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Dentsply Sirona Primescan 2 Instructions For Use Manual
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Dentsply Sirona Primescan 2 Instructions For Use Manual

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2024-09
New as of:
Primescan™ 2
Primescan™ 2 Cart
Single Use Sleeve Primescan™ 2
Instructions for use (valid for Canada, Australia and
New Zealand)
English

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Summary of Contents for Dentsply Sirona Primescan 2

  • Page 1 2024-09 New as of: Primescan™ 2 Primescan™ 2 Cart Single Use Sleeve Primescan™ 2 Instructions for use (valid for Canada, Australia and New Zealand) English...
  • Page 2 Table of contents Dentsply Sirona Instructions for use Primescan™ 2 Table of contents General data....................Dear Customer, ......................Contact information ..................... General information about these instructions for use..........1.3.1 Notes to the repository.................. General conventions and structure of the document...........
  • Page 3 Dentsply Sirona Table of contents Instructions for use Primescan™ 2 Technical data ......................3.6.1 Scanner......................3.6.2 Charger ......................3.6.3 Mobile display unit (optional) ................ Major components....................... Technical description....................Operation and functional elements................Scanner and charger ..................3.9.1 3.9.2 Mobile display unit (optional) ................
  • Page 4 Table of contents Dentsply Sirona Instructions for use Primescan™ 2 Operation......................Basics.......................... Software for acquisition ....................Optical impressions with the scanner................Scanner guide ......................6.4.1 Occlusal scan....................6.4.2 Buccal scan....................6.4.3 Lingual scan....................6.4.4 Approximal surface scan................Single and multiple buccal registration ............
  • Page 5 Dentsply Sirona Table of contents Instructions for use Primescan™ 2 Dismantling and disposal ................111 10.1 Disposal of batteries (scanner and mobile display unit) ..........112 10.2 Disposal of sleeves ..................... 112 10.3 Data security at disposal ..................... 112 Index........................ 113 68 51 351 D3775 D3775.201.01.09.02    2024-09...
  • Page 6 Always keep them within easy reach. Also observe the safety notices to prevent personal injury and material damage. Your Primescan™ 2 team Contact information Dentsply Sirona Product service Log in to register your units and make service requests: https://dentsplysirona.service-pacemaker.com/ Manufacturer's address Sirona Dental Systems GmbH...
  • Page 7 Dentsply Sirona 1 General data Instructions for use Primescan™ 2 1.3 General information about these instructions for use General information about these instructions for Observe the instructions for use. Please familiarize yourself with the unit by reading through these instructions for use before putting it into operation. It is essential that you observe the specified safety information and warning notices.
  • Page 8 1 General data Dentsply Sirona 1.4 General conventions and structure of the document Instructions for use Primescan™ 2 General conventions and structure of the document 1.4.1 Structure of the document 1.4.1.1 Identification of danger levels To prevent personal injury and material damage, please observe the warning and safety information provided in these operating instructions.
  • Page 9 Exclusion of liability If the operator does not meet the obligation to carry out such maintenance or error messages are ignored, Dentsply Sirona or its authorized dealer does not assume any liability for resulting damage. Obligation to notify authorities...
  • Page 10 1 General data Dentsply Sirona 1.8 Legend Instructions for use Primescan™ 2 Legend Manufacturer Date of manufacture: YYYY-MM-DD (year-month-day) Reference number Serial number Internal code for product identification. Batch number "Warning of optical radiation" symbol Warning of injuries to eyes and skin in the vicinity of optical radiation.
  • Page 11 Dentsply Sirona 1 General data Instructions for use Primescan™ 2 1.8 Legend Radio approval for Australia/New Zealand. Follow the instructions for use. To ensure safe operation of the unit, the user must follow the instructions for use. NOTICE!  Observe instructions for use!
  • Page 12 1 General data Dentsply Sirona 1.8 Legend Instructions for use Primescan™ 2 Labels electrical equipment intended for use indoors. MET mark MET certified product. CE mark Marking for CE conformity. UL-recognized component 68 51 351 D3775 D3775.201.01.09.02    2024-09...
  • Page 13 Dentsply Sirona 1 General data Instructions for use Primescan™ 2 1.8 Legend Symbols on the packaging Take note of the following symbols on the packaging: Keep dry. Fragile, handle with care. Temperature during storage and transport. Relative humidity during storage and transport Air pressure during storage and transport.
