Related Manuals for KaVo KEY Laser 3+ 1343
Summary of Contents for KaVo KEY Laser 3+ 1343
- Page 1 Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded Always be on the safe side.
- Page 2 Distributed by: Manufacturer: KaVo Dental GmbH Kaltenbach & Voigt GmbH Bismarckring 39 Bismarckring 39 D-88400 Biberach D-88400 Biberach Tel. +49 7351 56-0 www.kavo.com Fax +49 7351 56-1488...
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Page 3: Table Of Contents
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded Table of contents Table of contents User instructions ............................4 1.1 Service .............................. 4 1.2 Purpose – Proper use ........................4 1.2.1 Training opportunity ......................4 1.2.2 Effects ..........................5 1.2.3... - Page 4 Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded Table of contents 4.4 Switching on ............................ 34 4.4.1 Energy-saving mode ......................36 4.5 Using the touchscreen ........................36 4.6 Ready state ............................. 37 4.6.1 Trigger laser pulses ......................38 4.6.2...
- Page 5 Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded Table of contents Safety checks ............................62 6.1 Scope of tests ..........................62 6.2 Safety check of energy ........................62 6.3 Handpieces ............................. 63 6.4 Protective conductor test according to DIN VDE 0751 Part 1 ............63 6.5 Replacement device leakage current test according to DIN VDE 0751 Part 1 .......
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Page 6: User Instructions
The KaVo KEY Laser 3+ / III upgraded is a universally usable erbium laser for den‐ tistry in the dental environment for oral, jaw and facial surgery. With its variable pulse lengths, it is appropriate for treating enamel, bone and concrements and for pro‐... -
Page 7: Effects
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 1 User instructions | 1.2 Purpose – Proper use 1.2.2 Effects The physiological and biological effects of laser radiation on tissue, safety consid‐ erations (effects on the eye) and treatment instructions are described in a separate application manual. - Page 8 Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 1 User instructions | 1.2 Purpose – Proper use Therapy Indications Contraindications Incision, excision Incision for draining abscesses. Malignant tumours, obligate pre‐ Frenectomy, incision of cheek liga‐ cancerous tumours, hemangiomas...
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Page 9: Important Instructions
Additional steps for installation or startup as well as service of the KEY Laser 3+ / III upgraded must be performed by a technician trained by KaVo. These steps are described in training documents. The technician obtains these after successfully completing training for the KEY Laser 3+ / III upgraded. -
Page 10: Packaging Ordinance Of August 28,1998
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 1 User instructions | 1.4 Packages 1.4.2 Packaging ordinance of August 28,1998 Note Only valid for the Federal Republic of Germany Properly dispose of and recycle the sales packaging according the applicable pack‐... -
Page 11: Safety
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 2 Safety | 2.1 Safety instructions 2 Safety 2.1 Safety instructions 2.1.1 Description of danger levels Safety instructions with three hazard levels are used in this document for avoiding personal and property damage. -
Page 12: Laser Safety
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 2 Safety | 2.2 Laser safety 2.2 Laser safety 2.2.1 Safety instructions Medical Device Law (only applicable for Germany) The KEY 3+ / III upgraded is a class II b device according to EC directive 93/42/ EEC. -
Page 13: Safe Use
▶ Put electronic devices such as e.g. computer storage media, hearing aids etc. down during operation! The KaVo product is not permitted to be used in areas subject an explosion hazard. The user must ensure that that the unit works properly and is in a satisfactory con‐... - Page 14 Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 2 Safety | 2.3 Safe use CAUTION Hazard of air embolism and skin emphysema. There is a danger that the insufflation of spray in open wounds in the surgical area can cause air embolisms and skin emphysema.
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Page 15: Disposal Of Electronic And Electrical Devices
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 2 Safety | 2.3 Safe use Pacemakers CAUTION Risks from electromagnetic fields. The functions of implanted systems (such as pacemakers) can be influenced by electromagnetic fields. ▶ Observe current updates in journals. -
Page 16: Personal Eye Protection
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 2 Safety | 2.3 Safe use International (EU) For country-specific information on disposal, contact your dental supplier. 2.3.3 Personal eye protection All of the persons that are in the range of the laser during treatment must wear laser safety goggles. -
Page 17: Safe Laser Range
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 2 Safety | 2.4 Safe laser range CAUTION Damage from incorrect accessories The use of other accessories, transformers and lines than those indicated (with the exception of transformers and lines that KaVo sells as replacement parts for in‐... -
Page 18: Warning Lamps
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 2 Safety | 2.5 Electromagnetic compatibility 2.4.1 Warning lamps In the planning stage, make sure that warning lights are installed at all entrance doors to the treatment rooms in which the KEY Laser 3+ / III upgraded is operated. -
Page 19: Electromagnetic Transmissions
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 2 Safety | 2.5 Electromagnetic compatibility 2.5.1 Electromagnetic Transmissions Measurements of noise transmis‐ Conformance Electromagnetic environment - sions guidelines HF transmission according to Group 1 The KEY Laser 3+ / III upgraded... - Page 20 Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 2 Safety | 2.5 Electromagnetic compatibility Immunity tests IEC 60601 test level Conformance level Electromagnetic environ‐ ment - guidelines Voltage interruptions, < 5% U < 5% U The quality of the supply...
