DINAMAP ProCare Monitor Operation Manual Rev A

Contents Introduction Reissues and Updates... 3 Errors and Omissions ... 3 Hierarchy of Warnings and Cautions ... 4 About the DINAMAP® ProCare Monitor ... 7 Product Compliance ...10 Symbols ...11

Getting Started Unpacking the Monitor and Accessories ...15 Setting up BP Connections ...15 Setting up SpO2 Connections ...16 Setting up Temperature Connections ...16 Setting up the Printer (Installing the Paper) ...17 Power Sources...17 Powering the Monitor: Battery and DC Supply ...17 Replacing the Battery ...19 Switching the Monitor On and Off ...20 Setting the Date and Time ...20

Product Overview Buttons ...25 Front Panel ... 27 Rear Panel ...29 Left-Side Panel ...30 Right-Side Panel ...30 Windows... 31 Indicators ...31 Operating Modes ...31 Entering Configuration Mode ...31 Parameter Modes ...32 User Modes ... 32 Sounds ...33 Power Sources ...34 Specifications ...35 Mechanical ...35 Power Requirements ... 35 Environmental ...36

Printer Description ...41 Installing the Paper ...41 Print Button ...41 Printer Alarms ...42 Storage ... 42

Alarms Alarm Codes ...45 Adjusting Alarm Limits ... 45 Alarms Button ...45

Adjusting the Alarm Volume ... 46 Silencing and Acknowledging an Alarm ...46 Silence Button ... 46 Alarm Sounds ...46 Alarm Detection and Priorities ...47 Limit Alarms ...47 Parameter Status Alarms ...48 Printer Alarms ...48 Battery Alarms ...48 Memory Alarms ...48 System Failure Alarms ...48 Specifications ...49 Alarm Message Codes ...50

History Description... 55 Buttons Associated with History ...55 Erasing Stored History ...55 Windows Associated with History...56 Indicators Associated with History ... 56

BP Description... 59 Buttons Associated with BP ...62 Windows Associated with BP ...62 Indicators Associated with BP...63 Parameter Modes ...63 BP Modes of Operation ... 64 Manual BP Determinations ...64 Auto Cycle Determinations ...64 STAT BP Determinations ...65 User Settings... 66 Mode Settings ...66 Limit Settings ... 66 Neonate Settings ...66 Menu Settings ...67 Sounds Associated with B...67 Procedures ...67 Cuff Connections ...69 Quick-Disconnect Air Hose ... 69 Neonate Air Hose ...69 Alarms ... 70 Critikon US Patents ...70 European US Patents ...70 Specifications ...71 Factory Default Settings ...71

SpO2

NELLCOR® SpO2 ...74 Description ...74

Contents Configuration Settings Associated with SpO2 ...76 Buttons Associated with SpO2 ...77 Windows Associated with SpO2 ...77 Indicators Associated with SpO2 ...77 Parameter Modes ...77 User Settings ...78 Limit settings... 78 Menu Settings ...78 Sounds Associated with SpO2 ...78 Procedures ...78 Alarms ...80 Troubleshooting... 81 Specifications ...84 Measurement Range ...84 Accuracy and Motion Tolerance ...84 Saturation ...84 Pulse Rate ...84 NELLCOR® Sensor Accuracy ... 84 OxiMAX... 84 OxiCliq ...84 Reusable Sensor Models ...85 Factory Default Settings...85 NELLCOR® Patents ...85 Masimo Set® SpO2 ... 87 Description ...87 Configuration Settings Associated with SpO2 ...90 Buttons Associated with SpO2 ...91 Windows Associated with SpO2 ...91 Indicators Associated with SpO2 ...91 Parameter Modes ...91 User Settings ...92 Limit settings ...92 Menu Settings ...92 Sounds Associated with SpO2 ... 92 Procedures ...92 Alarms ...94 Troubleshooting ...95 Specifications ...98 Measurement Range ... 98 Accuracy and Motion Tolerance ...98 Saturation ...98 Pulse Rate ...98 Masimo® Sensor Accuracy ...99 Resolution ...99 Low Perfusion Performance...99 Interfering Substances ... 99 Sensor Light Source ... 99 Factory Default Settings... 100 Masimo® Patents ... 100

