Dräger Isolette 8000 plus User Manual

Instructions for use Isolette 8000 plus SW 5.n 11
For your safety and that of your patients
2 For your safety and that of your patients
2.1 Information on safety instructions and precautionary
statements
The following WARNING and CAUTION statements apply to general operation of
the medical device.
WARNING and CAUTION statements specific to subsystems or particular features
of the medical device appear in the respective sections of these instructions for use
or in the instructions for use of another product being used with this medical device.
2.2 Basic safety instructions
2.2.1 Strictly follow these instructions for use
Failure to observe these safety information statements constitutes a use of the
medical device that is inconsistent with its intended use.
► Any use of the medical device requires full understanding and strict observation
of all sections of these instructions for use. The medical device must only be
used for the purpose specified under Intended use on page 25 and with
appropriate patient monitoring (see page 13).
► Strictly observe all precautionary statements throughout these instructions for
use and all statements on medical product labels.
► Instructions for use must be kept accessible to the user.
2.2.2 Restrictions for use
► Device for use in healthcare facilities only and exclusively by persons with
specific training and experience in its use.
2.2.3 Service
If service is not performed regularly, malfunctions may occur, which can result in
personal injury and property damage.
► Observe chapter Service.
► The medical device must be inspected and serviced regularly by service
personnel. Repair and complex maintenance carried out on the medical device
must be performed by specialized service personnel.
► Dräger recommends that a service contract is obtained with DrägerService and
that all repairs are performed by DrägerService. For maintenance, Dräger
recommends the use of authentic Dräger repair parts.
► Do not service the device while the patient is in the incubator.
► Assess system components for signs of loosened fasteners according to
specified inspection intervals. See Inspection on page 148. Secure if necessary.
2.2.4 Safety checks
The medical device must be subject to regular safety checks. See chapter Service.

Dräger Isolette 8000 plus Specifications

General

Brand	Dräger
Model	Isolette 8000 plus
Category	Medical Equipment
Language	English