CARESCAPE V100 Vital Signs Monitor Operators Manual sw ver R1.5 April 2010

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.

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Contents

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Introduction... 1-1 About this device... 1-2 Indications for use... 1-2 Safety message signal words... 1-3 Contraindications... 1-3 Product compliance... 1-6 CARESCAPE V100 vital signs monitor...1-6 Exergen temporal scanner...1-8 Symbols... 1-8 CARESCAPE V100 vital signs monitor...1-8 Exergen temporal scanner... 1-11 About this manual... 1-11 Printed copies of this manual... 1-11 Conventions used in this manual... 1-12 Revision history... 1-12

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Getting started... 2-1 Unpacking the monitor and accessories... 2-2 Setting up NIBP connections... 2-2 Setting up SpO2 connections... 2-3 Setting up temperature connections... 2-4 Alaris...2-4 Exergen...2-4 Setting up the printer (installing the paper)... 2-5 Power sources... 2-5 Turning the monitor on and off... 2-6 Automatic shutdown...2-7 Procedure for testing alarms... 2-7 Configuration mode settings... 2-7 Entering configuration mode...2-8

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Configuring the default vital sign alarm limits... 2-10 Setting the date and time... 2-11 SpO2 configuration settings... 2-12 Temperature hardware configuration settings... 2-13 Advanced configuration mode... 2-15 Entering advanced configuration mode... 2-15 Printing the failure alarm history... 2-15

3

Product overview... 3-1 Buttons... 3-2 Front panel... 3-3 Rear panel... 3-5 Right-side panel... 3-6 Windows... 3-6 Indicators... 3-6 Operating (system) modes... 3-7 Clinical mode... 3-7 Configuration mode... 3-7 Advanced configuration mode... 3-8 Service mode... 3-8 Battery low shutdown... 3-8 System failure... 3-9 User modes... 3-9 Menu mode... 3-9 Cycle mode... 3-10 Limit adjustment mode... 3-10 History mode... 3-11 Sounds... 3-11 Start-up sound... 3-11 User interaction sounds... 3-11 Alarm sounds... 3-12 Battery low shutdown and system failure sounds... 3-12 Battery charger sounds... 3-12 Power sources... 3-13 Specifications... 3-13

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Printer... 4-1 Description... 4-2 Installing the paper... 4-2 Print button... 4-2 Printouts... 4-3 Current (real time)...4-3 Clinical history...4-4 Failure alarm history...4-4 Paper storage... 4-4 Alarms... 4-5 Specifications... 4-5

5

Alarms... 5-1 Description... 5-2 Alarm conditions... 5-2 Physiological alarm conditions...5-2 Technical alarm conditions...5-3 System failure alarm conditions...5-4 Alarm modes... 5-4 IEC alarm mode...5-4 Legacy alarm mode...5-4 Alarm signals... 5-5 Audible alarm signals...5-5 Visual alarm signals...5-5 Silencing an alarm... 5-6 Acknowledging an alarm... 5-7 Adjusting vital sign alarm limits... 5-7 Adjusting the alarm volume... 5-8 Alarms and priorities... 5-9 Specifications... 5-12 Factory default... 5-12

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History... 6-1 Description... 6-2 Buttons associated with history... 6-3 Erasing stored history... 6-3 Windows associated with history... 6-3 Indicators associated with history... 6-3

7

NIBP... 7-1 Description... 7-2 What is the difference between intra-arterial and auscultatory methods?... 7-3 Buttons associated with NIBP... 7-6 Inflate/Stop button... 7-6 Cycle button... 7-6 Windows associated with NIBP... 7-6 Indicators associated with NIBP... 7-7 NIBP modes of operation... 7-7 Manual NIBP determinations... 7-8 Auto cycle determinations... 7-8 Stat NIBP determinations... 7-9 User settings... 7-9 Mode settings... 7-9 Limit settings... 7-10 Menu settings... 7-10 Sounds associated with NIBP... 7-11 Procedures... 7-11 Checking the monitor’s NIBP technology configuration setting... 7-11 Taking NIBP measurements... 7-12 What to do when taking NIBPs on different patients... 7-14 Alarms... 7-14 Specifications... 7-15 Factory defaults... 7-16 GE Medical Systems Information Technologies, Inc. patents... 7-16

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Ohmeda TruSignal SpO2... 8-1 Description... 8-2 TruSignal enhanced SpO2...8-2 Configuration settings associated with SpO2... 8-5 Buttons associated with SpO2... 8-5 Windows associated with SpO2... 8-5 Indicators associated with SpO2... 8-6 User settings... 8-6 Limit settings...8-6 Menu settings... 8-6 Sounds associated with SpO2... 8-6 Procedures... 8-7 Alarms... 8-8 SpO2 hold-off period...8-8 Alarm timer...8-9 Specifications... 8-9 Factory default settings... 8-10 GE Medical Systems Information Technologies, Inc. patents... 8-10 Troubleshooting... 8-11

9

Nellcor OxiMax SpO2... 9-1 Description... 9-2 Configuration settings associated with SpO2... 9-4 SatSeconds...9-5 Buttons associated with SpO2... 9-5 Windows associated with SpO2... 9-5 Indicators associated with SpO2... 9-6 User settings... 9-6 Limit settings...9-6 Menu settings... 9-6 Sounds associated with SpO2... 9-6 Procedures... 9-7 Alarms... 9-8

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SpO2 hold-off period... 9-8 Alarm timer... 9-9 Specifications... 9-9 Factory default settings... 9-11 Nellcor patents... 9-11 Troubleshooting... 9-12

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Masimo SET SpO2... 10-1 Description... 10-2 Indications and contraindications... 10-3 Configuration settings associated with SpO2... 10-5 Buttons associated with SpO2... 10-5 Windows associated with SpO2... 10-6 Indicators associated with SpO2... 10-6 User settings... 10-6 Limit settings... 10-6 Menu settings... 10-6 Sounds associated with SpO2... 10-6 Procedures... 10-7 Alarms... 10-8 SpO2 hold-off period... 10-8 Alarm timer... 10-8 Specifications... 10-9 Factory default settings... 10-11 Masimo patents... 10-11 Troubleshooting... 10-12

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Alaris Temperature – Turbo Temp and Tri-Site... 11-1 Description... 11-2 Alaris Turbo Temp or Tri-Site temperature options... 11-2 Temperature measurement modes... 11-3 Calibration and self-checks of Alaris Turbo Temp or Tri-Site temperature... 11-5 Configuration settings associated with Alaris Turbo Temp and Tri-Site temperature... 11-6 Buttons associated with temperature... 11-6 Windows associated with temperature... 11-6 Indicators associated with temperature... 11-6 Measurement in progress indicators... 11-7 Measurement not in progress indicators... 11-8 User settings... 11-8 Menu settings... 11-8 Sounds associated with Alaris temperature probes... 11-8 Protective thermometer probe covers... 11-9 Alaris thermometer probe covers... 11-9 Proper storage of thermometer probe covers... 11-9 Guidelines for Alaris temperature measurements... 11-10 Procedures for oral fast (predictive) temperature measurements . . 11-12 Checking the monitor’s Alaris temperature technology configuration setting... 11-12 Taking oral fast (predictive) temperature measurements... 11-12 Procedures for rectal fast (predictive) temperature measurements 11-15 Checking the monitor’s Alaris temperature technology configuration setting... 11-15 Taking rectal fast (predictive) temperature measurements... 11-15 Procedures for axillary temperature measurements... 11-18 Checking the monitor’s Alaris temperature technology configuration setting... 11-18 Taking axillary temperature measurements... 11-19 Troubleshooting... 11-21 Specifications... 11-22 Factory default settings... 11-23

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Exergen Temperature... 12-1 Description... 12-2 Temperature measurement mode... 12-3 Configuration settings associated with Exergen temperature... 12-4 Buttons associated with temperature... 12-4 Windows associated with temperature... 12-4 Indicators associated with temperature... 12-4 Measurement in progress indicators... 12-4 Measurement not in progress indicators... 12-5 Additional indicators... 12-5 User settings... 12-5 Menu settings... 12-5 Sounds associated with Exergen temporal scanner... 12-5 Procedures for temperature determination... 12-6 Familiarize yourself with the scanner... 12-6 Basics of using the temporal scanner... 12-6 Alternate sites when temporal artery or behind ear is unavailable . . 12-9 Troubleshooting... 12-10 Specifications... 12-13 Factory default settings... 12-13 Batteries... 12-13

13

Pulse Rate... 13-1 Description... 13-2 Buttons associated with pulse rate... 13-2 Windows associated with pulse rate... 13-2 Indicators associated with pulse rate... 13-3 User settings... 13-3 Limit settings... 13-3 Menu settings... 13-3 Sounds associated with pulse rate... 13-3 Factory defaults... 13-3

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Battery... 14-1 Description... 14-2 Buttons associated with the battery... 14-3 Windows associated with the battery... 14-3 Indicators associated with the battery... 14-3 First use... 14-3 Battery charging... 14-3 Disposal of batteries... 14-4 Storage, care, and replacement of batteries... 14-4 Battery alarms... 14-5 Battery low... 14-5 E13 BATTERY LOW... 14-6 Battery specifications... 14-6 Troubleshooting... 14-7

