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KOHJ-H-15-EN1-1.0-15102021
This guide applies only to second-generation Carital
®
controllers. A sec-
ond-generation controller can be identified with its serial number beginning
with the PC identifier.
Any serious incident that has occurred in relation to the device described in
the user’s guide that directly or indirectly led, might have led or might lead to
any of the following: (a) the death of a patient, user or other person, (b) the
temporary or permanent serious deterioration of a patient’s, user’s or other
person’s state of health, (c) a serious public health threat; should be reported
to the manufacturer and the competent authority of the Member State or Sov-
ereign State in which the user and/or patient is established.
Read this guide carefully before starting to use the mattress system. Persons
who have not read this user’s guide or cannot understand its content may not
operate the mattress system independently.
Keep this guide.
2.7 Warnings
• This guide applies only to second-generation Carital
®
controllers. A second-genera-
tion controller can be identified with its serial number beginning with the PC iden
-
tifier.
• Only healthcare professionals can assess the need for and suitability of a mattress
system in the treatment situation.
• Any serious incident that has occurred in relation to the device described in the
user’s guide that directly or indirectly led, might have led or might lead to any of
the following: (a) the death of a patient, user or other person, (b) the temporary
or permanent serious deterioration of a patient’s, user’s or other person’s state of
health, (c) a serious public health threat; should be reported to the manufacturer
and the competent authority of the Member State or Sovereign State in which the
user and/or patient is established.
• If you have any questions regarding the commissioning, use or maintenance of the
mattress system or if you notice that the device works in an unanticipated way or a
way not described in this guide, contact the mattress system’s reseller.
• Contact the mattress system’s reseller if any part of the mattress system is damaged
or works in an unusual way. Do not attempt to repair damage before contacting the
reseller.
•
Do not use the device if the configuration is incomplete or any of its components is
broken, worn or contaminated. Worn, missing and broken parts must be replaced
and contaminated once cleaned.
