Instructions for use INTRA LUX motor K REF INTRA LUX motor K 200 F - REF

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1 Instructions for use INTRA LUX motor K REF INTRA LUX motor K 200 F - REF

2 Sales: KaVo Dental GmbH Bismarckring 39 D Biberach Tel Fax Manufacturer: Kaltenbach & Voigt GmbH Bismarckring 39 D Biberach

3 Table of contents 1 Table of contents Table of contents... 1 User instructions... 4 Warranty terms and conditions... 6 Safety... 8 Description of safety instructions... 8 Description of safety instructions: Warning symbol... 8 Description of safety instructions: Structure... 9 Description of safety instructions: Description of levels of danger Proper use Safety instructions Product description Technical data Transportation and storage conditions... 22

4 Table of contents 2 First use Connection to the supply hose Spray water regulation Connecting the attachments Connecting the attachments: Attaching Connecting the attachments: Removal Troubleshooting Check for malfunctions before initial startup Troubleshooting Troubleshooting: Changing the high-pressure lamp Troubleshooting: Exchanging the O-rings The setup methods follow DIN EN ISO Preparation at the site of use... 33

5 Table of contents 3 Cleaning Cleaning: Manual cleaning of the exterior Cleaning: Manual cleaning of the inside Cleaning: Mechanical cleaning of the exterior and interior Disinfection Disinfection: Manual disinfection of the the exterior Disinfection: Manual disinfection of the interior Disinfection: Mechanical disinfection of the exterior and interior Drying Care products and systems - Servicing Packaging Sterilization Storage Accessories... 50

6 User instructions 4 User instructions Dear user, KaVo hopes that you enjoy your new high-quality product. Following the instructions below will allow you to work smoothly, economically and safely. Symbols See the section Safety/Warning Symbols Important information for users and technicians Non-sterilizable

7 User instructions 5 CE mark (Communauté Européenne). A product with this mark meets the requirements of the relevant EC directives, i.e. the standards applicable in Europe. Action request Target group This document is intended for dentists and their assistants. The section on starting up is also intended for service technicians.

8 User instructions 6 Warranty terms and conditions The following warranty conditions apply to this KaVo medical device: KaVo provides the end customer with a warranty of proper function and guarantees zero defects in respect of material and processing for a period of 24 months from data of invoice, subject to the following conditions: In case of justified complaints, KaVo will honor its warranty with a repair or free replacement. Other claims of any nature whatsoever, in particular with respect to compensation, are excluded. In the event of default, gross negligence or intent, this shall only apply in the absence of mandatory legal regulations to the contrary. KaVo cannot be held liable for defects and their consequences that are or may be due to natural wear, improper handling, cleaning or maintenance, non-compliance with operating or connection instructions, calcination or corrosion, contaminated air or water supplies or chemical or electrical factors deemed abnormal or impermissible in accordance with KaVo's instructions for use or other manufacturer specifications. The warranty does not

9 User instructions 7 usually cover lamps, light conductors made of glass and glass fibers, glassware, rubber parts and the colorfastness of plastic parts. No liability is assumed when defects or their consequences are derived from manipulations or changes to the product by the customer or a third party. Service warranty claims will only be accepted if the product is submitted along with proof of purchase in the form of a copy of the invoice/delivery note. The dealer, purchase date, unit number or type and serial number must be clearly visible on this document.

10 Safety 8 Description of safety instructions: Warning symbol Warning symbol

11 Safety 9 Description of safety instructions: Structure DANGER The introduction describes the type and source of the danger. This section describes the possible consequences of misuse. The optional step contains necessary measures for avoiding hazards.

12 Safety 10 Description of safety instructions: Description of levels of danger The herein cited safety instructions with the three levels of danger will help avert property damage and injury. CAUTION WARNING CAUTION indicates a hazardous situation that can lead to property damage or minor to moderate injury. WARNING indicates a hazardous situation that can lead to serious injury or death.

13 Safety 11 DANGER DANGER indicates a maximum hazardous situation that can directly cause serious injury or death.

14 Safety 12 Proper use The motor is - a type 2, dental electrical low-voltage motor according to DIN EN IEC intended to drive and operate a dental handpiece or contra-angle handpiece equipped with a handpiece connection according to ISO not permitted for use in explosive areas. - only intended for dental use. Any misuse or change to the product is impermissible and can be hazardous. - a medical device according to relevant national statutory regulations. According to these provisions, this medical device may only be used for the described application by a knowledgeable user. The following must be observed: the applicable health and safety regulations the applicable accident prevention regulations

15 Safety 13 these instructions for use According to these regulations, the user is required to: Only use equipment that is operating correctly use the equipment for the proper purpose. to protect himself, the patient and third parties from danger. to avoid contamination from the product.

16 Safety 14 Safety instructions CAUTION CAUTION Premature wear and malfunctioning from improper storage during long periods of nonuse. Shortened product life. The instrument must be cleaned, serviced and stored dry if it has not been used for a long period. Injury or damage due to wear. Irregular running noise, significant vibration, overheating, imbalance or insufficient grip Stop work and seek service support.

