Service Manual
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GE Healthcare
DINAMAP™ ProCare Monitor Service Manual
DINAMAP ProCare Monitor English 2009381-001D (paper) © 2005-2008 General Electric Company. All Rights Reserved.
GE Healthcare
DINAMAP™ ProCare Monitor Service Manual
DINAMAP ProCare Monitor English 2009381-001D (paper) © 2005-2008 General Electric Company. All Rights Reserved.
GUARANTEE All equipment sold by GE Medical Systems Information Technologies, is fully guaranteed as to materials and workmanship for a specified period. Refer to your warranty for more information. GE Medical Systems Information Technologies reserves the right to perform guarantee service operations in its own factory, at an authorized repair station, or in the customer’s installation. Our obligation under this guarantee is limited to repairing, or, at our option, replacing any defective parts of our equipment, except fuses or batteries, without charge, if such defects occur in normal service. Claims for damage in shipment should be filed promptly with the transportation company. All correspondence covering the instrument should specify the model and serial numbers. GE MEDICAL SYSTEMS Information Technologies A GE Healthcare Company NOTE: In addition to software version RAI, the information in this manual also applies to earlier DINAMAP® ProCare Monitor software versions. There are no user-apparent differences among these software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice. GE Medical Systems Information Technologies will make available on request such circuit diagrams, component diagrams, component parts lists, descriptions, calibration instructions, or other information which will assist the users or appropriately qualified technical personnel to repair those parts of the equipment which are classified by GE Medical Systems Information Technologies as repairable. MASIMO SET® is a trademark of Masimo Corporation. Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to the device. NELLCOR®, OxiMax®, OxiCliq®,and SatSeconds™ are trademarks of Nellcor Puritan Bennett. IVAC® and TURBOTEMP® are trademarks of ALARIS Medical Systems
CAUTION: In the United States of America, Federal Law restricts this device to sale by or on the order of a physician.
DINAMAP, CLASSIC-CUF, SOFT-CUF, AND SENSA-CUF are registered trademarks of GE Medical Systems Information Technologies. GE is a registered trademark of General Electric Company. All other product and brand names are trademarks or registered trademarks of their respective companies. ©2005-2008 GE Medical Systems Information Technologies. All rights reserved. No part of this manual may be reproduced without the permission of GE Medical Systems Information Technologies.
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DINAMAP® ProCare Monitor
2009381-001D 24 October 2008
Contents
1
Introduction... 1-1 Revision History... 1-3 Manual Purpose... 1-3 Ordering Manuals... 1-3 Safety Information... 1-3 Responsibility of the Manufacturer...1-4 General...1-4 References to Persons, Places, and Institutions...1-4 Warnings, Cautions, and Notes...1-5 Product Specific Hazards...1-5 Warnings...1-5 Cautions...1-5 Equipment Symbols... 1-6 Service Requirements... 1-8 Equipment ID... 1-8 Intended Audience... 1-9 Intended Use...1-9 General Use...1-9 Related Manuals...1-9 Service Policy... 1-9 Service Contracts...1-9 Assistance...1-9 Service... 1-10 Packing Instructions... 1-10 Insurance... 1-10 Service No Charge Rental... 1-11 Repair Parts... 1-11 Disposal of Product Waste... 1-11 Batteries... 1-11 Patient Applied Parts... 1-12 Packaging Material... 1-12 Monitor... 1-12
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Equipment Overview... 2-1 Equipment Description... 2-3 Product Configurations...2-3 Basic Components... 2-4 Front Panel Controls and Indicators...2-4 Buttons...2-4 Front Panel...2-5 Product Compliance... 2-7 Theory of Operation... 2-8 Introduction...2-8 Overall Principles of Operation... 2-8 SpO2 (Model 300 and 400)...2-9 Cuff Blood Pressure (BP) and Pulse...2-9 Principles of Noninvasive Blood Pressure Determination...2-9 Temperature (Model 200 and 400)... 2-12 Host Communication Port... 2-12 Functional Description... 2-12 Main Board PWA... 2-12 User Interface (UI) Board PWA... 2-13 SPO2 PWA... 2-13 Printer... 2-14 Pneumatic Valve/Manifold (PVM)... 2-14 Optical Switch... 2-14
3
