Mindray Accutor VII User manual

/VS-900c

Vital Signs Monitor

Service Manual

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this product and this manual. This manual may refer to information 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.

Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rent, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

, , and are the registered trademarks or trademarks owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.

This posting serves as notice under 35 U.S.C.§287(a) for Mindray patents: http://www.mindrayna.com/patents.

The issued date for this manual is May 2019 (Version 11.0).

© Copyright 2013-2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

WARNING

Federal Law (USA) restricts this device to sale by or on the order of a physician.

NOTE

This manual describes all features and options. The equipment may not have all of them. Contact Mindray service department for any questions.

I

Manufacturer’s Responsibility

Contents of this manual are subject to changes without prior notice.

All information contained in this manual 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 manual.

Mindray is responsible for safety, reliability and performance of this product only in the condition that:

All installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel; and

The electrical installation of the relevant room complies with the applicable national and local requirements; and

This product is operated under strict observance of this manual.

Return Policy

In the event that it becomes necessary to return a unit to Mindray, follow the instructions below.

1.Obtain a return authorization.

Contact the Mindray Service Department and obtain a Mindray Customer Service Authorization Number. The Mindray Customer Service Authorization Number must appear on the outside of the shipping container. Return shipments will not be accepted if the Mindray Customer Service Authorization 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 this product is shipped to Mindray for service (including any relevant customs fees or other freight related charges).

3.Return address

Please send the part(s) or equipment to the address offered by Customer Service Department.

II

Contact Information

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen 518057 P.R. China

Tel: [phone]

Fax: [phone]

Website: www.mindray.com

Distributor: Mindray DS USA, Inc.

Address: 800 MacArthur Boulevard Mahwah, New Jersey 07430 USA

Tel: [phone]

Website: www.mindray.com

III

Preface

Manual Purpose

This manual provides detailed information about the assembling, dissembling, testing and troubleshooting of the equipment to support effective troubleshooting and repair. It is not intended to be a comprehensive, in-depth explanation of the product architecture or technical implementation.

Observance of the manual is a prerequisite for proper equipment maintenance and prevents equipment damage and personnel injury.

Intended Audience

This manual is for biomedical engineers, authorized technicians or service representatives responsible for troubleshooting, repairing and maintaining the equipment.

Passwords

A password may be required to access different modes of the following equipment. The passwords are listed below:

	User maintenance:	888888
	Configuration mode:	315666
	Demo mode :	Contact Mindray service personnel for the password
	Factory maintenace:	Contact Mindray service personnel for the password

It is recommended that the user should change the passwords for user maintenance and configuration mode once they take ownership of the equipment.

IV

Contents

1 Introduction..............................................................................................................	1-1
1.1 Manual Information.................................................................................................................	1-1
1.2 Safety Information....................................................................................................................	1-1
1.2.1 Warnings.........................................................................................................................	1-2
1.2.2 Cautions ..........................................................................................................................	1-2
1.2.3 Notes ................................................................................................................................	1-2
1.3 Equipment Symbols ................................................................................................................	1-2

2 Theory of Operation.................................................................................................	2-1
2.1 Overview......................................................................................................................................	2-1
2.2 Connectors for Peripheral Devices .....................................................................................	2-2
2.3 Main Unit .....................................................................................................................................	2-2
2.4 Front Housing Assembly........................................................................................................	2-4
2.5 Main Board..................................................................................................................................	2-4
2.6 Rear Housing Assembly..........................................................................................................	2-5
2.7 External Module........................................................................................................................	2-6

3 Equipment Installation ............................................................................................	3-1
3.1 Unpacking the Equipment....................................................................................................	3-1
3.2 Preparation for Installation ...................................................................................................	3-1
3.2.1 Preparation for Installation Site..............................................................................	3-1
3.2.2 Environmental Requirements .................................................................................	3-1
3.2.3 Electrical Requirements ............................................................................................	3-2
3.3 Equipment Installation ...........................................................................................................	3-2
3.3.1 Preparation for Power on..........................................................................................	3-3

