CardioSoft - Jaken Medical...

Introduction: Safety Information
Caution
Equipment Damage — Before connecting the device to
the power line, check that the voltage and frequency
ratings of your power line match those indicated on the
device label.
Loss of Data — To avoid loss of data, make a daily
backup of the system and patient information.
Restricted Sale — In the USA, U.S. Federal Law restricts
this product to sale by or on the order of a physician.
Password Protection — If access to the system is
protected with a password, the password must be stored
in a secure place and made available to registered system
users.
Acquisition Module — Use CardioSoft only in conjunction
with the CAM-14 or CORINA acquisition module.
Equipment Configuration — The equipment or system
should not be used adjacent to, or stacked with other
equipment. If adjacent or stacked use is necessary, test
the equipment or system to verify normal operation.
Refer to the Electromagnetic Immunity information in this product’s
service manual for EN 60601-1-2 (2001) Edition 2 compliance
information and safety information for this product.
Classification
Type of protection against electrical shock
Degree of protection against electrical
shock
Degree of protection against harmful
ingress of water
Degree of safety of application in the
presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide
Method(s) of sterilization or disinfection
recommended by the manufacturer
Mode of operation
class II
CAM USB / CAM-14: Type BF,
defibrillation-proof
CORINA: Type CF, defibrillation-proof
enclosed equipment without protection
against ingress of water
Not suitable for use in the presence of a
flammable anesthetic mixture with air or
with oxygen or nitrous oxide.
sterilization: not applicable
disinfection: see Appendix A
continuous operation
1-12 CardioSoft Revision A
2023324-053