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Related Manuals for KaVo FS Ergo
Summary of Contents for KaVo FS Ergo
- Page 1 FS Ergo Sensor User and Installation Manual ENGLISH 217161 rev. 7 0.805.5292...
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Page 3: Table Of Contents
Contents 1 Disclaimer..............5 2 Introduction..............6 2.1 FS Ergo Sensor..................6 2.2 Indications for use (for North America)............. 6 2.3 Intended use..................6 2.4 Intended user profile................6 2.5 Terms and abbreviations................. 7 2.6 Signal words..................7 2.7 Warnings and precautions............... 7 2.7.1 General warnings.................7... - Page 4 7.2 EMC information................... 32 7.3 Symbols that may appear on the device or its parts........38 8 Support and help............40 FS Ergo Sensor...
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Page 5: Disclaimer
1 Disclaimer 1 Disclaimer FS ERGO SENSOR User and Installation Manual, 217161 r7. © Copyright 8-2018 by PaloDEx Group Oy. All rights reserved. ™ KaVo is a registered trademark of Kaltenbach & Voigt GmbH in the United States and/or other countries. -
Page 6: Introduction
2 Introduction 2 Introduction 2.1 FS Ergo Sensor The FS Ergo sensor is a USB-driven digital sensor that has been designed specifically for healthcare professionals already acquainted with the standard procedures for acquiring dental intraoral radiographs. The sensor design uses advanced ergonomic principles. Four beveled corners, a rounded casing and soft material provide enhanced comfort for the patients. -
Page 7: Terms And Abbreviations
X-ray protection The rules of dental radiography still apply to digital X-ray systems. Continue to use protection for your patients. As a clinician, clear the immediate area when exposing the sensor. FS Ergo Sensor... -
Page 8: Disposal
Properly dispose of the sensor when it has reached its end of life. For information, refer to the explanation of this symbol in chapter Symbols that may appear on the device or parts. FS Ergo Sensor... -
Page 9: Unit Description
3.2 Main parts 1. Sensor head 2. Sensor cable 3. USB pod 4. Indicator light 5. USB connector Type label NOTICE! The label shown above is for reference only. The texts may be different in the actual label. FS Ergo Sensor... -
Page 10: Sensor Statuses
Power off Orange Standby USB cable is connected but there is no SW connection or Image capture is not activated. Green Ready Sensor is ready for capture Blue Integration During x-ray exposure (~1s) Orange blinking Readout Data transfer FS Ergo Sensor... -
Page 11: Sensor Holders
3 Unit description 3.4 Sensor holders The sensor holder system includes the following parts: Anterior holder Posterior holder Horizontal bitewing holder Vertical bitewing holder Universal bar Bitewing bar Universal positioning ring Alignment bar cable clip FS Ergo Sensor... -
Page 12: Accessories
3 Unit description 3.5 Accessories Sensor cable clip Sensor garage • USB extension cable • Sensor sheaths 100 sample pack FS Ergo Sensor... -
Page 13: Installation
• Bitewing bar (2 pcs) • Alignment bar cable clip (5 pcs) NOTICE! The FS Ergo Sensor and holders are designed for a custom fit. For best comfort, use only the FS Ergo sensor holders. NOTICE! If you want to order more consumables or accessories, refer to the list in Accessories. -
Page 14: Workstation Upgrades
“USB 2.0” or “USB high speed.” USB certified hubs can be used to extend the distance to the USB host/computer. The length of the cable connection to the hub or between hubs shall not exceed 5 m. FS Ergo Sensor... -
Page 15: Mounting The Sensor Garage
4.4.3.2 Distance of X-ray source to sensor There is a correlation between the distance of the cone to the sensor and the dose received by the sensor. The radiation that reaches the sensor decreases with the FS Ergo Sensor... - Page 16 4 Installation square of the distance. If you double this distance, the sensor receives only 25% of the radiation. FS Ergo Sensor...
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Page 17: Using The Sensor
Proper care of the sensor. 5.1 Assembling the sensor holders Assemble the ring, bars and sensor holders so that the entire sensor is visible through the ring. This applies both to bitewing and periapical assemblies. FS Ergo Sensor... - Page 18 • BW hole on the positioning ring Horizontal bitewing aim: Vertical bitewing aim: NOTICE! Check that the sensor is NOTICE! Check that the sensor is in the middle of of the posititioning in the middle of of the posititioning ring. ring. FS Ergo Sensor...
- Page 19 • 2 x cable clips Anterior aim: Posterior aim: NOTICE! Check that the sensor is NOTICE! Check that the sensor is in the middle of of the posititioning in the middle of of the posititioning ring. ring. FS Ergo Sensor...
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Page 20: Preparing The Sensor For Imaging
NOTICE! If the sensor holder is assembled so that the cable cannot be routed through the groove, use only the alignment bar cable clips to house the cable. FS Ergo Sensor... - Page 21 • Check that the cable is not between the sensor holder and the teeth because it may become crimped when the patient closes their mouth. Use the FS Ergo sensor holders because they are designed to protect the sensor and cable. If you choose not to use these holders, use an alternative way to protect the sensor and the cable.
