SiDLY CARE PRO Instructions For Use Manual
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SiDLY CARE PRO Instructions For Use Manual

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INSTRUCTIONS FOR USE OF
THE MEDICAL DEVICE

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Summary of Contents for SiDLY CARE PRO

  • Page 1 INSTRUCTIONS FOR USE OF THE MEDICAL DEVICE...
  • Page 3 ver. I.06.2023...

  • Page 5: Table Of Contents

    Table of contents 1. Description of the product ..............6 2. Manufacturer and Service ..............7 3. Warnings regarding safe use ............. 7 4. Contents of the package ..............8 5. Intended use ..................9 6. Contraindications ................9 7. Possible complications ..............10 8.

  • Page 6: Description Of The Product

    1. Description of the product The SiDLY Care PRO wristband the manufacturer). Installing is a medical device. Its basic a SIM card enables the device functionality is the ability to call to work properly, provided that for help / raise an SOS alarm in...

  • Page 7: Manufacturer And Service

    (the company’s address and contact details can be found on the following website: https://sidly.eu and on the device’s label). The manufacturer is liable only for defects and damage to the device resulting from the manufacturer’s fault, a...

  • Page 8: Contents Of The Package

    4. Contents of the package The package contains: After purchase, make sure that all listed elements are included in • SiDLY Care Pro band (color: black) the package. The package can be reused or recycled. • Torx T3 screwdriver (when...

  • Page 9: Intended Use

    Particular caution should be paid in a group of people with an implanted pacemaker or a cardioverter – defibrillator. It is recommended to insert the SiDLY Care PRO on the opposite side of the implanted device. In women after mastectomy, it is recommended to place...

  • Page 10: Possible Complications

    During operation, the band can periodically exceed the temperature of 41°C. There is a risk of burns. In the event of any skin changes, take off the band and consult a physician. The manufacturer recommends using the band on clean, undamaged skin.
  • Page 11 Remove the device for bathing or swimming in the pool. Do not immerse the device in water. A direct, strong impact on the wristband will damage it. Puncturing the battery with a sharp object may cause a fire by releasing the energy stored in the Lithium polymer battery.

  • Page 12: Charging

    9. Charging SiDLY Care PRO has a built-in In order to complete charging of lithium-polymer battery and a the SIDLY Care PRO : dedicated charger included in • check whether the red diode the set. turned off (thus signaling the...
  • Page 13 LED (if the band is not connected to the charger). In the event of a low battery condition, a message is sent to the SiDLY Care mobile app and a dedicated internet platform with the following content: “Battery low”.

  • Page 14: Warnings Regarding Elevated Temperature

    10. Warnings regarding elevated temperature SiDLY Care rare cases exceed temperature ° when worn. If 41 ° C, the band will automatically pulse orange diode everty 10 seconds to inform the user about reaching elevated temperature togheter with sending a notification „High Temperature”...

  • Page 15: Product Use

    3 hours. A full charge will be signaled by activation of The SiDLY Care PRO device is the green diode (the red diode designed to be placed on the will go out) and the appropriate wrist (it is recommended to voice message.
  • Page 16 In the next step, download and and the voice message install the “SiDLY Care” app from “device activated”), Google Play™ or App Store® d. Then the LEDs will turn (make sure that the device, on...
  • Page 17 “SiDLY Care” app (you can also turn on the SMS notification option). You should enter the band’s IMEI number in a correct way.
  • Page 18 “Congratulations! Your SiDLY being connected to the charger, Care has been set up and it is and the discharge status is now ready for use. We wish indicated by a red LED flashing you a pleasant use”. The above three times. Moreover, there is...
  • Page 19 Fig. 2 Light communication of the band When the band is completely discharged, it is not possible to turn it on without the connection to the charger, and the discharge is signaled by a red diode blinking three times. After a complete discharge, the band cannot send the SOS alarm.
  • Page 20 e. CONNECTION ERROR – Occurs when it was not possibly to correctly send the synchronization frame. f. REMEMBER YOUR MEDICATION – Occurs for the time the medication alert was set up on platform. g. WARNING POSSIBLE FALL DETECTED – Occurs when the band detected fall The language of voice messages can be set from the platform.
  • Page 21 “Configure” “Configure will be sent to the platform and band” tab. Select “Advanced the SiDLY Care mobile app. If the settings” option. band is installed for an hour, the After measurement following message will be sent: procedure is completed, the “The band is on for an hour”.
  • Page 22 Fig. 3 Correct location of the band.
  • Page 23 • Using www.sidly-platform.com or another platform dedicated by the manufacturer, the user is able to change the frequency of the measurements. The frequency of measurements can be set...
  • Page 24 5 minutes. Less frequent measurements result in longer operating time of the device. • The measurements performed by the SiDLY Care Pro device are displayed with a delay of at least 60 seconds from the start of the measurements. Each measurement has the date at which measurement was made .
  • Page 25 SOS button position band is pressed or when a fall is extreme cases, possible error detected. The SiDLY Care Pro is 1.5 km). The user’s location is band uses three independent communicated via a link to the technologies...
  • Page 26 manufacturer he or she can only press the responsible for exceeding the SOS button, should always do location discrepancy. it first (without waiting for the location discrepancy may be device to detect the fall). On caused by an insufficient level the other hand, if the user does of infrastructure of the mobile not cancel the detected fall, the...
  • Page 27 Google map or OpenStreetMap percentage of the determined will be sent to the SiDLY Care target. The target is declared mobile app and the online by the user on the website sidly- platform.

