- Classification: Imaging Diagnostic Equipment
- Medical Device Regulatory Type: Type 1
- Trademark: F1
- Specification: ISO13485
- HS Code: 90181930
- Type: Digital EEG/ECG/EKG/EMG/VCG
- Medical Devices Reg./Record No.: 20160017
- Transport Package: Neutral
- Origin: Shenzhen, China
Schiller AT 102 EKG Cable with Leadwires IEC
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.
3.1 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.
(EC13:2002 184.108.40.206/IEC60601-2-47 6.1aa)Clear dot-color and characters, the
corresponding printing should be correct.(EC13:2002 220.127.116.11/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
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
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.)
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.
1. Please let us know the product model you need
2. We will make proforma invoice for you.
3. Checking and confirm the invoice.
4. After payment, all goods will be sent to you in 5-7 days as usual.
5. OEM/ODM is welcomed.
T/T, Western Union.
1. EMS. DHL. UPS. FedEx, TNT.
2. It will take 3~7days for shipping (depend on country distance).
3. Any import charges or fees are buyer's responsibility.
4. We will provide you the tracking number once the goods sent, tracking it until you get the package.
5. The shipping cost will be on clients' side.
Cell phone:+86 13871430769