17 Safety 15 WARNING WARNING Risks from electromagnetic fields. The functions of implanted systems (such as pacemakers) can be influenced by electromagnetic fields. Ask patients before treatment and counsel them about the risks. Electricity Electrical shock from incorrectly connecting a non-kavo system to the medical device. When installing the operating the medical device for treatments and equipment from other manufacturers, observe the provisions of "Protection from electrical shock," "Leakage current," and "Not grounding the application part" in accordance with DIN EN IEC The medical device may only be combined with a treatment unit released by KaVo.

18 Safety 16 CAUTION WARNING Risks from the lack of control equipment. Hazards can arise if control equipment is not available for changing the speed and the direction of rotation. The connected dental treatment unit must have control equipment for changing the speed and direction of rotation. In addition, the accompanying documents must refer to them due to responsibilities relating to from safety, reliability and performance. The medical device may only be combined with a treatment unit released by KaVo. Damage from soiled and moist cooling air. Contaminated and moist cooling air can cause malfunctions and lead to premature bearing wear. In general, ensure dry, clean uncontaminated cooling air according to EN ISO

19 Safety 17 Note This medical device in conjunction with the dental treatment unit meets the requirements of DIN EN IEC The following individuals are authorized to repair and service KaVo products: Technicians at the KaVo branches throughout the world Technicians specially trained by KaVo The present product is subject to the EC Directive on used electrical and electronic devices and must be disposed within Europe at a special facility. Further information can be obtained from KaVo or a dental distributor.

20 Product description 18 Product description INTRA LUX Motor K 200, Mat. No INTRA LUX Motor K 200 F, Mat. No

21 Product description 19 Technical data Motor electronics Material nos , , , and Motor voltage Motor speed Motor torque min V DC, max. 26 V DC min. 400 rpm, max. 40,000 rpm max. 2.6 Ncm ( foot-pound) Ask the manufacturer for the connected loads on the device side and a connection diagram for the connection side.

22 Product description 20 Mode Operating voltage of the high-pressure lamp Performance of the high pressure bulb Cooling air Amount of cooling air Air exiting the motor coupling Spray air Spray water Exposure mode: 2 min. on, 5 min. off V DC (KaVo recommends 3.2 V DC) max.2.5 Watt bar ( psi) 32 ± 4 NL/min. 7.5 ± 1.5 NL/min bar ( psi) bar ( psi) All dental handpieces and contra-angle handpieces can be connected to an ISO 3964 compliant handpiece connection.

23 Product description 21 Note The INTRA LUX Motor K 200/K 200 F can only be combined with the specified motor electronics.

24 Product description 22 Transportation and storage conditions CAUTION Hazard starting up the medical device after it has been stored refrigerated. This can cause the medical device to malfunction. The temperature of very cold products must be raised to a range of 20 C (68 F) to 25 C (77 F). Temperature: -50 C (-58 F) to 80 C (176 F) Relative humidity: Non-condensing Air pressure: 700 hpa (10 psi) to 1060 hpa (15 psi) Protect from moisture.

25 First use 23 Connection to the supply hose Slightly wet the O-rings on the connection hose with KAVOspray. Insert the plug-in connector 1 into the motor bearing end plate (note the position of the plug contacts), and tighten the screw connection 2 in the direction of the arrow. Note Details on the hose connection can be obtained from the manufacturer.

26 First use 24 Spray water regulation Turn the regulating sleeve 3 to the left or right to meter the spray water. Maximum throughput is achieved when the "KaVo" imprint on the regulating sleeve is aligned with the button 4.

27 First use 25 Connecting the attachments All handpieces and contra-angle handpieces can be mounted with the INT RAmatic connection DIN EN ISO CAUTION Attaching or removing instruments during rotation Can cause damage. Do not attach or remove the instruments during rotation. Only use reliable handpieces.

28 First use 26 Connecting the attachments: Attaching Insert the instrument into the LUX motor until it locks in place. Turn the instrument until the catch audibly locks.

29 First use 27 CAUTION Make sure that the instrument is firmly seated on the INTRA LUX motor K 200 / K 200 F. If the instrument accidentally releases from the INTRA LUX motor K 200 / K 200 F during treatment, it can be dangerous to the patient and user. Pull on the instrument before each use to check that it is engaged and locked in place.

30 First use 28 Connecting the attachments: Removal Pull the instrument off the motor in an axial direction.

31 Troubleshooting 29 Check for malfunctions before initial startup The motor becomes too hot while idling: - Check the amount of cooling air being supplied. The motor runs too hot under load: - Also check the handpiece. Intermittent pauses or uneven running: - Replace the carbon brushes. Motor coupling O-ring missing: Replace O-rings. CAUTION Missing or damaged O-rings If the O-rings are missing and damaged, malfunctions and premature failure can occur. Check if all O-rings are on the coupling and undamaged.

