Operators Manual
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GE Healthcare
SEER™ MC Ambulatory Digital Analysis Recorder Software Version 3 Operator’s Manual 406344-046 Revision J
NOTE: The information in this manual only applies to SEER MC version 3. It does not apply to earlier software versions. Due to continuing product innovations, specifications in this manual are subject to change without notice. Marquette, MARS 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. © 2001, 2004, 2005, 2007, 2008 General Electric Company. All rights reserved.
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SEER MC Ambulatory Digital Analysis Recorder
406344-046J 4 April 2008
CE Marking Information
CE Marking Information Compliance The SEER MC Ambulatory Digital Analysis Recorder bears the CE mark “CE-0459”, notified body GMED, indicating its conformity with the provisions of the Council Directive 93/42/EEC, concerning medical device and fulfills the essential requirements of Annex I of this directive. The product is in radio-interference protection class B in accordance with EN 55011. The country of manufacture can be found on the equipment labeling. The product complies with the requirements of standard EN 60601-1-2 “Electromagnetic Compatibility - Medical Electrical Equipment”. The safety and effectiveness of this device has been verified against previously distributed devices. Although all standards applicable to presently marketed devices may not be appropriate for prior devices (i.e. electromagnetic compatibility standards), this device will not impair the safe and effective use of those previously distributed devices. Any other directive(s) and all the standards the product complies to are listed in the general information of the operator manual for the product following this page.
Exceptions The SEER MC Ambulatory Digital Analysis Recorder EMC: Immunity Performance There are no exceptions.
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CE Marking Information
General Information Users should be aware of known RF sources, such as radio or TV stations and hand-held or mobile two-way radios, and consider them when installing a medical device or system. Be aware that adding accessories or components, or modifying the medical device or system may degrade the EMI performance. Consult with qualified personnel regarding changes to the system configuration.
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Contents
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Introduction... 1-1 Manual Information... 1-3 Revision History... 1-3 Manual Purpose... 1-4 Conventions... 1-4 Intended Use... 1-5 Functional Overview of SEER MC Application... 1-6 Safety Information... 1-8 Responsibility of the Manufacturer... 1-8 General... 1-8 Equipment Symbols... 1-9 Warnings and Cautions... 1-10 Equipment Identification... 1-12 ECG Analysis... 1-13
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Equipment Overview... 2-1 Equipment Description... 2-3 Top View... 2-3 Back View With Cover Removed... 2-4 LCD Display... 2-5 Patient Cables... 2-6 Preparation for Use... 2-9 Overview... 2-9 Insert a Data Card... 2-10 Eject the data card... 2-10 Install Batteries... 2-11 Display Description... 2-13 Overview... 2-13 Complete Display... 2-13 Leadwire Fail Displays... 2-16
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Preparing the Patient... 3-1 Electrode Placement - Ambulatory... 3-3 Two Channel, Five Electrode, Bipolar-Bipolar... 3-3
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Three Channel, Seven Electrode... 3-4 Modified Mason-Likar Twelve Lead, Ten Electrode... 3-7 Standard Twelve Lead, Ten Electrode Placement... 3-8 Skin Preparation... 3-9 Patient Hookup... 3-10 Testing Voltage and Impedance... 3-12
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Recording ECG Data... 4-1 Preparation... 4-3 General Patient and Recorder Preparation... 4-3 Set Up the Patient Diary... 4-3 Instruct the Patient... 4-4 Recording... 4-6 Startup... 4-6 Recording a 12-Lead... 4-7 Recording an AECG... 4-8 After Data Acquisition... 4-9 Review the Diary... 4-9 Enter a Patient ID Number... 4-10 Enter a Patient’s Age... 4-12 Enter a Patient’s Age in Years... 4-12 Enter a Patient’s Date of Birth... 4-14
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Recording 12-Lead ECG Data... 5-1 Preparation... 5-3 General Patient and Recorder Preparation... 5-3 Recording... 5-4 Startup... 5-4 Enter a Patient ID Number... 5-4 Enter a Patient’s Age... 5-7 Site and Location for MUSE... 5-10 Recording a 12-Lead... 5-10
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Configuration Settings... 6-1 Default Settings... 6-3 Changing Settings... 6-4 Overview... 6-4 Menu Structure... 6-4 Overview of Navigation... 6-5 Configure the Recorder... 6-6 Configuration Category Reference... 6-8
Appendix A – Maintenance...A-1 Introduction... A-3 Maintenance/Repair Log...A-3 Environmental Protection...A-3 Inspection and Cleaning... A-4 Visual Inspection...A-4 Precautions...A-4 Frequency...A-4 Cleaning...A-4 Storing the Recorder... A-5 Maintenance/Repair Log... A-6
Appendix B – Troubleshooting...B-1 Introduction... B-3 First Things to Ask...B-3 Visual Inspection...B-3 System Error Messages... B-4
Appendix C – Technical Information...C-1 Technical Specifications... C-3
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Introduction
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Introduction: For your notes
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Introduction: Manual Information
Manual Information Revision History Each page of the document has the document part number and revision letter at the bottom of the page. The revision letter identifies the document’s update level. The revision history of this document is summarized in the table below. Revision
Date
Comment
A
12 February 2001
Initial Release
B
12 July 2002
Removed the data card ejection button information throughout. Updated data cards to 64 MB and ejection of card to be done with the pulltab, changed r2 to r3 throughout manual, and added graphic with new labels.