Installation... 3-1 Connections... 3-3 Rear Panel...3-3 Right-Side Panel...3-3 Powering the Monitor...3-4 Power Sources...3-4 Battery Charging...3-4 Unpacking and Preparation for Installation... 3-5 Configuring Your ProCare Monitor... 3-6 Operating Modes...3-6 Clinical Mode...3-6 Configuration Mode...3-6 Advanced Configuration Mode...3-9 Service Mode... 3-11
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Host Communications Connector... 3-13 DB15 Connector Pin Assignments... 3-13 Connection Details... 3-13
4
Maintenance... 4-1 Preventative Maintenance... 4-3 General...4-3 Integrity of Hoses and Cuffs...4-3 Visual Inspection... 4-3 Cleaning... 4-4 Cleaning the Monitor...4-4 Cleaning Recommendations...4-4 Monitor Exterior...4-4 Display...4-5 Cuffs...4-5 Temperature Devices...4-6 SpO2 Sensors...4-6 Long-Term Storage... 4-6 Battery Care...4-7 Replacing the Battery...4-8 Fuses...4-9 Parameter Level Functional Testing... 4-9 BP...4-9 Temperature...4-9 Nellcor SpO2 Technology...4-9 Masimo SpO2 Technology...4-9 Calibration Procedures and Tests... 4-10 Annual Procedures... 4-10 Parameter Test Procedures... 4-10 Leakage Testing... 4-11 Pressure Transducer Verification... 4-12 Pressure Transducer Calibration... 4-12 Overpressure Verification... 4-13 Button Testing... 4-13 LED Tests... 4-13 External DC Verification... 4-14 BP Determination... 4-14 BP Overpressure Verification... 4-14 Temperature (Perform if equipped with Temp module)... 4-14 SpO2 (Perform only if equipped with SpO2 module)... 4-16 Printer Output Test... 4-16 Temp Circuit Leakage Test... 4-16
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SpO2 Circuit Leakage Test... 4-16 Test Results Form... 4-17
5
Troubleshooting... 5-1 Alarm Code Interpretation... 5-3 System Failures...5-3 Alarm Conditions and Error Codes...5-3 Error Log...5-3 Procedure to View and Print Error Code History Log:...5-3
6
Parts List, Drawings, and Replacement... 6-1 Ordering Parts... 6-3 Service Parts... 6-3 Compatible Parts...6-3 Field-Replaceable Units (FRUs)...6-6 FRU List...6-6 FRU Main Reference Guide Drawing... 6-16 Assembly/Disassembly of FRUs... 6-17 Monitor Disassembly Procedure... 6-17 Battery... 6-17 Rear Case... 6-17 Printer... 6-18 SpO2 Board... 6-20 Main Board... 6-20 Display Board... 6-21
A
Technical Specifications... A-1 Specifications... A-3 Mechanical... A-3 Power Requirements... A-3 Environmental... A-4 BP... A-4 Factory Default Settings... A-4 Critikon US Patents... A-5 European Patents... A-5 Nellcor SpO2... A-5 Measurement Range... A-5
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Accuracy and Motion Tolerance... A-5 Saturation... A-5 Pulse Rate... A-5 NELLCOR® Sensor Accuracy... A-6 Factory Default Settings... A-7 NELLCOR® Patents... A-7 Masimo SpO2... A-7 Measurement Range... A-7 Accuracy and Motion Tolerance... A-7 Factory Default Settings... A-8 Masimo Patents... A-8 Temperature... A-9 Factory Default Settings... A-9 IVAC® Patents... A-9 Pulse Rate... A-9 Factory Default Settings... A-9
B
Appropriate Use of NIBP Simulators... B-1 Appropriate Use of NIBP Simulators... B-3 NIBP Accuracy... B-3 Clinical vs. Simulator Readings... B-3 What Do Simulator Manufactures Say?... B-4 Why Use Simulators?... B-5 Summary... B-5
C
Electromagnetic Compatibility (EMC)... C-1 Electromagnetic Compatibility (EMC): ProCare Monitor... C-3 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions... C-3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity... C-4 Recommended Separation Distances... C-6 Compliant Cables and Accessories... C-7
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Introduction
DINAMAP® ProCare Monitor 2009381-001
1-1
For your notes
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Introduction: Revision History
Revision History Each page of this manual has a revision letter located at the bottom of the page. This letter identifies the revision level of the entire manual. This may be important if you have different manuals and you do not know which is the most current. For the initial release, all pages have the revision letter A. For the second update, all pages receive the revision letter B. The latest letter of the alphabet added to the table below corresponds to the most current revision. Revision
Comment
A
Initial Release
B
Add EMC Compliance Testing Tables
C
Update specifications, tests, FRU drawings, FRU lists, format, and add error log feature information.
