DINAMAP PRO 1000V3 Monitor Operation Manual Rev A 2003

DINAMAP® PRO 1000V3 Monitor

DINAMAP® PRO 1000V3 Monitor Operation Manual

Revision: 2012093-001 A 2003 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 publication 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. Vital signs data values are fictitious. © Copyright 2003, GE Medical Systems Information Technologies. All rights reserved. Printed in U.S.A.

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Table of Contents Introduction... 1 Indications for Use... 3 Contraindications... 3 Warnings... 3 Cautions... 4 Notes... 4 Product Compliance... 5

Product Overview... 7 Monitor... 9 Parameters... 9 Mounting the PRO 1000V3 Monitor... 9 Display... 10 SelectKnob... 10 Hardkeys... 10 Optional Components... 11 Symbols... 11 Specifications... 13 Mechanical... 13 Weight... 13 Environmental... 13 Electrical... 13 Power Supply... 13 Battery... 13 Power Cable... 13 Fuses... 14 Internal...14 External... 14

Using the DINAMAP® PRO 1000V3 Monitor... 15 Basic Operation... 17 Menus... 17 Menu Options... 18 Accessing and Using Menu Options... 19 Display Screen... 19 Color Format... 19 Display Colors... 20 Screen... 20 Waveform and Vital Signs Priority... 20 Waveform Sweep Speed... 21 Popup window... 23 SelectBox... 23 Helplines... 24 Hardkeys... 24 GO/STOP Hardkey... 24 AUTO-BP/STAT Hardkey... 24 OFF/ON Hardkey... 26 Silence Hardkey... 26 Warning and Procedural Alarms... 26 Standby Hardkey... 26 Main Hardkey... 28 Trend Hardkey... 28

Freeze Hardkey... 28 Record Hardkey... 29 LED Displays... 30 Battery in Use... 30 AC Operation... 30 Loss of AC Power... 30 Other System Settings... 30 turn off system... 30 go to config mode... 30 go to service mode... 30 print to CS... 30 Always display battery icon?... 30 Adjust date & time... 31 Advanced settings... 31 Select color format... 31 Adjust keyclick volume... 31 Adjust system volume... 31 Config settings... 31 Config HostComm... 31 Turning the PRO 1000V3 Monitor Off... 31

Alarms... 33 Interruption of Visible and/or Audible Indications... 35 Alarm Priorities... 36 Crisis... 36 Warning... 37 Procedural... 37 Message... 37 Responding to Alarms... 37 Silence Hardkey... 37 Crisis Alarms... 38 Warning and Procedural Alarms... 38 Alarm Limit Settings... 38 Adjust Alarms Menu... 38 print limit... 38 Adjust alarm volume... 39 choose autoset %... 39 autoset all... 39 auto-set, hi, lo... 39 Config settings... 39 View Event History Menu... 39 Choose event history... 40 view older events... 40 view newer events... 40 print this page... 40 print all pages... 41 crisis events and frozen waveforms... 41 chose event to view... 41 print this event... 41 delete this event... 41 delete all frozen waveforms... 41 System Fault Alarm... 41 Default Alarm Limits... 42

Admit Patient... 43 General Note... 46 Admit Patient Menu... 46 admit... 46 discharge... 47 choose patient settings... 47 enter patient name... 47 enter bed number... 47 enter unit number... 47 print active settings... 47

Trends... 49 Trend Hardkey... 51 Scroll Bar... 52 Viewing Window... 52 Conventions Used in Trends... 52 View Patient Trends Menu: Numbers... 53 print this page... 53 print all pages... 53 Choose graphs to print... 53 Display as... 53 view older trends... 54 view newer trends... 54 Time to view... 54 Move cursor... 54 View vitals every... 54 Select patient... 54 Mini trends... 54 View Trends on Main Screen... 54 Display as... 55 View vitals every... 55 Config settings... 55 View Patient Trends Menu: Graphs... 55 print chosen graphs... 55 print all graphs... 55 Choose graphs to print... 55 Display as... 55 view older trends... 56 view newer trends... 56 Time to view... 56 Move cursor... 56 View vitals for... 56 Select patient... 56 Mini trends... 56 View Trends on Main Screen... 56 Display as... 56 View vitals every... 57 View vitals for... 57 Config settings... 57

