Edan M8, M9 User manual
Patient Monitor
Manual Ver: V1.5
Release Date: Jul. 2009
Part Numbe: MS1R-100235-V1.5
P/N: MS1R-100235-V1.5
Statement
This manual will help you understand the operation and maintenance of the product better. It is
reminded that the product shall be used strictly complying with this manual. User’s operation
failing to comply with this manual may result in malfunction or accident for which the
manufacturer can not be held liable.
The manufacturer owns the copyrights of this manual. Without prior written consent of the
manufacturer, any materials contained in this manual shall not be photocopied, reproduced or
translated into other languages.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information are contained in this manual, the user shall
not disclose such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of the manufacturer.
The manufacturer holds the rights to modify, update, and ultimately explain this manual.
Product Information
Product Name: Patient Monitor
Model: M9, M9A, M9B, M8, M8A, M8B.
Responsibility of the Manufacturer
The manufacturer only considers itself responsible for any effect on safety, reliability and
performance of the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by the manufacturer, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
Upon request, the manufacturer may provide, with compensation, necessary circuit diagrams, and
other information to help qualified technician to maintain and repair some parts, which the
manufacturer may define as user serviceable.
Using This Label Guide
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
I
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE: A NOTE provides useful information regarding a function or procedure.
Revision History
This user manual shall be revised whenever changes in regulatory requirements dictate.
Date ECO Version Revision History
30th, July 2007 V1.0 1st edition
13rd, Aug. 2007 ECO-M9-7018 V1.1 Updated menus.
10th, Sep. 2007 ECO-QR-7013 V1.2
5th, Sep. 2008 ECO-MPM-8013 V1.3
4th, Mar. 2009 ECO-MPM-9007 V1.4
27th Jul. 2009 V1.5 Added 12-lead ECG function.
Updated company address, add new
functions of ECG.
Added CO, GAS functions, change
Maintain functions, large font, update
menus, etc.
Added DATA STORE function, add
Smart lead off function.
II
Table of Contents
1 Intended Use and Safety Guidance................................................................................................1
1.1 Intended Use...........................................................................................................................1
1.2 Safety Guidance .....................................................................................................................1
1.2.1 Environment................................................................................................................1
1.2.2 Power Source Requirements .......................................................................................1
1.2.3 Grounding the Monitor ...............................................................................................1
1.2.4 Equipotential Grounding.............................................................................................2
1.2.5 Condensation............................................................................................................... 2
1.2.6 Safety Precautions.......................................................................................................2
1.2.7 Explanation of Symbols on the Monitor .....................................................................7
2 Installation of Monitor....................................................................................................................9
2.1 Opening the Package and Checking.......................................................................................9
2.2 Installing Wall Mount for the Monitor (Optional) .................................................................9
2.3 Connecting the Power Cable................................................................................................10
2.4 Powering on the Monitor .....................................................................................................11
2.5 Connecting Patient Sensors..................................................................................................11
2.6 Checking the Recorder.........................................................................................................12
3 Introduction...................................................................................................................................13
3.1 General Information.............................................................................................................13
3.2 Screen Display .....................................................................................................................18
3.3 Button Functions ..................................................................................................................22
3.4 Interfaces ..............................................................................................................................23
3.5 Built-in Rechargeable Battery..............................................................................................27
4 System Menu..................................................................................................................................28
4.1 Patient Setup.........................................................................................................................29
4.2 Default Setup........................................................................................................................30
4.3 Mark Event...........................................................................................................................31
4.4 Face Select ...........................................................................................................................32
4.5 Time Setup ...........................................................................................................................33
4.6 Record Setup ........................................................................................................................ 34
4.7 Module Setup .......................................................................................................................36
4.8 Tracing Waveforms Selection ..............................................................................................36
4.9 Monitor Version ...................................................................................................................37
4.10 Alarm Volume ....................................................................................................................37
III
4.11 Key Volume........................................................................................................................38
4.12 Drug Calculation ................................................................................................................ 38
4.13 Waveform Demonstration ..................................................................................................39
4.14 Maintenance ....................................................................................................................... 39
4.15 Data Storing .......................................................................................................................43
5 Face Select......................................................................................................................................48
5.1 Selecting Operating Screen..................................................................................................48
5.2 Standard Screen....................................................................................................................48
5.3 Trend Screen.........................................................................................................................49
5.4 oxyCRG Screen....................................................................................................................51
5.5 Large Font Screen ................................................................................................................52
6 Alarm..............................................................................................................................................56
6.1 Alarm Modes ........................................................................................................................ 56
6.1.1 Alarm Level...............................................................................................................56
6.1.2 Alarm Modes .............................................................................................................56
6.1.3 Alarm Setup...............................................................................................................58
6.2 Alarm Cause .........................................................................................................................60
6.3 Silence..................................................................................................................................61
