Endo IQ ipad Mini Protective Case. Directions For Use

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1 Endo IQ ipad Mini Protective Case Directions For Use EN

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3 Introduction Indications for Use Contraindications Warnings Precautions Adverse Reactions Step by Step Instructions Document Symbols Protective Case compatibility Package content Using Endo IQ ipad Mini Protective Case Activating the Assistive Touch Cleaning, Disinfection and Sterilization Foreword Single use of disposable custom barrier sleeve Cleaning procedure Disinfection procedure Technical Characteristics Protective Case error codes Troubleshooting Warranty Disposal of the Product Identification of Symbols B EN IQPC DFU WEB / Rev.0 / /20

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5 Indications for Use For Dental Use Only Introduction These Directions For Use (DFU) are kept current by Dentsply Sirona. The most current version can be accessed at dentsplysirona.com. The DFU has been compiled with the utmost care. Nevertheless, it is not always possible to completely rule out the risk of error, despite all efforts to do so. Some images in the DFU may vary slightly from the current device. We would appreciate your feedback in this area. If any errors are noted, please contact Dentsply Sirona. Maillefer Instruments Holding Sàrl Chemin du Verger 3 CH-1338 Ballaigues Switzerland Telephone Fax endo@dentsplysirona.com dentsplysirona.com 1 INDICATIONS FOR USE The Endo IQ ipad Mini Protective Case is an accessory designed by Dentsply Sirona to protect your ipad Mini during use. It is also designed to stabilize your ipad Mini and improve visibility of the information displayed by the Endo IQ App. To guarantee the safety, intended functionalities and good maintenance of the Endo IQ ipad Mini Protective Case, follow the indications given in the present DFU. Keep the DFU updated as described in the Introduction section. Dentsply Sirona will not accept any liability if the Endo IQ ipad Mini Protective Case is used, stored or manipulated outside of the indications given in the DFU. 2 CONTRAINDICATIONS There are no known contraindications. B EN IQPC DFU WEB / Rev.0 / /20

6 Warnings 3 WARNINGS Read the following warnings before use. Some sections / texts of this DFU are dedicated uniquely to readers from a specific territory. When this happens the section / text will be clearly identified with a sentence similar to: For US / EU readers. If nothing is indicated, the text is applicable to all of the intended territories. Endo IQ ipad Mini Protective Case is supplied un-disinfected. You must reprocess it prior to first use and between patients (Follow instructions given in section 7 Cleaning, Disinfection and Sterilization). Dentsply Sirona recommends using the Endo IQ ipad Mini Protective Case for your ipad Mini. X-Smart IQ Handpiece Case can be magnetically attached to the Endo IQ ipad Mini Protective Case. The combined devices can fall if subjected to abrupt movements. Ensure the ipad Mini and the accessories are in a stable position during treatment. The Endo IQ ipad Mini Protective Case and the X-Smart IQ Handpiece Case contain permanent magnets. Magnets could affect the normal functioning of pacemakers, implanted heart defibrillators and hearing aid devices. Do not place the Endo IQ ipad Mini Protective Case or the X-Smart IQ Handpiece Case near these devices or any other object sensitive to static magnetic fields. Do not reprocess the Endo IQ ipad Mini Protective Case if the protective plugs are not properly inserted. It is mandatory to reprocess the Endo IQ ipad Mini Protective Case before shipping it to the service centre (follow instructions given in section 7 Cleaning, Disinfection and Sterilization). Protect the Endo IQ ipad Mini Protective Case with appropriate packaging when sending it for service. ipad Mini The operating conditions and limitations specified by Apple must be complied with. Always check to ensure that the ipad Mini has sufficient battery charge before starting treatment. 6/20 B EN IQPC DFU WEB / Rev.0 /

