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2.6 Products whose use is described in this guide
• Neo
ICU
controller and cells
• Neo
IW
controller and cells
• Medicase
®
hygiene cover
This guide applies only to second-generation Carital
®
controllers.
A second-generation controller can be identified by a serial number
beginning with the PC identifier.
Serious incidents related to the medical devices described in the
user’s guide that directly or indirectly resulted in, could have re-
sulted in or could result in 1) death of a patient, user or other
person 2) serious or permanent deterioration in the health of a pa-
tient, user or other person 3) serious threat to public health must
be immediately reported to the manufacturer and the Medicines
and Healthcare products Regulatory Agency (MHRA).
Read this guide carefully before commissioning 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- generation
controller can be identified with its serial number beginning with the PC identifier.
• Only a healthcare professional can assess the need and suitability of using the mat-
tress system in a treatment situation.
• Serious incidents related to the medical devices described in the user’s guide that
directly or indirectly resulted in, could have resulted in or could result in 1) death of
a patient, user or other person 2) serious or permanent deterioration in the health
of a patient, user or other person 3) serious threat to public health must be immedi-
ately reported to the manufacturer and and the Medicines and Healthcare products
Regulatory Agency (MHRA).
• 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
distributor.
