PM-9000 Express Service Manual V3.2

Copyright Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns all rights to this unpublished work and intends to maintain this work as confidential. Mindray may also seek to maintain this work as an unpublished copyright. This publication is to be used solely for the purposes of reference, operation, maintenance, or repair of Mindray equipment. No part of this can be disseminated for other purposes.

In the event of inadvertent or deliberate publication, Mindray intends to enforce its rights to this work under copyright laws as a published work. Those having access to this work may not copy, use, or disclose the information in this work unless expressly authorized by Mindray to do so.

All information contained in this publication is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental 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 Mindray, nor the rights of others. Mindray 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.

PROPERTY OF SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. ALL RIGHTS RESERVED Responsibility on the manufacturer party Mindray is responsible for safety, reliability and performance of this equipment only in the condition that:

• all installation, expansion, change, modification and repair of this equipment are conducted by Mindray qualified personnel;

• applied electrical appliance is in compliance with relevant National Standards; • the monitor is operated under strict observance of this manual.

Patient monitor Service Manual（V3.2）

I

Warning For continued safe use of this equipment, it is necessary that the listed instructions are followed. However, instructions listed in this manual in no way supersede established medical practices concerning patient care. Do not rely only on audible alarm system to monitor patient. When monitoring adjusting the volume to very low or completely muting the sound may result in the disaster to the patient. The most reliable way of monitoring the patient is at the same time of using monitoring equipment correctly, manual monitoring should be carried out. This multi-parameter patient monitor is intended for use only by medical professionals in health care institutions. To avoid electrical shock, you shall not open any cover by yourself. Service must be carried out by qualified personnel. Use of this device may affect ultrasonic imaging system in the presence of the interfering signal on the screen of ultrasonic imaging system. Keep the distance between the monitor and the ultrasonic imaging system as far as possible. It is dangerous to expose electrical contact or applicant coupler to normal saline, other liquid or conductive adhesive. Electrical contact and coupler such as cable connector, power supply and parameter module socket-inlet and frame must be kept clean and dry. Once being polluted by liquid, they must be thoroughly dried. If to further remove the pollution, please contact your biomedical department or Mindray.

It is important for the hospital or organization that employs this equipment to carry out a reasonable maintenance schedule. Neglect of this may result in machine breakdown or injury of human health.

II

Patient monitor Service Manual（V3.2）

Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANT ABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the substitution upon it of parts or accessories not approved by Mindray or repaired by anyone other than a Mindray authorized representative.

This warranty shall not extend to any instrument which has been subjected to misuse, negligence or accident; any instrument from which Mindray's original serial number tag or product identification markings have been altered or removed, or any product of any other manufacturer.

Safety, Reliability and Performance Mindray is not responsible for the effects on safety, reliability and performance of the PM-9000 Portable Multi-Parameter Patient Monitor if: ■

assembly operations, extensions, re-adjusts, modifications or repairs are carried out by persons other than those authorized by Mindray.

■

the PM-9000 is not used in accordance with the instructions for use, or the electrical installation of the relevant room does not comply with NFPA 70: National Electric Code or NFPA 99: Standard for Health Care Facilities (Outside the United States, the relevant room must comply with all electrical installation regulations mandated by the local and regional bodies of government).

Patient monitor Service Manual（V3.2）

III

Return Policy Return Procedure In the event that it becomes necessary to return a unit to Mindray, the following procedure should be followed:

1.

Obtain return authorization. Contact the Mindray Service Department and obtain a Customer Service Authorization (Mindray) number. The Mindray number must appear on the outside of the shipping container. Return shipments will not be accepted if the Mindray number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return.

2.

Freight policy. The customer is responsible for freight charges when equipment is shipped to Mindray for service (this includes customs charges).