  • Page 14 2 Safety instructions Dentsply Sirona 2.1 Basic safety information Instructions for use Primescan™ 2 Safety instructions Basic safety information 2.1.1 Prerequisites NOTICE Important information on building installation In order to prevent the risk of an electric shock, this unit must only be connected to a supply mains with a ground wire.
  • Page 15 Risk of injury No system components are intended to be repaired by a technician except the Primescan™ 2 mobile display unit. ➢ In case of a defect, contact the Dentsply Sirona product service. CAUTION Risk of injury Evidently damaged or contaminated disposable sleeves (e.g. due to dropping the unwrapped disposable sleeves) may no longer be used on the patient.
  • Page 16 2 Safety instructions Dentsply Sirona 2.1 Basic safety information Instructions for use Primescan™ 2 CAUTION Restoration to be checked by trained personnel Each restoration created must be checked for suitability by a trained person (e.g. dentist). CAUTION Risk group 2: Potentially hazardous optical radiation! Direct radiation to the eye can be harmful for the eye.
  • Page 17 Dentsply Sirona 2 Safety instructions Instructions for use Primescan™ 2 2.1 Basic safety information When using the Primescan™ 2 Cart mobile display unit (optional), the following also apply CAUTION Risk of toxic liquid escaping from a damaged display There is a risk of injury if toxic liquid escapes from a damaged display.
  • Page 18 2 Safety instructions Dentsply Sirona 2.1 Basic safety information Instructions for use Primescan™ 2 Plug connections of external interfaces CAUTION Additional devices connected to external interfaces must be tested according to the relevant standards, e.g.: EN 60601-1:2006 + Cor.:2010 + A1:2013, IEC 60601-1 Edition 3.1:2012,...
  • Page 19 Dentsply Sirona 2 Safety instructions Instructions for use Primescan™ 2 2.1 Basic safety information When using the Primescan™ 2 Cart mobile display unit (optional), the following also apply CAUTION Trip/fall hazard When using the Primescan™ 2 Cart mobile display unit, you can trip and fall over the supply cable.
  • Page 20 2 Safety instructions Dentsply Sirona 2.1 Basic safety information Instructions for use Primescan™ 2 The Primescan™ 2 Cart mobile display unit can be moved from room to room for use in different treatment rooms. 2.1.5 Stability of the unit NOTICE...
  • Page 21 In order to ensure product safety, this device may be operated only with original Dentsply Sirona accessories or third-party accessories expressly approved by Dentsply Sirona. In particular, only the included power cable, power supply units and batteries may be used with the 68 51 351 D3775 D3775.201.01.09.02    2024-09...
  • Page 22 (e.g. USB sticks). Battery charger interface of the Primescan™ 2 Cart mobile display unit (optional) NOTICE Use original accessories Connect only the original Dentsply Sirona charger to the charger interface. Network connection of the Primescan™ 2 Cart mobile display unit (optional) WLAN...
  • Page 23 Dentsply Sirona 2 Safety instructions Instructions for use Primescan™ 2 2.3 Safety labels The hub/switch must: ● be permanently installed in the same room in which the mobile display unit is operated. ● be grounded via an additional protective conductor.
  • Page 24 Non-compliance can lead to a reduction in the performance features of the unit. Cybersecurity If Dentsply Sirona detects a security vulnerability in the Primescan™ 2 devices, Dentsply Sirona will provide an updated firmware with 68 51 351 D3775...
  • Page 25 Dentsply Sirona 2 Safety instructions Instructions for use Primescan™ 2 2.6 Cybersecurity necessary mitigations and you will be notified in DS Core when the new firmware is available. If you suspect a cybersecurity attack on the Primescan™ 2 has taken place, please report the incident using the contact information in chapter "Contact information" ...
  • Page 26 3 Product description Dentsply Sirona 3.1 Intended use Instructions for use Primescan™ 2 Product description Intended use CAUTION The unit may be operated only by medically trained and qualified personnel. The intraoral scanner records and generates digital images and impression data for dental use.
  • Page 27 Dentsply Sirona 3 Product description Instructions for use Primescan™ 2 3.3 Patient population Patient population The intended patient population includes children, adolescents and adults and patients of all age and ethnic groups relevant for dental treatment. Transportation and storage conditions...
  • Page 28 3 Product description Dentsply Sirona 3.6 Technical data Instructions for use Primescan™ 2 Technical data 3.6.1 Scanner Type designation Primescan™ 2 Type of protection against electric shock Protection class II equip- ment Type of protection against electric shock Type BF applied part...
