AGFA 5522/600 User Manual Download

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WS-Motorized-T-001

5522/600

User Manual

3255F EN 20210312 1125

Summary of Contents for 5522/600

Page 1: ...WS Motorized T 001 5522 600 User Manual 3255F EN 20210312 1125 ...

Page 2: ...iographic wall stand 22 Additional Labeling of the Radiographic Wall Stand 23 Cleaning and Disinfecting 24 Cleaning 25 Disinfecting 26 Disinfecting safety directions 27 Approved disinfectants 28 Maintenance 29 Maintenance of the radiographic table radiographic wall stand and X Ray Tube Head Unit 29 Safety Directions 31 General Safety Directions 31 Radiographic Wall Stand 33 Positioning the Radiogr...

Page 3: ...nt Classification 48 Product Complaints 49 Environmental protection 50 Training 51 Technical Data 52 Wall Stand Technical Data 52 Remarks for HF emission and immunity 54 Immunity to RF wireless communication equipment 59 Precautions on EMC 60 Cables transducers and accessories 61 Maintenance on EMC relevant parts 65 WS Motorized T 001 Contents iii 3255F EN 20210312 1125 ...

Page 4: ...le 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 process disclosed in this docum...

Page 5: ...Introduction to this Manual Topics Scope of this Manual About the safety notices in this document Disclaimer WS Motorized T 001 Introduction to this Manual 5 3255F EN 20210312 1125 ...

Page 6: ...Manual describes the features of the DR 600 System an integrated X Ray imaging system It explains how the different components of the DR 600 System work together 6 WS Motorized T 001 Introduction to this Manual 3255F EN 20210312 1125 ...

Page 7: ...on CAUTION 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...

Page 8: ...hat may appear 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 p...

Page 9: ...ction Topics Intended Use Intended User Applied Parts Operation Controls Installation Radiation Protection Labels Cleaning and Disinfecting Maintenance WS Motorized T 001 Introduction 9 3255F EN 20210312 1125 ...

Page 10: ...quipment and those who have 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 Applied Parts Applied Parts refer to parts of the medical electrical equipment that in normal use necessarily comes into physical contact with the patient for the equipment to perfor...

Page 11: ...is used for positioning of patients standing upright or sitting towards the bucky for exposure Figure 1 Radiographic wall stand with vertical bucky Related Links Radiographic Wall Stand on page 33 WS Motorized T 001 Introduction 11 3255F EN 20210312 1125 ...

Page 12: ...ray tube cover Close to the radiographic wall stand In the operator room Figure 2 Multiple emergency stop buttons are available on the system All motor driven movements will be stopped Motor driven movements Radiographic table Radiographic wall stand Ceiling suspension To allow motorized movements again turn the cap of the emergency switch in clockwise direction default position and restart the sy...

Page 13: ...CAUTION The emergency stop button does not switch off the voltage in the X ray system WS Motorized T 001 Introduction 13 3255F EN 20210312 1125 ...

Page 14: ...ws which DR detector is active and shows its status by means of the nickname of the DR detector An identical label is attached to the bucky of the X ray system to identify the dedicated workspace of each DR detector HF emission and immunity The HF emission and immunity can be influenced by connected data cables depending on length and the manner of installation A specific installation environment ...

Page 15: ...exposure and the material of the object Protective measures have to be taken to prevent exposure through scattered radiation Protective measures include structural configuration of the X ray room e g lead shielded rooms radiation protection for the operators e g personal radiation dosimeters lead aprons radiation protection glasses mobile lead screens keep maximum distance from X ray source regula...

Page 16: ...nment are adequate Inadequate or improper protection can lead to serious damage to the health To measure radiation personal radiation dosimeters are typically used They are worn on the body at all times during working in an environment where X ray radiation is applied They provide an indication for the amount of radiation the operator was exposed to 16 WS Motorized T 001 Introduction 3255F EN 2021...

Page 17: ...cm 55 1 1 1 X ray generator 2 X ray room 3 Patient environment 4 Workstation 5 Operator room protected area Figure 3 Protected area and significant zones of occupancy CAUTION The radiation protection has to be applied to the patient The position of the patient environment depends on the position of the X ray tube If operator or staff needs to be close to the patient during normal use e g some pedi...

Page 18: ...ge 15 Significant zones of occupancy at the radiographic wall stand 140 cm SID115 cm Phantom S1 S2 S S 50 cm 1 2 3 4 2 5 6 7 2 1 8 9 1 X ray tube 2 Focal spot label 3 Significant zone of occupancy Minimum area 60x60 cm Minimum height above the floor 200 cm 4 Dose meter 18 WS Motorized T 001 Introduction 3255F EN 20210312 1125 ...

Page 19: ...ignificant zone of occupancy at the left side of the radiographic wall stand Figure 4 Significant zones of occupancy at the radiographic wall stand CAUTION The radiation protection has to be applied for the patient and for the operator Related Links Radiation Protection on page 15 WS Motorized T 001 Introduction 19 3255F EN 20210312 1125 ...

Page 20: ...facture Manufacturer Medical device Serial number Unique device identifier in text format and in machine readable format The most recent version of this document is available on http www agfahealthcare com global en library index jsp Label Meaning Dangerous voltage Ionizing radiation Pinch Points Risk of stumbling 20 WS Motorized T 001 Introduction 3255F EN 20210312 1125 ...

Page 21: ...and explained in the relevant modules of the System Documentation Topics Warning labels on the radiographic wall stand Additional Labeling of the Radiographic Wall Stand WS Motorized T 001 Introduction 21 3255F EN 20210312 1125 ...

Page 22: ...Warning labels on the radiographic wall stand Figure 5 Warning labels on the radiographic wall stand 22 WS Motorized T 001 Introduction 3255F EN 20210312 1125 ...

Page 23: ...s is a Type B Equip ment Functional earth The bucky can be tilted to horizontal position Do not use the bucky as a seat The maximum load for the bucky movement in vertical direction is 20 kg A pinch point label is located on top of the tilt ing extension Additional pinch point labels are located at the top and at the bottom of the rail in the Wall Stand column Related Links Wall Stand Technical Da...

Page 24: ...xisting universal precautions should be extended to avoid potential contaminations and to avoid patients coming into close contact with the device The user is responsible for selecting a disinfection procedure Topics Cleaning Disinfecting Disinfecting safety directions Approved disinfectants 24 WS Motorized T 001 Introduction 3255F EN 20210312 1125 ...

Page 25: ... only a little moisture Do not spray disinfectants or detergents directly on the equipment Do not pour liquid directly on the equipment CAUTION Do not use solvents such as anhydrous or high solvency alcohols thinner or benzine Do not use any corrosive dissolving or abrasive cleaning or polishing detergents Doing so may damage the surface of the equipment Using unsuitable cleaning agents or methods...

Page 26: ...n damage the device UV disinfection 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...

Page 27: ...ticed due to disinfection contact the medical device manufacturer To disinfect the device Do not use any corrosive soluble or gaseous disinfectants Consult the manufacturer s Material Safety Data Sheets MSDS and recommendations on the product label for additional information prior to use Use of spray disinfection can cause malfunctions due to ingress of the disinfectant into the equipment Disinfec...

Page 28: ...on the disinfectants that have 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 28 WS Motorized T 001 Introduction 3255F EN 20210312 1125 ...

Page 29: ... WARNING Wear of equipment due to excessively long intervals between service may lead to personal injury and property damage due to worn and unsafe parts WARNING Incorrect or defective spare parts may adversely affect the safety of the system and lead to damages malfunctions or total failure Use only original spare parts provided by the manufacturer WARNING Improper changes additions maintenance o...

Page 30: ...ce by the user Check constant smooth movements Daily Check ease of movements Daily Check secure release and locking of brakes Daily Check functioning of operating controls Daily Check markers and warning signs Daily Warm up of X ray tube Daily Check all electric cables and connections for damage or broken cables Weekly Conditioning of the X ray tube After the X ray tube has not been used for more ...

Page 31: ...user must take precautions to protect themselves against dangerous X ray exposure when using the DR Detector in the X ray beam path of an X ray source WARNING The DR Detector is not intended to be used as a primary barrier to X rays The user is responsible for ensuring the safety of the operator bystanders and the subjects being radiographed WARNING Operating the equipment when it is faulty includ...

Page 32: ... warnings cautions notes and safety markings within this document and on the product CAUTION All Agfa medical products must be used by trained and qualified personnel 32 WS Motorized T 001 Safety Directions 3255F EN 20210312 1125 ...

Page 33: ...nd bucky is height adjustable in a large range The wall stand has blue LED in the top that is lit when the radiographic wall stand is selected as active workstation 1 6 8 7 5 2 3 4 1 Wall Stand column 2 Active workstation indicator 3 Bucky 4 Button to switch on the collimator light 5 Front panel 6 Vertical movement handle 7 Tilting extension 8 Tilting handle Figure 7 Radiographic wall stand vertic...

Page 34: ...ightly smaller than the indicated area Check the technical data of the cassette or detector for exact values Automatic centering on the wall stand with the X ray tube not perpendicular to the bucky will cause the laser lines not to coincide with the center marks on the front panel of the bucky because there is a distance between the front panel and the cassette or detector Topics Positioning the R...

Page 35: ...d to avoid them WARNING Be careful not to squeeze your finger or hand Keep your hands at the handles while positioning the system WARNING If the tilting bucky is out of vertical position do not use auto collimation In this case switch the collimator to manual mode When using automatic collimation on a tilting bucky make sure that the bucky is in vertical position Vertical movement To release the b...

Page 36: ...with excessive force to the end stop positions Tilting To tilt the bucky press and hold the button on the tilting handle and move the bucky The scale for the angle is visible at the mounting point of the bucky To lock the bucky into position release the button on the tilting handle Note The bucky can be tilted to horizontal position Do not use the bucky as a seat 36 WS Motorized T 001 Radiographic...

Page 37: ... a configuration with radiographic wall stand with motorization Adjusting the wall stand bucky height drives the X ray tube height Adjusting the height of the X ray tube drives the height of the wall stand bucky Adjusting the alpha rotation of the X ray tube head drives the wall stand bucky height On a configuration with radiographic wall stand without motorization Adjusting the wall stand bucky h...

Page 38: ...ally stopped if the distance between the X ray tube head and the table top would become too small less than 10 cm The lock button controls the behaviour of the position tracking after the exposure is made Table 4 Locking the position tracking Position tracking is not active for the next exposure It can be activated again by pressing the position tracking but ton Position tracking is kept active fo...

Page 39: ...perly attached to the system can lead to hazardous situations and injury Use only original accessories provided by the manufacturer Topics Patient hand grips Mounting the lateral arm rest Spacer Wall stand fixation kit WS Motorized T 001 Radiographic Wall Stand 39 3255F EN 20210312 1125 ...

Page 40: ...nd are mounted fixed at the backside of the bucky The patient uses these grips for stabilization and support of correct correct positioning e g for chest exams Figure 9 Patient hand grips 40 WS Motorized T 001 Radiographic Wall Stand 3255F EN 20210312 1125 ...

Page 41: ...e wall stand column To mount and position the lateral arm rest 1 Insert the lateral arm rest on the left or on the right side of the bucky frame 2 Grip the lower part of the lateral arm rest 3 Pull the lateral arm rest forward 4 Adjust the angle 5 Move the lateral arm rest back to fix the position 1 3 4 5 2 Figure 10 Lateral arm rest Movement of the X ray tube head is restricted in the neighbourho...

Page 42: ... The spacer allows examination of sitting patients by offering additional space to position legs and feed under the bucky Figure 11 Spacer 42 WS Motorized T 001 Radiographic Wall Stand 3255F EN 20210312 1125 ...

Page 43: ...d an additional fixation of the radiographic wall stand is provided The kit is installed at backside of the radiographic wall stand under the head cover and then fixed to a wall It has to be installed by service WS Motorized T 001 Radiographic Wall Stand 43 3255F EN 20210312 1125 ...

Page 44: ...pics Compatibility Compliance Equipment Classification Product Complaints Environmental protection Training Technical Data Remarks for HF emission and immunity 44 WS Motorized T 001 Product Information 3255F EN 20210312 1125 ...

Page 45: ...carried out by persons authorized to do so by Agfa Such changes must comply with best engineering practice and all applicable laws and regulations that have the force of law within the jurisdiction of the hospital Compliance The system is compliant with specific directives and standards Topics General Safety Electromagnetic Compatibility X Ray Safety X Ray Accuracy Environmental Compliance Biocomp...

Page 46: ...ned to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment 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 i...

Page 47: ...m fulfills the X ray radiation accuracy according EN IEC 60601 2 54 with a variation of max 0 05 5 Environmental Compliance European Council Directive 1907 2006 REACH European Council Directive 2011 65 EU RoHS 2 European Council Directive 2012 19 EU WEEE Biocompatibility EN ISO 10993 1 Usability IEC EN 62366 IEC EN 60601 1 6 WS Motorized T 001 Product Information 47 3255F EN 20210312 1125 ...

Page 48: ...ric shock particularly regarding allowable leakage cur rent and reliability of the protective earth protec tion Water ingress IP10 This device does not have protection against in gress of water Cleaning See section on cleaning and disinfecting Disinfection See section on cleaning and disinfecting Flammable anesthetics This device is not suitable for use in the presence of a flammable anesthetic mi...

Page 49: ...tries with identical regulatory regimes Regulation 2017 745 EU on Medical Devices if during the use 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 Septes...

Page 50: ...ation and or dealer The recycling of materials will help to conserve natural resources c2 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 documents m...

Page 51: ...The user must make sure that training is received in accordance with local laws or regulations that have the force of law Your local Agfa or dealer representative can provide further information on training The user must note the following information in the system documentation Intended Use Intended User Safety Directions WS Motorized T 001 Product Information 51 3255F EN 20210312 1125 ...

Page 52: ...g handles 825 mm with patient hand grips Depth 640 mm 990 mm with spacer Height of detector center 33 5 to 185 cm Angle of the detector 20 to 90 Minimum height of the bucky sur face in tilted horizontal position 72 cm Distance between front panel and detector 50 mm Front panel attenuation equivalent mm Aluminum 0 7 According to DIN EN 60601 1 3 with 100kV and HVL 3 6 mm Al 52 WS Motorized T 001 Pr...

Page 53: ... 106 kPa Environmental Conditions during normal operation Temperature ambient between 10 and 35 Celsius Humidity non condensing between 30 and 75 relative humidity Atmospheric pressure between 70 and 106 kPa Maximum altitude 3000 m For overall system environmental conditions the environmental conditions of the DR Detector or image plate should be taken into account Refer to the related User Manual...

Page 54: ...nly This device may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as re orienting or relocating the device or shielding the location WARNING The HF emission and immunity can be influenced by connected data cables depending on length and the manner of installation This device is intended for operation in the electromag...

Page 55: ...scharge Floors should consist of wood concrete or ceramic tiles The relative humidity must be at least 30 if the floor is made of synthetic material Fast transient electri cal disturbance varia bles bursts in accord ance with IEC 61000 4 4 2 kV mains 1 kV data lines The quality of the voltage supplied should correspond to a typical commercial or clinical environment Impulse voltages surges in acco...

Page 56: ...t level of professio nal medical equipment and basic EMC stand ards Electromagnetic En vironment Recommended pro tective distance Conducted high frequen cy disturbance variables in accordance with IEC 61000 4 6 3 V 150 kHz to 80 MHz 6 V within ISM bands Radiated high frequency disturbance variables in accordance with IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz RF communication Refer to the section Im mu...

Page 57: ... maximum output power of the communications equipment See also the section with precautions on EMC Recommended Protective Distances between Portable and Mobile High Frequency Communication Equipment and the Device Rated Power of the Transmitter W Protective Distance in accordance with RF emission Fre quency m 150 kHz to 80 MHz d 1 0 80 MHz to 800 MHz d 0 3 800 MHz to 2 7 GHz d 0 3 0 01 0 1 0 05 0 ...

Page 58: ... Cables transducers and accessories Maintenance on EMC relevant parts 58 WS Motorized T 001 Product Information 3255F EN 20210312 1125 ...

Page 59: ... FRS 460 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 WS Motorized T 001 Product Information 59 3255F EN 20210312 1125 ...

Page 60: ... are operating normally 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 system including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result WARNING The DR detectors might be interfered with by other equipment 60 W...

Page 61: ...le cable lengths are 16 m 20 m and 24 m CR Gen StC type maximum length m remark Mini Console 10x AWG26 30 20 m basic wiring 10 m extension allowed COM A 3 x AWG24 9p D SUB BU BU 20 Basic wiring Attention Cross Link COM B Standard RS 232 cable 9 Pin D SUB 20 Basic wiring LAN Connectin to the system CAT 5e SF UTP or F UTP 20 Basic wiring Positioning Control Box without ME func tionality 4 x AWG20 20...

Page 62: ... Basic wiring AEC CAT 5e SF UTP or F UTP 20 Basic wiring Sync 1 2 Cable Varian 8 x AWG26 16 Customized wiring PIN 9 NC Image Data Line Cable CR_PC_NIC WS Bucky direct wire CAT6 40 Customized wiring di rect wire Point to Point Extension not al lowed TP_WS StC type maximum length m remark ME ES Signal 2 x AWG22 20 Basic wiring for DR 600 WS Positioning Control Box 4 x AWG20 20 Basic wiring for DR400...

Page 63: ...G10 20 Basic wiring for DR 400 600 WS AEC CAT 5e SF UTP or F UTP 20 Basic wiring for DR 400 600 WS Sync 3 4 Cable Var ian 8 x AWG26 20 Customized wiring PIN 9 NC Image Data Line Cable CR_PC_NIC WS Bucky direct wire CAT6 40 Customized wiring direct wire Point to Point Extension not allowed CS StC type maximum length m remark ME ES Signal 4 x AWG22 20 Basic wiring CAN Signal 3 x AWG22 20 Basic wirin...

Page 64: ...WG10 20 Basic wiring LPB 2 x AWG22 20 Basic wiring LAN for THU CAT6 Energy chain 20 Basic wiring HV 1 2 3 x AWG16 20 Basic wiring Control cable for X ray tube 7 x AWG16 20 Basic wiring DAP 4 or 7 x AWG26 20 Basic wiring shielded 64 WS Motorized T 001 Product Information 3255F EN 20210312 1125 ...

Page 65: ... parts could be inspected by the operator EMC relevant parts will be inspected from AFGA service engineer within the regular service interval until the end of lifetime The needed verifications are described in the service manual WS Motorized T 001 Product Information 65 3255F EN 20210312 1125 ...

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