Gradian iM8B_manual Equipment Packet: Oxygen Concentrator

EDAN INSTRUMENTS, INC.

Patient Monitor

Multi-Parameter

Manual Ver: V1.1
Release Date: Apr. 2008
Part Numbe: MS1R-100464 -V1.1

EC Conformity Information

Manufacturer: EDAN Instruments , Inc.

Addr: 3/F-B, Nanshan Medical Equipm ents Park, Nanhai R d 1019#, shekou ,

Nanshan Sh enzhen, 518067 P.R. China

European Representative: Shangh ai International Holding C orp. Gmb H (Europe)

Addr: Eiffestrasse 8 0 D-20537 Hamburg German y

Product: Patient Moni tor

Model: M8B

Classificatio n (MDD, Annex IX): IIb

We herewith declare that the above mentioned product(s) meet the transposition into

national law, the provisions of Council Directive 93/42/ EEC of 14 June 19 93

concerning medical devices-as amended b y Directive 98/79/EC on in vitro

diagnostic medical devices.

All supporting d ocumentation is ret ained at the premises of the manufacturer.

DIRE CTI VES

General Applicable Directives:

Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC of 1 4 June 1993

concerning medical devices (MDD 93/ 42/EEC).

Standards applied: EN6060 1-1:1990+A1:19 93+A2:1995, IEC60 601-1-2:2001,

EN60601-2-27:1994, IEC606 01-2-30:1999, EN60601-2-34:2000,

IEC60601-2-49:200 1, IS O99 19:2005, EN12470-4:2001, EN106 0-1:1995,

EN1060-3:19 97, ANSI/ AAMI SP-10:2002, ISO9001:2000, ISO13485:2003, EN

ISO14971:2000, IEC 6 0601-1:1988, BS EN60601-1-4:1997, ISO 21647:2004,

ANSI/AAM I SP-1 0-200 2, EN1041:1998, IEC /TR 60878-2003, EN980:2003, EN

60417-2-20 00, EN475:1995, EN540:1993, ISO1 000:1998, EN ISO780:1999 .

Notified Body: TÜV SÜD Product Service GmbH, R idlerstr 65, D-80339 MÜnchen,

German y.

Identification number

Copyright

Copyright b y EDAN Instruments, Inc. 2008. All rights reserved.

Statement

EDAN Instruments, Inc. (hereinafter called EDAN) makes no w arranty o f any kind

with regard to t his material, incl u ding, but not limited to the implied warranties of

merchantability and fitness for a particular purpos e. EDAN owns all rights to this

unpublished work and intends to maintain t his work as confidential. EDAN may als o

seek to maintain this work as an unpublished copyright. This publication is to be

used solely for the purposes of reference, operation, maint enance, or repair of this

compan y equipment. No part of this can be disseminat ed for other purpos es.

In the event of inadvertent or deliberate publication, EDAN intend to enforce its

rights to this work under copyright laws as a published work. Those h aving access to

this work may not copy, u se, or disclose the information in t his work unless

expressl y authorized by thi s company to do so.

All information contained in this p ublication is believed to be correct. EDAN shall

not be liable for errors contained herein nor for incid ental or consequential damages

in connection with the furnishing, performance, or use of this material. This

publication may refer to information and protected by copyrights or patents and does

not convey any license under the patent rights of this company, nor the rights of

others. T his company does not assume any liability arising out of any infringements

of patents or other rights of third parties.

Content of this manual is subject to changes without prior notice.

Responsibility of the Manufacturer

This company is responsible for safety, reliabilit y and perform ance o f t his

equipment only in the conditio n that:

• All install ation, expansion, change, modification and repai r of this equipment are

conducted by EDAN quali fied personnel; and,

• Applied electrical appliance is in compliance with relevant National Standards;

I

and,

• The monitor is o perat ed under strict observance of this manual.

NOTE:

This equ ipment is not intended for family usage.

WARNING

This monitor is not a de vice for treatment purpose.

Using This Label Guide

This guide is desi gned to give key concepts on safety precautions.

WARNING

A WARNING label advises agai nst certain a cti ons or situations that could

result in personal injury or death.

CAUTION

A CAUTION l abel advises against actions or situations that could damage

equipment, produce inaccurate d ata, or invalidat e a proced ure.

NOTE: A NOTE provides useful information regarding a function or procedure.

Warranty

Workma nship & Materials

EDAN guarantees new equipment other than accessories to be free from defects in

workmanship and materials for a period of one year (six m onths for multi-site probes

and SpO2 sensor) from d ate of shipment under normal u se and service. This

compan y's obligation u nder this warranty is limited to repairing, at this company’s

option, an y part which upon this company's ex aminati on proves defective.

Exempti ons

This company's obligation or liability under t his warranty does not incl ude 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

II

substitution upon i t of parts or accessories not approved by this company or repaired

by an yone other than this compan y authorized representative.

This warranty shall not extend to any instrument which has been subjected to misuse,

negligence or accident; any instrument from which this compan y's ori gin al serial

number tag or product identification markings have been altered or removed, or any

product of an y other manufacturer.

Safety, Reliability and Performance

This company is not responsibl e for the e ffects o n safet y, reliabilit y and performance

of the Multi-parameter Patient Monitor if:

■ Assem bl y operations, exten sio ns, re-adjusts, modifications or repairs are carried

out by persons other than th ose authorized by this compan y.

■ The Multi-parameter Patient Monitor is not used in accordance wi th the

instructions.

Return Policy

Return Procedure

In the event that it becomes necessary to return a unit to EDAN, the following

procedure should be followed:

1) Obtain return aut horization. Contact EDAN Service Department and obtain a

Customer Service Authorization number. The Company number must appear on

the outside of the shipping con tainer. Return shipm ents will not be accepted if

the Company number is not clearl y visible. Please provide the model number,

serial number, and a brief description of the reason for return.

2) Freight policy. The customer is respon sible for freight charges when equipment

is shipp ed to EDAN for service (this includes customs charges).

III

Revision History

This user ma nua l shall be revised whenever cha n ges in regulatory requirements di c tate.

Dat e ECO Version Revision history

21st, Jan. 2 008 V1.0

8th, Apr. 2008 ECO-MPM-8005 V1.1

1st edition

Add CE information; add

3-channel recording.

IV

Contents

1 Introduction ....................................................................................................................1

1.1 General Information ................................................................................................ 1

1.2 Screen Display........................................................................................................ 2

1.3 Button Functions..................................................................................................... 5

1.4 Interfaces................................................................................................................ 7

1.5 Built-in Chargeable Battery ..................................................................................... 9

2 Installation of Monitor.................................................................................................. 11

2.1 Open the Package and Check .............................................................................. 11

2.2 Install Wall Mount for M8B (Optional).................................................................... 11

2.3 Connect the Power Cables ................................................................................... 13

2.4 Power on the Monitor............................................................................................ 13

2.5 Connect Patient Sensors ...................................................................................... 14

2.6 Check the Recorder.............................................................................................. 14

3 System Menu ................................................................................................................ 15

3.1 Patient Information Setup .....................................................................................15

3.2 Default Setup ........................................................................................................ 17

3.3 Mark Event............................................................................................................ 18

3.4 Face Select........................................................................................................... 19

3.5 Time Setup............................................................................................................ 19

3.6 Recorder Setup..................................................................................................... 20

3.7 Module Setup........................................................................................................ 22

3.8 Tracing Waveforms Selection ............................................................................... 22

3.9 Monitor Version..................................................................................................... 23

3.10 Alarm Volume...................................................................................................... 23

3.11 Key Volume......................................................................................................... 24

3.12 Drug Calculation ................................................................................................. 25

3.13 Waveform Demonstration ................................................................................... 25

3.14 Maintenance ....................................................................................................... 25

V

4 Face Select.................................................................................................................... 32

4.1 Select Operating Screen....................................................................................... 32

4.2 Standard Screen ................................................................................................... 32

4.3 Trend Screen ........................................................................................................ 33

4.4 oxyCRG Screen.................................................................................................... 34

4.5 Viewbed Screen.................................................................................................... 35

4.6 Large Font Screen ................................................................................................ 36

5 Alarm ............................................................................................................................. 39

5.1 Alarm Modes......................................................................................................... 39

5.1.1 Alarm Level.................................................................................................. 39

5.1.2 Alarm Modes................................................................................................ 39

5.1.3 Alarm Setup .................................................................................................41

5.2 Alarm Cause ......................................................................................................... 42

5.3 SILENCE ..............................................................................................................43

5.4 Parameter Alarm................................................................................................... 43

5.5 When an Alarm Occurs......................................................................................... 44

6 Freeze............................................................................................................................ 45

6.1 General ................................................................................................................. 45

6.2 Enter/Exit Freeze Status .......................................................................................45

6.3 FROZEN Menu ..................................................................................................... 46

6.4 Reviewing Frozen Waveform................................................................................ 46

7 Recording (Optional).................................................................................................... 47

7.1 General Information on Recording........................................................................ 47

7.2 Recording Type..................................................................................................... 47

7.3 Recording Startup ................................................................................................. 49

7.4 Recorder Operations and Status Messages ......................................................... 50

8 Trend and Event ........................................................................................................... 52

8.1 Trend Graph.......................................................................................................... 52

8.2 Trend Table ........................................................................................................... 53

8.3 NIBP Recall .......................................................................................................... 55

VI

8.4 Alarm Event Recall ............................................................................................... 56

9 Drug Calculation and Titration Table (Optional) ........................................................ 58

9.1 Drug Calculation ................................................................................................... 58

9.2 Titration Table ....................................................................................................... 60

10 Safety Guidance ......................................................................................................... 62

11 Maintenance/Cleaning................................................................................................ 70

11.1 System Check ..................................................................................................... 70

11.2 General Cleaning ................................................................................................ 70

11.3 Cleaning Agents.................................................................................................. 71

11.4 Sterilization.......................................................................................................... 72

11.5 Disinfection ......................................................................................................... 72

11.6 Replacement of Fuse .......................................................................................... 72

12 ECG/RESP Monitoring ............................................................................................... 73

12.1 What Is ECG Monitoring ..................................................................................... 73

12.2 Precautions during ECG Monitoring ................................................................... 74

12.3 Monitoring Procedure.......................................................................................... 74

12.3.1 Preparation ................................................................................................ 74

12.3.2 Installing ECG Lead ................................................................................... 75

12.4 ECG Screen Hot Keys ........................................................................................ 80

12.5 ECG Menu .......................................................................................................... 81

12.6 ECG Alarm Information....................................................................................... 87

12.6.1 Alarm Message .......................................................................................... 87

12.7 ST Segment Monitoring (Optional)...................................................................... 90

12.8 Arr. Monitoring (Optional) .................................................................................... 93

12.9 Measuring RESP ................................................................................................ 99

12.9.1 How to Measure RESP? ............................................................................ 99

12.9.2 Setting up RESP Measurement ................................................................. 99

12.9.3 Installing Electrode for RESP Measurement .............................................. 99

12.9.4 RESP Menu ............................................................................................. 100

12.9.5 RESP Alarm Message.............................................................................. 102

VII

12.10 Maintenance and Cleaning ............................................................................. 102

13 SpO2 Monitoring ....................................................................................................... 104

13.1 What is SpO2 Monitoring................................................................................... 104

13.2 Precautions during SpO2/Pulse Monitoring....................................................... 105

13.3 Monitoring Procedure........................................................................................ 106

13.4 Limitations for Measurement............................................................................. 107

13.5 SpO2 Menu ....................................................................................................... 107

13.6 Alarm Description.............................................................................................. 109

13.7 Maintenance and Cleaning ................................................................................111

14 NIBP Monitoring ....................................................................................................... 112

14.1 Introduction ....................................................................................................... 112

14.2 NIBP Monitoring................................................................................................ 113

14.2.1 NIBP Measuring....................................................................................... 113

14.2.2 NIBP Parameter Setup and Adjustment ................................................... 116

14.3 NIBP SETUP menu........................................................................................... 117

14.4 NIBP Alarm Message and Prompt Message..................................................... 120

14.5 Maintenance and Cleaning ............................................................................... 123

15 TEMP Monitoring...................................................................................................... 125

15.1 TEMP Monitoring .............................................................................................. 125

15.2 TEMP SETUP Menu......................................................................................... 126

15.3 TEMP Alarm Message ...................................................................................... 127

15.4 Care and Cleaning............................................................................................ 128

16 IBP Monitoring (Optional) ........................................................................................ 130

16.1 Introduction ....................................................................................................... 130

16.2 Precautions during IBP Monitoring.................................................................... 130

16.3 Monitoring Procedure........................................................................................ 131

16.4 IBP Menu .......................................................................................................... 132

16.5 Alarm Information.............................................................................................. 140

16.6 Maintenance and Cleaning ............................................................................... 141

17 Accessories and Ordering Information .................................................................. 143

VIII

18 Service Information.................................................................................................. 146

AppendixⅠ .................................................................................................................... 147

A1.1 Classification .................................................................................................... 147

A1.2 Specifications ................................................................................................... 147

A1.2.1 Size and Weight ...................................................................................... 147

A1.2.2 Environment ............................................................................................ 147

A1.2.3 Display..................................................................................................... 148

A1.2.4 Battery ..................................................................................................... 148

A1.2.5 Recorder (Optional)................................................................................. 148

A1.2.6 Recall ...................................................................................................... 148

A1.2.7 ECG......................................................................................................... 148

A1.2.8 RESPIRATION ........................................................................................ 150

A1.2.9 NIBP ........................................................................................................ 151

A1.2.10 SpO2...................................................................................................... 152

A1.2.11 TEMPERATURE .................................................................................... 152

A1.2.12 IBP......................................................................................................... 153

Appendix Ⅱ................................................................................................................... 154

A2.1 Electromagnetic Emissions-for all EQUIPMENT and SYSTEMS ..................... 154

A2.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS ..................... 154

A2.3 Electromagnetic Immunity-for EQUIPMENT and SYSTEMS that are not

LIFE-SUPPORTING.................................................................................................. 155

A2.4 Recommended Separation Distances .............................................................. 156

IX

M8B Multi-Parameter Patient Monitor User Manual

1 Introduction

1.1 General Information

M8B Multi-parameter patient monitor monitors parameters such as ECG, RESP, SpO2, NIBP,

dual-TEMP and dual-IBP (optional). It is adaptable to adult, pediatric, and neonatal usage. The user

can select different parameter configuration according to different requirements.