  • Page 29 Dentsply Sirona 3 Product description Instructions for use Primescan™ 2 3.6 Technical data Near infrared mode: 850  n m Optical system / sensor Optical system: Multiple lens system with protective glass Sensor type: CMOS Image size: 13.8  x   1 3.8  m m (at 8.5 mm working dis-...
  • Page 30 3 Product description Dentsply Sirona 3.6 Technical data Instructions for use Primescan™ 2 3.6.2 Charger Type designation Charger Primescan™ 2 Environment for use Use outside the patient environment or attached to the mobile display unit. Connection, input side 10  -   1 4  V   D C / 3.0  A / 36  W Output per charging slot 4.2 ...
  • Page 31 Dentsply Sirona 3 Product description Instructions for use Primescan™ 2 3.6 Technical data 3.6.3 Mobile display unit (optional) Type designation Primescan™ 2 Cart Nominal line voltage 100  -   2 40  V   A C / 50  -   6 0  H z Nominal power output 175 ...
  • Page 32 3 Product description Dentsply Sirona 3.7 Major components Instructions for use Primescan™ 2 Major components IMPORTANT Use of short forms In the interest of better legibility, the short forms provided for the component designations are used in the further course of the document.
  • Page 33 Dentsply Sirona 3 Product description Instructions for use Primescan™ 2 3.8 Technical description Technical description Intraoral scanner for precise optical impressions in the mouth ● High-resolution, heated intraoral scanner (3D scanner) with removable disposable sleeve and integrated image processing for wireless or cable operation, ●...
  • Page 34 3 Product description Dentsply Sirona 3.9 Operation and functional elements Instructions for use Primescan™ 2 Operation and functional elements 3.9.1 Scanner and charger Primescan™ 2 scanner Battery ON/OFF button Charger Operating status display Connect key Charger status displays Connection status display...
  • Page 35 Dentsply Sirona 3 Product description Instructions for use Primescan™ 2 3.9 Operation and functional elements Area for tapping the scan- Protective sleeve ner housing (acquisition mode) Scanner holder Disposable sleeve 3.9.2 Mobile display unit (optional) Primescan™ 2 Cart mobile Scanner holder...
  • Page 36 3 Product description Dentsply Sirona 3.9 Operation and functional elements Instructions for use Primescan™ 2 3.9.3 Connection set (optional) for cable operation Cable adapter Network cable Coupling box Power supply unit CAUTION Only use the power supply unit and power cable supplied by Dentsply Sirona for operating the connection set.
  • Page 37 Dentsply Sirona 3 Product description Instructions for use Primescan™ 2 3.9 Operation and functional elements LED display Description flashes The scanner is in cooling light orange mode. The scanner cannot be switched on again during cooling. At the end of the cooling process, the color changes to blue and the scanner can be switched on again.
  • Page 38 3 Product description Dentsply Sirona 3.9 Operation and functional elements Instructions for use Primescan™ 2 IMPORTANT Battery is not fully charged On delivery, the battery is not fully charged. Put the battery in the charger before the first use to reach full capacity.
  • Page 39 Dentsply Sirona 3 Product description Instructions for use Primescan™ 2 3.9 Operation and functional elements Network connection of the Primescan™ 2 Cart mobile display unit (optional) LED display Description flashes blue The mobile display unit is in search twice mode:...
  • Page 40 3 Product description Dentsply Sirona 3.10 Certification Instructions for use Primescan™ 2 3.10 Certification CE marking This product is compliant with EU Medical Device Regulation 2017/745 including all amendments. This product bears the CE mark in accordance with the provisions of Directive 2014/53/EU (RED).
  • Page 41 Dentsply Sirona 3 Product description Instructions for use Primescan™ 2 3.11 FCC and IC compliance 3.11 FCC and IC compliance FCC compliance statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
  • Page 42 3 Product description Dentsply Sirona 3.11 FCC and IC compliance Instructions for use Primescan™ 2 (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence.
  • Page 43 Dentsply Sirona 3 Product description Instructions for use Primescan™ 2 3.12 Electromagnetic compatibility 3.12 Electromagnetic compatibility The following information must be observed to ensure safe operation regarding EMC aspects. Primescan™ 2 complies with the requirements for electromagnetic compatibility (EMC) according to IEC 60601-1-2:2014+AMD1:2020.
  • Page 44 3 Product description Dentsply Sirona 3.12 Electromagnetic compatibility Instructions for use Primescan™ 2 3.12.2 Interference immunity The UNIT is intended for operation in the electromagnetic environment specified below. The customer or user of the UNIT should make sure that it is used in such an environment.
  • Page 45 Dentsply Sirona 3 Product description Instructions for use Primescan™ 2 3.12 Electromagnetic compatibility Interference immu- IEC 60601-1-2 Test level Compliance level Electromagnetic environment - nity tests guidelines Conducted RF in- 3  V 3  V d= [1.2] √P terference 150  k Hz to 80  M Hz IEC 61000-4-6 6 ...
  • Page 46 3 Product description Dentsply Sirona 3.12 Electromagnetic compatibility Instructions for use Primescan™ 2 Immunity to interference against high-frequency electromagnetic fields in the immediate vicinity of wireless com- munication devices IEC 61000-4-3 Test frequency Modulation Required immunity test Maintained immunity test level (V/m)
  • Page 47 Dentsply Sirona 3 Product description Instructions for use Primescan™ 2 3.12 Electromagnetic compatibility 3.12.3 Working clearances Recommended working clearances The UNIT is intended for operation in an electromagnetic environment between portable and mobile RF where radiated RF interference is checked. The customer or the user of...
  • Page 48 4 Installation requirements Dentsply Sirona 4.1 Network infrastructure requirements Instructions for use Primescan™ 2 Installation requirements Network infrastructure requirements Network topology SCANNER USER NETWORK ENVIRONMENT SCANNER NETWORK ENVIRONMENT USER 5GHz Primescan™ 2 5GHz GBit 5GHz Mesh GBit Accesspoint GBit-Switch GBit...
  • Page 49 Ensure that access data are stored safely and not shared with third parties. Dentsply Sirona or its partners will not ask you for access data. 68 51 351 D3775...
  • Page 50 WiFi is guaranteed by the CCMP (Counter Mode with Cipher Block Chaining Message Authentication Code Protocol) implemented in the WPA2 standard. Dentsply Sirona has successfully conducted performance tests concerning the electronic interfaces Wi-Fi and Ethernet under the above stated network infrastructure requirements. When these requirements are met, the system will work as intended.
  • Page 51 The unit/system can be installed and operated either by you as the user or by qualified personnel. Transport Dentsply Sirona units are carefully checked prior to shipment. Please perform an incoming inspection immediately after delivery. 1. Check the delivery note to ensure that the consignment is complete.
  • Page 52 5 Installation and commissioning Dentsply Sirona 5.2 Scope of supply Instructions for use Primescan™ 2 Scope of supply Primescan™ 2 scope of delivery Primescan™ 2 scanner Scanner holder Protective sleeve (black) Battery Charger Plug-in power supply with angled connection (for charger)
  • Page 53 Dentsply Sirona 5 Installation and commissioning Instructions for use Primescan™ 2 5.2 Scope of supply Package with disposable sleeves Cleaning swabs Quick start guide Scope of delivery of the Primescan™ 2 Cart mobile display unit (optional accessory) AIO monitor Mobile stand...
  • Page 54 5 Installation and commissioning Dentsply Sirona 5.2 Scope of supply Instructions for use Primescan™ 2 Power cable (in selected version) Charger connection cable Battery cover Battery (separate package) TX30 offset screwdriver TX20 offset screwdriver Unpacking slip Quick installation guide Instruction sheet...
  • Page 55 Dentsply Sirona 5 Installation and commissioning Instructions for use Primescan™ 2 5.2 Scope of supply Network cable Hook-and-loop strap 68 51 351 D3775 D3775.201.01.09.02    2024-09...
  • Page 56 5 Installation and commissioning Dentsply Sirona 5.3 Unpacking Instructions for use Primescan™ 2 Unpacking 5.3.1 Packaging concept Scanner The scanner (A) with accessories is delivered with one set of disposable sleeves (B) in a common outer packaging. The box (A) for the scanner is in an aluminum bag.
  • Page 57 Dentsply Sirona 5 Installation and commissioning Instructions for use Primescan™ 2 5.3 Unpacking 3. Take the quick start guide out of the upper box insert. 4. Take the scanner holder and the 3 batteries out of the upper box insert.
  • Page 58 5 Installation and commissioning Dentsply Sirona 5.3 Unpacking Instructions for use Primescan™ 2 Box 2: Disposable sleeves 1. Open the box. 2. Take the disposable sleeves out. 5.3.3 Unpacking the mobile display unit (optional) 1. Open the box at the top.