4 Testing and Maintenance.........................................................................................	4-1
4.1 Introduction................................................................................................................................	4-1
4.2 Performance Tests ....................................................................................................................	4-1
4.2.1 Performance Test Frequencies................................................................................	4-2
4.2.2 Visual Inspection..........................................................................................................	4-2
4.2.3 SpO2 test .........................................................................................................................	4-2
4.2.4 NIBP Test .........................................................................................................................	4-4
4.2.5 CO2 Test (Only Available For Accutorr 7)..............................................................	4-7
4.2.6 Exergen TemporalScanner Thermometer Test..................................................	4-9
4.2.7 SmarTempTM Module Test .........................................................................................	4-9
4.3 Electrical Safety and Other Tests ......................................................................................	4-10
4.3.1 Electrical Safety and Other Test Frequencies..................................................	4-10
4.3.2 Electric Safety Tests..................................................................................................	4-10
4.3.3 Power-on Test.............................................................................................................	4-10
4.3.4 Touchscreen Calibration.........................................................................................	4-11
4.3.5 Recorder check..........................................................................................................	4-11
4.3.6 Bar Code Scanner Test.............................................................................................	4-11
4.3.7 Battery Check.............................................................................................................	4-12
4.3.8 Nurse Call Reply Performance Test.....................................................................	4-12
4.4 Factory Maintenance............................................................................................................	4-13
1

4.4.1 Accessing Factory Maintenance Menu ............................................................	4-13
4.4.2 Drawing Waves..........................................................................................................	4-13
4.4.3 Software Version.......................................................................................................	4-14
4.4.4 Monitor Information ...............................................................................................	4-15
5 Troubleshooting.......................................................................................................	5-1
5.1 Overview .....................................................................................................................................	5-1
5.2 Part Replacement.....................................................................................................................	5-1
5.3 Checking Equipment Status.................................................................................................	5-1
5.4 Checking Software Version...................................................................................................	5-1
5.5 Checking Technical Alarms...................................................................................................	5-2
5.6 Troubleshooting Guide ..........................................................................................................	5-2
5.6.1 Power On/Off Failure .................................................................................................	5-2
5.6.2 Display Failures ............................................................................................................	5-3
5.6.3 Alarm Lamp Failures...................................................................................................	5-4
5.6.4 Button and Encoder Failures...................................................................................	5-4
5.6.5 Sound Failures..............................................................................................................	5-5
5.6.6 Battery Failures.............................................................................................................	5-5
5.6.7 Recorder Failures.........................................................................................................	5-6
5.6.8 Output Interface Failure............................................................................................	5-7
5.6.9 Data Storage Failure...................................................................................................	5-7
5.6.10 Wired Network Related Problems.......................................................................	5-8
5.6.11 Wi-Fi Related Problems (Only Available for Accutorr 7)..............................	5-9
5.6.12 Module defective......................................................................................................	5-9
5.6.13 Exergen TemporalScanner Thermometer Module Problems ................	5-10
5.6.14 CO2 Module Problems (Only Available for Accutorr 7).............................	5-11
5.6.15 Technical Alarm Messages..................................................................................	5-11
6 Disassembly and Repair ..........................................................................................	6-1
6.1 Tools Required...........................................................................................................................	6-1
6.2 Preparations for Disassembly ..............................................................................................	6-1
6.3 Disassembling the Main Unit...............................................................................................	6-2
6.3.1 Disassembling the Temperature Module (Optional)......................................	6-2
6.3.2 Removing the Recorder............................................................................................	6-3
6.3.3 Separating the Front and Rear Half of the Monitor ........................................	6-3
6.3.4 Removing the Parameter Connector Panel Assembly...................................	6-5
6.3.5 Disassembling the Main Bracket Assembly.......................................................	6-6
6.3.6 Removing the Parameter Board (SpO2 Optional) and Power Management
Board..........................................................................................................................................	6-8
6.3.7 Removing the Parameter Connector Panel Assembly (With CO2, Only
Available for Accutorr 7)......................................................................................................	6-9
6.3.8 Disassembling the CO2 Module Assembly (Only Available for Accutorr 7)6-10
6.3.9 Disassembling CO2 main Module (Only Available for Accutorr 7).........	6-10
6.3.10 Disassembling the Main Bracket Assembly (With CO2, Only Available for
Accutorr 7).............................................................................................................................	6-11
6.3.11 Disassembling Pumps and Valves ...................................................................	6-12
6.3.12 Disassembling AC/DC Power Board and Battery Converter Board .....	6-12
6.4 Disassembling the Front Housing Assembly ..............................................................	6-13
6.4.1 Removing the Touchscreen Control Board.....................................................	6-13

