Operations and Safety Manual Before using Skiin Underwear, please read this manual.
Myant Inc. 100 Ronson Drive, Toronto, ON, M9W 1B6 Canada +1 (416) 423-7906 info@Myant.ca LB00039 Rev.
Table of Contents 1 Introduction 5 2 Essential Performance 6 3 Indication for Use as a Medical Device (Medical Device Version Only) 6 4 Intended Use as a Medical Device (Medical Device Version Only) 7 5 Safety Information 7 6 Contents 7 Concept of Operation 10 8 Getting Started Step 1: Try the Underwear Step 2: Charge the Skiin Pod 10 10 12 Step 3: Download the Skiin Connected Life App 13 Skiin Und
10 Traveling with Skiin Garments 23 11 Limited Warranty 24 12 Device specifications 24 13 Symbols Glossar 27 14 Warnings 30 15 Cautions 31 16 General Safety Precautions 32 17 Other 33 Table C1 35 Table C2 36 Table C3 37 Table C4 39 4
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. The underwear is machine washable and can be laundered with your other clothes (use the included wash bag).
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. 3.
they are supervised by an individual responsible for their safety or receive instructions from the latter as to how the device should be used. 4. Intended Use as a Medical Device (Medical Device Version Only) 1.
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 8 2.2 A Micro-usb Cable 2.
(3) SKIIN UNDERWEAR Each kit has: 1. A 'Try me On' underwear that you must try first to check for fit before opening the other pairs. 2. 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.
NOTE N-N4 Some features described in this guide may not be available with your configuration of Skiin Underwear. WARNING: Use of accessories, and cables other than those specified or provided by the manufacturer of this device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 7. Concept of Operation The Skiin System collects your bio-signals such as heart rate and steps.
Sensor Zones Located in the waistband are 5 sensor zones, 3 on the left hip and 2 on the right hip. Make sure the five sensor zones located in the waistband of the underwear are in contact with your skin. If your skin is too dry, it may affect the performance of the electrodes. Apply a water-based (not glycerin-based) moisturizer to improve the performance. Wash your underwear after each wear as sweat, dead skin and dirt build up can prevent the electrodes from functioning properly.
The following sizing charts show waist measurement per size. The waist measurement should be taken around the hips, keeping a relaxed posture without holding in the abdomen. Size XS S M L XL Range (Inches) Women’s 29.5-32 32-34.5 34.5-37 37-40.5 40.5-45 Size XS S M L XL Men’s Range (Inches) 30-32.5 32.5-35 35-37.5 37.5-41.5 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.
STEP 3: DOWNLOAD THE SKIIN CONNECTED LIFE APP On your smartphone, download the Skiin Connected Life App from the Apple App Store or the Google Play Store. Open the App and follow the onboarding steps to setup and pair the Skiin Pod, start logging your health data and connect to the Skiin System. Please refer to the Skiin website (https://www.Skiin.com/#compatibility) for the latest list of compatible devices and operating system versions: 1. Open the App on your phone. 2.
Model #: 1011-001-001V9 FCC ID: 2AXVL-UW01 IC: 26604-UW01 MMWWWWW00001 Picture of Pod with Model Number, FCC, IC ID, Serial Number and markings 6. Slide the Skiin Pod into the Garment dock i.e. a small rigid pocket in the waistband of the underwear, located on 7. The App should begin sensing your ECG signal. The Skiin App will show you a demo of this.
9. Skiin Underwear System Components 9.1 SKIIN POD WARNING EN-W3 Only the components listed in this section may be connected to the Skiin Underwear system. If components other than those specified in this section are connected to the system, the 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.
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. We recommend that you fully charge the Pod for 1.5 hours before using. Charging Fully Charged If the LED appears GREEN while charging, this indicates the Pod is fully charged and ready to use.
Pod Connected State Once the Pod is connected to your phone via Bluetooth the Pod’s LED turns into a BLUE blink, once every second, indicating that it is connected. Pod Disconnected State If the Pod has no Bluetooth connection the Pod’s LED blinks yellow indicating that the Pod is not connected and is searching for a connection. Please check your phone settings to ensure that Bluetooth is activated or launch the Skiin Connected Life App to check the connection status.
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. When your phone reconnects ,your data will continue to sync again. It is recommended to keep your smart device close to you whenever possible to avoid data loss.
Our Skiin garments can be washed just like regular clothing. The underwear band includes Carbon and Silver yarns. Carbon yarn is used in the textile electrodes of the band and it serves as a conduit to human skin. Conductive silver yarn is used to connect textile electrodes within the band to the textile integration system. Underwear bottoms are made of 95% Bamboo / 5% Spandex - 260 GSM – Single jersey fabric.
To care and maintain your Skiin underwear follow the wash instructions on the wash bag. • Before wearing the underwear for the first time, please wash it. • Please wash after wearing the underwear for 24-48 hours • Washing: To wash, remove the Pod and put all the underwears in the washbag, use cold water when washing. Do not use bleach or fabric softener. • Drying: To dry the underwear, keep them in the washbag and dry on low.
NOTE EN-N8 Your smart device must be connected to the Skiin Pod and the internet for full functionality. Home The Home page for the app provides a summary of your timeline including all biometric data and manual logs. 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.
