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CEFLA NewTom GO Manual

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97050801
Rev. 09
2018-07
EN

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Summary of Contents for CEFLA NewTom GO

  • Page 1 97050801 Rev. 09 2018-07...

  • Page 2: Table Of Contents

    ITALIANO Contents 0. DEVICE IDENTIFICATION ............................4 1. INTRODUCTION AND INDICATIONS FOR USE ..................... 5 1.1. DESCRIPTION OF THE MANUAL ........................6 1.2. GENERAL WARNINGS ............................7 1.3. REQUIREMENTS (NOT PROVIDED WITH THE PRODUCT) ................8 1.4. STANDARDS AND REGULATIONS ........................8 1.5.
  • Page 3 6.3. PERFORMING THE EXAMINATION ......................... 49 6.4. SPECIAL CONSIDERATIONS FOR CBCT EXAMINATIONS WITH CHILDREN OR SMALL PATIENTS ..50 7. VIEWING AND SAVING ............................51 8. PERIODIC CHECKS AND MAINTENANCE ......................52 8.1. PERIODIC INSPECTIONS TO CHECK THE IMAGE ..................52 8.1.1.

  • Page 4: Device Identification

    Unless otherwise indicated, the instructions included in this manual apply to all models of the NewTom GO family (hereinafter referred to as "NewTom GO"). In the following part of this manual, instructions that only apply to the device model NewTom GO REF. 708J are Only for 2D machines identified by the description “...

  • Page 5: Introduction And Indications For Use

    This technique is known as CBCT. NewTom GO is a digital X-ray device, suitable for expert professionals, which allows to obtain dental images in a simple and automatic way. The image is acquired by means of an X-ray detector and a constant potential X-ray source, powered by a high-voltage and high-frequency generator.

  • Page 6: Description Of The Manual

    Contraindications: visualisation of cartilaginous structures; for 3D machines only the CBCT technique ( ) has a limited ability to detect soft tissues. In order to ensure a safe use of the device, specifically in the radiography of children it is suggested to consult the general indications described in the guidelines for dental radiographs as i.e.

  • Page 7: General Warnings

    1.2. GENERAL WARNINGS The digital X-ray system with its drivers and software have been developed and manufactured by CEFLA s.c. - Via Selice Prov.le 23/A 40026 Imola (Italia), hereinafter referred to as the Manufacturer, which is the manufacturer and distributor in compliance with the EC Medical Device Directive.

  • Page 8: Requirements (Not Provided With The Product)

    1.3. REQUIREMENTS (NOT PROVIDED WITH THE PRODUCT) For proper functioning, the device requires connection to a personal computer (PC) and the relative software. For the minimum requirements of the PC, refer to the paragraph TECHNICAL DATA. The PC is not included with the device. It is recommended to only use a PC compliant to the IEC 60950- 1:2007 standards for information technology devices.

  • Page 9: Stylistic Conventions

    1.6. STYLISTIC CONVENTIONS The following symbols may be found on the X-ray device: Equipment compliant with directive 93/42/EEC as amended. Notified body: IMQ spa. Applied part of type B, according to IEC 60601-1. Product/equipment identification code. Product serial number. Manufacturer. Date of manufacture (month / year).

  • Page 10: General Safety Warnings

    1.7. GENERAL SAFETY WARNINGS These instructions describe how to use the system correctly. Please carefully read this manual before using the device. The owner or the installation site manager is obliged to verify compliance with the local regulations in force and/or ask a Qualified Expert for advice.

  • Page 11: Conditions Of Use

    In case of claims or need of technical assistance, users in Brazil are required to contact the following email address: servico.odontologico@cefla.it. Users in the USA market are required to contact: Cefla North America Inc., 6125 Harris Technology Blvd., Charlotte, NC, 28269 United States Phone: +1 704 598 0020, e-mail: info@ceflaamerica.com 1.7.3.

  • Page 12: Maintenance And Disposal

    For any maintenance operation, please contact the Manufacturer via the website indicated on the cover of this manual by filling in the Information Request form. Further information about the device regular inspection and maintenance is provided in the document “NewTom GO - Inspection and Maintenance”.