6.4.2 Removing the 2.4G Wi-Fi Module (Optional, Only Available for Accutorr 7)

................................................................................................................................................... 6-14

2

6.4.3 Removing the 5G Wi-Fi Module (Optional, Only Available for Accutorr 7)6-15

6.4.4 Removing the Main Control Board ....................................................................	6-17
6.4.5 Removing SD Card ...................................................................................................	6-17
6.4.6 Removing the Touchscreen ..................................................................................	6-18
6.4.7 Disassembling the Display....................................................................................	6-18
6.4.8 Removing the Keypad ............................................................................................	6-19
6.4.9 Removing the Encoder...........................................................................................	6-19
6.4.10 Removing the Alarm Lamp.................................................................................	6-19
6.5 Disassembling the SmarTempTM Module (Optional).................................................	6-20
6.5.1 Removing the SmarTempTM Module PCBA and Module Power Board PCBA
...................................................................................................................................................	6-20
6.5.2 Disassembling the Temperature On-Position Detection Board PCBA ..	6-21
6.6 Disassembling the Exergen TemporalScanner Themometer Module (Optional)6-22
7 Parts...........................................................................................................................	7-1
7.1 Introduction................................................................................................................................	7-1
7.2 Main Unit .....................................................................................................................................	7-1
7.2.1 Exploded View ..............................................................................................................	7-1
7.2.2 Parts List..........................................................................................................................	7-2
7.3 Front Housing Subassembly (Touchscreen) ...................................................................	7-3
7.3.1 Exploded View ..............................................................................................................	7-3
7.3.2 Parts List..........................................................................................................................	7-4
7.4 Rear Housing Assembly (without CO2 module, CO2 Only Available for Accutorr 7)
................................................................................................................................................................	7-5
7.4.1 Exploded View ..............................................................................................................	7-5
7.4.2 Parts List..........................................................................................................................	7-5
7.5 Rear Housing Assembly (with CO2 module, Only Available for Accutorr 7) ........	7-7
7.5.1 Exploded View ..............................................................................................................	7-7
7.5.2 Parts List..........................................................................................................................	7-7
7.6 Main Bracket Assembly ..........................................................................................................	7-9
7.6.1 Exploded View ..............................................................................................................	7-9
7.6.2 Parts List..........................................................................................................................	7-9
7.7 Power Management Board Assembly............................................................................	7-10
7.7.1 Exploded View ...........................................................................................................	7-10
7.7.2 Parts List.......................................................................................................................	7-10
7.8 Parameter Connector Panel Assembly (without CO2 module, CO2 Only Available for
Accutorr 7).......................................................................................................................................	7-11
7.8.1 Exploded View ...........................................................................................................	7-11
7.8.2 Parts List.......................................................................................................................	7-11
7.9 Parameter Connector Panel Assembly (with CO2 module, Only Available for
Accutorr 7).......................................................................................................................................	7-12
7.9.1 Exploded View ...........................................................................................................	7-12
7.9.2 Parts List.......................................................................................................................	7-12
7.10 Predictive Temperature Assembly ................................................................................	7-13
7.10.1 Exploded View.........................................................................................................	7-13
7.10.2 Parts List ....................................................................................................................	7-13
7.11 Exergen TemporalScanner Thermometer Assembly..............................................	7-14
7.11.1 Exploded View.........................................................................................................	7-14
7.11.2 Parts List ....................................................................................................................	7-15
7.12 Exergen frame Assembly..................................................................................................	7-16
7.12.1 Exploded View.........................................................................................................	7-16
3

