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Myant SKIIN, Operation And Safety Manual, Page: 6 / 40

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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. Indication for Use as a Medical Device (Medical Device Version Only)

The Skiin Underwear is indicated for users in need of remote monitoring and aiding the identification of potential 

cardiovascular issues by skilled medical professionals through a 3rd party reporting tool. The medical features for ECG 

monitoring of this product are not to replace traditional methods of diagnosis or treatment. Wellness features such as 

activity, temperature, respiration rate, sleep quality, mood and stress and not indicated to use as a medical device.

Contraindications 

The Skiin Underwear is not for use by: 

•  Persons under 18 years of age

•  Pacemaker and/or (ICD) implantable cardioverter defibrillator users

•  Pregnant Women

 

This device is not intended for use by children. Do not leave the device near babies, infants or children. This device is 

not intended for use by individuals with limited physical capacities or limited experience and / or knowledge unless 

Risks for children and individuals requiring assistance

Summary of Contents for SKIIN

Page 1: ...1 Before using Skiin Underwear please read this manual Operations and Safety Manual ...

Page 2: ...ge 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 Version information System Skiin Underwear System Software Skiin Connected Life App Version 1 0 0 Operation and Safety Manual for Skiin Underwear System Revision 1 0 original instructions PP002 Myant Inc 100 Ronson Drive Toronto ON M9W ...

Page 3: ...fety Information 7 6 Contents 8 7 Concept of Operation 10 8 Getting Started 10 Step 1 Try the Underwear 10 Step 2 Charge the Skiin Pod 12 Step 3 Download the Skiin Connected Life App 13 9 Skiin Underwear System Components 15 9 1 Skiin Pod 15 9 2 Skiin Charging Kit 16 9 3 Skiin Underwear 18 9 4 Skiin Connected Life App 20 9 4 1 Sections in the App 12 9 4 2 Getting Help 22 9 4 3 System State Message...

Page 4: ...ith 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 ...

Page 5: ...lp you improve your wellness It includes Health Canada Approved continuous ECG Monitoring The underwear has been clinically validated and developed with doctors and users The ECG data captured from the Skiin Underwear system is to be used by qualified cardiologists and trained clinicians to supplement ECG data captured by other methods The data can also be used by individuals curious about their h...

Page 6: ...ular issues by skilled medical professionals through a 3rd party reporting tool The medical features for ECG monitoring of this product are not to replace traditional methods of diagnosis or treatment Wellness features such as activity temperature respiration rate sleep quality mood and stress and not indicated to use as a medical device Contraindications The Skiin Underwear is not for use by Pers...

Page 7: ...r 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 The ECG viewer is to confirm the presence of signal and not to be used for diagnostic purposes Circle of care consists of the user s trusted connections who have an interest in the user s health or wellbeing for example family members frie...

Page 8: ... 2 USB CHARGING KIT 6 Contents The standard configuration for the Skiin Connected Clothing System includes the following components 1 SKIIN POD 2 2 A Micro usb Cable 2 1 USB charging dock 2 3 A Wall Plug ...

Page 9: ...m is used with a user supplied compatible smart device 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 ...

Page 10: ... any time 8 Getting Started STEP 1 TRY THE UNDERWEAR Open the Try me On box and put on the underwear to check the fit It is important to ensure your underwear is the correct size as good contact of the sensor zones in the waistband with the skin surface is required to get a good signal for ECG recording Proper fit will ensure accurate heart rate readings Your underwear should be snug that means it...

Page 11: ...wear after each wear as sweat dead skin and dirt build up can prevent the electrodes from functioning properly Ensure all components are dry prior to use do not operate while wet or moist 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 ...

Page 12: ... 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 When the light on Pod shows magenta color the Pod is activated Take out the pod from the charger you should see a blinking yellow light and it is ready to be paired The blinking yellow light ...

Page 13: ...ur phone 2 Create an account or login with your Skiin username and password 3 Set up your account 4 Activate your Skiin Pod by charging it Your Skiin Pod should be partially charged when received Charge the Skiin Pod using the provided charger see Section 8 step 2 Charging Instructions 5 Ensure that Bluetooth has been enabled on your phone In the Skiin Health App proceed to the Devices Page and se...

Page 14: ...t in the waistband of the underwear located on 7 The App should begin sensing your ECG signal The Skiin App will showyou a demo of this Picture of Pod with Model Number FCC IC ID Serial Number and markings MMWWWWW00001 FCC ID 2AXVL UW01 IC 26604 UW01 Model 1011 001 001V9 ...

Page 15: ...e different states of charge and connection Remember to remove the Pod from your underwear before washing CAUTION EN C1 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 WARNING EN W3 Low batte...

Page 16: ... 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 While the Pod is charging it will not indicate Bluetooth connection status through the LED light Do not try to pair the device while charging NOTE EN N5 Fully Charged If the LED appears GREEN while charging this indicates the Pod is fully charged and ready to use...

Page 17: ... 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 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 To unpai...

Page 18: ...keep your smart device close to you whenever possible to avoid data loss Cleaning the Pod Do not wash the Pod or Charging dock USB cable or power cube or immerse them in water The surface of the Pod can be wiped clean with a soft moistened cloth Do not use any abrasive or solvent based cleaners Storing Pod Store the Pod in a clean dry safe location Do not store in extremely hot cold humid wet or b...