D
Update CE Mark Notified Body and equipment symbols.
Manual Purpose This manual supplies technical information for service representatives and technical personnel so they can maintain the equipment to the assembly level. Use it as a guide for maintenance and electrical repairs considered field repairable. Where necessary the manual identifies additional sources of relevant information and technical assistance. See the operator's manual for the instructions necessary to operate the equipment safely in accordance with its function and intended use.
Ordering Manuals A paper copy of this manual will be provided upon request. Contact your local GE representative and request the part number on the first page of the manual.
Safety Information The information presented in this section is important for the safety of both the patient and operator. This chapter describes how the terms Danger, Warning, Caution, Important, and Note are used throughout the manual. In addition, standard equipment symbols are defined.
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Introduction: Safety Information
Responsibility of the Manufacturer GE is responsible for the effects on safety, reliability, and performance only if:
assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE;
the electrical installation of the relevant room complies with the requirements of appropriate regulations; and
the monitor is used in accordance with the instructions of use.
General This device is intended for use under the direct supervision of a licensed health care practitioner. This device is not intended for home use. Federal law restricts this device to be sold by or on the order of a physician. Contact GE for information before connecting any devices to the equipment that are not recommended in this manual. Parts and accessories used must meet the requirements of the applicable IEC/ EN 60601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard. Periodically, and whenever the integrity of the device is in doubt, test all functions. The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include:
use of the accessory in the PATIENT VICINITY; and
evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard.
If the installation of the equipment, in the USA, will use 240V rather than 120V, the source must be a center-tapped, 240V, single-phase circuit.
References to Persons, Places, and Institutions References to persons, places, and institutions used within this manual are solely intended to facilitate user comprehension of the ProCare Monitor Monitor’s use and functions. Extreme care has been taken to use fictitious names and related information in the examples and illustrations provided herein. Any similarity of this data to persons either living or dead and to either current or previously existing medical institutions should be regarded as coincidental.
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Introduction: Safety Information
Warnings, Cautions, and Notes The terms danger, warning, and caution are used throughout this manual to point out hazards and to designate a degree or level or seriousness. Familiarize yourself with their definitions and significance. Hazard is defined as a source of potential injury to a person. DANGER indicates an imminent hazard which, if not avoided, will result in death or serious injury. WARNING indicates a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury. CAUTION indicates a potential hazard or unsafe practice which, if not avoided, could result in minor personal injury or product/property damage. NOTE provides application tips or other useful information to assure that you get the most from your equipment.
Product Specific Hazards Warnings
Do not use the ProCare Monitor in the presence of magnetic resonance imaging (MRI) devices. There have been reports of sensors causing patient burns when operating in an MRI environment.
Do not use the Monitor in the presence of flammable anesthetics.
To help prevent unintended current return paths with the use of high frequency (HF) surgical equipment, ensure that the HF surgical neutral electrode is properly connected.
To avoid personal injury, do not perform any servicing unless qualified to do so.
WARNING: These Monitors should not be used on patients who are connected to cardiopulmonary bypass machines.
If powering the Monitor from an external power adapter or converter, use only GE Medical Systems Information Technologies-approved power adapters and converters.