C
3 October 2002
Added IEC information to the Fail Displays tables in chapter 2.
D
13 February 2004
Revised CE Compliance Information.
E
26 May 2004
Removed battery note in chapter 5 and added pace detection warning.
F
1 April 2005
Software version reference updated to version 3.
G
30 September 2005
Added caution regarding altering limb leads. Added equipment symbols and descriptions for WEEE compliance and date of manufacture icons. Updated label graphics. Replaced the word “Resting” with “12-lead” throughout manual. Removed the word “interpretive” throughout manual. Added ECG Analysis section at end of Chapter 1. Added Intended Use section in Chapter 1. Replaced EKPRO with EK-Pro throughout manual. Caution regarding comparing serial 12-lead ECGs added to Chapter 3. Appendix C - changes to Certification Description. Appendix C changed Storage/Transport Conditions from -10C to -20C.
H
29 January 2007
Corrected the High Frequency Setting of the lowpass filter from 40 Hz to 35 Hz.
J
4 April 2007
Revised Document Assembly worksheet.
Manual Purpose This manual contains the instructions necessary to operate the SEER MC ambulatory digital analysis recorder safely in accordance with
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Introduction: Manual Information its function and intended use. These instructions include but are not limited to:
a fundamental description of controls and indicators,
operating procedures,
connection and disconnection of detachable parts and accessories, and
instructions for operator cleaning, preventive inspection and maintenance of equipment.
Where necessary the manual identifies additional sources of relevant information and/or technical assistance.
Conventions Following are the conventions used in this manual.
Definitions
Items shown in Bold text are:
keys on the keyboard,
text to be entered, or
hardware items such as buttons or switches on the equipment.
Items shown in Italicized text are software terms which identify menu items, buttons, or options in various windows.
Intended Use The SEER MC Ambulatory Digital Analysis Recorder is intended to provide ambulatory ECG signal and automated analysis of the recorded ECG data. Results of the automated analysis, when used in conjunction with an ECG review system, are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The SEER MC can collect and store up to 48 hours of continuous 2 or 3 channels of ambulatory ECG data. In addition, the SEER MC can record and analyze 12-lead ambulatory ECG data for definition of morphology shape and measurements, heart rate, rhythm, and ST segment trending. The SEER MC is intended for use on adult and pediatric (greater than 10Kg) patients in a clinical setting by qualified medical personnel. The SEER MC recorder, in its two- or three-channel mode of operation, detects the following: normal beats, ventricular beats, supraventricular
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Introduction: Manual Information beats, paced beats and artifact. This information, in conjunction with an ECG review system, documents the following: fastest and slowest heart rate, runs of ventricular beats, runs of supraventricular beats, pauses, ST segment changes, areas of atrial fibrillation, percentage of paced beats, prolonged QT, T-Wave Alternans, Heart Rate Turbulence, Heart Rate Variability and ECG strips associated with patient events and/or symptoms. The SEER MC in its 12-lead mode of operation, in conjunction with a ECG Review system, documents the aforementioned information and also measures and trends the following 12-lead parameters: PR interval, QT interval, QRS duration, ST measurements at J point plus 40, 60 and 80 milliseconds for all 12 leads and displays the Ventricular rate, and P, R and T axis for each 12-lead segment. The SEER MC is not intended to be used as a substitute for a standard, diagnostic-quality 12-lead electrocardiograph.
