Instructions: Meditech
microVENT
Page 2 of 28
Part number 011-0045-00
DOC300M
17/03/2021
Issue L
This manual refers to the
microVENT
handset (Serial No:
)
BNOS Meditech Ltd. is an ISO 13485:2016 registered company
The
microVENT
is registered with the U.S. FDA No. K930533
The
microVENT
is registered with the Canadian Ministry of Health
The
microVENT
is covered by the following Patents:
(UK) 2270629
(USA) 5537999
(USA) 5351361
Canada Patent No.2107358
European Patent 0578679
EC – DECLARATION OF CONFORMITY CE
2797
These products have been either manufactured or supplied under ISO 13485:2016. B.N.O.S.
Meditech Microvents are supplied in conformity under a quality system to meet Annex II of the Medical
Devices Directive 93/42/EEC as amended 2007/47/EC, Microvents are classified as Class IIa Medical
Devices.
The above quality system has been inspected by the Notified Body Ref: CE 2797 being BSI, Say
Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands. EC Certificate No. 662942
refers.
Other Standards
microVENT
also comply with the following standards:
ISO 13485:2016
BS 6850:2002 Gas powered ventilatory resuscitators
BS EN ISO 5356-1:2015
ISO 5359:2014 + A1:2017
BS 5682:2015 (where BS standard connector specified by customer).
ISO 15223-1:2016
EN 62366-1:2015
BS EN ISO 15001:2011
BS EN ISO 14971:2019
ISO10524-1:2018
It is also certified that the equipment listed above fully complies with all the required mandatory
standards and the performance, specifications, standards and sources agreed and contracted for this
order.
microVENT
is a registered trademark of B.N.O.S Meditech Ltd.
This manual is intended to provide operating instructions on the use of the
microVENT
® and should be
studied carefully by all persons required to operate the equipment
WARNING
Federal law restricts this device to sale by or on the order of a physician.
