chosen. In all cases follow the voice prompts and visual instructions given
by the defibrillator/monitor in AED mode.
78
Description of AED Mode Menu Functions
Figure 30. AED Mode Menu
Figure 31. ECG waveform display – ECG signal saturation (AED mode, Pads)
Note: If 1 channel ECG input from pads is saturated, waveform is displayed as shown as
Figure 31 in AED mode.
79
Table 24. AED Mode Menu
Level1 Level 2 Menu Level 3 Menu Level 4 Menu
Menu or Response or Response or Response
Patient Info
ID Confirm
Return
Name Confirm
Return
Age Confirm
Return
Gender Male
Female
Event Data review Print
records Return
ID# ID
Name
Age
Gender
Return
Return
Real-time Print
data Download
Return
Return
Patient Info
ID, Name, Age or Gender of patients can be entered in this menu. ID and Name can be
up to 14 characters long, Age can be up to 3 digit numbers and Gender can be selected
between Male and Female.
Figure 32. Patient Info: ID Menu
More details for Data Review and ID# in Event Records menu, please refer to Event
Section.
Select the Real-time data Menu to identify real-time data in Patient Info menu. More
details for Real-time data, please refer to Real-time Data Section.
80
MANUAL MODE
Make sure that the ECG signal quality is good and that sync marks are
correctly displayed above each QRS complex prior to performing
synchronized defibrillation (cardioversion).
Artifact introduced by paddle movement may resemble an R-wave and
trigger a defibrillation shock when performing synchronized
defibrillation (cardioversion).
Disconnect non-defibrillation-proof electronic devices or equipment
from patient before defibrillation.
The defibrillator/monitor has a mechanism to inhibit its output when the
impedance of human body which can be measured by paddle is out of
range between 15 and 250 ohm.
Whenever possible, Mediana recommended that user performs
synchronized defibrillation (cardioversion) procedures while directly
monitoring the patient through the defibrillator’s electrodes or lead
inputs.
This section explains how to prepare for and perform asynchronous defibrillation and
synchronous defibrillation (cardioversion) using multifunction electrode pads, external
paddles.
General
Defibrillation therapy is the definitive method for termination of a variety of potentially fatal
arrhythmias. The defibrillator/monitor provides this therapy through the application of a
brief biphasic waveform of electricity to the cardiac muscle. This electrical energy is
transferred through attached paddles or disposable multifunction pads applied to the
patient’s bare chest.
In manual mode, you must assess the ECG, decide if defibrillation or cardioversion is
indicated, select the appropriate energy setting, charge the defibrillator/monitor, and
deliver the shock. The entire defibrillation process is under your control. Voice prompts
are not present. However, text messages on the display provide relevant information
throughout the process. It is important to be attentive to these messages when displayed.
Note: Defibrillation is always performed through paddles or pads. However, during

defibrillation you may choose to monitor the ECG using an alternate ECG source
(3-, 5-, or 12- lead monitoring electrodes).
Note: Defibrillating asystole can inhibit the recovery of natural pacemakers in the heart
and completely eliminate any chance of recovery. Asystole should not be routinely
shocked.
Note: Successful resuscitation is dependent on many variables specific to the patient’s

physiological state and the circumstances surrounding the patient event. Failure to
have a successful patient outcome is not a reliable indicator of defibrillator/monitor
performance. The presence or absence or a muscular response to the transfer of
energy during electrical therapy is not a reliable indicator of energy delivery or
device performance.
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Preparing for Defibrillation
Using adult paddles
1. External paddles are placed on the device.
2. Remove the paddles from the paddle tray by pulling the paddles straight up and out
of the paddle tray.
3. Apply conductive matter to the paddle electrodes. Do not distribute conductive
matter by rubbing the paddle electrodes together.
4. Apply paddles to the patient’s bare chest.
Using pediatric paddles

1. The defibrillator/monitor external paddles come with pediatric paddles included.
2. Depress the latch at the front of the external paddles while pulling forward on the
adult paddle plate.
3. Apply paddle to the patient’s bare chest.
Note: The paddle is an assembled product which is intended to use for adult patient.
Remove the plate of paddle for adult, and there is the paddle for pediatric patient.
Operating the Manual Mode of defibrillator/monitor

1. Select manual mode of defibrillator/monitor by rotating the Mode select knob.
2. When the manual mode of defibrillator/monitor is activated normally, the energy
select display will be displayed on the top of the screen and other parameter
information will be displayed.
Figure 33. Manual Mode Screen
Note: Defibrillation is always performed through paddles or pads. However, during

defibrillation you may choose to monitor the ECG using an alternate ECG source
(3-, 5-, or 12- lead monitoring electrodes).
Note: Defibrillating asystole can inhibit the recovery of natural pacemakers in the heart
and completely eliminate any chance of recovery. Asystole should not be routinely
shocked.
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Defibrillating (async mode)
If the device and paddles are prepared for defibrillation, perform the following steps;
1. To select the energy setting, press the Select Energy Level button and rotate the
Multi function knob to the desired energy level. Energy choices range from 1 to
200J. (To choose higher value than 200J, enter the Service Menu by using extra
passcode)
Note: If Select Energy Level button is not pressed, defibrillator/monitor has default
energy level setting. To change default setting, enter the Service Menu.
Note: Clinicians must select an appropriate energy level for defibrillation of pediatric
patients.
2. To charge the energy, press the CHARGE button. If using external paddles, the
CHARGE buttons on the paddle or on the front panel can be used. When charging
is completed, Charge Indicator on the paddles lights up red. Before Step 3, check
the Charge Indicator.
Note: You may increase or decrease the selected energy at any time during charging or
after charging is complete.
3. There are two ways to shock the energy.

a. Press the SHOCK button which is placed on the front side of defibrillator/
monitor.
b. Press the SHOCK button located on the external paddles.
c. Press the SHOCK button appeared on the third soft key menu. (Refer to
Figure 34)
Note: If paddles are used, the SHOCK button on the front side does not work. Only the
SHOCK button on the paddles works.
Note: Defibrillation current can cause operator or bystander injury. Do not touch the
patient, or equipment connected to the patient, during defibrillation.
83
Figure 34. Shock Soft Key
SHOCK button on the front side is not pressed within 10 seconds in fully charged
state. This button is just an auxiliary function. If there is a fail of the SHOCK button
on the front side, it should be repaired.
Synchronized Cardioversion (sync mode)

Synchronized Cardioversion allows you to synchronize delivery of the shock with the R-
wave of the ECG being monitored in Wave Sector 1. You may choose to perform
synchronized cardioversion through either multifunction pads, or external paddles.
When using paddles, you should defibrillator/monitor the ECG through monitoring
electrodes connected to a 3-, 5- or 12- lead ECG cable or a defibrillator/monitor. You may
choose to defibrillator/monitor through an alternate source when using pads, as well.
During cardioversion, energy shock is still delivered through either pads or paddles.
If the defibrillator/monitor and paddles are prepared for defibrillation, perform the following
steps;
1. To activate Sync mode, press the Sync soft key located lower right corner of the
screen.
2. Confirm that the Sync marker appears with each R-wave.
3. To select the energy setting, rotate the Multi function knob to the desired Energy
Level button and press it. Energy choices range from 1 to 200J. (To choose higher
value than 200J, enter the Service Menu by using extra passcode)
Note: Clinicians must select an appropriate energy level for defibrillation of pediatric
patients.
84
4. To charge the energy, press the CHARGE button. If using external paddles, the
CHARGE button on the paddles may be used instead. When charging is
completed, Charge Indicator on the paddles lights up red. Before Step 5, check the
Charge Indicator.
Note: You may increase or decrease the selected energy at any time during charging or
after charging is complete.
5. There are two ways to shock the energy.

a. Press the SHOCK button which is placed on the front side of defibrillator/
monitor.
b. Press the SHOCK button located on the external paddles. The shock will be
delivered when the next R-wave is detected.
c. Press the SHOCK button appeared on the third soft key menu.
(Refer to Figure 34)
Note: It is important to continue to hold the SHOCK button (or the paddle SHOCK
button) until the shock is delivered. The defibrillator shocks with the next detected
R-wave.
Note: Defibrillation current can cause operator or bystander injury. Do not touch the
patient, or equipment connected to the patient, during defibrillation.
If additional synchronized shocks are indicated, perform the following steps;
6. Make sure the Sync function is still enabled, as indicated by the presence of the
Sync message in the upper right corner of the Wave Sector 1.
7. Repeat Steps 4-5 under “Delivering a Synchronized Shock”.
To turn off the Sync function of the defibrillator/monitor, Press the Sync soft key.
Note: The maximum time delay between synchronization pulse and delivery of energy is
not exceeded 60ms.
SHOCK button on the front side is not pressed within 10 seconds in fully charged
state. This button is just an auxiliary function. If there is a fail of the SHOCK button
on the front side, it should be repaired.
85
Description of Manual Mode Menu Functions
Figure 35. Manual Mode Menu
Table 25. Manual Mode Menu

Level 1 Level 2 Menu Level 3 Menu Level 4 Menu
12 Lead
Acquire
Setup Filter 0.05Hz ~ 40Hz
0.05Hz ~ 150Hz
Return
Transmission
Return
12 lead
ON / OFF
Patient info ID Confirm
Return
Name Confirm
Return
Age Confirm
Return
Gender Male
Female
Return
12 lead records Print
Transmission
ID # ID
Name
Age
Gender
Return
Return
86
Setup
Volume Alarm
Beep
Button
Charging alarm
Voice prompt
CPR metronome
Pacing alarm
Return
Printer Print on alarm On
Setting Off
Print on charge On
Off
Print on shock On
Off
Print on mark On
Off
Print on BP On
Off
Print on self-test On
Off
12 lead auto printing On
Off
Analyze auto printing On
Off
Return
Erase data Erase 12 lead records Yes
No
Erase event records Yes
No
Erase internal memory Yes
No
Return
Waveform 2nd Waveform ECG I, II, III, aVL, aVF, aVR, V1, V2,
setting V3, V4, V5, V6, Pads
SpO2
RESP
IBP1
IBP2
EtCO2
Return
3rd Waveform ECG I, II, III, aVL, aVF, aVR, V1, V2,
V3, V4, V5, V6, Pads
SpO2
RESP
IBP1
IBP2
EtCO2
Return
4th Waveform ECG I, II, III, aVL, aVF, aVR, V1, V2,
SpO2
87
RESP
IBP1
IBP2
EtCO2
Return
Return
Display Mode Large numeric display
Black-white Invert Mode
Clinical Clinical Action List 1 ~ 10
action list Return
Manual
self-test
Button test
Service menu (Display 3 digit code)
Return
Return
Alarm Limit
▲ Upper Alarm Limit
▼ Lower Alarm Limit
Patient Info
ID Confirm
Return
Name Confirm
Return
Age Confirm
Return
Gender Male
Female
Return
Event records Data review Print
Return
ID# ID
Name
Age
Gender
Return
Return
Real-time Print
data Download
Return
Return
Sync On/Off
88
12 Lead
Acquire
To acquire the 12 lead ECG data from patient, press the Acquire soft key.
Setup
This menu allows you to set Filter and Transmission. Filter can be selected between
0.05Hz~40Hz and 0.05Hz~150Hz. 12 lead ECG is transmitted to external devices via
wireless communication from the defibrillator/monitor. To transmit the result of 12 lead
ECG diagnosis, press the Transmission soft key.
12 lead ON / OFF
This menu allows you to set 12 lead display.
Patient info
Setup
Figure 36. Setup Menu
Volume
The Volume options allow you to adjust the volume of Alarm, Beep, Button, Charging
alarm, Voice prompt, CPR metronome and Pacing alarm. Alarm volume, Charging alarm
and Voice prompt can be set at level 1 to 8 and Beep volume, Button volume, CPR
metronome and Pacing alarm can be set at level 1 to 7 or Off.
1. Rotate the Multi function knob to highlight Alarm volume, Beep volume or Button
volume.
2. Press the Multi function knob. Levels of Alarm volume, Beep volume or Button
volume will appear.
3. Rotate the Multi function knob to select a volume level.
4. Press the Multi function knob to enter a desired volume into the
89
Printer setting
This menu allows you to set Print on alarm, Print on charge, Print on shock, Print on
mark, Print on BP, Print on self-test, 12 lead auto printing or Analyze auto printing.
1. Rotate the Multifunction knob to highlight Print on alarm, Print on charge, Print on
shock, Print on mark, Print on BP, Print on self-test, 12 lead auto printing or Analyze
auto printing.
2. Press the Multifunction knob. Multifunction knob toggles between On and Off.
Erase data
To clear Erase 12 lead records, Erase event records or Erase internal memory in the
defibrillator/monitor, set Erase data to Yes
Waveform setting
The defibrillator/monitor automatically detects the attached lead. For example, lead type
is selected to only Lead I, II and III when 3 leads are attached. You can select the
desired ECG lead type.
Display Mode
This menu allows the user to change a display format of Black-white invert mode. Large
numeric screen can only be selected in monitor mode.
Clinical Action List

This menu indicates the information of drug administration. Only authorized personnel
are allowed to set the Clinical Action List in the Service Menu. Refer to the service
manual for instructions.
Manual self-test
This menu allows the user to perform a Self-test manually. Refer to the Self test function
section.
Button test
The user can check buttons for proper functioning. It can be performed by ‘Button Test’
function in the Setup Menu.
Service Menu
Only authorized personnel are allowed to change the Service Menu settings. The 3 digit
code is required for access. Refer to the service manual for instructions.
90
Alarm Limit
Press the Multi function knob to select Alarm limits. The defibrillator/monitor will display
all alarm limits that are currently in effect for all monitored parameters. Select the alarm
limits to set
Patient Info
More details for Data Review and ID# in Event Records Menu, please refer to Event
Section.
Select the Real-time data Menu to identify real-time data in Patient Info. More details for
Real-time data, please refer to Real-time Data Section.
Sync On/Off
Press the Sync On/Off soft key to operate the sync mode. When pressing Sync On soft
key, Sync On soft key will be changed to Sync off soft key.
91
92
MONITOR MODE
General
In monitor mode, you can monitor Electrocardiography (ECG) acquired a 3-. 5-, or 10-
lead ECG electrodes. Optional monitoring of functional arterial oxygen saturation (SpO2),
respiration (RESP), temperature (TEMP), invasive blood pressure (IBP), noninvasive
blood pressure (NIBP), and end tidal CO2 (EtCO2), invasive blood pressure (IBP) are also
available. Measurements from these parameters are presented on the display and
alarms are available to alert you to changes in the patient’s condition. Monitor mode also
provides display format of large numeric screen. However, monitor mode cannot provide
the defibrillator function including select the delivered energy, analyze, charge, deliver the
shock and appear defibrillator messages on the display.
Description of Pacing Mode Menu Functions
Figure 39. Monitor Mode Menu
Table 26. Monitor Mode Menu

Level1 Menu Level 2 Menu Level 3 Menu Level 4 Menu
or Response or Response or Response
12 Lead
Acquire
Setup Filter 0.05Hz ~ 40Hz
0.05Hz ~ 150Hz
Return
Transmission
Return
12 lead ON / OFF
Patient info ID Confirm
Return
Name Confirm
Return
Age Confirm
93
Return
Gender Male
Female
Return
12 lead records Print
Transmission
ID # ID
Name
Age
Gender
Return
Return
Return
Setup
Volume Alarm
Beep
Button
Charging alarm
Voice prompt
CPR metronome
Pacing alarm
Return
Printer Setting Print on alarm On
Off
Print on charge On
Off
Print on shock On
Off
Print on mark On
Off
Print on BP On
Off
Off
Off
Off
Return
No
No
No
Return
Waveform setting 2nd Waveform ECG I, II, III, aVL, aVF, aVR, V1,
V2, V3, V4, V5, V6, Pads
SpO2
RESP
IBP1
IBP2
94
EtCO2
Return
3rd Waveform ECG I, II, III, aVL, aVF, aVR, V1,
V2, V3, V4, V5, V6, Pads
SpO2
RESP
IBP1
IBP2
EtCO2
Return
4th Waveform ECG I, II, III, aVL, aVF, aVR, V1,
V2, V3, V4, V5, V6, Pads
SpO2
RESP
IBP1
IBP2
EtCO2
Return
Return
Clinical action list Clinical Action List 1 ~ 10
Return
Manual self-test
Button test
Return
Return
Alram Limit
Patient Info
ID Confirm
Return
Name Confirm
Return
Age Confirm
Return
Gender Male
Female
Return
ID# ID
Name
Age
Gender
Return
Return
Real-time data Print
Download
Return
Return
95
12 Lead
Acquire
To acquire the 12 lead ECG data, press the Acquire soft key.
Setup
This menu allows you to set Filter and Transmission. Filter can be selected between
0.05Hz~40Hz and 0.05Hz~150Hz. To transmit the result of 12 lead ECG diagnosis,
press the Transmission soft key.
12 lead ON
This menu allows you to set 12 lead display.
Patient info
ID, Name, Age, Gender of patients or 12 lead records setting can be entered in this
menu. ID and Name can be up to 14 characters long, Age can be up to 3 digit numbers
and Gender can be selected between Male and Female.
Setup
Volume
alarm, Voice prompt, CPR metronome, Pacing alarm. Alarm volume, Charging alarm and
Voice prompt can be set at level 1 to 8 and Beep volume, Button volume, CPR
1. Rotate the Multi function knob to highlight Alarm volume, Beep volume or Button
volume.
2. Press the Multi function knob. Levels of Alarm volume, Beep volume or Button
volume will appear.
4. Press the Multi function knob to enter a desired volume into the
Printer setting
1. Rotate the Multifunction knob to highlight Printer on alarm, Print on charge, Print on
shock, Print on mark, Print on BP, Print on self-test,12 lead auto printing or Analyze
auto printing.
2. Press the Multifunction knob. Multifunction knob toggles between On and Off.
96
Erase data
defibrillator/monitor, set Erase data to Yes.
Waveform setting
Display Mode
This menu allows the user to change a display format of Large numeric screen or Black-
white invert mode.

Manual self-test
section.
Button test
Service Menu
Only authorized personnel are allowed to change the Service Menu settings. A 3 digit
Alarm Limit
limits to set.
97
Patient Info
Section.
Sync On/Off
Press the Sync On/Off soft key to operate the sync mode. When pressing Sync On soft
key, Sync On soft key will be changed to Sync off soft key.
98
PACING MODE
Use sync mode pacing whenever possible. Use Fixed mode pacing
when motion artifact or other ECG noise makes R-wave detection
unreliable.
Observe the patient continuously while the pacemaker is in use. Patient
response to pacing therapy (for example, capture threshold) may
change over time.
Prolonged invasive pacing may cause patient skin irritation and burns,
especially with higher pacing current levels. Discontinue noninvasive
pacing if skin becomes burned and another method of pacing is
available.
The ECG size must be properly adjusted so that the patient’s own beats
are detected. If ECG size is set too high or too low, pacing pulses may
not be delivered when required. Adjust ECG size so that pacing pulse
mark is placed on the patient’s QRS complexes.
If you are using the pacing function with battery power and the low
battery appears, plug the device into AC power. When the device
powers back up, pacing is no longer activated. Press Pacer to re-
activate the pacing function.
Using other manufacturers’ combination pads with this device could
cause a decrease in pacing efficacy or the inability to pace because of
unacceptably high impedance levels and invalidate the safety agency
certifications. Use only the pads that are specified in these operating
instructions.
Use of other ECG monitoring devices may provide misleading
information due to the presence of pace artifacts.
Under certain conditions it may not be possible to properly
defibrillator/monitor or pace while electrosurgical apparatus is
operating.
When poor pads contact, dry skin and/or skin with hair causes
excessively high impedance, which restrain the generation of the
selected pacing current, and that close surveillance is essential to avoid
any risk caused by high impedance if it occurs, the “Pacer out ___ mA”
warning message is provided on the screen.
Monitor the patient condition continuously through other physiological
measurements or mechanical captures when pacing is activated.
General
Pacing therapy is used to deliver pace pulses to the heart. Pace pulses are delivered
through multifunction pads that are applied to the patient’s bare chest.
Note: Use only approved lead sets when pacing with the defibrillator/monitor.
Note: Waveforms, ECG monitoring, measurements, and most alarms remain active and
retain their settings when you convert from manual mode or monitor mode to
pacing mode.
99
Demand Mode and Fixed Mode
The defibrillator/monitor can deliver pace pulses in either Demand mode or Fixed mode.
1. In Demand mode, the defibrillator/monitor only delivers pace pulses when the
patient’s heart rate is lower than the selected pacing rate.
2. In Fixed mode, the defibrillator/monitor delivers pace pulses at the selected rate.
Note: Use Demand mode pacing whenever possible. Use Fixed mode pacing when
motion artifact or other ECG noise makes R-wave detection unreliable or when
monitoring electrodes are not available.
The defibrillator/monitor requires a 3-, 5-, 12- lead ECG cable and monitoring electrodes
as the source of the ECG during standard pacing. Pace pulses are delivered through the
multifunction pads. However, the pads cannot be used to monitoring the ECG and deliver
pace pulses simultaneously.
Operating the Pacing Mode of defibrillator/monitor

Align the Mode select knob to ‘Pacer’ to select the pacing mode.
When the pacing mode of defibrillator/monitor is activated normally, the pace rate and
current value will be displayed on the top of the screen and other parameter information
will be displayed.
Figure 43. Pacing mode screen
Demand mode Pacing

When the pacing mode is turned on by selecting ‘Pacer’ mode, the Demand mode
operates automatically.
1. When the RATE button is pressed, each color of pulse rate value is changed and it
can be modified.
2. The ‘Select BPM’ defibrillator message is displayed.
100
3. Rotate the Multi function knob to the desired value of pace pulse per minute and
then press the Multi function knob to select the desired value of pace pulse per
minute. The value is changed by 2 bpm.
4. When the mA button is pressed, each color of output value is changed and the
output value can be modified.
5. The ‘Select mA’ defibrillator message is displayed.
6. Rotate the Multi function knob to the desired output value and then press the
Multi function knob to select the desired output value.
The value is changed by 2 mA.
7. When selected value of pace pulse per minute or below are detected, relevant
current (mA) is delivered to patient.
Note: The setting becomes effective only after color of values returns to white from
yellow.
Note: The pulse rate value in bpm unit is modified between 30 bpm and 180 bpm and the
output value is modified between 0 mA and 140 mA.
Note: When pacing in demand mode, the ECG cable must be directly connected from the
patient to the defibrillator/monitor.
Note: If you are using the pacing function with battery power and the low battery alarm is
annunciated, connect the device to external power or insert a fully charged battery.
Fixed Mode Pacing
Pacing rate should be set higher than the patient’s heart rate.
Close patient surveillance is required because ventricular fibrillation
could be induced when pacing pulse is activated on T-wave under fixed
mode.
Note: The amount of energy needed to induce ventricular fibrillation is approximately 12

times the amount needed to pace the heart in canine studies. Although the pace
stimulus is applied to the T-wave, the risk of inducing VF during precordial pacing
is small.
After the pacing mode is turned on by selecting ‘Pacer’ mode, press the Fixed soft key
to operate the Fixed mode pacing.
1. When the RATE button is pressed, each color of Pulse rate value is changed and
it can be modified.
2. The ‘Select BPM’ defibrillator message is displayed.
3. Rotate the Multi function knob to the desired value of pace pulse per minute and
then press the Multi function knob to select the desired value of pace pulse per
minute. The value is changed by 2 bpm.
4. When the mA button is pressed, each color of output value is changed and the
output value can be modified.
5. The ‘Select mA’ defibrillator message is displayed.
6. Rotate the Multi function knob to the desired output value and then press the
Multi function knob to select the desired output value.
The value is changed by 2 mA.
7. The set current value is delivered continuously.
Note: To pause pacing, press Pause Pacing soft key and to resume pacing, press
Pause Pacing soft key again.
101
Description of Pacing Mode Menu Functions
Figure 44. Pacing Mode Menu
Table 27. Pacing Mode Menu

Level 2 Menu Level 3 Menu Level 4 Menu
Level1 Menu
Pause/Resume Pacing
Setup
Volume Alarm
Beep
Button
Charging alarm
Voice prompt
CPR metronome
Pacing alarm
Return
Printer Print on alarm On
Setting Off
Print on charge On
Off
Print on shock On
Off
Print on mark On
Off
Print on BP On
Off
Off
Off
Off
Return
102
Level1 Menu
No
No
No
Return
Waveform 2nd Waveform ECG I, II, III, aVL, aVF, aVR, V1, V2,
setting V3, V4, V5, V6, Pads
SpO2
RESP
IBP1
IBP2
EtCO2
Return
3rd Waveform ECG I, II, III, aVL, aVF, aVR, V1, V2,
SpO2
RESP
IBP1
IBP2
EtCO2
Return
4th Waveform ECG I, II, III, aVL, aVF, aVR, V1, V2,
SpO2
RESP
IBP1
IBP2
EtCO2
Return
Return
Clinical action Clinical Action List 1 ~ 10
list Return
Manual self-
test
Button test
Return
Return
Alarm Limit
Patient Info
ID Confirm
Return
Name Confirm
Return
Age Confirm
Return
103
Level1 Menu
Gender Male
Female
Return
ID# ID
Name
Age
Gender
Return
Return
Real-time Print
data Download
Return
Return
Demand/Fixed
Pause Pacing
When the Pause Pacing soft key is pressed, if pacing is operating, pacing will be
paused, if pacing is not operating, pacing will be resumed.
Setup
Volume
alarm, Voice prompt, CPR metronome and Pacing alarm. Alarm volume, Charging alarm
and Voice prompt can be set at level 1 to 8 and Beep volume, Button volume, CPR
1. Rotate the Multifunction knob to highlight Alarm volume, Beep volume or Button
volume.
2. Press the Multifunction knob. Levels of Alarm volume, Beep volume or Button
volume will appear.
4. Press the Multi function knob to enter a desired volume into the defibrillator/monitor.
104
Printer setting
1. Rotate the Multi function knob to highlight Print on alarm, Print on charge, Print on
shock, Print on mark, Print on BP, Print on self-test, 12 lead auto printing or Analyze
auto printing.
2. Press the Multi function knob. Multi function knob toggles between On and Off.
Erase data
defibrillator/monitor, set Erase data to Yes.
Waveform setting
Display Mode
This menu allows the user to change a display format of Black-white invert mode. Large
numeric screen can only be selected in monitor mode.

Manual Self-test
section.
Button Test
Service Menu
Only authorized personnel are allowed to change the Service Menu settings. A 3digit
105
Alarm Limit

limits to set.
Patient Info
Section.
Fixed
Press the Fixed soft key to operate the Fixed mode pacing. When pressing the Fixed
soft key, Fixed soft key will be changed to Demand soft key.
106
NIBP MONITORING

standards.
Inaccurate measurements may be caused by incorrect cuff application
or use. This can include placing the cuff too loosely on the patient,
using the incorrect cuff size, or not placing the cuff at the same level as
the heart, leaky cuff or hose or excessive patient motion.
In some cases, rapid, prolonged cycling of an oscillometric, the cuff has
been associated with any or all of the followings: ischemia, purpura, or
neuropathy. Periodically observe the patient’s limb to make sure that
the circulation is not impaired for a prolonged period of time. Also make
sure the cuff is placed according to directions in this manual and the
cuff directions for use.
Do not place the cuff, the catheter or SpO2 sensor on an extremity being
used for intravenous infusion or any area where circulation is
compromised or has the potential to be compromised.
As with all automatically inflatable blood pressure devices, continual
cuff measurements can cause injury to the patient being monitored.
Weigh the advantages of frequent measurement and/or use of CONT
mode against the risk of injury.
Ensure the patient is quiet with minimal movement during NIBP
readings; minimize the patient’s shivering.
Never place the cuff on an extremity being used for intravenous infusion
or any area where circulation is compromised or has the potential to be
compromised. Never fit NIBP system with Luer Lock adapters.
Never use an adult monitor setting or cuff for an NIBP measurement on
a neonatal patient. Adult inflation limits can be excessive for neonatal
patients, even if a neonatal cuff is used.
Do not pull the cable because pulling the cable could cause the
disconnection of the cable from the defibrillator/monitor and can cause
the error for the measurement.
Noninvasive pacing may cause patient skin irritation and burns,
especially with higher pacing current levels. Inspect underlying skin of
the electrode frequently after 30 minutes of continuous pacing.
Discontinue pacing if skin burn develops and another method of pacing
is available. On cessation of pacing, immediately remove or replace
electrodes with new ones.
Do not place the cuff over a wound as this could cause further injury
when pressurized.
Application of the cuff to any limb where intravascular access or
therapy or an arterio-venous (A-V) shunt is present could result in injury
due to the temporary interference of blood flow during pressurization.
The application of the cuff to the arm on the same side as a mastectomy
should be avoided.
Any blood pressure reading can be affected by the measurement site,
the position of the patient, exercise, or the patient’s physiologic
condition. Environmental or operational factors which can affect the
performance of the defibrillator/monitor and/or its blood pressure
reading are common arrhythmias such as atrial or ventricular premature
107
beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes,
age, pregnancy, pre-eclampsia, renal diseases, patient motion,
trembling, and shivering.
In the automatic mode, the defibrillator/monitor displays results of the
last blood pressure measurement until another measurement starts. If a
patient’s condition changes during the time interval between
measurements, the defibrillator/monitor will not detect the change or
indicate an alarm condition.
Any excessive patient motion may cause inaccurate measurements of
non-invasive blood pressure. Minimize motion to improve blood
pressure measurements.
Do not apply the blood pressure cuff to the same extremity as the one to
which the SpO2 sensor is attached. Cuff inflation can disrupt SpO2
monitoring and lead to nuisance alarms.
Make sure that heavy objects are not placed on the cuff hose. Avoid
crimping or undue bending, twisting, or entanglement of the hose.
The sensor disconnect error message and associated alarm indicate the
sensor is either disconnected or the wiring is faulty. Check the sensor
connection and, if necessary, replace the sensor.
A compressed or kinked hose connection may cause continuous cuff
pressure resulting in blood flow interference and potentially harmful
injury to the patient.
Note: Blood pressure measurements can be affected by the position of the patient, the
patient’s physiological condition and other factors.
Note: Blood pressure measurements determined with the defibrillator/monitor are

equivalent to those obtained by a trained observer using the cuff/stethoscope
auscultatory method, within the limits prescribed by the American National Standard
for manual, electronic, and automated sphygmomanometers.
General
The defibrillator/monitor performs Non-Invasive Blood Pressure measurements using the
oscillometric measuring technique. A motorized pump inflates the cuff to initially blocking
the flow of blood in the extremity. Then, under defibrillator/monitor control, the pressure
in the cuff is gradually reduced, while a pressure transducer detects air pressure and
transmits a signal to the NIBP circuitry.
When the cuff pressure is still above systolic pressure, small pulses or oscillations in the
cuff pressure begin to be sensed by the transducer. As the cuff continues to deflate,
oscillation amplitude increases to a maximum and then decreases. When maximum
oscillation amplitude occurs, the cuff pressure at that time is measured as mean arterial
pressure (MAP). The systolic and diastolic pressures are calculated based on analysis of
the oscillation amplitude profile.
Setup Connections
1. Measure the patient’s limb and select a proper size cuff. As a general rule, cuff
width should span approximately two-thirds of the distance between the patient’s
elbow and shoulder.
2. Connect the cuff hose to the connector on the defibrillator/monitor’s side option
case and turn to right to lock (see Figure 2).
3. Connect a cuff to the cuff hose and turn the
connector to right to lock the hoses together. Firm
connection must be made.
108
4. Patient should be seated with back comfortably and arms supported.
5. Patient should have their legs uncrossed, feet flat on the floor with their back and
arms supported.
6. Wrap the cuff around a hare arm or around an arm covered in thin clothing. Thick
clothing or a rolled up sleeve will cause a major discrepancy in the blood pressure
reading.
7. Wrap the cuff around the patient’s arm so that
the center of the cuff’s rubber bladder sits on the
artery of the upper arm. The hose should be
brought out from the peripheral side without
bending (The Brachial artery is located on the
inside of the patient’s upper arm.) At this time,
check that the index line on the edge of the cuff
sits inside the range. Use a different sized cuff if
the index line is outside of the range because
this will cause a major discrepancy in blood pressure reading.
The adult cuff should be wrapped around the arm tightly enough so that
only two fingers can be inserted under it, above and below the cuff.
Refrain from talking during the measurement procedure, and at least 5
minutes should elapse before the first reading is taken.
8. Maintain the height of the cuff-wrapped upper arm artery to that of the heart’s right
ventricle during measurement.
9. Follow the cuff directions for use when applying the cuff to the arm.
Note: Obtaining NIBP readings can be more difficult in patients with arrhythmias. These
arrhythmias increase the beat-to-beat pressure fluctuations, which increases the
variability of the NIBP readings. Temporarily verify pressure using another method
if it becomes difficult to obtain readings in the presence of arrhythmias.
Table 28. Cuff Size

Model Number Arm circumference (cm)
Neonate Cuff No.10 3.5 to 6
Cuff No.11 5.0 to 7.5
Cuff No.13 8.5 to 13
Pediatric HEM-CS23 13 to 22
HXA-GCUFF-SSLA 12 to 18
HXA-GCUFF-SLA 17 to 22
Adult HEM-CR23 22 to 32
HEM-CL23 32 to 42
HEM-CX23 42 to 50
HXA-GCUFF-MLA 22 to 32
HXA-GCUFF-LLA 32 to 43
HXA-GCUFF-XLLA 42 to 50
109
Description of NIBP Menu Functions
2 3 4 5
6 7 8 9 10
1 NIBP icon 6 Systolic pressure value
2 NIBP unit 7 MAP value
3 NIBP auto mode interval 8 Initial pressure value
4 NIBP elapsed time 9 Diastolic pressure value
5 Bell icon 10 Neonatal icon
Figure 48. NIBP Display
Figure 49. NIBP Menu Display
Table 29. NIBP Menu

NIBP MENU
Inflate Pressure 120, 140, 160, 180, 200, 220, 240, 260, 280 (mmHg)
(Adult/Pediatric)
80, 100, 120, 140 (mmHg) (Neonatal)
Return
Auto Interval OFF, Cont, 1, 2.5, 3, 5, 10, 15, 30, 60, 90 (min)
Return
Patient Type Adult/Pedi
Neonatal
Return
Alarm Limit
▲ SYS Upper Limit Adjust
▼ SYS Lower Limit Adjust
▲ MAP Upper Limit Adjust
▼ MAP Lower Limit Adjust
▲ DIA Upper Limit Adjust
▼ DIA Lower Limit Adjust
(Limit Alarm Pause) On, Off
Return
Note: Initial Inflate Pressures shown above are for Adult patient mode. In order to set
alarm limits to Neonatal mode, change Patient type via the Setup Menu.
Note: The NIBP unit can only be changed by authorized personnel via the Service Menu.
110
Inflate Pressure
The inflating pressure can be set from 120 to 280 mmHg for adult and pediatric, or from
80 to 140 mmHg for neonatal.
Note: Measurement was stopped because measurement time exceeded and then blood
pressure measurement might be repeated up to 2 times.
Auto Interval
The NIBP measurement interval can be selected as Off, Cont, 1, 2.5, 3, 5, 10, 15, 30, 60
or 90 min. Continuous (Cont) mode can measure blood pressure as many measurement
as possible within a 5 minutes period. The measurement time will be integral multiple of
the selected interval starting from 0 minute.
Patient Type
The patient type can be selected as Adult/Pedi or Neonatal.
Limit Alarm Pause
When the Limit Alarm Pause is set to On, the audible alarm for NIBP systolic, MAP and
diastolic limit violation is paused.
111
Theory of Operation
Overview
The oscillometric technique does not use Korotkoff sounds to determine blood pressure.
The oscillometric technique monitors the changes in cuff pressure caused by the flow of
blood through the artery. The defibrillator/monitor inflates the cuff to a pressure that
occludes the artery. Even when the artery is occluded, the pumping of the heart against
the artery can cause small pressure pulses in the cuff baseline pressure. The
defibrillator/monitor lowers cuff pressure at a controlled rate. As the cuff pressure goes
down, blood starts to flow through the artery. The increasing blood flow causes the
amplitude of the pressure pulses in the cuff to increase. These pressure pulses continue
to increase in amplitude with decreasing cuff pressure until they reach a maximum
amplitude at which point they begin to decrease with decreasing cuff pressure. The cuff
pressure at which the pulse amplitude is the greatest is known as Mean Arterial
Pressure (MAP). The manner in which the pulse amplitudes vary is often referred to as
the pulse envelope. The envelope is an imaginary line that connects the peak of each
pressure pulse and forms an outline. The shape of the envelope is observed by the
defibrillator/monitor using a variety of techniques to determine the diastolic and systolic
blood pressure.
MAP ● Oscillometric Response

(Pressure Pulses)
Distole
Systole
TIME
Systole
Distole
MAP
Systole
● Cuff Pressure
MAP
Distole
TIME
112
Overall Accuracy Discussion
Overall system accuracy shall be determined by considering various influences of the
pressure sensor accuracy, motion artifacts, other artifact created by pressure valve,
technical errors of electrical components, and the origin error of oscillometric method.
The origin error of oscillometric comes from the basic theory of that the MAP is
determined by the pulse. Therefore, there might be an error of the time between two
pulses. In another words, the greatest amplitude point of pulses could not represent the
MAP point exactly.
On clinical trial perspective, overall system accuracy is not easy to be determined. The
clinical trial test protocols have been tried and have been described in many treatises,
and international standards. So, there are many methods to determine the overall
system accuracy of Automated Sphygmomanometer using the oscillometric method. But,
there are no absolute test protocols to determine the overall system accuracy of the
Automated Sphygmomanometer using oscillometric method. Normally, the Gold
standards of Blood pressure for the reference are the intra-arterial pressure and the
auscultatory method.
The popular standard for the overall system accuracy is AAMI, SP-10 2002+A1;2003
(Electronic or automated sphygmomanometers).
The main test conditions are as follow:
A. Data comparing the Intra-arterial or the auscultatory by the clinical experts with the
automated sphygmomanometer.
B. For data collection and the data analysis, Bland-Altman Plot is used.
C. On the systolic, diastolic, and MAP, the Deltas of all measurements shall be met
under +/- 5mmHg of mean difference (MD), and +/- 8mmHg of standard deviation
(SD).
(Delta = Intra-arterial or Auscultatory – Automated sphygmomanometer)
113
Oscillometric Method
The blood pressure values are determined by measuring the small oscillations (changes)
in the cuff pressure caused by the heart’s contractions as the pressure in the cuff is
released. Mediana’s measurement technology utilizes a unique deflation technique,
Dynamic Linear Deflation. This cuff deflation technique allows the Mediana monitor to
measure each small change in the cuff pressure oscillations that directly correspond to
the measurement’s systolic, mean and diastolic blood pressure values.
The cuff is first increased in pressure until it reaches a pressure above arterial occlusion.
As the cuff starts to deflate, the pulse rate of the patient is determined and the deflation
speed of the cuff is modified to create a patient specific deflation speed. As the pressure
decreases, small cuff pressure oscillations are recorded that correspond to the applied
pressure of the blood under the cuff as the heart contracts. These oscillations increase
in strength as the cuff pressure
approaches the systolic blood
pressure value. A sudden increase
in oscillation amplitude indicates
that the patient’s systolic blood
pressure is now able to push blood
completely through beneath the cuff.
The oscillation amplitude continues
to increase as the pressure in the
cuff is decreases until the mean
blood pressure value is reached.
The oscillation strength then starts
to diminish and finally drop off as
the diastolic blood pressure value is
reached.
The oscillometric method does not determine an instantaneous blood pressure reading
like the auscultatory method employing a microphone-type auto blood pressure
defibrillator/monitor but, as described above, determines blood pressure from an
uninterrupted changing curve, which means that the oscillometric method is not easily
effected by external noise and electrosurgical instruments.
Note: This equipment is suitable for use in the presence of electro-surgery.
114
SpO2 MONITORING

accessories manufactured by Nellcor® or supplied by Mediana. Use
accessories according to the manufacturer’s directions for use and your
facility’s standards.
Tissue damage can be caused by incorrect application or use of an
SpO2 sensor. Harm can be caused, for example, by wrapping the sensor
too tightly, by applying supplemental tape, or by leaving a sensor on too
long in one place. Inspect the sensor site as directed in the sensor
directions for use to ensure skin integrity, correct positioning, and
adhesion of the sensor.
Do not use damaged SpO2 sensors. Do not use an SpO2 sensor with
exposed optical components. Do not immerse sensor completely in
water, solvents, or cleaning solutions because the sensor and
connectors are not waterproof. Do not sterilize SpO2 sensors by
irradiation, steam or ethylene oxide. Refer to the cleaning instructions in
the directions for use for reusable SpO2 sensors.
Inaccurate measurements may be caused by:
 incorrect sensor application or use
 significant levels of dysfunctional hemoglobin (such as
carboxyhemoglobin or methemoglobin)
 intravascular dyes such as indocyanine green or methylene blue
 exposure to excessive illumination, such as surgical lamps (especially
ones with a xenon light source), bilirubin lamps, fluorescent lights,
infrared heating lamps, or direct sunlight
 excessive patient movement
 high-frequency electrosurgical interference and defibrillators
 venous pulsations
 placement of a sensor on an extremity with a blood pressure cuff,
arterial catheter, or intravascular line
 patient conditions such as hypotension, severe vasoconstriction,
severe anemia, hypothermia, cardiac arrest, or shock
 arterial occlusion proximal to the sensor
 environmental conditions
 unspecified length of the extension cable
Do not attach any cable to the sensor port connector that is intended for
computer use.
Do not pull the cable because pulling the cable could cause the
disconnection of the cable from the defibrillator/monitor and can cause
the error for the measurement.
Do not use a damaged sensor or cable. Do not alter the sensor or cable
in any way. Alternations or modification may affect performance and/or
accuracy. Never use more than one cable between the pulse oximeter
and the sensor to extend the length.
Sensors exposed to ambient light when incorrectly applied to a patient
may exhibit inaccurate saturation readings. Securely place the sensor
on the patient and check the sensor’s application frequently to help
ensure accurate readings.
Do not rely solely on SpO2 reading: assess the patient at all times. SpO 2
readings may be inaccurate in the presence of significant levels of
carboxyhemoglobin or methemoglobin, in patients with restricted blood
115
flow to the extremities (such as those in severe shock or hypothermia),
or in the presence of excessive motion.
Failure to apply the sensor properly may reduce the accuracy of the
SpO2 measurement.
Inspection the sensor application site at least every two hours for
changes in skin quality, correct optical alignment, and proper sensor
application. If skin quality is compromised, change the sensor site.
Change the application site at least every four hours. More frequent
checking may be required due to individual patient’s condition.
Severe anemia, methemoglobin, intravascular dyes that change usual
blood pigmentation, excessive patient movement, venous pulsations,
electrosurgical interference, exposure to irradiation and placement of
the sensor on an extremity that has a blood pressure cuff, intravascular
line, or externally applied coloring(such as nail polish) may interfere
with oximeter performance. The operator should be thoroughly familiar
with the operation of the oximeter of the oximeter prior to use.
The pulsations from intra-arotic ballon support can be additive to the
pulse rate on the oximeter pulse rate display. Verify patient’s pulse rate
against the ECG heart rate.
Prolonged, continuous use of a sensor may cause irritation, blistering,
or pressure necrosis of the skin. Check the sensor site regularly based
on patient condition and type of sensor. Change the sensor site if skin
changes occur. Do not use tape to hold the sensor in place as this may
cause inaccurate readings or damage to the sensor or skin.
Carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.
Carboxyhemoglobin and methemoglobin may erroneously increase
SpO2 readings. The amount that SpO2 increases is approximately equal
to the amount of carboxyhemoglobin or methemoglobin that is present.
connection and, if necessary, replace the sensor, extension cable or
both.
Reusable sensors may be used on the same site for a maximum of 4
hours, provided the site is inspected routinely to ensure skin integrity
and correct positioning.
General
The defibrillator/monitor uses pulse oximetry to measure functional oxygen saturation in
the blood. Because a measurement of SpO2 is dependent upon light from the SpO 2
sensor, excessive ambient light can interfere with this measurement. SpO2 and Pulse rate
are updated every second. This defibrillator/monitor measures functional saturation -
oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport
oxygen. It does not detect significant amounts of dysfunctional hemoglobin, such as
carboxyhemoglobin or methemoglobin.
116
Setup Connections
When selecting a sensor, consider the patient’s weight and activity, adequacy of perfusion,
availability of sensor sites, need for sterility, and anticipated duration of monitoring. Refer
to Table 30, or contact Nellcor® or Mediana sales department for ordering information.
1. Select the proper sensor for the patient.

2. Connect the extension cable to the SpO 2 connector on the defibrillator/monitor’s
front panel and lock it.
3. Connect the sensor to the extension cable and lock
it.
4. Carefully apply the sensor to the patient, as
described in the sensor directions for use. Observe
all warnings and cautions in the directions for use.
Note: Refer to directions for use to ensure the proper placement for various types of SpO2
sensors.
Note: Periodically check to see that the sensor remains properly positioned on the patient
and that skin integrity is acceptable. Refer to the sensor directions for use.
Table 30. SpO2 Sensors

Sensor Model Patient Size
OXIMAX® oxygen transducer (Sterile, single- MAX-N <3 or >40 kg
use only) MAX-I 3 to 20 kg
MAX-P 10 to 50 kg
MAX-A >30 kg
MAX-AL >30 kg
MAX-R >50 kg
OXIMAX Oxiband® oxygen transducer OXI-A/N <3 or >40 kg
(Reusable with disposable non-sterile OXI-P/I 3 to 40 kg
adhesive)
OXIMAX Durasensor® Oxygen transducer DS-100A >40 kg
(Reusable, non-sterile)
OXIMAX OxiCliq® oxygen transducers P 10 to 50 kg
(Sterile, single-use only) N <3 or >40 kg
I 3 to 20 kg
A >30 kg
OXIMAX Dura-Y® multisite oxygen transducer D-YS >1 kg
(Reusable, non-sterile)
For use with the Dura-Y sensor:
Ear clip (Reusable, non-sterile) D-YSE >30 kg
Pedi-CheckTM pediatric Spot Check clip
(Reusable, non-sterile) D-YSPD 3 to 40 kg
OXIMAX MAX-FAST® adhesive reflectance MAX- >40 kg
oxygen transducer FAST
117
Description of SpO2 Menu Functions
2 3
4
1 SpO2 icon 3 SpO2 value

2 Pulse amplitude indicator 4 Bell icon
Figure 50. SpO2 Display
1 SpO2 waveform icon 2 SpO2 waveform
Figure 51. SpO2 Waveform Display
Pulse Amplitude Indicator
The pulse amplitude indicator is the segmented display within the SpO 2 numerical area
that shows the relative strength of the detected pulse. A stronger pulse causes a larger
amplitude indicator.
Alarm Limit Return
Figure 52. SpO2 Menu Display
Table 31. SpO2 Menu

SpO2 MENU
(Alarm Limit)
▲ % SpO2 Upper Alarm Limit
▼ % SpO2 Lower Alarm Limit
Return
Limit Alarm Pause
When the Limit Alarm Pause is set to On, the audible alarm for SpO2 limit violation is
paused.
118
Theory of Operation
The defibrillator/monitor uses pulse oximetry to measure functional oxygen saturation in
the blood. Pulse oximetry works by applying a Nellcor™ pulse oximetry sensor to a
pulsating arteriolar vascular bed, such as a finger or toe. The sensor contains a dual light
source and a photodetector. Bone, tissue, pigmentation, and venous vessels normally
absorb a constant amount of light over time. The arteriolar bed normally pulsates and
absorbs variable amounts of light during the pulsations. The ratio of light absorbed is
translated into a measurement of functional oxygen saturation ( SpO2). Ambient conditions,
sensor application, and patient conditions can influence the ability of the pulse oximeter to
accurately measure SpO2. Pulse oximetry is based on two principles: oxyhemoglobin and
deoxyhemoglobin differ in their absorption of red and infrared light (measured using
spectrophotometry), and the volume of arterial blood in tissue (and hence, light absorption
by that blood) changes during the pulse (registered using plethysmography). A
defibrillator/monitor determines SpO2 by passing red and infrared light into an arteriolar
bed and measuring changes in light absorption during the pulsatile cycle. Red and
infrared low-voltage light-emitting diodes (LED) in the sensor serve as light sources; a
photo diode serves as the photo detector. Since oxyhemoglobin and deoxyhemoglobin
differ in light absorption, the amount of red and infrared light absorbed by blood is related
to hemoglobin oxygen saturation. The defibrillator/monitor uses the pulsatile nature of
arterial flow to identify the oxygen saturation of arterial hemoglobin. During systole, a new
pulse of arterial blood enters the vascular bed, and blood volume and light absorption
increase. During diastole, blood volume and light absorption reach their lowest point. The
defibrillator/monitor bases its SpO2 measurements on the difference between maximum
and minimum absorption (measurements at systole and diastole). By doing so, it focuses
on light absorption by pulsatile arterial blood, eliminating the effects of nonpulsatile
absorbers such as tissue, bone, and venous blood.
Functional versus Fractional Saturation

This defibrillator/monitor measures functional saturation where oxygenated hemoglobin
expressed as a percentage of the hemoglobin that can transport oxygen. It does not
detect significant amounts of dysfunctional hemoglobin, such as carboxyhemoglobin or
methemoglobin. In contrast, hemoximeters such as the IL482 report fractional saturation
where oxygenated hemoglobin expressed as a percentage of all measured hemoglobin,
including measured dysfunctional hemoglobin. To compare functional saturation
measurements to those from an instrument that measures fractional saturation, fractional
measurements must be converted using the listed equation.
functional saturation = fractional saturation

× 100
100 – (%carboxyhemoglobin + %methemoglobin)
119
Measured versus Calculated Saturation
When calculating saturation from a blood gas partial pressure of oxygen (PO 2), the
calculated value may differ from the SpO2 measurement of a defibirillator/monitor. This
usually occurs when saturation calculations exclude corrections for the effects of variables
such as pH, temperature, the partial pressure of carbon dioxide (PCO 2), and 2,3-DPG,
that shift the relationship between PO2 and SpO2.
Figure 53. Oxyhemoglobin Dissociation Curve
1 % Saturation Axis 3 Increased pH; Decreased temperature, PCO2, and 2,3-DPG

2 PO2 (mmHg) Axis 4 Decreased pH; Increased temperature, PCO2, and 2,3-DPG
120
Clinical Studies
Clinical studied conducted for the Nellcor™ Sensors
Overview
This appendix contains data from clinical studies conducted for the Nellcor™ sensors
used with the defibrillator/monitor.
One (1) prospective, controlled hypoxia clinical study was conducted to demonstrate the
accuracy of Nellcor™ sensors when used in conjunction with the defibrillator/monitor. The
study was performed with healthy volunteers at a single clinical laboratory. Accuracy was
established by comparison to CO-oximetry.
Methods
Data from 11 healthy volunteers were included in the analysis. Sensors were rotated on
digits and brow to provide a balanced study design. SpO 2 values were continuously
recorded from each instrument while inspired oxygen was controlled to produce five
steady state plateaus at target saturations of approximately 98, 90, 80, 70 and 60%. Six
arterial samples were taken 20 seconds apart at each plateau resulting in a total of
approximately 30 samples per subject. Each arterial sample was drawn over two (2)
respiratory cycles (approximately 10 seconds) while SpO 2 data were simultaneously
collected and marked for direct comparison to CO 2. Each arterial sample was analyzed by
at least two of the three IL CO-oximeters and a mean SaO2 was calculated for each
sample. End tidal CO2, respiratory rate, and respiratory pattern were continuously
monitored throughout the study.
Study Population
Table 32. Demographic Data

Type Class Total
Gender Male 5 people
Female 6 people
Caucasian 8 people
Race Hispanic 2 people
African American 1 people
Asian 0 people
Age - 19 ~ 48 years
Weight - 108 ~ 250 lb
Skin pigment Very light 2 people
Olive 5 people
Dark olive/Medium black 3 people
Extremely dark/Blue black 1 people
121
Study Results
Accuracy was calculated using the root mean square difference (RMSD).
Table 33. SpO2 Accuracy for Nellcor™ Sensors

SpO2 MAX-A MAX-N MAX-FAST
Decade Data Arms Data Arms Data Arms
Points Points Points
60-70 71 3.05 71 2.89 71 2.22
70-80 55 55 55 2.32 55 1.28
80-90 48 1.84 48 1.73 48 1.48
90-100 117 1.23 117 1.68 117 0.98
Figure 54. Modified Bland-Altman Plot
1 Test Sensor: 2 Avg CO-oximeter value 70-100% SpO2

Avg CO-oximeter value 70-100% SpO2
Oximetry board with MAX-A sensor Trendline of MAX-A sensor
Oximetry board with MAX-N sensor Trendline of MAX-N sensor
Oximetry board with MAX-FAST sensor Trendline of MAX-FAST sensor
Adverse Events or Deviations

The study was conducted as expected with no adverse events and no deviations from the
protocol.
Conclusion
The pooled results indicate that for a saturation range of 60-80% for SpO2, the acceptance
criterion was met for the defibrillator/monitor when tested with MAX-A, MAX-N and MAX-
FAST sensors. The pooled results indicate that for a saturation range of 70-100% for
SpO2, the acceptance criterion was met.
122
RESPIRATION MONITORING
standards.
The defibrillator/monitor does not detect apnea when the respiration
signal is measured by trans-thoracic impedance.
Keep patients under close surveillance when monitoring respiration.
Respiration signals are relatively more sensitive to interference from
radiated electromagnetic signals. Thus, it is possible, although unlikely,
that radiated electromagnetic signals from sources external to the
patient and defibrillator/monitor can cause inaccurate respiration
readings. Do not rely entirely on the defibrillator/monitor respiration
readings for patient assessment. If measured waveforms are not
appropriate readings, check external conditions to ensure there is no
equipment causing electromagnetic interference.
Impedance respiration technology is very sensitive to any of artifacts. If
impedance respiration is doubtful due to artifacts, it is not
recommended to assess the clinical state of patient only with
impedance respiration parameter.
General
The patient’s respiration is detected by using two of the three leads of the ECG electrodes
and cable. Real-time respiratory information is presented as a waveform and numeric
data; Impedance respiration source (IM).
The airway respiration measurement uses gases coming into the airway adapter in case
of the CO2 equipped. The defibrillator/monitor detects respiration rate by computing each
breath cycle form the continuous EtCO2 waveform; Airway respiration source (AW).
The respiration monitoring is designed to use the variation of this thoracic impedance. The
chest contains various materials, ranging from bone to air. Each of these materials has
different electrical properties and is located in a different portion of the chest. The
materials of the chest vary in electrical resistivity (the amount of electrical resistance
between opposite faces of a cube of that material), which is an important determinant of
electrical impedance in the body.
123
Setup Connections
Refer to the ECG Monitoring section for how to acquire the respiration signal by patient
impedance using the ECG electrodes, leads and cable.
The performance of impedance respiration can be improved by the particular placement

of the Left arm (LA) and Right arm (RA) electrodes. (See Standard ECG electrode
placement in Figure 14.)
Refer to the Capnography Monitoring section to detect the respiration signal by the
airway adapter in case that the CO2 equipped.
Note: Impedance respiration monitoring is active only if the paddles are not connected to
the defibrillator/monitor or if pads are not connected to pads cable. In case pads or
paddles are connected, the respiration rate is displayed as “---” and waveform of
respiration is not displayed on the screen.
Description of Respiration Menu Functions
1
4
2
3
5
1 Respiration rate icon 4 Respiration icon

2 Respiration rate source icon 5 Measurement Value
3 Bell icon
Figure 55. Respiration Display
1 Respiration waveform icon 2 Respiration waveform

Figure 56. Respiration Waveform Display
Respiration
Respiration Apnea time setting Alarm Limit Return
Setting
Figure 57. Respiration Menu Display
124
Table 34. Respiration Menu
RESPIRATION MENU
RR Source Auto (Airway > Impedance), Impedance, Airway,
Return
Size X 0.5, X 1, X 1.5, X 2
Apnea time setting Off, 10 seconds, 20 seconds, 30 seconds, 40
seconds, 50 seconds, 60 seconds, Return
(Alarm Limit)
▲ RR Upper Limit Adjust
▼ RR Lower Limit Adjust
Return
RR Source
User can select either Airway or Impedance for source of the respiration rate. If the Auto
is selected, the defibrillator/monitor will automatically drive the respiration rate from one
of the monitoring parameters in this order of priority; Airway and Impedance.
Note: You can select Airway as the source when CO2 module is installed.
Size
Size allows you to adjust the waveform size. Size can be selected as X 0.5, X 1, X 1.5 or
X 2.0.
Apnea time setting
When the patient’s breath is not detected from the airway measurement for the selected
time setting, the defibrillator/monitor will activate an apnea alarm. When 60 is selected,
the defibrillator/monitor will generate two tones after 20 seconds from no breath. Then
three tones are generated again after 20 seconds, and then an apnea alarm will be
activated after another 20 seconds. If Off is selected, the defibrillator/monitor does not
detect an apnea alarm.
When the defibrillator/monitor does not detect a respiration signal from the impedance
measurement for 40 seconds, the defibrillator/monitor will activate a loss of respiration
alarm.
Check the condition of the patient, then check the connections of the patient cables.
Limit Alarm Pause
When Limit Alarm Pause is set to On, the audible alarm for respiration rate limit violation
is paused.
125
Theory of Operation
The respiration monitoring is designed to use the variation of this thoracic impedance. The
chest contains various materials, ranging from bone to air. Each of these materials has
different electrical properties and is located in a different portion of the chest. The
materials of the chest vary in electrical resistivity (the amount of electrical resistance
between opposite faces of a cube of that material), which is an important determinant of
electrical impedance in the body.
Two of the major components of the chest, blood and air, are at opposite ends of the
scale. Furthermore, the volume of each of these materials varies with time over the
cardiac and breathing cycles. The variation of the thoracic impedance is caused by the
difference between air and blood in the thoracic impedance. Blood has relatively low
resistivity, which varies over the cardiac cycle owing to changing blood volumes in the
heart and in the vascular compartment. Air, on the other hand, has high electrical
resistivity and hence impedance, and it undergoes wide volume changes in the lungs
during normal breathing. i.e. the impedance of blood is 150 ohm/cm and the one of air is
5=000 ohm/cm.
The patient’s respiration is detected by using two of the three leads of the ECG electrodes
(RA and LA, or RA and LL) and cable. The electrical impedance between a pair of
electrodes is determined by dividing the voltage difference between the two electrodes by
the current that passes between them. When the electrodes are placed on the actual
structure, respective structures change.
A low-level excitation signal is applied to these leads, and the variation of the thoracic
impedance caused by the breathing is sensed and processed for display and
measurement. This variation is processed to the voltage value for the measurement.
In order to transfer the thoracic impedance by a transformer, it is used a minimum
constant current of the sine wave carrier signal. The transferred thoracic impedance is
changed to the voltage signal by using bridge circuit and differential amplifier. Then, ECG
signal is removed by filter, and carrier frequency is removed by full wave rectifier and filter
in order to extract only thoracic impedance in amplifying at the definite level of signal. This
extracted thoracic impedance signal is used to measure the respiration by digital signal
processing.
126
CAPNOGRAPHY MONITORING
according to your facility’s standards and the manufacturer’s
recommendation. Always refer to the manufacturer’s Directions for Use
for instruction about operation, cleaning, and replacement.
The EtCO2 readings do not always correlate closely with blood gas
values, especially in patients with pulmonary disease, pulmonary
embolism or inappropriate ventilation.
If uncertain about the accuracy of any measurement, first check the
patient’s vital signs by alternate means, and then make sure the
defibrillator/monitor is functioning correctly.
The defibrillator/monitor should not be used as an apnea monitor.
To ensure patient safety, do not place the defibrillator/monitor in any
position that might cause it to fall on the patient.
To ensure accurate performance and prevent defibrillator/monitor
failure, do not expose the defibrillator/monitor to extreme moisture,
such as rain.
The use of accessories, transducers, sensors and cables other than
those specified may result in increased emission and/or decreased
immunity of the equipment and/or system.
CO2 readings and respiratory rate can be affected by sensor application
errors, certain ambient environmental conditions, and certain patient
conditions.
The defibrillator/monitor is a prescription device and is to be operated
by qualified healthcare personnel only.
Ensure that the components of the airway are secure. If they become
loose, external air may be sucked in the tube and the sampling gas will
be diluted, causing incorrect measurement values.
Ensure that selection of a volatile anesthetic is done carefully. If an
improper selection is made, the measurement values may be incorrect.
Do not use accessories other than which are specified. Different
sampling tube lengths or inside diameters may have an effect on the
measurement.
The mainstream/sidestream capnography module should not be used in
the presence of flammable anesthetics or other flammable gases. Use
of this device in such an environment may present an explosion hazard.
Do not use device without rectifying a gas calibration failure, as correct
measurement readings will not be obtained.
Do not use device on patients that cannot tolerate the withdrawal of 50
cc/min ±10cc /min from airway.
CO2 should not be measured in the presence of aerosolized
pharmaceuticals.
Do not use a damaged airway adapter.
To ensure accurate performance and prevent the defibrillator/monitor
failure, do not connect the exhaust tube to the ventilator circuit.
Flow-related readings may significantly affected by a gas leak, such as
that caused by an un-cuffed endotracheal tube or a damaged
sidestream sensor and mainstream sensor.
In high-altitude environments, EtCO2 values may be lower than values
observed at sea level, as described by Dalton's law of partial pressures.
127
When using the defibrillator/monitor in high-altitude environments, it is
advisable to consider adjusting EtCO2 alarm settings accordingly.
Do not operate the Capnostat sensor when it is wet. Do not immerse the
device in water.
Do not operate the Capnostat sensor if it appears to have been damage
or if it fails to operate properly.
If the patient’s airway is configured with a closed suctioning system,
make sure the airway adapter is placed closed to the suctioning system
(on the ventilator side). This will help ensure that the sampling adapter
is not impaired during and after suctioning.
The disposable airway adapter, nasal and nasal/oral sampling cannulas,
and the airway adapter kit are intended for single patient use. Do not
reuse or sterilize these disposable adapters, because system
performance will be compromised.
Do not insert any object other than the sidestream sample cell into the
inlet port of the CO2 module.
Inspect the mainstream CO2 sensor and airway adapter connection to
ensure correct positioning.
Position sidestream airway adapter with the tubing in an upright
position. This help keep patient secretions from pooling into the tubing.
To prevent moisture from during into the mainstream airway or into the
sidestream airway adapter tubing, do not place the adapter in a gravity
dependent position.
It is recommended that the mainstream airway adapter and the
sidestream airway adapter be removed from the circuit whenever an
aerosolized medication is delivered. The increased viscosity of the
medication may contaminate the sensor windows, causing the sensor
to fail prematurely.
General
The defibrillator/monitor capnography option supports mainstream and sidestream gas
analysis designed to measure the concentration of carbon dioxide in a gas mixture and to
aid in determining the patient’s ventilatory, circulatory, and metabolic status. Mainstream
(nondiverting) and sidestream (diverting) capnography are highly accurate methods of
measuring respiratory gas values. When monitoring capnography, the defibrillator/monitor
automatically compensates for the ambient barometric pressure to ensure accurate
readings.
128
Setup Connections
The defibrillator/monitor has one capnography sensor receptacle which may be used for a
mainstream capnography sensor or a sidestream capnography sensor.
Note: Capnograpy is not analyzed during unit warm-up however, the capnography does
display to indicate that the defibrillator/monitor is working properly.
Note: The typical initial warm-up period can take up to two minutes. This time varies
based of the temperature of the sensor at the start of the initial warm-up.
Note: The airway adapter may require cleaning or replacement if the capnograph is used
on patients that emit excessive mucous.
Calibrating the CO2 Sensor
You must calibrate the CO2 sensor the first time it is connected to the defibrillator/monitor,
when the CO2 sensor is changed. You do not need to calibrate the sensor when you
power on the defibrillator/monitor. Once calibrated, the sensor may be disconnected and
reconnected without calibration.
Note: To maintain optimum performance of the sensor and capnograph, you should
perform a sensor calibration verification at least once a week.
Mainstream Operation
Mainstream monitoring uses an external, self-calibrating CO2 sensor to ensure continuous

monitoring without interruption of connection. Reusable, lightweight, or single-use airway
adapters are available for both adult and neonatal (low dead space) patients. Respiration
can be monitored via an airway adapter and endotracheal or tracheostomy tube using the
mainstream function of the module.
The external capnography device includes a small, lightweight sensor that continuously
measures the end-tidal and minimum carbon dioxide levels in the patient’s airway. The
sensor head contains a small infrared transducer that accurately measures the CO 2 in the
airway. The sensor is connected to the airway by a disposable or reusable airway adapter.
These adapters are available in adult and neonatal size.
Figure 58. Connection for mainstream
1 Y-piece 4 Elbow
2 Airway adapter 5 Mainstream CO2 sensor
3 Patient connector (Adult/Pedi)
129
Sidestream Operation
Sidestream monitoring uses an external, sidestream sensor that plug into the
capnography port on the defibrillator/monitor. Adult, pediatric, or infant sampling lines are
then plugged into the sensor receptacle. Respiration can be monitored for intubated or
non-intubated patients via an airway adapter, nasal cannula, or nasal/oral cannula using
the sidestream function of the module. Sidestream monitoring diverts patient gases at a
rate of 50 ml/min (±10ml/min).
The sidestream sampling lime consists of a sample cell on one end that into the
sidestream sensor receptacle on the defibrillator/monitor. The other end of sampling line
is connected to the patient either via a cannula or a sample-T, as shown in Figure 59.
Note: For connection method for exhaust tube, follow the instruction in the directions for
use of sidestream sensor.
Figure 59. Connection for sidestream
1 Cannula 3 Sampling-T
2 Sampling cell 4 Sidestream CO2 sensor
130
Description of EtCO2 Menu Functions
1 5
2 6
3 7
4
1 EtCO2 icon 5 EtCO2 unit

2 EtCO2 value 6 Bell icon
3 InCO2 icon 7 InCO2 unit
4 InCO2 value
Figure 60. EtCO2 Display
1 EtCO2 waveform icon 2 EtCO2 waveform

