User Manual - RomiPointer
Contents
1. customer service The device does not turn 1 Button malfunction Press the button on by pressing button several times 2 Flat battery Replace the battery 3 Electronic Contact your malfunction customer service No sound while measuring Audio feedback is Turn the device Off and disabled then turn it On One short beep indicates that audio feedback is enabled Device cannot indicate the 1 Sensor is Turn the device Off location of the implant disconnected remove the sensor clean contact surfaces of the sensor and reinsert it Turn the device On again Damage to the Replace the Sensor Sensor sensor coating or sensor contacts Sensor holder is Replace the Sensor damaged holder Bad contact Electronic Contact your malfunction customer service e ke 9 Warranty Implant Detector is warranted for 24 months from the date of purchase The accessories sensor holder and battery are warranted for 6 months from the date of purchase The warranty is valid for normal usage conditions Any damage caused by accident abuse misuse or as a result of service or modification other than by a person authorized by the manufacturer will render the warranty void The warranty is in lieu of any other warranty expressed or implied Sensors are disposable and are not covered by warranty 10 Disclaimer The manufacturer its representatives and its dealers shall have no liability or respon2. implant continue to the estimated position of the next implant e Slowly move the sensor along the jaw ridge The central dot will turn off and 4 segments will turn orange then the segment will blink green indicating that the Implant Detector is ready for detection of the next implant e Perform implant localization as described in 6 5 3 and 6 5 4 A Correct localization of implant position may be impossible when 2 or more implants are too close 6 6 Audio feedback Implant Detector is equipped with an audio feedback which enables monitoring of device operation additionally to visual indication Audio feedback may be disabled as described in s 6 4 above 6 7 Automatic Shutdown Implant Detector automatically shuts down after 2 minutes without use In order to prolong the battery life it is recommended to switch off the device after completing implant localization by pressing the O button and holding it for about 1 sec 2303 7 Maintenance cleaning and sterilization 7 1 General e The device does not contain user serviceable parts The service and repair should be provided by factory trained service personnel only e All objects that were in contact with potentially infectious agents should be cleaned and disinfected after each use A Use of agents other than specified in this section may cause damage to the equipment and its accessories 7 2 Device cleaning Before the first use and between treatments the
3. must be towards the inner part of the battery compartment Implant Detector is protected against incorrect battery polarity In case of polarity error remove the battery and reinsert it correctly e Screw in the battery cap and close the protective cap until click 6 4 Getting Started A Prior the first use and between the patients the device and sensor holder should be cleaned and disinfected using wipes moisturized by disinfectant The sensor should be cleaned and autoclaved as described in 87 6 4 1 Gently attach the sensor holder to the device as shown on Pic 5 For lower jaw implants For upper jaw implants Pic 5 e To remove the sensor holder press the holder lock button lt 4F gt and gently pull the holder from the device 6 4 2 Insert the sensor into the holder until stop as shown on Pic 6 For lower jaw implants For upper jaw implants Pic 6 6 4 3 Correct device configurations are shown on Pic 7 Device configuration for upper jaw implants Pic 7 6 6 4 4 6 4 5 6 4 6 Turn the device on by pressing the button One short beep indicates that audio feedback is enabled To disable the audio feedback hold the button pressed for about 1 sec Take care that no metallic object will be closer than 10 cm to the sensor Battery check up After turning the device on the battery status is checked If the battery is depleted or flat 4 segments are flashing red 3 times accompanied
4. Do not use disinfectant solution containing aldehyde phenol or any possible 5 Disinfection Rinse well the sensor in flowing water products which may damage the items Drying No particular requirements Visually inspect the sensor to detect possible damage to the sensor coating or to the gold plating of the contacts and the central hole Maintenance inspection and testing of the sensor Packaging Pack the sensor in Sterilization pouches Sterilization Steam sterilization at 134 C 273 2 F during 18 minutes in gravity type autoclave Table Top N type 10 Storage Keep sensors in sterilization packaging in a dry and clean environment Sensors with damages or scratches on the coating must be discarded Sensors with damages to the gold plating of the contacts or of the central hole must be discarded Check the validity period of the pouch given by the manufacturer to determine the shelf life of the Sterilized items Use packaging which is resistant up to a temperature of 141 C 286 F Follow maintenance and operation procedures of the autoclave provided by the manufacturer The only sterilization parameters to be used are those that have been validated and provided to the user in this User Manual Sterility cannot be guaranteed if packaging is open or damaged check the packaging before using the sensors 8 Troubleshooting Please review the suggested solutions before calling
