Monitor Mediana Lucon m30

OPERATOR’S MANUAL
Patient Monitor M30
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: A7124-6

Revised Date: 0314
Copyright © 2014 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 Mediana. employee or technician specified 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 M30. 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 M30 conforms to the EMC standard IEC60601-1-2.

Note that mobile phones should not be used in the vicinity of the M30.
Note, however, any device not complying to the EMC standard that is used with the
M30 renders the M30 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.
CONTENTS
CONTENTS .................................................................................................................................................... i
SAFETY INFORMATION .............................................................................................................................. 1
General Safety Information ................................................................................................................... 1
Warning ................................................................................................................................................. 1
Cautions ................................................................................................................................................ 3
INTRODUCTION ........................................................................................................................................... 5
Intended Use for the M30 ...................................................................................................................... 5
Indications For Use................................................................................................................................ 5
About This Manual................................................................................................................................. 6
Identifying the M30 Monitor Configurations ........................................................................................... 7
Features for the M30 ............................................................................................................................. 8
DESCRIPTION OF THE MONITOR.............................................................................................................. 9
Front Panel Components ...................................................................................................................... 9
Rear Panel Components ..................................................................................................................... 11
Left Panel Components ....................................................................................................................... 12
Right Panel Components .................................................................................................................... 13
Displays ............................................................................................................................................... 15
SETTING UP THE MONITOR ..................................................................................................................... 19
Unpacking and Inspection ................................................................................................................... 19
List of Components.............................................................................................................................. 20
Power Cable Connections ................................................................................................................... 21
Measurement Cable Connections ....................................................................................................... 22
BATTERY OPERATION .............................................................................................................................. 25
Operating the Monitor on Battery Power ............................................................................................. 25
Battery Status Indication ...................................................................................................................... 26
Charging a Low Battery ....................................................................................................................... 26
USING THE MONITOR ............................................................................................................................... 27
Turning On and Off the Monitor ........................................................................................................... 27
Setting Date and Time ......................................................................................................................... 29
Setting Basic Setup Parameters ......................................................................................................... 30
Setting the Main Screen ...................................................................................................................... 32
ALARMS AND LIMITS................................................................................................................................ 33
General ................................................................................................................................................ 33
Alarm Priority and Messages .............................................................................................................. 34
Visual Alarm Indication ........................................................................................................................ 38
Audible alarm Indication ...................................................................................................................... 38
Verifying Visual and Audible Alarm Indication ..................................................................................... 38
Changing Alarm Limits......................................................................................................................... 39
Alarm Audio Paused ............................................................................................................................ 42
Alarm Audio Off ................................................................................................................................... 43
ECG MONITORING .................................................................................................................................... 45
General ................................................................................................................................................ 45
Setup Connections .............................................................................................................................. 46
Arrhythmia Monitoring ......................................................................................................................... 47
ST Monitoring ...................................................................................................................................... 48
Description of HR/PR Menu Functions................................................................................................ 49
Description of ECG Waveform Menu Functions.................................................................................. 51
NIBP MONITORING .................................................................................................................................... 53
General ................................................................................................................................................ 55
NIBP Measurement Modes ................................................................................................................. 57
Description of NIBP Menu Functions .................................................................................................. 59
SpO2 MONITORING.................................................................................................................................... 61
General ................................................................................................................................................ 62
Clinical Studies .................................................................................................................................... 64
Description of SpO2 Menu Functions .................................................................................................. 68
Description of Pleth Waveform Menu Functions ................................................................................. 69
RESPIRATION MONITORING .................................................................................................................... 71
General ................................................................................................................................................ 71
i


Description of Respiration Menu Functions ........................................................................................ 72
Description of Respiration Waveform Menu Functions ....................................................................... 73
CAPNOGRAPHY MONITORING ................................................................................................................ 75
General ................................................................................................................................................ 76
Description of EtCO2 Menu Functions................................................................................................. 79
Description of EtCO2 Waveform Menu Functions ............................................................................... 80
TEMPERATURE MONITORING ................................................................................................................. 83
General ................................................................................................................................................ 83
Description of Temperature Menu Functions....................................................................................... 84
TRENDS ...................................................................................................................................................... 85
General ................................................................................................................................................ 85
Trend Data Printout ............................................................................................................................. 85
Tabular Trend Data .............................................................................................................................. 85
Graphical Trend Data .......................................................................................................................... 87
Trend Data Download .......................................................................................................................... 88
MENU STRUCTURE ................................................................................................................................... 99
PRINTING ................................................................................................................................................. 109
General .............................................................................................................................................. 109
Print-Out Configuration ...................................................................................................................... 110
EXTERNAL INTERFACE .......................................................................................................................... 113
General .............................................................................................................................................. 113
Setting Network ................................................................................................................................. 114
Cable Connection .............................................................................................................................. 114
Nurse Call Interface ........................................................................................................................... 115
Central System Communication ........................................................................................................ 115
MAINTENANCE ........................................................................................................................................ 117
Recycling and Disposal ..................................................................................................................... 117
Returning the Monitor and System Components .............................................................................. 117
Service ............................................................................................................................................... 117
Periodic Safety Checks ..................................................................................................................... 117
Cleaning ............................................................................................................................................ 118
Battery Maintenance ......................................................................................................................... 118
Loading Printer Paper ....................................................................................................................... 120
TROUBLESHOOTING .............................................................................................................................. 121
General .............................................................................................................................................. 121
Corrective Action ............................................................................................................................... 121
EMI (Electromagnetic Interference)................................................................................................... 124
Obtaining Technical Assistance ......................................................................................................... 124
FACTORY DEFAULTS .............................................................................................................................. 125
General .............................................................................................................................................. 125
Parameter Ranges and Default Settings ........................................................................................... 125
SPECIFICATION ....................................................................................................................................... 129
Display ............................................................................................................................................... 129
Controls ............................................................................................................................................. 129
Alarms ............................................................................................................................................... 129
Physical Characteristics and Printer.................................................................................................. 129
Electrical ............................................................................................................................................ 130
Environmental Conditions ................................................................................................................. 130
Tone Definition ................................................................................................................................... 131
Measurement Parameters ................................................................................................................. 132
Trends................................................................................................................................................ 137
Compliance........................................................................................................................................ 138
Manufacturer’s Declaration ............................................................................................................... 142
ii
Figures
Figure 1. Front Panel Components ................................................................................................................................ 9
Figure 2. Rear Panel Components .............................................................................................................................. 11
Figure 3. Left Panel Components ................................................................................................................................ 12
Figure 4. Right Panel Components .............................................................................................................................. 13
Figure 5. Displays ........................................................................................................................................................ 15
Figure 6. AC Power Connection .................................................................................................................................. 21
Figure 7. Battery Placement ........................................................................................................................................ 25
Figure 8. Initial Screen ................................................................................................................................................. 28
Figure 9. SET-UP menu ............................................................................................................................................... 30
Figure 10. 3-ch Wave Screen ...................................................................................................................................... 32
Figure 11. Big Number Screen..................................................................................................................................... 32
Figure 12. Standard 3 Electrode Placement ................................................................................................................ 46
Figure 13. 5 Electrode Placement................................................................................................................................ 46
Figure 14. HR/PR Display ............................................................................................................................................ 49
Figure 15. ECG Waveform Display .............................................................................................................................. 51
Figure 16. NIBP Display............................................................................................................................................... 59
Figure 17. Oxyhemoglobin Dissociation Curve ............................................................................................................ 62
Figure 18. Modified Bland-Altman Plot ........................................................................................................................ 66
Figure 19. SpO2 Display .............................................................................................................................................. 68
Figure 20. SpO2 Waveform Display ............................................................................................................................. 69
Figure 21. Respiration Display ..................................................................................................................................... 72
Figure 22. Respiration Waveform Display ................................................................................................................... 73
Figure 23. Connection for mainstream......................................................................................................................... 77
Figure 24. Connection for sidestream .......................................................................................................................... 78
Figure 25. EtCO2 Display ............................................................................................................................................. 79
Figure 26. EtCO2 Waveform Display............................................................................................................................ 80
Figure 27. Temperature Display ................................................................................................................................... 84
Figure 28. Tabular Trend Screen ................................................................................................................................. 85
Figure 29. Graphical Trend Screen .............................................................................................................................. 87
Figure 30. Sample of CP210x VCP Drivers Installer Window ...................................................................................... 89
Figure 31. Sample of License Agreement Window ...................................................................................................... 89
Figure 32. Sample of Destination Location Window .................................................................................................... 90
Figure 33. Sample of Installation Window .................................................................................................................... 90
Figure 34. Sample of Initial System Properties – Hardware ........................................................................................ 91
Figure 35. Sample of Ports (COM & LPT) list in Device Manager Window .................................................................. 91
Figure 36. Sample of Serial Port, Baud Rate, Receive Settings .................................................................................. 92
Figure 37. Sample of OPEN PORT: COM(X) in Operation window ............................................................................. 93
Figure 38. Sample of Trend data File Save .................................................................................................................. 94
Figure 39. Sample of Text Import Wizard – Step 1 of 3................................................................................................ 95
Figure 42. Sample of Trend data in spreadsheet ......................................................................................................... 96
Figure 43. One-Shot Printing ..................................................................................................................................... 110
Figure 44. Continuous Printing .................................................................................................................................. 110
Figure 45. Tabular Trend Printing ................................................................................................................................111
Figure 46. Setting Information Printing .......................................................................................................................111
Figure 47. Setup Menu .............................................................................................................................................. 113
Figure 48. Bed Number ............................................................................................................................................. 114
Figure 49. Nurse Call Interface Pin Layout ................................................................................................................ 114
Figure 50. Printer Paper Replacement ...................................................................................................................... 120
iii

Tables
Table 1. M30 Controls .................................................................................................................................................. 10
Table 2. Panel and Label Symbols .............................................................................................................................. 14
Table 3. Display Symbols............................................................................................................................................. 16
Table 4. Display Colors ................................................................................................................................................ 17
Table 5. Standard Accessories..................................................................................................................................... 20
Table 6. Optional Accessories...................................................................................................................................... 20
Table 7. Front Panel Indications for Power Source ...................................................................................................... 25
Table 8. The Monitor Battery Status Icon ..................................................................................................................... 26
Table 9. Front Panel Indications for Battery Status ...................................................................................................... 26
Table 10. Date/Time Menu........................................................................................................................................... 29
Table 11. SET-UP menu ............................................................................................................................................... 30
Table 12. High Priority Alarm ....................................................................................................................................... 34
Table 13. Medium Priority Alarm .................................................................................................................................. 34
Table 14. Low Priority Alarm ........................................................................................................................................ 35
Table 15. Informative Messages .................................................................................................................................. 36
Table 16. Visual Alarm Characteristics......................................................................................................................... 38
Table 17. Alarm Audio Characteristics ......................................................................................................................... 38
Table 18. Alarm/Limits Menu........................................................................................................................................ 39
Table 19. Alarm Limits Ranges .................................................................................................................................... 40
Table 20. ECG Lead Colors ......................................................................................................................................... 47
Table 21. ECG Lead Pairs ........................................................................................................................................... 47
Table 22. Heart Rate Ranges for Sinus and Rhythms. ................................................................................................ 47
Table 23. HR/PR Menu ................................................................................................................................................ 49
Table 24. ECG Waveform Menu .................................................................................................................................. 51
Table 25. Cuff Size....................................................................................................................................................... 56
Table 26. NIBP Menu ................................................................................................................................................... 59
Table 27. Demographic Data ....................................................................................................................................... 64
Table 28. SpO2 Accuracy for Mediana Sensors .......................................................................................................... 64
Table 29. Demographic Data ....................................................................................................................................... 65
Table 30. SpO2 Accuracy for Mediana Sensors .......................................................................................................... 65
Table 31. SpO2 Sensors .............................................................................................................................................. 67
Table 32. SpO2 Menu .................................................................................................................................................. 68
Table 33. SpO2 Waveform Menu ................................................................................................................................. 69
Table 34. Respiration Menu ......................................................................................................................................... 72
Table 35. Respiration Waveform Menu ........................................................................................................................ 73
Table 36. EtCO2 Menu ................................................................................................................................................. 79
Table 37. EtCO2 Waveform Menu ................................................................................................................................ 80
Table 38. Temperature Menu ....................................................................................................................................... 84
Table 39. Tabular Trend Menu ..................................................................................................................................... 86
Table 40. Graphical Trend Menu .................................................................................................................................. 87
Table 41. Operating Status Codes............................................................................................................................... 97
Table 42. Network Icon .............................................................................................................................................. 114
Table 43. Nurse Call Interface Connections............................................................................................................... 115
Table 44. Parameter Ranges and Factory Defaults ................................................................................................... 125
Table 45. Electromagnetic Emissions (IEC60601-1-2) .............................................................................................. 142
Table 46. Electromagnetic Immunity (IEC60601-1-2) ................................................................................................ 142
Table 47. Electromagnetic Immunity (IEC60601-1-2) ................................................................................................ 143
Table 48. Recommended Separation Distances ........................................................................................................ 144
Table 49. Cables (IEC60601-1-2) .............................................................................................................................. 144
iv
SAFETY INFORMATION
General Safety Information
This section contains important safety information related to general use of the M30
multi-parameter patient monitor. Other important safety information appears throughout
the manual. The M30 will be referred to as the monitor throughout this manual.
Important! Before use, carefully read this manual, accessory directions for use, all
precautionary information and specifications.
Warning
Warnings are identified by the WARNING symbol shown above.
Warnings alert you to potential serious outcomes (death, injury, or adverse events)
to the patient or user.
WARNING: Do not take into or use the 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.
WARNING: When using the monitor with a commercial electric power source, use
the monitor with an electric power wall socket with a grounding wire for medical
use. Not doing so could cause electric shock.
WARNING: Do not connect grounding wire to gas pipes. This could cause fire.
WARNING: Only doctors and officially certified personnel should use this monitor.
Do not allow patients to touch this monitor. Allowing patients to touch this monitor
could cause accidents.
WARNING: This monitor cannot be used when MRI is in progress. If MRI is in use,
keep patient attachments away from patients to prevent accidents.
WARNING: The 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 M30 may be
affected by electrical scalpels and microwave therapeutic apparatus. Please check
operation of the monitor during and after use of such equipment.
WARNING: Do not take mobile phones or transceivers into a room where this
monitor is installed, as such devices may cause accidents.
WARNING: In order to avoid accidents, do not use any unauthorized accessories
or options.
WARNING: 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.
WARNING: Do not open cover or disassemble this monitor. Doing so could cause
electric shock or fire. It is prohibited by law to modify the monitor without
authorization.
WARNING: Do not use power source other than the specified voltage, (100-
240V~50/60Hz) as this may cause fire or electric shock.
WARNING: Pre-use inspection and preventive maintenance must be performed for
safe use.
1

WARNING: The 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.
WARNING: This monitor is protected against the discharge of a defibrillator.
However, do not touch the monitor when a defibrillator is being discharged
(electrified), as doing so may cause electric shock.
WARNING: The following cautions apply when connecting the 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.
WARNING: Do not connect devices that do not meet medical safety standards
(such as commercial PCs), as they may cause electric shock. This monitor meets
the restricted level of leakage current required for medical devices. Therefore, this
monitor cannot be connected to a device that would give a combined total of
leakage current beyond the restricted level.
WARNING: Do not place anything on top of this monitor. If something is spilled
over the monitor or gets into it, such spillage may cause fire or electric shock. If
fluid spills on the monitor accidentally, disconnect power cord, wipe dry
immediately, and have the monitor serviced to make sure that no hazard exists.
WARNING: Do not place heavy objects on the power cord, as doing so may cause
fire or electric shock.
WARNING: Before conducting maintenance work, turn the power OFF and unplug
the power cord from the wall socket to prevent electric shock.
WARNING: 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 device.
 The device has been dropped or impacted by an object.
 Liquid or foreign matter gets inside the device.
 Device 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 wall socket.
2. Place an “Out of Order” sign on the device and do not use it.
WARNING: Do not connect more than one patient to the monitor. Do not connect
more than one monitor to a patient.
WARNING: The patient monitor is a prescription device and is to be operated by
qualified personnel only.
WARNING: As with any medical equipment, carefully route patient cabling to
reduce the possibility of patient entanglement or strangulation.
WARNING: Never lift the monitor by the sensor cable, blood pressure hose, power
cord, or any other accessory. Such accessories could detach, causing the monitor
to fall on the patient.
WARNING: Do not position the monitor so it is difficult to operate the
disconnection device when a separable plug is used as isolation.
2
Cautions
Cautions are identified by the CAUTION symbol shown above.
Caution statements identify conditions or practices that could result in damage to

the equipment or other property.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
CAUTION: The 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.
CAUTION: When connecting the patient monitor to any instrument, verify proper
operation before clinical use. Both the monitor and the instrument connected to it
must be connected to a grounded outlet.
CAUTION: Accessory equipment connected to the 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.
CAUTION: Risk of explosion if battery is replaced by an incorrect type.
CAUTION: 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.
3

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4
INTRODUCTION
WARNING: 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 M30

The M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR),
noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures,
functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration rate (RR),
capnography (EtCO2 and InCO2) temperature (Temp) for adult, pediatric and neonatal
patients in all areas of a hospital and hospital-type facilities. Monitor users should be
skilled at the level of a technician, doctor, nurse or medical specialist. The M30 is suitable
for continuous operation.
Note: Hospital use typically includes such areas as general care floors, operating rooms,
special procedure areas, intensive and critical care area, within the hospital.
Hospital-type facilities include physician office-based facilities, sleep labs, skilled
nursing facilities, surgical centers, and sub acute care centers.
Note: The medically skilled and trained user can be clinicians like doctors and nurses who
know how to take and interpret a patient’s vital signs. These clinicians must take
direct responsibility for the patient’s life. This can include care-givers or medically
trained interpreters who are authorized under the appropriate clinical facility
procedures to support patient care. Any inappropriate setting, especially the alarm
limit or alarm notification settings, can lead to a hazardous situation that injures the
patient, harms the patient, or threatens the patient’s life. This equipment should
only be operated by trained users who can adjust the settings of the patient monitor.
Indications For Use

Indications Contraindications
Electrocardiography The electrocardiography is No known contraindications
used to monitor
electrocardiography
waveform and pulse rate.
Noninvasive Blood Noninvasive blood pressure Noninvasive Blood Pressure
Pressure monitoring is intended for is not intended for use with
detection of hypertension or severe arrhythmia.
hypotension and monitoring Noninvasive Blood Pressure
BP trends in patient is not intended for patients
conditions. who are experiencing
convulsion or tremors.
Pulse Oximetry Pulse oximetry monitoring is Pulse Oximetry is not
intended to be used to intended for use with severe
monitor functional arterial peripheral vascular disease
oxygen saturation and pulse and severe anemia
rate. (decreased Hemoglobin).
End-Tidal CO2 EtCO2 monitoring is indicated No known contraindications
for detection of trends in the
5
Indications Contraindications
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.
Respiration Respiration monitoring is No known contraindications
intended to be used to
monitor respiration rate.
About This Manual

This manual explains how to set up and use the M30 patient monitor.
Read the entire manual including the Safety Information section, before you
operate the monitor.
6
Identifying the M30 Monitor Configurations
The following table identifies M30 monitor configurations and how they are indicated. The
reference number and serial number are located on the bottom of the monitor.
All information in this manual, including the illustrations, is based on a monitor configured
with the Battery, Mediana or Nellcor SpO2 module, Printer module, TCP/IP module, 3G
module and Wi-Fi module and Capnography (EtCO2 and InCO2). If the relevant functions
do not exist, please verify your unit configuration.
Reference no. Description
M30M-0(A) M30 Standard (ECG, NIBP, Respiration, Temperature)
+ Mediana SpO2
M30M-0P(A) M30 Standard + Mediana SpO2 + Printer
M30M-0L(A) M30 Standard + Mediana SpO2 + TCP/IP
M30M-0E(A) M30 Standard + Mediana SpO2 + Capnography
M30M-0PL(A) M30 Standard + Mediana SpO2 + Printer + TCP/IP
M30M-0W(A) M30 Standard + Mediana SpO2 + Wi-Fi
M30M-0PW(A) M30 Standard + Mediana SpO2 + Printer + Wi-Fi
M30M-0WE(A) M30 Standard + Mediana SpO2 + Wi-Fi + Capnography
M30M-0PWE(A) M30 Standard + Mediana SpO2 + Printer + Wi-Fi + Capnography
M30M-0G(A) M30 Standard + Mediana SpO2 + 3G
M30M-0PG(A) M30 Standard + Mediana SpO2 + Printer + 3G
M30M-0GE(A) M30 Standard + Mediana SpO2 + 3G + Capnography
M30M-0PGE(A) M30 Standard + Mediana SpO2 + Printer + 3G + Capnography
M30M-0PE(A) M30 Standard + Mediana SpO2 + Printer + Capnography
M30M-0LE(A) M30 Standard + Mediana SpO2 + TCP/IP + Capnography
M30M-0PLE(A) M30 Standard + Mediana SpO2 + Printer + TCP/IP + Capnography
M30M-0N(A) M30 Standard + Nellcor SpO2
M30M-0PN(A) M30 Standard + Nellcor SpO2 + Printer
M30M-0LN(A) M30 Standard + Nellcor SpO2 + TCP/IP
M30M-0NE(A) M30 Standard + Nellcor SpO2 + Capnography
M30M-0PLN(A) M30 Standard + Nellcor SpO2 + Printer + TCP/IP
M30M-0WN(A) M30 Standard + Nellcor SpO2 + Wi-Fi
M30M-0PWN(A) M30 Standard + Nellcor SpO2 + Printer + Wi-Fi
M30M-0WNE(A) M30 Standard + Nellcor SpO2 + Wi-Fi + Capnography
M30M-0PWNE(A) M30 Standard + Nellcor SpO2 + Printer + Wi-Fi + Capnography
M30M-0GN(A) M30 Standard + Nellcor SpO2 + 3G
M30M-0PGN(A) M30 Standard + Nellcor SpO2 + Printer + 3G
M30M-0GNE(A) M30 Standard + Nellcor SpO2 + 3G + Capnography
M30M-0PGNE(A) M30 Standard + Nellcor SpO2 + Printer + 3G + Capnography
M30M-0PNE(A) M30 Standard + Nellcor SpO2 + Printer + Capnography
M30M-0LNE(A) M30 Standard + Nellcor SpO2 + TCP/IP + Capnography
M30M-0PLNE(A) M30 Standard + Nellcor SpO2 + Printer + TCP/IP + Capnography
M30M-1EM EtCO2 Mainstream
M30M-1ES EtCO2 Sidestream
Note: The numeric after dash can be changed to 1, 3 or 5 in accordance with the
operating time of the installed battery. The numeric “0” represents that no battery is
installed.
Note: The alphabet “A” can be added as the last digit of reference number in accordance
with the region.
Note: The alphabet “E” means “Capnography”. Capnography has options that are M(Main
Streem, S(Side stream), X(None of EtCO2 Accessory).
Note: The configurations including Mediana SpO2 module are not sold in US market.
7
Features for the M30
Physical/Mechanical
The M30 is a multi-parameter patient monitor which can be battery-operated when AC
power source is not available.
Electrical
The M30 is powered by an internal battery pack that typically provides 1, 3 or 5 hour(s) of
monitoring from fully charged new battery. The batteries are continuously recharged when
the monitor is connected to AC power source. Refer to the Battery Operation section for
details.
Display
The monitoring screen is a color LCD that shows all graphic and numeric patient
information as well as status conditions and warning messages.
Knob
The knob provides user interaction with the display and the monitor functions. Rotating
and pressing the knob allows the user to navigate and make changes to the display
elements and monitor functions. Refer to the Using the Monitor section for details.
Auxiliary Input/Output(s)
The monitor provides USB and RJ11 ports, LAN port, 3G or Wi-Fi network
Note: 3G/Wi-Fi network is an option and is not available on all monitor.
8
DESCRIPTION OF THE MONITOR
Front Panel Components

1
3
4
5 6 7 8 9 10
1 Alarm indicator 6 NIBP start/stop button

2 LCD 7 Print button
3 AC/DC indicator 8 Home button
4 Battery charging indicator 9 Alarm stop button
5 Power button 10 Knob
Figure 1. Front Panel Components
9
Table 1. M30 Controls
Symbols Description
Power Button
turns on the monitor by pressing the Power Button for
approximately 1 second.
turns off the monitor by pressing the Power Button for
approximately 3 seconds.
NIBP Start/Stop Button
toggles between starting and stopping NIBP measurements.
begins the CONT mode by pressing the NIBP Start/Stop
Button for approximately 2 seconds.
Print Button
prints measured data if an optional printer is installed.
Home Button
exits a menu displayed on the screen and goes to the main
screen.
accesses the freeze status by pressing the Home Button for
approximately 2 seconds. In the freeze status, press the
Home Button again to quit the freeze status.
Alarm Stop Button
pauses the alarm audio temporarily.
off the alarm audio by pressing over 2 seconds.
Knob
provides user interaction with the monitor to control the
functions.
10
Rear Panel Components
3 4 5 6 7
1 Handle
2 AC power connector
3 Equipotential terminal
4 DC power connector
5 Speaker
6 Battery cover
7 External communication port
Figure 2. Rear Panel Components
11
Left Panel Components
1 Printer (option)
2 USB port (mini USB B Type)
3 USB port (USB A Type)
4 Nurse call port (RJ11 Type)
Figure 3. Left Panel Components
12
Right Panel Components
1 ECG connector
2 SpO2 connector
3 NIBP connector
4 Temperature connector
5 CO2 Connector (Option)
Figure 4. Right Panel Components
13
Table 2. Panel and Label Symbols
Symbols Description Symbols Description
Battery charging indicator Dust and water resistance
AC/DC power indicator Follow instructions for use
Type CF- Defibrillator proof CE mark
ECG connector Disposal instructions
Temperature connector Manufacturer
SpO2 connector Date of manufacture
EtCO2 connector Reference number
NIBP connector Serial number
Environmental
USB port shipping/storage
altitude limitations
Environmental
External communication port shipping/storage
humidity limitations
Environmental
Nurse call signal symbol shipping/storage
temperature limitations
Equipotential terminal Fragile-handle with care
AC power input rating This way up
DC power input rating Keep dry
CAUTION: Federal law

restricts this device to sale
UL mark
by or on the order of a
physician.
EU representative
14
Displays
1
13
14
2
3
15
5 6 7 8 9 10 11 12
1 Title of waveform parameter 9 Power status area

2 Waveform 10 Network status icon
3 Waveform area 11 Patient bed number
4 Alarm/Informative message 12 Date/Time display
area
5 Patient mode icon 13 Numerical value
6 Alarm/limits menu icon 14 Title of numeric parameter
7 Setup menu icon 15 Numeric area
8 Main screen select icon
Figure 5. Displays
15
Table 3. Display Symbols
Symbols Description Symbols Description
EtCO2 icon: End-tidal carbon
ECG waveform icon
dioxide concentration
InCO2 icon: Inspired carbon
ECG lead pair
dioxide concentration
ECG 1mV size bar Temperature icon
SpO2 waveform icon Temperature unit: Celsius
Impedance respiration Temperature unit:

waveform icon Fahrenheit
EtCO2 icon Audible Alarm Active icon
HR/PR icon & unit Alarm Audio Paused icon
HR source icon: ECG Alarm Audio Off icon
Alarm Audio Off icon

PR source icon: SpO2 (Alarm Audio Off Period:
Indefinite)
PR source icon: NIBP Patient mode: Adult
ST level icon Patient mode: Pediatric
Arrhythmia icon Patient mode: Neonatal
NIBP icon Setup menu icon
NIBP or EtCO2 unit: mmHg Alarm/limits menu icon
Main screen: Big number

NIBP or EtCO2 unit: kPa
screen
% SpO2 or EtCO2 unit: % Main screen: 3-ch wave screen
NIBP auto mode Interval Battery status icon
NIBP elapsed time Network status icon
Pulse amplitude indicator Time display
Respiration source: AW NIBP graphical trend icon
HR/PR, SpO2, RESP, TEMP,

Respiration source: IM
EtCO2 graphical trend icon
DC power input icon Bed number icon
16
Table 4. Display Colors
Function Color
ECG Waveform Green
SpO2 Waveform Cyan
Respiration Waveform Yellow
EtCO2 Waveform Gray
ECG Green
NIBP White
SpO2 Cyan
Respiration Rate Yellow
EtCO2 Gray
Temperature Dark blue
General background Black
HR/PR graphical trend Green
NIBP graphical trend White
SpO2 graphical trend Cyan
RESP graphical trend Yellow
TEMP graphical trend Dark blue
EtCO2 graphical trend Gray
Informative message Black background, Green 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
Battery status icon (normal) Green
Battery status icon (low battery) Yellow or Red (refer to Table 8)
17
18
SETTING UP THE MONITOR
WARNING: To ensure accurate performance and prevent device failure, do not

expose the monitor to extreme moisture, including direct exposure to rain. Such
exposure may cause inaccurate performance or device failure. Refer to
Specification section.
WARNING: The monitor should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the monitor should be
observed to verify normal operation in the configuration it is to be used.
WARNING: Make sure that the monitor speaker is not obstructed. Failure to do so
could result in an inaudible alarm tone.
CAUTION: Recharging the battery is strongly recommended when the battery has
not been recharged for 2 or more months.
CAUTION: Follow local government ordinances and recycling instructions

regarding disposal or recycling of device components, including battery.
Unpacking and Inspection

The 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 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.
19
List of Components
The following items are standard in the package.
Table 5. Standard Accessories

Items Qty
M30 monitor 1
Operation manual (English) 1
AC power cord 1
Printer paper 5
*Only when Printer option is installed.
Cuff/Bladder set medium HEM-CS23 (13-22cm) 1
Cuff/Bladder set medium HEM-CR23 (22-32cm) 1
Cuff hose No.1 (3.5m) 1
ECG trunk cable for 3 leads 1
ECG 3 leads wire pack (SNAP) 1
SpO2 reusable sensor YM-1/ WA-100 (for Mediana module) 1
or DS-100A (for Nellcor module)
SpO2 extension cable RCP058/ A0266 (for Mediana module) 1
or DOC-10 (for Nellcor module)
Optional items may be ordered if needed. Contact your local supplier for pricing and
ordering information.
Table 6. Optional Accessories
Items Qty
Cuff/Bladder set medium HEM-CL23 (32-42cm) -
Cuff/Bladder set medium HEM-CX23 (42-50cm) -
Cuff for neonatal -
Cuff hose No.3 (1.5m) -
NIBP Cuff V-Lok B-10 (10-19cm) -
NIBP Cuff V-Lok THIGH (46-66cm) -
ECG trunk cable for 5 leads -
ECG 5 leads wire pack (SNAP) -
ECG 3 leads wire pack (GRAB) -
ECG 5 leads wire pack (GRAB) -
SpO2 disposable sensor -
Mainstream CO2 monitoring reusable airway adapter -
Mainstream CO2 monitoring disposable airway adapter -
Cable holding clip -
Mainstream CO2 sensor -
Sidestream CO2 monitoring disposable nasal cannula -
Sidestream CO2 monitoring disposable nasal cannula with O2 delivery -
Sidestream CO2 monitoring disposable oral/nasal cannula -
Sidestream CO2 monitoring disposable oral/nasal cannula with O2 delivery -
Sidestream CO2 monitoring disposable adapter + sampling line -
Sidestream CO2 monitoring disposable adapter + sampling line with Nafion -
Sidestream CO2 Sensor -
Service manual (English) -
Li-ion battery (1 hour type) -
Li-ion battery (3 hours type) -
Li-ion battery (5 hours type) -
External DC-DC adaptor -
20
Power Cable Connections
WARNING: Do not connect to an electrical outlet controlled by a wall switch

because the device may be accidentally turned off.
CAUTION: If the integrity of the AC power source is in doubt, the 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 6. AC Power Connection
1. Connect the female connector end of the AC power cord to AC power connector on the
monitor’s rear panel.
2. Plug the male 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 Indicator on the monitor’s front panel is lit.
Note: Even if the monitor is not turned on, the Battery Charging Indicator is lit when the
AC power cord is connected into a mains outlet.
Note: If the Battery Charging Indicator is not lit, check:
 the power cord

 the AC power connector
 the DC power connector
 the power/ mains outlet
 No Battery
If the Battery Charging Indicator still is not lit although no problem is found,
contact qualified service personnel or your local supplier for assistance.
21
DC Power
CAUTION: When the DC power is used in the emergency environment such as

ambulance, the insulated DC convertor must be used.
The external DC power source can be used, when the M30 is used for the emergency
condition in the moving car.
1. Connect an external DC-DC adaptor (input: 12 to 16 volts DC, output: 14 volts DC)’s
input to the DC outlet of emergency vehicles.
2. Connect an external DC-DC adaptor’s output to monitor rear panel connecter identified
with the DC power symbol.
3. Verify that the DC power input icon appears on the screen.
Note. When the AC power and DC power are connected, the monitor will operate on AC
power.
Measurement Cable Connections

WARNING: 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.
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 4)
2. Attach the ECG lead wire to the end of the cable.
NIBP Hoses and Cuffs
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 4)
3. Attach the cuff to the end of the hose.
SpO2 Cables and Sensors
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 monitor’s right panel.
(see Figure 4)
3. Attach the sensor to the end of the cable.
Temperature Probes
1. Select the appropriate probe(s) for the desired application. (YSI 400 and 700 Series)
2. Connect the temperature probes to the Temperature connector on the monitor’s right
panel. (see Figure 4)
22
CO2 Sampling set (If configured with CO2 option)
1. Select the appropriate CO2 sensor (Mainstream or Sidestream) for the desired
application.
2. Connect the CO2 sensor to the CO2 connector on the monitor’s right panel. (see Figure
4)
3. Attach the CO2 sampling unit to the CO2 sensor’s connector. (Refer to the
Capnography Monitoring section.)
23
24
BATTERY OPERATION
CAUTION: Recharging the battery is strongly recommended when it has not been
fully recharged for 2 or more months.
CAUTION: When the voltage of the battery is very low, it is a possibility of not
operating.
Note: It is recommended that the monitor remain connected to AC power source 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 instrument shut-off may become
shorter. It is recommended for service personnel to check periodically or replace the
internal battery if necessary.
Operating the Monitor on Battery Power

The monitor has an internal battery that can be used to power the monitor when AC
power source is not available. The battery status icon appears on the screen when the
monitor is on battery power.
Figure 7. Battery Placement
1. Turn off the monitor.

2. Remove the battery cover.
3. Insert the battery into the main unit carefully.
Table 7. Front Panel Indications for Power Source

Power Connections Front Panel Indications
Battery status icon disappears on the screen.
AC power source
AC/DC indicator is lit.
External DC power DC power input icon appears on the screen.
source AC/DC indicator is lit.
Battery Battery status icon appears on the screen.
25
A new, fully charged optional battery will provide 1, 3 or 5 hour(s) monitoring operation
under the following conditions:
 Operation of ECG, Respiration, SpO2, and Temperature

 NIBP automatic measurement per 15 minutes
 No audible alarm condition
 No external communication operating
 No printing
 Ambient temperature at 25°C
Note: Three types of battery are available as the optional items.
Battery Status Indication

When operating on battery, the battery status icon in the lower part of the display
indicates the battery charge condition. See Table 8.
Table 8. The Monitor Battery Status Icon
Battery Status Icons Battery Status Icon Color
Green (full charged)
Green (used)
Yellow (≤ 15 minutes)
Red (≤ 5 minutes)
A low priority alarm occurs when the remaining battery power is only enough for 15
minutes of operation. The alarm message ‘Low Battery’ appears on the screen and the
visual alarm indicator is lit with yellow.
This alarm audio cannot be paused while running on battery power. Connecting the
monitor to AC power will pause the alarm.
A high priority alarm occurs for about 5 minutes before the monitor shuts off. The alarm
message ‘Critically Low-Battery Condition’ will appear and the visual alarm indicator
will flash with red. After that, the monitor will automatically shut down. Connect the
monitor to an AC power source or external DC power source to avoid any loss of trend
data or settings.
Charging a Low Battery

1. Connect the monitor to AC power source or external DC power source to charge a low
or depleted battery
(see the Setting up the Monitor section).
2. Verify that the Battery Charging Indicator is lit with orange.
Table 9. Front Panel Indications for Battery Status
Battery status Battery charging indicator
Full charged Green
Charging Orange
Not installed OFF
Note: Even if the monitor is turned off, the Battery Charging Indicator is lit while the
battery is recharged.
Note: A full charge of a depleted battery takes over 4, 8 or 12 hours per battery.
26
USING THE MONITOR
WARNING: If the Power On Self-Test is not completed successfully, do not try to

use the monitor.
WARNING: Each time the monitor is used, check alarm limits to make sure that
they are appropriate for the patient being monitored.
WARNING: 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.
WARNING: Keep patients under close surveillance when monitoring. It is
possible, although unlikely, that radiated electromagnetic signals from sources
external to the patient and the monitor can cause inaccurate measurement
readings. Do not rely entirely on the monitor readings for patient assessment.
Turning On and Off the Monitor

Before using the monitor, confirm that the monitor is working properly and is safe to use
as described below.
CAUTION: When power is turned on, the monitor automatically starts the Power-On
Self-Test (POST), which tests the monitor circuitry and functions. During POST,
confirm that the monitor screen turns on. If the monitor screen does not function
properly, do not use the monitor. Instead, contact qualified service personnel or
your local supplier.
Note: The post pass tone sounds when the monitor completes the Power-On Self-Test
(POST). This functions as an audible confirmation that the speaker is performing
properly. If the speaker does not function, the alarm warning sounds cannot be
heard.
Note: If unusable sound like buzzer can be heard, do not use the monitor. Instead, please
contact qualified service personnel or your local supplier.
1. Turn on the monitor by pressing the Power Button for about 1 second..
2. The monitor performs POST and the checksum. The bar shall be displayed on the
bottom of the screen to indicate the progress rate of checksum for system software.
The initializing screen appears during POST. The initializing screen displays the logo
and the version of system.
3. If there is no error, alarm indicator is lit during POST and the POST pass tone sounds
after POST is completed. Confirm that alarm indicator is lit during POST and the normal
screen appears after the POST pass tone sounds.
27
Figure 8. Initial Screen
Note: The system version shown above is only an example.
4. To turn off the monitor, press the Power Button for about 3 seconds..
Note: If the monitor detects an internal problem during POST, the monitor will display an
error code. If an error code is displayed, contact qualified service personnel or your
local supplier for assistance.
28
Setting Date and Time
You may set the date and time displayed on the screen and printed out printer paper..
1. Rotate the knob to highlight Date/Time Display, and then press the knob to select
Date/Time Menu.
2. Rotate the knob to display the desired number for year, month, day, hour, minute or
second and then press the knob to select the desired number.
Note: The time format is 24 hours only.
Table 10. Date/Time Menu

Level 1 Menu Level 2 Menu or Response
DATE/TIME MENU
Set Date Year
Month
Day
Return
Set Time Hour
Minute
Second
Return
Date Format mm/dd/yy
dd/mm/yy
yy/mm/dd
Return
29
Setting Basic Setup Parameters
This procedure will allow you to set Patient Mode, Trend Clear, Print Speed, Print Mode,
Alarm Volume, Key Beep Volume, QRS Volume, Trend Data Download and Service
Menu.
Rotate the knob to highlight the SET-UP menu Icon. Press the knob to display the SET-
UP menu.
Figure 9. SET-UP menu
Table 11. SET-UP menu

