Altus Product description / Instructions for Use IFU 6 Rev. 1

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Dwight Carr
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1 Content: 1 Introduction Legend Indication Contraindication Field of Application Sterilization Storage Allergies SYSTEM DESCRIPTION System overview components Cleaning Sterilization / Disinfection Risks Risks associated with cleaning Risks associated with the use of Instructions for use Preparation Sterilization Determine the matching end of the scale part Assembly of the gingiva height measuring tool Measuring procedure Post-use treatment... 9 Gingiva heigt measuring tool valid from 01/2017 Page 1 9

2 1 INTRODUCTION Please read this product description/ instruction manual before you use the gingiva height measuring tool for the first time. Correct adherence to the instructions below is the prerequisite and guarantee for the proper operational reliability of the system. The manufacturer accepts no liability whatsoever for any damage caused by failure to observe these instructions. 1.1 Legend Conformity symbol Do not reuse Manufacturer REF Article number Non-sterile LOT Batch code Instructions for use Do not expose to sunlight Caution: U.S. Federal law restricts this device to sale by or on the order of a dental professional. 1.2 Indication The gingiva height measuring tool allows the precise measurement of the gingiva height above the implant. can be used on implant platforms with a hole diameter of the inner connection up to 4.5mm. 1.3 Contraindication The gingiva height measuring tool is not applicable on gingiva heights greater than 6mm over the implant, implants with an external hex connection and implant platforms with a hole diameter of the inner connection greater than 4.5mm. 1.4 Field of Application Dentistry 1.5 Sterilization The product is delivered UNSTERILIZED. The gingiva height measuring tool must be cleaned and disinfected / sterilized before use. 1.6 Storage Plastic parts must be protected from strong light and heat radiation and stored at room temperature. 1.7 Allergies This product must not be used for patients with suspicion of an existing allergy to one or more elements of the materials used. The product must be used only after an allergy test has been performed and proof obtained that no allergy exists. Gingiva heigt measuring tool valid from 01/2017 Page 2 9

The gingiva height measuring tool consists of a slider (PEEK) and a multifunctional scale part (Inox) The gingiva height measuring tool convinces with its ease of use.

3 Note Using toothbrushes and toothpaste to clean products mechanically can lead to premature wear in functional areas. 2 SYSTEM DESCRIPTION The gingiva height measuring tool allows the precise measurement of the gingiva height above the implant for accurate determination and choice of the abutment height. The gingiva height measuring tool consists of a slider (PEEK) and a multifunctional scale part (Inox) The gingiva height measuring tool convinces with its ease of use. The positioning onto the implant is done with ease by placing the scale part onto the implant shoulder. Its specially shaped gingiva plate locates the highest gingiva position in all situations around the implant. A thread can be fixed to the hole in the gingiva plate, which serves as a safeguard against aspiration. The gingiva height measuring tool has a guide for tweezers for accessing even the most difficult positions in the mouth. The gingiva height measuring tool guarantees longevity in use and can be sterilized easily in the autoclave. 3 SYSTEM OVERVIEW 3.1 components Image Part no. Description Specifications Quantity per unit gingiva heightmeasuring tool sterilizable and disinfectable Slider: PEEK Scale part: Inox 1 pc Gingiva heigt measuring tool valid from 01/2017 Page 3 9

4 4 CLEANING Responsibility for regular maintenance and monitoring of cleaning, disinfection and sterilization equipment rests with the operator, as does the corresponding validation. The relevant product information by the manufacturer of the respective cleaning, disinfection and sterilization equipment is to be followed for all settings not listed here (e.g. pressure, time). All surfaces have to be accessible to the disinfection and sterilization agents. This requires prior removal of for the preparation (cleaning and sterilization). 4.1 Sterilization / Disinfection All components have to be cleaned, sterilized or disinfected prior to intraoral use. The recommended duration of autoclave/ steam sterilization is 18 minutes at a temperature of 134 C+3 C (273.2 F+5.4 F/ K+3K). Disinfection shall be performed with a low or medium EPA registered disinfectant. 5 RISKS 5.1 Risks associated with cleaning The gingiva height measuring tool has to be cleaned, disinfected and sterilized immediately after use. Always use freshly prepared cleaning and sterilization agents. No contamination must be allowed to dry on as this will make subsequent cleaning more difficult. The gingiva height measuring tool should not be immersed into physiological saline solution, as prolonged contact could lead to corrosion and surface changes. Neither metal brushes nor abrasive agents must be used to clean the. Extra care has to be taken specifically prior to sterilization to ensure that no residue is left inside hollow spaces of the gingiva height measuring tool. Slight changes of the colour of the handle cannot be ruled out after cleaning. These do not affect the function of the measuring tool. components must not come into contact with agents containing chloride or fluoride. 5.2 Risks associated with the use of General risks associated with the use of are allergic reactions to the material that is made of as well as loosening, wear and tear, corrosion and ageing of parts. Damage or improper handling can result in corrosion, oxidation, excessive wear or functional impairment of and may not be used anymore in these cases. can have sharp edges or pointed ends. These can cause damage to plastic/latex gloves. Users need to be aware of the associated risk of infection. During intraoral use, make sure that is properly fixed by a thread through the hole in the gingiva plate to ensure proper aspiration safety. In case of unexpected complications or pain, patients are advised to contact their dentist or dental prosthetician immediately. Gingiva heigt measuring tool valid from 01/2017 Page 4 9

5 6 INSTRUCTIONS FOR USE 6.1 Preparation Disassemble before the cleaning process Sterilization Sterilize the gingiva height measuring tool before use: The recommended duration of autoclave/ steam sterilization is 18 minutes at a temperature of 134 C+3 C (273.2 F+5.4 F/ K+3K). Abb. 1 Gingiva heigt measuring tool valid from 01/2017 Page 5 9

6 6.1.2 Determine the matching end of the scale part Abb. 2 Two different ends of the scale part are available since implant diameters and hole diameters of the inner connection can vary. In case of doubt, check if fits properly on a laboratory analogue to ensure a proper fit on the implant shoulder. Gingiva heigt measuring tool valid from 01/2017 Page 6 9

6.1.3 Assembly of the gingiva height measuring tool Variant

5 Fig. 6 Push scale part into the slider until it clicks.

7 6.1.3 Assembly of the gingiva height measuring tool Variant 3.3 mm scale part Fig. 3 Fig. 4 Push scale part into the slider until it clicks. Ready with 3.3 mm scale part. Variant 4.5 mm scale part Fig. 5 Fig. 6 Push scale part into the slider until it clicks. Ready with 4.5 mm scale part. Gingiva heigt measuring tool valid from 01/2017 Page 7 9

6.2 Measuring procedure Place on implant

7 Push the slider downwards until the highest

you measure the highest point of the gingiva

8 6.2 Measuring procedure Place on implant shoulder. Fig. 7 Push the slider downwards until the highest point of the gingiva has been located by the measuring plate. Fig. 8 The specially designed gingiva plate lets you measure the highest point of the gingiva in all situations around the implant. Fig. 9 Gingiva heigt measuring tool valid from 01/2017 Page 8 9

Remove carefully from the oral cavity and read the measurement result from the scale part. Fig. 10 6.

9 Remove carefully from the oral cavity and read the measurement result from the scale part. Fig Post-use treatment Disinfect or sterilize in the autoclave before the next intraoral use. Gingiva heigt measuring tool valid from 01/2017 Page 9 9

INSTRUCTIONS FOR USE AND CARE

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