Critikon Dinamap Pro1000V3 Service manual

PRO 1000V3 Monitor Service Manual
DINAMAP® PRO 1000V3 Monitor
ii
List of Effective Pages
Part No./Rev. Page No. 2012819-001 A
2012819-001 A2 2012819-001 B All September 2004
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a health care practitioner.
The content of this document, including all figures and drawings, is proprietary information of General Electric Medical Systems Information Technologies, provided solely for purposes of operation, maintenance or repair of PRO 1000V3 Monitors. Dissemination for other purposes or copying thereof without the prior written consent of General Electric Medical Systems Information Technologies, Tampa, Florida, is prohibited. Illustrations may show design models; production units may incorporate changes.
© Copyright 2003, 2004 GE Medical Systems Information Technologies. All rights reserved.
Printed in U.S.A.
World Headquarters
GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA Tel: + 1 414 355 5000 1 800 558 5120 (US only) Fax: + 1 414 355 3790
European Representative
GE Medical Systems Information Technologies GmbH Munzinger Straße 3-5 D-79111 Freiburg Germany Tel: + 49 761 45 43 - 0 Fax: + 49 761 45 43 - 233
Asia Headquarters
GE Medical Systems Information Technologies Asia; GE (China) Co., Ltd. 24th Floor, Shanghai MAXDO Center, 8 Xing Yi Road, Hong Qiao Development Zone Shanghai 200336, P.R. China Tel: + 86 21 5257 4650 Fax: + 86 21 5208 2008
All Original. 2003 Front matter & back cover
Date of Latest Revision
March 2004
ii
TABLE OF CONTENTS
SECTION 1 INTRODUCTION
1.1. Scope of Manual........................................................................................1-3
1.2. Manual Changes .......................................................................................1-4
1.3 Service Policy............................................................................................1-4
1.3.1 Extended Warranties.................................................................................1-4
1.3.2 Assistance.................................................................................................1-4
1.3.3 Service ......................................................................................................1-5
1.3.4 Service Loaners and Rentals ....................................................................1-6
1.3.5 Repair ....................................................................................................... 1-7
1.3.6 Replacement Accessories.........................................................................1-7
1.4 Product Description...................................................................................1-7
1.4.1 General Description...................................................................................1-7
1.4.2 Storage Batteries.......................................................................................1-9
1.5 Disposal of Product Waste........................................................................1-9
1.5.1 Batteries....................................................................................................1-7
1.5.2 Patient Applied Parts.................................................................................1-9
1.5.3 Packaging Material....................................................................................1-7
1.5.4 Monitor ......................................................................................................1-9
SECTION 2. PRODUCT DESCRIPTION
2.1. Introduction................................................................................................2-3
2.2. Product Configurations ..............................................................................2-3
2.3. Controls, Indicators, and Connectors.........................................................2-3
2.3.1 Rear Panel Connections............................................................................2-4
2.3.2 Front Panel Controls and Indicators...........................................................2-4
2.3.3 Symbols Associated With the PRO 1000 Monitor......................................2-5
2.4. Host Port Connectors.................................................................................2-7
2.4.1 Pin Assignments........................................................................................2-8
2.4.2 IPC-1928 Installation..................................................................................2-9
2.5. Compatible Parts .................................................................................... 2-11
2.6. Product Compliance................................................................................2-13
2.7. Specifications..........................................................................................2-15
2.7.1 Mechanical..............................................................................................2-15
2.7.2 Weight.....................................................................................................2-15
2.7.3 Environmental.........................................................................................2-15
2.7.4 Electrical .................................................................................................2-15
2.7.5 Power Supply..........................................................................................2-15
2.7.6 NIBP........................................................................................................2-16
2.7.7 TURBOTEMP......................................................................................2-17
2.7.8 NELLCOR
2.7.9 MASIMO SET
®
OXIMAX® SpO2...................................................................2-18
®
SpO2..............................................................................2-20
iii
2.7.10 ECG......................................................................................................2-22
2.7.11 RESP....................................................................................................2-23
2.7.12 HR/Pulse...............................................................................................2-23
SECTION 3. PRINCIPLES OF OPERATION
3.1. Introduction...............................................................................................3-3
3.2. Overall Principles Of Operation.................................................................3-3
3.2.1 Nellcor SpO
AND Masimo SpO2..............................................................3-3
2
3.2.2 Cuff Blood Pressure (BP) and Pulse .........................................................3-4
3.2.3 Alaris Oral and Rectal TURBOTEMP Thermometry...............................3-4
3.2.4 ECG with Heart Rate and Respiration.......................................................3-5
3.2.5 Host Communication Ports........................................................................3-5
3.3 Functional Description ..............................................................................3-6
3.3.1 PSU PWA..................................................................................................3-6
3.3.2 Mains Converter Module ...........................................................................3-7
3.3.3 Main Board................................................................................................3-7
3.3.4 SpO
PWA.................................................................................................3-9
2
3.3.5 Keyboard PWA..........................................................................................3-9
3.3.6 ECG PWA .................................................................................................3-9
3.3.7 Pneumatic Control...................................................................................3-10
3.3.8 LCD Assembly ........................................................................................3-12
3.3.9 Printer (Optional) .....................................................................................3-12
Block Diagram........................................................................................3-13
SECTION 4. GENERAL MAINTENANCE
4.1 Introduction................................................................................................4-3
4.2 Setting up the PRO 1000V3 Monitor for the First Time .............................4-3
4.2.1 Unpacking and Preparation for Installation................................................4-3
4.2.2 Set the Date and the Clock........................................................................4-5
4.2.3 Parameter Level Functional Testing..........................................................4-6
4.3 Periodic Maintenance................................................................................4-8
4.3.1 Required....................................................................................................4-8
4.3.1.1 Integrity of Cuffs and Hoses ..................................................................4-8
4.3.1.2 Cleaning of the Monitor..........................................................................4-8
4.3.1.3 Cleaning of Accessories........................................................................4-8
4.3.1.4 Long-Term Storage ............................................................................4-10
4.3.2 Annual Procedures..................................................................................4-10
4.4 Care of Storage Batteries........................................................................4-10
4.4.1 Procedures for First Use.........................................................................4-10
4.4.2 Battery Charging.....................................................................................4-11
4.4.3 Battery Troubleshooting..........................................................................4-11
4.5 Safety Resistance Testing......................................................................4-12
4.6 Hi-Pot Tests............................................................................................4-13
4.6.1 AC Mains Hi-Pot.....................................................................................4-14
iv
4.6.2 ECG/SpO
/TEMP Hi-Pot ........................................................................4-14
2
4.7 Alternate Hi-Pot Test ..............................................................................4-15
4.7.1 Earth to Protective Ground Continuity ....................................................4-15
4.7.2 AC Mains Leakage (Normal Polarity) .....................................................4-15
4.7.3 AC Mains Leakage (Reverse Polarity)....................................................4-16
4.7.4 Temperature Leakage ............................................................................4-16
4.7.5 SpO2 Leadage .......................................................................................4-16
Test Record (Appendix A) ......................................................................4-18
Test Record (Appendix B) ......................................................................4-19
4.8. Service Mode Operation.........................................................................4-20
4.8.1 SpO
4.8.1.1 For Monitors With Nellcor SpO
4.8.1.2 For Monitors With Masimo SpO
Tests.............................................................................................4-22
2
..........................................................4-22
2
........................................................4-22
2
4.8.2 NIBP Tests .............................................................................................4-24
4.8.2.1 Leak Test............................................................................................4-25
4.8.2.2 NIBP Calibration Check......................................................................4-27
4.8.2.3 Pressure Recalibration .......................................................................4-28
4.8.2.4 Overpressure Test..............................................................................4-30
4.8.3 ECG Tests..............................................................................................4-31
4.8.4 RESP Tests............................................................................................4-33
4.8.5 TEMP Tests............................................................................................4-33
4.8.6 Recorder Tests.......................................................................................4-34
4.8.7 Battery Tests ..........................................................................................4-36
4.8.8 Failsafe Logic Test .................................................................................4-38
4.8.9 Keypad LED Test ...................................................................................4-39
4.8.10 Keypad KEY Test...................................................................................4-39
4.8.11 Sound Test.............................................................................................4-39
4.8.12 Communications Tests........................................................................... 4-39
4.8.12.1 Set up Terminal ................................................................................4-39
4.8.12.2 Configure UUT for Communication...................................................4-40
4.8.12.3 Communication Test.........................................................................4-40
4.8.13 Communication Test ..............................................................................4-40
4.8.14 Turn off System......................................................................................4-41
4.9 Service Mode Exit...................................................................................4-41
APPENDIX A: Test Record APPENDIX B: Monitor Configuration Log APPENDIX C: Error Codes APPENDIX D: Required Service Equipment APPENDIX E: Troubleshooting
v
APPENDIX F: Electromagnetic Compatibility APPENDIX G: Field Replacement Units (FRUs)
vi
SECTION 1.
