Pulseoximeter,spot-check,w/accessories

GENERAL DESCRIPTION
Pulse oximeter, spot-check, with accessories

PRODUCT DESCRIPTION:
Ultra-compact pulse oximeter integrated into finger/toe clip
Robust shock resistant design allow use in demanding environments
Suitable for professional clinical use, all patient categories neonate, infant, adult
Accommodates finger/toe thicknesses 8 to 25mm directly or through the use of a separate sensor which can be connected to the device.
Spot-check of arterial blood oxygen saturation (SpO2) and heart rate(HR)
Measuring ranges:
SpO2 detection within the range of: 70 to 99%
SpO2 resolution: 1% or less
SpO2 accuracy within: +/-3%
Pulse rate detection: 30 to 240 bpm
Pulse rate resolution: 1 bpm)
Pulse rate accuracy: within: +/-3%
Display shows SpO2, pulse rate, signal strength, sensor error or disconnect and low battery.
Enclosure protection IPX2 or better
Suitable for cleaning and disinfection with hospital-grade cleaning products.v
Power requirements two 1.5V AAA batteries
Batteries must allow at least 2500 spot-checks, calculated at 30 seconds per spot-check, or at least 21 hours of operation.
The unit is equipped with an automatic power off feature.

ESTIMATED LIFE SPAN
Over two years

SUPPLIED WITH
2 x spare sets batteries.
1 x pouch
1 x neck lanyard for carrying
1 x set user and maintenance manuals, hard and soft copies, in local language, or in agreed other language if local is not available.
1 x quality certificate.

INSTRUCTIONS FOR USE
For spot-check of percentage arterial oxygen saturation (SpO2, %) and pulse rate (HR, bpm) of all patient categories. Non-invasive monitor using a clip-on sensor placed on a finger or toe. The spot-check pulse oximeter is ultra-compact and fits easily pocket or carry-on bag.
Pulse oximeter must be used and maintained properly according manufacturer's instructions.

WEIGHT/VOLUME
Estimated Weight 0.1kg
Estimated Volume 0.01M3

ENVIRONMENTAL CONDITIONS
Operating conditions temperature: 5 to 40°C / RH: 30 to 80%
Storage conditions temperature: -20 °C to 60°C / RH: 10% - 95%

ESTIMATED LEAD TIME:
6 weeks

WARRANTY:
24 months

COMPONENTS OF A KIT
Yes

REGULATION & CONFORMITY REQUIREMENTS
CE mark conforming to Medical Device Directive 93/42/EEC
CE Certificate (Class IIa or higher)
Of
USA FDA (Class II)

SAFETY & PRODUCT STANDARDS
Complies with the following standards:
ISO 13485:2003 Medical devices -Quality management systems -- Requirements for regulatory purposes
IEC 60601-1: Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
ISO 80601-2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

PACKAGING / LABELLING
Unit presentation: 1 (one)
Labelling on primary packaging must include:
- Name and/or trademark of the manufacturer
- Manufacturer's product reference
- Type of product and main characteristics
- If the packaging is not transparent, it must bear a diagram showing the essential parts of the product
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol)
- Information for handling, if applicable (or equivalent harmonised symbol)

Over packaging: Packaging unit
Labelling on the packaging unit: Labelling to be the same as primary packaging