6.4 Parameter Alarm...................................................................................................................61
6.5 When an Alarm Occurs ........................................................................................................62
7 Freeze .............................................................................................................................................63
7.1 General ................................................................................................................................. 63
7.2 Entering/Exiting Freeze Status.............................................................................................63
7.3 FROZEN Menu....................................................................................................................63
7.4 Reviewing Frozen Waveform...............................................................................................64
8 Recording (Optional)....................................................................................................................65
8.1 General Information on Recording ......................................................................................65
8.2 Recording Type ....................................................................................................................65
8.3 Recording Startup.................................................................................................................67
8.4 Recorder Operations and Status Messages ..........................................................................68
9 Trend and Event............................................................................................................................70
9.1 Trend Graph .........................................................................................................................70
9.2 Trend Table...........................................................................................................................71
9.3 NIBP Recall..........................................................................................................................73
9.4 Alarm Event Recall ..............................................................................................................74
10 Drug Calculation and Titration Table (Optional)....................................................................77
10.1 Drug Calculation ................................................................................................................ 77
IV
10.2 Titration Table ....................................................................................................................79
11 Maintenance/Cleaning ................................................................................................................81
11.1 System Check..................................................................................................................... 81
11.2 General Cleaning................................................................................................................81
11.3 Sterilization ........................................................................................................................82
11.4 Disinfection........................................................................................................................83
11.5 Replacement of Fuse..........................................................................................................83
11.6 Cleaning Battery and Battery Compartment Cover ...........................................................83
12 ECG/RESP Monitoring ..............................................................................................................84
12.1 What Is ECG Monitoring...................................................................................................84
12.2 Precautions During ECG Monitoring.................................................................................84
12.3 Monitoring Procedure ........................................................................................................85
12.3.1 Preparation ..............................................................................................................85
12.3.2 Placing Electrodes for ECG Monitoring.................................................................86
12.4 ECG Screen Hot Keys........................................................................................................91
12.5 ECG Menu .........................................................................................................................92
12.5.1 ECG SETUP............................................................................................................92
12.5.2 12-lead ECG............................................................................................................99
12.6 ECG Alarm Information...................................................................................................107
12.7 ST Segment Monitoring (Optional) .................................................................................109
12.8 Arr. Monitoring (Optional)............................................................................................... 113
12.9 Measuring RESP .............................................................................................................. 120
12.9.1 How to Measure RESP..........................................................................................120
12.9.2 Setting Up RESP Measurement ............................................................................120
12.9.3 Installing Electrode for RESP Measurement ........................................................120
12.9.4 RESP SETUP ........................................................................................................121
12.9.5 RESP Alarm Message ...........................................................................................124
12.10 Maintenance and Cleaning.............................................................................................124
13 SpO2 Monitoring.......................................................................................................................125
13.1 What is SpO2 Monitoring.................................................................................................125
13.2 Precautions during SpO2/Pulse Monitoring .....................................................................126
13.3 Monitoring Procedure ......................................................................................................127
13.4 Limitations for Measurement...........................................................................................127
13.5 SpO2 SETUP .................................................................................................................... 128
13.6 Alarm Description ............................................................................................................129
13.7 Maintenance and Cleaning...............................................................................................130
14 NIBP Monitoring.......................................................................................................................131
V
14.1 Introduction......................................................................................................................131
14.2 NIBP Monitoring..............................................................................................................132
14.2.1 NIBP Measurement...............................................................................................132
14.2.2 NIBP Parameter Setup and Adjustment ................................................................135
14.3 NIBP SETUP....................................................................................................................136
14.4 NIBP Alarm Message and Prompt Message ....................................................................140
14.5 Maintenance and Cleaning...............................................................................................142
15 TEMP Monitoring.....................................................................................................................144
15.1 TEMP Monitoring ............................................................................................................144
15.2 TEMP SETUP ..................................................................................................................144
15.3 TEMP Alarm Message .....................................................................................................146
15.4 Care and Cleaning............................................................................................................147
16 IBP Monitoring (Optional).......................................................................................................149
16.1 Introduction......................................................................................................................149
16.2 Precautions during IBP Monitoring .................................................................................149
16.3 Monitoring Procedure ......................................................................................................150