INTRODUCTION
DINAMAP® PRO 1000V3 Service Manual
1-2 INTRODUCTION
DINAMAP® PRO 1000V3 Service Manual
SECTION 1. INTRODUCTION
1.1 SCOPE OF MANUAL This Service Manual provides service and parts repair
information about the DINAMAP This manual is intended for use by trained service technicians who are familiar with electromechanical devices and digital and analog circuit techniques.
®
PRO 1000V3 Monitor.
WARNINGS
To reduce the risk of electric shock, do not remove covers. Refer servicing to qualified service personnel.
Only qualified service-technicians should perform repairs to this equipment.
Voltages dangerous to life exist in this unit. Take care when servicing power supply and display assembly.
For information about operating the Monitor in a clinical environment, refer to the separate Operation Manual.
This Service Manual consists of the following five sections:
Section 1 Describes how to use this manual. Information is also
provided about the physical and functional characteristics of the Monitor, and how to get assistance in the event the unit fails to function properly.
Section 2 Provides a general overview of the Monitor including user
controls, external connections, and product/parameter specifications.
Section 3 Presents principles of operation for the Monitor, including
an overall system description and principles of operation at the component level.
Section 4 Provides information about periodic and corrective
maintenance of the Monitor. Procedures include module performance tests and calibration procedures.
INTRODUCTION 1-3
DINAMAP® PRO 1000V3 Service Manual
Information is provided to facilitate isolating faults to the subassembly level.
1.2 MANUAL CHANGES If, in the normal use of this manual, you notice errors,
omissions, incorrect data, or if you can suggest comments that may help improve this manual, please notify:
GE Medical Systems Information Technologies Technical Publications 4502 Woodland Corporate Boulevard Tampa, Florida 33614
Changes to the Service Manual, either in response to user input or to reflect continuing product improvements, are accomplished through the reissuing of an updated manual.
Changes occurring between reissues are addressed through Change Information Sheets and replacement pages. If a Change Information Sheet does not accompany your manual, the manual is correct as printed.
1.3 SERVICE POLICY The warranty for this product is enclosed with the product
in the shipping carton. All repairs on products under warranty must be performed or approved by Product Service personnel. Only qualified electronics service personnel should repair products not covered by warranty.
Unauthorized repairs will void the warranty.
1.3.1 Extended Warranties Extended warranties may be purchased on most
products. Contact your Sales Representative for details and pricing.
1.3.2 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 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
1-4 INTRODUCTION
DINAMAP® PRO 1000V3 Service Manual
Information Technologies. Prior to calling, please be prepared to provide:
the product name and model number
a complete description of the problem
the software revision
If repair parts or service are necessary, provide the following information:
the product serial number
the facility's complete name and address
a purchase order number if the product is in need
of repair or when you order spare parts
the facility's account number, if possible
the part number for spare or replacement parts
1.3.3 Service If your product requires warranty, extended warranty or non-warranty repair service, call Customer Support and a representative will assist you. Estimates for non­warranty repairs are provided at no charge; however, the product must be sent to the GE Medical Systems Information Technologies Service Center in order to provide you with an estimate.
