GE Healthcare SEER Light Extend, Ambulatory Recorder Operator's Manual

GE Healthcare

SEER

®

Light

Ambulatory Recorder/Controller

Operator's Manual

2040604-012 Revision D

The information in this manual only applies to SEER

®

Light devices. 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.

© 2008-2009 General Electric Company. All rights reserved.

T-2 SEER

®

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14 April 2009

CE Marking Information


Compliance

NOTE

This CE mark information is part of the operator manual and is applicable for all products marketed and distributed by GE Medical

Systems Information Technologies in the European community.

These SEER

®

Light devices bear the CE mark 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”.

NOTE

Refer to the SEER Light service manual for additional compliance and exception information.

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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Contents

Manual Information

Manual Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

Manual Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Product References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9

Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

Underwriters Laboratories, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

Information Technology Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

Service Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14

Serial Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

Equipment Overview

General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

SEER Light Device Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

SEER Light/SEER Light Extend Compact Digital Holter Recorder . . . . . . . . . . . . 2-3

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4

SEER Light Extend Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

SEER Light Connect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Installing SEER Light Hookup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

Pouch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Operating Modes - SEER Light Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

SEER mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11

Transfer mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Set-up Condition Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Selecting a Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Parameter Descriptions and Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13

Battery Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Battery Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16

Care and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16

Storage and Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16

Preparing the Patient

Placing Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Two Channel, Five Electrode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2

Three Channel, Seven Electrode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

Preparing the Skin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Hooking Up the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Pouch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Holter ECG Patient Diary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Setting Up the Patient Diary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9

Instructing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Audible Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9

Activity Restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10

Keeping Track . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10

Shorter Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10

Entering Patient Data

Entering Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Using the SEER Light Extend Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2

Using the SEER Light Connect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4

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A

B

Recording Data

Operating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Before Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

After Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

Connecting the Patient Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Checking the Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Confirming ECG Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Starting the SEER Light Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

Inserting Batteries in the SEER Light Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Begin Recording with SEER Light Extend Controller . . . . . . . . . . . . . . . . . . . . . . 5-13

Begin Recording with SEER Light Connect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14

Begin Recording with SEER Light Recorder Button . . . . . . . . . . . . . . . . . . . . . . 5-14

Disconnecting the SEER Light Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Transferring Data

Transferring Data to the Holter Analysis System. . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Transferring to the Flash Card using the SEER Light Extend Controller . . . . . . . .6-2

Confirming Flash Card Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-5

Confirming Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-5

Displaying the ECG Waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6

Transferring Data to the Holter Analysis System via Flash Card . . . . . . . . . . . . . .6-6

Transferring Data to the Holter Analysis System via Connect . . . . . . . . . . . . . . . .6-7

Analyzing Waveforms and Patient Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-8

Troubleshooting

Troubleshooting Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

Accessories

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2

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Manual Information

2040604-012D SEER

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This manual includes operator’s instructions for:

SEER Light/SEER Light Extend Compact Digital Holter Recorder

SEER Light Extend Controller

SEER Light Connect

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.

Revision

A

B

C

D 14 April 2009

Revision History PN 2040604-012

Date

30 April 2008

11 August 2008

19 September 2008

Comment

Initial release of this document.

Revised to include the word "Greece" to Greek address on backcover.

Revised manual to reflect Suzuken responsibility and new controller configuration.

Revised to change CF Card part number.

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.

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Intended Use

The SEER Light recorder/SEER Light Extend recorders are designed to acquire 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients. The devices store data along with patient demographic information to on-board flash memory; they do not perform any analysis on the ECG data. These devices are intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional facility.

This device is not intended for use on patients weighing less than 10 kg

(22 lbs.).

Intended Audience

This manual is intended for an operator of the SEER Light devices. The

SEER Light operator requires some training to become familiar with the capabilities and operations of the devices.

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 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.

Style

Bold text

Italicized text

Styles

Definition

Indicates keys on the keyboard, text to be entered, or hardware items such as buttons or switches on the equipment.

Indicates software terms that identify menu items, buttons or options in various windows.

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Style

Ctrl+Esc

Styles

Definition

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.

<Space>

Enter

Illustrations

All illustrations in the manual are provided as examples only. All patient names and data are fictitious, and any similarity to actual persons is coincidental.

Safety Information

Definitions

For example, “Press Ctrl+Esc” means to press and hold down the Ctrl key while pressing the Esc key.

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.

Indicates that you must press the “Enter” or “Return” key on the keyboard. Do not type “enter”.

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.

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Messages

Warnings


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.

Additional safety messages may be found throughout this manual that provide appropriate safe operation information.

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 technician before it is used again.

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WARNING

CARDIAC APPLICATION — This device cannot be used for direct cardiac application.

WARNING

LEAKAGE CURRENT — Electrical shock to patient could result from component failure and lack of power isolation.

In the event this system is used in the patient vicinity/ environment, it must be configured in such a way that it and all of its electrically-connected peripheral devices are isolated from mains power to prevent excessive leakage current to the patient. Use of isolated mains power, or a medical grade isolation transformer (in compliance with

UL 60601, CAN/CSA C22.2 No. 601.1, EN/IEC 60601-1) with this system will support compliance with EN/IEC

60601-1-1. All nonmedical peripheral devices shall comply with applicable EN/IEC/ISO and UL safety standards that are relevant to that equipment (i.e., EN/

IEC 60950, UL 60950). The overall system (device and all of its connected peripheral devices) must comply with EN/

IEC 60601-1.

Use of SEER Light Connect device in the patient vicinity requires that these measures are observed.

Patient vicinity/environment defined as:

Any volume in which intentional or unintentional contact can occur between patient and parts of the system or between patient and other persons touching parts of the system (IEC 60601-1-1).

A space (volume), within a location intended for the examination and treatment of patients, extending 6 ft

(1.83 m) beyond the normal location of the bed, chair, table, treadmill, or other device that supports the patient during examination and treatment and extending vertically to 8 ft 2.4 in. (2.5 m) above the floor.

Areas where healthcare staff members monitor patients remotely and perform charting and administrative tasks are not considered to be Patient

Vicinity/environment areas.

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WARNING

PACEMAKER PATIENTS — Take precautions to avoid risks of hazard due to the operation of a cardiac pacemaker or other electrical stimulators.

WARNING

RF INTERFERENCE — Known RF sources, such as cell phones, radio or TV stations, and two-way radios, may cause unexpected or adverse operation of this device.

Consult qualified personnel regarding system configuration.

WARNING

CABLES — Cables present a possible strangulation hazard.

To avoid possible strangulation, route all cables away from patient's throat.

Use short version of cables for pediatric patients.

WARNING

CONDUCTIVITY — Electric shock or device malfunction may occur if electrodes contact conductive materials.

Keep the conductive parts of lead electrodes and associated parts away from other conductive parts, including earth.

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WARNING

DEFIBRILLATION — Do NOT contact unit or patient during defibrillation. Serious injury or death could result.

Patient signal inputs labeled with the CF and BF symbols with 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.

WARNING

ELECTROSURGERY — Take precautions to reduce risks of burns and injury to the patient.

If an electrosurgery device is used, it is necessary to disconnect the patient cable from the SEER Light recorder.

WARNING

OXYGEN RICH ENVIRONMENT — An oxygen rich environment may be flammable.

Do not use device in an oxygen rich environment or around other flammable or explosive gases.

WARNING

SUPERVISED USE — This device is intended for use under the direct supervision of a licensed health care practitioner.

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Cautions


CAUTION

BEFORE OPERATION — Check that the instrument operates properly.

See Chapter 5 of the SEER™ Light Ambulatory Recorder/

Controller Service Manual for proper maintenance practices.

When using with other instruments, request the assistance of a specialist.

CAUTION

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.

Dispose of the packaging material, observing the applicable waste regulations.

Keep the packaging material out of children’s reach.

CAUTION

EQUIPMENT CONFIGURATION — The equipment or system should not be used adjacent to, or stacked with other equipment.

If adjacent or stacked use is necessary, test the equipment or system to verify normal operation.

CAUTION

INTERFERENCE — Electrical emissions from an electric blanket may degrade signal quality.

Do not use in conjunction with an electric blanket.

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CAUTION

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 supersede established medical practices concerning patient care.

CAUTION

MODIFICATIONS — Do not make any modifications to the device. You will void the device’s warranty. See

“Responsibility of the Manufacturer” on page 1-10.

CAUTION

RESTRICTED SALE — U.S. Federal law restricts this device to sale by or on the order of a physician.

Responsibility of the Manufacturer

Suzuken Company, Ltd 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 Suzuken Company,

Ltd.

The equipment is used in accordance with the instructions for use.

General

To ensure patient safety, use only parts and accessories manufactured or recommended by GE Medical Systems Information Technologies, and

Suzuken Company, Ltd.

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

EN/IEC/UL 60601 or EN/IEC/UL 60950 series safety standards, and the

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system configuration must meet the requirements of the EN/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/ENVIRONMENT; and evidence that the safety certification of the ACCESSORY has been performed in accordance with the appropriate EN/IEC/UL 60601-1

(medical) or EN/IEC/UL 60950 (information technology), and EN/

IEC 60601-1-1 safety standard(s).

