`bob`=å~ãéê~=ó=å~êéi=åäé~åáåöi= ÇáëáåÑÉÅíáçå=~åÇ=ëíÉêáäáò~íáçå

Similar documents
MVKOMNT. kéï=~ë=çñw= bkal=swn. lééê~íáåö=fåëíêìåíáçåë. båöäáëü. Operating Instructions

Hygienic Reprocessing

Chapter 5: Checking and Maintaining Ultrasound Equipment

Bryan-Dumon Series II Rigid Bronchoscope and Stent Placement Kit USER MANUAL

áåi~ä=pa=ñçê=^äìíãéåíë=spksu

CoaguChek S System. Quick Reference Guide. This is a CLIA-waived System. Coagulation Testing with Fresh Whole Blood

How to use your gonal-f pre-filled pen

TJF-160F/VF Cleaning and Disinfection Checklist

Fibrlok II 2529 Universal Optical Fiber Splice

a perfect fit INSTRUCTION MANUAL CAMLOG TORQUE WRENCH WITH CONTINUOUS TORQUE ADJUSTMENT Handling Sterilization Care

insafe System - Directions for Use

book Seite 1 Freitag, 21. April : fjmi^kq=omwn. Operating instructions. båöäáëü. lééê~íáåö=fåëíêìåíáçåë

Instructions. Fibrlok Optical Fiber Splicing System. Issue 6, August 1991

INSTRUCTIONS FOR USE TYMLOS (tim lows ) (abaloparatide) injection, for subcutaneous use

book Seite 1 Mittwoch, 26. Juli : qq=ifkb=l=^áê=jçíçê. Operating Instructions / T4 LINE motor kit. båöäáëü. lééê~íáåö=fåëíêìåíáçåë

Rhino Clear Sprint Atomizer

Pollen Slide Mounting Protocol

ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein INSTRUCTIONS FOR USE Do not Do not YOUR KIT CONTAINS:

Breezhaler. Open to see clear capsule. How do I use my Breezhaler? Care of my Breezhaler

Fibrlok II 2529 Universal Optical Fiber Splice

LeadCare BLOOD LEAD ANALYZER. Quick Reference Guide

Manufacturer s information

How to Change a. Foley catheter. Patient Education Rehabilitation Nursing. Step-by-step instructions for the caregiver

Stratis INSTRUCTIONS FOR USE. Needle-free Injection System. 0.5mL volume (+/-5%)

Scope This policy applies to all personnel and departments that clean, prepare and/or sterilize items intended for patient care use.

Instructions. Fibrlok II Optical Fiber Splicing System. Issue 1, June 1992

LET OUR IMAGE ENHANCE YOUR IMAGE. Operating Instructions MedRx Video Portable OtoScope System

How to Use ENBREL : Vial Adapter Method

Lilly. Disposable Insulin Delivery Device User Manual

How to use your Pergoveris pre-filled pen

Instructions for Use Enbrel (en-brel) (etanercept) for injection, for subcutaneous use Multiple-dose Vial

Instructions for Use. For use with. 10 mg vial

For use only with INSTRUCTIONS FOR USE

PLEASE READ THIS USER MANUAL BEFORE USE

INSTRUCTIONS FOR USE AND CARE

MPKOMNO. kéï=~ë=çñw== `bob`=dìáçé. lééê~íáåö=fåëíêìåíáçåë. båöäáëü. Operating Instructions

MSKOMNP. kéï=~ë=çñw== `bob`=dìáçé. lééê~íáåö=fåëíêìåíáçåë. båöäáëü. Operating Instructions

IMPORTANT: PLEASE READ. Don t

INSTALLATION MANUAL. VIDEO Camera, Probe and Lightsource OTOSCOPES.

Instructions For Use PRALUENT (PRAHL-u-ent) (alirocumab) Injection, for Subcutaneous Injection Single-Dose Pre-Filled Syringe (75 mg/ml)

Instructions for Use. HUMALOG KwikPen. insulin lispro injection (rdna origin) 100 units/ml, 3 ml pen

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

Cap Clip Rubber Seal Plunger Pen Body Dose Window

Instructions For Use. SOLUTION FOR INJECTION IN PRE-FILLED PEN 250 micrograms

Blood Glucose Measurement. Omnitest 5 & Omnican Lance FAQ Frequently Asked Questions

Standard Operating Procedure for cannulation

Product Specifications and Usage Information P4405, P4410, & P4420 Genesys 30 Dosimeter Holder System

Patient Information Publications Warren Grant Magnuson Clinical Center National Institutes of Health

Anoro Ellipta Patient Handout

INSTRUCTIONS FOR USE. Norditropin NordiFlex Somatropin (rdna origin) injection 30 mg/3 ml Prefilled Pen

Instructions for Use HEMLIBRA (hem-lee-bruh) (emicizumab-kxwh) injection, for subcutaneous use