Company Contact Address:

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, P.R.China

IV

Phone:

+86 755 26582479 26582888

Fax:

+86 755 26582934 26582680

Patient monitor Service Manual（V3.2）

Safety Precautions 1 . Meaning of Signal Words In this manual, the signal words DANGER, WARNING, and CAUTION are used regarding safety and other important instructions. The signal words and their meanings are defined as follows. Please understand their meanings clearly before reading this manual.

Signal word

Meaning

DANGER

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.

CAUTION

Indicates a potentially hazardous situation which, if not avoided, may result in property damage.

2 . Meaning of Safety Symbols Symbol

Description Type-BF applied part "Attention"

(Refer to the operation manual.)

3 . Safety Precautions Please observe the following precautions to ensure the safety of service engineers as well as operators when using this system.

DANGER:

Do not use flammable gasses such as anesthetics, or flammable liquids such as ethanol, near this product, because there is danger of explosion.

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WARNING:

Do not connect this system to outlets with the same circuit breakers and fuses that control current to devices such as life-support systems. If this system malfunctions and generates an overcurrent, or when there is an instantaneous current at power ON, the circuit breakers and fuses of the building’s supply circuit may be tripped.

CAUTION: 1. Malfunctions due to radio waves (1) Use of radio-wave-emitting devices in the proximity of this kind of medical electronic system may interfere with its operation. Do not bring or use devices which generate radio waves, such as cellular telephones, transceivers, and radio controlled toys, in the room where the system is installed. (2) If a user brings a device which generates radio waves near the system, they must be instructed to immediately turn OFF the device. This is necessary to ensure the proper operation of the system. 2. Do not allow fluids such as water to contact the system or peripheral devices. Electric shock may result.

VI

Patient monitor Service Manual（V3.2）

Symbols

Be Careful

Protective earth ground

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.

Equipotential grounding terminal

CE mark 93/42/EEC a directive of the European Economic Community

Silence Symbol

！

Close all alarm volume

@

Mark Event

》

Next menu

***

Highest level alarm

**

Middle level alarm

*

Lowest level alarm

Ð

Trend graph cursor

u

SYS

t

DIA pressure(NIBP trend graph)

*

MEAN pressure (NIBP trend graph)

Î

Right moving indicator

Í

Left moving indicator

Alarm pause

Heart beat × SN

Gain magnify

pressure（NIBP trend graph）

Pace signal √

Confirm

Series Number

Patient Monitor Service Manual (V3.2)

I

Contents Chapter 1Menu Tree ··························································································· 1-1 Chapter 2Introduction ·························································································· 2-1 2.1General·········································································································· 2-1 2.2Screen Display ······························································································ 2-2 2.3Button and knob Functions ········································································ 2-6 Chapter 3principle ······························································································· 3-1 3.1PM-9000 Block diagram ··············································································· 3-1 3.2PCB connection diagram ··············································································· 3-1 3.3Main Board ··································································································· 3-2 3.4ECG/RESP/TEMP Module ··········································································· 3-3 3.5CO/IBPModule ····························································································· 3-5 3.6SPO2 Module ································································································ 3-6 3.7NIBP Module ································································································ 3-7 3.8RecorderModule ··························································································· 3-8 3.9 Keyboard ····································································································· 3-9 3.10 Power board······························································································································································3-10 3.11CO2 Module ····························································································· 3-13 3.12AG Module ·······························································································································································3-15 3.13 Masimo SPO2 Module ································································································································3-16 Chapter 4 Product specification ················································································ 4-1 ····································································································· 5-1 Chapter 5Tests 5.1System checks ······························································································· 5-1 5.2Safety tests ···································································································· 5-1 5.3 Parameter function testing ···········································································5-4 5.4NIBP Calibrate ··························································································· 5-9 5.5IBPCalibrate································································································ 5-10 5.6CO2 Check ································································································· 5-13 5.7AG Calibrate ···························································································· 5-14 Chapter 6Structure and Part list ················································································ 6-1 6.1Explosive view ······························································································ 6-1 6.2Dis and reassembly procedures ··································································· 6-13 6.3Part List ···································································································· 6-13 Chapter 7Maintenance menu ···················································································· 7-1 Chapter 8Maintaince and Cleaning ··········································································· 8-1 8.1Maintenance checks ······················································································ 8-1 8.2General cleaning ··························································································· 8-1 8.3 Sterilization ·································································································· 8-2 8.4Preventative maintenance ·············································································· 8-3