Classification

The SEER Light Connect is classified according to EN/IEC 60950.

The SEER Light recorders and controllers are classified, according to

EN/IEC/UL 60601-1, as:

Type of protection against electrical shock Internally Powered Equipment

Degree of protection against electrical shock

Degree of protection against harmful ingress of water

Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide

Type B Equipment

Ordinary Equipment (enclosed equipment without protection against ingress of water)

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

Mode of operation

Not applicable

Continuous operation

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Underwriters Laboratories, Inc.

Classified by Underwriters Laboratories Inc. with respect to electric shock, fire, mechanical and other specified hazards, only in accordance with UL 60601-1, CAN/CSA

C22.2 No. 601.1, EN/IEC 60601-1, and IEC 60601-2-47.

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 EN/IEC/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 leakage current requirements, a medical grade uninterruptible power supply (UPS) must be used (EN/IEC/UL 60601-1) to power all non-medical equipment.

In addition, non-medical electrical equipment must comply with EN/IEC/

UL safety standards that are relevant to that equipment (i.e., IEC 60950,

Safety of Information Technology Equipment).

Equipment Symbols

The following symbols may appear on the equipment.

Attention. Consult accompanying documents.

Manufacturer name and address.

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European authorized representative.

Serial Number.

USA only. For use by or on the order of a physician, or person licensed by state law.

Type B applied Part.

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.

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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.

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.

Serial Number

The serial number is a unique number used for identification. The serial number appears on the device label located on the back of the device, similar to the following.

1-14 SEER

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089A

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2

Equipment Overview

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General Information

For safe and effective operation, read this manual thoroughly prior to use.

NOTE

It is unsafe to start using the device before reading this entire manual.

SEER Light/SEER Light Extend Compact Digital Holter Recorder

1A

SEER Light Extend Controller with Compact Flash Card

2B

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084A

SEER Light Connect

SEER Light Device Compatibility

There are two types of recorders and controllers, with different capabilities: SEER Light and SEER Light Extend.

The SEER Light recorder acquires, stores and transfers up to 24 hours of ECG data.

The SEER Light Extend recorder and SEER Light Extend controller acquires, stores and transfers up to 48 hours of ECG data.

CAUTION

DATA TRANSFER — The SEER Light Extend recorder works with the 24-hour SEER Light controller for setup, but not for transferring data. The 24-hour SEER Light controller is no longer available.

Always use the SEER Light Extend recorder with the

SEER Light Extend controller when transferring data.

NOTE

The 24-hour SEER Light recorder can be used with the SEER Light

Extend controller.

SEER Light/SEER Light Extend Compact Digital

Holter Recorder

The SEER Light/SEER Light Extend Compact Digital Holter Recorder is shown and described below. This device is also referred to as “the recorder” in this document.

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NOTE

There are two recorders available: The SEER Light recorder that records up to 24 hours of ECG data, and the SEER Light Extend recorder that records up to 48 hours of ECG data. The stenciled label on each device identifies the recorder name.

2-4

A

B

C

D

E

Name

Battery box cover

Battery box

REC LED

Function

Slide the cover to open and set the batteries in the battery box.

NOTE

Do not open in patient vicinity.

Holds the batteries.

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 recording, the LED will flash every second.

Use to start recording.

Use mark events during recording.

3A

Start/event button

Patient cable connector Used to connect patient cable.

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F

G

DATA LED

Name Function

The LED lights while transferring data to the SEER

Light controller or SEER Light connect.

For transfer of data to the SEER Light controller or

SEER Light connect.

A data output connector

H

J

I

K

B output connector

Access LED

Infrared terminal (IR Window)

Not used.

NOTE

Do not connect to any unauthorized device.

Will flash during communication with the SEER

Light controller.

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).

Push this button with a ball point pen to stop the recording before 24 hours have elapsed (or 48 hours with the SEER Light Extend recorder).

Stop button

SEER Light Extend Controller

The SEER Light Extend Controller is shown and described below. This device is also referred to as “the controller” in this document.

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2-6

7

8

5

6

1

2

3

4

Name

Battery box

Battery box cover

Data transfer cable

Function buttons

F6 button

Select (ENT) button

Function

Holds the batteries.

In direction indicated, lift the cover open and place four new alkaline AAA type batteries in the battery box.

Used to transfer data from the SEER Light recorder. When not in use, store the cable in the guide on the backside panel.

Used to enter controller modes. Press F1 to enter

Preview mode to confirm the quality of ECG recording. Press F2 to enter Data Transfer mode to transmit data to SEER card. Press F3 to enter

Review mode to confirm SEER card contents.

Press F4 to return to SEER mode.

Used to start recording of the SEER Light recorder and to start transferring data to a SEER card.

Used to select items and navigate around the display panel.

Enter the patient’s alphanumeric information.

4A

Patient information entry keypad

F5 button Used to enter Set-up condition mode to change certain settings on the controller and recorder.

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9

10

Name

LCD (liquid crystal display)

Function

Displays operating conditions.

Used to turn the power on and off.

11

Power button

Infrared terminal (IR

Window)

Used to communicate with the SEER Light recorder.

Transfer the instructions to a SEER Light recorder before recording.

Receive ECG waveform recording data from a

SEER Light recorder to preview.

Used to insert a SEER card.

Used to eject a SEER card.

12

13

SEER Light Connect

SEER card slot

Eject button

The SEER Light Connect is used as a direct interface connection between the recorder and the Holter analysis system. This device is also referred to as “the connect” in this document.

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WARNING






IEC 60601-1.








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A

C

B

A

B

C

D

Name

Data transfer cable

Infrared terminal

(IR Window)

USB Connection

LED indicator

Function

Used to transfer data from the SEER Light recorder to the SEER Light Connect.

Used to communicate with the SEER Light recorder.

Receives ECG waveform data from a SEER

Light recorder to preview.

Transfers patient demographics to the SEER

Light recorder.

Starts the SEER Light recorder.

Uses a USB patch cord to transfer data from the

SEER Light Connect to the Holter analysis system.

Flashes when data is transferring.

Lights without flashing when a proper connection exists.

Installing SEER Light Hookup

This software is used in conjunction with the SEER Light Connect device. If you do not have a SEER Light Connect device, you may skip this section.

084A

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Before you connect the SEER Light Connect device to your Holter analysis workstation, follow these steps to install the SEER Light

Hookup software.

NOTE

You must have administrator privileges to install the SEER Light

Hookup software.

1. Insert the SEER Light Hookup software CD in the CD drive of your workstation.

NOTE

The computer you install the SEER Light Hookup software must be running Windows 2000, 2000 server, XP or 2003 server.

The software cannot be installed on Windows NT, 98 or ME.

2. The SEER Light Hookup InstallShield Wizard appears. Choose the appropriate language and select Next.

3. The SEER Light Hookup Setup welcome window appears. Select

Next.

4. The license agreement window appears. Review the license agreement and select Yes.

5. The Destination Disk window appears. Highlight the disk in which the SEER Light Hookup application will be installed. Select Next.

6. The software is now being installed. When finished, a message appears asking if you would like to view the installation report.

Select Yes to view the report or No to continue.

If you select Yes, the Installation Report appears.

To print the report, select the Print button.

To view previous installation reports, select the View History button. This button will be grayed out if no prior installations were done on your computer.

7. Select Next when finished.

8. At the InstallShield Wizard Complete window, select Yes, I want to

restart my computer now.

9. Select Finish. Your computer will restart.

10. Log back in as Administrator.

11. Plug the Universal Serial Bus (USB) cable into the USB port of your computer to load the USB drivers. Connect the USB cable to the

SEER Light Connect device.

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The Found New Hardware window appears.

12. If you are on a Windows 2000 operating system, the Insert Disk window will appear. Select OK.

Two additional files need to be loaded: the WinRTUSB.dll and the

WinRTUSB.sys. The Files Needed window appears. In the dropdown box, type in D:\drivers\ (or the letter assigned to the CD drive if it is not D). Select OK.

The Files Needed window appears again. In the dropdown box, type in D:\drivers\ (or the letter assigned to the CD drive if it is not D).

Select OK.

13. If you are on a Windows XP system the Found New Hardware

Wizard window appears. Select the button next to Install the

software automatically. Select Next.

The Found New Hardware Wizard window appears again. Select

Finish.

The SEER Light Hookup installation is now complete.

Pouch

It is recommended that the recorder be used in combination with the

SEER Light pouch (PN 2008596-001) for the entire duration of the recording. The pouch protects the connection between the patient cable and the recorder.

Operating Modes - SEER Light Controller

There are three operating modes for the controller:

SEER mode

Transfer mode

Set-up Condition mode

SEER mode

This is the main user mode of operation; patient information and

recording occurs from within SEER mode. Refer to “Entering Patient

Data” on page 4-1 and

“Recording Data” on page 5-1 for more

information.

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The controller starts up in SEER mode automatically.

Transfer mode

Recorded data is transferred from the recorder to the controller from

within Transfer mode. Refer to “Transferring Data” on page 6-1 for more

information.

Press F2 to enter Transfer mode.

