Trackit Mk3 User Manual
10
1 System Overview
1. 1 General description
I nt ende d use
The Trackit Mk3 is int ended to m easure and record EEG signals.
I ndica t ion s f or use
The Trackit Mk3 is used as an aid in t he diagnosis of neurophysiological disorders such as epilepsy.
Gene ra l de script ion
The Trackit Mk3 is a m ult i- channel, am bulat ory, elect roencephalograph recorder. I t is a com pact
body- worn device t hat is bat t ery powered and the data is st ored on a Com pact Flash card.
The device is suitable for use in a clinical environm ent and in an outpatient set t ing. The EEG
elect rodes are fitt ed to t he patient by a t rained clinician prior to t he patient being sent hom e. No
subsequent intervention is required by t he pat ient .
Upon com pletion of t he recording, t he dat a which is stored on a Com pact Flash card is reviewed by
a clinician using review and analysis soft ware on a PC.
This device is intended only as an adjunct device in pat ient assessm ent; it m ust be used in
conj unction wit h ot her m et hods of patient diagnosis.
The device does not sustain or support life.
I nt e nded Use r
The int ended user of the device is a healt hcare professional who has t he training and knowledge to
undert ake EEG exam inations and is fam iliar with EEG equipm ent and pract ice.
1. 2 Cautions and Warnings
CON TRAI N DI CATI ON S: Do not use the Trackit Mk3 in an MRI environm ent, in an explosive
atm osphere or during defibrillat ion.
W ARNI NG: This device is intended to be used by a healthcare professional and in accordance with
these inst ruct ions for use which m ust be read in their ent iret y before t he device is used.
W ARNI NG: This device in intended only as an adj unct device in patient assessm ent; it m ust be
used in conj unct ion wit h ot her m et hods of pat ient diagnosis.
W ARNI N G: Lifelines does not supply EEG elect rodes. The unit accept s st andard 1.5 m m
touchproof elect rodes using DI N 42802- style connectors. To ensure patient safet y, the electrodes
used m ust be approved t o the Medical Device Directive 93/ 42/ EEC in Europe or t o the relevant
local st andards outside Europe.
CAUTI ON : The conductive part of electrodes and their connect ors, including the Neutral elect rode,
should not cont act other conduct ive parts including earth.
W ARNI N G: Lifelines does not supply t he Nonin sensor. Only use t he ‘PureLight’ sensors specified
by Nonin t o be used wit h t heir Oxim et ers.
W ARNI N G: St rangulation hazard due t o long cables. As wit h all m edical equipm ent , carefully
rout e patient cabling to reduce t he possibilit y of pat ient ent anglem ent or st rangulation.
CAUTI ON : When in close proxim it y t o t he recorder, do not use m obile phones, t ransm it ters, power
transform ers, m otors, or ot her equipment t hat generates m agnet ic fields. Refer to t he Appendix for
m ore inform at ion. Medical elect rical equipm ent needs special precautions regarding EMC and needs
to be installed and put into service according to the EMC inform ation provided in t he Appendix.
W ARNI N G: The function or safety of t he equipm ent could be im paired if it has been subj ect ed to
unfavourable condit ions in storage or in t ransit. I f at any tim e funct ion or safety is thought t o be
im paired, t he inst rum ent should be t aken out of operat ion and secured against unint ended use.
W ARNI N G: Do not open the equipm ent.
W ARNI N G: Do not m odify t his equipm ent without the aut horization of t he m anufact urer.
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