Functional Overview of SEER MC Application The SEER MC recorder provides ambulatory ECG signal, as well as automated analysis of the recorded data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician’s role in over-reading the recorded ECG data. The SEER MC can collect and store up to 48 hours of continuous 2 or 3 bi-polar channels of ambulatory ECG data. In addition, the SEER MC can acquire 12-lead ECG data, periodically or on demand. The 12-lead ECG data is acquired using 3 frontal plane electrodes, the Wilson Terminal, and 6 unipolar chest electrodes. The resulting 12-lead ECG data is identified using the standard lead name convention (I, II, III, aVR, aVF, aVL, & V1-V6). It should be noted that a quality diagnostic resting 12-lead ECG requires that the patient be at rest, in a supine position. Inappropriate body position or failure to minimize and recognize artifacts while recording the ECG may result in an incorrect measurement or diagnosis. As a result, diagnostic 12-lead ECGs are typically acquired in the presence of medical personnel, which administer the test and keep the patient calm and supine. However, unsupervised ambulatory Holter recording provides an opportunity to assess cardiac function while the patient is undergoing routine, daily activities. The SEER MC allows the physician to monitor and record 12-lead ECG signals in the ambulatory environment.
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Introduction: Manual Information ECGs acquired in the ambulatory environment will include more artifact than ECGs acquired at rest. In addition, as the patient changes body position, the overall cardiac vector will change direction. As a result, the ambulatory ECG does not yield the same quality of information as the resting ECG. Furthermore, there is a large body of established criteria for resting electrocardiography that requires the measurement of small features in a single, 10-second ECG. This includes the recognition of small Q waves, on the order of 6ms in duration and 20uV in amplitude. Obtaining these small measurements in a single ECG is simply not practical in the ambulatory environment. In the ambulatory environment, each stored 10-second 12-lead ECG should be assessed as a sample that makes up a trend. The role of the SEER MC is to acquire these samples so that they can be trended over time. The SEER MC can trend the same measurements as available during treadmill exercise testing. These include QRS duration, PR interval, QT interval, ST deviation, and heart rate. The SEER MC can export 12-lead ECG measurements for the purposes of trending. In addition, the SEER MC can export each raw 12-lead, 10second record that corresponds to a single sample or measurement. As in most Holter applications, a review station is often used to assess the quality of the measurements in conjunction with the signal data. Trends can be accessed for outliers and confirmed with the accompanying signal data. This is also true of the data acquired by the SEER MC. As with most Holter analysis programs, signals or leads can be annotated by the program as having too much artifact to properly analyze. This is also true of the SEER MC. Noise annotations accompany the 12-lead recordings as well as the continuous 3-lead recordings. During conventional exercise testing, the 12-lead ECG is obtained via two different electrode positions. When the patient is at rest and supine, the limb electrodes are off of the torso, using the standard positions as defined for scalar 12-lead electrocardiography. While the patient is ambulatory, the limb electrodes are moved onto the torso. This standard modification of the 12-lead is referred to as the Mason-Likar position and it makes the ambulatory ECG more resilient in the presence of body motion. Extensive study has already been done to show the ECG differences that are exhibited when using the Mason-Likar electrode positions versus the conventional 12-lead resting electrode positions. Comparisons of ECGs acquired via the Mason-Likar and the conventional 12-lead resting electrode positions should be limited and often only include the assessment of ST/T changes in the pre-cordial leads.
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Introduction: Safety Information
Safety Information Responsibility of the Manufacturer GE Medical Systems Information Technologies is responsible for the effects of safety, reliability, and performance only if:
Assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE Medical Systems Information Technologies.
The equipment is used in accordance with the instructions for use.
General This device is intended for use under the direct supervision of a licensed health care practitioner. To ensure patient safety, use only parts and accessories manufactured or recommended by GE Medical Systems Information Technologies. Contact GE Medical Systems Information Technologies for information before connecting any devices to this equipment that are not recommended in this manual. If the installation of this equipment, in the USA, will use 240 V rather than 120 V, the source must be a center-tapped, 240 V, single-phase circuit. Parts and accessories used must meet the requirements of the applicable IEC 60601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard.
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The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include:
use of the accessory in the PATIENT VICINITY; and
evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard.
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Introduction: Safety Information
Equipment Symbols The following symbols may appear on the equipment. This symbol means that you must pay attention to the documents delivered with this equipment. It calls attention to the things to which you must pay special attention during operation and when the equipment is operated in conjunction with other equipment.
Patient cable connector on the SEER MC recorder. Type B equipment. Type B equipment is suitable for intentional external application to the patient, excluding direct cardiac contact.
Event button.
C
SSIFIE LA
D
SSIFIE LA
D
C
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.
R
UL 2601-1 CAN/CSA 601.1 4P41 MEDICAL EQUIPMENT
The SEER MC recorder is classified by Underwriters Laboratories, Inc.® with respect to electric shock, fire, and mechanical hazards only in accordance with UL 2601-1 and CAN/ CSA C22.2 No. 601.1.