7.12.2 Parts List....................................................................................................................	7-16
8 Hardware and Software Upgrade...........................................................................	8-1
8.1 Hardware Upgrade ..................................................................................................................	8-1
8.1.1 Upgrade Package........................................................................................................	8-1
8.1.2 Upgrading Parameter Modules .............................................................................	8-1
8.1.3 Upgrading Temperature ...........................................................................................	8-2
8.1.4 Upgrading Wi-Fi (Only Available for Accutorr 7)..............................................	8-2
8.1.5 Enabling Parameter Functions ...............................................................................	8-3
8.2 Software Upgrade....................................................................................................................	8-3
A Electrical Safety Inspection ....................................................................................	A-1
A.1 Power Cord Plug.....................................................................................................................	A-1
A.2 Device Enclosure and Accessories...................................................................................	A-2
A.3 Device Labeling ......................................................................................................................	A-2

4

1 Introduction

1.1 Manual Information

	Version	Revision History
	1.0	New
	2.0	Modify temperature module test method, update parts list
	3.0	Modify the Wi-Fi content
	4.0	Delete the equipment symbols
	5.0	Modify the description of equipment symbols, add the patent
		information
	6.0	Add CO2 description
	7.0	Update parts list for new cleaning and disinfecting agents
	8.0	Add VS-900c
	9.0	Add the VS-900c silicon button.
	10.0	Delete the warranty and exemption information
	11.0	Add Exergen TemporalScannerTM Themometer contents

1.2 Safety Information

WARNING

Indicates a potential hazard or unsafe practice that, if not avoided, will result in death or serious injury.

CAUTION

Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.

NOTE

Provides application tips or other useful information to ensure that you get the most from your product.

1-1

1.2.1 Warnings

WARNING

All installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel.

There is high voltage inside the equipment. Never disassemble the equipment before it is disconnected from the AC power source or the battery.

When you disassemble/reassemble a parameter module, a patient leakage current test must be performed before it is used again for monitoring.

The equipment must be connected to a properly installed power outlet with protective earth contacts only. If the installation does not provide for a protective earth conductor, disconnect it from the power line and operate it on battery power, if possible.

Disposal of the packaging material should observe the applicable waste control regulations and keeping it out of children’s reach.

1.2.2 Cautions

CAUTION

Make sure that no electromagnetic radiation interferes with the performance of the equipment when preparing to carry out performance tests. Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.

Before connecting the receiver to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the unit’s label or in this manual.

Protect the equipment from damage caused by drop, impact, strong vibration or other mechanical force during servicing.

1.2.3 Notes

NOTE

Refer to the operator’s manual for detailed operation and other information.

1.3Equipment Symbols

See theapplicable Operator’s Manual for information about the symbols used on this product and its packaging.

1-2

2 Theory of Operation

2.1 Overview

The Monitor is intended for monitoring physiologic parameters, including SpO2, Pulse Rate, NIBP and Temperature, on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

The equipment also:

Provides audible and visual alarm indications in case of patient or equipment problems;

Provides display, review, storage and printing of monitored information;

Incorporates multiple input devices such as buttons, knob, and touchscreen; and,

Enables program upgrade over the network.

Monitor

Nurse Call

	Mindray Proprietary LAN
	i
	i-F
	W
	AP
	Reserved port
Other device	CMS/Gateway

EMR Server

The above figure shows a system consisting of the vital signs monitor and its peripheral devices. The vital signs monitor:

Can be used for monitoring the physiological parameters, giving alarms and reviewing patient data, etc.

Supports recorder.

Supports nurse call function.

Supports Wi-Fi module, wired network, remote view, and communication with the BeneVision Central Monitoring System (hereinafter called CMS) (only available for the Accutorr 7).

Supports external AC power source and an internal battery.

Supports clinical data acquisition: by SD card or by USB drive.

NOTE

Wi-Fi module is only available for the Accutorr 7.

2-1

2.2 Connectors for Peripheral Devices

2

3

1

4

5

6

1.Connector for Temperature probe

2.Network connector: It is a standard RJ45 connector used to communicate with external devices, such as central monitoring system, e-Gateway, or used to export data or upgrade the system.

3.Multi-function connector: connects to the hospital's nurse call system, or connects external devices through DIAP protocol.

4.USB connector: connects to barcode scanner or USB disk.

5.AC Power Input

6.Equipotential grounding terminal: When the equipment and other devices are to be used together, their equipotential grounding terminals should be connected together to eliminate the potential difference between them.

2.3Main Unit

The main unit of the vital signs monitor consists of three parts:

Front housing assembly: main board, Wi-Fi module (only available for Accutorr 7), keypad board assembly (knob), display, touchscreen, and alarm lamp board.

Rear housing assembly: power module (AC/DC), power management and interface board (including SpO2 isolation power), recorder, speaker, battery, NIBP module, and SpO2 board.

External module:Temperature module.

2-2

The following figure shows the main unit architecture of the vital signs monitor.

Front Housing Assembly

SD card

Wi-Fi module

Touchscree

n control

Touch

Alarm lamp

I2C

board

screen

board

Power

Main board

LVD

Knob

On/Off

S

LCD display

keypad

Backlight

(Indicator)

Rear Housing Assembly
		Pump	NIBP socket
Speaker	Power	NIBP module
	management
	and interface
	board
	SpO	SpO2 board
Recorder		Standard	SpO2 socket
	2
battery	isolation		External Module
2600mAh
	power		Predictive
				Temp
			Temp
			module	probe
15V
AC-DC power
module
AC-IN	External interface
	RJ45/USB/Multifunctional
	(nurse call, extended ports)

2-3

2.4 Front Housing Assembly

Alarm lamp board

Touchscreen control board

Main board

Keypad

Screws securing the front and rear housing

2.5 Main Board

The main board is the control center of the equipment. It provides communication, display, and data storage functions, including:

Communication with SpO2 board, NIBP module, and Temperature module through connector;

Communication with power management board, keypad board, and recorder through connectors;

Providing drive for display and backlight;

Providing 2 USB connectors, a network connector, and a multifunctional connector;

Communication with touchscreen control board through I2C;

Providing drive for SD card; and,

Providing drive for Wi-Fi module(only available for Accutorr 7).

2-4

Keypad

The keypad scans and detects the input of keys and encoder, integrates the power on/off key, and connects AC and battery indicators.

Alarm Lamp Board

The alarm lamp board is located at the top of front housing. It has two-color indicators, red and yellow. The alarm lamp board directly connects the main board through a cable. It is controlled directly by the main board.

Touchscreen and Touchscreen Control Board

The touchscreen control board drives the touchscreen and implements communication with the vital signs monitor.

Wi-Fi Module (Optional, Only Available for Accutorr 7)

The Wi-Fi Module enables the equipment to connect to an 802.11 a/b/g/n Mindray proprietary network.

2.6 Rear Housing Assembly

Speaker
				Power
				management
NIBP
				and interface
module				board
Recorder				AC/DC
				power
				module
				SpO2 board

Rear housing assembly consists of power module (AC/DC), power management and interface board (including SpO2 isolation power), recorder, speaker, battery, NIBP module, and SpO2 board.

2-5

AC/DC Power Module

The AC/DC power board transforms the input AC into DC power, which is the power source for all voltages in the equipment.

Power Management and Interface Board

The power management and interface board provides the following functions:

Charge and discharge of battery and charge detection;

DC/DC conversion: outputs 12V and 5V DC power;

Control over power on/off key and AC, BAT indicator;

Communication transmission among parameter modules;

Providing isolation power for SpO2 module; and,

Providing external connectors, filter and protection for these connectors.

Recorder

The recorder receives data from the main board and sends them to the thermal printhead for printing.

NIBP Module

The NIBP module consists of blood pressure measurement board and pump and valve assembly, providing measurement acquisition of blood pressure data. The main functions of the NIBP module are:

NIBP measurement; and,

Data exchange with the main board.

SpO2 Board

The SpO2 board collects SpO2 signals, processes SpO2 algorithm and sends measurement results to the main board. The power management interface board provides isolation power for it.

CO2 Module (Only Available for Accutorr 7)

CO2 monitoring is a continuous, non-invasive technique for determining the concentration of CO2 in the patient’ airway by measuring the absorption of infrared (IR) light of specific wavelengths. The main functions of the CO2 module are:

Provides a CO2 waveform, and EtCO2, FiCO2, awRR measurement; and

Data exchange with the main board through the serial ports.

2.7External Module

An external Temp module can be attached to the monitor.

The independently developed Mindray Temperature module consists of an isolation power board, Temperature measurement board, and probes. The Temperature measurement board collects Temperature signals, processes algorithm and sends measurement results to the main board.

