2 quality control certification – Analytical Industries AII-2000 Palm O2 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 Palm O2 Oxy-
gen 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 485 CE
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
Palm O
2
Oxygen Analyzer S/N _______________
Sensor:
( ) AII-11-75-PO2
( ) AII-11-75-PO2R
(requires A-3654, CABL-1009)
S/N _______________
Electronics:
A-1190 PCB Assembly Main Software Version _______________
Accessories:
BATT-1008 Battery, 1.5V AA Alkaline (Qty 2)
FITN-1112-1 Flow Diverter
P-0188 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 ……………………………………………………….. _____
FITN-1065 Nipple Universal ………………………………………………….
____
A-3675-1 Home Care Kit (A-3675, TUBE-1007) …………………….. _____
A-3657-1 Dovetail Mounting Kit (A-3657, HRWR-1162) ………….
____
HRWR-1075 Dovetail Female Clamp Pole/Shelf ……………………...
____
HRWR-1157 Screwdriver ……………………………………………………… _____
HRWR-1158 Lanyard …………………………………………………………… _____
Delivery: