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Table of Contents
Summary of Contents for kube Innobyte
- Page 1 User Guide Innobyte...
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Page 2: Table Of Contents
................10 1.5 Storage: ....................10 1.6 Allergies: ....................10 1.7 Pain & Bleeding: ..................10 1.8 How to dispose of the Innobyte :............10 1.9 Reprocessing Instructions: ............... 11 1.10 High-level Disinfection Instructions: ............12 1.11 Markings and symbols: ................ - Page 3 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 Innobyte systems are subject to the previous technical specifications ...................... 29...
- Page 4 REVISION TABLE Revision Modified by Changes Date modified 2018/12/20 Frederik Marcil Final corrections Frederik Marcil Technical modification to 2021/01/08 comply with FDA regulatory requirements.
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Page 5: Considerations
Phone: +1 (514) 400-3713 E-mail: info@kubeinnovation.com Or Visit our website at: www.kubeinnovation.com The Innobyte 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. -
Page 6: Declaration Of Conformity
1.2 Declaration of Conformity: Kube Innovation Inc. is certified ISO 13485:2016 MDSAP. Certificate number: 0098685 The Innobyte 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:... -
Page 7: Table 1: Ism Band Immunities
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... -
Page 8: Warnings
The Innobyte '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. 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. - Page 9 15. Operating and transport conditions are specified in Table 4. 16. The Innobyte 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 Innobyte while in use.
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Page 10: Table 2: Immunity And Emissions Considerations
(HF) surgical equipment or RF shielded rooms. 3. Should the Innobyte be subject EMI, essential performance characteristics. In such cases the device would simply freeze and resetting it should fix the issue. -
Page 11: Sanitary Precautions
Pain is a limiting factor that should be taken into account by the health professional. 1.8 How to dispose of the Innobyte 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. -
Page 12: Reprocessing Instructions
1.9 Reprocessing Instructions: The Innobyte is a reusable medical device that must be reprocessed after use in patients. The Innobyte 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... -
Page 13: High-Level Disinfection Instructions
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. - Page 14 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.
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Page 15: Warranty
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. - Page 16 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.
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Page 17: Introduction
Using their knowledge and professional skills, the clinician can adequately assess the condition of a patient. It is important to note that the Innobyte does not require any additional training to operate the device. The following key factors... -
Page 18: System Overview
5% for a range of 0 to 1500N. As showcased in the following sections, the Innobyte has a minimalistic design. Its user interface is comprised of an LED screen and a multi-function capacitive sensor. -
Page 19: Table Of Figures Figure 1: Innobyte Tm
Figure 1: Innobyte Figure 2: Mouthpiece... -
Page 20: Figure 3: Lemo/Lemo Cable
Figure 3: Lemo/Lemo Cable Figure 4: Lemo/USB Cable Figure 5: Wall charging adaptor... -
Page 21: Set-Up Preparation
However, in order to comply with Immunity Standards, a ferrite (1) as shown in Figure 6, is clipped on the cable. Therefore, the end of the cable containing the ferrite must be connected closest to the Innobyte Figure 6: Mouthpiece Cable Ferrite In order to ensure durability and avoid possible damage caused by misconnections, the Lemo connectors feature a hardware keying for insertion. -
Page 22: Charging Set-Up
PC USB is 2.5W, and as such, would take double the estimated time to charge the Innobyte . Table 5 summarizes the time to fully charge the Innobyte based on the power supply used. -
Page 23: Device Operation
5. DEVICE OPERATION 5.1 Device interface: In order to create easy to use and elegant devices, Kube Innovation Inc. took a very minimalistic approach to the Innobyte ’s interface. Figures 8 and 9 highlight the basic interface components of the Innobyte... -
Page 24: Frequently Used Functions
Figure 10 will appear when booting. Figure 10: Bootup screen The screen should appear with the Kube Innovation Inc. Logo and the current official firmware version (upper right). This screen should appear for a period of approximately 10 seconds, during which the device performs its start-up procedure and assesses its status. -
Page 25: Sleep Mode
Following the screen seen in Figure 11, if no user input is detected, the device will timeout after one (1) minute, causing it to enter Sleep mode. When the battery is fully charged, the battery icon displays 4 bars along with the remaining percentage. As the battery level begins to decrease with use, the battery bars will gradually disappear. -
Page 26: Measurement Recording Mode
While charging, the same color/graphic representation as described in the Standby ON mode is used to indicate the battery level. 6.5 Measurement Recording Mode: When a valid mouthpiece is connected to the device, the Innobyte then enters the Measurement Recording Mode. As shown in Figure 13, the maximum reading is displayed on the superior row of the screen and the current reading is displayed on the inferior row of the screen. -
Page 27: Troubleshooting
60 minutes. If the error persists, please contact Kube Innovation Inc. as this might indicate an issue with the device or the mouthpiece. -
Page 28: Mouthpiece Cycles
In such a case, the mouthpiece cannot be used. If possible, please ensure the atmospheric pressure is in the specified range. If the atmospheric pressure is in the specified range and the warning is still present, please contact Kube Innovation Inc. as this might indicate an issue with the Innobyte or the mouthpiece. -
Page 29: Device Not Operating As Indicated
8. DEVICE NOT OPERATING AS INDICATED In the event that the device does not perform as indicated in Sections 6 through 7, notify Kube Innovation Inc. immediately. Do not continue to use the device until indicated to do so by the manufacturer. -
Page 30: Technical Specifications
Storage and Transport Conditions Temperature 5 to 35˚C (41 to 95F) Pressure 100 to 110 kPa Humidity 20% to 95% Official Firmware Version Innobyte firmware KI-V5.0.0 All InnobyteTM systems are subject to the previous technical specifications Table 8: Innobyte Technical Specifications...
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