Accutorr 7 Service Manual Rev 2 Nov 2014

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. Contents of this manual are subject to changes without prior notice. For this manual, the issued Date is January 2015 (Version 2.0). © Copyright 2013-2015 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.

Warranty Mindray warrants that components within its products will be free from defects in workmanship and materials for a period of three years from the date of purchase except that disposable or one-time use products are warranted to be free from defects in workmanship and materials up to a date one year from the date of purchase or the date of first use, whichever is sooner. This warranty does not cover consumable items such as, but not limited to, batteries, external cables, and sensors. Mindray shall not be liable for any incidental, special, or consequential loss, damage, or expense directly or indirectly arising from the use of its products. Liability under this warranty and the buyer’s exclusive remedy under this warranty is limited to servicing or replacing the affected products, at Mindray’s option, at the factory or at an authorized distributor, for any product which shall under normal use and service appear to Mindray to have been defective in material or workmanship. Recommended preventative maintenance, as prescribed in the service manual, is the responsibility of the user and is not covered by this warranty. No agent, employee, or representative of Mindray has any authority to bind Mindray to any affirmation, representation, or warranty concerning its products, and any affirmation, representation or warranty made by any agent, employee, or representative shall not be enforceable by buyer or user. THIS WARRANTY IS EXPRESSLY IN LIEU OF, AND MINDRAY EXPRESSLY DISCLAIMS, ANY OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE, AND OF ANY OTHER OBLIGATION ON THE PART OF MINDRAY. Damage to any product or parts through misuse, neglect, accident, or by affixing any II

non-standard accessory attachments, or by any customer modification voids this warranty. Mindray makes no warranty whatsoever in regard to trade accessories, such being subject to the warranty of their respective manufacturers. A condition of this warranty is that the equipment or accessories which are claimed to be defective be returned when authorized, freight prepaid to Mindray DS USA, Inc., Mahwah, New Jersey 07430 or its authorized representative. Mindray shall not have any responsibility in the event of loss or damage in transit.

Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty does not extend to:  Malfunction or damage caused by improper use or man-made failure.  Malfunction or damage caused by unstable or out-of-range power input.  Malfunction or damage caused by force majeure events, such as (i) flood, fire and earthquake or other similar elements of nature or acts of God; (ii) riots, war, civil disorders, rebellions, or revolutions in any country; or (iii) any other cause beyond the reasonable control of Mindray.  Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.  Malfunction of the instrument or part whose serial number is not legible.  Others not caused by instrument or part itself.

III

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.

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:

+86 755 81888998

Fax:

+86 755 26582680

Website:

www.mindray.com

Distributor:

Mindray DS USA, Inc.

Address:

800 MacArthur Boulevard Mahwah, New Jersey 07430 USA

Tel:

1.800.288.2121, 1.201.995.8000

Website:

www.mindray.com

IV

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

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

V

FOR YOUR NOTES

VI

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 ... 1-3 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 ... 4-1 4.2.2 Visual Inspection... 4-2 4.2.3 SpO2 test ... 4-2 4.2.4 NIBP Test ... 4-4 4.2.5 Temperature Test ... 4-6 4.2.6 Nurse Call Reply Performance Test ... 4-7 4.3 Electrical Safety and Other Tests ... 4-8 4.3.1 Electrical Safety and Other Test Frequencies ... 4-8 4.3.2 Electric Safety Tests ... 4-8 4.3.3 Power-on Test ... 4-8 4.3.4 Touchscreen Calibration ... 4-9 4.3.5 Recorder check ... 4-9 1

4.3.6 Bar Code Scanner Test ... 4-9 4.3.7 Battery Check ...4-10 4.4 Factory Maintenance ...4-10 4.4.1 Accessing Factory Maintenance Menu ...4-10 4.4.2 Drawing Waves ...4-11 4.4.3 Software Version ...4-11 4.4.4 Monitor Information ...4-12 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 ... 5-2 5.6.3 Alarm Lamp Failures... 5-3 5.6.4 Button and Knob Failures... 5-3 5.6.5 Sound Failures ... 5-4 5.6.6 Battery Failures ... 5-5 5.6.7 Recorder Failures ... 5-5 5.6.8 Output Interface Failure ... 5-6 5.6.9 Data Storage Failure ... 5-6 5.6.10 Wired Network Related Problems ... 5-7 5.6.11 Wi-Fi Related Problems ... 5-7 5.6.12 Module defective ... 5-8 5.6.13 Technical Alarm Messages... 5-8 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 Board6-8 6.3.7 Disassembling Pumps and Valves ... 6-9 6.3.8 Disassembling AC/DC Power Board and Battery Converter Board ...6-10 6.4 Disassembling the Front Housing Assembly ...6-10 6.4.1 Removing the Touchscreen Control Board...6-11 6.4.2 Removing the Wi-Fi Module (Optional) ...6-11 2

