Operating Instruction GENTLEray 982 Bleaching. Always be on the safe side.

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Gervase Neal
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1 Operating Instruction GENTLEray 982 Bleaching Always be on the safe side.

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

3 Contents Contents Contents User instructions User guide Abbreviations Symbols Target group Service Warranty provisions Transportation and storage Currently valid packaging regulations Damage in transit Information on the packaging: Storage and transport Environmental conditions transportation and storage Safety Description of safety instructions Warning symbol Description of danger levels Structure Purpose Proper use Setup methods according to DIN EN ISO Cleaning Cleaning instructions Manual cleaning Machine cleaning Disinfection Manual disinfection Machine disinfection Sterilisation in a steriliser in compliance with DIN EN Control and function test Packaging and storage Bleaching handpiece Description Disassemble the bleaching handpiece Cleaning the lens Mount the lens connector Bleaching fibre Description Connecting the bleaching fibre to the bleaching handpiece Exchanging the bleaching fibre General bleaching procedure Preparations Select the bleaching gel Preparing the teeth Bleaching /27

4 1 User instructions 1.1 User guide 1 User instructions 1.1 User guide This document is a supplement to the GENTLEray 980 instructions for use. Both documents must be read to obtain the full instructions. Requirement Read these instructions before the initial startup to prevent misuse and damage Abbreviations Short form GA PA MA TA STK IEC RA EMC Explanation Instructions for use Care instructions Assembly instructions Instructions for technicians Safety check International Electrotechnical Commission Repair instructions Electromagnetic compatibility Symbols See the section Safety/Warning Symbols Important information for users and technicians CE mark (Communauté Européenne). A product with this mark meets the requirements of the corresponding EU Directive, i.e. the applicable European standard. Action required Follow instructions for use Target group This document is for dentists and office personnel. 2/27

1 User instructions 1.2 Service 1.2 Service Service hotline: +49 7351 56-2800 Service.Laser@kavo.

5 1 User instructions 1.2 Service 1.2 Service Service hotline: Please indicate the product serial number in all requests. Additional information can be obtained at: 3/27

6 1 User instructions 1.3 Warranty provisions 1.3 Warranty provisions KaVo provides the end customer with a warranty that the product cited in the handover certificate will function properly and guarantees zero defects in respect of material and processing for a period of 12 months from data of purchase, subject to the following conditions: In the event of justified complaints due to defects or short delivery, KaVo may choose to fulfil the terms and conditions of the warranty either by supplying a replacement product free of charge or repairing the defective product. Other claims of any nature whatsoever, in particular with respect to compensation, are excluded. In the event of default and 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 due to natural wear, improper cleaning or maintenance, non-compliance with operating, maintenance or connection instructions, calcination or corrosion, contaminated air or water supplies or chemical or electrical factors deemed abnormal or impermissible in accordance with factory specifications. The warranty does not usually cover bulbs, glassware, optical components, rubber parts and the colourfastness of plastics. Defects or their consequences that can be attributed to interventions on or changes made to the product by the customer or a third party are excluded from the warranty. Claims from this warranty can only be asserted when the transfer form (copy) belonging to the product has been sent to KaVo, and the original can be presented by the operator or user. 4/27

7 1 User instructions 1.4 Transportation and storage 1.4 Transportation and storage Currently valid packaging regulations Only applicable for the Federal Republic of Germany. KaVo transport packaging must be disposed of and recycled by local disposal service providers and recycling companies in accordance with Dual System requirements. For more information about disposal and recycling, and an up-to-date list of local disposal service providers and recycling companies, please visit the following Internet sites: KaVo will bring KaVo transport packaging returned by the customer at the customer's own cost to the appropriate recycling companies without reimbursement Damage in transit In Germany If external damage to the packaging is visible upon delivery, follow the procedure below: 1. The recipient must record the loss or damage in the notice of delivery. The recipient and employee of the transportation firm must sign the notice of delivery. 2. Leave the product and packaging unchanged. 3. Do not use the product. 4. Report damage to the shipping company. 5. Report damage to KaVo. 6. A damaged product cannot be returned before talking with KaVo. 7. Send the signed notice of delivery to KaVo. If the product is damaged and there is no discernable damage to the packaging upon delivery, proceed as follows: 1. Report damage immediately or at least 7 days after the delivery to the delivery company.. 2. Report damage to KaVo. 3. Leave the product and packaging unchanged. 4. Do not use a damaged product. If the recipient does not follow one of the above instructions, the damage will be held to have occurred after the delivery (according to ADSp. Art. 28).. 5/27

8 1 User instructions 1.4 Transportation and storage Outside Germany KaVo is not liable for damage arising from transportation. Immediately inspect the delivery after receipt! If external damage to the packaging is visible upon delivery, follow the procedure below: 1. The recipient must record the loss or damage in the notice of delivery. The recipient and employee of the transportation firm must sign the notice of delivery. The recipient can only assert damages against the transportation company based on these records. 2. Leave the product and packaging unchanged. 3. Do not use the product. If the product is damaged and there is no discernable damage to the packaging upon delivery, proceed as follows: 1. Report the damage immediately or at least 7 days after the delivery to the delivery company. 2. Leave the product and packaging unchanged. 3. Do not use a damaged product. If the recipient does not follow one of the above instructions, the damage will be held to have occurred after the delivery (according to. CMR law, section 5, Art. 30). 6/27

3 Information on the packaging: Storage and transport Keep the packaging for returning the product

The symbols printed on the outside are for transportation and storage, and have the following

9 1 User instructions 1.4 Transportation and storage Information on the packaging: Storage and transport Keep the packaging for returning the product for service or repairs. The symbols printed on the outside are for transportation and storage, and have the following meaning: Transport upright with the arrows pointing upwards Fragile - protect against knocks Keep dry Maximum permitted stacking load Temperature range Humidity Air pressure Environmental conditions transportation and storage Temperature range -20 C to 60 C Relative humidity 10% to 90% Air pressure 800 hpa to 1060 hpa 7/27

10 2 Safety 2.1 Description of safety instructions 2 Safety 2.1 Description of safety instructions Warning symbol Warning symbol Description of danger levels Safety instructions with three hazard levels are used in this document for avoiding personal and property damage. CAUTION CAUTION indicates a hazardous situation that can lead to property damage or minor to moderate injury. WARNING WARNING indicates a hazardous situation that can lead to serious injury or death. DANGER DANGER indicates a maximum hazardous situation that can directly cause serious injury or death Structure DANGER The introduction describes the type and source of the hazard. This section describes the potential consequences of non-observance. The optional step contains necessary measures for avoiding hazards. 8/27

11 2 Safety 2.2 Purpose Proper use 2.2 Purpose Proper use The laser instrument is only for dental treatment together with the GENTLEray 980 and holds the bleaching fibre. All information regarding radiation protection can be found in the instructions for use for the GENTLEray 980. The overarching guidelines and/or national laws, national regulations and the rules of technology applicable to medical devices for startup and use of the KaVo product for the intended purpose are to be applied and complied with. Indications: Bleaching Fluoridation Contraindications: General information: Patients who suffer from photodermatosis and photosensitive patients (photoallergies). The preferential therapy must be carefully considered in light of the patient s individual situation when they have malignant tumours and obligate precancerous lesions. No other contraindications are known. According to these regulations, the user is required to: Only use equipment that is operating correctly use the equipment for the proper purpose. only use trained personnel. to protect himself, the patient and third parties from danger. to avoid contamination from the product. The laser beam is restricted to use on the area in the oral cavity to be treated. The bleaching handpiece 982 handpiece is exclusively for use with the diode laser GENTLEray 980 and the bleaching fibre. 9/27

