AGFA 6005/100 6005/200 User Manual Download Page 19 | Manualshive

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General

• The DR Full Leg Full Spine detector positioner has been designed in

accordance with Regulation (EU) 2017/745 on medical devices (MDR).

• The external collimator has been designed in accordance with the

MEDDEV Guidelines relating to the application of Medical Devices and
have been tested as part of the conformity assessment procedures required
by 93/42/EEC Medical Device Directive (European Council Directive
93/42/EEC on Medical Devices) amended by European Directive
2007/47/CE.

Safety

• IEC 60601-1
• IEC 60601-1-3
• IEC 60601-1-6
• IEC 60601-2-54
• ANSI/AAMI ES60601-1
• CAN/CSA-C22.2 No. 60601-1:14

Electromagnetic Compatibility

• IEC 60601-1-2

Environmental Compliance

• European Council Directive 1907/2006 (REACH)
• European Council Directive 2011/65/EU (RoHS 2)
• European Council Directive 2012/19/EU (WEEE)

Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application |

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0326A EN 20211014 1141

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Summary of Contents for 6005/100 6005/200

Page 1: ...Full Leg Full Spine DR Retrofit System 6005 100 6005 200 User Manual 0326A EN 20211014 1141 ...

Page 2: ... Labels 25 Additional labeling for the wall stand 27 Additional labeling for the external collimator 27 Cleaning and Disinfecting 28 Cleaning 29 Disinfecting 30 Approved disinfectants 31 Maintenance 32 Recurrent safety tests 32 Environmental protection 33 Safety Directions 35 Basic Workflow 37 Starting the DR Full Leg Full Spine application 38 Retrieve the patient info 39 Select the exposure 40 Pr...

Page 3: ...ers or cropping on or off 60 To save the stitched image 61 Rejecting a DR Full Leg Full Spine image 61 Making measurements 62 DAP reading when using the external collimator 64 Problem solving 65 Anatomical stitching is not optimal 66 Stitching fails 67 Not all three DR detector positions are available 68 Technical Data 69 Full Leg Full Spine wall stand technical data 70 External collimator technic...

Page 4: ...services may not be available for your local area Please contact your local sales representative for availability information Agfa NV diligently strives to provide as accurate information as possible but shall not be responsible for any typographical error Agfa NV shall under no circumstances be liable for any damage arising from the use or inability to use any information apparatus method or proc...

Page 5: ...Introduction to this Manual Topics Scope of this Manual About the safety notices in this document Disclaimer Full Leg Full Spine DR Retrofit System Introduction to this Manual 5 0326A EN 20211014 1141 ...

Page 6: ...ctive operation of the Full Leg Full Spine DR Retrofit System and the following accessories Full Leg Full Spine wall stand Full Leg Full Spine control unit External collimator optional 6 Full Leg Full Spine DR Retrofit System Introduction to this Manual 0326A EN 20211014 1141 ...

Page 7: ... A caution safety notice indicates a hazardous situation which can lead to a potential minor injury to a user engineer patient or any other person An instruction is a direction which if it is not followed can cause damage to the equipment described in this manual or any other equipment or goods and can cause environmental pollution A prohibition is a direction which if it is not followed can cause...

Page 8: ...pear in this document To improve reliability function or design Agfa reserves the right to change the product without further notice This manual is provided without warranty of any kind implied or expressed including but not limited to the implied warranties of merchantability and fitness for a particular purpose Note In the United States Federal law restricts this device on order of a physician f...

Page 9: ...ompliance Equipment Classification System Documentation Product Complaints Installation Accuracy of Measurements Labels Cleaning and Disinfecting Maintenance Environmental protection Safety Directions Full Leg Full Spine DR Retrofit System Introduction to the Full Leg Full Spine application 9 0326A EN 20211014 1141 ...

Page 10: ...itten for trained users of Agfa products and trained clinical personnel Users are considered as the persons who actually handle the equipment as well as the persons having authority over the equipment Before attempting to work with this equipment the user must read understand note and strictly observe all warnings cautions and safety markings on the equipment 10 Full Leg Full Spine DR Retrofit Sys...

Page 11: ...e hospital network using one of the following protocols DICOM IHE The NX workstation can be connected to a RIS system input scheduling a PACS system output image data management and to a hardcopy device output image Note The connections between the components of the system are separate from the hospital network and should not be disconnected or modified Full Leg Full Spine DR Retrofit System Intro...

