Table of Contents Dentsply Sirona Operating Instructions Primescan Connect Table of Contents General data ....................Dear Customer,......................Contact information ...................... General information about these operating instructions..........1.3.1 Notes to the repository .................. General conventions and structure of the document ...........
Page 3
Dentsply Sirona Table of Contents Operating Instructions Primescan Connect Electromagnetic compatibility..................3.6.1 Electromagnetic emission ................3.6.2 Interference immunity..................3.6.3 Working clearances..................Installation and commissioning ............... Transport and unpacking ..................... Disposal of packaging materials .................. Scope of supply......................Initial startup......................... 4.4.1 Plug connections ...................
Page 4
Table of Contents Dentsply Sirona Operating Instructions Primescan Connect 6.1.3.8 Hot air sterilization of the window sleeve........6.1.3.9 Using disposable sleeves ............6.1.3.10 Sterilizing autoclavable sleeves in the autoclave and using disposable windows..............6.1.4 Cleaning the inside of the sleeve window .............
Thank you for your purchase of this Primescan Connect unit from Dentsply Sirona. Primescan Connect allows you to send digital scans to a laboratory of your choice for manufacture at your laboratory partner. Improper use and handling can create hazards and cause damage.
1 General data Dentsply Sirona 1.3 General information about these operating instructions Operating Instructions Primescan Connect General information about these operating instructions Follow 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 comply with the warning and safety information listed.
Dentsply Sirona 1 General data Operating Instructions Primescan Connect 1.4 General conventions and structure of the document 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.
Exclusion of liability If the operator does not meet the obligation to carry out such maintenance or fault messages are ignored, Dentsply Sirona or its authorized dealer does not assume any liability for damage caused. 67 97 216 D3801...
Operating Instructions Primescan Connect 1.6 Intended use Intended use The Primescan Connect acquisition unit creates digital impressions for dental purposes. The unit may be operated only by medically trained and qualified personnel. This unit must not be used for any other purpose. If the unit is used for any purpose other than the one mentioned above, it may be damaged.
1 General data Dentsply Sirona 1.7 Legend Operating Instructions Primescan Connect Legend Year of manufacture 20XX Safety labels Identifies labels/imprints on the unit (see "Safety labels"). Product disposal symbol (see "Disposal [→ 72]"). Follow the operating instructions. To ensure safe operation of the unit, the user must follow the operat- ing instructions.
Page 11
Dentsply Sirona 1 General data Operating Instructions Primescan Connect 1.7 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...
CAUTION Note on the prevention, recognition, and elimination of unintended electromagnetic effects: The Primescan Connect acquisition unit is Class B equipment (classified according to CISPR 11, EN 60601-1-2: 2015 based on IEC 60601-1-2: 2014). This unit may be used in professional equipment of health services.
Page 13
Dentsply Sirona 2 Safety instructions Operating Instructions Primescan Connect 2.1 Basic safety information WARNING Danger of touching live parts If the housing is damaged, there is a possibility of touching live parts inside the unit. ➢ Check that the unit is intact. The unit can only be used for work purposes if it is intact.
Stability of the unit NOTE The Primescan Connect device could slip and fall off the table Ensure that you place the holder with the scanner and the coupling box on a flat surface. The oval plate on which the scanner holder is mounted is equipped with non-slip feet to help prevent movement.
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 power cable also supplied or the corresponding original spare part may be used with the unit.
2 Safety instructions Dentsply Sirona 2.2 Electrostatic charge Operating Instructions Primescan Connect ESD protective measures ESD protective measures include: ● Procedures for preventing electrostatic charge build-up (e.g. air conditioning, air moistening, conductive floor coverings and non- synthetic clothing) ● Discharging the electrostatic charges of your own body on the frame of the UNIT, the protective ground wire or large metallic objects ●...
Dentsply Sirona 2 Safety instructions Operating Instructions Primescan Connect 2.3 Wireless phone interference with equipment It is obvious that integrated circuits which are connected to plugs leading outside of the unit via cables are sensitive to electrostatic discharge. Even voltages which are imperceptible to the user can cause breakdown of the structures, thus leading to a discharge current which melts the chip in the affected areas.