Set-up Condition Mode

Use the Set-up Condition mode to configure operating parameters for the recorder and controller. Once configured, the settings will be saved if the power is turned off.

1. Press the Power button and the F5 button simultaneously.

Continue to hold the F5 button while releasing the Power button.

The Set-up condition display mode opens.

2. Press the buttons to select a parameter.

3. Press the buttons to set the parameter’s conditions.

4. Press the F1 button to exit the Set-up Condition mode.

Selecting a Language

Follow these steps to change the language that the SEER Light controller displays.

1. Press the Power button and the F5 button simultaneously.

Continue to hold the F5 button while releasing the Power button.

The Set-up condition display mode opens.

2. Press the 0 button to open the Language Selection display.

3. Use the Patient Information Entry keypad or the select the desired language.

buttons to

4. Press ENT to select the language.

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Parameter Descriptions and Configuration

The following operating parameters can be configured for the recorder and the controller.

Parameter Description

Heart rate synchronizing sound (controller) Heart rate synchronizing (shown as HR sound) can be set ON or OFF during the preview of ECG waveforms. (OFF is the initial setting.)

Press the

buttons to turn the selection ON or OFF.

Heart rate detection channel (controller) Used to select a recording channel to detect heart rate to calculate the heart rate and the heart rate synchronizing sound during the preview of ECG waveform.

Auto start (recorder)

Selections are CH1, CH2, or CH3 (CH1 is the initial setting).

Press the buttons to select CH1, CH2, or CH3.

If auto start is set to on, the controller will program the SEER Light recorder so it automatically starts 30 minutes after batteries are installed.

Once the recorder is setup this way it will always automatically start in this manner unless is it reprogrammed.

If auto start is set to off it will program the SEER Light recorder so it does not automatically start 30 minutes after the batteries are installed

Press the

buttons to turn the selection ON or OFF.

NOTE

The recorder will not Auto start if there is untransferred data in the recorder.

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Parameter

Date and Time (controller)

Description

Used to set the date and time of the controller. The start time of the recorder is calculated based on the date and time of the controller. The recorder does not have a time clock.

The recorder receives the date and time information from the controller when the recorder is started by the controller.

Or, in instances when recording is initiated from the recorder, the recording start time will be calculated from the time clock of the controller when the ECG data is transferred to a SEER card from the recorder using the controller.

Setting the Date

1. Press the alphanumeric buttons to enter DD, MON (the 3-letter code for the month), and YYYY in order. The Hungarian language version displays the date using the yyyy-MON-dd format.

2. Press to confirm the new date.

Setting the Time

1. Press the alphanumeric buttons to enter HH and MM in order.

2. Press to confirm the new time.

Not used Accelerometer Check

Battery Power

The controller and the recorder use AAA alkaline batteries. Always remove the batteries when storing either device.

SEER Light Controller

According to the battery power level, the battery icon will change.

The following table describes the battery power level icon(s).

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Battery Symbol Mark Battery Power Level

Sufficient power for normal operation.

Battery power sufficient for 6 normal recording operations, including preview of the ECG waveform for 5 minutes, start recorder, and data transfer. It is recommended to replace the batteries.

Battery power sufficient for 3 normal recording operations, including preview of the ECG waveform for 5 minutes, start recorder, and data transfer. Replace with new batteries

No power for operation. Replace the batteries.

SEER Light Recorder

NOTE

The Auto Power OFF function will be activated to save the battery power if no button is pressed for 15 minutes. The Auto Power OFF function will not be activated if any error message is displayed.

Always remove the batteries when not in use, and replace with new AAA

alkaline batteries when ready for use. See “Inserting Batteries in the

SEER Light Recorder” on page 5-12 for details.

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Battery Disposal

Do not burn the batteries, or dispose of batteries with other medical wastes. Contact your local recycling center for information on proper disposal of used batteries.

Care and Cleaning

Follow these cleaning instructions for the recorder, controller and the connect device.

Keep the device clean between each use to prevent infection.

Remove the batteries and disconnect any power and USB cords before cleaning the device.

Use a piece of cloth dampened with alcohol to clean the device and the patient cable.

NOTE

Do not clean and reuse electrodes. Use new electrodes for each use.

The devices cannot be sterilized.

Do not immerse the device in any liquid, or allow liquids to enter through connections, ports or buttons.

Do not use xylene or petroleum-based solvents for cleaning the device.

In case of a malfunction, call a service technician and precisely describe the problem.

Check the patient cable and connectors every month by connecting to an ECG simulator.

Storage and Operating Conditions

Follow these guidelines when storing and operating the SEER Light devices.

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Storage and Operation

Storage Conditions

Operating Conditions for SEER

Light Controller and SEER Light

Connect

Operating Conditions for SEER

Light Recorder and SEER Light

Extend Recorder

Environmental Conditions

Remove batteries from the recorder and controller

Temperature, SEER Light Recorder and

SEER Light Connect: -4°F to 149°F (-20°C to

65°C)

Temperature, SEER Light Controller: -4°F to

140°F (-20°C to 60°C)

Relative Humidity, SEER Light Recorder 5-

90% RH non-condensing

Relative Humidity, SEER Light Controller 30-

90% RH non-condensing

Temperature 50°F to 95°F (10°C to 35°C)

Relative Humidity 30-80% RH noncondensing

Temperature 32°F to 113°F (0°C to 45°C)

Relative Humidity 10-95% RH noncondensing

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Preparing the Patient

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Placing Electrodes

Two Channel, Five Electrode

In the two channel, five electrode configuration, two channels of ECG data are bipolar. Red positive (+) is referenced to white negative (–) and brown positive (+) is referenced to black negative (–).

B C

D

A

E

A

B

AHA

Color

Red

White

C Brown

D Black

E Green

IEC

Color

Yellow

Red

Green

White

Black

Channel

CH 1(+)

CH 1 (-)

CH 2 (+)

CH 2 (-)

Ground

045A

Lead Location

II (+)

II (-)

Fifth intercostal space, anterior axillary line.

Below the right clavicle, just lateral to the midclavicular line.

mV1 (+) Fourth intercostal space, right sternal edge.

mV1 (-) Below the left clavicle, just lateral to the midclavicular line.

On the lower right chest wall, on a rib.

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Three Channel, Seven Electrode

There are three possible electrode configurations for three channel, seven electrode recording.

Modified V3 Leads

A modified V3 lead may be helpful in identifying ST segment changes in ischemic episodes associated with the left anterior descending coronary artery. The following are the recommended electrode locations to record the modified V5 (mV5) on channel 1, the modified V1 (mV1) on channel 2, and the modified V3 (mV3) on channel 3.

F

D

B

E

C

A

G

046A

AHA

Color

IEC

Color

Channel Lead Location

A

B

Red

White

Yellow CH 1(+) mV5 (+) Fifth intercostal space at the left axillary line.

Red CH 1 (-) mV5 (-) Right clavicle, just lateral to the sternum.

C Brown Green CH 2 (+) mV1 (+) Fourth intercostal space at the right sternal edge.

D Black White CH 2 (-) mV1 (-) Left clavicle, just lateral to the sternum.

E Orange Orange CH 3 (+) mV3 (+) Equidistant between the normal locations for precordial leads V2 and V4.

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Modified aVF Leads

AHA

Color

F Blue

G Green

IEC

Color

Blue

Black


CH 3 (-) mV3 (-) Mid-sternum, at the level of the clavicles.

Ground Lower right chest wall.

A modified aVF lead may be helpful in identifying ST segment changes in ischemic episodes associated with the right coronary or circumflex arteries. The following are the recommended electrode locations to record the modified V5 (mV5) on channel 1, the modified V1 (mV1) on channel 2, and the modified aVF (maVF) on channel 3.

D

F

B

C

A

E

G

C

D

A

B

AHA

Color

Red

White

Brown

Black

IEC

Color

Yellow

Red

Green

White

047A


CH 1(+)

CH 1 (-) mV5 (+) Fifth intercostal space at the left axillary line.

mV5 (-) Right clavicle, just lateral to the sternum.

CH 2 (+) mV1 (+) Fourth intercostal space at the right sternal edge.

CH 2 (-) mV1 (-) Left clavicle, just lateral to the sternum.

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Modified Z Leads


E

F

G

AHA

Color

Orange

Blue

Green

IEC

Color

Orange

Blue

Black


CH 3 (+) maVF (+) Sixth rib, at the left midclavicular line.

CH 3 (-) maVF (-) Left clavicle, at the midclavicular line.

Ground Lower right chest wall.

A modified Z lead (mZ) may be helpful in identifying ST segment changes in ischemic episodes with an anteroposterior axis. The following are the recommended electrode locations to record the modified V5 (mV5) leads on channel 1, modified V1 (mV1) leads on channel 2, and Z leads on channel 3.

C

B

D

E

G

A

B

C

AHA

Color

Red

White

Brown

A

F

Front

Back

048A & 049A

IEC

Color

Yellow

Red

Green


CH 1(+)

CH 1 (-) mV5 (+) Fifth intercostal space at the left axillary line.

mV5 (-) Right clavicle, just lateral to the sternum.

CH 2 (+) mV1 (+) Fourth intercostal space at the right sternal edge.

