Care instructions. Primus 1058 Life

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Transcription:

Care instructions Primus 1058 Life

Manufacturer: Kaltenbach & Voigt GmbH Bismarckring 39 D-88400 Biberach www.kavo.com Distributed by: KaVo Dental GmbH Bismarckring 39 D-88400 Biberach Phone +49 (0) 7351 56-0 Fax +49 (0) 7351 56-1488

Table of contents Table of contents 1 User instructions... 4 1.1 User guide... 4 1.1.1 Abbreviations... 4 1.1.2 Symbols... 4 1.1.3 Target group... 4 2 Setup methods according to DIN EN ISO 17664... 5 2.1 References... 5 2.2 General instructions for the reprocessing of KaVo treatment units... 5 2.2.1 Reprocessing Overview Primus 1058 Life... 8 2.3 Reprocessing of the surfaces of treatment unit / upholstery... 8 2.4 Preparation of the dentist unit... 9 2.4.1 Reprocessing of handle and holder pad/anti-slip mat... 9 2.4.2 Reprocessing of the instrument holder of the TM table... 11 2.4.3 Reprocessing of the instrument arm S table... 12 2.4.4 Setting up the 3-function and multifunction handpiece... 14 2.4.5 Preparation of the instrument hoses... 16 2.4.6 Servicing the turbine return air filter... 17 2.4.7 Reprocessing KaVo ERGOcam One... 17 2.5 Reprocessing of the assistant unit... 19 2.5.1 Preparing the instrument holder... 19 2.5.2 Preparing the connector for the suction hose... 19 2.5.3 Reprocessing of sieve inserts and suction hoses... 20 2.6 Preparation of the patient unit... 20 2.6.1 Preparation of the tumbler... 20 2.6.2 Preparation of the tumbler holder and filler... 20 2.6.3 Preparation of the spittoon... 22 2.7 Manual reprocessing of the water-conducting system... 23 2.8 Automatic hygiene functions of the water conducting system... 23 2.8.1 Rinsing programme... 24 2.8.2 Intensive germ reduction... 27 2.9 Reprocessing and automatic hygiene functions of the suction system... 30 2.9.1 Reprocessing of the suction system including suction hoses... 30 2.9.2 HYDROclean function... 31 2.10 Preparation of the amalgam separator... 31 2.11 Reprocessing KaVo Screen One / KaVo Screen HD... 32 3 Replenish and check the disinfectant... 33 3.1 Replenish OXYGENAL 6... 33 3.1.1 Replenish OXYGENAL 6 when using the water bottle... 34 3.2 Check the OXYGENAL 6 concentration... 37 3 / 40

1 User instructions 1.1 User guide 1 User instructions 1.1 User guide Requirement Read these instructions prior to first use to avoid misuse and prevent damage. Comply with the Instructions for Use of the treatment unit! 1.1.1 Abbreviations Abbreviation IfU CI AI TI SC IEC RI EMC Scaler IR IrDA Explanation Instructions for use Care instructions Assembly instructions Technician's instructions Safety checks International Electrotechnical Commission Repair instructions Electromagnetic compatibility Scaler (ZEG) Infrared Infrared Data Association 1.1.2 Symbols Refer to the chapter on Safety/Warning symbol Important information for users and service technicians Action request CE mark according to Medical Devices Directive EC 93/42 Thermodisinfectable at up to 95 C (203 F) Suitable for steam sterilisation at up to 135 o C (275 F) 1.1.3 Target group This document is for dentists and dental office staff. 4 / 40

2 Setup methods according to DIN EN ISO 17664 2.1 References 2 Setup methods according to DIN EN ISO 17664 2.1 References The reprocessing consists of the following basic steps: Cleaning and disinfection ( manually or automatically) Sterilisation Comply with national hygiene requirements, e.g. RKI guidelines. Risk of injury during cleaning of the treatment unit. Lack of instructions to the cleaning staff and lack of preparation of the treatment unit can lead to the cleaning personnel sustaining injuries. Only trained professionals and instructed cleaning personnel may be present in the treatment rooms. Position the chair for cleaning and turn the device off. Product damage due to improper disinfection. Malfunctions. Use the disinfectant as prescribed by the manufacturer. No spray disinfection, perform wipe disinfection only. Do not immerse product or parts of the product in liquids. Mop up any spilled cleanser or disinfectant immediately. Improper disinfection may lead to health hazards and material damage. Infection hazard to users and patients. Damage to the sterile product. No hot air sterilisation, no chemical cold sterilisation, do not sterilise with ethylene oxide. Health hazard and property damage due to non-compliance with servicing schedule. Infection hazard to users and patients. Product damage. Comply with servicing schedule. The preparation methods for the instruments and motors are found in the separate instructions for use that accompany the instrument and motor packages. 2.2 General instructions for the reprocessing of KaVo treatment units Please comply with the general reprocessing instructions at all times. Detailed product-specific reprocessing instructions are provided subsequently. At the site of use Remove any surface contamination using a disposable cloth/paper towel. 5 / 40