SET-UP MENU
Patient Mode Adult, Pediatric, Neonatal
Trend Clear Yes, No
Print Speed* 25, 50 mm/s
Print Mode* One-Shot, Continuous
Printing Waveform Setup* Printing Waveform1 (ECG, SpO2, RESP, EtCO2, OFF),
Printing Waveform2 (ECG, SpO2, RESP, EtCO2, OFF),
Printing Waveform3 (ECG, SpO2, RESP, EtCO2, OFF)
Alarm Volume 1, 2, 3, 4, 5, 6, 7, 8
Key Beep Volume Off, 1, 2, 3, 4, 5, 6, 7
QRS Volume Off, 1, 2, 3, 4, 5, 6, 7
Trend Data Download Start, Cancel
Service Menu (Pass code)
Return
Note: If there is no activity for 20 seconds, the monitor will return to main screen.
Note: The menu options followed by an asterisk (*) are only displayed with as optional
printer installed.
Patient Mode
To select Patient Mode rotate the knob to highlight Patient Mode, and then press the
knob to select an appropriate mode: Adult, Pediatric or Neonatal.
30
Trend Data Download
To start downloading the trend data, rotate the knob to highlight Trend Data Download,
and then press the knob to select Start or Cancel. Refer to the Data Management section
for details.
Trend Clear
When Trend Clear is selected, trend data in the trend memory is cleared.
Setting Print
If an optional printer is installed, this menu will allow you it set Print Speed, Print Mode
and Printing Waveform Setup. Refer to the Printing section for details.
Setting Volume
Setting Volume allows you to adjust the alarm audio Volume, QRS volume and Key
beep volume. Alarm Volume can be set to level 1 to 8 and QRS Volume and Key Beep
Volume can be set to level 1 to 7 or Off (see Alarms and Limits section).
1. Rotate the knob to highlight Alarm Volume, QRS Volume or Key Beep Volume.
2. Press the knob. Levels of Alarm Volume, QRS Volume or Key Beep Volume will
appear.
3. Rotate the knob to select a volume level (see each volume level in the Table 11).
4. Press the knob to enter the desired volume into the monitor.
Service Menu
This menu includes Save Settings On Power Off, Alarm Audio OFF Period, Alarm Audio
Paused Period, Alarm Reminder Tone, Audible alarm Type, NIBP Unit, Temp Unit,
EtCO2 unit, Language Setting, NIBP Test, System Information and 3G Network Setting.
Only authorized personnel is allowed to change the Service Menu settings. A pass code
is required for access. Refer to the service manual for instructions.
31
Setting the Main Screen
You may select the main screen to be displayed; 3-ch Wave Screen or Big Number
Screen.
1. Rotate the knob to highlight the Big Number Screen Icon, and then press the knob to
display the Big Number Screen.
2. To return the 3-ch Wave Screen, rotate the knob to highlight the 3-ch Wave Screen
Icon, and then press the knob to display the 3-ch Wave Screen.
 3-ch Wave Screen: ECG + SpO2 + EtCO2
Figure 10. 3-ch Wave Screen

 Big Number Screen
Figure 11. Big Number Screen
32
ALARMS AND LIMITS
WARNING: 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.
General
When the monitor detects certain conditions that require user attention, the monitor enters
an alarm state. The monitor response is indicated by:
 Visual alarm indication

 Audible alarm indication
 Physiological alarms including identification of out-of-limit vital signs
 Technical alarms
Note: The audible and visual alarms on the monitor, used in conjunction with clinical
signs and symptoms, are the primary source for notifying medical personnel that
a patient alarm condition exists.
Changing Alarm Volume

You can select an alarm volume level of 1 to 8. Refer to the Using the Monitor section
(see Figure 9, Table 11).
33
Alarm Priority and Messages
There are three possible priorities for visual and alarm audios: High, Medium, and Low.
The high, medium and low priority messages are displayed in the alarm/informative
message area, and the informative messages are displayed in the alarm/informative
message area. A message is displayed alternatively every 2 seconds when the monitor is
in multiple alarm conditions. Refer to the Troubleshooting section for the recommended
actions.
High Priority
High priority indicates that immediate user response is required.
Table 12. High Priority Alarm

Condition Messages
Asystole Asystole
Loss of Pulse from SpO2 SpO2 Loss of Pulse
(no valid ECG and no motion artifact)
Critically Low-Battery condition Critically Low-Battery condition
APNEA EtCO2 – APNEA
Medium Priority
Medium priority indicates that prompt user response is required.
Table 13. Medium Priority Alarm

Parameter Condition Messages
High Heart Rate limits violated High Heart Rate/Pulse Rate limits violated
HR Low Heart Rate limits violated Low Heart Rate/Pulse Rate limits violated
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 NIBP-High Systolic blood pressure limits
violated violated
High Diastolic blood pressure limits NIBP-High Diastolic blood pressure limits
violated violated
High MAP blood pressure limits NIBP-High MAP blood pressure limits
violated violated
NIBP
Low Systolic blood pressure limits NIBP-Low Systolic blood pressure limits
violated violated
Low Diastolic blood pressure limits NIBP-Low Diastolic blood pressure limits
violated violated
Low MAP blood pressure limits NIBP-Low MAP blood pressure limits
violated violated
High Respiration Rate limits violated High Respiration Rate limits violated
Resp Low Respiration Rate limits violated Low Respiration Rate limits violated
Loss of Respiration Signal Loss of Respiration Signal
High EtCO2 limits violated EtCO2 - High limits violated
Low EtCO2 limits violated EtCO2 - Low limits violated
EtCO2
High InCO2 limits violated InCO2 - High limits violated
Low InCO2 limits violated InCO2 - Low limits violated
High Temperature limits violated High Temperature limits violated
Temp
Low Temperature limits violated Low Temperature limits violated
34
Low Priority
Low priority indicates that user awareness is required.
Table 14. Low Priority Alarm

ECG Leads Off ECG Leads Off
ECG
Chest Lead off Chest Lead Off
Temperature Probe Disconnect Temperature Probe Disconnect
Temp
Temperature – Out of range Temperature – Out of range
NIBP – Abnormal Cuff NIBP – Abnormal Cuff / EEE 11
NIBP – Abnormal Cuff NIBP – Abnormal Cuff / EEE 21
NIBP – Measurement Fail NIBP – Measurement Fail / EEE 12
NIBP NIBP – Measurement Fail NIBP – Measurement Fail / EEE 18
NIBP – Overpressure NIBP – Overpressure / EEE 19
NIBP – Artifact NIBP – Artifact / EEE 13
NIBP – Artifact NIBP – Artifact / EEE 16
NIBP - Time-Out NIBP – Time-Out / EEE 17
SpO2 – Technical Error Messages SpO2 Error - EEE001
Note: This message is for Nellcor ~ SpO2 Error: EEE289
module only. SpO2 Module Reset
Reconnect / Replace SpO2 sensor
Reposition / Replace SpO2 sensor
%SpO2
Replace SpO2 sensor
Loss of Pulse from SpO2 Loss of Pulse from SpO2
with valid ECG or with motion artifact
SpO2 Cable/Sensor Disconnect SpO2 Cable/Sensor Disconnect
Sensor Off from SpO2 Sensor SpO2 Sensor Off
Resp Respiration Leads Off Respiration Leads Off
CO2 – Adapter Calibration Failed CO2 – Adapter Calibration Failed
CO2 – Check Adapter CO2 – Check Adapter
CO2 – Faulty Sensor CO2 – Faulty Sensor
EtCO2 CO2 – Occlusion or leak CO2 – Occlusion or leak
CO2 – Out of Range CO2 – Out of Range
CO2 – Sample Line Disconnected CO2 – Sample Line Disconnected
CO2 – Sensor Disconnected CO2 – Sensor Disconnected
Printer Out of Paper Printer Out of Paper
System Low Battery condition Low Battery
Technical System Error EEE 401 ~
35
Informative Messages
Informative messages indicate a system condition that needs to be corrected.
Table 15. Informative Messages

SpO2 Sensor Adjust Condition SpO2 Weak pulse*
SpO2 Weak signal*
SpO2 Motion Interference
SpO2 Excess Infrared light*
SpO2 Electrical/Optical Interference*
High Pulse Amplitude*
SpO2 Sensor: Alternate site?*
SpO2 Sensor: Cover sensor site?*
SpO2 Sensor: Ear/Forehead sensor?*
SpO2 Sensor: Nasal/Ear sensor?*
SpO2 Sensor: OxiMax adhesive sensor?*
%SpO2 SpO2 Sensor: Secure cable*
SpO2 Sensor: Headband*
SpO2 Sensor: Warm site*
SpO2 Sensor: Bandage assembly*
SpO2 Sensor: Nail polish*
SpO2 Sensor: Sensor too tight?*
SpO2 Sensor: Reposition sensor*
SpO2 Sensor: Isolate interference
source.*
SpO2 Sensor: Clean sensor site.*
SpO2 Pulse search SpO2 Pulse search
The sensor is not for In-Sensor trend Not applicable sensor type*
CO2 - Pressure Not Zeroed CO2 - Pressure Not Zeroed
CO2 - Pressure Zero in Progress CO2 - Pressure Zero in Progress
EtCO2
CO2 - Sensor Too Warm CO2 - Sensor Too Warm
CO2 - Sensor Warming-up CO2 - Sensor Warming-up
Abnormally shut down last time Abnormally shut down last time.
Note: When power is lost for less than
30 seconds, the monitor will preserve
the current settings and trend data
restored automatically before the power
loss. However, if the power loss is over
30 seconds, the monitor will be back to
the previous user settings (or the
factory default settings) as per the ‘save
settings on power off’ in the service
Other menu.
Print button pressed when no optional Printer is not available.
printer installed
Exit Scrolling in Trend Screens Press Knob to Exit Scroll.
Exit Graphical Trend Screen Press Home switch to Exit Graphical
trend.
Exit Tabular Trend Screen Press Home switch to Exit Tabular trend.
Alarm Audio Pause Alarm audio pause
Alarm Audio Off Alarm audio off
Demo Mode Demo Mode
Freeze Freeze
36
Note: There may be other informative messages that are not listed above.
Note: An asterisk (*) by a message in the above table indicates that the message is only
displayed on the monitor with Nellcor SpO2 module.
37
Visual Alarm Indication
Table 16. Visual Alarm Characteristics
Alarm Category Color Alarm Indicator Flashing Rate
High priority Red 5 flashes in 3 seconds (approximately 1.7Hz)
Medium priority Yellow 5 flashes in 8 seconds (approximately 0.6Hz)
Low priority Yellow Always on (non-flashing)
Note: Alarm Indicator on the center top of the front panel respond with the flashing
rates described in Table 16 when an alarm occurs.
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
WARNING: Do not pause the alarm audio or decrease its volume if patient safety
could be compromised.
WARNING: Make sure that the monitor speaker is not obstructed. Failure to do so
could result in an inaudible alarm tone.
Table 17. Alarm Audio Characteristics

Tone Pitch Beep Rate
Alarm
IEC60601-1-8
Category GN924 GN924 IEC60601-1-8
HI LOW
High priority 976 Hz 976 Hz 540 Hz 7 beeps in 2 sec 10 beeps in 12 sec
Medium priority 697 Hz 697 Hz 480 Hz 2 beeps in 1 sec 3 beeps in 11 sec
Low priority 488 Hz 488 Hz 400 Hz 1 beeps in 15 1 beeps in 16 sec
sec
Note: Alarm audios may be decreased in volume as described in Table 11 or temporarily

paused.
Verifying Visual and Audible Alarm Indication

If the 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, Temp, EtCO2,
and Resp by following the below procedures.
1. Connect the monitor to an AC power source.

2. Press the Power Button to turn on the monitor.
3. Connect the sensor to simulator and connect the cable to monitor.
4. Set the simulator to a smaller value than the lower alarm limit on the monitor.
5. Verify the following monitor reaction:
38
a. The monitor begins to track the physiological signal from the simulator.
b. After about 10 to 20 seconds, the monitor displays the value measured as
specified by the simulator. Verify values are within the tolerances specified in
the Specification section for each parameter (ECG, SpO2, NIBP, Temp,
EtCO2, Resp).
c. Audible alarm sounds.
d. Alarm Indicator flashes.
e. “Low limits violated” message is displayed.
f. 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
WARNING: 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.
CAUTION: 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.
Limit alarm audio off for each parameter may be set in two ways:
 Via interaction with HR/PR, SpO2, NIBP, Respiration, EtCO2 and Temperature
menus
or
 Via interaction with the Alarm/Limits Menu that presents the limits in all the
parameters at one time
Setting Alarm Limits via Alarm/Limits Menu

1. Rotate the knob to highlight the Alarm/Limits Menu Icon on the lower of the screen,
then press the knob to display the Alarm/Limits Menu.
2. Press the knob to select Alarm Limits. The monitor will display all alarm limits that are
currently in effect for all monitored parameters. Select the alarm limits to set.
Table 18. Alarm/Limits Menu

ALARM/LIMITS MENU
Print-On-Alarm* On, Off
Alarm Limits HR/PR, SpO2, NIBP (SYS, DIA, MAP), RESP,
EtCO2, InCO2, TEMP
Limit alarm audio off for each parameter
Return
39
Note: The menu options followed by an asterisk (*) are only displayed with as optional
printer installed.
Alarm Limits Ranges

Table 19 describes the possible alarm limits. The monitor is shipped with factory default
settings.
Note: Authorized personnel can define the way to save the power default: user setting,
backup and factory default. The detailed information is described in the service
manual.
Table 19. Alarm Limits Ranges

Parameters Upper Limit, Default Lower Limit, Default Resolution
HR/PR (BPM)
Adult 25 ~ 300 BPM, 120 BPM 20 ~ 295 BPM, 50 BPM 5 BPM
Pediatric 25 ~ 300 BPM, 160 BPM 20 ~ 295 BPM, 75 BPM 5 BPM
Neonatal 25 ~ 300 BPM, 200 BPM 20 ~ 295 BPM, 100 BPM 5 BPM
ST level I (mV)
Adult -1.99 ~ 2.00 mV, 0.50 mV -2.00 ~ 1.99 mV,- 0.50 mV 0.01 mV
Pediatric -1.99 ~ 2.00 mV, 0.50 mV -2.00 ~ 1.99 mV,- 0.50 mV 0.01 mV
neonatal -1.99 ~ 2.00 mV, 0.50 mV -2.00 ~ 1.99 mV,- 0.50 mV 0.01 mV
ST level II (mV)
ST level III (mV)
ST level V (mV)
Arrhythmia
Adult 0 ~ 300 /min, 5 /min - 1 /min
Pediatric 0 ~ 300 /min, 5 /min - 1 /min
neonatal 0 ~ 300 /min, 5 /min - 1 /min
NIBP Systolic (mmHg, kPa)
35 ~ 270 mmHg, 160 mmHg 30 ~ 265 mmHg, 90 mmHg 5 mmHg
Adult
(4.6 ~ 36.0 kPa, 21.3 kPa) (4.0 ~ 35.3 kPa, 12.0 kPa) (0.6 or 0.7 kPa)
Pediatric
Neonatal
NIBP Diastolic (mmHg, kPa)
Adult
Pediatric
Neonatal
(3,3 ~ 12.0 kPa, 8.0 kPa) (2.6 ~ 11.3 kPa, 2.6 kPa) (0.6 or 0.7 kPa)
NIBP MAP (mmHg, kPa)
Adult
Pediatric
Neonatal 35 ~ 110 mmHg, 70 mmHg 30 ~ 105 mmHg, 30 mmHg 5 mmHg
40
Parameters Upper Limit, Default Lower Limit, Default Resolution
SpO2 (%)
Adult 21 ~ 100 %, 100 % 20 ~ 99 %, 90 % 1%
Pediatric 21 ~ 100 %, 100 % 20 ~ 99 %, 90 % 1%
Neonatal 21 ~ 100 %, 100 % 20 ~ 99 %, 85 % 1%
Respiration (BPM)
Adult 4 ~ 120 BPM, 30 BPM 3 ~ 119 BPM, 8 BPM 1 BPM
Pediatric 4 ~ 120 BPM, 30 BPM 3 ~ 119 BPM, 8 BPM 1 BPM
Neonatal 4 ~ 120 BPM, 100 BPM 3 ~ 119 BPM, 30 BPM 1 BPM
Temperature (°C, °F)
0.1 ~ 50.0°C, 39.0 °C 0 ~ 49.9 °C, 36.0 °C 0.1°C
Adult
(32.2 ~ 122.0°F, 102.2°F) (32.0 ~ 121.8°F, 96.8°F ) (0.1°F or 0.2°F)
0.1 ~ 50.0°C, 39.0 °C 0 ~ 49.9 °C, 36.0 °C 0.1°C
Pediatric
(32.2 ~ 122.0°F, 102.2°F) (32.0 ~ 121.8°F, 96.8°F ) (0.1°F or 0.2°F)
0.1 ~ 50.0°C, 39.0 °C 0 ~ 49.9 °C, 36.0 °C 0.1°C
Neonatal
(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, %)
1 ~ 80 mmHg, 80 mmHg 0 ~79 mmHg, 0 mmHg 1 mmHg
Adult (0.13 ~ 10.7 kPa, 10.7 kPa) (0 ~ 10.5 kPa, 0 kPa) (0.13 kPa)
(0.13 ~ 10.5 %, 10.5 %) (0 ~10.4 %, 0 %) (0.13 %)
Pediatric (0.13 ~ 10.7 kPa, 10.7 kPa) (0 ~ 10.5 kPa, 0 kPa) (0.13 kPa)
(0.13 ~ 10.5 %, 10.5 %) (0 ~10.4 %, 0 %) (0.13 %)
Neonatal (0.13 ~ 10.7 kPa, 10.7 kPa) (0 ~ 10.5 kPa, 0 kPa) (0.13 kPa)
(0.13 ~ 10.5 %, 10.5 %) (0 ~10.4 %, 0 %) (0.13 %)
InCO2 (mmHg, kPa, %)
Adult (0.13 ~ 2.7 kPa, 2.7 kPa) (0 ~ 2.5 kPa, 0 kPa) (0.13 kPa)
(0.13 ~ 2.6 %, 2.6 %) (0 ~2.5 %, 0 %) (0.13 %)
Pediatric (0.13 ~ 2.7 kPa, 2.7 kPa) (0 ~ 2.5 kPa, 0 kPa) (0.13 kPa)
(0.13 ~ 2.6 %, 2.6 %) (0 ~2.5 %, 0 %) (0.13 %)
Neonatal (0.13 ~ 2.7 kPa, 2.7 kPa) (0 ~ 2.5 kPa, 0 kPa) (0.13 kPa)
(0.13 ~ 2.6 %, 2.6 %) (0 ~2.5 %, 0 %) (0.13 %)
41
Alarm Audio Paused
WARNING: Do not pause the alarm audio or decrease its volume if patient safety
could be compromised.
When an alarm occurs, you can pause the alarm audio for the alarm audio paused period
(30, 60, 90 or 120 seconds) selected via service menu. However, visual alarms continue
during this time. The factory default for alarm audio paused is 60 seconds.
To pause the alarm audio:
1. Press the Alarm Stop Button to immediately pause the alarm tone. The alarm
resumes after the alarm audio period if the alarm condition has not been corrected.
2. Check the patient and provide appropriate care.
During the alarm audio paused period, you can press the Alarm Stop Button again to re-
enable the alarm audio tones. Also, if another alarm occurs during the alarm audio
paused period, the alarm audio tones will be automatically re-enabled.
Note: The alarm audios caused by some technical errors may be canceled by pressing
the Alarm Stop Button. However, battery failure and physiological alarms cannot
be canceled until the alarm condition is corrected.
42
Alarm Audio Off
WARNING: If an alarm condition occurs while in the Alarm Audio Off state, the
only alarm indication on the monitor will be visual displays related to the alarm
condition.
To initiate an alarm audio off:
1. To initiate an alarm audio off, press the Alarm Stop Button and hold it for at least 2
seconds.
2. To cancel alarm audio off condition, press the Alarm Stop Button for 2 seconds
again.
Note: You may disable limit violation audio alarms of each vital sign via the HR/PR, SpO2,
NIBP, Respiration, EtCO2, Temperature or Alarm/Limits menus.
This action disables alarm audios for a user-defined Alarm Audio Off (Off, 1, 3, 5, 10, 20,
30, 60 minutes or Indefinite) selected via the Service Menu. The factory default for alarm
audio off is indefinite.
If Alarm Audio Off Period is set to 1, 3, 5, 10, 20, 30 or 60 minutes, the alarm audio is not
activated for the specified time interval and the message “Alarm Audio Off” is displayed.
If OFF is selected, the alarm audio off is not allowed to activate.
If Indefinite is selected, the alarm audio is went off and the message “Alarm Audio Off”
is displayed. The alarm audio off state will be terminated by pressing the Alarm Stop
Button for at least 2 seconds.
In the alarm audio off state, an Alarm Reminder Tone will sound at the preset interval to
remind the user that the alarm audio is went off.
The preset interval for an Alarm Reminder Tone can be set to OFF, 3 or 10 minutes via
the Service Menu. If OFF is selected, the Reminder Tone will be disabled.
Note: The periods can only be changed by authorized personnel via the Service Menu.
43
44
ECG MONITORING
the manufacturer’s directions for use and your facility’s standards.
WARNING: Line isolation monitor transients may resemble actual cardiac
waveforms and thus off the heart rate alarms. Such transients may be minimized
by proper electrode and cable placement, as specified in this manual and
electrode directions for use.
WARNING: 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.
WARNING: Do not use ECG electrodes with expired dates. Do not use defective
ECG electrodes. These might cause improper performance.
WARNING: 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.
WARNING: It is possible for the patient to receive a burn due to an improperly
connected electrosurgical unit. Additionally, the 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.
WARNING: For pacemaker patients, the 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
monitor alarms. Keep pacemaker patients under close surveillance.
WARNING: 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.
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 monitor processes
and amplifies these signals and presents the ECG waveform on the screen. Also, the
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 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
45
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 12 and 13 for electrode placement
configurations.
Figure 12. Standard 3 Electrode Placement
Figure 13. 5 Electrode Placement
Note: One of 5-1 to 5-6 Lead electrode placement sites for the fifth lead.
2. Connect the ECG lead wires and ECG cable.

