2 Safety Information
2.1 General User Precautions
WARNING!
Risk of Personal Injury
The Nippy 4 must only be used:
• For the intended treatment in accordance with this manual and with the instruc-
tions given by the responsible clinical personnel.
• In accordance with the operating conditions specified in this manual.
• In original and unmodified shape and only with accessories specified or approved
by Breas Medical.
Every other use may lead to risk of personal injury!
Risk of Insufficient Ventilation
Usage outside the specified operating conditions may cause reduced performance.
The Nippy 4 must only be used in accordance with the operating conditions specified in
this manual.
Risk of Reduced Safety and Performance
Accessories that have not been tested with the Nippy 4 might affect safety features and
performance negatively. Only use the Nippy 4 with accessories approved by
Breas Medical.
Incompatible parts can result in degraded performance and change of pressure gradient.
If unapproved accessories are used, Breas Medical has no responsibility for the safe and
effective use of the Nippy 4.
The responsible organization is responsible for ensuring the compatibility of the ventila-
tor and all parts used to connect to the patient before use.
Changes to the patient circuit, like adding or removing accessories or changing type or
length of breathing tube, may affect both circuit compliance and alarm triggering
conditions.
It’s recommended to perform a pre-use test and re-test the alarm function after making
changes to the patient circuit.
When a patient is treated, there must be a supervising person present during the treat-
ment in order to take care of alarms and conditions that the patient cannot solve on their
own.
To prevent disconnection of the patient circuit during use, only tubes in compliance with
ISO 5367 or ISO 80601-2-74 should be used.
The ventilator may not work properly if any part has been dropped, damaged or sub-
merged in water.
WARNING!
Risk of Burns
Covering breathing tubes with a blanket or heating them with an overhead heater can
affect the quality of the therapy or injure the patient.
14
Safety Information
User Manual
Doc. 006553 M-6
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