TURBOTEMP™ Description ... 103 Predictive Mode ... 103 Monitor Mode ... 104 Configuration Settings Associated with Temperature ... 105 Buttons Associated with Temperature ... 105 Windows Associated with Temperature ... 105 Indicators Associated with Temperature ... 105 Measurement in Progress Indicators ... 105 Predictive Mode ... 105 Measurement NOT in Progress Indicators ... 106 Parameter Modes ... 106 User Settings... 107 Menu Settings ... 107 Sounds Associated with TURBO´TEMP™ ... 107 Procedures for Oral Predictive Mode Determinations ... 107 Procedures for Rectal Predictive Mode Determinations ... 108 Procedures for Monitor Mode Determinations (Axillary Determinations) ... 109 Alarms ... 111 Specifications ... 113 Factory Default Settings ... 113 IVAC® Patents ... 113

Pulse Rate Description ... 117 General Notes ... 117 Buttons Associated with Pulse Rate ... 117 Windows Associated with Pulse Rate ... 118 Indicators Associated with Pulse Rate ... 118 Parameter Modes ... 118 User Settings... 118 Limit settings ... 118 Menu Settings ... 118 Sounds Associated with Pulse Rate ... 118 Alarms ... 119 Specifications ... 120 Factory Default Settings ... 120

Appendix A: Principles of Noninvasive Blood Pressure Principles of Noninvasive Blood Pressure Determination ... 123 Systolic Search ... 124 Reference Used to Determine NIBP Accuracy ... 125 DINAMAP Monitors With Intra-Arterial Reference (DINAMAP Classic Technology)... 125 DINAMAP Monitors With Auscultatory Reference (DINAMAP Auscultatory Technology) ... 125

Appendix B: Maintenance Maintenance... 129 Cleaning the Monitor ... 129

Contents Cuff Cleaning and Disinfection ... 129 General ... 129 Materials ... 129 Procedure ... 130 Temperature Devices ... 130 SpO2 Sensors ... 130 Storage and Battery Care ... 131 Fuses ... 131 Calibration ... 131 Leak Testing ... 131 Disposal of Product Waste ... 133 Batteries ... 133 Patient Applied Parts ... 133 Packaging Material ... 133

Appendix C: Connection Details Connection Details ... 137 Host Port Connector (rear panel) ... 137

Appendix D: Warranty, Service, & Spare Parts Warranty, Service, and Spare Parts... 141 Warranty ... 141 Assistance and Parts ... 141 Repairs ... 142 Packing Instructions ... 142 Service Manuals ... 142

Appendix E: Reorder Codes Reorder Codes ... 145

DINAMAP® ProCare Monitor Operation Manual

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DINAMAP® ProCare Monitor

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DINAMAP® ProCare Monitor Operation Manual This manual is for DINAMAP ProCare Monitors models 100, 200, 300, and 400, with or without printers. • ProCare 100: BP, Pulse • ProCare 200: BP, Pulse, and Temp • ProCare 300: BP, Pulse, and SpO2 • ProCare 400: BP, Pulse, Temp, and SpO2 The model of the Monitor determines which parameters are in your monitor. Please refer to applicable sections.

Reissues and Updates Changes occurring between issues are addressed through Change Information Sheets, Addendums, and replacement pages. If a Change Information Sheet does not accompany this manual, it is correct as printed.

Errors and Omissions If errors or omissions are found in this manual, please notify: GE Medical Systems Information Technologies Technical Publications 4502 Woodland Corporate Boulevard Tampa, FL 33614 1-877-274-8456 Part No. 2009360-001 A The content of this document including all figures and drawings is proprietary information of GE Medical Systems Information Technologies, provided solely for purposes of operation, maintenance or repair, and dissemination for other purposes or copying thereof is prohibited without prior written consent by GE Medical Systems Information Technologies, Tampa, Florida. Illustrations may show design models; production units may incorporate changes. 3

Hierarchy of Warnings and Cautions A general warning is a statement that alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the misuse of the device. A warning relates to steps in a procedure. A general caution is a statement that alerts the user to the possibility of a problem with the device associated with its use or misuse. Such problems include device malfunction, device failure, damage to the device or damage to other property. A caution relates to steps in a procedure.

© GE Medical Systems Information Technologies 2002, TAMPA, FL 33614 Printed in the U.S.A. All rights reserved.

