OSYPKA PACE 203H, Instructions For Use Manual

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PACE 203H – Instructions for Use
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13 Technical Data
Classification
Safety Class: Device with internal power supply (primary battery)
Applied part classification: Type CF
Protection degree IP 43
Sterilization classification: PACE 203H: non-sterile
Extension cables connecting to pacing electrodes /
wires: sterile
No protection against inflammable
anesthesia supplies: PACE 203H must not be used in the presence of
inflammable mixtures of anesthesia supplies and
air, oxygen or nitrous oxide (N
2
O).
According to European Directives
93/42/EWG and 2007/47/EC: Class IIb
Continuous operation
Active therapeutical medical device
According to U.S. Regulations for
medical devices:
Cardiac Pacemaker Number: 21 CFR 870.3600
Name: External Pacemaker Pulse
Generator
Regulatory Class: 3
Product Code: 74DTE
Extension cable Number: 21 CFR 870.2900
Name: Cables, Transducer and
Electrode, Patient
Regulatory Class: 2
Product Code: 74DSA
Conformity to Standards The cardiac pacemaker is designed according to
and meets
EN 60601-1: 2006
EN 60601-1-2: 2007
EN 60601-2-31: 2008