dental IMPLANT POINTER dIP004 Patent Pending Operation Instructions 1 Thank you for purchasing dIP004 dental IMPLANT POINTER! For your safety and best results read this manual thoroughly before using the unit and pay attention to warnings and notes. CONTENTS 1. 2. 3. 4. 5. Prevent Accidents……………………………………………………………………………………………………………………………….……..3 Indication For Use………………………………………………………………………………………………………..…………………………….4 Parts Identification……………………………………………………………………………………………………………………………………. 4 Installing (Exchanging) the Battery ……………………………………………………………………………………………………….….. 5 Preparing the Unit…………………………………..…….………………………………………………………………………………………….. 5 I. Preparing the Disposable Set………………………………………………..…………………………………………………..………… 5 IV. Preparing the Marker……………………………………………………………………………………………………………………….….. 5 6. Operating the Unit…………………………………………………………………………………………………………………………………….. 6 I. Turning the Unit On…………………………………………………………………………………………………………………..………… 6 II. Heating the Sensor…………………………..………………………………………………………………………………………………….. 7 III. Scanning the Jaw…………………………………………………………………………………………………………………………..…….. 7 IV. Finding the center of the Implant………………………………………………………………………………….…….………………. 7 V. Pointing the Implant center position…………………………………………………………………………………………..……….. 8 VI. Resetting the last found Implant data…………………………………………………………………………………………….……. 8 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. After Using the Unit………………………………………………………………………………………………………….……………………….. 9 Sterilization…………....….……………..…………………………………………………………………………………………………….……….. 9 Storage in Clinic………………………………………………………………………………………………………………………….……………… 9 Storage and Transportation Conditions………………………………………………………………………………………………..……. 9 Working Life………………………………………………………………………………………………………………………………………….…… 9 Disposal of Medical Devices……………………………………………………………………………………………………………….……… 9 Service………………………………………………………………………………………………………………………………………………..…….. 10 Troubleshooting………………………………………………………………………………………………………………………………………… 10 Warranty…………………………………………………………………………………………………………………………………………………… 10 Technical Specifications ……………………………………………………………………………………………………………………….….. 11 2 1. Prevent Accidents Most operation and maintenance problems result from insufficient attention being paid to basic safety precautions and not being able to foresee the possibilities of accidents. Problems and accidents are best avoided by foreseeing the possibility of danger and operating the unit in accordance with the manufacturer’ s recommendations. First thoroughly read all precautions and instructions pertaining to safety and accident prevention; then, operate the equipment with the utmost caution to prevent either damaging the equipment itself or causing bodily injury. Note the meaning of the following symbols and expressions: - WARNING This warns that it may result in serious injury of the patient or operator if the instructions are not followed properly. PROHIBITION The user should not use in a way that may result in serious injury of the patient or operator. NOTE This alerts the user to the possibility of damage to the equipment, potential injury of the patient or operator, or important points concerning operation and performance. The user (e.g. the hospital, clinic etc.) is responsible for the maintenance and proper operation of the dIP004 dental I MPLANT POI NTER. dIP004 dental I MPLANT POINTER must only be operated by dentists and other legally licensed professionals. Do not use this equipment for anything other than its specified purpose. WARNINGS • This unit must not be connected to or used in combination with any other apparatus or system. It must not be used as an integral component of any other apparatus or system. • CTI ltd. will not be responsible for accidents, equipment damage, bodily injury or any other trouble which results from ignoring this prohibition. • Accurate implant pointing is not always possible depending on the distance from the top side of the sensor to the implant’s cap as well as on the distance between two adjacent implants. • Do not reuse sterilized Sensors, Markers and Protective Covers. • When Red LED appears for a few seconds instead of Yellow immediately after inserting the Sensor, it means that Battery should be replaced by a new one shortly. • Do not insert the Sensor with the lettering “TOP SIDE” faced down otherwise implant pointing will be incorrect. • Reset the instrument if you sense something odd or abnormal while searching for Implant. • The unit will not work at all if the Red LED is flashing. When this happens the Battery should be replaced immediately. • Dispose the used Sensor, Marker and Protective Cover after each treatment. • When searching for an Implant, no metal tools or instruments (like dental mirror, tweezers etc.) should be used in the proximity of the Sensor. 