CARESCAPE V100 Vital Signs Monitor Operators Manual Nov 2011

NOTE: The information in this manual applies to CARESCAPE V100 Vital Signs Monitor software version R1.5. Due to continuing product innovation, specifications in this manual are subject to change without notice. NOTE: For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical Systems Information Technologies, Inc. Listed below are GE Medical Systems Information Technologies, Inc. trademarks. All other trademarks contained herein are the property of their respective owners. Ohmeda Oximetry and other trademarks (OxyTip++, PIr, TruSat, TruSignal, TruTrak+) are the property of GE Medical Systems Information Technologies, Inc., a division of General Electric Corporation. All other product and company names are the property of their respective owners. CARESCAPE, CRITIKON, DINALINK, DINAMAP, DURA-CUF and SOFT-CUF Blood Pressure Cuffs, and SuperSTAT are trademarks of GE Medical Systems Information Technologies, Inc. Turbo TempTM, Alaris® Tri-Site, and IVAC are trademarks of CareFusion Corporation. Exergen and TAT-5000 are trademarks of Exergen Corporation. Cidex® is a trademark of Surgikos, Inc. Betadine® is a trademark of Purdue-Frederick. Masimo SET, LNOP, and LNCS are trademarks 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, C-LOCK and SatSeconds are trademarks of Nellcor Puritan Bennett. Bio-Tek and NIBP Pump 2 are trademarks of Bio-Tek Instruments.

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Contents

1

Introduction... 1-1 Revision history... 1-2 Manual purpose... 1-2 Intended audience... 1-2 Ordering manuals... 1-2 Conventions used in this manual... 1-3 Intended use... 1-3 General use...1-3 Safety information... 1-4 Responsibility of the manufacturer...1-4 General...1-4 Dangers, warnings, cautions, and notes...1-5 Product specific hazards...1-5 Equipment symbols... 1-10 Service requirements... 1-13 Equipment ID... 1-13 Related manuals... 1-14 Service policy... 1-14 Service contracts... 1-14 Assistance... 1-14 Service... 1-14 Packing instructions... 1-15 Insurance... 1-15 Repair parts... 1-15 Disposal of product waste... 1-15 Batteries... 1-16 Patient applied parts... 1-16 Packaging material... 1-16 Monitor... 1-16

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2

Equipment overview... 2-1 Equipment description... 2-2 Product configurations...2-2 Front controls and connectors... 2-3 Front panel indicators... 2-4 Right-side panel... 2-5 Rear panel... 2-6 Host communication port...2-6 CARESCAPE V100 vital signs monitor connectivity options...2-6 Product compliance... 2-7 Overall principles of operation... 2-7 SpO2...2-8 Cuff blood pressure (NIBP) and pulse...2-8 DINAMAP SuperSTAT algorithm...2-9 DINAMAP Classic and auscultatory reference algorithm... 2-11 Reference used to determine NIBP accuracy... 2-12 Temperature... 2-13 Alaris temperatures... 2-13 Exergen temperature... 2-14 Functional description... 2-14 Main board PWA... 2-14 User interface (UI) board PWA... 2-15 SpO2 PWA... 2-15 Printer... 2-16 Pneumatics... 2-16 Optical switch... 2-16

3

Installation... 3-1 Unpacking and preparation for installation... 3-2 Powering the monitor... 3-2 Power sources...3-2 Main battery charging...3-2 BATTERY OK...3-3 Battery alarms...3-3 When about 45 minutes of main battery charge remains:...3-3

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When about 5 minutes of main battery charge remains:...3-4 When 5 minutes of main battery charge expires:...3-4 After plugging the monitor into DC power:...3-4 E13 BATTERY LOW...3-4 Configuring the monitor... 3-5 Operating modes...3-5 Clinical mode...3-5 Configuration mode...3-5 Advanced configuration mode... 3-11 Service mode... 3-12 Host communication connector... 3-15 DB15 connector pin assignments... 3-16 Connection details... 3-16 Communication protocol... 3-16

4

Maintenance... 4-1 Preventative maintenance... 4-2 Maintenance schedule...4-2 Integrity of hoses and cuffs...4-2 Visual inspection... 4-3 Cleaning... 4-3 Cleaning schedule...4-3 Cleaning the monitor, monitor accessories, and the Exergen temporal scanner...4-3 Cleaning and disinfecting blood pressure cuffs...4-5 Cleaning the exterior surfaces of the Alaris temperature devices .4-6 SpO2 sensors...4-6 Long-term storage... 4-6 Battery care...4-7 Main battery...4-7 Exergen temporal scanner battery...4-9 Fuses... 4-10 Parameter level functional testing... 4-11 NIBP... 4-11 Temperature... 4-11 Alaris... 4-11 Exergen... 4-12 Ohmeda, Nellcor, and Masimo SpO2 technologies... 4-12

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Calibration procedures and tests... 4-13 Parameter test procedures... 4-13 Setup... 4-14 NIBP tests... 4-14 Pneumatic leakage testing... 4-14 Pressure transducer verification... 4-15 Pressure transducer calibration... 4-16 Overpressure verification... 4-16 Button testing... 4-17 NIBP functional test... 4-17 NIBP overpressure verification... 4-17 LED tests... 4-18 External DC verification... 4-18 Temperature (perform if equipped with Temp module)... 4-18 Alaris temperature calibration verification... 4-19 Alaris temperature probe date of manufacture... 4-20 Exergen temperature calibration verification... 4-20 SpO2 (perform only if equipped with SpO2 module)... 4-21 Printer output test... 4-22 Safety testing... 4-23 Electrical safety tests... 4-23 Recommendations... 4-23 Test equipment... 4-24 Power outlet test... 4-24 Power cord and plug... 4-24 Patient leakage current test... 4-25 Patient leakage current test (mains voltage on the applied part) 4-27 Test results form... 4-29

5

Troubleshooting... 5-1 Overview... 5-2 Problems...5-2 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 Error codes...5-4 Exergen-specific error codes...5-7

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Parts lists and drawings... 6-1 Ordering parts... 6-2 Compatible service parts... 6-2 NIBP accessories...6-2 SpO2 - Ohmeda accessories...6-9 SpO2 - Nellcor accessories... 6-10 SpO2 - Masimo accessories... 6-10 Temperature accessories - Alaris... 6-12 Temperature accessories - Exergen... 6-12 Power accessories... 6-13 Printer accessories... 6-13 Mounting accessories... 6-14 Connectivity accessories... 6-14 Field-replaceable units (FRUs)... 6-15 FRU list... 6-15 FRU photos... 6-17 FRU main reference guide drawing... 6-28 Disassembly/reassembly of FRUs... 6-36 Electrostatic discharge (ESD) precautions... 6-36 Monitor fascia replacement procedure... 6-37 Monitor disassembly procedure... 6-39 Main battery... 6-39 Rear case... 6-40 Printer... 6-41 SpO2 board... 6-42 Front bezel... 6-42 Main board... 6-43 Display board... 6-43 Exergen TAT... 6-44 Cable replacement... 6-44

A

Technical specifications and default settings A-1 Specifications... A-2 General... A-2 Printer... A-3 Alarms... A-3 NIBP... A-4

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Ohmeda SpO2... A-5 Nellcor SpO2... A-7 Masimo SpO2... A-10 Temperature... A-13 Battery... A-15 Monitor - main battery... A-15 Exergen temporal scanner... A-15 Default settings... A-16 Alarms... A-16 NIBP... A-16 Ohmeda SpO2... A-16 Nellcor SpO2... A-17 Masimo SpO2... A-17 Pulse rate... A-17 Temperature... A-17 Alaris... A-17 Exergen... A-18

B

Appropriate use of NIBP simulators . B-1 Appropriate use of NIBP simulators... B-2 NIBP accuracy... B-2 Clinical vs. simulator readings... B-2 What do simulator manufacturers say?... B-3 Why use simulators?... B-4 Summary... B-4

C

Electromagnetic compatibility (EMC) C-1 Electromagnetic compatibility (EMC): CARESCAPE V100 monitor... C-2 Guidance and manufacturer’s declaration – electromagnetic emissions... C-2 Guidance and manufacturer’s declaration – electromagnetic immunity... C-3 Recommended separation distances... C-5 Compliant cables and accessories... C-6

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Introduction

CARESCAPE V100 Vital Signs Monitor

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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 of the manual

B

Updated field-replaceable unit information.

C

Updated field-replaceable unit information and added content enhancements.