  • Page 13: Cleaning And Disinfection

    It is recommended to use the specific medium-level disinfectant, STER 1 PLUS (CEFLA S.C.), which is compatible with the painted surfaces, plastic parts and unpainted metal surfaces. Alternatively, it is recommended to use products that contain: 96% ethanol Concentration: maximum 30 g for every 100 g of disinfectant.

  • Page 14: Hygiene Procedures For Patient Protection

    1.7.6. HYGIENE PROCEDURES FOR PATIENT PROTECTION Single-use hygienic protections are the main means of protection against transmission of cross-infections between patients. In order to prevent transmission of infectious diseases from patient to patient, it is essential to always use the single-use protections. The single-use protections are classified as Class I medical device and may not be replaced with others in a lower class.

  • Page 15: Safety Warnings

    1.8. SAFETY WARNINGS 1.8.1. CONDITIONS OF USE In order to use the device in safe conditions, refer to the following paragraphs in the manual. 1.8.2. GENERAL SAFETY Do not forget to turn off the main switch on the equipment before leaving the surgery. The device is not protected against liquid penetration (Class IPX0 –...

  • Page 16: Emergency Button

    1.8.4. EMERGENCY BUTTON The system is equipped with an emergency button to stop X-ray device operation, located under the patient support arm in proximity of the telescopic column. A remote emergency button is connected using the dedicated connector on the board located at the feet of the lifting column. 1 - Emergency button These buttons must be activated in the event of danger and emergency, for example, failed interruption of radiation from the source, in situations of evident danger to persons or when an emergency is signalled.

  • Page 17: Electromagnetic Safety

    X-ray device. Guidance and Manufacturer's declaration - Electromagnetic emissions NewTom GO is designed to operate in the specified electromagnetic environment. The customer or the user of NewTom GO must ensure its use in an electromagnetic environment with the following features:...
  • Page 18 NewTom GO is intended for use in electromagnetic environment where RF irradiated disturbances are controlled. The customer or the user of the NewTom GO can prevent electromagnetic interferences by ensuring a minimum distance between RF mobile and portable (transmitter) communication devices and NewTom GO as shown below, according to maximum power output of the communication devices.

  • Page 19: Protection Against Radiation

    1.8.7. PROTECTION AGAINST RADIATION This system is an X-ray equipment. As such, it exposes patients and operators to risks from radiation. It must be used in compliance with the safety standards set forth by the radiological protection regulation in force in the country of use. Following are some of the provisions: Control the emission of X-rays exclusively from the control workstation, the exam room must be suitably shielded (if required by the local regulations in force).

  • Page 20: Stray Radiations

    1.8.9. STRAY RADIATIONS Stray radiation measurement is highly influenced by ambient conditions, such as wall composition and positioning, therefore, under certain circumstances, the detected values can be significantly different. The measurement points used are at 0.5 m, 1.0 m and 2.0 m, respectively, from a central rotation axis. The circular measurement points are determined based on the patient bite position on the machine.

  • Page 21: Description Of Operation

    2. DESCRIPTION OF OPERATION For the execution of panoramic X-rays or tomographic exams, the radiographic device consists of a rotating arm fitted on a column support. The rotating arm features motor-driven rotating shifting devices that allow moving the X- ray emission system and the image detector around the patient according to complex orbits following the morphological profile.

  • Page 22: Components

    3. COMPONENTS Basic machine 2D sensor for panoramic images (only for 2D machines) 3D/2D panel for panoramic / tomographic images (only for 3D machines) Craniostat Craniostat (only for 3D machines) Optional, standard stand Remote ray button (optional) USB Pen Drive containing the Instruction Manual, Driver and Software for image visualisation Declaration of conformity Certificate of warranty OPERATOR'S MANUAL...

  • Page 23: Control Panel

    4. CONTROL PANEL 4.1. CONSOLE ONBOARD THE MACHINE Control panel area Button Description and use Confirm button Column up movement Column down movement Vertical Laser Positioning - canine or condyle cusp for patient framing (+) Vertical Laser Positioning - canine or condyle cusp for patient framing (-) The control panel (console on-board the machine) allows controlling the X-ray device.

  • Page 24: Perform A Simulation (Dummy Run)

    If the acquisition is interrupted before its completion, the entire portion of analysed tissue will however be shown on the PC together with an error message. If the image is exhaustive, even if partial, the examination does not need to be repeated, thus avoiding subjecting the patient to a further dose of radiation.