HUMULIN 70/30 KwikPen

PRO-V IDS Kit. Bisco. Instructions for Use. Provisional Restorative System

Endoscopic Technology. Operating Manual. Cannula system

EduCare Knowledge & Skill Assessment Medication I Routes

A82-LIFE-Dog Nebulizer NBB02

PRIMA Lab SA Via Antonio Monti Balerna Switzerland 0041 (0) primahometest.com

Drainage Frequency: PATIENT GUIDE. Dressing Frequency: Every Drainage Weekly Drainage. Physician Contact Information. Dr. Phone:

Instructions for Use. BASAGLAR KwikPen. insulin glargine injection (100 units/ml, 3 ml pen)

HumaPen LUXURA HD INSULIN DELIVERY DEVICE INSTRUCTIONS FOR USE

Instructions for Use Enbrel (en-brel) (etanercept) injection, for subcutaneous use Single-dose Prefilled Syringe

INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF ENBREL POWDER

Ultra View Manual Rev. 2 Effective 7/05

Sharps Container (not included) 1 Gather and check supplies. Gather supplies

DONGBAO PEN (ELECTRONIC) INSTRUCTION MANUAL

MICAFUNGIN MIXING

Preparation Instructions for the CAMLOG /CONELOG Implant System

Medescan Nebuliser Med - S600A Instructions Manual

Assembly Instruction for Fiber Optic Series FOH Fischer Connectors

Cleaning and Care Instructions

Medications. Managing and Administering Medication

Effective Date: August 31, 2006 SUBJECT: CARE AND USE OF NEBULIZER AND INTERMITTENT POSITIVE PRESSURE BREATHING DEVICE

CURVES. Anatomically Adaptable IPR strips. Brochure Instructions for use Processing instructions

INSTRUCTION MANUAL. Orascoptic 3225 Deming Way, Suite 190 Middleton, WI USA T:

Inhaler technique reminder cards

max airless Operating Manual for Dispenser Read this manual thoroughly before operating the Labmax airless!

COMPRESSOR NEBULIZER MODEL: JB USER S MANUAL

How to Use Inhaled Medications for Asthma and COPD

INSTRUCTIONS FOR USE

User s Manual. Blood Glucose Meter

For use only with Puregon cartridge (follitropin beta injection) INSTRUCTIONS FOR USE

DO NOT TRANSFER TO A SYRINGE SEVERE OVERDOSE CAN RESULT

PLEASE READ THESE INSTRUCTIONS BEFORE USE

MRKOMNN. kéï=~ë=çñw== d^ifiblp. réç~íé=êéäé~ëé=omnnlmr. båöäáëü. Cover page

Patient/Carer instructions for the administration of Subcutaneous Cytarabine

Tips for Training New Customers

HumaPen SAVVIO INSULIN DELIVERY DEVICE INSTRUCTIONS FOR USE

PEN USER MANUAL Byetta 5 micrograms solution for injection in pre-filled pen (exenatide)

Convex Array Transducer

PRE-FILLED PEN 300 IU/0.5 ml N F

Specimen Collection Policies

THE. Curve THE CURVE STRIPPING TOOL

M6-C Artificial Cervical Disc Surgical Instruments

Instructions for Use. Welcome!

SELF-INJECTION GUIDE

Linear Array Transducer

Instructions for Use ALVESCO [ael- ves-koʊ] (ciclesonide) Inhalation Aerosol

Mini-Mist. Owner s Manual. portable nebulizer. PMM241 Rev.3 12/10

Laparoscopic Transducer User Guide. Types 8666 and 8666-RF

MESH NEBULIZER INSTRUCTION MANUAL. Model NE-U22

Transcription:

kéï=~ë=çñw MUKOMNT `bob`=å~ãéê~=ó=å~êéi=åäé~åáåöi= ÇáëáåÑÉÅíáçå=~åÇ=ëíÉêáäáò~íáçå fåëíêìåíáçåë=ñçê=`bob`=lãåáå~ã=~åç=`bob`=_äìéå~ã Eî~äáÇ=Ñçê=rp^F båöäáëü=erpf CEREC camera care, cleaning, disinfection and sterilization / Instructions f CEREC Bluecam and CEREC Omnicam =