A

Connections... A-1 Host port connector... A-2

B

Accessories... B-1 NIBP accessories... B-2 SpO2 - Ohmeda accessories... B-8 SpO2 - Nellcor accessories... B-9 SpO2 - Masimo accessories... B-10 Temperature accessories - Alaris... B-11 Temperature accessories - Exergen... B-12 Power accessories... B-12 Printer accessories... B-13 Mounting accessories... B-13 Connectivity accessories... B-13

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C

Maintenance... C-1 Assistance and parts... C-2 Maintenance, calibration, and cleaning... C-2 Calibration and leak testing... C-3 Cleaning... C-3 Battery and storage care... C-7 Extended battery storage... C-8 Replacing the battery... C-8 Repairs... C-10 Packaging material... C-10 Packing instructions... C-11 Disposal of product waste... C-11 Batteries... C-11 Patient applied parts... C-11 Monitor... C-12

D

Principles of Noninvasive Blood Pressure Determination... D-1 DINAMAP SuperSTAT algorithm... D-2 Systolic search... D-3 DINAMAP Classic and auscultatory reference algorithm... D-4 Systolic search... D-5 Reference used to determine NIBP accuracy... D-6

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Introduction

CARESCAPE V100 Vital Signs Monitor

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Introduction: About this device

About this device The CARESCAPE V100 vital signs monitor provides a small, portable, easy-to-use monitoring alternative for sub-acute hospital and non-hospital settings. The monitor is for use on adult, pediatric, or neonatal patients-one at a time. The battery-operated monitor offers noninvasive determination of systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse rate, oxygen saturation, and temperature. Monitors are available with or without integrated printers as well as the following parameters and technologies. 

NIBP, Pulse: SuperSTAT, Auscultatory, or Classic

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SpO2: Ohmeda TruSignal, Nellcor OxiMax, or Masimo SET

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Temperature: Alaris Turbo Temp, Alaris Tri-Site, or Exergen

The model of the CARESCAPE V100 vital signs monitor determines which parameters are in your monitor. Please refer to applicable sections. Using the CARESCAPE V100 vital signs monitor, a clinician can measure, display, and record patient vital sign data that is derived from each parameter. The monitor is also capable of alerting the clinician to changes in the patient’s condition or when it is unable to effectively monitor the patient’s condition. The monitor also detects alarm limit conditions and gives audible and visual notification of these conditions. All of the main operations of the monitor are easy-to-use and only a button-touch away. Please review the factory default settings and, where applicable, enter settings appropriate for your use.

Indications for use The CARESCAPE V100 vital signs monitor is for use as prescribed by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other qualified medical personnel trained in the use of the equipment. The CARESCAPE V100 vital signs monitor is intended to monitor and measure oscillometric noninvasive blood pressure (systolic, diastolic, and mean blood pressure), heart rate/pulse, oxygen saturation (SpO2) by noninvasive pulse oximetry, and temperature using fast predictive mode or continuous monitor mode. An interface to the Exergen TAT-5000 temporal scanner is also provided. Using this monitor, a clinician can view, record, and recall clinical data derived from each parameter. CARESCAPE V100 vital signs monitors are intended for use in various markets, from the physician’s office to sub-acute triage and medical/surgical units. The CARESCAPE V100 vital signs monitor is intended to monitor one patient at a time in a clinical setting.

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Introduction: Safety message signal words

Safety message signal words Safety message signal words designate the severity of a potential hazard. Danger: Indicates a hazardous situation that, if not avoided, will result in death or serious injury. Warning: Indicates a hazardous situation that, 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.

Contraindications This device is not designed, sold, or intended for use except as indicated. WARNINGS To avoid personal injury, do not perform any servicing unless qualified to do so. If powering the monitor from an external power adapter or converter, use only GE-approved power adapters and converters. Carefully route the external AC/DC power converter, air hoses, and all cables to reduce the possibility of entanglement or strangulation. Do not immerse monitor in water. If monitor is splashed with water or becomes wet, wipe it immediately with a dry cloth. Do not immerse sensors in water, solvents, or cleaning solutions (the sensors and connectors are not waterproof). Examine the power cord periodically. Discontinue use and replace if damaged. Replace the power cord, as necessary, with a regulatory-approved cord for the country of use. Avoid swinging the monitor, or entangling the monitor and its accessories with a mount or roll-stand, as this could cause the monitor to drop, leading to patient or user injury, and equipment damage. If any of the seven-segment indicator lights fails to illuminate during the display test, the accuracy of vital sign values could be misread. This indicates problems with the display. Contact GE Technical Support. Do not perform any testing or maintenance on a sensor while it is being used to monitor a patient.

