V.A.C.
ATS Operations and Maintenance Manual
31
HARDWARE
STERILE DISPOSABLES
EEC DIRECTIVE
The
KCI V.A.C.
ATS system
is in conformity with the Medical Device Directive (93/42/EEC) and
has been subject to the conformity assurance procedures laid down in the Council Directive.
KCI Medical Ltd. Engineering Division is certified by AMTAC Certification
Services Ltd. as an approved medical device manufacturer.
The
KCI V.A.C.
ATS system
conforms to the following International standards:
EN 60601-1-1:1990 including A13:1996, CAN/CSA-C22.2 No 601.1-M90, UL2601-1:1994 1
st
Edition-Amended 1996, EN60601-1-2:1993.
Class II
Equipment
Type B
Equipment
Alternating
Current
LOT / BATCH
METHOD OF
STERILIZATION -
IRRADIATION
EXPIRATION
DATE
DATE OF
MANUFACTURE
STORAGE
CONDITIONS
REFER TO USERS
INSTRUCTIONS
KEEP DRY
FRAGILE
The V.A.C.
ATS system
CONFORMS WITH THE
MEDICAL DEVICES
DIRECTIVE(93/42/EEC)
AND HAS BEEN SUBJECT TO
SINGLE USE ONLY
STERILE R
LOT
ON
OFF
– part of the
equipment
only
EXPLANATION OF SYMBOLS
ORDERING INFORMATION AND CONTACT ADDRESSES
