kube Innobyte User manual

User Guide
InnobyteTM

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TABLE OF CONTENTS
User Guide........................................................................................................ 1
1. CONSIDERATIONS...........................................................................4
1.1 Getting Assistance: .................................................................................... 4
1.2 Declaration of Conformity: ........................................................................ 5
1.3 Warnings: ................................................................................................... 7
1.4 Sanitary precautions: ............................................................................... 10
1.5 Storage: .................................................................................................... 10
1.6 Allergies: .................................................................................................. 10
1.7 Pain & Bleeding: ....................................................................................... 10
1.8 How to dispose of the InnobyteTM:........................................................... 10
1.9 Reprocessing Instructions: ....................................................................... 11
1.10 High-level Disinfection Instructions: ...................................................... 12
1.11 Markings and symbols: .......................................................................... 12
1.12 Warranty: ............................................................................................... 14
2. INTRODUCTION ............................................................................ 16
3. SYSTEM OVERVIEW ...................................................................... 17
3.1 Components: ............................................................................................ 17
4. SET-UP PREPARATION .................................................................. 20
4.1 Measurement recording set-up: .............................................................. 20
4.2 Charging set-up:....................................................................................... 21
5. DEVICE OPERATION ...................................................................... 22
5.1 Device interface: ...................................................................................... 22
6. FREQUENTLY USED FUNCTIONS .................................................... 23
6.1 Power-up: ................................................................................................. 23
6.2 Standby On Mode: ................................................................................... 23
6.3 Sleep Mode: ............................................................................................. 24
6.4 Charging mode:........................................................................................ 24
6.5 Measurement Recording Mode: .............................................................. 25
7. TROUBLESHOOTING ..................................................................... 26
7.1 Extreme temperatures: ............................................................................ 26
7.2 Extreme atmospheric pressure: ............................................................... 26
7.3 Mouthpiece cycles:................................................................................... 27

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8. DEVICE NOT OPERATING AS INDICATED ........................................ 28
9. CALIBRATION ............................................................................... 28
10. QUICK USE GUIDE ....................................................................... 28
11. TECHNICAL SPECIFICATIONS ........................................................ 29
TABLE OF FIGURES
Figure 1: InnobyteTM ........................................................................................... 18
Figure 2: Mouthpiece ......................................................................................... 18
Figure 3: Lemo/Lemo Cable ................................................................................ 19
Figure 4: Lemo/USB Cable .................................................................................. 19
Figure 5: Wall charging adaptor ......................................................................... 19
Figure 6: Mouthpiece Cable Ferrite .................................................................... 20
Figure 7: Lemo Connector Keying....................................................................... 20
Figure 8: InnobyteTM front .................................................................................. 22
Figure 9: InnobyteTM back ................................................................................... 22
Figure 10: Bootup screen.................................................................................... 23
Figure 11: Standby On Mode Screen .................................................................. 23
Figure 12: Charging screen ................................................................................. 24
Figure 13: Measurement Display Screen............................................................ 25
Figure 14: Out of Temperature Range Screen .................................................... 26
Figure 15: Atmospheric pressure warning ......................................................... 27
Figure 16: Replace Mouthpiece Screen .............................................................. 27
TABLE OF TABLES
Table 1: ISM Band Immunities .............................................................................. 6
Table 2: Immunity and Emissions Considerations ................................................ 9
Table 3: Storage and Transport Conditions ........................................................ 10
Table 4: Revital-Ox® RESERT® recommended processing conditions ................ 12
Table 5: Battery Life Estimation ......................................................................... 21
Table 6: Charging Time Estimation ..................................................................... 21
Table 7: Wakeup Conditions............................................................................... 24
Table 8: All InnobyteTM systems are subject to the previous technical
specifications ...................................................................................................... 29

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REVISION TABLE
Revision
Date
modified
Modified by
Changes
14
2018/12/20
Frederik Marcil
Final corrections
15
2021/01/08
Frederik Marcil
Technical modification to
comply with FDA regulatory
requirements.