- Page 22 5 Using the sensor FS Ergo Sensor...
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Page 23: Handling The Sensor
5.5 Correct sensor positioning using the parallering technique NOTICE! Use the FS Ergo sensor holders for best positioning. Correct placement of the sensor in the patient’s mouth is essential for acceptable X-ray image quality. - Page 24 If there is a large maxillary torus and you are unable to place the sensor/holder in a traditional position: • Place the sensor/holder on the torus as you would place traditional film. • Bisect the angle. FS Ergo Sensor...
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Page 25: Occlusal X-Rays
In both cases, place the sensor parallel to the occlusal plane and add a cotton roll for protection, comfort, and support. Ask the child to close their mouth gently. Use the standard occlusal technique to capture the image. FS Ergo Sensor... -
Page 26: After Exposure
4. Discard the sensor sheath. 5. Disinfect the sensor, if needed. 5.8 After using the sensor Store the sensor in the sensor garage when it is not in use. Disconnect the sensor from the workstation, if needed. FS Ergo Sensor... -
Page 27: Maintenance
It is highly recommended to use the FS Ergo sensor holders because they are designed to protect the sensor. If you choose to NOT use an FS Ergo sensor holder, you must protect the sensor and the cable. -
Page 28: Image Quality Assurance
It is recommended to use a dental phantom for a periodic (at least annual) assessment of the image quality by performing a side-by-side comparison of an initial dental phantom image to a current dental phantom image to ensure that the images have sufficient quality for diagnostic purposes in your application. FS Ergo Sensor... - Page 29 Dental phantom images should be acquired with fixed settings for X-ray dose (kV, mA, distance), and a fixed and reproducible alignment of the X-ray source and the dental phantom to the FS Ergo sensor. NOTICE! Contact technical support for recommendations about commercially available dental phantoms.
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Page 30: Technical Data
Quality system In accordance with ISO13485 standard Environmental management In accordance with ISO14001 standard system Conformity to standards The FS Ergo sensor conforms to safety standard IEC 60601-1. Electrical rating DC 5V, 500 mA max Connection to PC USB 2.0 Standard... - Page 31 Power supply USB connection PC Weight 100 g Software Operating system requirements Refer to operating software specifications SW architecture USB 2.0 compliant USB interface Other software Anti-virus software and firewall are recommended to protect the system against viruses. FS Ergo Sensor...
- Page 32 Hygiene sheats LDPE 7.2 EMC information The FS Ergo sensor is, like any electronic medical device, subject to electromagnetic interactions with other electronic devices. The EMC information in this chapter is provided for the medical system established by connecting the sensor to a computer. This computer must be compliant with IEC 60950-1 (if located outside the patient environment) or IEC 60601-1 (if located inside the patient environment).
- Page 33 Table 1: Electromagnetic emissions IEC 60601-1-2 Edition 4.0 2014-02 FS Ergo is suitable for use in the specified electromagnetic environment. The purchaser or user of FS Ergo should assure that it is used in an electromagnetic environment as described below:...
- Page 34 Table 2: Electromagnetic immunity IEC 60601-1-2 Edition 4.0 2014-02 FS Ergo is suitable for use in the specified electromagnetic environment. The purchaser or user of the FS Ergo should assure that it is used in an electromagnetic environment as described below:...
- Page 35 Table 3: RF immunity of non-life-support equipment or system IEC 60601-1-2 Edition 4.0 2014-02 FS Ergo is suitable for use in the specified electromagnetic environment. The purchaser or user of FS Ergo should assure that it is used in an electromagnetic environment as described below: Immunity...
- Page 36 Communications Equipment IEC 60601-1-2 Edition 4.0 2014-02 The FS Ergo is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer of the user of FS Ergo can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the FS Ergo as recommended below, according to the maximum output power of the communications equipment.
- Page 37 WARNING! 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 FS Ergo, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.”...
- Page 38 Conforms to AAMI ES60601-1:2006. Certified to CSA. CE symbol Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. This way up (Packaging) Fragile, Handle with Care (Packaging) Keep dry (Packaging) FS Ergo Sensor...
- Page 39 7 Technical data Humidity Limitations (Packaging) Atmospheric Pressure Limitations (Packaging) Temperature Limitations (Packaging) FS Ergo Sensor...
- Page 40 8 Support and help FS Ergo Sensor online resources: For DEXIS Software Users: Call DEXIS Support @ 1-888-883-3947, Option 1. Or, support@dexis.com FS Ergo Customer Care Center (United States and Canada): KAVO Dental 11727 Fruehauf Drive Charlotte NC 28273 888-ASK-KAVO Fax 704-927-0816 customerservice@kavo.com...
- Page 41 217602-2 Headquarters PaloDEx Group Oy | Nahkelantie 160 | P.O. Box 20 FI-04301 Tuusula | FINLAND | Tel. +358 10 270 2000 http://www.kavo.com/en/contact www.kavokerrgroup.com Instrumentarium Dental | 11727 Fruehauf Drive | Charlotte, NC 28273 | U.S.A Tel. 800-558-6120 | Fax. 877-292-6050...