VS-600 Service Manual Ver 1.0 May 2013

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.

, , and are the registered trademarks or trademarks owned by Mindray in China and other countries.

Revision History This manual has a revision number. This revision number changes whenever the manual is updated due to software or technical specification change. Contents of this manual are subject to change without prior notice. The version information of this manual is as follows: „

Version number:

1.0

„

Release time:

May 2013

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

I

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. This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any question, please contact our Customer Service Department. 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.

II

Contents 1 Introduction... 1-1 1.1 Information of This Manual...1-1 1.2 Safety Information...1-1 1.2.1 Dangers...1-1 1.2.2 Warnings...1-2 1.2.3 Cautions...1-2 1.2.4 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...3-3 4 Testing and Maintenance ... 4-1 4.1 Introduction...4-1 4.1.1 Test Equipment ...4-1 4.1.2 Test Report ...4-1 4.1.3 Preventative Maintenance...4-1 4.1.4 Recommended Frequency ...4-2 4.2 Visual Inspection...4-2 4.3 Power-on Test...4-3 4.4 Module Performance Tests...4-3 4.4.1 SpO2 Test...4-3 4.4.2 NIBP Test ...4-4 4.4.3 Temp Test...4-8 4.5 Electric safety tests...4-8 1

4.6 Battery Check... 4-8 4.7 Maintenance Mode... 4-9 4.7.1 Entering/Quitting Maintenance Mode ... 4-9 4.7.2 Checking Version Information... 4-9 4.7.3 Restoring Factory Default Configuration...4-10 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 5.3.6 Software Upgrade Problems... 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 Temp 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 Board6-5 6.3.6 Disassembling Pumps and Valves (NIBP optional) ... 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 Temp Module (Optional) ... 6-9 6.5.1 Removing the Temp Module PCBA and Temp Module Power Board PCBA... 6-9 6.5.2 Disassembling the Temp 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 2

7.2.2 Parts List...7-2 7.3 Front Housing Assembly...7-3 7.3.1 Exploded View ...7-3 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 ...7-6 7.5.1 Exploded View ...7-6 7.5.2 Parts List...7-6 7.6 Parameter Connector Panel Assembly ...7-7 7.6.1 Exploded View ...7-7 7.6.2 Parts List...7-7 7.7 Predictive Temp Assembly ...7-8 7.7.1 Exploded View ...7-8 7.7.2 Parts List...7-8 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 ...8-3 8.2.1 Upgrade program installation...8-3 8.2.2 Upgrading software ...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 A.4 Protective Earth Resistance ... A-2 A.5 Earth Leakage Test ... A-4 A.6 Patient Leakage Current ... A-5 A.7 Mains on Applied Part Leakage ... A-7

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FOR YOUR NOTES

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

Revision History

1.0

New

1.2 Safety Information DANGER z

Indicates an imminent hazard that, if not avoided, will result in death or serious injury.

WARNING z

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

CAUTION z

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

NOTE z

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

1.2.1 Dangers There are no dangers that refer to the product in general. Specific “Danger” statements may be given in the respective sections of this manual. 1-1

1.2.2 Warnings WARNING z

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

z

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

z

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

z

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.

z

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

1.2.3 Cautions CAUTION z

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.

z

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.

z

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

1.2.4 Notes NOTE z

Refer to Operator's Manual for detailed operation and other information.

1-2

1.3 Equipment Symbols NOTE z

Not all the symbols listed below are applied to your equipment.

Caution: Consult accompanying documents(this manual)

Neonate

Power ON/OFF

Pediatric

Clear

Adult

Alternating current (AC)

Equipotentiality

Battery indicator

Input/Output

DEFIBRILLATION –PROOF TYPE CF APPLIED PART

Date of manufacture

NIBP Start/Stop key

Manufacturer

Serial number

Insertion Direction

No alarming system

Protection against fluid ingress

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.

1-3

2 Theory of Operation 2.1 Overview The monitor is intended for spot-check monitoring physiologic parameters, including SpO2, PR, NIBP and TEMP, 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

1

2 3

1.

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

2.

AC power input

3.

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.

2-1

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 (including three types of configuration, i.e. Mindray, Masimo, and Nellcor); and,

„

External module: Temp module.

The following figure shows the main unit architecture of the vital signs monitor. Front Housing Assembly Segment-code display

I2C

Power On/Off keypad (indicator)

Main board

Backlight

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

2600mAh battery

NIBP receptacle

NIBP module

SpO2 board （Mindray standard, OEM optional）

SpO2 receptacle

External module Temp module

15V AC-DC power module AC-IN

External connector Only RS232 port (for upgrade, screened for end users)

2-2

Temp 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/IR (Infrared Radiation) Temp 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 inner RTC.

Keypad The keypad consists of elements like keypad and AC/Battery indicator etc.

2-3

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 (including three types of configuration, i.e. Mindray, Masimo, and Nellcor).

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 interface board mainly 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; 2-4

„

Providing isolation power for Mindray/OEM SpO2 module; and,

„

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

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 independently developed Mindray SpO2 board provides SpO2 measurement as good as other boards but with smaller size and lower consumption. The power management and interface board is also compatible with Nellcor NELL-1 SpO2 board and Masimo MS-2013 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 Temp module can be extended on the monitor. The independently developed Mindray Temp module consists of an isolation power board, Temp measurement board, and probes. The Temp measurement board collects Temp signals, processes algorithm and sends measurement results to the main board.

2-5

FOR YOUR NOTES

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 shall also be checked.

„

Notify the supplier if provided components are not correct as compared to the packing list.

„

In case of damage during transportation, keep the packing material and notify the supplier immediately.

„

Keep the packing material till new equipment is accepted.

3.2 Preparation for Installation 3.2.1 Preparation for Installation Site 1.

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

2.

Check that required power sockets are available.

3.

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

3.2.2 Environmental 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 (noncondensing)

Altitude (kPa)

Operating environment

0 to 40 (without Temp module) 5 to 40 (with Temp module)

15% to 95%

57.0 to 107.4

Storage environment

-30 to 70

10% to 95%

16.0 to 107.4

3-1

NOTE z

The environmental specifications of unspecified parameters are the same as those of the main unit.

3.2.3 Electrical Requirements Check that the system cables, power cords, and power plugs are not damaged, and that the pins are not loose. In case of any damage, remove it from use.

WARNING z

Only power sockets with protective grounding can be used.

z

Use the supplied power cord only!

z

If you doubt the completeness of the installation and cabling of the external protective cables, disconnect the equipment from the power line and operate it on battery. Otherwise, patient or operator might be shocked.

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.

Check the quantity of equipment and accessories as per the packing list.

2.

Check for mechanical damages on the equipment and accessories.

3.

Install the battery (optional). For detailed operations, please refer to the Operator's Manual of the vital signs monitor.

4.

Connect AC power.

5.

Connect the accessories.

The vital signs monitor can be mounted on a wall bracket or on a trolley support. The wall bracket or trolley support 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).

3-2

CAUTION z

Use mounting brackets we supply or approve. If other compatible mounting bracket is used, be sure it can be safely used on the vital signs monitor.

z

The mounting bracket should be installed by our qualified service personnel, or engineers who have adequate knowledge on it.

z

If other mounting solution is used, the installation personnel and the customer should verify if it can be safely used on the equipment, and the customer assume the responsibility for any risk resulting from that.

3.4 Preparation for Power on 1.

Before you start to make measurements, check the equipment 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

button on the front panel to turn on the equipment.

3-3

FOR YOUR NOTES

3-4