  • Page 59 Dentsply Sirona 5 Installation and commissioning Instructions for use Primescan™ 2 5.3 Unpacking 4. First push the clamping part aside out of the battery compartment of the mobile stand and then lift it off. 5. Take the bag with the AIO monitor out of the lower part of the packaging.
  • Page 60 5 Installation and commissioning Dentsply Sirona 5.3 Unpacking Instructions for use Primescan™ 2 2. Take all parts of the connection set out of the box insert. 5.3.5 Disposal of packaging materials The packaging must be disposed of in compliance with the relevant national regulations.
  • Page 61 Dentsply Sirona 5 Installation and commissioning Instructions for use Primescan™ 2 5.4 Installation Installation 5.4.1 Installing the wall holder for charger Required tools ● Drill or hammer drill, depending on the underground ● Spirit level ● Masonry drill bit 5 mm ●...
  • Page 62 5 Installation and commissioning Dentsply Sirona 5.4 Installation Instructions for use Primescan™ 2 2. Hold the wall holder (A) at the desired mounting site and align it horizontally using a spirit level. 3. Mark the two drilling holes on the wall with a pen.
  • Page 63 Dentsply Sirona 5 Installation and commissioning Instructions for use Primescan™ 2 5.4 Installation Cloud DI Software DI Scan 1. Insert the charger (A) into the wall holder (B) from above or place it on a flat surface outside the patient area.
  • Page 64 5 Installation and commissioning Dentsply Sirona 5.4 Installation Instructions for use Primescan™ 2 Integration into the practice network (onboarding) Follow the directions in the section "Integration into the practice network (onboarding)"  [→ 74] to connect the scanner with the practice network and make the unit available in your DS Core environment.
  • Page 65 Dentsply Sirona 5 Installation and commissioning Instructions for use Primescan™ 2 5.4 Installation Required tools (included in scope of delivery) ● Torx® TX30 offset screwdriver ● Torx® TX20 offset screwdriver Installing the AIO monitor ü The mobile stand, AIO monitor, mounting material and tools are unpacked.
  • Page 66 5 Installation and commissioning Dentsply Sirona 5.4 Installation Instructions for use Primescan™ 2 3. Connect the following cables of the AIO monitor to the respective connections on the mobile stand: - Network cable (F) - Power supply (G) - USB cable (H) Attach the monitor interface cover ü...
  • Page 67 Dentsply Sirona 5 Installation and commissioning Instructions for use Primescan™ 2 5.4 Installation Installing charger or cover at the charger interface As an alternative to wall installation, you can also install the charger for the scanner batteries directly on the mobile display unit. There is a charger interface on the front of the mobile display unit for this.
  • Page 68 5 Installation and commissioning Dentsply Sirona 5.4 Installation Instructions for use Primescan™ 2 Inserting the battery 1. Swivel the attachment bracket (A) to the side until it clicks into place. 2. Insert the battery (B) from below with the electrical connection facing upward into the battery compartment as far as it will go.
  • Page 69 Dentsply Sirona 5 Installation and commissioning Instructions for use Primescan™ 2 5.4 Installation Connecting the cable Cloud DI Software DI Scan 1. Ensure that the mobile display unit is switched off. 2. Only for cable operation: Connect the mobile display unit with a network connection of the practice network using the network cable (A).
  • Page 70 5 Installation and commissioning Dentsply Sirona 5.4 Installation Instructions for use Primescan™ 2 5.4.4 Installation in wired operating mode (optional) WARNING Hazard for patient and user If you do not use freely accessible sockets, there is a risk of injury to patients and users.
  • Page 71 Dentsply Sirona 5 Installation and commissioning Instructions for use Primescan™ 2 5.4 Installation When using the connection set (optional) CAUTION Placing the scanner holder The scanner holder must be placed on a flat, horizontal surface inside or outside of the patient environment.
  • Page 72 5 Installation and commissioning Dentsply Sirona 5.4 Installation Instructions for use Primescan™ 2 6. Plug the power supply unit (E) into a network socket. 7. Check the plug connections to the mains connection and the scanner. The scanner always remains connected.
  • Page 73 Dentsply Sirona 5 Installation and commissioning Instructions for use Primescan™ 2 5.4 Installation Integrating the mobile display unit into the practice network (onboarding) Follow the directions in the section "Integration into the practice network (onboarding)"  [→ 74] to connect the mobile display unit with the practice network and make the unit available in your DS Core environment.
