Mortara ECG Cable 10 Leads EKG Cable with Banana4.0 IEC Standard
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- Model NO.: F1K7600B84
- Type: Patient/Fetal/Maternal Monitor
- Medical Device Regulatory Type: Type 1
- Properties: Medical Materials & Accessories
- Place of Origin: Guangdong, China (Mainland)
- Cable Material: Medical TPU
- Sevice: OEM/ODM
- Transport Package: Neutral
- Origin: Shenzhen, China
- Classification: Imaging Diagnostic Equipment
- Certification: ISO13485
- Medical Devices Reg./Record No.: 20160017
- Types: Surgical Supplies, Snap Lead Wire
- Shipping: DHL/TNT/FedEx
- Certificate: ISO13485&CE
- Trademark: F1
- Specification: 13485 sgs
- HS Code: 90181930
This is MORTARA EKG ECG Cable 10 Leadwires
Banana 4.0 End IEC Standard
Cable lenth is 3.6 Meter,
Compatible for MORTARA INSTRUMENTS ELI 50, 100, 200
One-piece EKG cable with lead wire
IEC / AHA resistance/22K resistance
Banana / snap / clip / DIN3.0
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.
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 188.8.131.52/IEC60601-2-47 6.1AA) Clear DOT-color and characters. The corresponding printing should be correct. (EC13: 2002 184.108.40.206/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
To check the Size according to the drawing which was issued by the
Engineer. (The important size requirements. Please notify it on time)
The packaging in accordance with the requirements of the engineer
Drawing (Incase of special packaging requirements. Please promptly notify it.)
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.)
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.
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
Products designed to connect retention EC53-1995 4.5.9 requirements.
All the raw materials should comply with RoHS standard
All of the processing of materials. Products must meet ISO 10993 standards.
The proving documents of Samples Material.
Samples Test Report.