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Instructions for use elements™ 8:1

2 Safety | 2.1 Infection hazard

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2 Safety

Note

All serious events occurring in relation to the product must be reported to the
manufacturer and the competent authority of the member state, in which the
user and/or patient resides.

The instructions for use are a component of the product and must be read care-
fully prior to use and be accessible at all times.
The device may only be used in accordance with the intended use, any other
type of use is not permitted.

2.1 Infection hazard

Patients, users or third parties could be infected by contaminated medical
devices.

Take suitable personal protective measures.

Follow the instructions for use of the components.

Before initial startup and after each use, reprocess the product and ac-
cessories appropriately.

Carry out the reprocessing as described in the instructions for use. The pro-
cedure has been validated by the manufacturer.

If you deviate from this procedure, it is essential to make sure that the re-
processing is effective.

Reprocess the product and accessories appropriately before disposal.

If there is any injury to soft tissue, do not continue treatment in the oral
cavity with compressed air-driven instruments.

Use gloves or finger guard whenever you test, insert, and remove the tool.

2.2 Improper use

The improper use of the device could lead to burns or injuries.

Check the technical condition before each use.

See also:

2

2.3 Technical condition, Page 8

Never press the push-button during operation of the device.

Never use the instrument to keep the cheek, tongue or lip at a distance.

Never touch soft tissue with the handpiece head or instrument cover.

Do not use the medical device as a light probe.

Use an appropriate light probe for illumination of the oral cavity or site of
preparation.

After treatment, place the medical device properly in the cradle without the
tool.

2.3 Technical condition

A damaged device or components could injure patients, users and third parties.

Only operate devices or components if they are undamaged on the outside.

Содержание 815-1655

Страница 1: ...Instructions for use elements 8 1...

Страница 2: ...al com Manufacturer KaVo Dental GmbH Bismarckring 39 88400 Biberach Germany www kavo com Distributed by Kerr Australia Pty Limited Unit 6 12 Mars Road Lane Cove West New South Wales 2066 Australia 61...

Страница 3: ...6 1 Check for malfunctions 19 6 2 Troubleshooting 19 6 2 1 Replacing the O rings on the motor coupling 19 7 Reprocessing steps in accordance with ISO 17664 21 7 1 Preparations at the site of use 21 7...

Страница 4: ...9 Terms and conditions of warranty 30 Instructions for use elements 8 1 Table of contents 4 32...

Страница 5: ...00 KERR 123 Homepage www kerrdental com Email KerrCustCare kavokerr com Target group This document is for dentists and dental office staff The section on startup is also intended for the service staff...

Страница 6: ...not dispose this product into the ordinary municipal waste or garbage system Properly dispose of non corrugated fiberboard Properly dispose of polyethylene Properly dispose of all other plastics such...

Страница 7: ...structions for use elements 8 1 1 User instructions CAUTION In cases which if not prevented can lead to minor or moderate in jury NOTICE In cases which if not prevented can lead to material damage 7 3...

Страница 8: ...u deviate from this procedure it is essential to make sure that the re processing is effective Reprocess the product and accessories appropriately before disposal If there is any injury to soft tissue...

Страница 9: ...uthorised purposes 2 4 Accessories and combination with other equipment Use of un authorised accessories or un authorised modifications of the device could lead to injury Only use accessories that hav...

Страница 10: ...vicing and a func tion check Define the service interval depending on the frequency of use As a result of the use of NON KaVo original spare parts during the repair parts such as covers may become und...

Страница 11: ...Instructions for use elements 8 1 3 Product description 2 6 Service and repair 3 Product description elements 8 1 PN 815 1655 11 32...

Страница 12: ...ly trained user You need to comply with the following the applicable health and safety regulations the applicable accident prevention regulations these Instructions for use According to these regulati...

Страница 13: ...Consult instructions for use Please note the electronic instructions for use Certification CE mark Communaut Europ enne Medical device labelling of medical devices Product characteristics Manufacturer...

Страница 14: ...TICE Startup after refrigerated storage Malfunction Prior to startup strongly refrigerated products must be allowed to warm up to a temperature of 20 C to 25 C 68 F to 77 F Temperature 20 C to 70 C 4...

Страница 15: ...zard Reprocess and sterilise the product and accessories before disposal See also 2 7 Reprocessing steps in accordance with ISO 17664 Page 21 NOTICE Damage from soiled and moist cooling air Contaminat...

Страница 16: ...ile the drive motor is rotat ing NOTICE Pressing the foot switch while attaching or detaching the medical device Property damage to the medical device Do not connect or remove the medical device while...

Страница 17: ...y Pull on the dental bur to check if the clamping system works properly and if the dental bur is firmly clamped Wear gloves or a thimble when you check insert or remove the bits to prevent injury and...

Страница 18: ...tal bur Lacerations and damage to the chuck system Do not touch the rotating dental bur Never push the push button while the dental bur is rotating Remove the dental burs from the medical device after...

Страница 19: ...ose and cause injury Aspiration swallowing of parts and danger of suffocation Only use spare parts that comply with the specification for repair original KaVo spare parts comply with the specification...

Страница 20: ...Instructions for use elements 8 1 6 Checking for malfunctions and troubleshooting 6 2 Troubleshooting 20 32 Push the O ring to the front and remove it Insert new O rings into the grooves...

Страница 21: ...always wear protect ive gloves Remove the tool from the medical device Remove all residual cement composite or blood immediately Do not place in solutions or similar substances 7 2 Manual Reprocessing...

Страница 22: ...ot meet these requirements the process must be concluded by disinfection of the unit s without packaging using a steam steriliser NOTICE Never disinfect the medical device with chloride containing pro...

Страница 23: ...roducts use only disinfection agents that have been released by KaVo with respect to the compatibility of materials e g WL cid made by ALPRO Cover the medical device with the KaVo CLEANpac bag and pla...

Страница 24: ...lly or in a washer disinfector only 7 3 1 Automated internal and external cleaning and internal and external disinfection KaVo recommends washer disinfectors according to EN ISO 15883 1 which are oper...

Страница 25: ...each use i e after each cleaning disinfection and before each sterilisation Remove the tool from the medical device Cover the medical device with the KaVo CLEANpac bag and place it on the correspondin...

Страница 26: ...the far right A MULTIflex adaptor must be mounted there Press the handpiece together with the guide bush of the chuck to be ser viced against the tip of the service coupling Press the button marked wi...

Страница 27: ...tion and before each sterilisation Remove the tool from the medical device Service the product in the QUATTROcare See also 2 Instructions for use KaVo QUATTROcare 2104 2104A 2124A Servicing the chuck...

Страница 28: ...parameters Select a suitable process from the following sterilisation processes depending on the available steriliser Steriliser with triple pre vacuum at least 3 minutes at 134 C 1 C 4 C 273 F 1 6 F...

Страница 29: ...10 units 0 411 9691 Cellulose pad 100 units 0 411 9862 Spray head INTRA KaVo Spray 0 411 9911 Service coupling INTRA QUATTROcare 1 009 6143 Material summary Mat no Adaptor INTRAmatic CLEANspray and D...

Страница 30: ...consequences that have arisen or may arise from natural wear improper handling cleaning or maintenance non compliance with operating maintenance or connection instructions calcination or corrosion co...

Страница 31: ......

Страница 32: ...1 013 9552 bd 20210302 02 en...

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