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1. CONSIDERATIONS
1.1 Getting Assistance:
Kube Innovation Inc. will provide technical assistance for your InnobyteTM for a
period of 365 days following the date on which you received your device.
For any, issue, inquiry or product-related comments you can contact us at:
Kube Innovation Inc.
5524 Saint-Patrick, unit 540
Montreal, Qc, H4E 1A8
Phone: [phone]
E-mail: [e-mail]
Or Visit our website at: www.kubeinnovation.com
The InnobyteTM is protected by patent pending.
Kube 2020, Kube Innovation Inc.
Kube Innovation Inc. will not be liable for any design changes without notice to existing clients.

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1.2 Declaration of Conformity:
Kube Innovation Inc. is certified ISO 13485:2016 MDSAP.
Certificate number: 0098685
The InnobyteTM has been tested and conforms to the following standards for a
“Medical Non-Active Measuring Device”.
Canada:
Health Canada License: 101055
Components/Parts/Accessories/Devices for this Licence:
INNOBYTE TM:
Device ID: 1000820
Device Identifier: INNOCA01
MOUTHPIECE:
Device ID: 1000821
Device Identifier: INNOMP01
Safety standard:
-CSA 22.2 IEC 60601-1 3Rd Ed
-UL IEC 60601-1 3Rd Ed
EMC standard:
-IEC60601-1-2 4th Ed.
EMC Test standards and methods:
CISPR 11:2009 + A1:2010: Radiated radio frequency (RF) Emissions
IEC 61000-4-3:2006 + A1:2007 + A2:2010: Radiated RF EM Field
IEC 61000-4-3:2006 + A1:2007 + A2:2010: Proximity fields from RF wireless
communication equipment
IEC 61000-4-2:2008: Electrostatic Discharge
IEC 61000-4-6:2013: Conducted disturbances induced by RF fields
IEC 61000-4-8:2009: Power-Frequency Magnetic Field

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EMC Test Parameters
CISPR 11:2009 + A1:2010: Group 1, Class B Device
IEC 61000-4-3:2006 + A1:2007 + A2:2010: 3V/m, 80MHz to 2.7GHz, 80% AM at
1kHz
IEC 61000-4-3:2006 + A1:2007 + A2:2010: See Table 1
IEC 61000-4-2:2008: ±8kV contact, ±15kV air
IEC 61000-4-6:2013: 3V/m, 6V/m in ISM band, 150kHz to 80MHz, 80% AM at
1kHz
IEC 61000-4-8:2009: 30A/m, 50Hz and 60Hz
Table 1: ISM Band Immunities

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1.3 Warnings:
1. There are no user serviceable parts. Do not service or take apart the
InnobyteTM hardware. If the device does not perform as expected,
contact Kube Innovation Inc.
2. Battery: do not attempt to replace the InnobyteTM battery yourself; you
may damage the battery and cause overheating and/or injury. The
InnobyteTM's lithium-ion battery should only be replaced or recycled by
Kube Innovation Inc. It must be recycled or disposed of separately from
household waste.
3. Do not use autoclave or heat to sterilize the mouthpiece. The use of
standard disinfection products approved for medical use under the
norms published by Health Canada and FDA are recommended.
4. Do not use the device if there is any visible damage to the charging or
the connecting cable.
5. Medical equipment, such as the InnobyteTM, needs specific precautions
and considerations regarding electromagnetic interference (EMI).
These can be found in Table 2.
6. Portable and mobile RF communication equipment can affect the
medical device.
7. The use of cables and accessories not provided by Kube Innovation Inc.
can disturb the RF emission and immunity of the device.
8. Never attach or use any third-party instruments or components to the
InnobyteTM that are not provided and approved by Kube Innovation Inc.
9. EMI and/or electro-static discharge (ESD) can cause the device to
become unresponsive. If this occurs, reset the device by inserting a
small object at the back of the device to depress the reset button. If the
issue persists after a reset, contact Kube Innovation Inc.
10. Use of the InnobyteTM adjacent to or stacked with other equipment
should be avoided. This could result in improper operation. If such use
is necessary, these respective pieces of equipment should be observed
to verify their operational functionality.
11. Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be kept at least than 30
cm (12 inches) away from any part of the InnobyteTM, including cables
specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
12. When first unpacking the InnobyteTM, the device needs to charge for at
least 3 hours.

