Myant SKIIN Operation And Safety Manual

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Operations and

Safety Manual

Before using Skiin Underwear, please read this manual.

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Summary of Contents for Myant SKIIN

Page 1 Operations and Safety Manual Before using Skiin Underwear, please read this manual.
Page 2 Warranty information The Skiin underwear Biomonitoring device and its accessories, when supplied and delivered new, in the original device to the original purchaser, are covered under a one-year warranty that covers damage due to defective materials and or failure of the equipment to operate in accordance with the information in this Operation and Safety Manual for Skiin Underwear.
Page 3: Table Of Contents
Contents Concept of Operation Getting Started Step 1: Try the Underwear Step 2: Charge the Skiin Pod Step 3: Download the Skiin Connected Life App Skiin Underwear System Components 9.1 Skiin Pod 9.2 Skiin Charging Kit 9.3 Skiin Underwear 9.4 Skiin Connected Life App 9.4.1 Sections in the App...
Page 4 Traveling with Skiin Garments Limited Warranty Device specifications Symbols Glossar Warnings Cautions General Safety Precautions Other Table C1 Table C2 Table C3 Table C4...
Page 5: Introduction
1. Introduction This Operation and Safety Manual for Skiin Underwear System provides instructions for the safe and efficient use of the Skiin Underwear system for biometric monitoring Application. Skiin Underwear uses textile electrodes embedded in the waistband with electronics in the Skiin Pod to measure and analyze your ECG.
Page 6: Essential Performance
Operators of the system will be able to benefit from the Skiin Underwear system’s non-invasive form factor and ability to record continual data which can be analysed for cardiac abnormalities. 2. Essential Performance The essential performance of the Skiin Underwear system is the ability to monitor and export ECG raw data to generate an accurate report of the patient’s ECG through a 3rd party tool.
Page 7: Intended Use As A Medical Device (Medical Device Version Only)
4. Intended Use as a Medical Device (Medical Device Version Only) 1. The Skiin Underwear is intended for users 18 years of age or older, through over the counter or prescribed by a healthcare provider to record and monitor continual ECG data usable for a 3rd party reporting tool at static positions and shared with their circle of care, which includes skilled medical professionals.
Page 8: Contents
6. Contents The standard configuration for the Skiin Connected Clothing System includes the following components: (1) SKIIN POD (2) USB CHARGING KIT 2.1 USB charging dock 2.2 A Micro-usb Cable 2.3 A Wall Plug...
Page 9 A 'Try me On' underwear that you must try first to check for fit before opening the other pairs. PK0001 has 4 pairs of underwear (4) WASH BAG (5) QUICK START GUIDE (6) SKIIN CONNECTED LIFE APP The Skiin System is used with a user-supplied compatible smart device.
Page 10: Concept Of Operation
The Skiin System collects your bio-signals such as heart rate and steps. It is recommended to keep your smart device close to you whenever possible. When you put on the Skiin underwear, it can start sensing your heart rate and physical activity, which will be captured and stored as data by Skiin Pod and transmitted to the Skiin Connected Life App.
Page 11 The underwear without the ‘Try me On’ label on the box, cannot be returned if opened. EN-N3 If the underwear does not fit, visit www.Skiin.com/returns for instructions on how to return or exchange for the correct size. You may return the unopened boxes of underwear to exchange for the correct size. Please visit www.skiin.com/faq/...
Page 12: Step 2: Charge The Skiin Pod
40.5-45 41.5-45 STEP 2: FIND & CHARGE THE SKIIN POD Use the supplied charger to charge the Pod. Insert the Pod into the Charging dock. You should feel the magnets pulling the Pod followed by an audible “Snap”. Connect the Charger and the Wall Outlet using the micro-USB cable and plug it into a power source.
Page 13: Step 3: Download The Skiin Connected Life App
Ensure that Bluetooth has been enabled on your phone. In the Skiin Health App, proceed to the Devices Page and select ‘Add a new device’ on the screen. Connect the Skiin Pod to the App using QR Code or by using the Pod’s ID.
Page 14 Number and markings Slide the Skiin Pod into the Garment dock i.e. a small rigid pocket in the waistband of the underwear, located on The App should begin sensing your ECG signal. The Skiin App will show you a demo of this.
Page 15: Skiin Underwear System Components
Skiin Underwear software may fail and cause injury to the patient or operator. Your Skiin Pod records and securely sends your health information to the Skiin Connected Life App. Pair it with your phone, then slide it into the Garment dock. The Pod will easily ‘snap’ with the magnets when inserted in the underwear dock.
Page 16: Skiin Charging Kit
9.2 SKIIN CHARGING KIT Charging The Pod When the Pod is inserted into the charging dock and connected to a power source, the Pod’s LED will Appear YELLOW to indicate that the Pod is currently charging. The Pod’s LED will remain on and show a yellow light until the Pod has fully charged.
Page 17 Turning the device on/off The Skiin Pod is always “ON” as long as it is charged and has power. You cannot turn the Skiin Pod OFF, but you can unpair it from your phone in order to stop transmitting data. Refer above to Pod Disconnected State.
Page 18: Skiin Underwear
Data Storage and Syncing Your Skiin Pod will automatically sync data to your smart device when it is within range and the app is opened or in the background. When out of range or disconnected from your phone, the Skiin Pod will store ECG data for up to 45 minutes and wellness data for up to 24 hours depending on the amount of data saved.
Page 19 EN-N6 collected or transmitted. Laundering Instructions Remember to remove the Pod from your underwear before washing. EN-C1 Do not wash the Skiin Pod. Please remove the Pod from the underwear dock in the waistband before putting the underwear for wash.
Page 20: Skiin Connected Life App
