Medi-Globe ENDO-FLEX Beibring SU Manuel D'utilisation page 10

1. Product Description
The ENDO-Flex GmbH offers teethers with fixation
tape in different versions for adults as well as for chil-
EN
dren. These include teethers in standard and special
versions with tongue plates.
This Instructions for use is valid for products listed be-
low:
• 600005
• 600006
• 600010
• 600020
1.1. Contents of the packaging
600005 / 600006:
• 1 Carton
• 5 Beißring SU (single use), individually non-sterile
packed
• 1 Instructions For Use
600010 / 600020:
• 1 outer carton (dispenser box of 100 pieces)
• 100 Beißring SU (single use), individually non-ster-
ile packed
• 1 Instructions For Use
•
1.2. Intended Use
Beißring Are used to provide a safe passage for en-
doscopes and/or esophageal dilatators, in which they
protect them from damage/destruction by unintended
upsetting of the patient to be treated. Teethers SU are
equipped with a head strap for secure fixation.
1.2.1 Duration Of Use
The application duration is specified for less than 60
minutes.
10
1.2.2 Lifetime
The life of the product is 3 years.
1.2.3 Indication
• Safe passage of endoscopes/esophageal dilators
1.2.4 Contraindications
• Not known
1.2.5 Potential Complications/Risks
• Not known
1.2.6 Target group of users
Trained specialists and specialists.
1.3. Sterility
These disposable medical devices are supplied
non-sterile. Treatment and sterilization is no longer
possible after use and is prohibited! The product may
only be used once and must be disposed of after use in
accordance with national and local guidelines.
2. Safety Information
The safety and warning information used in these In-
structions for use is based on ANSI Z535 standards.
Warns of an imminent danger that
DANGER
leads to death or serious injury.
Warns of a potentially dangerous
WARNING
situation that could lead to death or
serious injury.
Warns of a potentially dangerous sit-
CAUTION uation that could lead to moderate or
minor personal injury.
Beißring