Carestream DENTAL CS 7600 Manual
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Carestream DENTAL CS 7600 Manual

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CS 7600
Safety, Regulatory and Technical Specifications

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Summary of Contents for Carestream DENTAL CS 7600

  • Page 1 CS 7600 Safety, Regulatory and Technical Specifications...
  • Page 2 Make sure you have the most current version. No part of this guide may be reproduced without the express permission of Carestream Dental, LLC. U.S. Federal law restricts this device to sale by or on the order of a dentist or physician.

  • Page 3: Table Of Contents

    Contents Chapter 1 Indications for Use ..1 Safety Information Clinical Benefits and Performance Characteristics ..1 Conventions in This Guide ..2 Warning and Safety Instructions .
  • Page 4 Chapter 3 Model ....29 Technical CS 7600 Technical Specifications ..29 Specifications Power Supply ..30 RF Information .

  • Page 5: Indications For Use

    These outcomes enable the healthcare professional to support image diagnosis, establish a relevant treatment plan, and thus improve clinical patient management. The clinical benefit of the CS 7600 is the positive impact on patient management. CS 7600_Safety, Regulatory, and Technical Specifications User Guide...

  • Page 6: Conventions In This Guide

    Provides extra information and hints. Note: Emphasizes important information. Warning and Safety Instructions There are no contraindications identified for the CS 7600. When operating the device, observe the following warnings and safety instructions. IMPORTANT: All known residual risks or undesirable side effects are listed in this guide. If...

  • Page 7: Scanner

    Keep this guide with the equipment.  You are responsible for the operation and maintenance of this device. You are required to have training to use the CS 7600. When necessary, have a trained authorized service technician carry out inspection and maintenance operations. ...
  • Page 8  DO NOT remove or open system covers or plugs. Internal circuits use high voltage capable of causing serious injury. Fuses blown within 36 hours of being replaced by a qualified technician may indicate malfunctioning electrical circuits within the system. Have the system checked by qualified service personnel.

  • Page 9: Imaging Plates

    the unit to prevent overheating and damage to the system.  The scanner should be positioned so that there is always easy access to the mains power supply socket.  Connection of the PEMS to an IT-NETWORK that includes other equipment could result in previously unidentified RISKS to PATIENTS, OPERATORS, or third parties.

  • Page 10: Computer

    disposal or recycling information, contact your local authorities.  Do not soak the imaging plate in any cleaning or disinfecting solutions. Do not autoclave; autoclaved imaging plates must be discarded.  Imaging plates should be stored in their original packing or storage box when they are not in use. Always store imaging plates in a dark and dry place.

  • Page 11: Disposal

    the peripheral equipment must conform to the IEC60950 standard.  See your computer installation guide for details of the data processing system and screen. Leave a sufficient amount of clear space around the CPU to ensure that it is properly ventilated. ...

  • Page 12: General Notice

    Immediately contact the service office, report the problem, and await further instructions. Laser Warnings WARNINGS The CS 7600 is a CLASS 1 Laser product.  During normal operation, always keep the unit enclosed in its protective cover to prevent the outside area from being exposed to laser radiation.

  • Page 13: Precautions Before Use

    Perform the following cleaning and disinfection activities on your product and accessories before use. Imaging Plate Care If used with care, Carestream Dental imaging plates can be used repeatedly. The imaging plates will show wear over time, due to continuous use. Inspect the imaging plates regularly, and replace them if they are scratched and/or show signs of excessive wear.

  • Page 14: Cleaning The Imaging Plate

    Warning: To prevent cross-contamination, use a new hygienic sheath for each new patient. Cleaning the Imaging Plate If the imaging plate is visibly contaminated with dirt, dust particles, or fingerprints, you must clean the imaging plate with the following cleaning materials before disinfecting it: ...