2-6

3 Equipment Installation

3.1 Unpacking the Equipment

Open the package and take out the packing list. Check that all the articles included in the packing list are available and the quantity and specification are correct. Make sure that:

All the optional parts purchased by the customer have been received.

Notify Mindray North America if your order is incorrect or is incomplete.

In case of damage during transportation, keep the packing material and notify Mindray North America immediately.

Keep the packing material until all equipment is checked and accepted.

3.2Preparation for Installation

3.2.1Preparation for Installation Site

1.Ensure that the site meets all safety, environmental and power requirements.

2.Ensure that a network connector is available if the equipment needs to be connected to network.

3.2.2Environmental Requirements

To avoid explosion hazard, do not use the equipment in the presence of flammable anesthetics, vapors or liquids. The environment where the equipment will be used should be reasonably free from vibration, dust and corrosive substances. If these conditions are not met, the system may not function normally.

The environmental specification is as follows:

Main Unit

	Item			Temperature ( )		Relative humidity		Altitude
						(noncondensing)		(mmHg)
				0 to 40 (without Temperature
	Operating			module)
				5 to 40 (with SmarTemp module)		15% to 95%		427.5 to 805.5
	environment
				16 to 40 (with Exergen Temp
				module)
	Storage			-30 to 70
				-20 to 50 (with Exergen Temp		10% to 95%		120.0 to 805.5
	environment
				module)

NOTE

The environmental specifications of unspecified accessories are the same as

3-1

those of the main unit.

3.2.3 Electrical Requirements

Check cables and power cords. Make sure that:

1.System cables, power cords, and power plugs are not damaged, and that the pins are not loose. If damage is noted, discontinue use and replace.

2.Patient cables and connections are secure.

WARNING

 Use only properly grounded power outlets.  Use the supplied power cord only!

Voltage	100 to 240V AC
Current	0.9 to 0.5A
Frequency	50/60 Hz

3.3 Equipment Installation

Follow the procedure below to install the equipment:

1.Ensure the unit and accessories are not damaged.

2.Install the battery (optional). For detailed operations, please refer to the operator’s manual.

3.Connect AC power.

4.Connect the accessories.

Installation Support

The vital signs monitor can be mounted on a wall bracket or on a rolling stand. The wall bracket or rolling stand can be ordered optionally. Each type of mounting bracket is delivered with a complete set of mounting hardware and instructions. For detailed installation information, please refer to Wall-mount Bracket Instructions for Use (PN: 0010-20-42933) and Rollstand Instructions for Use (PN: 0010-20-42934).

CAUTION

Use only Mindray supplied or approved mounting solutions.

The mounting bracket should be installed by qualified service personnel.

3-2

3.3.1Preparation for Power on

1.Before using the equipment, check for any mechanical damage and make sure that all external cables, plug-ins and accessories are properly connected.

2.Plug the power cord into the AC power source. If you run the equipment on battery power, ensure that the battery is sufficiently charged.

3.Press the Power ON/OFF button () on the front panel to turn on the equipment.

3-3

FOR YOUR NOTES

3-4

4 Testing and Maintenance

4.1 Introduction

The expected service life of the equipment is five years. To ensure the equipment always functions normally, qualified service personnel should perform regular inspection, maintenance and test. This chapter provides a checklist of the testing procedures for the equipment with recommended test equipment and frequency. The service personnel should perform the testing and maintenance procedures as required and use appropriate test equipment.

The testing procedures provided in this chapter are intended to verify that the equipment meets the performance specifications. If the equipment or a module fails to perform as specified in any test, repairs or replacements must be done to correct the problem. If you have any question, contact our Technical Support Department.

CAUTION

All tests should be performed by qualified service personnel only.

Care should be taken to avoid changing the settings in [User Settings >>] and [Factory Maintenance >>] menus to avoid loss of data.

Service personnel should acquaint themselves with the test tools and make sure that test tools and cables are available.

4.2Performance Tests

Performance test are designed to ensure that measurement results are accurate. The following sections provide a list of performance and accuracy tests and their recommended frequencies.

