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PDF Beneheart d6 Operators Manual Compress
PDF Beneheart d6 Operators Manual Compress
Defibrillator/Monitor
Operator’’s Manual
Operator Manual
© 2009-2012 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.
For this Operator’s
Operator’s Manual, the issue date is 2012-11.
I
Intellectual Property Statemen
Statementt
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property
rights to this Mindray product and this manual. This manual may refer to information protected by copyright or
patents and does not convey any license under the patent rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential informa
information.
tion. Disclosure of the information in
this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.
Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational
or editorial purposes. They are the property of their respective owners.
II
Responsibility on the Manufacturer Party
Contents of this manual are subject to change without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained
herein or for incidental or consequential damages in connection with the furnishing, performance,
performance, or use of this
manual.
Mindray is responsible for the effects on safety, reliability and performance of this product, only if:
if :
all installation operations, expansions, changes, modifications and repairs of this product are conducted by
Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable national and local
requirements;and
WARNING
This equipment must be operated by skilled/trained clinical professionals.
It is important for the hospital or organization that employs this equipment to carry out a reasonable
service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.
III
Warranty
THIS WARRANTY
WARRANTY IS EXCL
EXCLUSIVE
USIVE AND IIS
S IN LIEU OF ALL O
OTHER
THER W
WARRANTIES,
ARRANTIES, EXPRESS
EXPRESSED
ED OR IMPLI
IMPLIED,
ED, INC
INCLUDING
LUDING
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability
for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or
the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized
personnel.
Malfunction of the instrument or part whose serial number is not legible enough.
Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address: Mindray Building,Keji 12th Road South,High-tech industrial
park,Nanshan,Shenzhen 518057,P
518057,P.R.China
.R.China
Website: www.mindray.com
E-mail Address: service@mi
service@mindray.com.cn
ndray.com.cn
Te
Tel:l: +86 755 81888998
Fax: +86 755 26582680
EC-Representative:
EC-Representative: Shanghai International Holding Corp. GmbH (Europe)
IV
Preface
Manual Purpose
This manual contains
contains the instructions necessary to ope
operate
rate the product safely and in accordance
accordance with its function
function and
intended use. Observance of this manual is a prerequ
prerequisite
isite for proper product performance and correct operation and
ensures patient and operator safety.
Intended Audience
This manual is geared
geared for clinical profe
professionals
ssionals who are expected to ha
have
ve a wor
working
king knowledge of medical
medical proc
procedures,
edures,
practices and terminology as required for monitoring of critically ill patients.
Illustrations
All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on
your equipment.
Conventions
Italic text is used in this manual to quote the referenced chapte
chapters
rs or sections.
V
FOR YOUR NOTES
VI
Contents
1 Safety..................................
Safety.........................................................
.............................................
............................................
............................................
............................................
............................................
............................
......1-1
1-1
1.1 Safety Information ..........................................................................................................................
...................................................... ..................................................................................................................................
....................................................................
...... 1-1
1.1.1 Dangers ..............................................................................................................................
............................................................. ................................................................................................................................
.....................................................................
...... 1-2
1.1.2 Warnings ............................................................
.............................................................................................................................
................................................................................................................................
....................................................................
..... 1-2
1.1.3 Cautions .............................................................................................................................
.............................................................. ..............................................................................................................................
.....................................................................
...... 1-3
1.1.4 Notes .....................................................
.........................................................................................................................
...................................................................................................................................
...............................................................................
................ 1-3
1.2 Equipment Symbols ..........................................................
.................................................................................................................................
.................................................................................................................................
.......................................................... 1-4
1
3.4.4 Selecting High C
Contrast
ontrast Mode .......................................................
..........................................................................................................................
................................................................................................
............................. 3-4
3.4.5 Adjusting Waveform
Waveform P
Position...........................................................
osition..............................................................................................................................
...............................................................................................
............................ 3-4
3.5 Analog Output .........................................................
..............................................................................................................................
....................................................................................................................................
.......................................................................
........ 3-4
4 Managing Patients...........
Patients.................................
............................................
...........................................
...........................................
...............................................
...............................................
............................
...... 4-1
4.1 Overview................................................................................................................................................................................................................ 4-1
4.2 Editing Patient Information............................................................................................................................................................................. 4-1
5 Alarms.........................
Alarms...............................................
............................................
............................................
.............................................
............................................
...........................................
....................................
.............. 5-1
5.1 Alarm Categories................................................................................................................................................................................................. 5-1
5.2 Alarm Levels.......................................................................................................................................................................................................... 5-1
5.3 Alarm Indicators ............................................................................................................................
.......................................................... ......................................................................................................................................
........................................................................ 5-2
5.3.1 Alarm Lamps ........................................................
.............................................................................................................................
.................................................................................................................................
............................................................ 5-2
5.3.2 Audible Alarms..................................................................................................................................................................................... 5-2
5.3.3 Alarm Message..................................................................................................................................................................................... 5-2
5.3.4 Flashing Numeric................................................................................................................................................................................. 5-3
5.3.5 Alarm Status Symbols........................................................................................................................................................................ 5-3
5.4 Alarm Tone Configuration................................................................................................................................................................................ 5-3
5.4.1 Changing the Alarm Volume........................................................................................................................................................... 5-3
5.4.2 Setting the Interval between Alarm Sounds............................................................................................................................. 5-4
5.5 Understanding the Alarm Setup Menu....................................................................................................................................................... 5-4
5.5.1 Setting Alarm Properties for All Parameters.............................................................................................................................. 5-4
5.5.2 Adjusting Alarm Lim
Limits
its Automa
Automatically
tically .....................................................................................................................................
................................................................ .........................................................................
.... 5-5
5.6 Pausing Alarms ..........................................................
.............................................................................................................................
..................................................................................................................................
.......................................................................
........ 5-8
5.7 Switching Alarms Off ....................................................................
.........................................................................................................................................
.....................................................................................................................
................................................ 5-8
5.8 Pausing Alarm Sounds ..........................................................
.........................................................................................................................
............................................................................................................................
............................................................. 5-9
5.9 Switching Off Alarm Sounds........................................................................................................................................................................... 5-9
5.10 Reminder Tones................................................................................................................................................................................................. 5-9
5.11 Latching Alarms ........................................................
.........................................................................................................................
...............................................................................................................................
.....................................................................
.......5-10
5-10
5.12 Clearing
Clearing Te
Technical
chnical Alarms .............................................................................................................................
.......................................................... .................................................................................................................
.............................................. 5-10
5.13 When an Alarm Occurs
Occurs.....................................................
.......................................................................................................................
............................................................................................................................
.......................................................... 5-10
6 Monitoring ECG................
ECG......................................
............................................
............................................
.............................................
..............................................
.............................................
............................
...... 6-1
6.1 Overview................................................................................................................................................................................................................ 6-1
6.2 Safety....................................................................................................................................................................................................................... 6-1
6.3 Monitoring View.................................................................................................................................................................................................. 6-2
6.4 Preparing to Monitor ECG................................................................................................................................................................................ 6-2
6.4.1 ECG Monitoring with Electrodes.................................................................................................................................................... 6-2
6.4.2 ECG Monitoring with Paddles/Pads.............................................................................................................................................. 6-4
6.4.3 Checking
Checking Paced Status ..................................................
....................................................................................................................
....................................................................................................................
.................................................. 6-5
6.5 ECG Display ......................................................
.........................................................................................................................
..................................................................................................................................
..................................................................................
................... 6-5
6.6 Changing ECG Settings..................................................................................................................................................................................... 6-6
6.6.1 Change Lead Setting.......................................................................................................................................................................... 6-6
6.6.2 Changing ECG Wave Settings.......................................................................................................................................................... 6-7
6.6.3 Switching On
On or Off the N
Notch
otch Filte
Filterr ............................................................
........................................................................................................................................
................................................................................
.... 6-7
6.6.4 Adjusting Heartbeat Volume........................................................................................................................................................... 6-8
2
6.7 Arrhythmia Analysis............................................................................................................................................................................................ 6-8
6.7.1 Understanding the Arrhythmia Events........................................................................................................................................ 6-8
6.7.2 Switching Arrhythmia Analysis On and Off................................................................................................................................ 6-9
6.7.3 Changing Arrhythmia Alarm Settings.......................................................................................................................................... 6-9
6.7.4 Changing Arrhythmia Threshold Settings................................................................................................................................6-10
Settings................................................................................................................................6-10
6.7.5 Initiating Arrhythmia Relearning Manually..............................................................................................................................6-10
Manually..............................................................................................................................6-10
6.7.6 Automatic Arrhythmia Relearn.....................................................................................................................................................6-11
Relearn..................................................................................................................................................... 6-11
6.8 Calibrating ECG ............................................................
...............................................................................................................................
..................................................................................................................................
...................................................................
....6-11
6-11
8 AED ...................
.........................................
...........................................
...........................................
............................................
.............................................
..............................................
.............................................
........................
..8-1
8-1
8.1 Overview .................................................................................................................................
............................................................... ................................................................................................................................
...............................................................................
................. 8-1
8.2 Safety ..............................................................................................................................
............................................................ ................................................................................................................................
.........................................................................................
........................... 8-1
8.3 AED View................................................................................................................................................................................................................. 8-2
8.4 AED Procedure...................................................................................................................................................................................................... 8-2
8.5 Shock Advised .................................................................................................................................
............................................................... .................................................................................................................................
.....................................................................
...... 8-4
8.6 No Shock Advised (NSA) ........................................................
.........................................................................................................................
...........................................................................................................................
.......................................................... 8-4
8.7 CPR............................................................................................................................................................................................................................ 8-5
8.7.1 CPR Metronome..........................................................................
Metronome............... ...............................................................................................................................
.........................................................................................................
..................................... 8-5
8.8 AED Sound Recording .............................................................
.............................................................................................................................
..........................................................................................................................
.......................................................... 8-6
8.9 AED Setup .......................................................
.....................................................................................................................
............................................................................................................................
.........................................................................................
........................... 8-6
9 Manual Defibrillation...................
Defibrillation .........................................
............................................
...........................................
.............................................
..............................................
.......................................
.................9-1
9-1
9.1 Overview .................................................................................................................................
............................................................... ................................................................................................................................
...............................................................................
................. 9-1
3
9.2 Safety....................................................................................................................................................................................................................... 9-1
9.3 Manual Defibrillation View ............................................................................................................................
........................................................ ......................................................................................................................
.................................................. 9-3
9.4 Manual Defibrillation Proce
Procedure
dure ........................................................
............................................................................................................................
...........................................................................................................
....................................... 9-3
9.4.1 Using Pediatric Paddles..................................................................................................................................................................... 9-5
9.4.2 Using Internal Paddles....................................................................................................................................................................... 9-5
9.5 Synchronize
Synchronized
d Ca
Cardiover
rdioversion
sion ......................................................................................................................................
................................................................... ........................................................................................................
..................................... 9-6
9.5.1 Performing Synchronized
Synchronized Cardio
Cardioversion....................................................
version.....................................................................................................................
................................................................................
............... 9-7
9.5.2 Delivering Additional S
Synchronize
ynchronized
d Shocks ............................................................
.............................................................................................................................
................................................................. 9-7
9.5.3 Disabling the Sync Function............................................................................................................................................................ 9-7
9.6 Remote
Remote Sync
Synchronized
hronized Cardiove
Cardioversion
rsion .........................................................
.............................................................................................................................
.................................................................................................
............................. 9-8
9.7 Contact Impedance Indicator......................................................................................................................................................................... 9-9
10 Noninvasiv
Noninvasive
e Pacing ...................
..........................................
.............................................
............................................
...........................................
............................................
......................................
............... 10-1
10.1 Overview............................................................................................................................................................................................................10-1
Overview............................................................................................................................................................................................................ 10-1
10.2 Safety .......................................................
........................................................................................................................
................................................................................................................................
..........................................................................................
........................... 10-1
10.3 Pacing View.......................................................................................................................................................................................................10-2
View....................................................................................................................................................................................................... 10-2
10.4 Demand Mode ve
versus
rsus Fix
Fixed
ed Mode ..................................................
.....................................................................................................................
........................................................................................................
..................................... 10-3
10.5 Preparing
Preparing for Pacing...............
Pacing...................................................................................
....................................................................................................................................
...................................................................................................
................................... 10-3
10.5.1 Demand Mode Pacing...................................................................................................................................................................10-4
Pacing................................................................................................................................................................... 10-4
10.5.2 Fixed
Fixed Mode Pacing .........................................................................................................................
........................................................ .................................................................................................................
................................................ 10-5
12 Monitoring PR......................................
PR.............................................................
.............................................
............................................
.............................................
.............................................
..........................
.... 12-1
12.1 Overview............................................................................................................................................................................................................12-1
Overview............................................................................................................................................................................................................ 12-1
12.2 Entering the PR Setup................................................................................................................................................................................... 12-1
12.3 Setting the PR Source....................................................................................................................................................................................12-1
Source.................................................................................................................................................................................... 12-1
12.4 Adjusting Pulse Tone
Tone Volume...............................................
Volume.....................................................................................................................
......................................................................................................................
................................................ 12-1
4
13.6 SpO2 Desat Alarm............................................................................................................................................................................................13-5
Alarm............................................................................................................................................................................................13-5
13.7 Pitch Tone...........................................................................................................................................................................................................13-5
Tone...........................................................................................................................................................................................................13-5
13.8 Measurement Limitations............................................................................................................................................................................13-5
Limitations............................................................................................................................................................................13-5
13.9 Masimo Information
Information........................................................
..............................................................................................................................
..............................................................................................................................
........................................................13-6
13-6
13.10 Nellcor Information......................................................................................................................................................................................13-6
Information......................................................................................................................................................................................13-6
14 NIBP ...................
..........................................
.............................................
............................................
............................................
............................................
............................................
........................................
.................. 14-1
14.1 Introduction......................................................................................................................................................................................................14-1
Introduction......................................................................................................................................................................................................14-1
14.2 Safety...................................................................................................................................................................................................................14-1
Safety...................................................................................................................................................................................................................14-1
14.3 Measurement Limitations............................................................................................................................................................................14-2
Limitations............................................................................................................................................................................14-2
14.4 Measurement Modes.....................................................................................................................................................................................14-2
Modes.....................................................................................................................................................................................14-2
14.5 Measuring Proced
Procedure
ure ..........................................................
............................................................................................................................
..........................................................................................................................
........................................................14-2
14-2
14.5.1 Preparing for NIBP Measurement..............................................................................................................................................14-2
Measurement..............................................................................................................................................14-2
14.5.2 Starting and Stopping NIBP Measurements..........................................................................................................................
Measurements..........................................................................................................................14-2
14-2
14.5.3 Correcting the Measurement......................................................................................................................................................14-3
Measurement......................................................................................................................................................14-3
14.5.4 Enabling NIBP Auto Cycling.........................................................................................................................................................14-3
Cycling......................................................................................................................................................... 14-3
14.5.5 Starting a STAT Measurement.....................................................................................................................................................14-3
Measurement.....................................................................................................................................................14-3
14.6 Understanding
Understanding the NI
NIBP
BP Num
Numerics
erics ........................................................
........................................................................................................................
..................................................................................................
..................................14-3
14-3
14.7 Setting Initial Cuff Inflation P
Pressure
ressure ...............................................................................................................................
............................................................... ........................................................................................
........................14-4
14-4
14.8 Setting
Setting Pressure
Pressure Unit ..............................................................
.............................................................................................................................
.......................................................................................................................
........................................................14-4
14-4
15 Temp .......................
.............................................
............................................
............................................
.............................................
............................................
...........................................
....................................
.............. 15-1
15.1 Introduction......................................................................................................................................................................................................15-1
Introduction......................................................................................................................................................................................................15-1
15.2 Understanding
Understanding the Temp
Temp Display
Display......................................................
..........................................................................................................................
.......................................................................................................
...................................15-1
15-1
15.3 Making a Temp Measurement....................................................................................................................................................................15-2
Measurement....................................................................................................................................................................15-2
15.4 Setting the Temperature Unit.....................................................................................................................................................................15-2
Unit.....................................................................................................................................................................15-2
16 Monitoring IBP.......................
IBP.............................................
............................................
............................................
..............................................
..............................................
........................................
.................. 16-1
16.1 Introduction......................................................................................................................................................................................................16-1
Introduction......................................................................................................................................................................................................16-1
16.2 Safety...................................................................................................................................................................................................................16-1
Safety...................................................................................................................................................................................................................16-1
16.3 Zeroing IBP Transducer.................................................................................................................................................................................16-1
Transducer.................................................................................................................................................................................16-1
16.4 Making an IBP Measurement......................................................................................................................................................................16-2
Measurement......................................................................................................................................................................16-2
16.5 Understanding the IBP Display..................................................................................................................................................................16-3
Display..................................................................................................................................................................16-3
16.6 Changing IBP Settings...................................................................................................................................................................................16-4
Settings...................................................................................................................................................................................16-4
16.6.1 Changing a Pre
Pressure
ssure fo
forr Monitoring
Monitoring.......................................................................
.....................................................................................................................................
.................................................................
...16-4
16-4
16.6.2 Changing IBP Wave Settings ...................................................
.....................................................................................................................
....................................................................................................
..................................16-4
16-4
16.6.3 Setting Pressure Unit......................................................................................................................................................................
Unit......................................................................................................................................................................16-4
16-4
16.6.4 Setting IBP Filter...............................................................................................................................................................................16-4
Filter...............................................................................................................................................................................16-4
5
17.4.1 Accessing CO2 Setup Menu.........................................................................................................................................................
Menu.........................................................................................................................................................17-3
17-3
17.4.2 Changing
Changing Ope
Operating
rating Mode ...........................................................
..............................................................................................................................
..............................................................................................
........................... 17-3
17.4.3 Selecting Gas Compensations....................................................................................................................................................17-3
Compensations.................................................................................................................................................... 17-3
17.4.4 Setting Humidity Compensatio
Compensation
n ...................................................................................................................
..................................................... .........................................................................................
........................... 17-4
17.4.5 Choosing a Time Interval ffor
or Peak
Peak-Picking
-Picking ...........................................................
............................................................................................................................
................................................................. 17-4
17.4.6 Setting the Apne
Apnea
a Alarm Delay .....................................................
......................................................................................................................
............................................................................................
........................... 17-4
17.4.7 Changing CO2 Wave Settings......................................................................................................................................................17-4
Settings...................................................................................................................................................... 17-4
17.4.8 Setting the Auto Standby Time.................................................................................................................................................. 17-4
17.4.9 Setting
Setting Pressure
Pressure Unit .......................................................
.....................................................................................................................
..............................................................................................................
................................................ 17-5
17.5 Barometric
Barometric Pr
Pressure
essure C
Compensation....
ompensation..................................................................
...................................................................................................................................
......................................................................................
.................17-5
17-5
17.6 Measuremen
Measurementt Limitations ...........................................................................................................................
......................................................... ..................................................................................................................
................................................ 17-5
17.7 Troubleshooting the Sidestream CO2 Sampling System..................................................................................................................17-5
System.................................................................................................................. 17-5
17.8 Removing the Exhaust Gases from the System................................................................................................................................... 17-5
17.9 Zeroing
Zeroing the Transducer
Transducer ......................................................................................................................
...................................................... ..........................................................................................................................
.......................................................... 17-6
17.10 Calibrating
Calibrating tthe
he Transdu
Transducer
cer .....................................................
.......................................................................................................................
..................................................................................................................
................................................ 17-6
17.11 Oridion Information..............
Information.................................................................................
...................................................................................................................................
...................................................................................................
................................... 17-6
18 Marking Events
Events...................
.........................................
.............................................
.............................................
............................................
...........................................
............................................
....................... 18-1
19 Freezing Wav
Waveforms
eforms...................
........................................
...........................................
............................................
............................................
.............................................
......................................
............... 19-1
19.1 Freezing
Freezing Wavef
Waveforms
orms ........................................................
...........................................................................................................................
..............................................................................................................................
........................................................... 19-1
19.2 Reviewing Frozen Waveforms....................................................................................................................................................................19-1
Waveforms.................................................................................................................................................................... 19-1
19.3 Unfreezin
Unfreezing
g Wavef
Waveforms
orms ..............................................................
.................................................................................................................................
...................................................................................................................
................................................ 19-2
19.4 Recording
Recording Fro
Frozen
zen W
Waveforms
aveforms ..............................................................
..............................................................................................................................
......................................................................................................
...................................... 19-2
20 Review ...................
........................................
...........................................
............................................
...........................................
............................................
..............................................
......................................
............... 20-1
20.1 Reviewing Events............................................................................................................................................................................................ 20-1
20.2 Reviewing Tabular Trends............................................................................................................................................................................20-2
Trends............................................................................................................................................................................ 20-2
20.3 Reviewing 12-Lead Reports........................................................................................................................................................................20-2
Reports........................................................................................................................................................................ 20-2
21 Data Management....................................
Management..........................................................
............................................
...........................................
............................................
..............................................
....................... 21-1
21.1 Introduction......................................................................................................................................................................................................21-1
Introduction...................................................................................................................................................................................................... 21-1
21.2 Reviewing
Reviewing Patient Events ..........................................................