Recorder/Printer... 59 Description... 61 Record Hardkey... 61 Printing in Continuous Mode... 61 Printing in Timed Mode... 61 Alarm... 62

Printing Priorities... 62 Recorder/Printer Menu... 62 start timed recording... 62 print to CS... 63 Vitals summary with printout?... 63 Auto printout of vital summary?... 63 print on alarm?... 63 setup continuous... 63 setup timed... 63 Record hardkey printout... 63 Sample Printout... 64 Thermal Paper... 64 Storage... 64 Loading the Printer Paper... 64

Heart Rate/Pulse... 67 Procedure Checklist... 68 Description... 69 Indications and Contraindications... 69 General Notes... 69 Procedures... 70 HR/Pulse Menu... 70 Select source... 70 Adjust QRS volume... 70 Adjust limits... 70 Advanced settings... 71 Limit alarms priority... 71 Change color based on source?... 71 Select HR/Pulse’s color... 71 Specifications... 72 Alarm Limits... 72

ECG... 75 Procedure Checklist... 76 Description... 77 Indications and Contraindications... 77 General Warnings... 77 General Cautions... 78 Procedures... 79 Stress Loop Stabilization... 80 ECG Menu... 80 Turn parameter off... 80 Lead selection... 80 Waveform size... 81 Pacer detection?... 81 Arrhythmia detection... 82 Re-learn... 82 Config settings... 82 Advanced settings... 83 Cardiac sweep speed... 83 Cascade ECG?... 83 Calibration pulse... 83 Display filter... 83 QRS Width... 83 other alarm priorities... 83 Select ECG’s color... 84

Alarms... 84 Calibration... 84 Auxiliary Output... 84 Accessories... 85 Recommended... 85 Specifications... 86 Poor Signal Troubleshooting... 87 Muscle Interference... 87 60 or 50 Hz Cycle Interference... 87 Baseline Wandering... 87 Saturation... 88 Poor Electrode Connections... 88 Alarm Limits... 89

RESP... 91 Procedure Checklist... 92 Description... 93 Indications and Contraindications... 93 General Warning... 93 Procedures... 93 RESP Menu... 94 Turn parameter off... 94 Lead to analyze... 94 View waveform?... 94 Waveform size... 94 Adjust limits... 94 Config settings... 95 Advanced settings... 95 RESP sweep speed... 95 Cardiogenic filter... 95 Detection threshold... 95 Limit alarms priority... 95 Other alarm priorities... 95 Select RESP’s color... 96 Specifications... 97 Alarm Limits... 98

NIBP... 99 Procedure Checklist... 100 Description... 101 Indications and Contraindications... 101 General Warnings... 101 General Cautions... 102 General Notes... 102 Procedures... 102 NIBP Menu... 104 Turn parameter off... 104 Auto BP... 104 setup custom series... 105 Adjust limits... 106 Config settings... 106 Advanced settings... 107 Initial target pressure... 107 Limit alarms priority... 107 Other alarm priorities... 107 Select NIBP’s color... 107

NIBP Hardkeys... 107 GO/STOP Hardkey... 107 AUTO-BP/STAT Hardkey... 108 Auto Mode... 108 Manual Mode... 109 Stat Mode... 109 Mean Arterial Pressure (MAP)... 109 Cuff Cleaning and Disinfection... 110 Definitions... 110 Materials... 110 Procedure... 110 Service... 111 Accessories...111 Cuff-to-hose compatibility... 112 Specifications... 113 Appendix: Principles of Noninvasive Blood Pressure Determination... 114 Systolic Search... 115 Reverting and Accelerated Determination... 115 Alarm Limits... 116