2 Safety instructions Dentsply Sirona 2.4 Integrating the laptop in the network Operating Instructions Primescan Connect Integrating the laptop in the network NOTE Observe the following installation instructions The following installation instructions apply when integrating the laptop into a network: Network The laptop can be connected to a network via WiFi or LAN.
3 Product description Dentsply Sirona 3.2 Technical data Operating Instructions Primescan Connect Technical data Type designation Primescan Connect Rated line voltage 100-240 V ~ / 50-60Hz Nominal current 1.0 – 0.6 A Type of protection against electric shock Class I unit...
– EM10681C(02) from EDAC Power Electronics Co., Ltd., Taiwan Input voltage range: 100-240 VAC / 50-60 Hz Input current range: 2.0-1.0 A. The system ultimately used consists of the Primescan Connect, the Connect software and the laptop. Controls and functional elements 3.4.1...
USB cable (D) to the laptop can be found on the front of the coupling box (B). NOTE Connection to a USB hub can impair the performance of the coupling box. CAUTION Only use the power supply unit supplied by Dentsply Sirona for operating the coupling box! 67 97 216 D3801 D3801.201.01.03.02 2022-09...
Dentsply Sirona 3 Product description Operating Instructions Primescan Connect 3.5 Certification Certification CE mark This product is compliant with EU Medical Device Regulation 2017/745 including all amendments. NOTE CE mark for connected products Further products which are connected to this unit must also bear the CE mark.
Electromagnetic compatibility Observance of the following information is necessary to ensure safe operation regarding EMC aspects. Primescan Connect complies with the requirements for electromagnetic compatibility (EMC) according to EN 60601-1-2: 2015 based on IEC 60601-1-2: 2014. Primescan Connect is hereinafter referred to as "UNIT".
Dentsply Sirona 3 Product description Operating Instructions Primescan Connect 3.6 Electromagnetic compatibility 3.6.2 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 27
Dentsply Sirona 3 Product description Operating Instructions Primescan Connect 3.6 Electromagnetic compatibility Immunity to interference against high-frequency electromagnetic fields in the direct vicinity of wireless communi- cation devices IEC 61000-4-3 Test frequency Modulation Required immunity test Maintained immunity test level (V/m)
3 Product description Dentsply Sirona 3.6 Electromagnetic compatibility Operating Instructions Primescan Connect 3.6.3 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...
4.1 Transport and unpacking Installation and commissioning Transport and unpacking All products from Dentsply Sirona devices 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.
➢ Only use sockets which are freely accessible at all times. This ensures swift disconnection from the power. CAUTION Only use the power supply unit supplied by Dentsply Sirona for operating the coupling box! CAUTION Do not connect laptops without approval Laptops that have not been approved must not be connected.
Page 31
Additional devices connected to external interfaces of the laptop must be tested according to the relevant standards, e.g.: IEC 60601-1, IEC 61010-1 or IEC 62368-1. NOTE Primescan Connect (USB cable D) and license stick may only be connected to the USB-A ports. 67 97 216 D3801 D3801.201.01.03.02 2022-09...
Page 32
4 Installation and commissioning Dentsply Sirona 4.4 Initial startup Operating Instructions Primescan Connect 1. Place the window sleeve onto the scanner (A). Exercise a great deal of care. Push the window sleeve carefully onto the cone until it latches in.
Dentsply Sirona 4 Installation and commissioning Operating Instructions Primescan Connect 4.4 Initial startup 4.4.2 Switching the units on NOTE 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.
4 Installation and commissioning Dentsply Sirona 4.4 Initial startup Operating Instructions Primescan Connect 4.4.3 Switching the units off NOTE Proper shutdown procedure The operating system must always be shut down properly to prevent data loss. To prevent the laptop from becoming slower over time, perform a normal shutdown of the operating system at regular intervals.
Dentsply Sirona 5 Operation Operating Instructions Primescan Connect 5.1 Optical impressions with the scanner Operation Optical impressions with the scanner CAUTION Hot tip of the scanner sleeve! The tip of the scanner sleeve is continuously heated up! The surface temperature of the sleeve may be as high as 51°C. This may cause an unpleasant heat sensation on contact with a person's skin or mucous membrane.
