Revision C
MAC 1200/1200 ST
CE-1
2012250-021
CE Marking Information
CE Marking Information
Compliance
The MAC 1200/1200 ST bears CE mark “CE-0459”, notified body GMED,
indicating its conformity with the provisions of the Council Directive 93/
42/EEC concerning medical devices and fulfills the essential
requirements of Annex I of this directive.
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.
The country of manufacture can be found on the equipment labeling.
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”.
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. See user’s
information.
Exceptions
The MAC 1200/1200 ST EMC: Immunity Performance
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.
Содержание MAC 1200
Страница 1: ...MAC 1200 1200 ST Operator s Manual Software Version 6 2012250 021 Revision C ...
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Страница 13: ...Revision C MAC 1200 1200 ST 1 1 2012250 021 1 The Basics ...
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Страница 25: ...Revision C MAC 1200 1200 ST 2 1 2012250 021 2 Controls and Indicators ...
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Страница 31: ...Revision C MAC 1200 1200 ST 3 1 2012250 021 3 Operating and Performance Tests ...
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Страница 41: ...Revision C MAC 1200 1200 ST 4 1 2012250 021 4 Preparing for ECG Recording ...
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Страница 57: ...Revision C MAC 1200 1200 ST 5 1 2012250 021 5 Automatic Mode Recording ...
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Страница 81: ...Revision C MAC 1200 1200 ST 6 1 2012250 021 6 Manual Mode Recording ...
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Страница 87: ...Revision C MAC 1200 1200 ST 7 1 2012250 021 7 Arrhythmia Mode Recording ...
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Страница 96: ...7 10 MAC 1200 1200 ST Revision C 2012250 021 Arrhythmia Mode Recording Recording For your notes ...
Страница 97: ...Revision C MAC 1200 1200 ST 8 1 2012250 021 8 Stress Tests ...
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Страница 120: ...8 24 MAC 1200 1200 ST Revision C 2012250 021 Stress Tests Running a Stress Test ...
Страница 121: ...Revision C MAC 1200 1200 ST 9 1 2012250 021 9 Pacemaker Patients Recording During Defibrillation ...
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Страница 125: ...Revision C MAC 1200 1200 ST 10 1 2012250 021 10 System Setup ...
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Страница 158: ...10 34 MAC 1200 1200 ST Revision C 2012250 021 System Setup Direct ECG Transmission ...
Страница 159: ...Revision C MAC 1200 1200 ST 11 1 2012250 021 11 Loading Chart Paper ...
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Страница 165: ...Revision C MAC 1200 1200 ST 12 1 2012250 021 12 Cleaning Disinfection and Maintenance ...
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Страница 169: ...Revision C MAC 1200 1200 ST 13 1 2012250 021 13 Troubleshooting ...
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Страница 173: ...Revision C MAC 1200 1200 ST 14 1 2012250 021 14 Technical Specifications ...
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Страница 185: ...Revision C MAC 1200 1200 ST 15 1 2012250 021 15 Order Information ...
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Страница 191: ...Revision C MAC 1200 1200 ST A 1 2012250 021 A Entering Special Characters ...
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Страница 194: ...A 4 MAC 1200 1200 ST Revision C 2012250 021 Entering Special Characters Special Characters For your notes ...
Страница 195: ...Revision C MAC 1200 1200 ST Index 1 2012250 021 Index ...
Страница 196: ...Index 2 MAC 1200 1200 ST Revision C 2012250 021 ...
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