NELLCOR® OxiMAX® SpO2... 117

Procedure Checklist... 118 Description... 119 Indications and Contraindications... 119 General Warnings... 119 General Cautions... 120 General Notes... 120 Procedures... 120 SpO2 Menu... 121 Turn parameter off... 121 View waveform?... 122 Adjust limits... 122 Config settings... 122 Advanced settings... 123 View signal strength bar?... 123 View SpO2 PR?... 123 Spot check enable... 123 Turn C-LOCK® on?... 123 Cardiac sweep speed... 124 Limit alarms priority... 124 Other alarm priorities... 124 Select SpO2’s color... 124 Config settings... 124 Calibration... 124 Accessories... 124 Cleaning... 124 Specifications... 125 Troubleshooting... 127 Alarm Limits... 129

MASIMO SET® SpO2... 131 Procedure Checklist... 132 Description... 133 Indications and Contraindications... 133 General Warnings... 134 General Cautions... 134

General Notes... 135 Procedures... 135 SpO2 Menu... 136 Turn parameter off... 136 View waveform?... 136 Adjust limits... 136 Config settings... 137 Advanced settings... 137 View signal strength bar?... 137 View SpO2 PR?... 138 Spot check enable... 138 Cardiac sweep speed... 138 Limit alarms priority... 138 Other alarm priorities... 138 Select SpO2’s color... 138 Calibration... 138 Accessories... 138 Cleaning... 138 Specifications... 139 Troubleshooting... 141 Alarm Limits... 143

TURBOTEMP... 145 Procedure Checklist... 146 Description... 147 Indications and Contraindications... 147 General Warning... 147 General Cautions... 147 Predictive Mode... 148 Monitor Mode... 148 Procedures for Oral Predictive Mode Determinations... 149 Procedures for Rectal Predictive Mode Determinations... 149 Procedures for Monitor Mode Determinations (Axillary Determinations)... 150 TEMP Menu... 151 Turn parameter off... 151 Unit of measure... 151 Choose mode... 151 Trend monitor temp now... 151 Advanced Settings... 151 Other alarm priorities... 151 Select TEMP’s color... 151 Config settings... 151 Calibration... 152 Accessories... 152 Specifications... 153 Alarm Limits... 154

Battery... 155 Procedure Checklist... 156 Description... 157 General Warning... 157 General Cautions... 157 Procedures for First Use... 157 Battery Charging... 157 Battery Icon... 158 Battery State of Charge... 158

Battery Alarm... 159 Loss of Power Shutdown... 159 3.6 V Backup Battery...159 Disposal of Batteries... 159 Specifications...160 Troubleshooting... 161 Alarm Limits... 162

Appendix... 163 Data Connections... 165 Interface Cover... 165 Communication Adaptor Connector... 165 IPC-1928... 166 Overview... 166 Start Up Conditions... 166 Admit New Patient... 166 Configuration Mode... 166 Patient Discharge... 166 IPC-1928 Connections... 166 Host Port Connector... 167 Electromagnetic Interference (EMI) Considerations... 168 Auxiliary Output...170 Assistance and Parts... 169 Maintenance, Cleaning, and Calibration... 169 Repairs...169 Packaging Material...169 Packing Instructions... 169 Cleaning...170 Disposal of Product Waste...170 Patient Applied Parts... 170

Introduction

DINAMAP® PRO 1000V3 Monitor

2 Introduction

Introduction

The DINAMAP® PRO 1000V3 Monitor is a portable (intra-hospital) multiparameter unit designed for monitoring adult, pediatric, and neonate patient vital signs in subacute care settings, such as same-day surgery, emergency rooms, recovery/PACU, progressive care, interventional radiology, special care units, and GI/endoscopy. The PRO 1000V3 Monitor is self-contained and can be powered by batteries or AC. The Monitor has a carrying handle and can be operated on a shelf or table. It can also be mounted in a variety of ways (e.g., wall, pole, bed rail, or head/foot board) using a mounting plate located on the bottom of the Monitor or a pull-out hanger. The Monitor can be used as a stand-alone monitor with the capability to interface to a central station, a server or any other device capable of receiving data using the host communications protocol.

