NSK NAKANISHI
Dental Surgery Systems
Osseo 100 Osseointegration Monitoring Device Operation Manual Nov 2019
Operation Manual
24 Pages
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ENGLISH 1. Indications for Use Osseo100 is indicated for measuring the stability of dental implants in the oral cavity or 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 Fig 2 MulTipeg Driver Included in package Fig 3 Example MulTipeg Fig 4 Mains adapter and plugs Fig 5 Measurement position
Included in package Not included, sold separately Included in package Shows how the instrument tip is held towards the MulTipeg during a measurement
4. Specifications Power input: 5VDC, 1 VA Charger input: 100-240 VAC, 5VA Instrument weight: 100g Charger safety class: EN 60601-1 Class II Instrument safety class: EN 60601-1 ME Class II EMC: EN 60601-1-2, class B The instrument is intended for continuous use The instrument contains NiMH batteries. 5. Operating environment Ambient temperature: 16° to 40° C (60°-104° F) Relative humidity: 10% to 80% Rh, non-condensing
Only original parts should be used Power supply: Use only the supplied mains adapter and plugs No user modification of this equipment is allowed
Batteries should be collected separately
6. Transport and storage Ambient temperature: -20° to 40° C (-4°-104° F). Relative humidity: 10%-85% Rh. Atmospheric pressure: 500 hPa- 1060 hPa (0.5-1.0 atm). 7. Symbols
Consult Instructions for Use Magnetic field warning
Rx Only
Autoclavable up to 134° C Manufacturing year
CE mark
Delivered Non-sterile
Caution: Federal law restricts this device to sale by or on the order of a physician or dentist.
Warning
Type BF applied part The instrument and MulTipeg 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.
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.
Measurements should only be performed using the correct MulTipegs. Using the wrong MulTipeg could cause erroneous measurements or damages to the MulTipeg or implant.
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.
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 take 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 charging is ready, 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 Osseo 100 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 buzzing sound 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.
15. Cleaning and maintenance
Before use, the parts should be cleaned and disinfected. 15.1 Recommended disinfectants The following disinfectants are recommended for the instrument, the MulTipeg and the MulTipeg Driver: Schülke & Mayr: Mikrozid AF Liquid Dürr: AF 322 Metrex: CaviCide Follow the instructions for use for the disinfectant that is used.
Do not autoclave the instrument
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
The instrument must be used with a cover in all uses. (Only US) The instrument must be cleaned with a disinfectant between patients. 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. 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 REF 55003
Sterile Cover 55105
Mains adapter 55093 incl 1.5 m cable
EU plug 55094
UK plug 55095
AU plug 55096
US plug 55097
MulTipeg: Please refer to the updated list from the supplier. 19. Service In case of a malfunctioning instrument, the device should be sent to the manufacturer or distributor for repair or exchange. Osseo100 is covered by a two-year warranty.
20. 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 RF emissions C1SPR11
Group 1 Class B
Harmonic emissions IEC61000-3-2
Not applicable
Voltage fluctuations/flicker emissions IEC61000-3-3
Not applicable
Osseo 100 uses RF energy only for its internal function. Osseo100 Rechargeable battery operated device
Guidance and manufacturer's declaration - Electromagnetic Immunity Test Levels Osseo100 is intended for use in the electromagnetic environment specified below. Immunity test Electrostatic discharge (ESD) Radiated RF EM fields
Proximity fields form RF wireless communications equipment Rated power frequency magnetic fields
EMC standard or test method IEC61000-4-2 IEC61000-4-3
IEC61000-4-3 IEC61000-4-8
Electrical fast transient/burst
IEC 61000-4-4
Surges Line-to-line, Surges Line-to-ground
IEC 61000-4-5
Conducted disturbances induced by RF fields
IEC61000-4-6
Voltage dips, Voltage interruptions and Electrical transient condition along supply lines
IEC 61000-4-11
Professional healthcare facility environment ± 8kV contact ± 2 kV ± 4 kV ± 8 kV ± 15 kV air 3 V/m 80 MHz - 2.7 GHz 80 % AM at 1 kHz 30 cm minimum separation distance from radio transmitter 30 A/m 50 Hz or 60 Hz ± 2kV 100 kHz repetition frequency ± 0.5, ± 1 kV, ± 2 kV 3V 0,15 MHz – 80 MHz 6 V in ISM bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz 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)