25087-00 ML
9
The Smartpeg Mount should be cleaned and sterilized before each
use according to the instructions below.
SmartPeg Mount:
Must be autoclaved according to the recom-
mended sterilization method, validated to sterility assurance
levels (SAL), according to ISO 17665-1 and ISO 17664. The
SmartPeg Mount should be placed in suitable packaging for the
sterilization process.
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. Sterilize the Smartpeg Mount according to the auto-
clave manufacturer´s instructions. 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 equip-
ment, 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 standards 9687 and 15223 as far as possible.
Notes on electromagnetic compatibility (EMC)
Medical electrical equipment is subjected to particular precautions
with regards to EMC and must be put into operation in accordance
with the EMC notes included below:
Osstell guarantees the compliance of the device with the EMC
requirements only when used with original accessories and spare
parts. The use of other accessories / other spare parts can lead to an
increased emission of electromagnetic interference or to a reduced
resistance against electromagnetic interference.
You can find the current EMC manufacturer’s declaration on our
website at
osstell.com/products/Osstell-Beacon.
Alternatively, you can obtain it directly from your local sales repre-
sentative or distributor.
The Osstell Beacon contains a Bluetooth module.
FCC ID: QOQBLE113, IC5123A-BGTBLE113
Battery
The instrument contains a rechargeable lithium-ion battery.
The instrument should be charged using the Osstell USB cable
connected to a standard USB 2.0 or 3.0 type A outlet. Battery status
and charging is indicated in the lower display with a battery symbol
having 4 levels: 100 % (fully charged), 75 %, 50 % and less than 25%.
When the level is less than 10 %, the Osstell Beacon will change the
battery symbol to alert that it is time to charge the instrument.
Note! It is not possible to perform an ISQ measurement during
charging.
