Dash 3000, 4000 and 5000 Operator’s Manual Sept 2007

NOTE Due to continuing product innovation, specifications in this manual are subject to change without notice. The information in this manual supports software versions 5.4 or later. NOTE For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical Systems Information Technologies. Listed below are GE trademarks used in this document. All other trademarks contained herein are the property of their respective owners. CD TELEMETRY, CRG PLUS, DASH, DINAMAP, EAGLE, MARS, MUSE, RESPONDER, SAM, SOLAR, TRAM-NET, TRAMSCOPE, TRAM-RAC, TRIM KNOB, UNITY and UNITY NETWORK are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office. 12SL, CENTRALSCOPE, CIC PRO, DASH PORT, EK-PRO, IMPACT, INTELLIRATE, MENTOR, PRISM, PRN 50-M and SUPERSTAT are trademarks of GE Medical Systems Information Technologies.

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Contents 1

Introduction... 1-1 Equipment Information... 1-2 Intended Use... 1-2 Safety Statements... 1-2 Dangers... 1-2 Warnings... 1-2 Cautions... 1-8 Notes... 1-12 Equipment Symbols... 1-13 Equipment Compliance Information... 1-15 EN 60601-1 Component Classification... 1-15 Underwriters Laboratories, Inc. Classification... 1-16 AAMI EMI Environment Recommendations... 1-16 FCC Compliance Information Statement... 1-17 Manual Information... 1-17 Purpose... 1-17 Intended Audience... 1-17 Conventions... 1-17 Equipment... 1-17 User Interface... 1-18 Text... 1-19 Illustrations and Names... 1-19 Ordering Manuals... 1-19 Revision History... 1-19

2

Equipment Overview... 2-1 Hardware Overview... 2-2 Front... 2-2 Right... 2-2 Left... 2-3 Back... 2-4 Control Panel... 2-5 Trim Knob Control... 2-6 Indicators... 2-7 Alarm Light... 2-7 Power... 2-7 Charging Status... 2-7 Battery Status... 2-8 Optional Components... 2-8 TRAM-RAC 2A Module Housing... 2-8 Nellcor® 395 Pulse Oximeter... 2-8 Unity Network... 2-9 Centralscope Central Station... 2-9 CIC Pro Clinical Information Center... 2-9

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Wireless LAN System... 2-9 Laser Printer... 2-10 PRN 50-M Digital Writer... 2-10 Remote Control... 2-10 Dash Port... 2-12 Remote Display... 2-12 Cadex® SMart Two+ Charger... 2-12 Operating Modes... 2-12 Normal... 2-12 Off/Charging... 2-13 Off... 2-13 User Interface Overview... 2-13 Main Display... 2-13 Menus... 2-14 Windows... 2-15

3

Monitor Setup... 3-1 Getting Started... 3-2 Identifying Your Configuration... 3-2 Software Packages... 3-2 Software Options... 3-3 Monitoring/Admit Modes... 3-3 Patient-Monitor Type... 3-4 Language... 3-4 Locale... 3-4 France... 3-5 Customizing Monitor Setup... 3-5 Monitor Defaults Overview... 3-5 Factory Defaults... 3-6 Custom Defaults... 3-6 Control Settings... 3-7 Defining Custom Defaults... 3-7 Defining Control Settings... 3-8 Restoring Factory Defaults... 3-11 Defining Parameter Window Priority... 3-12

4

Alarms... 4-1 Introduction... 4-2 Overview... 4-2 Alarm Types... 4-3 Patient Status Alarms... 4-3 System Status Alarms... 4-3 Safety... 4-4 Control Settings... 4-5

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Silencing Alarms... 4-6 Temporarily... 4-6 Permanently... 4-7

5

Managing Patients... 5-1 Introduction... 5-2 Admit... 5-2 Overview... 5-2 Standard Admit... 5-2 Quick Admit... 5-3 Automatic Admit... 5-3 Control Settings... 5-3 Discharge... 5-5 View Other Patients... 5-5 Software Option Comparison... 5-6 Limitations... 5-7 Custom Defaults... 5-7 Control Settings... 5-9 Viewing Other Monitors... 5-10 Selecting a Monitor... 5-10 Understanding the Split-View Display... 5-10 Removing a Viewed Monitor Display... 5-11