16.4 IBP Menu .........................................................................................................................151
16.5 Alarm Information............................................................................................................158
16.6 Maintenance and Cleaning...............................................................................................159
17 CO2 Monitoring (Optional)......................................................................................................161
17.1 General ............................................................................................................................. 161
17.2 Monitoring Procedure ......................................................................................................162
17.3 CO
SETUP......................................................................................................................168
2
17.4 Alarm Information and Prompt ........................................................................................175
17.5 Maintenance and Cleaning...............................................................................................176
18 CO Monitoring (Optional) .......................................................................................................178
18.1 General ............................................................................................................................. 178
18.2 Monitoring Procedure ......................................................................................................178
18.2.1 CO Measurement Procedure .................................................................................178
18.2.2 CO Monitoring......................................................................................................180
18.2.3 Blood Temperature Monitoring.............................................................................183
18.3 CO SETUP.......................................................................................................................183
18.4 Hemodynamic Calculation...............................................................................................185
18.5 Alarm Information and Prompt ........................................................................................187
18.6 Maintenance and Cleaning...............................................................................................188
19 Anesthetic Gas Monitoring (Optional)....................................................................................190
19.1 General ............................................................................................................................. 190
VI
19.2 Measuring Principle and Operating Process ....................................................................191
19.3 Menus...............................................................................................................................194
19.3.1 GAS SETUP..........................................................................................................194
19.3.2 GAS ALARM SETUP ..........................................................................................199
19.3.3 ADJUST WAVE SETUP .......................................................................................202
19.3.4 DEFAULT menu ...................................................................................................203
19.4 Alarm Information and Prompts.......................................................................................204
19.5 Maintenance and Cleaning...............................................................................................207
20 Accessories and Ordering Information...................................................................................209
21 After-Sales Service.....................................................................................................................212
AppendixⅠSpecification...............................................................................................................213
A1.1 Classification...................................................................................................................213
A1.2 Specifications ..................................................................................................................213
A1.2.1 Size and Weight....................................................................................................213
A1.2.2 Environment.........................................................................................................213
A1.2.3 Display .................................................................................................................214
A1.2.4 Battery ..................................................................................................................214
A1.2.5 Recorder (Optional)..............................................................................................215
A1.2.6 Recall....................................................................................................................215
A1.2.7 ECG......................................................................................................................215
A1.2.8 RESP ....................................................................................................................221
A1.2.9 NIBP..................................................................................................................... 222
A1.2.10 SpO
...................................................................................................................223
2
A1.2.11 TEMP .................................................................................................................225
A1.2.12 IBP (Optional)....................................................................................................225
A1.2.13 CO
(Optional) ...................................................................................................226
2
A1.2.14 CO (Optional).....................................................................................................227
A1.2.15 GAS (Optional) ..................................................................................................228
AppendixⅡEMC Information......................................................................................................230
A2.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS ..............................230
A2.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS...............................230
A2.3 Electromagnetic Immunity - for EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING................................................................................................................232
A2.4 Recommended Separation Distances ..............................................................................233
VII
Patient Monitor User Manual
1 Intended Use and Safety Guidance
1.1 Intended Use
The monitor monitors parameters such as ECG (3-lead, 5-lead or 12-lead selectable), Respiration
(RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure
(dual-IBP, NIBP), Temperature (dual-TEMP), Cardiac output (CO), Expired CO2 and Anesthetic
gas (AG).
The monitor is intended to be used only under regular supervision of clinical personnel. It is
applicable to adult, pediatric, and neonatal usage in a hospital environment and during patient
transport inside a healthcare facility.
The monitor is equipped with alarms that indicate system faults (such as loose or defective
electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
1.2 Safety Guidance
1.2.1 Environment
Follow the instructions below to ensure a completely safe electrical installation. The environment
where the monitor will be used should be reasonably free from vibration, dust, corrosive or
explosive gases, extremes of temperature, humidity, and so on. For a cabinet mounted installation,
allow sufficient room at the front for operation and sufficient room at the rear for servicing with
the cabinet access door open.
The monitor operates within specifications at ambient temperatures between 5℃ and 40℃.
Ambient temperatures that exceed these limits could affect the accuracy of the instrument and
cause damage to the modules and circuits. Allow at least 2 inches (5cms) clearance around the
instrument for proper air circulation.
1.2.2 Power Source Requirements
Refer to AppendixⅠ.
1.2.3 Grounding the Monitor
To protect the patient and hospital personnel, the cabinet of the monitor must be grounded.
Accordingly, the monitor is equipped with a detachable 3-wire cable which grounds the
instrument to the power line ground (protective earth) when plugged into an appropriate 3-wire
receptacle. If a 3-wire receptacle is not available, consult the hospital electrician.
Connect the grounding wire to the equipotential grounding terminal in the main system. If it is
not evident from the instrument specifications whether a particular instrument combination is
hazardous or not, for example due to summation of leakage currents, the user should consult the
manufacturers concerned or an expert in the field, to ensure that the necessary safety of all
instruments concerned will not be impaired by the proposed combination.
