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Table 2

Electromagnetic immunity

The “CALAJECT™” is intended for use in the electromagnetic environment specified below. The customer or the user 

of the “CALAJECT™” should assure that it is used in such an environment.

Immunity test

IEC 60601-1 

Test level

Compliance level

Electromagnetic envi-

ronment guidance

Electrostatic discharge 

(ESD)

IEC 60601-1-2
IEC61000-4-2

±6KV contact
±8KV air
±15KV air

±6KV contact
±8KV air
±15KV air

Floors should be wood, 

concrete or ceramic tile. 

If floors are covered with 

synthetic material, the rela-

tive humidity should be at 

least 40%.

Electrical fast transient/

burst
IEC 60601-1-2

IEC61000-4-4

±2KV for power supply 

lines
±1KV for input/output lines

±2KV for power supply 

lines
±1KV for input/output lines

Mains power supply quality 

should be that of typical 
residential area.

Surge
IEC 60601-1-2

IEC61000-4-5

±1KV differential mode

±1KV differential mode

Voltage dips, short 

interruptions and voltage 

variations on power supply 

input lines.
IEC 60601-1-2

IEC61000-4-11

<5% UT for 0.5 cycle
40%UT for 5 cycles
70%UT for 25 cycles
<5%UT for 250 cycles

<5% UT for 0.5 cycle
40%UT for 5 cycles
70%UT for 25 cycles
<5%UT for 250 cycles

Mains power supply quality 

should be that of typical 
residential area.

Power frequency (50-60Hz) 

magnetic field.
IEC 60601-1-2

IEC61000-4-8

30A/m

30A/m

Power frequency magnetic 

fields should be that of 

typical residential area.

EMC Technical Information

Table 1

Electromagnetic emissions

The “CALAJECT™” is intended for use in the electromagnetic environment specified below. The customer or the user 

of the “CALAJECT™” should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment guidance

RF emissions

CISPR11

IEC 60601-1-2

EN55011

Group 1

The device uses RF energy only for its internal function. 

Therefore, its RF emissions are very low and are not likely to 

cause any interference in nearby electronic equipment.

RF emissions

CISPR11

IEC 60601-1-2

EN55011

Class B

The device is suitable for use in all establishments, including 
domestic establishments and those directly connected to the 
public low-voltage power supply network that supplies build-
ings used for domestic purposes.

Harmonic emissions

IEC 60601-1-2

IEC 61000-3-2

Class A

Voltage fluctuations/ 

flicker emissions

IEC 60601-1-2

IEC 61000-3-3

Complies

RD_brugervejledning_IFU-CALAJECT-USA-2019.01-VER 7_090119.indd   10

16-01-2019   17:41:07

Содержание Calaject

Страница 1: ...1 Computer Assisted Local Analgesia Instructions for Use USA ...

Страница 2: ...read these instructions thoroughly before you start using your CALAJECT INTENDED USE CALAJECT is intended for performing dental local analgesia CALAJECT MAY ONLY BE USED BY TRAINED PERSONNEL authorized to perform dental injections For this reason this manual does not include specific in structions in injection techniques The manufacturer cannot be held liable for injuries in patients due to unauth...

Страница 3: ...arrels are delivered non sterile and should be sterilized before first use Place the cartridge barrel in a sterilization pouch and seal it Sterilize it in a steam sterilization autoclave at 121 C 250 F for 15 minutes or at 134 C 275 F for 3 minutes The cartridge barrel may get a frosted appearance after a number of sterilizations so it is recom mended to replace the cartridge regularly in order to...

Страница 4: ...unit by a dental service engineer When connecting to the dental unit choose a potential free contact relaycontact The assistant call function can often be used for this purpose Connect to Calaject with a screened cable less than 3m long and with a 3 5mm minijack plug SERVICE WARRANTY REPAIR CALAJECT is covered by a 2 year guarantee on materials and construction Normal wear and tear and damages due...

Страница 5: ...y a rotating light signal at the front panel Do not inject in prime needle mode Select program When the foot switch is activated again the chosen injection program will be active CALAJECT will stop automatically when the cartridge is empty a long beep will be heard Return the piston rod by pressing R at the display Make sure to let the piston retract completely before you unscrew the barrel from t...

Страница 6: ...o high that CALAJECT stops the needle opening may have be come blocked and it is recommended to rotate the needle slightly in order to obtain a good flow TIP TIP R VISUAL SIGNALS When CALAJECT has been prepared and is switched on Program II will illuminate as default The piston will retract automatically which is indicated by three illuminated LEDs rotating around the R key During activation the L...

Страница 7: ... needle R R PROGRAM 2 Recommended for infiltration analgesia Activate the foot switch and hold it down throughout the injection The sequence begins with 10 seconds slow speed 0 006 ml sec followed by a gradual increase over 5 seconds to medium injection speed 0 03 ml sec When the injection has been stopped and is reactivated again the same sequence will repeat First 10 seconds slowly with gradual ...

Страница 8: ...y too much friction between the moving parts inside the handpiece Send in for repair Piston does not retract Piston O ring has become dry Lubricate the O ring with PTFE grease ac cording to Maintenance by User Lubricate regulary as advised in Maintenance by User Leakage The needle was screwed onto the barrel after inser tion of the cartridge That can cause an uneven per foration of the membrane wh...

Страница 9: ...ing regularly Avoid draining the battery com pletely several times CONTRA INDICATIONS AND PHYSIOLOGICAL HAZARDS Contra indications No specific for CALAJECT beyond the contra indications described in the product page and package insert of the applied analgesic solution purchased separately Possible physiological hazards In the event of the most serious technical failure that can be foreseen the den...

Страница 10: ...5 UT for 250 cycles 5 UT for 0 5 cycle 40 UT for 5 cycles 70 UT for 25 cycles 5 UT for 250 cycles Mains power supply quality should be that of typical residential area Power frequency 50 60Hz magnetic field IEC 60601 1 2 IEC61000 4 8 30A m 30A m Power frequency magnetic fields should be that of typical residential area EMC Technical Information Table 1 Electromagnetic emissions The CALAJECT is int...

Страница 11: ... envi ronment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the device b Ove...

Страница 12: ... www ronvig com RØNVIG Dental Mfg A S ALL RIGHTS RESERVED IFU CALAJECT USA 2019 02 VER 7 Explanation of symbols used in CALAJECT labelling CE mark with ID no of notified body Type B applied part Interference may occur in the vicinity of equipment marked with this symbol To be disposed of as electronic waste according to WEEE Directive 2012 19 EU Serial number Manufacturing company Read the instruc...

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