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B40/B20 Patient Monitor
1-2
Responsibility of the manufacturer
GE Medical Systems
Information Technologies
, Inc. is responsible for the effects on safety,
reliability and performance of the equipment only if:
•
Assembly operations, extensions, readjustments, modifications, or repairs are carried out
by persons authorized by GE.
•
The electrical installation of the relevant room complies with the requirements of the
appropriate regulations.
•
The equipment is used in accordance with the instructions for use.
•
The equipment is installed, maintained and serviced in accordance with the instructions
provided in the related technical manuals.
Product availability
Some of the products mentioned in this manual may not be available in all countries. Please,
consult your local representative for the availability.
Intended audience
This manual is intended for clinical professionals. Clinical professionals are expected to have a
working knowledge of medical procedures, practices, and terminology, as required for
monitoring critically ill patients.
Printed copies of this manual
A paper copy of this manual will be provided upon request. Contact your local GE
representative and request the part number on the first page of the manual.
Training requirements
No product-specific training is required for the use of this monitor.
CE marking information
CE compliance
The monior bears CE Mark CE-0459 indicating its conformity with the provisions of the Council
Directive 93/42/EEC concerning medical devices amended by 2007/47/EC and fulfills the
essential requirements of Annex I of this directive. The country of manufacture can be found on
the equipment labeling.
Product Compliance
•
This equipment is suitable for connection to public mains as defined in CISPR 11.
•
This Monitor conforms to general safety standard for medical devices to IEC 60601-1.
•
This Monitor conforms to EMC safety standard to IEC 60601-1-2.
•
This Monitor conforms to usability safety standard for medical devices to IEC 60601-1-6.
•
The application of usability engineering to medical device conforms to IEC 62366.
•
The software life cycle processes conforms to IEC 62304.
•
The application of risk management analysis to medical device conforms to ISO 14971.
•
The SpO2 Parameter conforms to ISO 80601-2-61.
Содержание B20
Страница 2: ......
Страница 16: ...B40 B20 Patient Monitor xii ...
Страница 17: ...1 Introduction ...
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Страница 27: ...2 System description ...
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Страница 58: ...B40 B20 Patient Monitor 2 30 ...
Страница 59: ...3 Installation ...
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Страница 69: ...4 Monitoring basic ...
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Страница 79: ...5 Alarms ...
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Страница 102: ...B40 B20 Patient Monitor 5 22 ...
Страница 103: ...6 Monitor setup ...
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Страница 123: ...7 Trends ...
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Страница 140: ...B40 B20 Patient Monitor 7 16 ...
Страница 141: ...8 Print and record ...
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Страница 153: ...9 Cleaning and care ...
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Страница 163: ...10 Troubleshooting ...
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Страница 181: ...11 ECG ...
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Страница 205: ...12 Impedance respiration ...
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Страница 215: ...13 Pulse oximetry ...
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Страница 232: ...B40 B20 Patient Monitor 13 16 ...
Страница 233: ...14 Non invasive blood pressure ...
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Страница 248: ...B40 B20 Patient Monitor 14 14 ...
Страница 249: ...15 Invasive blood pressure ...
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Страница 261: ...16 Temperature ...
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Страница 267: ...17 Airway gas ...
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Страница 293: ...18 Entropy ...
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Страница 316: ...Abbreviations A 12 ...
Страница 318: ...B40 B20 Patient Monitor B 2 ...
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