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RONVIG DENTAL Calaject, Instructions For Use Manual

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RONVIG DENTAL Calaject Instructions For Use Manual Download Page 12

12

Produced in Denmark by:

Gl. Vejlevej 59 . DK-8721 Daugaard . Tel.: +45 70 23 34 11 
Fax: +45 76 74 07 98 . E-mail: [email protected] . www.ronvig.com

/

Gl. Vejlevej 59 

.

 DK-8721 Daugaard 

Tlf: +45 70 23 34 11 

.

 Fax: +45 76 74 07 98

email: [email protected] 

.

 www.ronvig.com

RØNVIG Dental Mfg. 

A/S. 

ALL 

RIGHTS RESERVED. IFU-CALAJECT-USA-2019.0

2

-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 instructions

Standby key

0543

SN

0543

RD_brugervejledning_IFU-CALAJECT-USA-2019.01-VER 7_090119.indd   12

16-01-2019   17:41:07

Summary of Contents for Calaject

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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 ...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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