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Breas iSleep 20+ - Cleaning and Maintenance; Adverse Patient Symptoms

Breas iSleep 20+
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11Safety Information
iSleep 20+ users manual
Doc. 004270 En-Eu T-3b
2.6 Cleaning and Maintenance
2.7 Adverse Patient Symptoms
The iSleep 20+ shall be cleaned and maintained in accordance with this
user
manual.
Do not attempt to autoclave or sterilise the iSleep 20+.
The iSleep 20+ shall be subjected to maintenance, service and control and
any applicable upgrades, in accordance with Breas service instructions.
The iSleep 20+ should only be repaired or modified in accordance with
Breas service manuals, technical bulletins, and any special service instruc-
tions, by service technicians authorized by Breas Medical AB.
Do not under any circumstances attempt to service or repair the iSleep 20+
yourself. If you do so, the manufacturer will no longer be responsible for
the performance and safety of the iSleep 20+.
If the patient experiences any of the following symptoms while using the
iSleep 20+, a physician or responsible clinician shall be contacted immedi-
ately:
Bloated feeling from excessive swallowing of air while awake
Air continually leaking from the mouth while sleeping
Dryness of air passages or nose
Ear pain, runny nose or sinus discomfort
Day time sleepiness
Disorientation or memory lapse
Mood change or irritability
Skin sensitivity
Morning headache

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