background image

21 

(IEC 60601-1-2)

 

Table 2:  Guidance and Manufacture’s Declaration for Electromagnetic 

Immunity

 

The 

RomiApex™ A-15 is intended for use in the electromagnetic environment specified below.  The 

customer or user should ensure that it is used in such an environment. 

IMMUNITY test 

IEC 60601 test 

level 

Compliance 

level 

Electromagnetic environment 

guidance 

Electrostatic 
discharge (ESD) 

IEC 61000-4-2 

± 6kV contact 

 

± 8 kV air 

± 6kV 
contact 

± 8 kV air 

The 

RomiApex™ A-15 has built in ESD 

protection.  The physical environment 
should be restricted to the following: 

1.  Humidity range:  10% - 90% 

2.  Temperatures range:  10

 C - 42

 C 

Electrical fast 
transient/burst 

IEC 61000-4-4 

 

± 2 kV for power 
supply lines 

± 1 kV for  input/output 
lines 

Not 
applicable 

Not 
applicable 

The 

RomiApex™ A-15 does not have 

AC power input or AC power output, 
therefore testing for this is not 
applicable.  Interconnecting cables are 
not longer than 3m, therefore testing is 
not applicable. 

Surge 

IEC 61000-4-5 

± 1 kV line 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 in U for 5 
cycles) 

70% U 

(30% dip in U for 25 
cycles) 

<5% U 

(>95% dip in U for 5 s) 

Not 
applicable 

 

Not 
applicable 

 

Not 
applicable 

 

 

Not 
applicable 

The 

RomiApex™ A-15 does not have 

AC power input or AC power output, 
therefore testing for this is not 
applicable. 

 

Power 
frequency 

(50/60 Hz) 
magnetic field 

IEC 61000-4-8 

3 A/m 

3 A/m 

Power frequency magnetic fields should 
be at levels characteristic of a typical 
location in a typical, residential, 
commercial, hospital, or military 
environment. 

NOTE:   

is the AC. mains voltage prior to application of the test level 

Note 1:   The 

RomiApex™ A-15 is not equipped with any ports or any accessible I/O lines. 

Note 2:   The 

RomiApex™ A-15 may be susceptible to strong magnetic fields or static electric fields 

higher than the limits specified in testing, which could interrupt normal operation. If there is 
a reason to believe that this type of interference has occurred, simply remove and re-insert 
the batteries and the unit should reset. 

 

 
 

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...

Отзывы: