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