Accutorr 3 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 November 2014 (Version 2.0). © Copyright 2013-2014 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.

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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 is not 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 the effects on safety, reliability and performance of this product, only if:  all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;  the electrical installation of the relevant room complies with the applicable national and local requirements;  the product is used in accordance with the instructions for use.

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.

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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

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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.

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FOR YOUR NOTES

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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 ...2-1 2.3 Main Unit ...2-2 2.4 Front Housing Assembly ...2-3 2.5 Rear Housing Assembly ...2-4 2.6 External Module ...2-5 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 3.4 Preparation for Power on ...3-2 4 Testing and Maintenance ...4-1 4.1 Introduction...4-1 4.2 Performance Tests ...4-2 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 Temperature Test ...4-8 4.3 Electrical Safety and Other Tests ...4-9 4.3.1 Electrical Safety and Other Test Frequencies...4-9 4.3.2 Electric safety tests ...4-9 4.3.3 Power-on Test...4-9 4.3.4 Battery Check ... 4-10 4.4 Maintenance Mode ... 4-10 1

4.4.1 Entering/Quitting Maintenance Mode... 4-10 4.4.2 Checking Version Information ... 4-12 4.4.3 Restoring Factory Default Configuration ... 4-13 5 Troubleshooting ... 5-1 5.1 Overview ... 5-1 5.2 Parts Replacement ... 5-1 5.3 Troubleshooting Guide ... 5-1 5.3.1 Power On/Off Failure ... 5-1 5.3.2 Display Failures ... 5-2 5.3.3 Button Failures ... 5-2 5.3.4 Battery Failures... 5-2 5.3.5 Module defective ... 5-3 5.4 Error codes ... 5-3 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 Separating the Front and Rear Half of the Monitor ... 6-2 6.3.3 Removing the Parameter Connector Panel Assembly... 6-3 6.3.4 Disassembling the Main Bracket Assembly ... 6-4 6.3.5 Removing the Parameter Board (SpO2 Optional) and Power Management Board ... 6-5 6.3.6 Disassembling Pumps and Valves ... 6-6 6.3.7 Disassembling AC/DC Power Board and Battery Converter Board ... 6-6 6.4 Disassembling the Front Housing Assembly ... 6-7 6.4.1 Removing the Main Board ... 6-7 6.4.2 Removing the Display ... 6-8 6.4.3 Removing the Keypad ... 6-8 6.5 Disassembling the Temperature Module (Optional) ... 6-9 6.5.1 Removing the Temperature Module PCBA and Temperature Module Power Board PCBA ... 6-9 6.5.2 Disassembling the Temperature On-Position Detection Board PCBA ... 6-9 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 Assembly... 7-3 7.3.1 Exploded View ... 7-3 2

7.3.2 Parts List ...7-3 7.4 Main Bracket Assembly ...7-4 7.4.1 Exploded View ...7-4 7.4.2 Parts List ...7-5 7.5 Power Management Board Assembly ...7-5 7.5.1 Exploded View ...7-5 7.5.2 Parts List ...7-6 7.6 Parameter Connector Panel Assembly...7-6 7.6.1 Exploded View ...7-6 7.6.2 Parts List ...7-6 7.7 Predictive Temperature Assembly ...7-7 7.7.1 Exploded View ...7-7 7.7.2 Parts List ...7-7 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 Temp ...8-2 8.1.4 Enabling Parameter Functions ...8-2 8.2 Software Upgrade ...8-2 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

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FOR YOUR NOTES

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1 Introduction 1.1 Manual Information A detailed revision history of this manual is recorded in the table below: 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.

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

Neonate

On/Off for a part of equipment

Pediatric

Clear key

Adult

Alternating current

Equipotentiality

Battery indicator

Input/Output

DEFIBRILLATION –PROOF TYPE CF APPLIED PART

DATE OF MANUAFACTURE

NIBP Start/Stop key

MANUFACTURER

Protection against fluid ingress

Insertion Direction

Serial number

No alarming system

Refer to instruction manual/ booklet

Atmospheric pressure limitation

Temperature limit

Humidity limitation

AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

CATALOGUE NUMBER

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

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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. 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. 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. 80601-2-30, NO. 80601-2-56, NO. 80601-2-61.

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2 Theory of Operation 2.1 Overview The monitor is intended for spot-check 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.

2.2 Connectors for Peripheral Devices

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2 3

1. 2. 3.

Input/Output connector (RS-232 connector) This connector is used for software upgrade and DIAP communication. AC power input 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.

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2.3 Main Unit The main unit of the vital signs monitor consists of three parts:  Front housing assembly, consisting of main board, segment-code display, and Power On/Off keypad;  Rear housing assembly: power module (AC/DC), power management and interface board (including SpO2 isolation power), battery, NIBP module, and SpO2 board; and,  External module: Temperature module. The following figure shows the main unit architecture of the vital signs monitor. Front Housing Assembly Segment-code display

Power On/Off keypad (indicator)

Main board

Rear Housing Assembly Pump Power management and interface board SpO2 isolation power

2600mAh battery

NIBP connector

NIBP module

SpO2 board

SpO2 receptacle

External module Temperature module

15V AC-DC power module AC-IN

External connector RS232 port (for software upgrade and DIAP communications.)

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Temperature probe

2.4 Front Housing Assembly

Main Board

Keypad

Main Board The main board is the control center of the equipment. It provides communication and display functions, including:  Communication with SpO2 board, and NIBP module through serial ports, starting parameter measurement, and reading measured results;  Communication with Predictive temperature module through serial ports;  Communication with power management board through serial ports;  Extending an RS232 serial port;  Control over the Segment-code LCD display through I2C;  Providing backlight drive for segment-code display;  Recognition of keypad actions, and providing corresponding response;  Control over the beeper through IO port; and,  Providing 24 hour timing via the internal real time clock.

Keypad The keypad contains the power switch, function keys and AC Battery indicator etc.

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2.5 Rear Housing Assembly

Power management and interface board

AC/DC power module

SpO2 board

Battery compartment

NIBP module

Rear housing assembly consists of power module (AC/DC), power management and interface board (including SpO2 isolation power), battery compartment, NIBP module, and SpO2 board. AC/DC Power Module The AC/DC power board transforms the input AC into DC power, and is the power source for all voltages in the equipment. Power management and interface board The power management 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 the SpO2 module; and,  Providing external connectors, filter and protection for these connectors.

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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 through the serial ports.

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.

2.6 External Module An external Temperature module can be mounted on 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.

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