It centralizes the function of parameter measurement module, display, record 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 1-1①). The POWER indicator lights
when the monitor is powered on (Figure 1-1②). The CHARGE indicator shows the charging status
(Figure 1-1③). The ALARM indicator flashes when the alarm is triggered (Figure 1-1④). The

sockets of various sensors are on the left panel. Other sockets and power plug-in are on the rear

panel. The recorder is on the right panel.

M8B Multi-parameter patient monitor is a user-friendly device with operations conducted by a few

buttons and rotary knob on the front panel (Figure 1-1⑤⑥). Refer to Button Functions.

④

Figure 1-1 Button Functions of M8B

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M8B Multi-Parameter Patient Monitor User Manual

Figure 1-2 M8B Multi-parameter Patient Monitor

M8B Multi-parameter patient monitor can monitor:

ECG: Heart Rate (HR),

2-channel ECG waveform,

Arrhythmia and ST-segment analysis (optional);

RESP: Respiration Rate (RR),

Respiration Waveform;

SpO2: Oxygen Saturation (SpO2), Pulse Rate (PR),

SpO2 Plethysmogram;

NIBP: Systolic Pressure (NS), Diastolic Pressure (ND), Mean Pressure (NM);

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;

M8B Multi-parameter patient monitor provides extensive functions as visual & audible alarm,

storage for trend data, NIBP measurements, alarm events, and drug dose calculation and so on.

1.2 Screen Display

M8B Multi-parameter patient 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: 1 Information Area; 2 Waveform Area; 3 Parameter Area.

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M8B Multi-Parameter Patient Monitor User Manual

④

②

③

①

Figure 1-3 Main Interface of M8B

Information Area (① ④)

The Information Area is at the top and bottom of the screen, displaying operating state of the

monitor and status of the patient.

The information area contains following data:

Bed number of the monitored patient

ADU Type of patient. Three options: Adult, Pediatric, Neonate
Name Name of the monitored patient. When the user input patient’s name, this

name will be displayed on the right side of the Patient type. If the user

does not input patient name, this position will be vacant.

“12-05-2007” Current date

"11:33:23" Current time

Indicates the status of mains power supply

means the mains power supply is on,

means the mains power supply is off.

Indicates the battery and its capacity in the monitor

means there is a battery in the monitor, and the green part

indicates the battery’s charge.

means there is no battery is equipped in the monitor.

Indicates the audio alarm is turned off.

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M8B Multi-Parameter Patient Monitor User Manual

Indicates the audio alarm is paused.

Indicates the alarm for parameters is turned off.

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 at 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.

Under the maximum configuration, the system can display 2 ECG waveforms, SpO2 waveform,

Respiration waveform (can be from ECG module), 2 IBP waveforms.

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 “Waveform Sequence Selection” for details.

The name of the waveform is displayed on the upper left part of the waveform. The name of ECG 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: bpm)
 ST-segment analysis of Channel 1 & 2 – ST1, ST2 (Unit: mV)
 PVCs (Premature Ventricular Contraction) events (Unit: event/min)

Oxygen Saturation (SpO2):

 SpO2 (Unit: %)

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M8B Multi-Parameter Patient Monitor User Manual

NIBP:

 (From left to right) Systolic pressure, Mean pressure, Diastolic pressure (Unit: mmHg or

kPa)

TEMP:

 Temperature of channel1 and channel2 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)

Alarm Indicator and Alarm Status

Under normal status, the alarm indicator does not light.

When alarming, the alarm indicator lights or flashes. The color of light represents the alarm level.
Refer to “Alarm Functions” for details.

Refer to relative content of parameter for Alarm information and prompt.

Charge Indicator and Charge Status

The light can indicate the status of charging. When the battery is charged, the light color will turn to

orange.

1.3 Button Functions

All the operations to M8B Multi-parameter patient monitor can be finished by several buttons and a

knob. They are:

Figure 1-4 Buttons

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M8B Multi-Parameter Patient Monitor User Manual

① Menu Press to call up the SYSTEM MENU. Refer to Chapter System

Menu and Chapter Trend and Event for details.

② Start Press to fill gas into cuff and start blood-measuring. During the

measuring process, press the button to stop measuring and

deflating.

③ Record

④ Silence

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 ON， Press this button

to enter the status of ALARM SILENCE. All the alarm audio

will be closed. At the same time, “Alarm Pause ×× s” and

will be displayed in the interface. When repress it or the pause

time is over, the system will stop pausing, and resume the
normal monitoring status, and “Alarm Pause ×× s” and icon

will vanish.

Press this button and hold for more than 3 seconds can turn off

the audio alarm. displays on interface. Press or hold the

button again can resume the alarm.

⑤ Freeze

⑥ Main

⑦ Rotary Knob

NOTE:

Whether an alarm will be reset depends on the status of

the alarm cause. But by pressing SILENCE button

(suspend alarm) can permanently shut off audio sound of

the Lead Off or Sensor Off alarms. So the user can exit

the Alarm Silence Status by Technical Alarm.

When in normal mode, press this button to freeze all the

waveforms on the screen. When in FREEZE mode, press to

restore the waveform refreshing.

Press to return to the main interface.

The user may use the rotary knob to select the menu item and

modify the setup. It can be rotated clockwise or anticlockwise

and pressed like other buttons. The user may use the knob to

realize the operations on the screen and in the system menu

and parameter menu.

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M8B Multi-Parameter Patient Monitor User Manual

Method to Use the Knob to Operate on the Screen:

The rectangular mark on the screen that moves with the rotation of the knob is called “cursor”.

Operation can be performed at any position at which the cursor can stay.

When the cursor is in the waveform area, the user may immediately modify the current setup. When

the cursor is in the parameter area, the user may open the setup menu of the corresponding

parameter module so as to set up the menu items of the module.

Operating method:

■ Move the cursor to the item where the operation is wanted.

■ Press the knob.

■ One of the following four situations may appear:

1． The cursor with background color may become into the frame without background

color, which implies that the content in the frame can change with the rotation of the

knob.

2． Menu or measuring window may appear on the screen, or the original menu is replaced

by the new menu.

3． A check mark “√” appears at the position, indicating that the item is confirmed.
4． The system immediately executes a certain function.

1.4 Interfaces

For the convenience of operator, interfaces of different function are in different sites of the monitor.

Right Side of the Monitor

At the right side of the monitor, there is the bracket of hydrophobic bottle from the recorder’s paper
inlet cover (①).

①

Figure 1-5 Right panel

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M8B Multi-Parameter Patient Monitor User Manual

② ③ ④ ⑤ ⑥ ⑦

！

Left Side of the Monitor

Connectors for cables and sensors are as shown in Figure 1-6.

① TEMP1 probe connector
② TEMP2 probe connector
③ IBP2 transducer connector
④ IBP1 transducer connector
⑤ ECG cable connector

⑥ NIBP cuff connector

⑦ SpO2 sensor connector

IBP2

S

T1

T2

CO

O2

p

①

CO2

BP1

I

ECG

BP

I

N

Figure1-6 Left Panel

This symbol means “BE CAREFUL". Refer to the manual.

Indicates that the instrument is IEC60601-1 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.

Rear Panel

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M8B Multi-Parameter Patient Monitor User Manual

①

②

③

④

Figure 1-7 Rear panel of M8B

Sockets on the rear panel are shown in Figure 1-7.

① Network Interface (reserved): Standard RJ45 Socket, for connecting to MFM-CMS of EDAN.
② Equipotential grounding terminal for connection with the hospital’s grounding system.
③ Fuse box, used to put fuse in.
④ Power supply socket: AC100-240 V, 50/60 Hz.

1.5 Built-in Chargeable Battery

M8B Multi-parameter Patient Monitor is equipped with a built-in chargeable battery. When switch

on AC power supply, the battery will be charged automatically until full electric energy. There is a
sign “ ” in the lower left corner of screen to show the charging status, and the green part is

the electric energy of battery. When the monitor is not equipped with battery, the battery status will

be showed as the sign “ ”, which means no battery.

One battery can support the working of monitor. Under the cable connectors is the cover of battery

slot. See figure1-8 Battery Slot cover.

The charging time for battery resume to 90% quantity of electric charge needs 6 hours.

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M8B Multi-Parameter Patient Monitor User Manual

OPEN

Figure 1-8 Battery Slot Cover

Replace Battery

When the lifespan of battery is over, or foul odor and leakage has been detected, please contact with

manufacturer or local distributor for replacement of battery.

WARNING

Do not unplug the battery when monitoring.
The unexpected power off can not impact the device normal working, for it has battery for
standby.

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

Make sure the device is used in the appointed range of voltage, the effect of power supply
can be not noticeable.

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M8B Multi-Parameter Patient Monitor User Manual

2 Installation of Monitor

■ Open the package and check

■ Install wall mount for M8B

■ Connect the power cables

■ Power on the monitor

■ Connect patient sensors

■ Check the recorder

NOTE:

To ensure that the monitor works properly, please read Chapter Safety Guidance, and

follow the steps before using the monitor.

2.1 Open the Package and Check

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 cables, modules and accessories.

If there is any problem, contact the distributor immediately.

2.2 Install Wall Mount for M8B (Optional)

Figure 2-1

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M8B Multi-Parameter Patient Monitor User Manual

Figure 2-2

Figure 2-3

Installation Steps:

1. Outline along the part 1 edge against the wall with the desired location.

2. Drill 4 holes of 6 mm diameter in the wall, and knock the plastic nuts in the holes completely.

3. Knock 4 screws in the plastic nuts, when tighten them, secure the channel (part1) at the desired

location of the wall (as shown in Figure 2-1).

4. Slide the arm (part2) into channel (part1) as Figure2-2 shown 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 M8B, fix

it with 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 M8B with the device holding plate, and secure the

fixing screw totally through the fixing hole.

9. The M8B can be adjusted maximum 15 degrees by rotating the black knob.

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M8B Multi-Parameter Patient Monitor User Manual

2.3 Connect the Power Cables

Connection procedure of the AC power line:

Make sure the AC power supply complies with following specification: 100~240 VAC, 50/60

Hz.

Apply the power line provided with the monitor. Plug the power line to INPUT interface of the

monitor (Socket ④ in Figure 1-7). 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 Chapter 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 out of work. Switch on AC power supply can charge the battery no matter if the

monitor is powered on.

2.4 Power on the Monitor

Power on, LOGO information will be displayed on the screen.

NOTE:

Check all the functions that may be used to monitor and make sure that the M8B is in good

status.

NOTE:

If chargeable battery is provided, charge it after using the device every time to ensure the

electric power is enough.

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:

The interval between twice presses of POWER should be more than 1 minute.

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M8B Multi-Parameter Patient Monitor User Manual

NOTE:

After continuous 360-hour runtime, please restart the M8B to ensure the monitor’s steady

performance and long lifespan.

2.5 Connect Patient Sensors

Connect all the necessary patient sensors between the monitor and the patient.

NOTE:

For information on correct connection, refer to related chapters.

2.6 Check the Recorder

If your M8B is equipped with a recorder, open the recorder door to check if paper is properly

installed in the slot. If no paper is present, refer to Chapter Recording for details.

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M8B Multi-Parameter Patient Monitor User Manual

3 System Menu

M8B Multi-parameter patient monitor features flexible configurations. You can configure various

aspects of the monitor, including the parameters to be monitored, sweeping speed of the waveforms,

audio signal volume, and output content.
Press the MENU button on the front panel to call up “SYSTEM MENU” menu. You can perform

following operations in this menu.

Figure 3-1 System Memu

Review of trend graphs/tables and NIBP measurements will be described in Chapter Trend and

Event.

3.1 Patient Information Setup

NOTE:

To clear current patient data, refer to New Patient for details.

Pick "PATIENT SETUP" in SYSTEM MENU to call up the following menu.

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M8B Multi-Parameter Patient Monitor User Manual

Figure 3-2 Patient Setup

You can setup the following patient information:

DEPT. Department in which the patient receives treatment.

PAT NO Patient No.

BED NO Patient bed number (Range: 1~254)

DOCTOR Name of the doctor.

NAME Patient name (Valid characters: A~Z, 0~9; Max. length: 12 characters)

SEX Patient gender (Available options: "F" for Female, "M" for Male)

PAT TYPE Patient type (Available options: ADU, PED, and NEO)

ADMIT Hospitalization starting date (format: year\month\day)

BIRTH Patient date of birth (format: year\month\day)

HEIGHT(cm/inch) Patient height (Increase/decrease by 0.5 cm or 0.5 inch per switch)

WEIGHT(kg/lb) Patient weight (Increase/decrease by 0.5 kg or 0.5 lb per switch)

BLOOD Patient blood type (Pick A, B, O, AB, or N. "N" represents unknown blood

type)

NEW PATIENT Admission of new patient

Also in this menu, the user may select “NEW PATIENT” item to access “CONFIRM TO UPDATE

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M8B Multi-Parameter Patient Monitor User Manual

PATIENT” dialog box as shown below, in which the user decide whether to monitor a new patient.

Figure 3-3 Confirm to Update Patient

Pick YES to delete all information of the patient being currently monitored and exit the menu.

Pick NO to give up updating the patient and the system will keep the information of the current

patient and exit the menu.

NOTE:

Selecting “YES” will delete all information about the currently monitored patient.

3.2 Default Setup

NOTE:

Select any item in this sub-menu to cancel the current setup and use the selected default

setup.

Figure 3-4 Default Menu

In this sub-menu, you can select both the factory default and the user-defined default. Also in this

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M8B Multi-Parameter Patient Monitor User Manual

sub-menu, you can save the current configuration as the user-defined default configuration. At this

time, the system will automatically save all the setups in the parameter menu, ECG lead, gain and

filter way as the user-defined default configuration according to the patient type. And the dialog box

as shown below will pop up.

Figure 3-5 Confirm Save Default Config

Pick YES to save the current patient type config as user default configuration.

Pick NO to give up the operation.

3.3 Mark Event

There are four types of events that you can define.
Select “MARK EVENT” item in “SYSTEM SETUP” to call up the following menu:

Figure 3-6 Mark Event

To mark the event: Use the rotary knob to select one from event A, B, C and D. There is a “@”

signal for the one selected. To cancel your selection, repress the knob at selected item. Press EXIT

to return to the previous menu.

The point of using event function:

To differentiate the patient events that have impact on parameter monitoring, such as dose taking,

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M8B Multi-Parameter Patient Monitor User Manual

injection, therapy status, etc.

Event will be displayed on the Trend Graph, Trend Table to assist to analyse patient parameter of

the time event happened.

3.4 Face Select

Select “FACE SELECT” item in “SYSTEM SETUP” menu to access “FACE SELECT” dialog box

as shown below, in which five selections are available: STANDARD SCREEN, TREND SCREEN,

oxyCRG SCREEN, VIEWBED SCREEN and LARGE FONT SCREEN. Only one selection can be

chosen for each time.

Figure 3-7 Face Select

Enter LARGE FONT SCREEN can select three modes, see as follows:

Figure 3-8 Large Font Face Select

3.5 Time Setup

Select “TIME SETUP” item in “SYSTEM SETUP” menu to access the sub-menu of “TIME
SETUP” as shown below. System time is in format of year, month, day, hour, minute and second.
Pick the item you wish to modify and turn the knob. Select “EXIT” item to return to the previous

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M8B Multi-Parameter Patient Monitor User Manual

Figure 3-9 Time Setup

3.6 Recorder Setup

Select "RECORD" in “SYSTEM SETUP” menu to call up the following menu:

Figure 3-10 Record

In the sub-menu, the user may select the “REC WAVE1”, “REC WAVE2” or “REC WAVE3” items,

maximum 3 waveforms can be printed out.

The output waveforms can be selected for the following items:

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M8B Multi-Parameter Patient Monitor User Manual

ECG1, ECG2

SpO2

RESP

IBP1, IBP2

ECG1 waveform and ECG2 waveform. (There will be 7 ECG

waveforms on the screen when Full-Lead display). If no ECG

waveform is currently displayed on the screen, this item cannot be

picked.

SpO2 Plethysmogram. (If no SpO2 waveform is currently displayed on

the screen, this item cannot be picked. But under ECG Full-Lead

display mode, this item can be picked, although no SpO2 waveform is

currently displayed on the screen. )

RESP waveform. (If no RESP waveform is currently displayed on the

screen, this item cannot be picked. But under ECG Full-Lead display

mode, this item can be picked, although no RESP waveform is

currently displayed on the screen.)

IBP1 waveform and IBP2 waveform. (If no IBP waveform is currently

displayed on the screen, this item cannot be picked. But under ECG

Full-Lead display mode, this item can be picked, although no IBP

waveform is currently displayed on the screen.)

OFF No display for this waveform.

RT REC TIME represents “real-time recording time”, for which two selections are available:

CONTINUAL and 8S. “CONTINUAL” means once pressing the “Record” button on the front
panel, the recorder will continuously print out the waveform or parameter until the “Record”

button is pressed again.

TIMING REC TIME represents “time interval between two times of timing recording”. 10

selections are available: “OFF, 10MIN, 20MIN, 30MIN, 40MIN, 50MIN, 1HOUR, 2HOURS,
3HOURS and 4HOURS”. It means that the system will trigger the recording operation

according to the selected time interval. The recording time is fixed at 8 seconds.

NOTE:

REC TIME has the priority compared with TIMING REC TIME.

REC RATE: 25.0 mm/s or 50.0 mm/s..

CLEAR REC TASK can be used by the user to stop recorder from printing out too many tasks.

NOTE:

The recorder is an optional part.

NOTE:

If two same waveforms are selected, one of them is switched to a different waveform

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M8B Multi-Parameter Patient Monitor User Manual

automatically.

NOTE:

When ECG waveforms are selected for printing, with gain of ×1, ×0.5 or ×0.25, 3-channel
waveform can be printed out; however, with gain of ×2, only 2-channel waveform can be
printed out to avoid overlapping of waveforms, and the third waveform will be omitted.
The 3-channel waveform can be printed only in real-time recording, while it is not available
in other recording modes, such as alarm review recording, alarm triggered recording.

3.7 Module Setup

Select “MODULE SETUP” item in “SYSTEM SETUP” menu to call up the following menu:

Figure 3-11 Module Setup

You can choose the parameter you want to monitor from this menu, so that you can enhance the

display efficiency, and avoid interference from other messages.

3.8 Tracing Waveforms Selection

Select “TRACE SETUP” item in “SYSTEM SETUP” menu to call up the following menu:

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M8B Multi-Parameter Patient Monitor User Manual

Figure 3-12 Trace Setup

You can define the traces displayed on the screen in this menu. The waveforms available for
selection are those whose modules have been selected in “MODULE SETUP” menu.

3.9 Monitor Version

Pick VERSION to show the software version information of this monitor.

3.10 Alarm Volume

The system provides five levels of alarm volume and an alarm silence function. The system will

give audio alarm prompt (including no alarm sound) based on the selection.

The user may select different level of volume as per clinical requirement. The method is listed

below:
Press “ALARM SETUP” item in “SYSTEM SETUP” menu to call up “ALARM SETUP”

sub-menu as shown below, in which the user may set up the alarm volume and other alarm

information. Refer to Chapter Alarm for details.

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M8B Multi-Parameter Patient Monitor User Manual

Figure 3-13 Alarm Setup

Pick ALARM VOL to set the volume of alarm sounds by turning the knob. The selections are
“1~5”.
You can also set alarm parameters in MAINTAIN →USER MAINTAIN →ALARM SETUP.

Refer to Chapter5 Alarm for details.

WARNING

If the alarm volume is off, when there is alarm, the M8B can not give audio alarm prompt, so

the user should use this function cautiously.

3.11 Key Volume

Select “SELECTION” item in “SYSTEM SETUP” menu to call up “SELECTION” sub-menu as
shown below. Select “KEY VOL” item and set the volume. The selections are “OFF, LOW, MED,
HIGH”.

Figure 3-14 Selection

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M8B Multi-Parameter Patient Monitor User Manual

3.12 Drug Calculation

The M8B provide drug calculation and titration table display functions for fifteen different drugs.

For details, please refer to the Chapter: Drug Calculation and Titration Table.

3.13 Waveform Demonstration

Select “DEMO” item in “SYSTEM MENU” to call up “INPUT DEMO KEY”. After entering the

password, the system enters the Demonstration Waveform status.

The purpose of waveform demonstration is only to demonstrate the machine performance, and for

training purpose. In clinical application, this function is not recommended because the DEMO will

mislead the hospital workers to treat the waveform and parameter as actual data of the patient,

which may result in delay of treatment or mistreatment.

3.14 Maintenance

Select “MAINTAIN” item in “SYSTEM MENU” to call up “ENTER MAINTAIN PASSWORD”

dialog box as shown below, in which you can enter password and then customize maintenance

settings. User can not execute factory maintenance function, which is only available for the service

engineers of EDAN or local representative authorized by EDAN.

Figure 3-15 Enter Maintain Password

User Maintain

Input the password into the “ENTER MAINTAIN PASSWORD” box and press “CONFIRM”, the
“USER MAINTAIN” menu will pop up, in which you can set up following items.

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M8B Multi-Parameter Patient Monitor User Manual

Figure 3-16 User Maintain

LANGUAGE: You can set one of the eight interface languages, which are “CHINESE”,

“ENGLISH”, “RUSSIAN”, “ITALIAN”, “SPANISH”, “FRENCH”, “POLISH” and
“GERMAN”.

NOTE:

Please restart the monitor after changing the language.

LEAD NAMING: You can select “AHA” or “EURO”. To know the difference between these

two styles, refer to Chapter ECG/RESP Monitoring.

LOCAL NET NO: Physical No. of monitor.

ALM SETUP>>: You can set up parameters of alarm. For more details refer to Chapter Alarm:

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M8B Multi-Parameter Patient Monitor User Manual

Figure 3-17 Alarm Setup

OTHER SETUP>>: you can setup some parameters, such as module type. See as follows:

Figure 3-18 Other Setup

NURSE CALL: turn on or off nurse call. When a new alarm of physiological parameter

occurs, it gives 3-second NURSE CALL alarm; if the system alarm or the audio alarm is

turned off, the NURSE CALL is unavailable. It is connected to RJ45 socket, the same port

as connected to Ethernet. NURSE CALL occupies the 7th and 8th pins of RJ45. When alarm

occurs, the 7th and 8th pins are in short circuit, otherwise they are disconnected.

SERVER IP: Setup server IP.

SERVER PORT: Setup server port.

CO2 CHECK>>: For calibrating CO2. Unavailable for M8B.

GAS CALIBRATION>>: For calibrationing gas for AG monitoring. Unavailable for M8B.

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M8B Multi-Parameter Patient Monitor User Manual

Factory Maintain

Factory maintenance function is only available for the service engineers of EDAN or representative

authorized by EDAN.

1. Enter factory maintain through password.

Figure 3-19 Factory Maintain

VGA SIZE: set this item to 10.4’ WIDTH_SCREEN.

MODULE SELECT:

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M8B Multi-Parameter Patient Monitor User Manual

Figure3-20 Select Module

NOTE:

For M8B, the AG, CO2 functions are unavailable.

2. Enter representative maintain through password.

Figure 3-21 Representative Maintain

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SELECT MODULE:

M8B Multi-Parameter Patient Monitor User Manual

Figure3-22 Select Module

For changing password:

Figure 3-23 Change Password Interface

Prompts for changing password:

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M8B Multi-Parameter Patient Monitor User Manual

Figure 3-24 Save Failure

Figure 3-25 Save Successfully

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M8B Multi-Parameter Patient Monitor User Manual

4 Face Select

The M8B has five different operating screens, which are “Standard Screen”, “Trend Screen”,
“oxyCRG Screen”, “VIEWBED SCREEN”and “Large Font Screen”. When required, you can select

different operating screen for necessary information. Let’s probe into these four operating screens

one by one.

4.1 Select Operating Screen

Select “FACE SELECT” item in “SYSTEM SETUP” menu to access “FACE SELECT” dialog box

as shown below, in which five selections are available: STANDARD SCREEN, TREND SCREEN,

oxyCRG SCREEN, VIEWBED SCREEN and LARGE FONT SCREEN. Only one selection can be

chosen for each time.

Figure 4-1 Face Select

4.2 Standard Screen

In the “FACE SELECT” menu, select the “STANDARD SCREEN” option to enter the Standard

Screen. The Standard Screen displays to us the parameters in the Parameter area and the waveforms

being monitored. This screen is the basic operating screen of the monitor.