  • Page 25: Performing A 2D X-Ray Examination

    5. PERFORMING A 2D X-RAY EXAMINATION The steps to follow to properly perform an X-ray examination are: 1 – Switching on of system and PC where the acquisition driver is installed 2 – Selection of the X-ray examination from virtual control console (PC/iPAD) 3 –...

  • Page 26: Selecting The Examination From The Control Console

    4 year old child, he shall not be exposed to NewTom GO. In order to ensure a safe use of the device, specifically in the radiography of children, it is suggested to consult the general indications described in the guidelines for dental radiographies as i.e.
  • Page 27 PAN DENT HALF L Similar to PAN DENT but regarding only the left side. PAN FRONTAL Similar to PAN DENTITION but regarding only the front area. Set of optimised images that represent the crowns of all teeth PAN BITEWING only for 3D machines Set of optimised images that represent the crowns of the right- PAN BITEWING R only for 3D machines...
  • Page 28 Maxillary sinuses examinations (SIN) Preview Name Description Linear projection of the cranium in posteroanterior view at the SIN MAXILLARY level of the maxillary sinuses. Linear projection of the cranium in lateral view at the level of the SIN MAXILLARY R right-hand maxillary sinuses.

  • Page 29: Selecting An Examination

    Once the configuration is completed, the application can be started by using the relevant icon in the application list. From now on, every choice made on the console is sent directly to NewTom GO and displayed on the control panel. For 2D machine only...
  • Page 30 This screen contains the selectable examinations divided into families (PAN, SIN, TMJ) with all the specific exams available (that can be selected with the scroll bar). Select the icon to access the Settings screen containing the exposure parameter settings. The values are automatically adapted to the selected exposure protocol.
  • Page 31 Moreover, by touching the padlock icon, it is possible to directly work on exposure parameters, changing kV and mA settings. Press the confirmation button on the console of the machine, or press the NEXT button on the control console on PC or iPAD (enclosed in the red rectangle in the image on the left).
  • Page 32 The image is downloaded on the PC and displayed / hidden by pressing the button on the upper tool bar of the console on iPAD, if used. Open the menu on the bottom left-hand side to access the image editing tools; brightness, contrast, range and X, which restores the image to its original status.

  • Page 33: Setting The Projection Type

    5.2.3. SETTING THE PROJECTION TYPE Inside the examination families, different projection types are available. Select one of three projections icon: PAN, SIN and TMJ and then select the purple dots showing the name on the functional bar until the desired projection type appears.

  • Page 34: Preparation Of The X-Ray Examination

    5.3. PREPARATION OF THE X-RAY EXAMINATION 5.3.1. EDENTOLOUS PATIENTS DEVICES (OPTIONAL) In case of edentulous patients, for the PAN, DENT, SIN or CBCT examinations requiring the use of the bite piece, apply the single-use soft insert supplied, as follows: 1 - remove the soft bite from the mould (Fig. 1) 2 - apply the single-use protection on the bite piece (Fig.

  • Page 35: Laser Traces

    5.4.1. LASER TRACES The X-ray device features three light traces which help positioning the patient: 1) Upper Horizontal Laser Trace used in all PAN, DENT, SIN, TMJ, CBCT examinations 2) Sagittal Vertical Laser Trace used in all the examinations 3) Vertical Focusing Laser Trace used in PAN, DENT, SIN, TMJ examinations Upper horizontal trace (1)

  • Page 36: Patient Positioning Description (Craniostat)

    5.4.2. PATIENT POSITIONING DESCRIPTION (CRANIOSTAT) Craniostat components: 1 – Anatomic arches 2 – Bite 3 – Chinrest The craniostat is equipped, in its upper side, with anatomic arches that, once the patient is positioned, can be adjusted and automatically locked by simply pressing point (A) with your fingers.

  • Page 37: Pan, Dent Examinations

    5.4.3. PAN, DENT EXAMINATIONS 1) Adjust the height of the unit to facilitate patient access using the column up or down movement buttons. The telescopic column moves slowly at first and then picks up speed. Adjust the height until the bite piece is slightly higher than the occlusal plane of the patient.

  • Page 38: Tmj Examination

    8) Check the proper positioning of the Frankfurt plane superimposing the upper horizontal light beam (dotted line). To adjust the patient’s head inclination, work the column up and down movement buttons. Make sure that the patient keeps his or her back straight and extended. 9) Ask the patient to smile to uncover the upper teeth.