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13. The InnobyteTM should only be used by health professionals such as
dentists or denturists in healthcare facilities.
14. The InnobyteTM is not used to diagnose illnesses. The data acquired
should be interpreted by the professional using it.
15. Operating and transport conditions are specified in Table 4.
16. The InnobyteTM has no essential performance characteristics in any fail
mode. A hard reset should solve most issues. Contact Kube Innovation
Inc. if the issue persists.
17. Do not charge the InnobyteTM while in use.
18. Do not service or perform any preventive maintenance on any
components of the InnobyteTM. Maintenance or service shall only be
performed by Kube Innovation Inc.
19. Avoid covering or placing the InnobyteTM in an enclosed space while
charging.
20. Do not charge the mouthpiece component of the device with the
Lemo/USB cable.
21. Remove any debris and/or liquid from the Lemo connector port prior to
use.
22. Do not leave mouthpiece component in the mouth for longer than 30
seconds.

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Precaution
Test and Compliance
Electromagnetic Environment -
Guidance
RF Emissions
CISPR11 Group 1,
Class B
1. The InnobyteTM uses RF energy
only for its internal circuitry. As such,
the RF emissions of the device are
very low and unlikely to cause any
disturbance in nearby equipment.
2. Due to its classification, the
InnobyteTM can be used in any
professional care environment with
the exception of settings containing
high frequency (HF) surgical
equipment or RF shielded rooms.
Immunity
Tests
IEC 61000-4-3:2006
IEC 61000-4-2:2008
IEC 61000-4-8:2009
IEC 61000-4-6:2013
1. The device operates at relatively
low frequencies compared to the
ISM’s. As such, it is unlikely that any
device in the ISM range should
disrupt the InnobyteTM. As a
measure of precaution, do not use
the InnobyteTM at a distance of less
than 30 cm from any device
operating in the ISM band.
2. Due to its classification, the
InnobyteTM can be used in any
professional care environment with
the exception of settings containing
high frequency (HF) surgical
equipment or RF shielded rooms.
3. Should the InnobyteTM be subject
to EMI, it has no essential
performance characteristics. In such
cases the device would simply freeze
and resetting it should fix the issue.
Table 2: Immunity and Emissions Considerations

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1.4 Sanitary precautions:
Use latex or nitrile gloves in order to handle the mouthpiece with care. The
polyethylene disposable covers must be stored at room temperature, in a clean
environment, away from all potential sources of contamination.
1.5 Storage:
The device must be kept dry in a clean environment. Prolonged UV exposure
must be avoided.
Temperature
5 to 35˚C (41 to 95F)
Pressure
100 to 110 kPa
Humidity
20% to 95%
Table 3: Storage and Transport Conditions
1.6 Allergies:
If a patient indicates that he is allergic to silicone in his medical form, it
is the responsibility of the health professional not to use the device,
even though the silicone is covered by a polyethylene disposable cover.
The medical form is a document that every patient needs to complete
and update when appropriate.
1.7 Pain & Bleeding:
The health professional assumes the responsibility of using the device with
consideration given to the patient’s condition. The patient can have sensitive
gums, for instance, which could cause pain or bleeding when biting the
mouthpiece. Pain is a limiting factor that should be taken into account by the
health professional.
1.8 How to dispose of the InnobyteTM:
When the device’s electrical component no longer powers on and/or
the mouthpiece failed (see Section 1.9), the health professional is
responsible for its adequate disposal at appropriate electronic
recycling centers.