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M8B Multi-Parameter Patient Monitor User Manual

Figure 4-2 Standard Screen

4.3 Trend Screen

Enter TREND SCREEN
In the “FACE SELECT” menu, select the“TREND SCREEN”option to enter the Trend Screen.

Figure 4-3 Trend Screen

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M8B Multi-Parameter Patient Monitor User Manual

Position of trend graph

Trend graph is located to the right of the corresponding waveform in the Waveform area. Its color is

the same as that of the corresponding parameter.

Trend length

Dynamic trend length is 2 hours. On the trend graph, the scale of the right end of the X-axis is 0

hour while the left end is 2-hour.

Select trend parameter

If M8B are located at the same position on the trend graph, by selecting the corresponding hot key

of a parameter on the trend graph, you can have the trend graph of this parameter displayed on the

screen. For example, in ECG trend graph, you can select hot keys such as HR, ST or PVCs, then the

system will display their corresponding trend graphs respectively.

Close trend screen
In the “FACE SELECT” menu, select options of other operating screens to close the Trend Screen.

4.4 oxyCRG Screen

Enter oxyCRG SCREEN
In the “FACE SELECT” menu, select the“oxyCRG SCREEN”option to enter the oxyCRG Screen.

Trend graph of oxyCRG screen

Figure 4-4 oxyCRG Screen

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M8B Multi-Parameter Patient Monitor User Manual

Located at the lower part of the screen, oxyCRG screen consists of three trends: HR Trend, SpO2

Trend and RR Trend or Compressed Resp. Waveform.

Select oxyCRG trend length

There are two hot keys at the bottom part of the oxyCRG Screen, which are 4MIN/2MIN/1MIN,

RR/RESP WAVE.

By using hot keys for trend time, you may select to display trend graphs of three different lengths,

i.e., 1 min, 2 min and 4 min.

Select RR trend or Compressed Resp. Waveform

By using the hot keys for RR/RESP WAVE, you may select either RR trend graph or compressed
Resp. Wave. They occupy the same position. Therefore, if you select “RR”, the position displays the
dynamic trend of RR. If you select “RESP WAVE”, the position displays the compressed Resp.

Wave.

Close oxyCRG

In the FACE SELECT menu, select other options of operating screen to close the oxyCRG Screen.

4.5 Viewbed Screen

If another monitor is connected on the same LAN of this monitor, you can use this monitor to view
any measured waveform and information about all measured parameters from another monitor.

Enter Viewbed Screen

Select the “VIEWBED SCREEN” option in the “FACE SELECT” menu. Viewbed Screen window
occupies the space of the bottom four waveforms.

Figure 4-5 Viewbed Screen

Hot key of Viewbed

There are two hot keys in the Viewbed Screen: Select Bed Number and Select Waveform.

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M8B Multi-Parameter Patient Monitor User Manual

The hot key of Select Bed Number displays the bed numbers and patient names of other monitors
currently connected on the LAN. You can select a monitor to be monitored according to the patient
name and bed number. If at this time no other monitors are connected on the same LAN of this
monitor, the hot key of Bed Number will therefore display “N/A”. After you use this hot key to
select a monitor to be viewed, the system will toggle to the display of the selected monitor for your
view. The selected waveform is one of those listed in the hot key of Select Waveform.
The hot key of Select Waveform is used to select a waveform generated by the monitor being
viewed. If the hot key of Select Waveform displays “N/A”, it indicates that the bedside monitor
being viewed has no waveforms. You can use this hot key to select and therefore view different
waveforms of the monitor being viewed.

Alarm indicator of Viewbed

On the upper right side of the Viewbed Screen, there is an Alarm Indicator used to tell the alarm
status of the monitor being viewed. The activity of this alarm indicator is identical with that of the
alarm lamp on the panel of the monitor being viewed. That is to say, if the monitor being viewed
occurs medium/low level alarm, this alarm indicator illuminates yellow; if it occurs high level alarm,
this alarm indicator illuminates red. If the monitor being viewed has no alarm or the alarm is
screened, the icon for this alarm indicator will not be displayed.

Parameter area of Viewbed Screen

Under the hot key of Select Bed Number is the Parameter area, in which parameters of all monitors
being viewed are displayed.

Waveform area of Viewbed Screen

Under the hot key of Select Waveform is the Waveform area. The Sweep manner (refreshing or
scrolling) of the waveform is identical with that of this monitor. The feature description of the
displayed waveform is given above the waveform. Sweep speed is also identical with that set up for
the same waveform on this monitor.

Close Viewbed Screen

In the FACE SELECT menu, select options of other operating screens to close the Viewbed Screen.

Rules for automatically selecting monitor to be viewed and waveform

When you turn on the monitor or enter Viewbed Screen, the system will automatically select a
networked bedside monitor and a waveform of this monitor for you to view. If the monitor being
currently viewed is disconnected, the viewed monitor will automatically close, clear displays of all
alarms, parameters and waveforms. However in this situation, the Viewbed Screen still displays. If
you want to view another monitor, you must select again through using hot keys.
If a measure module of the viewed monitor is plugged out or closed, its corresponding waveform
will disappear and the waveform in the Waveform area will not be refreshed. Instead this Waveform
area will display empty. At this time, if you want to view other waveforms of this monitor, you need
to select again.

4.6 Large Font Screen

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M8B Multi-Parameter Patient Monitor User Manual

Large Font Screen is a kind of operating screen, just like Standard Screen, Trend Screen and other

operating screens. It is used by customer to meet different display requirements in monitoring.

Enter Large Font Screen

Choose LARGE FONT SCREEN in FACE SELECT menu to enter LARGE FONT FACE SELECT.
There are three modes, see as follows:

Figure 4-6 Large Font Face Select

Three display modes

1. ECG+SpO2+NIBP display mode:

Figure 4-7 ECG+SpO2+NIBP display mode

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M8B Multi-Parameter Patient Monitor User Manual

2. SpO2+NIBP display mode:

3. SpO2 display mode:

Figure 4-8 SpO2+NIBP display mode

Figure 4-9 SpO2 display mode

Exit Large Font Screen

In the LARGE FONT FACE SELECT menu, choose EXIT to return to FACE SELECT screen.

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M8B Multi-Parameter Patient Monitor User Manual

5 Alarm

This chapter gives general information about the alarm and measures to be taken accordingly.

Alarm setup and prompt messages are provided in respective parameter setup sections.

5.1 Alarm Modes

5.1.1 Alarm Level

Each alarm, either technical or physiological, has its own level. For alarm of higher level, when it
occurs, the system will give prompt in various ways. Some alarm’s level can be set by the user via

software. Others can not be changed once defined by the system. Alarms in M8B are divided into

three levels which are high, medium and low.

High-level alarm indicates the patient’s life is in danger or the monitor under using has serious

problem in technical respect. It is the most serious alarm.

Medium-level alarm means serious warning.

Low-level alarm is a general warning.

Alarms are classified into three categories, which are physiological alarm, technical alarm and
general alarm. Physiological alarm refer to those alarms triggered by patient’s physiological

situation which could be considered dangerous to his or her life, such as heart rate (HR) exceeding

alarm limit (parameter alarms). Technical alarm refer to system failure which can make certain

monitoring process technically impossible or make monitoring result unbelievable. Technical alarm

is also called System Error Message. General alarm belongs to those situations that can not be

categorized into these two cases but still need to pay some attention.

M8B Multi-parameter patient monitor has preset the alarm level for the parameters. You can also

modify the alarm level using the method described in this chapter.

Alarm level of the System Error Message (technical alarm) is preset in the system.

All technical alarm level and general alarm level, some of the physiological alarm levels are preset

in the system and can not be changed by user.

5.1.2 Alarm Modes

When alarm occurs, M8B Multi-parameter patient monitor may raise the user’s attention in at least

three ways, which are audio prompt, visual prompt and description. Audio and visual prompt is

given by TFT display device, the speaker on the display device and the alarm indicator. Description

is displayed on the screen. Physiological alarm is displayed in the Physiological Alarm area. Most

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M8B Multi-Parameter Patient Monitor User Manual

of technical alarms are displayed in the Technical Alarm area. Technical alarms related to NIBP

measurement are displayed in the NIBP Technical Alarm area at the bottom of NIBP parameter area.

NOTE:

The Physiological Alarm area is on the upper right part of the screen. The Technical Alarm

area is to the left side of the Physiological Alarm area.

NOTE:

If M8B is connected to the external alarm prompt system (e.g. the alarm speaker and

indicator connected onto the rear panel of the monitor), when alarm occurs, the external

alarm prompt system responds in the same way as the the monitor.

NOTE:

The concrete presentation of each alarm prompt is related to the alarm level.

How to indicate that the measured parameter has exceeded its alarm limits:

When physiological alarm of the monitored parameter exceeds the alarm limit, besides using the

above-mentioned three ways to give the alarm prompt, the M8B gives alarm by making the

monitored parameter flash in the frequency of 1Hz.

Screen Display

When the measured parameter exceeds its alarm limits and triggers a physiological alarm, the
corresponding parameter value will flash. “*” signal appears on the screen indicating the occurrence
of alarm. Red “***” indicates high-level alarm, yellow “**” indicates medium-level alarm, and
yellow “*” indicates low-level alarm. Technical alarm will not prompts “*” signal.

Lamp light

The high/medium/low-level alarms are indicated by the system in following different visual ways:

Alarm Level Visual Prompt

High Alarm indicator flashes in red with high frequency.

Medium Alarm indicator flashes in orange with low frequency.

Low Alarm indicator lights on in orange.

Alarm Sound

The high/medium/low-level alarms are indicated by the system in following different audio ways:

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M8B Multi-Parameter Patient Monitor User Manual

Alarm level Audio prompt

High

Mode is “DO-DO-DO------DO-DO, DO-DO-DO------DO-DO”, which

is triggered once every 10 seconds.

Medium Mode is “DO-DO-DO”, which is triggered once every 25 seconds.

Low Mode is “DO-”, which is triggered once every 30 seconds.

NOTE:

When alarms of different levels occur at the same time, the M8B prompts the one of the

highest level.

5.1.3 Alarm Setup

Setup alarm in the ALARM SETUP menu

Press the ALARM SETUP button on the SYSTEM SETUP menu to call up ALARM SETUP menu
(default menu) as shown below. In the “ALM SEL” item, the user may set up the information about
common alarm setup and the alarm setup of each parameter.

Figure 5-1 Alarm Setup

COMMON ALM SETUP

Select “COMMON ALM SETUP” selection in “ALM SEL” item. This operation may call up the
dialog box as the default one.

ALARM VOL: have five selections: 1, 2, 3, 4 and 5.
ALM REC TIME: which has three selections: 8S, 16S, 32S.

Alarm setup of each parameter

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M8B Multi-Parameter Patient Monitor User Manual

In the “ALARM SETUP” menu, select the “ALM SEL” item to set up the alarm information for
following parameters. They are HR, ST, PVCs, SpO2, NIBP, IBP (1, 2), RESP, TEMP, CO2, CO and
AG. For example:
Method to set up HR alarm information:
Step 1: Select the “HR ALM SETUP” option in the “ALM SEL” item. Then the menu only displays
HR setup items.
Step 2: You can set up five items in this menu, which are HR ALM (on/off of the alarm switch),
ALM LEV (alarm level), ALM REC (alarm recording switch), ALM HI (higher limit of HR alarm),
ALM LO (lower limit of HR alarm). You can move the cursor onto the item to be setup by using the
knob and press the knob to make the setup.
The method for setting the alarm information of other parameters is the same as HR.

Setup alarm in the User Maintain menu

You can also setup alarm parameters in SYSTEM MENU→ MAINTAIN→ USER MAINTAIN →
ALARM SETUP. See as follows:

Figure 5-2 Alarm Setup in User Maintain

ALM PAUSE TIME: set up the duration of Alarm Pause status. Three options are available, 1

minute, 2 minutes and 3 minutes.

ALARM SILENCE: when it set to ON, hold the Silence button on front panel for 3 seconds,

the alarm will be silenced. During the silence, the monitor gives Low alarm for alarm silenced

state per 3 minutes. Press this button again to turn on the alarm system.

SENSOR OFF ALARM: turn on or off the sensor off alarm. When this item is set ON, press

Silence button on front panel can pauze the audio alarm. And press again to resume the audio

alarm; at the alarm paused state, it will give alarm if sensor off alarm occurs.

5.2 Alarm Cause

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M8B Multi-Parameter Patient Monitor User Manual

Alarm occurs when:

1. Physiological alarm is evoked;

2. Alarm for error of the system (technical alarm) is evoked;

3. General alert occurs.

A. Conditions that activate the parameter alarms:

When the measurement value exceeds the alarm limit and the alarm is set “ON”. Alarm will not
activate if the alarm is set “OFF”.

B. Conditions that activate the system alarms (technical alarm):

Upon the system error, the monitor prompts alarm immediately.

C. General alert

In some circumstances, alerts will behave as physiological alarm but in normal sense, we do not

regard them as real patient health related items.