8.5Cuffmaintenanceandcleaning ···································································· 8-3 8.6 IBP transducer cleaning and disinfectin（reusable） ······························· 8-4 8.7TEMP sensor cleaning and disinfection (reusable) ··································· 8-5 8.8SpO2 sensor cleaning and disinfection ··························································· 8-6

8.9 CO2 sensor cleaning ····················································································· 8-6 8.10AG sensor cleaning······················································································ 8-7 APPENDIX ATroubleshooting and System Alarm prompt ········································ A-1 APPENDIX BInstruction of fixing kits ······································································· B-1

Menu Tree

Chapter 1

Menu Tree

LEAD

I, II, III, AVR, AVL, AVF, V

GAIN

.25, .5, 1, 2, auto

BANDWIDTH

Monitor, Diagnostic, Surgical

IBP LABLE

ART, PA, CVP, RAP, LAP, ICP, P1, P2

ECG

Alarm Setup-On/Off, Priority, Alarm Rec, Hi/Lo Limits. Source, Lead Type, Sweep Speed, ST ANAL, ARR ANAL, Other setup

NIBP

Alarm Setup-On/Off, Priority, Hi/Lo Limits, Alarm Rec, Display Type, Reset, Continual, Calibrate, Pneumatic, Default

SPO2

Alarm Setup-On/Off, Priority, Alarm Rec, Hi/Lo Limits, Sweep Speed, Beep Vol, Average Time, Default

IBP

Alarm Setup-On/Off, Priority, Alarm Rec, Sweep Speed, Unit, Filter, Hi/Lo Limits, Scale Adj, Expand Pressure, Default

RESP

Alarm Setup-On/Off, Priority, Hi/Lo Limits, Alarm Rec, Apnea Alarm, Sweep Speed, Amplify, Hold Type, Default

TEMP

Alarm Setup-On/Off, Priority, Alarm Rec, Hi/Lo Limits, Unit, Default

CO

Start, Stop, Cancel, Rec, Scale, Edit

Patient Monitor Service Manual (V3.1)

1-1

Menu Tree

CO2

Wave Scale, Mode, Pump Rate, Compensate

Agent, Unit, Pump Rate, Compensate, Sweep, Mode, Alarm

AG

Setup, Default

Patient Setup, Default, Trent Graph, Trent Table, NIBP Recall,

MENU

Alarm Recall, System Setup, Selection, Version, Drug Calculation, Maintain, Demonstration

Patient Setup

DEPT, PAT NO., BED NO., DOCTOR, NAME, SEX, PAT TYPE, ADMIT, BIRTH, HT, WT, BLOOD, NEW PATIENT

Default

Trent Graph

Trent Table

System Setup Selection

Factory/User –for A/P/N

Interval – 1s, 5s, 1, 5, 10 min, Parameter List

Interval – 1, 5, 10, 30, 60 min

Face Select, Time Setup, Recorder Setup, Analog, Mark Event, Module Setup, Trace Setup, Alarm Setup

Key Volume, Help, Scan Type, Alarm Limit

User Menu Password-“Mindray”, Language Select, Lead Style,

Maintain

Net type, Local Net NO., Color Self-define, System key setup Factory Menu Password-“332888”, ARR switch, Lead type, TEMP sensor type, CO2 check, Module setup AG & O2 calibrate Demo Password-“2088”

1-2

Patient Monitor Service Manual (V3.1)