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AHA

Color

Black D

E Orange

Blue

Green

IEC

Color

White

Orange

Blue

Black

Channel

CH 2 (-)

CH 3 (+)

CH 3 (-)

Ground

Lead Location

mV1 (-) Left clavicle, just lateral to the sternum.

Z (+) Posterior, just right of the spine, at the same level as the anterior lead.

Z (-) Mid-sternum, at the level of the fourth intercostal space.

Lower right chest wall.

Preparing the Skin

F

G

Determine electrode placement according to one of the configurations shown in this chapter. Use this procedure to insure good quality ECG data.

CAUTION

ELECTRODES — Make sure that the electrodes conducting elements do not make contact with each other or other metal parts.

Make sure that the device is not subject to disturbances from the electric mains.

Use only the specified electrodes for safety. Any other electrode may not give proper recording and may cause problems with the patient.

1. To minimize electrode problems, be sure to use the proper type of electrode. Check the expiration date on any pregelled electrode before using it. Also, check for dry gel pads on any pregelled electrodes that have been left out of their foil package.

2. Shave hair from each electrode site. This improves conductivity, helps hold the electrode to the skin, and makes the removal of the electrode easier.

3. Rub each electrode site thoroughly with alcohol. This removes oil from the skin.

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4. Mark each electrode site with a felt tip pen. This provides an easy way to determine when the epidermis has been sufficiently abraded.

5. Use an abrasive pad to remove the epidermal skin layer at each electrode site. The epidermal skin layer has been removed when the mark left from the felt tip pen has been erased.

WARNING

ELECTRODE CONDUCTIVITY — Keep the conductive parts of lead electrodes and associated parts away from other conductive parts, including earth.

6. Place an electrode on each prepared site.

Hooking Up the Patient

Complete patient hookup and prepare the patient for ECG data recording.

NOTE

Use only the 5- or 7-electrode patient cable designed for use with the recorder.

1. Connect each cable lead wire to the correct patient electrode per the electrode placement tables.

2. Use stress loops to reduce the movement of the electrodes caused by tension from the lead wires.

Form a stress loop in each lead wire using an electrode clip as shown below. This prevents a lead wire from pulling directly on the electrode contact points. Each loop should be about 1 or 2 inches in diameter, about 2 inches from the electrode.

Electrode Clip

3. Secure the electrodes with tape to prevent movement and maintain electrical contact.

If you are using wet gel electrodes, apply the tape loosely enough so that no gel squeezes onto the adhesive surfaces of the electrodes.

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NOTE

Special T-shirts (PN 9812-011/012/013) are available from GE

Medical Systems Information Technologies that minimize movement and increase comfort during the data recording period.

4. Connect the patient cable to the connector on the recorder.

An example of the completed hookup is shown below.

21A

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51A

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Pouch

It is recommended that the recorder be used in combination with the

SEER Light pouch (PN 2008596-001) for the entire duration of the recording. The pouch protects the connection between the patient cable and the recorder.

Holter ECG Patient Diary

Setting Up the Patient Diary

Enter the following items in the patient’s diary:

Patient name

Patient identification number

Data card number

Recorder type and number, and

Hook-up date and time

Instructing the Patient

Inform the patient of the recorder’s audible alarms to prevent patient anxiety when alarms sound. The recorder does NOT interfere with the patient’s normal routine, but there are a few restrictions while wearing it.

Describe the diary to the patient and emphasize the importance of keeping track of activities and symptoms.

Audible Alarms

The patient must understand that the recorder beeps under normal operation, and is NOT an indication of cardiac problems for the patient.

Describe these instances of audible alarms to prevent patient anxiety.

In case of insufficient battery level, an audible alarm will continuously sound. This indicates that new batteries are required.

A beep sounds for one minute when beginning a recording.

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Activity Restrictions

Do NOT tamper with the recorder, electrodes, or lead wires.

Do NOT take the recorder from the case and do not touch the cable or switch unnecessarily during Holter ECG checking.

Do NOT drop or hit the recorder as the Holter recorder is precision equipment.

Do NOT use other low frequency medical equipment at the same time.

Do NOT push the Stop button.

Do NOT take a shower or bath, or get the electrodes or recorder wet.

Do NOT submerge the recorder in water or other liquids, otherwise you may damage the recorder.

When wearing the recorder at night, do NOT use an electric blanket.

It may interfere with the recording.

Keeping Track

Record all diary entries with the date and time.

Record any physical signs and symptoms. When a symptom is felt, press the (Start/Event) button, describe it in the diary, and correlate it with the patient’s activity and position.

Press the (Start/Event) button for about one second to mark the beginning of an event. For prolonged events, you can also press the button to signal the end of an event.

Record activities throughout the test period. Make notations about physical activities, rest periods, meals, strong emotional conditions, and sleep.

Shorter Test

If you perform a test shorter than 24 hours (or 48 hours with SEER Light

Extend recorder), instruct the patient to disconnect the recorder when the test is complete.

Make sure the patient understands at what time the recording is complete.

Instruct the patient how to remove the lead wires from the electrodes and how to remove the electrodes.

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NOTE

The recorder continues to record even if you remove the cable or electrodes. Reconnect the patient to continue testing. Noise recorded during disconnection can be handled by the Holter analysis system.

To stop recording before 24 hours have elapsed (or 48 hours with

SEER Light Extend recorder), press the ball point pen.

(Stop) button with a

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Entering Patient Data

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Patient data can be entered via the controller or the connect device.

WARNING

MIXING PATIENT DATA — Accidental mixing of patient data can result in misdiagnosis and incorrect treatment.

Always transfer or delete old data before beginning a new recording session, and promptly enter patient demographics.

Using the SEER Light Extend Controller

Be sure that all information from previous patient recordings has been transmitted to the controller.

If data remains on the recorder that has not been transmitted to the controller, the controller will display the message Recorder still contains

untransmitted data. Press F6 to start a new recording. A beep will sound from the recorder.

Deleting Old Data

Press the F6 button to delete any old data remaining on the recorder and to begin entering patient data for this test.

Entering Patient Information

The controller displays the patient information screen when you press the POWER button. Use this screen to enter the followingpatient information:

ID number (up to 10 digits)

Age

Gender

Last Name [Displayed as NAME(L)]

First Name [Displayed as NAME(F)]

Items can be selected by pressing the buttons.

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Press CLR to correct error input.

Alphanumeric Entry

Choosing a Letter to Enter

Each patient information field accepts alphabetic or numeric data. ID# and Age are numeric-only fields. The bottom of the display panel shows

{1}. Name(L) and Name(F), which are alphabetic fields by default, and the bottom of the display planel shows {A}. Press F5 before entering numbers in these fields. Press F5 again to return to entering letters. The

8 and 9 buttons are used in the Gender field.

Each numbered button represents specific letters listed above the button.

Each time you press the button the letter displayed will change in the order they appear, first in UPPERCASE, then in lowercase. For example, if the button is pressed three times in the alphabet entry mode, the capital letter “C” will display. If the button is pressed four times in the alphabet entry mode, the lowercase letter “a” will be displayed.

Pressing F4 while in an information field will display a hyphen (-).

NOTE

Press the button to advance the cursor to enter the next letter in the name.

Button Alphabet Number

1

ABC abc 2

DEF def

GHI ghi

3

4

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Button Alphabet

JKL jkl

MNO mno

PQRS pqrs 7

TUV tuv 8

This button is also used to enter gender for male patients.

WXYZ wxyz 9

This button is used to enter gender for female patients.

. 0

Space

Number

5

6

Using the SEER Light Connect

To enter patient data using the SEER Light Connect device.

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WARNING






IEC 60601-1.








1. Select the SEER Light Hookup icon on your desktop

SEER Light Hookup window appears.

. The GE

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Enter Patient

Information Here

2. Enter the patient’s information. The Last Name and First Name fields are limited to a maximum of 14 characters. The ID field is limited to a maximum of 10 numeric characters.

080A

3. Refer to “Begin Recording with SEER Light Connect” on page 5-14.

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5

Recording Data

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Recording Data

Operating

Before Recording

After Recording

Follow these steps before recording. For information on each operation, see the page(s) indicated.

1. Prepare the patient by performing skin preparation and attaching the electrodes. Refer to

“Placing Electrodes” on page 3-2 and

“Preparing the Skin” on page 3-6 for more information.

2. Prepare the controller by checking the battery status. If necessary, replace the controller’s batteries. Install new batteries in the

recorder. Refer to “Battery Power” on page 2-14.

3. Connect the electrode lead wires. Refer to “Hooking Up the Patient” on page 3-7 for more information.

4. Do a lead check. Refer to

“Checking the Leads” on page 5-3 for more

information.

5. Enter patient information. Refer to Chapter 4,

“Entering Patient

Data” on page 4-1 for more information.

6. Start the recorder. Refer to “Starting the SEER Light Recorder” on page 5-11 for more information.

Follow these steps after recording. For information on each operation, see the page indicated.

1. Disconnect the patient from the recorder. Refer to

“Disconnecting the

SEER Light Recorder” on page 5-15 for more information.

2. Transfer the patient’s Holter data from the recorder/controller/ connect to the MARS system for analysis. Refer to Chapter 6,

“Transferring Data” for more information.

3. Clean and store the SEER Light devices. Refer to

“Care and

Cleaning” on page 2-16 and “Storage and Operating Conditions” on page 2-16 for more information.

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Connecting the Patient Cable

Recording Data

marks indicate placement

Connect the patient cable to the connector of the recorder with the mark facing up. Make sure it is connected properly.

Checking the Leads

After the patient is hooked up to the recorder, check the quality of the connections using the controller or the connect.

Check Leads Using the SEER Light Extend Controller

1. Turn the controller’s power on. Confirm the date and time; adjust if

necessary. Refer to “Set-up Condition Mode” on page 2-12 for more

information.

2. Align the infrared terminals on the controller and the recorder.

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Press the F1 button

Waveforms or lead quality information is displayed here.

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3. Press the F1 button on the controller.

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The Preview screen is displayed on the controller, showing the following elements:

The patient’s heart rate is displayed in the upper right corner

Two or three channels of waveform data are displayed

Adjust patient hookup if waveform height/quality are not satisfactory or if messages are displayed instead of waveforms.

CAUTION

WAVEFORM DIAGNOSTIC QUALITY — The ECG waveforms shown on the preview screen are used for assessing the quality of the connections only.

Do not use these preview waveforms for diagnostic purposes.

CAUTION

WAVEFORM DISPLAY — Fluorescent lights in the room may interfere with infrared communication between the recorder and controller. In this case, normal ECG waveform will not be displayed on the LCD.

Keep the device away from fluorescent lights. Turn off fluorescent lights when device is used. Cover the infrared window with a hand to shield the display from the fluorescent lights.

4. Select the F4 button to exit the Preview screen and return to the

SEER screen.

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Recording Data

Checking Leads Using the SEER Light Connect

WARNING






IEC 60601-1.


Patient vicinity/environment defined:






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1. Select the SEER Light Hookup icon on your desktop.

SEER Light Hookup window appears.

The GE

2. Connect the USB cable to the connect and the Holter analysis PC.

When properly connected, the LED on the connect turns amber.

NOTE

The following picture shows a USB port on the front of the PC.

Some PCs have the USB port(s) located on the back. The connect can be connected to either a front or back USB port.

Connect rectangular

USB connection to the computer’s USB port.

When the LED turns amber, the USB cable is properly connected.

Connect square

USB connection here.

3. Align the infrared terminals on the connect and the recorder.

4. At the GE SEER Light Hookup window, select the Start Preview button.

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Up to three channels of waveform data are displayed.

Adjust patient hookup if waveform height/quality are not satisfactory or if messages are displayed instead of waveforms.

CAUTION

WAVEFORM DIAGNOSTIC QUALITY — The ECG waveforms shown on the preview screen are used for assessing the quality of the connections only.

Do not use these preview waveforms for diagnostic purposes.

5. Select the Stop Preview button to stop the lead preview.

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Confirming ECG Recording

The quality of a Holter ECG recording is very important. To record ECG without artifact, confirm the recording conditions before starting the recording. To improve the ECG quality, adjust the electrode attachments.

Wireless Data Transfer

The controller and the connect use infrared wireless data transfer to confirm the ECG waveform recorded by the recorder. In preview mode, the controller displays two channels of real-time ECG waveforms at a time, and the connect displays up to three channels of real-time ECG waveforms.

Considerations Using the SEER Light Extend Controller

Insert the batteries in the recorder before entering the preview mode.

The ECG waveform cannot be checked without inserting the batteries.

By entering the preview mode, infrared data transfer will be checked automatically. Point the controller to the infrared terminal of the recorder, and press the F1 button.

As the preview mode of the controller consumes battery power, return to the SEER mode after checking the ECG waveform.

Preview mode by remote wireless operation can only be done before starting the recorder (pressing the F6 button) and during the first three minutes of the recording phase (after pressing the F6 button).

The recorder will beep for the first minute of the recording phase.

The recorder will enter Power Save mode after setting the batteries.

Confirming ECG Recording Using the SEER Light Extend

Controller

1. From the SEER screen, point the controller to the infrared terminal of the recorder, and press the F1 button. The Preview screen will display.

2. By pressing the or F4 button after checking the ECG waveform, it will return to the SEER screen.

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Considerations Using the SEER Light Connect

Insert the batteries in the recorder before entering the preview mode.

The ECG waveform cannot be checked without inserting the batteries.

By entering the preview mode, infrared data transfer will be checked automatically.

You can only enter preview mode by remote wireless operation before starting the recorder (selecting the Record button) and during the first three minutes of the recording phase (after pressing the Record button). The recorder will beep for the first minute of the recording phase.

The recorder will enter Power Save mode after setting the batteries.

Confirming ECG Recording Using the SEER Light Connect

1. At the GE SEER Light Hookup window, select the Start Preview button.

NOTE

Selecting the Start Preview button will cause the button text to change to Stop Preview.

2. At the Lead Preview screen, review the displayed channels for ECG waveform confirmation.

NOTE

You may continue to enter patient demographics while the waveform is scrolling.

3. Select the Stop Preview button after checking the ECG waveforms.

Interruption of Infrared Communication

Distance, direction, objects, and so on. between the recorder and controller or connect can interrupt the infrared communication, causing the ECG waveform to become a bold line on the LCD display.

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CAUTION

SIGNAL QUALITY — If there is a severe muscle interference or artifact on the ECG when you tap the top of the electrodes lightly or when the patient moves, it is possible that the electrodes are not attached properly.

To increase the accuracy of analysis, make sure that the channel has a high amplitude of QRS complex (greater than 10 mV). If the amplitude of QRS is small, shift the electrodes to find a suitable location for electrode attachment.

Confirming Pacemaker Pulses

When viewing the ECGs of pacemaker patients, it can be difficult to see the pacemaker pulses on the ECG waveform. If the pacemaker pulse of

CH1 is small, it may not be detected. Verify accurate pace detection before starting to record.

To verify accurate pace detection using the controller:

1. While in SEER mode, point the controller to the infrared terminal of the recorder, and press the F1 button. The Preview screen will display.

2. A down pointing arrow mark is displayed above the pacemaker pulse detected by the recorder. If the down pointing arrow mark is not shown on the pacemaker waveform, change CH1 to another lead that produces big pacemaker pulses.

3. By pressing the F4 button after checking the ECG waveform, it will return to SEER mode.

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CAUTION

PACEMAKER PATIENTS — Pacemaker pulses are only detected on CH1. Before attaching the recorder, check the patient’s ECG to predict which lead will produce a big pacemaker pulse. That is the lead that should be assigned to CH1 (refer to table below).

If the pacemaker pulse of CH1 is small, there is a possibility that the pacemaker pulse may not be detected.

Change the lead of CH1 to another lead that has a bigger pacemaker pulse.

The down pointing arrow mark of the pacemaker pulse location for the preview mode is only displayed when using the remote method.

Holter ECG Leads

CM

5

, CC

5

CM

1

NASA

Similar 12-Leads

V

5

II, III, aV

1

V

1

To verify accurate pace detection using the connect:

At the Lead Preview window, the position of the pacemaker spikes are displayed with vertical bars. Refer to the following illustration.

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Bars indicate dual pacemaker spikes

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Starting the SEER Light Recorder

There are three ways to start the recorder.

Startup with the controller:

The recorder can be started remotely by the controller. The controller starts the recorder and at the same time the patient information (ID number, age, gender, and name) and the recording date and time are transmitted to the recorder memory. The recording date and time information remains in the recorder if the batteries are removed

before transferring the data. See “Begin Recording with SEER Light

Extend Controller” on page 5-13.

Startup with the connect:

In the SEER Light Hookup application, you will enter the patient information (ID number, age, gender, and name) and then select the

Record button to start the recorder. See

“Begin Recording with SEER

Light Connect” on page 5-14.

Startup with the recorder button:

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The recorder can also be started by pressing the record button. In this case, do not remove the batteries from the recorder. Otherwise, the recording date and time information will be erased from the recorder memory.

“Begin Recording with SEER Light Recorder

Button” on page 5-14.

Inserting Batteries in the SEER Light Recorder

If you are recording up to 24 hours of ECG data, use the SEER Light recorder. If you are recording up to 48 hours of ECG data, use the SEER

Light Extend recorder.

1. Slide the battery box cover to open.

NOTE

Install new batteries for each use to prevent loss of power and data.

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2. Insert two new AAA type alkaline batteries.

3. Confirm the audible beep sounds for approximately 2 seconds.

In case of insufficient battery level, an audible alarm will continuously sound. This indicates that new batteries are required.

4. Hold the battery string and slide the battery box cover to close.

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CAUTION

BATTERIES — Do not use any battery other than new alkaline batteries. Use of other types of batteries, including manganese, rechargeable, or used alkaline batteries will not ensure ECG recording for the life of the recorder (24 hours for the SEER Light recorder, 48 hours with the SEER Light Extend recorder).

Do not leave the batteries in the recorder for a long time.

This may cause leakage of battery liquid.

