Oxygen Analyzer, ultrasonic, handheld

GENERAL DESCRIPTION
Hand held, battery powered device that measures the oxygen concentration in a flow of gas from a medical gas source or, with adapters, through a medical gas-flow device such as a ventilator or anaesthesia system. The intended application is checking gas supply equipment performance.

TECHNICAL SPECIFICATIONS
Operational Characteristics:
Ultrasonic oxygen sensing technology, with permanent sensing chamber.
O2 measurement to include the range 21 - 96%.
O2 resolution: 0.1%.
O2 accuracy: within ± 1.5% of full scale.
Flow rate measurement: up to 10 LPM
Flow rate accuracy within ± 0.2 LPM
Flow rate resolution 0.1 LPM
Suitable for measuring gas supply with pressure up to 50 psi (344 kPa)
Response time < 20 s.
Warm-up time < 1 s.
Display visualizing O2 concentration, flow rate, system messages and battery status.

Electrical characteristics:
Operated by 2 x AA alkaline replaceable single use batteries.
Battery life > 1000 hours continuous use.
Automatic power-off when not in use.

Casing and environment
IPX1 ingress protection.
Suitable for cleaning and disinfection with hospital-grade cleaning products.

SUPPLIED WITH
1 x protective case
Connector tube for gas sampling
1 x set single use batteries (2 AA batteries)
1 x Instructions for Use, hard and soft copies in English, French, Spanish, German, Dutch and Italian.
1 x Contact details of manufacturer.

ENVIRONMENTAL CONDITIONS
Capable of being stored continuously in ambient temperature from -15°C to 60°C, RH: 0 to 95%
Capable of operating continuously in ambient temperature from 15°C to 40°C, RH: 0 to 95%

WARRANTY
24 months

REGULATION & CONFORMITY REQUIREMENTS
CE mark conforming to Medical Device Directive 93/42/EEC
CE Certificate (class IIb)

SAFETY & PRODUCT STANDARDS
Complies with the following standards:
ISO 13485:2003 Medical devices -Quality management systems -- Requirements for regulatory purposes
EN ISO 14971:2012 Medical devices — Application of risk management to medical devices
EN 1041:2008 Information supplied by the manufacturer of medical devices
EN ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

PACKAGING/LABELLING
Unit presentation: 1 (one)
Manufacturer’s name and logo
Manufacturer’s product reference
Manufacture and expiry date, lot number
Main characteristics (dimensions, capacity)
Recommended storage conditions
Information for handling

Over packaging:
Packaging unit
Labelling on the packaging unit: Labelling to be the same as primary packaging
Number of units per box: 1