5.3 SILENCE

SILENCE

Enter SYSTEM MENU→ MAINTAIN→ USER MAINTAIN → ALARM SETUP, if the ALARM

SILENCE is set to ON, press Silence button to turn off the audio alarm or paused it.

1. Audio alarm paused icon

When the ALARM SILENCE is ON, press Silence button on front panel, then the audio alarm is

paused. And the paused time can be set in ALARM SETUP menu, see figure 5-2. The audio

alarm paused icon displays in Information area. Press Silence button again can resume the audio

alarm.

2. Audio alarm off icon

Press the Silence button for more than 3 seconds, the audio alarm is turned off. Then press

Silence button again or hold it for few seconds can turn on the audio alarm. At the audio alarm

off state, the monitor gives a Low alarm beep per 3 minutes to prompt that the alarm is turned

off.

NOTE:

Whether an alarm will be reset depends on the status of the alarm cause.

5.4 Parameter Alarm

The setup for parameter alarms is in their menus. In the menu for a specific parameter, you can

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M8B Multi-Parameter Patient Monitor User Manual

check and set the alarm limit, alarm status. The setup is isolated from each other.

When a parameter alarm is off, a symbol “ ” displays near the parameter. If the alarms are

turned off individually, they must be turned on individually.

For the parameters whose alarm is set to ON, the alarm will be triggered when at least one of them

exceeds alarm limit. The following actions take place:

1. Alarm message displays on the screen as described in alarm mode;

2. The monitor beeps in its corresponding alarm class and volume;

3. Alarm lamp flashes.

5.5 When an Alarm Occurs

NOTE:

When an alarm occurs, you should always check the patient's condition first.

The alarm message appears at the top of the screen on the right side. It is needed to identify the

alarm and act appropriately, according to the cause of the alarm.

1. Check the patient's condition.

2. Identify the cause of the alarm.

3. Identify which parameter is alarming or which alarm is happening.

4. When cause of alarm has been over, check that the alarm is working properly.

You will find the alarm messages for the individual parameter in their appropriate parameter

chapters of this manual.

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M8B Multi-Parameter Patient Monitor User Manual

6 Freeze

General

Freeze & Unfreeze

Review Frozen Waveforms

6.1 General

When monitoring a patient, you may freeze the waveforms of interest so as to view them carefully.

Generally you can review maximally 120 seconds of a frozen waveform. The Freeze function of

this monitor has following features:

Freeze status can be activated on any operating screen;

At the same time of entering the Freeze status, the system exits all other operating menus.

Besides, the system freezes all waveforms in the Waveform area of the Basic Screen, and also

freezes Full Lead ECG waveforms and extra waveforms in the Full Lead ECG interface(if

have). Nevertheless the Parameter area refreshes normally.

The frozen waveforms can be reviewed.

6.2 Enter/Exit Freeze Status

Enter Freeze Status

In the Non-Freeze status, press the “Freeze” button on the control panel of the monitor to let the

system exit the Menu being currently displayed (if available), then enter the Freeze status and
display the popup “FROZEN” menu. In the Freeze status, all other waveforms are frozen. In other

words, the system will no longer refresh all other waveforms.

Exit Freeze Status

In the Freeze status, executing any of the following operations will command the system to exit the

Freeze status:

Select the “EXIT” option on the “FROZEN” menu;
Press the “Freeze” button on the control panel again;

Press the non-immediate-to-execute button (such as a button once pressed, a menu will pop up

for you to further select an option) on the front panel and system buttons of Menu and Main;

Execute any operation that may trigger the adjustment of the screen or display of a new menu.

After exiting the Freeze status, the system will discharge the Freeze status, clear screen waveforms

and resume display real-time waveforms. In the Screen Refresh mode, the system will sweep the

waveforms from the left to right in the Waveform Area.

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M8B Multi-Parameter Patient Monitor User Manual

6.3 FROZEN Menu

Press the “FREEZE” button on the control panel, the FROZEN menu will appear on the bottom part

of the screen. At the same time, the system enters the Freeze status.

Figure 6-1 Frozen

RECALL: used to review frozen waveforms.

EXIT: after pressed, the system closes the FROZEN menu and exits the Freeze status.

NOTE:

Pressing the “Freeze” button repeatedly in short time may result in discontinuous

waveforms on the screen.

6.4 Reviewing Frozen Waveform

By moving the waveform, you may review a waveform of 120 seconds before the moment when it

is frozen. For a waveform less than 120 seconds, the remaining part is displayed as a straight line.
Use the rotary snob on the control panel to move the cursor to the “RECALL” option on the

FROZEN menu. Press the knob. By turning the knob left or right, frozen waveforms on the screen

will move left or right correspondingly. There is an arrow indicating upward under the right side of
the last waveform. There is also a time scale beside the arrow. “-0S” is used to mark the moment

when waveforms are frozen. With waveforms moving right, this time mark will in turn change into

-1S, -2S, -3S… These time marks are applied to all waveforms on the screen.

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M8B Multi-Parameter Patient Monitor User Manual

7 Recording (Optional)

General information on recording

Instructions for configuring and recording

Recording messages

7.1 General Information on Recording

A thermal dot matrices recorder with 48mm wide printout paper is used for M8B Multi-parameter

Patient Monitor.

Performance of the Recorder

Waveform record is printed out at the rate of 25 mm/s or 50 mm/s.

It can record up to 3 waveforms.

English printout.

User-selectable real-time recording time and waveform.

Auto recording interval is set by the user, the waveform is in accordance with the real time

recording.

7.2 Recording Type

M8B Multi-parameter patient monitor provides several stripe recording types:

Continuous real-time recording

8 second real-time recording

Auto 8 second recording

Alarm recording

Frozen waveform recording

Trend graph, trend table recording

Arrhythmia review recording

Drug calculation titration recording

NIBP review recording

Alarm review recording

oxyCRG recording

NOTE:

When ECG waveforms are selected for printing, with gain of ×1, ×0.5 or ×0.25, 3-channel
waveform can be printed out; however, with gain of ×2, only 2-channel waveform can be
printed out to avoid overlapping of waveforms, and the third waveform will be omitted.

The 3-channel waveform can be printed only in real-time recording, while it is not available

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M8B Multi-Parameter Patient Monitor User Manual

in other recording modes, such as alarm review recording, alarm triggered recording.

Real-time Recording

Real-time recording starts as you press the “Record” button on the recorder.

The waveforms for continuous real-time recording and continuous 8 second recording are

automatically set by the monitor (usually the first three waveforms displayed on the screen). You

can also configure it through the menu. Refer to related section for details.

In RECORD menu, the user can choose three waveforms to be printed out. The User can setup one

or two waveforms off. Thus, the real time record will print out one or two waveforms. If three

waveforms are off, the real time record will print out measure parameters only.

NOTE:

When the system is executing a recording task, the system can start executing next alarm

recording task only when the current one is finished.

Auto Recording

The monitor starts the recorder for 8 seconds according to interval time set in the “TIMING REC
TIME” of the “RECORD” menu. Refer to Chapter Recorder Setup for details.

Alarm Recording

Parameter Alarm

The monitor records waveforms 4, 8, or 16 seconds prior to and after the alarm (totally 8, 16 or 32

seconds) (which can be selected in System Menu). All parameter values during the alarm will also

be recorded.

When parameter alarm occurs, two recorded waveforms can be printed out.

In order to avoid repeated printout of alarm waveforms:
① If more than two parameter alarms are switched on and triggered simultaneously, the recorder

will print out those of the highest level. If of the same alarm level, the latest alarm will be

printed out.

② If an alarm occurs during the alarm of another parameter, it will be printed out after the current

recording is finished.

③ If many alarms occur at the same time, some of waveforms will be stored for printout in turn.

ST Segment Alarm

The M8B records 2-channel ECG waveforms 4, 8, or 16 seconds prior to and after the alarm (totally

8, 16 or 32 seconds) (which can be selected in the ECG SETUP menu). All parameter values during

the alarm will also be recorded.

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M8B Multi-Parameter Patient Monitor User Manual

Arrhythgmia Alarm

The M8B records 2-channel ECG waveforms 4, 8, or 16 seconds prior to and after the alarm (totally

8, 16 or 32 seconds). All measurement results during the alarm will also be recorded.

Titration Table

The M8B can print out the message in the current TITRATION window.

Notes on Recording

Recording types:

Real time Report

Periodic Report

Para Alarm Report

Titration Table

Patient bed number, name, sex, height, weight, date of birth, admission date

Parameter name and value

Recording time

Waveform name

Waveform scale (for ECG waveform)

ECG lead, scale, filter mode, (if having ECG waveforms, it will be printed out within the first

second or when changing the lead, gain and filter mode during real-time recording.)

IBP scale (the first second of IBP waveform)

Date and time.

7.3 Recording Startup

You can start the recording in the following ways:

Continuous real-time

recording

8 second real-time

Press the “Record” button to start/stop the recording.

Press the “Record” button to start recording. It will automatically

recording

stop in 8 seconds.

Auto recording Record the three waveforms selected in RECORD menu

according to the setup time interval in RECORD menu. It will

automatically stop in 8 seconds.

Alarm recording When alarm recording is set ON, it automatically starts when

alarm occurs.

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M8B Multi-Parameter Patient Monitor User Manual

Trend graph recording Access the “TREND GRAPH” menu, then press the “Record”

button to start recording.

Trend table recording Access the “TREND TABLE” menu, then press the “Record”

button to start recording.

Arrhythmia review

recording

Enter the “ECG SETUP” menu via hot key, select “ARR
ANALYSIS”→“ARR RECALL”, then press the “Record” button

to start recording.

Alarm review recording Access the “ALARM RECALL” menu, then press the “Record”

button to start recording.

NIBP review recording Access the “NIBP RECALL” menu, then press the “Record”

button to start recording.

Titration table recording Access the “DRUG CALC” menu from the “SYSTEM MENU”

menu. Pick the “TITRATION” button in the menu to access the
“TITRATION” window. Pick the “REC” button to print out the

titration currently displayed in the window.

NOTE:

You can press the “Record” button on the control panel to stop the current recording

process.

Access the “RECORD” menu from the “SYSTEM SETUP” menu. Then pick the “CLEAR REC
TASK” button to stop all recording tasks.

7.4 Recorder Operations and Status Messages

Record Paper Requirement

Only standard thermosensitive record paper can be used, otherwise the recorder may not function,

the recording quality may be poor, and the thermosensitive printhead may be damaged.

Proper Operation

■ When the recorder is working, the record paper goes out steadily. Do not pull the paper outward

with force, otherwise the recorder may be damaged.

■ Do not operate the recorder without record paper.

Paper Out

When "RECORDER OUT OF PAPER" alarm is displayed, the recorder can not start. Please insert

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M8B Multi-Parameter Patient Monitor User Manual

record paper properly.

Inserting Paper

■ Place fingers under the two sides flange of the recorder casing, pull outwards directly to release

the casing.

■ Insert a new roll of paper into the paper cassette, printing side facing upwards.

■ Ensure proper position and tidy margin.

■ Pull about 2 cm of the paper out, and close the recorder casing.

NOTE:

Be careful when inserting paper. Avoid damaging the thermo-sensitive print head. Unless

when inserting paper or shooting troubles, do not leave the recorder catch open.

Removing Paper Jam

When the recorder functions or sounds improperly, you should open the recorder casing to check if

there is a paper jam. Removing the paper jam in the following way:

■ Cut the record paper from the feeding edge.

■ Open the recorder casing.

■ Re-insert the paper.

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M8B Multi-Parameter Patient Monitor User Manual

8 Trend and Event

M8B Multi-parameter patient monitor provides 96-hour trend data of all parameters, storage of 500

NIBP measurement results and 60 alarm events. This chapter gives detailed instruction for review

of all data.

8.1 Trend Graph

■ The latest 1-hour trend is displayed every 1 or 5 seconds;

■ The latest 96-hour trend is displayed every 1, 5 or 10 minutes;

Pick "TREND GRAPH" in the SYSTEM MENU to call up the following menu:

Figure 8-1 Trend Graph Menu

In the trend graph, the Y-axis stands for the measured value and X-axis time. " " is the cursor of

the trend graph, the parameter value of the position pointed by the cursor is displayed below the

trend graph and the corresponding time is displayed above the trend graph. Other trends except

NIBP trend are displayed as continuous curves. In NIBP trend graph, "▼" indicates systolic value,

"▲" indicates diastolic value, and "*" indicates mean value.

To select trend graph of a specific parameter

Pick PARA SELECT item and select a requested parameter name by turning the knob.

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M8B Multi-Parameter Patient Monitor User Manual

To select 1-hour or 96- hour trend graph

Pick RESOLUTION item, choose 1 or 5 sec for 1-hour trend graph and 1, 5 or 10 min for 96-hour

trend graph.

To view other trend curves

When " " appears on the right part of the screen, pick "L-RIGHT", turn the knob clockwise to

view later trend curves. When " " appears on the left part of the screen, pick the same item, turn

the knob counterclockwise to view earlier trend curve.

To change the display scale

Pick the “ZOOM” button to adjust the Y-axis scale and thus change the trend curve in proportion.