  • Page 74 5 Installation and commissioning Dentsply Sirona 5.5 Initial startup Instructions for use Primescan™ 2 Initial startup 5.5.1 Switching the units on NOTICE Do not put the unit into operation at low temperatures! If you move the unit to the operating site from a cold environment, condensation may form and result in a short circuit.
  • Page 75 Dentsply Sirona 5 Installation and commissioning Instructions for use Primescan™ 2 5.5 Initial startup IMPORTANT Further information on DS Core Find information on using the cloud platform DS Core in the FAQ on the DS Core portal www.dscore.com in the "Feedback & Support"...
  • Page 76 5 Installation and commissioning Dentsply Sirona 5.5 Initial startup Instructions for use Primescan™ 2 5. Select your region. 6. Enter the login data for your DS Core account. 7. Complete entry by clicking on the "Log in" button. 8. Click on the "Add new device" button.
  • Page 77 Dentsply Sirona 5 Installation and commissioning Instructions for use Primescan™ 2 5.5 Initial startup 5.5.3 Switching the units off Using the Primescan™ 2 intraoral scanner without a cable ü The scanner is not in acquisition mode. ➢ Switch the scanner off by pressing the ON/OFF button (A).
  • Page 78 5 Installation and commissioning Dentsply Sirona 5.5 Initial startup Instructions for use Primescan™ 2 IMPORTANT Emergency shutdown The mobile display unit has an emergency shutdown mechanism. Use the emergency shutdown mechanism only if the system cannot be switched off by holding the ON/OFF button (approx. 1 sec.).
  • Page 79 Dentsply Sirona 5 Installation and commissioning Instructions for use Primescan™ 2 5.5 Initial startup LED display Description No LED is lit Charging error: ● Check whether the battery is inserted completely into the charging slot. ● Check the charging slot for foreign bodies.
  • Page 80 The Primescan™ 2 intraoral scanner can be used with DI Scan software version 1.0 or higher. Optionally, Dentsply Sirona offers the Primescan™ 2 Cart mobile display unit that is optimally coordinated for operation with the Primescan™ 2 intraoral scanner.
  • Page 81 Dentsply Sirona 6 Operation Instructions for use Primescan™ 2 6.3 Optical impressions with the scanner Optical impressions with the scanner WARNING Risk of injury for those diagnosed with epilepsy For persons who have been diagnosed with epilepsy, there is a risk of epileptic shock due to the flashing light of the scanner.
  • Page 82 6 Operation Dentsply Sirona 6.3 Optical impressions with the scanner Instructions for use Primescan™ 2 CAUTION Hot tip of the scanner sleeve! When switched on, the tip of the scanner sleeve is continuously preheated. The surface temperature of the sleeve can be up to 48  ° C when the scanner is in the holder and up to 58 ...
  • Page 83 Dentsply Sirona 6 Operation Instructions for use Primescan™ 2 6.3 Optical impressions with the scanner IMPORTANT Do not use cotton rolls in the scan area Do not use any cotton rolls in the vicinity of the scan area, as they can reduce the precision of the scan and create image interference.
  • Page 84 6 Operation Dentsply Sirona 6.4 Scanner guide Instructions for use Primescan™ 2 Ä As soon as you move the scanner, a live image appears that can be used for orientation in the patient's mouth. 4. Activate the acquisition mode. To do this, tap your finger on the scanner housing (A).
  • Page 85 Dentsply Sirona 6 Operation Instructions for use Primescan™ 2 6.4 Scanner guide 6.4.2 Buccal scan distal mesial ü The scanner is on the adjacent tooth located mesial to the preparation. 1. Rotate the scanner 20° in buccal direction. 2. Guide the scanner over the entire distance in buccal to distal direction over the prepared tooth.
  • Page 86 6 Operation Dentsply Sirona 6.4 Scanner guide Instructions for use Primescan™ 2 6.4.5 Single and multiple buccal registration The buccal registration establishes the arrangement of jaw images. ü The jaw with the preparation is scanned. 1. Scan the occlusal, buccal and lingual view of the antagonist (see section “Occlusal scan" ...
  • Page 87 Dentsply Sirona 6 Operation Instructions for use Primescan™ 2 6.4 Scanner guide 2. Move the scanner as shown below (1) for the second quadrant. 3. Then scan the anterior teeth from cuspid to cuspid in the coronal- apical direction. Ensure that both the labial surface and the oral surfaces are visible.
