NSK Osseo 100+ User manual

Osseointegration Monitoring Device
Osseo 100+
English
OPERATION MANUAL
Please read this OPERATION MANUAL carefully
before use and file for future reference
MADE IN SWEDEN
55185 Rev. 1, March 2020

Fig 1 Fig 2
Fig 3 Fig 4
Fig 5

ENGLISH
1. Indications for Use
Osseo 100+ is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region.
2. Intended users
Professional health care users and Professional health care facility environments only. Please read the instruction for use before the first usage.
3. Figures and System components
Fig 1 Osseo100+ Instrument Included in package
Fig 2 MulTipeg Driver Included in package
Fig 3 Example MulTipeg Not included, sold separately
Fig 4 Mains adapter and plugs Included in package
Fig 5 Measurement position Shows how the instrument tip is held towards the MulTipeg during a measurement
4. Specifications Only original parts should be used
•Power input: 5VDC, 1 VA
•Charger input: 100-240 VAC, 5VA Power supply: Use only the supplied mains adapter and plugs
•Instrument weight: 78g
•Charger safety class: EN 60601-1 Class II
•Instrument safety class: EN 60601-1 ME Class II No user modification of this equipment is allowed
•EMC: EN 60601-1-2, class B
•The instrument is intended for continuous use
•The instrument contains NiMH batteries.
•Frequency band: 2.4GHz ISM band (2.402-2.480GHz)
•Transmitting power: Class2 2.5mW[dBm]
•Modulation: GFSK
•Channnels: 40 channels with 2 MHz spacing
•Compatibility: EN 300 328, EN 300 489-1, EN301 489-17, EN 62479:2010
5. Operating environment
Ambient temperature: -20° to 65° C (-4°-149° F)
Relative humidity: 45% to 85% Rh, non-condensing
6. Transport and storage
Ambient temperature: -20° a 45° C (-4°-113° F). Relative humidity: 45%-85% Rh.
7. Symbols
Warning
Keep dry
Follow instructions for use
Temperature limit
Magnetic field warning
Manufacturer
Autoclavable up to 134° C
Manufacturing year
Delivered Non-sterile
CE mark
Catalog number
Caution: Federal law restricts this device to sale
by or on the order of a physician or dentist.
Lot/Batch code
Waste from electronic equipment must be handled
according to local regulations
Serial number
Type BF Applied part
The instrument and MulTipeg
Bluetooth technology
Federal Communications Commission (FCC) approved
equipment. FCC ID: 2AEMXY7011A00000, IC 20194-
Y7011A00000
8. Characteristics
Osseo 100+ is an instrument for measuring the stability (ISQ) of dental and craniofacial implants. The instrument measures the resonance frequency of a
measurement pin “MulTipeg” and presents it as an ISQ value. The ISQ value, 1-99, reflects the stability of the implant –the higher the value, the more stable the
implant.
The instrument measures the ISQ-value with a precision of +/- 1 ISQ unit. When mounted onto an implant, the MulTipeg resonance frequency can vary up to 2 ISQ
units depending on the tightening torque.
By connecting Osseo100+ to a pairable instrument, the ISQ value and battery status is transferred. For more information, see the pairable instrument manual and
“14. Usage” below.
Batteries should be collected separately
Warning: Use of this equipment adjacent to or stacked with other equipment should
be avoid because it could result in improper operation.

9. MulTipeg
The MulTipeg is made from titanium, and has an integrated grip for the driver on top. Inspect the MulTipeg for damage before use. Damaged MulTipegs should not
be used due to the risk of erroneous measurements.
There are different MulTipegs available made to fit different implant systems and types. Please refer to the updated list from the supplier.
10. Technical function
For bringing the measurement pin into vibration, short magnetic pulses are sent from the instrument tip. The magnetic pulses interact with the magnet inside the
measurement pin and cause the pin to vibrate. A pickup in the instrument picks up the alternating magnetic field from the vibrating magnet, calculate the
frequency and from that, the ISQ value.
11. Implant stability
An implant can have different stabilities in different directions. Make sure to measure from different directions around the top of the MulTipeg.
12. ISQ-value
The stability of the implant is presented as an “ISQ value”. The higher the value, the more stable the implant. The ISQ is described in numerous clinical studies. A
list of studies can be ordered from the supplier.
13. Batteries & charging
The instrument contains 2 NiMH battery cells that have to be charged before use. A full charge takes approximately 3 hours. From fully charged, the instrument can
measure continuously for 60 minutes before it needs to be recharged. The yellow LED is lit when the battery needs recharging. When the battery reaches a critical
level, the instrument shuts off automatically. When the batteries are charging, the blue LED is lit. When the batteries are fully charged, the light goes off. The
charger should not be plugged in while measuring due to the risk of power line interference making it difficult to measure.
14. Usage
14.1 Instrument on/off
To turn the instrument on, press the operating key. A short beep should be heard and then all display segments are lit up for a short while. Check that all display
segments are lit.
The software version is then shown briefly before the instrument starts to measure. If any error code (EX, where “X” is the error number) is shown during start up,
please refer to the section “Troubleshooting”.
To turn off, press and hold the operating key until the instrument turns off. The instrument will power down automatically after 1 minute of inactivity.
14.2 Measurement
A MulTipeg (fig 3) is mounted onto the implant by using the MulTipeg driver (fig 2). Use hand-tightening with 6-8 Ncm of tightening torque. Turn on the instrument
and hold the tip close to the top of the pin (fig 5). When a signal is received, a beep is heard and then the ISQ-value is shown on the display for a short while before
the instrument starts to measure again.
If electromagnetic noise is present, the instrument cannot measure. The electromagnetic noise warning is audible as well as visible on the display. Try to remove
the source of the noise. The source could be any electric equipment close to the instrument.
14.3 ISQ Bluetooth transfer
Connection to other equipment can result in unidentified risks to patients, operators or others. Identification, analysis, evaluation and control of these risks are the
responsibilities of the user. Changes to this or the paired device can introduce new risks that require additional analysis.
14.3.1 Bluetooth pairing
To establish Bluetooth data transfer, the instrument has to be paired with a pairable instrument. The pairing only needs to be done once.
To pair, turn on the instrument and press and hold the key for at least 3 seconds until the instrument enters pairing mode, ”PA” is shown on the display and the
beeper sounds while pairing. To abort pairing attempts, press the key again. When pairing is completed, a beep is heard and measurements starts. After 2 minutes
of pairing attempts without succesful pairing, the instrument will return to measurement mode.
14.3.2 Sending ISQ value
If the Osseo100+ is paired, the displayed ISQ and battery status is automatically sent to the paired device.
15. Cleaning and maintenance
15.1 Recommended disinfectants
The following disinfectants are recommended for the instrument, the MulTipeg and the MulTipeg Driver:
•Schülke & Mayr: Mikrozid AF Liquid
•Dürr: FD 322
•Metrex: CaviCide
Follow the instructions for use for the disinfectant that is used. Do not autoclave the instrument
The instrument emits short magnetic pulses with pulse duration of 1 ms and strength of +/- 20 gauss, 10 mm
from the instrument tip. Precautions might be necessary when using the instrument close to cardiac
pacemakers or other equipment sensitive to magnetic fields.
Before use, the parts should be cleaned and disinfected.
Measurements should only be performed using the correct MulTipegs. Using the wrong MulTipeg could cause
erroneous measurements or damages to the MulTipeg or implant.