6

Printing... 6-1 Introduction... 6-2 Overview... 6-2 Options... 6-2 Control Settings... 6-2 Printed Output... 6-3 Guidelines... 6-4

7

Patient Data... 7-1 Introduction... 7-2 Reviewing Patient Data... 7-2 Alarm History... 7-2 Vital Signs... 7-4 Graphic Trends... 7-5 CRG Trends... 7-6 Lab Data... 7-8 Customizing the Trends Key... 7-9

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Calculations... 7-9 Cardiac Calculations... 7-9 Dosage Calculations... 7-10 Pulmonary Calculations... 7-11

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Monitoring ECG... 8-1 Introduction... 8-2 Overview... 8-2 Options... 8-3 AFIB Arrhythmia Detection... 8-3 IntelliRate... 8-5 Combo and Rover Combo Monitoring Guidelines... 8-5 Analog Output... 8-6 Additional Information... 8-7 Safety... 8-7 Pacemaker... 8-7 Arrhythmia... 8-9 Monitoring... 8-9 Control Settings... 8-10 Custom Defaults... 8-13 Turning Off ECG... 8-13 Permanently... 8-13 Constraints... 8-13 ECG Setting Source... 8-14 Selecting ECG Setting Source... 8-14 ECG Setting Source When Entering COMBO Mode... 8-14 ECG Setting Source When Exiting COMBO Mode... 8-15 ECG Rate Averaging... 8-15 IntelliRate... 8-16 AFIB Alarm Level... 8-16 Performing ST Analysis... 8-16 Overview... 8-16 Control Settings... 8-17 Performing 12 Lead Analysis... 8-19 Troubleshooting... 8-20

9

Monitoring Invasive Pressures... 9-1 Introduction... 9-2 Overview... 9-2 Pressure Site Names and Values... 9-2 Default Site Labels... 9-3 Analog Output... 9-3 Additional Information... 9-3

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Monitoring... 9-4 Control Settings... 9-4 Performing PA Wedge Measurements... 9-7 Automatic... 9-7 Manual... 9-8 Troubleshooting... 9-9

10

Monitoring NBP... 10-1 Introduction... 10-2 Overview... 10-2 Options... 10-3 Additional Information... 10-4 Safety... 10-4 Monitoring... 10-6 Control Settings... 10-7 Custom Defaults... 10-9 Setup Custom Automatic NBP Measurements... 10-9 Auto NBP Cancellation Notification... 10-9 Extended NBP Alarm Silence... 10-10 Troubleshooting... 10-10

11

Monitoring SpO2... 11-1 Introduction... 11-2 Overview... 11-2 Primary Parameter Monitoring Considerations... 11-3 Configuration Options... 11-3 Masimo... 11-3 Nellcor... 11-4 Ohmeda... 11-5 Additional Information... 11-6 Safety... 11-6 General... 11-6 Neonates and Infants... 11-8 Monitoring... 11-8 Control Settings... 11-9 Nellcor 395 Pulse Oximeter... 11-12 Connecting... 11-12 Guidelines... 11-14

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Troubleshooting... 11-15

12

Measuring Cardiac Output... 12-1 Introduction... 12-2 Overview... 12-2 Additional Information... 12-2 Measuring... 12-3 Control Settings... 12-3 Performing the CO Procedure... 12-4 Troubleshooting... 12-6

13

Monitoring Respiration... 13-1 Introduction... 13-2 Overview... 13-2 Additional Information... 13-2 Safety... 13-3 Monitoring... 13-3 Control Settings... 13-3 Troubleshooting... 13-4

14

Monitoring Temperature... 14-1 Overview... 14-2 Monitoring... 14-2 Control Settings... 14-3 Troubleshooting... 14-3