Page 36
5 Operation Dentsply Sirona 5.1 Optical impressions with the scanner Operating Instructions Primescan Connect CAUTION Potentially hazardous optical radiation The scanner transmits potentially hazardous optical radiation which may cause harm to the eyes. ➢ During operation, do not look directly at the scanner for long periods.
Page 37
Dentsply Sirona 5 Operation Operating Instructions Primescan Connect 5.1 Optical impressions with the scanner IMPORTANT Detection of the scanner by the Connect SW Exit the Connect SW, before you disconnect the scanner from the power supply, e.g. to transport it inside the rooms of your practice.
5 Operation Dentsply Sirona 5.2 Scanner guide Operating Instructions Primescan Connect Scanner guide CAUTION After each use Prepare the scanner once again after each patient. ➢ Follow the instructions in the "Scanner [→ 49]" section on cleaning, disinfection and sterilization in order to avoid cross- contamination between patients.
Dentsply Sirona 5 Operation Operating Instructions Primescan Connect 5.2 Scanner guide 5.2.1 Occlusal scan Important: Ensure that the distance between the coated sapphire glass of the scanner and the scanned surface is observed. The distance must be between 0 - 2 0 mm (ideally: 2 m m). The scanner does not rest on the teeth or the gums.
5 Operation Dentsply Sirona 5.2 Scanner guide Operating Instructions Primescan Connect 5.2.3 Lingual scan ü The scanner is on the tooth that is positioned next to the preparation in the distal direction. 1. Rotate the scanner to maximum 20° toward the lingual direction.
Dentsply Sirona 5 Operation Operating Instructions Primescan Connect 5.2 Scanner guide 5.2.5 Single and multiple buccal registration The buccal registration establishes the allocation of jaw exposures. ü The jaw with the preparation is scanned. 1. Scan the occlusal, buccal and lingual view of the antagonist (see the section “Occlusal scan ...
5 Operation Dentsply Sirona 5.2 Scanner guide Operating Instructions Primescan Connect 5.2.6 Square and full jaw scan You can use different scanning procedures for scanning a quadrant or a full jaw. Find two procedures as follows to help you gain access should such help be necessary.
Page 43
Dentsply Sirona 5 Operation Operating Instructions Primescan Connect 5.2 Scanner guide 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.
5 Operation Dentsply Sirona 5.2 Scanner guide Operating Instructions Primescan Connect 5.2.7 Scan strategy for edentulous cases Use the same scan strategy as for a full jaw scan, but split the first run- through. It is important to have overlapping data (A) so that the run- throughs can be joined together.
Dentsply Sirona 5 Operation Operating Instructions Primescan Connect 5.3 Software for the scanner Software for the scanner 5.3.1 Cut out model areas With the "Cut" function, you can should be able to cut out model areas. These can be areas in which parts of cotton rolls or cheeks were unintentionally acquired.
Some countries have legal regulations which 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 so- called "retest" (repeat test) must be carried out for the Primescan Connect at least every three years.
Dentsply Sirona 6 Maintenance Operating Instructions Primescan Connect 6.1 Cleaning, disinfection, and sterilization Cleaning, disinfection, and sterilization NOTE Approved cleaning agents and disinfectants Use only cleaning and disinfecting agents which have been approved by Dentsply Sirona! 6.1.1 Cleaning agents and disinfectants 6.1.1.1...
6 Maintenance Dentsply Sirona 6.1 Cleaning, disinfection, and sterilization Operating Instructions Primescan Connect 6.1.2 Non-critical surfaces NOTE Never use corrosive cleaning agents, wax or solvents. CAUTION Risk of infection There is a risk of infection if surfaces are not regularly disinfected.
Dentsply Sirona 6 Maintenance Operating Instructions Primescan Connect 6.1 Cleaning, disinfection, and sterilization 6.1.3 Scanner CAUTION Risk of injury An evidently damaged scanner must no longer be used on patients. If the Primescan scanner accidentally falls off, check to make sure that the sapphire glass is not damaged.