Page 19: ...fast drying and thermal regulating Bamboo fabric is also anti static so it doesn t cling to other materials The Band is made of 69 Nylon 26 Spandex and 5 of other fibres 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 Do not wash the Skiin Pod Please remove the Pod from the unde...

Page 20: ...r 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 performance 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...

Page 21: ... to you The main page is presented in the form of cards for each biometric data parameter that is captured It gives you a quick view of the most recent system captured biometric for Heart Health Activity Sleep Stress Location and More Vitals Connections The Connections page helps you to connect share and communicate with your friends family and health care professionals You can connect with your c...

Page 22: ... 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 battery level These are the symbols indicating bluetooth connectivity These are the symbols indicating garment signal quality ECG The user can use the App to monito...

Page 23: ...being of travel Skiin Pods contain lithium rechargeable battery and should not be included in checked luggages 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 ...

Page 24: ...les Visit www Skiin com For more information visit www Skiin com 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 Myant will only replace the defec...

Page 25: ...Interface Protocol Bluetooth Low Energy 4 2 Operating Frequencies 2 4 2 48GHz Frequency Deviation 2 MHz channel Power Requirements Battery Type Rechargeable Lithium Polymer 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...

Page 26: ...5 degrees from vertical Skiin Pod is compliant with standard IEC60601 1 11 2015 Expected Service Life The expected service life for the Skiin Pod is 2 years and 50 washes each pair of Skiin Underwear Warm up time There is no warm up time but for optimal performance it is recommended that the user Applies moisturizer to the skin location where textile electrodes contact prior to use User Interface ...

Page 27: ...s adverse reactions potential safety hazards and limitations in use imposed by a condition The warning will identify steps that should be taken if the incident occurs Messages with this heading indicate information regarding any special care to be exercised by the operator and or patient for the safe and effective use of the device and to prevent damage All caution statements should be followed to...

Page 28: ...ier segment that conveys serial number and manufacturing date Serial Number FCC Number IC ID CE Marking Refer to operating instructions Type BF applied part 21 CFR 801 20 ISO 15223 1 Clause 5 4 3 IEC 60601 1 symbol 10 in table D 2 IEC 60601 1 Table D 1 Symbol 20 IEC 60417 5333 Symbols on the Skiin Underwear System Device Label Skiin Pod ...

Page 29: ...Package Symbol Meaning Symbol Reference Manufacturer s catalog number ISO15223 1 symbol 5 1 6 Device serial number Refer to instruction manual ISO 15223 1 symbol 5 1 7 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 19 b ...

Page 30: ...evices should not be scanned MR Unsafe Items should not enter the MRI scanner room Patients with MR Unsafe devices should not be scanned Risks for children and individuals requiring assistance This device is not intended for use by children This device is not intended for use by individuals with limited physical capacities or limited experience and or knowledge unless they are supervised by an ind...

Page 31: ...allergic or skin reaction please discontinue use and contact customer support at support skiin com If necessary you should seek medical attention Do not operate the device if the device feels hot to touch EN W5 EN W6 EN W9 EN W13 EN W15 Do not drop the device It is important that the user takes care when handling the Pod Repeated drops from 1m or over may damage and or affect the performance of th...

Page 32: ...nets use with caution around magnetic strips and metallic objects EN C6 Electrical Safety Do not spray or drip any liquid onto the Skiin Underwear system s Pod as this could affect reliable operation After a year of use dispose of the Skiin Pod and Skiin Garments according to policies set out by your local governing authority Do not use the Skiin Pod or Skiin Charging Kit or Skiin Underwear if the...

Page 33: ... Operation is subject to the following two conditions 1 This device may not cause harmful interference 2 This device must accept any interference received including interference that may cause undesired operation This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the Federal Communication Commission FCC rules These limits are desi...

Page 34: ...T RESPONSIBLE FOR ANY CHANGES OR MODIFICATIONS NOT EXPRESSLY APPROVED BY THE PARTY RESPONSIBLE FOR COMPLIANCE SUCH MODIFICATIONS COULD VOID THE USER S AUTHORITY TO OPERATE THE EQUIPMENT RF Exposure Warning This equipment complies with FCC 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...

Page 35: ...quipment might not offer adequate protection to radio frequency communication services The user might need to take mitigation measures such as relocating or re orienting the equipment Table C 1 Example Emission Class and Group Compliance The ME EQUIPMENT is intended for use in the electromagnetic environment specified below The customer or the user of the ME EQUIPMENT should assure that it is used...

Page 36: ... the ME EQUIPMENT should assure that it is used in such an environment Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient Burst IEC 61000 4 4 Surge IEC 61000 4 5 8 kV Contact 15 kV Air 2 kV for power supply lines 0 5 kV 1 kV line to line 8 kV Contact 15 kV Air 2 kV for power supply lines 0 5 kV 1 kV line to line Floors should be wood concrete or ceramic tile If floors are covered ...

Page 37: ...UT for 25 cycles 0 UT 100 dip in UT for 5 sec 30 A m 30 A m 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 0 UT 100 dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the ME EQUIPMENT requires continued operation during power mains interruptions it is recommended that the ME EQUIPM...

Page 38: ...site surveya should be less than the compliance level in each frequency rangeb Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field ...

Page 39: ...ated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These...

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