15

Monitoring End-Tidal CO2... 15-1 Introduction... 15-2 Overview... 15-2 Compatible Devices/Sensors... 15-2 Additional Information... 15-2 Safety... 15-3 Monitoring... 15-4

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Control Settings... 15-4 Calibrating... 15-6 Sensors... 15-6 Adapters... 15-6 Sample Lines... 15-7 Troubleshooting... 15-7

16

Monitoring Anesthesia Gases... 16-1 Introduction... 16-2 Overview... 16-2 Options... 16-3 Guidelines... 16-3 Additional Information... 16-3 Safety... 16-3 Monitoring... 16-5 Control Settings... 16-6 CO2... 16-6 Gas... 16-7 Enabling HAL and ENF... 16-8 Troubleshooting... 16-8

17

Monitoring Impedance Cardiography (ICG)... 17-1 Introduction... 17-2 Overview... 17-2 Monitored Parameters... 17-2 Additional Information... 17-2 Safety... 17-3 Monitoring... 17-4 Control Settings... 17-5 Troubleshooting... 17-6

18

Monitoring Bispectral Index (BIS)... 18-1 Introduction... 18-2 Overview... 18-2 Additional Information... 18-3 Safety... 18-3 Considerations... 18-3

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General... 18-3 Monitoring... 18-4 Control Settings... 18-5 Disabling Continuous Lead Detection... 18-6 Disabling the Waveform Filter... 18-6 Testing the BIS... 18-6 Understanding Displayed Values... 18-6 BIS... 18-6 SR... 18-7 SQI... 18-7 SEF... 18-7 EMG... 18-7 Troubleshooting... 18-7

A

Maintenance...A-1 Overview... A-2 Biocompatibility...A-2 Inspection...A-2 Disposal...A-2 Cleaning... A-3 Exterior Surface...A-3 Display...A-4 Applied Parts... A-4 Cables and Leadwires...A-4 Capnostat Sensor and Adapter...A-4 NBP Cuff and Hose...A-4 Other...A-5 Printer/Writer(s)... A-5 Changing Writer Paper...A-5 Batteries... A-6 Overview... A-6 General...A-6 Lithium-Ion Technology...A-6 Cadex SMart Two+ Battery Charger...A-7 Safety...A-7 Identifying Capacity...A-8 Installation Guidelines...A-10 Battery Care... A-10 Charging...A-10 Conditioning...A-10 Storing...A-11 Waking Up...A-12

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Recycling...A-13 Troubleshooting...A-13 Technical Maintenance... A-14 Safety Tests... A-14 General...A-14 Temperature Testing...A-15 NBP Testing...A-15 Alarm Verification...A-17

B

Software Packages...B-1 Feature Comparison by Software Package... B-2

C

Factory Defaults...C-1 Arrhythmia Alarm Levels... C-2 Parameter Alarm Levels... C-2 Parameter Limits... C-4 Display Defaults... C-6 Default Parameter Priority... C-11

D

Custom Defaults...D-1 Overview... D-2

E

Interfacing with Non-GE Devices...E-1 Introduction... E-2 General...E-2 Safety...E-2 Non-GE Device Information... E-3 Displayed Data...E-3 Compatible Devices...E-4 Limitations... E-7 Duplicate Devices...E-7 Duplicate Parameters...E-8 Setup... E-9 Connecting the Monitor...E-9 Connecting Peripheral Devices...E-9 Establishing Communication...E-10 Customizing Data Display... E-11 Default Parameter Alarm Levels...E-11 Alarm Limits...E-12

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Parameter Windows and Menus...E-12 Peripheral Device Monitoring Guidelines... E-12 Anesthesia Interface...E-12 Gas Interface...E-12 Pulse Oximeter Interface...E-12 Transcutaneous pO2/pCO2 Interface...E-13 Ventilator Interface...E-13 Continuous Cardiac Output...E-13 IV Pump...E-13 Urometers...E-13 Additional Information...E-13

F

Abbreviations and Symbols... F-1 Abbreviations... F-2 Symbols... F-8

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CE Marking Information Compliance The Dash™ 3000/4000/5000 patient monitor bears CE mark CE-0459 indicating its conformity with the provisions of the Council Directive 93/ 42/EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive. The product is in radio-interference protection class A in accordance with EN 55011. The country of manufacture can be found on the equipment labeling. The product complies with the requirements of standard EN 60601-1-2 “Electromagnetic Compatibility - Medical Electrical Equipment”. The system meets the requirements of EN 60601-1-2 (2001) Medical Electrical Equipment, Part 1: General Requirements for Safety, 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests.