The Monitor does not include any user-replaceable fuses. Refer servicing to qualified service personnel.
To reduce the risk of electric shock, do not remove the cover or the back. Refer servicing to a qualified service person.
If the accuracy of any determination reading is questionable, first check the patient’s vital signs by alternate means and then check the ProCare Monitor for proper functioning.
The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity performance of the equipment or system.
Do not use replacement batteries other than the type supplied with the Monitor. Replacement batteries are available from GE Medical Systems Accessories and Supplies.
Cautions
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Introduction: Equipment Symbols
The ProCare Monitor is designed to conform to Electromagnetic Compatibility (EMC) standard IEC 60601-1-2 and will operate accurately in conjunction with other medical equipment which also meets this requirement. To avoid interference problems affecting the Monitor, do not use the Monitor in the presence of equipment which does not conform to these specifications.
Place the ProCare Monitor on a rigid, secure surface. Monitor must only be used with mounting hardware, poles, and stands recommended by GE Medical Systems Information Technologies.
The weight of the accessory basket contents should not exceed 5 lb (2.7kg).
Arrange the external AC/DC power converter, air hoses, and all cables carefully so they do not constitute a hazard.
Verify calibration of BP parameter (temp and pulse oximeter do not require calibration). Ensure that the display is functioning properly before operating the ProCare Monitor.
Do not immerse the Monitor in water. If the Monitor is splashed with water or becomes wet, wipe it immediately with a dry cloth.
Do not gas sterilize or autoclave.
Use of portable phones or other radio frequency (RF) emitting equipment near the system may cause unexpected or adverse operation.
The equipment or system should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, the equipment or system should be tested to verify normal operation in the configuration in which it is being used.
The ProCare Monitor, when used with GE Medical Systems Information Technologies-approved applied parts and accessories, is protected against defibrillator damage.
NOTE: The electromagnetic compatibility profile of the ProCare Monitor may change if accessories other than those specified for use with the ProCare Monitor are used.
Equipment Symbols The following symbols are associated with the ProCare Monitor. Some of the symbols may not appear on all equipment. NOTE: The model of the Monitor determines which symbols appear on it. Attention, consult accompanying documents Silence Alarms +/Menu
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Introduction: Equipment Symbols
Inflate/Stop Cycle History Print On/Off Battery Power External Communications Port Connector Charging Defibrillator-proof type BF equipment External AC or DC power indicator Class II equipment according to IEC 60536 Manufacturer: This symbol is accompanied by the name and the address of the manufacturer. Manufacturing Date: This symbol is accompanied by the date of the manufacturing.
European authorized representative.
Packaging label depicting the transportation and storage atmospheric pressure range of 500 to 1060 hPa.
WASTE OF ELECTRICAL AND ELECTRONIC EQUIPMENT (WEEE): This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.
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Introduction: Service Requirements
The DINAMAP® ProCare Monitor is protected against vertically falling drops of water and conforms with the IEC 529 standard at level of IPX1. Vertically falling drops shall have no harmful effects to the Monitor.
IPX1 Service Requirements
Follow the service requirements listed below.
Refer equipment servicing to GE Medical Systems Information Technologies authorized service personnel only.
Any unauthorized attempt to repair equipment under warranty voids that warranty.
It is the user’s responsibility to report the need for service to GE Medical Systems Information Technologies or to one of GE’s authorized agents.
Failure on the part of the responsible individual, hospital or institution using this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.
Regular maintenance, irrespective of usage, is essential to ensure that the equipment will always be functional when required.
Equipment ID The following graphic illustrates the components of the monitor’s serial number.
GEMS IT Global Serial Number Format 13- Digit ### ## ## #### ##
Misc. : Prototype, refurbish, etc. Manufacturing site Sequential serial number (up to 9999) Fiscal week Year 3-character product code
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Introduction: Intended Audience
Intended Audience This manual is intended for service representatives and technical personnel who maintain, troubleshoot, or repair this equipment.
Intended Use General Use
The ProCare Monitor is intended to monitor one patient at a time in a clinical setting.