Page 12: ...Configuration Topics Full Leg Full Spine wall stand External collimator 12 Full Leg Full Spine DR Retrofit System Introduction to the Full Leg Full Spine application 0326A EN 20211014 1141 ...

Page 13: ...d and a control unit 1 2 3 1 Wall mounted base with height adjustment mechanism optional or fixed height wall mounted base 2 DR detector holder 3 Front panel Figure 1 Full Leg Full Spine wall stand Full Leg Full Spine DR Retrofit System Introduction to the Full Leg Full Spine application 13 0326A EN 20211014 1141 ...

Page 14: ...nism to automatically position the detector and anti scatter grid for making Full Leg Full Spine partial images Figure 2 DR detector holder Topics Front panel of the DR detector holder Control unit Anti scatter grids 14 Full Leg Full Spine DR Retrofit System Introduction to the Full Leg Full Spine application 0326A EN 20211014 1141 ...

Page 15: ...hen using a 14x17 inch DR detector 3 Center line for each position of the DR detector 4 Overlap zone Figure 3 Front panel of the DR detector holder Control unit 1 2 1 Button to move the DR detector to the next position 2 Indicator for the current position of the DR detector Figure 4 Control unit Full Leg Full Spine DR Retrofit System Introduction to the Full Leg Full Spine application 15 0326A EN ...

Page 16: ...detector positions are available on page 68 Anti scatter grids Anti scatter grids are used to reduce scattered radiation and improve image quality Grids are available as an option Refer to the Agfa website for specifications on the anti scatter grids that have been found compatible with the system and the DR Detectors http www agfahealthcare com global en library overview jsp ID 54332498 16 Full L...

Page 17: ... Full Spine partial images 2 X ray collimator 3 Initialization button 4 Height adjustment button 5 Floor mount lock Figure 5 External collimator optional The movement of the collimator is synchronized with the movement of the DR detector and anti scatter grid Full Leg Full Spine DR Retrofit System Introduction to the Full Leg Full Spine application 17 0326A EN 20211014 1141 ...

Page 18: ...ompliance Topics General Safety Electromagnetic Compatibility Environmental Compliance 18 Full Leg Full Spine DR Retrofit System Introduction to the Full Leg Full Spine application 0326A EN 20211014 1141 ...

Page 19: ...2 EEC Medical Device Directive European Council Directive 93 42 EEC on Medical Devices amended by European Directive 2007 47 CE Safety IEC 60601 1 IEC 60601 1 3 IEC 60601 1 6 IEC 60601 2 54 ANSI AAMI ES60601 1 CAN CSA C22 2 No 60601 1 14 Electromagnetic Compatibility IEC 60601 1 2 Environmental Compliance European Council Directive 1907 2006 REACH European Council Directive 2011 65 EU RoHS 2 Europ...

Page 20: ...ock particularly re garding allowable leakage current and reliability of the protective earth protection Water Ingress This device does not have protection against ingress of wa ter Cleaning See section on maintenance and cleaning Disinfection See section on maintenance and cleaning Flammable An esthetics This device is not suitable for use in the presence of a flammable anesthetic mixture with ai...

Page 21: ...y have been purchased or licensed on a particular piece of equipment Refer to the System User Documentation before using the Full Leg Full Spine application User Manual of the DR system and related user documentation NX User Manual The most recent version of this document is available on http www agfahealthcare com global en library index jsp Full Leg Full Spine DR Retrofit System Introduction to ...

Page 22: ... of this device or as a result of its use a serious incident has occurred please report it to the manufacturer and or its authorised representative and to your national authority Manufacturer address Agfa Service Support local support addresses and phone numbers are listed on www agfa com Agfa Septestraat 27 2640 Mortsel Belgium Agfa Fax 32 3 444 7094 22 Full Leg Full Spine DR Retrofit System Intr...

Page 23: ...ed service engineer Contact your local support organization for more information CAUTION Position the device so that it is possible to disconnect the mains plug if required Full Leg Full Spine DR Retrofit System Introduction to the Full Leg Full Spine application 23 0326A EN 20211014 1141 ...

Page 24: ...m The accuracy applies to the difference between the size of the projection of the object on the stitching grid and that measured with the product on these conditions The image is stitched based on the grid markers The object has not moved during the examination No pressure is applied on the stitching grid causing it to bend WARNING If the patient leans against the stitching grid the bending of th...

Page 25: ...st recent version of this document is available on http www agfahealthcare com global en library index jsp c NRTL us label certified according Standard AAMI ES60601 1 US certified according Standard CAN CSA 22 2 no 60601 1 14 Canada Pinch Points Read and understand all instructions and warning labels in the product documentation before using the equipment Keep man ual for future reference No stepp...