6 Maintenance Dentsply Sirona 6.1 Cleaning, disinfection, and sterilization Operating Instructions Primescan Connect 6.1.3.1 General information The Primescan scanner is a very sensitive optical device and must therefore be handled with the utmost care. Protect the coated sapphire glass and the scanner window against scratches and clean them with a lint-free cloth and ethanol (commercially available cleaning alcohol) if any haze is noted during the acquisition.
Dentsply Sirona 6 Maintenance Operating Instructions Primescan Connect 6.1 Cleaning, disinfection, and sterilization 6.1.3.2 Components of the scanner CAUTION Risk of cross-contamination The scanner must not be used inside the patient's mouth without a window sleeve/disposable sleeve/autoclavable sleeve. Without the...
6 Maintenance Dentsply Sirona 6.1 Cleaning, disinfection, and sterilization Operating Instructions Primescan Connect 6.1.3.3 Removing the sleeve If it is necessary to remove the sleeve, proceed as follows: 1. Grip the sleeve in the marked area. NOTE There is a risk of damaging the scanner window or the sleeve window if the sleeve is not pushed straight toward the front.
Dentsply Sirona 6 Maintenance Operating Instructions Primescan Connect 6.1 Cleaning, disinfection, and sterilization 6.1.3.6 Wipe disinfection of the scanner and window sleeve NOTE Do not spray the Primescan scanner or immerse it in cleaning agents or disinfectants! 1. Carry out a preliminary cleaning process (see "Preliminary cleaning of the sleeve ...
6 Maintenance Dentsply Sirona 6.1 Cleaning, disinfection, and sterilization Operating Instructions Primescan Connect 6.1.3.7 High-level disinfection of the window sleeve NOTE The hot air sterilization and high-level disinfection must not be combined. The complete process for high-level disinfection (HLD) is as follows –...
Page 55
Dentsply Sirona 6 Maintenance Operating Instructions Primescan Connect 6.1 Cleaning, disinfection, and sterilization 6. Push the plug completely into the metal bracket. 7. Press the sleeve onto the plug while holding the metal bracket firmly in place in order to ensure that no particle contamination or fluids penetrate the inside of the sleeve.
Page 56
6 Maintenance Dentsply Sirona 6.1 Cleaning, disinfection, and sterilization Operating Instructions Primescan Connect 9. Insert the metal bracket with the sleeve. 10. Place the cover on the container and leave the sleeve in the ® disinfectant for at least 12 minutes (CIDEX OPA).
Page 57
Dentsply Sirona 6 Maintenance Operating Instructions Primescan Connect 6.1 Cleaning, disinfection, and sterilization 11. Remove the cover and take the bracket with the sleeve out of the container. 12. Carefully rinse the sleeve with tap water for at least 30 seconds while holding it with the bracket.
Page 58
6 Maintenance Dentsply Sirona 6.1 Cleaning, disinfection, and sterilization Operating Instructions Primescan Connect 17. Dry the entire outer surface of the sleeve as well as the inner section around the plug using a soft lint-free cloth. Ensure that no fluid is able to penetrate the inside of the sleeve.
Dentsply Sirona 6 Maintenance Operating Instructions Primescan Connect 6.1 Cleaning, disinfection, and sterilization 6.1.3.8 Hot air sterilization of the window sleeve NOTE Hot air sterilization and high-level disinfection must not be combined. The process for hot air sterilization is as follows: 1.
6 Maintenance Dentsply Sirona 6.1 Cleaning, disinfection, and sterilization Operating Instructions Primescan Connect 6.1.3.9 Using disposable sleeves The Primescan scanner can be operated with disposable plastic sleeves in order to ensure maximum infection control. The sleeves are available using order number 66 86 880.
Dentsply Sirona 6 Maintenance Operating Instructions Primescan Connect 6.1 Cleaning, disinfection, and sterilization 6.1.3.10 Sterilizing autoclavable sleeves in the autoclave and using disposable windows The Primescan scanner can be operated with autoclavable metal sleeves with replaceable disposable windows. These parts can be ordered using the following order numbers: ●...
