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Biobeat BB-613WP User Manual

Biobeat BB-613WP User Manual

Monitoring wristwatch

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Monitoring Wristwatch | Disposable Patch
User Guide

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Questions and answers

Taiki Katsumata
February 5, 2025

How many times should I do the calibration by using cuff type blood pressure mesurement for this device's accuracy?

1 comments:
Mr. Anderson
February 10, 2025

The Biobeat BB-613WP should be calibrated using a standard blood pressure cuff-based oscillometric device by taking an average of three consecutive measurements as a baseline reference.

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Summary of Contents for Biobeat BB-613WP

  • Page 1 Monitoring Wristwatch | Disposable Patch User Guide...
  • Page 2 Biobeat Technologies Ltd. Biobeat Technologies Ltd. reserves the right to change or improve its products and accompanying technical literature without specific notice of changes or improvements.
  • Page 3: Overview Of System

    3.2. Contraindications ¡ Do not use with neonatal or pediatric patients. ¡ If the BB-613WP is mechanically damaged it must not be used and must be disposed. ¡ Do not use with patients with significant deformity, swelling, irritation, degenerative changes or edema of the wrist.
  • Page 4 ¡ Do not use with patients with localized infection, ulceration or skin lesions involving the wrist. ¡ Do not use with patients that have restricted blood flow e.g. tourniquet, pressure cuff or IV line. ¡ Do not use with patients with tremors or convulsions. ¡...
  • Page 5 device on the other hand. ¡ Do not use the device if you have known allergy to plastic, silicon and metals. ¡ If a skin reaction appears following the use or during the use of the device, stop using the device immediately. ¡...
  • Page 6 › Do not disassemble any part of the system components. This system is not user-serviceable. › Do not place the device in liquid or put it where it could fall into liquid. › Use the device only for the purpose described in the instructions for use.
  • Page 7 › This device is a precision electronic instrument and must be repaired by Biobeat Technologies Ltd. qualified technical professionals. Field repair of the device is not possible. Do not attempt to open the case or repair the electronics.
  • Page 8: Cleaning And Maintenance

    (70-85%) until visually clean. 6. LABELS AND SYMBOLS 6.1. Label Box label 14.1. SYMBOLS A number of internationally recognized symbols are found on the Biobeat BB-613WP and packaging. These relate to safety requirements and standards and are described below.
  • Page 9 Symbol Meaning CE Mark, indicating that the device complies with the Council Directive 98/79/EC (IVD) 0086 The System cannot be disposed as unsorted municipal waste. Contact your local distributor for unit disposal. Caution, consult accompanying documents Serial number Manufacturer Manufacturing date Consult instructions for use Catalogue number Caution: law prohibits dispensing without...
  • Page 10: Specifications

    Symbol Meaning Ingress Protection Marking level 22: Protected IP22 against access of fingers or similar objects, and water dripping at an angle of up to 15 degrees “Do not use the device in an MR environment.” Storage temperature -20*C - +70*C 15.
  • Page 11 Battery charging time 4 hours when powered off Use- life 3 years Shelf- life 2 years Charger Isolation: class ll 5V AC/DC Adapter double isolation AC Power for battery 100-240V, 50-60 Hz, 10VA charger Battery for Patch Capacity 5 days of continuous use Shelf- life 3 years Non-rechargeable...
  • Page 12 Biobeat shall be referred to herein, collectively, as the “Biobeat Services”. Please read these terms of use (“Terms”) carefully as they govern the User’s use of Biobeat Services and create a binding contract between the User and Biobeat.
  • Page 13 Use of the Biobeat Devices is permitted only to individuals above the age of 18. In order to make use of Biobeat Devices, the User will be required to download, install and register and create a designated account at Biobeat’s Application and/or the Website. Use of Biobeat Devices without providing the required personal details (such as age, weight etc.) through Biobeat's Application and/...
  • Page 14 Services, Biobeat Materials, Biobeat Stats and/or any portion thereof in a manner not explicitly permitted herein. 4. Warranty Biobeat warrants to the User (for as long as Biobeat Devices were purchased from Biobeat and/or any authorized retailers and/or distributors and/or resellers of Biobeat (collectively “Authorized Resellers”), that Biobeat Devices...
  • Page 15 Without derogating from any warranty disclaimers under Section 5, which shall apply to the Warranty as well, the Warranty shall not apply (a) to any Biobeat Device that has been subject to misuse, accident or neglect, or which has been used in a manner not compliant with these Terms, the Documentation, or industry practices and standards;...
  • Page 16 (a) any services or information produced by medical or scientific measurement devices )except with respect to a specific indication for which Biobeat holds a valid approval to be used with respect to, from the applicable regulatory authorities in...
  • Page 17 (i) the User breach of these Terms, or (ii) the reliance by any third party upon the Biobeat Stats, in a manner not explicitly allowed under these Terms (an “Indemnifiable Claim”). Biobeat shall have...
  • Page 18 Biobeat Services and/or Biobeat Materials or embodied therein (“Feedback”). The User hereby irrevocably assigns to Biobeat any rights that it may have in such Feedback, and to the extent such rights may not be assigned, the User hereby provides...
  • Page 19 11. Communication Should the User have any questions regarding these Terms, or wish to report a violation of these Terms or abuse of the Biobeat Service, to receive help or for any other matter, the User may contact us at: info@bio-beat.com 12.
  • Page 20 Biobeat Technologies Ltd. UM-0001-03 March 2020 Email: Info@bio-beat.com Website: http://www.bio-beat.com/...