3 PROHIBITION • Illumination devices such as fluorescent lights and the Film viewer which use an inverter can cause the dIP004 to operate erratically. Do not use dIP004 near devices such as these. NOTE • • dIP004 will switch itself to the Low Power Mode (much lower Blue light intensity) after being left idle for 2-10 minutes. It will be returned to the Full Power Mode by putting the sensor close to an implant or by resetting. dIP004 turns itself off automatically after being left idle for more than 10 minutes. Then it can be turned on by pulling out the Sensor and inserting it back again. 2. Indication for use dIP004 is a dental IMPLANT POINTER. It can be used to point the implants buried under the gum. 3. Parts Identification NOTE dIP004 is supplied without the battery installed. Remove the Battery Cover and install the AA battery 4 4. Installing (Exchanging) the Battery I. Remove the Battery Cover by turning it in the counterclockwise direction. II. Insert the AA battery included in the package by first pressing center of the “-“side against its spring contact. III. IV. Slide the “+” side down into place and make sure the contacts are not bent or damaged. Return the Battery Cover by turning it in the clockwise direction. 5. Preparing the Unit I. II. III. Open the dental IMPLANT POINTER Kit Box. Take out the dIP004 Unit, a new sealed Disposable Set and the Marker Handle. Unseal Disposable Set comprising a Sensor with a Protective Cover on it and a Marker. IV. Twist in the Marker into the Marker Handle. 5 6. Operating the Unit I. Turn the Unit on by inserting the Sensor (with the Protective Cover on it) in such a way that the notice “TOP SIDE” will be in the same direction as the logo “CTI” on the Battery Cover. NOTE The Sensor should be inserted into the front slot and pushed inside until a clear click is recognized. Immediately after inserting the Sensor the Yellow LED will turn on indicating the Initialization State. WARNING If the Red LED is turned on instead of Yellow it indicates that the battery is low and it should be replaced by a new one in a few days. After a few seconds the Blue LED will replace the Yellow (or Red) one, indicating the “Ready to Use” state. Meanwhile, the Protective Cover should be pulled on the front end of the Unit for tightly covering the Sensor Slot and protecting it from the penetration of undesirable substances like blood or saliva. 6 II. The bottom side of the Sensor should be gently clasped to the gum in the area where the implant is supposed to be. NOTE It is recommended to keep the Sensor motionless for a few (~5) seconds for equalizing its temperature with the temperature of the gum, which would improve its accuracy. III. The Sensor should be slowly moved along the gum, while keeping it in a constant contact with the gum. IV. When the LED turns from Blue to Green, the sensor is close enough to the Implant. 7 NOTE It is desirable to scan the area, where an implant has been recognized, by a smooth spiral movement. IMPLANT POINTER records the closest distance to the Implant Center and then cuts down the area where it indicates the Implant’s presence, providing a more accurate Implant Center pointing. V. Keeping the Sensor exactly above the found Implant, insert the tip of the Marker into the hole in the center of the Sensor and mark the Implant position by pushing the Marker into the gum, simultaneously turning it in opposite directions for better marking. VI. Reset the last found implant parameters by bringing the Sensor close to any metal object like the Marker Handle and keep it attached to the Handle until the indicator switches from Blue to Yellow, then take it away. The LED will switch back to Blue, indicating that the Unit is ready to be used again. 8 7. After Using the Unit I. II. III. IV. Turn the Unit off by extracting the Sensor. Remove the Protective Cover. Twist off the Marker from the Marker Handle. Dispose the used Sensor, Protective Cover and Sensor. 8. Sterilization I. The Marker Handle should be autoclaved at 135⁰C (249.8⁰F), 4 minutes minimum with a sterilization pouch. Minimum Drying Time after sterilization: - 10 minutes. WARNING The Marker Handle must be thoroughly washed and cleaned before autoclaving. It must be autoclaved after each patient. WARNING Do not autoclave the Unit, Markers, Sensors and Protective Covers. II. Sterilize the surface of the Unit by wiping it with a piece of gauze dampened with Ethanol for Disinfection (Ethanol 70~80 vol%). Wring the gauze out to make sure it is not too wet. WARNING Avoid spilling chemical solutions used for treatment on the dIP004. These chemicals could cause damage, deform or discolor the Unit. Be especially careful to avoid spilling formalin cresol (FC) and sodium hypochlorite as they are quite strong. Wipe off any chemical spills immediately. 