5. RomiPointer Implant Detector User Manual RE I e 10 11 12 13 14 Table of Contents IDEO CHE HOLD ae 2 INGICATIONS TOMUSE Ne 3 CONWAINGICALIONS aure 3 MW ANNI ka ak Aa n a e ek tt kb e e ae 3 EFE GAL NO AS md east a tn ev t fes v ky sanne 3 Adverse Reactions w wwwwmaanamananwana 3 Step by Step Instructions eamwwmnanamana 4 6 1 Packaging Box Content 4 6 2 Implant Detector outlook wmmnama 4 6 3 Installing Replacing the Battery 5 6 4 Getting Started ii 5 6 5 DEVICE OPER NON sciana eee 8 6 6 Audio feedback sm 10 Gr ANO MINE SHU WA saa 10 Maintenance cleaning and sterilization 11 TPOUDIGSNOOUNG Tr TR E 13 NT 14 IDISCIAIM ON aa da Redd 14 eei ee ones ane de e ii WAPAA e MINA ma 14 European Authorized Representative 14 Technical Specifications 15 Staridardsymbols ke n ko oH T PE RS 15 FOR DENTAL USE ONLY Congratulations you have made a good choice with RomiPointer Implant Detector innovative device for precise localization of implants buried under gum tissue Ergonomic user friendly design of Implant Detector makes it a choice of preference in modern dental clinic Utilizing the advanced technology Implant De
6. by 3 beeps e Incase of depleted battery the device may continue normal operation before the battery is replaced e Incase of flat battery the device turns off and cannot operate before battery replacement Self test and calibration Before starting device operation the self test is performed e If sensor holder is not properly connected to the device or sensor is not inserted into the holder the error is indicated by running red segment After 10 sec the device turns off automatically To correct the error turn the device off connect the sensor holder insert the sensor until stop and turn the device on again After the self test the device performs automatic calibration e Running green segment indicates calibration in progress When calibration is completed 4 segments blink green indicating that the device is ready for operation Pressing the button will restart automatic calibration cycle described above Presence of metallic objects close to the sensor during self test and calibration may prevent correct device operation or reduce precision of implant localization e If calibration error is detected it is indicated by running orange segment After 10 sec the device turns off automatically To correct calibration error turn the device off check proper connection of the sensor holder and of the sensor If required replace the sensor Verify that there are no metallic objects in the vicinity of the sensor and tur
7. c bodies near the sensor may distort device indication Avoid presence of metallic items in the vicinity of the sensor during device operation e For your own safety please use personal protection gear gloves mask e Implant Detector should be stored at normal environmental conditions Temperature 10 C to 60 C 50 F to 140 F Relative humidity 10 to 90 non condensing 5 Adverse Reactions None 6 Step by Step Instructions 6 1 Packaging Box Content Check the content of the packaging box before use e RomiPointer Implant Detector 1 pc e AA alkaline battery 1 pc e Sensor holder 2 pcs e Sensor 5 pcs e User Manual 1 pc 6 2 Implant Detector outlook General view of Implant Detector is shown on Pic 2 LED Indicators On Off button s ka PONES Mu ANN Sensor Holder KA 4 Protective Cap Pic 22 6 3 Installing Replacing the Battery Implant Detector is powered by one 1 5V AA alkaline primary battery A Prior to battery replacement the device must be turned off 6 3 1 To install replace the battery remove the protective cap and unscrew the battery cap Pic 3 Protective Cap Battery Cap Pic 3 e Remove old battery from the battery compartment e Insert new battery into the battery compartment according to the marking on the device as shown on Pic 4 Pic 4 A Take care for correct polarity during battery insertion
8. device should be cleaned using tissue or soft cloth impregnated with aldehyde free disinfecting and detergent solution a bactericidal and fungicidal 7 3 Sensor holder cleaning and disinfection Before the first use and between treatments the sensor holder should be separated from the device cleaned and disinfected using tissue or soft cloth impregnated with aldehyde free disinfecting and detergent solution a bactericidal and fungicidal A No visible impurities should remain on the sensor holder after cleaning and disinfection process 7 4 Disinfection and sterilization procedure for sensor Before the first use and between treatments the Sensor should be disinfected and sterilized by autoclaving as described below A The sensor is intended for 10 sterilization cycles maximum Preparation at the No particular point of use prior to requirements processing Preparation for No particular decontamination requirements preparation before cleaning Cleaning The sensor is not Automated intended for automated cleaning Cleaning Manual Clean the sensor with an After cleaning no visible impurities adequate brush or towel should remain on the sensor in soaked in a disinfectant particular inside and near the solution central hole 44 Soak the sensor in a Follow instructions given by the disinfectant solution disinfectant manufacturer combined with concentration immersion time proteolytic enzyme if etc
9. n the device on again 6 5 Device operation 6 5 1 When Implant Detector is ready 4 segments blink green Pic 8 Pic 8 6 5 2 Insert the device into the mouth cavity and place the sensor plane onto the gum at some distance from the estimated position of the implant The central hole of the sensor should be approximately in the middle of the jaw ridge Slowly move the sensor along the jaw towards estimated position of hidden implant Pic 9 Pic 9 To ensure correct measurements take care that the sensor plane will be always slightly pressed to the gum without gap Thick gum layer covering the implant may prevent correct implant localization or reduce precision 6 5 3 Implant localization e When the sensor is approaching the implant 4 segments turn steady green Pic 10a e Continue fluent movement of the sensor in the same direction without stopping until the segments turn orange indicating that the sensor has passed the implant position Pic 10b e Reverse direction and slowly move the sensor back along the same path Four segments turn green again indicating sensor movement towards the implant Pic 10c Continue sensor movement in reverse direction without stopping 8 e When the sensor returns to the implant position 4 segments turn off and the central dot turns green indicating detection of implant location Pic 10d The visual indication is accompanied by solid audio signal b C Se
