PenguinII Osseointegration Monitoring Device Instruction Manual

PenguinII Osseointegration Monitoring Device

Product Information

The Monitor Osseointegration is a dental instrument that measures the stability of dental implants in the oral cavity and the maxillofacial region. It is intended for use by professional healthcare users and professional healthcare facility environments only. The package includes the Penguin II Instrument, Charging station, MulTipeg Driver, Example MulTipeg, Mains adapter & plugs, Measurement position, ISQ Tester, and USB with IFU. The MulTipeg is made from titanium and has an integrated grip for the MulTipeg Driver on top. There are different MulTipegs available made to fit different implant systems and types. The stability of the implant is presented as an ISQ value. The higher the value, the more stable the implant.

Product Usage Instructions

• Before using the Monitor Osseointegration, read the instructions for use provided with the package. The following instructions should be followed:
  1. Ensure that the Monitor Osseointegration is used only by professional healthcare users and professional healthcare facility environments.
  2. Inspect the MulTipeg for damage before use. Do not use damaged MulTipegs due to the risk of erroneous measurements.
  3. Use only original parts provided in the package.
  4. Measurements should only be performed using the correct MulTipegs. Using the wrong MulTipeg could cause erroneous measurements or damages to the MulTipeg or implant.
  5. Make sure to measure from different directions around the top of the MulTipeg.
  6. Place the instrument correctly in the charging station to charge the batteries.
  7. When the batteries have reached their lifetime, follow the instructions provided with the battery pack to change them.
  8. Precautions might be necessary when using the instrument close to cardiac pacemakers or other equipment sensitive to magnetic fields.
• The Monitor Osseointegration emits short magnetic pulses (1 ms, +/- 20 gauss), 10 mm from the instrument tip. The magnetic pulses interact with the magnet inside the MulTipeg and cause the MulTipeg to vibrate. The instrument picks up the alternating magnetic field from the vibrating magnet, calculates the frequency and from that, the ISQ value. The stability of the implant is presented as an ISQ value. The higher the value, the more stable the implant. A list of clinical studies can be ordered from the supplier to understand ISQ values better.

Components

Indications for Use
Penguin II is indicated for use in measuring the stability of dental implants in the oral cavity and the maxillofacial region.

Intended Users
Professional health care users and Professional health care facility environments only. Please read the instruction for use before the first usage.

Figures and System components

• Fig 1 Penguin II Instrument Included in package
• Fig 2 Charging station Included in package
• Fig 3 MulTipeg Driver Included in package
• Fig 4 Example MulTipeg Not included, sold separately
• Fig 5 Mains adapter & plugs Included in package
• Fig 6 Measurement position Shows how the instrument tip is held towards the MulTipeg during a measurement
• Fig 7 ISQ Tester Included in package
• Fig 8 USB with IFU Included in package
  Only original parts should be used

Specifications

• Power input: 5VDC, 2.3W
• Charger input: 100-240 VAC, 50-60Hz, 5VA
• Instrument weight: 89g
• Charger station weight: 285g
• Charger safety class: EN 60601-1 Class II
• Instrument safety class: EN 60601-1 ME Class II
• EMC: EN 60601-1-2, class B
•  Intended for continuous use
• Contains NiMH batteries
• Bluetooth specification:
  • Frequency band: 2.4GHz ISM band (2.402-2.480GHz)
  • Transmitting power: Class2 1mW [0 dBm]
  • Modulation: GFSK
  • Channels: 40 channels with 2 MHz spacing
  • Compatibility: EN 300 328, EN 300 489-1, EN301 489-17, EN 62479:2010
  • No specific security aspects (other than those listed in 14.3) applies to the Bluetooth connection

WARNING

• Power supply: Use only the supplied mains adapter & plugs
• No user modification of this equipment is allowed except for battery change
• Batteries should be collected separately

Operating environment

• Ambient temperature: 16° to 40°C (60°-104°F)
• Relative   humidity: 10% – 80% Rh, Atmospheric pressure: 500 hPa- 1060 hPa (0.5-1.0 atm).

Transport & 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).

Symbols

Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided since it could result in improper operation

MulTipeg

The MulTipeg is made from titanium and has an integrated grip for the MulTipeg 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 (1 ms, +/- 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

Technical function

To stimulate the MulTipeg into vibration, short magnetic pulses are sent from the instrument tip. The magnetic pulses interact with the magnet inside the MulTipeg and cause the MulTipeg to vibrate. The instrument picks up the alternating magnetic field from the vibrating magnet, calculates the frequency and from that, the ISQ value.

Implant stability

An implant can have different stabilities in different directions. Make sure to measure from different directions around the top of the MulTipeg.

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.