9. Storage in clinic I. Keep the Unit, the sterilized Marker Handle and Disposable Sets in the closed Kit Box. 10. Storage and Transportation Conditions: Temperature: - -10⁰C (14⁰F) to 70⁰C (158⁰F); Relative Humidity: - 8% to 80% (without condensation; Atmospheric Pressure: - 700 hPa to 1060 hPa; 11. Working Life The Working Life of this equipment is at least 6 years from the date of shipment, provided it is regularly and properly inspected and maintained. 12. Disposal of Medical Devices The battery should be recycled. Metal parts of the equipment are disposed as scrap metal. Synthetic materials, electrical components and printed circuit boards are disposed as electrical scrap. Material must be 9 disposed according to the relevant national legal regulations. Consult specialized disposal companies for this purpose. Please inquire of the local administration concerning local disposal companies. 13. Service dIP004 dental IMPLANT POINTER cannot be repaired and it will be replaced by a new one in case of any malfunction, subject to the warranty conditions, by CTI subsidiaries or authorized dealers all over the word. 14. Troubleshooting Problem Check Points No Power Check Sensor insertion. Check battery installation. Check battery power. Sporadic switching from Blue to Green and vise-versa when touching the gum. The implant seats too deeply within the jaw. Check if Sensor is inserted correctly. Try resetting the dIP004, see item 2.X on page 9. Response Insert Sensor properly. Replace Sensor Insert battery properly. Replace battery. Reinsert the Sensor with the notice “Top Side” in the proper direction Try finding the implant by scanning the side face of the gum. Less accurate but still useful. 15. Warranty a. The manufacturer gives a guarantee for one year beginning from the date of purchase. Within this period any defect that is due to faulty manufacturing or material will be remedied by replacement at the judgment of the manufacturer or its distributor. b. Warranty service: In the event of a claim under this guarantee, the device is to be sent to the service facility of the distributor, postage and shipping paid, including a short description of the problem, and a copy of the sales receipt from the dealer as proof of purchase and title to warranty. Always ship prepaid. Distributor does not accept collect shipments. c. In the case of damage caused by wear and tear, careless handling and any repairs, the warranty ceases to be valid. This guarantee may not form the basis for any claims for damages, in particular not for compensation of consequential damages. d. The buyer assumes responsibility for damage due to dropping of the unit, improper use and utilization of product and chemicals other than those stated in this instruction manual for cleaning. It is the customer’ s responsibility to use the exact type of battery defined in the specifications. e. This warranty does not include the external accessories, Marker Handle, batteries, or transportation costs. 10 ATTENTION 1. Creative Team Instruments (CTI) ltd. will not be responsible for accidents, equipment damage, or bodily injury resulting from any repairs of the Unit. 2. Creative Team Instruments (CTI) ltd. will not be responsible for accidents, equipment damage, or bodily injury resulting from any changes, modifications, or alterations of its products. 3. Creative Team Instruments (CTI) ltd. will not be responsible for accidents, equipment damage, or bodily injury resulting from the use of products or equipment made by other manufacturers, except for those procured by the Creative Team Instruments (CTI) ltd. 4. Creative Team Instruments (CTI) ltd. will not be responsible for accidents, equipment damage, or bodily injury resulting from operating the equipment in ways other than the operating procedures described in this manual or resulting from not following the cautionary remarks and warnings in this manual. 5. Creative Team Instruments (CTI) ltd. will not be responsible for accidents, equipment damage, or bodily injury resulting from workplace conditions and environment which do not conform to those stated in this manual. 6. Creative Team Instruments (CTI) ltd. will not be responsible for accidents, equipment damage, or bodily injury resulting from fires, earthquakes, floods, lightning, natural disasters, or acts of God. 16. Technical Specifications: Power Source Rated Current max Power Consumption max Dimensions Weight 1.5 V (One AA Alkaline Battery) 0.04 A 0.06 VA 170 mm * 24 mm 50 g 11