Indications for Use The PRO 1000V3 Monitor is intended to monitor and measure oscillometric noninvasive blood pressure (systolic, diastolic, and mean blood pressure), heart rate/pulse, respiration rate, ECG with lethal arrhythmia (VTACH, VFIB/VTACH, and asystole), oxygen saturation (SpO2) by noninvasive pulse oximetry, and predictive temperature with an electronic thermometer. The PRO 1000V3 Monitor also detects alarm limit conditions and is capable of recording up to two waveforms. Using this Monitor, a clinician can view, record, and recall clinical data derived from each parameter.

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.

Warnings •If cables and hoses are pulled with sufficient force, unsecured monitors may fall causing injury or equipment damage. To PREVENT injury or equipment damage, install the monitor with mounting hardware recommended by GE Medical Systems Information Technologies. •Do not use the PRO 1000V3 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. •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. •Disconnect the power supply before servicing. •To reduce the risk of electric shock, do not remove the cover or the back of the unit. 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 PRO 1000V3 Monitor for proper functioning. •PACEMAKER PATIENTS: Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance. See this manual for disclosure of the pacemaker pulse rejection capability of this instrument. • VENTRICULAR ARRHYTHMIA: The arrhythmia analysis program is intended to detect ventricular arrhythmias. It is not designed to detect atrial or supraventricular arrhythmias. Occasionally it may incorrectly identify the

Introduction 3

presence or absence of an arrhythmia. Therefore, a physician must analyze the arrhythmia information in conjunction with other clinical findings.

• SUSPENDED ANALYSIS: Certain conditions suspend arrhythmia analysis. When suspended, arrhythmia conditions are not detected and alarms associated with arrhythmias do not occur. The ECG waveform message ARR OFF alerts you to the condition causing suspended arrhythmia analysis.

Cautions •Arrange the power cord, air hoses, and all cables carefully so they do not constitute a patient strangulation, entanglement, or tripping hazard. •Verify calibration and ensure that the PRO 1000V3 Monitor is functioning properly before operating it. •Allow for heat dissipation by ensuring that the vent in the rear is unobstructed. •If fluid is spilled on the PRO 1000V3 Monitor, disconnect the Monitor and contact a qualified service person. •Do not gas sterilize or autoclave. •Where the integrity of the external earth conductor in the installation or its arrangement is in doubt, equipment shall be operated from its internal electrical power source. Notes • Waveforms may be distorted and readings inaccurate when electrosurgical cautery equipment is used while monitoring with the PRO 1000V3 Monitor. • The electromagnetic compatibility profile of the PRO 1000V3 Monitor may change if accessories other than those specified for use with the PRO 1000V3 Monitor are used.

4 Introduction

Product Compliance The DINAMAP® PRO 1000V3 Monitor is classified in the following categories for compliance with IEC 601-1: • Class I, internally powered • Transportable (intra-hospital) • 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 and type CF applied parts • Defibrillation protected. When used with the GE Medical Systems Information Technologiesrecommended accessories, the Monitor is protected against the effects of defibrillator discharge. If monitoring is disrupted by the defibrillation, the Monitor will recover.

IPX1

The DINAMAP® PRO 1000V3 Monitor is protected against vertically falling drops of water and conforms with the IEC 529 standard at level of IPX1. Vertically falling drops of water shall have no harmful effects when making contact with the Monitor.

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

0086 DINAMAP® PRO 1000V3 Monitor is 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.

• This equipment is suitable for connection to public mains as defined in CISPR 11. • The signal systems of the Monitor conform to EN 475:1995. • This Monitor conforms to safety standard for medical devices to IEC 601-1, EN 60601, BS 5724-1, AS/NZS3200.1.0. • This Monitor conforms to EMC safety standard to IEC 60601-1-2. • Software is developed in accordance with IEC 601-1-4. • The ECG parameter conforms to IEC 60601-2-27. • The SpO2 parameter conforms to EN 865:1997 with the exception of Clauses 36, 48, sub-clause 51.104.1. • The NIBP parameter conforms to IEC 601-2-30 with the exception of Clause 36, sub-clause 51.105, EN 1060 Part 1 & 3, ANSI/AMMI SP10 & SP10a. • The TEMP parameter conforms to ASTM E 1112.

Introduction 5

6 Introduction

Product Overview

Front of DINAMAP® PRO 1000V3 Monitor

8 Product Overview