Exceptions Users should be aware of known RF sources, such as radio or TV stations and hand-held or mobile two-way radios, and consider them when installing a medical device or system. Be aware that adding accessories or components, or modifying the medical device or system may degrade the EMI performance. Consult with qualified personnel regarding changes to the system configuration.

Radio and Telecommunication Terminal Equipment Directive The monitor contains a transmitter. The transmitter bears a CE mark indicating conformity with the essential requirements specified in Article 3 of the Council Directive 1999/5/EC of 9 March 1999 concerning Radio Equipment and Telecommunications Terminal Equipment (R&TTE). The essential requirements are as follows: Article 3.1 (a) Health Safety; the product complies with the particular medical device safety standards specified in the Medical Device Directive 93/42/EEC: EN 60601-1/1990 + A1: 1993 + A2: 1995: Medical electrical equipment. General requirements for safety. Article 3.1 (b) EMC; the product complies with:

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EN 60601-1-2 (2001) Medical electrical equipment: Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility - requirements and test.

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ETS 300 826 (1997): “Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC)

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standard for 2.4 GHz wideband transmission systems and HIgh PErformance Radio Local Area Network (HIPERLAN) equipment”. Article 3.2 Protection of the Radio Spectrum: the product complies with: ETSI EN 300 328 (2003): “Radio Equipment and Systems (RES); Wideband transmission systems; Technical characteristics and test conditions for data transmission equipment operating in the 2.4 GHz ISM band and using spread spectrum modulation techniques.

General Information

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This manual is an integral part of the product and describes its intended use. It should always be kept close to the equipment. Observance of the manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.

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The symbol documents.

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Information which refers only to certain versions of the product is accompanied by the model number(s) of the product(s) concerned. The model number is given on the nameplate of the product.

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The warranty does not cover damages resulting from the use of accessories and consumables from other manufacturers.

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GE is responsible for the effects on safety, reliability, and performance of the product, only if:

means ATTENTION: Consult accompanying

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assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE;

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the electrical installation of the relevant room complies with the requirements of the appropriate regulations; and,

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the device is used in accordance with the instructions for use.

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All publications conform with the product specifications and applicable EN publications on safety and essential performance of electromedical equipment as well as with applicable UL and CSA requirements and AHA recommendations valid at the time of printing.

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The quality management system complies with the international standards ISO 9001 and ISO 13485, and the Council Directive on Medical Devices 93/42/EEC.

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Introduction

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Introduction

Equipment Information Intended Use The intended use of this device is to monitor physiologic parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. Physiologic data includes the parameters covered in this manual. The monitoring system is also intended to provide physiologic data over the optional network to clinical information systems. This information can be viewed, trended, stored and printed.

Safety Statements The safety statements presented in this chapter refer to the equipment in general and, in most cases, apply to all aspects of the monitor. There are additional safety statements in the parameter chapters which are specific to that monitored parameter. The order in which safety statements are presented in no way implies order of importance.

Dangers Danger statements identify an imminent hazard which, if not avoided, will result in death or serious injury. No danger statements apply to this monitoring system.

Warnings Warning statements identify a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury. The following warning statements apply to this monitoring system: WARNING ACCIDENTAL SPILLS - To avoid electric shock or device malfunction, liquids must not be allowed to enter the device. If liquids have entered a device, take it out of service and have it checked by a service technician before it is used again.

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Introduction

WARNING ACCURACY - If the accuracy of any value viewed on the monitor, central station, or printed on a graph strip is questionable, determine the patient's vital signs by alternative means. Verify that all equipment is working correctly.