Page 26: ...d municipal waste and must be collected separately Please contact an au thorized representative of the manufacturer or an authorized waste management company for information concerning the decommissioning of your equipment Topics Additional labeling for the wall stand Additional labeling for the external collimator 26 Full Leg Full Spine DR Retrofit System Introduction to the Full Leg Full Spine a...

Page 27: ...pe label Type label of the wall stand Additional labeling for the external collimator Figure 7 Sample of type label Type label of the collimator Full Leg Full Spine DR Retrofit System Introduction to the Full Leg Full Spine application 27 0326A EN 20211014 1141 ...

Page 28: ...nly be used by trained people with required knowledge to complete the cleaning and disinfecting task in a save and effective way The selection of the appropriate legally marketed disinfecting agents and procedures is the responsibility of the hospital The selection shall be performed according amongst others to the severity of the contamination Topics Cleaning Disinfecting Approved disinfectants 2...

Page 29: ...osive dissolving or abrasive cleaning or polishing agents Make sure no liquid gets in the device CAUTION Clean the equipment with only a little moisture Note Do not open the equipment for cleaning No components inside the device require cleaning by the user Using unsuitable cleaning agents or methods can damage the property when surface becomes dull and brittle e g alcohol containing agents 3 Star...

Page 30: ...ection is also not allowed Perform the procedure following the instructions for use the disposal instructions and the safety instructions of the selected disinfectants and tools and of the hospital Items contaminated with blood or body fluids which may contain blood borne pathogens should be cleaned and then receive intermediate level disinfection with a product having an EPA registered claim for ...

Page 31: ... been found compatible with the cover material of the device and can be used on the outer surface of the device http www agfahealthcare com global en library overview jsp ID 41651138 Full Leg Full Spine DR Retrofit System Introduction to the Full Leg Full Spine application 31 0326A EN 20211014 1141 ...

Page 32: ...your local support organization Recurrent safety tests The device shall be tested according to IEC 62353 in a time interval of at least 36 months or less if local regulations are different Medical electrical equipment Recurrent test and test after repair of medical electrical equipment 32 Full Leg Full Spine DR Retrofit System Introduction to the Full Leg Full Spine application 0326A EN 20211014 1...

Page 33: ...ce organization and or dealer The recycling of materials will help to conserve natural resources CAUTION By ensuring this product is disposed of correctly you will help prevent potential negative consequences for the environment and human health which could otherwise be caused by inappropriate waste handling of this product Battery notice The battery symbol on the products and or accompanying docu...

Page 34: ...For battery replacements please contact your local sales organization 34 Full Leg Full Spine DR Retrofit System Introduction to the Full Leg Full Spine application 0326A EN 20211014 1141 ...

Page 35: ...ngineer performing a modification or service intervention on a medical device acts on his own responsibility and makes the warranty void WARNING The user is responsible for judging image quality and controlling environmental conditions for diagnostic softcopy or print viewing WARNING System unavailability due to hardware or software failure If the product is used in critical clinical workflows a b...

Page 36: ...ings prior to exposing the patient WARNING Responsibility for risks related to the use of the original X ray system remains with the user CAUTION Strictly observe all warnings cautions notes and safety markings within this document and on the product CAUTION Damaged grid Reduced image quality Please handle the grids with special care CAUTION While every care has been taken it is possible that mino...

Page 37: ...figuration Prepare the Full Leg Full Spine configuration with external collimator Prepare the examination Execute the exposures Execute the exposures with external collimator Perform a quality control Finalize the examination Stopping the DR Full Leg Full Spine application Full Leg Full Spine DR Retrofit System Basic Workflow 37 0326A EN 20211014 1141 ...

Page 38: ...d then connect the wall stand to the power supply 1 Connect the external collimator to the Full Leg Full Spine wall stand 2 Connect the Full Leg Full Spine wall stand to the power supply WARNING Because the equipment cable is long take care that cables do not become tangled during use Also be careful not to get your feet caught in the cable It may cause a malfunction of the equipment or injury to ...

Page 39: ...tient info In the operator room at the NX workstation 1 When a new patient comes in define the patient info for the exam 2 Start the exam Full Leg Full Spine DR Retrofit System Basic Workflow 39 0326A EN 20211014 1141 ...

