2 quality control certification – Analytical Industries AII-2000 M Oxygen Analyzer User Manual
Page 4
1.4 Declaration of Conformity
We hereby declare the above product meets the provisions of the directives
and standards specified. All supporting documents are retained on the prem-
ises of the manufacturer.
Patrick Prindible, QA Manager
4
2 Quality Control Certification
5
Manufacturer:
Analytical
Industries
Inc.
2855 Metropolitan Place, Pomona, California 91767 USA
Tel: 909-392-6900, Fax: 909-392-3665
e-mail: [email protected], www.aii1.com
Authorized EC
Representative:
RGV Lda.
Rua Jose Joaquim de Freitas, 247
2750-404 Cascais-Portugal
Product:
AII 2000, AII 2000A, AII 2000HC, AII 2000 TruO2 Oxygen
Analyzers; AII 2000M Oxygen Monitor
PSR Series Oxygen Sensors
Classification:
IIb
Directives:
Medical Device Directive 93/42/EEC, Annex II as amended
by 2007/47/EC
Standards &
Certificates:
510(k) K952736 O2 Sensors
510(k) K053407 O2 Analyzers
EN 12598:1999 (ISO 7767: 1997) Oxygen devices for
patient breathing mixtures – Safety requirements
Medical Device Directive 93/42/EEC, Annex II as amended
by 2007/47/EC, Certificate 485CE
ISO 9001:2008, Certificate 485
ISO 13485:2003, Cert 485A
Medical Device Regulations, F-27/ SOR-98-282 (Canada)
Notified Body:
AMTAC Certification Services Limited
Davy Avenue, Knowhill
Milton Keynes MK5 8NL
United Kingdom
CE mark affixed:
February 21, 2006
Customer:
________________________ Order No. _____________ Date: _______
Model:
( ) AII-2000 A Oxygen Analyzer
( ) AII-2000 M Oxygen Monitor
( ) AII-2000 HC Oxygen Analyzer S/N _______________
Sensor:
( ) AII-11-60 or ( ) AII-11-60-HC S/N _______________
Electronics:
A-1162 PCB Assembly Main Software Version _______________
Accessories:
AII-2000 A / M: CABL-1006 Cable, Coiled Phone Jack
FITN-1112-1 Flow Diverter
AII-2000 HC: A-3675 Adapter, 5/32” Tube to Sensor
TUBE-1007 1/4” Tubing 7 ft. with Adapter
All units: BATT-1008 Battery, 1.5V AA (Qty 2)
P-0187 Manual, Instructions for Use ……… Included ______
PASS
QC Test:
LCD display 3-1/2 digits ……………………………………………………. ______
Battery symbol displays when battery is low ……………………….. ______
Span adjustment +10-30% FS with 100% oxygen
calibration ______
Following calibration with 99-100% oxygen and flushing with
ambient air, oxygen reading as displayed by LCD 20.9% +2%
____
Span adjustment +10-30% FS with air calibration ……………….. ______
Following calibration with air (20.9% oxygen) and exposing
to 99-100% oxygen, LCD displays 100% +2% ……………………. ______
Overall inspection for physical defects ………………………………... ______
Options: Item
No.
Qty
FITN-1009 Tee Adapter ……………………………………………………….. _____
ENCL-1072 Carrying Case ……………………………………………………. _____
Other:
_____
Delivery:
HRWR-1075 Dovetail Female Clamp Pole/Shelf ………………………
____