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.
The number found under this symbol is the date of manufacture in the YYYY-MM format.
002A, 003A, 004A, 005A, 006A, 174A, 175A
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Introduction: Safety Information
Warnings and Cautions Safety Messages DANGER Danger safety messages indicate an imminently hazardous situation which, if not avoided, WILL result in death or serious injury.
WARNING Warning safety messages indicate a potentially hazardous situation which, if not avoided, COULD result in death or serious injury.
CAUTION Caution safety messages indicate a potentially hazardous situation which, if not avoided may result in minor or moderate injury. NOTE Note messages provide additional user information.
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Introduction: Safety Information
DANGER Do NOT use in the presence of flammable anesthetics.
WARNINGS Keep the conductive parts of lead electrodes and associated parts away from other conductive parts, including earth. Equipment failure hazard. Disconnect the leadwires from the patient before defibrillating. Otherwise, serious injury or death could result. This device is intended for use under the direct supervision of a licensed health care practitioner. Do NOT contact unit or patient during defibrillation. Strangulation hazard. Route all cables away from the patient's throat to avoid possible strangulation.
CAUTION U.S. Federal law restricts this device to sale by or on the order of a physician.
CAUTION Caution should be exercised when comparing serial 12lead ECGs that include both standard and altered lead positions. Altering limb lead positions during a 12-lead recording (i.e. torso placement of leads) can result in a 12 lead ECG with different properties (changes in inferior Q waves, changes in QRS axis) when compared to an ECG recorded with limb leads in the traditional position. ST segments measured using altered limb lead positions are not significantly affected
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Introduction: Safety Information
Equipment Identification Every GE Medical Systems Information Technologies device has a unique serial number for identification. The serial number appears on the product label on the bottom of each unit. Bar code, serial number, and manufacturing location appear in this window.
Bottom Label
Top Label Name
172A, 173A
Description
Name of Device
SEER MC ambulatory ECG recorder
Serial Number
Unique identifier, made up of the following elements: Month Manufactured A = January, B = February, C = March, D = April, E = May, F = June, G = July, H = August, J = September, K = October, L = November, M = December Year Manufactured 02 = 2002, 03 = 2003, 04 = 2004 (and so on) Product Code Two-character product descriptor. HX = SEER MC Product Sequence Number Manufacturing number (of total units manufactured) Manufacturing site Miscellaneous Characteristic
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Introduction: ECG Analysis
ECG Analysis The ECG analysis in the SEER MC is performed by the Ek-Pro and 12SL algorithms. Both Ek-Pro and the 12SL analysis program analyze the ambulatory ECG data in order to obtain waveform measurements. Waveform measurements include beat detection times, beat classification types and the various waveform features of the QRS complex. These measurements are performed during recording for use in analysis and review within the ambulatory ECG system. The SEER MC with computerized ECG analysis is designed for use as an ambulatory monitor for indications appropriate for ambulatory monitoring. It is not intended to be a substitute for a standard diagnostic electrocardiograph. Both EK-Pro and 12SL analyze the ECG for the following:
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Beat Detection Times - detection and delineation of QRS complex locations. Beat detection information includes delineation of beat location, as well as grouping beats of similar shape based on a correlation function. Results of beat detection are used by subsequent processing performed on the ECG.
Beat Classification Types- QRS complexes are grouped by shape in the beat detection and then analyzed for morphologic features that are used to help classify beats according to type. Examples of morphologic features are QRS width, QRS axis, T wave morphology, presence of a P wave, QRS amplitude. Beat classification uses morphologic information, as well as waveform measurements and contextual information (prematurity, noise level, rhythm information, etc.) to determine the best classification for each beat. Beat classification may be in terms of beat type (normal, ventricular, supraventricular, etc.) or in terms of morphologic features, which are tied to physiologic conditions (conduction defects, pacemaker/fusion, or ischemia related waveform features).
Waveform Measurement from the QRS Complex- measurements are made based on delineation of various waveform features such as QRS width, ST deviation, PR/QT intervals, QRS axis etc.
SEER MC does not perform ST measurements or detect ST segment shifts in two and three channel mode. ST measurements and detection of ST segment shifts for 2 and 3 channel continuous ambulatory data can be performed by the Holter analysis workstation. In the 12-lead Mode, SEER MC measures ST segment amplitude in all leads. SEER MC records ECG data using digital media and is not susceptible to gain variances, therefore, calibration is not necessary
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