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 records all necessary information and provides you with a Return Merchandise Authorization number (RMA). Prior to returning any product for repair, you must have an RMA number. Contact technical support at 1-877-274-8456, Option 4, Monday through Friday, 8:00 a.m. to 6:00 p.m. EST, excluding holidays.
INTRODUCTION 1-5
DINAMAP® PRO 1000V3 Service Manual
Packing Instructions
If the original shipping
carton is available,
follow these
recommended packing
instructions:
If the original shipping
carton is not available,
follow these
recommended packing
instructions:
1) Remove all hoses, cables, sensors, and power cords from the Monitor before packing.
2) 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.
3) Use the original shipping carton and packing materials, if available.
1) 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
2) Use a sturdy corrugated container to ship the product; tape securely to seal the container for shipping
3) Pack with 4 to 6 inches 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.
1.3.4 Service Loaners and Rentals A loaner unit is provided at no charge during the warranty
period of the product when we perform the repair service. Within 48 hours of your request, a loaner will be shipped to your facility.
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 loaner.
All loaners provided to customers must be returned within the specified time stated on the loaner agreement or a rental fee will be incurred.
1-6 INTRODUCTION
DINAMAP® PRO 1000V3 Service Manual
1.3.5 Repair Repair parts can be ordered from GE Medical Systems
Information Technologies:
Via phone 1-800-558-7044 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 account number
1.3.6 Replacement Accessories Replacements, such as hoses and sensors, must be
purchased from GE Medical Systems Information Technologies at 1-877-274-8456. Have the
Reorder/Product Code of the item you wish to order, your purchase order and account number available.
1.4 PRODUCT DESCRIPTION The Monitor and storage batteries are described below.
Refer to Section 2 for specifications.
1.4.1 General Description The Monitor is designed for patient monitoring in acute
care settings such as critical care, emergency room, radiology, labor and delivery, and operating room. It allows the clinician to view, record, and recall clinical data derived from each parameter. These data include heart rate, respiration rate, oxygen saturation, noninvasive blood pressure, and temperature. Alarm limit conditions are also detected.
The recorder provides numeric and waveform printouts of monitored data. Up to two waveforms can be traced simultaneously. Each Monitor can monitor one patient at
INTRODUCTION 1-7
DINAMAP® PRO 1000V3 Service Manual
the bedside. Patient sensor connections are made at the side of the unit, and network and device connectors are at the rear. Indicators for external AC/DC operation, battery operation, and battery charging are at the front of the unit.
At the time of publication, the available functioning parameters included the following:
DINAMAP
®
NIBP*
NELLCOR oximetry (SpO
®**
OXIM
)
2
®
AX
or MASIMO SET
®***
pulse
EK-Pro® 3-lead ECG*, with respiration
2-channel thermal recorder
IVAC TURBO
TEMP™†, oral or rectal
thermometry
The Monitor series uses a TFT active-matrix-color liquid display. The 10.4” diagonal color display area contains 640 x 480 pixels. The LCD has the following specific characteristics. These are neither defects nor malfunctions:
The ambient temperature may affect the display condition of the LCD.
The LCD uses replaceable cold cathode tubes for backlighting. Optical characteristics, such as luminance or uniformity change over the course of time or viewing angle.
Uneven brightness and/or small spots may be noticed depending on different display patterns.
*DINAMAP **NELLCOR ***MASIMO SET
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.
† IVAC TURBOTEMP
®
and EK-Pro® is a trademark of GE Medical Systems Information Technologies.
®
, OXIMAX®, OXIMAX XL™, OxiCliq®, C-LOCK®, and SatSeconds™ are trademark of Nellcor Puritan Bennett Inc.