3. Connect the ECG cable to the ECG connector on the monitor’s right panel.
4. Attach the leads to the electrodes, and then apply the electrodes to the patient, using
the color-code guide in Table 21. Verify that the desired Lead Selection is active in the
ECG waveform area. Refer to Table 22. Lead II is best suited for most monitoring
situations.
46
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
Arrhythmia Monitoring
Arrhythmia monitoring provides information on your patient’s condition, including heart
rate, PVC rate, rhythm, and ectopics. If arrhythmia detection is enabled, the monitor
calculates the number of premature ventricular contractions (PVCs) per minute and
displays the value on the monitor. The PVC value is used a base measurement for
several of the arrhythmia alarms.
The monitor displays arrhythmia status messages as follows:

PVCs, R on T PVCs, Pair PVCs, Run PVCs, Ventricular Rhythm, Ventricular tachycardia,
Multiform PVCs, Ventricular Bigeminy, Ventricular Trigeminy, Pause, Paced Beat,
Bardycardia, Tachycardia, Unknown, In Learn, V-FIB (Ventricular Fibrillation).
The messages are displayed on the monitor for 1minute after generated more than 1
minute. For more information about messages, refer to the Alarms and limits section.
The table below indicates the heart rate ranges for sinus and SV rhythms.
Table 22. Heart Rate Ranges for Sinus and Rhythms.

Heart Rate Range
Rhythm
Adult Pediatric Neonatal
Bradycardia 15 to 60 15 to 80 15 to 90
Normal 60 to 100 80 to 160 90 to 180
Tachycardia > 100 > 160 > 180
47
Selecting ECG Lead for Arrhythmia Monitoring
When 3 leads are attached, an ECG lead displayed on ECG waveform area is used for
the arrhythmia detection. When 5 leads are attached, an ECG lead displayed on ECG
waveform area and Lead I or II are used for arrhythmia detection. At this time, Lead I or II
is selected by the monitor at random.
Arrhythmia Alarms
The monitor detects arrhythmia alarm condition by comparing ECG data to a set of pre-
defined criteria. An alarm can be triggered by a rate exceeding the alarm limits, an
abnormal rhythm, or an ectopic event. For more information about the alarm condition,
refer to the Alarm and limits section.
ST Monitoring
The monitor performs ST level analysis on normal and atrially paced beats and measures
ST level elevations and depressions. This information can be displayed in the form of ST
value snippets on the monitor. A position ST value indicates ST segment elevation; a
negative value indicates depression.
ST Measurement Point
ST level is measured by calculating average the range of 60 ~ 80msec after J point. ST
measurement point can be changed by QTc value according to heart rate.
ST Alarms
ST alarms are triggered when ST value exceeds it’s alarm limit. The monitor can detect
alarms on each ST lead separately, so you can set high and low ST alarm limits
individually for each ST lead. Set the high and low alarm limits based on your assessment
of the patient’s clinical condition unit protocols, physician orders or medication specified
limits. A good guideline is 0.1 mV or -0.1 mV from the patient’s ST, or follow your hospital
protocol. In the HR/PR menu, select the alarm to be adjusted.
48
Description of HR/PR Menu Functions
The calculated Heart Rate/Pulse Rate may be derived from different sources (ECG,
SpO2 or NIBP) as shown by the icon in the HR/PR numerical area.
3
2 4
5 6 7 8 9 10 11
1 HR/PR icon 7 ST level
2 HR/PR unit 8 ST level unit
3 HR/PR source icon 9 Arrhythmia detection icon
4 HR/PR value 10 Arrhythmia beats cont
5 ST level icon 11 Arrhythmia beats cont unit
6 ST level designator
Figure 14. HR/PR Display
Table 23. HR/PR Menu

HR/PR MENU
HR/PR Source Auto (ECG > SpO2 PR > NIBP PR),
ECG, SpO2, NIBP
(Alarm Limits Adjustment)
▲ Upper Alarm Limit
▼ Lower Alarm Limit
Arrhythmia Detection/ST Level Analysis On, Off
(HR/PR Alarm Limits Adjustment)
(HR/PR Alarm Inhibition) On, Off
(STⅠ Alarm Limit Adjustment)
(STⅡ Alarm Limit Adjustment)
(STⅢ Alarm Limit Adjustment)
(STⅤ Alarm Limit Adjustment)
(Arrhythmia Alarm Limit Adjustment)
(Limit Alarm audio off) On, Off
Return
49
HR/PR Source
You may select Auto, ECG, SpO2 or NIBP to decide the source of the heart rate or pulse
rate. If you select Auto, the monitor automatically derives the heart rate or pulse rate from
one of the monitoring parameters in this order of priority: ECG, SpO2 or NIBP. When ECG
is selected, the heart rate is measured from ECG. When SpO2 or NIBP is selected, the
pulse rate is measured from SpO2 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 removed from the display. The HR/PR tone volume can be adjusted
in the SET-UP menu. Refer to the Using the Monitor section. (See Figure 9, Table 11.)
Arrhythmia Detection/ST Level Analysis

You may select On to use arrhythmia and ST monitoring function. When Arrhythmia
Detection/ST Level Analysis is set to On, Filter Mode is automatically changed to Low
Extend and the number of Arrhythmia per minute, ST level and arrhythmia detection and
ST level icon are displayed on the HR/PR numerical area. When 3 leads are attached, the
ST level of the Lead used for ECG waveform is displayed. However, the ST level of Lead
II is displayed if the monitor does not display ECG waveform on the screen during ECG
monitoring. When 5 leads are attached, the ST level of Lead I, II, III or V is displayed in
turn.
Limit alarm audio off
When limit alarm audio off is set to On, the alarm audio for limit alarm is went off.
50
Description of ECG Waveform Menu Functions
2
3
1 ECG waveform icon 3 ECG waveform

2 ECG 1mV size bar 4 ECG lead pair
Figure 15. ECG Waveform Display
Table 24. ECG Waveform Menu

ECG WAVEFORM MENU
Lead Select Lead I, II, III, aVR, aVL, aVF, V (Chest Lead)
Sweep Speed 12.5 mm/s, 25.0 mm/s, 50.0 mm/s
Size (mm per 1mV) Auto, 1.25 mm/mV, 1.7 mm/mV, 2.5 mm/mV, 5.0 mm/mV,
7.5 mm/mV , 10.0 mm/mV, 15.0 mm/mV, 20.0 mm/mV
Pacer Detect On, Off
Filter Mode Monitor, Low Extend, Filter
Large Numeric NIBP -
Waveform Menu ECG waveform, SpO2 waveform, Respiration waveform,
EtCO2 waveform
Trend Menu Tabular trend, Graphical trend
Relearn Yes, No
Return
ECG Cable Select

The monitor detects ECG 3 lead wire or 5 lead wire automatically.
Lead Select
The monitor automatically detects the attached lead and the available ECG lead
selection is displayed when the lead select menu is selected. For example, Lead Select
shows only Lead I, II and III when 3 leads are attached. You can select the desired ECG
lead. For more information about the lead selection, refer to Table 22.
Sweep Speed
The user-selectable sweep speed determines the speed at which the ECG waveform
trace moves across the screen. Sweep Speed can be selected from 12.5 mm/s, 25.0
mm/s and 50.0 mm/s, and ECG waveform is synchronized with pleth waveform.
Size
The user-selectable ECG waveform size allows you to adjust the amplitude of an ECG
waveform. The size can be selected from Auto, 1.25mm/mV, 1.7mm/mV, 2.5mm/mV, 5.0
mm/mV, 7.5 mm/mV, 10.0 mm/mV, 15.0 mm/mV, 20.0 mm/mV. When the size is set to
Auto, The monitor automatically determines the optimal size of the ECG waveform to fit
the space.
51
Pacer Detect
Pacer detect should always be On for patients with pacemakers (refer to the warning in
this section). When Pacer detect is On, the 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 Off to avoid
misdiagnosis.
Filter Mode
The monitor can filter ECG waveform noise with different ranges of frequency response:
Low Extend (0.05 Hz to 40 Hz): Expands the range to display very low frequencies down
to 0.05 Hz.
Filter (0.5 Hz to 30 Hz): Generally called a filter mode, it reduces ECG waveform noise.
Monitor (0.5 Hz to 40 Hz): Choose this mode to see just the ECG waveform monitoring.
Note: The clause 50.102.8 Frequency and impulse response and 50.102.15 Heart rate
range, accuracy and QRS detection range of IEC60601-2-27 are tested only for
Monitor(0.5Hz to 40Hz) of ECG filter mode menu.
Large Numeric NIBP

When Large Numeric NIBP is selected, Large Numeric NIBP is displayed on the
waveform area.
Relearn
If ECG lead or lead level is changed manually or ECG monitoring restarts, Relearn is
automatically initiated. Also you can select Relearn manually to initiate relearning. During
the learn sequence, ‘In Learn’ is displayed on the monitor while the system establishes
the heart rate and beings to classify each beat. If QRS size is too small or not wider than
the normal QRS, the error occurs in the analysis algorithm although PVC is detected. So,
you should select large QRS enough to be detected.
52
NIBP MONITORING
WARNING: 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.
WARNING: In some cases, rapid, prolonged cycling of an oscillometric,
noninvasive blood pressure monitor cuff has been associated with any or all of
the following: 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.
WARNING: 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.
WARNING: 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.
WARNING: Ensure the patient is quiet with minimal movement during NIBP
readings; minimize the patient’s shivering.
WARNING: 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 not specified by
Mediana..
WARNING: 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.
WARNING: Too frequent measurements can cause injury to the patient due to
blood flow interference.
WARNING: The cuff should not be applied over a wound as this can cause further
injury.
WARNING: The cuff should not be placed on the arm on the side of a mastectomy.
In the case of a double mastectomy use the side of the least dominant arm.
WARNING: Pressurization of the cuff can temporarily cause loss of function of
simultaneously used monitoring equipment on the same limb.
WARNING: Do not attach the cuff to a limb being used for IV infusions or any
other intravascular access, therapy or an arterio-venous (A-V) shunt. The cuff
inflation can temporarily block blood flow, potentially causing harm to the patient.
WARNING: 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
device and/or its blood pressure reading are common arrhythmias such as atrial
or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor
perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases, patient
motion, trembling, and shivering.
CAUTION: In the automatic mode, the 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 monitor will not
53
detect the change or indicate an alarm condition.
CAUTION: Any excessive patient motion may cause inaccurate measurements of

non-invasive blood pressure. Minimize motion to improve blood pressure
measurements.
CAUTION: 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.
CAUTION: Make sure that heavy objects are not placed on the cuff hose. Avoid
crimping or undue bending, twisting, or entanglement of the hose.
CAUTION: A compressed or kinked connection hose 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 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.
Note: 5 minutes should elapse before the first reading is taken.
54
General
The 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 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.
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 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.
55
Setup Connections
When performing the NIBP measurements, including hypertension blood pressure
measurements, it is important to follow suitable procedures to ensure valid, accurate
results. Follow these procedures:
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 monitor’s right panel and turn to
clockwise to lock in the clockwise direction. (see Figure
4).
3. Connect a cuff to the cuff hose and turn the connector
to right to lock the hoses together. Firm connection
must be made.
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. The patient should not talk during the BP measurements.
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.
CAUTION: 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.
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 25. Cuff Size

Model Number Arm circumference (cm) Subject
Cuff No.10 3.5 to 6 Neonate
Cuff No.11 5.0 to 7.5
Cuff No.12 7.5 to 10.5
Cuff No.13 8.5 to 13
HEM-CS23 13 to 22 Pediatric
HEM-CR23 22 to 32 Adult
HEM-CL23 32 to 42
HEM-CX23 42 to 50
56
Model Number Arm circumference (cm) Subject
V-Lok B-10 10 to 19 Infant
V-Lok B-18 18 to 26 Pediatric / Small adult
V-Lok B-25 25 to 35 Adult
V-Lok B-33 33 to 47
V-THIGH 46 to 66
NIBP Measurement Modes

Blood pressure measurements can be made in three modes:
 MANUAL mode: Single measurement of systolic/diastolic/mean arterial pressure.
 Automatic (AUTO) mode: Measurements at preset intervals.
 Continuous (CONT) mode: As many measurements as possible within a 5-minute
period.
To Initiate MANUAL Measurement Mode

1. Press the NIBP Start/Stop Button.
A single blood pressure measurement will be made. The measurement will be displayed
for 180 minutes unless another measurement is initiated. A manual NIBP reading can be
obtained in AUTO mode by pressing NIBP Start/Stop Button between two AUTO
measurements without the cancellation of AUTO mode.
To Initiate Automatic (AUTO) Measurement Mode

1. Select the desired automatic mode interval from NIBP Menu, accessed via the NIBP
numerical area (see Table 27). The initial measurement will start automatically in a
selected interval.
2. An NIBP reading can be cancelled by pressing the NIBP Start/Stop Button during the
AUTO measurements.
Note: When the time interval is set to 1 minute, the initial measurement will automatically
start after 5 seconds or it can be activated by pressing the NIBP Start/Stop Button
after selecting 1 minute. Then the measurement interval will be automatically
converted to Off after 12 minutes elapsed.
The NIBP numerical area will display the NIBP Auto Mode Interval and NIBP Elapsed
Time Icon. The interval is the time from when one measurement starts to when the next
measurement starts. The measurement value will be displayed until another
measurement starts. When AUTO mode is cancelled, the last measurement will be
displayed for 180 minutes.
In AUTO mode, the monitor attempts to meet the requirement of SVRP (Safe Venous
Return Pressure) as long as starting a new reading does not violate the requirement of
being 30 seconds below SVRP between readings. A new blood pressure reading will not
start until the 30 second period has elapsed. When CONT or 1 minute are selected in the
NIBP Menu, this SVRP can be shortened over 2 seconds since CONT is the intensive
measurement during the short term which is 5 minutes and 1 minute is the auto
measurement during the short term which is 12 minutes.
Automatic setting pressure value

In AUTO mode, the cuff pressure is automatically calculated used the previous systolic. If
the last systolic blood pressure value does not exist, inflation value is set to initial value.
57
Smart Inflation
Smart inflation means that the cuff pressure appropriate to the patient’s blood pressure
value is automatically estimated and the cuff pressure raised to that pressure.
To Initiate Continuous (CONT) Measurement Mode

You may press the NIBP Start/Stop Button and hold it for at least 2 seconds to activate
the continuous measurement. The initial measurement will automatically starts after 5
seconds, or it can be also activated by pressing the NIBP Start/Stop Button after
initiating Cont. The measurement interval will automatically be converted to Off after 5
minutes elapsed. Also, if the NIBP Start/Stop Button is pressed during CONT mode, the
measurement will be canceled and the interval will be converted to Off.
To Stop Blood Pressure Measurements

You may press the NIBP Start/Stop Button at any time to stop the current measurement
and deflate the cuff. If an automatic measurement is underway, the next measurement will
start at the next interval after the current measurement stops.
58
Description of NIBP Menu Functions
2 3 4
5 6 7 8
1 NIIBP icon 5 Systolic pressure value

2 NIBP unit 6 MAP value
3 NIBP auto mode interval 7 Initial pressure value
4 NIBP elapsed time 8 Diastolic pressure value
Figure 16. NIBP Display
Table 26. NIBP Menu

NIBP MENU
Automatic Mode Interval Off, 1 min, 2.5 min, 3 min, 5 min, 10 min, 15 min,
30 min, 60 min, 90 min
Initial Inflate Pressure Smart, 120, 140, 160, 180, 200, 220, 240, 260, 280
(mmHg) (Adult/pediatric)
80, 90, 100, 110, 120, 130, 140 (mmHg) (Neonatal)
(SYS Alarm Limits Adjustment)
(MAP Alarm Limits Adjustment)
(DIA Alarm Limits Adjustment)
(Limit alarm audio off) 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 mode via the SET-UP menu.
Note: The NIBP unit can only be changed by authorized personnel via the Service Menu.
Initial 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.
In AUTO mode, the cuff pressure is automatically calculated used the previous systolic. If
the last systolic blood pressure value does not exist, inflation value is set to initial value.
Smart can be set for adult and pediatric mode. Smart is Smart inflation that means the
cuff pressure appropriate to the patient’s blood pressure value is automatically estimated
and the cuff pressure raised to that pressure.
When the limit alarm audio off is set to On, the limit alarm for NIBP systolic, MAP and
diastolic is went off.
59
60
SpO2 MONITORING
accessories manufactured by Covidien Healthcare Inc. or supplied by Mediana.
Use accessories according to the manufacturer’s directions for use and your
facility’s standards.
WARNING: 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.
WARNING: 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.
WARNING: 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
 unspecified environmental conditions
 unspecified length of the extension cable
WARNING: Do not attach any cable to the sensor port connector that is intended
for computer use.
WARNING: Use only pulse oximetry sensors and pulse oximetry cables
manufactured by Covidien Healthcare Inc. or supplied by Mediana when
connecting to the sensor connector. Connecting any other cable or sensor
influences the accuracy of the sensor data, which may lead to adverse results.
WARNING: Misapplied sensors with excessive pressure for prolonged periods
may damage the patient.
WARNING: Do not use any other cables to extend the length of the approved
interface cable. Increasing the length will degrade signal quality and may lead to
inaccurate measurements.
CAUTION: 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, extension cable or both.
CAUTION: 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.
61
Refer to the notice below if the Nellcor SpO2 module is installed.
Notice: Purchase of this instrument confers no express or implied license under any
Covidien patent to use the instrument with any sensor that is not manufactured or
licensed by Covidien.
General
The monitor uses pulse oximetry to measure functional oxygen saturation in the blood.
Because a measurement of SpO2 is dependent upon light from the SpO2 sensor,
excessive ambient light can interfere with this measurement. SpO2 and Pulse rate are
updated every second. This 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 mehtemoglobin.
Functional versus Fractional Saturation

This 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. In
contrast, hemoximeters such as the IL482 report fractional saturation — 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 as follows:
functional saturation = fractional saturation

× 100
100 – (%carboxyhemoglobin + %methemoglobin)
Measured versus Calculated Saturation

When calculating saturation from a blood gas partial pressure of oxygen (PO2), the
calculated value may differ from the SpO2 measurement of a monitor. This usually occurs
when saturation calculations exclude corrections for the effects of variables such as pH,
temperature, the partial pressure of carbon dioxide (PCO2), and 2,3-DPG, that shift the
relationship between PO2 and SpO2.
s
Figure 17. 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
62
Data Upload Period, Data Averaging and Signal Processing
The advanced signal processing of the Oximax™ algorithm automatically extends the
amount of data required for measuring SpO2 and pulse rate depending on the
measurement conditions. The Oximax™ algorithm automatically extends the dynamic
averaging time required beyond 7 seconds during degraded or difficult measurement
conditions caused by low perfusion, signal artifact, ambient light, electrocautery other
interference, or a combination of these factors, which results in an increase in the
dynamic averaging. If the resulting dynamic averaging time exceeds 20 seconds for SpO2,
the algorithm sets the pulse search bit while continuing to update SpO2 and pulse rate
values every seconds.
As such measurement conditions extend, the amount of data required may continue to
increase. If the dynamic averaging time reaches 40 seconds and/or 50 seconds for pulse
rate, a low priority alarm state results: the algorithm sets the Pulse Timeout bit and the
monitoring system reports a zero saturation indicating a loss-of pulse condition, which
should result in an alarm audio.
Automatic Calibration
Because light absorption by hemoglobin is wavelength dependent and because the mean
wavelength of LEDs varies, an oximeter must know the mean wavelength of the OXIMAX
sensor’s red LED to accurately measure SpO2. The wavelength range of the light emitted
are near 660 nm and 890 nm with the energy not exceeding 15 mW. During monitoring,
the instrument’s software selects coefficients that are appropriate for the wavelength of
that individual sensor’s red LED; these coefficients are then used to determine SpO2.
Additionally, to compensate for differences in tissue thickness, the light intensity of the
sensor’s LEDs is adjusted automatically.
63
Clinical Studies
Clinical studied conducted for the Mediana sensors
Overview
Pulse oximetry is routinely used in clinical practice for determination of functional arterial
oxygen saturation, an important physiologic measurement. Validation of pulse Oximeters
is commonly accomplished by comparison of measurements against a co-oximeter during
oxygen desaturation. Comparisons will be made between the SpO2 measurement
determined using the Mediana MD1 Oximetry Module and a measurement calculated with
oxy- and deoxyhemoglobin concentrations determined from an arterial blood sample
using a co-oximeter. Monitor safety will be monitored closely throughout the Clinical
Investigation.
Methods
Ten subjects were studied during the Clinical Investigation over a two day period (5
subjects the first day, 5 subjects the second day). The number of subjects chosen for the
study was based on the work of Severinghaus and has been approved by the IRB of the
Medical College of Wisconsin and the Milwaukee VA Medical Center. Subjects completed
a case report form and sign an informed consent form prior to the Clinical Investigation.
Any subject with health problems (i.e. diabetes, asthma), smokers, or those who have not
given consent could not participate in the clinical investigation. After the subject gives
informed oral and written consents, a radial artery catheter was inserted by an
anesthesiologist.
Sensors were placed on both index, middle, ring and pinky fingers. The monitors were
linked to a computer data acquisition system via a serial communications multiplexer.
Study Population
Table 27. Demographic Data

Type Class Total
Gender Male 6 people
Female 4 people
White 6 people
Race Hispanic 3 people
African American 1 people
Age - 20 ~ 34 years
Weight - 105 ~ 225 lb
Study Results
Accuracy was calculated using the root mean square difference (RMSD).
Table 28. SpO2 Accuracy for Mediana Sensors

SpO2 sensor The total number of Accuracy
processed samples
YM-1 566 1.708 %SpO2
YM-2 571 1.906%SpO2
YM-5 505 1.807%SpO2
Conclusion
The pooled results indicate that for a saturation range of 70-100% for SpO2, the
acceptance criterion was met for the monitor when tested with YM-1, YM-2 and YM-5
sensors.
64
Clinical studied conducted for the Nellcor™ Sensors
Overview
This appendix contains data from clinical studies conducted for the Nellcor™ sensors
used with the monitor.
One (1) prospective, controlled hypoxia clinical study was conducted to demonstrate the
accuracy of Nellcor™ sensors when used in conjunction with the 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. SpO2 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 SpO2 data were simultaneously
collected and marked for direct comparison to CO2. 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 29. 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
Study Results
Accuracy was calculated using the root mean square difference (RMSD).
Table 30. SpO2 Accuracy for Mediana 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
65
Figure 18. 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 monitoring system 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.
66
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 32, or contact Tyco Healthcare Inc. or Mediana sales department for ordering
information.
1. Select the proper sensor for the patient.