2 Setup methods according to DIN EN ISO 17664 2.2 General instructions for the reprocessing of KaVo treatment units Storage and transport Preparations for cleaning Manual cleaning Automatic cleaning Manual disinfection KaVo recommends reprocessing as soon as possible after use. Fixtures: Brush or cloth Tap water 30 C ± 5 C Comply with product-specific reprocessing instructions. Remove any dirt on the surface using a suitable cleanser according to the recommendations of the manufacturer. Before doing so, check the compatibility of the cleanser on a inconspicuous place of the treatment centre. KaVo recommends washer disinfectors in accordance with EN ISO 15883-1, which are operated with alkaline cleaning agents with a ph value of max. 10 (e.g. Miele G 7781 / G 7881 Validation was carried out with the "VARIO-TD" programme, cleaning agent "neodisher mediclean" and rinsing agent "neodisher mielclear" and only applies to the material compatibility with KaVo products). For programme settings as well as cleansers and disinfectants to be used, please refer to the Instructions for Use of the washer disinfector. Directly after automated cleaning/disinfection, treat the medical device with the care products and systems provided by KaVo. Perform wipe disinfection only, the use of spray disinfection and disinfection baths is not feasible. Wipe all outer surfaces with a soft cloth and an approved disinfectant. Approved disinfectants: CaviCide / CaviWipes (Metrex) Microcide AF Liquid (Schülke & Mayr) FD 322 (Dürr Dental) Incidin Liquid (Ecolab) Use disinfectants according to the manufacturer's Instructions for Use. Please note the disinfectant safety data sheet. 6 / 40

2 Setup methods according to DIN EN ISO 17664 2.2 General instructions for the reprocessing of KaVo treatment units Automatic disinfection KaVo recommends washer disinfectors in accordance with EN ISO 15883-1, which are operated with alkaline cleaning agents with a ph value of max. 10 (e.g. Miele G 7781 / G 7881 Validation was carried out with the "VARIO-TD" programme, cleaning agent "neodisher mediclean" and rinsing agent "neodisher mielclear" and only applies to the material compatibility with KaVo products). For programme settings as well as cleansers and disinfectants to be used, please refer to the Instructions for Use of the washer disinfector. In order to prevent negative effects on the medical device, make sure that the interior and the exterior of the medical device are dry after completion of the cycle, and then grease it immediately with servicing agents from the KaVo care system. Manual drying Supply dry, clean and uncontaminated compressed air according to ISO 7494-2 only. Blow off the outside and inside with compressed air until water drops are no longer visible. Automatic drying Usually, automatic drying is part of the cleaning/disinfection cycle of the washer disinfector and should not be carried out above 95 C. Servicing Control and functional test Discard damaged products. Perform a visual inspection to check for damage and wear and tear. Test products for function regularly. Packaging Use standardised packaging material. Sealing should not be under tension. Use sterile goods packaging in order to ensure sterility. Sterilisation All sterilisable products are temperature-resistant up to max. 138 C. Select a suitable procedure (depending on the available autoclave) from the following sterilisation processes: Storage Autoclave with three times pre-vacuum: - at least 3 minutes at 134 C -1 C / +4 C (273 F -1.6 F / +7.4 F) Autoclave using the gravity method: - at least 10 minutes at 134 C -1 C / +4 C (273 F -1.6 F / +7.4 F) Use according to the manufacturer's Instructions for Use. Reprocessed products should be stored protected from dust with minimum exposure to germs in a dry, dark and cool place. Comply with the expiry date of the sterilised items. 7 / 40

2 Setup methods according to DIN EN ISO 17664 2.3 Reprocessing of the surfaces of treatment unit / upholstery 2.2.1 Reprocessing Overview Primus 1058 Life Reprocessing items/medical devices Surfaces Unit Cushion Gripping sleeve, white Gripping sleeve, grey Light Dentist element Handpiece sleeve 3F and MF handpieces Cannula for 3F and MF handpieces Holder pad/anti-slip mat Handpiece holder Swing-arm S-table Assistant element Connection parts of the suction hose Patient element Tumbler support Tumbler filler Porcelain spittoon bowl Glass spittoon bowl Cleaning Disinfection Sterilisation manual automatic manual automatic automatic 2.3 Reprocessing of the surfaces of treatment unit / upholstery Position the chair for cleaning Adjust the backrest to vertical position and move the chair upward. Also refer to: Instructions for use Turn device off Switch main device switch off. 8 / 40

2 Setup methods according to DIN EN ISO 17664 2.4 Preparation of the dentist unit Cleaning and disinfecting the surfaces of treatment unit / upholstery Non-colour-fast textiles. Non-colour-fast textiles can cause permanent discoloration. Remove discolourations with water immediately. Approved disinfectants: CaviCide / CaviWipes (Metrex) Microcide AF Liquid (Schülke & Mayr) FD 322 (Dürr Dental) Incidin Liquid (Ecolab) Clean the surfaces and upholstery with a soft cloth and water, and wipe-disinfect them with an approved surface disinfectant. Damage caused by spray disinfection. Disinfectant gets into cracks and loosens the paint. No spray disinfection. Only disinfect by wiping. Cleaning and disinfection of the foot control Damage caused by inappropriate use of water. Damage to the foot control. For cleaning, the foot control must not be immersed in water or placed under running water. When wiping it off with a moist cloth, do not touch the contacts of the charge socket. Only wipe off. Do not spray. 2.4 Preparation of the dentist unit 2.4.1 Reprocessing of handle and holder pad/anti-slip mat The handle of the TM table cannot be detached. 9 / 40