  • Page 15: Disposing Of The Imaging Plate

    sanitizers; as well as surfactants and lubricants) that can cause damage to the hygienic sheaths and imaging plates. To disinfect the sheaths and imaging plates, follow these steps: Follow the disinfectant manufacturer’s instructions for disinfecting the sheaths and imaging plates. The sheaths and plates should be kept visibly wet for the full contact time specified on the disinfectant label.

  • Page 16: Scanner Care

    Evacuate and ventilate the area before turning off the system. Cleaning the Detachable Insertion Panel The CS 7600 makes use of three insertion panel sizes according to the inserted plates size (0, 1–3, and 4). The cleaning procedure is identical for all insertion panels.
  • Page 17 To clean and disinfect the insertion panels, follow these steps: Remove the installed insertion panel by inserting a finger in the designated removal depression at the bottom of the insertion panel (A) and lifting out the insertion panel (B). Use disinfection wipes for medical equipment to clean the detachable insertion panels thoroughly from all sides, including the slot.
  • Page 18 the insertion slot panel in from right to left (B) until it is completely inserted (C). The scanner displays an insertion confirmation. For size 0, press the left function button to confirm and return to the main screen. For size 1-3, press the right function button to confirm and return to the main screen.
  • Page 19 If insertion Panel 4 is inserted, the scanner displays the following insertion confirmation. For size 4, press the middle function button to confirm and return to the main screen. CS 7600_Safety, Regulatory, and Technical Specifications User Guide (8J4070)_Ed08...

  • Page 20: Marking And Labeling Symbols

    Warning: General warning sign Using accessories other than those specified in this document with the exception of those sold by Carestream Dental LLC may result in a lower level of security for the entire system. General mandatory action sign Refer to instruction manual/booklet.
  • Page 21 Label Description Name of the Responsible Person in the United Kingdom and address of the registered place of business. Name of the Swiss authorized representative and address of the registered place of business. Caution—Consult accompanying documents Power On/Off Caution—Electrical shock hazard Caution—Electrical shock hazard (located on the PM board) Laser-emitting product (located on the laser...

  • Page 22: Label Locations

    Label Locations The following figures are used only to illustrate the label locations. The label’s contents may be different. 18 Chapter 1 Safety Information...

  • Page 23: General Regulatory

    Regulatory Information General Regulatory Information Compliance with European and International Standards Medical Electrical Equipment, Part 1: General EN 60601-1 / IEC Requirements for Basic Safety and Essential 60601-1 Performance Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential EN 60601-1-2 / IEC performance - Collateral Standard: 60601-1-2...
  • Page 24 Compliance with European and International Standards Biological evaluation of medical devices - Part 1: EN ISO 10993-1 Evaluation and testing within a risk management process ANSI AAMI Medical Electrical Equipment - Part 1: General ES60601-1 Requirements for Safety CAN/CSA-C22.2 Medical Electrical Equipment - Part 1: General No.
  • Page 25 (EMC). The CS 7600 must be installed and put into service according to the EMC information provided in this documentation. The CS 7600 may interfere with other equipment, even if that other equipment complies with CISPR emission requirements. Warning: Portable and mobile Radio Frequency (RF) communications equipment can affect the Electromagnetic Compatibility of the CS 7600.
  • Page 26 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the CS 7600, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

  • Page 27: Guidance And Manufacturer's Declarations

    Guidance and Manufacturer’s Declaration - Electromagnetic Emissions (IEC 60601-1-2) The CS 7600 is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 7600 should assure that it is used in such an environment. Emissions...
  • Page 28 0 % U and voltage 0 % U is recommended that the variations on cycle cycle CS 7600 be powered from power supply an uninterruptible power input lines 70 % U supply. 70 % U 25/30...

  • Page 29: Emc Standards Information

    Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2) The CS 7600 is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 7600 should assure that it is used in such an environment. Immunity...
  • Page 30 Electromagnetic Immunity For the immunity to proximity fields from RF wireless communications equipment, the CS 7600 is compliant with the test levels specified below according to IEC60601-1-2 standard. The customer or the user of the CS 7600 should assure that it is used in such an environment.