2. Connect the extension cable to the SpO2 connector on the monitor’s right panel and
lock it (see Figure 4).
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 31. SpO2 Sensors

Sensor Model Patient Size
For SpO2 reusable sensor YM-1 YM-1 >40 kg
Mediana SpO2 disposable sensor YM-2 YM-2 <3 kg or >40 kg
Module SpO2 disposable sensor YM-5 YM-5 10 to 30 kg
SpO2 reusable sensor WA-100 WA-100
For OXIMAX oxygen transducer (Sterile, single- MAX-N <3 or >40 kg
Nellcor use only) MAX-I 3 to 20 kg
Module 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 D-YS >1 kg
transducer
For use with the Dura-Y sensor: D-YSE >30 kg
Ear clip (Reusable, non-sterile)
Pedi-Check TM pediatric spot-check clip D-YSPD 3 to 40 kg
OXIMAX MAX-FAST ® adhesive reflectance MAX- >40 kg
oxygen transducer FAST
67
Description of SpO2 Menu Functions
2 3
1 SpO2 icon 3 SpO2 value

2 Pulse amplitude indicator
Figure 19. SpO2 Display

Pulse Amplitude Indicator
The pulse amplitude indicator is the segmented display within the SpO2 numerical area
that shows the relative strength of the detected pulse. A stronger pulse causes a larger
amplitude indicator.
Table 32. SpO2 Menu

SpO2 MENU
C-Lock On, Off
Return
C-Lock
When C-Lock is turned on in the SpO2 menu, C-Lock automatically becomes operational
any time a valid ECG signal is detected by the monitor. It is not necessary to turn C-Lock
off if an ECG signal is not available; the monitor handles this function automatically. If the
ECG signal is noisy, or of poor quality, SpO2 performance may be improved by turning C-
Lock off. C-Lock provides ECG synchronization for more reliable saturation
measurements. An ECG (R-wave) signal can be used as a time reference to identify the
pulse and synchronize saturation measurements. C-Lock enhances performance while
maintaining rapid response time.
Note: This menu is for Nellcor SpO2 module only.

68
Description of Pleth Waveform Menu Functions
1 SpO2 waveform icon 2 SpO2 waveform
Figure 20. SpO2 Waveform Display
Table 33. SpO2 Waveform Menu

SpO2 WAVEFORM MENU
Waveform Menu ECG waveform, SpO2 waveform, Respiration waveform
EtCO2 waveform
Trend Menu Tabular Trend, Graphical Trend
Return
Sweep Speed
The user-selectable Sweep Speed determines the speed at which the SpO2 waveform
trace moves across the screen. Sweep Speed can be selected from 12.5 mm/s, 25.0
mm/s and 50.0 mm/s, and the SpO2 waveform is synchronized with the ECG waveform.
Large Numeric NIBP

waveform area.
69
70
RESPIRATION MONITORING
WARNINGS: The monitor does not detect apnea when the respiration signal is
measured by trans-thoracic impedance.
WARNING: 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 monitor can
cause inaccurate respiration readings. Do not rely entirely on the 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.
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 monitor detects respiration rate by computing each breath cycle
form the continuous EtCO2 waveform; Airway respiration source (AW).
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 12.)
Refer to the Capnography Monitoring section to detect the respiration signal by the
airway adapter in case that the CO2 equipped.
71
Description of Respiration Menu Functions
1
2 3
1 Respiration icon 3 Respiration rate

2 Respiration source
Figure 21. Respiration Display
Table 34. Respiration Menu

RESPIRATION MENU
Respiration On, Off
Respiration Source AUTO (AW > IM), AW, IM
Return
Respiration
When respiration is set to On, The measurement value for respiration rate and respiration
waveform are displayed on the screen. And when the respiration is set to Off, respiration
rate is not measured and respiration value is displayed with “---”.
Respiration Source
User can select either AW or IM for source of the respiration rate. If the AUTO is
selected, the monitor will automatically drive the respiration rate from one of the
monitoring parameters in this order of priority; AW and IM.
Note: You can select AW as the source when CO2 module is installed.

72
Description of Respiration Waveform Menu Functions
1 Impedance respiration waveform 2 Respiration waveform

icon
Figure 22. Respiration Waveform Display
Table 35. Respiration Waveform Menu

RESPIRATION WAVEFORM MENU
Size Auto, 1, 2, 3, 4, 5, 6, 7, 8
EtCO2 waveform
Trend Menu Tabular trend, Graphical Trend
Return
Sweep Speed
The user-selectable sweep speed determines the speed at which the respiration
waveform trace moves across the screen. Sweep Speed can be selected from 6.25
mm/s, 12.5 mm/s and 25.0 mm/s.
Size
Size allows you to adjust the waveform size. When the size is set to Auto, The monitor
automatically determines the optimal size of the respiration waveform to fit the space.
Large Numeric NIBP

waveform area.
73
74
CAPNOGRAPHY MONITORING
WARNING: 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.
WARNING: Ensure that selection of a volatile anesthetic is done carefully. If an
improper selection is made, the measurement values may be incorrect.
WARNING: Do not use accessories other than which are specified. Different
sampling tube lengths or inside diameters may have an effect on the
measurement.
WARNING: 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.
WARNING: For best product performance and measurement accuracy, use
only accessories supplied or recommended by Mediana. Use accessories
according to your facility’s standards and the manufacturer’s recommendatio
n. Always refer to the manufacturer’s Directions for Use for instruction about
operation, cleaning, and replacement.
WARNING: Do not use device without rectifying a gas calibration failure, as
correct measurement readings will not be obtained.
WARNING: Do not use device on patients that cannot tolerate the withdrawal
of 50 cc/min ±10cc /min from airway.
WARNING: Do not return sample gas to ventilated circuit.
WARNING: While using the CO2/Flow sensor, a system leak, such as that
caused by an un-cuffed endotracheal tube or a damaged CO2/Flow sensor
may significantly affect flow-related readings. These include flow, volume,
pressure and other respiratory parameters.
CAUTION: Do not operate the Capnostat sensor when it is wet. Do not immerse the
device in water.
CAUTION: Do not operate the Capnostat sensor if it appears to have been damage
or if it fails to operate properly.
CAUTION: 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.
CAUTION: 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.
CAUTION: Do not insert any object other than the sidestream sample cell into the
inlet port of the CO2 module.
CAUTION: Inspect the mainstream CO2 sensor and airway adapter connection to
ensure correct positioning.
CAUTION: Position sidestream airway adapter with the tubing in an upright position.
This help keep patient secretions from pooling into the tubing.
75
CAUTION: 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.
CAUTION: 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 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 monitor
automatically compensates for the ambient barometric pressure to ensure accurate
readings.
Setup Connections
WARNING: The exhaust port on the rear of the module contains barbs for
attaching scavenging tubing. The port contains two different sized barbs. The
small barb is sized for 0.060 inch (1.524 mm) ID and up to 0.100 inch (2.54 mm)
OD. The large barb is sized for 0.125 inch (3.175 mm) ID and up to 0.375 inch
(9.525 mm) OD.
The 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 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.
76
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 CO2 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.
1 Y-piece 4 Elbow
2 Airway adapter 5 Mainstream CO2 sensor
3 Patient connector (Adult/Pedi)
Figure 23. Connection for mainstream
77
Sidestream Operation
Sidestream monitoring uses an external, sidestream sensor that plug into the
capnography port on the 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 monitor. The other end of sampling line is connected
to the patient either via a cannula or a sample-T, as shown in Figure 22.
1 Cannula 3 Sampling-T
2 Sampling cell 4 Sidestream CO2 sensor
Figure 24. Connection for sidestream
78
Description of EtCO2 Menu Functions
1 5
2
4
1 EtCO2 icon 4 InCO2 value

2 InCO2 icon 5 EtCO2 value
3 EtCO2 unit
Figure 25. EtCO2 Display
Table 36. EtCO2 Menu

EtCO2 MENU
APNEA Alarm Off, 10sec, 15sec, 20sec, 25sec, 30sec,
35sec, 40sec
Zero calibration Yes, No
(EtCO2 Alarm Limits Adjustment)
(EtCO2 Alarm Inhibition) On, Off
(InCO2 Alarm Limits Adjustment)
(Limit Alarm audio off) On, Off
Return
Note: The EtCO2 unit can only be changed by authorized personnel via the Service Menu.
APNEA Alarm
If a patient breath is not detected when the APNEA alarm is being set, the alarm will
sound. The monitor can detect patient apnea only when respiration is measured by an
airway method.
Zero calibration
When the CO2 sensor is changed or the ‘CO2 - Pressure Not Zeroed’ message appears,
the user calibrates the CO2 sensor. When Zero calibration is set to On, the CO2 sensor is
calibrated.
Limit Alarm audio off

79
Description of EtCO2 Waveform Menu Functions
3
1 EtCO2 waveform icon 2 EtCO2 waveform

3 EtCO2 size bar
Figure 26. EtCO2 Waveform Display
Table 37. EtCO2 Waveform Menu

EtCO2 WAVEFORM MENU
N2O Gas On, Off
O2 Gas On, Off
Size AUTO, 0-40 mmHg, 0-60 mmHg, 0-80 mmHg, 0-100 mmHg
(AUTO, 0-5.0 kPa, 0-7.5 kPa, 0-10.0 kPa, 0-12.5 kPa)
(AUTO, 0-5.0 %, 0-7.5 %, 0-10.0 %, 0-12.5 %)
Scale Off, 20, 40, 60, 80, 100
Zero Calibration Yes, No
EtCO2 waveform
Trend Menu Tabular Trend, Graphical Trend
Return
Sweep Speed
The user-selectable sweep speed determines the speed at which the respiration
waveform trace moves across the screen. Sweep Speed can be selected from 6.25
mm/s, 12.5 mm/s and 25.0 mm/s.
N2O Gas
As the N2O in the sample gas, an assumption is made: if N2O is administered to the
patient, then the remaining balance of the administered mixture is O2. 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 CO2
molecule is free to absorb even more energy which leads to an increase in absorption. It
is recommended N2O Gas is set to On when N2O concentrations is above 50%.
Note: High N2O levels cause a higher than expected CO2 reading.
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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 O2 effect when the O2
concentration is greater than 60%. At O2 levels equal to or less than 60%, the correction
should not be used.
Note: High concentrations of O2 will cause a lower than expected CO2 reading.
Size
The user-selectable EtCO2 waveform size allows you to adjust the amplitude of an EtCO2
waveform without affecting the signal gain. The waveform size cannot be adjusted while
the scales are displayed.
Scale
The user-selectable pressure waveform scale allows you to adjust the scale of a pressure
waveform. The scale can be selected from Off, 20, 40, 60, 80, and100.
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TEMPERATURE MONITORING
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 monitor is designed to accept signals from the temperature probes, YSI 400 series
and 700 series for skin, rectal or etc. Refer to the temperature probe directions for use for
details.
1. Insert a body temperature probe into the temperature connector on the monitor’s right
panel (see Figure 4).
2. Follow the directions for use accompanying the temperature probe.
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Description of Temperature Menu Functions
2 3
1 Temperature icon 3 Temperature value

2 Temperature unit
Figure 27. Temperature Display
Table 38. Temperature Menu

TEMPERATURE MENU
Return
Note: The temperature unit can only be changed by authorized personnel via the
Service Menu.

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TRENDS
General
The trend data is stored in memory. When the monitor turns on and starts to measure vital
signs, the monitor saves data at 20 seconds interval. Also, the monitor saves all
physiological alarm conditions, NIBP measurements and error events. The data remains
even if the monitor is powered off. After the monitor has stored 20,480 trend data, the
monitor begins to store the new data over the oldest data.
Trend Data Printout

Trend data in either graphical or tabular format may be displayed or printed if a printer
module is installed (see Printing section).
1. Rotate the knob to highlight one of the waveform areas.

2. Press the knob to display waveform menu on the screen.
3. Rotate the knob to highlight Trend Menu and press the knob to display Trend Menu.
4. Select the Tabular Trend or Graphical Trend.
5. Press the Home Button to return to the main screen.
Tabular Trend Data

The monitor presents trend information in tabular format for all monitored parameters. The
newest data appears at the bottom of tabular trends.
For the NIBP trends, the data may display the latest measurement.
Figure 28. Tabular Trend Screen
To scroll or change viewing options, push the knob on the tabular trend screen when the
tabular trend screen is highlighted. The monitor displays the Tabular Trend Menu.
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Table 39. Tabular Trend Menu
TABULAR TREND MENU
Scroll The knob is activated for scrolling.
Note: Press the Home Button to exit.
Display Time Interval 20sec, 1, 2, 3, 5, 10, 20 minutes
Trend Display Select Normal, NIBP, Alarm, Normal + NIBP,
Normal + Alarm, NIBP + Alarm, ALL
Tabular Trend Off -
Return Exits Tabular Trend Menu immediately, returns to
Tabular Trend Screen.
Scrolling Tabular Trend Data

1. Rotate the knob to highlight Scroll.
2. Press the knob to activate scrolling.
3. Rotate the knob to scroll through the trend data.
Clockwise rotation moves forward to newer data. Counterclockwise rotation moves
backward to older data.
4. After viewing the trends, press the Home button to exit the scrolling.
Display Time Interval

The display time interval can be selected from 20 sec, 1, 2, 3, 5, 10, 20 minutes. The
tabular trend will be displayed in a selected interval.
Trend Display Select

The monitor displays the trends selected by the user.
- Normal: trend data, no physiological alarm condition, no NIBP measurement
- NIBP: NIBP measurements
- Alarm: physiological alarm condition
- Normal + NIBP: trend data, NIBP measurements
- Normal + Alarm: trend data, physiological alarm condition
- NIBP + Alarm: NIBP measurements, physiological alarm condition
- ALL: trend data, NIBP measurements, alarm condition
Tabular Trend Off

To exit tabular trend display, select Tabular Trend Off.
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Graphical Trend Data
Trend information in graphical format for all monitored parameters is displayed in screen.
The user can select each parameter to display via interaction with Graphical Trend Menu.
The graphical trend data of each parameter is indicated by the symbols specified in Table
3. The vertical range of a graphical trend is presented with fixed value, and the horizontal
range is 150 minutes. The newest data appears at the right of graphical trend. Use the
scroll function to view more data.
Figure 29. Graphical Trend Screen
To scroll or change viewing options, push the knob on the graphical trend screen when
the graphical trend screen is highlighted. The monitor displays the Graphical Trend
Menu.
Table 40. Graphical Trend Menu

GRAPHICAL TREND MENU
Scroll The knob is activated for scrolling.
Note: Press the Home Button to exit.
HR/PR Graphical Trend On, Off
SpO2 Graphical Trend On, Off
NIBP Graphical Trend On, Off
RESP Graphical Trend On, Off
TEMP Graphical Trend On, Off
CO2 Graphical Trend On, Off
Graphical Trend Off -
Return Exits Graphical Trend Menu immediately,
returns to Graphical Trend Screen.
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Scrolling Graphical Trend Data
1. Rotate the knob to highlight Scroll.
2. Press the knob to activate scrolling.
3. Rotate the knob to scroll through the trend data.
Clockwise rotation moves forward to newer data. Counterclockwise rotation moves
backward to older data.
4. After viewing the trends, press the Home button to exit the scrolling.
Selecting Graphical Trend Data

1. Rotate the knob to select HR/PR, NIBP, SpO2, RESP, EtCO2 or TEMP.
2. Press the knob to set to On.
3. Rotate the knob to highlight Return, then press the knob to return to the graphical trend
screen. Only parameters set to On will be displayed in the graphical trend screen.
Note: Setting Off will not display the trends of the selected parameter.
Graphical Trend Off

To exit graphical trend display, select Graphical Trend Off.
Trend Data Download

Connect the micro 5-pin USB port to the monitor and connect the connector of micro 5-pin
USB port cable to a PC for downloading trend data. PC connected to the data port must
be certified according to IEC standard 60950. All combinations of equipment must be in
compliance with IEC standard 60601-1-1 system requirements.
System Compatibility Prerequisites

- Windows XP/7
- Pentium 100 MHz CPU
- 256 MB RAM
- USB COM port
- Application software ‘SerialCom.exe’
COM port USB Driver Alternatives

Data transfer relies on existing communication software drivers for USB-based devices
already on the computer, so should not require any modification of the derivers used by
the USB interface. If, for some reason, the computer does not have the correct USB
driver, download the device driver provided from Silicon labs. Available on online website
at http://www.silabs.com/products/mcu/pages/usbtouartbridgevcpdrivers.aspx.
Hardware
- Micro 5-pin USB port
To install a USB driver

1. Download the CP210x USB to UART Bridge VCP Drivers from Silicon labs homepage,
installing it in the desired program folder.
2. Right-click on the zipped folder.
3. Select EXTRACT ALL.
4. Open the extracted folder.
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5. Launch the Driver Installer executable.
6. Click NEXT button.
Figure 30. Sample of CP210x VCP Drivers Installer Window
7. When the InstallShield Wizard provides the end-user license agreement, read it
carefully, then click the button for accepting the terms of the license.
Figure 31. Sample of License Agreement Window
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8. Click NEXT button to formally accept the agreement.
Figure 32. Sample of Destination Location Window

9. Click INSTALL button in the resulting driver installer window. Do not click the CANCEL
button.
Figure 33. Sample of Installation Window

10. Click the FINISH button to complete the installation in the resulting success window.
11. Reboot the PC for changes to take effect.
12. Connect the monitor to PC with micro 5-pin USB port.
13. From the START menu, click the Settings menu option and select the Control Panel
option.
14. Select the System option to open the System Properties window.
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15. Click the Hardware tab, then the DEVICE MANAGER button.
Figure 34. Sample of Initial System Properties – Hardware

16. Select the Ports option from the resulting list.
17. Check the Silicon Labs CP210x USB to UART Bridge (COM(X)) from Ports (COM &
LPT) list.
Figure 35. Sample of Ports (COM & LPT) list in Device Manager Window
18. Run the SerialCom.exe file.
Note: Contact service center or check the Mediana homepage to download
SerialCom.exe. SerialCom.exe is suitable for Windows 7 and Window XP.
91
19. Open the SerialCom window, select the COM(X) to Serial port. COM(X) is the same
as COM(X) of Silicon Labs CP210x USB to UART Bridge (COM(X)) in Ports (COM &
LPT) list of Device manage window.
20. Set the Baud Rate of SerialCom window the same as Baud Rate of M30. Factory
default of M30 Baud Rate is 19200.
Note: Only a qualified service technician change the baud rate of the M30 via the
Service menu. Refer to the Service manual for instructions.
21. Set the Receive of Data Type to ASCII.
Figure 36. Sample of Serial Port, Baud Rate, Receive Settings
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22. Click the Open button to check OPEN PORT: COM(X) in Operation window.
Figure 37. Sample of OPEN PORT: COM(X) in Operation window
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To download trend data
1. Select the SET-UP menu on the monitor.

