Manual

Mark-VII™ Apex Locator – MEASURING THE BIOLOGICAL APEX
Operating Manual
The Mark-VII™ Apex Locator is designed to meet international safety and performance standards.
Personnel operating the instrument must have a thorough understanding of the proper operation of the
instrument. These instructions have been prepared to aid medical and technical personnel to understand
and operate the instrument. Do not operate the instrument before reading this manual and gaining a clear
understanding of the operation of the instrument. If any part of this manual is not clear, please contact
yourMiltexrepresentativeforclarication.
NOTE:
The Mark-VII™ Apex Locator should be used only as a supplement to normal endodontic procedures.
An x-ray must be taken before beginning treatment, in order to determine an estimate working length. Only
qualied personnel, with extensive knowledge of the root canal anatomy should use this device.
TheMark-VII™ApexLocatorcalculatesthedistancefromthetipofyourendodonticletotheforamen
bymeasuringchangesinimpedancebetweentwoelectrodes.Therstelectrodeisthelipclip(2).The
secondistheleclip(1)whichmakescontactwithalethathasbeeninsertedintotherootcanal.
Initial Setup
1. Remove the clear plastic strip that insulates the battery from contact. Firmly pull the strip with your
ngers.ActivatetheMark-VII™ApexLocatorbypressingthe“ON”buttononthefaceoftheunitto
ensure contact between the battery and the Mark-VII™. If the device does not turn on, open the
battery cover, remove battery and clear away any remnants of the insulation strip.
2. Attachtheleclipcable(1)andliphookcable(2)totheplugslocatedatthetopofthedevice
(either left or right plug).
3. Insert the Mark-VII™ Apex Locator into a disposable sleeve.
4.
Place the Mark-VII™ Apex Locator near the mouth of the patient, and attach the clasp (1) to the apron.
5.
Place the lip hook (2) located at the end of the cable to the lower lip. Now you are ready to begin treatment.
6. Placetheleattheentrancetothecanal(pic.X)andthenconnectittothelecliplocatedattheend
oftheleclipcable.
You are now ready to begin treatment.
Directions For Use
1. ActivatetheMark-VII™ApexLocator,bypressingthe“ON”buttononthefaceoftheunit.Once
activated,theLEDswillashinsequenceasa“self-check”.
2. Following the check, the top green LED light, nearest the ON/OFF button will blink slowly indicating the
Mark-VII™ Apex Locator is in stand-by-mode and ready for use.
3. Whenthelereachesthe“1.5”point,ablueLEDwilllightcontinuously.
4. AdditionalblueLEDlightswilllightcontinuouslyinincrementsof0.2mmfromthe“0.8”mmpointuntil
thelereachesthe“0.5”mmpointblueLED.
5. Advancetheletowardstheapexinacircularmanner,backandforthuntilthe“0.5”pointblueLED
turns on and the alarm sounds (slow frequency).
NOTE:Theunitissensitiveandrespondstominutechangesinleposition.
The LEDs numbers appear on both sides and can be read from any angle.
6. Whenthelereachesthebiologicalapex,the“Apex”greenLEDwilllightandthealarmsoundchanges
to a faster frequency.
7. Markthedepthofthecanalwiththelerubberstop.Measurethedepthoftheleandpreparethe
restofthelesforthetreatmentaccordingtothismeasurement.Ifyoupassthebiologicalapex,the
“OverApex”yellowLEDwillbegintoashandthealarmwillsound(fastestfrequency).Atthisstage,
pulllebackoutofthecanaluntiltheyellowLEDstopsashingandthealarmsoundslows
its frequency.
Important:
• The Mark-VII™ Apex Locator provides precise measurements of the canal under all conditions,
including wet, dry and bleeding canals. You can immediately measure another canal, without any
special preparation.
• There is NO need to calibrate the Mark-VII™ Apex Locator.
• In most cases, the Mark-VII™ Apex Locator allows accurate measurement even during momentary
contactwithanamalgamllingorametalcrown.