ECG The user can use the App to monitor their ECG (non-diagnostic) and generate ECG data for a third party to generate reports. 9.4.2 Getting Help The Preferences > System Information screen allows the operator to access information including: • Contact Information for Myant Technical Support • Configurations for hardware, software, the activation key • Message log export options 9.4.
NOTE EN-N9 For Technical Support contact us at: +1 (844) 501-0252 or support@skiin.com NOTE EN-N10 In the event that an unexpected software error occurs, an error message will be displayed on the App. 10. Traveling with Skiin Garments Flying while wearing a Skiin garment is straightforward. Simply show the security statement (below) during screening, and if required/or asked to remove the Skiin Pod from the Skiin garment dock to disable the Skiin System health data tracking for the time-being of travel.
temperature, and other biometric data via the Skiin Pod. The Pod can be removed from the garment to stop the transmission of data to their Bluetooth connected mobile device for ease of screening while travelling if required. If you have any questions, please contact the Skiin Customer support at support@skiin.com 24 hours/day, 7 days/week. You’re all set! We love hearing from our users, send us an e-mail at feedback@Skiin.com or visit www.Skiin.com to let us know how we can improve your experience.
ECG Channel...............................................................................................................................................................................3 Channels ECG Dynamic Range......................................................................................................................................+/- 400 mV Peak-to-Peak Memory Recording Format ....................................................................................................................
Operational Humidity .....................................................15% to 90%, non-condensing, water vapour partial pressure <50hPa Operational Altitude.................................................................................................................................................700hPa to 1060hPa Storage Humidity .............................................................15% to 90%, non-condensing, water vapour partial pressure <50hPa Storage Temperature…...........................
13. Symbols Glossary 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.
Symbols on the Skiin Underwear System Device Label (Skiin Pod) Symbol Meaning Symbol Reference UDI The unique device identifier (“UDI”); includes a production identifier segment that conveys serial number and manufacturing date 21 CFR 801.20 MMWWWWW 00001 Serial Number 2AXVL-UW01 FCC Number 26604-UW01 IC ID CE Marking 28 Refer to operating instructions ISO 15223-1, Clause 5.4.3 IEC 60601-1 symbol 10 in table D.2 Type BF applied part IEC 60601-1. Table D.
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, Symbol 10 Indicates authorization under the FCC Declaration of Conformity procedure FCC title 47, Part 18.209 b (symbol shown in 47 CFR 15.
Temperature range limitation ISO 15223-1 symbol 5.3.7 Do not use the Skiin Underwear system if its packaging has been damaged ISO 15223-1 symbol 5.2.8 Non Sterile ISO 15223-1, Clause 5.2.7 ISO 7000-2609 MR Unsafe. Items should not enter the MRI scanner room. Patients with MR Unsafe devices should not be scanned. ASTFM F2503 MR Unsafe. Items should not enter the MRI scanner room. Patients with MR Unsafe devices should not be scanned. IEC 60601-1-2:2007, Clause 5.1.1 14.
EN-W5 Contraindication The Skiin Underwear is not for use by: Persons under 18 years of age. Pacemaker and/or (ICD) implantable cardioverter defibrillator users. EN-W6 DO NOT expose the device to a magnetic resonance (MR) environment. EN-W9 Do not ingest the Skiin pod, Skiin Charging Kit or Skiin underwear. EN-W13 Warning: If you have an allergic or skin reaction, please discontinue use and contact customer support at support@skiin.com. If necessary, you should seek medical attention.
EN-C6 The Skiin Pod contains magnets, use with caution around magnetic strips and metallic objects 16. General Safety Precautions Explosion Hazard WARNING EN-W8 The equipment is not designed to be used in potentially explosive environments. Do not operate the Skiin Underwear system in the presence of flammable liquids or gases. Electrical Safety CAUTION EN-C4 Do not spray or drip any liquid onto the Skiin Underwear system’s Pod, as this could affect reliable operation.
EN-W11 Do not put your finger into the Skiin charger. EN-W12 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.
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: • 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.
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).
RF Emissions CISPR 11 Class B Harmonic Emissions IEC 61000-3-2 Class A Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3 Complies The ME EQUIPMENT is suitable for use in all establishments including domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes. Table C.2 – Example Immunity Test Level Compliance The ME EQUIPMENT is intended for use in the electromagnetic environment specified below.
Voltage Dips, short 0% UT interruptions and (100% dip in UT) voltage variations on for 0,5 cycle power supply input lines 0% UT IEC 61000-4-11 (100% dip in UT) for 1 cycles Power Frequency Magnetic Field (50/60 Hz) IEC 61000-4-8 0% UT (100% dip in UT) for 0,5 cycle 0% UT (100% dip in UT) for 1 cycles 70% UT (30% dip in UT) for 25 cycles 70% UT (30% dip in UT) for 25 cycles 0% UT (100% dip in UT) for 5 sec 0% UT (100% dip in UT) for 5 sec 30 A/m 30 A/m Mains power quality should be that of a typical
Immunity Test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 Compliance Level Electromagnetic Environment – Guidance 3 Vrms 150 kHz to 80 MHz 3 Vrms 150 kHz to 80 MHz 6 Vrms ISM/Amateur Radio bands inside 150 kHz to 80 MHz 6 Vrms ISM/Amateur Radio bands inside 150 kHz to 80 MHz Portable and mobile RF communications equipment should be used no closer to any part of the ME EQUIPMENT including cables, than the recommended separation distance calculated from the equation applicable to the frequenc
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.