2. In the SET-UP menu, select the Trend Data Download menu and then press the
knob to select Start.
3. Confirm the monitor is sending trend data to a PC by observing the SerialCom
application software screen.
4. The status bar indicating total percentage of the download appears.
5. Click the File Save button on Serial Com screen as a text format.
Figure 38. Sample of Trend data File Save
6. Open trend data in a spreadsheet from the Microsoft Excel.

7. Set trend data text file using Text Import Wizard.
94
Figure 39. Sample of Text Import Wizard – Step 1 of 3
95
8. After text import wizard step, check the trend data in spreadsheet
Figure 42. Sample of Trend data in spreadsheet
96
9. Match the Operating status codes to Table 41 for pertinent system information.
Table 41. Operating Status Codes
Alarm Condition Alarm Messages Code
ECG Leads Off ECG Leads Off ELO
Asystole Asystole AST
Signal saturation signal saturation SSN
HR/PR
High High HI
Low Low LO
Chest Lead off Chest Lead Off CLO
SpO2 Cable/Sensor SpO2 Cable/Sensor SCD
Disconnect Disconnect
Sensor Off from SpO2 Sensor SpO2 Sensor Off SSO
Loss of Pulse from SpO2, Loss of Pulse from SpO2, SPL
SpO2 SpO2 Pulse Search SpO2 Pulse Search
Loss of Pulse from SpO2 Loss of Pulse from SpO2 LPS
SpO2 Pulse Search SpO2 Pulse Search SPS
High High HI
Low Low LO
High High HI
NIBP
Low Low LO
Respiration Leads Off Respiration Leads Off RLO
Respir
High High HI
ation
Low Low LO
Temperature Probe Disconnect Temperature Probe TPD
Disconnect
TEMP
High High HI
Low Low LO
CO2 - Check Adapter CO2 - Check Adapter CCA
CO2 - Faulty Sensor CO2 - Faulty Sensor CFS
CO2 - Sensor Disconnected CO2 - Sensor Disconnected CSD
EtCO2
CO2 - Occlusion or Leak CO2 - Occlusion or Leak COL
High High HI
Low Low LO
AC Input AC Input AC
DC Input DC Input DC
Power FULL Battery Full Battery FB
Status HALF Battery Half Battery HB
Low Battery Low Battery LB
Critically Low Battery Critically Battery CB
HR/PR Source AUTO Source AS
HR/PR ECG Source ES
source SpO2 Source SS
NIBP Source NS
Note: Only a qualified service technician change the baud rate of the monitor via the
Service menu. Refer to the Service Manual for instructions.
97
98
MENU STRUCTURE
ECG WAVEFORM MENU

- Lead Select
- - Lead I
- - Lead II
- - Lead III
- - aVR
- - aVL
- - aVF
- - V (Chest Lead)
- - Return
- Sweep Speed
- - 12.5 mm/s
- - 25.0 mm/s
- - 50.0 mm/s
- - Return
- Size
- - Auto
- - 1.25 mm/mV
- - 1.7 mm/mV
- - 2.5 mm/mV
- - 5.0 mm/mV
- - 7.5 mm/mV
- - 10.0 mm/mV
- - 15.0 mm/mV
- - 20.0 mm/mV
- - Return
- Pacer Detect
- - On
- - Off
- Filter Mode
- - Monitor
- - Low Extend
- - Filter
- - Return
- Large Numeric NIBP
- Waveform Menu
- - ECG waveform
- - SpO2 waveform
- - Respiration waveform
- - EtCO2 waveform
- - Return
- Trend Menu
- - Tabular Trend
- - Graphical Trend
- - Return
- Relearn
- - Yes
- - No
- - Return
- Return
99
SpO2 WAVEFORM MENU
- Sweep Speed
- - 12.5 mm/s
- - 25.0 mm/s
- - 50.0 mm/s
- - Return
- Waveform Menu
- - ECG waveform
- - SpO2 waveform
- - EtCO2 waveform
- - Return
- Trend Menu
- - Tabular Trend
- - Graphical Trend
- - Return
- Return
RESPIRATION WAVEFORM MENU

- Sweep Speed
- - 6.25 mm/s
- - 12.5 mm/s
- - 25.0 mm/s
- - Return
- Size
- - Auto
- - 1
- - 2
- - 3
- - 4
- - 5
- - 6
- - 7
- - 8
- - Return
- Waveform Menu
- - ECG waveform
- - SpO2 waveform
- - EtCO2 waveform
- - Return
- Trend Menu
- - Tabular Trend
- - Graphical Trend
- - Return
- Return
100
EtCO2 WAVEFORM MENU
- Sweep Speed
- - 6.25 mm/s
- - 12.5 mm/s
- - 25.0 mm/s
- - Return
- N2O Gas
- - On
- - Off
- O2 Gas
- - On
- - Off
- Size
- - Auto
- - 0 ~ 40 mmHg
- - 0 ~ 60 mmHg
- - 0 ~ 80 mmHg
- - 0 ~ 100 mmHg
- - Return
- Scale
- - Off
- - 20
- - 40
- - 60
- - 80
- - 100
- - Return
- Zero Calibration
- - Yes
- - No
- - Return
- Waveform Menu
- - ECG Waveform
- - SpO2 Waveform
- - Respiration Waveform
- - EtCO2 Waveform
- - Return
- Trend Manu
- - Tabular Trend
- - Graphical Trend
- - Return
- Return
Note: You can select the same waveform to display in two consecutive waveform areas.
101
HR/PR MENU
- HR/PR Source
- - AUTO “HR > SpO2 PR > NIBP PR”
- - ECG
- - SpO2
- - NIBP
- - Return
Arrhythmia Detection/ST Level Analysis
- - On
- - Off
“Alarm limits adjustment”
HR/PR ST l ST ll ST lll ST V Ar
120 0.50 0.50 0.50 0.50 5
50 -0.50 -0.50 -0.50 -0.50
“Limit alarm audio off”
-
On
-
Off
- Return
102
NIBP MENU
- Automatic Mode Interval
- - Off
- - 1 min
- - 2.5 min
- - 3 min
- - 5 min
- - 10 min
- - 15 min
- - 30 min
- - 60 min
- - 90 min
- - Return
- Initial Inflate Pressure
- - “Adult/Pediatric”
- - Smart
- - 120 mmHg
- - 140 mmHg
- - 160 mmHg
- - 180 mmHg
- - 200 mmHg
- - 220 mmHg
- - 240 mmHg
- - 260 mmHg
- - 280 mmHg
- - Return
- - “Neonatal”
- - 80 mmHg
- - 90 mmHg
- - 100 mmHg
- - 110 mmHg
- - 120 mmHg
- - 130 mmHg
- - 140 mmHg
- - Return
“Alarm limits adjustment (mmHg)”
- SYS MAP DIA
160 110 90
90 60 50
-
On On On
-
Off Off Off
- Return
103
SpO2 MENU
- C-Lock
- - On
- - Off
100
90
“Limit alarm audio off ”
-
On
-
Off
- Return
RESPIRATION MENU
- Respiration
- - On
- - Off
- Respiration Source
- - AUTO “AW > IM”
- - AW
- - IM
- - Return
30
8
-
On
-
Off
- Return
104
TEMPERATURE MENU
“Alarm limits adjustment (ºC)”
39.0
36.0
-
On
-
Off
- Return
EtCO2 Menu
- APNEA Alarm
- - Off
- - 10sec
- - 15sec
- - 20sec
- - 25sec
- - 30sec
- - 35sec
- - 40sec
- - Return
- Zero Calibration
- - Yes
- - No
- - Return
“Alarm limits adjustment (mmHg)”
- EtCO2 InCO2
80 20
0 0
-
On On
-
Off Off
- Return
105
TABULAR TREND MENU
- Scroll
- Display Time Interval
- - 20 sec
- - 1 min
- - 2 min
- - 3 min
- - 5 min
- - 10 min
- - 20 min
- - Return
- Trend Display Select
- - Normal
- - NIBP
- - Alarm
- - Normal + NIBP
- - Normal + Alarm
- - NIBP + Alarm
- - ALL
- - Return
- Tabular Trend Off
- Return
GRAPHICAL TREND MENU

- Scroll
- HR/PR Graphical Trend
- - On
- - Off
- SpO2 Graphical Trend
- - On
- - Off
- NIBP Graphical Trend
- - On
- - Off
- RESP Graphical Trend
- - On
- - Off
- TEMP Graphical Trend
- - On
- - Off
- CO2 Graphical Trend
- - On
- - Off
- Graphical Trend Off
- Return
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SET-UP MENU
- Patient Mode
- - Adult
- - Pediatric
- - Neonatal
- - Return
- Trend Clear
- Print Speed
- - 25 mm/s
- - 50 mm/s
- Print Mode
- - One-Shot
- - Continuous
- Printing Waveform Setup
- - Printing Waveform1
- - - ECG
- - - SpO2
- - - RESP
- - - EtCO2
- - - OFF
- - - ECG
- - - SpO2
- - - RESP
- - - EtCO2
- - - OFF
- - - ECG
- - - SpO2
- - - RESP
- - - EtCO2
- - - OFF
- Alarm Volume
- - 1
- - 2
- - 3
- - 4
- - 5
- - 6
- - 7
- - 8
- Key Beep Volume
- - 1
- - 2
- - 3
- - 4
- - 5
- - 6
- - 7
- - Off
- QRS Volume
- - 1
- - 2
- - 3
- - 4
- - 5
- - 6
107
- - 7
- - Off
- Trend Data Download
- - Start
- - Cancel
- Service Menu
- - (Pass code)
- - Return
- Return
ALARM/LIMITS MENU
- Print-On-Alarm
- - On
- - Off
- Alarm Limits “Alarm limits adjustment/Limit alarm audio off for each parameters”
NIBP CO2
HR/PR SpO2 SYS MAP DIA RESP EtCO2 InCO2 TEMP
120 100 160 110 90 30 80 20 39.0
50 90 90 60 50 8 0 0 36.0
- -
On On On On On On On
- -
Off Off Off Off Off Off Off
- - Return
- Return
Note: Alarm limits shown above are for Adult patient mode. In order to set alarm limits to
Pediatric or Neonatal patient mode, change Patient mode via the SET-UP menu.
DATE/TIME MENU
- Date
- - Year
- - Month
- - Day
- - Return
- Set Time
- - Hour “24 hours only”
- - Minute
- - Second
- - Return
- Date Format
- - mm/dd/yy
- - dd/mm/yy
- - yy/mm/dd
- - Return
108
PRINTING
General
The monitor can print real-time measurement and trend data as follows. Printer is an
option and is not available on all monitors.
1. Set Print Speed, Print Mode or Printing Waveform Setup via the SET-UP menu and
Print-On-Alarm via the Alarm/Limits Menu.
2. To start printing, press the Print Button.
3. To stop printing during print out, press the Print Button again.
Print Speed
The print speed for is user-selectable: either 25 or 50mm/s.
Print Mode
One-Shot
A one-shot print, recording real-time graphical and numeric information beginning 10
seconds before the print initiation and ending 10 seconds after that event.
Continuous
A print of real-time graphical and numeric information, beginning 10 seconds before
initiating the action and continuing until stopped.
Print-On-Alarm
If Print-On-Alarm is set to On in Alarm/Limits menu, the monitor will automatically print
out whenever a physiological alarm condition occurs.
Printing Waveform
In SET-UP menu, printing waveform can be changed in Printing Waveform Setup menu.
The printing waveform can be set as ECG, SpO2, RESP, EtCO2 or OFF. The monitor will
print out measurement values and waveform when the Print Button is pressed.
109
Print-Out Configuration
One-Shot Print-Out
If Print Mode is set to One-Shot, the monitor will print out numeric data and waveforms
by pressing the Print Button as shown Figure 43.
Figure 43. One-Shot Printing
Continuous Print-Out
If Print Mode is set to Continuous, the monitor will print out numeric data and
waveforms continuously by pressing the Print Button as shown in Figure 44.
Figure 44. Continuous Printing
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Tabular Trend Data Print Out
When tabular trend data is displayed on the screen, the monitor will print out the
displayed data by pressing the Print Button as shown in Figure 45.
Figure 45. Tabular Trend Printing
Setting Information Print-Out

When the monitor is in the Service Menu, the monitor will print out all internal settings by
pressing the Print Button as shown in Figure 46.
Figure 46. Setting Information Printing
111
112
EXTERNAL INTERFACE
General
The monitor provides external connectors to support communication
with external equipment and functions such as a nurse call, software upgrades or PC
connection. Refer to Figure 2 and Figure 3. The monitor, with its optional built-in
network(LAN, 3G or Wi-Fi) module, functionally performs the same as a monitor
connected to the central system. The monitor with a network(LAN, 3G or Wi-Fi) can send
and receive patient data through the central system.
WARNING: Any connections between this 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.
WARNING: The external interface function(wired network, wireless network and
nurse call interface) should not be used as the primary source of alarm
notification. The audible alarms of the monitor, used in conjunction with clinical
signs and symptoms, are the primary sources for notifying medical personnel
that an alarm condition exists.
Note: This equipment is to be used on a wireless network (Wi-Fi or 3G) and the
communication wirings (LAN Interface or RJ11 Nurse Call Interface) are limited to
inside of the building.
Set Bed Number

The bed number identifies a particular patient bed. Up to two characters are used to
identify bed number. This number displays at the bottom of the screen.
1. Rotate the knob to highlight the Setup Menu Icon. Press the knob to display the SET-
UP menu.
Figure 47. Setup Menu
2. Rotate the knob to highlight the Service Menu and the press the knob to select
Service Menu.
3. At first, rotate the knob until 9 is displayed and then press the knob to select 9.
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4. Rotate the knob to display the desired number of bed and then press the knob to select
the desired number. Bed number can be input from 9, 0, 1 to 9, 9, 9.
For instance, to set the bed number 1, enter the 9, 0, 1 as shown below.
Note: Bed number from 9,0,1 to 9,9,9 is not pass code of service menu. Only
authorized personnel can enter the service menu.
Figure 48. Bed Number
5. Verify that the Network icon appears at the bottom of the display. Network icon reflects
the current network connectivity condition.
Table 42. Network Icon
Icon Color Description
Red Network is unavailable
Green Network is available
Setting Network
Wired Connection
To connect the monitor to the LAN (Local Area Network) using a wired connection, plug a
LAN cable into the external communication port on the rear panel of the monitor. See
Figure 2.
Wireless Connection
The monitor can connect to a network using a wireless network (Wi-Fi or 3G). The
wireless connection can only be set by authorized personnel via the Service Menu.
Cable Connection
RJ11 Nurse Call Interface
The Pin layouts of 6-pin Nurse call interface are illustrated below.
1 2 3 4 5 6
Figure 49. Nurse Call Interface Pin Layout
114
Table 43. Nurse Call Interface Connections
Pin # Signal
1 Nurse call normally closed
2 Nurse call common
3 Nurse call normally open
4 12V
5 NC
6 GND
Nurse Call Interface

CAUTION: The nurse call feature is not functional whenever the monitor alarms are
paused.
CAUTION: The nurse call function needs to be tested after it has been set up in
your facility. The nurse call feature should be tested whenever setting up the M30 in
a location that uses nurse call. One way to test the nurse call function is to create
an alarm condition (for example, sensor disconnect) and verify that your facility’s
nurse call system is activated.
The nurse call feature of the monitor is operational when the monitor is powered by AC
power or battery power. The nurse call feature of the monitor works in conjunction with the
nurse call system of your institution when the monitor sounds an audible alarm.
The monitor provides the nurse call interface of relay closure type. The interface functions
when the monitor is operating either on AC power or battery power.
The remote location is signaled anytime there is an alarm audio. If the alarm audio has
been turned off or paused, the nurse call function is also turned off.
Nurse Call Relays Normally Open/Closed
Pins 2 and 3 provide a relay that closes when an alarm is sounding on the monitor. Pins 1
and 2 provide a relay that opens when an alarm is sounding. Pin 2 is a common lead for
both relays.
Central System Communication
All vital signs are transmitted by using wireless network (Wi-Fi or 3G) to the medical
person in the hospital. All vital sign can be transmitted in real-time.
Note: The details are provided in the central system. Please contact the representative of
Mediana for more information.
115
116
MAINTENANCE
WARNING: The cover should be removed only by qualified service personnel.

There are no internal user-serviceable parts except for the battery.
WARNING: Do not spray, pour, or spill any liquid on the monitor, its accessories,
connectors, switches or openings in the chassis.
WARNING: Unplug the power cord from the monitor before cleaning the monitor.
Recycling and Disposal

When the 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 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 monitor.
Returning the Monitor and System Components

Pack the 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 monitor during shipping.
Service
The 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 monitor service manual. Qualified service personnel in the user’s institution should
perform periodic inspections of the 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.
117
Cleaning
The 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 monitor.
 70% Isopropyl alcohol

 10% Chlorine bleach solution
For cables, sensors, cuffs, and probes, follow the cleaning instructions in the directions
for use shipped with those components.
Avoid spilling liquid on the monitor, especially in connector areas. If liquid is accidentally
spilled on the monitor, clean and dry thoroughly before reuse. If in doubt about monitor
safety, refer the unit to qualified service personnel for checking.
Battery Maintenance
CAUTION: Recharging the battery is strongly recommended when the battery has
not been recharged for 2 or more months.
CAUTION: Follow local government ordinances and recycling instructions

regarding disposal or recycling of device components, including battery.
CAUTION: 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.
CAUTION: Do not solder the battery directly. Heat applied during soldering may
damage the safety vent in the battery’s positive cover.
CAUTION: Do not deform the battery by applying pressure. Do not throw, hit, drop,
fold or impact the battery.
CAUTION: 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.
CAUTION: Do not use any chargers not specified by Mediana.
CAUTION: 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.
CAUTION: Do not mistreat the battery, or use the battery in applications not
recommended by Mediana.
CAUTION: Keep the battery out of reach of babies and children to avoid any
accidents.
CAUTION: If there are any problems with the battery, immediately put the battery in
a safe place and contact qualified service personnel.
118
If the monitor has not been used for 2 months, the Li-ion battery will need charging. To
charge the battery, connect the monitor to an AC power source as described in the
Battery Operation section.
Note: Storing the monitor for a long period without charging the battery may degrade the
battery capacity. A full charge of a depleted battery takes over 4, 8 or 12 hours.
Note: The service menu displays the number of deep discharge cycles seen by the
battery. The monitor records a deep discharge cycle when the battery reaches the
voltage at which a “Critically low battery” alarm is issued. Refer to the service
manual for details.
Note: The battery should be removed from the monitor if placed in storage or if it will not
be used for a long period.
It is recommended that the monitor’s Li-ion battery be replaced every 6 months. Refer to
the service manual for battery replacement and general service instructions.
119
Loading Printer Paper
CAUTION: Use only printer paper specified by Mediana.
Note: The paper roll is easier to load if it is held horizontally with your thumb on top and
your forefinger and/or index finger underneath it.
Load printer paper as follows:
1. Open the printer door by pulling the latch on the printer slightly and carefully. The door
should tilt open. Gently pull the door open if necessary.
2. Reach in and remove the empty paper core by pulling it over gently with your thumb
and index finger.
3. Insert a new paper roll oriented properly.
4. Pull the paper out towards you until approximately 2 inches (5 cm) of paper have been
unrolled.
5. Align the paper with the pinch roller attached to the printer door.
6. Close the printer door.
Note: To make sure that the paper is aligned in the slot and has not been pinched in the
door, pull the loose edge until a few inches of paper is showing. If the paper will not
move, open the door and return to step 4.
Figure 50. Printer Paper Replacement
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TROUBLESHOOTING
WARNING: If you are uncertain about the accuracy of any measurement, check
the patient’s vital signs by alternate means; then make sure the monitor is
functioning correctly.
WARNING: The cover should be removed only by qualified service personnel.
There are no user-serviceable parts inside except for the battery.
General
If the monitor detects an error, it can display an error code. The error codes are listed in
the monitor service manual. If an error code is displayed, write down the code and contact
your service department. Before calling your local supplier, make sure that the battery is
charged and that all power connections are in place.
Corrective Action
If you experience a problem while using the monitor and are unable to correct it, contact
qualified service personnel or your local supplier. The service manual provides additional
troubleshooting information for qualified personnel.
Following is a list of possible errors and suggestions for corrective action.
Error Corrective Action

