S0845029

Oxygen Analyzer, ultrasonic, handheld


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.
Indicative Price 448.11 USD

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
Hand-held oxygen analyzer for spot-check or continuous measurement of the oxygen concentration from a medical gas source.
Ultrasonic oxygen sensing technology, with permanent sensing chamber.
O2 measurement to include the range 21 - 96 %.
O2 resolution: 0.1 %.
O2 accuracy: within ± 3 %.
Flow rate measurement: up to at least 10 LPM
Flow rate accuracy within ± 3 %
Flow rate resolution 0.1 LPM
Suitable for measuring gas supply with pressure up to 50 psi (344 kPa).
Self-calibration in typical conditions of use.
Response time < 30 s.
Warm-up time < 15 s.
Display visualizing O2 concentration, flow rate, system messages and battery status.

Electrical characteristics
Operated by battery power supply.
2 x AA alkaline replaceable single use batteries.
Battery life > 250 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 carry case.
1 x calibration certificate.
Supplied with connectors and/or adapters suitable for measurement of various medical gas supply sources, for example (but not limited to) oxygen concentrators, ventilators/anaesthesia machines and patient circuits (T-piece and/or in-line adapters), wall/column/cylinder supplies (compliance with ISO 7396 - 1).
1 x set single use batteries.
User and maintenance manuals, hard and soft copies, in English, French, German and Spanish.
1 x Certificate of calibration and inspection to be provided.
1 x List to be provided of equipment and procedures required for local calibration and routine maintenance.
1 x List to be provided of common spares and accessories, with part numbers.
1 x Contact details of manufacturer, supplier and local service agent to be provided.

ENVIRONMENTAL CONDITIONS
Operating conditions temperature: 10 to 40°C / RH: 15 to 95%
Storage conditions temperature: 0 °C to 40°C / RH: 15% - 95%

ESTIMATED LEAD TIME:
6 weeks

WARRANTY:
24 months

COMPONENTS OF A KIT
No

REGULATION & CONFORMITY REQUIREMENTS
CE mark conforming to Medical Device Directive 93/42/EEC
Or
USA FDA 510(k)

SAFETY & PRODUCT STANDARDS
Complies with the following standards:
ISO 13485:2003 Medical devices -Quality management systems -- Requirements for regulatory purposes
ISO 14971: Medical devices — Application of risk management to medical devices
IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-4: Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems
EN 62366: Medical devices. Application of usability engineering to medical devices
EN ISO 21647: Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors
EN 1041: Information supplied by the manufacturer of medical devices
ISO 15223-1: Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
ISO 10993-1: Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

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 harmonisedsymbol)

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