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Patient Monitor User Manual
1.2.4 Equipotential Grounding
Protection class 1 instruments are already included in the protective grounding (protective earth)
system of the room by way of grounding contacts in the power plug. For internal examinations on
the heart or the brain, the monitor must have a separate connection to the equipotential grounding
system. One end of the equipotential grounding cable (potential equalization conductor) is
connected to the equipotential grounding terminal on the instrument rear panel and the other end
to one point of the equipotential grounding system. The equipotential grounding system assumes
the safety function of the protective grounding conductor if ever there is a break in the protective
grounding system. Examinations in or on the heart (or brain) should only be carried out in
medically used rooms incorporating an equipotential grounding system. Check each time before
use that the instrument is in perfect working order. The cable connecting the patient to the
instrument must be free of electrolyte.
WARNING
If the protective grounding (protective earth) system is doubtful, the monitor must be
supplied by internal power only.
1.2.5 Condensation
Make sure that during operation, the instrument is free of condensation. Condensation can form
when equipment is moved from one building to another, and thus being exposed to moisture and
differences in temperature.
1.2.6 Safety Precautions
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the instrument.
WARNING
The monitor is provided for the use of qualified physicians or personnel professionally
trained. They should be familiar with the contents of this user manual before operation.
WARNING
Only qualified service engineers can install this equipment. And only service engineers
authorized by the manufacturer can open the shell.
WARNING
EXPLOSION HAZARD-Do not use the device in a flammable atmosphere where
concentrations of flammable anesthetics or other materials may occur.
WARNING
SHOCK HAZARD-The power receptacle must be a three-wire grounded outlet. A hospital
grade outlet is required. Never adapt the three-prong plug from the monitor to fit a
two-slot outlet.
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Patient Monitor User Manual
WARNING
SHOCK HAZARD-Do not attempt to connect or disconnect a power cord with wet hands.
Make certain that your hands are clean and dry before touching a power cord.
WARNING
Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing
equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configurations
shall comply with the valid version of the standard IEC/EN 60601-1-1. Therefore anybody,
who connects additional equipment to the signal input or output connector to configure a
medical system, must make sure that it complies with the requirements of the valid
version of the system standard IEC/EN 60601-1-1. If in doubt, consult our technical
service department or your local distributor.
WARNING
When the monitor is equipped with a wireless network interface, intentionally receives RF
electromagnetic energy for the purpose of its operation. Therefore, other equipment may
cause interference, even if other equipment complies with CISPR emission requirements.
WARNING
Make sure the device is used in the appointed range of voltage, and the effect of power
supply can not be noticed.
WARNING
Before using the rechargeable lithium-ion battery (hereinafter called battery), be sure to
read the user manual and safety precautions thoroughly.
WARNING
Do not place battery in the monitor with the (+) and (-) in the wrong way around.
WARNING
Do not connect the positive (+) and negative (-) terminals with metal objects, and do not
put the battery together with metal object, which can result in short circuit.
WARNING
Do not unplug the battery when monitoring.
WARNING
Do not heat or throw battery into a fire.
WARNING
Do not use, leave battery close to fire or other places where temperature may be above
60℃.
WARNING
Do not immerse, throw, or wet battery in water/seawater.
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Patient Monitor User Manual
WARNING
Do not destroy the battery: do not pierce battery with a sharp object such as a needle; Do
not hit with a hammer, step on or throw or drop to cause strong shock; Do not
disassemble or modify the battery.
WARNING
Use the battery only in the monitor. Do not connect battery directly to an electric outlet or
cigarette lighter charger.
WARNING
Do not solder the leading wire and the battery terminal directly.
WARNING
If liquid leaking from the battery gets into your eyes, do not rub your eyes. Wash them
well with clean water and go to see a doctor immediately.
WARNING
If liquid leaks of the battery splash onto your skin or clothes, wash well with fresh water
immediately.
WARNING
Keep away from fire immediately when leakage or foul odor is detected.
WARNING
Stop using the battery if abnormal heat, odor, discoloration, deformation or abnormal
condition is detected during use, charge, or storage. Keep it away from the monitor.
WARNING
Do not use a battery with serious scar or deformation.
WARNING
Only patient cable and other accessories supplied by the manufacturer can be used. Or
else, the performance and electric shock protection can not be guaranteed, and the
patient may be injuried.
WARNING
The user should check the monitor and accessories before use.
WARNING
Be sure that all electrodes have been connected to the patient correctly before operation.
WARNING
When connecting the cables and electrodes, make sure no conductive part is in contact
with the ground. Verify that all ECG electrodes, including neutral electrodes, are securely
attached to the patient.