Figure 61. EtCO2 Waveform Display
Figure 62. EtCO2 Menu Display
Table 35. EtCO2 Menu

Menu Level 2 Menu or Response Level 3 Menu or Response
EtCO2 MENU
EtCO2 On
Off
Return
EtCO2 Setting N2O Gas On
Off
Return
O2 Gas On
Off
Return
Enter
Calibration
Return
Scale 0 ~ 40 mmHg
0 ~ 60 mmHg
0 ~ 80 mmHg
Auto
Return
(Alarm Limit)
▲ EtCO2 Upper Limit Adjust
▼ EtCO2 Lower Limit Adjust
131
▲ InCO2 Upper Limit Adjust
▼ InCO2 Lower Limit Adjust
Return
Note: The EtCO2 unit can only be changed by authorized personnel via the Service Menu.
EtCO2
When the capno measurement is On, EtCO2, InCO2 and capno waveform measurement
are activated.
EtCO2 Setting
O2 Gas
As the N2 in the sample gas is replaced by O2, the effect is a decrease in IR absorption.
This results in a lower than actual measured CO2 value (CO2 measured).
It is recommended O2 Gas is set to On to correct for the O 2 effect when the O2
concentration is greater than 50%. At O2 levels equal to or less than 50%, the correction
should not be used.
N2O Gas
As the N2O in the sample gas, an assumption is made: if N 2O is administered to the
patient, then the remaining balance of the administered mixture is O 2. The combined
effect of these gases is two-fold: O2 presence decreases IR absorption, and N2O
presence increases absorption. Though N2O does not directly absorb the filtered IR
energy, it cause the CO2 molecule to absorb and pass along some of it energy to the
N2O molecule of similar molecular weight. By passing off some of this energy, the CO 2
molecule is free to absorb even more energy which leads to an increase in absorption.
Since the increased absorption effect due to N 2O presence is greater than the decrease
due to O2 presence, an optimal administered mixture of 25% N2O and 75% O2 effectively
cancels the combined effect. The effect of desflurane on the CO 2 measurement is similar
to the effect of N2O. It is recommended N2O Gas is set to On when N 2O or desflurane
concentrations is above 12%.
Calibration
When the calibration is set to Enter, the EtCO2 calibration will be performed
automatically.
Scale
The user can select the scale of capno waveform. When Auto is selected, the
defibrillator/monitor will automatically set the scale upon the measurement value.
Limit Alarm Pause
When Limit Alarm Pause is set to On, the audible alarm for EtCO2 or InCO2) limit
violation is paused.
132
Theory of Operation
The CO2 sensor measures CO2 by using the infrared technique. The principle is based on
the fact that CO2 molecules absorb infrared (IR) light energy of specific wavelengths, with
the amount of energy absorbed being directly related to the CO 2 concentration. When an
IR beam is passed through a gas sample containing CO 2, the electronic signal from the
photodetector (which measures the remaining light energy) is measured. This signal is
then compared to the energy of the IR source and adjusted to accurately reflect CO 2
concentration in the sample. The CO 2 sensor’s response to a known concentration of CO 2
is stored at the factory in the sensor’s memory. A reference channel accounts for optical
changes in the sensor, allowing the system to remain in calibration without user
intervention.
133
134
TEMPERATURE MONITORING
For best product performance and measurement accuracy, use only YSI
400 and 700 series temperature probes recommended by Mediana. Use
accessories according to the manufacturer’s directions for use and your
facility’s standards.
General
Measurement of patient temperature is accomplished by processing the signal from a
probe containing a resistance element whose impedance is temperature dependent.
These devices are called thermistors. The measuring time required to obtain accurate
readings at the specific body site is about 20 seconds.
Setup Connections
The defibrillator/monitor is designed to accept signals from the temperature probes, YSI
400 series and 700 series for skin, rectal or etc.
1. Insert a body temperature probe into the temperature connector on the

defibrillator/monitor’s side option case. (see Figure 1).
2. Follow the directions for use accompanying the temperature probe.
Table 36. Temperature Sensors

Sensor Description
YSI 401 or compatible Mono, rectal type
YSI YSI 409 or compatible Mono, skin type
sensors YSI 701 or compatible Stereo, rectal type
YSI 709 or compatible Stereo, skin type
Description of Temperature Menu Functions

1 5
2 6
3 7
4 7
1 Temperature1 icon 5 Temperature1 unit

2 2
Temperature1 value 6 Bell icon
3 Temperature2 icon 7 Temperature2 unit
4 Temperature2 value
Figure 63. Temperature Display
Alarm Limit Return
Figure 64. Temperature Menu Display
135
Table 37. Temperature Menu
Menu Level 2 Menu or Response
TEMPERATURE MENU
(Alarm Limit)
▲ Temperature1 Upper Limit Adjust
▼ Temperature1 Lower Limit Adjust
▲ Temperature2 Upper Limit Adjust
▼ Temperature2 Lower Limit Adjust
Return
Note: The temperature unit can only be changed by authorized personnel via the Service
Menu.
Limit Alarm Pause
When the Limit Alarm Pause is set to On, the audible alarm for Temperature limit
violation is paused.
Theory of Operation
Temperature measurement used by the defibrillator/monitor based on a thermistor whose
resistance is inversely proportional to its temperature. By measuring the thermistor’s
resistance, its temperature can be calculated. The resistance of the thermistor is
measured by passing a current through it and measuring the voltage developed across it.
The defibrillator/monitor is designed to accept the signals from electrically isolated a range
of temperature probes from YSI-400 and YSI-700 series. The probes may be used for
skin or rectal temperature measurement. Probes are furnished with a standard 10-feet
lead; extension leads are available. The signal from the probe is conditioned by the
defibrillator/monitor input circuitry, processed, and used to drive the numeric display.
136
IBP MONITORING
Proper measurements may not be possible,
 If improper zero calibration was performed.
 If air bubbles are mixed into the patient circuit.
If the height of the three-way tap for zero calibration and the right
auricle have changed.
If the pressure transducer has been dropped or subjected to strong
physical shock, check for faults before use.
Be sure to thoroughly read the instruction manuals for each item-such
as the transducer, monitoring kit and transfusion set-that are used in
invasive blood pressure measurements before using them. The
cautions and warnings for such items are not included in this manual.
Use a CE certified transducer with a sensitivity of 5μV/V/mmHg at an
excitation voltage of 5 VDC, and a measurement range of -50 to
300mmHg.
Do not reuse disposable (single use) transducers.
Check the time limit on the package not to use transducers with expired
dates.
Ensure that reusable transducers are sufficiently sterilized.
To ensure patient safety, do not contact any conductive parts to the
applied part.
Never install or remove the IBP module while the defibrillator/monitor is
powered on. It is likely to break when installing or removing it while
powered on.
Do not perform the pressure zero setting while measuring the patient.
If air bubbles appear in the pressure line or transducer, flush the
system with the solution to be infused again.
Invasive pressure alarms (and pulse alarm, if there are being derived
from the invasive pressure) are turned off while the transducer is
zeroing. The alarms turn back on 30 seconds after the zeroing is
finished.
Make sure the correct label has been selected before you set the alarm
limits The alarm limits you set are valid only for labels in the current
group. Changing the label could change the alarm limits.
connection and, if necessary, replace the sensor.
Zeroing is necessary before IBP monitoring can begin.
Verify the IBP zero (per hospital procedures) and alarm at least once
daily and whenever the patient’s position changes to ensure that IBP
measurements are accurate.
Zero the pressure transducer to atmospheric pressure to ensure
pressure readings are accurate.
137
General
The invasive blood pressure measurement measures the systolic pressure, mean
pressure, diastolic pressure and pulse rate for up to 2 blood pressure line channels using
blood pressure transducers, and displays the blood pressure waveform.
Setup Connections
1. Connect the interface cable for the transducer to the IBP connector (6pin, red
round connector) on the defibrillator/monitor’s side option case. An interface cable
for the transducer has to be selected correctly as it depends on the each
transducer type.
2. Set up the patient circuit according to the directions for use of the transducer,
monitoring kit and IV set.
The drawing below shows the example.
Figure 65. IBP connections
1 Pressure bag 3 Interface cable

2 Transducer 4 To patient
138
Description of IBP 1 Menu Functions
1 4
5
2
3 6
1 IBP 1 label icon 4 IBP 1 unit

2 Systolic value 5 Diastolic value
3 Mean arterial
4 pressures value 6 Bell icon
Figure 66. IBP 1 Display
1 IBP 1 label icon 2 IBP 1 waveform

Figure 67. IBP 1 Waveform Display
Zero Setting Scale Label Alarm Limit Return
Figure 68. IBP 1 Menu Display
Table 38. IBP 1 Menu

Menu Level 2 Menu or Response
IBP 1 MENU
Zero Setting Enter
Return
Scale 0 ~ 50mmHg, 0 ~ 100mmHg, 0 ~ 200mmHg, 0 ~
300mmHg, Auto, Return
Label P1
ABP
Return
(Alarm Limit)
▲ MEAN Upper Limit Adjust
▼ MEAN Lower Limit Adjust
Return
139
Zero Setting
When Zero Setting is set to Enter, IBP 1 channel is calibrated.
Scale
The user-selectable pressure waveform scale allows you to adjust the scale of a pressure
waveform. The scale can be selected as 0 to 0 ~ 50mmHg, 0 ~ 100mmHg, 0 ~ 200mmHg,
0 ~ 300mmHg or Auto.
Label
The label can be selected as P1 or ABP.
Limit Alarm Pause
When the Limit Alarm Pause is set to On, the audible alarm for IBP 1 limit violation is
paused.
Description of IBP 2 Menu Functions
1 4
2
5
3 6
1 IBP 2 label icon 4 IBP 2 unit

2 Systolic value 5 Diastolic value
3 Mean arterial
4 pressures value 6 Bell icon
Figure 69. IBP 2 Display
1 P2 (CVP, PAP, LAP) icon 2 P2 waveform

Figure 70. IBP 2 Waveform Display
Zero Setting Scale Label Alarm Limit Return
Figure 71. IBP 2 Menu Display
140
Table 39. IBP 2 Menu
IBP 2 MENU
Zero Setting Enter
Return
Scale 0 ~ 50mmHg, 0 ~ 100mmHg, 0 ~ 200mmHg, 0 ~
300mmHg, Auto, Return
Label P2
CVP
PAP
LAP
Return
(Alarm Limit)
▲ MEAN Upper Limit Adjust
▼ MEAN Lower Limit Adjust
Return
Zero Setting
When Zero Setting is set to Enter, IBP 2 channel is calibrated.
Scale
The user-selectable pressure waveform scale allows you to adjust the scale of a pressure
waveform. The scale can be selected as 0 ~ 50mmHg, 0 ~ 100mmHg, 0 ~ 200mmHg, 0 ~
300mmHg or Auto. When the Auto is selected, the defibrillator/monitor automatically set
the scale upon the IBP measurement value.
Label
The label can be selected as P2, CVP, PAP or LAP.
Limit Alarm Pause
When the Limit Alarm Pause is set to On, the audible alarm for IBP 2 limit violation is
paused.
141
Theory of Operation
The pressure transducer is connected to a pressure line which, by means of a catheter is

invasively connected to the patient blood stream. The force of movement of the blood in
the patient vessels in transported by the fluid column in the pressure line to the transducer.
This movement cause an electrical signal to be generated which is then amplified to
display the pressure wave and the numeric for the systolic, diastolic and mean pressure
values.
The blood pressure is influenced by the respiratory system. This occurs in spontaneous
breathing patients, but is more apparent in positive pressure ventilated patients. To
reduce this respiration artifact the module uses a variable weight filter technique in the
processing of the pressure values.
142
SELF-TEST FUNCTION
General
This defibrillator/monitor incorporates a Self-test function. The defibrillator/monitor should
be checked at regular intervals so that it will always be ready-to-use for emergency
situations. There are three modes: Manual Self-test, Auto Self-test and Button test.
Additionally, the external shock test should be performed prior to use.
Manual Self-test
If the user wants to perform a High-voltage module alive test, Body impedance test, ECG
circuit and algorithm test, internal shock test, internal pacing output test, pads/paddle
connection test, system ROM test, system RAM test, real time clock test, installed module
alive test and battery test, it can be performed by ‘Manual Self-test’ function in Setup
Menu.
Auto Self-test
When the defibrillator/monitor has been turned off, Auto Self-test (or scheduled Self-test)
is operated automatically according to the user’s setting. The Self-test interval can be
selected as Off, 24, 48, and 72 hours. If the residual of battery power is less than 60%
without using the AC or DC, the Self-test will not be performed.
If the defibrillator/monitor is in use at the time of a scheduled Auto Self-test, the Auto Self-
test will be canceled. If the defibrillator/monitor is turned on when the Auto Self-test is in
process, the Auto Self-test will be canceled and the defibrillator/monitor will be operated
normally.
Note: The setting of the Auto self-test (time and interval) can only be changed by
authorized personnel via the Service Menu.
Button test
The defibrillator/monitor has the button test function. User can check buttons that are
working correctly. It can be performed by ‘Button Test’ function in Setup Menu.
Button test is to check button is working correctly by pressing the denotative buttons.
Button test can be divided into two types, Front panel and paddles. ‘Shock’, ‘Charge’,
‘Analyze’, ‘Energy Select’, ‘BPM’, and ‘mA’ buttons can be checked on the front panel,
and ‘Shock’, ‘Charge’, ‘Energy Up’, ‘Energy Down’, and ‘Recording’ buttons can be
checked on the paddles.
Note: It is recommended to run ‘Button test’ manually once a week.
143
Functions to be tested in Self-test
The defibrillator/monitor Self-test performs 11 test steps. Lists and descriptions of the
tests are indicated below.
Figure 72. Auto Self-test display
Table 40. Self-test functions

No. Test Description
1 High-Voltage module To check if the High-Voltage module is operational
operational test and available to communicate.
2 Body Impedance test To check impedance of internal fixed resistance from
25Ω to 175Ω
3 ECG circuit and algorithm To check the result of diagnosis for normal sinus
test rhythm and Ventricular Fibrillation for ECG input.
4 Internal Shock test To check the energy accuracy for discharge of set
energy to internal discharge resistance.
5 Internal Pacing output test To check the normal condition of pacing output of
fixed value of current and bmp.
6 Pads/Paddle connection test To check if paddles or pads are connected correctly.
7 System ROM test To check if the internal program is normal.
8 System RAM test To check if the Read/Write performance of RAM is
normal.
9 Real time clock test To check the accuracy of the time.
10 Installed module alive test To check if installed measurement parameter
modules are operational and working correctly.
11 Battery test To check the status of the battery.
Self-test result transmission (if configured with Wireless module option)

The result of the Self-test can be transmitted to a hospital biomedical engineer by using
the 3G/Wi-Fi module and can also be printed out by the printer module.
Self-test result printing

Printing the result of a Self-test can be set as On or Off in the Service menu by authorized
personnel as described in the service manual.
144
External shock test
The user must verify the ability to deliver defibrillation energy once a week.
Figure 73. External shock test
1. Make sure the paddles and the paddle tray are thoroughly clean and there is no
residue including the conductive material on electrode surfaces of the paddle and
paddle tray.
2. Place the paddles on the paddle tray. (see Figure 73).
3. Turn on the defibrillator/monitor.
4. Select the defibrillation energy by pressing the Energy level button on paddle.
5. Press the CHARGE button on paddle to charge the selected energy.
6. When charging is completed, Charge Indicator lights up red. Before Step 7, check
the Charge Indicator.
7. Press the SHOCK button on paddle.
8. Confirm the energy level on the display.
145
Trouble shooting
After finish the auto self-test, the defibrillator/monitor will be turned off itself again. If there
was no fail, the service LED will be blinking. But if any fail was detected, service LED and
buzzer sound will be generated. (when the defibrillator/monitor is using the AC or DC
power, the result of auto self-test will be displayed). But when the residual of battery
power has dropped less than 60 %, those LED and buzzer will be turned off for saving the
power.
Table 41. Trouble shooting of Self-test

LED condition Situation To do
LED OFF Possibility 1: The self-test has not Turn on the defibrillator/monitor
been performed. (Connect the AC or DC power if it is
Possibility 2: The self-test has been not connected) and perform the
performed but the residual of battery manual self-test via setup menu.
was dropped less than 60%, it turned
off the LED and buzzer itself.
LED Blink The self-test was finished, and no Turn on the defibrillator/monitor and
failure was detected. use it safely.
LED Fixed The self-test was finished and any If AC or DC power is connected, check
failure was detected. If AC or DC the failed item of self-test and contact
power is connected, self-test result qualified service personnel or your
will be displayed, and buzzer sound local supplier.
will be generated. If the If the device is using battery power
defibrillator/monitor is using battery only, turn on the defibrillator/monitor
power only, the buzzer sound will be and can check the failed item. After
generated without display screen. then, contact qualified service
personnel or your local supplier.
146
EVENT
General
Event data in either graphical or tabular format may be displayed on 3rd and 4th waveform
display area.
1. Press the Patient Info soft key.

2. Rotate the Multi function knob to Event records on the screen and press the Multi
function knob to display.
The event data is stored in memory. When the defibrillator/monitor turns on and starts to
measure vital signs, the defibrillator/monitor saves data of elapsed time before and after
10 seconds from the point of event generation. The events are including Defibrillation,
Pacer mode, Heart rate alarm, and VF alarm. Also, the defibrillator/monitor saves all NIBP
measurements events. The data remains even if the defibrillator/monitor is powered off.
After the defibrillator/monitor has stored 250 event data, “SYSTEM: Not enough memory”
message or “SYSTEM : Not enough memory(Internal memory)” message is displayed on
the screen.
Event Data List Display

The defibrillator/monitor presents event information in tabular format for all monitored
parameters. Event type, Patient ID, name, age, gender and time are displayed. The
newest data appears at the top of tabular events. To scroll the event data list, rotate the
Multi function knob when the event data list is displayed.
For the NIBP event may display the latest measurement.
Figure 74. Event Data List Display
147
Event Review Display
Event information in graphical format for ECG data is displayed in a graph. The
defibrillator/monitor displays the event information through recent 10sec after and before
event occurred. When printing the event information, all the parameters like ECG, SpO2,
NIBP, Temp, EtCO2, IBP and Respiration are printed.
The event review display of each parameter is indicated by the symbols specified in table.
The vertical range of a graphical event is presented with fixed value, and the horizontal
range is 20 seconds. The newest data appears at the right of graphical event. Use the
scroll function to view more data.
Figure 75. Event Review Display
148
12 Lead Record Display
The 12 lead data is displayed in tabular format as shown in Figure 76. Patient ID, name,
age, gender and time are displayed. The newest data appears at the top of tabular events.
To scroll the event data list, rotate the Multi function knob when the 12 lead data list is
displayed.
Figure 76. 12 Lead Record Display
ID#
To display ID Menu, press the ID soft key on the lower side of Event records. ID Menu is
displayed equal to Patient Info menu. Refer to Figure 77.
Figure 77. Patient Info Menu
149
150
REAL-TIME DATA
General
This defibrillator/monitor is designed to print the Real-time data and download to Real-
time data in SD card.
Real-time data menu

List of Real-time data shows a maximum of 18 data in Real-time data menu as shown in
Figure 75. When the Real-time data has been exceeded 18 data, user can identify the
exceeded 18 data. Data were identified when to press the previous icon or next icon,
which located in the upper-left corner. The Start time and Date duration of Real-time data
and data reading in memory(%) is displayed on the table. The newest data appears at the
top of tabular events.
Figure 78. Real-time data Menu
151
Real-time data recording
Real-time data contains header(print case, patient info and device info), event messages,
waveform, shock information and trend in real time. In order to write by user, the
comments, weight, height, device type and operator are left blank.
Header recording
The defibrillator/monitor prints case, patient info and defibrillator/monitor info in header as
shown in Figure 76.
Case
Case contains Date/time when the real-time data is stored, and comments for the real-
time data.
Patient info
Patient info contains patient ID, patient name, patient gender, patient age, patient weight,
patient height, number of shock, pacing time and number of 12-lead ECG diagnosis.
Device info
The device info contains device type, operator, serial number.
Event messages recording
The event messages contain event time, event message and ECG number as shown in
Figure 76. The event of ECG, V-FIB, Shock, Pacing and ECG sequentially is assigned
number. The table is displayed time, event message and ECG number from left to right.
When above event occurred at the same time, the time displayed only once. Table
contains maximum 20 data. When exceeding 20 data, data is displayed next table.
Case Time Event ECG-Nr.