The value beyond maximum value will be represented by the maximum value.

To obtain trend data of a specific time

The time to which the cursor points will change as the knob is turned. Parameter at this time is

displayed below the X-axis. When " " appears on the right part of the screen, the trend graph

pages down for later trend curve as the cursor moves here. When " " appears on the left part of

the screen, the trend graph pages up for earlier trend curve as the cursor moves here.

Mark Event

If an event is marked A, B, C, or D, then the corresponding event type will display on the axis time

of the trend graph，such as , , or .

Operation Example

To view the NIBP trend graph of the last 1 hour:

Pick the Menu button on the lower right of the screen.

Pick TREND GRAPH item in the SYSTEM MENU.

Select parameter: pick the PARA item and turn the knob until NIBP appears.

Select 1S or 5S in the RESOLUTION item.

Pick the L-Right button and turn the knob to view changes of the trend graph time and trend

curve.

Stop at requested trend time section for careful review. Pick the ZOOM button to adjust the

display scale if necessary.

For measurement result of a specific time, pick CURSOR to move the cursor to the point,

corresponding time and value will display on above and below respectively.

Pick EXIT to return to trend graph display.

8.2 Trend Table

The latest 96-trend table data can be displayed at every 1, 5, 10, 30, or 60 minutes.

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M8B Multi-Parameter Patient Monitor User Manual

Pick TREND TABLE in the SYSTEM MENU to call up the following menu:

Figure 8-2 Trend Table

Time in response to each group of trend data is displayed at the leftmost list with date in bracket.

Marked event corresponds to marking time. Trend data of each parameter is divided into 8 groups.

HR, PVC

ST1, ST2

RR

T1, T2, TD

SpO2, PR

NIBP NS/NM/ND

IBP1, IBP2

To choose trend table of different resolution

Pick the RESOLUTION item and turn the knob to change its content so as to change the time

interval of trend data.

To view other trend data

When " " appears on the upper part of the screen, pick UP-DOWN button and turn the knob

counterclockwise to view later trend data. When " " appears on the lower part of the screen, pick

the same item and turn the knob clockwise to view earlier trend data.

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M8B Multi-Parameter Patient Monitor User Manual

To obtain trend data of different parameter

Pick L-RIGHT to select one from the 8 groups of parameters. A " " by the rightmost item

indicates following page available. A " " by the leftmost item indicates previous page available.

Mark Event

If an event is marked A, B, C, or D, the corresponding event type will display on the axis time of

the trend table.

Operation Example

To view a NIBP trend table:

Pick the Menu button on the lower right of the screen to access “SYSTEM MENU”.

Pick TREND TABLE.

Pick L-RIGHT and switch to NIBP by turning the knob.

Pick RESOLUTION to select requested time interval.

Pick UP-DOWN and turn the knob to view NIBP trend data of different time.

Pick EXIT to return to SYSTEM MENU.

8.3 NIBP Recall

M8B Multi-parameter patient monitor can review the latest 500 NIBP measurement data.

Pick NIBP RECALL in the SYSTEM MENU to invoke the result and time of the latest 15

measurements, as shown in the figure below.

Figure 8-3 NIBP Recall

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M8B Multi-Parameter Patient Monitor User Manual

Data is listed chronologically from the latest to the earliest. 15 measurements can be displayed in

one screen. Pick UP-DOWN to view other trend curve up to 500 results. When you press the
“RECORD”button, the recorder will pint out the metrical data of current window.

8.4 Alarm Event Recall

M8B Multi-parameter patient monitor can display the latest 60 alarm events.
Select “ALARM RECALL” in the SYSTEM MENU to access ALARM RECALL

CONDITION menu as shown below.

Figure 8-4 ALARM RECALL CONDITION

In this menu, the user may select the conditions for alarm review, including:

1. Start and End time of review:

The user may select the start time of review in the item of START.

Then the user may select the end time of review. Two selections are available: current time and

the user-defined time.

For user-defined end time, the user can use the knob to select.

2. ALARM RECALL EVENT

In the pull-down list of ALARM RECALL EVENT, the user can select the parameter whose

alarm events he wants to review. The selections include ALL (alarm events of all parameters),

ECG, REST, SpO2, NIBP, IBP, TEMP, HR_H>180 (the value of HR is higher than the upper

alarm limit), HR_L<60 (the value of HR is below the lower alarm limit), SpO2<90%,
IBP_H>200mmHg, IBP_L<40mmHg, RR_H>40, RR_L<10, TEMP_H>40ºC, TEMP_L<34ºC.
After setting up all the review conditions, press the “ALARM RECALL” button to access
“ALARM RECALL” window.

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M8B Multi-Parameter Patient Monitor User Manual

ALARM RECALL

The ALARM RECALL window is as shown below, in which following data are displayed:

① Time span (Format: month-day-year hour: minute-month-day-year hour: minute).
② Event type.
③ Serial number (Format: NO. ×× of ××).
④ The value at the time of alarm. NIBP result is with time.
⑤ Two 8/16/32-second waveforms.

Figure 8-5 ALARM RECALL Menu

To view all waveforms during the alarming process

Pick L-RIGHT and turn the knob to view all 8/16/32-second waveforms stored.

To view other alarm events

Events of up to 60 are listed chronologically from the latese to the earliest. Pick UP-DOWN button

and turn the knob to view later or earlier events.

Recording

Pick REC to print our all data and waveform this event.

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M8B Multi-Parameter Patient Monitor User Manual

9 Drug Calculation and Titration Table (Optional)

M8B Multi-parameter patient monitor provides Drug calculation and titration table display

functions for fifteen drugs and outputs the content of titration table on the recorder.

9.1 Drug Calculation

The drug calculations that can be performed by the system are AMINOPHYLLINE,

DOBUTAMINE, DOPAMINE, EPINEPHRINE, HEPARIN, ISUPREL, LIDOCAINE, NIPRIDE,

NITROGLYCERIN and PITOCIN. Besides DRUG A, DRUG B, DRUG C, DRUG D and DRUG E

are also provided to flexibly replace any of the drugs.
Select “DRUG CALC” in SYSTEM MENU, the following “DRUG CALC” display appears:

Figure 9-1 DRUG CALC

The following formulas are applied for dose calculation:

Concentrat = Amount / Volume

INF Rate = DOSE / Concentrat

Duration = Amount / Dose
Dose = Rate × Concentrat
DRIP Rate = INF Rate / 60 × DROP Size

Operating Method:

In the Drug Calculation window, the operator should first select the name of the drug to be

calculated, and then confirm the patient weight. Afterwards, the operator should also enter other

known values.

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M8B Multi-Parameter Patient Monitor User Manual

Turn the knob to select the value of the item to be calculated. Turn the knob to change the value.

When it is the required value, press the knob to view the calculation result. Each item has its
calculation range. If the result exceeds the range, it displays “---.--”.

NOTE:

For the drug calculation, the prerequisite is that the operator must enter the patient weight

and drug name at first. The system first gives a group of random initial values, which can

not be used by the operator as the calculation reference. Instead, he should enter a new

group of values at the doctor’s instruction.

NOTE:

Each drug has its fixed unit or unit series. Operator must select the proper unit at the

doctor’s instruction. If the result exceeds the system-defined range, it will display “---”.

NOTE:

After entering a value, a conspicuous prompt will appear in the menu warning the operator

to confirm the correctness of the entered value. The correct value is the guarantee for the

reliability and safety of the calculated results.

NOTE:

For each entered value, the system will always give a dialog box asking for the user ’s

confirmation. You must be careful when answering each box. The calculated result is

reliable only after the entered value is confirmed to be correct.

Select the Drug Name:

Turn the knob to pick the DRUG NAME item in DRUG CALC menu. The user may select the drug

name in the pull-down list, including AMINOPHYLLINE, DOBUTAMINE, DOPAMINE,

EPINEPHRINE, HEPARIN, SUPREL, LIDOCAINE, NIPRIDE, NITROGLYCERIN, PITOCIN,

Drug A, Drug B, Drug C, Drug D and Drug E. Calculation for only one type can be generated each

time.

NOTE:

A, B, C, D and E are only code for drugs instead of their real names. The units for these five

drugs are fixed. The operator may select the appropriate units according to the convention

of using these drugs. The rules for expressing the units are:

“mg” series units are fixedly used for drug A, B and C: g, mg, mcg.

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M8B Multi-Parameter Patient Monitor User Manual

“unit” series units are fixedly used for drug D: unit, k unit, m unit.

“mEq” is fixedly used for drug E.

Patient Weight:

After accessing the DRUG CALC window, the operator should enter the patient weight into the first

or the second item. The entered weight will be used as the independent data only for the calculation

of drug concentration.

NOTE:

This drug calculation function acts only as a calculator. That means the patient’s weight in

Drug Calculation menu and Patient Information menu are independent on each other.

When the Weight in “Drug Calculation” is changed, the Weight in “Patient Information” will

not change. In this way, we can say, the Drug Calculation menu is independent on other

menus in the system. Any change of it will not affect other information about the patient

being currently monitored.

9.2 Titration Table

Access Titration Table:

Select TITRATION item in DRUG CALC menu to enter titration table display.

Titration table display for drug is as following:

Figure 9-2 TITRATION

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M8B Multi-Parameter Patient Monitor User Manual

Method to operate the titration table:

1. In the TITRATION table, turn the knob to pick BASIC item. Press and turn the knob to select

either INF RATE or DOSE or DRIP RATE.

2. Then turn the knob to pick STEP item. Press and turn the knob to select step. 1 ~ 10 are

available for selection with the increment being 1.

3. Turn the knob to pick DOSE TYPE item. Press and turn the knob to select the unit in the

pull-down list.

4. Use UP-DOWN item in the table to view the data in previous or following pages.

5. Turn the knob to pick REC item. After pressing the knob, the recorder prints out the data

displayed in tne current titration table.

6. Turn the knob to pick EXIT to return to DRUG CALC menu.

Total amount, dose, volume, INF rate, drip rate and patient weight and drug name are displayed on

the top of the titration table. Meaning of each English identifier is:

AMOUNT: drug amount

VOLUME: liquid volume

DOSE/min: drug dose

INF RATE: flow rate

DRIP RATE: drop rate

WEIGHT: patient weight

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M8B Multi-Parameter Patient Monitor User Manual

10 Safety Guidance

The M8B Multi-parameter Patient Monitor is designed to comply with the International National

Safety requirements for medical electrical equipment IEC60601-1, EN60601-2-27 and

EN60601-2-30. This device has floating inputs and is protected against the effects of defibrillation

and electrosurgery. If the correct electrodes are used and applied in accordance with the

manufacturer instructions (see Chapter ECG/RESP Monitoring), the system can restore screen

display within 10 seconds after defibrillation.

This symbol indicates that the instrument is IEC 60601-1 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.

Environment

Follow the instructions below to ensure a completely safe electrical installation. The environment

where the M8B Multi-parameter patient 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.

M8B Multi-parameter patient 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.

Power Source Requirements

Refer to APPENDIX Ⅰ.

Grounding the M8B

To protect the patient and hospital personnel, the cabinet of the M8B Multi-parameter patient

monitor must be grounded. Accordingly, the M8B 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 on 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 else 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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M8B Multi-Parameter Patient Monitor User Manual

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 M8B 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 M8B must be supplied

by inner power only.

Condensation

Make sure that during operation, the instrument is free of condensation. Condensation can form

when equipment is moved from one building to another, thus being exposed to moisture and

differences in temperature.

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 M8B is provided for the use of qualified physicians or personnel professionally trained.

And 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 EDAN can open the shell.

WARNING

EXPLOSION HAZARD-Do not use M8B in a flammable atmosphere where concentrations

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M8B Multi-Parameter Patient Monitor User Manual

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.

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

complying with the respective IEC standards (e.g. IEC 950 for data processing equipment

and IEC 60601-1 for medical equipment). Furthermore all configurations shall comply with

the valid version of the system standard IEC 60601-1-1. Everybody who connects

additional equipment to the signal input connector or signal output connector configures a

medical system, and is therefore responsible that the system complies with the

requirements of the valid version of the system standard IEC 60601-1-1. If in doubt, consult

our technical service department or your local distributor.

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 M8B 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.

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M8B Multi-Parameter Patient Monitor User Manual

WARNING

Do not heat or throw battery into fire.

WARNING

Do not use, leave battery close to fire or other places where temperature may be above
60℃.

WARNING

Do not immerse, throw, and wet battery in water/seawater.

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 M8B. 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 of the battery leaks onto your skin or clothes, wash well with fresh water

immediately.

WARNING

Keep away from fire immediately when leakage or foul odor is detected.

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M8B Multi-Parameter Patient Monitor User Manual

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 EDAN can be used. Or else, the

performance and electric shock protection can not be guaranteed.

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.

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.

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M8B Multi-Parameter Patient Monitor User Manual

WARNING

When the M8B and electrosurgical device are used together, the user (physician or nurse)

should guarantee the safety of patient.

WARNING

The M8B will be damaged if the water level in the hydropohobic bottle reachs the bottom of

drainpipe.

WARNING

Please replace the hydrophobic bottle if it is nearly full.

WARNING

Please sterilize and disinfect timely to prevent the cross infection between patients.

CAUTION

Electromagnetic Interference - Ensure that the environment in which the M8B is installed

is not subject to any sources of strong electromagnetic interference, such as radio

transmitters, mobile telephones, etc.

CAUTION

The device is designed for continuous and is “ordinary” (i.e. no 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 sterilizer to the M8B, recorder or any accessories.

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M8B Multi-Parameter Patient Monitor User Manual

CAUTION

The M8B 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.

Explanation of Symbols in the Monitor

This symbol means “BE CAREFUL”. Refer to the user manual.

This symbol indicates that the equipment is IEC 60601-1 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 consisting of two parts, see below.

It indicates that the equipment should be sent to the special agencies according to local

regulation for separate collection after its useful life.

It indicates that the equipment is put on the market after 13th August 2005.

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M8B Multi-Parameter Patient Monitor User Manual

Serial number

CE Mark

Authorised representative in the European community

Manufacture date

Manufacturer

Equipotential grounding system

Standby. It designates that the switch or switch position which one part of the device has

been switched on, while the device is at the status of stand-by.

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M8B Multi-Parameter Patient Monitor User Manual

11 Maintenance/Cleaning

11.1 System Check

Before using M8B, do the following:

■ Check if there is any mechanical damage;

■ Check if all the outer cables, inserted modules and accessories are in good condition;

■ Check all the functions of the M8B to make sure that the monitor is in good condition.

If you find any damage on the monitor, stop using the monitor on patient, and contact the

biomedical engineer of the hospital or Customer Service immediately.

The overall check of the monitor, including the safety check, should be performed only by qualified

personnel once every 6 to 12 months, and each time after fixing up.

All the checks that need to open the M8B should be performed by qualified customer service

technician. The safety and maintenance check can be conducted by persons from this company. You
can obtain the material about the customer service contract from the local company’s office.

WARNING

If the hospital or agency that is responding to using the M8B does not follow a satisfactory

maintenance schedule, the M8B may become invalid, and the human health may be

endangered.

NOTE:

To prolong the life of chargeable battery, charging it once every month at least is

recommended, and it must be done after the electric energy is run out.

WARNING

Replace batteries according to the instruction of our servicing engineer.

11.2 General Cleaning

WARNING

Before cleaning the monitor or the sensor, make sure that the equipment is switched off and

disconnected from the power line.

M8B Multi-parameter patient monitor must be kept dust-free.

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M8B Multi-Parameter Patient Monitor User Manual

Regular cleaning of the monitor shell and the screen is strongly recommended. Use only

non-caustic detergents such as soap and water to clean the monitor shell.

CAUTION

Please pay special attention to the following items:

1. Avoid using ammonia-based or acetone-based cleaners such as acetone.

2. Most cleaning agents must be diluted before use. Follow the manufacturer's

directions carefully to avoid damaging the monitor.

3. Do not use the grinding material, such as steel wool etc.

4. Do not let the cleaning agent enter into the chassis of the system.

5. Do not leave the cleaning agents at any part of the equipment.

11.3 Cleaning Agents

Examples of disinfectants that can be used on the instrument casing are listed below:

■ Diluted Ammonia Water

■ Diluted Sodium Hypochlorite (Bleaching agent).

NOTE:

The diluted sodium hypochlorite from 500 ppm (1:100 diluted bleaching agent) to 5000 ppm

(1:10 bleaching agents) is very effective. The concentration of the diluted sodium

hypochlorite depends on how many organisms (blood, mucus) on the surface of the chassis

to be cleaned.

■ Diluted Formaldehyde 35% ~ 37%

■ Hydrogen Peroxide 3%

■ Alcohol

■ Isopropanol

NOTE:

M8B and sensor surface can be cleaned with hospital -grade ethanol and dried in air or with

crisp and clean cloth.

NOTE:

This company has no responsibility for the effectiveness of controlling infectious disease

using these chemical agents. Please contact infectious disease experts in your hospital for

details.

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M8B Multi-Parameter Patient Monitor User Manual

11.4 Sterilization

To avoid extended damage to the equipment, sterilization is only recommended when stipulated as

necessary in the Hospital Maintenance Schedule. Sterilization facilities should be cleaned first.

Recommended sterilization material: Ethylate, and Acetaldehyde.

Appropriate sterilization materials for ECG lead, blood pressure cuff are introduced in relative

chapters respectively.

WARNING

Please sterilize and disinfect timely to prevent the cross infection between patients.

CAUTION

Follow the manufacturer’s instruction to dilute the solution, or adopt the lowest possible

density.

Do not let liquid enter the monitor.

No part of this monitor can be subjected to immersion in liquid.

Do not pour liquid onto the monitor during sterilization.

Use a moistened cloth to wipe up any agent remained on the monitor.

11.5 Disinfection

To avoid extended damage to the equipment, disinfection is only recommended when stipulated as

necessary in the Hospital Maintenance Schedule. Disinfection facilities should be cleaned first.

Appropriate disinfection materials for ECG lead, SpO2 sensor, blood pressure cuff, TEMP probe,

IBP sensor are introduced in relative chapters respectively.

CAUTION

Do not use EtO gas or formaldehyde to disinfect the monitor.

11.6 Replacement of Fuse

Unscrew the fuse cap anticlockwise, replace the fuse (protector tube) and screw down the fuse cap
clockwise. Fuse size: Ф5x20, Rated value: T1.6AL/250V.

NOTE:

Switch off the power switch of the M8B before examining the fuse.

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M8B Multi-Parameter Patient Monitor User Manual

12 ECG/RESP Monitoring

12.1 What Is ECG Monitoring

Monitoring the ECG produces a continuous waveform of the patient's cardiac electric activity to

enable an accurate assessment of his current physiological state. Only proper connection of the

ECG cables can ensure satisfactory measurement. On the Normal Display, The monitor provides

display of 2-channel ECG waveforms.

■ The patient cable consists of 2 parts

The cable that connects to the monitor,

The lead set that connects to the patient.

■ Using a 3-lead set, one waveform is displayed on the screen. Using a 5-lead set, the ECG can

derive up to two waveforms from two different leads. For requested lead, you may choose from

the left side of ECG waveform.

■ The monitor displays the Heart Rate (HR), ST segment and Arrhythmia analysis.

■ Lead off detecting, detect all the electrods, indicate the broken off leads.

■ Anti-electrotome function: if the monitor works with high-frequency electrotome, it will not be

deadlock or restarting.

■ Every ECG channel has Pacing impulse rejection and Bandpass filter circuit.

■ Defibrillation protection (needs 1K resistance ECG cables in series) and hardware clampe

function.

■ A 20 seconds monitor stabilization period shall be allowed before testing. The active noise
suppression is less than 0.1µA, has Tall T-wave rejection capability.

■ Response time of heart rate meter to change in heart rate is less than 10s.

The type of averaging done to compute the minute heart rate, its updating interval is 1s.

■ Alarm for tachycardia with different plus is given within 10s.

NOTE:

In the default settings of the M8B, the ECG waveforms are the first two waveforms from top

in the Waveform Area.

NOTE：

The monitor can only be used on one patient at the same time.

NOTE：

The defibrillator cables should be used in the ECG monitoring, it can avoid burned by high
frequency.

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M8B Multi-Parameter Patient Monitor User Manual

12.2 Precautions during ECG Monitoring

WARNING

Do not come into contact with the patient, table, or the monitor during defibrillation.

WARNING

Use only the original ECG cable for monitoring.

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 but not the conductive part or ground.

NOTE:

Interference from a non-grounded instrument near the patient and ESU interference can

cause inaccuracy of the waveform.

EN60601-1-2 (protection against radiation is 3v/m) specifies that the electrical field density

exceeding 1v/m may cause measurement error in various frequencies. It is accordingly

suggested that do not use equipment generating electrical radiation near ECG/RESP

monitoring devices.

NOTE:

The simultaneous use of cardiac pacemaker or other patient-connected equipments does

not cause safety hazard.

NOTE:

If the pacemaker signals are higher than the claimed range, the heart rate may be
calculated incorrectly.

12.3 Monitoring Procedure

12.3.1 Preparation

1. Prepare the patient's skin prior to placing the electrodes.

■ The skin is a poor conductor of electricity, therefore preparation of the patient's skin is

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M8B Multi-Parameter Patient Monitor User Manual

important to facilitate good electrode contact to skin.

■ Shave hair from sites, if necessary.

■ Wash sites thoroughly with soap and water. (Never use ether or pure alcohol, because this

increases skin impedance).

■ Rub the skin briskly to increase capillary blood flow in the tissues and remove skin scurf

and grease.

2. Attach clip or snap to electrodes prior to placement.

3. Put the electrodes on the patient. Before attaching, apply some conductive jelly on the

electrodes if the electrodes are not electrolyte self-supplied.

4. Connect the electrode lead to the patient's cable.

5. Make sure the monitor is ready with power supply.

WARNING

Placed the electrode carefully and make sure contact good.

WARNING

Check everyday whether there is skin irritation resulted from the ECG electrodes. If so,

replace electrodes every 24 hours or change their sites.

WARNING

Check if the lead connection is correct before monitoring. Unplug the ECG cable from the

socket, the screen will display the error message “ECG LEAD OFF” and the audible alarm

is activated.

NOTE:

For protecting environment, the used electrodes must be recycled or disposed of properly.

12.3.2 Installing ECG Lead

Placing the Electrodes for ECG Monitoring

Electrode placement for 3-lead set (Figure 12-1)

■ Red (R) electrode - Be placed near the right shoulder, directly below the clavicle.

■ Yellow (L) electrode - Be placed near the left shoulder, directly below the clavicle.

■ Green (F) electrode - Be placed on the left hypogastrium.

NOTE: The following table gives the corresponding lead names used in Europe and
America respectively. (Lead names are represented by R, L, F in Europe, whose

corresponding lead names in America are RA, LA and LL.)

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M8B Multi-Parameter Patient Monitor User Manual

America Europe

Lead names Color Lead names Color

RA White R Red

LA Black L Yellow

LL Red F Green

Figure 12-1 Electrode Placement for 3-lead Set

Electrode placement for 5-lead set (Figure 12-2)

■ Red (R) electrode - Be placed near the right shoulder, directly below the clavicle.

■ Yellow (L) electrode - Be placed near the left shoulder, directly below the clavicle.

■ Black (N) electrode - Be placed on the right hypogastrium.

■ Green (F) electrode - Be placed on the left hypogastrium.

■ White (C) electrode - Be placed on the chest as illustrated in the Figure 12-3.

NOTE:

The following table gives the corresponding lead names used in Europe and America

respectively. (Lead names are represented by R, L, N, F and C respectively in Europe,

whose corresponding lead names in America are RA, LA, RL, LL and V.)

America Euro

Lead names Color Lead names Color

RA White R Red

LA Black L Yellow

LL Red F Green

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M8B Multi-Parameter Patient Monitor User Manual

RL Green N Black

V Brown C White

Lewis

R

Red

C

White

N

Black

Figure 12-2 Electrode Placement for 5-lead Set

L

Yellow

F

Green

NOTE:

To ensure patient safety, all leads must be attached to the patient.

For 5-lead set, attach the C (V)-electrode to one of the indicated positions as below (Figure 12-3):

■ V1 On the 4th intercostal space at the right sterna margin.

■ V2 On the 4th intercostal space at the left sterna margin.

■ V3 Midway between V2 and V4 electrodes.

■ V4 On the 5th intercostal space at the left clavicular line.

■ V5 On the left anterior axillary line, horizontal with V4 electrode.

■ V6 On the left middle axillary line, horizontal with V4 electrode.

■ V3R-V7R On the right side of the chest in positions corresponding to those on the left.

■ VE Over the xiphoid position.

■ V7 On the 5th intercostal space at the left posterior axillary line of back.

■ V7R On the 5th intercostal space at the right posterior axillary line of back.

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M8B Multi-Parameter Patient Monitor User Manual

Figure 12-3 C-electrode Placement for 5-lead Set

Recommended ECG Lead Placement for Surgical Patients

WARNING

When using Electrosurgery (ES) equipment, leads should be placed in a position in equal

distance from Electrosurgery electrotome and the ES grounding plate to avoid cautery.

Electrosurgery equipment wire and ECG cable must not be tangled up.

Monitoring ECG leads are mainly used for monitoring the patient’s vital signs. When using the

M8B with other Electrosurgery equipments, we advice to use the counteracting defibrillation ECG

lead.

The placement of the ECG leads will depend on the type of surgery that is being performed. For

example, with open chest surgery the electrodes may be placed laterally on the chest or on the back.

In the operating room, artifacts may affect the ECG waveform due to the use of ES (Electrosurgery)

equipment. To help reduce this you can place the electrodes on the right and left shoulders, the right

and left sides near the abdomen, and the chest lead on the left side at mid-chest. Avoid placing the

electrodes on the upper arm, otherwise the ECG waveform will be too small.