If the recorder (with batteries inserted) is not started for over one hour when the power is ON, the battery Power

Save mode will be activated. In this case, the batteries must be removed to deactivate the Power Save mode. To reset the recorder, leave the recorder without the batteries for 30 seconds.

Make sure the batteries are set in the correct directions.

Then begin the recording process again.

Begin Recording with SEER Light Extend Controller

1. Press the F6 button on the controller to start recording. Refer to

“Entering Patient Data” on page 4-1.

NOTE

Recording can be started without entering patient information.

NOTE

If data remains on the recorder that has not been transmitted to the controller, the message Recorder still contains untransmitted

data. Press F6 to start a new recording. will be displayed, and a beep will sound from the recorder. Press the F6 button to delete the data and start recording.

If the data is needed, transfer the remaining data to the

controller. Refer to Chapter 6, “Transferring Data”

.

2. Confirm that the beep sounds for one minute and that the LED flashes (twice per second) for three minutes.

The recording date and time will be displayed on the LCD of the controller.

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3. Put the recorder in the carrying pouch with the up.

Begin Recording with SEER Light Connect

button facing

1. Select the SEER Light Hookup icon located on your desktop.

The GE SEER Light Hookup window appears.

NOTE

If data remains on the recorder that has not been transmitted to the connect, the message Recorder contains untransmitted data.

Press the “Record” button to start a new recording is displayed.

If the data is needed, transfer the remaining data to the connect.

Refer to Chapter 6, “Transferring Data” .

2. Point the infrared terminal of the recorder to the connect.

3. At the GE SEER Light Hookup window, select Record.

A message appears stating the Holter recording started successfully.

Select OK.

NOTE

If the infrared sensors are not aligned properly, or if the cables are not connected, a message will appear stating Error occurred

while starting the recorder. Check the connections and infrared

sensor alignment.

4. Confirm that the beep sounds for one minute and that the LED flashes (twice per second) for three minutes.

NOTE

If you press the Record button after the recording has already started, a message appears stating Holter recording has already

started.

5. Put the recorder in the carrying pouch with the up.

button facing

Begin Recording with SEER Light Recorder Button

1. Insert the batteries. Refer to “Inserting Batteries in the SEER Light

Recorder” on page 5-12 for more information.

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2. Connect the patient cable to the connector of the recorder with the mark facing up.

3. Press and hold the button on the recorder. Confirm beep sounds for one minute and that the LED flashes (twice per second) for three minutes.

button facing up. 4. Put the recorder in the carry case with the

Attach the case to the patient belt.

Disconnecting the SEER Light Recorder

NOTE

ECG recording will stop after 24 hours (48 hours if using the SEER

Light Extend recorder) and the LED will stop flashing. To stop recording before 24 (48) hours, press the (Stop) button with a ball point pen and disconnect the patient cable.

If the batteries are removed from the recorder before recording of 24

(48) hours or before the (Stop) button is pressed, the recorder may not transmit data correctly.

1. Disconnect the patient cable from the recorder.

2. Remove the electrodes.

3. Clean the skin with alcohol. Adhesive material remaining on the skin may cause itchiness.

4. After transferring data from the recorder (with controller or connect and Holter analysis system), remove the batteries from the recorder.

NOTE

Do not remove the batteries from the recorder before transferring the data from the recorder, or before analyzing the data with the

Holter analysis system as the time will be erased when the battery is removed from the recorder.

The recorder retains the data for about one week after recording.

Transfer the data to the Holter analysis system or copy it to a flash card within one week to prevent loss of data.

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Transferring Data

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Transferring Data to the Holter Analysis System

The procedure for transferring data from the recorder to the Holter analysis system depends on which device is used to transfer the data: the controller, or the connect.

If using the controller, the transfer must undergo a two-step process:

1. Data is transferred from the recorder to a compact flash card via the controller. See

“Transferring to the Flash Card using the

SEER Light Extend Controller” on page 6-2.

2. Data is transferred from the compact flash card to the Holter analysis system. See

“Transferring Data to the Holter Analysis

System via Flash Card” on page 6-6.

If using the connect, the data is acquired directly into the Holter analysis system. See

“Transferring Data to the Holter Analysis

System via Connect” on page 6-7

.

Transferring to the Flash Card using the SEER Light Extend

Controller

Follow these steps to transfer data from the recorder to a compact flash card via the controller. See the matrix below for SEER Light recorder and controller compatibility.

CAUTION

EQUIPMENT DAMAGE — To avoid equipment damage, follow the considerations below when using a flash card:

Do not place the patient label over another label.

Do not touch the connector with your hand, or scratch it with a hard object.

Do not get the card wet.

Do not subject the card to any external force or shock.

Use only the flash card specified by GE Medical

Systems Information Technologies.

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SEER Light Recorder/Controller Compatibility

SEER Light Controller (24

Hour)

YES

SEER Light Extend

Controller (48 Hour)

YES SEER Light Recorder (24

Hour)

SEER Light Extend

Recorder (48 Hour)

NO YES

NOTE

The SEER Light Controller (24 hour) is no longer available. The

SEER Light Extend Controller is compatible with both SEER Light

(24 hour) and SEER Light Extend (48 hour) recorders.

NOTE

The SEER Light Extend Recorder (48 hours) is compatible with

MARS v7.x and higher only. It is not compatible with MARS v4, v5, or v6.

1. Remove the data transfer cable from the back side of the controller.

Switch on the controller’s power supply by pressing the POWER button, as in the following graphic.

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2. Confirm the date and time. Change the date and time if it is not

correct. Refer to “Set-up Condition Mode” on page 2-12.

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3. Insert flash card with the mark facing up into the controller. Pivot the EJECT button to prevent inadvertent ejection of the flash card.

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4. Connect the cable to the data output connector of the recorder ( ).

5. Press the F2 button to enter the data transfer mode. Press the F6 button. The data will be transferred to the flash card.

6. You will be asked to confirm transfers under the following conditions.

Refer to “Confirming Flash Card Contents” on page 6-5 if this occurs.

The flash card contains any data that has not been analyzed by the Holter analysis system.

The recording is stopped by pressing the button on the recorder with a ball point pen, or removing the recorder’s batteries, before recording 24 hours (48 hours if using the SEER

Light Extend recorder).

NOTE

An error message will appear on the screen if a flash card is not inserted into the controller. Make sure the card is inserted before attempting to transfer.

7. Data transfer is completed when the transfer progress bar on the controller reaches 100%. Confirm the time displayed on the screen.

8. Remove the flash card by pressing the EJECT button.

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9. Disconnect the data transfer cable from the recorder. Switch off the power supply by pressing the controller’s POWER button.

Confirming Flash Card Contents

You can confirm that the data transferred to the flash card through the controller. This data includes:

Patient information (ID, age, gender, and name)

ECG waveform (close to the event point, close to the starting point, close to the ending point, specific times) copied into the card

By confirming the contents of the flash card, the patient information can be edited.

Confirming Patient Information

1. Insert the flash card into the controller.

NOTE

If the flash card is not inserted into the controller before starting the operation, error messages will appear on the screen.

2. Press the F3 button to open Review mode, where you can confirm the flash card contents.

3. Select Patient Information. Press ENT.

4. The patient information to be transferred from the recorder will be displayed on the screen of the controller.

Patient information can be edited. Refer to “Entering Patient

Data” on page 4-1.

By pressing the F4 button after editing the data, a message appears prompting you whether or not to save the edited data.

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Press the ENT button to save the data and return to the screen in Step 3.

5. Press the F4 button to return to SEER mode.

Displaying the ECG Waveform

1. Insert the flash card into the controller.

NOTE

If the flash card is not inserted into the controller before starting the operation, error messages will appear on the screen.

2. Press the F3 button under SEER mode. It will proceed to the confirmation of flash card contents.

3. Select ECG Display. Press ENT.

4. Select the ECG waveform that you want to display by using the and buttons. Choices are Event, Start, End and Time. Press the

ENT button.

If you select Time, the starting time of the recording will be displayed first. By entering the time you want to review in this screen and pressing the ENT button, the ECG waveform corresponding to that specified time will be displayed on the screen.

Scroll forward through the ECG waveform by pressing the or

F1 button. You cannot scroll backward through the waveform.

5. Press the or F4 button until you are returned to the screen in Step

4. Press the or F4 button again to return to SEER mode.

Transferring Data to the Holter Analysis System via Flash Card

Follow these steps to transfer data from the flash card to the Holter analysis system.

1. Insert the flash card into the flash card adapter.

NOTE

ECG data recorded by the recorder can only be analyzed by the

Holter analysis system.

2. Insert the flash card adapter into the acquisition unit. Proceed with data transfer as outlined in the operator’s manual for the Holter analysis system.

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Transferring Data to the Holter Analysis System via Connect

Follow these steps to transfer data from the recorder through the connect.

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1. Connect the cable on the connect to the USB port of your MARS workstation. (The USB port may be located on the front or the back of the PC.)

2. Remove the lead wires.

3. Connect the recorder to the connect device.

4. Refer to the Holter analysis system Operator Manual for instructions on acquiring the data.

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Analyzing Waveforms and Patient Treatment

Refer to the Holter analysis system Operator Manual for instructions on viewing and analyzing waveform data.

