CARESCAPE V100 Service Manual 1st edition

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, DINAMAP, DURA-CUF, SOFT-CUF Blood Pressure Cuffs, and SuperSTAT are trademarks of GE Medical Systems Information Technologies, Inc. Turbo Temp™, 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... 9 Revision history ... 9 Manual purpose ... 9 Intended audience ... 9 Ordering manuals ... 9 Conventions used in this manual... 9 Intended use... 10 General use... 10 Safety information ... 10 Responsibility of the manufacturer... 10 General ... 10 Dangers, warnings, cautions, and notes ... 11 Product specific hazards... 11 Equipment symbols ... 14 Service requirements... 16 Equipment ID... 16 Related manuals ... 17 Service policy... 17 Service contracts... 17 Assistance... 17 Service ... 17 Repair parts ... 18 Disposal of product waste... 18 Batteries... 18 Patient applied parts... 19 Packaging material ... 19 Monitor... 19

2

Equipment overview...21 Equipment description... 21 Product configurations ... 21 Front controls and connectors... 22

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Front panel indicators... 23 Right-side panel ... 24 Rear panel ... 25 Host communication port... 25 Product compliance... 26 Overall principles of operation ... 26 SpO2 ... 27 Cuff blood pressure (NIBP) and pulse... 27 Temperature ... 31 Functional description ... 32 Main board PWA... 33 User interface (UI) board PWA ... 33 SpO2 PWA ... 33 Printer ... 34 Pneumatics... 34 CARESCAPE V100 block diagram ... 35 3

Installation...37 Unpacking and preparation for installation ... 37 Installation checkout ... 37 Powering the monitor ... 38 Power sources ... 38 Main battery charging ... 38 BATTERY OK ... 39 Battery alarms... 39 E13 BATTERY LOW ... 40 Configuring the monitor ... 40 Operating modes ... 40 Host communication connector ... 50 DB15 connector pin assignments ... 51

4

Maintenance...53 Preventive maintenance... 53 Maintenance schedule... 53 Visual inspection ... 54 Cleaning and disinfection ... 54

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Long-term storage... 54 Battery care ... 55 Fuses ... 57 Parameter level functional testing... 58 NIBP... 58 Temperature ... 58 Ohmeda, Nellcor, and Masimo SpO2 technologies... 59 Calibration procedures and tests... 59 Parameter test procedures... 60 NIBP tests... 60 LED tests ... 63 External DC verification... 64 Temperature (perform if equipped with Temp module)... 64 SpO2 (perform only if equipped with SpO2 module) ... 67 Printer output test ... 67 Safety testing ... 68 Electrical safety tests ... 68 Test result form ... 73 5

Troubleshooting...77 Overview... 77 Problems ... 77 Alarm code interpretation ... 78 System failures ... 78 Error log ... 78 Error codes... 79

6

Parts lists and drawings ...83 Ordering parts ... 83 Compatible service parts... 83 Field replaceable units (FRUs)... 83 FRU list ... 83 FRU photos ... 85 FRU main reference guide drawing ... 94 Disassembly/reassembly of FRUs ... 102 Electrostatic discharge (ESD) precautions ... 102

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Monitor fascia replacement procedure ... 103 Monitor disassembly procedure... 106 Main battery ... 107 Rear case ... 107 Printer... 109 SPO2 board ... 111 Front bezel ... 111 Main board... 112 Display board... 112 Exergen TAT... 113 A

Technical specifications and default settings...115 Specifications ... 115 General ... 115 Printer... 116 Alarms ... 116 NIBP... 116 Ohmeda SpO2 ... 117 Nellcor SpO2 ... 119 Masimo SpO2 ... 121 Temperature ... 123 Default settings ... 125 Alarms ... 125 NIBP... 125 Ohmeda SpO2 ... 126 Nellcor SpO2 ... 126 Masimo SpO2 ... 126 Pulse rate ... 126

B

Appropriate use of NIBP simulators ...129 Appropriate use of NIBP simulators... 129 NIBP accuracy ... 129 Clinical vs. simulator readings ... 129 What do simulator manufacturers say? ... 130 Why use simulators? ... 131 Summary ... 131

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C

Electromagnetic compatibility (EMC) ...133 Electromagnetic compatibility (EMC): CARESCAPE V100 monitor ... 133 Guidance and manufacturer’s declaration – electromagnetic emissions... 133 Guidance and manufacturer’s declaration – electromagnetic immunity... 134 Guidance and manufacturer’s declaration – electromagnetic immunity... 134 Recommended separation distances... 135

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Introduction Revision history Revision

Comments

1st edition

Initial release.