  • Page 88 6 Operation Dentsply Sirona 6.4 Scanner guide Instructions for use Primescan™ 2 Procedure 2 1. Start occlusally on the distal tooth, tilt the scanner approx. 60° in an oral direction and move it orally along the dental arch up to the opposite distal tooth.
  • Page 89 Dentsply Sirona 6 Operation Instructions for use Primescan™ 2 6.5 Work with the AIO monitor of the mobile display unit (optional) 1. Start from occlusal in the incisal area and tilt the scanner approx. 60° in oral direction and move it orally along the dental arch to the distal area.
  • Page 90 6 Operation Dentsply Sirona 6.5 Work with the AIO monitor of the mobile display unit (optional) Instructions for use Primescan™ 2 6.5.2 Operating the foot control Press the battery cover upward with the tip of the foot to trigger the foot control.
  • Page 91 Dentsply Sirona 6 Operation Instructions for use Primescan™ 2 6.5 Work with the AIO monitor of the mobile display unit (optional) 6.5.3 Multi-touch gestures You can use the multi-touch gestures with and without a glove. The following gestures can be made: Edit a 3D model with multi-touch You can edit the 3D model using multi-touch gestures.
  • Page 92 Required materials NOTICE Approved cleaning agents and disinfectants Use only cleaning and disinfecting agents which have been approved by Dentsply Sirona! CAUTION Handling cleaning agents and disinfectants For general handling of the cleaning agents and disinfectants, see the respective safety data sheets or manufacturers' specifications.
  • Page 93 Dentsply Sirona 7 Reprocessing Instructions for use Primescan™ 2 7.2 Components of the scanner Components of the scanner CAUTION Risk of cross-contamination Without the disposable sleeve, the scanner may not be used in the patient’s mouth. Cross-contamination may occur if used without a disposable sleeve.
  • Page 94 7 Reprocessing Dentsply Sirona 7.3 Cleaning and disinfection Instructions for use Primescan™ 2 Cleaning and disinfection CAUTION Risk of infection There is a risk of infection if the scanner is not regularly disinfected. ➢ Immediately after using the scanner, carry out cleaning and disinfection of the scanner.
  • Page 95 Dentsply Sirona 7 Reprocessing Instructions for use Primescan™ 2 7.3 Cleaning and disinfection 4. Check under good lighting (min. 500 lux) whether the product is visibly clean. 5. If there is visible contamination, repeat the process with a new, thoroughly moistened, lint-free cloth.
  • Page 96 7 Reprocessing Dentsply Sirona 7.3 Cleaning and disinfection Instructions for use Primescan™ 2 2. Moisten the cloth thoroughly with cleaning agent (see "Cleaning agent"  [→ 92]). 3. Thoroughly wipe down the entire scanner body except the optical window. 4. Wipe down the protruding part of the battery / cable adapter thoroughly.
  • Page 97 Dentsply Sirona 7 Reprocessing Instructions for use Primescan™ 2 7.3 Cleaning and disinfection 3. Thoroughly wipe down the scanner holder and the heater plate of the mobile display unit and clean them for at least 1 minute until there is no more visible contamination.
  • Page 98 Some countries have legal regulations that require regular safety inspections of electrical devices or systems by the operator. Dentsply Sirona would like to draw your attention to the fact that a repeat inspection according to IEC 62353 must be carried out for the Primescan™...
  • Page 99 Dentsply Sirona 8 Maintenance Instructions for use Primescan™ 2 8.1 Calibration of the scanner Calibration of the scanner Use a calibrated scanner NOTICE Use calibration set only with a clean, dry Primescan™ 2 scanner In order to achieve optimal results, the Primescan™ 2 scanner must be clean, disinfected and dry before the calibration.
  • Page 100 8 Maintenance Dentsply Sirona 8.1 Calibration of the scanner Instructions for use Primescan™ 2 Starting the calibration process from the DS Core device management 1. In DS Core, click on the "Equipment" entry in the left column. Ä The device management is displayed.
  • Page 101 Dentsply Sirona 8 Maintenance Instructions for use Primescan™ 2 8.1 Calibration of the scanner Ä The calibration application will be loaded. Calibrate scanner When you start calibration, you are guided through the entire process with step-by-step instructions on the monitor. To give you an overview of this process, the steps of the calibration process are summarized below.
  • Page 102 8 Maintenance Dentsply Sirona 8.1 Calibration of the scanner Instructions for use Primescan™ 2 5. Wait while the system acquires a first image. Ä After the acquisition is made, you will be prompted to turn the screw of the calibration set to the next latching position.