2 Setup methods according to DIN EN ISO 17664 2.4 Preparation of the dentist unit Cleaning and disinfection of the handle TM table / cart Clean the handle with a soft cloth and water, and wipe-disinfect it with an approved surface disinfectant. Cleaning and disinfection of S-table handle and holder pad/anti-slip mat Press the push button and pull off the handle. Clean the handle under flowing water. Disinfect the white and grey handle by wiping or thermodisinfection (minor discolouration may occur). Sterilise the holder pad and anti-slip mat by thermodisinfection. 10 / 40

2 Setup methods according to DIN EN ISO 17664 2.4 Preparation of the dentist unit Sterilisation of S-table handle and holder pad/anti-slip mat Damage caused by sterilisation. Do not sterilise the white standard handle. Sterilise the holder pad/ anti-slip mat. The grey handle (Mat. no. 1.002.4489) can be sterilised (see symbol on the handle). 2.4.2 Reprocessing of the instrument holder of the TM table The handpiece holder (Mat. no. 3.001.4229) can be removed to facilitate cleaning. Cleaning and disinfection of the instrument holder Damage caused by thermodisinfection. Do not thermodisinfect the instrument holder. Place the instrument hoses in the provided places of the germ reduction attachment during the cleaning and germ reduction of the handpiece holder. 11 / 40

2 Setup methods according to DIN EN ISO 17664 2.4 Preparation of the dentist unit Pull the latches evenly outward and carefully remove the handpiece holder. Clean the handpiece holder under running water. Wipe-disinfect the instrument holder. Sterilize the instrument holder Damage caused by sterilisation. Do not sterilise the instrument holder. 2.4.3 Reprocessing of the instrument arm S table The instrument arm S table (Mat. no. 1.007.4756) can be removed to facilitate cleaning. Cleaning and disinfection of the instrument arm S table Damage caused by thermodisinfection. Do not sterilise the instrument arm S table by thermodisinfection. Neither the rinsing program nor the intensive germ reduction can be carried out when the instrument arm is removed. Switch off the unit at the main switch. 12 / 40

2 Setup methods according to DIN EN ISO 17664 2.4 Preparation of the dentist unit Fit the germ reduction attachment to the spittoon bowl. Take the handpieces off the hoses. Take the roller out of the instrument arm and then place the hose in the germ reduction attachment. Pull-off the swing-arm in an upward direction. Clean the swing-arm and roller under running water. Wipe the instrument arm S table with disinfectant. Sterilisation of instrument arm S table Damage caused by sterilisation. Do not sterilise the instrument arm S table 13 / 40

2 Setup methods according to DIN EN ISO 17664 2.4 Preparation of the dentist unit 2.4.4 Setting up the 3-function and multifunction handpiece Wet the O-rings of the gripping sleeves after sterilisation using silicone grease (Mat. no. 1.000.6403) or KaVo Rota Spray 2 (Mat. no. 0.411.7510). After replacing the cannula, the air channel must be blown out before the start of treatment to ensure that the air exiting during treatment is dry. Cleaning the triple-function and multifunctional handpiece Automatic cleaning Not applicable. Damage caused by improper cleaning/disinfection. Do not wash the gripping sleeve and the cannula in the thermodisinfector. Do not sterilise the gripping sleeve and the cannula in the hot-air steriliser. Do not place the gripping sleeve and the cannula in a disinfectant or ultrasonic bath. Manual cleaning Combine manual cleaning with disinfection. Cleaning the interior Leave the gripping sleeve and cannula on the instrument, and activate the air and water for 60 seconds. External cleaning Danger of injury if the valve body is hot (heating elements, high-pressure lamp). Risk of burn injury. Switch off the unit at the main switch. Let the handpiece cool after long use. Accessories required: Tap water 30 o C ± 5 o C Brush, e.g. medium-hard toothbrush Disassemble the gripping sleeve and cannula. Detach the key part from the gripping sleeve. Clean the key part, gripping sleeve and cannula by brushing them under running water (at least tap water quality). Immediately remove contamination from materials used in the dental practice (impression materials, caustic chemicals). 14 / 40

2 Setup methods according to DIN EN ISO 17664 2.4 Preparation of the dentist unit Carefully wipe off contamination from the cannula tip with a soft Q-tip or soft cloth and water. Damage caused by using a nozzle needle that is too long. Damage to the internal hoses of the cannula. Use a short nozzle needle (Mat. no. 1.004.4986) to clean the media exit holes. Carefully remove contamination from the media exit ports using the short nozzle cleaning needle. Disinfection of the 3-function and multifunction handpiece Manual disinfection External disinfection Wipe-disinfect the surfaces with a soft cloth. Automatic disinfection Not applicable. Damage caused by improper cleaning/disinfection. Do not wash the gripping sleeve and the cannula in the thermodisinfector. Do not sterilise the gripping sleeve and the cannula in the hot-air steriliser. Do not place the gripping sleeve and the cannula in a disinfectant or ultrasonic bath. Drying the 3-function and multifunction handpiece Manual drying Blow off the outside and inside with compressed air until water drops are no longer visible. Automatic drying Not applicable. Care of the 3-function and multifunctional handpiece Requirement The multifunctional handpiece has been reprocessed. 15 / 40