WARNING ALARMS - Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in a hazard to the patient. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. After connecting the monitor to the central station and/or nurse-call system, verify the function of the alarm system. The functions of the alarm system for monitoring of the patient must be verified at regular intervals.

WARNING BEFORE USE - Before putting the system into operation visually inspect all connecting cables for signs of damage. Damaged cables and connectors must be replaced immediately. Before using the system, the operator must verify that it is in correct working order and operating condition. Periodically, and whenever the integrity of the product is in doubt, test all functions.

WARNING CABLES - Route all cables away from patient's throat to avoid possible strangulation.

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WARNING CONDUCTIVE CONNECTIONS - Extreme care must be exercised when applying medical electrical equipment. Many parts of the human/machine circuit are conductive, such as the patient, connectors, electrodes, transducers. It is very important that these conductive parts do not come into contact with other grounded, conductive parts when connected to the isolated patient input of the device. Such contact would bridge the patient's isolation and cancel the protection provided by the isolated input. In particular, there must be no contact of the neutral electrode and ground.

WARNING DEFIBRILLATION - Do not come into contact with patients during defibrillation. Otherwise serious injury or death could result.

WARNING DISCHARGE TO CLEAR PATIENT DATA - When admitting a new patient, you must clear all previous patient data from the system. To accomplish this, disconnect patient cables then do a discharge.

WARNING DISCONNECTION FROM MAINS - When disconnecting the system from the power line, remove the plug from the wall outlet first. Then you may disconnect the power cord from the device. If you do not observe this sequence, there is a risk of coming into contact with line voltage by inserting metal objects, such as the pins of leadwires, into the sockets of the power cord by mistake.

WARNING DISPOSAL - Dispose of packaging material, observing the applicable waste control regulations and keeping it out of children’s reach.

WARNING EXPLOSION HAZARD - Do not use this equipment in the presence of flammable anesthetics, vapors or liquids.

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Introduction

WARNING WIRELESS COMMUNICATION INTERFERENCE - Wireless LAN equipment contains an intentional RF radiator that has the potential of interfering with other medical equipment, including patient implanted devices. Before installation and any time new medical equipment is added to the Wireless LAN coverage area, complete the following tests: „

Software version 5.3 or earlier - Perform the electromagnetic compatibility test as described in the Wireless LAN Configuration Guide.

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Software version 5.4 or later - Perform the ad-hoc tests AND the electromagnetic compatibility test as described in the Wireless LAN Configuration Guide.

WARNING INTERFACING OTHER EQUIPMENT - Devices may only be interconnected with each other or to parts of the system when it has been determined by qualified biomedical engineering personnel that there is no danger to the patient, the operator, or the environment as a result. In those instances where there is any element of doubt concerning the safety of connected devices, the user must contact the manufacturers concerned (or other informed experts) for proper use. In all cases, safe and proper operation should be verified with the applicable manufacturer's instructions for use, and system standard EN 60601-1-1 must be complied with.

WARNING - Before using the monitor for the first time, please read the “Safety Statements” on page 1-2.

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Introduction

WARNING INTRACARDIAC APPLICATION - When applying devices intracardially, electrically conductive contact with parts connected to the heart (pressure transducers, metal tube connections and stopcocks, guide wires, etc.) must be avoided in all cases. To prevent electrical contact, we recommend the following: „

Always wear isolating rubber gloves.

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Keep parts that are conductively connected to the heart isolated from the ground.

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Do not use tube fittings or stopcocks made of metal.

During intracardiac application of a device, a defibrillator and pacemaker whose proper functioning has been verified must be kept at hand.

WARNING LEAKAGE CURRENT TEST - When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients.

WARNING PATIENT AMBULATION - A patient must be assisted if ambulating with a roll-stand mounted monitor.

WARNING POWER SUPPLY - The device must be connected to a properly installed power outlet with protective earth contacts only. If the installation does not provide for a protective earth conductor, disconnect the monitor from the power line and operate it on battery power, if possible. All devices of a system must be connected to the same power supply circuit. Devices which are not connected to the same circuit must be electrically isolated when operated.

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