Operators Manual
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SEER® Light Ambulatory Recorder/Controller Operator’s Manual Software Version 1 2008626-006
Revision C
127( The information in this manual only applies to SEER Light Ambulatory Recorder/Controller software version 1. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice.
Listed below are GE Medical Systems Information Technologies trademarks. All other trademarks contained herein are the property of their respective owners. 900 SC, ACCUSKETCH, AccuVision, APEX, AQUA-KNOT, ARCHIVIST, Autoseq, BABY MAC, C Qwik Connect, CardioServ, CardioSmart, CardioSys, CardioWindow, CASE, CD TELEMETRY, CENTRA, CHART GUARD, CINE 35, CORO, COROLAN, COROMETRICS, Corometrics Sensor Tip, CRG PLUS, DASH, Digistore, Digital DATAQ, E for M, EAGLE, Event-Link, FMS 101B, FMS 111, HELLIGE, IMAGE STORE, INTELLIMOTION, IQA, LASER SXP, MAC, MAC-LAB, MACTRODE, MANAGED USE, MARQUETTE, MARQUETTE MAC, MARQUETTE MEDICAL SYSTEMS, MARQUETTE UNITY NETWORK, MARS, MAX, MEDITEL, MEI, MEI in the circle logo, MEMOPORT, MEMOPORT C, MINISTORE, MINNOWS, Monarch 8000, MULTI-LINK, MULTISCRIPTOR, MUSE, MUSE CV, Neo-Trak, NEUROSCRIPT, OnlineABG, OXYMONITOR, Pres-R-Cuff, PRESSURE-SCRIBE, QMI, QS, Quantitative Medicine, Quantitative Sentinel, RAC RAMS, RSVP, SAM, SEER, SILVERTRACE, SOLAR, SOLARVIEW, Spectra 400, Spectra-Overview, Spectra-Tel, ST GUARD, TRAM, TRAM-NET, TRAM-RAC, TRAMSCOPE, TRIM KNOB, Trimline, UNION STATION, UNITY logo, UNITY NETWORK, Vari-X, Vari-X Cardiomatic, VariCath, VARIDEX, VAS, and Vision Care Filter are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office. 12SL, 15SL, Access, AccuSpeak, ADVANTAGE, BAM, BODYTRODE, Cardiomatic, CardioSpeak, CD TELEMETRY®-LAN, CENTRALSCOPE, Corolation, EDIC, EK-Pro, Event-Link Cirrus, Event-Link Cumulus, Event-Link Nimbus, HI-RES, ICMMS, IMAGE VAULT, IMPACT.wf, INTER-LEAD, IQA, LIFEWATCH, Managed Use, MARQUETTE PRISM, MARQUETTE® RESPONDER, MENTOR, MicroSmart, MMS, MRT, MUSE CardioWindow, NST PRO, NAUTILUS, O2SENSOR, Octanet, OMRS, PHiRes, Premium, Prism, QUIK CONNECT V, QUICK CONNECT, QT Guard, SMART-PAC, SMARTLOOK, Spiral Lok, Sweetheart, UNITY, Universal, Waterfall, and Walkmom are trademarks of GE Medical Systems Information Technologies. © GE Medical Systems Information Technologies, 2001, 2002, 2003, 2004. All rights reserved.
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CE Marking Information
CE Marking Information Compliance The SEER Light Ambulatory Recorder/Controller bears the CE mark “CE-0459”, notified body GMED, indicating its conformity with the provisions of the Council Directive 93/42/EEC, concerning medical device 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 safety and effectiveness of this device has been verified against previously distributed devices. Although all standards applicable to presently marketed devices may not be appropriate for prior devices (i.e. electromagnetic compatibility standards), this device will not impair the safe and effective use of those previously distributed devices. Any other directive(s) and all the standards the product complies to are listed in the general information of the operator manual for the product following this page.