7 Precautions Cleaning, Disinfection and Sterilization Never place the Endo IQ ipad Mini Protective Case in a washer-disinfector, autoclave or ultrasonic bath. If you use a disinfectant in the form of a spray, never spray the accessories directly. Instead, spray a paper towel with the surface disinfectant or use a pre-moistened disinfectant towelette (wipe). Only use surface disinfectants that are certified by officially recognized institutes that do not contain chlorine and have been declared aldehyde-free. Use only cleaning agents that do not have a protein-binding effect. Repairs and defects Do not use the Endo IQ ipad Mini Protective Case if you suspect damage or defects. If a defect should occur, contact Dentsply Sirona (Telephone or fax ). Transport Intact devices and defective devices can be transported by land freight or air freight in the original packaging. The applicable requirements must be met. 4 PRECAUTIONS There are no known precautions to take before use. 5 ADVERSE REACTIONS There are no known adverse reactions. 6 STEP BY STEP INSTRUCTIONS Refer to the section 3 Warnings to verify any special care to exercise before starting to use the Endo IQ ipad Mini Protective Case. Before use check the exact contents of the package. See 6.3 Package content. B EN IQPC DFU WEB / Rev.0 / /20

Step by Step Instructions 6.1 Document Symbols Symbol Identification Additional information, explanation on operation and performance. Suggestion or advice. 6.2 Protective Case compatibility The Endo IQ ipad Mini Protective Case is compatible with ipad Mini 2, ipad Mini 3 and ipad Mini 4.

8 Step by Step Instructions 6.1 Document Symbols Symbol Identification Additional information, explanation on operation and performance. Suggestion or advice. 6.2 Protective Case compatibility The Endo IQ ipad Mini Protective Case is compatible with ipad Mini 2, ipad Mini 3 and ipad Mini 4. See Endo IQ App User Manual - 6 Step by Step Instructions for information on the ipad models that are compatible with the Endo IQ App. Apple, the Apple logo, ipad, ipad Pro and ipad Mini are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. 6.3 Package content List of components Endo IQ ipad Mini Protective Case Endo IQ ipad Mini Protective Case Opener 8/20 B EN IQPC DFU WEB / Rev.0 /

4 Using Endo IQ ipad Mini Protective Case To correctly use the Endo IQ ipad Mini Protective Case, place it on a clean, dry, flat surface, and

9 Step by Step Instructions List of components Accessories for ipad Mini TM 2 or 3 Accessories* for ipad Mini 2, 3 or 4 (Rubber plugs and foams). *These accessories may not be available in all kits Components not included ipad with ios Operating System. 6.4 Using Endo IQ ipad Mini Protective Case To correctly use the Endo IQ ipad Mini Protective Case, place it on a clean, dry, flat surface, and follow the steps described below. N Action A Remove carefully the Endo IQ ipad Mini Protective Case from its packaging and place it on a flat surface. B EN IQPC DFU WEB / Rev.0 / /20

B B Enclose and center the ipad Mini in the Endo IQ ipad Mini Protective Case.

10 Step by Step Instructions N Action According to your ipad Mini model, use the suitable kit. Stick the foams of your kit at the places indicated on the Endo IQ ipad Mini Protective Case. B B Enclose and center the ipad Mini in the Endo IQ ipad Mini Protective Case. Place the corresponding plugs on the camera and the charging port. C C 10/20 B EN IQPC DFU WEB / Rev.0 /

Separate X-Smart IQ Handpiece Case from X-Smart IQ Handpiece Support.

11 Step by Step Instructions N Action Pay attention to the ipad Mini orientation. In case of error, use the red key to open the protective case. Separate X-Smart IQ Handpiece Case from X-Smart IQ Handpiece Support. D D Install the X-Smart IQ Handpiece Case as a protective case holder. E E Place the Endo IQ ipad Mini Protective Case and holder on a steady surface. Multiple configurations are possible. B EN IQPC DFU WEB / Rev.0 / /20

12 Step by Step Instructions N Action F Activate the Assistive Touch function on your ipad Mini (see following section). Position 1 has a limited stability. Monitor the device carefully if you choose this position. The X-Smart IQ Handpiece Case is available in X-Smart IQ Handpiece kit (see X-Smart IQ Directions For Use) or you can buy it from your dealer or Dentsply Sirona Endodontics customer service. None of the accessories are supplied disinfected or sterilized. 6.5 Activating the Assistive Touch The AssistiveTouch feature replaces the actions of the ipad Mini Home button which is not accessible when in the Endo IQ ipad Mini Protective Case. To activate the Assistive Touch. N Key Action A Select Settings. B Select General. C D E Select Accessibility. Select Assistive Touch. Set Assistive Touch to ON. A virtual Home key is displayed. 12/20 B EN IQPC DFU WEB / Rev.0 /

