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Summary of Contents for Biobeat BB-613W
- Page 1 Instructions for Use...
- 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.
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Page 3: System Overview
1. ABOUT THIS USER MANUAL This User Manual provides the information necessary to operate the Biobeat wrist-monitor and chest monitor. PLEASE READ THIS USER MANUAL BEFORE OPERATING THE DEVICE. If any part of this User Manual is not clear, contact Customer Support for assistance. -
Page 4: Electrical Safety
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. Do not use the wrist monitor on patients with localized infection, ¡... - Page 5 This device is intended only as an adjunct in patient assessment. ¡ The system contains no user-serviceable components. ¡ Do not immerse the device in water or any other liquid. ¡ Diseases with peripheral circulatory disturbance may cause incorrect ¡ readings (including, but not limited to, diabetes, hyperlipemia, hypertension and atherosclerosis).
- Page 6 This device contains WEEE materials; please contact your distributor regarding return or recycling of the device. If you are unsure how to reach your distributor, please call Biobeat Technologies Ltd. for your distributor’s contact information. Cyber warnings Android OS level restrictions that prevent unauthorized operations.
- Page 7 Respiration Rate warnings The device is not intended to be used as an apnea monitor. ¡ Do not to rely on the respiration monitoring for detection of cessation ¡ of breathing and to always follow hospital guidelines and best clinical practices, including monitoring additional parameters that indicate the patient’s oxygenation status.
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Page 8: Cleaning And Maintenance
5. CLEANING AND MAINTENANCE 5.1. Notes on Cleaning and Maintenance The Biobeat System does not require maintenance or cleaning on a routine basis, except as suggested in this User Manual. Service should only be provided by an authorized Biobeat Technologies Ltd. representative. Failure to do so voids the warranty. - Page 9 6.2. 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. Symbol Meaning CE Mark, indicating that the device complies with the Council Directive 98/79/EC (IVD)
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Page 10: Medical Device
Symbol Meaning “Do not use the device in an MR environment.” Storage Temperature -20*C - +70*C Read Instruction Manual Batch Code Humidity Limitation Authorized Representative Regulatory Compliance Mark (RCM) FCC Compliant Device Keep away from sunlight Bluetooth Wireless Technology Atmospheric Pressure Limitation Non Sterile Medical device... -
Page 11: Specifications
Symbol Meaning Latex free 7. Specifications Performance Measurement Range Sys: 60 to 250 Blood Pressure Dias: 40 to 150 ±5 mmHg Mean arterial pressure 50-180 ±5 mmHg PR (pulse rate) 40-250 ±3% Beats per minute 70-100 % ±2% or ±2 digits Saturation (spo2 ) 40-70 % ±3% or ±3 digits Respiratory Rate... - Page 12 Use- life 3 years Shelf- life 2 years Charger Isolation: Class ll double isolation 5V AC/DC Adapter Power requirements AC Power for battery charger - 100- 240V, 50-60 Hz, 10VA max Environmental Operating temperature 4°C to 42°C (39°F to 103°F) Operating humidity Up to 95%, non-condensing Pressure...
- Page 13 Bluetooth Operating Frequency Range 2402-2480 MHZ Channels Channel separation 2 MHZ Modulation GFSK External Antenna gain n-VARIANT: 2.14 DBI Bluetooth 4.2 IEEE 802.15.1 Transmission range 8 Meter The Wrist-monitor measures skin temperature and the Chest-patch- ǂ monitor measures body temperature. Approximated body temperature accuracy may be greater than ±0.5⁰C / ǂ...
- Page 14 The FCC requires the user to be notified that any changes or modifications to this device that are not expressly approved by Biobeat Ltd. may void the user’s authority to operate the equipment. Electromagnetic Emission and Electromagnetic Immunity Table:...
- Page 15 Footnotes to table: Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radiobroadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
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Page 16: Terms Of Use
Company. License Biobeat hereby grants you a limited non-exclusive license to use and access the Technology Offering, all subject to the terms and conditions set forth in these Terms. As and when you cease using a Device, the App or any Services for any reason, your license therefor shall automatically terminate. - Page 17 Account Credentials. Please notify us immediately at support@ Biobeat.com if you become aware that your Account is being used without authorization or of any other breach of security.
- Page 18 In addition to the diagnostic data that is collected via your use of the Technology Offering, we reserve the right to collect usage and technical data that is gathered to improve Biobeat products and services, and to facilitate the provision of updates, product support and other services related to the Technology Offering.
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Page 19: Limitation Of Liability
Nothing in the Terms constitutes a waiver of the Company’s intellectual property rights under any law. Without limiting the generality of the foregoing, Biobeat retains all rights, title and interest, including without limitation design rights, patents, copyrights,... - Page 20 Except for the rights expressly granted to the User hereunder, these Terms do not grant the User any rights or licenses by implication or otherwise with respect to any of Biobeat’s intellectual property. Any goodwill derived through the use of the Company’s intellectual property rights pursuant to the terms of this Agreement shall inure solely to the benefit of the Company and its licensors.
- Page 21 enhance, improve, make any other changes to, or discontinue, temporarily or permanently the Technology Offering, automatically and without notice, at any time. You agree that your continued use of the Technology Offering following such modifications constitutes your acceptance of such modifications. We shall not be liable to you or to any third party for any modification, suspension, or discontinuance of the Technology Offering and/or Our Content included therein.
- Page 22 If a defect or malfunction arises with respect to a product during the applicable warrant period, and Biobeat receives notice of such defect/malfunction, Biobeat will, at its option and to the extent permitted by law, either (1) repair the product at no charge, using new or refurbished replacement parts, or (2) replace the product with a new product or a refurbished product.
- Page 23 Limitation of damages Except to the extent prohibited by applicable law, Biobeat shall not be liable for any incidental, indirect, special, or consequential damages, including, without limitation, loss of profits, revenue or data, resulting from any breach of express or implied warranty or condition or under any other legal theory, even if Biobeat has been advised of the possibility of such damages.
- Page 24 Biobeat Technologies Ltd. UM-0001-08 July 2022 Email: Info@bio-beat.com Website: http://www.bio-beat.com/...
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24 hour monitor complete, how to enter sleep hours?