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1.9 Reprocessing Instructions:
The InnobyteTM is a reusable medical device that must be reprocessed after use
in patients. The InnobyteTM mouthpiece is always intended to be used in
conjunction with the single-use disposable covers provided in the device
packaging. Following patient measurement, the process below should be used
to limit patient contamination with harmful pathogens that may be introduced
to the surface of the mouthpiece during use (always use caution when
performing cleaning and disinfecting procedures):
1. Use latex or nitrile gloves while handling the mouthpiece after patient use to
limit contamination of the surface.
2. Disassemble the device by unplugging the mouthpiece from the Lemo
connector and carefully remove the disposable cover.
3. Discard the disposable cover in the appropriate waste container. Do not
reuse the disposable cover.
4. Place the mouthpiece apart from possible sources of contamination.
5. Thoroughly clean all surfaces of the mouthpiece immediately with water, a
brush, and instrument-grade detergent. Do not submerge any part of the
device in a bath of liquid.
6. Rinse the surface of the mouthpiece with clean water and place it on a clean,
dry surface apart from possible sources of contamination. Take care not to
trap water in the Lemo connector port.
7. Wipe all visible surfaces of the mouthpiece with gauze soaked in 70% iso-
propyl alcohol.
8. Ensure that all external surfaces of the mouthpiece are thoroughly dried prior
to subsequent steps.
9. Inspect the device for any soiling with sufficient lighting and magnification. If
any area is soiled, repeat process 4 - 7.
10. Inspect the device for leaks, cuts, and cracks as above. If present, the
mouthpiece has failed and should be disposed (see Section 1.8).
11. If the mouthpiece has been contaminated during use, a high-level
disinfection or sterilization process should be used. Do not place any parts of
the device in a heated sterilization cycle.

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1.10 High-level Disinfection Instructions:
A high-level disinfection of the mouthpiece is required between each use to
render it safe for subsequent patient use. Kube Innovation Inc. recommends
using a high-level disinfectant such as Revital-Ox® RESERT® or 2% hydrogen
peroxide. Follow the manufacturer’s guidance for safe handling and use of High-
level disinfectants. Below are the manufacturer’s recommended processing
conditions for Revital-Ox® RESERT®:
Contact Time
8 minutes
Temperature
20 °C / 68°F
Reusability
21 days
Rinse
Once with clean, sterile water
Table 4: Revital-Ox® RESERT® recommended processing conditions
1.11 Markings and symbols:
This sign represents a general warning symbol. In this case, it is
used for the warnings section of this document.
This sign indicates that the device presents an allergic risk. In
this case, the silicone used for the mouthpiece might represent
an allergic risk.
This sign indicates that the device cannot be disposed of in the
garbage due to the materials used in its construction.
This sign indicates that the device contains Type B applied
parts.
This sign indicates the device manufacturer.
This sign indicates the date when the device was
manufactured.

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This sign indicates the manufacturer’s serial number so that a
specific medical device can be identified.
This sign indicates that the device has been tested for
compliance with IEC60601 by Nemko Inc.
This sign indicates that the device is subjected to the specified
temperature limits.
This symbol indicates to not reuse the part.
This symbol indicates that it is mandatory to refer to the
instruction manual before using the device.
This label indicates that the device needs to be protected from
moisture.
This label indicates that the device is fragile.
This label indicates the range of atmospheric pressure to which
the medical device can be safely exposed.
This label indicates the range of relative humidity to which the
medical device can be safely exposed.
This label indicates: Caution: Federal law restricts this device to
sale by or on the order of a Dentist or denturist. (USA only)

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1.12 Warranty:
Kube Innovation Inc. - Limited 1-Year warranty
1. SHALL THE DEVICE PRESENT ANY DAMAGE, MALFUNCTION OR NOT MEET THE
EXPECTED OPERATING CONDITIONS AS A RESULT OF IMPROPER WORKMANSHIP
OR DEFECTIVE MATERIALS, Kube Innovation Inc. warrants the purchaser of this
device:
A. InnobyteTM Main Device
The device functionality is covered for a period of one (1) year. In case any of
the aforementioned issues occur, Kube Innovation Inc. will inspect the device
and establish if it can be repaired or replaced by another device. All costs
incurred, including shipping, will be covered by Kube Innovation Inc. except
for cases where it is deemed that the damage or malfunction was caused by
the purchaser’s improper use of the device, then the purchaser will be
responsible for all incurred costs. The repaired or replaced device will then
be covered for the remainder of the original warranty.
B. Mouthpiece
The mouthpiece is covered for a maximum number of one thousand (1000)
cycles
1
. In case any of the aforementioned issues occur, Kube Innovation Inc.
will inspect the mouthpiece and establish if it can be repaired or replaced by
another mouthpiece. All costs incurred, including shipping, will be covered
by Kube Innovation Inc. except for cases where it is deemed that the damage
or malfunction was caused by the purchaser’s improper use of the
mouthpiece, then the purchaser will be responsible for all incurred costs. The
repaired or replaced mouthpiece will then be covered for the remainder of
the original warranty.
C. Cable Assemblies
All cable assemblies are covered for a period of one (1) year. In case any of
the aforementioned issues occur, Kube Innovation Inc. will inspect the cable
and establish if it can be repaired or replaced by another cable. All costs
incurred, including shipping, will be covered by Kube Innovation Inc. except
for cases where it is deemed that the damage or malfunction was caused by
the purchaser’s improper use of the cable, then the purchaser will be
responsible for all incurred costs. The repaired or replaced cable will then be
covered for the remainder of the original warranty.
1
A cycle is recorded when more than sixty (60) Newton of force is applied to the mouthpiece