13 Step by Step Instructions To press the Home button with Assistive Touch. Tap on the virtual Home button. A B Select HOME. It is also possible to use the 5 fingers to swipe in and to return to the Home screen. B EN IQPC DFU WEB / Rev.0 / /20

14 Cleaning, Disinfection and Sterilization 7 CLEANING, DISINFECTION AND STERILIZATION You must consult the special reprocessing X-Smart IQ Getting Started Guide before proceeding with cleaning disinfection and sterilization. The following parts shall be reprocessed before and after each treatment. Part Reprocessing steps Endo IQ ipad Mini Protective Case. Clean and disinfect. Do not sterilize. Dentsply Sirona accepts no liability in the event that these instructions are disregarded or processes that have not been validated are used to reprocess the accessories. 7.1 Foreword The Endo IQ ipad Mini Protective Case has not been disinfected when it is delivered. Please perform the necessary steps before the first treatment. Always ensure that only validated methods of cleaning and disinfection are used, that regular maintenance and inspections are performed on the equipment used (disinfector) and that the validated parameters are maintained in every cycle. Comply with your national guidelines, standards and requirements for cleaning and disinfection. 14/20 B EN IQPC DFU WEB / Rev.0 /

15 Cleaning, Disinfection and Sterilization 7.2 Cleaning procedure The components of the kit must be cleaned and subjected to a wipe-down with a disinfection wipe prior to and following each treatment. Cleaning is intended to remove all the visible soiling (e.g. organic and inorganic) from the surface of the device and accessories so that the subsequent disinfection process can be efficient. N Cleaning steps A B Always wear protective clothes for you own safety (gloves, mask, glasses and a waterproof gown) for the reprocessing process. After any pre-cleaning, lightly soak a paper tissue or soft cloth in a mild, aldehyde-free disinfection and cleaning solution (bactericidal and fungicidal) and use it to clean/disinfect the Endo IQ ipad Mini Protective Case. 7.3 Disinfection procedure Disinfection shall be done immediately after cleaning using the procedure described below. The Endo IQ ipad Mini Protective Case and the other elements in this kit are not approved for machine-based cleaning (i.e. Thermal disinfection, washer disinfectors) and they should not be sterilized. Refer to Section 3 Warnings for important information on the reprocessing of the Protective Case. For wipe-down disinfection of components proceed as follows. Please refer to the manufacturer's information on use of the disinfectant. B EN IQPC DFU WEB / Rev.0 / /20

Cleaning, Disinfection and Sterilization N Action A B C D E Always wear protective clothes for you own safety (gloves, mask, glasses and a waterproof gown) for the reprocessing process.

16 Cleaning, Disinfection and Sterilization N Action A B C D E Always wear protective clothes for you own safety (gloves, mask, glasses and a waterproof gown) for the reprocessing process. Separate X-Smart IQ case from the Endo IQ ipad Mini Protective Case. Disinfect the surface of Endo IQ ipad Mini Protective Case paying special attention to grooves of the device. Use a single-use wipe or soft clean cloth lightly soaked in disinfectant. Remove all disinfectant residue. No visible impurities or liquid should remain on the Endo IQ ipad Mini Protective Case after disinfection. If the Endo IQ ipad Mini Protective Case is not being used immediately after the reprocessing process, keep it in a safe and clean environment and follow the instructions for storage and transport. Dentsply Sirona recommends the use of a disinfectant with Alcohol Quaternary Ammonium active ingredients (e.g. CaviWipes or CaviCide ). Do not use CaviCide1 or CaviWipes1 on any items shown or listed in this section. Use only EPA-registered disinfectants with a tuberculocidal claim. A list of EPAregistered disinfectants is available at In addition, the disinfectant should be aldehyde-free and compatible with the device and accessories (see 8 Technical Characteristics). Leave the disinfectant to act in accordance to manufacturer's instructions. Avoid leaving the disinfectant in contact with the device surfaces for a time longer than that recommended by the manufacturer of the disinfectant product. It can result in damage to the device. Endo IQ ipad Mini Protective Case 16/20 B EN IQPC DFU WEB / Rev.0 /

