| Customization: | Available |
|---|---|
| Classification: | Physiological Functions of Diagnosis and Monitoring Equipment |
| Type: | ECG |
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1.0 The usage range
This specification suited for customer's appointed models.
2.0 Usage condition(GB9706.1-2007 10.2.1)
2.1 Rated temperature:25ºC.
2.2 Operation environment:10ºC~40ºC.
2.3 Storage and transport method:individual moistureproof package for each
Product,Transport under the conditions of ambient temperature.
3.0 Construction
3.Appearance requests:
3.1 a The cable is round and glossy,the color uniformity, the jacket is ok,no
Disrepair,no dirt,no disfigurement,etc.
3.1 b The surface of the connector is glossy, no burr,no obvious machine scar,no
disfigurement,no modification,no dirt,no metal rust etc.
3.1 c
(EC13:2002 4.1.1.5/IEC60601-2-47 6.1aa)Clear dot-color and characters, the
corresponding printing should be correct.(EC13:2002 4.1.1.5/IEC60601-2-47 3.1d Product labels for use in line with the requirements of EC53-1995 4.1
3.1 e Product labels and graphics in line with the engraved die EN980-2008 / EU CE
requirement
f Product cleaning, disinfection and chemical resistance in ine with the requirements
of EC53-1995 4.3
3.2 Size requirements:
To check the Size according to the drawing which was issued by the
engineer. (The important size requirements, please notify it on time)
3.3 Packaging requirements:
The packaging in accordance with the requirements of the engineer
drawin(Incase of special packaging requirements, please promptly notify it.)
4.0 Technical requirements
4.1:ANSI/AAMI EC53:1995/(R)2001
ECG executive standards:ANSI/AAMI EC53:1995/(R)2001
Note:ANSI/AAMI EC53:1995/(R)2001 Standard the not description
general requested by the executive.
4.2 Customer special electrical and mechanical performance requirements.
(Please check the Implementation standards in remarks.)
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