Introduction

Chapter 2 Introduction 2.1 General PM-9000 EXPRESS is a Portable Patient Monitor that has abundant monitoring functions and is used for the clinical monitoring of adult, pediatric and neonate. In addition, the user may select the different parameter configuration according to different requirements. PM-9000 EXPRESS can be connected to the central monitoring system via the Mindray network so as to form a network monitoring system. PM-9000 EXPRESS (Figure 2-1) can monitor vital signals as ECG, Respiratory Rate, SpO2, NIBP, Dual-channel TEMP, Dual-channel IBP, CO, CO2 and AG. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Replaceable built-in battery facilitates transportation of patient. Large high-resolution display provides clear view of 8 waveforms and full monitoring parameters. The POWER switch is on the bottom left quarter of the front panel (① in Figure 2-1). The CHARGE indicator on the right side of the POWER switch lights when the device is powered on (② in Figure 2-1). The ALARM indicator is on the upper side of the front panel. The ALARM indicator flashes when alarm occurs (③ in Figure 2-1). The sockets of the sensors are at the left side. The recorder socket is at the right side. Other sockets and power plug-in are at the rear panel. PM-9000 EXPRESS has a very friendly operation interface for the users, and you can finished all the operations via a few buttons (④)and a rotary knob(⑤)on the front panel.

3

1

2

4

5

Figure 2-1 PM-9000 EXPRESS Portable Patient Monitor

Patient Monitor Service Manual (V3.2)

Introduction

PM-9000 EXPRESS portable patient monitor performs monitoring of: Heart Rate (HR) ECG

2-channel ECG waveforms Arrhythmia and S-T segment analysis（optional）

RESP SpO2 NIBP TEMP

Respiratory Rate (RR) Respiration Waveform Oxygen Saturation (SpO2), Pulse Rate (PR) SpO2 Plethysmogram Systolic Pressure (NS), Diastolic Pressure (ND), Mean Pressure (NM) Channel-1 Temperature (T1), Channel-2 Temperature (T2), Temperature Difference between two channels (TD) Channel-1 SYS, DIA, MAP

IBP

Channel-2 SYS, DIA, MAP Dual-IBP waveforms

CO

Blood Temperature (TB) Cardiac Output (CO) End Tidal CO2 （EtCO2）

CO2

Inspired Minimum CO2 (InsCO2) Air Way Respiration Rate (AwRR) EtCO2 Nitrous oxide

AG

(N2O)

5 Agent gases O2

(optional function)

Respiring time per minute

(AwRR)

PM-9000 EXPRESS provides extensive functions such as visual & audible alarm, storage and report printout of trend data, NIBP measurements, and alarm events, OxyCRG review and drug dose calculation.

2.2 Screen Display The display of PM-9000 EXPRESS parameter monitor is a color LCD, which can display the collected patient parameters, waveforms, alarm information as well as bed number, time and monitor status, etc. The screen is divided into three areas(Figure 2-2): Information area①④, waveform area② and parameter area③.

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Patient Monitor Service Manual (V3.2)

Introduction

① ③ ②

④

Figure2-2 PM-9000 EXPRESS Main Screen

Information Area(①): Information area lies on the top part of the screen, which is used to display the current status of the monitor and the patient. The information area contains following data: Bed No.: used to indicate the bed number of the patient being monitored. Adult: used to indicate the patient type. 3/1/2001: used to indicate the current date. 10:23:45: used to indicate the current time. Patient sex: Patient gender. Displayed to the right side of the patient name. Other information displayed in the information area appears or disappears together with the status being reported, which are divided into following parts based on the contents: ● Monitor Prompt Information: Informing the status of monitor or sensor, which always appears to the right side of the time. When this information appears, it will cover the patient sex and name. ● “ ” is the SILENCE mark. When pressing SILENCE button, this mark appears, indicating that all kinds of sound are manually muted. The system gives out the sound only after the operator discharge the SILENCE status or the system has new alarm event. ● “！

” is the mark indicating that the alarm volume is closed. When select the “OFF”

item in the USER MAINTAIN menu, this mark appears indicating that the operator has permanently closed the audio alarm function. This audio alarm function can resume only after the operator discharges the closing alarm volume setup. ●

Patient parameter alarm information: this information is fixedly displayed in the extreme right side of the screen.

