Armstrong Medical 10190001, User Manual

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AquaVENT® FD140i, User Manual, English Issue 01 72
EC Declaraon of Conformity
9.1 EC Declaraon of Conformity
Who is the natural and legal person with responsibility for the design, manufacture, packaging and
labelling before the device is placed on the market under this manufacturer’s name regardless of whether
these operations are carried out by the manufacturer or on his behalf by a third party.
Declaration of Conformity
No. AML2401
for Gas Flow Driver
European Communities Council Directive 93/42/EEC as amended by
2007/47/EC concerning Medical Devices as transposed into European
national law by the member states
The undersigned declares that the products described in this document
meet the Council Directive provisions that apply to them and the CE Mark
may be affixed.
General Product Name: Gas Flow Driver (AquaVENT
®
FD140i)
Legal Manufacturer:
Armstrong Medical Ltd, Wattstown Business Park, Newbridge Road
Coleraine BT52 1BS, Northern Ireland
Variants: As per Appendix II (This document)
–
Product Listing/Schedule
Intended Use:
AquaVENT
®
FD140i is a clinical respiratory therapy device that delivers
an air and oxygen mixture at 21
-
100%. The device assists spontaneous
and natural patient respirations by providing continuous positive airway
pressure (CPAP) and high flow oxygen therapy (HFOT) in patients in a
professional healthcare facility. AquaVENT
®
FD140i is not a life
-
support
device. It is intended for use with adults, children and new
-
born babies,
should they be medically indicated for the therapy.
MDD Classification: Class IIb
Notified Body:
SGS Belgium NV, CE1639, SGS House Noorderlaan 87, 2030 Antwerp,
Belgium
CE Certificate
Reference
GB19/964541
EU Authorised
Representative
Advena Ltd, Tower Business Centre, 2
nd
Flr, Tower Street,
Swatar, BKR 4013, Malta
MDD Conformity
Assessment Route:
Full Quality Assurance in accordance with Annex II of the Medical Device
Directive
Name Ciaran Magee Position Technical Director
Signed Date 06/04/2020
Appendix I
–
Applicable Standards
List of Standards including date of issue and relevant parts are listed in the Technical Documentation.
Appendix II
–
Product Listing/Schedule
Part/Catalogue
Number
Description/Name GMDN Code
AMFD140i
-
EU FD140i Gas Flow Driver, Complete EU 57831
AMFD140i
-
UK FD140i Gas Flow Driver, Complete UK 57831