Spacelabs SpO2 Sensor 10pin Neonate Wrap Type
|1-49 50-99 100+|
|FOB Unit Price:||US $25 US $20 US $15|
|Purchase Qty. (Pieces)||FOB Unit Price|
|Payment Terms:||T/T, Western Union|
- Model NO.: F1S1B03F11
- Type: Patient/Fetal/Maternal Monitor
- Medical Devices Reg./Record No.: 20160017
- Transport Package: Neutral
- Origin: Shenzhen, China
- Classification: Imaging Diagnostic Equipment
- Medical Device Regulatory Type: Type 1
- Trademark: F1
- Specification: 13485
- HS Code: 90181930
1.0 The usage range
This specification suited for customer's appointed models.
2.0 Ambient condition
2.1 Ambient temperature: +5- - +40
2.2 Relative humidity: Below80%
2.3 Atmospheric pressure: 86Kpa-106KPa
2.4 Storage and transport method: Individual moistureproof package. Transport conditions is under the 0 - +45 temperature.
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) Plugs. Cable. Connections between the sensors should be strong. Reliable
3.2 Size requirements:
Testing the Size according to the drawing.
(The important size requirements. Please notify it on time)
3.3 Packaging requirements:
The packaging in accordance with the requirements of the engineer drawing. (In case of special packaging requirements. Please promptly notify it. )
4.0 Technical requirements
4.1Reference to ISO 9919: 2005 (E) Special requirements of pulse oximetry GB 9706.1-2007 Medical lectrical equipment - Part 1: General requirements for safety and essential performance
4.2 Use performance
4.2.1 SpO2 Test range and precision
4.2.1. 1 SpO2 Test range: Should be 70% -100%
4.2.1. 2 SpO2 Test precision: (90% -100%) 2%; (70% -89%) 3%
4.2.2 Pulse Test range and precision
188.8.131.52Pulse Test range: Should be 30bpm-245bpm
4.2.2. 2 Pulse Test precision: 3 bpm
4.3 Mechanical properties:
4.3.1Insertion and extraction force: 0.3-2 kgf.
4.3.3Vertical pull length: > 10kg. 1 minutes continuously and the jacket is ok.
5.0 environmental protection requirements:
5.1All the raw materials should comply with ROHS standard