  • Page 39: Frontal Tmj

    6) Make sure that the examination required is selected correctly. keys to position the vertical focusing light trace exactly on the condyle head, as shown in the figure. 7) Press the CONFIRMATION button and, immediately before leaving the room to press the X-ray emission button, ask the patient to close his/her eyes and remain still.

  • Page 40: Acquisition Of The Exam

    4) Check the symmetry of the patient’s head using the sagittal vertical trace as a guide; check the correct positioning of the Frankfurt plane by overlapping the upper horizontal light trace, as shown in the previous figure. 5) Once the correct orientation has been found, lock the craniostat as explained in paragraph 5.4.2.

  • Page 41: Typical Images Of The Exams

    5.6. TYPICAL IMAGES OF THE EXAMS 5.6.1. ADULT PANORAMIC IMAGING The program of standard panoramic exposure enables a thorough or partial analysis of the patient’s state by selecting the area of diagnostic relevance. The image on the left shows a typical image with PAN standard exposure.

  • Page 42: Sin Examinations

    5.6.4. SIN EXAMINATIONS The program for the X-ray of maxillary sinuses (SIN) allows a study of the state of this anatomical region with one latero-lateral or postero-anterior X-ray image. The image on the left shows a typical image with SIN exposure.

  • Page 43: D Tomographic Examination (Cb3D)

    6. 3D TOMOGRAPHIC EXAMINATION (CB3D) Only for 3D machines The CBCT exam consists in the three-dimensional reconstruction of an X-rayed anatomical region, which produces both two-dimensional views and three-dimensional representations that are generated by a software on a workstation (PC). Instructions about image processing can be found in the NNT software user manual.
  • Page 44 In order to display the FAVOURITES starting page, press the icon. If the 3D exam is among the favourites, it will be possible to select it by touching its icon, otherwise the 3D section can be accessed by pressing the icon.
  • Page 45 2) Protocol setting Select the exam protocol by pressing the icon. The protocol selection menu will appear; depending on the kind of machine and on the diameter of the selected field of view, the following options will be available: Lower arch protocol Upper arch protocol Two arches protocol Maxillary sinuses protocol...
  • Page 46 4) Selection of the volumetric reconstruction centre Select the centre of the CBCT reconstruction in the EXAM screen by touching the region to be reconstructed. A red circle will highlight the selected area. The choice of the reconstruction centre is only preliminary: at the end of the patient positioning, the final selection of the anatomical region for the 3D exam will be realised via a guided procedure on the PC workstation.
  • Page 47 The following screen requires you to reset the device to the default position. In order to start the reset, press the NEXT button once again. After pressing NEXT, wait for the device to complete the automatic reset procedure. 6) Support selection and patient positioning Once the reset is completed, follow the instructions displayed in the left-hand box and, if necessary, mount the specific patient support on the unit.
  • Page 48 Afterwards, let the patient in and position him/her as described in paragraph 6.2 "Positioning the patient for 3D exams". By clicking on the arrows in the right-hand box it is possible to improve the column positioning, moving it upwards or downwards. Once the patient has been correctly positioned, click on the NEXT button.

  • Page 49: Positioning The Patient For 3D Examinations

    6.2. POSITIONING THE PATIENT FOR 3D EXAMINATIONS Only for 3D machines 1) After preparing the X-ray device, let the patient in. 2) Adjust the height of the motorised column with the buttons to facilitate patient access. The column must reach the height of the patient. 3) The patient must grip the handles with both hands and stand straight.

  • Page 50: Special Considerations For Cbct Examinations With Children Or Small Patients

    6.4. SPECIAL CONSIDERATIONS FOR CBCT EXAMINATIONS WITH CHILDREN OR SMALL PATIENTS The NewTom GO device has been specifically designed for patients that are more than 104 cm in height and more than 19 Kg in weight. These height and weight measurements approximately correspond to that of an average 4 year old.

  • Page 51: Viewing And Saving

    7. VIEWING AND SAVING In order to view and save an examination, a PC is required. The X-ray system is supplied with the NNT program for viewing and saving the examinations. Please refer to the NNT user manual. The use of NNT is essential for the acquisition of tomographic examinations, because it includes the volumetric image reconstruction technology (only for 3D machines).