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Page 21: Recommended Safe Distances
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 2 Safety | 2.5 Electromagnetic compatibility The conformance levels in the ISM frequency bands between 150 kHz and 80 MHz and the frequency range of 80 MHz and 2.5 GHz are intended to reduce the prob‐... -
Page 22: Device Description
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 3 Device description | 3.1 KEY Laser 3+ 1343 (Mat. no. 1.006.4200) 3 Device description 3.1 KEY Laser 3+ 1343 (Mat. no. 1.006.4200) ① Laser hose ⑥ Key-operated switch (on/off function) ②... -
Page 23: Multifunctional Foot Control
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 3 Device description | 3.1 KEY Laser 3+ 1343 (Mat. no. 1.006.4200) 3.1.1 Multifunctional foot control ① Step protector ④ Energy setting ② Ready button ⑤ Laser pulse trigger ③... -
Page 24: Rear Of The Laser Device
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 3 Device description | 3.1 KEY Laser 3+ 1343 (Mat. no. 1.006.4200) 3.1.2 Rear of the laser device Version A (230 V~ / 50 Hz / 60 Hz) ①... -
Page 25: Touchscreen
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 3 Device description | 3.2 Touchscreen Note Connection for external door contact: max. 5 V/10 mA (load of the door contact) max. 24 V/1 A (switch contact for external warning lamp) Do not connect external voltage with the door contact. -
Page 26: Type Plate And Power Rating Plate
If installed by KaVo The type and rating plates are on the back of the KEY Lasers III upgraded, and the plate for the upgrade version installed by KaVo (I, II or III) is next to them. Type: Device type... - Page 27 Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 3 Device description | 3.3 Type plate and power rating plate Follow instructions for use CE mark (statement of conformity) according to 93/42/EEC For disposal information, see use in accordance with intended purpose...
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Page 28: Location To Affix The Laser Warning Plates And Laser Reference
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 3 Device description | 3.4 Location to affix the laser warning plates and laser reference 3.4 Location to affix the laser warning plates and laser reference On the back of the laser unit, there is a triangle warning sign and the reference sign IEC 60825-1 . -
Page 29: Technical Data And Requirements
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 3 Device description | 3.5 Technical data and requirements In addition, the triangular laser warning sign and instructions sign are affixed where the laser hose is connected. Laser aperture distal end 3.5 Technical data and requirements... - Page 30 Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 3 Device description | 3.5 Technical data and requirements Operating conditions Ambient temperature 15 - 35 °C Relative humidity max. 85 % Condensate on unit not permissible Suitable for operation up to 2,000 m above sea level.
- Page 31 Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 3 Device description | 3.5 Technical data and requirements Heat emission 0.4 – 8 KJ/h Cooling air-cooled with internal water circuit Cooling water Conductivity below 10 µS/cm (refer to...
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Page 32: Operation
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.1 Emergency-off switch 4 Operation 4.1 Emergency-off switch The emergency off switch is for emergencies during normal operation. In confusing and hazardous situations, press the emergency off switch to immedi‐... -
Page 33: Laser Hose And Handpieces
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.3 Laser hose and handpieces Fill the spray water as indicated below. ▶ Open the flap ③ at the rear of the unit. ▶ Unscrew the spray water storage bottle ② clockwise. -
Page 34: Couple The Handpieces
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.3 Laser hose and handpieces CAUTION Dropping the laser hose. Damage to the coating and construction of the exit window. ▶ Do not let the laser hose drop. -
Page 35: Undo The Connection
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.3 Laser hose and handpieces ▶ Press the handpiece axially all the way onto the laser hose coupling until it per‐ ceptibly locks in place. -
Page 36: Switching On
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.4 Switching on ▶ Pull off the handpiece by twisting it axially. ▶ To prevent soiling the hose coupling window ② wipe off the laser hose coupling with a clean, dry cloth from back to front. - Page 37 Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.4 Switching on ▶ Turn on the main switch on the back of the device. ▶ Insert the key in the key-operated switch. ▶ Turn the key to the right to turn on the KEY Laser 3+ / III upgraded.