---------------------------------------------------------------------- -----------------------------------------------------------------------------------------------------------
Start time: 2014-12-26 15:18:49 15:18:49 Power on
Data duration : 00:01:55 AED mode
Comments: Start ECG 1
15:18:50 Adult pads
Patient Info. 15:18:52 Analyzing heart rhythm
---------------------------------------------------------------------- 15:18:54 Low heart rate limits violated
Patient ID: 15:19:02 ECG: V-FIB 2
Patient name: Shock advise
Gender: Age: 15:19:04 Charging (125J)
Weight: Height: 15:19:08 Shock ready
Total Shocks: 3 15:19:11 Shock delivered (1, 125J, 51ohm) 3
Total time paced: 00:00:00 15:19:13 CPR
Total 12-Lead ECG: 0 15:20:14 Manual mode: NO SYNC
15:20:15 Charging (125J)
Device Info. 15:20:19 Shock ready
---------------------------------------------------------------------- 15:20:20 Shock delivered (2, 125J, 51ohm) 4
Device type: 15:20:30 Charging (125J)
Operator: 15:20:33 Shock ready
Serial number: 000000000000 15:20:37 Shock delivered (3, 125J, 51ohm) 5
15:20:43 Power off
Figure 79. Real-time print (Header and Event messages)
152
Waveform recording
Waveform which the event occurred is displayed. Waveform contains ECG, V-FIB, shock
and pacing event as shown in Figure 80.
Shock information recording
Shock info displays the shock event among all events. Shock info contains shock time,
number of shock and energy as shown in Figure 80. The time, number of shock and
energy is displayed from left to right.
Table contains maximum 20 data. When exceeding 20 data, data is displayed next table.
Trend recording auto print.
Parameter alarm event among trend event prints out. Trend contains parameter alarm
event time, parameter value and alarm as shown in Figure 77. The time, HR/PR,
respiration, SpO2, temperature, NIBP, IBP1, IBP2 and CO2 is displayed from left to right.
The newest data appears at the top of table. Table is displayed up to 10 data on a screen.
When exceeding 10 data, data is displayed next screen.
Time Shock# Energy Time HR/PR RR SpO2 TEMP NIBP

I -------------------------------------- --------------------------------------------------------------
ECG-Nr. 1
15:19:11 1 125J 15:18:54 0↓ --- --- ---.- ---/---
15:18:49
15:20:20 2 125J (---)
25mm/s 15:20:37 3 125J 15:19:02 51 --- --- ---.- ---/---
10mm/mV (---)
15:18:44
Pads
15:18:44
Figure 80. Real-time print (Waveform, Shock info and Trend)
Download
When download begins, ‘Check SD card’ message is displayed. After inserting the SD
card, this defibrillator/monitor identifies the SD card, if the SD card was inserted, the real-
time data is downloaded. At this time, ‘Downloading Real-time Data’ message is
displayed on the screen. If the SD card were not inserted, the downloading will be
stopped. At this time, 'SD card - Not Insert' message is displayed on the screen.
Note: When pressing the Return icon, return to Screen mode.
Print Setting
After selecting the data, press the Print menu icon. The defibrillator/monitor prints the
event massages all occurred events. If the print is not available, ‘Printer is not available’
message is displayed. When a printer runs out of paper, ‘Out of paper’ message is
displayed.
153
154
MENU STRUCTURE
MANUAL MODE MENU

- 12 lead
- - Acquire
- - Setup
- - - Filter 0.05Hz ~ 40Hz / 0.05Hz ~ 150Hz / Return
- - - Transmission
- - - Return
- - 12 lead ON/OFF
- - Patient info
- - - ID Confirm / Return
- - - Name Confirm / Return
- - - Age Confirm / Return
- - - Gender Male / Female / Return
- - - 12 lead records
- - - - Print / Transmission / ID # / Return
- - Return
- Setup
- - Volume Alarm / Beep / Button / Charging alarm / Voice prompt
/ CPR metronome / Pacing alarm / Return
- - Printer setting
- - - Print on alarm On / Off
- - - Print on charge On / Off
- - - Print on shock On / Off
- - - Print on mark On / Off
- - - Print on BP On / Off
- - - Print on self-test On / Off
- - - 12 lead auto printing On / Off
- - - Analyze auto printing On / Off
- - - Return
- - Erase data
- - - Erase 12 lead records Yes / No
- - - Erase event records Yes / No
- - - Erase internal memory Yes / No
- - - Return
- - Waveform setting
- - - 2nd Waveform
- - - - ECG l, ll, lll, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - - Return
- - - 3rd Waveform
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - - Return
- - - 4th Waveform
155
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - - Return
- - - Return
- - Display Mode
- - - Large Numeric Display
- - - Black-white Invert Mode
- - - Return
- - Clinical action list
- - Manual self-test
- - Button test
- - Service Menu
- - - Display 3 digit code
- - - Return
- Alarm Limit “Alarm limits adjustment/Limit Alarm Pause for each parameters”
HR/PR SpO2 RESP EtCO2 InCO2 T1 T2

120 100 30 80 20 39.0 39.0
50 90 8 0 0 36.0 36.0
- -
On On On On On On On
- -
Off Off Off Off Off Off Off
NIBP P1 CVP
SYS MAP DIA SYS MEAN DIA SYS MEAN DIA
160 110 90 120 90 70 120 90 70
90 60 50 70 50 40 70 50 40
- -
On On On On On On On On On
- -
Off Off Off Off Off Off Off Off Off
- - Return
- Patient Info
- - ID Confirm / Return
- - Name Confirm / Return
- - Age Confirm / Return
- - Gender Male / Female / Return
- - Event records
- - - Data review Print / Return
- - - ID#- - ID / Name / Age / Gender / Return
- - - Return
- - Real-time Data Print / Download / Return
- - - Return
- Sync On/Off (Toggle button)
156
AED MODE MENU
- Patient Info
- - Gender Male / Female
- - Event records
- - - ID# ID / Name / Age / Gender / Return
- - - Return
- - - Return
- Resume analyzing (Menu activated only during CPR mode)
PACING MODE MENU

- Pause/Resume Pacing
- Setup
- - Printer setting
- - - Return
- - Erase data
- - - Return
- - - 2nd Waveform
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - - Return
- - - 3rd Waveform
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - - Return
- - - 4th Waveform
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
157
- - - - EtCO2
- - - - Return
- - - Return
- - Display Mode
- - - Return
- - Button test
- - Service Menu
- - - Return
- - Return

120 100 30 80 20 39.0 39.0
50 90 8 0 0 36.0 36.0
- -
- -
NIBP P1 CVP
160 110 90 120 90 70 120 90 70
90 60 50 70 50 40 70 50 40
- -
- -
- - Return
- Patient Info
- - Event records
- - - ID# ID / Name / Age / Gender / Confirm / Return
- - - Return
- - - Return
- Demand / Fixed
MONITOR MODE MENU

- 12 lead
- - Acquire
- - Setup
- - - Filter 0.05Hz ~ 40Hz / 0.05Hz ~ 150Hz / Return
- - - Transmission
- - - Return
- - 12 lead ON/OFF
- - Patient info
- - - ID Confirm / Return
- - - Name Confirm / Return
158
- - - Age Confirm / Return
- - - Gender Male / Female / Return
- - - 12 lead records Print / Transmission / ID # / Return
- - Return
- Setup
- - Printer setting
- - - Return
- - Erase data
- - - Return
- - - 2nd Waveform
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - - Return
- - - 3rd Waveform
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - - Return
- - - 4th Waveform
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - - Return
- - - Return
- - Display Mode
- - Button test
- - Service Menu
- - - Return
159

120 100 30 80 20 39.0 39.0
50 90 8 0 0 36.0 36.0
- -
- -
NIBP P1 CVP
160 110 90 120 90 70 120 90 70
90 60 50 70 50 40 70 50 40
- -
- -
- - Return
- Patient Info
- - Event records
- - - ID# ID / Name / Age / Gender / Return
- - - Return
- - - Return
- Sync On/Off (Toggle button)
MONITORING PARAMETER (It is applied to 4 modes equally)
HR/PR MENU
- HR/PR Source Auto / HR / PR / Return
- Pacer Detect Enable / Disable / Return
- Filter Select 0.5Hz ~ 21Hz / 0.05Hz ~ 40Hz / 1Hz ~ 21Hz / Return
- Alarm Limit
“Alarm limit”
- HR/PR
120
50
“Limit Alarm Pause”
-
On
-
Off
- Return
160
SpO2 MENU
- Alarm Limit
“Alarm limit (%)”
- %SpO2
100
90
-
On
-
Off
- Return
NIBP MENU
- Inflate Pressure
- - “Adult/Pediatric” 120/140/160/180/200/220/240/260/280 mmHg, Return
- - “Neonatal” 80/100/120/140 mmHg, Return
- Auto Interval Off, Cont, 1/2.5/3/5/10/15/20/30/60/90 min, Return
- Patient Type Adult / Pedi, Neonatal, Return
- Alarm Limit
“Alarm limit (mmHg)”
- SYS MAP DIA
160 110 90
90 60 50
-
On
-
Off
- Return
IBP1 MENU
- Zero Setting Enter / Return
- Scale 0~50 / 0~100 / 0~200 / 0~300mmHg, Auto, Return
- Label P1 / ABP / Return
- Alarm Limit
- SYS MEAN DIA
120 90 70
70 50 40
-
On
-
Off
- Return
161
IBP2 MENU
- Zero Setting Enter / Return
- Scale 0~50 / 0~100 / 0~200 / 0~300mmHg, Auto, Return
- Label P2 / CVP / PAP / LAP / Return
- Alarm Limit
- SYS MEAN DIA
120 90 70
70 50 40
-
On
-
Off
- Return
EtCO2 MENU
- EtCO2 On / Off / Return
- EtCO2 Setting
- - N2O Gas On / Off / Return
- - O2 Gas On / Off / Return
- - Calibration Enter / Return
- Scale 0~40mmHg / 0~60mmHg / 0~80mmHg / Auto / Return
- Alarm Limit
“Alarm limit”
- EtCO2 InCO2
80 20
0 0
-
On
-
Off
- Return
RESPIRATION MENU
- Respiration Setting
- - PR Source Auto / Impedance / Airway / Return
- - Size X 0.5 / X 1 / X 1.5 / X 2
- - Return
- Apnea time setting Off, 10 / 20 / 30 / 40 / 50 / 60 seconds, Return
- Alarm Limit
“Alarm limit”
- RESP
30
8
-
On
-
Off
- Return
162
TEMPERATURE MENU
- Alarm Limit
“Alarm limit (ºC)”
T1 T2
39.0 39.0
36.0 36.0
-
On On
-
Off Off
- Return
DATE TIME MENU

- Date Format
- - YY/MM/DD
- - MM/DD/YY
- - DD/MM/YY
- - Return
- Set Date
- - Year
- - Month
- - Day
- - Return
- Set Time
- - Hour
- - Minute
- - Second
- - Return
- Return
163
164
PRINTING
General
The defibrillator/monitor prints real-time graphical and numeric information after that event
in accordance with current mode until Print soft key is pressed. Printing may be set in
two ways:
1. When the print is displayed on the screen, select the Print soft key.
2. To start printing, press the PRINT button and to stop printing during print out,
press the PRINT button again. (Refer to Figure 79.)
Printer Settings
1. Press the Setup soft key. (Setup is displayed on the initial screen of each mode.)
2. Rotate the Multi function knob to highlight Printer setting via Setup Menu, and
then press the Multi function knob to select Printer setting.
Figure 81. Printer setting Menu
3. Set Printer on alarm, Printer on shock, 12 lead auto printing and Analyze auto
printing.
165
Print on alarm
If Print on alarm is set to On, the defibrillator/monitor will automatically print out
information before and after 10 seconds when a physiological alarm condition is activated.
Print on charge
information before and after 10 seconds when the defibrillator/monitor is charging.
Print on shock
If Print on shock is set to On, the defibrillator/monitor will automatically print out
information before and after 10 seconds when a shock is generated.
Print on mark
information before and after 10 seconds when a clinical action is activated.
Print on BP
information before and after 10 seconds when NIBP measurement is completed.
Print on self-test
information before and after 10 seconds when a 12 lead measurement is completed.
12 lead auto printing
If 12 lead auto printing is set to On, the defibrillator/monitor will automatically print out
after 12 lead ECG is acquired.
Analyze auto printing
If Analyze auto printing is set to On, the defibrillator/monitor will automatically print out
analyzing data for 10 seconds after starting the analyze.
166
Print-Out
Print-out
The defibrillator/monitor prints numeric data and waveforms by pressing PRINT button.
Patient Information.
ID : _________________
NAME : _________________
Gender : _________________
AGE : _________________ ECG II
Filter : 0.5HZ ~ 21HZ
Time.
2010-01-01 05:30:00
RESP
Mode : DEFIB
HR/PR : 60/min
RESP : 15/min
NIBP : 120/ 80 ( 93) mmHg
1mV
SpO2 : 98% ECG III
T1 : 36.7°C T2 : 36.7°C Filter : 0.5HZ ~ 21HZ
EtCO2 : 80mmHg
InCO2 : 2mmHg
ABP : 120/ 80 ( 94) mmHg
CVP : 120/ 80 ( 40) mmHg
05:29:50
Figure 82. Print-out
Print-out on shock
The defibrillator/monitor prints shock information by pressing SHOCK button. Shock can
be delivered when the defibrillator/monitor is turned on in Manual or AED mode.
Patient Information.
ID : _________________
NAME : _________________ Shock Count : 2 / Select Energy : 150 J / Charge Energy : 50 J /
Gender : _________________ ECG II
AGE : _________________ Filter : 0.5HZ ~ 21HZ
Time.
2010-01-01 05:30:00
Mode : DEFIB
HR/PR : 60/min
RESP : 15/min
NIBP : 120/ 80 ( 93) mmHg
1mV
SpO2 : 98%
T1 : 36.7°C T2 : 36.7°C
EtCO2 : 80mmHg
InCO2 : 2mmHg
ABP : 120/ 80 ( 94) mmHg
CVP : 120/ 80 ( 40) mmHg
05:29:50 05:29:53
Figure 83. Print-out on shock
167
Print-out on 12 lead ECG data
If 12 lead auto printing is set to On, the defibrillator/monitor prints the 12 lead ECG data
automatically after 12 lead ECG analysis. When the defibrillator/monitor displays 12 lead
records, desired 12 lead ECG analysis can be printed by pressing PRINT soft key.
Note: The printer speed option for 12 lead ECG can be selected via the Service Menu.
The detailed information is described in the service manual.
Patient Information. Analyzing Result. Analyze Data.

ID : _________________ SINUS RHYTHM
NAME : _________________ ECG LEAD P amplitude P’ amplitude q amplitude … …
Gender : _________________ Public Analyze Data. (mV) (mV) (mV)
AGE : _________________ PR Interval : 0ms ------------------------------------------ ------------------------------------------ --------
QT Interval : 0ms ECG I 0 0 0 ……
Time. QTc Interval : 0ms ECG II 0 0 0 ……
2010-01-01 05:30:00 P-axis : 0deg ECG III 0 0 0 ……
QRS-axis : 0deg
T-axis : 0deg ECG AVL 0 0 0 ……
HR/PR : 60/min P duration : 0ms ECG AVR 0 0 0 ……
RESP : 15/min QRS duration : 0ms ECG AVF 0 0 0 ……
NIBP : 120/ 80 ( 93) mmHg ECG V1 0 0 0 ……
SpO2 : 98%
T1 : 36.7°C T2 : 36.7°C ECG V2 0 0 0 ……
EtCO2 : 80mmHg ECG V3 0 0 0 ……
InCO2 : 2mmHg ECG V4 0 0 0 ……
ABP : 120/ 80 ( 94) mmHg
ECG V5 0 0 0 ……
CVP : 120/ 80 ( 40) mmHg
ECG V6 0 0 0 ……
Filter : 0.05HZ ~ 40 HZ / Recording Speed : 25 mm/s
ECG I ECG aVR ECG V1 ECG V4
ECG II ECG aVL ECG V2 ECG V5
ECG III ECG

ECG V3 ECG V6
aVF
05:29:57 05:29:57 05:29:57 05:29:57
Figure 84. Print-out on 12 lead ECG data
Print-out on self-test result
If ‘Print On Self-test’ menu is set to On, the defibrillator/monitor prints the self-test result
automatically after self-test analysis.
S/N : 150123456789
Self Test Time.

2010-01-01 05:30:00
Self Test Result.

HV Module Alive Test : PASS
Body Impedance test : PASS
ECG Circuit/Algorithm : PASS
Internal Shock Test
: PASS ( 10J / 11J)
Internal Pacing Test : PASS
Pads/Paddle connection
: Pads connected
System ROM Test : PASS
System RAM Test : PASS
Battery Test : PASS
Real Time Clock Test : PASS
Installed Module Alive Test : PASS
Figure 85. Print-out on self-test result
168
Print-out on setting information
When the defibrillator/monitor is in Service Menu, the defibrillator/monitor will print out all
internal settings by pressing the PRINT button. Refer to the service manual for the
detailed instructions.
2010-01-01 05:30:00 Alarm off time : Indefinite : _________________________

Alarm reminder tone : off Manual mode protection : Disable
System Setting------------------------------------- Alarm active at power up : Disabled Pacing mode protection : Disable
System information Voice recording : On
Serial number : 000000000000 Self-test time : 0 o＇clock Printer Setting-------------------------------------
Main software : 0.00.00 Self-test interval : Off Print on alarm : Off
Display software : 0.00.00 (ENG) Internal shock energy :10J Print on charge : Off
Analog software : 0.00.00 Clinical action list 1 : None Print on shock : Off
Voice prompt : 0.0 (ENG) Clinical action list 2 : None Print on mark : Off
Charger : 0.00 Clinical action list 3 : None Print on BP : Off
Printer : 0.00 Clinical action list 4 : None Print on self-test : On
H/V : 0.00 Clinical action list 5 : None
ECG : 0.00 Clinical action list 6 : None Parameter Default Setting----------------------
SpO2 : 0.0.0.0 Clinical action list 7 : None HR/PR High alarm (BPM) : 120
NIBP main : 0.0.0 Clinical action list 8 : None HR/PR Low alarm (BPM) : 50
NIBP sub : 0.0.0 Clinical action list 9 : None RESP High alarm (RR/min) : 30
TEMP : 00.00 Clinical action list 10 : None RESP Low alarm (RR/min) : 8
IBP : 0.00 Device installation ID : ______________ Power on waveform select
EtCO2 : 0.00 Device ID : ____________ 1st waveform : I
Alarm volume : 5 12 lead institution name 2nd waveform : SpO2
Beep volume : 4 : ________________________ 3rd waveform : IBP1
Button volume : 4 12 lead location code : ______________ 4th waveform : EtCO2
Alarm pause time : 60 sec Communication phone numbers SpO2 High alarm (%) : 100
Case Time Event ECG-Nr.

---------------------------------------------------------------------- -----------------------------------------------------------------------------------------------------------
Start time: 2014-12-26 15:18:49 15:18:49 Power on
Data duration : 00:01:55 AED mode
Comments: Start ECG 1
15:18:50 Adult pads
Patient Info. 15:18:52 Analyzing heart rhythm
---------------------------------------------------------------------- 15:18:54 Low heart rate limits violated
Patient ID: 15:19:02 ECG: V-FIB 2
Patient name: Shock advise
Gender: Age: 15:19:04 Charging (125J)
Weight: Height: 15:19:08 Shock ready
Total Shocks: 3 15:19:11 Shock delivered (1, 125J, 51ohm) 3
Total time paced: 00:00:00 15:19:13 CPR
Total 12-Lead ECG: 0 15:20:14 Manual mode: NO SYNC
15:20:15 Charging (125J)
Device Info. 15:20:19 Shock ready
---------------------------------------------------------------------- 15:20:20 Shock delivered (2, 125J, 51ohm) 4
Device type: 15:20:30 Charging (125J)
Operator: 15:20:33 Shock ready
Serial number: 000000000000 15:20:37 Shock delivered (3, 125J, 51ohm) 5
15:20:43 Power off
Time Shock# Energy Time HR/PR RR SpO2 TEMP NIBP

I -------------------------------------- --------------------------------------------------------------
ECG-Nr. 1
15:19:11 1 125J 15:18:54 0↓ --- --- ---.- ---/---
15:18:49
15:20:20 2 125J (---)
25mm/s 15:20:37 3 125J 15:19:02 51 --- --- ---.- ---/---
10mm/mV (---)
15:18:44
Pads
15:18:44
Figure 86. Print-out on setting information
169
170
EXTERNAL INTERFACE
General
The defibrillator/monitor provides external connectors on the right panel to support
communication with external equipment and functions such as software upgrade or data
download. The defibrillator/monitor with its optional wireless network(3G or Wi-Fi) module,
functionality performs the same as a defibrillator/monitor connected to the central system.
The defibrillator/monitor with a wireless network(3G or Wi-Fi) can send and receive
patient data through the central system
Any connections between this defibrillator/monitor and other devices

must comply with applicable medical systems safety standards such as
IEC 60601-1. Failure to do so could result in unsafe leakage current and
grounding conditions.
Inserting or removing the data card while the defibrillator/monitor is on
or reading and writing on the data card can corrupt the Data Card and
prevent the defibrillator/monitor from powering on again. If this occurs,
see Troubleshooting Tips.
Use only a Mediana defibrillator/monitor-compatible SD Card. These
cards, or other types of cards (such as memory cards) will not work,
and may cause the defibrillator/monitor to malfunction.
Note: The defibrillator/monitor is to be used on a wireless network are limited to inside of

the building.
SD Memory Card
The SD Memory Card is used to the new system software and to load voice prompt data
and to download the trend data. Trend data downloaded on SD card can be viewed on PC.
Wireless Connection
The defibrillator/monitor can connect to a network using a wireless network (3G or Wi-Fi).
The wireless connection can only be set by authorized personnel via the Service Menu.
Table 42. Wireless Status Icon and Bed Number Icon

Icon Description
Not connected to Wi-Fi network
Active Wi-Fi network connection
Not connected to 3G network
Active 3G network connection
Configured bed number
Not configured for bed number
171
Central System Communication
The transmitted data by using 3G/Wi-Fi module is divided as follows;

- All vital signs are transmitted to the medical person in the hospital.
- 12-Lead reports for 20 seconds are transmitted to the medical person in the hospital.
- The self-test result and the log file are transmitted to the biomedical engineer in the
hospital.
The defibrillator condition, service action according to the self-test and the history of the
key pressing are transmitted by the wireless network. All vital sign can be transmitted in
real-time.
Note: The details are provided in the central system manual. Please contact the
representative of Mediana for more information.
172
MAINTENANCE
The cover should be removed only by qualified service personnel.
There are no internal user-serviceable parts except for the battery.
Do not use the defibrillator/monitor when the case appears damaged.
Do not spray, pour, or spill any liquid on the defibrillator/monitor, its
accessories, connectors, switches or openings in the chassis.
Unplug the power cord from the defibrillator/monitor before cleaning
the defibrillator/monitor.
Disposal of the defibrillator/monitor with the battery inserted presents a
potential shock hazard.
Do not autoclave, ultrasonically clean, or immerse the Mediana
defibrillator/monitor. Do not use abrasive cleaners or strong solvents
such as acetone or acetone-based cleaners.
Do not ultrasonically clean or immerse the paddles and paddles cables.
Do not ultrasonically clean, immerse, autoclave or steam sterilize the
pads cable.
Do not ultrasonically clean, immerse, autoclave or steam sterilize the
ECG cable. Do not clean the ECG cable with alcohol. Alcohol can cause
the plastic to become brittle and may cause the cable to fail
prematurely.
Do not clean any part of this defibrillator/monitor or accessories with
bleach dilution or phenolic compounds. Do not use abrasive or
flammable cleaning agents. Do not attempt to sterilize this
defibrillator/monitor or any accessories unless otherwise specified in
accessory operation instructions.
Do not soak or immerse the sensors or cables in any liquid solution. Do
not attempt to sterilize.
Recycling and Disposal

