GE SEER Light, SEER Light Extend Ambulatory Recorder, SEER Light Extend Ambulatory Controller, SEER Light Connect Device Service Manual

SEER® Light
Ambulatory Recorder/Controller
Service Manual
Software Version 1
2019818-008 Revision B
Service Instructions for:
SEER Light/SEER Light Extend Controller
SEER Light Connect
NOTE: The information in this manual only applies to SEER Light devices 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.
Marquette®, MARS®, MUSE®, and SEER® are trademarks owned by GE Medical Systems Information Technologies, a General Electric Company going to market as GE Healthcare. All other marks are owned by their respective owners.
© 2005 General Electric Company. All rights reserved.
T-2 SEER Light Ambulatory Recorder/Controller Revision B
2019818-008 15 July 2005
Contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Manual Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Manual Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Related Manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7
Serial Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8
Disposal of the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9
Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
Information Technology Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11
Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
2 SEER Light/SEER Light Extend Recorder . . . . . . . . . . . 2-1
Component Names and Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Self-Test Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5
No Buzzer Sound After Installing the Batteries . . . . . . . . . . . . . . . . . . . . . . .2-6
Beep Sound Will Not Stop After Installing the Batteries . . . . . . . . . . . . . . . .2-7
ECG Cannot Be Previewed with Controller (I.R.) . . . . . . . . . . . . . . . . . . . . .2-8
ECG Cannot be Previewed with Controller (Cable) . . . . . . . . . . . . . . . . . . . .2-9
ECG Cannot Be Previewed with SEER Light Connect Device . . . . . . . . . .2-10
Recording Cannot Start with the Controller (I.R.) . . . . . . . . . . . . . . . . . . . .2-11
Recording Cannot Start with the SEER Light Connect Device . . . . . . . . . .2-12
Cannot Start by Pressing the Start Button . . . . . . . . . . . . . . . . . . . . . . . . . .2-13
Cannot Record for 24 Hours . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Cannot Record for 48 Hours . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Cannot Transfer Data from the Controller . . . . . . . . . . . . . . . . . . . . . . . . . .2-16
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Cannot Transfer Data from the Recorder to the
SEER Light Connect Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17
Record Start Date/Time is Initialized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
Artifact on ECG Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19
Cannot Detect Pacemaker Pulse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20
3 SEER Light/SEER Light Extend Controller . . . . . . . . . . . 3-1
Component Names and Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Software Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
Self-Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
No Operation After Inserting Batteries and Pressing Power Button . . . . . . . . . . .3-6
ECG Cannot be Previewed with the Controller (I.R.) . . . . . . . . . . . . . . . . . . . . . . .3-7
ECG Cannot be Previewed by the Controller (Cable) . . . . . . . . . . . . . . . . . . . . . .3-8
Cannot Start Recording (I.R.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9
Pressing the Appropriate Key(s) Does Not Start Operation . . . . . . . . . . . . . . . . .3-10
Beep Sounds While the Flash Card is Inserted . . . . . . . . . . . . . . . . . . . . . . . . . .3-11
Data Cannot be Transferred from the Recorder . . . . . . . . . . . . . . . . . . . . . . . . .3-12
Recording Start Date/Time is Not Correct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13
Time is Not Correct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
4 SEER Light Connect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Component Names and Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Software Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
ECG Cannot Be Previewed with SEER Light Connect Device . . . . . . . . . . .4-5
Recording Cannot Start with the SEER Light Connect Device . . . . . . . . . . .4-6
Cannot Transfer Data from the Recorder to the
SEER Light Connect Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
Recording Start Date/Time is Not Correct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8
5 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
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Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
Cleaning Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
Storing the Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Maintenance/Repair Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Maintenance/Repair Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . .A-1
Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
SEER Light/SEER Light Extend Ambulatory Recorder . . . . . . . . . . . . . . . . . . . . .A-3
SEER Light Ambulatory Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A -4
SEER Light Connect Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-5
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . .B-1
Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions . . . . . . .B-3
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity . . . . . . . .B-4
Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-6
Compliant Cables and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-7
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1
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iv SEER Light Ambulatory Recorder/Controller Revision B
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1 Introduction

Revision B SEER Light Ambulatory Recorder/Controller 1-1
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For your notes
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Introduction: Manual Information

Manual Informatio n

Revision History

Each page of the document has the document part number followed by a revision letter at the bottom of the page. This letter identifies the document’s update level. The latest letter of the alphabet corresponds to the most current revision of the document.
The revision history of this document is summarized in the table below.
Table 1. Revision History 2019818-008
Revision Date Comment
A 15 May 2005 Initial release of manual. B 15 July 2005 Manual updated for clarity.