2 Setup methods according to DIN EN ISO 17664 2.4 Preparation of the dentist unit Apply KaVo silicone grease (Mat. no. 1.000.6403) or KaVo Rota Spray 2 (Mat. no. 0.411.7510) to the O-rings of the joint between the gripping sleeve and cannula. Use cotton buds for this purpose. Sterilising the 3-function and multifunction handpiece The grip sleeve and cannula can be sterilised. Hold the 3-way or multifunctional handpiece at the gripping sleeve and take off the cannula with a slight twisting motion. Pull the gripping sleeve off the valve body. Sterilization in a steam sterilizer in compliance with DIN EN 13060 Weld the cannula and grip sleeve in sterile goods packaging. Sterilise with a triple fractionated vacuum (B class steriliser); hold for 4 minutes; 134 C ± 1 C; overpressure: 2.13 bar. Damage caused by over-heating. Damage to the gripping sleeve. Immediately remove the parts from the steriliser after the sterilisation cycle is completed. Storage Reprocessed products should be stored protected from dust with minimum exposure to germs in a dry, dark and cool place. 2.4.5 Preparation of the instrument hoses Cleaning and disinfection of instrument hoses Clean the hoses and couplings with a cloth and water. Damage caused by spray disinfection. Do not subject instrument hoses to spray disinfection. Subject instrument hoses to wipe disinfection. 16 / 40

2 Setup methods according to DIN EN ISO 17664 2.4 Preparation of the dentist unit 2.4.6 Servicing the turbine return air filter Cleaning the turbine return air filter The liquid collector must be checked weekly. If there is any liquid in the filter, drain the liquid and replace the O-rings of the multiflex couplings. If necessary, replace the turbine return air filter (Mat. no. 0.200.3098) and clean the filter holder. The turbine return air filter is in the same position in the dentist element variant with S table. 2.4.7 Reprocessing KaVo ERGOcam One The camera handle cannot be sterilised or disinfected with heat. Cleaning Disinfect the camera before cleaning. Disinfect after cleaning if necessary. Exterior cleaning by hand Damage to camera due to improper cleaning. To avoid the surface or optical system of the camera being destroyed: Do not use abrasives or aggressive cleaning substances Do not immerse camera in water or other fluids Switch main device switch off. Remove the camera. 17 / 40

2 Setup methods according to DIN EN ISO 17664 2.4 Preparation of the dentist unit Clean the surface with a soft cloth and mild liquid cleaning agent. Disinfection Exterior disinfection by hand WARNING Highly flammable gases-. Explosion. Allow product to cool before disinfecting. Damage to the camera due to improper disinfection. Irreversible destruction of the camera. Disinfect with wipes only, do not use disinfectant sprays. Do not immerse the camera in liquids. Do not sterilise the camera in an autoclave! Do not store the camera in steri pack. Do not sterilise the camera with hot air or thermo disinfectant. Switch main device switch off. Allow the camera to cool down. Remove the camera. Disinfect the surface using a soft wipe and disinfectant. Approved disinfectants: CaviCide / CaviWipes (Metrex) Microcide AF Liquid (Schülke & Mayr) 18 / 40

2 Setup methods according to DIN EN ISO 17664 2.5 Reprocessing of the assistant unit FD 322 (Dürr Dental) Incidin Liquid (Ecolab) The exterior of the camera and camera hose can be disinfected with chemical disinfectants. Comply with the manufacturer's instructions for use with regard to the application range. and exposure time. Material damage due to use of non-approved disinfectant. Damage to the camera. Use approved disinfectants only. 2.5 Reprocessing of the assistant unit 2.5.1 Preparing the instrument holder The instrument holder on the assistant unit is prepared in the same way as the instrument holder on the dentist unit. See also: 2 2.4.2 Reprocessing of the instrument holder of the TM table, Page 11 2.5.2 Preparing the connector for the suction hose Remove connectors 1 and 2 from the suction hoses. Cleaning and disinfection of the suction hose connector Clean the disassembled parts under running water. Thermodisinfect the disassembled parts for at least 10 minutes at 93 C (total cycle: approximately 20 minutes) Sterilising the suction hose connector Damage caused by sterilisation. Do not sterilise the suction hose connector. Sterilise the suction cannulas according to the manufacturer's instructions. 19 / 40

2 Setup methods according to DIN EN ISO 17664 2.6 Preparation of the patient unit 2.5.3 Reprocessing of sieve inserts and suction hoses Check the sieve inserts daily and after each surgery. The sieve inserts must be replaced at the latest when the suction decreases (Mat. no. 0.763.3423). Cleaning is not recommended for hygienic reasons. Remove the suction hoses from the holder. ð The suction motor starts automatically when the suction tubes are removed from the holder. Hold the cloth under the sieve seat, and pull the sieve insert out of the housing. If needed, insert a new sieve insert (Mat. no. 07633423) into the seat. Wipe the suction tubes with disinfectant. 2.6 Preparation of the patient unit 2.6.1 Preparation of the tumbler Reprocess as specified by the manufacturer. 2.6.2 Preparation of the tumbler holder and filler Water in the device. Material damage from leaking water upon actuation of the "Tumbler filler" or "Bowl flush" keys. Make sure that the unit is turned off before removing the tumbler filler or the spittoon bowl. Always check the correct seating of tumbler filler and spittoon bowl before turning on the unit. Cleaning and disinfection of the tumbler holder and filler When assembling, make sure that the O-ring is present on the tumbler filler. 20 / 40

