SEER 12 User Manual Rev A

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.

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Contents

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Indications and Intended Use ... 1-1 Indications... 1-1 Intended use... 1-1

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CE Compliance, Device Label, and Packaging Label... 2-1 CE Compliance... 2-1 Information on the Device Label ... 2-2 Symbols on the Packaging Label... 2-3

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Safety and Reliability ... 3-1 Definitions... 3-1 General Safety Information... 3-1 WARNINGS... 3-1 CAUTIONS... 3-3 Electromagnetic Interference ... 3-5 Safety Only with Approved Accessories ... 3-6 Safety and Reliability Only with Proper Maintenance... 3-6 Cleaning the Recorder and Accessories ... 3-7 Cleaning the Battery Contacts... 3-8 Disposing of the Device, Batteries, and Accessories ... 3-8

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Control Elements – Switching the Recorder On and Off ... 4-1 Switching On the Recorder... 4-1 Switching Off the Recorder... 4-2 Switching Off When the Device is Not Recording... 4-2 Switching Off When the Device is Recording ... 4-3

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Preparing the Recording ... 5-1 Instructing the Patient on the Required Safety Precautions and Recording Diary...5-1 Checking the Electrode Connection Leads and Patient Cable ...5-3 Always Use the Same Patient Cable With a Recorder...5-3 Attaching the Electrodes...5-3 Materials Required ...5-3 Patient Preparation...5-4 Electrode Layout With 10 leads for 12-channel Recordings...5-4 Reference table of the electrode coding...5-6 Connecting the Patient Cable...5-7 Power Supply...5-8 Battery State Display ...5-8 Behavior of the Device with Discharged Battery...5-9 Inserting a Battery...5-9 Removing a Battery...5-10 Using the Optional Two-battery Compartment...5-10 Using the CompactFlash Memory Card...5-11 Inserting the CompactFlash Card...5-11 Formatting and Erasing the CompactFlash Card...5-12 Start-Up Screens ...5-13 The PATID Display Screen...5-13 The INFO Display Screen...5-13 How to restore the factory settings...5-13

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Accessing Menus ... 6-1 Using the Y Key...6-1 Using the Z Key...6-2

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ECG Recording Settings... 7-1

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Selecting and Modifying SEER 12 Settings...7-1 Entering Numbers and Letters Using the Arrow Keys...7-2 MEAS Menu Field Descriptions...7-2 SEER 12 2049152-010A

SYS Menu Field Descriptions... 7-4 Checking Signal Quality... 7-6 Checking Single Channel Signal Quality... 7-6 Checking Multiple Channel Signal Quality... 7-7 Starting the Recording... 7-7 Auto-Start ... 7-9 Auto-Switch off ... 7-9

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Operation During Recording ... 8-1 Recording Status Display... 8-1 Accessing Menus During the Recording... 8-1 Manually Ending a Recording ... 8-2

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After Completing the Recording... 9-1 Removing the Electrodes... 9-1 Removing the Patient Cable From the Recorder ... 9-2 Transferring the ECG Data to a PC ... 9-2

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Specifications ...10-1 Electrical ...10-1 Mechanical...10-2 Safety class...10-2 EMC Specifications According to IEC 60601-1-2 ...10-3 General Specifications, Table 201 ...10-3 Table 202 ...10-3 Non Life-Sustaining Systems, Table 204...10-4 Recommended Separation Distances from Portable and Mobile RF Communications Equipment, Table 206...10-4 Supplies...10-5

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Indications and Intended Use

Indications The SEER® 12 is a Holter recorder which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality.

Intended use The SEER 12 digital Holter recorder is intended to continuously record up to 48 hours of ECG data on a digital flash memory card. The SEER 12 performs no cardiac analysis by itself and is intended to be used with the MARS® Ambulatory ECG Analysis System. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or health care professional.

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Indications and Intended Use FOR YOUR NOTES

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CE Compliance, Device Label, and Packaging Label The following section explains the symbols used with the SEER 12 system.

CE Compliance

This CE mark information is part of the user manual and is applicable for all products marketed and distributed by GE Medical Systems Information Technologies in the European community. The SEER 12 bears the CE mark 0197, notified body TÜV Rheinland, indicating its conformity with the provisions of the Council Directive 93/42/EEC, concerning medical devices and fulfills the essential requirements of Annex A of this directive. The product is in radio-interference protection class A in accordance with EN 55011. The product complies with the requirements of standard EN 60601-1-2 “Electromagnetic Compatibility – Medical Electrical Equipment”.