When the defibrillator/monitor, battery, or accessories reach the end of useful life,
recycle or dispose of the equipment according to appropriate local and regional
regulations.
Note: The defibrillator/monitor should be disposed of separately from the municipal waste
stream via designated collection facilities appointed by the government or the local
authorities.
Note: The correct disposal of your old appliance will help prevent potential negative
consequences for the environment and human health.
Note: For more detailed information about disposal of your old appliance, please contact
your city office, waste disposal service or the shop where you purchased the
173
Returning the defibrillator/monitor and System Components
Pack the defibrillator/monitor with sensors, cable or other accessory items in its original
shipping carton. If the original carton is not available, use a suitable carton with
appropriate packing material to protect the defibrillator/monitor during shipping.
Service
The defibrillator/monitor requires no routine service other than cleaning, battery
maintenance, and service activity which is mandated by the user’s institution. For more
information, refer to the defibrillator/monitor service manual. Qualified service personnel in
the user’s institution should perform periodic inspections of the defibrillator/monitor. If
service is necessary, contact qualified service personnel or your local supplier.
Periodic Safety Checks

It is recommended that the following checks be performed every year.
 Inspect the equipment for mechanical and functional damage.
 Inspect the external safety labels for legibility.
Cleaning
The defibrillator/monitor may be surface-cleaned by using a soft cloth dampened with
either a commercial, nonabrasive cleaner or one of the solutions listed below. Lightly
wipe the top, bottom and front surfaces of the defibrillator/monitor.
 Quatemary Ammonium (fungicidal, bactericidal and virucidal against enveloped

viruses)
 70% Isopropyl alcohol
 10% Chlorine bleach solution
 PDI sani-system
The cleaning method for paddles and paddle plates are same as defibrillator/monitor.
For cables, sensors, cuffs, and probes, follow the cleaning instructions in the directions
for use shipped with those components.
Avoid spilling liquid on the defibrillator/monitor, especially in connector areas. If liquid is

accidentally spilled on the defibrillator/monitor, clean and dry thoroughly before reuse. If in
doubt about defibrillator/monitor safety, refer the unit to qualified service personnel for
checking.
174
Battery Maintenance
Recharging the battery is strongly recommended when the battery has

not been recharged for 6 or more months.
Follow local government ordinances and recycling instructions regarding
disposal or recycling of defibrillator/monitor components, including
batteries.
Do not short-circuit the battery, as it may generate heat. To avoid short-
circuiting, do not let the battery come in contact with metal objects at any
time, especially when transporting.
Do not solder the battery directly. Heat applied during soldering may
damage the safety vent in the battery’s positive cover.
Do not deform the battery by applying pressure. Do not throw, hit, drop,
fold or impact the battery.
Do not connect the battery reversed in positive (+) and negative (-)
terminals. Do not charge the battery with polarities reversed, as it may
swell or explode.
Do not use any chargers not specified by Mediana.
Do not use the battery with other maker’s batteries, different types or
models of batteries such as dry batteries, nickel-metal hydride batteries,
or Li-ion batteries together, as they might leak electrolyte heat or
explode.
Do not mistreat the battery, or use the battery in applications not
recommended by Mediana.
Keep the battery out of reach of babies and children to avoid any
accidents.
If there are any problems with the battery, immediately put the battery in a
safe place and contact qualified service personnel.
If the defibrillator/monitor has not been used for 6 months, the Li-ion battery will need
charging. To charge the battery, connect the defibrillator/monitor to an AC or DC power
source as described in the Battery Operation section.
Note: Storing the defibrillator/monitor for a long period without charging the battery may
degrade the battery capacity. It would take about 8 hours to fully charge the battery
from the moment that low battery alarm is activated.
Note: The battery should be removed from the defibrillator/monitor if placed in storage or if
it will not be used for a long period.
It is recommended that the defibrillator/monitor’s Li-ion battery be replaced every 24

months. Refer to the service manual for battery replacement and general service
instructions.
175
Loading Printer Paper
Using other manufacturers’ printer paper may cause the printer to

function improperly or damage the print head. Use only Mediana printer
paper.
Load printer paper as follows:
1. Pull the printer door.

2. Pick out the paper by using the ejector.
3. Insert a new printer paper with grid side up.
4. Push the printer door.
Note: To make sure that the paper is aligned in the slot and has not been pinched in the
door.
Figure 87. Printer Paper Replacement
176
TROUBLESHOOTING
If you are uncertain about the accuracy of any measurement, check the
patient’s vital signs by alternate means; then make sure the
defibrillator/monitor is functioning correctly.
The cover should be removed only by qualified service personnel. There
are no user-serviceable parts inside except for the battery.
The large current draw required for defibrillator charging may cause the
defibrillator to reach a shutdown voltage level with no low battery
indication.
General
If the defibrillator/monitor detects an error or potential problem during use, it displays a
system or momentary message. If service is necessary, contact qualified service
personnel. Before calling to qualified service personnel or your local supplier, make sure
it meets environmental conditions provided in the manual as temperature, humidity,
altitude and so on.
Note: For repair instructions or for additional technical information, refer to the
defibrillator/monitor Service Manual.
Obtaining Technical Assistance

For technical information and assistance, or to order a service manual, call your local
supplier. The service manual provides information required by qualified service personnel
when servicing the defibrillator/monitor.
When calling your local supplier, you may be asked to provide the software version
number of your defibrillator/monitor. The software version can confirm in service menu.
177
EMI (Electromagnetic Interference)
Keep patients under close surveillance when monitoring. It is possible,

although unlikely, that radiated electromagnetic signals from sources
external to the patient and defibrillator/monitor can cause inaccurate
measurement readings. Do not rely entirely on the defibrillator/monitor
readings for patient assessment.
It is possible that any radio frequency transmitting equipment and other
nearby sources of electrical noise may result in disruption in the
defibrillator/monitor operation. Operator’s manual is attached for the
minimum recommended separation distance between the RF emitting
equipment and the device.
It is possible, although unlikely, that large equipment using a switching
relay for its power on/off may affect defibrillator/monitor operation. Do
not operate the defibrillator/monitor in such environments.
Using cables, electrodes or accessories not specified for use with this
device may result in increased emissions or decreased resistance to
electromagnetic interference which could affect the performance of this
defibrillator/monitor or of equipment in close proximity. Use only parts
and accessories specified in this manual.
Defibrillator/monitor may cause electromagnetic interference (EMI)
especially during charge and energy transfers. EMI may affect the
performance of equipment operating in close proximity. If possible,
verify the effects of defibrillator discharge on other equipment prior to
using the defibrillator in an emergency situation.
Operating high frequency electrosurgical equipment in the vicinity of
the defibrillator/monitor can produce interference in the
defibrillator/monitor and cause incorrect measurements.
Do not use the defibrillator/monitor with nuclear spin tomography (MRT,
NMR, NMT) as the function of the defibrillator/monitor may be disturbed.
This device has been tested and found to comply with the limits for medical devices to
the IEC60601-1-2, and the Medical Device Directive 93/42/EEC. These limits are
designed to provide reasonable protection against harmful interference in a typical
medical installation.
However, because of the proliferation of radio-frequency transmitting equipment and

other sources of electrical noise in health care environments (such as electrosurgical
equipment, defibrillator, cellular phones, mobile two-way radios, electrical appliances,
and high-definition television), it is possible that high levels of such interference due to
close proximity or strength of a source may affect defibrillator/monitor operation.
178
The defibrillator/monitor is designed for use in environments in which
the signal can be obscured by electromagnetic interference. During
such interference, measurements may seem inappropriate or the
defibrillator/monitor may not seem to operate correctly.
The defibrillator/monitor disruption may be indicated by erratic readings, cessation of

operation, or other incorrect functioning. If this occurs, survey the site to determine the
source of this disruption. Try the following actions to see if they eliminate the disruption:
 Turn equipment in the vicinity off and on to isolate the offending equipment.
 Reorient or relocate the interfering equipment.
 Increase the separation between the interfering equipment and this equipment.
The defibrillator/monitor generates, uses, and can radiate radio frequency energy. If the
defibrillator/monitor is not installed and used in accordance with these instructions, the
defibrillator/monitor may cause harmful interference with other devices in the vicinity.
If assistance is required, contact your local supplier.
179
180
FACTORY DEFAULTS
General
The defibrillator/monitor is shipped with factory default settings. Authorized personnel
can use the procedures described in the service manual to change default settings.
Parameter Ranges and Default Settings
Table 43. Parameter Ranges and Factory Defaults

Parameter Ranges / Selections (Adjust step) Factory Defaults
ECG MENU
HR/PR Source Auto, HR, PR Auto
AC line filter* 50Hz, 60Hz, Off 60 Hz
Pacer Detect Enable, Disable Disable
ECG size* x0.5, x1, x1.5, x2, x3 x1
Filter Select 0.5 to 21 Hz, 0.05 to 40 Hz, 1 to 21 Hz 1 to 21 Hz
HR/PR High Alarm Limits 25 to 300 BPM (5 BPM steps) 120 BPM
HR/PR Low Alarm Limits 20 to 295 BPM (5 BPM steps) 50 BPM
Auto transmit* On, Off On
Print on 12 lead On, Off On
measurement**
Print on 12 lead On, Off On
interpretation**
Setting print lead I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6 I
- 1st waveform*
Setting print lead I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6 II
- 2nd waveform*
Setting print lead I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6 III
- 3rd waveform*
12 lead frequency response* 0.05 Hz ~ 40 Hz, 0.05 Hz ~ 150 Hz 0.05 Hz ~ 40 Hz
Print 2 copies 12 lead** On, Off Off
12 lead print second** 2.5 sec, 10 sec 2.5 sec
12 lead print speed** 25mm/sec, 50mm/sec 25mm/sec
SpO2 MENU
% SpO2 High Alarm Limits 21 to 100 % (1 % steps) 100 %
% SpO2 Low Alarm Limits 20 to 99 % (1 % steps) 90 %
NIBP MENU
Inflate Pressure 120, 140 160, 180, 200, 220, 240, 260, 280 mmHg 180 mmHg
(Adult/Pediatric) (Adult/Pediatric)
80, 100, 120, 140 mmHg (Neonatal) 120 mmHg (Neonatal)
Auto Interval 1, 2.5, 3, 5, 10, 15, 30, 60, 90, Off Off
Patient type Adult/Pedi, Neonatal Adult/Pedi
NIBP Unit* mmHg, kPa mmHg
NIBP SYS High Alarm Limits adult/pediatric adult/pediatric
35 to 270 mmHg 160 mmHg
(4.7 to 36.0 kPa) (21.3 kPa)
neonatal neonatal
(6.0 to 17.3 kPa) (12.0 kPa)
(5 mmHg, 0.6 or 0.7kPa steps)
181
NIBP SYS Low Alarm Limits adult/pediatric adult/pediatric
(4.0 to 35.3 kPa) (12.0 kPa)
neonatal neonatal
(5.3 to 16.7 kPa) (5.3 kPa)
NIBP DIA High Alarm Limits adult/pediatric adult/pediatric
(2.0 to 33.3 kPa) (12.0 kPa)
neonatal neonatal
(3.3 to 12.0 kPa) (8.0 kPa)
NIBP DIA Low Alarm Limits adult/pediatric adult/pediatric
(1.3 to 32.7 kPa) (6.7 kPa)
neonatal neonatal
(2.7 to 11.3 kPa) (2.7 kPa)
NIBP MAP High Alarm Limits adult/pediatric adult/pediatric
(3.3 to 34.7 kPa) (14.7 kPa)
neonatal neonatal
(4.7 to 14.7 kPa) (9.3 kPa)
NIBP MAP Low Alarm Limits adult/pediatric adult/pediatric
(2.7 to 34.0 kPa) (8.0 kPa)
neonatal neonatal
(4.0 to 14.0 kPa) (4.0 kPa)
IBP1 MENU
IBP1: Scale Auto, 0~50mmHg, 0~100mmHg, 0~200mmHg, Auto
0~300mmHg
IBP1: Label P1, ABP P1
IBP 1 SYS High Alarm Limits adult/pediatric adult/pediatric
-45 to 300 mmHg 120 mmHg
(-6.0 to 40.0 kPa) (16.0 kPa)
IBP 1 SYS Low Alarm Limits adult/pediatric adult/pediatric
-50 to 295mmHg 70 mmHg
(-6.7 to 39.3 kPa) (9.3 kPa)
IBP 1 DIA High Alarm Limits adult/pediatric adult/pediatric
(-6.0 to 40.0 kPa) (9.3 kPa)
IBP 1 DIA Low Alarm Limits adult/pediatric adult/pediatric
(-6.7 to 39.3 kPa) (5.3 kPa)
182
IBP 1 MEAN High Alarm Limits adult/pediatric adult/pediatric
(-6.0 to 40.0 kPa) (12.0 kPa)
IBP 1 MEAN Low Alarm Limits adult/pediatric adult/pediatric
(-6.7 to 39.3 kPa) (6.7 kPa)
IBP2 MENU
IBP2: Scale Auto, 0~50mmHg, 0~100mmHg, 0~200mmHg, Auto
0~300mmHg
IBP2: Label P2, CVP, PAP,LAP P2
IBP 2 SYS High Alarm Limits adult/pediatric adult/pediatric
(-6.0 to 40.0 kPa) (16.0 kPa)
IBP 2 SYS Low Alarm Limits adult/pediatric adult/pediatric
(-6.7 to 39.3 kPa) (9.3 kPa)
IBP 2 DIA High Alarm Limits adult/pediatric adult/pediatric
(-6.0 to 40.0 kPa) (9.3 kPa)
IBP 2 DIA Low Alarm Limits adult/pediatricl adult/pediatric
(-6.7 to 39.3 kPa) (5.3 kPa)
IBP 2 MEAN High Alarm Limits adult/pediatric adult/pediatric
(-6.0 to 40.0 kPa) (12.0 kPa)
IBP 2 MEAN Low Alarm Limits adult/pediatric adult/pediatric
(-6.7 to 39.3 kPa) (6.7 kPa)
IBP unit* mmHg, kPa mmHg
EtCO2
EtCO2 On, Off ON
N2O Gas On, Off OFF
O2 Gas On, Off OFF
Scale 0~40 mmHg, 0~60 mmHg, 0~80 mmHg, Auto Auto
EtCO2 High Alarm Limits adult/pediatric adult/pediatric
(0.1 to 10.7 kPa), (0.1 to 10.5 %) (10.7 kPa), (10.5 %)
(1 mmHg, 0.13 kPa, 0.13 % steps)
EtCO2 Low Alarm Limits adult/pediatric adult/pediatric
0 to 79 mmHg 0 mmHg
(0 to 10.5 kPa), (0 to 10.4 %) (0 kPa), (0 %)
(1 mmHg, 0.13 kPa, 0.13 % steps)
InCO2 High Alarm Limits adult/pediatric adult/pediatric
(0.1 to 2.7 kPa), (0.1 to 2.6 %) (2.7 kPa), (2.6 %)
(1 mmHg, 0.13 kPa, 0.13 % steps)
183
InCO2 Low Alarm Limits adult/pediatric adult/pediatric
0 to 19 mmHg 0 mmHg
(0 to 2.5 kPa), (0 to 2.5 %) (0 kPa), (0 %)
(1 mmHg, 0.13 kPa steps)
EtCO2 unit* mmHg, kPa, % mmHg
Temperature MENU
TEMP1 High Alarm Limits 0.1 to 50.0 °C 39.0 °C
(32.1 to 122.0 °F) (102.2 °F)
(0.1°C, 0.1 or 0.2°F steps)
TEMP1 Low Alarm Limits 0.0 to 49.9 °C 36.0 °C
(32.0 to 121.8 °F) (96.8 °F)
(0.1°C, 0.1 or 0.2°F steps)
TEMP2 High Alarm Limits 0.1 to 50.0 °C 39.0 °C
(32.2 to 122.0 °F) (102.2 °F)
(0.1°C, 0.1 or 0.2°F steps)
TEMP2 Low Alarm Limits 0.0 to 49.9 °C 36.0 °C
(32.0 to 121.8 °F) (96.8 °F)
(0.1°C, 0.1 or 0.2°F steps)
TEMP Unit* °C, °F °C
Respiration MENU
Respiration ON ON
OFF
RR Source Auto Auto
Impedance
Airway
Size x0.5, x1, x1.5, x2 x1
Apnea time setting Off, 10 seconds, 20 seconds, 30 seconds 10 seconds
40 seconds, 50 seconds, 60 seconds
RR High Limits 4 to 120 BPM (1 BPM step) 30 BPM
RR Low Limits 3 to 119 BPM (1 BPM step) 8 BPM
Manual, AED, Pacing, Monitor Mode MENU
Alarm 1, 2, 3, 4, 5, 6, 7, 8 5
Beep OFF, 1, 2, 3, 4, 5, 6, 7 4
Button OFF, 1, 2, 3, 4, 5, 6, 7 4
Charging alarm 1, 2, 3, 4, 5, 6, 7, 8 4
Voice prompt 1, 2, 3, 4, 5, 6, 7, 8 4
CPR metronome OFF, 1, 2, 3, 4, 5, 6, 7 4
Pacing mode OFF, 1, 2, 3, 4, 5, 6, 7 2
nd
2 Waveform ECG I, ECG II, ECG III, ECG aVL, ECG aVF, ECG SpO2 Waveform
aVR, ECG V1, ECG V2, ECG V3, ECG V4, ECG V5,
ECG V6, Pads, SpO2, RESP, IBP1, IBP2, EtCO2
3rd Waveform ECG I, ECG II, ECG III, ECG aVL, ECG aVF, ECG IBP1 Waveform – P1
4th Waveform ECG I, ECG II, ECG III, ECG aVL, ECG aVF, ECG EtCO2 Waveform
Print on alarm** On, Off Off
Print on charge** On, Off Off
Print on shock** On, Off Off
Print on mark** On, Off Off
Print on BP** On, Off Off
Print on self-test** On, Off On
12 lead auto printing** On, Off On
184
Analyze auto printing** On, Off Off
Message display* On, Off Off
Elapsed time display* Enable, Disable Enable
CPR guide display* Enable, Disable Enable
Voice prompt* Enable, Disable Enable
Basic auto energy escalation* Enable, Disable Enable
Above 200J setting* Enable, Disable Disable
Manual shock energy – 1st 1~200J (Adult) 125J (Adult)
energy* 1~100J (Pediatric) 50J (Pediatric)
Manual shock energy – 2nd 1~200J (Adult) 150J (Adult)
Manual shock energy – 3rd 1~200J (Adult) 200J (Adult)
Analyze continuous mode* Enable, Disable Enable
Auto charge* On, Off On
Remain in sync mode after On, Off On
shock*
Charging hold time* 15 sec, 60 sec 60 sec
ECG display with paddle in On, Off On
openair*
Setup Menu* Enable, Disable Disable
Alarm Limit Menu* Enable, Disable Disable
12 Lead Menu* Enable, Disable Disable
AED display setting – Enable, Disable Enable
Waveform display*
Icon display*
Value display*
AED display setting – Enable, Disable Disable
AED step 1 display*
AED step 2 display*
AED step 3 display*
AED Mode energy – Enable, Disable Disable
Above 200J setting*
AED shock energy – 1~200J (Adult) 125J (Adult)
1st energy* 1~100J (Pediatric) 50J (Pediatric)
2nd energy* 1~100J (Pediatric) 50J (Pediatric)
3rd energy* 1~100J (Pediatric) 50J (Pediatric)
Fixed Pacing* On, Off Off
Pace Pulse Rate* 30 ~ 180 bpm 70 bpm
Default Pacing Energy* 0, 30, 70, 100, 140 mA 0 mA
Others
Parameters Color - ECG* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 00FA00(Green)
6464FA(Light blue), FA96FA(Pink), FA0000(Red),
FAFA00(Yellow), 9696C8(Light purple), FA9600,
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - NIBP* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), FAFAFA(White)
185
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - SpO2* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 64FAFA(Cyan)
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - RESP* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 9696C8(Light blue)
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - TEMP* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), FA96FA(Pink)
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - IBP 1* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), FA0000(Red)
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - IBP 2* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), FAFA00(Yellow)
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Parameters Color - EtCO2* 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 9696C8(Light purple)
0096FA, FA00FA, 96FA32, C8C8C8, 0096C8,
C89600, C8C832
Brightness* 1, 2, 3, 4 4
Audio pause time* 30 sec, 60 sec, 90 sec, 120 sec 60 sec
Audio off time* 3 min, 5 min, 10 min, Indefinite Indefinite
Alarm reminder tone* 3 min, 10 min, Off Off
Alarm active at power up* Enable, Disable Disable
Auto block erase* Enable, Disable Disable
Auto self-test : 0 ~ 23 o‘clock 0 o‘clock
Self-test time*
Auto self-test : 24 hours, 48 hours, 72 hours, Off Off
Self-test time interval*
Auto self-test : 1 ~ 10 J 10 J
Internal shock energy*
Clinical action list* None, CPR, EPI, Atrop, DOPA, PHEN, Bicarb, Aspirin, None
Oxygen, IV, Morphine, Valium, β-block, LIDO, Mag
Sulf, Thrombo, Sedation, Heparin, Procain, Cordar,
Thiamine, Dilantin, Intubate, Narcan, Atrovent,
Adenosin, Fentanyl, Digoxin, Vasopr, Dextrose,
Paralytic, Nitro, Albuterol, Amrinon, Benadryl,
Demerol, Oral Glu, Lasix, Calcium
Manual mode protection* Disable, Confirm, Passcode Disable
Manual mode locking 000~999 (Passcode)
186
passcode*
Pacing mode protection* Disable, Confirm, Passcode Disable
Pacing mode locking 000~999 (Passcode)
passcode*
Service menu passcode* 000~999 (Passcode)
Power on waveform select – ECG I, ECG II, ECG III, Pads ECG I
1st waveform*
Power on waveform select – ECG I, ECG II, ECG III, Pads, SpO2, RESP, IBP1, SpO2
2nd waveform* IBP2, EtCO2
Power on waveform select – ECG I, ECG II, ECG III, Pads, SpO2, RESP, IBP1, IBP1
3rd waveform* IBP2, EtCO2
Power on waveform select – ECG I, ECG II, ECG III, Pads, SpO2, RESP, IBP1, EtCO2
4th waveform* IBP2, EtCO2
Wi-Fi* On, Off On
Wireless Channel* Channel 1 ~ 13, Auto Channel 1
Wireless security mode* None, WEP, WPA, WPA2, EAP None
WEP key length* 64 bit (10 hex digits), 128 bit (24 hex digits) 64 bit (10 hex digits)
Outer Authentication* EAP-FAST, EAP-TLS, EAP-TTLS, EAP-PEAP EAP-FAST
Inner Authentication* EAP-MSCHAP, EAP-GTC EAP-MSCHAP
3G* On, Off On
USIM1* Enable, Disable Enable
Authentication protocol* None, PAP, CHAP PAP
USIM2* Enable, Disable Enable
Note: An asterisk (*) by a parameter in the above table indicates that the parameter can only be changed by
authorized personnel as described in the service manual
Note: Asterisks (**) by a parameter in the above table indicate the settings only when an optional printer is installed
in the defibrillator/monitor.
187
188
SPECIFICATION
Display
Screen Size 8.4” measured diagonally across the TFT-LCD screen

Screen Type Liquid Crystal Display (LCD) Color
Size 170 x 128 mm
Number of Traces 4 waveforms
Korean, English, Spanish, Italian, German, French,
Portuguese, Czech, Polish, Russian
Note: The language installed in the device is set only at the
factory per the country of sales. If you would like to
Language
change the language, please consult with our service
center or local distributor as the language is subject
not to be changed by the customer. The software
update should be required to change the language.
Controls
Multi function knob; Mode select knob (Off, AED, Manual,

Pacing and Monitor); 11 buttons (Shock, Energy Level,
Standard
Charge, Analyze, NIBP, LEAD, Alarm, Size, Print, RATE,
mA); 5 soft key
Alarms
Categories Patient Status and System Status

Priorities Low, Medium and High Priorities
Notification Audible and Visual
Setting Default and Individual
Alarm Volume Level 45 to 85 dB
Distributed Alarm Less than 3 sec.
System Delay
189
Physical Characteristics and Printer
Instrument
Dimensions 340 × 308 × 216 (mm) (W×H×D) including battery and
excluding paddles, options and accessories
Weight Approx. 6.16 (kg) including battery and excluding paddles,
options and accessories.
Degree of Protection ECG: Type CF with defibrillator protection
against Electric SpO2: Type CF with defibrillator protection
Shock Temperature: Type CF with defibrillator protection
EtCO2: Type CF with defibrillator protection
NIBP: Type CF with defibrillator protection
IBP: Type CF with defibrillator protection
Paddle: Type BF with defibrillator protection
Pads: Type BF with defibrillator protection
Mode of Operation Continuous
Classification Class IIb (MDD Annex IX Rule9:MEDDEV 2.4/1 Rev.9)
Printer
Type Thermal
Weight 190 g
Number of Channels 1 to 3 channels
Paper Type Thermal
Paper Width 80 mm
Printer Speed 25 mm/sec, 50 mm/sec
Electrical
Instrument
Power Requirements AC Mains
100 - 240V, 50/60Hz, 120 - 130VA
DC Mains
18Vdc, 7.0A with DC/DC adapter, Model:MDD150-1218
(MDD150-1218: Input: 12-16Vdc, 160 - 160VA,
Output: 18Vdc, 7.0A)
Note: For 120 Volt applications, use only UL Listed detachable power cord with
NEMA configuration 5-15P type (parallel blades) plug cap. For 240 Volt
applications use only UL Listed Detachable power supply cord with NEMA
configuration 6-15P type (tandem blades) plug cap.
Battery (option)
Type Li-ion battery
Dimension 156 × 104 × 28 (mm) (W×H×D)
Voltage/Capacity 4S2P 14.4V/5200mAh
Discharge A minimum of 200 shocks at 200 Joules (per battery)
Operating time 5 hours (per battery), 10 hours (with two batteries)
At the following condition:
no printing
no external communication
190
no audible alarm sound
room temperature : 25°C
Recharge Over 8 hours with defibrillator/monitor turned on/off
(It would take about 8 hours to fully charge the battery from
the moment that low battery alarm is activated.)
6 months, new battery fully-charged
(- The battery life cycle may vary with the number of
recharging, operating temperature, and storage condition.
Typically, about 80% capacity of battery may remain after
300 cycles of recharge. If one cycle of recharging would be
Life Cycle about 2 or 3 days, the battery may have 80% capacity after
about 24 months.
- The battery is designed not to be charged for safety
reason when it reaches 40°C.)
After 2 months storage the defibrillator/monitor would run for
50% of stated battery life.
Environmental Conditions
Operation
Temperature 0 to 50°C (32 to 122°F)
Humidity 15 to 95% RH, non-condensing
Altitude -170 to 4,877m (-557 to 16,000 ft)
Note: The system may not meet its performance specifications if stored or used
outside the specified temperature and humidity range.
Note: The battery will not be charged for safety if the operating temperature exceeds
40°C.
Shipping and Storage (in shipping container)
Temperature −20°C to 70°C (−4°F to 158°F)
Humidity 15 to 95% RH, non-condensing
Altitude -304 to 6,096m (-1,000 to 20,000ft)
Note: The system may not meet its performance specifications if stored or used
outside the specified temperature and humidity range.
191
Tone Definition
High Priority Alarm Tone

Volume level Adjustable (level 1~8)
Pitch (± 48.8Hz) 976 Hz
Pulse width (± 10msec) 210 msec
Number of pulses 10 pulses per 4 sec, 10 sec inter burst
Repetitions Continually
Medium Priority Alarm Tone
Pitch (± 34.85Hz) 697 Hz
Number of pulses 3 pulses per 1 sec, 15 sec inter burst
Low Priority Alarm Tone
Pitch (± 9.4Hz) 488 Hz
Number of pulses 1 pulse per 0.25 sec, 30 sec inter burst
Alarm Reminder Tone
Volume level Not changeable
Pitch (± 40Hz) 800 Hz
Number of pulses 1 pulse per 1 second, 3 min, 10 min inter burst
HR/PR Tone
Volume level Not changeable
650 Hz (ECG)
Pitch (± 32.5Hz)
(162 + 5*SpO2) Hz
Number of pulses N/A
Repetitions No repeat
Key Beep
Volume level Adjustable (Off, level 1~7)
Pitch 440 (± 22) Hz (valid)
168 (± 8.4)Hz (invalid)
Number of pulses N/A
Repetitions No repeat
192
Measurement Parameters
Pacing Mode
Pacing Mode
Pacing rate Variable from 30 bpm(ppm) to 180 bpm(ppm) ± 1.5%
(increments or decrements by a value of 2 bpm(ppm))
Resolution 2 bpm(ppm)
Accuracy ± 1.5 %
Output current 0 mA to 140 mA
Resolution 2 mA
Accuracy ± 5% or 5 mA, whichever is greater.
Pulse Type 40 ms constant current pulse
Pulse Amplitude Variable 0 mA to 140 mA ± 5% or 5 mA, whichever is
greater. Digitally displayed on the defibrillator/monitor
(increments or decrements by a value of 2 mA)
Defibrillator
AED mode
Lead Lead ll
Patient Impedance 25 to 175 Ohm
Heart Rate 20 to 300 BPM
Accuracy 1 per min
Detection Ventricular Fibrillation at a amplitude greater than or
equal to 0.2mV,
Ventricular Tachycardia at a heart rate greater than or
equal to 160 bpm
Shock Analysis Time < 10 seconds typical
Note: Shock analysis would take about 20 seconds at
maximum from the start to the completion of
analysis if ECG signal is interfered by motion or
others.
Charging Time to 200J* Within 6 seconds with rated main voltage/DC main
voltage
Within 7 seconds with fully charged battery
*Charging time for other cases, refer to defibrillator (technical specification)
Manual Mode
Shock Energy Level External paddles:
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, 75, 100,
125, 150, 175, 200, 300, 360 J
Automatic Discharge Time 60 seconds
Charging Time to 200J* Within 6 seconds with rated main voltage/DC main
voltage
Charging Time to 360J Within 8 seconds with rated main voltage/DC main
voltage
*Charging time for other cases, refer to defibrillator (technical specification)
193
ECG
Heart Rate
Measurement Range 0, 20 to 300 BPM
Resolution 1 BPM
Accuracy ± 10% or ±5 bpm, whichever is greater
Average Response Time 5 seconds (from 80 to120 BPM)
9 seconds (from 80 to 40 BPM)
Tall T-wave Rejection maximum T-wave amplitude 1.8 mV
ECG (Electrocardiograph)
Leads 3 / 5 / 12 Lead
Lead I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6,
Paddle, Pads
Lead Off Detection Detected and displayed
Pacer Detection Detect pacer pulses of ±2mV to ±700mV with pulse
widths of 0.1 to 2msec and rise times 10% of width not
to exceed 100msec
Input
Input Impedance 5 M ohm or more
Input Dynamic Range ±5 mV AC, ±300 mV DC
Voltage Range ±0.5 mV ~ ±5 mV
Signal Width 40 to 120 ms (Q to S)
Output
Filter mode 0.5 to 21 Hz
0.05 to 40 Hz
1 to 21 Hz
ECG Size Auto, 5.0, 10.0, 15.0, 20.0, 30.0 mm/mV
Display Sweep Speeds 25.0 mm/sec
Wave Size x0.5, x1, x1.5, x2, x3
Display Sensitivity 10 mm/mV (×1)
Pacing Pulse Detection On, Off
Electrode Disconnect Alarm Display and/or sound
CMRR 90 dB or more
Defibrillator Discharge <5 sec per IEC60601-2-27
Recovery
Defibrillator Protection Protected
ECG (Arrhythmia Supplemental Information as required by AAMI EC13)
Respiration, leads-off amp 0.03 µA
sensing, and active noise common 0.25 µA
suppression
Tall T-wave rejection Maximum T-Wave amplitude 1.8 mV
capability
Accuracy of input signal Displacement: 0.1 mV
reproduction Slope: 0.1 mV/s
Heart rate meter accuracy Provides correct heart rates, as follows:
and response to irregular Ventricular bigeminy: 79 to 83 bpm
rhythm Slow alternating ventricular bigeminy: 51 to 63 bpm
Rapid alternating ventricular bigeminy: 119 to 121 bpm
Bidirectional systoles: 82 to 94 bpm
194
Response time of heart rate HR change from 80 to 120 bpm: 3.16 sec
meter to change in heart HR change from 80 to 40 bpm: 3.05 sec
rate
Time to alarm for Vent Tachycardia 1 mVpp, 206 bpm:
tachycardia Amplitude 0.5mV, Alarm activated time 6.79 sec
Amplitude 1mV, Alarm activated time 9.80 sec
Amplitude 2mV, Alarm activated time 8.19
Vent Tachycardia 2 mVpp, 195 bpm:

Time to alarm for cardiac Average: 3.28 sec
standstill
Time to alarm for heart rate Low heart rate: average: 5.48 sec
High heart rate: average: 5.30 sec
Time base selection and 10 successive peaks: 10 mm
accuracy 20 successive peaks: 20 mm
40 successive peaks: 40 mm
Pacemaker pulse rejection Rejection of pacemaker pulses with amplitudes from
capability ±2mV to ±700mV with pulse widths of 0.1 to 2msec
Overshoot time constant 4 ms, Test method B (with
overshoot)
Pacer pulse detector Slew rate: 595mV/s
rejection of fast ECG signals
Respiration
IM Respiration
Technique Impedance Pneumography
Range 0, 3 to 120 breaths/min
Resolution ±3 breaths/min
Leads RA to LA
Base impedance 500 to 2000 ohm
Delta impedance 0.5 to 3 ohm
Lead Off Condition Detected and displayed
Display Sweep Speeds 25 mm/sec
Wave Size x0.5, x1, x1.5, x2
AW Respiration
Technique Nondispresive Infrared Spectroscopy
Range 0 to 150 breaths/min
Accuracy ±1 breaths/min
195
NIBP
Pulse Rate
Pulse Rate Range Adult/Pediatric 40 to 200 BPM
Neonatal 40 to 240 BPM
Resolution 5 BPM
Pulse Rate Accuracy ±2 BPM or ±2%, whichever is greater
NIBP (Non-Invasive Blood Pressure)
Technique Oscillometric Measurement
Measurement Modes Off, Cont, 1, 2.5, 3, 5, 10, 15, 30, 60, 90 minutes
Measurement Range Adult/Pediatric
SYS 60 to 250 mmHg
MAP 45 to 235 mmHg
DIA 40 to 200 mmHg
Neonatal
SYS 40 to 120 mmHg
MAP 30 to 100 mmHg
DIA 20 to 90 mmHg
NIBP Accuracy Mean error and standard deviation per ANSI/AAMI
SP10:2002+A1:2003+A2:2006, IEC 60601-2-30:2009, EN
1060-4:2004
Pressure Display Range Adult/Pediatric 0 to 300 mmHg
Neonatal 0 to 150 mmHg
Pressure Display Within ±3 mmHg or 2%
Accuracy
Initial Cuff Inflate Adult/Pediatric
Pressure 120, 140, 160, 180, 200, 220, 240, 260, 280 mmHg
(16.0, 18.7, 21.3, 24.0, 26.7, 29.3, 32.0, 34.7, 37.3 kPa)
Neonatal
80, 90, 100, 110, 120, 130, 140 mmHg
(10.7, 12.0, 13.3, 14.7, 16.0, 17.3, 18.7 kPa)
Automatic Cuff Deflation Measurement time exceeding 180s in adult/pediatric (90s
in neonatal) or maximum pressure value exceeding 300
mmHg in adult (150 mmHg in neonatal).
Overpressure Protector Adult/Pediatric: 300 mmHg
Neonatal: 150 mmHg
Measurement Speed About 20 seconds
At the following condition:
Adult
Cuff size 12 cm
SYS 120 mmHg
MAP 90 mmHg
DIA 80 mmHg/ PR 80 BPM
Manual Measurements (180 mmHg)
196
IBP
Pulse Rate
Pulse Rate Range 20 to 250 BPM
Accuracy ± 1 % or ± 1 bpm
Pulse Rate Resolution 1 BPM
IBP (Invasive Blood Pressure)
Parameter Displayed P1, ABP
P2, CVP, PAP, LAP
Measurement Range -50 mmHg to 300 mmHg
20 bpm to 250 bpm
Resolution 1 mmHg
Accuracy ± 3 mmHg
Input sensitivity 5µV/V/mmHg
Transducer Volume 0.1mm3/100mmHg
Displacement
Zero calibration range ± 100mmHg
Frequency response DC - 10 Hz ± 1 Hz, -3db
Wave Size 0 to 50, 0 to 100, 0 to 200, 0 to 300, Auto Size
Display Sweep Speeds 25.0 mm/sec
SpO2
Measurement Ranges
SpO2 saturation range 1% to 100%
Pulse rate range 20 to 300 beats per minute (bpm)
Perfusion range 0.03% to 20%
Display sweep speed 25.0 mm/sec
Measurement Accuracy
Pulse rate accuracy 20 to 250 beats per minute (bpm) ±3 digits
SpO2 saturation accuracy 70% to 100% ±2 digits, neonates: ±3 digits
Note: SpO2 saturation accuracy – The defibrillator/monitor measurements are
statistically distributed; about two-thirds of the defibrillator/monitor
measurements can be expected to fall in this accuracy (ARMS) range.
Reference the Clinical Studies section for test results. For a complete listing of
SpO2 accuracy across the full line of available Nellcor™ sensors, contact
Covidien, a local Covidien representative, or locate it online at
www.covidien.com.
Operating Range and Dissipation
Red Light Wavelength Approximately 660 nm
Infrared Light Wavelength Approximately 900 nm
Optical Output Power Less than 15 mW
Power Dissipation 52.5 mW
197
Capnography
Capnography
Parameter Displayed EtCO2, InCO2
Range 0 mmHg ~ 150 mmHg (0kPa ~ 20kPa, 0% ~ 20%)
Accuracy 0-40mmHg ±2mmHg of reading
41-70mmHg ±5% of reading
(No degradation due to respiration rate or
Inspiration/Expiration ratio (I/E ratio))
Display Accuracy ±2mmHg
Response Time Mainstream: Less than 60ms
Sidestream: Less than 3sec.
Baromatric Pressure -152.4 to 4572 meters
Correction (-500 to 15,000 feet),
775 to 429 mmHg, Automatic
Gas Compensation User selective at O2 >60% and N2O >50%
Stability and drift Short term drift: Less than 0.8 mmHg over 4 hours.
Long term drift: Accuracy specification will be maintained
over a 120 hour period.
Accuracy Change for 0-40 mmHg ±1 mmHg additional error
interfering Gases and 41-70 mmHg ±2.5% additional error
Vapors Anesthetic and 71-100 mmHg ±4% additional error
interfering agents 101-150 mmHg ±5% additional error
Additional worst case error when compensation for O 2

and N2O is correctly selected for actual fractional gas
constituents present.
Warm Up Time 2 minutes maximum
Sweep Speeds 25.0 mm/sec
Sampling rate 100Hz
Sound Noise Level Less than 41dB when ambient sound pressure level is
22dB
Note: Respiration rate accuracy was verified by using a solenoid test setup to deliver
a square wave of known CO2 concentration to the device. 5% and 10% CO2
concentrations were used and respiration rate was varied over the range of the
device. Pass/Fail criteria was comparison of the respiratory rate output from the
sensor to the frequency of the square wave. EtCO 2 measurements at those
rates were compared to the CO2 readings under static flow conditions.
198
Temperature
Thermistor Temp
Probe Type Thermistor probe YSI 400 series and 700 series
Measurement Method Thermistor
Operating Mode Direct
Range 0.0 to 50°C (32.0 to 122°F)
Display Accuracy ±0.1
Probe Accuracy YSI 400 series and YSI 700 series Probes:
±0.1°C from 25 to 45°C,
±0.2°C from 0 to 25°C and from 45 to 50°C
Transient Response Time About 17 sec
Event
Type 12 lead, Event

Data storage Internal memory, SD card
Memory 12 lead
saves total 100 data
saves ECG waveform
saves ECG analysis result data
saves ECG analysis date and time
saves HR/PR, NIBP, SpO2, Respiration,
Temperature, IBP 1, IBP 2, EtCO2 numeric data
saves alarm condition
Event
saves total 250 data
saves defibrillation shock information (number of
shock, energy level, actual passed energy,
impedance)
saves pacing information (pace rate, pace current,
async mode)
saves clinical action list
saves 1 channel ECG waveform
saves Event date and time
saves HR/PR, NIBP, SpO2, Respiration,
Temperature, IBP 1, IBP 2, EtCO2 numeric data
saves alarm condition
199
Defibrillator (Technical Specification)
AED Mode
AED Mode
Charging Time - 200J Charging condition Time (sec)
With Rated Mains Voltage 5.8
With DC Mains Voltage 5.9
With fully charged battery 6.4
Charging Time - 200J Charging condition Time (sec)
(including time from the With Rated Mains Voltage 18.1
initiation of rhythm With DC Mains Voltage 18.4
analysis with a clear ECG With fully charged battery 19.3
signal to readiness for With Mains Voltage of 90% of the Rated
discharge.) 18.1
value
With DC Mains Voltage of 90% of the
18.8
Rated value
After 15 maximum energy discharges
19.6
taken from a new fully charged battery
With Mains Voltage of 90% of the Rated
value, but measured from initially
26.4
switching power on to ready for
discharge at maximum energy
Rated value, but measured from initially
26.3
switching power on to ready for
taken from a new fully charged battery,
but measured from initially switching 26.7
power on to ready for discharge at
maximum energy
Note: A used battery normally takes more time than the
charging time specified in above.
Waveform parameters The defibrillator/monitor delivers shocks to load
impedances from 25 to 175 ohms. The duration of each
pulse of the waveform is dynamically adjusted based on
delivered charge, in order to compensate for patient
impedance variations, as shown below:
(When 200J is selected)
Load resistance (Ω) Delivered energy(J)
25 195
50 200
75 196
100 199
125 199
150 200
175 200
200
Manual Mode
Manual Mode
Charging Time – 200J Charging condition Time (sec)
With Mains Voltage of 90% of the
5.8
Rated value
6.4
Rated value
6.6
Rated value, but measured from
11.7
initially switching power on to ready for
11.9
maximum energy
Charging Time – 360J Charging condition Time (sec)
7.4
Rated value
8.0
Rated value
8.5
13.0
14.0
maximum energy
201
Number of discharges The number of maximum energy discharges which are
available from a new and fully charged battery at 20°C
ambient temperature is above 200 times for 360J and
250 times for 200J
ECG Analysis Performance
Rhythm class AHA-DB MIT-DB CU-DB VF-DB Total number of

sample size
VF-shockable: TP 1905 47 549 1052 3553
VF-shockable: FN 65 1 11 8 85
VF-shockable: 96.70 97.92 98.04 99.25 97.66
sensitivity(%)
VT-shockable: TP 9 - - 1304 1313
VT-shockable: FN 0 - - 30 30
VT-shockable: 100.00 - - 97.75 97.72
sensitivity(%)
Non-shockable: TN 64798 33297 2565 14543 115203
Non-shockable: FP 8 10 29 73 120
Specificity(%) 99.99 99.97 98.88 99.50 99.90
Database for ECG Analysis

 From AHA (American Heart Association) official database
 From MIT (Massachusetts institute Technology) official database
(CU-DB: The Creighton University Sustained Ventricular Arrhythmia Database,
VF-DB: MIT-BIH Malignant Ventricular Arrhythmia Database)
ECG rhythm to determine if a shock is appropriate

