VitalConnect VitalPatch Manual
Biosensor
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- Quick start manual (2 pages)
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Summary of Contents for VitalConnect VitalPatch
- Page 1 CorVitals, Distributor IFU-02 Rev. J Page ! of ! DCO-M-1556 | Date: 06Mar2018...
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Page 2: Device Description
Relay device when in range of the Relay device. The encrypted wireless data provided by the VitalPatch device may be downloaded from the Relay device for storage, or integrated into a Third-Party Relay Application via the APIs of the Relay Software Library. - Page 3 Histories of skin irritations should be considered before placing the VitalPatch device on a patient. • Do not use the VitalPatch device during an MRI scan or in a location where it will be exposed to strong electromagnetic forces. Only place the VitalPatch device on intact skin.
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Page 4: Product Storage
Note: It is recommended that healthcare providers advise users to replace the VitalPatch device after 120 hours (5 days) of use. To preserve data, the VitalPatch device must be connected to the Relay device prior to the end of battery life (120 hours). The device will no longer be usable after 120 hours. - Page 5 Step 2: Remove VitalPatch from pouch. Tear open the pouch using the notch mark and remove the VitalPatch device carefully, to avoid pressing the Power Button. Retain the pouch or the adhesive backing with the device Bluetooth ID number. You will need this information to connect to your software application after the VitalPatch device is applied to the patient.
- Page 6 Step 4: Position VitalPatch on the body. With the adhesive backings still adhered, place the VitalPatch device on a flat body surface on the left chest with one electrode two fingers below the suprasternal (jugular) notch, and angled diagonally toward the heart.
- Page 7 Refer to your software application provider’s user manual for more instructions on how to connect to the VitalPatch device. A connection is required to establish a start time in the data file. For calibrating your VitalPatch device, refer to your software application provider’s user manual.
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Page 8: Troubleshooting
See image to the right. Note: The VitalPatch device is Single Use Only. Do not reapply the device once it is removed. Please observe local laws for disposal of battery-operated electronic products. -
Page 9: Contact Information
CorVitals, Distributor Contact Information VitalConnect, Inc. CorVitals, Inc. 224 Airport Parkway, Suite 300 990 Stewart Ave. San Jose, CA 95110 USA Suite LL45A Phone: (408) 963-4600 Garden City, NY, 11530 www.vitalconnect.com Tel: (888) 401.9998 Fax: (800) 559-3413 IFU-02 Rev. -
Page 10: Product Specifications
CorVitals, Distributor Product Specifications IFU-02 Rev. J Page ! of ! DCO-M-1556 | Date: 06Mar2018... - Page 11 Barometric Pressure 70 kPa to 102 kPa Electromagnetic Emission Declaration The VitalPatch device is intended for use in the electromagnetic environment specified below. The end user of the device should assure that it is used in such an environment. Emission test...
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Page 12: Fcc Compliance
FCC Compliance (FCC ID:SPO-VCI-VP2) The VitalPatch device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation (FCC Title 47, Subpart A, Part 15.19(3)). - Page 13 (For ME equipment ME system that are not life-supporting) The VitalPatch device is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The end user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the VitalPatch device as recommended below, according to the maximum output power of the communications equipment.
- Page 14 (W) according to the transmitter manufacturer. The VitalPatch device complies with the applicable requirements and relevant provisions of the Radio Equipment Directive 2014/53/EU (RED). Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
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Page 15: General Symbols
CorVitals, Distributor General Symbols IFU-02 Rev. J Page ! of ! DCO-M-1556 | Date: 06Mar2018... - Page 16 CorVitals, Distributor Symbol Title Symbol Title Protected against splashing water Protected against submerging in water (up to 1 meter for 30 minutes) Re-use is not allowed Read usage instructions Properly dispose of EEE Non-ionizing radiation (Electrical and Electronic Equipment) Defibrillation proof type CF MR Unsafe applied part CE Marking conformity...
- Page 17 CorVitals, Distributor IFU-02 Rev. J Page ! of ! DCO-M-1556 | Date: 06Mar2018...
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