®
is a trademark of Masimo Corporation. Possession or purchase of this device does not convey any express
TM
is a trademark of ALARIS Medical Systems.
1-8 INTRODUCTION
DINAMAP® PRO 1000V3 Service Manual
Other Monitor features include:
The ability to use industry standard accessories.
Remote alarm capability.
An intuitive graphical user interface, with a simple
SelectKnob that moves the user through menus in a logical and easy to understand format.
Eight hard keys for quick access to alarm silence,
standby, record, freeze, NIBP Go/Stop, AUTO-BP or STAT NIBP, trend and the main menu.
1.4.2 Storage Batteries The Monitor operates from AC mains power, an external
DC power supply, or from the internal Nickel Metal Hydride storage battery. When external DC power becomes available, the system rapidly switches from battery power to external power.
1.5 DISPOSAL OF PRODUCT WASTE
As you use the PRO Monitor, you will accumulate solid wastes that require proper disposal or recycling. These include batteries, patient applied parts, and packaging material.
1.5.1.Batteries
Caution: Do not incinerate batteries.
The sealed, rechargeable backup battery contains lead and can be recycled. The rechargeable memory battery is of the Nickel Metal Hydride 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.
1.5.2 Patient
Applied Parts
Certain patient applied parts, such as those with adhesive (disposable SpO
sensors), are intended for
2
single use and should be disposed of properly as medical waste in accordance with regional body controlled guideline.
INTRODUCTION 1-9
DINAMAP® PRO 1000V3 Service Manual
Other patient applied parts, such as blood pressure cuffs, should be cleaned according to instructions. Inspect reusable applied parts for wear, replace as necessary, and dispose of used product as medical waste in accordance with regional body controlled guideline.
1.5.3 Packaging Material
Retain original packaging materials for future use in storing or shipping the Monitor and accessories. This recommendation includes corrugated shippers and inserts.
Whenever possible recycle the packaging of accessories and patient applied parts.
1.5.4 Monitor
At the end of its service life, the product described in this manual, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have questions concerning disposal of the product, please contact GE Medical Systems Information Technologies or its representatives.
1-10 INTRODUCTION
SECTION 2.
PRODUCT DESCRIPTION
DINAMAP® PRO 1000V3 Service Manual
2-2 PRODUCT DESCRIPTION
DINAMAP® PRO 1000V3 Service Manual
SECTION 2. PRODUCT DESCRIPTION
®
2.1 INTRODUCTION DINAMAP
determination of systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse rate, 3-lead ECG, temperature, and oxygen saturation. These portable AC and DC operated Monitors are primarily intended for use in hospital acute care settings such as outpatient surgery, accident and emergency, labor and delivery, GI/endoscopy, and medical/surgical units.
2.2 PRODUCT
CONFIGURATIONS Each Monitor is supplied with an accessory pack. The
contents of the pack vary according to model. Unpack the items carefully, and check them against the checklists enclosed within the accessory boxes. If an accessory is missing or if an item is in a nonworking condition, contact GE Medical Systems immediately.
PRO 1000V3 Monitors provide non-invasive
It is recommended that all the packaging be retained, in case the Monitor must be returned for service in the future.
2.3 CONTROLS,
INDICATORS, AND CONNECTORS Descriptions of the items shown are listed on the pages
that follow. For symbol definitions, refer to 2.3.2 Front Panel Controls and Indicators.
PRODUCT DESCRIPTION 2-3
DINAMAP® PRO 1000V3 Service Manual
2.3.1 Rear Panel Connections
2.3.2 Front Panel Controls and Indicators
2-4 PRODUCT DESCRIPTION
DINAMAP® PRO 1000V3 Service Manual
NIBP
GO/STOP
AUTO-
BP/STAT
OFF/ON
silence
standby
starts and stops any determination of noninvasive blood pressure.
is a dual-function hard key. Starts auto BP determinations by a single-press and gives you access to change the NIBP cycle time. Starts stat determinations pressing and holding the key down (5 minutes of continuous NIBP cycles).
turns Monitor off and on. temporarily silences alarms; acknowledges alarming crisis
conditions. enters and exits standby mode.
main
trend
freeze
closes the menu system and takes you back to the main screen.
enters and exits trends (view patient trends data). This hard key can be configured through the configuration mode to display two different views: mini trends or full trends.
captures up to 16.8 seconds of waveforms on the screen. The number of seconds varies depending on the selected sweep speed.
record
prints a snapshot (timed recording) with a single-press. Pressing and holding the key down allows for a continuous recording of the chosen waveforms.