Table of contents Sirona Dental Systems GmbH Instructions f CEREC Omnicam and CEREC Bluecam Table of contents 1 Cleaning agents... 3 2 CEREC Omnicam... 4 2.1 General infmation... 4 2.2 Components of the Omnicam... 5 2.3 Removing the mirr sleeve... 5 2.4 Refitting the mirr sleeve... 5 2.5 Mirr sleeve reprocessing overview... 6 2.6 Pre-cleaning of the mirr sleeve... 6 2.7 Disinfecting the camera body and mirr sleeve... 7 2.8 High-level disinfection of the mirr sleeve (with HLD Set)... 7 2.9 Dry heat sterilization of the mirr sleeve... 12 2.10 Use of CEREC Omnicam Disposable Sleeves... 13 2.10.1 Assembly of disposable sleeve on the CEREC Omnicam s mirr sleeve 13 3 CEREC Bluecam... 14 3.1 CEREC Bluecam without sapphire glass... 14 3.1.1 General infmation... 14 3.1.2 Components of the CEREC Bluecam without sapphire glass... 15 3.1.3 Removing the prismatic tube... 15 3.1.4 Refitting the prismatic tube... 16 3.1.5 Prismatic tube (without sapphire) reprocessing overview... 16 3.1.6 Pre-cleaning of the prismatic tube... 17 3.1.7 Disinfecting the camera body... 17 3.1.8 High-level disinfection of the prismatic tube without sapphire glass 17 3.1.9 Dry heat sterilization of the prismatic tube without sapphire glass... 19 3.2 CEREC Bluecam with sapphire glass... 19 3.2.1 General infmation... 19 3.2.2 Components of the CEREC Bluecam with sapphire glass... 20 3.2.3 Removing the prismatic tube... 20 3.2.4 Refitting the prismatic tube... 21 3.2.5 Prismatic tube (with sapphire glass) reprocessing overview... 21 3.2.6 Pre-cleaning of the prismatic tube... 22 3.2.7 Disinfecting the camera body... 22 3.2.8 High-level disinfection of the prismatic tube with sapphire glass... 22 2 D3492.201.03.09.23 08.2017

Sirona Dental Systems GmbH Instructions f CEREC Omnicam and CEREC Bluecam 1 Cleaning agents 1 Cleaning agents Use only chemical products recommended by Sirona. Kerr Cpation CaviCide Cavi Wipes Patterson pdcare pdcare Wipes > 60% isopropyl alcohol D3492.201.03.09.23 08.2017 3

2 CEREC Omnicam Sirona Dental Systems GmbH 2.1 General infmation Instructions f CEREC Omnicam and CEREC Bluecam 2 CEREC Omnicam CAUTION If the CEREC Omnicam accidentally falls down, check to make sure that the camera windows and coated sapphire glass are not damaged. If the CEREC Omnicam has been damaged, it must no longer be used on patients. The CEREC Omnicam must be recalibrated. Do not sterilize the CEREC Omnicam the camera cable! The mirr sleeves are not autoclave sterilizable! 2.1 General infmation The CEREC Omnicam is a very sensitive optical device and must therefe be handled with the utmost care. Protect the coated sapphire glass and the camera windows against scratches and clean them with a clean lint-free cloth and ethanol (commercially available cleaning alcohol) whenever a film is noticed during imaging. Dental health care providers are advised to select the reprocessing method that aligns with their infection control process. An effective infection control program is practical, reasonable, and reproducible. 3 methods have been validated to reprocess the CEREC Omnicam between patient care: High-level disinfection of the mirr sleeve (with HLD Set) [ 7] Dry heat sterilization of the mirr sleeve [ 12] Use of CEREC Omnicam Disposable Sleeves [ 13] One of these methods is strongly recommended to be used f the reprocessing of the mirr sleeve. 4 D3492.201.03.09.23 08.2017

Sirona Dental Systems GmbH Instructions f CEREC Omnicam and CEREC Bluecam 2 CEREC Omnicam 2.2 Components of the Omnicam A Press detent to release C Sapphire glass (coated) B Mirr sleeve D Camera windows 2.3 Removing the mirr sleeve If required to remove the mirr sleeve do the following: 1. Press the mirr sleeve against the camera body. 2. Press detent A. There is a risk of damaging the camera windows the coated sapphire glass, if the mirr sleeve is not pushed straight toward the front. Push the mirr sleeve straight toward the front do not tilt. 3. Pull off the mirr sleeve. 2.4 Refitting the mirr sleeve There is a risk of damaging the camera windows the coated sapphire glass, if the mirr sleeve is not pushed straight toward the camera body. The mirr sleeve must not come into contact with the camera windows. Push the mirr sleeve straight toward the camera body do not tilt. Carefully refit the mirr sleeve until it locks in place. D3492.201.03.09.23 08.2017 5