CAUTION

PATIENT TREATMENT — Various clinical persons may view, analyze and make recommendations based on patient waveforms, but a plan of treatment requires confirmation from a qualified physician or cardiologist.

A qualified physician or cardiologist MUST confirm all information pertaining to treatment of a patient.

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Troubleshooting

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Troubleshooting

Troubleshooting Chart

Use the chart below to troubleshoot problems.

Trouble

Alarm sound continues when batteries are inserted.

(Recorder)

No beeping sound when batteries are inserted.

(Recorder)

Cause

Battery power is low.

Wrong type of batteries, or batteries other than alkaline are inserted.

Battery power is low.

is

Batteries are reinserted quickly right after completing the data transfer.

This may occur because the condenser in the recorder has power reserve function.

The damage may be caused by physical shock.

The button was pressed too rapidly.

No beep sound for start-up when pressed.

(Recorder)

The recorder does not start up when the controller sends a start up command through infrared, and The recording has

already started. is displayed.

(Recorder and controller)

Recommendation

Replace with new alkaline batteries.

Replace with new alkaline batteries.

Reposition batteries 30 seconds after replacement, and resume the function.

Check with service, or open a service call.

Press gently and slowly.

The recorder is already in the recording process.

It has been more than 1 hour after batteries are inserted.

The recorder automatically cancels startready mode in order to reduce battery power loss. This function makes the button inactive.


Press again 30 seconds after batteries are reset.

Press F6 again 30 seconds after batteries are replaced.

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Troubleshooting

Trouble

The recorder does not start up when the controller sends a start up command through infrared, and Communication Error is displayed.


Cause

Infrared transfer does not work due to the distance or an obstruction between the recorder and controller.

It has been more than 1 hour after batteries are inserted.

The recorder automatically cancels startready mode in order to reduce battery power loss. This function makes the F6 button not work.


The SEER Light Hookup window displays a dialog box stating Holter recording has

already started. when the Record button is selected.

(Recorder and connect)

The SEER Light Hookup window displays a dialog box stating Error occurred while

starting the recorder. Check the connections and the infrared sensor

alignment. when the Record button is selected.


Infrared transfer does not work due to the distance or an obstruction between the recorder and connect.

Patient data not available because cables are not properly connected.

The recorder does not start up when the controller sends a start up command through infrared, and Recorder still

contains untransmitted data. Press the F6

button to start a new recording. is displayed.


Data remains in the recorder and was not transferred to the controller.

Recommendation

Adjust the position of the infrared terminal part of the recorder. Set both devices within 1 meter and adjust the direction so that the terminal of infrared between the recorder and controller are aligned. Press

F6 button again.

Press the F6 button again 30 seconds after batteries are replaced.

Select OK. The dialog box closes and the recording continues.

Select the OK button to close the dialog box. Set both devices within 1 meter and adjust the direction so that the terminal of infrared between the recorder and connect are aligned. Select the Record button again.

Select the OK button to close the dialog box. Connect the cables. Select the

Record button again.

If the data is not needed, press the F6 button. Otherwise, transfer the old data to the controller.

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Troubleshooting

Trouble

The SEER Light Hookup window displays a dialog box stating Recorder contains

untransmitted data. Press the Record

button to start a new recording. when the

Record button is selected.


The recorder starts using the controller command through infrared. However, the controller displays Communication Error.


Patient data is not transferring between the recorder and the controller.


Beep sound is heard. However, LED does not blink.

(Recorder)

LED blinking stops before 24- or 48-hour period.

(Recorder)

Cause Recommendation

The recorder contains untransmitted data.

Select the OK button to close the dialog box. If the data is not needed, select the

Record button again. If the data is needed, transfer the data before beginning a new recording.

The controller does not receive a response back to start recording from the recorder.

An Extend device is used with a non-

Extend device.

The recorder is malfunctioning internally.

May be using rechargeable or manganese type batteries.

Align the infrared terminals then repeat the process. If the Communication Error condition persists, check with service, or open a service call.

Always transfer data from the SEER Light

Extend recorder to a SEER Light Extend controller.


Use new alkaline batteries.

When the F1 button on the controller is pressed for preview through infrared, transfer error occurs.


The batteries were removed while recording.

Do not touch or remove the batteries while recording.

Damage to unit caused by physical shock.


Infrared transfer does not work due to the distance or an obstruction between the recorder and controller.

Set both devices within 1 meter and adjust the direction so that the terminal of infrared between the recorder and controller are directly facing each other. Press the F1 button again.

The F1 button was pressed 1 hour after the batteries are inserted.

The recorder beeps the first minute after the recording has started. For the remaining 2 minutes of calibration, the recorder’s LED flashes twice per second.

Reset the batteries 30 seconds after the batteries are removed. Press the F1 button within 1 hour.

After the beeping sound, the controller cannot preview using infrared. Otherwise, the recorder and controller must be connected by the cable.

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Troubleshooting

Trouble

The SEER Light Hookup Lead Preview window displays no waveforms when the

Start Preview button is selected.


Cause

The batteries are not inserted in the recorder.

The batteries in the recorder do not have enough power.

Infrared transfer does not work due to the distance or an obstruction between the recorder and connect.

The notched waveform is displayed while using infrared preview.

(Recorder and controller/connect)

When the flash card is set in the slot of the controller, CARD ERROR Insert the SEER

card properly displays.

(Controller)

Patient data not available because cables are not properly connected.

Infrared transfer does not work due to the distance or an obstruction between the recorder and controller/connect.

The flash card is inserted upside down.

The flash card is not completely inserted into the slot of the controller

Recommendation

Insert the batteries and press the F1 button.

Replace the batteries and press F1 button.

Set both devices within 1 meter and adjust the direction so that the terminal of infrared between the recorder and connect are aligned. Select the Start Preview button again.

Connect the cables properly. Select the

Start Preview button again.

Set both devices within 1 meter and adjust the direction so that the terminal of infrared between the devices are aligned.

Place the flash card with mark facing up on the card into the controller. Press the power switch to on.

When flash card is set in the slot of the controller, CARD ERROR Press F6 to

format the card is displayed on the controller screen.

(Controller)

CARD ERROR Press F6 to format the card is displayed on the controller screen when the data transfer starts.

(Controller)

Card contains unanalyzed data. Pressing

F6 will overwrite this data. is displayed on the controller screen when the data transfer to the flash card does not start.

(Controller)

The flash card has not been initialized.

A different type of card other than the flash card is inserted.

The data is not transferred to the Holter analysis system, and remains on the flash card.

Place the flash card all the way into the slot of the controller. Press the power switch to on. If the flash card is correctly positioned, it should not protrude from the side of the controller.

Follow the initialization instructions provided by the flash card manufacturer.

Insert the correct flash card.

If necessary, transfer the data to the Holter analysis system. Otherwise, press the F6 button to overwrite the old data with the new recording.

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Troubleshooting

Trouble

Data Error No data in the recorder is displayed on the controller screen when the data transfer starts.

Cause

The recorder is shut down within three minutes of when recording was started.

Recommendation

No data in the recorder. Record the data again.

(Recorder)

Controller/connect transfers the data from the recorder up to 100% (progress bar scans through twice) and completes the transfer.

(Recorder)

DATA ERROR Recorder contains data

error(s) is displayed on the controller screen/SEER Light Hookup window after the data is transferred from the recorder.

(Recorder)

Data LED does not blink while the data is transferred from the recorder.

(Recorder)

Data LED does not blink while the data is transferred through connect.

(Connect)

Wrong date and time on the report.

(Controller)

Wrong date and time on the report.

(Connect)

The batteries are removed before the 24- or 48-hour recording is completed.

Files are damaged and cannot be transferred from the recorder.

LED may be broken.

LED may be broken.

Date and time settings are wrong on the controller.

The backup battery for the clock in the controller is worn out.

Date and time setting are wrong on the

SEER Light Hookup dialog box when starting a recording, stating Holter

recording started successfully. Hook-up date and time are: dd/mm/yyyy hh:mm:ss

AM/PM.

The data recorded before the batteries were removed remains. If the data is needed, proceed with the transfer.




Reset date and time on the controller.


Have the IT department or biomed reset date and time on the MARS PC, or network.

A-6 SEER

®

Light 2040604-012D

B

Accessories

2040604-012D SEER

®

Light B-1

Accessories

Accessories

The following are accessories that may be included with the system.

Information is subject to change without notice.

CAUTION

— Use only the specified accessories. Use of any other accessories may cause problems.