............................................................................................................................
..................................................................................................................
................................................ 21-2
21.3 Exporting Data.................................................................................................................................................................................................21-2
Data................................................................................................................................................................................................. 21-2
22 Recording
Recording....................
..........................................
...........................................
...........................................
............................................
..............................................
..............................................
..............................
........ 22-1
22.1 Using a Recorder.............................................................................................................................................................................................22-1
Recorder............................................................................................................................................................................................. 22-1
22.2 Recording Types..............................................................................................................................................................................................22-1
Types.............................................................................................................................................................................................. 22-1
22.3 Starting and Stopping Recordings...........................................................................................................................................................22-1
Recordings........................................................................................................................................................... 22-1
22.4 Setting the Recorder ..........................................................
...........................................................................................................................
...........................................................................................................................
.......................................................... 22-2
22.4.1 Accessing the Record Setup Menu........................................................................................................................................... 22-2
22.4.2 Selecting Waveforms for Recording.........................................................................................................................................22-2
Recording......................................................................................................................................... 22-2
22.4.3 Setting the Realtime Reco
Recording
rding Le
Length
ngth ......................................................
............................................................................................................................
...........................................................................
.....22-2
22-2
22.4.4 Changing
Changing the Recording Speed ...........................................................
................................................................................................................................
.....................................................................................
................22-3
22-3
22.4.5 Switching Gridlines On or Off.....................................................................................................................................................22-3
Off..................................................................................................................................................... 22-3
22.5 Loading Paper..................................................................................................................................................................................................22-3
Paper.................................................................................................................................................................................................. 22-3
6
22.6 Removing Paper Jam.....................................................................................................................................................................................22-4
Jam.....................................................................................................................................................................................22-4
22.7 Cleaning the Recorder Print head.............................................................................................................................................................22-4
head.............................................................................................................................................................22-4
24 Configuration Management
Management.....................
...........................................
............................................
...........................................
.............................................
.............................................
..................... 24-1
24.1 Introduction......................................................................................................................................................................................................24-1
Introduction......................................................................................................................................................................................................24-1
24.2 Passwo
Password
rd ......................................................
.....................................................................................................................
.............................................................................................................................
.......................................................................................
.........................24-1
24-1
24.3 Accessing
Accessing Co
Configuration
nfiguration Management......
Management.....................................................................
..............................................................................................................................
.............................................................................
..............24-1
24-1
24.3.1 General Setup Menu .........................................................
.........................................................................................................................
.............................................................................................................
.............................................24-2
24-2
24.3.2 Manual Defib Setup Menu...........................................................................................................................................................24-3
Menu...........................................................................................................................................................24-3
24.3.3 AED Setup Menu ...........................................................
................................................................................................................................
..................................................................................................................
.............................................24-3
24-3
24.3.4 Pacer Setup Menu...........................................................................................................................................................................24-4
Menu...........................................................................................................................................................................24-4
24.3.5 ECG Setup Menu..............................................................................................................................................................................24-4
Menu..............................................................................................................................................................................24-4
24.3.6 12-Lead Setup Menu......................................................................................................................................................................24-6
Menu......................................................................................................................................................................24-6
24.3.7 12-Lead Transmission Setup........................................................................................................................................................24-6
Setup........................................................................................................................................................24-6
24.3.8 Resp Setup Menu ...............................................................
................................................................................................................................
.............................................................................................................
............................................24-6
24-6
24.3.9 SpO2 Setup Menu............................................................................................................................................................................24-7
Menu............................................................................................................................................................................24-7
24.3.10 PR Setup Menu .............................................................
.................................................................................................................................
.................................................................................................................
.............................................24-7
24-7
24.3.11 NIBP Setup Menu..........................................................................................................................................................................24-7
Menu..........................................................................................................................................................................24-7
24.3.12 CO2 Setup Menu............................................................................................................................................................................24-8
Menu............................................................................................................................................................................24-8
24.3.13 IBP Setup Menu ..............................................................
................................................................................................................................
...............................................................................................................
.............................................24-9
24-9
24.3.14 Te
Temp
mp Setup Menu ............................................................
...........................................................................................................................
.........................................................................................................
.......................................... 24-12
24.3.15 Waveform Setup Menu............................................................................................................................................................ 24-13
24.3.16 Alarm Setup Menu..................................................................................................................................................................... 24-13
24.3.17 Mark Event Setup Menu.......................................................................................................................................................... 24-14
24.3.18 Record Setup Menu ......................................................
........................................................................................................................
............................................................................................................
.......................................... 24-14
24.3.19 Data Management Setup Menu........................................................................................................................................... 24-15
24.3.20 User Test Setup Menu............................................................................................................................................................... 24-15
24.3.21 Network Setup............................................................................................................................................................................ 24-15
24.3.22 Others Menu................................................................................................................................................................................ 24-15
25 Batteries ....................
...........................................
.............................................
............................................
............................................
............................................
............................................
................................
.......... 25-1
25.1 Introduction......................................................................................................................................................................................................25-1
Introduction......................................................................................................................................................................................................25-1
25.2 Installing the Batteries ...................................................................
.......................................................................................................................................
...............................................................................................................
...........................................25-2
25-2
25.3 Battery Alarms..................................................................................................................................................................................................25-2
Alarms..................................................................................................................................................................................................25-2
25.3.1 No Battery Alarm .............................................................
................................................................................................................................
................................................................................................................
.............................................25-2
25-2
25.3.2 Low Battery Alarm...........................................................................................................................................................................
Alarm...........................................................................................................................................................................25-2
25-2
25.3.3 Battery Aged Alarm ..........................................................
...........................................................................................................................
..............................................................................................................
.............................................25-3
25-3
25.3.4 Battery Error Alarm ..........................................................
............................................................................................................................
...............................................................................................................
.............................................25-3
25-3
25.4 Checking the Batteries..................................................................................................................................................................................25-3
Batteries..................................................................................................................................................................................25-3
7
25.5 Charging batteries.......................................................................................................................................................................................... 25-4
25.6 Storing Batteries..............................................................................................................................................................................................25-4
Batteries.............................................................................................................................................................................................. 25-4
25.7 Recycling the Batteries....
Batteries........................................................................
..........................................................................................................................................
.........................................................................................................
................................... 25-4
28 Accessori
Accessories
es ......................
...........................................
...........................................
............................................
...........................................
..............................................
...............................................
..........................
.... 28-1
28.1 ECG Accessorie
Accessoriess .........................................................................................................................
.......................................................... .............................................................................................................................
.....................................................................
.......28-1
28-1
28.2 SpO2 Accessories.............................................................................................................................................................................................28-3
Accessories............................................................................................................................................................................................. 28-3
28.3 NIBP Accessorie
Accessoriess .....................................................
........................................................................................................................
.................................................................................................................................
.....................................................................
.......28-4
28-4
28.4 Temp Accessories............................................................................................................................................................................................ 28-5
28.5 IBP/ICP Accessories...............................................................................
Accessories................ ..................................................................................................................................
.........................................................................................................
...................................... 28-6
28.6 CO2 Accessorie
Accessoriess ........................................................
..........................................................................................................................
.................................................................................................................................
.....................................................................
......28-6
28-6
28.7 Therapy Accessories.......................................................................................................................................................................................28-7
Accessories....................................................................................................................................................................................... 28-7
28.8 Miscellaneous ...........................................................
..............................................................................................................................
.......................................................................................................................................
.................................................................... 28-8
A Specifications ......................
............................................
.............................................
.............................................
............................................
............................................
.............................................
.........................
.. A-1
A.1 General Specifications ................................................................
......................................................................................................................................
......................................................................................................................
................................................ A-1
A.2 Defibrillator Specifications.............................................................................................................................................................................. A-2
A.3 Pacer Specifications...........................................................................................................................................................................................A-5
Specifications........................................................................................................................................................................................... A-5
A.4 Monitor Specifications......................................................................................................................................................................................A-5
Specifications...................................................................................................................................................................................... A-5
A.5 Power
Power Supply Specifications ........................................................................................................................
.......................................................... .............................................................................................................
............................................... A-12
A.6 Recorder Specifications................................................................................................................................................................................. A-12
A.7 Alarm Specifications....................................................................................................................................................................................... A-13
A.8 Data
Data Management Specifications ......................................................................................................................................
................................................................ .............................................................................................
....................... A-13
A.9 Wireless Network ..............................................................
.....................................................................................................................................
...............................................................................................................................
........................................................ A-13
A.10 Environmental Specifications................................................................................................................................................................... A-14
8
B EMC....................................
EMC..........................................................
............................................
.............................................
..............................................
.............................................
............................................
...........................
..... B-1
G Device Trac
Tracking
king ......................
...........................................
...........................................
............................................
...........................................
.............................................
..............................................
........................ G-1
9
FOR YOUR NOTES
10
1 Safety
1.1 Safety Information
DANGER
Indicates an imminent hazard that, if not avoided, will result in death or serious injury.
WARNING
Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury.
CAUTION
Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or
product/property damage.
NOTE
Provides application tips or other useful information to ensure that you get the most from your product.
1-1
1.1.1 Dangers
DANGER
The equipment delivers up to 360 J of electrical energy. Unless properly used as described in these
Operating Instructions, this electrical energy may cause serious injury or death. Do not attempt to operate
this defibrillator unless thoroughly familiar with these operating instructions and the function of all
controls, indicators, connectors, and accessories.
Defibrillation current can cause operator or bystander severe injury or even death. Keep distance with the
patient or metal devices connected to the patient during defibrillation.
Do not disassemble the defibrillator. It contains no operator serviceable components and dangerous high
voltages may be present. Contact authorized service personnel for repair.
To avoid explosion hazard, do not use the equipment in the presence of oxygen-rich atmospheres,
flammable anesthetics, or other flammable agents (such as gasoline). Keep the equipment and the
operating environment dry and clean.
1.1.2 Warnings
WARNING
Before putting the system into operation, the operator must verify that the equipment, connecting cables
and accessories are in correct working order and operating condition.
Make sure the synchronous input system is applied to this equipment and the input signal is correct if
necessary.
The equipment must be connected to a properly installed power outlet with protective earth contacts
only. If the installation does not provide for a protective earth conductor, disconnect it from the power line
and operate it on smart lithium-ion batteries.
Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume
to a low level or off may result in a hazard to the patient. Remember that alarm settings should be
customized according to different patient situations and always keeping the patient under close
surveillance is the most reliable way for
f or safe patient monitoring.
Do not perform any functional check if the equipment is connected with a patient; otherwise the patient
might be shocked.
Remain attentive to the patient during applying therapy. Delay in delivering a shock may result in a
rhythm that was analyzed as shockable converting spontaneously to non-shockable and could result in
inappropriate delivery of a shock.
1-2
For the treatment of patients with implantable pacemakers, place therapy pads or paddles away from
internal pacemaker generator if possible to help prevent damage to the pacemaker.
To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard. Wrap and
secure excess cabling to reduce risk of entanglement
ent anglement or strangulation by patients or personnel.
Do not touch device connectors, recorder print head, battery connector or other live equipment if in
contact with the patient; otherwise patient injury may result.
To ensure patient safety, use only parts and accessories specified in this manual.
Package material may contaminate the environment. Properly dispose of the package material according
to applicable waste control regulations and keep it out of children’s reach.
1.1.3 Cautions
CAUTION
Use of Manual Therapy security password requires the clinician to know and remember the password.
Failure to enter correct password will prevent the delivery of manual defibrillation, synchronized
cardioversion and pacing therapy.
Magnetic and electrical fields are capable of interfering with the proper performance of the equipment.
For this reason make sure that all external devices operated in the vicinity of the equipment comply with
the relevant EMC requirements. Mobile phones, X-ray equipment or MRI devices are a possible source of
interference as they may emit higher levels of electromagnetic radiation.
Before connecting the equipment to the power line, check that the voltage and frequency ratings of the
power line are the same as
a s those indicated on the equipment’s label or in this manual.
Always install or carry the equipment properly to avoid damage caused by drop, impact, strong vibration
or other mechanical force.
1.1.4 Notes
NOTE
Put the equipment in a location where you can easily see the
t he screen and access the operating controls.
Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed.
If the equipment is run on a DC power supply, a DC/AC adapter we supply should be used.
This manual describes all features and options. Your equipment may not have all of them.
1-3
1.2 Equipment Symbols
Equipotentiality
Equipotentiality Dangerous voltage
1-4
Fragile
Fragile Right side up
Manufacturer
1-5
FOR YOUR NOTES
1-6
2 The Basics
2.1 Overview
In Monitor Mode, the equipment is intended for monitoring, displaying, reviewing, storing and printing multiple
physiological parameters and waveforms including ECG, pulse oximetry (SpO 2), temperature (Temp), non-invasive
blood pressure (NIBP), invasive blood pressure (IBP) and carbon dioxide (CO 2).
In AED mode, the equipment automatically analyzes the patient’s ECG rhythm and indicates whether or not a
shockable rhythm is detected. V
Voice
oice prompts provide easy-to-follow instructions and patient information to guide
you through the defibrillation process. Messages and flashing buttons are also presented to reinforce the voice
prompts.
In the Manual Defib Mode, the operator analyzes the patient’s ECG, and, if appropriate, follows this procedure:
1 Select the Manual Defib mode, adjust the energy level if necessary;
2 Charge; and
The Pacer
Pacer Mode offe
offers
rs non-invasive transcutaneou
transcutaneouss pacing therap
therapy.
y. P
Pace
ace pulses are
are delivered
delivered through
through multifunction
electrode pads. Use of Pacer Mode may also be password protected.
The equipment
equipment can be pow
powered
ered by sm
smart
art lithium ion ba
batteries
tteries which ar
are
e recharg
rechargeable
eable and main
maintenance-free.
tenance-free. You can
easily determine the remaining battery charge by viewing the battery power gauge displayed on the screen or by
checking the indicator on the battery itself. An external AC mains or a DC power supply connected throug
through
h a DC/AC
adapter may also be used as a power source and for continuous battery charging.
charging.
The equipment
equipment can be conn
connected
ected to a CMS system th
through
rough a Wi-Fi m
module
odule and a 3G router and
and work as part of the
Pre-Hospital Emergency Information System (hereinafter called PHEIS system). With the PHEIS system, you can pass
the pre-hospital patient information to the in-hospital professional medical personnel for better diagnosis and earlier
preparation for treatments.
The equipment
equipment automatic
automatically
ally stores pat
patient
ient data in an internal stor
storage
age card
card.. Y
You
ou can also expo
export
rt the data through
through the
USB port for viewing and editing on a PC through the data management software.
2-1
2.2 Intended Use
The equipment
equipment is intende
intended
d for exte
external
rnal defibrillation, iinternal
nternal defibrillat
defibrillation,
ion, synchroniz
synchronized
ed cardiov
cardioversion
ersion and
semi-automatic
semi-automatic defibrillation (AED). It can also be used for non-invasive external pacing as well as ECG, SpO2, PR, NIBP,
CO2, IBP and Temp monitoring.
The equipment
equipment is for u
use
se in hospital and pre-hospital settings b
byy qualified m
medical
edical personne
personnell trained in the
the operation
of the equipment and qualified by training in basic life support, advanced cardiac life support or defibrillation.
2.2.1 AED
The AED mode
mode is to be used only on ccardio
ardio arre
arrest
st patients w
who
ho are at le
least
ast 8 years. The patients must be:
Unresponsive
2.2.4 ECG
The ECG monitoring fu
function
nction is used to monitor and/
and/or
or recor
record
d the patient’s ECG wa
waveform
veform and heart rate.
rate.
2.2.5 Resp
The respiration
respiration monitorin
monitoring
g function is used to continu
continuously
ously monitor the patient’s respiratio
respiration
n rate and respiration
respiration
waveform.
2.2.6 SpO2
The SpO2 function is intended to measu
measure
re patien
patient’s
t’s o
oxygen
xygen sa
saturation
turation in arterial bl ood.
2.2.7 NIBP
The NIBP function
function is intended for non-inv
non-invasive
asive measur
measurement
ement of a p
patient’
atient’ss arterial blood pr
pressure.
essure.
2-2
2.2.8 Temp
The Temperat
Temperature
ure function is ind
indicated
icated for monitoring a pa
patient’
tient’ss tempera
temperature.
ture.
2.2.9 IBP
The IBP function is intended ffor
or measuring a patient’
patient’ss arterial, venous
venous,, intracranial and other physio
physiological
logical pressu
pressures.
res.
2.2.10 CO2
The CO2 function is intended for monitoring a patient’s exhaled carbon dioxide and to provide a respiration rate.
External paddle
Handle
Area 3
Area 1
Recorder
Area 2
2-3
Area 1
3
4
6
1. Alarm lamp
2. Display screen
3. AC power indicator
4. Battery indicator
Green: when the battery is fully charged or the equipment is run on battery.
5. Service indicator
Flashing: when a failure is detected, or when battery is not installed but AC mains is connected if
[No Battery]
Battery] is configured as [Service
[Service Indicator ON],
ON], or in case of low battery when AC mains is not
connected.
6. Soft keys
2-4
Area 2
1 6
4
8
5 9
Press this button to select the lead for the first ECG waveform.
Or Event Summary button (for equipments configured without 12-lead ECG analysis function)
4. NIBP button
5. Speaker
If no menu is displayed on the screen, pressing it will enter the main menu. If there is a menu displayed, pressing
it will close that menu.
7. Navigation knob
You can:
Press it to manually mark specified events. If a menu has been open, pressing this button will close the menu.
9. Microphone
2-5
Area 3
Rotate this knob to select the operating mode or turn the equipment off.
3. Charge button
4. Shock button
2-6
Recorder
1 2
3 5
1. Start/Stop key
2. Indicator
Flashes: when an error occurred to the recorder, or the recorder runs out of paper.
3. Paper outlet
4. Recorder door
5. Latch
2-7
2.3.2 Side View
Therapy port
2-8
5
1 6
2 7
8
3
4. Gas outlet
9. CO2: sampling line connector (for microstream CO2 module) or watertrap connector (for sidestream CO2 module)
2-9
2.3.3 Rear View
6
7
2
9
3
4 5
1. Hook
2. Battery 2
3. Battery 1
It connects an AC power cord or a DC/AC adapter to run the equipment respectively on the external AC mains or
DC power supply.
When the defibrillator/monitor and other devices are to be used together, their equipotential grounding
terminals should be connected together to eliminate the potential difference between them.
6. USB connector
7. Network connector
8. Multifunctional connector
9. VGA connector
2-10
2.3.4 External Paddles
1 2 5
3
4
1. Shock button
3. Shock indicator
4. Charge button
5. Shock button
2-11
2.4 Display Views
A typical screen in Manual Defib Mode is shown below.
1 2 3 4 5
6 7
10 11 12
2-12
3 Physiological Alarm area
6. Waveform area
7. Parameter area
2-13
FOR YOUR NOTES
2-14
3 Basic Operations and Settings
3.1 Installation
WARNING
The equipment shall be installed by personnel authorized by the manufacturer.
The software copyright of the equipment is solely owned by the the manufacturer. No organization or
individual shall resort to juggling, copying, or exchanging it or to any other infringement on it in any form
or by any means without due permission.
input/output port is responsible for providing evidence that the safety certification of the devices has
been performed in accordance to the IEC 60601-1-1. If you have any question, please contact the the
manufacturer.
If it is not evident from the equipment specifications whether a particular combination is hazardous, for
example, due to summation of leakage currents, consult the manufacturers or else an expert in the field, to
ensure the necessary safety of all devices concerned will not be impaired by the proposed combination.
WARNING
Package material may contaminate the environment. Properly dispose of the package material according
to applicable waste control regulations and keep it out of children’s reach.
The equipment might be contaminated during storage and transport. Before use, please verify whether
the packages are intact, especially the packages of single use accessories. In case of any damage, do not
apply it to patients.
NOTE
Save the packing case and packaging material as they can be used if the equipment must be reshipped.
3-1
3.1.2 Environmental Requirements
The operating
operating environ
environment
ment of the equipment m
must
ust meet the requ
requirements
irements sp
specified
ecified in this manual.
manual.
The environment
environment where
where the e
equipment
quipment is use
used
d shall be re
reasonably
asonably free from noises
noises,, vibration, dust, corrosive,
corrosive,
flammable and explosive substances. If the equipment is installed in a cabinet, sufficient space in front and behind shall
be left for convenient operation, maintenance and repair. Moreover, to maintain good ventilation, the equipment shall
be at least 2 inches (5 cm) away from around the cabinet.
When the equipment is moved from one place to another, condensation may occur as a result of temperature or
humidity difference.
difference. In this case, never start the system before the condensation disappears.
NOTE
Make sure that the operating environment of the equipment meets the specific requirements. Otherwise
unexpected consequences, e.g. damage to the equipment, could result.
WARNING
Do not use the equipment for any monitoring or therapy procedure on a patient
p atient if you suspect it is not
working properly, or if it is mechanically damaged. Contact your service personnel or us.
4. Enter tthe
he appropr
appropriate
iate ope
operating
rating m
mode
ode and check tthat
hat the settings ar
are
e prope
properr for your patient.
patient.
