Compatibility:
Mindray
Siemens
Viggo-Spectramed
(Statham)
WESTINGHOUSE
5 lead, Snap, AHA
1.0 this specification suited for customer's appointed models.
2.0 usage condition(gb9706.1-2007 10.2.1)
2.1 rated temperature: 25º C.
2.2 operation environment: 10º C~40º C.
2.3 storage and transport method: Individual moistureproof package for each
Product, transport under the conditions of ambient temperature.
3.0 construction
3.1 appearance requests:
A) the cable is round and glossy, the color uniformity, the jacket is ok, no
Disrepair, no dirt, no disfigurement, etc.
B) the surface of the connector is glossy, no burr, no obvious machine scar, no
Disfigurement, no modification, no dirt, no metal rust etc.
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 6.1aa)
D) product labels for use in line with the requirements of ec53-1995 4.1
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. )
4.2.1 electrical performance:
A) conduction test: 100conduct ok, no short circuit, no open circuit,
No color difference.
B) (ec53: 1995 4.5.8&gb/t 5095.2-1997)conduct resistance: Dc500v
≤ 2ω . (ec53: 1995 4.5.8&gb/t 5095.2-1997)
C) high voltage test: Wire&wire, wire&shield for 1000v ac ≤ 0.25ma 1min,
Wire&outside for 5000v dc ≤ 0.25ma 1s(ec53: 1995 4.5.1)
D) insulation test: Dc500v ≥ 20mω . (gb/t 5095.2-1997 11.3)
E) product design their own anti-ec53-1995 4.5.4 comply with the requirements.
4.2.2 mechanical properties:
A) the connector&snap should be done with 90 angle swing test. (ec53-1995 4.5.5)
B) main cable the swing test will weigh 500g, swing angle± 90 degree,
10000 times, height 300mm. Swing speed 40 times / min. (ec53-1995 4.5.5)
C) the trunk cable sr weight 15kg with 1 minute. (ec53-1995 4.5.6)
D). Plug life of products in line with the requirements of ec53-1995 4.5.7,
Eia364 reference design at the same time.
E) connector to connect products in line with the impedance requirements of
Ec53-1995 4.5.8.
F) products designed to connect retention ec53-1995 4.5.9 requirements.
5.0 standard
5.1 all the raw materials should comply with rohs standard
5.2 all of the processing of materials, products must meet iso 10993 standards.
Introduction:
We specialize in the design,development,manufacturing of the medical device and
accessories,include ECG cable,EKG cable,ECG electrodes,SPO2 sensor,Temperature
probe,NIBP CUFF,etc.
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