2 CEREC Omnicam Sirona Dental Systems GmbH 2.5 Mirr sleeve reprocessing overview Instructions f CEREC Omnicam and CEREC Bluecam 2.5 Mirr sleeve reprocessing overview See detailed instructions after summary. Mirr sleeve f CEREC Omnicam Pre-Cleaning process (while mirr sleeve is attached to the camera) 1. Clean with a cotton gauze moistened with tap water of potable water quality that meets Federal Clean Water Standards and ph neutral soap use a clean lint-free cloth which has been soaked in CaviCide use Cavi Wipes use pdcare Wipes use a clean lint-free cloth which has been soaked in >60% isopropyl alcohol 2. Dry the mirr sleeve with a clean lint-free cloth. HLD process Dry heat sterilization process 1. Use CIDEX OPA Spox II Sterilizing and Disinfecting Solution (use steel mirr sleeves) as disinfectant f high-level disinfection per manufacturer s instructions. 2. Leave the mirr sleeve in CIDEX OPA f 12minutes in Spox II f 30minutes at 20 C. 3. Rinse the sleeve under tap water of potable water quality that meets Federal Clean Water Standards. 4. Dry the mirr sleeve with a clean lint-free cloth. Dry heat 160 C (Sterident Model 200) f 120 minutes (wrapped unwrapped) Dry heat 160 C (SteriSURE) f 60minutes (wrapped unwrapped) Dry heat 190 C (Cox RAPIDHEAT Sterilizer) f 6 minutes (unwrapped), Dry heat 190 C (Cox RAPIDHEAT Sterilizer) f 12minutes (wrapped). 2.6 Pre-cleaning of the mirr sleeve Cleaning process immediately after using the CEREC Omnicam: While the mirr sleeve is attached to the camera, wipe off so that any surface contamination cannot harden and adhere to the surface of the mirr sleeve. Use a cotton gauze moistened with tap water of potable water quality that meets Federal Clean Water Standards and ph neutral soap use a clean lint-free cloth which has first been soaked in one of the cleaning products listed in the Cleaning agents [ 3] section to remove visible contamination. Then dry the mirr sleeve with a clean lint-free cloth. 6 D3492.201.03.09.23 08.2017

Sirona Dental Systems GmbH Instructions f CEREC Omnicam and CEREC Bluecam 2 CEREC Omnicam 2.7 Disinfecting the camera body and mirr sleeve Do not spray the CEREC Omnicam immerse it in cleaning agents disinfectants! Use a new cotton gauze moistened with one of the cleaning products listed in the Cleaning agents [ 3] section. Wipe the camera body first and then the mirr sleeve. This step disinfects the camera body and the mirr sleeve. Then dry the mirr sleeve with a clean lint-free cloth. 2.8 High-level disinfection of the mirr sleeve (with HLD Set) Dry heat sterilization and high-level disinfection must not be combined. The complete process f high-level disinfection is as follows: With HLD Set Spox II should only be used with steel mirr sleeves. Steel mirr sleeves are marked with the letters ST (see the image). A HLD set to suppt the HLD process should be dered from Sirona with REF 66 05 120. A HLD container C Metal holder B Lid D Plug 1. Pre-cleaning (see Pre-cleaning of the mirr sleeve [ 6] ). 2. Put on Personal Protective Equipment at the latest when handling the high-level disinfectant. 3. Remove the mirr sleeve from the CEREC Omnicam (see Removing the mirr sleeve [ 5] ). D3492.201.03.09.23 08.2017 7

2 CEREC Omnicam Sirona Dental Systems GmbH 2.8 High-level disinfection of the mirr sleeve (with HLD Set) Instructions f CEREC Omnicam and CEREC Bluecam It is recommended that you never switch between disinfecting and sterilizing solutions. However if you do, make sure you thoughly rinse the HLD set befe switching. 4. Place the white protective cap on the camera tip and place the camera in the camera cradle. 5. Use one of the following disinfectants f the high-level disinfection: CIDEX OPA, Spox II. 6. Slid the plug into the metal holder. 7. Press the mirr sleeve onto the plug while holding the metal holder in der to ensure that no particle contamination fluids penetrate the inside of the mirr sleeve. If attached crectly, the plug seals the mirr sleeve watertight. CAUTION Observe the disinfectant s manufacturer s safety indications! 8 D3492.201.03.09.23 08.2017

Sirona Dental Systems GmbH Instructions f CEREC Omnicam and CEREC Bluecam 2 CEREC Omnicam 8. Cautiously fill the HLD container up to the marked level (B) per manufacturer s instructions. A funnel can be used to assist with filling the liquid (A). Do not spill any disinfectant. If spillage occurs please follow disinfectant s manufacturer s safety indications f cleaning. 9. Insert the metal holder with the mirr sleeve. D3492.201.03.09.23 08.2017 9

2 CEREC Omnicam Sirona Dental Systems GmbH 2.8 High-level disinfection of the mirr sleeve (with HLD Set) Instructions f CEREC Omnicam and CEREC Bluecam 10. Place the lid on the container and leave the mirr sleeve at least 12 minutes f CIDEX OPA 30 minutes f Spox II in the disinfectant. While exceeding the recommended immersion time may not cause damage to the mirr sleeve, the mirr sleeve should be removed as soon as possible after the recommended time. 11. Remove the lid and the holder with the mirr sleeve from the container. 12. Thoughly rinse the mirr sleeve with tap water of potable water quality that meets Federal Clean Water Standards holding it with its holder. 10 D3492.201.03.09.23 08.2017