The Skiin Connected Life App is used to record, display and store your health information. The Skiin Pod can be paired with any android mobile device with Android OS 5.0 or above and any iPhone with iOS 11.0 and above. We recommend you use a mobile device which is compatible with Bluetooth 4.2 for the best App...
Page 21 Devices The Devices page lets you add and manage your Skiin devices. The connected devices on this page help capture the biometric data points of heart health, activity, sleep, stress and more vitals. You can see the real-time connectivity and status of your Skiin device here.
Page 22: Getting Help
9.4.3 System State Messages The Skiin Underwear software provides information to operators when unusual operating conditions occur that affect the system state. The type of condition determines the effect on the Skiin Underwear system state. These are the symbols indicating...
Page 23: Traveling With Skiin Garments
AIRPLANE MODE USAGE To prevent the Skiin Pod from transmitting data, remove the Pod from the garment dock. Store it safely in your bag or pocket for use after your flight. Post deboarding the airplane, to reconnect to the Skiin System again simply insert the Skiin Pod in the garment dock and make sure you turn on bluetooth service on your mobile device.
Page 24: Limited Warranty
11. Limited Warranty The underwear garment has a limited warranty of 30 days (on the date of purchase), and the Skiin Pod and accessories have a limited warranty of 1 year. If during this time the product malfunctions or does not perform as intended the user can request a new product to be shipped to them.
Page 25 Battery Capacity…............................200mAh, 2-3 days of use Battery life ....................minimum 24 Hours Operational Time, 1 year warranty Physical Characteristics Skiin Pod ..........................12.0 grams +/- 0.5g 27.9x46.5x10.6mm Skiin Underwear ....................Men’s and Women’s sizes range from 24” to 47” Environmental Specifications Operational Temperature ................................5 to 45°C...
Page 26 Ingress Protection Marking Skiin Pod is IP22 rated, which means it is protected from touch by fingers and objects greater than 12 millimeters. It is also protected from water spray less than 15 degrees from vertical. Skiin Pod is compliant with standard IEC60601-1- 11:2015.
Page 27: Symbols Glossar
The tables in the following sections contain brief explanations of the safety symbols and other information used to label the Skiin Underwear system, its accessories, and its consumables. Warnings, cautions, and notes are used to describe serious and non-serious conditions of the system. The symbols used to...
Page 28 Symbols on the Skiin Underwear System Device Label (Skiin Pod) Symbol Meaning Symbol Reference The unique device identifier (“UDI”); includes 21 CFR 801.20 a production identifier segment that conveys serial number and manufacturing date MMWWWWW Serial Number 00001 2AXVL-UW01 FCC Number...
Page 29 Symbols on the Skiin Underwear System Package Symbol Meaning Symbol Reference Legal manufacturer ISO15223-1 symbol 5.1.1 Date of manufacture ISO 15223-1 symbol 5.1.3 Manufacturer’s catalog number ISO15223-1 symbol 5.1.6 Device serial number ISO 15223-1 symbol 5.1.7 Refer to instruction manual IEC 60601-1 Table D.2,...
Page 30 Temperature range limitation ISO 15223-1 symbol 5.3.7 Do not use the Skiin Underwear system if ISO 15223-1 symbol 5.2.8 its packaging has been damaged ISO 15223-1, Clause 5.2.7 Non Sterile ISO 7000-2609 MR Unsafe. Items should not enter the ASTFM F2503 MRI scanner room.
Page 31: Cautions
Pacemaker and/or (ICD) implantable cardioverter defibrillator users. DO NOT expose the device to a magnetic resonance (MR) environment. EN-W6 Do not ingest the Skiin pod, Skiin Charging Kit or Skiin underwear. EN-W9 Warning: If you have an allergic or skin reaction, please discontinue use and contact EN-W13 customer support at support@skiin.com.
Page 32: General Safety Precautions
After a year of use, dispose of the Skiin Pod and Skiin Garments according CAUTION to policies set out by your local governing authority EN-C5 Do not use the Skiin Pod, or Skiin Charging Kit or Skiin Underwear if they EN-W14 are damaged in any way.
Page 33: Other
Do not operate the device while wet or moist. EN-W13 Do not hold the Skiin pod, or Skiin Charging Kit directly to skin for extended periods of time 17. Other HIPAA (the American Health Insurance Portability and Accountability Act of 1996) is a set of U.S. federal standards that ensure the privacy and security of all health-care related data.
Page 34 this equipment causes 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 doing one or more of the following measures: •...
Page 35 RF Exposure Information This equipment complies with ISED RSS-102 radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. Emissions Characteristic NOTE The Emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A).
Page 36 RF Emissions CISPR 11 Class B The ME EQUIPMENT is suitable for use in all establishments including Harmonic Emissions IEC Class A domestic establishments and those directly connected to the public low- 61000-3-2 voltage power supply network that supplies buildings used for domestic purposes.
Page 37 Mains power quality should be that of a typical 0% U Voltage Dips, short 0% U (100% dip in U commercial or hospital environment. If the user of the interruptions and (100% dip in U for 0,5 cycle ME EQUIPMENT requires continued operation during voltage variations on for 0,5 cycle power mains interruptions, it is recommended that the...
Page 38 Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance Conducted RF IEC 3 Vrms 3 Vrms Portable and mobile RF communications equipment 61000-4-6 150 kHz to 80 MHz 150 kHz to 80 MHz should be used no closer to any part of the ME EQUIPMENT including cables, than the recommended 6 Vrms 6 Vrms...
Page 39 Table C.4 – Example Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT The ME EQUIPMENT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ME EQUIPMENT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ME EQUIPMENT as recommended below, according to the maximum output power of the communications equipment.