Refer to the appropriate sections for details of how to perform patient monitoring and therapy.
3-2
3.2.3 Disconnecting from Power
To disconnect the e
equipment
quipment fr
from
om the AC power sou
source,
rce, fo
follow
llow this proc
procedure:
edure:
Other menus are similar to the main menu and contain the following parts:
1. Heading
2. Main body:
body: displays options, but
buttons,
tons, prom
prompt
pt messag
messages,
es, etc. Pressing the menu
menu button with “>>’’ enters a
submenu to reveal more options or information.
3. Exit button
required password.
3-3
You can also set system time by selecting [Configuration
[Configuration >>]
>>] → [View Config]
Config] → [General Setup >>].
>>]. However, you
cannot select date format and time format in this case. After the completion of setting system time, exit the
configuration
configuration mode, and then the system will restart.
2. Set [Brightness
Brightness]] to an appropriate level: 10 is the brightest, and 1 is the least bright.
You can also change screen brightness by entering configuration mode and selecting [[Others
Others]] from the Configuration
Main menu.
You can also change key volume by entering configuration mode and selecting [Others
[Others]] from the Configuration Main
menu.
In the Monitor, Manual Defib and Pacer mode, press the Main Menu button on the front panel, and then select
[High Contrast].
Contrast]. To disable high contrast display, select [Full
[Full Color]
Color] in the Main Menu.
Once High Contrast is selected, the system remains in high contract mode when you change the operating mode.
However, the setting will not be saved if the equipment is turned off.
2. In the [Waves
Waves]] menu, set [Wave
[Wave 2],
2], [[Wave 3] and [Wave
Wave 3] [Wave 4].
4]. Wave 1 is always ECG1, which is unchangeable.
You can also change waveform position by entering configuration mode and selecting [Waveform
[ Waveform Setup]
Setup] from the
Configuration
Configuration Main menu.
3-4
4 Managing Patients
4.1 Overview
Patient information
information management function enables you to edit and manage information of the current patient.
Archive ID is created automatically when the equipment is turned on. It is unchangeable. When the equipment is turned
off, the current patient is discharged and the archive ID turns to be historical archive ID.
For a new patient, if patient category is changed, the system will restore the default alarm settings of this patient
category; if patient category is not changed, the alarm settings remain unchanged. If you restart the equipment after
normal power-off, the default alarm settings will be loaded.
4-1
FOR YOUR NOTES
4-2
5 Alarms
Alarms, triggered
triggered by a vital sign that appears abnormal or by technical problems of the equipment, are indicated
indicated to the
user by visual and audible alarm indications.
WARNING
A potential hazard exists if different alarm presets are used for the same or similar device in any single
area, e.g. an intensive care unit or cardiac operating room.
1. Physiological alarms
3. Prompt messages
As a matter of fact, prompt messages are not alarm messages. Apart from the physiological and technical alarms,
the equipment also shows some messages indicating system status. Messages of this kind are usually displayed in
the prompt area. Therapy-related prompts are shown in correspond
corresponding
ing information area. Some special prompts are
shown in dialog boxes.
5-1
5.3 Alarm Indicators
When an alarm occurs, the equipment indicates it to the user through visual or audible alarm indications.
Alarm lamp
Alarm tones
Alarm message
Flashing numeric
NOTE
When multiple alarms of different levels occur simultaneously, the equipment will select the alarm of the
highest level and give visual and audible alarm indications accordingly. Alarm messages will be displayed
circularly.
Some physiological alarms, such as Asystole, are exclusive. They have identical alarm tones and alarm
lights with normal high level physiological alarms, but their alarm messages are displayed exclusively.
That is to say, when an exclusive physiological alarm and a normal high level physiological alarms are
triggered simultaneously, only alarm message of the exclusive physiological alarm is displayed.
5-2
Additionally,, the alarm message has different background color which matches the alarm level.
Additionally
For physiological alarms
If [[Audio
Audio Off] is enabled, alarm volume can be set to a value between 0 and 10, in which 0 means audio off
and 10 the maximum volume level.
If [[Audio
Audio Off] is disabled, alarm volume can be set to a value between 1 and 10, in which 1 is the minimum
volume level and 10 the maximum.
The setting of
of alarm volum
volume
e will not be sa
saved
ved when tthe
he system is power off
off..
Yo
You
u can also set alarm volume in configuration mode. In this case, the setting will be saved.
5-3
NOTE
You cannot adjust alarm volume when an alarm is switched off.
required password.
WARNING
Do not rely exclusively on audible alarm system. Setting alarm volume to a low level may result in a hazard
to the patient. Always keep the
th e patient under close surveillance.
5.5.1
In Setting
the main Alarm
menu, select Properties
[ Alarm
[Alarm >>] for
Setup >>] AllAlarm
[Para.
→
Parameters
>>] to enter the Para. Alarm setup menu, where you can
>>]
review and set alarm limits, alarm switches, alarm level and alarm recordings for all parameters.
When a parameter alarm is switched on, the equipment gives alarm indications in accordance with the preset
5-4
When a parame
parameter
ter ala
alarm
rm is swi
switche
tched
d off, the alarm o
off
ff symb
symbol
ol “ ” is displ
displayed
ayed iin
n the paramet
parameter
er win
window.
dow. F
For
or
NIBP and
and IBP, tthe
he alar
alarm
m off sy
symbol
mbol “ ” is displ
displayed
ayed o
only
nly whe
when
n all the NI
NIBP
BP or IB
IBP
P alarms
alarms are sswitch
witched
ed off
simultaneously.
NOTE
You cannot simultaneously switch on HR and PR alarms. In the case that PR alarm is on, switching on HR
alarm will automatically turn off PR alarm, and
a nd vice versa.
You can also set parameter alarm properties by selecting a parameter window and select [Para.
[Para. Alarm >>]
>>] in the
pop-up menu.
WARNING
Make sure that the alarm limits settings are appropriate for your patient before patient monitoring.
Setting the alarm limit to an extreme value may cause the alarm system to be ineffective. For example,
high oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a consideration,
do NOT set the SpO2 high alarm limit to 100%, which is equivalent to switching the alarm off.
When auto alarm limits have been applied, you can manually adjust the alarm limits through the Para. Alarm Setup
menu so that they are appropriate for your patient.
The defibrillator/monitor
defibrillator/monitor ccalculates
alculates the au
auto
to limits based on the follow
following
ing rules.
5-5
Low alarm limit High alarm limit Auto alarm limits
Module Parameter
Adult/pediatric Neonate Adult/pediatric Neonate range
RR×0.5 or 6/min (RR-10) or 30/min RR×1.5 or 30/min Adult/pediatric:
(RR+25) or 85/min
Resp RR (whichever is (whichever is (whichever is 6 to 55
(whichever is lower)
greater) greater) lower) Neonate: 10 to 90
Same as the default Same as the Same as the Same as the default Same as the
SpO2
alarm limit default alarm limit default alarm limit alarm limit measurement range
(SYS-15) or
(SYS + 15) or Adult: 45 to 270
SYS×0.68 + 45mmHg SYS×0.86 +
IBP: ART/ IBP-S 105mmHg Pediatric: 45 to 185
10mmHg (whichever is 38mmHg
Ao/ (whichever is lower) Neonate: 35 to 115
greater)
UAP/
BAP/ (Dia-15) or (Dia + 15) or Adult: 25 to 225
20mmHg Dia×0.86 +
FAP/ IBP-D Dia×0.68 + 6mmHg 80mmHg (whichever Pediatric: 25 to 150
(whichever is 32mmHg
LV/ is lower) Neonate: 20 to 90
greater)
P1-P2
(Mean-15) or
(Arterial (Mean + 15) or Adult: 30 to 245
Mean×0.68 + 35mmHg Mean×0.86 +
pressure) IBP-M 95mmHg (whichever Pediatric: 30 to 180
8mmHg (whichever is 35mmHg
is lower) Neonate: 25 to 105
greater)
IBP-S SYS×0.75 SYS×0.75 SYS×1.25 SYS×1.25
PA IBP-D Dia×0.75 Dia×0.75 Dia×1.25 Dia×1.25 3 to 120mmHg
IBP-M Mean×0.75 Mean×0.75 Mean×1.25 Mean×
Mean×1.25
1.25
5-6
Low alarm limit High alarm limit Auto alarm limits
Module Parameter
Adult/pediatric Neonate Adult/pediatric Neonate range
IBP:
CVP/
ICP/
LAP/
RAP/ IBP-M Mean×0.75 Mean×0.75 Mean×1.25 Mean×1.25 3 to 40mmHg
UVP/
P1-P2
(Venous
pressure)
0-32mmHg: 0-32mmHg: 0-32mmHg:
0-32mmHg:
remains remains remains
remains unchanged
unchanged unchanged unchanged
NOTE
You can enable auto alarm limits only when the current parameter measurement is within the auto alarm
limits range.
5-7
5.6 Pausing Alarms
You can temporarily
temporaril y disable alarm indicators by pressing the hardkey on the equipment’s front. When alarms are
paused:
For physiological alarms, no alarm indication is shown. New physiological alarm will not be presented.
For technical alarms, alarm sounds are paused, but alarm lamps and alarm messages remain presented.
is displayed in the sound symbol area. If a new technical alarm is triggered in the alarm paused period, the
When the alarm pause time expires, the alarm paused status is automatically deactivated. You
You can also cancel the alarm
required password.
2. Select [Alarm Setup >>]
>>] → [Alarm Pause Time]
Time] and then select an appropriate value.
The equipment
equipment is switched to the Manual DeDefib
fib mode. Or
The equipment
equipment exit synchr
synchronous
onous defibrillatio
defibrillation
n when operat
operating
ing in the Manual De
Defib
fib mode.
5-8
5.8 Pausing Alarm Sounds
sound symbol area indicating all system sounds are silenced temporarily. In the audio paused status, all alarm indicators
except audible alarm tones works properly.
properly. If alarms are switched off or paused, the [ Audio Pause]
Pause] soft key is not
shown.
The hardkey is pr
pressed
essed to perm
permanently
anently or ttemporarily
emporarily sw
switch
itch off the alarm
alarms.
s.
mode, Manual Defib mode or Pacer mode. In the audio off status, appears in the sound symbol area. In this case,
the alarm status is the same with that when alarm tones are paused.
The hardkey is pressed. In this case, the equipment enters the alarm paused status and the alarm volume is
reset to the default level. The symbol is displayed in the sound symbol area.
The [Audio
[Audio Pause]
Pause] soft key is pressed. In this case, the equipment enters the audio paused status and the alarm
volume is reset to the default level. The symbol is displayed in the sound symbol area.
Operating mode is switched. Then the equipment enters the default alarm status of corresponding operating
mode. Or
The reminder
reminder tone is sw
switched
itched off by default. Yo
You
u can switch it on by selecting [Alarm Setup]
Setup] →[Reminder Tone]
Tone]
through the Configuration Management Main menu. You can also change reminder volume. The default reminder
volume is [Med
[Med].
].
5-9
5.11 Latching Alarms
The latching setting for physiological alarms defines ho
how
w alarm indicat
indicators
ors behave w
when
hen you do not acknowledge
acknowledge them.
If an alarm is latched, alarm indications remain presented even though alarm conditions end, except that:
The parameter
parameter reading and violated alarm limit stop flashing.
If an alarm is not latched, the alarm indications disappear as soon as the alarm conditions end.
To latch a phy
physiological
siological alarm,
alarm status, it can give alarm indications correctly in case these alarms are triggered again.
For some technical alarms, all their alarm indications are cleared after the hardkey or [Audio Pause]
Pause] soft key is
For others, their alarm tones are cleared but the alarm lamp flashing and alarm messages remain after the hardkey
or [Audio
[Audio Pause]
Pause] soft key is pressed. After the equipmen
equipmentt restores the normal alarm status, all the alarm indications will
continue if the alarm conditions still present.
For actions taken with regard to specific alarms, see Appendix D Alarm Messages.
Messages.
5-10
6 Monitoring ECG
6.1 Overview
The electrocardiogram
electrocardiogram (ECG) m
measures
easures the electrical activity of the heart and displa
displays
ys it as wav
waveforms
eforms and numerics.
numerics. The
equipment enables ECG monitoring through
through 3-, 5-, 12- lead ECG sets, external paddles and multifunction electrode pads.
If both ECG sets and paddles/pads are connected, the configured ECG waveforms are displayed in the waveform area.
6.2 Safety
WARNING
Periodically inspect the electrode application site to ensure skin quality. If the skin quality changes,
replace the electrodes or change the application site.
When monitoring a patient implanted with a pacemaker, be sure to select correct paced status. Otherwise,
the pacing pulses may be counted in the case of cardiac arrest or some arrhythmias. Do not completely rely
on the heart rate reading or the heart rate alarms. Always keep paced patients under close surveillance.
NOTE
When connecting electrodes and/or patient cables, make sure that the connectors never come into contact
with other conductive parts, or with earth. Particularly make sure that all of the ECG electrodes are
attached to the patient.
Interference from a non-grounded instrument near the patient and electrosurgery interference may cause
problems with the waveform.
If selected lead cannot provide valid ECG signals, a dash line is shown in the ECG waveform area.
Use the same type of ECG electrodes when monitoring ECG through ECG lead set.
6-1
6.3 Monitoring View
You can access Monitor mode by switching the Mode Select k nob to the Monitor position. When operating in Monitor
mode, the equipment displays up to two ECG waveforms, the heart rate reading, other available parameter values and
active alarm settings.
Gently rub skin surface at application sites to remove dead skin cells.
Thoroughly clean
clean the sites w
with
ith mild soap and w
water.
ater. We do not recommend
recommend using ether
ether or pure alcohol,
because this dries the skin and increases the resistance.
6-2
6.4.1.1 Placing Electrodes
3-Lead Placement
RA placement: directly below the clavicle and near the right shoulder.
LA placement: directly below the clavicle and near the left shoulder.
5-Lead Placement
RA placement: directly below the clavicle and near the right shoulder.
LA placement: directly below the clavicle and near the left shoulder.
V5 placement: on the left anterior axillary line, horizontal with the V4 electrode
position.
V6 placement: on the left midaxillary line, horizontal with the V4 electrode position.
V7R placement: on posterior chest at the left posterior axillary line in the fifth intercostal space.
6-3
WARNING
When using electrosurgical units (ESU), place ECG electrodes between the ESU and its grounding plate to
prevent unwanted burns. Never entangle ESU cable and ECG cable together.
When using electrosurgical units (ESU), never place ECG electrodes near to the grounding plate of the ESU,
as this can cause a lot of interference on the ECG signal.
If multifunction electrode pads are used, apply pads according to the instructions for use indicated on pads
package. Use anterior-lateral
anterior-lateral placement.
If external paddles are used, remove the paddle set from the paddle tray by grasping the handles and
pulling them straight up. Apply conductive gel to paddle electrodes. Place the paddles to the patient’s
chest using the anterior-late
anterior-lateral
ral placement.
3. If m
multifunction
ultifunction electrode pads are used, connect the p
pads
ads to the pa
pads
ds cable.
Sternum
paddle
RA
LL
Apex paddle
NOTE
Anterior - lateral placement is the only placement that can be used for ECG monitoring with paddles/pads
accessories.
6-4
6.4.3 Checking Paced Status
It is important to set the paced status correctly when you start monitoring ECG. The paced symbol is displayed
→ →
[Main Menu]
Menu] [Patient Demographics>>]
Demographics>>] [Paced], or
Paced],
The ECG parameter
parameter wind
window
ow to ente
enterr the [[ECG Setup] menu, and then, select [Others>>
ECG Setup] [ Others>>]] [Paced
→ ],
Paced],
Warning
For paced patients, you must set [Paced] to [Yes]. If it is incorrectly set to [No], the patient monitor could
mistake a pace pulse for a QRS and fail to alarm when the ECG signal is too weak. Do not rely entirely on
rate meter alarms when monitoring patients with pacemakers. Always keep these patients under close
surveillance.
For non-paced patients, you must set [Paced] to [No]. If it is incorrectly set to [Yes], the equipment may be
Heartbeat icon
Alarm limits
PVC values
HR value
PVCs values is shown only when arrhythmia analysis is switched on. When external paddles or multifunctional electrode
pads are used for ECG monitoring, the PVCs values is shown as “---”.
6-5
6.6 Changing ECG Settings
6.6.1 Change Lead Setting
6.6.1.1 Selecting Lead Type
1. Press th
the
e Menu button o
on
n the equipment’s front pane
panel.l. In the Main Menu, selec
selectt [[Others >>]
Others >>] [Configuration
→
>>]
>>]→ enter the required password to enter the Configuration Main menu.
To compute heart
heart rate and to detect and an
analyse
alyse arrhythm
arrhythmia
ia more accurately
accurately,, you can choose
choose a lead of best
best quality
signals as the HR calculation lead. T
To
o do so, select [[ECG1
ECG1]] from the [ECG
[ECG Setup]
Setup] menu and then select the lead you want.
The P-waves
P-waves and T-w
T-waves
aves should be less than 0.2mV
0.2mV..
6-6
6.6.2 Changing ECG Wave Settings
You can select the ECG parameter area to enter the [ ECG Setup]
Setup] menu to set ECG cascade and wave speed. You can also
select the hot keys above the ECG waveform to change ECG lead, size and filter.
You can press the Lead Select button on the equipment’s front panel or use the Navigation knob to select the
lead hot key above the first ECG waveform to select a lead.
If the wave is too small or clipped, you can change its size by selecting the Size hot key above the ECG waveform.
When monitoring ECG through ECG lead set, filter mode is displayed above the first ECG waveform. To change
filter mode, select the filter mode hot key using the Navigation knob.
During 3/5-lead ECG monitoring, the available filter mode settings are [Monitor
[Monitor],
], [[Therapy], and
Therapy],
[Diagnostic]. The default is [Therapy
Diagnostic]. [ Therapy].
].
In the [ECG
[ECG Setup]
Setup] menu, select [Sweep
[ Sweep],
], and then choose an appropriate value. The faster the wave sweeps, the
wider the wave is. You can also access [Sweep
[Sweep]] to adjust wave speed from the [ECG Setup]
Setup] menu in the
Configuration mode.
In the [ECG
[ECG Setup]
Setup] menu, select [ECG
[ ECG Cascade]
Cascade] and toggle between [On
[On]] and [Off
[Off].
NOTE
For paced patients, you must set [Paced] to [Yes]. If it is incorrectly set to [No], the system may mistake an
internal pace pulse for a QRS or fail to alarm when the pacer is broken.
Switching on the notch filter is recommended when there is interference with the waveform.
Set notch frequency according to the electric power frequency of your country. Follow this procedure:
NOTE
The setting of Notch Filter will not be changed by restoring to factory default settings nor shutting down
the system.
6-7
6.6.4 Adjusting Heartbeat Volume
In the case that ECG alarm is switched on, or both ECG alarm and PR alarm are switched off, heartbeat tone is issued.
To adjust the heartbeat
heartbeat volume,
WARNING
Arrhythmia analysis program is intended to detect ventricular arrhythmias. It is not designed to detect
atrial or supraventricular arrhythmias. It may incorrectly identify the presence or absence of an
arrhythmia. Therefore, a physician must analyze the arrhythmia
a rrhythmia information with other clinical findings.
6-8
Arrhythmia event Description Category
Trigeminy A dominant rhy
rhythm
thm of N, N, V
V,N,
,N, N, V, N, N, V.
R ON T R on T detected in normal heartbeats.
Missed Beats* No beat detected for 1.75x average R-R interval for HR <120, or No beat for 1
second with HR >120 (for non-paced patients only), or No beat detected for
more than the set pause threshold.
Brady The average heart rate is less than 60 bpm.
When multifunctional electrode pads are used for ECG monitoring, the equipment provides only 4 arrhythmia
alarms, including asystole, ventricular fibrillation/ventricular tachycardia, PNP, and PNC.
When paddles are used, the equipment provides only 3 arrhythmia alarms, including ventricular
fibrillation/ventricular
fibrillation/ventricular tachycardia, PNP, and PNC.
2. Select [Arrhythmia
Arrhythmia]] and toggle between [On
[On]] and [Off
[Off].
Yo
You
u can also switch arrhythmia analysis on or off in the Configuration mode. Follow this procedure: Enter the
Configuration
Configuration Main menu. Select [ECG Setup]
Setup] → [Arrhythmia
Arrhythmia]] and toggle between [On
[On]] and [Off
[Off].
You can also set arrhythmia alarm properties in the Configuration mode through the ECG Setup menu.
NOTE
The alarm level for asystole, ventricular fibrillation, ventricular tachycardia, ventricular bradycardia,
extreme bradycardia, and extreme tachycardia alarms is always high and unchangeable. These alarms are
always on. As long as the alarm condition occurs, corresponding alarm will be triggered whether
arrhythmia analysis is switched on or off.
6-9
6.7.4 Changing Arrhythmia Threshold Settings
To change arrhythmia
arrhythmia thresho
threshold
ld settings, se
select >>]→[Arrh. Threshold >>].
lect the ECG parameter window [Arrhythmia >>]
→ >>].