6.4.3 Removing the Main Control Board ...6-12 6.4.4 Removing SD Card ...6-13 6.4.5 Removing the Touchscreen ...6-13 6.4.6 Disassembling the Display...6-14 6.4.7 Removing the Keypad ...6-14 6.4.8 Removing the Encoder...6-14 6.4.9 Removing the Alarm Lamp...6-15 6.5 Disassembling the Temperature Module (Optional)...6-15 6.5.1 Removing the Temperature Module PCBA and Module Power Board PCBA ...6-15 6.5.2 Disassembling the Temperature On-Position Detection Board PCBA ...6-16 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 ... 7-1 7.3 Front Housing Subassembly (Touchscreen) ... 7-2 7.3.1 Exploded View ... 7-2 7.3.2 Parts List ... 7-3 7.4 Rear Housing Assembly ... 7-4 7.4.1 Exploded View ... 7-4 7.4.2 Parts List ... 7-4 7.5 Main Bracket Assembly ... 7-6 7.5.1 Exploded View ... 7-6 7.5.2 Parts List ... 7-6 7.6 Power Management Board Assembly ... 7-7 7.6.1 Exploded View ... 7-7 7.6.2 Parts List ... 7-7 7.7 Parameter Connector Panel Assembly ... 7-8 7.7.1 Exploded View ... 7-8 7.7.2 Parts List ... 7-8 7.8 Predictive Temperature Assembly... 7-9 7.8.1 Exploded View ... 7-9 7.8.2 Parts List ... 7-9 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 Enabling Parameter Functions ... 8-2 8.2 Software Upgrade ... 8-2 A Electrical Safety Inspection ... A-1 3

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

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 operator’s manual for detailed operation and other information.

1-2

1.3 Equipment Symbols Some symbols may not appear on your equipment. Caution

Power ON/OFF

Alternating current (AC)

Battery indicator

Alarm Reset

NIBP Start/Stop key

Alarm Paused

Record

Admit a new patient

Insertion Direction

DEFIBRILLATION –PROOF TYPE CF APPLIED PART

Input/Output

Network connector

Equipotentiality

USB connectors

Manufacturer

Serial number

Protection against fluid ingress

DATE OF MANUAFACTURE

CATALOGUE NUMBER

Temperature limit

Humidity limitation

Atmospheric pressure limitation

Refer to instruction manual/ booklet

AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

Interference may occur in the vicinity of equipment marked with this symbol

The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive.

1-3

The following definition of the WEEE label applies to EU member states only. This symbol indicates that this product should not be treated as household waste. By ensuring that this product is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health. For more detailed information with regard to returning and recycling this product, please consult the distributor from whom you purchased it. * For system products, this label may be attached to the main unit only. The presence of this label indicates the machine was certified by ETL with the statement: Conforms to AAMI Std ES 60601-1, IEC Std 60601-1-6, IEC Std 60601-1-8, IEC Std 60601-2-49, IEC Std 80601-2-30, ISO Std 80601-2-56, ISO Std 80601-2-61. Certified to CSA Std C22.2 NO. 60601-1, NO. 60601-1-6, NO. 60601-1-8, NO. 60601-2-49, NO. 80601-2-30, NO. 80601-2-56, NO. 80601-2-61.

1-4

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 Fi Wi-

AP

Reserved port

CMS/Gateway

Other device

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 Hypervisor Central Monitoring System (hereinafter called CMS).



Supports external AC power source and an internal battery.



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

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.

2.3 Main Unit The main unit of the vital signs monitor consists of three parts: 

Front housing assembly: main board, Wi-Fi module, 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. SD card

Front Housing Assembly Alarm lamp board Knob

Wi-Fi module

I2C

Power On/Off keypad (Indicator)

LVD S

Main board

Touchscree n control board

Touch screen

LCD display

Backlight

Rear Housing Assembly Pump Speaker

NIBP module

Power management and interface board

SpO2 board （Standard Mindray, OEM optional）

SpO2 isolation power

Recorder 2600mAh battery

SpO2 socket

External Module

Predictive Temp module

15V AC-DC power module AC-IN

NIBP socket

External interface RJ45/USB/Multifunctional (nurse call, extended ports)

2-3

Temp probe

2.4 Front Housing Assembly Alarm lamp board

Touchscreen control board Wi-Fi antenna

Wi-Fi module

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.

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

2.6 Rear Housing Assembly

Speaker Power management and interface board

NIBP module

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