17 Technical Characteristics 8 TECHNICAL CHARACTERISTICS Specification Description Manufacturer Dimensions Weight Material Ambient conditions Conditions for transport and storage Maillefer Instruments Holding Sàrl Chemin du Verger 3 CH-1338 Ballaigues Switzerland Telephone Fax endo@dentsplysirona.com dentsplysirona.com Endo IQ ipad Mini Protective Case: Length: 212 mm Width: 143 mm Height: 13mm Endo IQ ipad Mini Protective Case: 174g (0.38 lbs) TPE (thermoplastic elastomer) ABS/ PC Somalac VP290 Glass Use: in enclosed spaces Ambient temperature: 15 C - 35 C (59 F - 95 F) Relative humidity: < 80%, non-condensing at 0 C (32 F) Operating altitude: <2000 m (~ 6561ft 8in) above see level Maximum housing temperature according to IEC Ambient temperature: -20 C C (-4 F F) Relative humidity: 20% - 80%, non-condensing at > 40 C (104 F) B EN IQPC DFU WEB / Rev.0 / /20

18 Protective Case error codes 9 PROTECTIVE CASE ERROR CODES N/A 10 TROUBLESHOOTING N/A 11 WARRANTY Dentsply Sirona Endodontics offers customers the following product warranty: Dentsply Sirona Endodontics guarantees proper manufacturing of the product, the use of top quality materials, performance of all required tests and compliance with all applicable relevant laws and regulations relating to the product. The full functionality of the Endo IQ ipad Mini Protective Case is covered by a 6-month warranty. Warranty period begins on the date of equipment purchase. The customer is only entitled to warranty services within the warranty period and under the condition that Dentsply Sirona has been informed of the defect within a one-month period from the date of discovery of the defect. Component Protective Case Warranty period 6 months This warranty covers only the exchange or repair of individual components or parts affected by manufacturing defects. The cost for personnel to be dispatched for purposes of technical assistance from the dealer to the customer, and / or packaging expenses of the customer will not be covered by Dentsply Sirona. Any customer claims beyond the realm of repair, such as claims for damages, will not be covered. This warranty does not include any compensation for direct or indirect personal injuries or material damage of any kind. The customer will not be entitled to damages covering downtime of the equipment. The warranty does not extend to damage for which evidence can be provided by Dentsply Sirona that such damage has been caused by negligence on the part of the user as related to Directions For Use. The warranty explicitly excludes any defects arising on the basis of: damage occurring during transportation to Dentsply Sirona for the purposes of repair; damage occurring through environmental events such as lightning strikes, fire and / or humidity. This warranty shall automatically become cancelled and void if the product has been improperly repaired, modified or manipulated in any manner by the user, by non-authorized persons or by third party personnel. Legal claims, such as under product liability law remain unaffected. 18/20 B EN IQPC DFU WEB / Rev.0 /

19 Disposal of the Product 12 DISPOSAL OF THE PRODUCT Comply with your national and regional regulations, guidelines and requirements for the disposal of this product. 13 IDENTIFICATION OF SYMBOLS Normative Symbols Symbol Identification SN Serial number Batch Code Catalogue number Consult Instructions for Use Manufacturer Date of manufacture Opened packages are not replaced Temperature limit Humidity limitation Keep dry Fragile, handle with care Accessory xxx C P Do not sterilize Plastic CE Mark Caution, consult instructions for use B EN IQPC DFU WEB / Rev.0 / /20

20 dentsplysirona.com Maillefer Instruments Holding Sàrl Chemin du Verger 3 CH-1338 Ballaigues Switzerland Telephone Fax endo@dentsplysirona.com dentsplysirona.com B EN IQPC DFU WEB / Rev.0 /

Getting Started Guide. Just a few images to help you easily set up your motor and get the most out of it.

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