Cleaning And Maintenance; Adverse Patient Symptoms - Breas iSleep 20+ User Manual

2.6 Cleaning and Maintenance

• 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+.

2.7 Adverse Patient Symptoms

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
Doc. 004270 En-Eu T-3b
Safety Information
iSleep 20+ users manual
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