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CE compliance, device label and packaging label

Information on the Device Label

Figure 1. Device Label

The label shows the name and address of the manufacturer along with the product and model identification. The serial number of the device is given beside the symbol SN. This device is suitable for use on patients weighing less than 10 kg (22Ibs.). The following symbols appear on the device label. The triangle with the exclamation mark indicates that failure to comply with the user manual instructions can result in risk of patient's life or risk of injury. The book symbol means that you must not use the device when you are not familiar with the information contained in these operating instructions. The heart symbol informs clinicians that the device is classified as “cardiac floating” (CF) and that it is NOT protected against defibrillation.

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The Rx only symbol indicates that, in the United States of America, federal law restricts the device to use by or on the order of a physician.

Rx only

Use the battery type printed on the device label. The waste bin symbol with an X indicates that you must dispose of the device properly. Further information is provided in the section “Disposing of the Device, Batteries, and Accessories” on page 3-8. The hollow factory symbol identifies the year in which the device was manufactured. The solid factory symbol identifies the name of the manufacturer.

Symbols on the Packaging Label The REF (reference) number on the packaging label is used to identify and order the product. 65°C – 20°C

The thermometer symbol identifies the upper and lower temperature limitations prescribed for the device’s storage and shipping.

The umbrella symbol indicates that you must keep the device dry.

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The sun symbol indicates that you must keep the device away from direct sunlight.

The glass symbol indicates the device is fragile and must be handled with care.

The arrow symbols indicate the proper orientation of the packaging.

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Safety and Reliability Carefully read this manual. It contains important information for a correct ECG recording. These operating instructions are intended for medical doctors and medical personnel. Additional safety messages that provide appropriate safe operation information may be found throughout this manual.

Definitions The terms 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. WARNING indicates a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury. CAUTION indicates a potential hazard or unsafe practice which, if not avoided, could result in minor personal injury or damage to the product or property. NOTE provides application tips or other useful information to assure that you get the most from your equipment.

General Safety Information WARNINGS WARNING Ambulatory ECG data from Holter recorders are not intended to be used as a substitute for a standard diagnostic quality resting 12-channel ECG.

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Safety and Reliability

WARNING The SEER 12 device is not a monitoring device and is not intended for monitoring the clinical condition of a patient.

WARNING Risks for the health and life of a patient can occur if one patient is assigned another patient's ECG recording.

WARNING DEFIBRILLATION – No Defibrillation Protection! Disconnect electrodes and recorder from the patient when using a defibrillator.

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 recorder.

WARNING EXPLOSION HAZARD – Do not use device in an oxygen rich environment or around other flammable or explosive gases. Establish whether a patient, possibly job related, is liable to be in such environments.

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. Use only the biocompatible ECG cables (patient cables) and the biocompatible electrodes supplied by GE Healthcare. 3-2

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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. Also make sure that no contact to other conductive parts is possible if the electrodes loosen during recording.

WARNING It is the responsibility of the medical doctor to provide the patient with the information required for the ECG recording. See “Instructing the Patient on the Required Safety Precautions and Recording Diary” on page 5-1 for more information.

CAUTIONS CAUTION When attaching and affixing the patient cable, make sure not to bend it excessively, as this can damage the cable.

CAUTION When the device is not in use, remove the battery from the device. For more information, see “Removing a Battery” on page 5-10.

CAUTION Pacemaker pulses of more than 100 mV may cause a channel overload.

CAUTION With the exception of pacemakers, the SEER 12 device must not be used with other medical electrical stimulators. 2049152-010A

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CAUTION The lack of proper patient preparation can result in the quality of the ECG recordings being unsatisfactory. Properly prepare the patient for the recording as described in section “Preparing the Recording” on page 5-1.

CAUTION Each time before connecting the recorder and the electrodes to the patient, visually check the recorder, the ECG patient cable, and, if used, the connection to the PC or other devices for damage.

CAUTION Changes in temperature and humidity can cause condensation inside the recorder. Wait at least two hours after the externally visible dampness of the recorder has disappeared before reusing it.

CAUTION To access the memory card, remove the battery compartment. Under no circumstances use force when handling the recorder.

CAUTION INSTRUCTIONS FOR USE – For continued safe use of this equipment, it is necessary that the listed instructions be followed. However, instructions listed in this manual IN NO WAY supersede established medical practices concerning patient care.

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CAUTION RESTRICTED SALE – US Federal law restricts the recorder to sale by or on the order of a physician.

Electromagnetic Interference WARNING Do not operate the SEER 12 device in the proximity of MRI (magnetic resonance imaging) devices or other systems that generate strong electromagnetic fields. Among other things, the electrode leads can heat up inductively, which can result in burns to the patient.

WARNING During evaluation, false diagnoses are possible if ECG recordings have been distorted by electromagnetic interference and the medical doctor does not detect this. Frequently, devices with high electric power consumption generate electromagnetic interference. Inform the patient to keep a distance from electrically driven machines including, but not limited to: drills and saws, electric welding systems, large operating loudspeakers, radio, or TV electric devices with obviously large power electric blankets mobile phones Certain systems such as electric welding systems or radio, TV, and transmission systems can interfere with the ECG recording even from a larger distance. Determine possible sources of electromagnetic interference in the patient's everyday life.

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Safety Only with Approved Accessories CAUTION Safe and reliable operation of the SEER 12 device is only possible when using the supplied and approved accessories. Observe the information contained in this user manual and in the accessories’ operating instructions.

Safety and Reliability Only with Proper Maintenance CAUTION Proper maintenance is vital for long-term safety and reliability of the SEER 12 device. Each time before connecting the recorder and the electrodes to the patient, visually check the recorder and ECG patient cables for damage.

CAUTION After each recording, remove the battery from the device.

CAUTION For hygienic reasons, do not return disposable parts that have had direct contact with the patient such as ECG electrodes.

CAUTION Repairs must be carried out only by persons authorized by GE Healthcare. If you find or even suspect a malfunction, send the device for testing to GE Healthcare or a facility authorized by GE Healthcare. Please add a detailed description of the assumed malfunction.

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CAUTION When returning the recorder for service or repair, please remember to include the patient cable and the memory card.

CAUTION Avoid wrapping the patient cable tightly around the recorder, as this can damage the cable.

CAUTION For hygienic reasons and especially to help protect our service personnel, please disinfect the recorder and patient cable before returning them to us for inspection or maintenance.

Cleaning the Recorder and Accessories WARNING If any CONTAMINATION of the recorder or accessories has occurred, observe both, standard procedures for handling contaminated objects and the following precautions: Use protective gloves to handle the equipment. Isolate the material by using suitable packaging and labeling. Contact the addressee before sending the equipment. Observe the following guidelines when cleaning the recorder and accessories: Remove the battery before cleaning the recorder. Disinfect the device at regular intervals, prior to first use, and before passing it on to another person. Clean the device before performing surface disinfection. Use a lint-free cloth slightly moistened with water or a mild soap solution to externally clean the recorder and carrying pouch. 2049152-010A

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CAUTION Do not submerge the recorder or allow fluid to enter the recorder or cable connectors under any circumstances. Wash the carrying pouch by hand at 30 °C (86 °F). Do not machine wash or dry the carrying pouch. Use cleaning and disinfection agents only in accordance with the manufacturer’s instructions, for example, be sure to use the correct dilution factor. GE Healthcare recommends disinfecting the device with Virkon®, available as a spray or wiping solution. Do not use solvents such as ether, acetone, or petroleum ether; such substances can damage the plastic of the device housing and cables. Patient cables can be cleaned with a liquid for cable care or with a 70 % alcohol solution. Baby oil has proved to be effective in removing residue from adhesive strips. Do not sterilize the recorder or accessories.

Cleaning the Battery Contacts If the battery status indicates the battery’s charge is too low despite inserting a new or fully charged battery, it is recommended that you clean the battery contacts. Use a cleaning cloth slightly moistened with 70 % alcohol.

Disposing of the Device, Batteries, and Accessories Electrical devices and the accessories contain metal and plastic parts. To avoid any adverse environmental impact, dispose of the device and its accessories in accordance with applicable waste regulations after the product’s lifetime has expired. If you have questions concerning the disposal of this product, contact GE Healthcare or its representatives.

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WARNING Keep the packaging material out of children's reach.

CAUTION The symbol with the waste bin on the battery packaging reminds you not to dispose of used batteries together with normal waste. As the end user, you are required to dispose of any batteries in accordance with local and national regulations.

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