V-Tach
V-Tach Rate 100 to 200 130 5 bpm
V-Tach
V-Tach PVCs 3 to 12 6 1 Beats
Pause Time 1.5, 2.0, 2.5 2.0 / s
Vbrd Rate 15 to 60 40 5 bpm
Vbrd PVCs 3 to 99 5 1 Beats
You can also set arrhythmia threshold from the ECG Setup menu in the configuration mode.
To initiate relearning
relearning manually
manually,, select the EC
ECG
G parame
parameter
ter window to enter the [ECG
[ECG Setup]
Setup] menu, select [Arrhythmia
[ Arrhythmia
>>]
>>] → [Relearn Arrh.].
Arrh.]. When the equipment is learning, the message “Learning ECG” is displayed in the technical alarm
area.
NOTE
Arrhythmia relearning in the case of ventricular tachycardia may affect correct arrhythmia alarm.
6-10
6.7.6 Automatic Arrhythmia Relearn
Arrhythmia relearning is initiated automatically whenever:
[Stop Calibrating]
Calibrating] is selected after ECG calibration is completed.
1. Select ECG filter hot key. Turn the navigation knob to select [Diagnostic
Diagnostic]] mode.
You can print out the waveform and wave scale and then measure the difference between them if necessary. If the
difference exceeds 5%, contact your service personnel.
6-11
FOR YOUR NOTES
6-12
7 Resting 12-Lead ECG
7.1 Overview
The optional resting
resting 12-lead EC
ECG
G function is availa
available
ble in Monitor m
mode
ode and allow
allowss you to acquire,
acquire, analyze,
analyze, store
store,, print,
and transmit a 12-lead ECG.
For resting 12-lead ECG, the available filter mode settings are [Diagnostic
[Diagnostic]] and [ST
[ST].
]. The default is [ST
[ ST].
]. When [Filter
[Filter]] is
set to [ST
[ST],
], the notch filter is always [On
[ On].
]. When [Filter
[Filter]] is set to [Diagnostic
[ Diagnostic],
], you can switch the notch filter [On
[ On]] or [Off
[Off]
as required.
However, you can place the limb electrodes anywhere along the limbs.
7-1
WARNING
When using electrosurgical units (ESU), place ECG electrodes between the ESU and its grounding plate to
prevent unwanted burns. Never entangle ESU cable and ECG cable together.
When using electrosurgical units (ESU), never place ECG electrodes near to the grounding plate of the ESU,
as this can cause a lot of interference on the ECG signal.
2. Refer to section 6.4.1 ECG Monitoring with Electrodes to prepare patient, apply electrode
electrodes,
s, and connect leadwires
and trunk cable.
3. Press the 12-Lead ECG hardkey on the front panel to enter the full 12-lead ECG screen.
In the 12-lead ECG screen, waveforms are always displayed in the sequence of I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and
V6. You cannot change waveform position. The [Waves
[Waves >>]
>>] option in the Main Menu is disabled
NOTE
If the equipment is connected with AC mains, the [Notch Filter] shall be set to [On] to avoid interference on
the acquiring or display of 12-Lead ECG.
7-2
7.4 12-lead ECG Analysis
12-lead ECG analysis function is intended for adult, pediatric and neonatal patients.
NOTE
Always input the correct patient information before you start 12-Lead ECG analysis because the patient
information, especially age, gender, and race, greatly affect
affec t the interpretation of the acquired ECG.
If no patient information is inputted, the system will interpret the acquired ECG on the basis of a default of
If any of the RA, LA, LL, or RL electrodes or trunk cable is detached during data acquisition or analysis, a message “Lead
Off, Cannot Acquire.” will be presented.
During 12-lead ECG acquisition or analysis, you cannot select a parameter window to enter the parameter setup menu.
The Main Menu button
button and the Ev
Event
ent button on the fron
frontt panel are also disabled.
CAUTION
Keep the patient still while acquiring or analyzing 12-lead ECG. Motion of patient can lead to potential
misdiagnosis.
NOTE
The Lead Select hard key is disabled in the 12-lead ECG screen.
The filter mode is set to [ST] automatically for 12-lead ECG acquiring and analysis.
If the defibrillator is on a moving vehicle, stop the vehicle when acquiring 12-lead ECG.
For more details about the interpretation of acquired ECG, refer to the Mindray 1 2-Lead ECG Interpretive Program
Physician’s Guide (PN: H-046-003506-00).
The [Record
[Record]] and [Transmit
[Transmit]] buttons are disabled if no 12-lead ECG report is stored.
7-4
7.5.2 Recording 12-Lead ECG Report
1. Check the currently acquired ECG re
report eport as described in 7.5.1 Reviewing 12-Lead ECG
port or select a stored rreport
Report..
Report
Patient information
information about critical value and diagnosis, refer to the Mindray 12-Lead ECG Interpretive Program
For more information
Physician’s Guide (PN: H-046-003506-00).
12-Lead reports can be transmitted to a fax machine via a wireless transmission module with networking capability. The
wireless transmission module is connected to the multifunctional connector using a Y-cable.
A SIM card bonding fax service is required to support 12-Lead ECG Transmission.
Wireless
transmission Base Fax machine
module station
BeneHeart
Caution
Data transmission via wireless transmission module may sometimes be unreliable. A strong signal and
stationary transmission will improve the transmission
tra nsmission success rate.
7-5
“Wireless Transmission
For further information concerning installing the wireless transmission module, refer to the “Wireless
Module Installation Guide”
Guide” (PN: H-046-001242-00).
select a site preset in the configuration mode. In this case, the fax number is shown automatically, or
select [Custom
[Custom]] and then enter the fax No.
A message “12-Lead Report Transmission Complete!” displays if the 12-Lead Report is successfully sent.
is set to Fax Mode. If the fax machine is set to Automatic Mode, the times of Ring To Answer setting is preferred
1 or 2.
NOTE
The 12-lead transmission support paper sizes of A4 and Letter.
7-6
12-Lead Transmission Problems
7.5.3.2 To CMS
In the Transmit Menu, select a preset site or enter the IP address of the target CMS and then select [Transmit
[Transmit]] to send
the 12-lead ECG report to CMS.
1. Menu]→[Others >>]
Select [Main Menu] >>]→[Configuration >>]
>>]→enter the required password.
NOTE
The [Tachy (Adu)] setup is only effective for patients at the age of 18 or above.
The [Brady (Adu)] setup is only effective for patients at the age of 13 or above.
7-7
7.6.2 Setting V3 Placement
If the V3 electrode is placed on the position of V4R as shown below, you need to set the [[V3 Placement] to improve the
V3 Placement]
accuracy of ECG interpretat
interpretation:
ion:
To set [V3
[V3 Placement]:
Placement]:
Hodges
Bazett
Fridericia
Framingham
For details about QTc formula, refer to the Mindray 12-Lead ECG Interpretive Program Physician’s Guide (PN:
H-046-003506-00).
2. Select [On
On]] or [Off
[Off] to turn on o r off the baseline correction filter.
NOTE
The baseline correction function is only for 12-lead ECG monitoring. In 3-lead or 5-lead ECG monitoring,
this function is disabled.
7-8
7.6.5 Setting Patient Information Input Prompt
Select [Main Menu]→[Others >>]
[Main Menu] >>]→[Configuration >>]
>>]→enter the required password→[12-Lead Setup]
Setup]→[Patient
Prompt] and toggle between [On
Info. Input Prompt] [On]] or [Off
[Off] to turn on or off patient information input prompt:
On: the patient information input prompt is displayed after you select [Start
[Start Acquire]
Acquire] to start 12-lead ECG
analysis.
NOTE
It is recommended to turn on the patient information input prompt for your convenience to check the
patient information before you start 12-lead ECG analysis.
1. Menu]→[Others >>]
Select [Main Menu] >>]→[Configuration >>]
>>]→enter the required password.
7-9
Below are examples of printed 12-lead ECG report:
[3 4]:
1
6 7 8 9 10 11 12 13
2 3
4
5
[3 4 Compact]
Compact]
1 2 3 4 5
6 7 8 9 10 11 12 13
7-10
[Median Complexes]
1 2 3
6 7 8 9 10 11 12 13
[Measurements Matrix]
2 1 14
12 13
1. Time of acquisition
2. Patient information
3. Global measurem
measurements
ents
4. Critical value
5. Diagnostic statements
6. Gain
7. Paper speed
8. Notch filter
9. Frequency response
10. Baseline correction filter
11. QT
QTcc formula
12. Software/Algorithm
Software/Algorithm version
13. Serial number
14. Measurements
7-11
7.6.8 Setting up Destination Sites
You can preset up to 8 sites and their fax numbers where the 12-lead ECG may be sent in the configuration mode. You
can use maximum 15 characters to define the site name and maximum 20 digits to define the fax number.
The following
following figure shows an example
example of 3×4 fo
format
rmat rep
report
ort receiv
received
ed by a fax m
machine.
achine.
NOTE
The transmission speed is 7200 bps by default. In the case that wireless communication signal is not good,
selecting 2400 bps may improve transmission success rate, but this takes considerably
c onsiderably longer time.
7-12
7 12
8 AED
8.1 Overview
This chapter describes
describes how to operate tthe
he equipmen
equipmentt in AED Mode
Mode.. While o
operating
perating in AED Mode, the e
equipment
quipment
analyses the patient’
p atient’ss ECG waveform
waveformss and guides you through the defibrillation process.
The equipment
equipment starts analyzing tthe
he patient’s heart rhythm immediat
immediately
ely after ente
entering
ring AED mode.
mode. Wh
When
en a shockable
rhythm is detected, the equipment
equipment gives a prompt and automatically starts charging. If a shockable rhythm is not
detected, a “No shock advised” prompt
prompt is given. Smart defibrillation analysis goes through automated
automated external
defibrillation until the equipment enters CPR or abnormal pads connection occurs.
While operating in AED Mode, the capabilities of the device are limited to those essential to the performance of
semi-automated
semi-automated external defibrillation. Only ECG signals acquired through
through pads are displayed. Previously set alarms and
scheduled measurements
measurements are indefinitely paused and entry of patient information is disabled. Additionally
Additionally,, the Lead
Select, Alarm Pause, NIBP Start/Stop and Main Menu buttons are inactive.
8.2 Safety
DANGER
Defibrillation current can cause operator or bystander severe injury or even death. Never touch the
patient or any equipment connected to the patient (including the bed or gurney) during defibrillation.
Avoid contact between parts of the patient’s body such as exposed skin of head or limbs, conductive fluids
such as gel, blood, or saline, and metal objects such as a bed frame
f rame or a stretcher which may provide
unwanted pathways for the defibrillating current.
Do not allow multifunction electrode pads to touch each other or to touch other ECG monitoring
electrodes, lead wires, dressings, etc. Contact with metal objects may cause electrical arcing and patient
skin burns during defibrillation and may divert current away from the heart.
To avoid explosion hazard, do not use the equipment in the presence of oxygen-rich atmospheres,
flammable anesthetics, or other flammable agents (such as gasoline). Keep the equipment and the
operating environment dry and clean.
WARNING
During defibrillation, air pockets between the skin and multifunction electrode pads can cause patient
skin burns. To help prevent air pockets, make sure defibrillation pads are completely adhered to the skin.
sk in.
In AED mode, this equipment is not designed to administer energy at pediatric joule settings. The
American Heart Association recommends AEDs be used only on patients who are more than eight years
old.
81
CAUTION
Aggressive handling of multifunction electrode pads in storage or prior to use can damage the pads.
Discard the pads if they become damaged.
For patients with implantable pacemaker, the sensitivity and specificity of AED algorithm may be
impaired.
In AED mode, HR numeric and one ECG waveform acquired from the multifunction electrode pads are displayed. Below
the ECG is the information area which displays the defibrillation mode, prompt message, contact impedance indicator,
selected energy and a shock counter.
For details about the contact impedance indicator, refer to 9.7 Contact Impedance Indicator.
Indicator.
Then:
1. Remove clothing from the patient’s chest. Wipe moisture from the patient’s chest and, if necessary,
necessary, clip or
or shave
excessive chest hair.
2. Apply multifu
multifunction
nction electr
electrode
ode pads to the p
patient
atient as di
directed
rected o
on
n the pads package. Use anterior-lateral
anterior-lateral placement.
3. Connect the pads with pads cable, and then plug the pads cable in the eq
equipment’s
uipment’s therapy
therapy p
port.
ort.
When the equipment enters AED mode, it checks to see if the pads
p ads and pads cable are properly connected.
connected. If not, the
message “Connect
“Connect Pads Cable”
Cable” or “Apply
“Apply Pads”
Pads” will appear in the AED information area until corrective action has been
taken.
Once an ECG is detected through the multifunction electrode pads, the equipment automatically analyzes the patient’s
heart rhythm and warns you not to touch the patient. If a shockable rhythm is detected, the equipment charg
charges
es
automatically.
You can switch on/off the voice prompt by accessing configuration management or adjust the volume of the voice
prompts by pressing the voice volume soft key.
Delivery of the shock is confirmed by the voice and screen prompt "Shock
"Shock Delivered"
Delivered" and the shock counter on the
display is updated to reflect the number of shocks given. If the configured [Shock
[Shock Series]
Series] is greater than one, the
equipment resumes analyzing the patient’s rhythm after the shock is delivered to see if the shock was successful. Voice
and text prompts continue to guide you through additional shocks.
NOTE
Do not use anterior-posterior pads placement (multifunction electrode pads placed on the patient’s chest
and back). The AED algorithm used by the equipment has not been validated using this placement.
The Shock button must be pressed to deliver a shock. The equipment will not automatically deliver a
shock.
Impedance is the resistance between the defibrillator’s pads or paddles that the defibrillator must
overcome to deliver an effective discharge of energy. The degree of impedance differs from patient to
patient and is affected by several factors including the presence of chest hair, moisture, and lotions or
powders on the skin. If the “Impedance too high. Shock not delivered” message appears, make sure that
the patient’s skin has been washed and dried and that any chest hair has been clipped. If the message
persists, change the pads and/or the pads cable.
83
When the equipment is being charged or have been fully charged, you can remove the charged energy at any time by
pressing the [Pause
[Pause for CPR]
CPR] soft key.
If the [NSA
[NSA Action]
Action] is set to [CPR
[ CPR]]
The equipment
equipment enters CP
CPR
R status and yo
you
u will see and he
hear
ar ““No CPR.”
No Shock Advised! Paused. If Needed, Begin CPR.”
The remaining pause time is displayed as show
shown
n below. The pau
pause
se period can be defined by setting
setting [CPR
[CPR Time]
Time]
through configuration management.
Analysis resumes at the completion of the pause period or when you press the [[Resume Analyzing]] soft key in CPR
Resume Analyzing
status.
If the [NSA
[NSA Action]
Action] is set to [Monitor
[ Monitor]]
The equipment
equipment continues to monitor the ECG and autom
automatically
atically resum
resumes
es analysis if a pot
potentially
entially shockable rhythm
rhythm
is detected. You will hear “No
“ No Shock Advised! If needed press pause for CPR”.
CPR ”. The message "No
"No Shock Advised!"
Advised!"
and “Monitoring
“Monitoring”” are shown circularly in the AED information area.
8.7 CPR
If [[Initial Time] is not configured as Off, the system enters initial CPR if AED mode is entered. You can set [Initial
Initial CPR Time] [Initial
Time] to an appropriate time or switch it off through configuration manageme
CPR Time] management.
nt.
After the shock series, ECG analysis pauses and the equipment enters
enters the CPR status. Analysis resumes at the completion
of the pause period or when you press the [Resume
[ Resume Analyzing
Analyzing]] soft key in CPR status.
In current shock series, the equipment enters the CPR status if you press the [Pause
[ Pause for CPR]
CPR] soft key after a shock is
delivered. The CPR pause time is defined by setting [CPR
[ CPR Time]
Time] through configuration management.
NOTE
You can start analyzing patient’s heart rhythm again at any time by pressing the [Resume Analyzing] soft
key in CPR status.
When activated, the metronome sounds 120 times per minute and give voice prompts to indicate the rescuers to
perform ventilation at configured compression/ventilation
compression/ventilation rate.
To activate or d
deactivate
eactivate CPR m
metronome
etronome,,
Warning
The CPR metronome sounds do not indicate information regarding the patient’s condition. Because
patient status can change in a short time, the patient should be assessed at all times. Do not perform CPR
on a patient who is responsive or is breathing normally.
NOTE
CPR metronome and its volume is affected by the settings of [Voice Prompt] and [Voice Volume] in the AED
Setup menu.
8-5
To switch on or
or off the sound
sounding
ing recordin
recording,
g,
The symbol
symbol is shown at the top right ccorner
orner of the AED inform
information
ation area if the sounding rrecording
ecording fun
function
ction is
enabled.
The equipment
equipment can store up to 180 min
minutes,
utes, maxim
maximum
um 60 minute
minutess for one p
patient,
atient, of sound recording.
recording.
9 Manual Defibrillation
9.1 Overview
This chapter explains
explains how to pr
prepare
epare ffor
or and perform asynchronous defibrillation and synchronous
synchronous car
cardioversion
dioversion using
multifunction electrode pads and external paddles.
While operating manual defibrillation, besides ECG you can select to monitor up to three parameters from SpO2, NIBP,
CO2, IBP and Temp. You can define the parameters to be monitored through configuration management. All the
monitored parameters, except ECG, are switched off by default.
Alarms are turned off automatically when you enter Manual Defib mode. Pressing the Alarm Pause button can turn on
the alarms.
9.2 Safety
DANGER
Defibrillation current can cause operator or bystander severe injury or even death. Never touch the
patient or any equipment connected to the patient (including the bed or gurney) during defibrillation.
Avoid contact between parts of the patient’s body such as exposed skin of head or limbs, conductive fluids
such as gel, blood, or saline, and metal objects such as a bed frame
f rame or a stretcher which may provide
unwanted pathways for the defibrillating current.
Do not allow multifunction electrode pads and paddles to touch each other or to touch other ECG
monitoring electrodes, lead wires, dressings, etc. Contact with metal objects may cause electrical
e lectrical arcing
and patient skin burns during defibrillation and may divert current away from the heart.
During manual defibrillation, make sure your hands are dry and free from conductive gel to avoid shock
hazard.
Use care when operating this equipment close to oxygen sources (such as bag-valve-mask devices or
ventilator tubing). Turn off gas source or move source away from
f rom patient during defibrillation. This can
cause an explosion hazard.
9-1
WARNING
During synchronous cardioversion, if monitoring patient’s ECG through external paddles, artifact
introduced by paddle movement may resemble an R-wave and trigger a defibrillation shock.
Do not use conductive liquid. Use only conductive gel specified by the equipment manufacturer.
If external paddles are used for defibrillation, apply the paddles tightly and evenly to the patient’s chest to
ensure good skin contact.
Clinicians must select an appropriate energy level for defibrillation of pediatric patients.
CAUTION
Use of Manual Defib mode may be password protected. Make sure the operator knows and remembers the
password as defined in Configuration. Failure to enter correct password will prevent the delivery of
manual defibrillation therapy.
Clear the conductive gel from the external paddles at the completion of the therapy to prevent the
paddles from being corroded.
Prior to using this defibrillator, disconnect from the patient all equipment that is not
defibrillator-protected.
NOTE
Impedance is the resistance between the defibrillator’s pads or paddles that the defibrillator must
overcome to deliver an effective discharge of energy. The degree of impedance differs from patient to
patient and is affected by several factors including the presence of chest hair, moisture, and lotions or
powders on the skin. If the “Impedance too high. Shock not delivered” message appears, make sure that
the patient’s skin has been washed and dried and that any chest hair has been clipped. If the message
persists, change the pads and/or the pads cable.
Alarms are switched off automatically and the “Alarm Off” message is displayed when the equipment
enters the asynchronous defibrillation mode. Alarms remain off until toggled on by pressing the Alarm
Pause button, the Sync mode is entered, or the Mode Select knob is moved to Monitor or Pacer.
9-2
In the enlarged ECG area, an ECG waveform and related parameters are displayed. In the middle of the screen,
defibrillation mode, synchronous icon, prompt message, selected energy, contact impedance indicator (configurable),
If multifunction electrode pads are used, apply pads according to the instructions for use indicated on pads
package. Use anterior-lateral or anterior-poste
anterior-posterior
rior placement.
If external paddles are used, remove the paddle set from the paddle tray by grasping the handles and
pulling them straight up. Apply conductive gel to the electrode surface of each paddle. Place the paddles to
the patient’s chest using the anterior-lateral placement.
WARNING
Hold only the insulating parts of the paddle handles to avoid shock hazard during charging or shock
delivery.
5. Select energy.
You can select desired energy level by the adjusting the Energy Select buttons on the equipment’s front panel or
the Energy Select buttons on external paddles if external paddles are used.
6. Charge
Press the Charge button on the front panel. If external paddles are used, the Charge button on the paddles may be
used instead. As the equipment charges, a progress bar is shown in the defibrillation information area. A charging
tone sounds until desired energy level is reached, when you will hear a charge done tone.
If you have to increase or decrease the selected energy during charging or after charging is complete, adjust the Energy
Select button to select the desired energy level as explained above. Then press the charge button again to restart
charging.
