DINAMAP ProCare Monitor Operation Manual Rev C

Contents Introduction About the DINAMAP® ProCare Monitor ... 7 Indications ... 7 Contraindications ... 7 Warnings ... 8 Cautions ... 9 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 ... 6 Setting up the Printer (Installing the Paper) ...17 Power Sources ...17 Powering the Monitor: Battery and DC Supply ...17 Configuration Mode Settings ...19 Setting the Date and Time ...20 Procedures ...20 Inflation Pressure Default Settings (Refer to the BP Section for options) ...21 Procedures ...21 Alarm Default Settings (Refer to Alarms Section for options) ...21 SPO2 Configuration Settings ...22 Procedure for units with Nellcor® Technology (Refer to the Nellcor® section for options) ...22 Procedure for units with Masimo® Technology (Refer to the Masimo® section for options) ...22

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 Cautions ...42 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 Memory Alarms ...48 Battery Alarms ...48 System Failure Alarms ...49 Specifications ...50 Alarm Message Code Table ...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 General Warnings ...60 General Cautions ...61 General Notes ...61 Buttons Associated with BP ...62 Windows Associated with BP ...63 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 BP ...67

Contents Procedures ...67 Cuff Connections ...69 Quick-Disconnect ...69 Air Hose ...69 Neonate Air Hose ...70 Alarms ...70 Critikon US Patents ...70 Specifications ...71 Factory Default Settings ...71

SpO2 NELLCOR® OxiMax® SpO2 ...75 Description ...75 General Warnings ...76 General Cautions ...76 General Notes ...77 Configuration Settings Associated with SpO2 ...77 Buttons Associated with SpO2 ...78 Windows Associated with SpO2 ...78 Indicators Associated with SpO2 ...78 Parameter Modes ...78 User Settings ...79 Limit settings ...79 Menu Settings ...79 Sounds Associated with SpO2 ...79 Procedures ...79 Warnings ...80 Patient safety ...80 Cautions ...80 Patient safety ...80 Alarms ...81 Troubleshooting ...82 Specifications ...85 Measurement Range ...85 Accuracy and Motion Tolerance ...85 Saturation ...85 Pulse Rate... 85 NELLCOR® Sensor Accuracy ...85 OxiMax® ...85 OxiCliq® ...85 Reusable Sensor Models ...86 Factory Default Settings ...86 NELLCOR® Patents ...87 Masimo Set® SpO2 ...89 Description ...89 General Cautions ...90 General Notes ...92 Configuration Settings Associated with SpO2 ...92 Buttons Associated with SpO2 ...93 Windows Associated with SpO2 ...93 Indicators Associated with SpO2 ...93

Parameter Modes ...93 User Settings ...94 Limit settings ...94 Menu Settings ...94 Sounds Associated with SpO2 ...94 Procedures ...94 Warnings ...95 Patient safety ...95 Cautions ...95 Patient safety ...95 Alarms ...96 Troubleshooting ...97 Specifications ... 100 Measurement Range ... 100 Accuracy and Motion Tolerance ... 100 Saturation ... 100 Pulse Rate ... 100 Masimo® Sensor Accuracy ... 101 LNOP ... 101 Resolution ... 101 Low Perfusion Performance ... 101 Interfering Substances ... 101 Factory Default Settings ... 102 Masimo Patents ... 102

TURBOTEMP® Description ... 105 Predictive Mode ... 105 Monitor Mode ... 106 General Warning ... 106 General Cautions ... 106 Configuration Settings Associated with Temperature ... 107 Buttons Associated with Temperature ... 107 Windows Associated with Temperature ... 107 Indicators Associated with Temperature ... 107 Measurement in Progress Indicators ... 107 Predictive Mode ... 107 Measurement NOT in Progress Indicators ... 108 Parameter Modes ... 109 User Settings ... 109 Menu Settings ... 109 Sounds Associated with TURBOTEMP® ... 109 Procedures for Oral Predictive Mode Determinations ... 109 Procedures for Rectal Predictive Mode Determinations ... 110 Procedures for Monitor Mode Determinations (Axillary Determinations) ... 111 Alarms ... 113 Specifications ... 114 Factory Default Settings ... 114 IVAC® Patents ... 114

Contents 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 SpO2 Associated Alarms (If SpO2 is the source) ... 119 BP Associated Alarms (If BP is the source) ... 119 Specifications ... 120 Factory Default Settings ... 120

Appendix A: Principles of Noninvasive Blood Pressure Determination 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 Materials ... 129 Cuff Cleaning and Disinfection ... 129 General ... 129 Materials ... 130 Procedure ... 130 Temperature Devices ... 130 SpO2 Sensors ... 131 Storage and Battery Care ... 131 Replacing the Battery ... 132 General Caution ... 133 Fuses ... 133 Calibration ... 133 Leak Testing ... 134 Disposal of Product Waste ... 134 Batteries ... 134 Patient Applied Parts ... 134 Packaging Material ... 135 Monitor ... 135

Appendix C: Connection Details Connection Details ... 139 Host Port Connector (rear panel) ... 139

Appendix D: Warranty, Service, and Spare Parts Warranty, Service, and Spare Parts ... 143 Warranty ... 143 Assistance and Parts ... 143 Repairs ... 144 Packing Instructions ... 144 Service Manuals ... 144

Appendix E: Reorder Codes Reorder Codes ... 147

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 1-800-558-7044 Part No. 2009360-001 C 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. © Copyright 2002, 2004. GE Medical Systems Information Technologies. All rights reserved.

World Headquarters GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA Tel: + 1 414 355 5000 1 800 558 5120 (US only) Fax: + 1 414 355 3790 European Representative GE Medical Systems Information Technologies GmbH Munzinger Straße 3-5 D-79111 Freiburg Germany Tel: + 49 761 45 43 - 0 Fax: + 49 761 45 43 - 233 Asia Headquarters GE Medical Systems Information Technologies Asia; GE (China) Co., Ltd. 24th Floor, Shanghai MAXDO Center, 8 Xing Yi Road, Hong Qiao Development Zone Shanghai 200336, P.R. China Tel: + 86 21 5257 4650 Fax: + 86 21 5208 2008 4

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 physician.

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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. • Use of portable phones or other radio frequency (RF) emitting equipment near the system may cause unexpected or adverse operation. • 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. • The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity performance of the equipment or system. 8

Introduction 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 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. 9

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. Vertically falling drops shall have no harmful effects to 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. 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. 15

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. 3. Refer to the TURBOTEMP® section of this manual for complete instructions on taking a temperature reading. 16