D

Revised manual to reflect revised addendum pn 2001005202C. There are no content changes in the manual itself.

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.

Intended audience This manual is intended for service representatives and technical personnel who maintain, troubleshoot, or repair this equipment.

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.

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Introduction: Conventions used in this manual

Conventions used in this manual Within this manual, special styles and formats are used to distinguish between terms viewed on screen, a button you must press, or a list of menu commands you must select: 

For technical documentation purposes, the abbreviation GE is used for the legal entity names, GE Medical Systems Information Technologies, Inc.



In this manual, the CARESCAPE V100 vital signs monitor is referred to as the monitor.



Names of hardware keys on the equipment are written in bold typeface: Inflate/Stop.



Menu items are written in bold italic typeface: Monitor Setup.



Emphasized text is in italic typeface.



Menu options or control settings selected consecutively are separated by the > symbol: Procedures > Cardiac Output.



When referring to different sections in this manual, section names are enclosed in double quotes: “Maintenance.”



The word “select” means choosing and confirming.



Messages (alarm messages, informative messages) displayed on the screen are written inside single quotes: 'Learning.'



Note statements provide application tips or other useful information.



All illustrations in this manual are provided as examples only. They may not necessarily reflect your monitoring setup or data displayed on your monitor.



Any names appearing in examples and illustrations are fictitious. The use of any real person’s name is purely coincidental.



The monitor is intended to monitor one patient at a time in a clinical setting.

Intended use General use

CAUTION Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

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

To ensure patient safety, use only parts and accessories manufactured or recommended by GE. Parts and accessories used shall meet the requirements of IEC 60601-1.



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.

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Introduction: Safety information

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, and Note are used throughout the manual. In addition, standard equipment symbols are defined.

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 (U.S.A.) 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 U.S.A., will use 240V rather than 120V, the source must be a center-tapped, 240V, single-phase circuit.

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Introduction: Safety information

Dangers, warnings, cautions, and notes The terms Danger, Warning, Caution and Note 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 a hazardous situation that, 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 hazardous situation that, if not avoided, could result in minor or moderate injury. NOTE provides application tips or other useful information to assure that you get the most from your equipment.

Product specific hazards DANGER Do not service the battery while the monitor is connected to external power.

WARNING Do not immerse the monitor in water. If the monitor is splashed with water or becomes wet, wipe it immediately with a dry cloth.

WARNING Do not immerse sensors in water, solvents, or cleaning solutions (the sensors and connectors are not waterproof).

WARNING Do not perform any testing or maintenance on a sensor while it is being used to monitor a patient.

WARNING Place the monitor on a rigid, secure surface or use the monitor with mounting hardware, poles, and stands recommended by GE.

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Introduction: Safety information

WARNING Only use the monitor in areas where adequate ventilation exists.

WARNING Arrange the external AC/DC power converter, air hoses, and all cables carefully so they do not constitute a hazard.

WARNING If powering the monitor from an external power adapter or converter, use only GE-approved power adapters and converters.

WARNING The speaker is tested during unit power-up. If the power-up tones are not heard, audible alarms will also not be heard.

WARNING If the Power-On Self Test fails, do not use the monitor.

WARNING Inspect the device for damage prior to use.

WARNING Do not disassemble, modify, or destroy the battery. Doing so can cause battery fluid leakage, heat generation, fire, and/or explosion.

WARNING Do not incinerate the battery or store it at high temperatures. Doing so may cause the battery to explode.

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Introduction: Safety information

WARNING Do not short-circuit the battery terminals by directly connecting the metal terminals together. Be certain that no metal objects (e.g., coins, paper clips, etc.) touch both battery terminals simultaneously. Doing so can cause the battery to overheat and/or explode, resulting in possible caustic burns and/or battery damage.

WARNING Do not use any battery other than a GE-recommended battery. Other batteries may not provide the same operating time and may cause unexpected monitor shutdown. Other batteries may be incompatible with the internal charger and may cause battery acid leakage, fire, or explosion.

WARNING The battery will completely discharge if the monitor is stored for a prolonged period of time with the battery left inside and not periodically recharged. Configuration settings may be lost as a result.

WARNING Charge the battery pack with the monitor’s internal charger only. Use of an unrecommended charger may cause battery fluid leakage, overheating of the battery, and possible explosion.