7. Shock
Confirm that a shock is still indicated and that the equipment has charged to the selected energy level. Make sure
no one is touching the patient, bed or any equipment connected to the patient. Call out loudly and clearly, ““Stay
Stay
Clear!””
Clear!
If pads are used, press the flashing Shock button on the front panel to deliver a shock to the patient.
9-4
If external paddles are used, simultaneously press the Shock buttons located on the paddles to deliver a
shock to the patient.
NOTE
Defibrillation is always performed through paddles or pads. However, during defibrillation you may
choose to monitor the ECG using an alternate ECG source (3- or 5-lead monitoring electrodes). If an
alternate ECG source is connected, any available lead may be displayed.
When external paddles are used, the Shock button on the equipment’s front panel is disabled.
To defibrillate, rrefer
efer to tthe
he proced
procedure
ure as described in Section 9.4 Manual Defibrillation Procedure.
described Procedure.
1. Turn on tthe
he d
defibrillator
efibrillator and enter the manual defib mode.
6. Charge the d
defibrillator
efibrillator by pre
pressing
ssing the Charge key o
on
n the front panel.
Using internal paddles for synchronized cardioversion requires that the patient’s ECG be acquired through a standard
ECG cable. The patient’s ECG acquired through the internal paddles may be unreliable for synchronized cardioversion
due to excessive noise or artifact
ar tifact causing inappropriate R-wave detection.
NOTE
When internal paddles are used for defibrillation, the energy selection is automatically limited to 50 joules
because of possible cardiac damage from higher energies.
Sterilize the internal paddles before each use. Otherwise, severe infection may result.
External paddles
To use synchronized
synchronized cardio
cardioversion,
version, pr
press
ess the [[Enter Sync] soft key in the asynchronous defibrillation mode. Then “Sync”
Enter Sync]
appears in the manual Defibrillation information area and a marker appears above each R-wave, see the figure below:
Sync marker
R-wave marker
You can monitor ECG through multifunction electric pads, or external paddles, or electrodes
electrodes connected to a 3- or 5-lead
ECG cable. Shock is delivered through either pads or paddles.For synchronized cardioversion, we recommend to acquire
patient’s ECG through ECG lead set
NOTE
When you enter synchronous cardioversion, monitoring alarms is reactivated autonomously.
9-6
2. With the
the Mode Select knob in the Manu
Manual
al Defib position, pr
press
ess the [Enter Sync
Sync]] soft key to activate the
synchronous cardioversion function.
4. Verify tha
thatt a white R-wave ma
marker
rker appears above each R-wave, as sho
shown
wn in the figure be
below.
low. If tthe
he R-wave markers
do not appear or do not coincide with the R-waves, for example above the T-waves, select another lead.
5. Verify that
that the e
equipment
quipment e
enters
nters the Sync mode
mode,, as indicate
indicated
d by the SYNC mark shown in the defibrillation
information area.
6. Press the E
Energy
nergy Select button to se
select
lect a desired energy level.
8. Confirm that
that a shock is still indicated and that tthe
he equipm
equipment
ent has char
charged
ged to the selected
selected energy
energy level. Make
Make sure
no one is touching the patient, bed or any equipment connected to the patient. Call out loudly and clearly, “Stay
“Stay
”.
Clear!”.
Clear!
NOTE
During synchronized cardioversion, it is important to continue to hold the shock button (or the paddle’s
Shock buttons) until the shock is delivered. The equipment shocks with the next detected R-wave.
If [[Sync
Sync after Shock] is set to [Y
[ Yes],
es], the equipment remains in the sync mode after a shock is delivered; if set to [No], the
No],
equipment exits the sync mode and enters the asynchronous defibrillation mode after a shock.
To switch on remote
remote synchr
synchronization,
onization, select [[Manual Setup]
Manual Defib Setup] →
[Remote Sync]
Sync] →
[On
On]] through the Configuration
Main Menu.
The remote
remote synchro
synchronization
nization proc
procedure
edure is as follows:
1. Use a sy
sync
nc cable to connect the defibrillator/m
defibrillator/monitor
onitor wit
with
h a bedside monitor through the defibrillator/m
defibrillator/monitor’s
onitor’s
multifunctional connector.
4. Select [Remote
Remote]] to enter remote synchronizat
synchronization.
ion. Then the message ““Remote Sync” is presented.
Remote Sync”
8 Follow Steps 6 through 9 from 9.5.1 Performing Synchronized Cardioversion as described previously.
9-8
NOTE
During remote synchronous defibrillation, the local defibrillator/monitor does not display the ECG
waveform. To view the patient’s ECG, check the remote monitor.
When you use an remote monitor as the ECG source, a biomedical technician must verify that the remote
monitor and the defibrillator/monitor combination will deliver a synchronized shock within 60 ms of the
peak of the R-wave.
Contact Impedance
Indicator
indicates the impedance is too high for the defibrillation or the pads or paddles are not
1. In Monitor,
Monitor, Manual Defib or Pacer mode, pr
press
ess the Main Menu button on the front panel, and then select→
button
>>]→[Configuration >>]
[Others >>] >>]→Enter the required password.
Note
It is recommended to perform defibrillation on a patient when the contact impedance is in normal range.
However, you can also perform defibrillation when the contact impedance is slightly higher.
9-9
10 Noninvasive Pacing
10.1 Overview
In pacer mode, the patient’s ECG is monitored through ECG lead set and pace pulses are delivered through multifunction
electrode pads. The pads cannot be used to monitoring ECG rhythm and deliver pacing current at the same time.
During pacing, parameters except Resp continue to be monitored and parameter alarms remain active.
In demand mode pacing, a 3-lead or 5-lead ECG cable and electrodes are required to acquire ECG signal. Pace pulses are
delivered through multifunction electrode pads. However, the pads cannot be used to monitor the ECG and deliver pace
pulses simultaneously
simultaneously..
NOTE
In Pacer mode, arrhythmia analysis is supported and available arrhythmia alarms are asystole, ventricular
vibrillation and ventricular tachycardia.
10.2 Safety
WARNING
To avoid explosion hazard when pacing a patient who is receiving oxygen delivery, properly route the
oxygen delivery tube. Do not keep it close to the multifunction electrode pads.
10-1
CAUTION
Use of Pacer mode may be password protected. Make sure the operator knows and remembers the
password as defined in Configuration. Failure to enter correct password will prevent the delivery of pacing
therapy.
Prolonged noninvasive pacing may cause patient skin irritation and burns. Periodically inspect the
underlying skin and change ECG electrodes and multifunction electrode pads.
NOTE
If pacing is interrupted for any reason, the [Start Pacing] soft key must be pressed to resume pacing.
In pacer mode, you cannot change the patient’s internal paced status from the ECG Setup menu.
In the case that pads poorly contact the patient, the alarm “Pacer Stopped Abnormally” and “Pads Off”
may be presented.
Pads are not an available choice for the source of ECG waveform in Pacer mode.
In pacer mode, an ECG waveform, related parameters and waveforms are displayed. The pacer information area shows
the pacer mode, pacer rate and output, as well as pacer-related prompts and alarms. Soft keys available for setting
pacing functions are also displayed.
10-2
In demand mode, the pacer only delivers paced pulses when the patient’s heart rate is lower than the selected
pacing rate.
In fixed mode, the pacer delivers paced pulses at the selected rate.
During pacing, you can change pacer mode. Then the equipment continues to deliver pace pulses at selected pacer rate
and pacer output.
CAUTION
Use demand mode pacing whenever possible. Use fixed mode pacing if noise or artifact interferes with
proper sensing of R-wave or when monitoring electrodes are not available.
During fixed mode pacing, R-wave markers do not appear on the paced beats.
During demand mode pacing, spontaneous beats may be presented which are not associated with the
delivery of pace pulse. If the patient’s
p atient’s heart rate is above the pacer rate, pace pulses are not
n ot delivered and,
therefore, pacing markers do not appear.
4. Apply the
the pads to the patient using a
anterior-lateral
nterior-lateral or ant
anterior-posterio
erior-posteriorr placement.
placement.
You can access manual therapy directly, by confirmation or by password, which can be defined through
configuration management.
management. The default setting is [[Direct].
Direct].
3. Verify tthat
hat white R-wave m
markers
arkers appear above the R-waves, as sh
shown
own in the figure be
below.
low. If th
the
e R-wave markers do
not appear or do not coincide with the R-waves, for example above the T-waves, select another lead.
4. Select pace
pacerr rate. If necessary
necessary,, select iinitial
nitial pacer o
output.
utput. To sselect
elect pace
pacerr rate o
orr pacer output, rot
rotate
ate the Navigation
knob to select an appropriate value and press it to confirm the selection. Do not forget to press the Navigation
knob to exit the setting after desired value is selected.
NOTE
Pacing mark
10-4
7. Adjust pacer
pacer output: increase pace
pacerr output until cardiac capture oc
occurs
curs (captur
(capture
e is indicated
indicated by tthe
he appearance of a
QRS complex after each pacing marker), and then decrease the output to the lowest level that still maintains
capture.
Yo
You
u can temporarily withhold pacing pulse and observe the patient’s
patient’s underlying rhythm by pressing and holding the
[4:1
4:1]] soft key. This causes pacing pulse to be delivered at 1/4 of the defined pacer rate. To resume pacing at set rate,
release this key.
To stop pacing, pr
press
ess the [[Stop Pacing] soft key. Pressing the [Start
Stop Pacing] [Start Pacing]
Pacing] soft key can resume pacing.
CAUTION
Routinely assess the patient’s cardiac output.
10.5.2 Fixed
To pace Mode
in fixed mode:Pacing
fixed
2. Switch the pacer to the Fixed mode. To do so, move the cursor to the Pacer Mode hot key and rotate the
Navigation knob to select [Fix
[ Fix Mode];
Mode]; then press it to confirm the selection, see the figure below:
Pacer mode
hot key
4. Select pacer
pacer rate. If necessary
necessary,, select pacer outpu
output.
t. To selec
selectt pacer rate or pacer output,
output, rotate the Navigation
Navigation knob
to select an appropriate value and press it to confirm the selection.
5. Start pacing.
7. Adjust pacer
pacer output: increase pace
pacerr output until cardiac capture oc
occurs
curs (captur
(capture
e is indicated
indicated by tthe
he appearance of a
QRS complex after each pacing marker), and then decrease the output to the lowest level that still maintains
capture.
You can temporarily withhold pacing pulse and observe the patient’s underlying rhythm by pressing and holding the
[4:1]
4:1] soft key. This causes pacing pulse to be delivered at 1/4 of the defined pacer rate. To resume pacing at set rate,
release this key.
To stop pacing,
pacing, press the [[Stop Pacing] soft key.
Stop Pacing]
WARNING
Use care when handling the multifunction electrode pads on the patient to avoid shock hazard during
pacing.
If you are using the pacing function with battery power and the Low Battery alarm is presented, connect
the equipment to external power or install a fully charged battery.
CAUTION
The monitoring or pacing function may be unstable in the presence of ESU or other electronic devices.
10-6
11 Monitoring Resp
11.1 Overview
Impedance respiration
respiration is measured across the thorax. When the patient is breathing or ventilated, the volume of air
changes in the lungs, resulting in impedance changes between the electrodes. Respiration rate (RR) is calculated from
these impedance changes, and a respiration waveform appears on the equipment screen.
11.2 Safety
WARNING
When monitoring the patient’s respiration, do not use ESU-proof ECG cables.
The respiration measurement does not recognize obstructive and mixed apneas: it only indicates an alarm
when a pre-adjusted time had elapsed since the last detected breath. The safety and effectiveness of the
respiration measurement method in the detection of apnea, especially the apnea of prematurity and
apnea of infancy, has not been established.
RR unit
RR alarm
high limit
RR reading
RR alarm
low limit
11-1
As the Respiration measurement adopts the standard ECG electrode placement, you can use different ECG cables (3-lead,
NOTE
To optimize the respiration waveform, place the RA and LA electrodes horizontally when monitoring
respiration with ECG Lead I; place the RA and LL electrodes diagonally when monitoring respiration with
ECG Lead II.
Lead I Lead II
11-2
Cardiac activity that affects the Resp waveform is called cardiac overlay. It happens when the Resp electrodes pick
up impedance changes caused by the rhythmic blood flow. Correct electrodes
electrodes placement can help to reduce
cardiac overlay. Avoid the liver area and the ventricles of the heart in the line between the respiratory electr
electrodes.
odes.
This is particularly important for neonates.
Some patients with restricted movement breathe mainly abdominally. In these cases, you may need to place the
left leg electrode on the left abdomen at the point of maximum abdominal expansion to optimize the respiratory
wave.
In clinical applications, some patients (especially neonates) expand their chests laterally, causing a negative
intrathoracic pressure.
pressure. In these cases, it is better to place the two respiration electrodes in the right midaxillary
and the left lateral chest areas at the patient’s maximum point of the breathing movement to optimize the
respiratory waveform.
NOTE
Respiration monitoring is not for use on the patients
p atients who are very active, as this will cause false alarms.
Select [Gain
[Gain]] and then choose an appropriate setting. The bigger the gain is, the larger the wave amplitude is.
Select [Sweep
[Sweep]] and then choose an appropriate setting. The faster the wave sweeps, the wider the wave is.
Select [Lead
[Lead]] to set lead for RESP monitoring.
In the [Resp
[Resp Setup]
Setup] menu, you can also change the [Apnea Alarm Delay]
Delay] as desired.
11-3
12 Monitoring PR
12.1 Overview
The pulse numeric
numeric counts tthe
he arterial pulsations th
that
at result fr
from
om the me
mechanical
chanical activity of the heart. You
You can display a
pulse from SpO2 or any arterial pressure. The displayed pulse numeric is color-coded to match its source.
PR unit
To set PR sourc
source,
e,
13 Monitoring SpO 2
13.1 Introduction
SpO2 monitoring is a non-invasive technique used to measure the amount of oxygenated haemoglobin and pulse rate
by measuring the absorption of selected wavelengths of light. The light generated in the probe passes through the
tissue and is converted into electrical signals by the photodetector in the probe. The SpO2 module processes the
electrical signal and displays a waveform and digital values for SpO 2 and pulse rate.
5 6
2. SpO2 unit
5. Oxygen saturation of arterial blood (SpO2): percentage of oxygenated hemoglobin in relation to the sum of
oxyhemoglobin
oxyhemoglobin and deoxyhem
deoxyhemoglobin.
oglobin.
13.2 Safety
WARNING
Use only SpO2 sensors specified in this manual. Follow the SpO2 sensor’s instructions for use and adhere to
all warnings and cautions.
When a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a
laboratory co-oximeter to completely understand the patient’s condition.
Do not use SpO 2 sensors during magnetic resonance imaging (MRI). Induced current could potentially
cause burns.
Prolonged continuous monitoring may increase the risk of undesirable changes in skin characteristics,
such as irritation, reddening, blistering or burns. Inspect the sensor site every two hours and move the
sensor if the skin quality changes. Change the application site every four hours. For neonates or patients
with poor peripheral blood circulation or sensitive skin, inspect the sensor site more frequently.
For Masimo or Nellcor SpO2 modules, you will see corresponding logo on the equipment.
2. Clean tthe
he application
application site, e.g. rremoving
emoving colored nail polish from the application
application site.
site.
4. Select an appropriate ad
adapter
apter cable according to the connect
connector
or type and connect it with tthe
he equipm
equipment.
ent.
NOTE
The SpO2 simulator can be used to check if the SpO2 sensor works properly. However, it cannot be used to
verify the accuracy of the SpO2 sensor.
13-2
The Sat-Seconds
Sat-Seconds featur
feature
e is available w
with
ith the Nellcor SpO2 module to decrease the likelihood of false alarms caused by
motion artifacts. The Sat-Seconds limit controls the amount of time that SpO2 saturation may be outside the set limits
before an alarm sounds. The method of calculation is as follows: the number of percentage points that the SpO2
saturation falls outside the alarm limit is multiplied by the number of seconds that it remains outside the limit. This can
be stated as the equation: Sat-Seconds= Points × Seconds
Only when the Sat-Seconds limit is reached, the monitor gives a Sat-Seconds alarm. The figure below demonstrates the
alarm response time with a Sat-Seconds limit set at 50 and a low SpO 2 limit set at 90%. In this example, the patient’s
SpO2 drops to 88% (2 points) and remains there for 2 seconds. Then it drops to 86% (4 points) for 3 seconds, and then to
84% (6 points) for 6 seconds. The resulting Sat-Seconds are:
Points Seconds Sat-Seconds
2× 2= 4
4× 3= 12
6× 6= 36
Total
Total Sat-Seconds = 52
After approximately
approximately 10.9 seconds, a Sat-Second alarm would sound, because the limit of 50 Sat-Seconds would have
been exceeded.
SpO2%
Seconds
Saturation levels may fluctuate rather than remaining steady for a period of several seconds. Normally, the patient’s SpO2
may fluctuate above and below an alarm limit, re-entering the non-alarm range several times. During such fluctuation,
the system sums the number of SpO 2 points, both positive and negative, until either the Sat-Seconds limit is reached, or
the patient’s SpO2 re-enters the non-alarm range and remains there.
Yo
You
u can Press the Main Menu button on the front panel, and then select [[Alarm >>]→ [Para. Alarm >>]
Alarm Setup >>] >>]→
[Desat], or select a parameter windo
Desat], window
w and then select [[Para. >>]→ [Desat
Para. Alarm >>] Desat]] to set the Desat alarm.
NOTE
In the case that the SpO2 low limit alarm value is set below the Desat limit, the the SpO2 low limit is
automatically adjusted to the Desat value.
There are
are two pitch to
tone
ne modes
modes.. The se
select
lect pitch tone m
mode,
ode, select [[SpO2 Setup]
SpO2 Setup] → [Pitch Tone]
Tone] from the Configuration
Main menu and toggle between [Mode
[Mode 1]
1] and [Mode
[Mode 2].
2].
If the SpO2 is disabled, the pitch tone function will be disabled also.
Ambient light
Patient movement (active and imposed motion)
Diagnostic testing
Low perfusion
Electromagnetic
Electromagnetic interference, such as MRI environment
Electrosurgical
Electrosurgical units
Drop of arterial blood flow to immeaurable level caused by shock, anemia, low temperatur
temperature
e or vasoconstrictor.
13-5
Masimo Patents
No Implied License
Possession or purchase of this device does not convey any express or implied license to use the device with
unauthorized
unauthorized sensors or cables which would, alone, or in combination with this device, fall within the scope of one or
more of the patents relating to this device.
Nellcor Patents
No Implied License
Possession or purchase of this device does not convey any express or implied license to use the device with
unauthorized
unauthorize d replacement parts which would, alone, or in combination with this device, fall within the scope of one or
more of the patents relating to this device.
13-6
14 NIBP
14.1 Introduction
Automatic non-invasive
non-invasive blood pressure monitoring uses the oscillometric method of measurement.
measurement. It is intended for
adult, pediatric and neonatal patients. To understand how this method works, we’ll compare it to the auscultative
method.
With auscultation, the clinician listens to the blood pressure and determines the systolic and diastolic pressures. The
mean pressure can then be calculated with reference
reference to these pressures as long as the arterial pressure curve is normal.
Since the equipment cannot hear the blood pressure, it measures cuff pressure oscillation amplitudes. Oscillations are
caused by blood pressure pulses against the cuff. The oscillation with the greatest amplitude is the mean pressure. Once
the mean pressure is determined, the systolic and diastolic pressures are calculated with reference to the mean.
Simply stated, auscultation measures systolic and diastolic pressures and the mean pressure is calculated. The
oscillometric method measures the mean pressure and determines the systolic and diastolic pressures.
NIBP diagnostic significance must be decided by the doctor who performs the measurement.
14.2 Safety
WARNING
Be sure to select the correct patient category setting for your patient before measurement. Do not apply
the higher adult settings for pediatric or neonatal patients. Otherwise it may present a safety hazard.
Do not measure NIBP on patients with sickle-cell disease or any condition where skin damage has occurred
or is expected.
Use clinical judgment to determine whether to perform frequent unattended blood pressure
measurements on patients with severe blood clotting disorders because of the risk of hematoma in the
limb fitted with the cuff.
Do not use the NIBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could
cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation.
If you doubt the NIBP readings, determines the patient’s vital signs by alternative means and then verify
that the equipment is working correctly.
14-1
The measurement
measurement ma
mayy be inaccur
inaccurate
ate or impo
impossible,
ssible,
Obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery.
STAT: continually rapid series of measurements over a five minute period, then return to the previous mode.
3. Select a cor
correct
rect sized ccuff
uff by refer
referring
ring to the limb circumfe
circumference
rence mar
marked
ked on the cuff. The width of the
the cuff should
be 40% (50% for neonates) of the limb circumference
circumference,, or 2/3 of the upper arm’s length. The inflatable part of the
cuff should be long enough to encircle at least 50% to 80% of the limb.
2. Select [Interval
Interval]] and then select a desired time interval. Selecting [Manual
[Manual]] switches to manual mode.