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
To ensure patient safety, use only parts and accessories manufactured or recommended by GE Medical Systems Information Technologies. Parts and accessories used shall meet the requirements of IEC 60601-1-1.
Disposable devices are intended for single use only. They should not be reused.
Periodically, and whenever the integrity of the monitor is in doubt, test all functions.
Related Manuals Manual
Title
2009360-001
DINAMAP ProCare Operation Manual
Service Policy The warranty for this product is enclosed with the product in the shipper carton. All repairs on products under warranty must be performed or approved by Product Service personnel. Unauthorized repairs will void the warranty. Only qualified electronics service personnel should repair products not covered by warranty.
Service Contracts Extended warranties can be purchased on most products. Contact your Sales Representative for details and pricing.
Assistance If the product fails to function properly, or if assistance, service or spare parts are required, contact Customer Support. Before contacting Customer Support, it is helpful to attempt to duplicate the problem and to check all accessories to
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Introduction: Service Policy ensure that they are not the cause of the problem. If you are unable to resolve the problem after checking these items, contact GE Medical Systems Information Technologies. Prior to calling, please be prepared to provide:
product name, model number, and serial number
a complete description of the problem
If repair parts or service are necessary, you will also be asked to provide:
the product serial number
the facility's complete name, address, and account number
a purchase order number if the product is to need of repair or when you order spare parts
the facility's GE Medical Systems Information Technologies account number, if possible
the appropriate part number for spare or replacement parts
Service If your product requires warranty, extended warranty or non-warranty repair service, call Customer Support and a representative will assist you. To facilitate prompt service in cases where the product has external chassis or case damage, please advise the Customer Support representative when you call. The Customer Support representative will record all necessary information and will provide you with a Return Merchandise Authorization Number (RMA). Prior to returning any product for repair, you must have a RMA number. Contact GE Medical Systems Information Technologies at 1-800-558-7044. Monday through Friday, 8:00 a.m. to 6:00 p.m. EST, excluding holidays.
Packing Instructions Follow these recommended packing instructions.
Remove all hoses, cables, sensors, and power cords from the monitor before packing.
Pack only the accessories you are requested to return; place them in a separate bag and insert the bag and the product inside the shipping carton.
Use the original shipping carton and packing materials, if available.
If the original shipping carton is not available:
Place the product in a plastic bag and tie or tape the bag to prevent loose particles or materials from entering openings such as hose ports.
Use a sturdy corrugated container to ship the product; tape securely to seal the container for shipping.
Pack with 4 to 6 in. of padding on all sides of the product.
Insurance Insurance is at the customer's discretion. The shipper must initiate claims for damage to the product.
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Introduction: Disposal of Product Waste
Service No Charge Rental A no charge rental unit is provided at no charge during the warranty period of the product when we perform the repair service.
GE Medical Systems Information Technologies pays the shipping charges for a loaner sent to the customer for product repairs under the warranty.
Rental units are available in non-warranty situations.
The customer pays the shipping charges to return a rental.
All loaners provided to customers must be returned within the specified time stated on the loaner agreement or a rental fee will be incurred.
Repair Parts Repair parts can be ordered from GE Medical Systems Information Technologies: Via phone: 1-800-558-7044, or Via FAX: 1-800-421-6841 Exchange replacement assemblies such as Circuit Board Assemblies also are available; ask the Customer Support representative for details. Please allow one working day for confirmation of your order. All orders must include the following information.
Facility's complete name, address, and phone number
FAX number
Your purchase order number
Your GE Medical Systems Information Technologies account number
Disposal of Product Waste As you use the ProCare Monitor, you will accumulate solid wastes that require proper disposal or recycling. These include batteries, patient applied parts, and packaging material.
Batteries CAUTION Do not incinerate batteries.
The sealed, rechargeable backup battery contains lead and can be recycled. The rechargeable memory battery is of the Sealed Lead Acid form. Discharge this battery prior to disposal. Place the battery in packaging which electrically isolates its contents. Do not puncture or place the battery in a trash compactor. Do not incinerate the battery or expose it to fire or high temperatures. Dispose in accordance with regional body controlled guideline.
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