12 3 Setup methods according to DIN EN ISO Cleaning 3 Setup methods according to DIN EN ISO The instructions on cleaning and sterilisation were validated by the manufacturer of the medical device as suitable for preparation. The individual preparing the devices is responsible for the preparation facility achieving the desired results. Normally, validation and routine monitoring of the process are required. Likewise, any deviation from the instructions by the person preparing the device should be carefully checked to see if it is effective, and potential negative consequences should be evaluated. Frequently setting up does not substantially influence the product. The product life normally ends due to wear and damage from use. The handpieces must be prepared. Preparation (cleaning and sterilisation) should be carried out directly after each use. CAUTION Product damage from improper disinfection Malfunctions. Use disinfectant in accordance with manufacturer's instructions. Only disinfect by wiping. Do not immerse product or product parts in liquids. CAUTION Product damage due to improper sterilisation. Damage to the sterile product. No hot air sterilisation, no chemical cold sterilisation, do not sterilise with ethylene oxide! CAUTION Moisture Nonsterility Ensure dryness. Autoclaves with a subsequent vacuum ensure dryness. In addition, drying can be accelerated with a 10 minute drying phase with the autoclave door open. 3.1 Cleaning Cleaning instructions CAUTION Damage from improper cleaning and disinfection The use of unsuitable cleansers and disinfectants can cause malfunctions or damage the device. Only clean the outer surfaces! Only use a soft cloth and mild cleanser solution! Never used solvents or aggressive chemicals! To keep the residual tissue from baking on, the instrument should be thoroughly cleaned before being sterilised and after each use. 10/27

13 3 Setup methods according to DIN EN ISO Cleaning Manual cleaning Cleaning the bleaching handpiece and bleaching fibre Clean the complete surface of the handpiece and bleaching fibre with a clean cotton cloth saturated with isopropanol (70%) until no visible contamination remains. Unscrew the bleaching sleeve 1 from the cap 4 and seal the lens connector 3 with the dust cap 2. Clean the bleaching sleeve 1 with a medium-hard toothbrush under flowing water (tap water, 30 C ±5 C, 2 l/min) for 30 sec Machine cleaning Not applicable. 11/27

14 3 Setup methods according to DIN EN ISO Disinfection 3.2 Disinfection CAUTION Damage due to improper disinfection Liquids can enter the handpiece. Only disinfect the handpiece by wiping. Do not disinfect by spraying! Manual disinfection The following disinfectant is permissible: Isopropanol 70% Spray the disinfectant on a cloth and use it to wipe off the bleaching handpiece 982 and bleaching fibre Machine disinfection Not applicable. 12/27

15 3 Setup methods according to DIN EN ISO Sterilisation in a steriliser in compliance with DIN EN Sterilisation in a steriliser in compliance with DIN EN All handpieces must be prepared. Preparation (cleaning and sterilisation) should be carried out directly after each use. Always cover the lens with the dust cap 2. Screw the bleaching sleeve 1 off the cap 3 and remove. Put the bleaching sleeve 1 in a bag. The lens connector including the lens and bleaching fibre may not be sterilised. They must be cleaned or disinfected. The bleaching sleeve can be sterilised in a fractionated initial vacuum at 134 C ± 1 C, 3.04 bar, for 4 minutes (sterilisable up to max. 138 C). The bleaching sleeve can be steam sterilised (up to 135 C, 2.1 bar, 10 minutes). CAUTION The bleaching fibre should not be sterilised This can damage the bleaching fibre. Clean and disinfect the bleaching fibre when it is becomes dirty. 13/27

16 3 Setup methods according to DIN EN ISO Control and function test 3.4 Control and function test CAUTION Contamination of the lens and incoupling and outcoupling surfaces of the bleaching fibre Contamination can damage the bleaching handpiece, the bleaching fibre and the GENTLEray 980 diode laser. Always check if the lens and incoupling and outcoupling surfaces of the bleaching fibre are contaminated. Check the cleanliness of the bleaching handpiece 982 and the lens. 14/27

