OXXIOM USER MANUAL true wearables 29826 Avenida de Las Banderas, Suite 300 Rancho Santa Margarita CA 92688 True Wearables Condential and Proprietary, February 2017 Version 1.0.0 TABLE OF CONTENTS PACKAGE CONTENT3 OXXIOM OPERATION4 TECHNICAL SPECIFICATIONS..5 WARNINGS..6 QUICK START....7 SHARING DATA...11 SETTINGS.....12 UN-PAIRING OXXIOM....13 COPYRIGHT NOTICE.....14 CONTACT INFORMATION.....15 OXXIOM LABEL INFORMATION..16 FCC DECLARATION.......17 True Wearables Condential and Proprietary, February 2017 2 PACKAGE CONTENT Each OXXIOM pack contains Six 2 x 6 in self-
adhering breathable gentle tapes Two barcode packages with one OXXIOM unit each One User Manual True Wearables Condential and Proprietary, February 2017 3 OXXIOM OPERATION Oxxioms innovative design has combined the latest electronics and biosensing technology for the measurement of the patients functional arterial oxygen saturation (SpO2), perfusion index (PI), and pulse rate (PR). The device is a cableless, completely wireless, continuous, fully disposable, single-use pulse oximeter with the combined function of a clinical grade pulse oximeter monitor and reective sensor into a single disposable device. Oxxiom is a small, lightweight, easy to use, battery operated pulse oximeter that offers 24 hours of continuous monitoring. Oxxiom wirelessly transfers the patients data to a host device (such as an iPhone or an iPad). The host device functions as a primary display and is required for Oxxioms operation. Measurements are continuously taken by Oxxiom and the data is simultaneously and wirelessly transferred to the host device for display, alarms, and storage. Measurement Principle The red and infrared light rays penetrate the blood perfused dermis and interact with the hearts pulsatile signal in order to create red and infrared optical pulsatile signals Epidermis Dermis OXXIOM Red and Infrared lights are applied to the measurement site Emitter Detector True Wearables Condential and Proprietary, February 2017 The optical pulsatile signals
(photoplethysmographs) are captured by the light detector, ltered and of SpO2, PR, and PI conditioned to produce readings 4 TECHNICAL SPECIFICATIONS Features Specications Safety Electrical, EMC, Pulse Oximetry, Biocompatibility IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, ISO 0993-5, ISO 10993-10 Dimensions, Weight 30 x 17 x 7.5 mm (12 x 0.7 x 0.3 in), 3.5 g (0.12 oz) Physical Emitted light energy, Wavelength range SpO2 (70-100%) PR (25-250 BPM) SpO2 PR PI SpO2, PR Optical Sensor 15 mW, 500-1,000 nm Accuracy per ISO 80601-2-61
+/- 3% on 68% of the population
+/- 3 BPM on 68% of the population Measurements Range on Host Device 1-100%
25-250 BPM 0.03-20%
Alarms on Host Device Congurable high and low limits Enviromental Operating temperature, Operating humidity, Operating altitude Storage temperature, Storage humidity, Storage altitude 5-40 (41-104), 95% RH max. at 40 (104), Up to 3,012m (9,882 ft) 0-60 (32-140), 95% RH max. at 60 (140), Up to 5,574m (18,228 ft) Protocol, Range Wireless Bluetooth Low Energy (BLE), 10 m (33 f) Battery Technology, Nominal voltage, Nominal capacity Life True Wearables Condential and Proprietary, February 2017 Non-rechargeable lithium/manganese dioxide (LiMnO2), 3 V, 150 mAh 24 h of continuous monitoring 5 WARNINGS Keep OXXIOM away from children and pets. OXXIOM is not a toy OXXIOM complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) OXXIOM may not cause harmful interference, and (2) OXXIOM must accept any interference received, including interference that may cause undesired operation. Any changes or modications to OXXIOM not expressly approved by True Wearables may cause harmful radio frequency interference and void your authority to operate OXXIOM OXXIOM is a wireless device. Other equipments may interfere with OXXIOM even if they comply with CISPR emission requirements OXXIOM uses a non-rechargeable LiMnO2 battery. Do not recharge, heat, expose to open ames, or disassemble OXXIOM OXXIOM must be used in conjunction with other methods of assessing clinical signs and symptoms (adjunctive device) Inspect OXXIOM measurement site at least every 8 hours to ensure correct sensor alignment and placement Patient sensitivity to OXXIOM biocompatible adhesive may vary due to skin condition Avoid excessive pressure to OXXIOM measurement site as this may cause damage to the skin beneath OXXIOM or No modications to OXXIOM are allowed as they may affect OXXIOM performance Do not use a damaged OXXIOM. If OXXIOM is damaged, discontinue use immediately and replace OXXIOM unit OXXIOM general operation may be affected when in proximity to Electrosurgical Unit (ESU) Do not use OXXIOM in an Magnetic Resonance(MR) environment Do not use OXXIOM in an explosive atmosphere