ZONARE Z.ONE, Руководство по обслуживанию

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Q00110 Rev A 8/06 Page 30 of 225
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•
Models:
- Z316 : Domestic Version.............. 110 VAC power cord
- Z317 : International Version ....... 220 VAC power cord
•
Voltage Output
- +9V to +12V.................................. +/- 5% over loading
3.12 Temperature, Humidity, Pressure Limits
System: (During Operation) :
•
Temperature 0
o
to 35
o
Celsius | (32
o
to 95
o
F)
•
Relative Humidity 15–80%
•
Elevation 3,100 to (-116) Meters | 10,200 to (-1,250) Feet
System: (During Shipping/Storage) : Battery MUST be REMOVED from Scan Engine!
•
Temperature -20 to 60
o
Celsius | (-4
o
to 158
o
F)
•
Relative Humidity 15–90%
•
Elevation 5,944 to (-116) Meters | 19,500 to (-1,250) Feet
3.13 Device Classification
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FDA Class II Device Classification
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CE / MDD Class IIa-rule 10 active device intended for diagnosis
3.14 Safety Standards
All ZONARE instruments, cables, and diagnostic ultrasound imaging transducers have been designed
to meet the essential requirements contained in:
•
93/42/EEC (Medical Device Directive).
In addition, all the above listed equipment meets the following appropriate requirements:
•
UL 2601-1 (Standard for Medical Electrical Equipment Part 1: General Requirements for
Safety)