IEC62366-可用性报告范例-Humidifier.docVIP

Usability File MLD 9.05e BS EN 62366:2008 Documentation of Compliance Product Description Bubble Humidifier Product Series ACME001 Issue: 1 Date: 18.3.10 Signed: J Bloggs 1 Inputs to the USABILITY SPECIFICATION 1.1 Specification of the INTENDED USE/INTENDED PURPOSE 1.1.1 Description The ACME Bubble Humidifier has been design specifically to be used with Oxygen. The unit can be used in most types of medical environments such as Hospital, Medical Centres, Ambulances and Domestic purposes. The humidifier works by conducting gas down the small internal tube that is submerged in water. The gas passes through the diffuser (sintered metal), which breaks the gas into small bubbles, increasing the surface area. The bubbles float passively to the surface, absorbing water vapour. The humidified gas then flows out through the outlet. The bottle component is moulded in autoclavable HDPE. The Humidifier has been designed to connect to Flowmetering Devices via a 9/16 Connector and that can provide a flow rates from 2 to 6 Lpm with a backpressure of 4 bar. 1.1.2 EQUIPMENT application specification 1.1.2.1 Medical purpose To humidify the medical gas flow (Oxygen) to a patient e.g. via attached tubing and facemask. 1.1.2.2 PATIENT population a) Age: newborn to geriatric b) Weight: 2.5 kg c) Health: not relevant d) Nationality: multiple e) PATIENT state: - PATIENT is not the OPERATOR 1.1.2.3 Part of body or type of tissue applied to or interacted with No direct contact with the patient – though attached tubing and facemask would contact nose and mouth. 1.1.2.4 Intended OPERATOR Trained medical or paramedical staff who understand how to connect to a flowmeter and the use of humidified oxygen. 1.1.2.5 Application a) Environment General: Hospital Care Home/Hospice Ambulance Could be damaged by impact e.g. dropping or collision, then not function. When functioning is shall keep humidifying the oxygen.. Conditions of visibility: