1.5 Intended Users
This section describes the intended users of the Nippy 4, their qualifications and their
related documents.
1.5.1 Respiratory Health Care Specialists
Health care professionals such as physicians and respiratory therapists, assigned to form the
clinical authority when it comes to operating mechanical ventilators.
They have a good understanding of the human respiratory system and a general understand-
ing of mechanical ventilators.
They are allowed to change the clinical settings of a ventilator and prescribe new settings.
They may also operate software applications for follow-up on patient’s ventilator treatment.
Training
The respiratory health care specialists shall be trained to a good knowledge of the Nippy 4,
its capabilities and the settings that can be made. This training consists of reading the Clini-
cian’s manual in full and it shall be conducted before operating the Nippy 4.
Related Documents
The Clinician’s manual is intended for the respiratory health care specialists. It shall be avail-
able for training of new personnel and as reference when operating the Nippy 4. When
using a Clinician’s manual, make sure that it is of the same version as the User’s manual.
1.5.2 Lay Operators
Day-to-day caregivers, patients, relatives and other non-professional users that operate the
Nippy 4 within the prescribed settings.
They are allowed to operate the Nippy 4 with the Home mode activated. The lay operator
may also perform basic maintenance that doesn’t require special equipment or a service
environment.
In Home mode, the device is locked in order to limit settings accessibility and hide features/
controls.
The User Manual contains the information intended for patients and lay operators.
Training
The lay operator shall be trained to basic knowledge of the Nippy 4 and in the specific
operations they are assigned to perform. The training shall be based on the user manual
and the responsible clinical personnel shall assess the level of training required for each lay
operator.
Related Documents
The User manual is intended for lay operator. It shall be available for the training and as
reference when operating the Nippy 4.
1.5.3 Service Personnel
Certified service personnel with responsibility to maintain the equipment in proper working
order. They have a technical education and/or relevant experience of technical work on elec-
trical equipment. If local or national regulations requests additional authorization or compe-
tence, these shall be complied to.
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Introduction
User Manual
Doc. 006553 M-6
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