Description

Electrodes, ECG, SilverTRACE, MULTI P20MO, Ad, Foam Oval,

Tab, 300/bx

Electrodes, ECG, SilverTRACE, FIRST P28MO, Ad, Foam Rect,

300/bx

Electrodes, ECG, SilverTRACE, FIRST P28MO,Ad, Foam Rect,

300/bx

Electrodes, ECG, SilverTRACE, SOFT STRESS PS50MO, Ad,

Foam Rnd, 300/cs

Electrodes, ECG, SilverTRACE, SOFT STRESS PS50MO, Ad,

Foam Rnd, 600/cs

Electrodes, ECG, SilverTRACE, WINDOW P50TR Vinyl Tape

Rnd, 30/pch 300/cs

Electrodes, ECG, SilverTRACE, WINDOW P50TR, Vinyl Tape

Rnd, 5/strip 300/cs

Electrodes, ECG, SilverTRACE WINDOW P50TR Vinyl Tape

Rnd, 7/pch, 350/cs

Electrodes, ECG, SilverTRACE Disposable, Foam Oval, 5/strip,

600/cs

Electrodes, ECG, SilverTRACE Disposable, Foam Oval, 30/pch,

300/cs

Electrodes, ECG, SilverTRACE Disposable, Ad, Clear Vinyl

Tape, 5/strip, 300/cs

GE Part Number

2014768-001

2014775-001

2014776-001

2014780-001

2014781-001

2014783-001

2014784-001

2014785-001

900703-205

900703-230

9653-305

B-2 SEER

®

Light 2040604-012D

Accessories

Description

Electrodes, ECG, SilverTRACE Disposable, Ad, Clear Vinyl

Tape, 7/pch, 350/cs

SEER Light Cable/lead wires, 2 Channel, AHA

SEER Light Cable/lead wires, 3 Channel, AHA

SEER Light Cable/lead wires, 2 Channel, IEC

SEER Light Cable/lead wires, 3 Channel, IEC

SEER Light Patient Cable/lead wires 2ch AHA - Short

SEER Light Patient Cable/lead wires 3ch AHA - Short

SEER Light Patient Cable/lead wires 2ch IEC - Short

SEER Light Patient Cable/lead wires 3ch IEC - Short

Holter Kit, 5-Lead, 24 kits/case

Holter Kit, 7-Lead, 24 kits/case

Prep Razors, Disposable

Pre-Cut Tape Strips for Stress Loops, 100/pack

SEER Light Carrying Case, Belt and Strap

Holter Patient Diary

Holter/Exercise/Stress Vests, Medium

Holter/Exercise/Stress Vests, Large

Holter/Exercise/Stress Vests, Extra Large

SEER Light 64MB Memory Card

SEER Light Memory Card Adapter

Alcohol/Pumice Prep Pads

Sandpaper Prep Strips

Dry Skin Prep Pads

GE Part Number

9653-507

2008594-001

2008594-002

2008594-003

2008594-004

2008594-005

2008594-006

2008594-007

2008594-008

400068-026

400068-027

3704-901

4829-002

2008596-001

90026-902

9812-011

9812-012

9812-013

2008750-003

2008751-001

4828-004

4828-005

9386-001

2040604-012D SEER

®

Light B-3

Accessories

B-4 SEER

®

Light 2040604-012D

Index

Index

A

Access LED ............................................................ 2-5

Accessories.................................................... 1-10, B-2

ACCIDENTAL SPILLS ............................................ 1-5

Acquisition unit........................................................ 6-6

Adapter, flash card.................................................. 6-6

AHA

American Heart Association ............................. 3-2

Alphanumeric

entry.................................................................. 4-3

keypad .............................................................. 2-6

B

Battery box

controller........................................................... 2-6 cover .......................................................... 2-6

recorder ............................................................ 2-4 cover .......................................................... 2-4

Battery status, checking.......................................... 5-2

C

Cardiac application warning .................................... 1-6

Caution definition .................................................... 1-5

CH

channel ............................................................. 3-2

Cleaning

cleaning instructions ................................ 2-16, 3-6

cleaning the recorder........................................ 5-2

Conductivity warning............................................... 1-7

D

Danger definition..................................................... 1-4

DATA LED .............................................................. 2-5

Data transfer

data transfer cable............................................ 2-6

Defibrillation warning............................................... 1-8

Delete old data........................................................ 4-2

Disconnect the patient ............................................ 5-2

Disconnecting the recorder ................................... 5-15

Disposal

caution .............................................................. 1-9

E

Eject button ............................................................. 2-7

Electrode

attaching ........................................................... 5-2

placement

modified aVF lead ...................................... 3-4

modified V3 lead ........................................ 3-3

modified Z lead........................................... 3-5

problems........................................................... 3-6

Electrosurgery warning ........................................... 1-8

Entering patient information .................................... 4-2

Event..................................................................... 1-13

F

Flash card ............................................................... 6-3

adapter ............................................................. 6-6

H

Heart rate

detection channel, controller........................... 2-13 synchronizing sound....................................... 2-13

Holter analysis system ............................................ 6-6

Holter card slot........................................................ 2-7

I

IEC ........................................................................ 1-11

International Electrotechnical Commission....... 3-2

Infrared terminal............................................... 2-5, 2-7

Input connector ..................................................... 1-13

Instructions for use caution ................................... 1-10

L

Language

selecting ......................................................... 2-12

LCD......................................................................... 2-7

Lead check.............................................................. 5-2

M

Modifications caution ............................................ 1-10

N

Note definition ......................................................... 1-5

O

Output connector ........................................... 1-14, 2-5

P

Parameter descriptions ......................................... 2-13

Patient

hookup.............................................................. 3-7

Patient cable

connect ............................................................. 5-2

connector.......................................................... 2-4

Polarity of batteries ............................................... 1-13

Power.................................................................... 1-13

button on controller........................................... 2-7

R

REC LED ................................................................ 2-4

Recorder, disconnection ....................................... 5-15

Restricted sale caution.......................................... 1-10

S

SEER card slot........................................................ 2-7

SEER Light controller, diagram............................... 2-5

SEER

®

Light 2040604-012D Index-1

Index

SEER Light recorder, diagram ................................ 2-3

Set-up button .......................................................... 2-6

Skin preparation...................................................... 5-2

ST segment changes ................................ 3-3, 3-4, 3-5

Start

recorder .......................................................... 5-11

start/event button .................................................... 2-4

Stop....................................................................... 1-13

button................................................................ 2-5

recording......................................................... 3-11

Stress loops ............................................................ 3-7

Supervised use warning.......................................... 1-8

T

Transfer data........................................................... 5-2

from recorder to controller ................................ 6-2

Transfer mode....................................................... 2-12

T-shirts .................................................................... 3-8

W

Warning definition ................................................... 1-4

Wet gel electrodes .................................................. 3-7

Index-2 SEER

®

Light 2040604-012D

Suzuken Company, Limited

8 Higashikataha-machi, Higashi- ku

Nagoya, Aichi-Ken Japan

ANTISEL A. Selidis bros S.A.,

6, I.P. Karatasiou Street

54250, Harilaou, Thessaloniki Greece

DISTRIBUTOR

GE Medical Systems

Information Technologies, Inc.

8200 West Tower Avenue

Milwaukee, WI 53223 USA

Tel: + 1 414 355 5000

1 800 558 7044 (US Only)

Fax: + 1 414 355 3790 www.gehealthcare.com

DISTRIBUTOR

GE Medical Systems

Information Technologies GmbH

Munzinger Straße 5

D-79111 Freiburg

Germany

Tel: + 49 761 45 43 - 0

Fax: + 49 761 45 43 - 233

DISTRIBUTOR

GE Medical Systems

Information Technologies Asia; GE (China) Co., Ltd.

11th Floor, Shanghai MAXDO Center,

8 Xing Yi Road, Hong Qiao Development Zone

Shanghai 200336, People’s Republic of China

Tel: + 86 21 5257 4650

Fax: + 86 21 5208 2008

GE Healthcare SEER Light Extend, Ambulatory Recorder Operator's Manual

Assistant Bot

GE Healthcare

SEER

®

Light

Ambulatory Recorder/Controller

Operator's Manual

CE Marking Information

Compliance

Contents

Manual Information

Manual Information

Revision History

Manual Purpose

Intended Use

Intended Audience

Product References

Conventions

Illustrations

Safety Information

Definitions

Messages

Warnings

Cautions

Responsibility of the Manufacturer

General

Classification

Underwriters Laboratories, Inc.

Information Technology Equipment

Equipment Symbols

Service Information

Requirements

Serial Number

Equipment Overview

General Information

SEER Light Device Compatibility

SEER Light/SEER Light Extend Compact Digital

Holter Recorder

SEER Light Extend Controller

SEER Light Connect

Installing SEER Light Hookup

Pouch

Operating Modes - SEER Light Controller

SEER mode

Transfer mode

Set-up Condition Mode

Selecting a Language

Parameter Descriptions and Configuration

Battery Power

SEER Light Controller

SEER Light Recorder

Battery Disposal

Care and Cleaning

Storage and Operating Conditions

Preparing the Patient

Placing Electrodes

Two Channel, Five Electrode

Three Channel, Seven Electrode

Modified V3 Leads

Modified aVF Leads

Modified Z Leads

Preparing the Skin

Hooking Up the Patient

Pouch

Holter ECG Patient Diary

Setting Up the Patient Diary

Instructing the Patient

Audible Alarms

Activity Restrictions

Keeping Track

Shorter Test

Entering Patient Data

Entering Patient Data

Using the SEER Light Extend Controller

Deleting Old Data

Entering Patient Information

Alphanumeric Entry

Choosing a Letter to Enter

Using the SEER Light Connect