Troubleshooting
In certain cases, (e.g. wide canals, or atypical canal shape) the Mark-VII™ Apex Locator may register the
depthreadingof“0.2”mmtooearly.Inanyevent,theMark-VII™ApexLocatorwillalwaysidentifythe
biological apex exactly, and will never register the apex too late.
Therefore, it is imperative to take an x-ray prior to beginning treatment. Also, it is recommended to make
surethatthelemaintainscontinuouscontactwiththesideofthecanalduringmeasurement.
For greater precision, prior to treatment ensure that:
• All canals are isolated from each other.
• The canal is free of all tissues.
• The lip hook fully contacts the patient’s lip.
• Check all connections.
Frequently Asked Questions
Q. Unit shows that the file is at the apex when instrument has only just been introduced
to the canal.
A. Either pulp chamber floor is not completely dry or the file has contacted a metallic
restoration. In either case, the inaccurate readings are due to shorting the circuit.
Q. Reading on unit is not steady.
A. File is in intermittent contact with the canal walls. Either place a curve at the tip of the file
or try a larger size file so the tip touches the wall near the apex.
Q. No lights show
A. Battery is flat or has not been replaced correctly (see below)
Q. LEDs illuminate simultaneously
A. Warning to replace battery as soon as possible.
Q. Yellow lights keep on flashing.
A. Battery is too low and needs replacing immediately. As a warning of this the yellow lights
flash 12 times before going off. Replace battery.
Q. The unit will not switch off.
A. Battery is low. Replace battery.
Q. Unit does not work when battery has been replaced.
A. A. The battery has been placed upside down
(+ sign should always be outermost).
B. Cable is damaged and needs to be replaced
(call Customer Service for advice).
Q. Main cable of unit is damaged after autoclaving.
A. Neither cable nor unit is stated as autoclavable. Disinfect only as per directions.
Device Power Off
As an energy-conservation feature, the Mark-VII™ Apex Locator will turn off after approximately 90
seconds of non-use.
Battery Power
Warning! Low battery power affects accuracy.
When the Mark-VII™ Apex Locator recognizes low battery power, upon turning on the unit, the LED lights
will blink 12 consecutive times along with beeping sounds. This is a warning to change the battery as
soon as possible. If after an additional period of time the operator has not changed the battery, the unit
will turn off automatically upon being turned on and will not allow the operator to use the unit. Replace the
battery immediately. There are no other user serviceable items within the unit.
Battery Replacement
Usingangernailorsmallatscrewdriver,gently lever open the battery cover located on the back side of
theMark-VII™ApexLocator.Removethebatterybyinsertingasmallatscrewdriveratthecornerofthe
battery housing. Be sure to insert the battery with the (+) sign facing upwards. Hold the battery at an angle,
andinsertthe(-)signtowardsthespring,andpushthebatterydownrmly.
Attention! Take care not to damage the battery contactors when inserting a fresh battery.
Dispose of depleted battery in accordance to local regulations.
Sterilization
• Do not place the Mark-VII™ Apex Locator into the Autoclave!
• Do not submerge the device or allow liquid to enter the unit enclosure!
Theleclipcable(1)andtheliphookcable(2)canbesterilizedintheautoclaveat121ºCfor20minutesor
at 134ºC for 5 minutes.
Attention! All surfaces of the device and its accessories should be disinfected when the unit is initially
received and thereafter between procedures, to prevent cross-infection. Wipe the surface of the unit with a
clean cloth moistened in 70% ethyl alcohol solution.
Classication
• Type BF applied part.
• IEC 601-1 Compliant Medical Equipment
TechnicalSpecications
• Power Supply: Single AA battery
• Power input: 2.4 – 3.0 V
• Maximum current: 12mA
• Operating temperature: +10ºC - +40ºC
• Humidity: 10% - 90% without condensation.
WARNING: The Mark-VII™ Apex Locator should NOT be used on a patient with a pacemaker.