Sirona Dental Systems GmbH Instructions f CEREC Omnicam and CEREC Bluecam 2 CEREC Omnicam 13. Carefully and slowly remove the plug with the holder from the mirr sleeve by downward movement of the holder. Make sure that the mirr sleeve points upwards not to risk any damage by liquids entering the inside of the mirr sleeve. 14. Remove the plug from the holder. 15. Dry the plug with a clean lint-free cloth. 16. Pri to each use of the HLD set test the solution f its effectiveness per manufacturer s instructions. If not in use rinse container and holder and ste the holder inside the empty container. 17. Dry the whole surface of the mirr sleeve and also the lower part of the inner surface using a clean soft, lint-free cloth. 18. Ste the mirr sleeve in a manner to protect it from contamination until the time of use. 19. At time of use remove the white protective cap from the camera tip. 20. Carefully re-attach the mirr sleeve and allow it to lock in place (see Refitting the mirr sleeve [ 5] ). D3492.201.03.09.23 08.2017 11

2 CEREC Omnicam Sirona Dental Systems GmbH 2.9 Dry heat sterilization of the mirr sleeve Instructions f CEREC Omnicam and CEREC Bluecam 2.9 Dry heat sterilization of the mirr sleeve Dry heat sterilization and high-level disinfection must not be combined. The process f dry heat sterilization is as follows: 1. Pre-cleaning (see Pre-cleaning of the mirr sleeve [ 6] ) 2. Remove the mirr sleeve from the CEREC Omnicam (see Removing the mirr sleeve [ 5] ). 3. Sterilize the mirr sleeve using dry heat at 190 C f 6 minutes (unwrapped) 12 minutes (wrapped). Use only pouches which are suitable f dry heat sterilization cycle of at least 190 ⁰ C, 12 minutes. Alternatively, sterilize mirr sleeve using dry heat at 160 C f 120minutes f 60minutes (unwrapped wrapped). Use only pouches which are suitable f dry heat sterilization cycle of at least 160 ⁰ C, 120minutes. The CPAC Cox RAPIDHEAT Sterilizer, the CPAC Sterident Model 200 and the CPAC SteriSURE have been validated by Sirona Dental Systems. F 6 minutes 190 C program # 1 has to be set on the CPAC Cox RAPIDHEAT Sterilizer. F 12 minutes 190 C program # 3 has to be set on the CPAC Cox RAPIDHEAT Sterilizer. F 120 minutes 160 C the CPAC Sterident Model 200 is to be used. F 60 minutes 160 C the CPAC SteriSURE is to be used. 4. Ste the mirr sleeve in such a way that it is protected from contamination until the next use. 5. Carefully re-attach the mirr sleeve and allow it to lock in place (see Refitting the mirr sleeve [ 5] ). The mirr sleeve changes its col which will not have any negative impact upon the mirr sleeve s durability. 12 D3492.201.03.09.23 08.2017

Sirona Dental Systems GmbH Instructions f CEREC Omnicam and CEREC Bluecam 2 CEREC Omnicam 2.10 Use of CEREC Omnicam Disposable Sleeves The CEREC Omnicam can use disposable plastic sleeves to ensure maximum infection control. These are available with der number 66 32 264. The disposable sleeves cannot be used with the CEREC AF and CEREC AI systems when using the shade detection feature using the Ortho software. 2.10.1 Assembly of disposable sleeve on the CEREC Omnicam s mirr sleeve 1. Remove a disposable sleeve from its packaging. Slide the disposable sleeve on the Omnicam mirr sleeve until the stop limit is reached, so that it is mounted firmly to the Omnicam. Do not hold the Omnicam only with the sleeve to prevent dropping the Omnicam. 2. Place the CEREC Omnicam on the cradle to allow it to warm up f at least 15 minutes pri to intraal scan. Ensure that the cradle is disinfected. 3. While intraally scanning with mirr sleeves the Omnicam should be placed nearer to the teeth than when not using sleeves. If the 3D preview has artifacts, check if the window of the disposable sleeve is clean and wipe it off with alcohol. At the end of each scanning session, remove the disposable sleeve from the CEREC Omnicam mirr sleeve and discard it accding to standard procedures. D3492.201.03.09.23 08.2017 13

3 CEREC Bluecam Sirona Dental Systems GmbH 3.1 CEREC Bluecam without sapphire glass Instructions f CEREC Omnicam and CEREC Bluecam 3 CEREC Bluecam CAUTION If the CEREC Bluecam accidentally falls down, check to make sure that the front lens and prism are not damaged. If the CEREC Bluecam has been damaged, it must no longer be used on patients. The CEREC Bluecam must be recalibrated. Do not sterilize the CEREC Bluecam the camera cable! The prismatic tubes are not autoclave sterilizable! 3.1 CEREC Bluecam without sapphire glass 3.1.1 General infmation The CEREC Bluecam is a very sensitive optical device and must therefe be handled with the utmost care. Protect the front lens and the prism against scratching and clean them with a clean lint-free cloth and ethanol (commercially available cleaning alcohol) whenever a film is noticed during imaging. Dental health care providers are advised to select the reprocessing method that aligns with their infection control process. An effective infection control program is practical, reasonable, and reproducible. Two methods have been validated to reprocess the CEREC Bluecam without sapphire glass between patient care: High-level disinfection of the prismatic tube without sapphire glass [ 17] Dry heat sterilization of the prismatic tube without sapphire glass [ 19] One of these methods is strongly recommended to be used f the reprocessing of the prismatic tube. 14 D3492.201.03.09.23 08.2017