  • Page 103 Dentsply Sirona 8 Maintenance Instructions for use Primescan™ 2 8.1 Calibration of the scanner Ä After the acquisition is made, you will be prompted to turn the screw of the calibration set to the next latching position. 8. Execute steps 6 and 7 a total of 16 times.
  • Page 104 8 Maintenance Dentsply Sirona 8.1 Calibration of the scanner Instructions for use Primescan™ 2 Measuring the position of the exit window 1. Take the calibration set off the tip of the scanner. 2. Mount the bottom side of the calibration set on the tip of the scanner.
  • Page 105 Dentsply Sirona 8 Maintenance Instructions for use Primescan™ 2 8.1 Calibration of the scanner 4. Take the calibration set off the tip of the scanner. 5. Turn the screw of the calibration set clockwise back to its original position. 6. Wait until the calculations are complete.
  • Page 106 8 Maintenance Dentsply Sirona 8.1 Calibration of the scanner Instructions for use Primescan™ 2 End calibration ü The software indicates that the calibration was completed successfully. ➢ Click on the "Finish" button to finish the calibration process. Ä The scanner is calibrated.
  • Page 107 Dentsply Sirona 8 Maintenance Instructions for use Primescan™ 2 8.2 Charge scanner battery (optional) 2. Restart the calibration process. Charge scanner battery (optional) NOTICE Information on charging cycles Under normal operating conditions, the battery is sufficient for up to 60 minutes of wireless operation. Full charging requires approx. 2.5 hours.
  • Page 108 8 Maintenance Dentsply Sirona 8.4 Replace battery of the mobile display unit (optional) Instructions for use Primescan™ 2 Replace battery of the mobile display unit (optional) NOTICE Damage to the battery or unit The battery of the unit is not hot-plug capable and may not be exchanged during operation.
  • Page 109 Dentsply Sirona 8 Maintenance Instructions for use Primescan™ 2 8.4 Replace battery of the mobile display unit (optional) 4. Pull the old battery (D) down out of the battery compartment and take it out of the unit. 5. Insert the new battery (D) into the battery compartment from below as far as it will go.
  • Page 110 9 Troubleshooting Dentsply Sirona 9.1 Reset scanner to factory settings Instructions for use Primescan™ 2 Troubleshooting Reset scanner to factory settings If necessary, you can reset the scanner to the condition as delivered. To do this, proceed as follows: ➢ Press and hold down the ON/OFF button and the connect button on the scanner simultaneously for at least 10 seconds.
  • Page 111 Dentsply Sirona 10 Dismantling and disposal Instructions for use Primescan™ 2 9.1 Reset scanner to factory settings Dismantling and disposal IMPORTANT Operators of units with storage functions for customer and patient data are responsible for deleting all personal data before disposing of the equipment.
  • Page 112 10 Dismantling and disposal Dentsply Sirona 10.1 Disposal of batteries (scanner and mobile display unit) Instructions for use Primescan™ 2 IMPORTANT Please observe the disposal regulations applicable in your country. For country-specific information on disposal, contact your local dental dealer.
  • Page 113 Status display, 78 Cleaning agents and disinfectants, 92 Compliance, 40 Network, 22 Conditions Network cable, 69, 71 Operation, 27 Onboarding, 75 Storage, 27 Nominal line voltage, 31 Transport, 27 Nominal mains current, 28, 30 Nominal mains voltage, 28, 30 Nominal power output, 31 Dentsply Sirona Product service, 6 Designated use, 26 68 51 351 D3775 D3775.201.01.09.02    2024-09...
  • Page 114 Index Dentsply Sirona Instructions for use Primescan™ 2 Wi-Fi Wi-Fi band, 49 Operating mode, 28, 31 Wi-Fi standard, 49 Wireless phones, 24 Packaging, 60 Plug connections, 69 Product safety, 22 Protection class, 28, 31 Protective conductor, 23 Relative humidity Operation, 27 Storage, 27 Transport, 27 Repair, 21 Safety instructions, 8 Sleeves Disposable sleeve, 83, 93 Protective sleeve, 83...
  • Page 116 We reserve the right to make any alterations which may be required due to technical improvements. © SIRONA Dental Systems GmbH Sprache: englisch Printed in Germany D3775.201.01.09.90F1 2024-09 Ä.-Nr.:  000 000 SIRONA Dental Systems GmbH 68 51 351 D3775 Fabrikstraße 31 Order No   ...
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