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3. Precautions 

  Verify  that  the  canal  has  been  properly  isolated  and  that  there  are  no  metallic 

restorations present which may contact the file. 

  Normally 

RomiApex™  A-15  provides  accurate  measurements  during  foramen 

location in dry and wet canals, in presence of various electrolytic solutions (Sodium 
Hypochlorite, EDTA, saline, etc.). 

  A #15 endodontic K-file #15 is the minimum recommended file size for apical foramen 

localization.  However,  smaller  or  larger  files  may  be  used  when  anatomically 
necessary. 

  For convenience of use it is recommended that selected file will be about 5mm longer 

than the radiographic working length. 

  Before measuring, check the accessories and verify good connectivity. 

 

RomiApex™ A-15

 

should not be dropped or subjected to other manners of impact or 

shock as this could result in malfunction of the device and voiding of the warranty. 

  When  disconnecting  the  lip  clip,  file  clip  or  measuring  cable,  always  grip  the 

connectors. 

 Do not

 pull directly on the wires to disconnect. 

  Discard any old, damaged or leaky battery.  Battery should be disposed of according 

to  local  codes  and  regulations.  Battery  cannot  be  disposed  of  as  municipal  waste 
within the European Union. 

  Ensure the battery is installed with correct polarity. 

 

Do not immerse 

RomiApex™ A-15 unit. This may damage the device and will 

void the warranty

  Only use recommended cleaning solutions on the device.  See the 

Maintenance, 

cleaning  and  sterilization

”  section  7  (page  13)  for  recommended  cleaning  and 

sterilization. 

  The items which may contact the patient during intended use of the device (lip clip, 

file  clip  and  touch  probe)  must  be  cleaned  and  sterilized  before  the  first  use  and 
between patients to avoid the risk of cross-contamination. 

  Care  should  be  exercised  when  the 

RomiApex™  A-15  is  used  around  devices 

emitting  electromagnetic  noise  such  as  fluorescent  lamps,  film  viewers,  ultrasonic 
devices, radio frequency transmitters, cell phones, remote controls, or devices that 
radiate electromagnetic (EM) fields, areas where there are strong magnetic fields, or 
conditions where there is high static electricity (ESD). While the 

RomiApex™ A-15 

has been built to withstand these conditions, EM and ESD fields may interfere with 
the 

device’s  proper  operation.  If the  RomiApex™  A-15  must  be  used  under  these 

conditions, take care to see that the device 

is operating normally (See manufacturer’s 

declaration of electromagnetic compatibility). 

 

 

Содержание RomiApex A-15

Страница 1: ...RomiApex A 15 APEX LOCATOR User Manual Please scan the QR code to view RomiApex A 15 additional instructions...

Страница 2: ...y 7 5 3 Cable connection test 8 5 4 Device operation 9 5 5 Audio feedback 12 5 6 Automatic Shutdown 12 6 Demo mode 13 7 Maintenance cleaning and sterilization 13 8 Troubleshooting guide 15 9 Certifica...

Страница 3: ...ietary algorithms to determine the position of the apical foramen Utilizing the advantages of its well proven patented technology RomiApex A 15 offers the operator performing root canal treatments an...

Страница 4: ...nit with patients who have a pacemaker as its effect has not been evaluated RomiApex A 15 should not be used in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide R...

Страница 5: ...tions Battery cannot be disposed of as municipal waste within the European Union Ensure the battery is installed with correct polarity Do not immerse RomiApex A 15 unit This may damage the device and...

Страница 6: ...the package before use 1 RomiApex A 15 1 Cradle 1 AAA 1 5V Alkaline Battery 1 Measuring cable 2 File clips 5 Lip clips 1 Touch probe 1 Screwdriver for battery compartment 1 User Manual 1 Measuring ca...

Страница 7: ...tenance of the RomiApex A 15 5 2 Installing Replacing the Battery The RomiApex A 15 is powered by a standard AAA size 1 5V alkaline battery included 5 2 1 To install replace the battery unscrew and re...

Страница 8: ...h use the RomiApex A 15 should be checked for functionality The RomiApex A 15 has a connection test feature in order to check the cables 5 3 1 Connect the measuring cable to the device Connect the fil...

Страница 9: ...t a 15 hand K file or other appropriate file into the canal 5 4 6 Press the On Off button to turn the device on The initial image appears on the display 5 4 7 Plug the measuring cable into the device...

Страница 10: ...s toward the foramen color segments inside the root canal image accompanied by audio signals with varied frequency will indicate the file s progress Numerical readings 2 0 1 75 1 5 1 25 1 0 0 75 0 5 0...

Страница 11: ...electronically obtained length using an endodontic ruler To establish the working length subtract 0 5 1 0mm from the electronic length The red OVER indication accompanied by frequent beeps indicates t...

Страница 12: ...dry wet with blood pulp In case of very dry canal or previous obturation retreatment cases you may use irrigation solution such as Sodium Hypochlorite Saline etc to provide a conductive electrical en...

Страница 13: ...mo cycle RomiApex A 15 exits Demo mode and switches automatically to regular operation mode 7 Maintenance Cleaning and Sterilization 7 1 General The device does not contain user serviceable parts The...

Страница 14: ...ak the accessories in a disinfectant solution that contains a proteolytic enzyme if possible Rinse accessories thoroughly in running water Follow manufacturer s instructions on the disinfectant concen...

Страница 15: ...re lip clip is contacting the oral mucosa and file clip is clean and free of debris Fill the canal with an electrolytic solution if required i e Sodium Hypochlorite Saline etc The endodontic file is n...

Страница 16: ...lip dirty Clean the file clip with Ethanol 70 80 vol Is blood or other fluids over flowing the access cavity of the tooth If blood or other fluids are overflowing the access cavity they may create a c...

Страница 17: ...surfaces infected with caries Deep caries may create a conductive path outside the canal and cause incorrect measurements OVER indication unstable readings etc Are there external resorption or is the...

Страница 18: ...54 Fax 32 2 732 60 03 E Mail mail obelis net 11 Limited Warranty RomiApex A 15 is warranted for 24 months from the date of purchase The accessories Measuring cable file clips lip clips touch probe are...

Страница 19: ...ut obligation to notify any person of such changes modifications or revisions 13 Technical Specifications The RomiApex A 15 belongs to the following category of medical devices Internally powered equi...

Страница 20: ...sions EN 5011 European Norm equivalent to CISPR 11 Group 1 The RomiApex A 15 uses low voltage and low current electrical and electromagnetic energy only for its internal functions Therefore its RF emi...

Страница 21: ...ine to line 2 kV line to earth Not applicable Not applicable Voltage dips shorts interruptions and variations on the power supply input lines IEC 61000 4 11 5 U 95 dip in U for 0 5 cycle 40 U 60 dip i...

Страница 22: ...80 MHz 3 V m 80 MHz to 2 5 GHz 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz RomiApex A 15 is not affected by portable and mobile RF communications equipment in close proximity There is no recomme...

Страница 23: ...nsmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 0 35 P 80 MHz to 800 MHz d 0 35 P 800 MHz to 2 5 GHz d 0 7 P 0 01 0 04 0 04 0 07 0 1 0 11 0 11 0 22 1 0 35 0...

Страница 24: ...s Special disposal of waste electrical and electronic equipment Follow instructions for use Direct current Type BF applied part Manufacturer SN Serial Number Caution Federal law restricts this device...

Страница 25: ...RomiApex A15 Rev 07 04 14 Manufacturer Romidan Ltd 5 Simcha Holzberg St 55022 Kiryat Ono Israel Email export romidan com www romidan com...

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