Page 40: ...erator room at the NX workstation 1 In the Image Overview pane of the Examination window select the thumbnail for the DR Full Leg Full Spine FLFS examination 2 In the Image Detail pane click Start FLFS For each partial image a thumbnail is displayed in the Image Overview pane 40 Full Leg Full Spine DR Retrofit System Basic Workflow 0326A EN 20211014 1141 ...

Page 41: ...guration 5 Adjust the height aligning the center of the X ray beam to the center of the DR detector holder 6 Apply collimation using the collimator on the X ray tube Adjust the width according to the region of interest Adjust the height to make sure the exposed area on the DR Detector holder has a height of at least 45 cm 7 Move the DR detector to the first position Depending on the region of inte...

Page 42: ...uring installation The value must be large enough for the X ray field to cover the region of interest completely For a good result of the automatic stitching the SID should be at least 220 cm Figure 11 Configuration with external collimator 5 Adjust the height aligning the center of the X ray beam to the center of the DR detector holder If the external collimator is already in place the vertical c...

Page 43: ... adjustment button on the external collimator to move it upward or downward The center line of the external collimator must be aligned to the center line of the X ray beam b Once aligned press the initialization button on the external collimator The external collimator will initialize its position and align to the DR detector in the top most position of the DR detector holder 9 Apply collimation u...

Page 44: ...nts Patient hands must be kept away from mobile components of the unit Intravenous tubing catheters and other patient connected lines should be routed away from moving equipment WARNING Secure all moveable parts in position before the device can be used for X ray exposures When performing a Full Leg examination the patient s feet should be as close as possible to the stitching grid 44 Full Leg Ful...

Page 45: ...ector is moved to the next position inside the DR detector holder 4 Repeat previous steps to move the DR detector to each required position rotate the X ray tube correspondingly and acquire the partial images If only two partial images are required and the examination contained three partial image thumbnails the FLFS workflow can be cancelled after the second exposure The stitching must be started...

Page 46: ...ition inside the DR detector holder The external collimator is also moved to the next position 3 Repeat previous steps to move the DR detector to each required position and acquire the partial images If only two partial images are required and the examination contained three partial image thumbnails the FLFS workflow can be cancelled after the second exposure The stitching must be started manually...

Page 47: ... of the anatomical information in the image The stitching parameters are displayed on the right side of the image Table 3 Stitching parameters Button Parameter 0 0 Vertical correction in respect to the stitching grid for the align ment of the anatomical information in the image 0 1 Horizontal correction in respect to the stitching grid for the align ment of the anatomical information in the image ...

Page 48: ...by the system The user is responsible for observation of the movement of the patient during the examination To perform quality control 1 If required adjust the stitching 2 Click Accept Depending on the configuration settings the stitching parameters are added to the image as a text annotation The text annotation contains following information Table 4 Annotations V Vertical correction in respect to...

Page 49: ...dication that no patient movement is detected Figure 13 Example of a text annotation containing stitching parameters 3 Prepare the image for diagnosis by using e g L R markers or annotations 4 If the image is OK send the image to a hardcopy printer and or PACS Picture Archiving and Communication System Related Links To stitch a set of partial images on page 55 Manually adjusting a DR Full Leg Full...

Page 50: ...l collimator by pushing the lower lever of the floor mount lock 2 Move the external collimator to its parking position and activate the brakes on the wheels to prevent unintended movement 50 Full Leg Full Spine DR Retrofit System Basic Workflow 0326A EN 20211014 1141 ...

Page 51: ...application 1 Disconnect the Full Leg Full Spine wall stand from the power supply 2 Disconnect the external collimator from the Full Leg Full Spine wall stand Full Leg Full Spine DR Retrofit System Basic Workflow 51 0326A EN 20211014 1141 ...

Page 52: ...y adjusting a DR Full Leg Full Spine image Rejecting a DR Full Leg Full Spine image Making measurements DAP reading when using the external collimator 52 Full Leg Full Spine DR Retrofit System Advanced Operation 0326A EN 20211014 1141 ...

Page 53: ...images based on their projection on the stitching grid To align the partial images based on the analysis of the anatomical information in the image To manually align two partial images To turn the black borders or cropping on or off To save the stitched image Full Leg Full Spine DR Retrofit System Advanced Operation 53 0326A EN 20211014 1141 ...

Page 54: ...es Click the following button to rotate 90 clockwise Figure 14 Rotate clockwise Click the following button to rotate 90 counterclockwise Figure 15 Rotate counterclockwise 54 Full Leg Full Spine DR Retrofit System Advanced Operation 0326A EN 20211014 1141 ...

