Humidifier bottle, nonheated, reusable

GENERAL DESCRIPTION
A sealed bottle of water inserted into a breathing circuit to add moisture to the breathing gases for administration to a patient. This type of humidifier does not heat the gas.

TECHNICAL SPECIFICATIONS
Non-heated, reusable humidifier for oxygen therapy.
Bubble-through humidification system.
Flow rate capacity up to 15 LPM.
Transparent, polycarbonate humidification bottle, shatter resistant.
Graduation showing minimum and maximum water level.
Humidification chamber working volume 350 ml.
DISS 1240 inlet connection.
Barbed outlet (diameter 6-9 mm).
Relief valve exhaust pressure: 0.04-0.1 MPa.
Detachable rigid durable polymer cap with gas connectors.
Connectors made of brass.
Autoclavable and disinfectable as per manufacturer’s instructions.

ENVIRONMENTAL CONDITIONS
Storage and operating conditions: -23°C to 60°C, 10 to 95% humidity.

SUPPLIED WITH
1 x Set user and maintenance manuals to be supplied in English, French and Spanish. If compete manuals are only available digitally, a quick reference guide and information sheet which clearly indicates the url to access complete manuals must be included with the device.
1 x List of all equipment and procedures required for routine maintenance (in IFU).
1 x Document with contact details of manufacturer, supplier and local service agent (in catalogue).

WARRANTY
Includes 2-year standard warranty, dated from the completion of the terms of delivery.

ESTIMATED LIFE SPAN
10 years
The supplier commits to the to the availability of spare parts & consumables for the above indicated lifespan.

WEIGHT/VOLUME (Packaged)
Weight: 0.26 kg
Volume: 1.04 dm3

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485:2016 Medical devices – Quality management systems -- Requirements for regulatory purposes
- Supplier is certified for ISO 9001 Quality management systems - Requirements.

REGULATION & CONFORMITY REQUIREMENTS
Market clearance as a class IIa medical device under EU regulations – CE certificate

SAFETY & PRODUCT STANDARDS
Complies with the following standards:
ISO 14971 Medical Devices - Application of risk management to medical devices.
ISO 18562 Biocompatibility evaluation of breathing gas pathways in healthcare applications.