Operator's Manual

Operator Manual – Prodigy Sleep System
Revision: 04; CCRF-625
Effective Date: 30-Jan-19
Document Number: YST-UDoc-PR2-001-04
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8. Appendices
APPENDIX A EQUIPMENT CLASSIFICATION
The system belongs to protection class II with a BF applied part according to ANSI/AAMI ES60601-
1:2005/(R)2012
with amendments.
Table 2 - Equipment Classification
Equipment
Type
Class of ME
Equipment
Type
(B/BF/CF)
IP
Rating
Disinfection
Operating
mode
Prodigy
Sleep
System
HMU
Body-
Worn,
Internally
Powered
II BF IP 22
Cleaning products
containing 15 to
55% isopropyl
alcohol
Continuous
Prodigy
Sleep
System
CMU
Body-
Worn,
Internally
Powered
II BF IP 22
Cleaning products
containing 15 to
55% isopropyl
alcohol
Continuous
Prodigy
Sleep
System TTU
Portable N/A N/A N/A
Cleaning products
containing 15 to
55% isopropyl
alcohol
Continuous
HMU &
CMU Power
supply
Portable II N/A N/A
Cleaning products
containing 15 to
55% isopropyl
alcohol
Continuous
Prodigy
Sleep
System TTU
Power
supply
Portable N/A N/A N/A
Cleaning products
containing 15 to
55% isopropyl
alcohol
Continuous
This device has a rating of IP22 in accordance with IEC 60529:1989+AMD1:1999+AMD2:2013 which
means it is protected against:
a) Solid particle protection: greater than 12.5mm (e.g. fingers or similar objects).
b) Liquid ingress protection: vertically dripping water shall have no harmful effect when the
enclosure is tilted at an angle up to 15 degrees from its normal position.
UNCONTROLLED COPY - SGS - 30-JAN-19