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Patient Monitor User Manual
WARNING
Do not touch the patient, bed or instrument during defibrillation.
WARNING
Please set the alarm according to the individual status of patient to avoid delaying
treatment. Ensure there will be alarm audio prompt when alarming.
WARNING
Devices connecting with monitor should be equipotential.
WARNING
When the monitor and electrosurgical device are used together, the user (physician or
nurse) should guarantee the safety of patient.
WARNING
CO2 module shall be avoided from crash and vibration.
WARNING
The patient monitor will be damaged if the water quantity in the water trap reaches the
limit.
WARNING
The machine will be damaged if any pipeline from the CO2 module has been
disconnected, or the air tube/air inlet/air outlet has been plugged by water or other
materials.
WARNING
The accuracy of the measurement of the CO2 will be affected by the following reasons:
— The air way was highly obstructed or air leaks;
— The leakage of air way connection or quick variation of environment temperature.
WARNING
Do not startup the CO2 module if the water trap was not connected. This is to avoid the
machine from damage after impurity enters the pipeline.
WARNING
Please replace the water trap if it is nearly full.
WARNING
Please sterilize and disinfect timely to prevent the cross infection between patients.
WARNING
This equipment is not intended for family usage.
WARNING
Do not unplug the USB storage during storing data.
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Patient Monitor User Manual
If the damaged data caused by unpluging the USB storage during data storing can not be
deleted on the monitor, the user can delete it on the PC.
WARNING
During monitoring, if the power supply is off and there is no battery for standby, the
monitor will be off. After reconnecting the power supply, the user should turn on the
monitor for monitoring.
CAUTION
Electromagnetic Interference -Ensure that the environment in which the patient monitor
is installed is not subject to any sources of strong electromagnetic interference, such as
radio transmitters, mobile telephones, etc.
CAUTION
The monitor is designed for continuous operation and is “ordinary” (i.e. not drip or
splash-proof).
CAUTION
Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine, dust
area, high temperature and humid environment.
CAUTION
Do not immerse transducers in liquid. When using solutions, use sterile wipes to avoid
pouring fluids directly on the transducer.
CAUTION
Do not use autoclave or gas to sterilize the monitor, recorder or any accessories.
CAUTION
The device and reusable accessories could be sent back to the manufacturer for
recycling or proper disposal after their useful lives.
CAUTION
Remove a battery whose life cycle has expired from the monitor immediately.
CAUTION
Avoid liquid splash and excessive temperature. The temperature must be kept between 5
℃ and 40℃ while working. And it should be kept between -20℃ and 55℃ during
transportation and storage.
CAUTION
Before use, the equipment, patient cable and electrodes etc. should be checked.
Replacement should be taken if there is any evident defectiveness or aging symptom
which may impair the safety or performance.
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Patient Monitor User Manual
NOTE:
The monitor can only be used on one patient at a time.
NOTE:
The monitor may not be compatible with all models of USB disks, It is recommended to
use PNY USB disk of 1G or 2G.
NOTE:
If the monitor gets damp, put it in dry circumstance to dry it until it can work normally. If
liquid pours on the monitor, please contact the service personnel of the manufacturer.
NOTE:
The manufacturer suggests that the lifetime of the monitor is 5 years.
NOTE:
This monitor is not a device for treatment purpose.
NOTE:
The function of SpO2 measurement does not require calibration.
NOTE:
The pictures and interfaces in this manual are for reference only.
1.2.7 Explanation of Symbols on the Monitor
This symbol indicates that the equipment is IEC/EN60601-1 Type
CF equipment. The unit displaying this symbol contains an F-Type
isolated (floating) patient applied part providing a high degree of
protection against shock, and is suitable for use during
defibrillation.
This symbol indicates that the instrument is IEC/EN 60601-1 Type
BF equipment. The unit displaying this symbol contains an
F-Type isolated (floating) patient applied part providing a high
degree of protection against shock, and is suitable for use during
defibrillation.
This symbol means 'BE CAREFUL'. Refer to the user manual.
Equipotential grounding system
Stand-by. It designates that the switch or switch position which
one part of the monitor has been switched on, while the monitor is
at the status of stand-by.
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Patient Monitor User Manual
Serial number
Date of manufacture
Manufacturer
P/N
Part Number
Recycle
The symbol indicates that the device should be sent to the special
agencies according to local regulations for separate collection after
its useful life and that this unit was put on the market after 13
August 2005.
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Patient Monitor User Manual
2 Installation of Monitor
Installation should be carried out by qualified service personnel, either by the hospital’s
biomedical department, or by the manufacturer.