OXXIOM is not debrillation proof (IEC 60601-1) OXXIOM has been tested and found to comply with IEC 60601-1-2 for electromagnetic compatibility of medical devices. inaccurate measurements This standard is designed to provide reasonable protection against harmful interferences in a typical medical installation. However, given the increased number of radio-frequency transmitting equipments and other interference sources in medical installations and other environments, high interference levels might occur and disrupt the operation of OXXIOM Follow governing ordinances and recycling instructions regarding disposal or recycling of OXXIOM and its components, including batteries OXXIOM contains WEEE materials. In compliance with the European directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC, do not dispose OXXIOM as unsorted waste. Please contact True Wearables regarding disposal or recycling of OXXIOM and its components. True Wearables Condential and Proprietary, February 2017 6 QUICK START STEP 1: Download OXXIOM App In your iPad or iPhone, and search for Oxxiom select App Store Oxxiom Select Oxxiom to download App Oxxiom App will be now available in your iPad or iPhone True Wearables Condential and Proprietary, February 2017 7 QUICK START STEP 2: Unpack and Turn On OXXIOM Pull tab 1 Press blue dot Pull tab 2 OXXIOM will blink ON and OFF and ON True Wearables Condential and Proprietary, February 2017 8 QUICK START STEP 3: Attach OXXIOM to Patient Align OXXIOM to nger tip and press it against tip for adhesion Make sure blue arrow points outwards around digit to properly keep Wrap self-adhering breathable tape OXXIOM in place Do Not wrap tape too Make sure it is comfortable tight or too loose for the patient True Wearables Condential and Proprietary, February 2017 9 QUICK START STEP 4: Pair OXXIOM With App OXXIOM App Start App Select side drawer icon Select Start Enter ID, Gender, and DOB Select Scan Scan barcode from package and then, select Done First, waveforms are displayed True Wearables Condential and Proprietary, February 2017 and then, measurements 10 SHARING DATA Select Share Data Choose between Trends and Waveforms Select Share Select side drawer icon Choose sharing method
(Mail, Cloud, Message, AirDrop, etc.) True Wearables Condential and Proprietary, February 2017 11 SETTINGS Set memory trend data chart (landscape mode) Set storage time for trend data (Measurements) Set upper and lower SpO2 alarm limits Set upper and lower PR alarm limits Set waveform storage ON or OFF True Wearables Condential and Proprietary, February 2017 12 UN-PAIRING OXXIOM Select Side Drawer Select Start Select Barcode Field Delete Barcode Select Done Exit OXXIOM App True Wearables Condential and Proprietary, February 2017 13 COPYRIGHT NOTICE Copyright 2017 by True Wearables, Inc. This User Manual is intended to be employed only for the purpose of OXXIOM operation and reference. All rights reserved. No part of this Manual may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of True Wearables, Inc. True Wearables intends to keep this Manual condential and owns all rights to this unpublished work. True Wearables reserves the right to make changes or to discontinue this Manual and OXXIOM without notice or obligation True Wearables Condential and Proprietary, February 2017 14 CONTACT INFORMATION At True Wearables, we value our customers and take great pride in our products and technology. We welcome your inquiries and comments. Please direct all inquiries and/or comments regarding OXXIOM by email to:
contact@truewearables.com or by mail to:
True Wearables, Inc 29826 Avenida de Las Banderas, Suite 300 Rancho Santa Margarita CA 92688 with message subject:
Customer Service, OXXIOM and message with inquire and/or comments True Wearables Condential and Proprietary, February 2017 15 OXXIOM LABEL INFORMATION Non Sterile OXXIOM should not be used on a sterile eld and should not be sterilized Consult User Manual for instructions on how to use OXXIOM IPX1 Resistant to liquid ingress Type B Applied Part
(Comply with specied requirements for protection against electric shock) Latex Not made with natural rubber latex 60 Storage temperature range: 0C to 60C 0 2 0123 Do not re-use Mark of Conformity to European Medical Device Directive 93/42/EEC True Wearables Condential and Proprietary, February 2017 16 FCC DECLARATION This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
$ Reorient or relocate the receiving antenna
$ Increase the separation between the equipment and receiver
$ Connect the equipment into an outlet on a circuit different from that to which the receiver is connected
$ Consult the dealer or an experienced radio/TV technician for help True Wearables Condential and Proprietary, February 2017 17