Use Instructions
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Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System
AVA Activity Analytics
1.3 Procedures for Accident Prevention
The AVA Activity Analytics System is made according to the current
state of the art technology and is reliable. However, hazards may arise
during the use of this device if it is operated by untrained personnel or it
is not operated as described in these Instructions for Use.
1.3.1 Procedures for Handing Over the Device
In order to comply with the regulations of accident prevention and to
prevent accidental damage, the following procedural guidelines are to
be followed when handing over the device:
• The initial start-up of the device, as well as the hand over to the
user must be carried out by an authorized personnel assigned by
the operator.
• After completion of the training, it must be documented that the user
has understood the operation and use of the device for therapy or
care purposes.
1.3.2 Qualication Requirements Hygiene Sta
The nature of hygiene measures is determined by the use environment
of the device.
• If the device is used in clinical areas (e.g. in hospitals, clinics,
nursing home, elderly homes etc.) the cleaning and disinfection
must be carried out on the product or parts only by appropriately
qualified personnel, who are familiar with the relevant hygiene
regulations.
• When using the device in non-clinical areas the users or trained
cleaning personnel can perform cleaning of the device.
1.3.3 Availability of the Instructions for Use
The Instructions for Use are an integral part of the device and must
be stored in a place so that the safety instructions and other important
information are accessible at any time and can reviewed by the users.
Do not pass the device to a third party without these Instructions for
Use. Using the edition version as a guide always ensures that a current
and valid Instructions for Use document is supplied with the device.
1.3.4 Home Healthcare Environment
• This is any place a patient lives (either their own home or a nursing
home) and other places where patients are present (e.g. being
outdoors; in a wheelchair; traveling by any mode and whilst at work)
• Exclusions are: professional healthcare facilities where staff with
medicaltraining are continually on hand when patients are present
(e.g. hospitals;doctors surgeries; dental surgeries)
• Since the Home Healthcare Environment includes a variety of
environments, there is a chance that the medical equipment may
be used in locations with unreliable electrical sources and poor
electrical grounding.
Hygiene
measures
Obligation
to provide
information
Important Notes for Safe Use
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