For mechanical and electrical installation, you need technically qualified personnel with a
knowledge of english. Additionally, for monitor configuration, you need clinically qualified
personnel with a knowledge of the use environment.
NOTE:
The monitor configuration settings must be specified by authorized hospital personnel.
NOTE:
To ensure that the monitor works properly, please read Chapter Safety Guidance, and
follow the steps before using the monitor.
2.1 Opening the Package and Checking
Open the package and take out the monitor and accessories carefully. Keep the package for
possible future transportation or storage. Check the components according to the packing list.
Check for any mechanical damage.
Check all the functions, cables and accessories.
If there is any problem, contact the manufacturer or local representative immediately.
2.2 Installing Wall Mount for the Monitor (Optional)
Figure 2-1
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Patient Monitor User Manual
Figure 2-2
Figure 2-3
Installation Steps:
1. Outline along the part 1 edge against the wall to the desired location.
2. Drill 4 holes of 6mm in diameter in the wall, and knock the plastic nuts in the holes
completely.
3. Knock 4 screws in the plastic nuts, when tightening them, secure the channel (part 1) at the
desired location of the wall (as shown in Figure 2-1).
4. Slide the arm (part2) into channel (part1) as Figure2-2 shows to the desired location.
5. Tighten the manual screw and secure the arm (part2) at the desired position within the
channel (part1).
6. Face the side with duplexing piece of the device holding plate to the underside of the patient
monitor, fix it with an M4×25mm screw (as shown in Figure 2-3).
7. Pull out the fixing screw from the fixing hole.
8. At the same time, put the arm (part2) into the patient monitor with the device holding plate,
and secure the fixing screw totally through the fixing hole.
9. The patient monitor can be adjusted by a maximum of 15 degrees by rotating the black knob.
2.3 Connecting the Power Cable
Connection procedure of the AC power line:
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Patient Monitor User Manual
Make sure the AC power supply complies with the following specifications: 100V-240V~,
50Hz/60Hz.
Apply the power line provided with the monitor. Plug the power line to INPUT interface of
the monitor. Connect the other end of the power line to a grounded 3-phase power output.
NOTE:
Connect the power line to the jack special for hospital usage.
Connect to the ground line if necessary. Refer to Chapter1.2 Safety Guidance for details.
NOTE:
When the battery configuration is provided, after the device is transported or stored, the
battery must be charged. Powering on without connecting AC power supply may cause
the device to malfunction. Switching on AC power supply can charge the battery no
matter if the monitor is powered on.
2.4 Powering on the Monitor
After you power on the monitor, LOGO information will be displayed on the screen.
WARNING
If any sign of damage is detected, or the monitor displays some error messages, do not
use it on any patient. Contact biomedical engineer in the hospital or Customer Service
Center immediately.
NOTE:
Check all the functions of the monitor and make sure that the monitor is in good status.
NOTE:
If rechargeable batteries are provided, charge them after using the device every time, to
ensure the electric power is enough.
NOTE:
The interval between double pressing of POWER switch should be longer than 1 minute.
NOTE:
After continuous 360-hour runtime, please restart the monitor to ensure the monitor’s
steady performance and long lifespan.
2.5 Connecting Patient Sensors
Connect all the necessary patient sensors between the monitor and the patient.
NOTE:
For information on correct connection, refer to related chapters.
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Patient Monitor User Manual
2.6 Checking the Recorder
If your monitor is equipped with a recorder, open the recorder’s door to check if paper is properly
installed in the slot. If no paper exists, refer to Chapter8 Recording for details.
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Patient Monitor User Manual
3 Introduction
3.1 General Information
The monitor integrates the functions of parameter measurement module, display, recording and
output to compose a compact, portable device. Its built-in replaceable battery provides
convenience for patient movement. On the high-resolution display screen, 7 waveforms and all
the monitoring parameters can be displayed clearly.
The POWER switch is on the left of the front panel (Figure 3-1, 3-2 ①). The POWER indicator
lights when the monitor is powered on (Figure 3-1, 3-2 ②). The CHARGE indicator shows the
charging status (Figure 3-1, 3-2 ③). The ALARM indicator flashes when the alarm is triggered
(Figure 3-1, 3-2 ④). The sockets of various sensors are on the left panel. Other sockets and the
power plug-in are on the rear panel. The recorder is on the right panel.
The monitor is a user-friendly device with operations conducted by a few buttons and a rotary
knob on the front panel (Figure 3-1, 3-2 ⑤⑥). Refer to 3.3 Button Functions.
④
②
MenuStart
⑤
①
Power
Charge
③
FreezeMain
RecordSilence
Figure 3-1 M9 Patient Monitor
⑥
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Patient Monitor User Manual
③
②
Figure 3-2 M8 Patient Monitor
The monitor has 6 models: M9, M9A, M9B, M8, M8A and M8B.
Product
Shell figure
Size (L×W×H)
models
Host:
/ Screen size
Round /
ECG/RESP, SpO2, NIBP, TEMP,
M9
322mm×150mm×285mm
Host:
12.1-inch
Round /
IBP, CO, CO2, GAS
ECG/RESP, SpO2, NIBP, TEMP,
M9A
322mm×150mm×285mm
10.4-inch
IBP, CO, CO2, GAS
⑥
Functions
M9B
M8
M8A
M8B
Host:
320mm×150mm×265mm
Host:
320mm×150mm×265mm
Host:
320mm×150mm×265mm
Host:
320mm×150mm×265mm
Square /
10.4-inch
Square /
12.1-inch
Square /
10.4-inch
Square /
10.1-inch
Width_screen
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ECG/RESP, SpO2, NIBP, TEMP,
IBP, CO2
ECG/RESP, SpO
NIBP,TEMP,
2,
IBP, CO2
ECG/RESP, SpO
NIBP, TEMP,
2,
IBP, CO2
ECG/RESP, SpO2, NIBP, TEMP,
IBP
Patient Monitor User Manual
Figure 3-3 M9 Patient Monitor
Figure 3-4 M9A Patient Monitor
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Patient Monitor User Manual
Figure 3-5 M9B Patient Monitor
Figure 3-6 M8 Patient Monitor
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Patient Monitor User Manual
Figure 3-7 M8A Patient Monitor
Figure 3-8 M8B Patient Monitor
The monitor can monitor the following parameters and waveforms:
ECG: Heart Rate (HR)
Maximum 7-channel/12-channel ECG waveform
Arrhythmia and ST-segment analysis (optional)
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Patient Monitor User Manual
RESP: Respiration Rate (RR)
Respiration Waveform
SpO2: Oxygen Saturation (SpO2), Pulse Rate (PR)
SpO2 Plethysmogram
NIBP: Systolic Pressure (SYS), Diastolic Pressure (DIA), Mean Pressure (MAP), PR (NIBP)
TEMP: Channel-1 Temperature (T1), Channel-2 Temperature (T2),
Temperature Difference between two channels (TD)
IBP: Channel-1 SYS, DIA, MAP
Channel-2 SYS, DIA, MAP
Dual-IBP waveforms
CO2: End Tidal CO2 (EtCO2)
Inspired Minimum CO2 (InsCO2)
Air Way Respiration Rate (AwRR)
CO2 waveform
CO: Blood Temperature (TB)
Cardiac Output (CO)
GAS: Inspired or expired CO2 (FICO2, ETCO2)
Inspired or expired N2O (FIN2O, ETN2O)
Inspired or expired O2 (FIO2, ETO2)
Inspired or expired Anesthetic Agent (FIAA, ETAA):
HAL (Halothame)
ISO (Isoflurane)
ENF (Enflurane)
SEV (Sevoflurane)
DES (Esflurane)
Airway respiration rate (respiring time per minute, rPM), AwRR
Minimal Alveolar Concentration (MAC)
4 anesthetic gas waveforms (CO2, N2O, O2, AA)
The monitor provides extensive functions such as visual and audible alarms, storage for trend
data, NIBP measurements, alarm events, drug dose calculation and so on.
3.2 Screen Display
The monitor is equipped with a high-resolution multicolor TFT LCD screen. The patient
parameters, waveforms, alarm messages, bed number, time, monitor status and other data can be
reflected from the screen.
The screen is divided into three areas:
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1 Information Area ① ④;
③
2 Waveform Area ②;
3 Parameter Area ③.
①
Patient Monitor User Manual
②
Figure 3-9 Main Display
Information Area(① ④)
The Information Area is at the top and bottom of the screen, displaying the operating state of the
monitor and the status of the patient.
The information area contains the following data:
④
Bed number of the monitored patient
ADU Type of patient. Three options: Adult, Pediatric, Neonatal.
Name Name of the monitored patient, when the user inputs patient name, this
name will be displayed on the right side of the patient type. If the user
doesn’t input patient name, this position will be vacant.
10-11-2008 Current date
14: 08: 29 Current time
Indicates the status of mains power supply
means the mains power supply is on,
means the mains power supply is off.
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Patient Monitor User Manual
Indicates the battery and its capacity;
gives information about remaining battery charge, estimated
operating time and maintenance requirements;
means there is no battery equipped in the monitor.
Indicates the audio alarm is turned off.
Indicates the audio alarm is paused.
Displays beside a parameter to indicate the alarm is turned off.