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CE Marking Information
For your notes
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Contents
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Manual Information... 1-1 Manual Information... 1-3 Revision History... 1-3 Manual Purpose... 1-3 Intended Audience... 1-3 Product References... 1-4 Conventions... 1-4 Safety Information... 1-5 Intended Use... 1-5 Definitions... 1-6 Messages... 1-7 Warnings... 1-7 Cautions... 1-8 Responsibility of the Manufacturer... 1-9 General... 1-9 Classification... 1-10 Underwriters Laboratories, Inc... 1-10 Equipment Symbols... 1-11 Service Information... 1-12 Requirements... 1-12
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Equipment Overview... 2-1 General Information... 2-3 SEER Light Ambulatory Recorder... 2-4 SEER Light Controller... 2-6 Pouch... 2-9 Operating Modes... 2-10 SEER mode... 2-10 Transfer mode... 2-10 Set-Up Condition mode... 2-10 Set-up Condition Mode... 2-10
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Parameter Descriptions and Configuration... 2-11 Battery Power... 2-12 Care and Cleaning... 2-13
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Preparing the Patient... 3-1 Electrode Placement... 3-3 Two Channel, Five Electrode... 3-3 Three Channel, Seven Electrode... 3-4 Modified V3 Leads... 3-4 Modified aVF Leads... 3-5 Modified Z Leads... 3-6 Skin Preparation... 3-7 Patient Hookup... 3-8 Pouch... 3-10 Holter ECG Patient Diary... 3-11 Set Up the Patient Diary... 3-11 Instruct the Patient... 3-11 Activity Restrictions... 3-11 Keeping Track... 3-11 Shorter Test... 3-12
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Entering Patient Data... 4-1 Before Operation... 4-3 Deleting Old Data... 4-3 Operating the Controller... 4-4 Entering Patient Information... 4-4 Alphanumeric Entry... 4-4 Choosing a Letter to Enter... 4-4
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Recording Data... 5-1 Operating... 5-3 Before Recording... 5-3 After Recording... 5-3
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Connect the Patient Cable... 5-4 Check the Leads... 5-5 Confirming ECG Recording... 5-6 Wireless Data Transfer... 5-6 Considerations... 5-6 Procedure... 5-7 Interruption of Infrared Communication... 5-7 Confirming Pacemaker Pulses... 5-8 Starting the Recorder... 5-9 Startup with the Controller... 5-9 Insert Batteries in the Recorder... 5-9 Starting Recording... 5-11 Data Remaining on the Recorder... 5-11 Starting the Recorder without the Controller... 5-12 Disconnecting the Recorder... 5-13
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Transferring Data... 6-1 Transferring Data to the Holter Analysis System... 6-3 Transferring Data to the Controller... 6-4 Flash Cards - Supplementary Information... 6-6 Confirming Flash Card Contents... 6-6 Confirming Patient Information... 6-6 Displaying the ECG Waveform... 6-7 Transferring Data to the Holter Analysis System... 6-8
Appendices
Troubleshooting...A-1 Troubleshooting Chart... A-3
Accessories...B-1 Accessories... B-3
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For your notes
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Manual Information
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For your notes
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Manual Information: Manual Information
Manual Information Revision History Each page of the document has the document part number followed by a revision letter at the bottom of the page. The revision letter identifies the document’s update level.
Table 1. Revision History PN 2008626-006 Revision
Date
Comment
A
21 December 2001
Initial release of this document.
B
23 September 2002
Revised to reflect minor editorial changes.
C
13 February 2004
Revised CE Compliance information.
Manual Purpose This manual contains the instructions necessary to operate the equipment safely in accordance with its function and intended use. These instructions include but are not limited to:
an explanation of the function of controls and indicators the sequence of operation connection and disconnection of detachable parts and accessories instructions for operator cleaning, preventive inspection and maintenance
Where necessary, the manual identifies additional sources of relevant information and/or technical assistance.
Intended Audience The SEER Light Ambulatory Recorder/Controller is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.
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Manual Information: Manual Information
Product References Regardless of the Holter analysis system (MARS PC workstation or MARS Unity workstation) used, the product will be referred to as “SEER Light Ambulatory Recorder/Controller” throughout this document. Instances where functionality differs due to Holter analysis system will be called out specifically.
Conventions These are the conventions used in this manual. Table 2. Styles Style
Definition
Bold text
Indicates keys on the keyboard, text to be entered, or hardware items such as buttons or switches on the equipment.
Italicized text
Indicates software terms that identify menu items, buttons or options in various windows.
Ctrl+Esc
Indicates a keyboard operation. A (+) sign between the names of two keys indicates, you press and hold the first key while pressing the second key once. For example, “Press Ctrl+Esc” means to press and hold down the Ctrl key while pressing the Esc key.
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<Space>
Indicates that you must press the spacebar. When instructions are given for typing a precise text string with one or more spaces, the point where the spacebar must be pressed is indicated as: <Space>. The purpose of the < > brackets is to ensure you press the spacebar when required.
Enter
Indicates that you must press the “Enter” or “Return” key on the keyboard. Do not type “enter”.
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Manual Information: Safety Information
Safety Information Intended Use The SEER Light recorder is a two and three channel digital Holter ECG recorder that records the electrical signals associated with cardiac activity for 24 hours. It is used in diagnosing cardiac abnormalities and revealing trends or changes in heart function. This device is for the use of trained personnel only. This device is not intended for use on patients weighing less than 10 kg.
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Manual Information: Definitions
Definitions The terms danger, warning, and caution are used throughout this manual to point out hazards and to designate a degree or level of seriousness. Familiarize yourself with their definitions and significance. Hazard is defined as a source of potential injury to a person. DANGER indicates an imminent hazard which, if not avoided, will result in death or serious injury. WARNING indicates a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury. CAUTION indicates a potential hazard or unsafe practice which, if not avoided, could result in minor personal injury or product/property damage. NOTE provides application tips or other useful information to assure that you get the most from your equipment.
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Manual Information: Definitions
Messages Additional safety messages may be found throughout this manual that provide appropriate safe operation information.
Warnings :$51,1*6 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 technician before it is used again. CABLES - Use of any patient cables other than those specified in this document is unsafe. CARDIAC APPLICATION - This device cannot be used for direct cardiac application. CONDUCTIVITY - Keep the conductive parts of lead electrodes and associated parts away from other conductive parts, including earth. DEFIBRILLATION - Do NOT contact unit or patient during defibrillation. Disconnect leadwires from patient before defibrillating. Otherwise serious injury or death could result. DISPOSAL - Dispose of the packaging material, observing the applicable waste regulations and keeping it out of childrens’ reach. ELECTROSURGERY - If an electrosurgery device is used, it is necessary to disconnect the patient cable from the SEER Light recorder. Take precautions to reduce risks of burns and injury to the patient. PACEMAKER PATIENTS - Take precautions to avoid risks of hazard due to the operation of a cardiac pacemaker or other electrical stimulators.
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Manual Information: Definitions
:$51,1*6 STRANGULATION HAZARD - Route all cables away from the patient’s throat to avoid possible strangulation. SUPERVISED USE - This device is intended for use under the direct supervision of a licensed health care practitioner.
Cautions &$87,216 BEFORE OPERATION - Check that the instrument operates properly. When using with other instruments, request the assistance of a specialist. DISPOSAL - At the end of its service life, the product described in this manual, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have questions concerning the disposal of this product, contact GE or its representatives. INSTRUCTIONS FOR USE - For continued safe use of this equipment, it is necessary that the listed instructions are followed. However, instructions listed in this manual IN NO WAY supercede established medical practices concerning patient care. MODIFICATIONS - Do not make any modifications to the device. RESTRICTED SALE - U.S. Federal law restricts this device to sale by or on the order of a physician.
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Manual Information: Responsibility of the Manufacturer
Responsibility of the Manufacturer GE Medical Systems Information Technologies is responsible for the effects of safety, reliability, and performance only if:
Assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE Medical Systems Information Technologies.
The equipment is used in accordance with the instructions for use.
General This device is intended for use under the direct supervision of a licensed health care practitioner. To ensure patient safety, use only parts and accessories manufactured or recommended by GE Medical Systems Information Technologies. Contact GE Medical Systems Information Technologies for information before connecting any devices to this equipment that are not recommended in this manual. Parts and accessories used must meet the requirements of the applicable IEC 60601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard. The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: use of the accessory in the PATIENT VICINITY; and
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evidence that the safety certification of the ACCESSORY has been performed in accordance with the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard.
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Manual Information: Classification
Classification The device is classified, according to IEC 60601-1, as: Type of protection against electrical shock
Internally Powered Equipment
Degree of protection against electrical shock
Type B Equipment
Degree of protection against harmful ingress of water
Ordinary Equipment (enclosed equipment without protection against ingress of water)
Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide
Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide
Method(s) of sterilization or disinfection recommended by the manufacturer
Not applicable
Mode of operation
Continuous operation
Underwriters Laboratories, Inc. Classified by Underwriters Laboratories Inc. with respect to electric shock, fire, mechanical and other specified hazards, only in accordance with UL 2601-1, CAN/CSA C22.2 No. 601.1, IEC 60601-1, and IEC 60601-2-47.
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Manual Information: Equipment Symbols
Equipment Symbols The following symbols may appear on the equipment. Attention. Consult accompanying documents.
Event.
This symbol indicates the polarity orientation that each battery should have when you insert it into the unit. This unit requires you to insert the batteries so that the polarities are oriented in alternating directions. Power.
Stop.
Input connector.
Output connector.
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Manual Information: Service Information
Service Information Requirements Refer equipment servicing to GE Medical Systems Information Technologies’ authorized service personnel only. Any unauthorized attempt to repair equipment under warranty voids that warranty. It is the user’s responsibility to report the need for service to GE Medical Systems Information Technologies or to one of their authorized agents. Every GE Medical Systems Information Technologies device has a unique serial number for identification. The serial number appears on the device label similar to the one shown below.
50A
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