Warning
Continuous non-invasive blood
blood pressure measurements may cause purpura, ischemia and neuropathy in
the limb with the cuff. Inspect the application site regularly to ensure skin quality and inspect the
1 2
3 7
4
8
5
6
14-3
1. Measurement mode
6. Systolic pressure
7. Diastolic pressure
8. Mean pressure at the completion of measurement, or cuff pressure during the measurement
NOTE
Setting initial cuff inflation pressure is disabled during NIBP measurement.
The initial cuff inflation pressure is restored to the default setting if NIBP module has been reset or patient
category has been changed.
15 Temp
15.1 Introduction
This equipment
equipment allows you to simultaneo
simultaneously
usly monitor two tempe
temperature
rature ssites.
ites.
5
1
6
2
7
3
8
4
9
2. Temperature
Temperature at site 1
4. Temperature
Temperature at site 2
5. Temperature
Temperature unit
6. Temperature
Temperature difference
7. The value of T1
8. The value of TD
9. The value of T2
15-1
NOTE
Verify that the probe detection program works correctly before Temp monitoring. If plug out the probe
cable from the T1 or T2 connector, the equipment shall give an alarm and display corresponding message
correctly.
16 Monitoring IBP
16.1 Introduction
The equipment
equipment can moni
monitor
tor two inv
invasive
asive blood pr
pressures
essures and dis
displays
plays the sys
systolic,
tolic, diastolic and mean pre
pressures
ssures and a
waveform for each pressure.
16.2 Safety
WARNING
Use only pressure transducers specified in this manual. Never reuse disposable pressure transducers.
Make sure that the applied parts never contact other conductive parts.
To reduce the hazard of burns during high-frequency surgical procedure, ensure that the equipment’s
cables and transducers never come into contact with the high-frequency surgical units.
When accessories are used, make sure the operation environment meets the requirements for accessory’s
operation temperature specified by the instructions for use.
The equipment
equipment restarts.
2. Vent the
the transdu
transducer
cer to atmospheric pressure by turning on the stopcock tto
o the air.
Pressure transducer
3-way stopcock
Adapter cable
Defibrillator
/monitor
NOTE
If air bubbles appear in the tubing system, flush the system with the infusion solution again. Air bubble
may lead to wrong pressure reading.
Heparinized
fluid bag
Pressure
transducer
Valve
Stopcock
Adapter cable for pressure
Flushing set
transducer
Pressure line
Defibrillator
/monitor
NOTE
If measuring intracranial pressure (ICP) for a sitting patient, level the transducer with the top of the
patient’s ear. Incorrect leveling may give incorrect reading.
1 2 3 4 5
1. IBP waveform
2. Systolic pressure
3. Diastolic pressure
4. Mean pressure
5. Pressure unit
For some pressures, the parameter window may show the mean pressure only. For different pressures, their default unit
may be different. If the Art/Ao and ICP are measured simultaneously, the parameter window of the ICP display will show
CPP reading, which is obtained by subtracting ICP from the Art/Ao mean pressure.
16-3
2. Select [Label
Label]] and then select your desired label from the list. The already displayed labels cannot be selected.
Select [Sweep
[Sweep]] and then choose an appropriate setting. The faster the wave sweeps, the wider the wave is.
17 Monitoring Carbon CO 2
17.1 Introduction
CO2 monitoring is a continuous, non-invasive technique for determining the concentration of CO2 in the patient’s airway
by measuring the absorption of infrared (IR) light of specific wavelengt
wavelengths.
hs. The CO2 has its own absorption characteristic
and the amount of light passing the gas probe depends on the concentration of the measured CO 2. When a specific
band of IR light is passed through respiratory gas samples, some of IR light will b
bee absorbed by the CO2 molecules. The
amount of IR light transmitted after it has been passed through the respirat
respiratory
ory gas sample is measured with a
photodetector. From the amount of IR light measured, the concentration of CO 2 is calculated.
The equipment
equipment monitors the patient’s CO2 using either a sidestream or a microstream CO 2 module.
1. A CO2 waveform.
2. End tidal CO2 value (EtCO2): the CO2 value measured at the end of the expiration phase.
3. Fraction of inspired CO2 (FiCO2): the smallest CO2 value measured during inspiration.
17.2 Safety
CAUTION
The watertrap collects water drops condensed in the sampling line and therefore prevents them from
entering the module. If the collected water reaches to a certain amount, you should drain it to avoid
blocking the airway.
The watertrap has a filter preventing bacterium, water and secretions from entering the module. After a
long-term use, dust or other substances may compromise the performance of the filter or even block the
airway. In this case, replace the watertrap. Replacing the watertrap once a month is recommended.
Do not apply adult watertrap to the neonate patient. Otherwise, patient injury could rresult.
esult.
NOTE
To extend the lifetime of the watertrap and module, disconnect the watertrap and set the operating mode
to Standby when CO2 monitoring is not required.
17-1
1. Attach the w
watertrap
atertrap to the module and tthen
hen cconnect
onnect the CO2 components as shown below.
Watertrap fixer
Sampling line
17-2
2. After the module finishes warmup, you can take CO2 measurement. During module warmup, the message “CO2
“CO2
Up” is displayed.
Warming Up”
In the standby mode, the gas intake pump, infrared light source, etc. are automatically switched off to reduce
power consumption and extend the lifetime of the CO2 module.
WARNING
Make sure that the appropriate compensations are used. Inappropriate compensations may cause
inaccurate measurement values and result in misdiagnosis.
2. Respectively select:
You can set the humidity compensation on or off according to the actual condition. To set the humidity compensation:
[Single Breath]:
Breath]: EtCO2 and FiCO2 are calculated for every breath.
[10 s],
s], [20
[20 s]
s] or [30
[30 s]:
s]: EtCO2 and FiCO2 are calculated using 10, 20 or 30 seconds of data.
Select [Sweep
[Sweep]] and then choose an appropriate setting. The faster the wave sweeps, the wider the wave is.
Select [Scale
[Scale]] and adjust the upper scale to change the amplitude of CO2 waveform.
Select [Others
[Others >>]
>>] → [Wave Type]
Type] and toggle between [Draw
[Draw]] and [Fill]:
[Fill]:
[Fill]:
Fill]: The CO2 wave is displayed as a filled area.
Mechanical shock
Cyclic pressure higher than 10 kPa (100 cmH2O) or abnormal change to airway pressure
WARNING
When using the Sidestream or Microstream CO 2 measurement on patients who are receiving or have
recently received anesthetics, connect the outlet to a scavenging system, or to the anesthesia
17-5
This trademark
trademark is regist
registered
ered in Isr
Israel,
ael, Japan, Germ
German
an and America
America..
Oridion Patents
The capnography
capnography compo
component
nent of this pr
product
oduct is cov
covered
ered by one or mor
more
e of the fo
following
llowing US patents:
patents: 6,428,483;
6,997,880; 6,437,316; 7,488,229; 7,726,954 and their foreign equivalents. Additional patent applications pending.
No Implied License
Possession or purchase of this device does not convey any express or implied license to use the device with
unauthorized CO2 sampling consumables which would, alone, or in combination with this device, fall within the scope of
one or more of the patents relating to this device and/or CO 2 sampling consumable.
17-6
18 Marking Events
During patient monitoring or therapy, some events may exert effects on the patient and as a result change related
waveforms and parameter values. To help analysing the waveforms or numerics at that time, you can mark these events.
Before marking an event, you can define events A to L, for example, define event D as injecting Atropine. You can only
define an event through configuration management. Event A is always [Generic
[Generic]] and cannot be changed.
To mark an eve
event,
nt,
1. In Monitor
Monitor m
mode,
ode, Manual De
Defib
fib mod
mode,
e, or Pacer mode, press tthe
he [Event
[Event]] button on the front panel to access the
[Mark Event]
Event] menu as shown below.
When you mark an event, the event name and the time when the event is triggered will be displayed at the prompt
information area. This information
information disappears automatically after a period of 5 seconds.
18-1
19 Freezing Waveforms
During patient monitoring, the freeze feature allows you to freeze the currently displayed waveforms on the screen so
that you can have a close examination of the patient’s status. Besides, you can select any frozen waveform for recording.
Waveforms can be frozen only in the Monitor Mode.
The equipment
equipment can free
freeze
ze the wa
waveforms
veforms for 120 seconds
seconds..
At the lower right corner of the bottommost waveform, there is an upward arrow. The frozen time is displayed below the
arrow. With each step or click, the frozen time changes at intervals of 1 second. The time can be applied to all the
waveforms on the screen.
19-1
Select [Exit
[Exit]] to return to the Main screen, or
Perform any other action that causes the screen to be readjusted or opens a menu, such as plugging in or out a
module, pressing the [Lead
[Lead Select]
Select] or [Main
[Main Menu]
Menu] button, etc.
[Wave 1],
1], [Wave
[Wave 2]
2] and [Wave
[Wave 3]
3] if 50 mm recorder is configured. Or
[Wave 1],
1], [Wave
[Wave 2],
2], [[Wave 3] and [Wave
Wave 3] [Wave 4]
4] if 80 mm recorder is configured.
20 Review
20.1 Reviewing Events
The equipment
equipment can automa
automatically
tically reco
record
rd and save patient ev
events.
ents. You can review patient events
events following this
procedure:
To review ev
events,
ents, you ccan:
an:
In the Monitor, Manual Defib or Pacer mode, press the Main Menu button on the front panel, and then select
[Review>>
Review>>]] [Review Events >>]
>>] to enter the [Review
[ Review Events]
Events] menu, or
In the [Review
[Review Events]
Events] menu, you can
Select [Event
[Event Type],
Type], and then select [Operator
[Operator Initiated], [Phys. Alarm], [Arrhythmia], [NIBP Meas.], [Tech.
Alarm] or [All
[All]] to review events as desired.
Select [Prev/Next
[Prev/Next]] to page up/down to view more events.
Select [Index
[Index]] to enter the [Index
[ Index]] menu. In this menu, you can set the time span in which the events happened.
Select [Record
[Record]] to print out the current event list.
Select [Previous
[Previous Menu]
Menu] to return to previous menu.
Select [Exit
[Exit]] to return to the Main screen.
20-1
Patient events will be saved as archived events when the equipment is turned off. In case of power failure, the saved
patient events will not be cleared or lost; they will be turned into archived events instead.
In the Monitor, Manual Defib or Pacer mode, press the Main Menu button on the front panel, and then select
[Review>>
Review>>]] [12-Lead Report>>]
Report>>] to enter the [12-Lead
[ 12-Lead Report]
Report] menu.
21 Data Management
21.1 Introduction
The data management
management functio
function
n enables you to:
To access data m
management,
anagement, p
press
ress the Main Menu button on the front panel to enter the Main Menu, and then
then select
[Others>>
Others>>]] → [Archives>> ]. A prompt pops up as shown below:
Archives>>].
Select [Y
[Yes]
es] to enter the Archives Main screen as shown below
Only in Monitor, Manual Defib and Pacer mode can you access archive mode. When you enter the Archives Main screen,
patient monitoring and therapy automatically
automatically end and the patient last admitted will be saved as the latest archived
patient.
21-1
After the data is completely exported, you can select the [Return
[ Return]] soft key to return to the Archives Main screen.
NOTE
Do not remove the USB flash memory from the equipment before data is completely exported.
21-2
22 Recording
22.1 Using a Recorder
The thermal recorder
recorder records patient inform
information,
ation, measur
measurement
ement nume
numerics
rics and up to four waveforms.
waveforms.
The equipment
equipment can be config
configured
ured with 50 mm or 80 mm therm
thermal
al recor
recorder.
der.
1. Manually-triggered
Manually-triggered realtime waveform recordings.
2. Event-triggered
Event-triggered recordings.
4. Manually-triggered,
Manually-triggered, task-related recordings.
The task-related
task-related rec
recordings
ordings include
include::
Event recording
Check report
Configuration recording
At the completion of recording, two columns of “*” marks will be printed to indicate the end of recording.
22-1
If both [Alarm
[Alarm]] and [Alm
[Alm Rec]
Rec] for a measurement are switched on, an alarm recording will be triggered
automatically as an alarm occurs.
A recording is completed.
The recorder
recorder runs out o
off paper.
The recorder
recorder has a failure
failure..
NOTE
If you change the ECG Lead, Gain or Filter during recording, the recorded ECG waveform changes
accordingly, but the label of Lead, Gain or Filter recorded remains unchanged.
[8 s]:
s]: record a waveform 4 seconds before and 4 seconds after the current moment;
[16 s]:
s]: record a waveform 8 seconds before and 8 seconds after the current moment;
[32 s]:
s]: record a waveform 16 seconds before and 16 seconds after the current moment;
22-2
2. Select [Gridlines
Gridlines]] and toggle between [On
[ On]] and [Off
[Off].
2. Insert a new
new pape
paperr roll int
into
o the
the ccompartment
ompartment as show
shown
n be
below.
low.
50 mm recorder 80 mm recorder
22-3
CAUTION
Use only specified thermal paper. Otherwise, it may cause damage to the recorder’s print head, the
recorder may be unable to print, or poor print quality may result.
Never pull the recorder paper with force when a recording is in process. Otherwise, it may cause damage to
the recorder.
Do not leave the recorder door open unless you have to reload paper or remove troubles.
2. Take out the paper and tear off the draped part.
1. Take me
measures
asures against the static electricity, such as disposable wr
wrist
ist strap, for the work.
3. Gently wipe ar
around
ound the print he
head
ad using cotton swabs dam
dampened
pened w
with
ith alco
alcohol.
hol.
4. After tthe
he alcohol has comp
completely
letely be
been
en drie
dried,
d, reload the paper and close the recorder
recorder door.
CAUTION
Do not use anything that may destroy the thermal element.
23 Network Connection
23.1 Overview
With AP modules and 3G routers, the equipment can work as part of the PHEIS system and be connected to a Central
Monitoring System (hereinafter
(hereinafter called CMS) and send the following information to the CMS to support further
treatment:
Patient information;
Equipment information;
Configuration information;
Waveforms;
Monitoring parameters;
Working mode.
Caution
The PHEIS system shall be installed and maintained by professional service personnel. If any problem
occurs, contact the manufacturer for support.
23-1
4. Select [Return
Return]] and then exit configuration mode.
Caution
Do not change the local IP address randomly. If any problem occurs, contact the manufacturer for support.
3. Select a number
number in the drop-down list after [Select Site]
Site] and enter the name and IP address of the target CMS in the
[Site Name]
Name] and [Set
[Set IP Address]
Address] boxes.
24 Configuration Management
24.1 Introduction
Configurations management enables you to customize you equipment to best meet your needs. With this function, you
can:
After the system configurations have been changed, the equipment restarts and new configuration settings take effect
immediately.
24.2 Password
Accessing configuration management is password protected. The required password is set to 315666 before the
equipment leaves the factory.
To view the configurations or change system time, select [View Config]. In this case, password is not required.
Selecting [Factory
[Factory Config]
Config] and confirming the selection restores all the current settings to factory default
settings:
Selecting [Exit
[Exit]] pops up a dialog box as shown below:
WARNING
Never connect the equipment with the patient while performing configuration management.
24-2
Time Format
Format 12 h, 24 h 24 h /
Month 01 to 12 01 /
Day 01 to 31 01 /
System Time 24 h: 00 to 23 24 h: 00
Hour /
12 h: 12AM to 11PM 12 h: 12AM
Minute 00 to 59 00 /
Second 00 to 59 00 /
Pads Default 2, 5, 10, 50, 100, 150, 170, 200, 300 J 200 J /
Internal Default 2, 5, 10, 20, 30, 50 10 /
Time to Auto Disarm 30s, 60s, 90s, 120s 60s /
Syn After Shock Yes, No No /
Remote Sync On, Off Off /
Monitor Para. 1 Off
SpO2, NIBP, CO2, IBP1 (Label), IBP2
Monitor Para. 2 Off The three parameters
parameters are mutually exclusive.
exclusive.
(Label), Temp, Off
Monitor Para. 3 Off
Charge Tone Vlm High, Med, Low Med /
Contact Impedance IndicatorOn, Off Off /
24-3
Voice Prompt Interval Off, 30s, 60s, 90s, 120s, 150s, 180s 30s /
Voice Recording On, Off Off /
12-Lead:
12-Lead: III,I, II,, II
III,I, aV
aVL,
L, aVR,
aVR, aV
aVF,
F, V
V1
1 V1 2. The options of ECG1 are not available for ECG2.
Couplet
PVC
Vent Rhythm
Bigeminy
Trigeminy
Tachy
Brady
PNP
PNC
Missed Beat
Multif. PVCs
Nonsus. Vtac
Pause
Irr. Rhythim
Asystole Delay 3 to 10 5 /
V-Tach Rate 100 to 200 130 /
V-Tach PVCs 3 to 99 6 /
Vbrd Rate 15 to 60 40 /
Vbrd PVCs 3 to 99 5 /
Adu 60 to 300 160 /
Extreme Tachy
Ped 60 to 300 180 /
Adu 15 to 120 35 /
Extreme Brady
Ped 15 to 120 50 /
PVCs High 1 to 10 10 /
Adu 60 to 300 120 /
Tachy
Ped 60 to 300 160 /
Adu 15 to 200 50 /
Brady
Ped 15 to 200 75 /
Multif. PVCs Window 3 to 31 15 /
Pause Time 1.5, 2.0, 2.5 2.0 /
24-5
Medication
Class
Height
Select Weight
Patient Info. V3 On, Off Off /
Options Placement
Institution
Department
Physician
3 × 4, 3 × 4 Compact, 4 × 3, Median
Report Format Complexes, Measurements Matrix 3×4 /
Neo 90
Adu 80
Desat Ped 50 to (High-1) 80 /
Neo 80
Averaging Masimo SpO2 2-4s, 4-6s, 8s, 10s, 12s, 14s, 16s 8s For Masimo SpO2 module only.
Mindray SpO2 High, Med, Low Med Different options are available to
Sensitivity
Masimo SpO2 Normal, Maximum Normal match the SpO2 module used.
24-7
NIBP-Mean
Alm Lev High, Med Med /
Adu (Low+5) to 270 160
Neo 40
Adu (Low+5) to 230 110
Mean High Ped (Low+5) to 165 90 /
Neo 25
Neo 20
Press. Unit mmHg, kPa, % mmHg Alarm limits are refreshed in real time when
pressure unit is changed.
Sweep 6.25mm/s, 12.5mm/s, 25 mm/s 6.25mm/s /
mmHg 15/20/25/40/50/60/80 50
Different options are available to match the
Scale kPa 2/2.5/3.5/5/7/8/10 7
selected pressure unit.
% 2/2.5/3.5/5/7/8/10 7
For sidestream CO2 module only. If
Flow Rate 70/100 ml/min 100 ml/min microstream CO2 module is used, this item
will be inactive.
Adu 50 The range is different
different according
according to the
EtCO2 High Ped (Low+2) to 99 50 selected pressure unit. The default pressure
Neo 45 unit is mmHg.
24-8
24-9
Adu 160
Sys High Ped (Low+2) to 300 120
Neo 90
Adu 90
Sys Low Ped 0 to (High-2) 70
Neo 55
Adu 110
Mean High Ped (Low+2) to 300 90
Neo 70
Adu 70
Mean Low Ped 0 to (High-2) 50
Neo 35
Adu 90
Dia High Ped (Low+2) to 300 70
Neo 60
Adu 50
PA Settings
24-10
Neo -4
(Upper Scale-1).
Lower Scale -10 to (Upper Scale-2) 0
Adu 13.6
Mean High Ped (Low+2) to 40 5.4
Neo 5.4
Adu 0
Mean Low Ped -10 to (High-2) 0
Neo 0
P1 and P2 Settings
Adu 160
Sys High Ped (Low+2) to 300 120
Neo 90
24-11
Neo 70
Adu 70
Mean Low Ped -50 to (High-2) 50
Neo 35
Adu 90
Dia High Ped (Low+2) to 300 70
Neo 60
Adu 50
Dia Low Ped -50 to (High-2) 40
Neo 20
ECG Green
RESP Yellow
SpO2 Cyan
The same as the
the /
PR
color of PR source
Parameter/Wave NIBP Green, Yellow, Cyan, White, Red, Blue, Purple, Orange White
Color
CO2 Yellow
TEMP White
24-13
Select Site 1, 2, 3, 4, 5, 6, 7, 8 1
25 Batteries
25.1 Introduction
The equipment
equipment is designed to opera
operate
te on battery po
power
wer wh
when
en external power
power supply is not available. The battery is
charged whenever the equipment is connected to AC mains or the DC power supply through an external DC/AC adapter,
regardless
regardless of whether or not the equipment is currently turned on. In case of power failure, the equipment will
automatically run power from internal batteries. So we recommend you always install a fully charged battery in the
equipment.
The equipment
equipment can be conf
configured
igured with two smart lithium ion batterie
batteriess which are ffree
ree of m
maintenance.
aintenance. Battery
Battery icons 1
and 2 displayed on the screen correspond with Battery 1 and Battery 2, see the figure below:
Battery 1
Battery 2
On-screen battery symbols indicate the current battery charge status, taking Battery 1 for an example:
≤ 20% of capacity
If the battery charge is too low, a technical alarm will be triggered and the “Low Battery” message displayed in the
Te
Technical
chnical Alarm Area.