Sirona Dental Systems GmbH Instructions f CEREC Omnicam and CEREC Bluecam 3 CEREC Bluecam 3.1.2 Components of the CEREC Bluecam without sapphire glass A Press detent to release D Camera suppt 6 pcs., Order No. 5945360 B Prismatic tube E Protective cap C Prism without sapphire glass (bcl / bcb) F Front lens 3.1.3 Removing the prismatic tube 012 345 A A Detent 1. Press the prismatic tube against the camera body. 2. Press detent A. Risk of damaging the front lens prism. Push the prismatic tube straight toward the front, do not tilt it. 3. Pull off the prismatic tube. D3492.201.03.09.23 08.2017 15

3 CEREC Bluecam Sirona Dental Systems GmbH 3.1 CEREC Bluecam without sapphire glass Instructions f CEREC Omnicam and CEREC Bluecam 3.1.4 Refitting the prismatic tube Do not use CEREC 2 / CEREC 3 prismatic tubes. Risk of damaging the front lens prism. The prismatic tube must not touch the front lens. Push the prismatic tube straight toward the camera body; do not tilt it. Carefully refit the prismatic tube until it locks in place. 3.1.5 Prismatic tube (without sapphire) reprocessing overview See detailed instructions after summary. Prismatic tube f CEREC Bluecam without sapphire glass Pre-Cleaning process (while prismatic tube is attached to the camera) 1. Clean with a cotton gauze moistened with tap water of potable water quality that meets Federal Clean Water Standards and ph neutral soap use a clean lint-free cloth which has been soaked in CaviCide use Cavi Wipes use pdcare Wipes use a clean lint-free cloth which has been soaked in >60% isopropyl alcohol 2. Dry the prismatic tube with a clean lint-free cloth. HLD process Dry heat sterilization process 1. Use CIDEX OPA Spox II Sterilizing and Disinfecting Solution as disinfectant f high-level disinfection per manufacturer s instructions. 2. Leave the prismatic tube in CIDEX OPA f 12minutes in Spox II f 30minutes at 20 C. 3. Wipe off the prismatic tube. Use a cotton gauze moistened with tap water of potable water quality that meets Federal Clean Water Standards. 4. Dry the prismatic tube with a clean lint-free cloth. Dry heat 160 C (Sterident Model 200) f 120 minutes (wrapped unwrapped) Dry heat 160 C (SteriSURE) f 60minutes (wrapped unwrapped). 16 D3492.201.03.09.23 08.2017

Sirona Dental Systems GmbH Instructions f CEREC Omnicam and CEREC Bluecam 3 CEREC Bluecam 3.1.6 Pre-cleaning of the prismatic tube Cleaning process immediately after using the CEREC Bluecam: While the prismatic tube is attached to the camera, wipe off so that any surface contamination cannot harden and adhere to the surface of the prismatic tube. Use a cotton gauze moistened with tap water of potable water quality that meets Federal Clean Water Standards and ph neutral soap use a clean lint-free cloth which has first been soaked in one of the cleaning products listed in the Cleaning agents [ 3] section to remove visible contamination. Then dry the prismatic tube with a clean lint-free cloth. 3.1.7 Disinfecting the camera body Do not spray the CEREC Omnicam immerse it in cleaning agents disinfectants! Use a new cotton gauze moistened with one of the cleaning products listed in the Cleaning agents [ 3] section. Wipe the camera body first and then the prismatic tube. This step disinfects the camera body and removes cleaning residues from the prismatic tube. Then dry the prismatic tube with a clean lint-free cloth. 3.1.8 High-level disinfection of the prismatic tube without sapphire glass Dry heat sterilization and high-level disinfection must not be combined. The complete process f high-level disinfection is as follows: With HLD set A HLD set to suppt the HLD process should be dered from Sirona with REF 63 46 907. Fragment USA 1. Remove the CEREC camera suppt (if present). 2. Pre-cleaning (see Pre-cleaning of the prismatic tube [ 17] ). 3. Remove the prismatic tube from the CEREC Bluecam (see Removing the prismatic tube [ 15] ). 4. Place the protective cap on the camera and place the camera in the camera cradle. 5. Use one of the following disinfectants f the high-level disinfection: CIDEX OPA, Spox II. CAUTION Observe the disinfectant s manufacturer s safety indications! D3492.201.03.09.23 08.2017 17

