Smiths Graseby MS16A, Technical & Service Manual

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Te c h n i c a l S e r v i c e M a n u a l I s s u e 6 ( February 2 0 0 5 )
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S m i t h s M e d i c a l M S 1 6 A S y r i n g e D r i v e r
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Standards
Electrical safety:
Complies with EN 60601-1: 1990 (IEC 601-1:1988).
Type BF Applied Part for protection against electric shock.
EMC:
Complies with EN 60601-1-2:1993 for emissions and immunity to electromagnetic
disturbances. Group 1 Class B for emitted RF radiation according to EN 55011:1991
making it acceptable for use in domestic establishments.
Complies with RTCA DO-160D (Operation in a commercial aircraft with controlled
pressurised cabin area which maintains cabin pressure at normal cabin
environment.) Smiths Medical International Ltd. ref. CIB B1100.
Biological evaluation:
Complies with EN 30993-1:1994 Biological evaluation of medical devices - Part 1:
Guidance on selection of tests.
Packaging:
Complies with EN 20780:1993 Packaging - Pictorial marking for handling of goods.
Medical device directive 93/42/EEC:
CE marked under Annex II, risk class IIb (active medical device).
Notified Body: AMTAC (0473).
Quality system standards used:
EN ISO 9001 and EN 46001.
Symbols
An electrical safety classification in the international safety standard for medical
electrical equipment, Type BF. If the equipment is used as intended there is no risk
of a serious electric shock. But it is not suitable for direct connection to the heart.
Refer to the accompanying instructions on how to use the equipment.
Detailed instructions on how to use the syringe driver are given in the Instruction
Manual,
part number 0105-0549 .
The CE mark demonstrates that the Syringe Driver conforms to the requirements in
the European Council Directive 93/42/EEC concerning medical devices.
The number 0473 identifies the Notified Body under which the Quality Systems
operated within Smiths Medical are assessed.
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