2 Setup methods according to DIN EN ISO 17664 2.6 Preparation of the patient unit Inspect the O-ring (Mat. no. 0.200.6128) for damage and exchange if necessary to prevent water or oxidation damage. Remove the tumbler filler 1 (Mat. no. 0.764.8541) by pulling upwards. Take off the tumbler holder 3 (Mat. no. 07646153). Clean the tumbler holder and tumbler filler under running water. Wet the O-ring 2 (Mat. no. 02006128) with silicone grease (Mat. no. 10006403). Damage caused by thermodisinfection. Do not subject the tumbler holder to thermodisinfection. The tumbler filler can be subjected to thermodisinfection. Sterilisation of the tumbler holder and filler Damage caused by sterilisation. Do not sterilise the tumbler holder and filler. 21 / 40

2 Setup methods according to DIN EN ISO 17664 2.6 Preparation of the patient unit 2.6.3 Preparation of the spittoon Water in the device. Material damage from leaking water upon actuation of the "Tumbler filler" or "Bowl flush" keys. Make sure that the unit is turned off before removing the tumbler filler or the spittoon bowl. Always check the correct seating of tumbler filler and spittoon bowl before turning on the unit. Cleaning and disinfection of the spittoon bowl Damage caused by inappropriate cleaning agents. Do not use acid-containing, sand-containing, and form-forming cleaning agents. Add a dose of DEKASEPTOL gel to the spittoon bowl and distribute the agent with a brush. For cleaning, allow the gel to act for approx. 5 minutes. For disinfection, allow the gel to act for approx. 15 minutes. After letting it work, press the "Spittoon bowl" button. Clean the spittoon bowl thoroughly using a brush. For thorough cleaning or thermodisinfection, rotate the spittoon bowl and lift it off. Damage caused by thermodisinfection. Do not subject spittoon bowls made of glass to thermodisinfection. The spittoon bowl made of porcelain can be subjected to thermodisinfection. 22 / 40

2 Setup methods according to DIN EN ISO 17664 2.7 Manual reprocessing of the water-conducting system 2.7 Manual reprocessing of the water-conducting system Using the "Water block, compact", a water bottle or the Water block DVGW assembly kit with integrated germ reducing facility but no intensive germ reduction assembly kit, the water-conducting system must be rinsed manually. The automatic hygiene functions are available through the intensive germ reduction assembly kit only. WARNING Risk of infection if the "Water block, compact" is used without additional safeguards. Contamination of the treatment water and/or drinking water supply with germs. With regard to the "Water block, compact" assembly kit, please note that no disinfection facility is installed in the unit, and take appropriate safeguards. KaVo recommends to use the "Water block DVGW with integrated water disinfection facility in combination with KaVo OXYGENAL 6 (Mat. no. 04893451). If the Water bottle kit is used with the enclosed dosing attachment (Mat. no. 10020287), add the proper amount of KaVo OXYGENAL 6 (Mat. no. 04893451) with each filling. For the correct amount, please refer to the Instructions of the dosing attachment for water disinfection. Manual reprocessing procedure: Before first start-up and after the device has not been used for a while (weekends, holidays, vacation times, etc.) Before you start working After each patient (short rinsing programme of 20 seconds) Rinse all water outlets without handpieces for 2 minutes and actuate tumbler filler repeatedly. Before first start-up and after the device has not been used for a while, briefly blow air through the air lines. 2.8 Automatic hygiene functions of the water conducting system Intensive germ reduction kit and water block DVGW required. Health damage due to germ formation. Infection hazard. Before starting, rinse all the water drain lines without instruments. Before start-up and after the device has not been used for a while (weekends, holidays, vacations, etc.), rinse or purge with air the air and water lines. Carry out an intensive germ reduction. Actuate the tumbler filler repeatedly. The water-conducting system includes all water ducts of the treatment unit to which the patient may be exposed. This includes the handpieces on the dentist element and assistant element as well as the tumbler filler on the spittoon bowl of the treatment centre. 23 / 40

2 Setup methods according to DIN EN ISO 17664 2.8 Automatic hygiene functions of the water conducting system During normal operation of the treatment centre, the continuous germ reduction function secures continuous germ reduction in the water conducting systems due to the automatic dosing of the disinfectant, KaVo OXYGENAL 6. The rinsing programme and the intensive germ reduction facilitate the automatic rinsing and germ reduction of the water-conducting system. This counteracts the formation of micro-organisms in times of stagnation and ensures hygienic water supply for the patients. 2.8.1 Rinsing programme The rinsing programme 02 provides for automatic rinsing of the water-conducting system and all the instruments including the tumbler filler for 2 minutes each (hydrogen peroxide concentration 0.02 %). In the short rinsing programme 01, all instruments on the dentist unit and assistant unit are rinsed for 20 seconds each. Carry out the rinsing programme: before you srat working after each patient (short rinsing programme) Briefly press the "Intensive germ reduction" button. Preparation for rinsing programme and intensive germ reduction Position the germ reduction attachment on the porcelain spittoon bowl. Place the instruments on the sterilisation attachment The cannula of the triple-function and multifunctional handpieces must be removed for the rinsing program and the intensive germ reduction. S-table Lock the swing-arm into the front catching position to ensure that the handpiece is removed. 24 / 40