Batteries & charging

The instrument contains 2 NiMH battery cells that must be charged before use. A full charge takes approximately 3 The instrument contains 2 NiMH battery cells that must be charged before use. A full charge takes approximately 3 hours. From fully charged, the instrument can measure continuously for up to 2 hours before it needs to be recharged. The battery status is visible in the display. When the battery reaches a critical level, the instrument turns off automatically. When the charging station (fig 2) is connected to the mains adapter (fig 5), it is indicated through a blue LED light on the top of the charging station. When the instrument is correctly placed in the charging station and the batteries are charging, a LED is indicating charging with a flashing green light. When the batteries are fully charged, the light will change to a fixed green light. The instrument should not be docked in the charging station while measuring.
Make sure to place the instrument correctly in the charging station

Change of batteries

When the batteries have reached their lifetime they have to be exchanged. Instructions how to change the batteries are provided with the battery pack.
Only batteries supplied by the manufacturer should be used

Usage

1. Instrument on/off
   To turn the instrument on, press the operating key. Before the measurements starts a short beep will be heard and the software version will be displayed.
   If any error code (EX, where “X” is the error number) is shown during start up, please refer to section “Troubleshooting”. To turn off, press the operating key. The instrument will shut down automatically after 30 seconds of inactivity.

2. Measurement

   • A MulTipeg (fig 4) is mounted onto the implant by using the MulTipeg driver (fig 3). Use hand-tightening approximately 6-8 Ncm of tightening torque. Turn on the instrument and hold the tip close to the top of the pin (fig 6). When a signal is received, a beep is heard and the ISQ-value is shown on the display.
   • 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.

3. ISQ Bluetooth transfer

   • The ISQ number is automatically sent through a serial Bluetooth link, and can be received by any device with the The ISQ number is automatically sent through a serial Bluetooth link and can be received by a device with the capability to receive serial Bluetooth data such as an Iphone with app “SmartData” from Microchip.
   • 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.
   • To establish Bluetooth data transfer, the instrument has to be connected to another Bluetooth device. To connect, find “Penguin II” in the other device and connect.

Reprocessing

The instrument must always be used with an FDA cleared sterile dental sleeve (REF 55105).

Instrument

1. Cleaning & Disinfection
   Use a cloth and water to clean the instrument. To disinfect, wipe the instrument for 1 minute with a cloth soaked in 70% Isopropyl alcohol and leave it for another 2 minutes to let the alcohol vanish.
   Do not autoclave the instrument

2. MulTipeg & MulTipeg Driver
   Inspect the MulTipeg and the MulTipeg Driver for damages before use. Dispose of the MulTipeg if there are visible damages such as severe miscoloring or if the threads are damaged. Dispose of the MulTipeg Driver if the connection part (to the MulTipeg) is visibly worn.

3. Cleaning

  * Immerse the device in 1% Alconox solution in tap water for 5 minutes
  * Brush with an interdental brush for 1 minute, in the solution
  * Rinse in tap water for 10 seconds
  * Dry with a lint-free towel  

Do not sonicate the MulTipeg. Could cause damage

2.  **Sterilization**  

Sterilization should be made in a pre-vacuum steam sterilizer (autoclave) according to ISO 17665-1. Clean the MulTipeg and MulTipeg Driver and put them into an FDA-cleared autoclave bag before sterilization.
The following sterilization process shall be used:

  * 3 minutes at 270°F (132°C).
  * 30 minutes drying time.

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 100 autoclave cycles, and a MulTipeg is guaranteed for 20 autoclave cycles, before they are degraded in any way.

Troubleshooting & testing

The instrument can be tested by using the ISQ tester (fig. 7). 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.

Possible errors

• Difficult to achieve a measurement:
  In some cases, it is more difficult for the instrument to make the MulTipeg vibrate. If so, try to hold the instrument tip closer to the top of the MulTipeg. Check also that no soft-tissue is touching the peg which could affect the 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 may also turn off if the battery level is too low or due to any of the error codes described below.

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

Accessories & Spare Parts

Model| MulTipeg Driver| Sterile Cover| Power adapter Model No. UES06WNCP- 052080SPA

05WC052080SPC

| EU plug| UK plug| AU plug| US plug| Battery lid| Battery lid screws| Battery pack| ISQ

tester

---|---|---|---|---|---|---|---|---|---|---|---
REF| 55003| 55105| 55263| 55264| 55265| 55266| 55267| 55242| 55244| 55243| 55217

MulTipeg: Please refer to the updated list from the supplier.

Repair

In case of a malfunctioning instrument, contact the manufacturer or distributor. Penguin II is covered by a two-year warranty.

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.

Penguin II is intended for use in the electromagnetic environment specified below.

Emissions tests| Compliance| Electromagnetic environment – guidance
RF emissions C1SPR11| Group 1| Penguin II uses RF energy for its internal function and for Bluetooth
RF emissions C1SPR11| Class B| ****

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

Penguin II is intended for use in the electromagnetic environment specified below.

Immunity test| EMC standard or test method| Test levels, 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| 80 MHz – 2.7 GHz: 10 V/m

2.7 GHz – 6 GHz: 3V/m 80 % AM at 1 kHz

Proximity fields form RF wireless communications equipment| IEC61000-4-3| 3 m 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

5kHz / 100 kHz repetition frequency

Surges Line-to-line, Surges Line-to-ground| IEC 61000-4-5| ± 0.5, ± 1 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| 0% UT, 0.5 cycle: At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

0 % UT; 1 cycle: At 0°, 180°,

70 % UT; 25 cycles. At 0°

0 % UT; 250 cycles. At 0°

ABOUT COMPANY

• Integration Diagnostics Sweden AB Furstenbergsgatan 4
• 416 64 Gothenburg, Sweden
• www.penguininstruments.com

References

• Penguin Instruments

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