  • Page 52: Periodic Checks And Maintenance

    8. PERIODIC CHECKS AND MAINTENANCE In the interest of safety and health of patients, the staff or third parties, inspections and maintenance need to be carried out at scheduled intervals. Period Operator Object Description Yearly Specialised technician of The X-ray device as a In order to ensure the the dealer that initially whole...

  • Page 53: Collimator Test

    8.1.2. COLLIMATOR TEST In order to verify correct X-ray beam alignment, the following check should be performed at least yearly: “Tools” → “Scanner Test” a) From the main bar of the NNT software, select “Tools” and “service window bar” b) From the service window bar, select .

  • Page 54: Image Quality Controls

    8.1.4. 3D IMAGE QUALITY CONTROLS Acquisition of Blank image The Blank acquisition allows optimising the scanning performance. This short procedure is compulsory and the NNT software requires it every two weeks. Please find below the sequence of instructions to be carried out for a correct acquisition. Make sure the scan area is empty.

  • Page 55: Qa Phantom Acquisition

    8.2. QA PHANTOM ACQUISITION QA Phantom for Quality Control. Before carrying out the quality control, fill QA phantom with water. Please find below a description of the operations required to position the QA phantom and perform the quality control. From the software main menu, select “Scan” and “QA Phantom scan”.
  • Page 56 Once the correct position is reached, press “Next”. Then, in order to acquire a front positioning scout, click on “X-ray Flash” and press the rays button when prompted. The front scout is acquired. Assess phantom position and correct it as you did for the side scout.

  • Page 57: Qa Phantom Troubleshooting

    The following table provides a brief description of the values calculated during the phantom analysis. Abbreviation Name Description Phantom’s angle in the Inclination angle of the symmetry axis of the first scout view phantom in the first scout view Phantom’s angle in the Inclination angle of the symmetry axis of the second scout view phantom in the second scout view...

  • Page 58: Technical Data

    9. TECHNICAL DATA 9.1. ELECTRICAL CHARACTERISTICS Supply voltage Single-phase 115 – 240 VAC (allowed fluctuation +/- 10%) Power supply frequency 50 / 60 Hz Current absorbed in rest conditions 1A @ 115V; 0.5A @ 240V Maximum current absorbed in operating conditions 20A @ 115V;...
  • Page 59 Exposure time (PAN/CB3D) 2D mode: 1s - 15s continuous radiation (depending on the 2D examination type selected) 3D mode: 6.4s-16.8s pulsed mode Source distance - primary collimator 100mm Output radiation intensity (Output dose) 0.20 mG/mAs @ 70 kV, 500 mm/ 0.30 mG/mAs @ 90 kV, 500 mm/ tolerance ±30% Source - detector distance (SID) - PAN...

  • Page 60: Isodose Curves For 2D Examinations

    9.3. ISODOSE CURVES FOR 2D EXAMINATIONS 9.4. ISODOSE CURVES FOR CBCT EXAMINATIONS Only for 3D machines OPERATOR'S MANUAL...

  • Page 61: Panoramic Sensor Characteristics(Pan)

    9.5. PANORAMIC SENSOR CHARACTERISTICS(PAN) For 2D machine only: Sensitive area dimensions 6 x 151 mm Resolution 5 lp/mm (PAN projection) Primary screen > 0.5 mm Pb Pixel size 100μm Sensor technology CMOS Scintillator material & type Direct deposition CsI 58% @ 1 lp/mm 70% @ 0 lp/mm Sensor matrix dimensions 1.512 x 60...

  • Page 62: Dimensional Characteristics

    9.8. DIMENSIONAL CHARACTERISTICS Suspended version For 2D machine only: Weight (basic machine) 70 kg For 3D machine only: 76 kg Maximum overall dimensions diagram (basic 972 x 872 mm machine) Height Min 1626 mm Max 2226 mm Use the installation template for wall mounting. OPERATOR'S MANUAL...
  • Page 63 Version with floor column and wall mount For 2D machine only: Weight (basic machine) 84 kg For 3D machine only: 90 kg Maximum overall dimensions diagram (basic 1027 x 872 mm machine) Height Min 1636 mm Max 2256 mm Use the installation template for wall mounting. OPERATOR'S MANUAL...
  • Page 64 Version with floor column and 45° wall mount For 2D machine only: Weight (basic machine) 102 kg For 3D machine only: 108 kg Maximum overall dimensions diagram (basic 1030 x 1213 mm machine) Height Min 1636 mm Max 2256 mm Use the installation template for wall mounting.

  • Page 65: Environment Characteristics

    Version with floor column and stand For 2D machine only: Weight (basic machine) 120 kg For 3D machine only: 126 kg Maximum overall dimensions diagram (basic 1030 x 872 mm machine) Height Min 1661 mm Max 2281 mm 9.9. ENVIRONMENT CHARACTERISTICS Operating conditions Temperature + 10 - +35 °C Relative humidity 10 –...

  • Page 66: Pc Requirements

    9.10. PC REQUIREMENTS Requirements for the PC workstation directly connected to the X-ray acquisition device. BASIC CONFIGURATION COMPONENT CONFIGURATION 1 CONF. 2 CONF. 3 CONF. 4 (For 2D machine only) Intel Core i3 4150 (3.5GHz, 3MB L3 1 CPU INTEL Cache, 1600MHz) XEON E3-1270 V3 –...

  • Page 67: Mobile Device Requirements

    9.11. MOBILE DEVICE REQUIREMENTS Requirements for the mobile device running the control console or its limited version. APP NAME OPERATING SYSTEM DISPLAY SIZE NewTom GO Remote Panel Apple IOS 7 or higher 7.9-inch (minimum diagonal) (control console) Apple IOS 7 or higher...

  • Page 68: Identification Label Position

    WARNING and DHHS plate Main plates and brand plates Column plate These figures show the plates on all models of the NewTom GO family, and they are for illustrative purposes only; please refer to the plate on your machine. OPERATOR'S MANUAL...

  • Page 69: Error Messages

    10. ERROR MESSAGES Code Message Description/Solution WARNING W 0.1 X-ray button released during Hold down the X-ray emission button exposure. until the end of the procedure. W 0.2 X-ray button not released at the end 1) X-ray button pressed for too of the examination.

  • Page 70: User's Licence Contract

    X-ray system, and to the image display and storage software altogether identified as “NNT” and “NNT viewer” (hereinafter referred to as “Software”) designed by CEFLA s.c. - Via Selice Prov.le 23/A 40026 Imola (Italia), (hereinafter referred to as ”Author”) and handed to the customer (hereinafter referred to as “User”). These conditions are understood fully recognised and accepted at the time of program installation.

  • Page 71: Use Of The Software Product And Express Termination Clause

    11.1.3. USE OF THE SOFTWARE PRODUCT AND EXPRESS TERMINATION CLAUSE a. Software. The User can install the Software and can use it under the conditions and within the limits established in this licence. The User is not authorised to distribute the Software, whether free-of-charge or upon payment, and cannot provide services or develop products or software applications based on the Image Software or which make use of it in any way whatsoever.

  • Page 72: Written Form

    11.1.7. WRITTEN FORM Any modifications should be made in written form. Failure to observe the above shall result in the agreement being made null and void. The parties agree not to recognise the validity in law of any verbal agreements made by any person previously, at the same time or subsequently to the written contract and state that at no time from this moment on shall any attempt be made to validate any verbal agreement which might alter that laid down in the present general conditions.

  • Page 73: Inspection And Maintenance

    12. INSPECTION AND MAINTENANCE 12.1. USER INSPECTION These instructions describe the maintenance procedures for the extraoral X-ray system. These instructions apply to all versions of said equipment, as well as all the accessories that may have been provided, therefore the description of some parts may not correspond to your equipment. Inspection and preventive maintenance must be performed at scheduled intervals to protect the health and safety of patients, users and other persons in accordance with national regulations regarding the use and maintenance of dental x-ray units that are in force in the country where the device is installed.

  • Page 74: Technical Maintenance

    12.2. TECHNICAL MAINTENANCE These instructions describe the maintenance procedures for the extraoral X-ray system. These instructions apply to all versions of said equipment. In order to ensure the operational safety and functional reliability of the equipment installed, at least once a year an authorized service technician must perform a full inspection of the device. When taking measurements that require a multimeter, always use a calibrated digital multimeter.
  • Page 75 Figure 1 Figure 2 OPERATOR'S MANUAL...

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