2 Setup methods according to DIN EN ISO 17664 2.8 Automatic hygiene functions of the water conducting system In the case of swing-arms without a catching function, insert the swing-arm lock (Mat. no. 1.008.1511) to ensure that the handpiece is removed. Hold the 3-way or multifunctional handpiece at the gripping sleeve and take off the cannula with a slight twisting motion. Insert the triple-function or multifunctional handpieces without the cannula into the clamping device of the germ reduction attachment. Make sure that the "W" button (water) of the triple-function or multifunctional handpiece is activated, and that no air is exiting. Place the instrument hoses of the dentist and assistant elements in the corresponding places of the germ reduction attachment. Support tubing with the enclosed holder. All water regulation mechanisms for the motor, instruments, and multiflex couplings must be open. Place the COMFORTbase on the rinsing attachment A seat adapter for the germ reduction attachment is available for the COMFORTbase. 25 / 40

2 Setup methods according to DIN EN ISO 17664 2.8 Automatic hygiene functions of the water conducting system For the rinsing programme and intensive germ reduction, press the seat adapter into one of the four rubber seats of the germ reduction attachment. Place the COMFORTbase in the seat adapter. Carry out the rinsing programme Set rinsing time Requirement The MEMOspeed licence is activated. Press the "decrease value" or "increase value" keys to select rinsing program 01 "Programm vorbereiten: 01" or rinsing program 02 "Programm vorbereiten: 02". ð The standard value for rinsing program 01 is 00:20 minutes per instrument. ð The standard value for rinsing program 02 is 2:00 minutes per instrument. M T Press the foot pedal to display the time for rinsing the instrument hoses and the three-function or multifunctional handpiece. With the foot pedal of the foot control being pressed down, the rinsing time for the respective rinsing programme can be set in the range from 00:01 to 4:00 minutes using the "Decrease value" and "Increase value" buttons. The rinse program proceeds in four steps. For rinse program 01, the cycle starts in step 2, and for rinse program 02, the cycle starts in step 4. Step Description 4.0 Fresh water supply Duration: 60 seconds 3.0 Tumbler rinsing Duration: 20 seconds 2.0 Rinsing of the handpieces The rinsing time can be set variably for each handpiece. Standard setting: Rinsing programme 01 = 20 seconds per instrument Rinsing programme 02 = 2 minutes per instrument 1.0 Rinsing the triple-function and multifunction handpiece Set rinsing time of rinsing programme 01 or 02 26 / 40

2 Setup methods according to DIN EN ISO 17664 2.8 Automatic hygiene functions of the water conducting system Step Description 0.1 Waiting position for setting down the handpieces Start rinsing programme The rinsing program can be started immediately or the next morning. Briefly press the "Intensive germ reduction" button to immediately start the process. ð The selected rinse program starts. or Turn off the device and do not restart it until the next morning. ð The cycle is started automatically. The rinsing time follows rinsing program 02. If the device is not used the entire day (i.e., the instruments are not mounted), the rinsing program automatically starts the next morning when the device is turned on. The rinsing programme can be stopped at any time by pressing the "intensive germ reduction" key. If the device is turned off and then on again, the rinsing program also stops. 2.8.2 Intensive germ reduction Observe the instructions for use for the instruments. Intensive germ reduction prevents the formation of microorganisms during extented periods when the equipment is out of use. During intensive germ reduction, the afferent water ducts are automatically filled with a higher concentration of KaVo OXYGEN AL 6. The intensive germ reduction program lasts ca. 45 minutes. The increased hydrogen peroxide concentration acts in the system for at least 30 minutes. An additional intensive germ reduction must be carried out during extended downtimes (> 4 weeks). The need for intensive disinfection is automatically displayed in the top LED of the "Intensive germ reduction" button at first start-up and after downtimes (weekend, holidays, vacation, etc.). If an audible signal is issued every 10 seconds and the bottom LED of the "Intensive germ reduction" button flashes, the KaVo OXYGENAL 6 must be replenished. If a beep is issued during the filling process (10 times at a one-second interval), the container is full. See also: 2 Replenish OXYGENAL 6 The suction device cannot be used during the HYDROclean step (4.6). 27 / 40

2 Setup methods according to DIN EN ISO 17664 2.8 Automatic hygiene functions of the water conducting system If the amalgam separator malfunctions during intensive germ reduction, the entire process is stopped. The bottom LED of the "HYDROclean" button flashes. Intensive germ reduction must be carried out: At first start-up Before, during and after prolonged downtimes (more than 4 weeks) Over the weekend During vacations After treatment of patients at high risk Start intensive germ reduction Press the "Intensive germ reduction" button for more than 4 seconds until you hear an acoustic signal and the upper LED of the "intensive germ reduction" button flashes. The display switches to the intensive germ reduction menu. Perform the preparations for intensive germ reduction. See also: 2 2.8.1.1 Preparation for rinsing program and intensive germ reduction, Page 24 Press the "Intensive germ reduction" button. ð This starts up the intensive germ reduction, which proceeds through several stages. The process can be followed on the display. The major steps are listed below. Step Description 7.0 Germ reduction of the triple-function and multifunctional handpiece and the spittoon bowl Duration: 60 seconds 6.0 Disinfection of the handpieces Duration: 30 seconds each 5.0 Disinfection of the tumbler Duration: 40 seconds 4.0 Dwell time (acoustic signal, switch off is possible) Duration: 30 minutes 3.0 Rinsing of the tumbler Duration: 40 seconds 2.0 Rinsing of the handpieces Duration: 30 seconds 1.0 Rinsing of the triple-function and multifunctional handpiece Duration: 30 seconds 0.1 Waiting position for setting down the handpieces Intensive germ reduction is completed when "01 intensive germ reduction completed" appears on the display. Put all handpieces in holders and take off the germ reduction attachment. 28 / 40