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Page 38: Energy-Saving Mode
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.5 Using the touchscreen The default values are displayed, and the unit switches to standby. Note Never leave the laser device turned on unsupervised. See also: 4.18 Switching off, Page 56 4.4.1 Energy-saving mode... -
Page 39: Ready State
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.6 Ready state Press the PAGE UP/PAGE DOWN keys to move the selection bar six lines up or down. Press the OK key to accept the setting that has been made and return to the higher- level menu. -
Page 40: Trigger Laser Pulses
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.6 Ready state 4.6.1 Trigger laser pulses A holder switch is integrated in the bearing of the swing arm that detects the rear, resting position of the swing arm. When the handpiece is removed, the swing arm swings out of its rear resting position, whereby the unit notices that the handpiece has been removed from its holder (handpiece holder switch). -
Page 41: Ending Ready Mode
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.7 Setting pulse energy and pulse frequency The KEY Laser 3+ / III upgraded independently switches from ready to standby when: ▪ A control element is not used for three minutes (touch screen, foot control, handpiece holder switch). -
Page 42: Select Pulse Frequency
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.8 User test with handpiece 2060 Note If the pulse energy is changed when the laser is in ready mode, the KEY Laser 3+ / III upgraded automatically switches to standby mode. -
Page 43: Modes
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.9 Modes ▶ Direct the handpiece toward a cotton ball or pad moistened with water. If the pilot laser is difficult to see, dissipated or cannot be seen at all, the laser exit window is probably dirty or damaged. -
Page 44: Switch Mode
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.9 Modes When the following points are not taken into consideration, the detection and feed‐ back values can be misinterpreted: ▪ Soiling ▪ Composite fillings that are fluorescent ▪... -
Page 45: S-Pulse (Short Pulses)
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.9 Modes 4.9.3 S-PULSE (short pulses) By using the S-PULSE function, you can switch to short pulses when working on hard tissue (programs 15 - 18) and thereby increase the individual pulse efficiency. -
Page 46: Setting The Threshold
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.10 Setting the threshold When the laser pulse trigger is actuated in Ready mode, laser pulses are only trig‐ gered if altered tooth substance is detected; that is, when the measured fluores‐... -
Page 47: Spray Settings
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.11 Spray settings Press the arrow key to reduce the threshold by one value. Note Once the minimum or maximum is reached, two beeps sound. -
Page 48: Footswitch
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.11 Spray settings Water and air Water No spray Press OK to accept the changed spray setting. Press Stop to return to the start menu without accepting the changed spray setting. -
Page 49: Spray Test
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.12 System menu 4.11.3 Spray test The spray test function is activated by holding down the spray button on the foot control. Use the graduated collar on the handpiece to regulate the amount of spray water. -
Page 50: Programs
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.13 Programs Note After the language is selected with the OK key, all of the texts including the pre‐ defined programs are reloaded. This means that a program reset is also triggered. -
Page 51: Delete Program
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.14 Program settings Press the Stop key to return to the start menu without accepting the selected pro‐ gram. 4.13.3 Delete program The predefined programs cannot be deleted. Only programs defined by the user can be deleted. -
Page 52: New Program
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.14 Program settings 4.14.1 New program If a new parameter setting has been generated in the parameter menu by changing the settings of an existing program, you can be saved as new programme. -
Page 53: Reset The New Settings
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.15 Handpiece selection Note The number of newly definable programs is limited. Once a total of 50 programs have been created, the message "NOTE: it is not possible to create an additional program"... -
Page 54: Detector Adjustment
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.16 Detector adjustment A maximum of six lines can be shown in the handpiece overview. Press the PAGE UP/PAGE DOWN keys to move the selection bar six lines up or down. -
Page 55: Check Or Change The Reference Value
If the letter on the touchscreen does not correspond to the letter on the reference, the corresponding reference should be obtained through the Customer Service Centre. For this purpose, it is essential to notify the contact person at KaVo of the letter code of the reference value which is displayed on the touchscreen. -
Page 56: Determining The Zero Value
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.16 Detector adjustment ▶ In the detector adjustment menu, press the START key to start adjustment. ▶ The user will be guided through the detector adjustment by the program. Follow the instructions on the touchscreen. -
Page 57: Complete Detector Adjustment
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.17 Spray regulation 4.16.5 Complete detector adjustment The following information appears on the touchscreen: "The detector adjustment was successfully completed!" Pressing the OK key saves the result and returns you to the start menu. -
Page 58: Switching Off
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.18 Switching off Turning it to the left increases the amount of water (long scale marks), and turning it to the right reduces the amount of water (short scale marks). -
Page 59: System Menu
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.19 System menu Press the main switch on the back of the unit to completely disconnect the unit from the mains. 4.19 System menu The system menu can be opened from the program menu by pressing the System menu key. - Page 60 Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 4 Operation | 4.19 System menu When selecting a language, a list of all available language files appears. Note After the language is selected with the OK key, all of the texts including the pre‐...