32 Troubleshooting 30 Troubleshooting: Changing the high-pressure lamp Press the button 1 while pulling off the sleeve 2 in the direction of the arrow. Turn the ring 3 until the lamp is exposed 4. Push the lamp 4 out of the holder in the direction of the arrow and lift it out. Insert a new lamp in the recess so that the contact surfaces mate with those in the holder. Push the lamp into the holder. To secure the lamp, turn the ring 3, mount the sleeve 2 and engage it in place.

33 Troubleshooting 31 Troubleshooting: Exchanging the O-rings Press the O-rings between your fingers to form a loop. Slide the O-rings forwards and remove them. Insert new O-rings into the grooves. Spray with KAVOspray. CAUTION Vaseline, oils or other greases. This can cause malfunctions. Do not use Vaseline, oils or other greases on this medical device.

34 Troubleshooting 32 Note The O-ring on the motor attachment may only be lubricated with a cotton ball which has been coated with KAVOspray.

35 The setup methods follow DIN EN ISO Preparation at the site of use CAUTION Hazard from nonsterile products. An infection hazard exists from contaminated medical devices. Observe suitable personal protective measures. Remove residual cement, composite or blood at the site of use. The medical device must be dry when transporting it to be prepared. Do not place it in a solution or the like. The medical device should be prepared as close to the treatment time as possible.

36 The setup methods follow DIN EN ISO Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit. Defects in the product. Only clean manually!

37 The setup methods follow DIN EN ISO Cleaning: Manual cleaning of the exterior Required accessories: Tap water 30 C ± 5 C (86 F ± 41 F) and a 60 to 70% alcohol solution Soft cotton cloth First wipe off the outside surfaces of the motor with a cloth moistened with water, then wipe with a cloth moistened with 60 to 70% alcohol solution, and then dry with a soft cotton cloth.

38 The setup methods follow DIN EN ISO Cleaning: Manual cleaning of the inside Required accessories: Tap water 30 C ± 5 C (86 F ± 41 F) and a 60 to 70% alcohol solution Soft cotton cloth Pull off the sleeve from the motor (once a week).

39 The setup methods follow DIN EN ISO Rub the motor with a dry cloth to remove residual oil.

40 The setup methods follow DIN EN ISO First wipe off the motor sleeve with a cloth moistened with water, then wipe the inside with a cloth moistened with 60 to 70% alcohol solution, and then dry with a soft cotton cloth.

41 The setup methods follow DIN EN ISO Cleaning: Mechanical cleaning of the exterior and interior Not applicable. Note Germ formation Infections - After treating a patient, allow spray air and spray water to exit for at least 20 seconds.

42 The setup methods follow DIN EN ISO Disinfection CAUTION Malfunctioning from using a disinfectant bath or chlorine-containing disinfectant. Defects in the product. Only disinfect manually!

43 The setup methods follow DIN EN ISO Disinfection: Manual disinfection of the the exterior KaVo recommends the following products based on material compatibility. The microbiological efficacy must be ensured by the disinfectant manufacturer. Microcide AF by Schülke&Mayr (liquid or cloths) FD 322 by Dürr CaviCide by Metrex Required tools: Cloths for wiping off the medical device. Note Observe the instruction for use for the disinfectant.

44 The setup methods follow DIN EN ISO Spray the disinfectant on a cloth, then thoroughly wipe down the medical device and leave the disinfectant to soak in according to the instructions of the disinfectant manufacturer. Note Do not place the motor in disinfectant baths.

45 The setup methods follow DIN EN ISO Disinfection: Manual disinfection of the interior The interior of this product is not designed for manual disinfection.

46 The setup methods follow DIN EN ISO Disinfection: Mechanical disinfection of the exterior and interior Not applicable.

47 The setup methods follow DIN EN ISO Drying Manual drying If there is any residual moisture after cleaning and disinfecting, dry with a soft cotton cloth. The inside and outside of the removed motor sleeve can be dried with compressed air. Note Always make sure that the supply of cooling air is dry, clean and uncontaminated according to EN ISO Machine drying Not applicable.

48 The setup methods follow DIN EN ISO Care products and systems - Servicing The bearings of the INTRA LUX Motor K 200 / K 200 F are lubricated with a high-quality lifelong lubricant. Note Excess fluids exiting the contra-angle handpiece (oil, cleanser or disinfectant) can penetrate the motor and cause a malfunction. Please ensure that the care instructions supplied with the instruments are always followed. Note Remove the motor sleeve once a week, and use a dry cloth to wipe off the inside and outside of the motor sleeve and the outside of the open motor.

49 The setup methods follow DIN EN ISO Packaging Not applicable for the medical product INTRA LUX Motor K 200 / K 200 F. Note Only the removable motor sleeve can be sterilized in an autoclave up to 135 C.

50 The setup methods follow DIN EN ISO Sterilization Not applicable for the medical product INTRA LUX Motor K 200 / K 200 F. Note Only the removable motor sleeve can be sterilized in an autoclave up to 135 C.

51 The setup methods follow DIN EN ISO Storage Prepared products should be stored protected germ-free from dust in a dry, dark and cool room.

52 Accessories 50 Accessories Accessories obtainable from dental and medical suppliers. Material summary Mat. no. High-pressure bulb O-ring Airflow measuring tube

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