United States GE Medical Systems Information Technologies 4502 Woodland Corporate Boulevard Tampa, FL 33614 Germany GE Medical Systems Information Technologies GmbH Munzinger Strasse 3 79111 Freiburg, Germany

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Introduction

Introduction About the DINAMAP® ProCare Monitor The ProCare Monitor provides a small, portable, easy-to-use monitoring alternative for sub-acute hospital and nonhospital settings. 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. ProCare Monitors are intended for use in various markets, from the physician’s office to sub-acute triage and medical/surgical units. • ProCare 100: BP, Pulse • ProCare 200: BP, Pulse, and Temp • ProCare 300: BP, Pulse, and SpO2 • ProCare 400: BP, Pulse, Temp, and SpO2 The model of the Monitor determines which parameters are in your monitor. Please refer to applicable sections. Using the ProCare Monitor, a clinician can view, print, and recall clinical 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. All of the main operations of the ProCare 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 The ProCare Monitor is intended to monitor one patient at a time in a clinical setting.

Contraindications This device is not designed, sold, or intended for use except as indicated. Federal law (U.S.A.) restricts this device to sale by or on the order of a clinician.

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Warnings • Do not use the ProCare Monitor in the presence of magnetic resonance imaging (MRI) devices. There have been reports of sensors causing patient burns when operating in an MRI environment. • Do not use the Monitor in the presence of flammable anesthetics. • To help prevent unintended current return paths with the use of high frequency (HF) surgical equipment, ensure that the HF surgical neutral electrode is properly connected. • To avoid personal injury, do not perform any servicing unless qualified to do so. • WARNING: These Monitors should not be used on patients who are connected to cardiopulmonary bypass machines. • If powering the Monitor from an external power adapter or converter, use only GE Medical Systems Information Technologies-approved power adapters and converters. • The Monitor does not include any user-replaceable fuses. Refer servicing to qualified service personnel. • To reduce the risk of electric shock, do not remove the cover or the back. Refer servicing to a qualified service person. • If the accuracy of any determination reading is questionable, first check the patient’s vital signs by alternate means and then check the ProCare Monitor for proper functioning.

Cautions • Do not use replacement batteries other than the type supplied with the Monitor. Replacement batteries are available from GE Medical Systems - Accessories and Supplies. • The ProCare Monitor is designed to conform to Electromagnetic Compatibility (EMC) standard IEC 601-1-2, 1993 and will operate accurately in 8

Introduction conjunction with other medical equipment which also meets this requirement. To avoid interference problems affecting the Monitor, do not use the Monitor in the presence of equipment which does not conform to these specifications. • Place the ProCare Monitor on a rigid, secure surface. Monitor must only be used with mounting hardware, poles, and stands recommended by GE Medical Systems Information Technologies. • The weight of the accessory basket contents should not exceed 5 lb (2.7kg). • Arrange the external AC/DC power converter, air hoses, and all cables carefully so they do not constitute a hazard. • Verify calibration of BP parameter (temp and pulse oximeter do not require calibration). Ensure that the display is functioning properly before operating the ProCare Monitor. • Do not immerse the Monitor in water. If the Monitor is splashed with water or becomes wet, wipe it immediately with a dry cloth. • Do not gas sterilize or autoclave. • The ProCare Monitor, when used with GE Medical Systems Information Technologies-approved applied parts and accessories, is protected against defibrillator damage. Note • The electromagnetic compatibility profile of the ProCare Monitor may change if accessories other than those specified for use with the ProCare Monitor are used.

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Product Compliance The DINAMAP® ProCare Monitor is classified in the following categories for compliance with IEC 601-1: • Internally powered or Class II when powered from external supply • Transportable • For continuous operation • Not suitable for use in the presence of flammable anesthetics • Not for use in the presence of an oxygen-enriched atmosphere (oxygen tent) • Type BF applied parts • IPX1, degree of protection against ingress of water • Sterilization/Disinfection, see Appendix B

• Software is developed in accordance with IEC 601-1-4. • This equipment is suitable for connection to public mains via power adaptors as defined in CISPR 11. • The SpO2 parameter conforms to EN 865:1997 with the exception of Clauses 36, 48, sub-clause 51.108.1and to ISO 9919. • 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. DINAMAP® PROCARE MONITOR CLASSIFIED WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL AND OTHER SPECIFIED HAZARDS ONLY IN ACCORDANCE WITH CAN/CSA C22.2 NO. 601.1. ALSO EVALUATED TO IEC-601-2-30.

