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Schiller BR-102 PLUS - Safety Standards

Schiller BR-102 PLUS
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Page 61
Art. no.: 2.511076 Rev.: g
Technical Data 7
User Guide Error Messages 6.5
BR-102 plus / BR-102 plus PWA
Safety Standards IEC 60601-1
ISO 81060-2:2013
a
IEC 80601-2-30
IEC 60601-1-2 (EMC)
Protection Class Internal power supply
Protection Class of Casing IP42 when using the carrying pouch
Applied Part BF according to IEC/EN 60601-1
Conformity CE 0123 according to Annex II 93/42/EEC (medical devices)
Classification IIa according to MDD 93/42/EEC
Trusted Accuracy The BR-102 plus / BR-102 plus PWA is clinically validated to all
internationally recognised organisations:
BHS (in progress)
ESH (2002)
AAMI SP10:2002
Environmental conditions
(Operation)
Operating temperature
Relative humidity
Pressure during operation
0°C to + 40°C (+ 32°F to + 104°F)
15 % to 95 % (non-condensing)
540 hPa to 1060 hPa
Environmental Conditions
(storage and transport)
Transport temperature
Storage temperature
Relative humidity (storage
and transport)
Pressure (storage and
transport)
- 10°C to + 50°C (+ 14°F to + 122°F)
+ 5°C to + 50°C (+ 41°F to + 122°F)
10 % to 95 % (non-condensing)
500 hPa to 1060 hPa
a. The sphygmonometer was clinically investigated according to the requirements of ISO 81060-2:2013

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