Page 55: ...tching grid and a correction is applied based on the alignment of the anatomical information in the image The area of the image where two partial images are stitched together is indicated by the stitching tools displayed on the right side of the image In this area the two partial images slightly overlap If the anatomical structures in the overlapping area are not aligned stitching can be adjusted ...

Page 56: ...grid The anatomical structure in the partial images may not be aligned due to patient movement during the examination The values of the horizontal and vertical correction are set to zero Next to the stitching areas the following label is displayed 0 0 0 1 Figure 17 Stitching tools align partial images 56 Full Leg Full Spine DR Retrofit System Advanced Operation 0326A EN 20211014 1141 ...

Page 57: ...the overlapping areas are aligned by automatically shifting the partial images in vertical and horizontal direction The new alignment is applied to each stitching area Next to the stitching areas this label is displayed as well as the vertical and horizontal relative position of the partial images 0 0 0 1 Figure 19 Stitching tools align partial images via anatomical information Full Leg Full Spine...

Page 58: ... im age Right click hold the image and drag the mouse arrow to any direction Press the SHIFT or CTRL button while dragging the mouse arrow to adjust the vertical or horizon tal alignment only Use the arrow keys on the keyboard Click the arrow buttons on the screen Roaming over the images Left click hold the image and drag the mouse ar row to any direction Zooming in out on the images Use the scrol...

Page 59: ...e each of which is locked to the position of one of the partial images 3 If the anatomical structures in the partial images are aligned click Accept to confirm Next to the stitching areas this label is displayed as well as the vertical and horizontal relative position of the partial images 0 0 0 1 Figure 23 Stitching tools manual alignment Full Leg Full Spine DR Retrofit System Advanced Operation ...

Page 60: ...k borders or cropping on or off To turn the black borders or cropping on or off Click the following icon Figure 24 Crop uncrop button 60 Full Leg Full Spine DR Retrofit System Advanced Operation 0326A EN 20211014 1141 ...

Page 61: ...another DR Full Leg Full Spine image Rejecting a DR Full Leg Full Spine image By rejecting an image you indicate that the image is not suitable for diagnosis and that a retake is needed Rejecting an image does not remove the image from the exam To reject a DR Full Leg Full Spine image 1 Reject each partial image 2 If the DR Full Leg Full Spine image was created reject this image also No images wil...

Page 62: ...is applied on NX Measurements on the DR Full Leg Full Spine image are based on the projection of the object on the stitching grid To make measurements see the NX User Manual on Adding annotations to an image and using the measurement tools To modify the Estimated Radiographic Magnification Factor see the NX User Manual on Adding an Estimated Radiographic Magnification Factor ERMF 5 1 4 6 8 10 7 3 ...

Page 63: ...etector 10 Source image distance SID This distance is received together with the X Ray generator parameters Figure 26 Making measurements on DR Full Leg Full Spine images The respective distances between the plane in which the measurement is made the stitching grid the DR Detector and the X ray tube are used to calculate the Estimated Radiographic Magnification Factor to calibrate the distance mea...

Page 64: ...ally are shown in the Image Detail pane of the Examination window A correction factor of 1 3 is applied internally to the DAP value The corrected DAP value is shown in the View All pane of the Main Menu The DAP value that is stored with the stitched FLFS image equals the sum of the corrected DAP values of the partial images On NX software with version Type 22 or older the correction is not applied...

Page 65: ...oblem solving Topics Anatomical stitching is not optimal Stitching fails Not all three DR detector positions are available Full Leg Full Spine DR Retrofit System Problem solving 65 0326A EN 20211014 1141 ...

Page 66: ...n the image is suspicious because of possible movement of the patient during the examination this icon is displayed in the Stitching pane Cause The patient has changed position during the examina tion Brief Solution Manually adjust the DR Full Leg Full Spine image If the partial images cannot be manually adjusted click Cancel in the Stitching pane No DR Full Leg Full Spine image is available 66 Fu...

Page 67: ... grid markers in the stitching grid are not visible in the parti al images Cause The stiching grid was not used for the examination Brief Solution Click Cancel in the Stitching pane No DR Full Leg Full Spine image is available Full Leg Full Spine DR Retrofit System Problem solving 67 0326A EN 20211014 1141 ...

Page 68: ...ight up this indicates that the external collimator cannot reach that position and no exposure can be made in that position Cause The middle position of the external collimator is too low or too high Brief Solution The examination can be continued if only two images are needed If an image is required for the missing posi tion the workflow must be restarted with an adjusted center position 68 Full ...