15.2 Autoclave sterilization (MulTipeg & MulTipeg Driver)
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
Follow the instruction for the autoclave that is used.
Do not clean the MulTipeg by ultrasound. Could cause damage
15.3 Cleaning
•Instrument
The instrument is cleaned with a wet cloth. Any of the above disinfectants can be used. For use in environments requiring sterility, the instrument should be
covered with a sterile cover. Recommended covers (US) are Probe Covers, for instance #DYNJE5900 by Medline or part #10040 by Medical Resources.
•MulTipeg Driver and MulTipegs
The MulTipeg Driver and the MulTipeg should be cleaned with water with or without detergent, using a light brush. Any of the above disinfectant fluids can be
used. For use in environments requiring sterility, the MulTipeg Driver and MulTipeg should be autoclaved before use according to the above instructions.
16. Lifetime
The lifetime of the instrument is determined by the number of charging cycles. The internal batteries can be fully charged more than 500 times before they need to
be replaced. 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
17.1 Possible errors
•Difficult to achieve a measurement:
In some cases it is more difficult for the instrument to bring the MulTipeg into vibration. If so, try to hold the instrument tip closer to the tip of the peg. Check
also that no soft-tissue is touching the peg 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 1 minute 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
18. Accessories & Spare Parts
Model
MulTipeg Driver
Sterile Cover
Mains adapter
EU plug
UK plug
AU plug
US plug
REF
55003
55105
55093
incl 1.5 m cable
Fuhua Electronic Co., Ltd
UE05WCP-052080SPC
55094
55095
55096
55097
MulTipeg: Please refer to the updated list from the supplier.
19. Pairable instruments
Product
Model
Surgic Pro2 (Control unit)
NE335
20. Service
In case of a malfunctioning instrument, the device should be sent to the manufacturer or distributor for repair or exchange.
Osseo 100+ is covered by a two-year warranty.
The instrument must be used with a cover in all uses. (Only US)
The instrument must be cleaned with a disinfectant between patients.
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.

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 foruse in theelectromagnetic environment specified below.
Emissions tests
Compliance
Electromagnetic environment - guidance
RF emissions C1SPR11
Group 1
Osseo 100 uses RF energy only forits internal function.
RF emissions C1SPR11
Class B
Osseo100+ 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
Osseo100+ is intended forusein 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 RFfields
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)

NAKANISHI INC.
www.nsk-inc.com
700 Shimohinata, Kanuma, Tochigi 322-8666, Japan
Integration Diagnostics Sweden AB
Furstenbergsgatan 4, 416 64 Göteborg, Sweden
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NSK Europe GmbH
Elly-Beinhorn-Strasse 8, 6750 Escborn, Germany
NSK France SAS
32 rue de Lisbone, 75008 Paris, France
NSK United Kingdom Ltd
Office 5, Gateway 1000, Arlington Business Park
Whittle Way, Stevenage, SG1 2FP, UK
NSK Dental Spain SA
C/ Módena, 43 El Soho-Európolis
28232 Las Rozas, Madrid, Spain
NSK America Corp
1800 Global Parkway, Hoffman Estates, IL 60192, USA
NSK America Latina Ltda
Rua Blumenau, 735 –Sala 02, América
Joinville, SC 89204-251, Brazil
NSK Oceania Pty Ltd
Unit 12/809-821 Botany Road
Roseberry, NSW 2018, Australia
NSK Asia
9 Tampines Grande, #03-15, 528735, Singapore
NSK Middle East
Room 6EA701, 7th Floor, East Wing No. 6
Dubai Airport Free Zone, PO Box 54316, Dubai, UAE
Specifications are subject to change without notice.
55185 Rev. 1, March 2020