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 user 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.

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: ● ● ● ● ● ●

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For technical documentation purposes, the abbreviation GE is used for the legal entity name, 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, keypad, remote control, and modules 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.

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Introduction

● ● ● ● ● ●

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. Any illustrations appearing 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.

Intended use General use ●

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

CAUTION

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. 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. ●

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.

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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.

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

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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.

WARNING

Only use the monitor in areas where adequate ventilation exists.

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Introduction

12

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.

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.

WARNING

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

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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.

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

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

MR Unsafe. Indicates that the device is not intended for use in an MR environment. This symbol is identified by a white background, red or black circular band, and a black symbol. Battery Power

Medical Equipment With respect to electric shock, fire and mechanical 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. 4P41 Charging Class II equipment

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Consult instructions for use.

Defibrillator-proof type BF equipment

External communications port connector

External DC power input Fragile. Handle with care.

Humidity limitations.

Ordinary equipment (Exergen only)

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.

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

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, Belarus, and Kazakhstan only. Eurasian Conformity mark. Conformity to applicable technical regulations of Customs Union.

Prescriptive Device. USA only. For use by or on the order of a Physician, or persons licensed by state law.

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Introduction

Device serial number. Medical device Indicates the item is a medical device. 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

Service requirements Follow the service requirements listed below. ●

Refer equipment servicing to GE-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 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 Every GE device has a unique serial number for identification. A sample of the information found on a serial number label is shown below.

Description

16

A

product code1

B

year manufactured

C

fiscal week manufactured

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Description D

production sequence number

E

manufacturing site

F

miscellaneous characteristic, indicating prototype, refurbish, etc.

1. The current CARESCAPE™ V100 Vital Signs Monitor product codes are SDT or SH6.

Related manuals Manual

Title

2010566

Host Communications Reference Manual. Contact your GE sales representative or distributor.

5816673

CARESCAPE V100 Vital Signs Monitor User Manual (English). Contact your GE sales representative for information on other available languages.

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 ensure that they are not the cause of the problem. If you are unable to resolve the problem after checking these items, contact GE. 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 facility's complete name, address, and account number

●

a purchase order number if the product needs repair or when you order spare parts

●

the facility's GE 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, contact GE Technical Support or contact your local GE representative. To facilitate prompt service in cases where the product has external chassis or case damage, please advise the representative when you call.

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Introduction

The representative will record all necessary information and will provide a Return Authorization Number. Prior to returning any product for repair, a Return Authorization Number must be obtained.

Packaging instructions If you have to return goods for service, 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.

●

Observe the environmental conditions detailed in the Technical specifications and default settings section of this manual.

●

It is recommended that all returned goods be insured. Claims for loss or damage to the product must be initiated by the sender.

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 at least 4 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.

Repair parts To order parts, contact your GE representative. 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 account number

Disposal of product waste Unless otherwise indicated, dispose of product waste in accordance with your local or national regulations.

Batteries WARNING

Do not incinerate the battery or expose it to fire or high temperatures. Doing so may cause the battery to explode.

The sealed, rechargeable battery contains lead and can be recycled.

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The rechargeable 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.

Battery recycling

This product contains sealed lead acid (monitor) and alkaline 9-volt (Exergen scanner) batteries. At the end of their service life, batteries in this product must not be disposed as trash or unsorted municipal waste. Batteries must be recycled or disposed of in accordance with local or national regulations. Requirements and services for recycling of batteries vary among countries. Customers in the USA may follow the battery manufacturer’s instructions on the battery to recycle it. Alternatively, customers may return GE product batteries to GE for recycling. For information about returning batteries to GE, contact your authorized GE Service representative or contact GE Equipment Services at 1- 800-437-1171. Customers in Canada should contact the approved battery stewardship program in your province for information on recycling your batteries. Customers not in the USA or Canada should recycle batteries through your local, regional or national collective scheme in accordance with your local or national regulations.

Patient applied parts Certain patient applied parts, such as those with adhesive (disposable SpO2 sensors), are intended for single use and should be disposed of properly as medical waste in accordance with regional body controlled guideline. Other patient applied parts, such as NIBP cuffs, should be cleaned according to instructions. Inspect reusable applied parts for wear before each use, replace as necessary, and dispose of used product as medical waste in accordance with your local or national regulations.

Packaging material Retain original packaging materials for future use in storing or shipping the monitor and accessories. This recommendation includes corrugated shippers and foam/corrugated spacers. If you decide to dispose of these materials, we recommend recycling them.

Monitor At the end of its service life, the product described in this manual, as well as its accessories, must be disposed of in accordance with your local or national regulations.

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Introduction

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