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21. EMC Information
The instrument fulfils the requirements according to EN 60601-1-2 regarding emission and immunity.
If sensitive electronic equipment is affected by the instrument, try to increase the distance to such equipment.
The charger should not be connected during measurements.
Guidance and manufacturer’s declaration – Electromagnetic Emissions
Osseo 100 is intended for use in the electromagnetic environment specified below.
Emissions tests Compliance Electromagnetic environment – guidance
RF emissions C1SPR11 Group 1 Osseo 100 uses RF energy only for its internal
function.
RF emissions C1SPR11 Class B Osseo 100 Rechargeable battery operated device.
Harmonic emissions IEC61000-3-2 Not applicable
Voltage fluctuations/flicker emissions IEC61000-3-3 Not applicable
Guidance and manufacturer’s declaration – Electromagnetic Immunity Test Levels
Osseo 100 is intended for use in the electromagnetic environment specified below.
Immunity test EMC standard or
test method
Professional healthcare facility environment
Electrostatic discharge (ESD) IEC61000-4-2 ± 8kV contact
± 2 kV ± 4 kV ± 8 kV ± 15 kV air
Radiated RF EM fields IEC61000-4-3 3 V/m
80 MHz – 2.7 GHz
80 % AM at 1 kHz
Proximity fields form RF wireless communications
equipment
IEC61000-4-3 30 cm minimum separation distance from radio
transmitter
Rated power frequency magnetic fields IEC61000-4-8 30 A/m
50 Hz or 60 Hz
Electrical fast transient/burst IEC 61000-4-4 ± 2kV
100 kHz repetition frequency
Surges Line-to-line, Surges Line-to-ground IEC 61000-4-5 ± 0.5, ± 1 kV, ± 2 kV
Conducted disturbances induced by RF fields IEC61000-4-6 3V
0,15 MHz – 80 MHz
6 V in ISM bands between 0,15 MHz and 80 MHz
80 % AM at 1 kHz
Voltage dips, Voltage interruptions and Electrical
transient condition along supply lines
IEC 61000-4-11 5% UT, 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0 % UT; 1 cycle
And 70 % UT; 25/30 cycles (50/60Hz)
Single phase: at 0°
0 % UT; 250/300 cycle (50/60 Hz)
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Do not autoclave the instrument.
The instrument must be used with a cover in all
uses. (Only US)
The instrument must be cleaned with a disinfectant
between patients.
15.2 MulTipeg and MulTipeg Driver
Inspect the MulTipeg and MulTipeg Driver for damage
before use. Dispose of the MulTipeg if there are visible
damages such as severe miscoloring or damage. Dispose
of the Driver if the connection part (to the MulTipeg) is
visibly worn.
• Cleaning
Immerse in 1% Alconox solution in tap water (20-30°C)
for 5 minutes. Brush with an interdental brush for 1
minute, in the solution. Rinse in running tap water
(25–35°C) for 10 seconds. Dry with a lint-free towel.
• Sterilization
Sterilization should be made in a pre-vacuum steam
sterilizer (autoclave) according to ISO 17665-1. Clean
the products and put them in an FDA-cleared (USA)
autoclave bag before sterilization. The following
sterilization process shall be used:
• At least 3 minutes at 134 (-1/+4)°C or 273 (-1.6/+7.4)°F
• 30 minutes of drying time
Follow the instruction for the autoclave that is used.
Do not clean the MulTipeg by ultrasound.
Could cause damage.
16. Lifetime
The batteries are expected to last >500 charge cycles
before a noticeable capacity change. This corresponds
to a lifetime of 5 years. The internal batteries can be fully
charged more than 500 times. The instrument should not
be left uncharged for more than 1 year.
The MulTipeg Driver is guaranteed for at least 100
autoclave cycles, and a MulTipeg is guaranteed for at least
20 autoclave cycles, before they are degraded in any way.
17. Troubleshooting
The instrument can be tested by using the ISQ tester
(fig. 6). Turn on the instrument and hold the tip close to the
top of the pin. When a signal is received, a beep is heard
and then the ISQ-value is shown on the display.
17.1 Possible errors
• Dicult to achieve a measurement:
In some cases it is more dicult for the instrument to
bring the MulTipeg into vibration. If so, try to hold the
instrument tip closer to the tip of the MulTipeg. Check
also that no soft tissue is touching the MulTipeg which
might stop its vibration.
• Noise warning (audible and visible on the display):
An electric device close to the instrument is causing the
warning. Try to remove the source.
• The instrument suddenly turns off:
The instrument turns off automatically after 30 seconds
of inactivity. It also turns off if the battery level is too
low, and due to any of the error codes described below.
• Not all segments are lit up when instrument is started:
The instrument is damaged and has to be sent for repair
or exchange.
17.2 Error codes
If malfunctioning, these error codes are shown on the
display before it turns off:
E1: Hardware error. Malfunctioning electronics
E2: Noise error. Shown if constant electromagnetic noise
is present
E3: Pulse power error. Malfunctioning magnetic pulse
generation
Use of accessories other than those specified or
provided by the manufacturer of this equipment
could result in increased emissions or decreased
electromagnetic immunity of this equipment and
result in improper operation.
18. Accessories & Spare Parts
Model MulTipeg
Driver
Sterile
Cover
Mains adapter
Model No.
UE05WCP-052080SPC
Or
UES06WNCP-052080SPA
REF 55003 55105 55093
55263
Model EU plug UK plug AU plug US plug ISQ tester
REF 55094
55264
55095
55265
55096
55266
55097
55267
55217
MulTipeg: Please refer to the updated list from the
supplier.
19. Service
In case of a malfunctioning instrument, contact the
manufacturer or distributor. Osseo 100 is covered by a
two-year warranty.
20. Serious incidents
Any serious incident that has occurred in relation to the
device should be reported to Integration Diagnostics
Sweden AB, and the competent authority of your state.
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