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D. Wall charging adaptor
The wall charging adaptor is covered for a period of one (1) year. In case any
of the aforementioned issues occur, Kube Innovation Inc. will replace the wall
charging adaptor with a new one. All costs incurred, including shipping, will
be covered by Kube Innovation Inc. except for cases where it is deemed that
the damage or malfunction was caused by the purchaser’s improper use of
the charging adaptor, then the customer will be responsible for all incurred
costs. The repaired or replaced charging adaptor will then be covered for the
remainder of the warranty.
2. THIS WARRANTY DOES NOT COVER defects caused by modifications,
alterations or repairs handled by anyone other than a Kube Innovation Inc.
technician. Any physical abuse, misuse, liquid damage or operation in a manner
contrary to recommended use will void the warranty. In addition, if the device
and/or any of the above-mentioned accessories is resold without Kube
Innovation Inc’s. consent, then all warranty and safety responsibilities will be
nullified.
3. TO OBTAIN WARRANTY SERVICE, contact Kube Innovation Inc. at +1 (514) 400-
3713. If instructed to ship the device to Kube Innovation Inc., the company will
be responsible for the shipping costs. Thereafter, if it is deemed that the issue is
not covered under the warranty, the purchaser shall repay Kube Innovation Inc.
for said shipping costs.

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2. INTRODUCTION
Although an essential tool for general assessment of one’s bite force, the
InnobyteTM is not intended to diagnose conditions. It is therefore mandatory that
the person using the InnobyteTM and analyzing the collected data is a qualified
clinician such as a dentist, denturist or health professional. Using their
knowledge and professional skills, the clinician can adequately assess the
condition of a patient. It is important to note that the InnobyteTM does not
require any additional training to operate the device. The following key factors
specify the main conditions of operation of the InnobyteTM.
User profile: The InnobyteTM is intended to be used by a qualified professional,
such as a dentist, denturist or other health professional.
Patient population: The InnobyteTM is intended to be used in order to assess the
maximal bite force of the general population, with exception to pediatric
patients (18 years of age and younger).
Medical purpose: The intended use of the InnobyteTM is primarily to measure the
maximal bite force of patients.
Indication for Use: The InnobyteTM is a measurement device for dental clinicians
in the quantitative evaluations of a patient’s bite strength.

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3. SYSTEM OVERVIEW
The mouthpiece, being the only applied part, is used to measure the bite force
applied by human teeth. In order to achieve this measurement, the mouthpiece
contains a fluid. When a force is applied to the mouthpiece, it transmits the
applied force throughout the medium which is then read by the sensors.
Thereafter, each mouthpiece is calibrated to correlate the pressure with an
applied force in Newtons. Although every mouthpiece has slightly different
characteristics, the accuracy under the conditions described in the technical
specifications is verified to be within 5% for a range of 0 to 1500N.
As showcased in the following sections, the InnobyteTM has a minimalistic design.
Its user interface is comprised of an LED screen and a multi-function capacitive
sensor.
3.1 Components:
Each InnobyteTM system is provided with the following components. For a more
thorough understanding, Figure 1 identifies each one of them:
1. InnobyteTM Main Device
2. Mouthpiece
3. Lemo/Lemo cable used to connect the mouthpiece
4. Lemo/USB cable used to charge InnobyteTM
5. Wall adaptor
6. Disposable Covers for the mouthpiece

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Figure 1: InnobyteTM
Figure 2: Mouthpiece

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Figure 3: Lemo/Lemo Cable
Figure 4: Lemo/USB Cable
Figure 5: Wall charging adaptor