10. nsor is Sensor has passed Sensor moves Detection of approaching the the implant position back to the implant location implant implant position Continue in the Reverse direction Continue in the same direction reversed direction Pic 10 e Through the hole in the middle of the sensor mark on the gum location of the implant using dental probe A The sensor movement should be smooth without stopping or unnecessary reversing the direction of the movement This may cause incorrect readings A Stopping sensor movement for more than 3 sec before completing detection of implant location is indicated central green dot turns on will cause automatic reset 4 segments blink green Implant localization should be repeated from the beginning 9 6 5 4 Cross scanning e To improve the precision of implant localization it is possible to perform additional cross scanning in Buccal Lingual direction as shown schematically on Pic 11 Pic 11 e After initial implant localization as shown on Pic 10d slowly move the sensor in Buccal Lingual direction pressing it slightly to the gum The operating sequence is similar to the sequence described in 6 5 3 A Presence of metal crown abutment tooth with large amalgam filling metallic instrument close to the implant may prevent correct implant localization or reduce precision 6 5 5 Localization of multiple implants In case of multiple implants after locating and marking the first
11. sibility to customers or any other person or entity with respect to any liability loss or damage caused or alleged to be caused directly or indirectly by equipment sold or furnished by us including but not limited to any interruption of service loss of business or anticipatory profits or consequential damages resulting from the use or operation of the equipment The manufacturer reserves the right to implement changes and modifications of the product at any time to revise this publication and to make changes in the contents hereof without obligation to notify any person of such changes modifications or revisions 11 Certification Implant Detector complies with IEC 60601 1 2005 Safety and IEC 60601 1 2 2007 Electromagnetic compatibility standards including conducted and radiated immunity tests as specified for equipment of Group 1 Class B 12 European Authorized Representative European Authorized Representative who has been empowered to enter into commitments on our behalf Obelis s a Bd General Wahis 53 1030 Brussels BELGIUM Tel 32 2 732 59 54 Fax 32 2 732 60 03 E Mail mail obelis net 14 13 Technical Specifications Implant Detector belongs to the following category of medical devices Internally powered equipment Type B applied parts Not suitable for use in the presence of flammable anesthetic mixtures with air oxygen or nitrous oxide Continuous operation Ingress of liquids not protec
12. tector is a precise user friendly affordable device suitable both for skilled implantologists and for general practitioners working with implants av kai FY RomiPointer Implant Detector Pic 1 1 Indications for use RomiPointer Implant Detector is an electronic device used for localization of implants covered by gum tissue during two stage implantology The device enables to obtain good results with various implant systems 2 Contraindications RomiPointer Implant Detector is not recommended for use in patients or by personnel having a pacemaker or other implanted electrical devices 3 Warnings This product must only be used in hospital environments clinics or dental offices by qualified dental personnel 4 Precautions e Do not use RomiPointer Implant Detector near devices emitting electromagnetic noise such as fluorescent lamps film viewers ultrasonic devices etc Cellular phones remote controls or other devices generating electromagnetic waves may cause abnormal operation of Implant Detector Such devices should be turned off e During device operation protect Implant Detector from occasional spillage of liquids e Do not use Implant Detector in presence of flammable materials e Implant Detector should be used with the manufacturer s original accessories only e n order to prevent infectious agent transmission the sensor should be changed or sterilized between patients e Presence of metalli
13. ted The device is intended for indoor use only Environmental conditions during transportation Temperature 20 C to 60 C 0 F to 140 F Relative humidity 10 to 90 non condensing Implant Detector is intended for use in electromagnetic environment specified for equipment of Group 1 Class B Specifications Dimensions 215 x 45 dia 21 mm Weight 60 gr Type of display LED segments Power source 1 x 1 5V AA alkaline primary battery 14 Standard symbols Device marking includes the following standard symbols Type B applied part iud Manufacturer e Consult instructions for use X Recycling PLEASE DO NOT THROW AWAY This product and all its i mmm Direct current 1 5V components must be recycled through your supplier Device label includes the following standard symbol Date of manufacture 15 RomiPointer Implant Detector Rev 01 05 2015 Manufacturer Romidan Ltd 5 Simcha Holzberg St 5502213 Kiryat Ono Israel Email export romidan com www romidan com DENTAL QUALITY PRODUCTS
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