● When the waveform on the screen is frozen, the corresponding prompt “FROZEN” window appears on the bottom part of the screen.

Patient Monitor Service Manual (V3.2)

Introduction

Waveform / Menu Area(②) The waveform area can maximally display 8 waveforms. The displaying order of the waveforms on the screen can be adjusted. For the maximum configuration, the waveforms provided by the system for selection are: 2 ECG waveforms, SpO2 waveform, 2 IBP waveforms, RESP waveform, CO2 waveform, O2 waveform and AG waveform.

All the waveforms in the system are listed out in the “WAVEFORM SETUP” menu. The user may select the waveform to be displayed and adjust their displaying positions. The specific method is illustrated in the part: Set Up Screen Waveform.

The name of the waveform is displayed on the upper left part of the waveform. The user may choose ECG lead based on the requirements. The gain and the filter of the channel are also displayed on each ECG waveform. A 1mV scale bar is also displayed to the right side of ECG waveform. The IBP waveform scale can also be selected according to the actual requirement. Its range is described in the part: Measure IBP. In the IBP waveform area, the waveform scale is displayed. The three dotted lines for each IBP waveform form 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: Measure IBP.

When wanted during screen operation, the menu always occupies the fixed position in the middle part of the waveform area, therefore part of waveform can not be viewed temporarily. After exiting the menu, the system will restore the original screen. 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) The parameter area lies to the right side of the waveform area, whose position basically corresponds to the waveform. The parameters displayed in the parameter area include: ECG - Heart rate or pulse rate (unit: beats/minute) - The ST analyzing result of channel 1 and 2: ST1, ST2 (unit: mV) - PVCs（unit: times/minute） NIBP - From left to right, there are Systolic pressure, Mean pressure and Diastolic pressure（unit: mmHg or kPa） SpO2 - SpO2（unit: %） - Pulse Rate（unit: beats/minute）（When “BOTH” item is selected） 2-4

Patient Monitor Service Manual (V3.2)

Introduction

CO ─ CO（unit: liter/minute） ─ TB（unit: ℃ or ℉） 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）. RESP - Respiration Rate（unit: times/minute） CO2 - EtCO2（unit: mmHg or kPa） - INS CO2 (unit: mmHg or kPa) - AwRR (times/minute) TEMP - Temperature of channel 1 and 2: T1, T2 and the difference between them TD. (unit: ℃ or ℉) AG - EtCO2 (CO2) - Nitrous Oxide (N2O) - Oxygen (O2) (optional function) - Respiring Time per Minute (AwRR) - Anaesthetic agent

Alarm lamp and alarm status: In normal status: the alarm lamp is not on. When alarm exists, the alarm lamp flashes or lights on. The color of the lamp corresponds to the alarm level.

Figure 2-3 PM-9000 EXPRESS buttons and knob

Patient Monitor Service Manual (V3.2)

Introduction

2.3 Button and knob Functions All the operations to PM-9000 EXPRESS are through the buttons and a knob at the bottom of the screen.