4-1

4.2.1 Performance Test Frequencies

	Check/Maintenance Item		Frequency
	Visual inspection		1. When first installed or reinstalled.
	SpO2test
		Leakage test	1. If the user suspects that the measurement is
	NIBP test	Accuracy test
			incorrect.
		NIBP cuff	2. Following any repairs or replacement of
		overpressure test
			relevant module.
	CO2 test	Performance test
			3. Every two years for SmarTempTM module test
		Calibration
	(Accutorr 7 only)		and SpO2 test.
		Exergen	4. Per year is recommended for NIBP and CO2
		TemporalScanner
			tests.
	TEMP test	thermometer
		SmarTempTM
		module

4.2.2 Visual Inspection

Perform an overall inspection on the appearance of the equipment. The test is passed if the equipment has no obvious signs of damage. Follow these guidelines when inspecting the equipment:

Carefully inspect the case, display screen, buttons, and knob for obvious signs of damage.

Inspect all external connections for loose connectors, bent pins or frayed cables.

Inspect all connectors on the equipment for loose connectors or bent pins.

Make sure that safety labels and data plates on the equipment are clearly legible.

4.2.3SpO2 test

Test Method 1

Tool required:  None

Test procedure:

1.Connect SpO2 sensor for adult to the SpO2 connector of the monitor. Set [Patient Category] to [Adult].

2.Place the SpO2 sensor on your finger.

3.Verify the Pleth Wave and Pulse Rate are displayed on the screen.

4.Remove the SpO2 sensor from your finger and make sure that the SpO2 Sensor Off alarm is triggered.

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Measurement validation

The SpO2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, and only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements.

NOTE

The SpO2 simulator can only be used to verify that the pulse oximeter operates properly. It cannot be used to verify the accuracy of the pulse oximeter or the SpO2 sensor. To verify the accuracy, clinical tests are required.

Test Method 2

Tool required:

 SpO2 simulator, Index-2 recommended

Test procedure:

1.Connect the SpO2 sensor to the SpO2 simulator.

2.Selected the model and manufacturer of the SpO2 module to be tested on the simulator, and set the simulator as follows: SpO2 to 96% and Pulse Rate to 80 bmp.

3.Set the patient type to [Adult], [Pediatric], and [Neonatal] respectively. Observe the monitor and make sure the displayed SpO2 and Pulse Rate value fall in the following range.

	Manufacturer	SpO2			Pulse Rate
	Nellcor	96%	± 2% (Adult, pediatric)		80 ± 3 bpm
		96%	± 3%	(Neonate)
	Masimo	96%	± 2%	(Adult, pediatric)	80 ± 3 bpm
		96%	± 3%	(Neonate)

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4.2.4 NIBP Test

Leakage Test

NOTE

Perform NIBP leakage test before any other NIBP test and calibration.

Tools required:

Adult NIBP Cuff

NIBP Hose

Cylinder

Follow this procedure to perform the leakage test:

1.In the [Patient Demographics] menu, set [Patient Category] to [Adult].

2.Connect the NIBP cuff to the NIBP connector on the monitor.

3.Apply the cuff to the cylinder as shown below.

Monitor		Cylinder
Connector for NIBP cuff	NIBP Hose	Cuff

4.Select [Main]→[Maintenance >>]→[User Settings>>]→Enter required password→→[Module Maintenance >>]→[NIBP Leakage Test]. The message [Leakage Testing…] is displayed in the NIBP parameter area.

After about 20 seconds, the monitor will automatically deflate. This means the test is complete. If no message is displayed in the NIBP parameter area, it indicates that the system has no leakage. If the message [NIBP Pneumatic Leak] is displayed, it indicates that the system may have a leak. Check the tubing and connections for leakages. Ensure that the tubing and connections are all correct, perform a leakage test again. If the problem persists, contact our Technical Support Department.

You may also perform a manual leakage test:

1.Perform steps 1 to 4 in the NIBP Accuracy Test section.

2.Raise the pressure in the rigid vessel to 250 mmHg with the manometer bulb. Then, wait for 5 seconds to allow the pressure to stabilize.

3.Record the current pressure value, wait 60 seconds and record the pressure again.

4.Compare the two pressure values and verify the difference is 6mmHg or less.

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NIBP Accuracy Test

Tool required:

T-shape connector

Appropriate tubing

Manometer bulb

Rigid Vessel with volume 500 ± 25 ml

Reference manometer (calibrated with accuracy equal to or better than 0.75 mmHg)

Follow this procedure to perform the accuracy test:

1.Connect the equipment as shown below.