3 CEREC Bluecam Sirona Dental Systems GmbH 3.1 CEREC Bluecam without sapphire glass Instructions f CEREC Omnicam and CEREC Bluecam 6. Cautiously fill the HLD container up to the 40ml marked ( Bluecam mark) level per manufacturer s instructions. A funnel can be used to assist with filling the liquid. Do not spill any disinfectant. If spillage occurs please follow disinfectant s manufacturer s safety indications f cleaning. Only place the prismatic tube into the container and not the entire CEREC Omnicam. Ensure that the prismatic tube is placed upright in the disinfectant (glass down) so that the solution cannot penetrate the inside of the prismatic tube. 7. Insert the prismatic tube in the crect position (glass down). 8. Place the lid on the container and leave the prismatic tube at least 12 minutes f CIDEX OPA 30 minutes f Spox II in the disinfectant. While exceeding the recommended immersion time may not cause damage to the prismatic tube, the prismatic tube should be removed as soon as possible after the recommended time. 9. Remove the prismatic tube from the container. 10. Wipe off the prismatic tube. Use a cotton gauze moistened with tap water of potable water quality that meets Federal Clean Water Standards f this purpose. 11. Dry the prismatic tube using a clean soft, lint-free cloth. 12. Ste the prismatic tube in such a way that it is protected from contamination until the next use. 13. Remove the protective cap from the camera befe use. 14. Carefully re-attach the prismatic tube (see "Refitting the prismatic tube [ 16] ). 18 D3492.201.03.09.23 08.2017

Sirona Dental Systems GmbH Instructions f CEREC Omnicam and CEREC Bluecam 3 CEREC Bluecam 3.1.9 Dry heat sterilization of the prismatic tube without sapphire glass Dry heat sterilization and high-level disinfection must not be combined. The process f dry heat sterilization is as follows: 1. Remove the CEREC camera suppt (if present). 2. Pre-cleaning (see Pre-cleaning of the prismatic tube [ 17] ). 3. Remove the prismatic tube from the CEREC Bluecam (see Removing the prismatic tube [ 15] ). 4. Sterilize the prismatic tube using dry heat at 160 C f 120minutes (wrapped unwrapped) 60minutes (wrapped unwrapped). The CPAC Sterident Model 200 and the CPAC SteriSURE have been validated by Sirona Dental Systems. F 120 minutes 160 C the CPAC Sterident Model 200 is to be used. F 60 minutes 160 C the CPAC SteriSURE is to be used. Use only pouches which are suitable f dry heat sterilization cycle of at least 160 ⁰ C, 120 minutes. 5. Ste the prismatic tube in such a way that it is protected from contamination until the next use. 6. Carefully re-attach the prismatic tube and allow it to lock in place. See section Refitting the prismatic tube [ 16]. The prismatic tube changes its col which will not have any negative impact upon the prismatic tube s durability. 3.2 CEREC Bluecam with sapphire glass 3.2.1 General infmation The CEREC Bluecam is a very sensitive optical device and must therefe be handled with the utmost care. Protect the front lens and the prism against scratching and clean them with a clean lint-free cloth and ethanol (commercially available cleaning alcohol) whenever a film is noticed during imaging. Dental health care providers are advised to select the reprocessing method that aligns with their infection control process. An effective infection control program is practical, reasonable, and reproducible. One method has been validated to reprocess the CEREC Bluecam with sapphire glass between patient care: High-level disinfection of the prismatic tube with sapphire glass [ 22] This method is strongly recommended to be used f the reprocessing of the prismatic tube with sapphire glass. D3492.201.03.09.23 08.2017 19

3 CEREC Bluecam Sirona Dental Systems GmbH 3.2 CEREC Bluecam with sapphire glass Instructions f CEREC Omnicam and CEREC Bluecam 3.2.2 Components of the CEREC Bluecam with sapphire glass A Press detent to release D Camera suppt 6 pcs., Order No. 5945360 B Prismatic tube E Protective cap C Prism with sapphire glass (bcl sa / bcb sa) F Front lens 3.2.3 Removing the prismatic tube 012 345 A A Detent 1. Press the prismatic tube against the camera body. 2. Press detent A. Risk of damaging the front lens prism. Push the prismatic tube straight toward the front, do not tilt it. 3. Pull off the prismatic tube. 20 D3492.201.03.09.23 08.2017

Sirona Dental Systems GmbH Instructions f CEREC Omnicam and CEREC Bluecam 3 CEREC Bluecam 3.2.4 Refitting the prismatic tube Do not use CEREC 2 / CEREC 3 prismatic tubes. Risk of damaging the front lens prism. The prismatic tube must not touch the front lens. Push the prismatic tube straight toward the camera body; do not tilt it. Carefully refit the prismatic tube until it locks in place. 3.2.5 Prismatic tube (with sapphire glass) reprocessing overview See detailed instructions after summary. Prismatic tube f CEREC Bluecam with sapphire glass Pre-Cleaning process (while prismatic tube is attached to the camera) 1. Clean with a cotton gauze moistened with tap water of potable water quality that meets Federal Clean Water Standards and ph neutral soap use a clean lint-free cloth which has been soaked in CaviCide use Cavi Wipes use pdcare Wipes use a clean lint-free cloth which has been soaked in >60% isopropyl alcohol 2. Dry the prismatic tube with a clean lint-free cloth. HLD process Dry heat sterilization process 1. Use CIDEX OPA Spox II Sterilizing and Disinfecting Solution as disinfectant f high-level disinfection per manufacturer s instructions. No sterilization possible. 2. Leave the prismatic tube in CIDEX OPA f 12minutes in Spox II f 30minutes at 20 C. 3. Wipe off the prismatic tube. Use a cotton gauze moistened with tap water of potable water quality that meets Federal Clean Water Standards. 4. Dry the prismatic tube with a clean lint-free cloth. D3492.201.03.09.23 08.2017 21