Page 62
6 Maintenance Dentsply Sirona 6.1 Cleaning, disinfection, and sterilization Operating Instructions Primescan Connect 12. Slide the sterilized sleeve that has been fitted with the disposable window onto the scanner body as far as it will go, so that it is securely positioned on the Primescan scanner.
Dentsply Sirona 6 Maintenance Operating Instructions Primescan Connect 6.1 Cleaning, disinfection, and sterilization 6.1.4 Cleaning the inside of the sleeve window NOTE! This process applies only to the window sleeve (standard sleeve). If you notice during the scanning process that the inside of the...
6 Maintenance Dentsply Sirona 6.2 Calibrating the scanner Operating Instructions Primescan Connect Calibrating the scanner NOTE Always calibrate scanner with window sleeve (standard sleeve) or autoclavable sleeve The scanner must always be calibrated with the window sleeve (standard sleeve) or autoclavable sleeve.
Page 65
Dentsply Sirona 6 Maintenance Operating Instructions Primescan Connect 6.2 Calibrating the scanner Calibrating the scanner NOTE Use calibration set only with clean, dry Primescan scanner In order to achieve optimum results, the Primescan scanner must be clean, disinfected and dry before the calibration.
Page 66
6 Maintenance Dentsply Sirona 6.2 Calibrating the scanner Operating Instructions Primescan Connect Measuring the position of the exit window 1. Mount the bottom side of the calibration set to the tip of the scanner. 2. Click on the "OK" button.
Dentsply Sirona 6 Maintenance Operating Instructions Primescan Connect 6.3 Color calibration Color calibration General information NOTE Always perform color calibration with window sleeve (standard sleeve) The scanner must always be color-calibrated with the window sleeve (standard sleeve). ➢ Do not use the disposable sleeve or the autoclavable sleeve for color calibration.
Page 68
6 Maintenance Dentsply Sirona 6.3 Color calibration Operating Instructions Primescan Connect 5. Confirm the changes below with "Ok" . 6. Click the "Color Calibration" button and carry out the color calibration. Color-calibrating the scanner NOTE Only use color calibration set with clean, dry Primescan scanner In order to achieve optimum results, the Primescan scanner must be clean, disinfected and dry before color calibration.
Page 69
Dentsply Sirona 6 Maintenance Operating Instructions Primescan Connect 6.3 Color calibration Replacing the color calibration set NOTE Regularly replacing the color calibration set In order to achieve optimum results, the color calibration set must be replaced regularly. ➢ Observe the following: Please note that the color calibration set ●...
6 Maintenance Dentsply Sirona 6.4 Replacing the O-ring Operating Instructions Primescan Connect Replacing the O-ring Removing the worn O-ring ü The sleeve has been removed from the scanner body. 1. Hold the holding ring between your thumb and index finger.
Page 71
Dentsply Sirona 6 Maintenance Operating Instructions Primescan Connect 6.4 Replacing the O-ring 1. Slide the O-ring at one point into the O-ring groove. 2. Starting from this point, carefully use your thumb and index finger to push the O-ring into the groove (in a similar way to pushing it out but without any force).
7 Disposal Dentsply Sirona Operating Instructions Primescan Connect Disposal On the basis of the Directive 2012/19/EU and the country-specific disposal regulations for old electrical and electronic equipment, we would like to stress that such equipment must be disposed of accordingly within the European Union (EU). These regulations require the environmentally friendly recycling/disposal of old electrical and electronic equipment.
Page 73
Dentsply Sirona 7 Disposal Operating Instructions Primescan Connect IMPORTANT Operators of equipment with storage functions for customer and patient data are responsible for deleting all personal data before disposing of the equipment. 67 97 216 D3801 D3801.201.01.03.02 2022-09...
8 Appendix Dentsply Sirona 8.1 Making backup copies Operating Instructions Primescan Connect Appendix Making backup copies To increase the system's data security and protect themselves against data losses, users should make backup copies of the data regularly. 67 97 216 D3801...
Need help?
Do you have a question about the Primescan Connect and is the answer not in the manual?
Questions and answers
is there a manual on how to use the connect software