USB storage indicator
STANDBY Select this item to enter Standby mode, the dialog pops up:
Figure 3-10 Standby Mode
Select YES to enter Standby mode and display the current time; if you select NO, the monitor
will return to the main display.
Other information of the Information Area comes up only with respective monitoring status. They
are:
Signs indicating the operating status of the monitor and the sensors are displayed at the right
side of patient name.
Alarm message is displayed in the right most area.
“FREEZE” appears when the waveforms are frozen.
Waveform Area (②)
Seven waveforms can be displayed at the same time. The sequence of waveforms can be adjusted.
With the maximum configuration, the system can display 2 ECG waveforms, an SpO2 waveform,
a respiration waveform (can be from ECG module), 2 IBP waveforms and a CO2 waveform.
In the TRACE SETUP menu, all the waveforms are listed. The user can select the waveform to
be displayed, and adjust the display position. Refer to Chapter4.8 Tracing Waveforms Selection
for details.
The name of the waveform is displayed on the upper left part of the waveform. The name of ECG
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Patient Monitor User Manual
is user-selectable. Gain and filter way of this channel are displayed as well. A 1mV scale is
marked on the right of ECG waveform. The IBP waveform scale can also be selected according
to the actual requirement. Its range is described in the part: IBP Monitoring. In the IBP waveform
area, the waveform scale is displayed. The three dotted lines for each IBP waveform from up to
down represent respectively the upper limit scale, reference scale and lower limit scale. The
values of these three scales can be set. The specific method is given in the part: IBP Monitoring.
When a certain menu is displayed, some waveforms become invisible. Main display is restored
when you exit the menu.
The user may set up the rate to refresh the waveform. The method to adjust the refreshing rate of
each waveform is discussed in the setup description of each parameter.
Parameter Area(③)
Parameter area is on the right of Waveform area, and parameters are displayed corresponding to
waveforms basically. They are:
ECG:
⎯ Heart Rate (Unit: beats per minute, bpm)
⎯ ST-segment analysis of Channel 1 & 2-ST1, ST2 (Unit: mV)
⎯ PVCs (Premature Ventricular Contraction) events (Unit: event/min)
SpO2:
⎯ Oxygen Saturation SpO2 (Unit: %)
⎯ PR (Unit: BPM)
NIBP:
⎯ Systolic pressure, Mean pressure, Diastolic pressure (Unit: mmHg or kPa)
⎯ PR (NIBP) (Unit: BPM)
TEMP:
⎯ Temperatures of channel 1, channel 2 and their temperature difference: T1, T2, TD
(Unit:°C or °F)
RESP:
⎯ Respiration Rate (Unit: breath/min)
IBP:
⎯ The blood pressure of channel 1 and 2. From left to right, there are Systolic pressure,
Mean pressure and Diastolic pressure（Unit: mmHg or kPa)
CO2:
⎯ EtCO2 (Unit: %, mmHg or kPa)
⎯ INS CO2 (Unit: %, mmHg or kPa)
⎯ AwRR (Unit: times/minute)
CO:
⎯ CO (Unit: liter/minute)
⎯ TB (Unit: °C or °F)
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Patient Monitor User Manual
GAS:
⎯ Airway Respiring Rate (Respiring per minute)
⎯ Minimal Alveolar Concentration.
Alarm Indicator and Alarm Status
In normal status, the alarm indicator does not light.
When an alarm occurs, the alarm indicator will light or flash. The color of light represents the
alarm level. Refer to Chapter6 Alarm for details.
Refer to relative content of parameter for Alarm information and prompt.
Charge Indicator and Charge Status
To indicate the status of charging: When the battery is charged, the light color turns to orange.
3.3 Button Functions
All the operations to the monitor can be finished by several buttons and a knob. They are:
① Menu
② Start
③ Record
④ Silence
h
i
c
g
Press to call up the SYSTEM MENU. Refer to Chapter4 SYSTEM
MENU and Chapter9 Trend and Event for details.
Press to fill air into cuff and start blood-measuring. During the
measuring process, press the button to stop measure.
Press to start a real-time recording. The recording time is set in RT
REC TIME of RECORD submenu.
When the SYSTEM MENU > MAINTAIN > USER MAINTAIN >
ALARM SETUP is set to ON, press this button to silence the alarm.
All the alarm audio will be closed. At the same time, “Alarm Pause
f
e
Figure 3-11 Buttons
d
×× s” and will be displayed in the Information area. When you
repress it or the pause time is over, the system will resume the normal
monitoring status, and “Alarm Pause ×× s” and icon will vanish.
Pressing this button and holding for more than 3 seconds can turn off
the audio alarm. is shown in the Information area. Pressing or
holding the button again can resume the alarm.
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