IFU-01, Rev. A
Page 1 of 20
Instructions-For-Use (IFU)
& Information Guide
IFU-01
Страница 1: ...IFU 01 Rev A Page 1 of 20 Instructions For Use IFU Information Guide IFU 01...
Страница 2: ...authorized persons to receive data and notifications generated by the system The VitalConnect Sensor is a battery operated adhesive patch with integrated sensors and wireless transceiver worn on the...
Страница 3: ...ceiver through a 2 inductor matching network that has been optimized to maximize the power radiated by the antenna and minimize the voltage standing wave ratio VSWR The product is for use with BT 4 0...
Страница 4: ...VitalConnect Sensor should be kept out of the reach of children pets or anyone who may swallow components or otherwise be at risk of being harmed by components If any component is swallowed seek emerg...
Страница 5: ...r drying time Handle the VitalConnect System with care and according to instruction of use Incorrect handling use of excessive force or dropping of any components of the VitalConnect System may cause...
Страница 6: ...provider will be notified as applicable VitalConnect Sensor is o Type BF applied part o Not reusable o IPX4 protected against water spray o IPX7 protected against water submersion No installation or...
Страница 7: ...ting altitude 2000 m Recommended barometric pressure 80 kPa Data Accuracy Data accuracy for the following attributes is measured through various bench testing test cases in compliance with ANSI AAMI I...
Страница 8: ...the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This...
Страница 9: ...ion Vital Connect Sensor i e patch model 545 00006 00 and module model 600 0001 00 is intended for use in the electromagnetic environment specified below The patient or the end user of the Vital Conne...
Страница 10: ...mitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the followi...
Страница 11: ...60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic t...
Страница 12: ...mum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 80 kHz to 800 MHz 800 kHz to 2 5 GHz 0 01 0 17...
Страница 13: ...Inc 2105 S Bascom Ave Campbell CA 95008 408 963 4600 www vitalconnect com IP24 IP27 Underwriters Laboratories MEDICAL PATIENT MONITORING EQUIPMENT AS TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS O...
Страница 14: ...er assigned password 6 Select Start Download b Ensure that applicable software tools drivers etc have been properly installed to allow communication between the server software library service provide...
Страница 15: ...If the VitalConnect Sensor is assembled and placed on the torso per the IFU physiologic data should be automatically collected and transmitted to the server designated by the Service Provider Shut dow...
Страница 16: ...cavity 3 Figure 5 Inside patch Paper Liner of Back Flap 5 2 5 1 3 Figure 4 Adhesive Side Back Flap 1 Clear Release Liner 6 1 6 Crescent shaped tab located at the edge is designed to help you grip and...
Страница 17: ...lining up the edges as much as possible Figure 5 Press down firmly on the edge of back flap 1 to ensure it is sealed Figure 6 Separate patch from clear release liner by carefully peeling off clear lin...
Страница 18: ...ing side with 1 hand pulling upward position With the other hand place thumb on top edge of the module side To take patch off lift the edge off one wing and slowly peel it off skin Position 2 Position...
Страница 19: ...times if module is properly connected AND patch has sufficient battery life to operate After showering or bathing system may lose connection Please allow 15 minutes to air dry and retry connecting to...
Страница 20: ...ype CF applied part Underwriters Laboratories MEDICAL PATIENT MONITORING EQUIPMENT AS TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI AAMI ES60601 1 2005 Medical Electrica...