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Page 61: Setup Methods According To Din En Iso 17664
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 5 Setup methods according to DIN EN ISO 17664 | 4.19 System menu 5 Setup methods according to DIN EN ISO 17664 The instructions on cleaning and sterilisation were validated by the manufacturer of the medical device as suitable for preparation. -
Page 62: Manual Cleaning
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 5 Setup methods according to DIN EN ISO 17664 | 5.1 Manual cleaning As damage to the surface is very much dependent on the exposure time, it is vital that the affected areas are wiped down immediately with a moist cloth. -
Page 63: Automated Disinfection
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 5 Setup methods according to DIN EN ISO 17664 | 5.4 Automated disinfection 5.4 Automated disinfection Not applicable. 5.5 Sterilisation Not applicable. 5.6 Cooling circuit CAUTION Damage from tipping The laser device contains a water cooler for cooling. -
Page 64: Safety Checks
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 6 Safety checks | 6.1 Scope of tests 6 Safety checks CAUTION Damage due to improper servicing Using improper servicing tools can restrict the function or damage the unit. -
Page 65: Handpieces
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 6 Safety checks | 6.3 Handpieces Note Only energy meters that have been properly calibrated and monitored of the type Gentec SUN EM1, Gentec PRJ-M RS-232 or OPHIR NOVA are approved for the safety check of the energy of the KEY Laser 3+ / III upgraded. -
Page 66: Additional Tests
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 6 Safety checks | 6.6 Additional tests ▶ Document the measured value in the medical device reference. 6.6 Additional tests ▪ Visual check of the device and accessories ▪... -
Page 67: Safety Check Report (Example)
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 6 Safety checks | 6.7 Safety check report (example) 6.7 Safety check report (example) 65/76... -
Page 68: Accessories
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 7 Accessories | 7.1 Handpieces 7 Accessories Note The described safety instructions must be observed. See also: 2.2 Laser safety, Page 10 2.3 Safe use, Page 11 7.1 Handpieces... -
Page 69: Warning Signs
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 7 Accessories | 7.2 Warning signs The laser hose (Mat. no. 1.000.6774) and handpieces listed below have been tested and approved for use with the KEY Laser 3+ / III upgraded: ▪... -
Page 70: Laser Safety Goggles
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 7 Accessories | 7.3 Laser safety goggles Warning sign (Mat. no. 0.236.2440) 7.3 Laser safety goggles Laser safety goggles come with the KEY Laser 3+ / III upgraded. -
Page 71: References
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 7 Accessories | 7.4 references Protective laser goggles with mask design for the pa‐ tient and glasses wearer were available up to Novem‐ ber 2008. (Mat. no. 1.004.9809) Current protective laser goggles for the dentist and as‐... -
Page 72: Malfunctions
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 8 Malfunctions | 8.1 Error messages 8 Malfunctions 8.1 Error messages The user guidance system controlled by a microprocessor helps you operate the KEY Lasers 3+ / III upgraded with a touchscreen. In addition, there are numerous automatic self tests incorporated in the unit that control the device. -
Page 73: Troubleshooting
CAUTION Danger when opening the KEY Laser Damage to the device ▶ The KaVo KEY Laser 3+ 1343, KEY Laser III 1243 upgraded may only be opened and repaired by specially trained technicians. ▶ Never open the KEY Laser! Malfunction... - Page 74 Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 8 Malfunctions | 8.4 Troubleshooting Malfunction Cause Remedy The nozzle needle is in the ac‐ cessories. See also: Handpiece instructions. ▶ Cleaning the spray nozzle See also: Handpiece instructions.
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Page 75: Assembly Instructions
The castors may not be used on soft floors (rugs, etc.). The screed, floor covering, adhesive and floor sealant must be appropriate for castors. KaVo assumes no liability for any damage that may occur if the castors are im‐ properly used on different floor coverings. 9.2 Media 9.2.1 Spray water... -
Page 76: On The Unit 230 V Version
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded 9 Assembly instructions | 9.4 Transportation and storage 9.3.2 On the unit 230 V version ▪ Requirements for the power cable, the device-side and mains-side plugs: – 230 V rated voltage –... -
Page 77: What Should Be Done If There Is Damage From Transportation
▶ Do not touch the goods and packaging; do not use the goods. ▶ Report the damage to the shipping company. ▶ Within four days, contact the shipping department at KaVo. Tel.: 0 73 51 / 56 – ▶ Damaged goods cannot be returned before talking with KaVo. - Page 78 D D E E R R L L ASE ASERR RRA A U U M M M M U U SS SS I I M M E E I I N N G G A A N N G G SBE SBER R E E I I CH CH DURC DURCH H S S CH CHI I L L D D E E R R UND...