PREPARATORY TREATMENT RECOMMENDATIONS
Prior to measuring root canal length with “Apex Locator”
• Makesurethatthepulpchamber1,iscleananddrybeforeInsertingthemeasuringle.Itis
recommended to dry the pulp chamber with a cotton pellet or by a slight aspiration of the
moisture (from the root canal as well) with an aspiration syringe.
• Whenthewallsofthepulpchamberaredamaged2,salivaleakagecanoccurfromtheoral
cavity, which will prevent drying of the chamber. A moist chamber will cause the immediate
formation of a closed electrical circuit, i.e. a short circuit. In this event the Mark-VII™
Apex-Locator will issue a warning (red light) as if it reached the apex. In such cases the
damaged chamber wall should be permanently or temporarily restored, but only with
non-conductive materials such as Composite, IRM, GI (glass iononer) etc. After restoration,
an absolutely dry chamber can be achieved and accurate measurement effected.
• Checkthatanydamagedllings3,havebeenremovedinordertopreventmarginalleakage.
Such leakage will result In a moist working area and Interfere with the Mark-VII™
Apex Locator reading. The red light will flash, indicating that it has identified the
apex when in fact, the file is only at the canal entrance area.
• Takespecialcaretopreventcontactbetweentheleandanyexistingmetal-basedrestoration
of the tooth by amalgam filing or crown. In such instances, an adequate insulation of the file
fromthemetallicenvironmentcanbeachievedbytting2-3rubberstoppersontothepartof
the file that may contact the metal of the restoration.
• Inadditiontoensurethatthechamberisdryandinsulated,takecaretoremovemostsoft
tissue from the root canal, by extirpation, before measuring. Residual tissue may result in a
premature and erroneous reading.
• Whenusingarubberdam,makesurethatItprovidesapropersealoftheinsertionarea.Any
aperture between the rubber dam and tooth can be sealed with a temporary restoration (cavit)
Recommendations for the measurement process:
Prepareawidecanalorociumandpreparetherst2/3thintaperedwaytopreventcontactwithpremature
constrictions in the canal.
• InsertthelewhilerotatingItforwardandclockwise,andthenpartwayback.
• Takecaretoensurecontinuouscontactbetweentheleandtherootcanalwall,Itis
recommended to use the thickest possible file that will reach the estimated working length.
• Ensurecontinuousandreliablecontactofthestainless-steelhookwithoralmucose.
• Ensurecontinuousandstrongcontactbetweentheleanditsholder(thismaybeproblematic
with the thinner files 6,8, 10 mm).
• Inexcessivelydesiccatedcanals,moisteningisrecommendedtoimproveconductivity.This
can be effected by slight irrigation and/or by slight lubrication of the file with RC-PREP.
Exceptions
• Inaverywidecanal,theMark-VII™ApexLocatormaybeabletoreadthemeasurementonly
at the tip, where the canal constricts toward the apical tissue. In such cases only a depth of
0,5 mm and foramen apicale, will be identified, Reading may be improved by using the thickest
file and pressing it against the canal wall.
• TheMark-VII™ApexLocatorreadingmaybeunstableinthesetoothpathologysituations:
(tooth pathology) decay (caries), strong bleeding in the canal, metallic restoration, periapical
lesion, open apex 4, excessively wide canal.
• Awornoutbatterymaygarblethereading.Thebatteryshouldbereplacedassoonasthe
instrument's warning signal appears, as detailed in the user manual, Take care to follow the
instructions for connecting the cables to the instrument as specified in the user manual.
Attention!
In all instances of erroneous readings as described above only a premature reading situation is possible,
due to ostensible recognition of the apex, Under no circumstances will the
Mark-VII™Apex Locator
show a
delayed reading that may endanger the apex tissues.
Manufactured for Miltex
589 Davies Drive
York, PA 17402
toll-freephone866-854-8300
toll-free fax 866-854-8400
phone717-840-9335
fax717-840-9347
email dental@miltex.com
www.miltex.com
EU Representative
Miltex Gmbh
78604 Rietheim-Weilheim, Germany
0297