for Philips Holter ECG Cable

• Classification: Imaging Diagnostic Equipment
• Type: ECG
• Certification: ISO13485
• Weight: 0.15kg
• Transport Package: Neutral
• Specification: 13485
• Model NO.: F1K8405A13
• Trademark: F1
• Origin: Shenzhen, China
• HS Code: 90181930
• Production Capacity: 5000

Product Description

                                                                  Dynamic instrument for  philips




 

The usage range

   This specification suited for customer s appointed models.

 Usage condition(GB9706.1-2007 10.2.1)

 Rated temperature:25

 Operation environment:10~40.

 Storage and transport method:individual moistureproof package for each

      Product.Transport under the conditions of ambient temperature.

Construction

Appearance requests:

 The cable is round and glossy.the color uniformity. the jacket is ok.no  

        Disrepair.no dirt.no disfigurement.etc.

 The surface of the connector is glossy. no burr.no obvious machine scar.no disfigurement.no modification.no dirt.no metal rust etc.

 (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)

 Product labels for use in line with the requirements of EC53-1995 4.1

 Product labels and graphics in line with the engraved die EN980-2008 / EU CE        requirement

Product cleaning. disinfection and chemical resistance in ine with the requirements       of EC53-1995 4.3

 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)

 Packaging requirements:

     The packaging in accordance with the requirements of the engineer

      drawing(Incase of special packaging requirements. please promptly notify it.)

 Technical requirements

 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.

Customer special electrical and mechanical performance requirements.

      (Please check the Implementation standards in remarks.)

  Electrical performance:

 Conduction test: 100conduct ok.no short circuit.no open circuit.

       no color difference.

(EC53:1995 4.5.8&GB/T 5095.2-1997)conduct resistance: DC500V 

       ≤2Ω.(EC53:1995 4.5.8&GB/T 5095.2-1997)  

1000V  AC  ≤0.25mA  1min.

 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)

Insulation test: DC500V  ≥20MΩ.(GB/T 5095.2-1997  11.3)

Product design their own anti-EC53-1995 4.5.4 comply with the requirements.   

 Mechanical properties:

 The connector&snap should be done with 90 angle swing test.

Main cable the swing test will weigh 500g. swing angle±90 degree.

        30000 times. height 300MM.(EC53-1995 4.5.5)

 The trunk cable SR weight 15KG with 1 minute.(EC53-1995 4.5.6)

 Plug life of products in line with the requirements of EC53-1995 4.5.7.

   EIA364 reference design at the same time.

 Connector to connect products in line with the impedance requirements of

        EC53-1995 4.5.8 .

 Products designed to connect retention EC53-1995 4.5.9 requirements.

  Environmental Standard

 All the raw materials should comply with ROHS standard

 All of the processing of materials. products must meet ISO 10993 standards.

 The accessory

 The proving documents of Samples Material.

 Samples Test Report.