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WARNING:

  Use of this equipment adjacent to or stacked with other 

equipment should be avoided because it could result in improper 

WARNING:

  Use of accessories, transducers and cables other than 

could result in increased electromagnetic emissions or decreased 

operation. 

WARNING:

  Portable RF communications equipment (including 

peripherals such as antenna cables and external antennas should be 

Otherwise degradation of the performance of this equipment could 

result. 

The EMISSIONS characteristics of this equipment make it suitable for 

use in industrial areas and hospitals (CISPR 11 Class A).  If it is used in a 

required) this equipment might not offer adequate protection to 

mitigation measures, such as relocating or re-orienting the equipment.  

In addition to the requirements of 7.9.3 of the general standard, the 

technical description shall describe precautions to be taken to prevent 

adverse events to the PATIENT and OPERATOR due to 

ELECTROMAGNETIC DISTURBANCES

a: 

The compliances for each EMISSIONS and IMMUNITY standard or test 

and IMMUNITY TEST LEVEL. 

Warning

Summary of Contents for DigiVibe

Page 1: ...Owner s Booklet...

Page 2: ...WR RXU EUDLQ ThisOwner sBooklet offersacomplete explanation of how touse RXU QHZ LJL9LEH DQG WHVWLQJ VXSSOLHV W UHYLHZV WKH GR V DQG GRQ WV RI XVLQJ RXU LJL9LEH GHYLFH ZKLOH WHVWLQJ RXU EORRG 3OHDVH...

Page 3: ...UptheDigiVibe SettingUptheLancingDevice TakingaTestwithDigiVibe Removing theUsedLancet Device Careand Maintenance of theLancingDevice Careand Maintenance of theDigiVibe Troubleshooting TechnicalInform...

Page 4: ...XURSHDQ RQIRUPLW EuropeanAuthorizedRepresentative SinglePatient MultipleUse 6 PERO DigiVibe Symbols and Icons CautionsandWarnings Refertoall instructionsandinsertsthat FDPH ZLWK RXU V VWHP IRU VDIHW U...

Page 5: ...The DigiVibe is intended to be used during the quantitative measurement of glucose sugar in fresh FDSLOODU ZKROH EORRG VDPSOHV GUDZQ IURP WKH QJHUWLS The system is intended to be used by a single pat...

Page 6: ...fectthe DigiVibebeforeinitial useand onceaweekwithcleaninganddisinfectingwipes HHS DZD IURP RXQJ FKLOGUHQ 6PDOO SDUWV PD presentachokinghazard R QRW XVH LQ DQ R JHQ ULFK RU H SORVLYH HQYLURQPHQW Do no...

Page 7: ...s into place 7R DFFHVV WKH EDWWHU compartment door slide the DigiVibe stand off the device Familiarize yourself with the device a b c d e f g 8 b a d c g f e DigiVibe device Power button DigiVibe tip...

Page 8: ...k Remove the DigiVibe tip E WXUQLQJ LW FRXQWHU clockwise 1 4 turn and lifting up 2SHQ WKH EDWWHU FRPSDUWPHQW E pressing the latch on the bottom of the DigiVibe Remove the EDWWHU SDSHU WDE protector OR...

Page 9: ...nterclockwiseandthen pullingitstraightupfrom thedevice 2 Inserta sterilelancetinto thegroovesof thelancet holder Push thelancetinto WKH GHYLFH XQWLO LW LV IXOO seatedintheholder Twist theprotectivecov...

Page 10: ...JHU E VOLGLQJ the device back until it clicks If it does not click LW PD DOUHDG KDYH EHHQ FRFNHG ZKHQ RX inserted the lancet The lancing device is now UHDG WR XVH 4 Adjust the depth setting RI WKH ODQ...

Page 11: ...the stand until it slides through to the other side 3 Be sure the Rubber Suction Base and the surface it is attaching to are clean 1 Place the DigiVibe device with the stand at WKH HGJH RI D FOHDQ DW...

Page 12: ...HHS RXU QJHUWLS LQ FRQWDFW ZLWK the vibrating tip for at least 12 to 15 seconds EHIRUH SULFNLQJ RXU QJHU DQG VHFRQG DIWHU 6 Position the lancet in the center of the DigiVibe WLS RSHQLQJ VR WKDW RX FD...

Page 13: ...WKH ODQFHW GHYLFH 4 Replace the lancing device cap 3ODFH WKH FDS EDFN RQWR WKH GHYLFH WXUQ FORFNZLVH WR secure the cap Do not over tighten It is important to use D QHZ ODQFHW HDFK WLPH RX REWDLQ D EOR...

Page 14: ...DQG OLIH RI RSHUDWLRQ EHIRUH QHHGLQJ WR UHSODFH WKH EDWWHU 6WDUW ZLWK WKH GHYLFH WXUQHG RII 5HPRYH WKH EDWWHU FRYHU E slidingitdownwardandpressing thereleaselatch 3XOO XS RQ WKH EDWWHU WR OLIW LW RXW...

Page 15: ...not allow liquids dirt dust blood or control VROXWLRQ WR HQWHU WKH EDWWHU DUHD R QRW VSUD FOHDQLQJ VROXWLRQ RQ WKH LJL9LEH RU lancing device Do not immerse the DigiVibe or lancing device in DQ OLTXLG...

Page 16: ...UHFKDUJHDEOH EDWWHU H UHFRPPHQG D 9 OLWKLXP EDWWHU ONDOLQH batteries are not powerful enough to run the device at full strength 3 What if my DigiVibe will not turn on D QVXUH WKDW WKH EDWWHU LV LQVWDO...

Page 17: ...OH XVH XVH RI DQ WLS RWKHU WKDQ WKRVH VXSSOLHG E LQJ QQRYDWLRQV VHUYLFH SHUIRUPHG RU DWWHPSWHG E XQDXWKRUL HG VHUYLFH DJHQFLHV IDLOXUH WR SURYLGH UHDVRQDEOH DQG QHFHVVDU PDLQWHQDQFH RU XQLWV WKDW KDYH...

Page 18: ...ce of this equipment could result The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals CISPR 11 Class A If it is used in a required this equipment...

Page 19: ...ome Contra indications User does not fit profile Device is used off label for other injections Device is used for multiple patients IP rating This device has an IP21 rating which means that it is resi...

Page 20: ...21 EMC...

Page 21: ...22...

Page 22: ...23...

Page 23: ...ROH RU LQ SDUW ZLWKRXW WKH H SUHVV ZULWWHQ FRQVHQW RI LQJ QQRYDWLRQV YHU HIIRUW KDV EHHQ made to ensure that the information in this manual is accurate Bing Innovations LLC is not responsible for prin...

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