3 CEREC Bluecam Sirona Dental Systems GmbH 3.2 CEREC Bluecam with sapphire glass Instructions f CEREC Omnicam and CEREC Bluecam 3.2.6 Pre-cleaning of the prismatic tube Cleaning process immediately after using the CEREC Bluecam: While the prismatic tube is attached to the camera, wipe off so that any surface contamination cannot harden and adhere to the surface of the prismatic tube. Use a cotton gauze moistened with tap water of potable water quality that meets Federal Clean Water Standards and ph neutral soap use a clean lint-free cloth which has first been soaked in one of the cleaning products listed in the Cleaning agents [ 3] section to remove visible contamination. Then dry the prismatic tube with a clean lint-free cloth. 3.2.7 Disinfecting the camera body Do not spray the CEREC Omnicam immerse it in cleaning agents disinfectants! Use a new cotton gauze moistened with one of the cleaning products listed in the Cleaning agents [ 3] section. Wipe the camera body first and then the prismatic tube. This step disinfects the camera body and removes cleaning residues from the prismatic tube. Then dry the prismatic tube with a clean lint-free cloth. 3.2.8 High-level disinfection of the prismatic tube with sapphire glass The complete process f high-level disinfection is as follows: With HLD set A HLD set to suppt the HLD process should be dered from Sirona with REF 63 46 907. Fragment USA 1. Remove the CEREC camera suppt (if present). 2. Pre-cleaning (see Pre-cleaning of the prismatic tube [ 22] ). 3. Remove the prismatic tube from the CEREC Bluecam (see Removing the prismatic tube [ 20] ). 4. Place the protective cap on the camera and place the camera in the camera cradle. 5. Use one of the following disinfectants f the high-level disinfection: CIDEX OPA, Spox II. CAUTION Observe the disinfectant s manufacturer s safety indications! 22 D3492.201.03.09.23 08.2017

Sirona Dental Systems GmbH Instructions f CEREC Omnicam and CEREC Bluecam 3 CEREC Bluecam 6. Cautiously fill the HLD container up to the 40ml marked ( Bluecam mark) level per manufacturer s instructions. A funnel can be used to assist with filling the liquid. Do not spill any disinfectant. If spillage occurs please follow disinfectant s manufacturer s safety indications f cleaning. Only place the prismatic tube into the container and not the entire CEREC Omnicam. Ensure that the prismatic tube is placed upright in the disinfectant (glass down) so that the solution cannot penetrate the inside of the prismatic tube. 7. Insert the prismatic tube in the crect position (glass down). 8. Place the lid on the container and leave the prismatic tube at least 12 minutes f CIDEX OPA 30 minutes f Spox II in the disinfectant. While exceeding the recommended immersion time may not cause damage to the prismatic tube, the prismatic tube should be removed as soon as possible after the recommended time. 9. Remove the prismatic tube from the container. 10. Wipe off the prismatic tube. Use a cotton gauze moistened with tap water of potable water quality that meets Federal Clean Water Standards f this purpose. 11. Dry the prismatic tube using a clean soft, lint-free cloth. 12. Ste the prismatic tube in such a way that it is protected from contamination until the next use. 13. Remove the protective cap from the camera befe use. 14. Carefully re-attach the prismatic tube (see "Refitting the prismatic tube [ 21] ). D3492.201.03.09.23 08.2017 23

té=êéëéêîé=íüé=êáöüí=íç=ã~âé=~åó=~äíéê~íáçåë=ïüáåü=ã~ó=äé=êéèìáêéç=çìé=íç=íéåüåáå~ä=áãéêçîéãéåíëk «=páêçå~=aéåí~ä==póëíéãë=dãäe péê~åüéw ÉåÖäáëÅÜ=ErpF mêáåíéç=áå=déêã~åó apqvokomnkmpkmvkop MUKOMNT ûkjkêkw= NOQ=OVR páêçå~=aéåí~ä=póëíéãë=dãäe c~äêáâëíê~ É=PN SQSOR=_ÉåëÜÉáã déêã~åó ïïïkëáêçå~kåçã `çåí~åí=áå=íüé=rp^w páêçå~=aéåí~äi=fååk QUPR=páêçå~=aêáîÉ `Ü~êäçííÉI=k`=OUOTP rp^ lêçéê=kç SP=MV=USP=aPQVO