  • Page 28: Damages / Repair / Maintenance

    13. Cleaning and disinfection • If the SiDLY Care PRO product is dirty (e.g. with dust, mud, ink, cosmetics), the device should be immediately cleaned. • In order to clean the SiDLY Care PRO product, turn off the device (put the band on the charger in order to enter the charging mode, then hold the SOS button for approx.

  • Page 29: Working, Storage And Transport Conditions

    (in this case, it might be necessary to wait until the condensed water is completely dry). While using or charging the battery, the SiDLY Care PRO device may get hot – this is a normal phenomenon. Start using the device when the temperature of the device decreases.

  • Page 30: Technical Data

    Signal strength range for proper operation Operating frequencies of the wristband 1800 1900 Battery charging time Device life years Water resistance Charging voltage Maximum charging current 1550 Battery capacity Table 1. SiDLY Care PRO – parameters of the device...
  • Page 31 Parameter Unit Charger for SiDLY Care PRO Charger type WL-1 Supply voltage Power consumption 1.55 Charging frequency Device protection class Table 2. Parameters of the charges Parameter Unit Plug-in power adapter for SiDLY Care PRO Output voltage Supply voltage 110-240 Power consumption 1.55...
  • Page 32 Parameters of measurements Parameter Value Heart rate 35 [1/min] - 240 [1/min] Measurement measurement range Saturation 70%SpO2 - 100%SpO2 measurement Heart rate 1 [1/min] Measurement measurement resolution Saturation 1%SpO2 measurement Heart rate +/- 3 [1/min] measurement Measurement accuracy Saturation +/- 3%SpO2 (for the measurement value: 70%SpO2 - 100%SpO2) undefined...

  • Page 33: Electromagnetic Compatibility

    adaptation take 60 seconds. during movement. During the measurement, partial band does not have a declared pulse and saturation data is measurement accuracy under collected. After completing the low perfusion conditions. measurement procedure According to the ISO 80601-1- partial data with the highest 61: 2017 standard, functional reliability of the measurements testers...

  • Page 34: Disposal

    Emission tests: RF emission Emission tests: RF emission CISPR 11 Compliance: Group 1 CISPR 11 Compliance: Class B Electromagnetic environment: Electromagnetic environment: tips: The device uses RF energy tips: The device is suitable for only for its internal function use in all institutions, including and periodically to send data homes.

  • Page 35: Incidents

    19. Incidents Each serious medical incident related to the device should be reported to the manufacturer and to the competent authority of the Member State, in which the user or patient resides. 20. Warranty conditions • The warranty does not exclude, limit or suspend the rights of the buyer resulting from the provisions concerning the warranty for defects in the sold products;...
  • Page 36 consent of the manufacturer or if the device has been improperly stored, used or maintained. This also applies to identified previous attempts to repair the device. The warranty does not cover: • Defects resulting from the use of the device in a manner inconsistent with the principles of use, modifications or design changes made by the user or third parties;...

  • Page 37: Explanation Of Symbols Used By The Manufacturer

    21. Explanation of symbols used by the manufacturer Symbol Explanation The symbol identifies the manufacturer of the medical device This symbol indicates the date of production (medical device) It indicates that the instruction manual must be read It indicates the manufacturer’s serial number enabling the identification of a specific medical device The product meets the essential requirements...

  • Page 38: Troubleshooting

    Symbol Explanations IP 67 The symbol that specifies the tightness class 6 – protection against access to hazardous parts by wire and dustproof protection 7 – protection against effects of short-term immersion in water (30 minutes to a depth of 0.15 m above the top of the housing or 1 meter above the bottom for housings lower than 0.85 The symbol that denotes a medical device...
  • Page 39 4. Lack of measurements on the charger is flashing green. platform If the diode on the charger Check whether the band shows does not flash green, check band status other than whether charger “Inactive” on the platform. If the properly connected status of the band is presented adapter...
  • Page 40 position of the band” 8. The band does not show the location If the correction of the band’s position on the charger does The band gets the current location not work and the band / charger every 24 hours of operation – seems to be very hot –...
  • Page 42 Sidly Sp. z o.o. Chmielna 2/31 Street 00-020 Warsaw...

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