User's Manual

2/2020 CY-0090-018, Rev.A Page 7 of 49
Temperature Limitation ISO 7000:2014-0632
Pressure Limitation
ISO 7000:2014-2621
Keep the device away from sunlight
ISO 15223-1:2012(E)
5.3.2
Keep the device dry
ISO 15223-1:2012(E)
5.3.4
Do not iron device ISO 7000:2014-3113
Do not machine wash device ISO 7000:2014-3123
Do not use bleach to clean device ISO 7000:2014-3124
Do not tumble dry device ISO 7000:2014-3109
Do not dry clean ISO 7000:2014-3114
CE Marking Medical Device
Directive
93/42/EEC
Authorized Representative ISO 15223-1:2012(E)
5.1.2
ETC Classified C US, 9900900, Electronic Testing
Lab, indicates product meets US and Canadian
product safety standards. This device conforms
to AAMI Std. ES60601-1. Certified to CAN/CSA
Std. C22.2#60601-1
ISO 60601-1:2005(E)
Attention – consult instructions for
use
ISO 15223-1:2012(E)
Caution
ISO 15223-1:2012(E)
5.4.4
IP20
Protection against medium-sized
foreign bodies with a diameter > 12
mm
IEC 60529 Edition 2.1
2001-02