No response Press the Power On/Off button.
to Power Check the battery installation or AC connection.
Button press. Check the battery charging indicator is lit.
If the error continues, contact a qualified service technician.
Monitor does Check the battery installation.
not power on Check the battery charging indicator is lit.
with battery. Recharge the battery for 12 hours or if it persists, replace the battery.
Low Battery / Connect the monitor to AC power source and verify the Battery
Critically Low- Charging Indicator.
Battery Replace the battery with new battery.
condition. If the error continues, contact a qualified service technician.
Display is Contact a qualified service technician.
deformed or
not displayed.
No sound Verify the volume setting is loud enough to hear.
generation. Verify the alarm audio is not paused.
Date and Time Set the date and time from the Date and Time menu.
incorrect. Turn off the monitor and a few minutes later, turn on the monitor.
Verify the data and time.
Abnormally Contact a qualified service technician.
shut down last
time message.
Technical Do not use the monitoring system; Contact Technical Services or a
System Error qualified service technician.
(ex. EEE801~)
ound like Press the Power button for more than 15 second.
121
buzzer is Contact Technical Services or a qualified service technician.
heard and the
monitor cannot
be turned off.
Poor ECG Check that the patient is not shivering.
signal quality Check the electrode quality and positioning
(noisy trace, If necessary, prepare the patient’s skin and apply new electrodes.
wandering Check the connection between ECG cable and lead wire.
baseline, etc.) Set the ECG Filter mode to Filter.
or no QRS is Pre-gelled electrodes are recommended.
detected. Do not place them on body hair, bones close to skin, and layers of fat
and major muscles.
Relocate or turn off equipment that may be causing RFI.
Change the ECG lead.
ECG Lead off Check the electrode quality and positioning.
Check the connection between ECG cable and lead wire.
Faulty of SpO2 Check perfusion at the measurement site.
Loss of pulse Check that the sensor is applied properly.
error Make sure the sensor site has a pulse.
Relocate the sensor to another site with improved circulation.
If the message occurs due to NBP measurement on the same limb,
wait until the NBP measurement is finished.
Try another sensor.
The SpO2 Check the connection between sensor and sensor cable.
waveform is Check the damages of sensor and sensor cable.
not displayed. Try another sensor.
SpO2 signal is Check the sensor and sensor positioning.
poor: Check that skin pigment causes differences.
Make sure that the patient is not moving.
Check the damages of sensor and sensor cable.
Make sure the sensor cable is not positioned too close to power
cables.
The pump Check the Patient mode (adult or pediatric or neonatal)
operates, but Check the NIBP Hose and cuff connections, if needed.
the cuff does Replace the cuff.
not inflate or
fails to inflate
fully.
NIBP Use the correct cuff size.
measurements Check the NIBP cuff positioning.
appear The patient should not talk and not move during the BP
high/low. measurements.
NIBP Check that cuff hose are not bent, stretched, compressed or loose.
Measurement Prevent motion artifacts.
does not work Use the correct cuff size.
Temperature Check the setting of temperature unit.
measurement Check that you are using the correct probe.
does not work Check the damages of probe.
and Try another probe.
measurement If the error continues, contact a qualified service technician.
values are in
doubt.
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Impedance Set the Respiration to On from Repiration menu
respiration Select appropriate gain from the Respiration menu.
measurement Check the electrode quality and positioning.
does not work Remove other electrical devices from the vicinity of the respiration
and measurement as they may cause interference.
measurement
values are in
doubt.
Printer Paper Reload paper or clear jam. If paper is wet, replace with fresh, dry roll.
won’t move. Use only recommended paper type.
Paper moves Check door latch.
then stops. Replace the battery with new battery.
If the battery is low, connect the monitor to an AC power source.
Reload paper or clear jam.
123
EMI (Electromagnetic Interference)
WARNING: Keep patients under close surveillance when monitoring. It is

possible, although unlikely, that radiated electromagnetic signals from sources
external to the patient and monitor can cause inaccurate measurement readings.
Do not rely entirely on the monitor readings for patient assessment.
WARNING: It is possible that any radio frequency transmitting equipment and
other nearby sources of electrical noise may result in disruption in the monitor
operation.
WARNING: It is possible, although unlikely, that large equipment using a
switching relay for its power on/off may affect monitor operation. Do not operate
the monitor in such environments.
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 monitor operation.
WARNING: The 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 monitor may not seem to operate
correctly.
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 monitor generates, uses, and can radiate radio frequency energy. If the monitor is
not installed and used in accordance with these instructions, the monitor may cause
harmful interference with other devices in the vicinity.
If assistance is required, contact your local supplier.
Obtaining Technical Assistance

For technical information and assistance, or to order a monitor service manual, call your
local supplier. The service manual provides information required by qualified service
personnel when servicing the monitor.
When calling your local supplier, you may be asked to provide the software version
number of your monitor. The software version is displayed when monitor power is
activated.
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FACTORY DEFAULTS
General
The 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 44. Parameter Ranges and Factory Defaults
Factory Defaults
Parameter Ranges/Selections
ECG
ECG Lead Select I, II, III, aVR, aVL, aVF, V(Chest Lead) Lead II Lead II Lead II
ECG Size (mm/mV) Auto, 1.25, 1.7, 2.5, 5.0, 7.5, 10.0, 15.0,
10.0 mm/mV 10.0 mm/mV 10.0 mm/mV
20.0 mm/mV
ECG Filter Mode Monitor, Low Extend, Filter Monitor Monitor Monitor
ECG Pacer Detect On, Off Off Off Off
ECG Sweep Speed 12.5, 25.0, 50.0 mm/s 25.0 mm/s 25.0 mm/s 25.0 mm/s
HR/PR Source AUTO, ECG, SpO2, NIBP AUTO AUTO AUTO
Limit alarm audio off On, Off Off Off Off
HR/PR Upper Alarm Limits 25 to 300 BPM (Adult/Pedi/Neo)
120 BPM 160 BPM 200 BPM
(5 BPM steps)
HR/PR Lower Alarm Limits 20 to 295 BPM (Adult/Pedi/Neo)
50 BPM 75 BPM 100 BPM
(5 BPM steps)
NIBP
Automatic Mode Interval Off, 1, 2.5, 3, 5, 10, 15, 30, 60, 90 min Off Off Off
NIBP Initial Cuff Inflation Smart, 120, 140, 160, 180, 200, 220,
240, 260, 280 mmHg (Adult/Pediatric)
(16.0, 18.7, 21.3, 24.0, 26.7, 29.3, 32.0,
34.7, 37.3 kPa) 180 mmHg 180 mmHg 120 mmHg
80, 90, 100, 110, 120, 130, 140 mmHg 24.0 kPa 24.0 kPa 16.0 kPa
(Neonatal)
(10.7, 12.0, 13.3, 14.7, 16.0, 17.3, 18.7
kPa)
NIBP SYS Upper Alarm 35 to 270 mmHg (Adult/Pediatric)
Limits 4.6 to 36.0 kPa (Adult/ Pediatric)
160 mmHg 120 mmHg 90 mmHg
45 to 130 mmHg (Neonatal)
21.3 kPa 16.0 kPa 12.0 kPa
6.0 to 17.3 kPa (Neonatal)
(5 mmHg / 0.6 or 0.7 kPa steps)
NIBP SYS Lower Alarm 30 to 265 mmHg (Adult/Pediatric)
Limits 4.0 to 35.3 kPa (Adult/Pediatric)
12.0 kPa 9.3 kPa 5.3 kPa
NIBP DIA Upper Alarm Limits 15 to 250 mmHg (Adult/Pediatric)
2.0 to 33.3 kPa (Adult/Pediatric)
12.0 kPa 9.3 kPa 8.0 kPa
3.3 to 12 kPa (Neonatal)
NIBP DIA Lower Alarm Limits 10 to 245 mmHg (Adult/Pediatric) 50 mmHg 40 mmHg 20 mmHg
1.3 to 32.6 kPa (Adult/Pediatric) 6.6 kPa 5.3 kPa 2.6 kPa
125
Factory Defaults
NIBP MAP Upper Alarm 25 to 260 mmHg (Adult/Pediatric)
14.6 kPa 12.0 kPa 9.3 kPa
NIBP MAP Lower Alarm 20 to 255 mmHg (Adult/Pediatric)
8.0 kPa 6.6 kPa 4.0 kPa
SpO2
C-Lock On, Off Off Off Off
%SpO2 Upper Alarm Limits 21 to 100 % (Adult/Pedi/Neo) (1 % steps) 100 % 100 % 100 %
%SpO2 Lower Alarm Limits 20 to 99 % (Adult/Pedi/Neo) (1 % steps) 90 % 90 % 85 %
Respiration
Respiration On, Off On On On
Respiration source AUTO, AW, IM AUTO AUTO AUTO
RR Upper Alarm Limits 4 to 120 BPM (1 BPM steps) 30 BPM 30 BPM 100 BPM
RR Lower Alarm Limits 3 to 119 BPM (1 BPM steps) 8 BPM 8 BPM 30 BPM
Temperature
Temp Upper Alarm Limits 0.1 ~ 50.0°C (Adult/Pedi/Neo)
(0.1º C steps) 39.0 °C 39.0 °C 39.0 °C
32.2 ~ 122.0°F (Adult/Pedi/Neo) (102.2 °F) (102.2 °F) (102.2 º F)
(0.1°F or 0.2°F steps)
Temp Lower Alarm Limits 0.0 ~ 49.9°C (Adult/Pedi/Neo)
(0.1º C steps) 36.0 °C 36.0 °C 36.0 °C
32.0 ~ 121.8°F (Adult/Pedi/Neo) (96.8 °F) (96.8 °F) (96.8 °F)
(0.1°F or 0.2°F steps)
EtCO2
APNEA Alarm Off, 15, 20, 25, 30, 35, 40 sec, 20 sec 20 sec 20 sec
Zero Calibration Yes, No No No No
EtCO2 Upper Alarm Limits 1 to 80 mmHg (Adult/Pedi/Neo)
(1 mmHg steps)
0.13 to 10.7 kPa (Adult/Pedi/Neo)
10.7 kPa 10.7 kPa 10.7 kPa
(0.13 kPa steps)
10.5 % 10.5 % 10.5 %
0.13 to 10.5 % (Adult/Pedi/Neo)
(0.13 % steps)
EtCO2 Lower Alarm Limits 0 to 79 mmHg (Adult/Pedi/Neo)
(1 mmHg steps)
0 to 10.5 kPa (Adult/Pedi/Neo)
0 kPa 0 kPa 0 kPa
(0.13 kPa steps)
0% 0% 0%
0 to 10.4 % (Adult/Pedi/Neo)
(0.13 % steps)
InCO2 Upper Alarm Limits 1 to 20 mmHg (Adult/Pedi/Neo) 20 mmHg 20 mmHg 20 mmHg
(1 mmHg steps) 2.7 kPa 2.7 kPa 2.7 kPa
0.13 to 2.7 kPa (Adult/Pedi/Neo) 2.6 % 2.6 % 2.6 %
126
Factory Defaults
(0.13 kPa steps)
0.13 to 2.6 % (Adult/Pedi/Neo)
(0.13 % steps)
InCO2 Lower Alarm Limits 0 to 19 mmHg (Adult/Pedi/Neo)
(1 mmHg steps)
0 to 2.5 kPa (Adult/Pedi/Neo)
0 kPa 0 kPa 0 kPa
(0.13 kPa steps)
0% 0% 0%
0 to 2.5 % (Adult/Pedi/Neo)
(0.13 % steps)
Others
Patient Mode Adult, Pediatric, Neonatal Adult
Print Speed** 25mm/s, 50mm/s 25mm/s
Print Mode** One-Shot, Continuous One-Shot
Printing Waveform1** ECG, SpO2, RESP, EtCO2, OFF OFF
Print-On-Alarm** On, Off Off
Display Time Interval 20 sec, 1, 2, 3, 5, 10, 20 min 20 sec
Normal, NIBP, Alarm, Normal + NIBP,
Trend Display Select ALL
Normal + Alarm, NIBP + Alarm, ALL
Alarm Volume 1, 2, 3, 4, 5, 6, 7, 8 5
QRS Volume Off, 1, 2, 3, 4, 5, 6, 7 4
Key Beep Volume Off, 1, 2, 3, 4, 5, 6, 7 4
Trend Data Download Start, Cancel Start
Temp Unit* °C, °F °C
EtCO2 Unit* mmHg, kPa, % mmHg
Save Settings On Power Off* Custom, Back up, Default Default
Alarm Audio Off Period* Off, 1, 3, 5, 10, 20, 30, 60 min, Indefinite Indefinite
Alarm Audio Paused Period* 30, 60, 90, 120 sec 60 sec
Alarm Reminder Tone* Off, 3, 10 min 3 min
GN924, IEC60601-1-8 HI, IEC60601-1-8
Audible Alarm Type* IEC60601-1-8 LOW
LOW
한국어 (Korean), 中文 (Chinese),
English, Français (French), Deutsch
(German), Italiano (Italian), 日本語
(Japanese), Português (Portuguese),
Language* Dansk (Danish), Nederlands (Dutch), English
Suomi (Finnish), Ελληνικά (Greek), Norsk
(Norwegian), Polski (Polish), Русский
(Russian), Castellano (Spanish), Svenska
(Swedish), Türkçe (Turkish)
Year/Month/Day, Month/Day/Year,
Date Format* Year/Month/Day
Day/Month/Year
3G* On, Off Off
Authentication Protocol* None, PAP, CHAP None
WIFI* On, Off Off
Protocol Mode* SMC, CMS CMS
Security Type* Disable, Open, WEP, WPA-Psk, WPA2-
Disable
Psk, WPA-EAP/WPA2-EAP
EAP Outer Authentication* EAP-FAST, EAP-FLS, EAP-TTLS, EAP-
EAP-FAST
PEAP
EAP Inner Authentication* EAP-MSCHAP, EAP_GTC EAP-MSCHAP
Baud Rates* 19200, 38400
19200
57600, 115200
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 monitor.
127
128
SPECIFICATION
Display
Screen Size 8.5” measured diagonally across the TFT-LCD screen
Screen Type/Color Liquid Crystal Display (LCD) Color
Resolution 800 × 480 pixel
Number of Traces 3 waveforms
Controls
Knob control;
Standard 5 buttons (Alarm Stop, NIBP Start/Stop, Home, Print,
Power)
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 3sec
System Delay
Physical Characteristics and Printer
Instrument
Dimensions 250 × 210 × 170 (mm) (W×H×D)
including a handle and excluding options and accessories
Weight Approx. 3.2 kg excluding optional configurations
and accessories
Degree of Protection ECG: Type CF with defibrillator protection
against Electric NIBP: Type CF with defibrillator protection
Shock SpO2: Type CF with defibrillator protection
Temperature: Type CF with defibrillator protection
EtCO2: Type CF with defibrillator protection
Mode of Operation Continuous
Liquid ingress IPX1: Protection against vertically falling drops of water
Classification Class IIb (MDD Annex IX Rule10:MEDDEV 2.4/1 Rev.8)
Printer (Optional)
Type Thermal
Weight 150 g
Resolution 8 dot/mm
Number of Channels 1 to 2 channels
Paper Type Thermal
Paper Width 50 mm
Printer Speeds 25 mm/s and 50 mm/s
129
Electrical
Instrument
Power Requirements AC Mains
100 to 240V~, 50/60 Hz, 110 VA
DC Mains
14Vdc, 3.5A with DC/DC adapter, Model:MDD150-1214
(MDD150-1214: Input: 12-16Vdc, 5.2A,
Output: 14Vdc, 3.5A)
AC Mains
q’ty 2, T3.15 A, 250 volts/T5.0A, 250 volts
Fuses
DC Mains
T10.0A, 250 volts
Battery (option)
Type Li-ion battery
Operating time 1 hour (23.76 Wh), 3 hours (47.52 Wh), 5 hours (71.28 Wh)
At the following condition:
no printing
no external communication
no alarm audio
one NIBP measurement per 15 minutes at 25°C
10.8 V / 2200 mAh (1 hour type)
Voltage/Capacity 10.8 V / 4400 mAh (3 hours type)
10.8 V / 6600 mAh (5 hours type)
Recharge 4, 8 or 12 hours for depleted battery to 90% of battery
capacity and for full recharge with monitor turned on/off.
6 months, new battery fully-charged
Life Cycle After 2 months storage the M30 would run for 50% of
stated battery life.
Environmental Conditions
Operation
Temperature 5 to 40°C (41 to 104°F)
Humidity 30 to 85% RH, non-condensing
Atmospheric pressure 700 to 1060 hPa
Transport and Storage (in shipping container)
Temperature −20°C to 60°C (−4°F to 140°F)
Humidity 10 to 95% RH, non-condensing
Atmospheric pressure 500 to 1060 hPa
Note: The system may not meet its performance specifications if stored or used
outside the specified temperature and humidity range.
130
Tone Definition
High Priority Alarm Tone

Volume level Adjustable (level 1~8)
976 Hz (IEC60601-1-8, HI),
Pitch (± 5%) 540 Hz (IEC60601-1-8, LOW)
976 Hz (GN924)
Pulse width (± 5%) 170 msec (IEC60601-1-8), 250 msec (GN924)
10 pulses per 4 sec, 8 sec inter burst (IEC60601-1-8)
Number of pulses
7 pulses per 2 sec (GN924)
Repetitions Continually
Medium Priority Alarm Tone
697 Hz (IEC60601-1-8, HI)
Pitch (± 5%) 480 Hz (IEC60601-1-8, LOW)
697 Hz (GN924)
3 pulses per 1 sec, 10 sec inter burst (IEC60601-1-8)
Number of pulses
2 pulses per 1 sec (GN924)
Low Priority Alarm Tone
488 Hz (IEC60601-1-8, HI)
Pitch (± 5%) 400 Hz (IEC60601-1-8, LOW)
488 Hz (GN924)
1 pulse per 1 sec, 15 sec inter burst (IEC60601-1-8)
Number of pulses
1 pulse per 1 sec, 15 sec inter burst (GN924)
Alarm Reminder Tone
Volume level Not changeable
Pitch (± 5%) 800 Hz
Pulse width (± 5%) 200 msec
Number of pulses 1 pulse per 1 second, 3 min, 10 min inter burst
HR/PR Tone
650 Hz (ECG),
Pitch (± 5%)
(162 + 5*SpO2) Hz
Number of pulses N/A
Repetitions No repeat
Key Beep
Pitch (± 5%) 440 Hz (valid),
168 Hz (invalid)
POST Pass Tone
Volume level Not changeable
Pitch (± 5%) 780 Hz
131
Measurement Parameters
ECG
Heart Rate
Measurement Range 0, 20 to 300 BPM
Accuracy ±1 BPM or ±1% whichever is greater
Average Response Time 3 seconds (from 80 to120 BPM)
4 seconds (from 80 to 40 BPM)
ECG (Electrocardiograph)
Leads 3 / 5 Lead
Lead I, II, III, aVR, aVL, aVF, V (Chest Lead)
Lead Off Detection Detected and displayed
Input
Input Impedance 5 M ohm or more
Input Dynamic Range ±5 mV AC, ±600 mV DC
Voltage Range ±0.5 mV ~ ±5 mV
Signal Width 40 to 120 ms (Q to S)
Output
Frequency Response (Bandwidth)
Low Extend 0.05 to 40 Hz
Filter 0.5 to 30 Hz
Monitor 0.5 to 40 Hz\
Hum filter 50 Hz and 60 Hz
ECG Size Auto, 1.25, 1.7, 2.5, 5.0, 7.5, 10.0, 15.0, 20.0 mm/mV
Display Sweep Speeds 12.5 mm/sec, 25.0 mm/sec, and 50.0 mm/sec
Display Sensitivity 10 mm/mV (×1)
Pacer Pulse Detection On, Off
ST Level Analysis On, Off
Arrhythmia Detection On, Off
Electrode Disconnect Display and/or sound
Alarm
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 Lead off sensing current : amp 0.03 µA
sensing, and active noise common 0.20 µA
suppression
Tall T-wave rejection Maximum T-Wave amplitude 1.4 mV
capability
Accuracy of input signal Displacement: 0.1 mV
reproduction Slope: 0.15 mV/s
132
Heart rate meter accuracy Provides correct heart rates, as follows:
and response to irregular
rhythm Ventricular bigeminy: 78 bpm
Slow alternating ventricular bigeminy: 59 ~ 65 bpm
Rapid alternating ventricular bigeminy: 115 ~ 120 bpm
Bidirectional systoles: 84 ~ 94 bpm
Time to alarm for Vent Tachycardia 1 mVpp, 131 ~ 168 bpm:
tachycardia Amplitude 0.5 mV: 13.28 sec
Amplitude 1 mV: 15.82 sec
Vent Tachycardia 2 mVpp, 63 ~ 128 bpm:

Time to alarm for cardiac Average: 4.35 sec
standstill
Time to alarm for heart rate Low heart rate: average: 3.0 sec
High heart rate: average: 4.0 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: 4V/s
rejection of fast ECG
signals
Pacer pulse detector Pacer Detect On, Off
disabling
133
Respiration
IM Respiration
Technique Impedance Pneumography
Range 0, 3 to 120 breaths/min
Accuracy ±3 breaths/min
Leads RA to LA
Display Sweep Speeds 6.25 mm/s, 12.5 mm/s, 25.0 mm/s
Lead Off Condition Detected and displayed
Display Size 10 mm/ohm (×1)
Wave Size Auto, Level 1~8
AW Respiration
Technique Nondispresive Infrared Spectroscopy
Range 0 to 150 breaths/min
Accuracy ±1 breaths/min
Display Sweep Speeds 6.25 mm/s, 12.5 mm/s, 25.0 mm/s
Wave Size Auto, Level 1~8
NIBP
Pulse Rate
Pulse Rate Range Adult/Pediatric 40 to 200 BPM
Neonatal 40 to 240 BPM
Pulse Rate Accuracy ±2 BPM or ±2%, whichever is greater
NIBP (Non-Invasive Blood Pressure)
Technique Oscillometric Measurement
Measurement Modes MANUAL, AUTO and CONT
NIBP AUTO Mode Off, 1, 2.5, 3, 5, 10, 15, 30, 60, 90 minutes
Intervals
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 ISO 81060-
2:2013
Pressure Display Range Adult/Pediatric 0 to 300 mmHg
Neonatal 0 to 150 mmHg
Pressure Display Within ±3mmHg
Accuracy
Initial Cuff Inflation Adult/Pediatric
Smart, 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)
134
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 300 ±10 mmHg for Adult
150 ± 5 mmHg for Neonatal
Measurement Speed About 20 seconds
At the following condition:
Adult
SYS 120 mmHg
MAP 95 mmHg
DIA 80 mmHg/ PR 80 BPM
Manual Measurements (180 mmHg)
SpO2
Pulse Rate
Range Nellcor module: 20 to 300 BPM
Mediana module: 30 to 300 BPM
Accuracy Nellcor module: 20 to 250 beats per minute (bpm)
±3 digits
Mediana module: ±2% or 2BPM, whichever is greater
SpO2
Range Nellcor module: 1 to 100 %
Mediana module: 0 to 99 %
Low Perfusion 0.03 to 20 %
(Nellcor module only)
Accuracy Nellcor module:
Without Interference-Adult/Pediatric
70 to 100 % ±2 digits
1 to 69 % unspecified
Without Interference-Neonatal
70 to 100 % ±3 digits
Low Perfusion 70 to 100 % ±2 digits
Mediana module:
Adult/Pediatric/Neonatal
70 to 99 % ±2 digits
Display Sweep Speeds 12.5 mm/sec, 25.0 mm/sec and 50.0 mm/sec
Neonatal specifications are shown for neonatal sensors with the monitor. Saturation accuracy
will vary by sensor type as specified by the manufacturer.
Note: The wavelength range of the light emitted are near 660 nm and 890 nm with the energy
not exceeding 15mW.
Note: SpO2 saturation accuracy - Monitoring system measurements are statistically distributed;
about two-thirds of monitoring system 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.
135
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 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 O2

and N2O is correctly selected for actual fractional gas
constituents present.
Warm Up Time 2 minutes maximum
Sweep Speeds 6.25mm/sec, 12.5 mm/sec and 25.0 mm/sec
Sampling rate 100Hz
Sound Noise Level Less than 41dB when ambient sound pressure level is
22dB
Temperature
Thermistor Temp
Probe Type Thermistor probe YSI 400 series and 700 series
Measurement Method Thermistor
Range 0.0 to 50°C (32.0 to 122°F)
Display Accuracy ±0.1°C
Probe Accuracy YSI 400 series: ±0.1°C
YSI 700 series: ±0.2°C
Operating Mode Direct
136
Trends
Types Graphical and Tabular
Memory saves total 20,480 data
saves date and time
saves alarm condition
saves HR/PR data (Heart Rate, Pulse Rate from SpO2
and NIBP)
saves NIBP, SpO2, Resp, Temp, EtCO2 measurements
Graphical Format Total 2 graphs
 A graph for HR/PR, Resp, SpO2, parameters
 A graph for NIBP, Temp, EtCO2 parameters
User-selectable each parameter to be desired
Tabular Format One table for all parameters
Display 10 lists
Display Time Interval 20 sec, 1, 2, 3, 5, 10, 20 minutes
137
Compliance
Item Standard Description
Classification IEC60601-1:2005, Class I (on AC power)
EN60601- Internally powered (on battery power)
1:2006/AC:2010
Type of protection IEC60601-1:2005, Type CF – Applied part
EN60601-
1:2006/AC:2010
Mode of operation IEC60601-1:2005, Continuous
EN60601-
1:2006/AC:2010
Degree of protection IEC60529:1989 IPX1 (provided by enclosures)
+A1:1999,
EN60529:1991
+A1:2000
General 93/42/EEC as Directives for medical devices
amended by
2007/47/EC
21CFR820 Code of federal regulations
2012/19/EU Waste electrical and electronic equipment directive
(WEEE)
93/86/EEC Battery disposal directive
2006/66/EC as Battery directive
amended by
2008/103/EC
1999/5/EC Radio and Terminal Telecommunication
directive(R&TTE)
ISO13485:2003 Quality systems - Medical Devices - Requirements
/Cor1:2009, for regulating purposes
ENISO13485:2012
/AC:2012
ISO14971:2007, Risk analysis managements – medical devices
EN ISO14971:2012
IEC60601-1:2005, General requirements for safety of medical
EN60601-1:2006 electrical equipment
/AC:2010
IEC60529:1989 Degree of protection provided by enclosures (IPX1)
+A1:1999,
EN60529:1991
+A1:2000
ISO14155:2011 Clinical investigation of medical devices for human
/Cor1:2011, subjects – part 1: General requirements
EN ISO14155:2011
AAMI HE75:2009 Human factors engineering guidelines and
preferred practices for the design of medical
devices
IEC62304:2006, Medical device software - Software life-cycle
EN62304:2006 processes
/AC:2008
IEC60601-1-6:2010, Medical electrical equipment - Part 1-6: General
EN60601-1-6:2010 requirements for basic safety and essential
performance - Collateral standard: Usability
138
IEC62366:2007, Medical devices - Application of usability
EN62366:2008 engineering to Medical devices
ISO10993-1:2009 Biological evaluation of medical devices – Part 1:
/Cor1:2010, Evaluation and testing
EN ISO10993-1:2009
/AC: 2010
ISO10993-5:2009, Biological evaluation of medical devices – Part 5:
EN ISO10993-5:2009 Tests for in vitro cytotoxicity
ISO10993-10:2010 Biological evaluation of medical devices – Part 10:
EN ISO10993-10:2010 Tests for irritation and delayed-type hypersensitivity
IEC60601-2-49:2011 Particular requirements for multifunction patient
EN60601-2-49:2001 monitoring equipment
Ambulance EN1789:2007+A1:2010 Medical vehicles and their equipment - road
ambulance
EN13718-1:2008 Medical vehicles and their equipment - Air
ambulances - Part1:Requirements for medical
devices used in air ambulances
RTCA/DO-160G Environmental Conditions and Test Procedures for
Airborne Equipment
Alarms IEC60601-1-8:2006 Alarm systems requirements, tests and guidance in
+A1:2012, medical electrical equipments systems
EN60601-1-8:2007
+A1:2013
Electrocardiograph IEC60601-2-27:2011, Particular requirements for the safety of
EN60601-2-27:2006 Electrocardiographic monitoring equipment
IEC60601-2-25:2011 Particular requirements for the basic safety and
EN60601-2-25:1995 essential performance of electrocardiographs
AAMI EC53:1995 ECG cable and leads
/(R2008)
Non-invasive blood ISO81060-2:2013 Non-invasive sphygmomanometers - Part 2:
pressure Clinical validation of automated measurement type
ISO81060-1:2007 Non-invasive sphygmomanometers
EN ISO81060-1:2012
EN1060-3:1997 Supplementary requirements for electrical-
+A2:2009 mechanical blood pressure measuring systems
EN1060-4:2004 Non-invasive sphygmomanometers - Test
procedures to determine the overall system
accuracy of automated non-invasive
sphygmomanometers
IEC80601-2-30:2009 Particular requirements for the safety, including
EN80601-2-30:2010 essential performance, of automatic cycling indirect
blood pressure monitoring equipment
Oxygen saturation ISO80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular
EN ISO80601-2-61: requirements for basic safety and essential
2011 performance of pulse oximeter equipment
Temperature ISO 80601-2-56:2009 performance of clinical thermometers for body
monitoring EN ISO80601-2- temperature measurement
56:2012
Capnography ISO80601-2-55:2011, Particular requirements for the basic safety and
ENISO80601-2- essential performance of respiratory gas monitors
55:2011
Electromagnetic IEC60601-1-2:2007, Electromagnetic compatibility-requirements & test
compatibility EN60601-1-
2:2007/AC:2010
139
IEC61000-3- Harmonic emission Ed 3.2
2:2005+A1:2008
+A2:2009,
EN61000-3-2:2006
+A1:2009+A2:2009
IEC61000-3-3:2013, Voltage fluctuations/Flicker emission Ed 2.0
EN61000-3-3:2013
IEC61000-4-2:2008, Electrostatic discharge Ed 2.0
EN61000-4-2:2009
IEC61000-4-3:2006 Radiated RF electromagnetic field Ed 3.1
+A1:2007+A2:2010,
EN61000-4-3:2006
+A1:2008+A2:2010
IEC61000-4-4:2012, Electrical fast transient/burst Ed 2.0
EN61000-4-4:2012
IEC61000-4-5:2005, Surge current Ed 2.0
EN61000-4-5:2006
IEC61000-4-6:2008, Conducted disturbances, induced by RF field Ed
EN61000-4-6:2009 3.0
IEC61000-4-8:2009, Power frequency (50/60Hz) magnetic field Ed 2.0
EN61000-4-8:2010
IEC61000-4-11:2004, Voltage dips, short interruption and voltage
EN61000-4-11:2004 variation on power supply input lines Ed 2.0
CISPR11:2009 Limits and methods of measurement of radio
+A1:2010, disturbance characteristics of industrial scientific
EN55011:2009 and medical (ISM) radio-frequency equipment RF
+A1:2010 Emissions Group 1, Class B
CISPR22:2008, Information technology equipment – Radio
EN55022:2010 disturbance characteristics - Limits and methods of
measurement
Package ISTA (Procedure 2A, Pre-Shipment test procedures (Package)
2001)
Reliability IEC60068-1:2013 Environmental testing, Part1: General guidelines
EN 60068-1:1994
IEC60068-2-1:2007, Environmental testing - Part 2-1: Tests - Test A:
EN60068-2-1:2007 Cold
IEC60068-2-2:2007, Environmental testing - Part 2-2: Tests - Test B:
EN60068-2-2:2007 Dry heat
IEC60068-2-30:2005, Environmental testing - Part 2-30: Tests - Test Db:
EN60068-2-30:2005 Damp heat, cyclic (12 h + 12 h cycle)
IEC60068-2-27:2008, Environmental testing – Shock
EN60068-2-27:2009
IEC60068-2-31:2008 Environmental testing: Rough handling shocks,
EN60068-2-31::2008 primarily for equipment-type specimens
IEC60068-2-6:2007, Environmental testing – Vibration
EN60068-2-6:2008
IEC60068-2-64:2008, Environmental testing: vibration, broad-band
EN60068-2-64:2008 random (digital control) and guidance
Labeling EN1041:2008 Information supplied by the manufacturer with
medical devices
140
Marking IEC /TR60878:2003 Graphical symbols for electrical equipment in
medical practice
ISO15223-1:2012, Symbols to be used with medical device labels,
EN ISO15223-1:2012 labelling and information to be supplied -- Part1:
General requirements
ISO15223-2:2010 Symbols to be used with medical device labels,
labelling, and information to be supplied -- Part2:
Symbol development, selection and validation
ISO7000:2012 Graphical symbols for use on equipment-index and
synopsis
EN50419:2006 Marking of electrical and electronic equipment in
accordance with article II (2) of directive
2002/96/EC (WEEE)
Others With respect to electric shock, fire and mechanical hazards only in
accordance with UL60601-1 AND CAN/CSA C22.2 NO.601.1 ADDITIONAL
IEC60601-2-27, IEC60601-2-30, IEC60601-2-49
141
Manufacturer’s Declaration
accessories supplied or recommended by Mediana. Use accessories according
to the manufacturer’s directions for use and your facility’s standards. The use
of accessories, transducers, and cables other than those specified may result
in increased emission and/or decreased immunity of the M30.
The M30 is suitable for use in the specified electromagnetic environment. The
customer and/or user of the M30 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 Group 1 The M30 must emit electromagnetic energy
CISPR 11 in order to perform its intended function.
Nearby electronic equipment may be
affected.
RF emissions Class B The M30 is suitable for use in all
CISPR 11 establishments.
Harmonic emissions Class A
IEC 61000-3-2
Voltage fluctuations/flicker Complies
emission
IEC 61000-3-3
Table 46. Electromagnetic Immunity (IEC60601-1-2)
Immunity Test IEC 60601-1-2 Compliance Electromagnetic

Test Level Level Environment Guidance
Electrostatic ±6 kV contact ±6 kV contact Floor should be wood,
discharge (ESD) ±8 kV air ±8 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 ±1 kV differential ±1 kV differential Mains power quality should be
IEC 61000-4-5 mode mode that of a typical commercial
±2 kV ±2 kV and/or hospital environment
common mode common mode
Voltage dips, <5 % U T <5 % U T Mains power quality should be
short (>95 % dip in UT ) (>95 % dip in U T) that of a typical commercial
interruptions and for 0.5 cycle for 0.5 cycle and/or hospital environment. If
voltage the user of the M30 requires
variations on continued operation during
power supply power mains interruption, it is
recommended that the M30 be
powered from an
IEC 61000-4-11 40 % U T 40 % U T uninterruptible power supply or
(60 % dip in UT ) (60 % dip in U T) battery.
for 5 cycles for 5 cycles
70 % U T 70 % U T
(30 % dip in UT ) (30 % dip in UT)
for 25 cycles for 25 cycles
142
Immunity Test IEC 60601-1-2 Compliance Electromagnetic
Test Level Level Environment Guidance
<5 % U T <5 % U T
(95 % dip in UT ) (95 % dip in UT)
for 5 sec. for 5 sec.
Power 3 A/m 3 A/m It may be necessary to position
frequency the M30 further from the
(50/ 60 Hz) sources of power frequency
magnetic field magnetic fields or to install
magnetic shielding. The power
IEC 61000-4-8 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.
Table 47. Electromagnetic Immunity (IEC60601-1-2)
Immunity Test IEC 60601 Compliance Electromagnetic environment

test level level guidance
The M30 is intended for use in the electromagnetic environment specified below. The
customer or the user of the M30 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
M30 including cables, than the
recommended separation distance
calculated from the equation
appropriate to the frequency of the
transmitter.
Recommend separation distance
Conducted RF 3 Vrms 3 Vrms d = 1.2 p

IEC 61000-4-6 150 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 800 MHz
3 V/m 3 V/m d = 2.3 p 800 MHz to 2.5 GHz

800 MHz to 2.5
GHz where P is the maximum output
power rating of the transmitter in
watts (W) according to he 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 he
following symbol:
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.
143
Immunity Test IEC 60601 Compliance Electromagnetic environment
test level level guidance
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 M30 is used exceeds the applicable RF compliance level
above, the M30 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the M30.
b Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m
Table 48. Recommended Separation Distances
Recommended separation distance between

portable and mobile RF communications equipment and the M30
The M30 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the M30 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the M30 as recommended below,
according to the maximum output power of the communications equipment.
Rated Maximum Separation distance according to frequency of transmitter in
Output Power of meter
Transmitter in 150 kHz to MHz 80 MHz to 800 MHz 800 MHz to 2.5GHz
watt d = 1.2 p d = 1.2 p d = 2.3 p
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
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.
Table 49. Cables (IEC60601-1-2)
Maximum
Cables and Sensors Complies with
Length
Power Cable 1.8 m ~ 2.5 m
NIBP Hose 3.5 m -RF emissions, CISPR 11, Class B/ Group 1
Trunk Cable 2.8 m -Harmonic emissions, IEC 61000-3-2
ECG Lead Cable 1.0 m -Voltage fluctuations/flicker emission,
IEC 61000-3-3
SpO2 Cable 3.2 m
-Electrostatic discharge (ESD), IEC 61000-4-2
Finger Probe Cable 0.9 m
-Electric fast transient/burst, IEC 61000-4-4
LAN Cable 10.0 m -Surge, IEC 61000-4-5
Temperature Cable 3.0 m -Conducted RF IEC 61000-4-6
Cuff Hose 0.3 m -Radiated RF, IEC 61000-4-3
Nurse Call Cable 0.3 m
144

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OPERATOR’S MANUAL

Patient Monitor M30

Part Number: A7124-6

Copyright © 2014 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.

 The M30 conforms to the EMC standard IEC60601-1-2.

Setup Connections .............................................................................................................................. 71

Warnings are identified by the WARNING symbol shown above.

WARNING: The monitor may be used with electrical surgical equipment.

Cautions are identified by the CAUTION symbol shown above.

Caution statements identify conditions or practices that could result in damage to

CAUTION: The monitor may not operate properly if it is operated or stored at

CAUTION: Accessory equipment connected to the monitor’s data interface must be

CAUTION: Risk of explosion if battery is replaced by an incorrect type.

CAUTION: Where the integrity of the external protective conductor in the

This page is intentionally left blank.

WARNING: Patient conditions may result in erroneous readings. If the

Intended Use for the M30

Indications For Use

About This Manual

Note: 3G/Wi-Fi network is an option and is not available on all monitor.

Front Panel Components

1 Alarm indicator 6 NIBP start/stop button

Figure 1. Front Panel Components

Figure 3. Left Panel Components

Figure 4. Right Panel Components

Battery charging indicator Dust and water resistance

AC/DC power indicator Follow instructions for use

Type CF- Defibrillator proof CE mark

ECG connector Disposal instructions

Temperature connector Manufacturer

SpO2 connector Date of manufacture

EtCO2 connector Reference number

NIBP connector Serial number

Equipotential terminal Fragile-handle with care

AC power input rating This way up

DC power input rating Keep dry

CAUTION: Federal law

1 Title of waveform parameter 9 Power status area

ECG 1mV size bar Temperature icon

SpO2 waveform icon Temperature unit: Celsius

Impedance respiration Temperature unit:

EtCO2 icon Audible Alarm Active icon

HR/PR icon & unit Alarm Audio Paused icon

HR source icon: ECG Alarm Audio Off icon

Alarm Audio Off icon

PR source icon: NIBP Patient mode: Adult

ST level icon Patient mode: Pediatric

Arrhythmia icon Patient mode: Neonatal

NIBP icon Setup menu icon

NIBP or EtCO2 unit: mmHg Alarm/limits menu icon

Main screen: Big number

% SpO2 or EtCO2 unit: % Main screen: 3-ch wave screen

NIBP auto mode Interval Battery status icon

NIBP elapsed time Network status icon

Pulse amplitude indicator Time display

Respiration source: AW NIBP graphical trend icon

HR/PR, SpO2, RESP, TEMP,