17 3 Setup methods according to DIN EN ISO Packaging and storage 3.5 Packaging and storage Store the bleaching sleeve in a bag. Always cover the lens and the bleaching fibre with the provided dust cap. 15/27

18 4 Bleaching handpiece Description 4 Bleaching handpiece 982 The bleaching handpiece 982 (Mat. no ) may only be used together with the bleaching fibre (Mat. no ). 4.1 Description 1 Bleaching sleeve 2 Lens connector 3 Lens fastener 4 Lens (Mat. no ) 5 Lens holder 6 Cap 7 Bleaching fibre (Mat. no ) 16/27

19 4 Bleaching handpiece Disassemble the bleaching handpiece 4.2 Disassemble the bleaching handpiece When assembling and disassembling, the individual parts may only be screwed hand-tight. Do not use any tools. Screw the bleaching sleeve 1 off the cap 6 and remove. Push the cap 6 on the bleaching fibre 7. Screw off the lens fastener 3 from the lens holder 5 and make sure that the lens 4 does not fall out. Carefully tip the lens 4 out of the lens fastener 3 onto a clean surface. If the lens 4 does not want to come out, it can be pushed out with a Q-tip. 17/27

20 4 Bleaching handpiece Cleaning the lens 4.3 Cleaning the lens CAUTION Lens damage Dirt particles, deposits from the surroundings and fingerprints can damage the lens surface and impair the laser beam quality and intensity. Make sure that the outside and inside of the lens remains clean. To protect the bleaching fibre, close it with the lens holder or the provided cap for the bleaching fibre. Grip the outer diameter of the lens with a tweezers. Clean both lens surfaces with alcohol and lint-free cloth or Q-tip. Make sure that no residue is left. 18/27

21 4 Bleaching handpiece Mount the lens connector 4.4 Mount the lens connector Carefully place the lens 2 on the lens holder 3 with the flat side down. Screw the lens fastener 1 to the lens 2 and the lens holder 3. Make sure that it screws on easily. Check the installation position. Make sure that the curved lens surface is visible. 19/27

22 5 Bleaching fibre 5.1 Description 5 Bleaching fibre 5.1 Description The bleaching fibre (Mat. no ) is only approved and suitable for use with the GENTLEray 982 bleaching handpiece. 1 Handpiece plug - outcoupling surface 2 Device plug - incoupling surface (identifiable by the silver sleeve) CAUTION The bleaching fibre should not be sterilised This can damage the bleaching fibre. Clean and disinfect the bleaching fibre when it is becomes dirty. CAUTION Contamination of the bleaching fibre on the incoupling and outcoupling surfaces Dirty fibre end surfaces from fingerprints or dust can wear the bleaching fibre. When the bleaching fibre is not connected to the GENTLEray 980 or bleaching handpiece 982, always cover the incoupling and outcoupling surfaces with the provided dust caps. 20/27

23 5 Bleaching fibre 5.2 Connecting the bleaching fibre to the bleaching handpiece Connecting the bleaching fibre to the bleaching handpiece 982 Push the cap 2 on the bleaching fibre 3. Remove the dust cap 1. Screw the bleaching fibre 3 hand-tight to the lens connector 2. Push the lens connector 2 into the bleaching sleeve 1 and screw on the cap 4. 21/27