Manual Purpose

Definitions
This manual supplies technical information for service representative and technical personnel so they can maintain the equipment. Use it as a guide for maintenance and electrical repairs considered field repairable. Where necessary the manual identifies additional sources of relevant information and or technical assistance.
See the operator manual for the instructions necessary to operate the equipment safely in accordance with its function and intended use.
Items shown in Black text are keys on the keyboard, text to be
entered, or hardware items such as buttons or switches on the equipment.
Items shown in Italicized text are software terms which identify
menu items, buttons, or options in various windows.
To perform an operation which appears with a plus (+)sign between
the names of two keys, you press and hold the first key while pressing the second key once. This is called a keystroke combination.
For example, “Press Ctrl + Esc” means to press and hold down the Ctrl key while pressing the Esc key.
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: you press the spacebar when required.
Revision B SEER Light Ambulatory Recorder/Controller 1-3
<Space>. The purpose of the < > brackets is to ensure
2019818-008
Introduction: Manual Information
Enter means to press the “Enter” or “Return” key on the keyboard.
Do not type “enter”.
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Introduction: Related Manuals

Related Manuals

See the documents listed below for additional information.
Table 2. SEER Light Documents
Part Number Name
2019818-007 SEER Light Ambulatory Recorder/Controller Operator’s Manual
Revision B SEER Light Ambulatory Recorder/Controller 1-5
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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 fo r 24 or 48 h our s . It i s u se d in diagnosing card i ac a bno r mal i t ie s 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 infants weighing less than 10 kg (22 lbs).

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.
Introduction: Safety Information
Warnings
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.
WARNINGS
ACCIDENTAL SPILLS — If liquids have entered a device, take it out of service and have it checked by a service technician before it is used again. To avoid electric shock or device malfunction liquids must not be allowed to enter the device.
CABLES — To avoid possible strangulation, route all cables away from patient's throat.
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.
DEFIBRILLATOR PRECAUTIONS — Do not come into
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Introduction: Safety Information
contact with patients during defibrillation. Otherwise, serious injury or death could result. Patient signal inputs labeled with the CF and BF symbols wi th paddles are protected against damage resulting from defibrillation voltages. To ensure proper defibrillator protection, use only the recommended cables and leadwires. Proper placement of defibrillator paddles in relation to the electrodes is required to ensure successful defibrillation.
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.
LEAKAGE CURRENT — Electrical shock to patient could result from component failure and lack of power isolation.
In the event this syste m is used in the patient vicinity, it must be configured in such a way that it and all of its electrically-connecte d peripheral devices ar e isolated from mains power to prevent excessive leakage current to the patient. This can be accomplished through the use of isolated mains power, or a medical grade isolation transformer (in compliance with UL 60601, CAN/CSA C22.2 No. 601.1, IEC 60601-1) with this system. All non­medical peripheral devices shall comply with IEC and ISO safety standards that are relevant to that equipment (i.e., IEC 60950, UL 60950).
Cautions
Use of the SEER Light Connect device in the patient vicinity requires that these measures are observed.
PACEMAKER PATIENTS — Take precautions to avoid risks of hazard due to the operation of a cardiac pacemaker or other electrical stimulators.
SUPERVISED USE — This device is intended for use under the direct supervision of a licensed health care practitioner.
CAUTIONS
RESTRICTED SALE — U.S. federal law restricts this device to sale by or on the order of a physician.
BEFORE OPERATION — Check that the instrument operates properly.
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 local, state, or federal
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Introduction: Safety Information
A
guidelines regulating the disposal of such products. If you have questions concerning dispos al of the product , please contact GE or its representatives.
MODIFICATIONS — Do not make an y modifications to the device.
AFTER DEVICE USE — Clean the device after each use to ensure trouble-free op eration for the next use.
Use a piece of damp cloth with alcohol to clean the
device and the patient cable.
The device cannot be sterilized. Do not use xylene and petrol related liquid for
cleaning the device.
To ensure proper operation of the device, it is
necessary to periodically have the device checked by authorized service personnel.
Check the patient cable and connectors every month
by connecting them to an ECG simulator.

Serial Number

INSTALLATION — Adhere to the following recommendations during installation:
Install and keep device away from splashing water. Do not install the device where it may be affected by
humidity, ventilation, direct sunlight, air conditioning, dust, salt, sulfur, etc.
Prevent the device from ti lting, and protect it from
the possibility of vibration or shock.
Do not install the device in a chemical storage area or
where gas is generated.
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
.
50
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Disposal of the Device

Introduction: Safety Information
When disposing the device, follow the applicable national rules and regulations of disposal of medical equipment.
When disposing the recyclable battery, follow the applicable national rules and regulations concerning the environmental issues.
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Introduction: Responsibility of the Manufacturer

Responsibility of the Manu facturer

GE is responsible for the effects of safety, reliability, and performance only if:
Assembly operations, extensions, readju stments, modifications, or
repairs are carrie d out by persons aut horized b y GE Medica l Systems Information Technologies.
The equipment is used in accordance with the instructions for use.