WARNING The electromagnetic compatibility profile of the monitor may change if accessories other than those specified for use with the monitor are used. Please refer to the Accessories list provided with your monitor.

WARNING Use only accessories approved for use with the monitor. Failure to use recommended accessories may result in inaccurate readings.

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Introduction: Safety information

WARNING Use of portable phones or other radio frequency (RF) emitting equipment near the monitor may cause unexpected or adverse operation.

WARNING Verify calibration of NIBP parameter (temperature and pulse oximeter do not require calibration; refer to the “Maintenance” section for instructions). Ensure that the display is functioning properly before operating the monitor.

WARNING Keep the Exergen scanner secured when it is not in use.

WARNING 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.

WARNING The use of accessories, transducers, and cables other than those specified may result in increased emissions and/or increased susceptibility to electromagnetic interference. This may result in impaired operation of the monitor and/or devices in the area, leading to inaccurate readings or loss of operation.

CAUTION To avoid personal injury, do not perform any servicing unless qualified to do so.

CAUTION 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.

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Introduction: Safety information

CAUTION Magnetic and electrical fields are capable of interfering with the proper performance of the monitor. For this reason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements.

CAUTION The monitor does not include any user-replaceable fuses. Refer servicing to qualified service personnel.

CAUTION Do not use replacement batteries other than the type supplied with the monitor. Use only batteries recommended by GE. Other batteries could result in monitor shutdown. Replacement batteries are available from GE.

CAUTION The 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.

CAUTION Do not exceed a load weighing 5 lbs. (2.7 kg) in the accessory basket.

CAUTION The monitor meets standards IEC 60601-1 and ISO 9919 for shock and vibration. If the monitor is subjected to conditions exceeding these standards, performance may be degraded.

CAUTION The performance of the monitor may be degraded if it is operated or stored outside of the environmental conditions specified in this manual.

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Introduction: Equipment symbols

CAUTION To prevent cross-contamination, clean exterior surfaces of the monitor, monitor accessories, and reusable sensors on a regular basis in compliance with your institution’s infection control unit and/or biomedical department’s local policy.

CAUTION Do not sterilize the monitor by irradiation, gas-, heat- or chemical-based sterilization. NOTE This equipment is suitable for use in the presence of electrosurgery. NOTE Medical electrical equipment requires special electromagnetic compatibility (EMC) precautions which must be considered when installing and putting this equipment into operation. For detailed information, refer to the Electromagnetic compatibility (EMC) appendix in this manual.

Equipment symbols The following symbols are associated with the CARESCAPE V100 vital signs monitor. NOTE The model of the monitor determines which symbols appear on it.

Alarms Silence

Atmospheric pressure limitations.

Attention, consult accompanying documents

Battery Power

Classified with respect to electric shock, fire, and mechanical and other specified hazards only in accordance with CAN/CSA C22.2 No. 601.1 and UL 2601-1 (UL 60601-1). Also evaluated to IEC 60601-2-30.

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Introduction: Equipment symbols

This product conforms with the essential requirements of the Medical Device Directive 93/42/EEC. Accessories without the CE mark are not guaranteed to meet the Essential Requirements of the Medical Device Directive. Charging

Class II equipment

Consult instructions for use.

Defibrillator-proof type BF equipment

European authorized representative

External communications port connector External DC power input

Fragile. Handle with care.

Humidity limitations.

IPX0

Ordinary Equipment (Exergen only)

IPX1

This product is protected against vertically falling drops of water and conforms with the IEC 60529 standard at level of IPX1. No harmful effects will come of vertically falling drops of water making contact with the monitor. Manufacturer: This symbol is accompanied by the name and the address of the manufacturer.



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Manufacturing Date: This symbol is accompanied by the date of the manufacturing.

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Introduction: Equipment symbols

CAUTION - Safety ground precaution. Remove power cord from the mains source by grasping the plug. Do not pull on the cable.

Catalog or orderable part number.

Russia only. GOST-R mark. Prescriptive Device. USA only. For use by or on the order of a Physician, or persons licensed by state law. Device serial number. The PSE mark (Product Safety Electric Appliance and Materials) is a mandatory mark required on Electrical Appliances in Japan as authorized by the Electrical Appliance and Material Safety Law (DENAN). This mark signifies that a product complies with the law according to a set of standards for electric devices. Temperature limitations. 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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