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KaVo FS Ergo User And Installation Manual Download Page 30

7 Technical data

7 Technical data

7.1 Technical specifications

Manufacturer

PaloDEx Group Oy, Nahkelantie 160, FI-04300

Tuusula, FINLAND

Quality system

In accordance with ISO13485 standard

Environmental management

system

In accordance with ISO14001 standard

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

Method of sterilization

Sensor not suitable for sterilization

Environmental conditions

Humidity

Air Pressure

Ambient Temperature

Usage
FS Ergo sensor is not

suitable to be operated in

oxygen rich and/or explosive

environments

30% to 85%

5° to 40°C

Transportation and storage
Transport in the supplied

protective package

10% to 95%

700 to 1060

hPa

-40° to 70°C

EU classification

Class IIa medical device according to MDD 93/42/EU

Product name

FS Ergo

Product type

Portable digital intraoral sensor

30

FS  Ergo  Sensor

Summary of Contents for FS Ergo

Page 1: ...FS Ergo Sensor User and Installation Manual ENGLISH 217161 rev 7 0 805 5292 ...

Page 2: ......

Page 3: ... requirements 13 4 3 Workstation upgrades 14 4 4 Installing the sensor 14 4 4 1 Connecting the sensor 14 4 4 2 Mounting the sensor garage 15 4 4 3 Adjusting the X ray source 15 5 Using the sensor 17 5 1 Assembling the sensor holders 17 5 2 Preparing the sensor for imaging 20 5 3 Cable protection 20 5 4 Handling the sensor 23 5 5 Correct sensor positioning using the parallering technique 23 5 6 Occ...

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 4 FS Ergo Sensor ...

Page 5: ... of PaloDEx Group Oy The original language of this manual is English PaloDEx Group Oy reserves the right to make changes in specification and features shown herein or discontinue the product described at any time without notice or obligation Contact your PaloDEx Group Oy representative for the most current information The manufacturer has no liability for consequential damage personal injury loss ...

Page 6: ... purchased separately The acquired images can be optimized for specific diagnostic tasks archived as image files and printed out on a suitable printer if desired with imaging software The imaging software is one example of a dedicated software that provides a number of utilities for optimizing viewing and printing of images 2 2 Indications for use for North America The FS Ergo sensor is a digital ...

Page 7: ...WARNING No modification of the equipment is allowed WARNING Any service attempts by unauthorized persons are strictly prohibited The sensor has no serviceable parts Do not open the sensor to service it All aspects of the sensor that are meant to be attended to by you are accessible without opening the internal components of the sensor If there is a problem contact a qualified dealer service repres...

Page 8: ... Always inspect the sensor cable and positioning devices for physical damage prior to every use See chapter Proper care of the sensor WARNING Remove sensor from use if damage to the cable or housing is observed otherwise exposure to elevated surface temperature or electrical energy may result 2 7 2 Disposal CAUTION Dispose of sheaths and other consumable products following the normal dental office...

Page 9: ...e which is perceptible to the sensor Digital X ray images are quickly displayed on the screen Images can be optimized for viewing via imaging software stored as image files and printed out on a suitable printer if desired The sensor must be connected to a workstation through a standard USB port 3 2 Main parts 1 Sensor head 2 Sensor cable 3 USB pod 4 Indicator light 5 USB connector Type label NOTIC...

Page 10: ...Indicator light Default state Function No color 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 10 FS Ergo Sensor ...

Page 11: ...s 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 11 ...

Page 12: ...3 Unit description 3 5 Accessories Sensor cable clip Sensor garage USB extension cable Sensor sheaths 100 sample pack 12 FS Ergo Sensor ...

Page 13: ...ing 2 pcs Universal bar 2 pcs 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 4 2 Hardware requirements NOTICE Connecting the unit to an IT network that includes other equipment or cha...

Page 14: ...ck up efforts have been successful make sure that you understand the backup process and try the restore process at least once on a test system Verify that both the operating system and data have been preserved To protect patient records and other critical data consider the following solutions Purchase a new computer and run a parallel system on it If you must upgrade your existing system purchase ...

Page 15: ...mpatible with any dental X ray unit and intraoral X ray device that can supply the required range of exposure times and doses Refer to your X ray device s User manual for the recommended exposure times for digital sensors NOTICE X ray devices even the same brands and types purchased at the same time differ widely in their performance In addition on a newer X ray device the digital setting on your ...

Page 16: ...4 Installation square of the distance If you double this distance the sensor receives only 25 of the radiation 16 FS Ergo Sensor ...

Page 17: ...h the sensor and the proper handling guidelines in section 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 17 ...

Page 18: ...BW hole on the positioning ring Required equipment Vertical bitewing holder Bitewing bar BW hole on the positioning ring Horizontal bitewing aim NOTICE Check that the sensor is in the middle of of the posititioning ring Vertical bitewing aim NOTICE Check that the sensor is in the middle of of the posititioning ring 18 FS Ergo Sensor ...