General

Refer equipment servicing to GE authorized service personnel only. Any unauthorized attempt to repair equipment under warranty voids that warranty.
It is the user’s respons ibility t o report the need for se rvice to GE or to one of its authoriz ed agents.
This device is intended for use under the direct supervision of a licensed health care practitioner.
To ensure patient safety, use only parts and access ories manufactured or recommended by GE.
Contact GE for information before connecting any devices to this equipment that are not recommended in this manual.
Parts and accessories used must meet t he requireme nts of t he appli cable IEC 60601 series sa fety st andard s, and/ or t he sy stem co nfigura tion mus t 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 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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Introduction: Responsibility of the Manufacturer

Information Technology Equipment

The hardware components supplied by GE for the MARS® Holter analysis workstation, on which the SEER Light Connect application runs, are considered to be Information Technology Equipment (ITE). These individual components have been found to comply with the standard for Safety of Information Technology Equipment, including Electrical Business Equipment EN60950 (UL 60950).
The software used in the MARS® Holter analysis workstation is considered as medical software. The software has been designed and manufactured to the appropriate medical regulations and controls.
In order for the MARS® Holter analysis workstation to comply with medical equipment standard leakage current requirements, a medical grade uninterruptible power supply (UPS) must be used (UL 60601-1, CSA 22.2 No. 60601-1, EN 60601-1) to power all non-medical equipment.
In addition, non-medical electrical equipment must comply with IEC and ISO safety standards that are relevant to that equipment (i.e., IEC 60950, Safety of Information Technology Equipment.)
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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.
Introduction: Equipment Symbols
Stop.
Input connector.
Output connector.
This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.
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2 SEER Light/SEER Light
Extend Recorder
Revision B SEER Light Ambulatory Recorder/Controller 2-1
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For your notes
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SEER Light/SEER Light Extend Recorder: Component Names and Locations

Component Names and Locations

Structure

The SEER Light ambulatory recorder is shown and described below.
A B
.60 in.
(15 mm)
I H G
2.17 in.(55 mm)
F E D
Table 3. SEER Light Ambulatory Recorder
Item Name Description
A REC LED To display operation conditions:
After pressing the start/event button, the LED will flash twice per second for three
minutes. During this time data is not recorded.
During reco rding, the LED will flash every second.
C
3.35 in.
(85 mm)
J
017A
B
start/event button
Use to start recording.Use to mark events during recording.
C battery compartment cover Slide the cover to open and set the batteries in the battery compartment. D
A data output
For transfer of data to the SEER Light controller or to the SEER Light Connect device.
connector E access LED Will flash during communication with the SEER Light controller. F infrared terminal (I.R. Window) Used to receive the signal from the SEER Light controller to begin ECG recording.
Used to receive patient information and ECG recording starting time.Used to confirm the ECG waveform recorded by the recorder (ECG preview).
G
B output connector
Not used.
H DATA LED The LED flashes while transferring data to the SEER Light controller.
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SEER Light/SEER Light Extend Recorder: Component Names and Locations
Table 3. SEER Light Ambulatory Recorder (Continued)
I patient cable connector Used to connect patient cable for ECG input.
J Stop button Push to stop recording
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SEER Light/SEER Light Extend Recorder: Troubleshooting

Troubleshooting

Self-Test Mode
A self-test can be done on the following functions.
1. Self-test I (pacemaker detection check mode)
Provide a pacemaker signal to the recorder with an ECG simulator. To enter the pacemaker detection mode, set the batteries while
pressing the STOP button.
Confirm the audible sound synchronizes with the pacemaker
signal input through the patient input connector.
Remove the batteries to end the self-test.
2. Self-tes t II (accelerometer sensor check mode)
After setting the batteries, press the STOP button three times
within a second.
Confirm the audible so und synchronizes as the recorder is moved
around.
Remove the batteries to end the self-test.
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SEER Light/SEER Light Extend Recorder: Troubleshooting
No Buzzer Sound After Installing the Batteries
No buzzer sound after installing the batteries.
Are the batteries
installed properly?
Yes
Are the batteries
new?
Yes
Were the batteries reinstalled over 10
seconds after the
batteries were
removed?
Yes
No
Install the batteries
properly.
No
Replace with new
batteries.
No
Reinstall the batteries over 10 seconds after
removing them.
Are the battery
electrodes clean and
properly soldered?
Yes
Call GE service.
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No
Call GE service.
SEER Light/SEER Light Extend Recorder: Troubleshooting
Beep Sound Will Not Stop After Installing the Batt eries
Beep sound will not stop
after installing the batteries.
Are the batteries new?
Yes
Are the alkaline
batteries
installed?
Yes
Call GE service.
No
Replace with new alkaline batteries.
No
Set new alkaline
batteries.
Revision B SEER Light Ambulatory Recorder/Controller 2-7
2019818-008
SEER Light/SEER Light Extend Recorder: Troubleshooting
ECG Cannot Be Previewed with Controller (I.R.)
ECG cannot be previewe d
with the controller (I.R.).
Is the dista nce from the controller withi n
4.9 ft. (1.5 m)?
No
Yes
Is the I.R.
window facing the
controller properly?
Yes
Were the batteries
set within one hour?
Yes
Has recording
already started?
Position the controller
within 4.9 ft (1.5 m).
No
Reposition the I.R . window
properly to the controller,
or remove any obstacle
between the recorder and
the controller.
No
Reset the batteries.
Yes
No
Call GE service.
2-8 SEER Light Ambulatory Recorder/Controller Revision B
2019818-008
Preview ECG with the cable. Cannot preview ECG by I.R.
operation if more than 3
minutes has elapsed since
recording started.
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