24 5 Bleaching fibre 5.3 Exchanging the bleaching fibre 5.3 Exchanging the bleaching fibre The bleaching fibre must be exchanged when it is damaged. The following factors indicate that that the lens or bleaching fibre is damaged or dirty: Unclear spot diameter (no clear border of the red target beam) distinct loss of bleaching performance Check the surface to see if the lens is dirty. To clean it, follow the directions under the section "Cleaning the lens". See also: 4.3 Cleaning the lens, Page 18 CAUTION Contamination of the incoupling surface of the bleaching fibre Dirty fibre end surfaces from fingerprints or dust can wear the bleaching fibre. When the bleaching fibre is not connected to the GENTLEray 980, the incoupling surfaces (device-side plug) of the bleaching fibre must be covered with the provided dust caps. To protect the optical components in the device, the SMA socket in the device must always be closed (with a bleaching fibre or protective cap). Removing a defective bleaching fibre Screw the bleaching sleeve 1 off the cap 3 and remove. Put the cap on the lens connector 2. Do not remove! Unscrew the bleaching fibre 4 from the lens connector 2 and thread it through the cap 3. 22/27

25 5 Bleaching fibre 5.3 Exchanging the bleaching fibre Installing the bleaching fibre See also: 5.2 Connecting the bleaching fibre to the bleaching handpiece 982, Page 21 23/27

26 6 General bleaching procedure 6.1 Preparations 6 General bleaching procedure 6.1 Preparations Select the bleaching gel The bleaching effect and possible side-effects depend on the selected bleaching gel and the teeth that are treated. Consult the manufacturer's information for the bleaching gel for instructions CAUTION Increasing the output setting This can cause hyperthermia in the pulp. Do not perform bleaching at a higher output. KaVo accepts no liability for damage arising from the bleaching procedure. Important factors for selecting the bleaching gel: The bleaching gel must be suitable for use with the GENTLEray 980 diode laser at a wavelength of 980 nm (see manufacturer's instructions concerning the bleaching gel) Preparing the teeth Requirement The teeth must be carefully cleaned for bleaching to be successful (the plaque and residue must be completely removed). Clean with pumice. Do not use polishing pastes since they contain oil. Follow the bleaching gel manufacturer's instructions exactly. 24/27

27 6 General bleaching procedure 6.2 Bleaching 6.2 Bleaching The general bleaching procedure with the bleaching handpiece 982 will be describe in the following section. These instructions can vary depending on the bleaching gel. The instructions of the bleaching manufacturer are authoritative when in doubt (see the safety data sheet). Identify the tooth discoloration. This can be done using colour gradation or digitally with suitable software. All of the people in the room must wear the provided protective goggles. Apply gingiva protector and let it harden. 25/27

28 6 General bleaching procedure 6.2 Bleaching Apply bleaching gel. First apply the bleaching gel on the upper or lower front teeth. Remove any bubbles in the gel when applying the bleaching gel. With multicomponent bleaching gels, following the manufacturer's instructions for use. To activate to the bleaching gel, each tooth must be irradiated for a maximum of 30 seconds. Settings of 1 W to 1.6 W are usual; this depends on the bleaching gel used and must be agreed with the manufacturer of the bleaching gel. These parameters are already preset when selecting the indication "Bleaching (single tooth)" in the indication menu of the GENTLEray 980. Depending on the software version for the GENTLEray 980, the set output can vary. Comply with the manufacturer's instructions for using the bleaching gel, failing which use a maximum output of 1.6 W. The beam diameter is about 5 mm. A distance between the tooth and instrument of 3 cm to 8 cm is recommended. The output of the laser beam remains about the same in this region and enables the best bleaching. The suction off the gel, carefully rinse and dry. Compare the tooth brightness and repeat if necessary. Depending on the bleaching gel, the process should be performed three to four times a session. Depending on the bleaching gel, two to three sessions are required (at least one week apart). The maximum total exposure time for the bleaching gel should be 15 minutes hen not otherwise indicated by the gel manufacturer. Remove the gingiva protector and apply fluoride gel. Irradiate each tooth with 1 W for 10 seconds. 26/27

29 6 General bleaching procedure 6.2 Bleaching Record the initial status and end result with pictures to clarify and confirm the success of the treatment. These parameters are already preset when selecting the indication "Bleaching (fluoridation)" in the indication menu of the GENTLEray /27

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Always be on the safe side.

Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383, 1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386 Always be on the safe side.