MAIN(Figure 2-3 ①) Whatever levels of menu the system is in, press the button and the system will always return to the main screen. FREEZE(Figure 2-3 ②) Press this button and the system will access the FREEZE status. In this status the user may review the waveform of 40 seconds. Also, the frozen waveform can be printed out. In the FREEZE status, press this button again to discharge the FREEZE status. For detailed information, refer to related chapter: Freeze. SILENCE(Figure 2-3 ③) Press this button and the system will access the Alarm Pause status. All the alarm sounds are muted. However, other sounds such as heart beat, button sound and pulse sound will still exist. At this time, the “ALARM PAUSE xx s” appears in the parameter alarm information area. Press this button again or when the pause time runs out, the system terminates the alarm pause status and returns to the normal monitoring status, then the alarm sound resumes and the prompt “ALARM PAUSE xx s” disappears from the screen. What’s more, pressing this button more than 1 second will mute the sound. REC/STOP(Figure 2-3 ④) Press to start a real time recording. The recording time is set in REC TIME of RECORD SETUP submenu. Press this button during recording to stop the recording. In Freeze mode, the user may use(press) this button to select the waveform to be output. For detailed information, refer to related chapter. NIBP(START) (Figure 2-3 ⑤) Press to inflate the cuff to start a blood pressure measurement. In the process of measuring, pressing this button can cancel the measurement and deflate the cuff. Rotary knob (Figure 2-3 ⑥) The user may use the rotary knob to select the menu item and modify the setup. It can be rotated clockwise or counter-clockwise 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.

2-6

Patient Monitor Service Manual (V3.2)

Introduction

Figure 2-4 PM-9000 EXPRESS rear panel ■

Network Interfaces (Socket ①):

■

FUSE ( Socket ②) Standard T 1.6A

■

Power Supply(Socket ③): External 100-250 (VAC), 50/60 (Hz).

■

ANALOG OUTPUT or AUX OUTPUT(Socket ④)

Standard RJ45 Socket.

ANALOG OUTPUT is replaced by AUX OUTPUT on July 2004. ■

VGA MONITOR: (Socket ⑤) Monitor interface for external standard VGA color monitor.

■

(Socket ⑥) Equipotential grounding terminal for connection with the hospital’s grounding system.

Patient cables and sensor sockets are shown in the figure below;

① TB 1 probe socket ② CO2 sensor socket ③ TB 2 probe socket ④ IBP1 transducer socket ⑤ IBP2 transducer socket ⑥ ECG cable socket ⑦ CO cable socket ⑧ NIBP cuff socket ⑨ SpO2 sensor socket

Figure 2-5

Patient Monitor Service Manual (V3.2)

Principle

Chapter 3 Principle 3.1 PM-9000 block diagram TFT Display 12.1 inchs 800 X 600

X14

FAN X15

PE Connector

J9

P4(TFT_DIGITAL) J6

P2(CRT)

X16

Main Power Input

Alarm LED

P1(LVDS)

Power Supply PCB J3

J2

P10

J5

P3(FOR 9000 VGA) P12

J4

P11

Key & Alarm P.C.B.

Speaker

P7(BDM)

X1

P13

P5

Knob

Recorder Module X2

P16

TO X2

J8

Host P.C.B.

P17(FOR 509C) P15

Battery

J7

P6

P9

P14

P8

VGA interface

X5 NET Interface

AG or EtCO2 Module

X7

X8

SPO2 P.C.B.

NIBP Module

IBP & CO P.C.B.

X9

X10

X11

X12

SpO2 Sensor

Cuff

CO Cable

IBP

NIBP

ECG Cable

CO

SPO2

TEMP Sensor

ECG

TEMP

Tube

Analog output

X6

ECG/ RESP/ TEMP P.B.C.

IBP Cable

Figure 3-1 PM-9000 block diagram

3.2 PCB connection diagram P1(LVDS) J9

P4(TFT_DIGITAL) P2(CRT)

J6 X16

Power Supply PCB J3

J2

P10

J5

P3(FOR 9000 VGA) P12

J4

P11

P7(BDM)

AG or EtCO2 Module

X1

P13

Recorder Module X2

P16

P5

X5

J8

Host P.C.B.

P17(FOR 509C) P15 TO X2

J7

Key & Alarm P.C.B.

P6

P9

P14

P8

X6

X7

X8

ECG/ RESP/ TEMP P.B.C.

SPO2 P.C.B.

NIBP Module

IBP & CO P.C.B.

X9

X10

X11

X12

Figure 3-2 PCB connection diagram

Patient Monitor Service Manual (V3.2)

3-1