W&H Osstell Beacon, User Manual

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25087-05 US
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Acceptable Cleaning fluids:
Low foaming, neutral pH, enzymatic detergents like:
Medizime LF
Enzol
Acceptable disinfectant fluids:
CIDEX ® OPA Solution
Do not use:
Acidic or phenolic based cleaners/disinfectants.
Strong alkali detergent of any type, including hand soaps and dish soaps
Bleach based cleaners
Hydrogen Peroxide based cleaners
Abrasive cleaners
Acetone of hydrocarbon based cleaners
MEK (Methyl Ethyl Ketone)
Birex
Gluteraldehyde
Quaternary Ammonium Chloride salt-based cleaners
The instrument does not require regular maintenance. In the event of
an instrument malfunction, contact the local sales representative or
distributor for further instructions.
SmartPegs:
Delivered sterile. The SmartPegs are disposable and
should only be used for one or multiple measurements at one
treatment session, for a single patient only (to avoid cross-contami-
nation).
TestPeg: Is not used intra-orally, does not require sterilization.
The Smartpeg Mount should be cleaned and sterilized before each use
according to the instructions below.
SmartPeg Mount: Must be autoclaved according to the recommended
sterilization method, validated to sterility assurance levels (SAL),
according to ISO 17665-1 and ISO 17664. The SmartPeg Mount should
be placed in a FDA cleared autoclave bag such as:
PeelVue – Ref# 31610, size 3.5 x 5.25 or equivalent bag.
Sterilization Exposure Exposure
Method: temperature time
Pre-vacuum 132 °C (270 °F) 4 min
Pre-vacuum 134 °C (273 °F) 3 min
Gravity 134 °C (273 °F) 10 min
Warnings: do not exceed 135 °C (275 °F). Drying time: 30 minutes
Carefully inspect the Smartpeg Mount for damage or wear. Hand
wash the Smartpeg Mount using a neutral instrument detergent.
Rinse and dry; carefully inspect the Smartpeg Mount for damage and
wear. Do not wash in dishwasher.
Store sterile goods dust-free and dry.
16) Technical information
Technical description
Osstell Beacon is CE-marked according to MDD in Europe (Class IIa,
internally powered, type BF applied parts. Not AP or APG equipment, not
protected against ingress of water).
Osstell Beacon is in accordance with applicable parts of
IEC 60601-1/ANSI/AAMI ES 60601-1.
The symbols used, follow the European standard EN 60601-1 and
ISO 15223 as far as possible.