Page 69: ... Data Topics Full Leg Full Spine wall stand technical data External collimator technical data Remarks for HF emission and immunity Full Leg Full Spine DR Retrofit System Technical Data 69 0326A EN 20211014 1141 ...

Page 70: ...ion 1 2 mm Al According to DIN EN 60601 1 3 with 100kV and HVL 3 6 mm Al FDA 21 CFR 1020 30 n with 100kV and HVL 3 6 mm Al Environmental requirements Room temperature 10 C to 35 C Maximum temperature change 0 5 C min Relative humidity 30 to 75 Atmospheric pressure 70 kPa to 106 kPa Relative altitude 3000 m to 0 m Environmental requirements storage Temperature 20 C to 40 C Environmental requirement...

Page 71: ...wer supply from 100 to 240Vac 10 Class I equipment Connected to earthed supply circuitry only Mains frequency 50 60Hz Current rating Maximum 2A Mains fuse protection Europe min 10A max 16A USA Japan min 10A max 15A Full Leg Full Spine DR Retrofit System Technical Data 71 0326A EN 20211014 1141 ...

Page 72: ... 200 Electrical connection operating voltage 24V DC 1 0A Supplied by the Full Leg Full Spine wall stand Dimensions Width 940 mm Height 1970 mm Depth 580 mm Weight approx 62 kg Expected product lifetime 7 years 72 Full Leg Full Spine DR Retrofit System Technical Data 0326A EN 20211014 1141 ...

Page 73: ...munication services The user might need to take mitigation measures such as relocating or re orienting the equipment Harmonic emis sion in accord ance with IEC 61000 3 2 Class A Voltage fluctua tions flickering in accordance with IEC 61000 3 3 Fulfilled The device is intended for use in a professional healthcare facility environment Environmental conditions are stated in the user manual This devic...

Page 74: ... clini cal environment Voltage break throughs short term interrup tions and varia tions in the volt age supplied in accordance with IEC 61000 4 11 0 Ur for peri od 0 Ur for 1 peri od 70 Ur 30 breakthrough of Ur for 25 peri ods 0 Ur for 250 pe riods 0 Ur for period 0 Ur for 1 periods 70 Ur 30 break through of Ur for 25 periods 0 Ur for 250 periods The quality of the voltage sup ply should corre spo...

Page 75: ...ile radio sets at a safe distance from the device including the leads not closer than the recommended protective distance which is calculated according to the equa tion suitable for the RF emission frequen cy Recommended pro tective distance Conducted high frequency disturbance variables in ac cordance with IEC 61000 4 6 6 V m in ISM fre quency bands be tween 150 kHz and 80 MHz 6 V m in ISM fre qu...

Page 76: ...s and people a The field strength of stationary transmitters such as base stations of radio telephones mobile broadcasts for rural areas amateur stations and AM and FM radio transmitters cannot be precisely predetermined theoretically An investigation of the location is recommended to ascertain the electromagnetic environment as a result of stationary high frequency transmitters If the field stren...

Page 77: ...73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 The distance can be determined through the equation for each respective column P is the rated power of the transmitter in watts W according to the manu facturer information on the transmitter only for transmitters where the rat ed power is not mentioned in the above table REMARK 1 An additional factor of 10 3 has been used to calculate the recommended p...

Page 78: ... Cables transducers and accessories For USA For Canada 78 Full Leg Full Spine DR Retrofit System Technical Data 0326A EN 20211014 1141 ...

Page 79: ...r of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation CAUTION 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 system including cables specified by the manufacturer Otherwis...

Page 80: ...0 0 3 28 704 787 LTE Band 13 17 0 3 9 800 960 GSM 800 900 TETRA 800 IDEN 820 COMA 850 LTE Band 5 0 3 28 1700 1990 GSM 1800 COMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS 0 3 28 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 0 3 28 5100 5800 WLAN 802 11 a n 0 3 9 80 Full Leg Full Spine DR Retrofit System Technical Data 0326A EN 20211014 1141 ...

Page 81: ...nsducers and accessories There are no cables transducers and other accessories in this device which can be replaced by the hospital Full Leg Full Spine DR Retrofit System Technical Data 81 0326A EN 20211014 1141 ...

Page 82: ...ipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the installation manual may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense If required contact your local ser...

Page 83: ...or Canada This class A digital apparatus meets all requirements of the Canadian Interference Causing Equipment Regulations Full Leg Full Spine DR Retrofit System Technical Data 83 0326A EN 20211014 1141 ...

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