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

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Symbols The following symbols are associated with the ProCare Monitor. Note: The model of the Monitor determines which symbols appear on it. Attention, consult accompanying documents

Silence Alarms

+ / - Increase / decrease adjustable settings

Menu Inflate/Stop Cycle History

Print On/Off Battery Power External communications port connector Charging

Defibrillator-proof type BF equipment External DC power input Class II equipment according to IEC 60536

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Packaging label depicting the transportation and storage atmospheric pressure range of 500 to 1060 hPa.

IPX1 The DINAMAP® ProCare Monitor is protected against vertically falling drops of water and conforms with the IEC 529 standard at level of IPX1. No harmful effects will come of vertically falling drops of water making contact with the Monitor.

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Getting Started Unpacking the Monitor and Accessories Before attempting to use the ProCare Monitor, take a few minutes to become acquainted with the Monitor and its accessories. Unpack the items carefully. This is also a good time to check for any damage or accessory shortage. If there is a problem or shortage, contact GE Medical Systems Information Technologies. It is recommended that all the packaging be retained, in case the Monitor must be returned for service in the future.

Setting up BP Connections 1. Connect the end of the air hose that has quick-release clips to the BP connector on the front of the Monitor. Make sure that the hose is not kinked or compressed. Note: To disconnect the hose from the Monitor, squeeze the quick-release clips together and pull the plug from the BP connector. 2. Select appropriate cuff size. Measure patient’s limb and select appropriately sized cuff according to size marked on cuff or cuff packaging. When cuff sizes overlap for a specified circumference, choose the larger size cuff. Precaution: Accuracy depends on use of proper size cuff. 3. Inspect cuff for damage. Replace cuff when aging, tearing, or weak closure is apparent. Do not inflate cuff when unwrapped. Precaution: Do not use cuff if damaged. 4. Connect the cuff to the air hose. Refer to the BP section for complete cuff connection instructions. Warning: It is mandatory that the appropriate hose and cuff combination be used. Any attempt to modify the hose will inhibit the Monitor from switching between the neonatal and adult measurement modes.

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Note: Care should be taken in reconnecting the cuff to a hose, ensuring that threads of the cuff and hose are in alignment and no cross-threading occurs. 5. Refer to the BP section of this manual for complete instructions on taking an accurate BP determination. Note: Use only CRITIKON® Blood Pressure Cuffs. The size, shape, and bladder characteristics can affect the performance of the instrument. Inaccurate readings may occur unless CRITIKON® Blood Pressure Cuffs are used. Refer to Appendix E for reorder codes.

Setting up SpO2 Connections 1. Plug the appropriate SpO2 sensor into the SpO2 sensor extension cable. 2. Then plug the SpO2 sensor extension cable into the SpO2 sensor connector on the Monitor.

3. Refer to the applicable SpO2 section of this manual for complete instructions on monitoring SpO2.

Setting up Temperature Connections 1. Connect the temperature probe cable to the temperature probe connector on the Monitor. 2. Insert the temperature probe into the probe holster at the side of the Monitor.

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Getting Started 3. Refer to the TURBOTEMP™ section of this manual for complete instructions on taking a temperature reading.

Setting up the Printer (Installing the Paper) 1. With the Monitor powered on, turn it so that the side with the printer is facing you. 2. While grasping the side of the Monitor, lift the printer door open by placing your thumb in the indented area and pulling. The printer door will pop open. 3.Place the roll of paper into the compartment so that the end of the paper comes off the right-side of the roll (paper is wound around the roll clockwise). Push the roll all the way to the back of the printer cavity, making sure the paper extends out of the printer cavity at least two inches. 4.Firmly press the door to close it. 5.Refer to the Printer section of this manual for complete instructions.

Power Sources The ProCare Monitor is designed to operate from an internal lead-acid battery (see “Specifications” in Product Overview section). Note: The ProCare Monitor is not designed to operate without an internal battery.

Powering the Monitor: Battery and DC Supply Before the ProCare Monitor is used for the first time, the battery should be charged in the Monitor for at least 8 hours. With external DC power connected, the green CHARGING indicator will light to indicate that the battery is charging. 17