Area. At this m
moment,
oment, chang
change
e the batte
battery
ry or apply extern
external
al power to the equipme
equipment.
nt.
WARNING
The batteries should be charged in this equipment or in a device approved by the equipment
manufacturer.
25-1
NOTE
Always connect the equipment to AC mains whenever
w henever it is possible.
After long term use, the power capacity indicated by the battery symbol may be different from the actual
capacity. Always observe the alarm information displayed on the screen.
To replace a battery,
battery, press
press the latch on the battery and push the batt
battery
ery to the ri
right
ght until you
you remo
remove
ve it. Insert a new
battery into the battery compartment.
Press the Main Menu button on the front panel of the equipment. Select [Others
[Others >>]
>>] → [[Configuratio
Configuration >>]
n >>] →enter the
required password. In the Configuration main menu, select [Alarm
[ Alarm Setup]
Setup] → [[No Battery], and toggle between [Service
No Battery], [ Service
On] and [Service
Indicator On] [Service Indicator Off]. The default setting is [Service
[ Service Indicator Off].
If [[Service On] is selected, the service indicator flashes in the case that battery is not installed,
Service Indicator On]
meanwhile a message “No Battery” is presented in the Technical Alarm Area.
If [[Service
Service Indicator Off] is selected, the service indicator will not be illuminate in the case that battery is
not installed; the message “No Battery” will be presented in the Technical Alarm Area.
If the battery is almost depleted, a prompt “Battery depleted! System will shut down imminently. Connect to AC mains or
replace battery” pops
pops up. IIn
n monitoring, manual defibrillation, and pacing mode, additional alarm lights and alarm tones
are provided.
provided. In this case, take appropriate actions immediately
immediately.. This prompt will not disappear until the battery is
replaced or the equipment is connected to the external power supply. The equipment automatically shuts down if no
NOTE
The Low Battery alarm means that the battery is beginning to weaken and should be replaced at the first
opportunity. At least 20 minutes of monitoring and six full energy shocks can be performed when the Low
Battery alarm is activated. Replace the battery or connect the equipment to AC mains as soon as possible.
1. Connect the
the equipme
equipment
nt to th
the
e extern
external
al power sup
supply
ply and allow the batteri
batteries
es to charge
charge uninterruptedly
uninterruptedly ti
tillll it is fully
charged.
NOTE
Life expectancy of a battery depends on how frequent and how long it is used. When properly cared for,
the lithium-ion battery has a useful life of approximately 2 years. For improper use models, life expectancy
can be less. We recommend replacing lithium-ion batteries every 2 years.
To optimize performance, a depleted, or nearly depleted battery should be charged as soon as possible.
Battery operating time depends on the device configuration and operation. For example, measuring NIBP
repeatedly will shorten the battery operating time.
25-3
Batteries should be charged at temperatures between 0℃ (32℉) to 45℃ (113℉). To optimize performance, a fully (or
nearly fully) discharged battery should be charged as soon as possible.
Remove the battery from the equipment if the equipment is not used for a prolonged time. Otherwise the battery may
be over discharged and it will take significantly longer time to charge the battery. Stored batteries should be charged
every 2 months to 40% to 60% of full capacity. They should be charged to full capacity prior to use.
NOTE
Do not store a battery in the equipment if the equipment is not used for an extended period of time.
Storing batteries at temperature above 38 (100℉) for an extended period of time significantly shorten
the life expectancy of a battery
WARNING
Do not disassemble, puncture or incinerate batteries. Do not short the battery terminals. They may ignite,
explode, or leak, causing personal injury.
25-4
disinfect your equipment. Warranty does not cover damages caused by unapproved cleaning and disinfection
substances or methods.
We make no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. For
For the
method to control infection, consult your hospital’s infection control officer or epidemiologist.
epidemiologist.
In this chapter we only describe cleaning and disinfection of the main unit. For the cleaning and disinfection of external
paddles and other reusable accessories, refer to instructions for use of corresponding accessories.
Keep the paddles clean, Before user checks or after each use, thoroughly clean the paddles and paddle tray.
Never use abrasive materials (such as steel wool or silver polish), or erosive cleaners (such as acetone or
acetone-based cleaners).
WARNING
Be sure to shut down the system, disconnect the power cord and other cables, and remove the batteries
before cleaning the equipment.
CAUTION
Contact your service personnel in case of spilling liquid on the equipment or accessories.
NOTE
To clean or disinfect reusable accessories, refer to the instructions for use delivered with the accessories.
26-1
26.2 Cleaning
Your equipment should be cleaned on a regular basis. If there is heavy pollution or lots of dust and sand in your place,
the equipment should be cleaned more frequently. Before cleaning the equipment, consult your hospital’s regulations
for cleaning the equipment.
ammonia (diluted)
Ethanol (70%)
1. Shut dow
down
n the equipment, disconnect the powe
powerr cord and othe
otherr cables, and remove
remove the batteries.
2. Clean tthe
he display screen using a soft, cle
clean
an clot
cloth
h dampe
dampened
ned w
with
ith a glass cle
cleaner.
aner.
4. Clean tthe
he paddle
paddle tray using a soft, cle
clean
an cloth dampened with a glass cle
cleaner.
aner.
5. Wipe o
off
ff all the cle
cleaning
aning solut
solution
ion with a dry cloth aft
after
er cle
cleaning
aning if necessary.
26.3 Disinfecting
Disinfection may cause damage to your equipment and is therefore not recommended unless otherwise indicated in
your hospital’s servicing schedule. Cleaning equipment before disinfecting is recommended.
The recommended
recommended disinfectants
disinfectants includ
include:
e: ethanol 70%, isopropanol 70%, and Perform* classic concentrate
concentrate OCY (KH
(KHSO
SO4
solution).
26-2
WARNING
Failure for the responsible individual, hospital or institution employing this equipment to implement a
satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.
The safety checks or maintenance involving any disassembly of the equipment should be performed by
professional servicing personnel. Otherwise, undue equipment failure and possible health hazards could
result.
If you find a problem with any of the equipment, contact your service personnel or the manufacturer.
27.1 Overview
Before every use, each shift or once a week, checks shall be done to ensure that the equipment is ready for operation at
any time. After the equipment has been used for 12 months, or whenever the equipment is repaired or upgraded, a
thorough inspection should be performed by qualified service personnel to ensure the reliability.
reliability.
Shift check
Recorder inspection
User test
Pacing test
Paddles and cables are critical parts for defibrillation but damageable. We rec
recommend
ommend you to check the appearance and
performance of these parts every day and replace them every 3 years.
In case of any damage or abnormity, remove the equipment from use. Contact the hospital’s biomedical engineers or
your service personnel immediately.
27-1
Test
est ite
tem
m Weekl
eekly
y Aft
fter
er us
use
e 12 mo
mont
nths
hs 24 mon
onth
thss
Cleaning equipment and accessories ×
Routine Test ×
Controls test ×
Recorder check ×
Charge/
discharge
Manual defibrillation tests
Energy disarming ×
Synchronous defibrillation
Pacing test
Accuracy test
NIBP tests ×
Leakage test
Power module,
Therapy module,
module, and
Monitoring function.
27-2
You need to power on the equipment every day, or when the equipment is first installed, or following any maintenance
or the replacement of any main unit parts to verify that the equipment can be turned on properly.
The equipment
equipment displays no inf
information
ormation on the scree
screen
n during Auto Te
Test.
st.
In the case that Auto T
Test
est fails, the service indicator is illuminated and the equipment gives a beep periodically till the
equipment is restarted. Then a low level technical alarm “Last Auto Test Failed” will be displayed. The “Last Auto Test
Failed” alarm is cleared if Auto Test is passed for the next time or the failed Routine Test or Energy Delivery Test is passed
during User Test. We recommend you to perform the User Test if Auto Test failed.
At the completion of Auto Test, a report is saved automatically. Enter the Configuration Main menu → select [Record
[Record
Setup]]
Setup → [Auto
[Auto Test Report]
Report] → select [On
[On],
], [[Off
Off], or [Only
[Only if Failed],
Failed], you can choose to print the Auto Test Report or not
after the tests are completed, or print it only if Auto Test Failed.
You can review the result of Auto Test by selecting the [History
[ History]] softkey from the User Test Main menu.
27-3
NOTE
With power off, auto Test is performed
p erformed only when AC mains is connected.
Thoroughly clean the paddles and properly place them in the paddle tray after each use. Automated test
passes only when paddles properly contact the metal parts of the paddle tray.
Install at least one battery and
an d properly place the external paddles in the paddle tray or connect the pads
cable and 50 Ω test load. Otherwise the Auto Test will fail.
WARNING
Do not perform user test when a patient is connected to the equipment.
Routine Test,
NOTE
Before user test or after each use, thoroughly clean the paddles and properly place them in the paddle
tray. User test passes only when paddles properly contact the metal parts of the paddle tray.
Check the test items you want to perform and select [Start
Start]] to start user test. The message “Test completed” will be
presented when selected tests have been finished. Then you can press the [ Record
Record]] soft key to print the test result.
Batteries,
Mainboard,
Monitor function
If any of above items fails, the service indicator will be illuminated. If mainboard, Defib/Pacer
Defib/Pacer function, or monitor
function fails, a low level technical alarm “Last User Test Failed” will be displayed in the technical alarm area when the
equipment is restarted. We recommend you to perform a successful User Test to clear this alarm.
Energy delivery test delivers a 200J external discharge to check the defibrillation circuit.
If the test fails, the service indicator will be illuminated and a low level technical alarm “Last User Test Failed” will be
displayed in the technical alarm area when the equipment is restarted. We recommend you to perform a successful User
Te
Test
st to clear this
this alarm.
27-5
Display test
Follow the displayed prompts to run the controls test.
NOTE
The tested controls are indicated in green during controls test.
If any of above items fails, the service indicator will be illuminated and a low level technical alarm “Last User Test Failed”
will be displayed in the technical alarm area when the equipment is restarted. We recommend you to perform a
successful User Test to clear this alarm.
NOTE
The“Off” position of the Mode Select knob is not tested during the Controls Test. If you turn the knob to
“Off” for more than 3 seconds. The equipment is turned off.
The results
results of User Te
Test
st are automatically
automatically save
saved
d as summaries
summaries.. You
You can select tthe
he [History
[History]] button from the User Test
Main menu to review the test summaries.
The equipment
equipment can store up to 300 histor
historical
ical test summ
summaries
aries which are listed in the sequence o
off time, with
with the latest o
on
n
the top. You can use the knob to select a test result and press the knob to check the detailed test report.
27-6
We recommend that Routine Test and Energy Delivery Test are executed once per week and Controls Test once every 12
months.
Each time when the equipment is turned on, the time to last Routine Test, Energy Delivery Test and Controls Test is
checked automatically. The equipment can be configured to give a “User Test Due” message to remind you that the
equipment is due for User Test.
The [User
[User Test Prompt]
Prompt] is switched off by default. Y
You
ou can switch it on by selecting [[User Setup]
User Test Setup] [User Test
→
Prompt]]
Prompt →[On
On]] through the configuration mode.
NOTE
In case that automated Routine Test is not performed, we recommend you to run Routine Test once per
day through User Test.
2. Start recording
recording to verify that the reco
recorder
rder wor
works
ks properly and the pr
printout
intout is le
legible
gible and correct.
3. Simulate errors,
errors, such as removing the paper roll and lo
losing
sing the latch, correct
correct information
information shall be sho
shown
wn in the
prompt area. The recorder shall work properly after the faults are corrected.
Te
Test
st tool: ECG simulator
2. Connect the EC
ECG
G cable to the defibrillator and the electrodes to the simulator.
For 12-lead ECG cables, select “Record” button to record realtime 12-lead ECG waveform. Make sure that there are normal
ECG waveforms displayed for each lead on the printout.
27-7
Charge/discharge
2. Connect th
the
e external paddles to the equipm
equipment
ent and place the paddles on the defibrillator/pacer
defibrillator/pacer analyzer.
3. Enter the C
Configuration
onfiguration Main scre
screen.
en. Fr
From
om tthe
he Rec
Record
ord Se
Setup
tup m
menu
enu se
sett [[Shock Event] to [On
Shock Event] [On]] so that shock events
can be recorded automatically if happened.
6. Charge/discharg
Charge/discharge
e the equipment tto
o verify the ene
energies
rgies me
measured
asured by the analyzer
analyzer meet the following accuracy:
8. Disconnect tthe
he equipm
equipment
ent from the AC mains. Run the equipment on fully ch
charged
arged batte
battery.
ry. Move the Mode Select
knob to Manual Defib. Repeat Steps 2 to 7.
Energy Disarming
2. Connect th
the
e external paddles to the equipm
equipment
ent and place the paddles on the defibrillator/pacer
defibrillator/pacer analyzer.
8. Verify tthat
hat a prom
prompt
pt “Charge Removed” appears on the scree
screen
n and the charge done
done tone stops.
Synchronous Defibrillation
1. Connect the
the external paddles and ECG cable to the equipment. Place the paddles ECG electrodes on the
defibrillator/pacer
defibrillator/pacer analyzer.
7. When charging
charging finishes, pr
press
ess and hold tthe
he “Shoc
“Shock”
k” button to de
deliver
liver a shock.
9. Verify that
that the delay time of synchro
synchronous
nous defibrillatio
defibrillation
n measure
measured
d by the analyzer is less than 60ms.
60ms.
Accessing installation mode is password protected. The required password is set to 888888 before the equipment leaves
the factory.
27-9
You can access Installation Mode while operating in the Monitor, Manual Defib or Pacer mode. Patient monitoring and
therapy automatically
automatically end when you enter Installation Mode.
Tools
Tools requir
required:
ed:
T-shape connector
connector
Tubing
Balloon pump
Manometer
Defibrillator/monitor
Connector for Tubing
NIBP cuff
2. Before inflation,
inflation, the re
reading
ading of the manom
manometer
eter shou
should
ld be 0. If not, disconnect
disconnect the airway and reconnect it until the
readings is 0.
If the difference between the values of the manometer and defibrillator/monitor is greater than 3 mmHg, contact your
service personnel.
Tools
Tools require
required:
d:
An adult cuff
An air tubing
27-11
Defibrillator/monitor Cylinder
Tools
Tools requir
required:
ed:
T-shape connector
connector
Tubing
For sidestream CO2 module, zeroing is required before calibration. Enter the CO 2 Setup menu and select [Zero
[Zero]] to
perform zeroing.
1. Make sure that the CO2 module has been warmed up or started up.
Tubing
Gas valve
Defibrillator
/monitor
Gas cylinder
You can format the storage card if data in the card is useless, or if the card has a failure. To format the storage card, select
[Format Data Card]
Card] → [Format
Format]] through the Installation Mode Main menu. Then a dialog box pops up as shown below:
If storage card is formatted successfully, a prompt “Formatting is completed!” appears. If there is a failure, the system
stops formatting and present a prompt “Formatting fails!”. Contact the service personnel if formatting fails for 3 times”.
After installing the wireless transmission module, you have to send a test page to check if wireless transmission function
works properly.
27-13
Caution
Data transmission via wireless transmission module may sometimes be unreliable. A strong signal and
stationary transmission will improve the transmission
tra nsmission success rate.
Periodically test your equipment transmission function to ensure that the equipment and
an d transmission
accessories are ready for use.
28 Accessories
WARNING
Use accessories specified in this chapter. Using other accessories may cause damage to the equipment or
not meet the claimed specifications.
Single-use accessories are not designed to be reused. Reuse may cause a risk of contamination and affect
the measurement accuracy.
Check the accessories and their packages for any sign of damage. Do not use them if any damage is
detected.
When using the accessories, consider the accessories’ operating temperature. Refer to corresponding
accessory’s instrution for use for details.
Lead Sets
Adapting Cable
SpO2 Sensors
The SpO2 sensor material that patients or other staff will come into contact with have undertaken the bio-compatibility
test and is verified to be in compliance with ISO 10993-1.
512E 512E-30-90390
Adult (Finger type)
512F 512F-30-28263
512G 512G-30-90607
Pediatric (Finger type)
512H 512H-30-79061
28-3
Wavelength of Mindray 518B, 512E, 512F, 512G and 512H SpO2 sensors: red light 660 nm, infrared light 905 nm.
Wavelength
Wavelength of Masimo SpO2 sensors: red light: 660 nm, infrared light: 940 nm.
Wavelength of Nellcor SpO2 sensors: red light: 660 nm, infrared light: 890 nm.
The maximum
maximum photic outpu
outputt consumption of the sensor is less than 18 mW
mW..
The information
information about the waveleng
wavelength
th range and maximum pho
photic
tic output co
consumption
nsumption can be especially useful
useful to
clinicians, for example, clinicians performing photodynamic therapy.
therapy.
Cuff
Temp Probes
MR401B Esophageal/Rectall
Esophageal/Recta 0011-30-37392
Adult
MR403B Skin 0011-30-37393
Reusable
MR402B Esophageal/Rectall
Esophageal/Recta 0011-30-37394
Pediatric, neonate
MR404B Skin 0011-30-37395
MR411 Esophageal/Rectal
Esophageal/Rectal 0011-30-37398
Disposable Adult, pediatric, neonate
MR412 Skin 0011-30-37397
Adapting Cable
008174 / 0010-10-42577
008177 Adult Humidified 0010-10-42572
008180 Humidified, plus O2 0010-10-42575
007266 / 0010-10-42567
008175 / 0010-10-42578
008178 Humidified 0010-10-42573
Pediatric
008181 Humidified, plus O2 0010-10-42576
007269 Plus O2 0010-10-42569
007743 Long, plus O2 0010-10-42571
008179 Infant, neonate Humidified 0010-10-42574
28.8 Miscellaneous
Description Model PN
Te
Test
st load MR6905 040-000413-00
Wireless transmission module kit / 115-006297-00
Y-cable / 009-000829-00
Synchronous
Synchronous defibrillation input cable / 0651-20-77046
A Specifications
Size
Without external paddles 295×218×279 mm
With external paddles 295×218×323 mm
Weight
Main Unit 5.6 kg
Display
Type TFT Color LCD
LCD
Size 8.4 inch
Resolution 800×600 pixels
Viewed waveforms Max. 4
Wave viewing time Max. 16s (ECG)
Equipment connectors
USB connector Connects USB flash memory
Multifunctional connector Connects a cable for analog output or a cable for defibrillator synchronizati
synchronization.
on.
VGA connector Connects TFT display of medical grade.
RJ45 connector Connects standard network cable.
A-1
Audio Indicator
Multifunctional connector
Meets the requirements of EN60601-1 for short-circuit
short- circuit protection and leakage
Standard
current
Output impedance Typically 50Ω
ECG Analog Output
Diagnostic mode: 0.05 to 100 Hz
Bandwidth (-3 dB; refere
reference
nce
Monitor mode: 0.5 to 40 Hz
frequency: 10 Hz)
Therapy mode:
mode: 1 to 20 Hz
Max transmission delay 25 ms (in diagnostic mode, and with Notch off
off))
Sensitivity 1 V/mV ±5%
PACE
PACE rejection/e
rejection/enhancement
nhancement No pace rejection or enhancement
Synchronous input
Input signal range 0 to 5V (TTL level)
Input impedance ≥10 kΩ
Pulse width >5 ms
360 J defibrillation waveform into impedance of 25Ω, 50Ω, 75Ω, 100Ω, 125Ω, 150Ω, 175Ω
)
(V
e
g
tla
o
V
Time (ms)
Impedance
25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 175Ω Accuracy
Energy
1J 1 1 1 0.9 0.9 0.9 0.8 ±2J
2J 2 2 2 1.9 1.8 1.7 1.6 ±2J
3J 2.9 3 2.9 2.8 2.7 2.6 2.4 ±2J
4J 3.9 4 3.9 3.7 3.6 3.4 3.2 ±2J
5J 4.9 5 4.9 4.7 4.5 4.3 4.1 ±2J
6J 5.8 6 5.8 5.6 5.3 5.1 4.9 ±2J
7J 6.8 7 6.8 6.6 6.3 6 5.7 ±2J
8J 7.8 8 7.8 7.4 7.1 6.8 6.5 ±2J
9J 8.8 9 8.8 8.4 8 7.7 7.3 ±2J
10 J 9.7 10 9.7 9.3 8.9 8.5 8.1 ±2J
15 J 15 15 15 14 13 13 12 ±15%
20 J 20 20 20 19 18 17 16 ±15%
30 J 29 30 29 28 27 25 24 ±15%
50 J 49 50 49 47 45 43 41 ±15%
70 J 68 70 68 65 62 60 57 ±15%
100 J 97 100 97 93 89 85 81 ±15%
150 J 146 150 146 140 134 128 122 ±15%
170 J 166 170 166 159 151 145 138 ±15%
200 J 195 200 195 187 178 170 163 ±15%
300 J 292 300 292 280 267 255 244 ±15%
360 J 351 360 350 336 321 306 293 ±15%
A-3
AED
Energy level: 100 to 360J, configurable;
Shock series Shocks: 1, 2, 3, configurable;
Meeting AHA guidelines 2010 by default.
