This document specifies requirements for
user-powered resuscitator intended for use with all age groups and which are intended to provide
lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range.
Example
user-powered resuscitators include:
— self-inflating bag
resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and
NOTE 1 Self-inflating bag
resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations.
— flow-inflating bag
resuscitators intended to be squeezed by the user’s hand and refilled by a flow from a medical gas source.
This document is also applicable to those
accessories that are intended for use with
resuscitators where the characteristics of those
accessories can affect the safety of the
user-powered resuscitator.
Examples of such
accessories include face
masks,
PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment.
This document is also applicable to point-of-use packaging.
| File Size : | 1
file
, 4.3 MB |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Published : | 03/01/2023 |