  • Page 31: Compliance With International Regulations

    Compliance with International Regulations The CS 7600 is an active device specifically intended for the scanning of X-ray diagnostic images. This device complies with the following regulations:  Medical Device Regulation (EU) 2017/745, Class IIa following the rule 17. ...

  • Page 32: Compliance With Fcc Rules

    Compliance with FCC Rules This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:  This device may not cause harmful interference.  This device must accept any interference received, including interference that may cause undesired operation.

  • Page 33: Model

    Technical Specifications Model CS 7600 CS 7600 Technical Specifications Components Technical Specifications CS 7600 Laser power Up to 12 mW 635 660 nm (Class 3B) Laser wavelength SL Power Model #: MW174KB2403F01 Power supply 100 – 240 V (ac), 50/60 Hz, 1.5 A...

  • Page 34: Power Supply

    Description Length Manufacturer for this Cable) Scan & Go PC USB USB cable Device USB Shield Port Port Network CS 7600 Network Unshielded cable Network Port Port Adapter AC Power cord Mains Unshielded 1.5 m inlet RF Information RF Information Scan &...

  • Page 35: Imaging Plate Technical Specifications

    Imaging Plate Technical Specifications Components Technical Specifications Imaging Plates Imaging Plate Environmental Requirements 35 C Operating temperature – Transportation and storage -10 60 C temperature Operating relative humidity 85% (Non-condensing) – Transportation and storage 95% (Non-condensing) – relative humidity Operating atmospheric 1060 hPa –...
  • Page 36 Imaging Plate Dimensions Height (mm) 22 Width (mm) 35 Height Super 1356 1476 1500 1802 2800 (pixels) High Resolution Width 2052 2298 2000 3009 3750 (SHR) (pixels) Height 1026 1580 High (pixels) Resolution Width (HR) 1169 1308 1150 1713 2122 (pixels) Height High...

  • Page 37: Minimum Computer System Requirements

    Minimum Computer System Requirements Minimum System Item Comments Requirement For best performance, it is 2 GHz Intel® Dual Core™ recommended to use an Intel® Dual Core™ AMD Athlon or higher processor. RAM has a major impact on 2 GB (4 GB recommended) system performance.
  • Page 38 34 Chapter 3 Technical Specifications...

  • Page 39: Manufacturer's Address

    Authorized Representative in the European Community Trophy 4, Rue F. Pelloutier Croissy-Beaubourg 77435 Marne-la-Vallée, Cedex 2 France UK Responsible Person Carestream Dental Ltd. Jessica Igies-Mikaelson Wiltron House, Rutherford Close Stevenage, Hertfordshire SG1 2EF England, United Kingdom CS 7600_Safety, Regulatory, and Technical Specifications User Guide (8J4070)_Ed08...

  • Page 40: List Of Importers For European Union According To The Mdr 2017/745

    Authorized Representative in Brazil Carestream Dental Brasil Eireli Rua Romualdo Davoli, 65 1º Andar, Sala 01 - São José dos Campos São Paulo - Brazil CEP (Zip code): 12238-577 Authorized Representative in Brazil Carestream Dental Brasil Eireli Rua Romualdo Davoli, 65 1º...

  • Page 41: List Of Importers For Switzerland

    List of Importers for Switzerland CURADEN AG Riedstrasse 12 CH-8953 Dietikon Switzerland Dema dent AG Furtbachstrasse 16 CH-8107 Buchs Switzerland Jordi Röntgentechnik AG Dammstrasse 70 CH-4142 Münchenstein Switzerland E. Schweizer AG Bernerstrasse Nord 182 CH-8064 Zürich Switzerland CS 7600_Safety, Regulatory, and Technical Specifications User Guide (8J4070)_Ed08...
  • Page 42 For more information, visit: www.carestreamdental.com To give documentation feedback, visit: www.carestreamdental.com/documentationfeedback ©Carestream Dental, LLC, 2023. 2023-03 8J4070 Ed08...

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