Shockable rhythm VF,
VF, VT (HR>150bpm and QRS width>120ms)
A-4
40ppm to 170ppm
Pacing rate Accuracy: ±1.5%
Resolution: 5 ppm
0mA to 200mA,
Pacing output Accuracy: ±5% or ±5mA, whichever is greater
Resolution: 5mA
200 to 300 ms (depending on pacing rate)
Refractory period
Accuracy: ±3%
4:1 pacing Pacing pulse frequency reduced by factor of 4 when this function is activated.
Output protection The equipment has no sign of damage after defibrillation-proof
defibrillation-proof test.
3-lead ECG cable, 5-lead ECG cable, 12-lead ECG cable, paddles or multifunction
Patient connection
electrode pads
Defibrillation electrodes: pads/paddles
3-lead ECG set: I, II, III
ECG inputs
5-lead ECG set: I, II, III, aVR, aVL, aVF, V,
12-lead ECG set: I, II, III, aVR, aVL, aVF, V1 to V6
Gain 2.5 mm/mV (×0.25), 5 mm/mV (×0.5), 10 mm/mV (×1), 20 mm/mV (×2), 40mm/mV (×4)
Paper speed 6.25mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s
Digital sampling 500 samples/seco
samples/second/channel
nd/channel
Diagnostic mode: 0.05 to 150 Hz
Bandwidth
Monitor mode: 0.5 to 40 Hz
(-3dB, ECG lead set)
Therapy mode:
mode: 1 to 20 Hz
Bandwidth (-3dB, defibrillation
Therapy mode:
mode: 1 to 20 Hz
electrodes)
Diagnostic mode: >90 dB
Common mode rejection
Monitor mode: >105 dB
(ECG lead set)
Therapy mode:
mode: >105 dB
Common mode rejection
Therapy mode:
mode: >90 dB
(defibrillation electrodes)
50/60Hz,
Notch filter In Monitor and Therapy mode: notch filter turns on automatically
In Diagnostic mode: notch filter is turned on manually
ECG signal range ±8mV
Electrode offset potential ±500mV
A-5
ECG
tolerance
Neonate 15 to 350 bpm
HR measurement range Pediatric 15 to 350 bpm
Adult 15 to 300 bpm
HR accuracy ±1% or ±1bpm, which ever is greater
HR resolution 1 bpm
Measuring electrode: <0.1 μA
Lead-off detection current
Drive electrode: <1 μA
Baseline recove
recovery
ry time <5 s (after defibrillation, in monitor mode and therapy mode)
When the test is performed based on part 4.1.2.1 c) of ANSI/AAMI EC 13-2002, the heart
Tall T-wa
T-wave
ve rejection capability rate meter will reject all 100 ms QRS complexe
complexess with less than 1.2 mV of amplitude, and
T waves with
with T
T-wave
-wave in
interval
terval of 180 ms and tthose
hose with Q-T
Q-T interval of 350 m
ms.
s.
4bd - range: 11 s
requirements in Clause 4.1.2.1 d)of ANSI/AAMI EC13-2002, the
In compliance with the requirements
following method is used:
If the last 3 consecutive RR intervals are greater than 1200 ms, the 4 most recent RR
Heart rate averaging intervals are averaged to compute the HR. Otherwise, heart rate is computed by
subtracting the maximum and minimum ones from the most recent 12 RR intervals
and then averaging them.
The HR value displayed o
on
n the monitor screen is up
updated
dated every
every second.
Asystole, V-Fib/V-Tach, Vtac, Vent. Brady, Extreme Tachy, Extreme Brady, PVCs/min, PVC,
Arrhythmia Analysis Classifications Couplet, VT>2, Bigeminy, Trigeminy, R on T, Tachy, Brady, Missed Beats, PNP, PNC, Vent.
Rhythm, Multif. PVC, Nonsus. Vtac, Pause, Irr. Rhythm
A-6
Pace Pulse
Pace pulses meeting the following conditions are labelled with a PACE marker:
Amplitude: ±2 to ±700 mV
Pace pulse markers
Width: 0.1 to 2 ms
Rise time: 10 to 100 µs
Resp
Technique
Technique Trans-thor
Trans-thoracic
acic impedance
Adult: 0 to 120 rpm
Measurement range
Pediatric, neonate 0 to 150 rpm
7 to 150 rpm: ±2 rpm or ±2%, whichever is greater.
Accuracy
0 to 6 rpm: Not specified
Respiration excitation waveform <300 µA, sinusoid, 62.8 kHz (±10%)
Detectable respiration impedance
0.3 to 5Ω
range
Reference
Reference impedance range 200 to 2500Ω, using ECG cable with 1 kΩ resistor
Difference
Difference input impedance >2.5 MΩ
Apnea alarm time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s
A-7
PR
Measurement range 20 to 254 bpm
±3 bpm (measured without motion)
Accuracy
±5 bpm (measured with motion)
PR
Measurement range 25 to 240 bpm
±3 bpm (measured without motion)
Accuracy
±5 bpm (measured with motion)
Low perfusion PR accuracy ±3 bpm
Measurementt range
Measuremen 0 to 100%
Resolution 1%
Sensor Range Accuracy*
Refreshing rate 1s
PR
Measurementt range
Measuremen 20 to 300 bpm
Accuracy ±3 bpm (20 to 250 bpm)
Not specified (251 to 300 bpm)
A-8
Temp
Parameters
Parameters Max. 2 channels. T1, T2, TD
Measurement range 0 to 50 °C (32 to 122 °F)
Accuracy ±0.1 °C or ±0.2 °F (without considering probe error)
Resolution 0.1 °C
Minimum time for accurate Body surface: <100 s
NIBP
Standards Meet standards of EN60601-2-30/IEC60601-2-30, EN1060-1, EN1060-3, EN1060-4 and SP10
Technique
Technique Oscillometry
Mode of operation Manual, Auto and STA
STAT
T
Static pressure measurement
0kPa to 40.0kPa (0mmHg to 300mmHg)
range
Static pressure measurement
±0.4kPa (±3mmHg)
accuracy
120s for adult and pediatric patients
Maximum measurement time
90s for neonatal patients
IBP
Channels 2
Sensitivity 5 μV/V/mm
μV/V/mmHg
Hg
Measurementt range
Measuremen -6.7 kPa to 40.0 kPa (-50 mmHg to 300mmHg)
±2% or ±1mmHg, whichever is greater
Accuracy
(without considering transducer error)
Operation temperature:
temperature: 15 to 40ºC
IBP sensor temperature range
Storage temperature: -25 to 70ºC
Waveform
Wavefor m label
lab el Art
Art,, Ao, FAP,
FAP, BAP, UAP
UAP,, PA, CVP, CPP
CPP,, LAP, RAP, ICP,
ICP, P1, P2, etc
PR
Measurementt range
Measuremen 25 to 350 bpm
Accuracy ±1 bpm or ±1%, whichever is greater
Flow rate
ml/min
Initialization time 30 s (typical)
2.9 s (typical)
(The response time is the sum of the rise time and the delay time when using a sampling
Response time line of standard length)
Rise time: <190 ms (10% to 90%)
Delay time: 2.7 s (typical)
awRR measureme
measurement
nt range 0 to 150 rpm
0 to 70 rpm: ±1 rpm
awRR accuracy 71 to 120 rpm: ±2 rpm
121 to 150 rpm: ±3 rpm
Apnea alarm time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s
A-10
Accuracy drift Meets the requirement for measurement accuracy within 6 hours.
Resolution 1mmHg
70, 100 ml/min
Flow rate
Accuracy: ±15% of set value, or ±15 ml/min, whichever is greater.
Warm-up time 1 min
Measured with an adult watertrap and a 2.5-meter long neonatal sampling line:
<5.5s@100ml/min
<7s@70ml/min
Response time
Measured with a neonatal watertrap and a 2.5-meter adult sampling line:
<3.5s@100ml/min
<4s@70ml/min
awRR measurement range 0 to 120 rpm
awRR accuracy ±2 rpm
Apnea alarm time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s
Battery
14.8V/4.5AH, smart lithium ion battery, rechar
rechargeable
geable and free of maintenance,
maintenance, two batteries can be
Battery type
configured
Less than 2 hours to 80% and less than 3 hours to 100% with equipment power off;
Charge time
Less than 6 hours to 80% and less than 9 hours to 100% with equipment power
power on.
Two new
new fully
One new fully charged Te
Testing
sting condition
charged battery
batteries
Without recording, typical ECG monitoring,
≥5 h ≥10 h
LCD brightness set to 1
Monitoring Without recording, all parameters under
50 Ω load impedance,
impedance,
Pacing ≥3 h ≥6 h pacing rate: 80bpm,
A-12
Parameter
Parameter alarm setting Alarm properties
properties of all available param
parameters
eters can be set simultaneously in the P
Para.
ara. Alarm menu
Auto alarm limits Parameter alarm limits can be automatical
automatically
ly adjusted according to currently measured vital signs
Frequency
Frequency range 2.412 to 2.462GHz
3G
Standards IEEE 802.11b/g or IEEE 802.11n
A-13
Storage environment
Shock
Vibration
Bump
Duration: 6ms
Number of impacts: 1000
Impact direction: vertical impacts are applied when the equipment under test is placed at normal operating position.
Free fall
B EMC
The equipment
equipment meets the require
requirements
ments of IE
IEC
C 60601-1-2.
NOTE
Use of accessories, transducers, and cables other than those specified may result in increased emission
and/or decreased electromagnetic immunity of the defibrillator/monitor.
The equipment or its components should not be used adjacent to or stacked with other devices. If a
adjacent
djacent
or stacked use is necessary, the equipment should be observed to verify normal operation in the
configuration in which it will be used.
The equipment needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided below.
When the inputted signal is below the minimum amplitude provided in technical specifications, erroneous
measurements could result.
IEC 60601
Immunity test Test level Comp
Complianc
liance
e leve
levell Electromag
Electromagnetic
netic envi
environme
ronment
nt - guidance
guidance
Conduced RF 3 Vrms 3 Vrms (V1) Portable and mobile RF communications equipment should
IEC 61000-4-6 150k to 80 MHz be used no closer to any part of the device, including cables,
Outside ISM than the recomm
recommended
ended separation distance calculated from
bandsa the equation applicable to the frequency of the transmitter.
transmitter.
Recommended
Recommended separation distance:
⎡ 3 .5 ⎤
d = ⎢ P
10 Vrms 10 Vrms (V2) ⎣ V 1 ⎥⎦
150kHz to ⎡ 12 ⎤
d = ⎢ P
80MHz ⎣ V 2 ⎥⎦
in ISM bandsa ⎡ 12 ⎤
d = ⎢ P 80 MHz to 800 MHz
(for life support ⎣ E 1 ⎥⎦
devices) ⎡ 23 ⎤
d = ⎣⎢ E 1 ⎦⎥ P 800 MHz to 2.5 GHz
Radiated RF 10V/m 10 V/m (E1)
IEC 61000-4-3 80 MHz to 2.5 where P is the maximum output power rating of the
a
The ISM (industrial, scientific,
scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz
to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b
Compliance level in the ISM frequency bands between 150 kHz to 80 MHz and in the frequency range 80 MHz to 2.5 GHz
are intended to decrease the likelihood that portable/
por table/ mobile communication equipment
equipment could cause interference if it is
inadvertently brought
brought into patient areas. For this reason, an additional factor of 1
10/3
0/3 is used in calculating the
B-4
C-1
NOTE
Remember to disconnect the test load when the test is finished. Otherwise, delay could happen in patient
treatment.
C-2
D Alarm Messages
This chapter lists only the mo
most
st important phy
physiological
siological and te
technical
chnical alarm me
messages.
ssages. Some messages appearing
appearing on
your equipment may not be included.
In this chapter:
Pause] softkey is pressed: “A” means all alarm indications are cleared; “B” indicates alarm light and alarm tones are
cleared and the alarm messages change to prompt messages; and “C” indicates only alarm tone is disabled, but
alarm light and alarm message remain presented.
XX represents a measurement or parameter label, such as ECG, NIBP, HR, PVCs, RR, SpO2, PR, etc.
In the “Cause and solution” column, corresponding solutions are given instructing you to troubleshoot problems. If the
problem persists, contact your service personnel.
D-1
XX Comm Stop H C
XX Overrange L C The measured XX value is not within the specified range for
XX measurement. Contact your service personnel.
ECG ECG Lead Off L* B The ECG electrode
electrode has be
become
come detached
detached from the
the patient or
ECG YY Lead Off L* B the lead wire has become disconnected from the trunk cable.
(YY represents the Check the connection of the electrodes and leadwires.
leadwires V, LL, LA, and
RA, as per AHA standard,
or C, F, L and R as per IEC
standard.)
Pads/Paddles off L* B The pads/paddles have been detached from the patient or
the therapy cable is loose. Check that the pads/paddles and
therapy cable are properly connected.
ECG Noise L A The ECG signal is noisy. Check for any possible sources of
signal noise form the area around the cable and electrode,
and check the patient for excessive motion.
ECG Signal Invalid L A ECG amplitude is so low that ECG signal is undetectable.
Check for any possible source of interference from the area
around the cable and electrode; check the patient’s condition.
D-2
SpO2 Sensor L C sensor is not damaged. Reconnect the sensor or use a new
Incompatible sensor.
SpO2 Too Much Light L C There is too much light on the SpO2 sensor. Move the sensor
to a place with lower level of ambient light or cover the
sensor to minimize the ambient light.
l ight.
SpO2 Low Signal L C The SpO2 signal
signal is too low or too weak. Check
Check the patient’s
patient’s
SpO2 Weak Signal L C condition and change the sensor application site. If the error
SpO2 Weak Pulse L C persists, replace the sensor.
SpO2 Low Perf L B
SpO2 Interference L C The SpO2 signal has been interfered. Check for any possible
sources of signal noise form the area around the sensor, and
check the patient for excessive motion.
SpO2 Non-Pulsatile L C
SpO2 Board Fault L C There is a problem with the SpO2 measurement board. Do not
use the module and contact your service personnel.
NIBP NIBP Loose Cuff L A The NIBP cuff is not properly connected, or
or there is a leak in
NIBP Air Leak L A the airway.
NIBP Pneumatic Leak L A Check the NIBP cuff and pump for leakages.
NIBP Cuff Type Wrong L A The cuff type applied mismatches the patient category. Verify
the patient category and replace the cuff.
NIBP Air Press. Err L A An error occurred to the air pressure. Verify that the
D-3
CO2 CO2 Sensor High Temp L C Check, stop using or replace the sensor.
CO2 Sensor Low Temp L C Check, stop using or replace the sensor.
CO2 High Airway Press. L C An error occurred in the airway pressure. Check the patient
CO2 Low Airway Press. L C connection and patient circuit. Restart the equipment.
CO2 High Barometric L C Verify that the equipment application site meets the
CO2 Low Barometric L C environmentall requirements and check if there is any source
environmenta
that affects the air pressure. Restart the equipment.
CO2 Occlusion L C The airway or watertrap was occluded. Check the airway and
remove the occlusion.
CO2 No Watertrap L B Check the watertrap connections.
Normalization failed L C Check the CO2 connections. After the sensor’s temperature
becomes stabilized, perform a normalization again.
CO2 Hardware Err L C An error occurs to the power supply, gas pump or T-piece.
Restart the equipment.
CO2 Purging… L C An error occurred to the airway. Check the airway.
CO2 Pump Err L C There is a problem with the gas pump. Check, clean or replace
the CO2 module.
CO2 Sensor Fault L C There is a problem with the transducer. Check, clean or
replace the CO2 transducer.
CO2 Check Adapter L A There is a problem with the airway adapter. Check, clean or
replace the airway adapter.
CO2 Tubing Err L C Check if there is a leak in the CO2 sample line or the CO2
sample line has been occluded.
CO2 Zero Failed L A Check the CO2 connections. After the sensor’s temperature
CO2 Cal Fail L A becomes stabilized, perform a zero calibration again.
CO2 System Err L A Re-plug the module or restart the equipment.
CO2 Check Cal. L C Perform a calibration.
CO2 Check Airway L C An error occurred to the airway.
CO2 No Tubing L A Make sure that the sample line is connected.
CO2 Change Sensor L C There is a problem with the CO2 module. Re-plug the module
or restart the equipment.
D-4
Battery 2 Err H C damage; verify that correct batteries are used. Replace the
batteries if necessary.
Battery Depleted! System S C Connect the equipment to AC mains.
will shut shown
imminently. Connect to
AC Mains or Replace
Battery.
Battery 1 Aged L C Replace the battery.
Battery 2 Aged L C
Battery 1 failed charging M C Battery failure or power board hardware failure. Replace the
Battery 2 failed charging M C battery. If the problem persists, contact your service
personnel.
Therapy module
module Therapy Equip selftest Err S C An error o
occurred
ccurred during
during therapy module self te
test.
st. Restart the
equipment or replace the therapy module low voltage board.
Defib Malfunction S C The defibrillation function fails or both the defibrillation and
pacing functions fail. Restart the equipment and test
defibrillation function. If the problem persists, contact your
service personnel.
Pacer Malfunction! S C The pacing function fails. Restart the equipment and test
pacer function. If the problem persists, contact your service
personnel.
D-5
Mornitor Module Reset H C MPM module reset abnormally. In this case, the MPM module
Err restores to default configuration. You can ignore this
problem.
Mornitor Module Voltage L C The voltage of MPM module is abnormal. Replace the MPM
Err module.
Recorder Recorder Init Err L A Restart the equipment.
Recordhead Overheated L A The recorder has been working for a prolonged time. Clear
the recording tasks and resume the recording till the
recorder’s
recorder’s print head cools down.
Recorder Overcurre
Overcurrent
nt L A Re-load the recorder paper.
Others Load Config Err L A Check if the configuration is correct, or restore the factory
configuration.
Pacer Pads cable Off H C Check that pads cable is properly connected.
Pads Off H C Check that pads are properly connected.
ECG Lead Off H C Check that ECG leadwires are properly connected.
Pacer Stopped H C Check paddles. Check that pads well contact with patient’s
Abnormally skin. Make sure pads are properly applied, and then start
pacing again.
Note: In the “L” column “S” refers to special technological alarm. The special technological alarms cannot be paused or
silenced, and the alarm volume is unchangeable
unchangeable.. These alarms stops only when the alarm condition is eliminated.
D-6
All tests can be performed by using commercially available safety analyzer test equipment. These procedures assume
the use of a 601PROXL International Safety Analyzer or equivalent safety analyzer. Other popular testers complying with
IEC 60601-1 used in Europe, such as Fluke, Metron or Gerb, may require modifications to the procedure. Please follow the
instructions of the analyzer manufacturer.
Integrated
Integrated warning labels
LIMITS
For all countries, R = 0.2 Ω Maximum
E-2
LIMITS
For UL60601-1,
For IEC60601-1,
reverse polarity (Normal Condition)
normal polarity with open neutral (Single Fault Condition)
LIMITS
E-3
conditions
The following
following outlet co
conditions
nditions apply whe
when
n performing the Mains on Applied P
Part
art test.
Normal Polarity
Reversed Polarity
LIMITS
The following
following outlet co
conditions
nditions apply whe
when
n performing tthe
he Patien
Patientt Auxiliary Curr
Current
ent test.
LIMITS
E-4
F.1 Units
µA microampere
µV microvolt
A ampere
Ah ampere hour
ºC centigrade
cc cubic centimeter
cm centimeter
dB decibel
DS dyne second
ºF fahrenheit
g gram
GHz gigahertz
GTT gutta
h hour
Hz hertz
in inch
J Joule
k kilo
kg kilogram
kPa kilopascal
L litre
lb pound
m meter
Mb mega byte
mcg microgram
mEq milli-equivalents
mg milligram
min minute
ml milliliter
mm millimeter
F-1
ms millisecond
mV millivolt
mW milliwatt
MΩ megaohm
nm nanometer
rpm breaths per minute
s second
V volt
VA volt ampere
Ω ohm
W watt
F.2 Symbols
– negative, minus
% percent
/ per; divide; or
+ plus
= equal to
± plus or minus
× multiply
© copyright
F-2
Art arterial
aVF left foot augmented lead
aVL left arm augmented lead
aVR right arm augmented lead
awRR airway respiratory rate
BAP brachial aterial pressure
F-3
LV
LVET
ET left ventricular ejection time
F-4
MVe expiratory
expirator y minute volume
MVi inspiratory
inspirator y minute volume
N/A not applied
Neo neonate
O2 oxygen
OR operating room
PA pulmonary
pulmonar y arter
arteryy
PAWP pulmonary
pulmonar y arter
arteryy wedge pressure
PD photodetector
Ped pediatric
Pleth plethysmogram
PR pulse rate
R right
RA right arm
RHb reduced
reduced hemoglobin
RL right leg
RM respiratory mechanics
RR respiration rate
RSBI rapid shallow breathing index
F-5
G Device Tracking
In order to provide high quality product and perform better service, we are going to track our product. Please contact us
with the device tracking information when you have received your defibrillator/monitor:
Please fill the information in the next page, cut the table and fax it to +86 755 26582934. You
You can also email your
information to service@mindray.com
service@mindray.com..
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