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Introduction: Contraindications

WARNINGS Verify calibration of NIBP parameter (temperature and pulse oximeter do not require calibration; refer to the service manual for instructions). The monitor should only be used by people who have familiarized themselves with its operation. Keep the monitor and its accessories out of the patient’s reach when not in use. Place the monitor on a rigid, secure surface or use the monitor with mounting hardware, poles, and stands recommended by GE. Only use the monitor in areas where adequate ventilation exists. 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 shut-down. Other batteries may be incompatible with the internal charger and may cause battery acid leakage, fire, or explosion. Caution should be taken to not set alarm limits to extreme values, as this can render the alarm system useless.

CAUTIONS Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. The performance of the monitor may be degraded if it is operated or stored outside of the environmental conditions specified in this manual. 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. Do not use the 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. Do not use in the presence of an oxygen-enriched atmosphere (oxygen tent).

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Introduction: Contraindications

CAUTIONS Operating the monitor near equipment which radiates highenergy electromagnetic and radio frequencies (electrosurgical/ cauterizing equipment, portable radios, cellular telephones, etc.) may cause false alarm conditions. If this happens, reposition the monitor and temperature probe away from the source of interference and perform a new measurement. Do not gas sterilize or autoclave the monitor. The monitor should not be used on patients who are connected to cardiopulmonary bypass machines. 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 monitor for proper functioning. 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. Do not exceed a load weighing 5 lb. (2.7 kg) in the accessory basket. 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. Do not disassemble the monitor as personal injury may result. NOTES

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This equipment is suitable for use in the presence of electrosurgery.

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The use of approved accessories will provide protection from burns during high frequency surgery.

CARESCAPE V100 Vital Signs Monitor

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Introduction: Product compliance

Product compliance CARESCAPE V100 vital signs monitor Compliance classifications The monitor is classified in the following categories for compliance with IEC 60601-1:

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Internally powered or Class II when powered from external supply.

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Transportable.

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For continuous operation.

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Not suitable for use in the presence of flammable anesthetics.

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Not for use in the presence of an oxygen-enriched atmosphere (oxygen tent).

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Type BF defibrillator-proof applied parts.

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IPX1, degree of protection against ingress of water.

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Sterilization/Disinfection, refer to Appendix C, “Maintenance” .

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Software is developed in accordance with IEC 60601-1-4.

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The monitor complies to IEC 60601-2-49.

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The alarm system is developed in accordance with IEC 60601-1-8.

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This equipment is suitable for connection to public mains via power. adapters as defined in CISPR 11.

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The SpO2 parameter complies to ISO 9919.

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The NIBP parameter complies to IEC 60601-2-30, EN 1060-1, EN 1060-3, and ANSI/AAMI SP10.

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The Temperature parameter complies to ASTM E-1112-00.

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Defibrillation protected. When used with the recommended accessories, the monitor is protected against the effects of defibrillator discharge. If monitoring is disrupted by the defibrillation, the monitor will recover.

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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.

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Introduction: Product compliance

Electromagnetic compatibility (EMC) WARNINGS Use of known RF sources, such as cell/portable phones, or other radio frequency (RF) emitting equipment near the system may cause unexpected or adverse operation of this device/ system. Consult qualified personnel regarding device/system configuration. Use only approved accessories, including mounts and defibrillator-proof cables. For a list of approved accessories, see the supplies and accessories list delivered with the manual. Other cables and accessories may cause a safety hazard, damage the equipment or system, result in increased emissions or decreased immunity of the equipment or system or interfere with the measurement.

CAUTIONS 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. EMC - Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements. X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. Changes or modifications to this device/system not expressly approved by GE Healthcare may cause EMC issues with this or other equipment. This device/system is designed and tested to comply with applicable standards and regulations regarding EMC and needs to be installed and put into service according to the EMC information stated as follows: This device/system is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Mains power should be that of a typical commercial or hospital environment. NOTE Medical electrical equipment require special electromagnetic compatibility (EMC) precautions which must be considered when installing and putting this equipment into operation. Refer to the service manual for information.

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Introduction: Symbols

Exergen temporal scanner The Exergen temporal scanner has these additional classifications: 

Type BF applied part

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Internally powered (battery operated)

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IPX0, degree of protection against ingress of water

Symbols The following symbols are associated with the monitor and Exergen temporal scanner.

CARESCAPE V100 vital signs monitor NOTE The model of the monitor determines which symbols appear on it. Attention, consult accompanying documents

Silence Alarms Silence

+ / - Increase / decrease adjustable settings Inflate/Stop On/Off Battery Power External communications port connector Charging External DC power input Class II equipment

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