2.3.3 Symbols Associated With the PRO 1000 Monitor
NOTE:
Interconnected equipment must be installed by a qualified service person.
Symbol Definition
CE Mark
External Communications Port Connector
Attention, consult accompanying documents
Type CF applied part
PRODUCT DESCRIPTION 2-5
DINAMAP® PRO 1000V3 Service Manual
Symbol Definition
Battery in use
Canadian Standards Association
Storage temperature
External AC or DC power indicator External DC power input External AC power input
Keep away from heat
This way up
Keep dry
SN REF
Fragile, handle with care
Serial number Catalog number
Predictive temperature
Functional earth terminal (ground lug)
Defibrillator-proof type BF equipment
Defibrillator-proof type CF equipment
2-6 PRODUCT DESCRIPTION
DINAMAP® PRO 1000V3 Service Manual
2.4 HOST PORT
CONNECTORS (BENEATH REAR PANEL)
All host port signals should be only connected to equipment conforming to IEC 60601-1. Where isolation level converter should be used. If an external alarm control is required, GE Medical Systems Information Technologies part number 487208 (Isolated Remote Alarm Cable Assembly) should ALWAYS be used.
Please refer to the Information Sheet included with the isolated remote alarm cable for operational details.
NOTE:
When using the remote alarm, the Monitor should be considered the primary alarm source. The secondary alarm is used for secondary purposes only.
PRODUCT DESCRIPTION 2-7
DINAMAP® PRO 1000V3 Service Manual
2.4.1 DB15 / DB9 Connector Pin Assignments
Pins are numbered from right to left, top to bottom.
DB15 Connector Pins
DB9 Connector Pins
Pin Function Pin Function
Ground
1
TX2_Inverted TTL Data
2
RX2_Inverted TTL Data
3
AUX5V (600mA max.)
4
AUX12V (250mA max.)
5
Serial Level Control (High=TTL Low=-RS-232)
6
Ground
7
Remote Alarm (open collector, 75mA Max Sink)
8
No Connection
9
No Connection
10
TX2_RS232
11
Ground
1
TX1 Inverted TTL Data
2
RX1
3
TX2
4
RX2
5
+5V (600mA Max)
6
+12V (400mA Max)
7
No Connection
8
No Connection
9
Port Enable Control <low=port 2>
12
(When in use, DB9 4 & 5 disabled) RX2_RS232
13
No connection
14
No connection
15
2-8 PRODUCT DESCRIPTION
DINAMAP® PRO 1000V3 Service Manual
2.4.2 IPC-1928
INSTALLATION The IPC-1928 allows the Monitor to communicate with a
central monitoring station.
CAUTION!
Before the installation procedure starts, be sure that the Monitor’s power source is turned off.
1. Use a Phillips-head screwdriver to remove the screw securing the Host Communications cover at the rear of the Monitor. Remove the cover.
2. Insert the nine-pin connector of the IPC-1928 with the receptor found under the Host Communication
PRODUCT DESCRIPTION 2-9
DINAMAP® PRO 1000V3 Service Manual
cover. Use the Phillips-head screwdriver to tighten the securing screw. Hand-tighten only.
3. Replace the Host Communications cover and use the Phillips-head screwdriver to tighten the screw to secure the cover.
When the Monitor is reconnected to the power source and turned on, an amber light should be seen indicating that the IPC-1928 is ready to send and receive communications. A green light indicates that communication is taking place.
2-10 PRODUCT DESCRIPTION
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