WARNING

When using the M8B with the defibrillator or other high frequency equipments,

counteracting defibrillation ECG lead should be used to avoid cautery.

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M8B Multi-Parameter Patient Monitor User Manual

WARNING

When using Electrosurgery (ES) equipment, do not place an electrode near the grounding

plate of the Electrosurgery device, otherwise there will be a great deal of interference with

the ECG signal.

Using 5-lead ECG Set

You can set the leads on ECG CH1 and ECG CH2 according your needs. The lead label is displayed

on the upper left part of the waveform. You can set them corresponding to any two from I, II, III,

AVR, AVL, AVF and V. If you set both to the same value, one of them will be adjusted to another

option automatically. (Figure 12- 4)

F

Figure 12-4 ECG Lead

NOTE:

If an ECG waveform is not accurate, while the electrodes are tightly attached, try to change

the lead.

NOTE:

Interference from a non-grounded instrument near the patient and ESU interference can

cause inaccuracy of the waveform.

Normal QRS complex should be:

Tall and narrow with no notches.

With tall R-wave completely above or below the baseline.

With pacemakr spike no higher than R-wave height.

With T-wave less than one-third of the R-wave height.

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M8B Multi-Parameter Patient Monitor User Manual

① ② ③

With P-wave much smaller than the T-wave.

Figure 12-5 Standard ECG Waveform

12.4 ECG Screen Hot Keys

④

⑤

Figure 12-6 Hot Key for ECG

① Leads of channel 1:

1）The selectable leads are I, II, III, aVR, aVL, aVF, V.
2）When the ECG is 5-lead, the selectable leads are: I, II, III, aVR, aVL, aVF, V; when ECG is
3-lead, the selectable leads are: I，II，III.
3）Leads on the ECG wave must not have the same name. Otherwise, the system will

automatically change the ECG waveform name that has the same name as the waveform being

currently adjusted to another name.

② Waveform gain of channel 1: used to adjust the size of ECG waveforms

Signal amplification and collection of Channel 1 ECG (12 bits, 500Hz), it can collect plus value

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M8B Multi-Parameter Patient Monitor User Manual

for each channel setting as ×0.25, ×0.5, ×1, ×2, or AUTO mode. Under "AUTO" mode, the

monitor chooses an appropriate level automatically. A 1mv scale displays on each ECG

channel's right side. The height of 1mV bar is directly proportional to the waveform amplitude.

NOTE:

When the input signals are too large, the peak of the waveform may be not able to be

displayed. In this case the user may manually change the setup method of ECG waveform

according to the actual waveform so as to avoid the occurrence of the unfavorable

phenomena.

③ Filter method: used for displaying clearer and more detailed waveform

There are three filter modes for selection. DIAGNOSTIC, MONITOR and SURGERY modes

may reduce perturbance and interference from Electrosurgery equipment. The filter method is

the item applicable for both channels, which is always displayed at the waveform place of the

channel 1 ECG waveform.

NOTE:

Only in Diagnosis mode, the system can provide non-processed real signals. In M8B or

Sugery mode, ECG waveforms may have distortion of different extent. In either of the latter

two modes, the system can only show the basic ECG and the results of ST analysis may

also be greatly affected. In Surgery mode, results of ARR analysis may be somewhat

affected. Therefore, it is suggested that in the environment having relative small

interference, you’d better monitor a patient in Diagnosis mode.

④ Leads of channel 2: refer to ① for detailed information.
⑤ Waveform gain of channel 2: refer to ② for detailed information.

NOTE:

Pacemaking signal detected is marked by a " | " above the ECG waveform.

12.5 ECG Menu

Pick the ECG hot key on the screen, and the following menu will pop up.

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■ ECG Alarm Setting

M8B Multi-Parameter Patient Monitor User Manual

Figure 12-7 ECG Setup

• HR ALM: pick "ON" to enable prompt message and data record during the ECG alarm; pick

"OFF" to disable the alarm function, and there will be a beside “ECG”.

WARNING

In order to avoid endangering the patient’s life, the user should use this function cautiously.

• ALM LEV: selectable from HIGH, MED, LOW. Level HIGH represents the most serious

case.

• ALM REC: pick "ON" to enable report printing upon ECG alarm.

• ALM HI: used to set up the upper limit of ECG alarm.

• ALM LO: used to set up the lower limit of ECG alarm.

ECG alarm is activated when the heart beat exceeds set ALM HI value or falls below ALM LO

value.

The adjusting range of ECG alarm limits is: 15~350.

ECG alarm limits for default:

ALM HI ALM LO Step

HR ADU 120 50 1

HR PED 160 75 1

HR NEO 200 100 1

The adjusting range of ECG alarm limits：

Max.ALM HI Min. ALM LO Step

HR ADU 300 15 1

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M8B Multi-Parameter Patient Monitor User Manual

HR PED 350 15 1

HR NEO 350 15 1

NOTE:

Please set the alarm limits according to clinical condition of individual patient. The upper

limit shall not exceed 20 beats per minute higher than the patient's heart rate.

WARNING

Response time for heart rate meter to change in heart rate calculation is less than 10s.
The updating interval of averaging type done to compute the heart rate per minute is 1s.

■ HR FROM

ECG, SpO2, AUTO and BOTH may detect heart rate. AUTO distinguishes heart rate source

according to the quality of signal. When the quality of ECG signal and SpO2 signal is the same,

ECG takes priority over SpO2. By picking ECG, the monitor prompts HR and activates HR beep.

By picking SpO2, the monitor prompts PULSE and activates pulse beep. BOTH mode displays HR

and PR simultaneously, when this item is picked, PR parameter is displayed to the right side of

SpO2. As for the sound of HR or PR in BOTH mode, HR is given the priority, i.e., if HR is available,

whose sound will be sent out, but if HR is not available, then the sound will be for PR.

■ HR CHANNEL

"CH1" to count the heart rate by CH 1 waveform

"CH2" to count the heart rate by CH 2 waveform

■ LEAD TYPE: used to select either 5 LEADS or 3 LEADS.

■ SWEEP

Available options for ECG SWEEP are 12.5, 25.0, and 50.0 mm/s.

■ ST ANALYSIS

Pick this item to access ST ANALYSIS menu, the detailed information about the menu is to be

discussed in the following section.

■ ARR ANALYSIS

Pick this item to access ARR ANALYSIS menu, the detailed information about the menu is to

be discussed in the following section.

■ OTHER SETUP

Pick this item to access ECG SETUP menu as shown below:

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M8B Multi-Parameter Patient Monitor User Manual

Figure 12-8 ECG Setup

In the sub-menu, following functions are available:

ECG DISPLAY

Select NORMAL DISPLAY to display 2 ECG waveforms for 5-lead (for 3-lead, only 1 ECG

waveform is displayed.). Select MULTI-LEADS DISPLAY, the waveform area on the screen
only displays 7 ECG waveforms，occupying the area of 7 waveforms. Select HALF-SCAN

MULTI-LEADS, those 7 ECG waveforms are displayed on the screen, occupying the area of 4

waveforms.

Figure 12-9 MULTI-LEADS DISPLAY

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M8B Multi-Parameter Patient Monitor User Manual

Figure 12-10 HALF-SCAN MULTI-LEADS display

NOTE:

If 3 LEADS is selected in the ECG SETUP menu, only NORMAL DISPLAY can be selected

for ECG DISPLAY item in the sub-menu.

BEAT VOL

Six selections are available: 0, 1, 2, 3, 4, 5. “5” indicates maximum volume. “0” indicates no

sound.

PACE

"ON" detected signal will be marked by a " | " above the ECG waveform

"OFF" for non-pacemaking patient.

NOTE:

If monitoring a patient with the pacemaker, set “PACE” to On. If monitoring a patient without

pacemaker, set “PACE” to Off.

If “PACE” is on, the system will not perform some types of ARR analysis. For detailed

information, please refer to the section: ARR ALARM.

PACE FROM: to set ON or OFF PACE FROM which means all the ECG waveforms occupy 2

channels waveform area. It functions only when the ECG DISPLAY is set to NORMAL

DISPLAY.

ECG CAL

Pick this item to start ECG calibrating process. Picking this item again or change lead name on

the screen can end calibrating process.

It can use Standardizing voltage to set the display width for 1mV signal, such as X1 is for

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M8B Multi-Parameter Patient Monitor User Manual

10mm, X2 is for 20mm.

ADJUST WAVE POS

Pick this item to call up the ADJUST WAVE POS dialog box and adjust the position of ECG

waveforms on the screen. The user may use CH NAME item to select the channel to be

adjusted, UP-DOWN to adjust the position of the selected channel on the screen, BACK TO

DEFAULT to let the waveform go back to the default position on the screen.

Figure 12-11 ADJUST WAVE POS Menu

DEFAULT

Pick the DEFAULT item to call up the ECG DEFAULT CONFIG dialog box, in which you can

select the FACTORY DEFAULT CONFIG or the USER DEFAULT CONFIG item. After

selecting any of the items and exiting the dialog box, the system will pop up a dialog box

asking for your confirmation.

Figure 12-12 ECG Default Configure

WARNING

For pacemaker patient, the pacing impulse analysis function must be switched on,

otherwise, the pacing impulse may be counted as normal QRS complex, which results in

failure of detection.

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M8B Multi-Parameter Patient Monitor User Manual

NOTE:

When Pacer Switch is On, the Arrhythmia events related to PVCs will not be monitored. At

the same time, the ST analysis will not be performed either.

If the monitor can do ST segment monitoring and Arrhythmia monitoring, please refer to section

12.7 and 12.8.

12.6 ECG Alarm Information

12.6.1 Alarm Message

Alarms occurring in the process of ECG measurement contain two types: physiological alarm and

technical alarm. For the audio and visual features during the appearance of these alarms in the

process of ECG measurement, please refer to the related description in Chapter Alarm. In the

screen, physiological alarm messages are displayed in the Physiological Alarm area. Technical

alarms messages are displayed in the Technical Alarm area.This section does not describe the

content about Arr. and ST analysis.

Tables below describe respectively the possible various alarms those may occur during the

measurement.

Physiological alarms:

Message Cause Alarm level

ECG SIGNAL
WEAK

Can not detect the signal in designated time period.

High

HR TOO HIGH HR measuring value is above the upper alarm limit User-selectable

HR TOO LOW HR measuring value is below the lower alarm limit User-selectable

Technical alarms: (take American Standard for example)

Message Cause

Alarm
level

Remedy

ECG LEAD OFF

ECG C LEAD OFF

More than one ECG
electrodes fall off the
skin or ECG cables fall
off the monitor.

ECG electrode C falls
off the skin or ECG
cables fall off the
monitor.

Low

Low

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Make sure that all electrodes, leads
and patient cables are properly
connected.

M8B Multi-Parameter Patient Monitor User Manual

ECG V LEAD OFF

ECGⅠLEAD OFF

ECGⅡLEAD OFF

ECG F LEAD OFF

ECG electrode V falls

off the skin or ECG

cables fall off.

ECG electrode Ⅰ falls

off the skin or ECG

cables fall off the

monitor.

ECG electrode Ⅱ falls

off the skin or ECG

cables fall off the

monitor.

ECG electrode F falls

off the skin or ECG

cables fall off the

monitor.

Low

Low

Low

Low

ECG L LEAD OFF

ECG R LEAD OFF

ECG LL LEAD
OFF

ECG LA LEAD
OFF

ECG electrode L falls

off the skin or ECG

cables fall off the

monitor.

ECG electrode R falls

off the skin or ECG

cables fall off the

monitor.

ECG electrode LL falls
off the skin or ECG
cables fall off the
monitor.

ECG electrode LA falls
off the skin or ECG
cables fall off the
monitor.

Low

Make sure that all electrodes, leads
and patient cables are properly
connected.

Low

Low

Low

ECG RA LEAD
OFF

ECG electrode RA falls
off the skin or ECG
cables fall off the
monitor.

Low

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M8B Multi-Parameter Patient Monitor User Manual

ECG EXCEED

ECG INIT ERR

ECG INIT ERR 1

ECG INIT ERR 2

ECG INIT ERR 3

ECG INIT ERR 4

ECG INIT ERR 5

ECG measuring
value is beyond
measuring range.

ECG module failure

ECG module failure

High

High

High

Check lead connection and patient
condition

Stop using measuring function of
ECG module, notify biomedical
engineer or Manufacturer’s service
staff.

Stop using measuring function of
ECG module, notify biomedical
engineer or Manufacturer’s service
staff.

ECG INIT ERR 6

ECG INIT ERR 7

ECG INIT ERR 8

ECG COMM STOP

ECG COMM ERR

HR ALM LMT
ERR

ECG NOISE

ECG module failure or
communication failure

High

Functional safety failure High

ECG measuring signal is
greatly interfered.

Low

Stop using measuring function of
ECG module, notify biomedical
engineer or Manufacturer’s service
staff.

Stop using HR alarm function, notify
biomedical engineer or
Manufacturer’s service staff.

Check lead connection and
patient condition

HR EXCEED

HR measuring value is
beyond measuring range.

High

- 89 -

Check lead connection and
patient condition