 Ventricular Fibrillation at a amplitude greater than or equal to 0.2mV
 Ventricular Tachycardia at a heart rate greater than or equal to 160 bpm
202
Biphasic Waveform Characteristics
The efficiency of Mediana’s Biphasic waveform has been clinically verified during a
ventricular fibrillation (VF) and ventricular tachycardia (VT) defibrillation study. This study
(which was conducted using D500 defibrillator/monitors) and the findings are described
below.
Table 44. Delivered Energy at Every Defibrillator Settings into a Range of Loads
Selected Load Accuracy
Energy 25 50 75 100 125 150 175
1J 1.0 1.0 1.0 1.0 1.0 1.0 1.0 15%
2J 2.0 2.0 2.0 2.0 2.0 2.0 2.0 15%
3J 3.0 3.0 3.0 3.0 3.0 3.0 3.0 15%
4J 4.0 4.0 4.0 4.0 4.0 4.0 4.0 15%
5J 5.0 5.0 5.0 5.0 5.0 5.0 5.0 15%
6J 6.0 6.0 6.0 6.0 6.0 6.0 6.0 15%
7J 7.0 7.0 7.0 7.0 7.0 7.0 7.0 15%
8J 8.0 8.0 8.0 8.0 8.0 8.0 8.0 15%
9J 9.0 9.0 9.0 9.0 9.0 9.0 9.0 15%
10J 10.0 10.0 10.0 10.0 10.0 10.0 10.0 15%
15J 14.0 15.0 15.0 15.0 15.0 15.0 15.0 15%
20J 19.0 20.0 20.0 20.0 20.0 20.0 20.0 15%
30J 29.0 30.0 30.0 30.0 30.0 30.0 30.0 15%
40J 38.0 40.0 40.0 40.0 40.0 39.0 40.0 15%
50J 48.0 50.0 49.0 50.0 50.0 50.0 50.0 15%
75J 71.0 74.0 74.0 75.0 74.0 74.0 74.0 15%
100J 96.0 100.0 101.0 101.0 100.0 100.0 100.0 15%
125J 120.0 125.0 125.0 126.0 124.0 124.0 124.0 15%
150J 141.0 148.0 150.0 150.0 149.0 149.0 149.0 15%
175J 164.0 173.0 175.0 175.0 174.0 174.0 173.0 15%
200J 187.0 197.0 200.0 198.0 198.0 199.0 198.0 15%
300J 292.0 299.0 302.0 300.0 300.0 299.0 282.0 15%
360J 373.0 370.0 364.0 345.0 323.0 302.0 282.0 15%
Note: When the energy is set to 360J and the impedance on the patient chest through
the paddle is more than 150ohm or 175ohm, the energy delivered to the paddle,
is supposed to be automatically reduced from 360J to approximately 300J, in
order to avoid re-fibrillation caused by the increase of duration of energy
waveform. Some of study reported that energy delivery with more than 24ms
could cause re-fibrillation. HeartOn Biphasic waveformTM adjusts the energy level
only with duration. It does not deliver energy more than 24ms.
203
Figure through show the biphasic waveforms that are produced when the
defibrillator/monitor is discharged into loads of 25, 50, 75, 100, 125, 150 and 175 ohms
at each energy setting (360, 300, 200, 175, 150, 125, 100, 75, 50, 40, 30, 20, 15, 10, 9,
8, 7, 6, 5, 4, 3, 2 and 1 joule[s]).
The vertical axis shows the voltage in volts (V); the horizontal axis shows the duration in
milliseconds (ms).
Figure 88. Biphasic Waveforms at 300 Joules and 360 Joules
Figure 89. Biphasic Waveforms at 200 Joules
204
205
206
207
Figure 96: Biphasic Waveforms at 40 Joules
208
209
210
211
212
213
214
Compliance
Item Standard Description

Classification IEC 60601-1:2005 Class I (on AC power)
+A1:2012, Internally powered (on battery power)
EN 60601-1:2006
+A1:2013
Type of protection IEC 60601-1:2005 Type BF and Type CF – Applied part
+A1:2012,
EN 60601-1:2006
+A1:2013
Mode of operation IEC 60601-1:2005 Continuous
+A1:2012,
EN 60601-1:2006
+A1:2013
Degree of protection IEC 60529:1989 IP34 (provided by enclosures)
+A1:1999+A2:2013,
EN 60529:1991
+A1:2000+A2:2013
General 93/42/EEC as amended by Directives for medical devices
2007/47/EC
21CFR820 Code of federal regulations
2012/19/EU Waste electrical and electronic equipment directive
(WEEE)
2011/65/EU Restriction of the use of Hazardous Substances in
electrical and electronic equipment II
93/86/EEC Battery disposal directive
2006/66/EC as amended Battery directive
by 2008/103/EC
ISO 13485:2003 Quality systems - Medical Devices - Requirements
/Cor1:2009 for regulating purposes
EN ISO 13485:2012
/AC:2012
ISO 14971:2007, Risk analysis managements – medical devices
EN ISO 14971:2012
IEC 60601-1:2005 General requirements for safety of medical
+A1:2012, electrical equipment
EN 60601-1:2006
+A1:2013
IEC 60529:1989 Degree of protection provided by enclosures (IP34)
+A1:1999+A2:2013,
EN 60529:1991
+A1:2000+A2:2013
ISO 14155:2011 Clinical investigation of medical devices for human
/Cor1:2011 subjects – part 1: General requirements
EN ISO 14155:2011
IEC 60601-1-6:2010, Collateral standard for usability
215
EN 60601-1-6:2010
ISO 10993-1:2009 Biological evaluation of medical devices – Part 1:
/Cor1:2010, Evaluation and testing
EN ISO 10993-1:2009
/AC:2010
ISO 10993-5:2009, Biological evaluation of medical devices – Part 5:
EN ISO 10993-5:2009 Tests for in vitro cytotoxicity
ISO 10993-10:2010, Biological evaluation of medical devices – Part 10:
EN ISO 10993-10:2010 Tests for irritation and delayed-type hypersensitivity
IEC 60601-2-49:2011, Particular requirements for multifunction patient
EN 60601-2-49:2015 monitoring equipment
IEC 62366:2007 Medical devices – Application of usability
EN 62366:2008 engineering to medical devices
IEC 62304:2006+A1:2015 Medical device software – Software life-cycle
EN 62304:2006+A1:2015 processes
Ambulance EN 1789:2007+A1:2010 Medical vehicles and their equipment – road
ambulance
EN 13718-1:2008 Medical vehicles and their equipment – Air
ambulances – Part1:Requirements for medical
devices used in air ambulances.
RTCA/ DO-160 section 20, Environmental Conditions and Test Procedures for
21 Airborne Equipment
Alarms IEC 60601-1-8:2006 Alarm systems requirements, tests and guidance in
+A1:2012, medical electrical equipments systems
EN 60601-1-
8:2007/AC:2010
Electrocardiograph IEC 60601-2-27:2011, Particular requirements for the safety of
EN 60601-2-27:2014 Electrocardiographic monitoring equipment
IEC 60601-2-25:2011, Particular requirements for the basic safety and
EN 60601-2-25:2015 essential performance of electrocardiographs
AAMI EC53:2013 ECG cable and leads
AAMI EC57:2012 Testing and reporting performance results of
cardiac rhythm and ST-segment measurement
algorithms
Non-invasive blood ISO 81060-2:2009/Cor Electronic or automated sphygmomanometers
pressure 1:2011
EN 1060-3:1997+A2:2009 Supplementary requirements for electrical-
mechanical blood pressure measuring systems
EN 1060-4:2004 Non-invasive sphygmomanometers - Test
procedures to determine the overall system
accuracy of automated non-invasive
sphygmomanometers
IEC 80601-2-30:2009 Particular requirements for the safety, including
+A1:2013, essential performance, of automatic cycling indirect
216
EN 80601-2- blood pressure monitoring equipment
30:2010/A1:2015
Oxygen saturation ISO 80601-2-61:2011, Basic safety & essential performance of pulse
EN ISO 80601-2-61:2011 oximeter for medical use
Temperature ISO 80601-2-56:2009, Performance of electrical thermometers for
monitoring EN ISO 80601-2-56:2012 continuous Measurement
Invasive blood IEC 60601-2-34:2011 Particular requirements for the safety, including
pressure EN 60601-2-34:2014 essential performance, of invasive blood pressure
monitoring equipment
Capnography ISO 80601-2-55:2011, Particular requirements for the basic safety and
EN ISO 80601-2-55:2011 essential performance of respiratory gas monitors
Defibrillator IEC 60601-2-4:2010 Safety of cardiac defibrillators
EN 60601-2-4:2011
Electromagnetic IEC 60601-1, sub clause Electromagnetic compatibility-requirements & test
compatibility 36, and
IEC 60601-1-2:2014
EN 60601-1-2:2015
IEC 61000-3-2:2014 Harmonic emission Ed 3.2
EN 61000-3-2:2014
IEC 61000-3-3:2013, Voltage fluctuations/Flicker emission Ed 2.0
EN 61000-3-3:2013
IEC 61000-4-2:2008, Electrostatic discharge Ed 2.0
EN 61000-4-2:2009
IEC 61000-4- Radiated RF electromagnetic field Ed 3.1
3:2006+A1:2007+A2:2010
EN 61000-4-3:2006
+A1:2008+A2:2010
IEC 61000-4-4:2012 Electrical fast transient/burst Ed 2.1
EN 61000-4-4:2012
IEC 61000-4-5:2014, Surge current Ed 2.0
EN 61000-4-5:2014
IEC 61000-4-6:2013, Conducted disturbances, induced by RF field Ed
EN 61000-4-6:2014 3.0
IEC 61000-4-8:2009, Power frequency (50/60Hz) magnetic field Ed 2.0
EN 61000-4-8:2010
IEC 61000-4-11:2004, Voltage dips, short interruption and voltage
EN 61000-4-11:2004 variation on power supply input lines Ed 2.0
CISPR11:2009 +A1:2010 Limits and methods of measurement of radio
EN 55011: 2009 +A1:2010 disturbance characteristics of industrial scientific
and medical (ISM) radio-frequency equipment RF
Emissions Group 1, Class B
CISPR22:2008 Information technology equipment - Radio
EN 55022:2010/AC:2011 disturbance characteristics - Limits and methods of
measurement
Package ISTA (Procedure 1A, Pre-Shipment test procedures (Package)
2014)
217
IEC 60068-1:2013 Environmental testing, Part1: General guidelines
EN 60068-1:2014
IEC 60068-2-1:2007 Environmental testing - Part 2-1: Tests - Test A:
EN 60068-2-1:2007 Cold
IEC 60068-2-2:2007 Environmental testing - Part 2-2: Tests - Test B:
EN 60068-2-2:2007 Dry heat
IEC 60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db:
EN 60068-2-30:2005 Damp heat, cyclic (12 h + 12 h cycle)
Reliability IEC 60068-2-27:2008, Environmental testing – Shock
EN 60068-2-27:2009
IEC 60068-2-6:2007, Environmental testing – Vibration
EN 60068-2-6:2008
IEC 60068-2-31:2008 Environmental testing: Rough handling shocks,
EN 60068-2-31:2008 primarily for equipment-type specimens
IEC 60068-2-64:2008, Environmental testing: vibration, broad-band
EN 60068-2-64:2008 random (digital control) and guidance
Labeling EN 1041:2008 Information supplied by the manufacturer with
medical devices
Marking IEC TR 60878:2015 Graphical symbols for electrical equipment in
medical practice
ISO 15223-1:2012 Symbols to be used with medical device labels,
EN ISO 15223-1:2012 labelling and information to be supplied -- Part 1:
General requirements
ISO 15223-2:2010 Symbols to be used with medical device labels,
labelling, and information to be supplied -- Part 2:
Symbol development, selection and validation
ISO 7000:2014 Graphical symbols for use on equipment-index and
synopsis
EN 50419:2006 Marking of electrical and electronic equipment in
accordance with article II (2) of directive
2002/96/EC (WEEE)
218
Manufacturer’s EMC Declaration

standards. The use of accessories, transducers, and cables other than
those specified may result in increased emission and/or decreased
immunity of the defibrillator/monitor.
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to any part of the monitor, including cables specified
by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
The defibrillator/monitor is suitable for use in the specified electromagnetic

environment. The customer and/or user of the defibrillator/monitor should assure that it
is used in an electromagnetic environment as described below;
Table 45. Electromagnetic Emissions (IEC60601-1-2)
Emission Test Compliance Electromagnetic Environment

RF emission CISPR 11 Group 1, The defibrillator/monitor is suitable for use
Class B in all establishments
Harmonic emissions Class A The defibrillator/monitor is suitable for use
IEC 61000-3-2 in all establishments.
Voltage fluctuations/flicker Complies The defibrillator/monitor is suitable for use
emission IEC 61000-3-3 in all establishments.
Table 46. Electromagnetic Immunity (IEC60601-1-2)
Immunity Test IEC 60601-1-2 Compliance Electromagnetic

Test Level Level Environment Guidance
Electrostatic ±8 kV contact ±8 kV contact Floor should be wood,
discharge (ESD) ±2, 4, 8, 15 kV air ±2, 4, 8, 15 kV air concrete, or ceramic tile. If
IEC 61000-4-2 floors are covered with
synthetic material, the relative
humidity should be at least
30 %.
Electric fast ±2 kV for ±2 kV for Mains power quality should be
transient/burst power supply lines power supply that of a typical commercial
IEC 61000-4-4 ±1 kV for lines and/or hospital environment
input/output lines ±1 kV for
input/output lines
Surge (Input Power (Input Power Mains power quality should be
IEC 61000-4-5 Ports) Ports) that of a typical commercial
± 0.5, 1 kV ± 0.5, 1 kV and/or hospital environment
differential mode differential mode
±0.5, 1, 2 kV ±0.5, 1, 2 kV
common mode common mode
(Signal (Signal
input/output) input/output)
2 kV 2 kV
common mode common mode
219
Immunity Test IEC 60601-1-2 Compliance Electromagnetic
Test Level Level Environment Guidance
Voltage dips, Voltage dips Voltage dips Mains power quality should be
short >95 % U T >95 % U T that of a typical commercial
interruptions and for 0.5 cycle for 0.5 cycle and/or hospital environment. If
voltage At 0°, 45°, 90°, At 0°, 45°, 90°, the user of the
variations on 135°, 180°, 225°, 135°, 180°, 225°, defibrillator/monitor requires
power supply 270° and 315° 270° and 315° continued operation during
power mains interruption, it is
IEC 61000-4-11 Voltage dips Voltage dips recommended that the
>95 % U T >95 % U T defibrillator/monitor be
for 1 cycle for 1 cycle powered from an
At 0° At 0° uninterruptible power supply or
Voltage dips Voltage dips battery.
30 % U T 30 % U T
for 25/30 cycle for 25/30 cycle
At 0° At 0°
Voltage interruption Voltage
>95 % U T interruption
for 250/300 cycle >95 % U T
At 0° for 250/300 cycle
At 0°
Power 30 A/m 30 A/m It may be necessary to position
frequency the defibrillator/monitor further
(50/ 60 Hz) from the sources of power
magnetic field frequency magnetic fields or to
install magnetic shielding. The
IEC 61000-4-8 power frequency magnetic field
should be measured in the
intended installation location to
assure that it is sufficiently low.
Note: UT is the AC mains voltage prior to application of the test level.
220
Table 47. Electromagnetic Immunity (IEC60601-2-4)
Immunity Test IEC 60601 Compliance Electromagnetic environment
test level level guidance
The defibrillator/monitor is intended for use in the electromagnetic environment specified
below. The customer or the user of the defibrillator/monitor should assure that it is used in
such an environment.
Portable and mobile RF
communications equipment should
be used no closer to any part of the
defibrillator/monitor including cables,
than the recommended separation
distance calculated from the
equation appropriate to the
frequency of the transmitter.
Recommend separation distance

Conducted RF 3 V RMS outside 3 Vrms d = 1.2 p
IEC 61000-4-6 the ISM band
6 V RMS in the ISM 6 Vrms d = 0.6 p

and amateur
radio bands
150 kHz to 80 MHz
Radiated RF 3 V/m 3 V/m d = 1.2 p 80 MHz to 800 MHz

IEC 61000-4-3 80 MHz to 2.5 GHz
(80 % AM at 2 Hz) d = 2.3 p 800 MHz to 2.5 GHz
According to
IEC60601-1-2:2007
10 V/m 10 V/m d = 0.4 p 80 MHz to 800 MHz

80 MHz to 2.7 GHz
(80 % AM at 1 kHz) d = 2.3 p 800 MHz to 2.7 GHz
According to
IEC60601-1-2:2014
20 V/m 20 V/m d = 0.2 p 80 MHz to 800 MHz

80 MHz to 2.5 GHz
(80 % AM at 1 kHz) d = 0.4 p 800 MHz to 2.5 GHz
According to
particular standards
where P is the maximum output

power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in
metres (m).
Field strengths from fixed RF

transmitters as deter-mined by an
electromagnetic site survey,a should
be less than the compliance level in
each frequency range.b
Interference may occur in the vicinity

of equipment marked with the
following symbol:
221
Immunity Test IEC 60601 Compliance Electromagnetic environment
test level level guidance
Note: At 80 MHz and 800 MHz, the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the defibrillator/monitor is used exceeds the applicable RF
compliance level above, the defibrillator/monitor should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating the defibrillator/monitor.
b Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m
Table 48. Electro-surgical Unit Interference (IEC 60601-2-27, IEC 60601-2-30)
Interference Test IEC 60601 test level Complies with

Test in cut mode Output power 300W, 5 times IEC 60601-2-2
Output power of 100W,
Test in coagulation mode Working frequency of 400 kHz ± 10 % 5
times
Table 49. Recommended Separation Distances
Recommended separation distance between

portable and mobile RF communications equipment and the defibrillator/monitor
The defibrillator/monitor is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the defibrillator/monitor can help
prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the defibrillator/monitor as
recommended below, according to the maximum output power of the communications
equipment.
Rated Separation distance according to frequency of transmitter in meter
Maximum 150 kHz to 150 kHz to 80 MHz to 800 MHz to
Output Power 80MHz 80MHz 800MHz 2.5GHz
of Transmitter d = 1.2 p (ISM and (Test level (Test level
in watt amateur 20 V/m) 20 V/m)
radio bands) d = 0.2 p d = 0.4 p
d = 0.6 p
0.01 0.12 0.06 0.02 0.04
0.1 0.38 0.19 0.06 0.13
1 1.2 0.6 0.2 0.4
10 3.8 1.9 0.63 1.3
100 12 6 2 4
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
Note: At 80MHz and 800MHz, the separation distance for the higher frequency range applies
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
222
Table 50. Immunity to proximity fields from RF wireless communications equipment
(IEC 60601-1-2)
Test frequency Compliance Level Immunity test level

Modulation
(MHz) (V/m) (V/m)
Pulse modulation b
385 27 27
18 Hz
FM a
450 ± 5 kHz deviation 28 28
1 kHz sine
710
Pulse modulation b
745 9 9
217 Hz
780
810
Pulse modulation b
870 28 28
18 Hz
930
1720
Pulse modulation b
1845 28 28
217 Hz
1970
Pulse modulation b
2450 28 28
217 Hz
5240
Pulse modulation b
5500 9 9
217 Hz
5785
a As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because
while it does not represent actual modulation, it would be worst case.

b The carrier shall be modulated using a 50 % duty cycle square wave signal.
Table 51. Cables (IEC60601-1-2)
Maximum
Cables and Sensors Complies with
Length
AC Power Cable 2.5m
DC In Cable 1.8 m -RF emissions, CISPR 11, Class B/ Group 1
NIBP Hose 3.5 m -Harmonic emissions, IEC 61000-3-2
Cuff Hose 0.5 m -Voltage fluctuations/flicker emission,
IBP Cable 3.0 m IEC 61000-3-3
ECG Lead Cable 3.0 m -Electrostatic discharge (ESD), IEC 61000-4-2
Defibrillator/AED Cable 3.0 m -Electric fast transient/burst, IEC 61000-4-4
Temperature Cable 3.0 m -Surge, IEC 61000-4-5
EtCO2 Cable 2.0 m -Conducted RF IEC 61000-4-6
SpO2 Cable 4.0 m -Radiated RF, IEC 61000-4-3
SpO2 Sensor 1.0 m
223

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OPERATOR’S MANUAL

Part Number: A7226-10

Copyright © 2019 All rights reserved.

 Copyright law allows no part of this instruction manual to be reproduced without

 Please contact your local distributor about the warranty period.

This defibrillator/monitor is equipped with epoch-making ECG monitoring

Do not take or use the defibrillator/monitor in locations where highly

Always check that the defibrillator/monitor functions properly and is in

Patient conditions may result in erroneous readings. If the

Intended Use for the D500

The other monitoring functions (Electrocardiography (ECG, Heart Rate), Non-invasive

Indications for Use

External Pacing External pacing is indicated for External pacing is

Electrocardiography The 12-lead electrocardiogram No known contraindications

Noninvasive Blood Noninvasive blood pressure Noninvasive Blood Pressure is

Pulse Oximetry Pulse oximetry monitoring is Pulse Oximetry is not intended

Invasive Blood Invasive pressure monitor is No known contraindications

End-Tidal CO2 EtCO2 monitoring is indicated No known contraindications

Temperature Temperature monitoring is No known contraindications

Identifying the D500 Configurations

Front Panel Components 1

Figure 1. Front panel components

Mode select knob

Energy Level button

Multi function knob

Figure 2. Top panel components

1 Paddle 4 SHOCK button

Table 2. The defibrillator/monitor controls on paddle

Energy Level button

1 Side Option Case

Figure 4. Left panel components

Right Panel Components

1 Wireless(3G, Wi-Fi) module

Figure 5. Right panel components

AC indicator Dust and water resistance

Direct current CE mark

Battery charging status

Service indicator Follow instructions for use

Type BF- Defibrillator Proof Separate Collection

Type CF- Defibrillator Proof EU representative

NIBP connector Manufacturer

Temperature 1 connector Date of manufacture

Temperature 2 connector Reference number

IBP 1 connector Serial number

ECG connector Fragile

AC power input rating Keep dry

Equipotential terminal This way up

Class II equipment Single patient use only

1 Shock count number/icon 8 Title of waveform parameter

ECG source: Lead lll Respiration Icon

ECG source: Lead V EtCO2 respiration: AW

ECG source: Lead V1 Thoracic impedance respiration: IM

ECG source: Lead V2 NIBP auto mode interval

ECG source: Lead V3 NIBP elapsed time

ECG source: Lead V4 HR/PR icon & unit

ECG source: Lead V5 Communication source: 3G

ECG source: Lead V6 Communication source: Wi-Fi

ECG source: Pads Bed number icon

IBP2 waveform icon Alarm active

IBP2 waveform icon Audio pause

IBP2 waveform icon Audio off or Limit alarm pause

IBP2 waveform icon Pacer pulse detection icon

Temperature 1 icon ECG gain

Temperature 2 icon Wi-Fi communication icon