2 Setup methods according to DIN EN ISO 17664 2.8 Automatic hygiene functions of the water conducting system Interrupt intensive germ reduction during the dwell time So that no one will have to remain with the device throughout the entire intensive germ reduction process, intensive germ reduction can be interrupted in program step 4 (e.g. on the last workday before the weekend). Program step 4 is the dwell time, in which the microorganisms are killed by an increased OXYGENAL 6 concentration. Requirement intensive germ reduction is in program step 4. Requirement You hear a beep for 4 seconds. Turn the device off. When the device is switched on after 30 minutes of dwell time, the remaining program steps run immediately and automatically. If the device is turned on before the 30 minute period is elapsed, the dwell times finishes first before the remaining steps of the intensive germ reduction program run. Skip exposure phase This function is required when the treatment unit needs to be used (for example in an emergency, at hospitals, etc.) even though the germ reduction procedure has already started. See also: 2 2.8.1.2 Procedure of the rinsing program, Page 26 Intensive germ reduction is in step 4: Press and hold down the "Hydroclean" and "Intensive germ reduction" keys. M Simultaneously press the foot pedal on the foot control. T ð The intensive germ reduction switches to step 3.7. ð The automatic rinsing process starts up. Intensive germ reduction during extended periods of non-use (> 4 weeks) During extended periods of non-use, e.g. semester breaks at university, intensive germ reduction must be carried out during the time of non-use. The germ reduction fluid remains inside the system during the period of non-use. Before the period of non-use Start the intensive germ reduction and stop it in step 4 after the signal tone during the dwell time of 30 minutes. To prevent damage due to hoses getting kinked, remove hoses from the germ reduction attachment and place them in the dentist support. Keep the germ reduction attachment in the spittoon bowl. 29 / 40

2 Setup methods according to DIN EN ISO 17664 2.9 Reprocessing and automatic hygiene functions of the suction system Cover the treatment unit during extended periods of non-use. After the period of non-use Turn on the central compressor. Switch on the water supply for the treatment unit after the system pressure is achieved. Replace the instrument hoses of the dentist and assistant units in the places provided in the germ reduction attachment. Turn the treatment unit on. ð The unit automatically starts the remaining steps of the unfinished cycle. Allow the cycle to complete and then carry out a second full intensive germ reduction. ð The unit is now ready for use. Additional intensive germ reduction during period of non-use KaVo recommends carrying out an additional intensive germ reduction at universities during semester breaks. This flushes the parts of the unit and replaces the germ reduction liquid. 2.9 Reprocessing and automatic hygiene functions of the suction system 2.9.1 Reprocessing of the suction system including suction hoses Cleaning and disinfection of the suction system including suction hoses Clean the suction hoses after each treatment and disinfect them with DEKASEP TOL Gel daily. Application of DEKASEPTOL Gel Aspirate one tumbler of cold water with each suction hose. With the suction handpiece attached or by hand, press down the DEKASEPTOL dosing facility once each for the saliva ejector hose and the spray mist ejector. Aspirate the DEKASEPTOL Gel from the dosing facility. Aspirate another tumbler of cold water with each suction hose. Finally, aspirate another dose of DEKASEPTOL Gel and allow it to act. Place the suction hoses in the holder. DEKASEPTOL Gel basic set DEKASEPTOL Gel refill canister Mat. no. 10007204 Mat. no. 10007205 30 / 40

2 Setup methods according to DIN EN ISO 17664 2.10 Preparation of the amalgam separator 2.9.2 HYDROclean function The HYDROclean function is an automatic programme for hydro-mechanical cleaning of the drainage and separation systems within and outside the treatment unit. The cleaning process is carried out by the supply of fresh, clear water (limited rinsing). The water is aspirated from the Aquamat through the filter housing to the separation system. The spittoon bowl rinsing is alternately turned on and off. The HYDROclean function prevents the coagulation and adhesion of proteins inside the drainage system and improves the transporting of fine particles. Carrying out the HYDROclean function: After each treatment Preparation Requirement Suction hoses remain hanging in the holder. Press the "HYDROclean" button. ð The HYDROclean function is in the preparatory stage. Start the HYDROclean function Press the "HYDROclean" button. ð This starts-up the HYDROclean function. The HYDROclean function is completed when the top LED goes dark. The process can be discontinued at any time by pressing the "HYDROclean" button. 2.10 Preparation of the amalgam separator The following systems can be used as options: "Dürr" Amalgam separator Preparation for external wet suction for connection to a central amalgam separator "Dürr" separation kit 31 / 40