Monitor	Standard
	sphygmomanometer
Connector for NIBP cuff	Appropriate tubing

Manometer bulb

Rigid Vessel

2.Before inflation, check that the reading of the manometer is 0. If not, turn off the manometer bulb to let the whole airway open to the atmosphere. Turn on the manometer bulb after the reading is 0.

3.Select [Main]→[Maintenance >>]→[User Settings>>]→Enter required password→[Module Maintenance >>]→[NIBP Accuracy Test].

4.Check the manometer values and the monitor values. Both should be 0 mmHg.

5.Raise the pressure in the rigid vessel to 50 mmHg with the manometer bulb. Then, wait for 10 seconds to let the measured values become stable.

6.Compare the manometer values with the monitor values. The difference between the manometer and displayed values should be ± 3 mmHg. If it is greater than ± 3 mmHg, contact Mindray Technical Support.

7.Raise the pressure in the rigid vessel to 200 mmHg with the manometer bulb. Then, wait for 10 seconds to let the measured values become stable. Repeat step 6.

NOTE

You can use an NIBP simulator to replace the manometer bulb and the reference manometer to perform the test.

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NIBP Cuff Overpressure Test

Tools required:

T-shape connector

Appropriate tubing

Manometer bulb

Metal Vessel with volume 500 ± 25 ml

Reference manometer (calibrated, with accuracy equal to or better than 0.75 mmHg)

Follow this procedure to perform the calibration:

1.Perform steps 1 to 4 in the NIBP Accuracy Test section.

2.Select [Main]→[Maintenance >>]→[Factory Maintenance >>]→enter the required password→[Calibrate NIBP >>]→[Overpressure Protection Circuit].

3.In [Overpressure Protection Circuit] menu, set [Patient Category] to [Adu/Ped]. Raise the pressure to 330 mmHg. After the pressure value is stabilized, select [Calibrate] to start calibration.

4.In the [Overpressure Protection Circuit] menu, set [Patient Category] to [Neonatal]. Raise the pressure to 165 mmHg. When the pressure value is stabilized, select [Calibrate] to start calibration.

5.All calibration results are displayed in the [Calibrate NIBP] menu. If the calibration fails, check the test system for leakage and perform another calibration.

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4.2.5 CO2 Test (Only Available For Accutorr 7)

Accuracy Test

Tools required:

A steel gas cylinder with 5% CO2 , 21% O2, and balance gas N2 (P/N 0075-00-0033-01)

T-shape connector

Tubing

1.Select [Main]→ [Maintenance >>]→[User Maintenance>>]→enter the required password→ [Module Maintenance>>]→[Calibrate CO2>>]

2.Connect the test system as follows:

Relief valve

T-shape connector	Tubing	Monitor

Cylinder

3.Open the valve to start flowing CO2 and make sure that there is sufficient flow to vent to atmosphere.

4.Verify the realtime CO2 value is within 5.0 ± 0.3% in the [Calibrate CO2] menu.

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CO2 Calibration

Tools required:

A steel gas cylinder with 5% CO2, 21% O2, and balance gas N2 (P/N 0075-00-0033-01)

T-shape connector

Tubing

1.Select [Main]→ [Maintenance >>]→[User Maintenance>>]→enter the required password→ [Module Maintenance>>]→[Calibrate CO2>>].

2.In the [Calibrate CO2] menu, select [Zero].

3.After the zero calibration is finished successfully, connect the equipment as follows:

Relief valve

T-shape connector	Tubing	Monitor

Cylinder

4.Open the valve to start flowing CO2 and make sure that there is sufficient flow to vent to atmosphere.

5.In the [Calibrate CO2] menu, enter the CO2 concentration in the [CO2] field.

6.In the [Calibrate CO2] menu, the measured CO2 concentration is displayed. After the measured CO2 concentration becomes stable, select [Calibrate CO2] to calibrate the CO2 module.

If the calibration is completed successfully, the message [Calibration Completed!] is displayed in the [Calibrate CO2] menu. If the calibration fails, the message [Calibration Failed] is displayed. In this case, attempt to calibrate the CO2 module again.

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