Page 19: ...itioning ring 2 x cable clips Required equipment Posterior holder Universal bar A P hole on the positioning ring 2 x cable clips Anterior aim NOTICE Check that the sensor is in the middle of of the posititioning ring Posterior aim NOTICE Check that the sensor is in the middle of of the posititioning ring FS Ergo Sensor 19 ...

Page 20: ...ion between patients place a new sheath on the sensor for each new patient CAUTION Due to intraoral imaging geometry and positioning accurate distance and angle measurements cannot be taken from intraoral images 5 3 Cable protection NOTICE Check the condition of the cable before use Do not use the sensor if the cable is broken The sensor holders have a groove for housing the sensor cable during im...

Page 21: ... 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 The use of a bitewing tabs can offer additional protection but you still need to protect the cable Ask the patient to close their mouth lightly so that there is only a slight contact Do not allow the patient to bite ...

Page 22: ...5 Using the sensor 22 FS Ergo Sensor ...

Page 23: ...e interproximal spaces By drawing an imaginary line through the occlusal incisal surfaces occlusal line of the teeth to be X rayed and placing the sensor parallel to this line it will be perpendicular to the interproximal spaces To achieve parallel positioning the sensor holder must be positioned away from the lingual palatal surface and located in the deeper areas of the mouth in all areas except...

Page 24: ...n parallel to the roots bisect the angle 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 also the angle If the incisal edges are missing from the images place a cotton roll between the tooth and the holder and or verify that the sensor holder is parallel to th...

Page 25: ...ensor placed lengthwise from right to left and capture the necessary information in one exposure Dual exposure image In some cases you may need to place the sensor width wise from anterior to posterior on half of the arch and then repeat for the other half 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 t...

Page 26: ...h 2 Detach the sensor from the sensor holder 3 Disassemble the sensor holder assembly 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 26 FS Ergo Sensor ...

Page 27: ... that exert excessive force for example hemostats or clamps of any type CAUTION Do not autoclave the sensor Autoclave sterilizers will permanently damage the sensor CAUTION Do not use chemical heat sterilizers The sensor material may deteriorate when using unapproved chemicals Decontaminate the sensor and cable in accordance with CDC or your country s e g OSHA standards for infection control We re...

Page 28: ...tributing system parts as instructed below X ray dose Exposure time settings The sensor has been designed to be used with a wide range of dose settings to allow adjustments of the dose to the specific diagnostic task and to compensate for both under and overexposure Start by using dose exposure time settings recommended by your X ray source manufacturer for digital X ray sensors The sensor can be ...

Page 29: ...ntact technical support for recommendations about commercially available dental phantoms Display Refer to your software manual for instructions on how to ensure good display settings and image display properties It is recommended to view images on an SVGA monitor with at least 1 024 x 768 pixel resolution at 0 25 to 0 26 dot pitch or better and 24 bit true color 32 bit preferred in native resoluti...

Page 30: ...DC 5V 500 mA max Connection to PC USB 2 0 Standard Method of sterilization Sensor not suitable for sterilization Environmental conditions Humidity Air Pressure Ambient Temperature Usage FS Ergo sensor is not suitable to be operated in oxygen rich and or explosive environments 30 to 85 5 to 40 C Transportation and storage Transport in the supplied protective package 10 to 95 700 to 1060 hPa 40 to 7...

Page 31: ...f liquids USB pod IP44 Sensor IP68 Mode of operation Continuous 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 31 ...

Page 32: ...el PPSU Ultem Sensor garage ABS 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...

Page 33: ...l as any other electronic medical equipment 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 Emissions Test Compliance Electromagnetic Environment Radio Frequency Emissions CISPR11 Group 1 FS ...

Page 34: ...mode 0 5 1 2 kV common mode 0 5 1 kV differential mode 0 5 1 2 kV common mode Mains power quality is that of a typical commercial and or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 11 0 U mains 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 U mains 1 cycle At 0 70 U mains 25 30 cycles At 0 0 U mains 250 300 cycle At 0 0 U main...

Page 35: ... rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey are less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Field strengths from fixed t...

Page 36: ...s m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTICE At 80 MHz the separation distance for the higher frequency range applies NOTICE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and refl...

Page 37: ...ARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other equipment should be observed to verify that they are operating normally Interference may occur in the vicinity of equipment marked with the following symbol WARNING Portable RF communications equipment includi...

Page 38: ...c equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment Do not reuse Recyclable Sterilizable in a steam sterilizer autoclave at temperature specified NRTL Mark Conforms to AAMI ES60601 1 2006 Certified to CSA CE symbol Caution Federa...

Page 39: ...7 Technical data Humidity Limitations Packaging Atmospheric Pressure Limitations Packaging Temperature Limitations Packaging FS Ergo Sensor 39 ...

Page 40: ...s 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 40 FS Ergo Sensor ...

Page 41: ...epresentative for the most current information Copyright by PaloDEx Group Oy All rights reserved 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 USA Instrumentarium Dental 11727 Fruehauf Drive Charlotte NC 28273 U S A Tel 800 558 6120 Fax 877 292 6050 Email KKG Imaging CS kavokerrgroup...

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