2 Setup methods according to DIN EN ISO 17664 2.11 Reprocessing KaVo Screen One / KaVo Screen HD Optimal care of the amalgam separation system includes the correct and regular use of the HYDROclean function and use of DEKASEPTOL gel. See also: 2 2.9 Reprocessing and automatic hygiene functions of the suction system, Page 30 follow the instructions for use for the amalgam separator. 2.11 Reprocessing KaVo Screen One / KaVo Screen HD Cleaning and disinfection Non-colour-fast textiles. Non-colour-fast textiles can cause permanent discoloration. Remove discolourations with water immediately. Damage caused by spray disinfection. Disinfectant gets into cracks and loosens the paint. No spray disinfection. Only disinfect by wiping. Clean the surfaces with a soft cloth and water, and wipe-disinfect them with an approved surface disinfectant. Approved disinfectants: CaviCide / CaviWipes (Metrex) Microcide AF Liquid (Schülke & Mayr) FD 322 (Dürr Dental) Incidin Liquid (Ecolab) 32 / 40

3 Replenish and check the disinfectant Care instructions Primus 1058 Life 3 Replenish and check the disinfectant 3.1 Replenish OXYGENAL 6 3.1 Replenish OXYGENAL 6 The only permissible agent for use in KaVo water germ reduction systems is KaVo OXYGENAL 6 (Mat. no. 04893451). The OXYGENAL 6 consumption depends on the water consumption during the treatment of patients. When the OXYGENAL 6 container is empty, you hear an acoustic signal every 10 seconds. Replenish KaVo OXYGENAL 6 only if the acoustic signal is issued every 10 seconds. The signal can be turned off as follows: Hold down the control pedal, and move the backrest up and down. The next time the treatment unit is turned on, the signal sound is issued again. Remove rinsing tumbler filler 1 and cover 2. Fill-up with KaVo OXYGENAL 6 (max. 1 litre). Do not fill through the centre opening (tumbler drain). 33 / 40

3 Replenish and check the disinfectant 3.1 Replenish OXYGENAL 6 Quit replenishing immediately if you hear a signal sound being issued every second (10 sounds). ð Reservoir is full. Attach the tumbler holder and the tumbler filler. Check the O-ring on the tumbler filler for damage. 3.1.1 Replenish OXYGENAL 6 when using the water bottle Overdosing OXYGENAL. Using the water bottle in combination with water block DVGW, there is no need to add more OXYGENAL 6 into the water bottle. Damage caused by defective water bottle. Malfunctions or failures from a leaky water bottle. Do not wash the water bottle in a dish washer, and do not rinse it with water hotter than 50. Do not use the water bottle if it is scratched, deformed or discoloured. the maximum useful life of the water bottle on the label. Water bottle complete: (Mat. no. 0.710.4151) Dosing attachment: (Mat. no. 1.002.0287) 34 / 40

3 Replenish and check the disinfectant 3.1 Replenish OXYGENAL 6 Removing and cleaning the water bottle Slowly turn the water bottle counterclockwise to take it off. This allows the over-pressure to be released slowly from the water bottle. The water in the water bottle needs to be changed at least one daily. In order to ensure the efficiency of the measures, KaVo urgently recommends reprocessing the water with KaVo OXYGENAL 6. For cleaning, rinse the water bottle with water at less than 50 o C. Filling the water bottle with the dosing facility. Wipe up any spilled OXYGENAL immediately in order to prevent discolouration of the surfaces. Remove the protective hose from the tube of the KaVo OXYGENAL 6 dosing facility. Guide the tube through the orifice of the coarse sieve of the KaVo OXYGENAL 6 bottle. Screw the KaVo OXYGENAL 6 dosing facility tightly to the KaVo OXYGENAL 6 bottle. Rotate the orifice in the lid to a filling level of 1.5 litres. ð Lid snaps-in in the filling position. 35 / 40

3 Replenish and check the disinfectant 3.1 Replenish OXYGENAL 6 Place the KaVo OXYGENAL 6 bottle on a level surface. Squeeze the KaVo OXYGENAL 6 bottle until the germ reduction liquid rises above the red marker. ð In response to over-filling, the excess quantity above the tick mark is aspirated automatically to ensure exact dosing. Place the water bottle in the KaVo OXYGENAL 6 bottle. Make sure that the spout of the KaVo OXYGENAL 6 dosing facility (nose) is situated right above the opening of the water bottle. Then fill-up the water bottle with tap water. 36 / 40

3 Replenish and check the disinfectant 3.2 Check the OXYGENAL 6 concentration Substances remaining in the dosing head are not contamination, but rather agents that are deposited there during extended periods of non-use after condensation of the water. These deposits redissolve after several dosing processes. Screw the water bottle tightly to the treatment centre in a clockwise rotation. ð Apply compressed air to the water bottle. 3.2 Check the OXYGENAL 6 concentration Fill the tumbler with water. Use Merckoquant peroxide test strips 100 to 1000 mg/l H 2 O 2 (Mat. no. 0.229.5003) to determine the OXYGENAL 6 concentration in the water germ reduction system. The OXYGENAL 6 concentration should be in the range from 150 to 250 mg/l H 2 O 2 in normal operation. 37 / 40

1.011.8575 Fk 20151215-1 en