SIEMENS = Basic System 2 Memoskop Digital Image Memory 3 Curves and Diagrams 4 Accessories 5 Image Intensifier Laser Aimer 6 Laser Targeting Device on the X-Ray Unit 7 DICOM Bridge 8 Operating Manual Multispot 2000 9 SIREMOBIL Compact L Meer 10 Video Recorder "1 12 0123 13 Short Operating Instructions 14 Supplements 15Please observe Safety operating instructions Order No.: SPR2-130,621.19 These must be studied exactly before system startup. Important information from the manufacturer This product is provided with a CE marking in accordance with the Cc € regulations stated in Appendix II of the Directive 93/42/EC of June 0123, 14th, 1993 concerning medical devices The CE marking applies only to medical products which have been put on the market according to the above-mentioned EC Directive. Unauthorized changes to this product invalidate this declaration The original version of this manual was written in the German languageSIREMOBIL Compact L Overall Table of Contents Operating Manual Overall Table of Contents Register: Lists Chapter: Overall Table of Contents Register: Safety General information Operating safety and satety precautions Checks and inspections Radiation protection Safety information regarding accessories Cleaning and cisinfection Register: Basic System System overview Start-up. ‘System movements: Transport in transport position Overview of operating elements and aisplays Primary collimation and image display Operating modes Technical descrition Register: Memoskop Memoskop C-E, C-E 100, C and C-SUB Digital mage Memory User programs: Selection of menu parameters: Patient directory Patient registration Subwaction operating mode Roadmap operating mode Post-processing subtraction scenes Using he video recorder Technical data 16 18 20 21 12 18 21 4 7 62 SIREMOBIL Compact L SPR2-130.620.03.01.02SIREMOBIL Compact L Overall Table of Contents Register: Curves and Graphs SIREPHOS 2000 SIREMATIC curves kv/mA curves for Digital Radiography (DR} Register: Accessories Spacing device Sterilizable covers for the C-arm Clamps to keep covers in place Grouncing cable (optional Register: Short Operating Instructions Magnetic label Operating Manual ‘SPR2-130.620.03.07.02SIEMENS Operating Instructions SIREMOBIL Compact L Safety ee SPPlease observe Safety operating instructions These must be studied exactly before system startup. The original version of this manual was written in the German language.Safety Tobie of Contents Operating Instructions Safety General Information Using the operating instructions information on the text format Identification of safety warnings ‘Supplements to the operating instructions Values .. Pictograms Proper use of the product Laws and regulations CE Mark... National reguistions Legally required tests Software Data protection Disposal DODAAMAARARROWY Operating safety and safety precautions Installation and start-up Maintenance ... fossnsnnnnese System operation with ine voltage SUpBIY... EMERGENCY STOP . Switch over to emergency power Equipotential bonding Cardiac and cranial examinations Use in connection with high frequency surgical equipment : seo 9 POINtS OF in|UY aneesentntntntnetsenen ———— — seve 10 Collisions : u Malfunctions ..... . : . 12 Malfunctions or error messages ro a 12 Fite POLECLION soe rnrnnetteststntnnnnietinnennenenie = sone 1, Explosion protection 13 Overioad protection «.... eens . : 214 Correct image orientation 16 Correct orientation of image and patient dat .. oe ontarereeseees 15 Electromagnetic compatibility 18 Protecting the system from fluids es — ee @onmovus SIREMOBIL Compact L SPR2-130.621.19.01.02Safety Table of Contents Checks and inspections . 16 Deily checks : ercrenecrnntnniterens 18 Prior to the examination renee Se 16 For cardiac or cranial examinations 16 During the examination Sonninnnnn . 16 Monthly checks 7) Checking the EMERGENCY STOP function for motordriven system movements: wa 7 Radiation protection ..... . . sv ceescenntnee 18 Important points to remember .... . . enrree 18 Location and size of the critical examination region : 19 Maximum scatter radiation in the cftical examination region —— 20 Interrupting radiation for all operating Modes «semen 0 Safety information regarding accessories 0 Combinations with other systems 20 Original accessories 20 Cleaning and disinfection . v2 System parts 21 Monitor Ser@@n oss. . fone serves 22 Keyboard . OD Disinfection oneness . o 7 : 23 ‘Operating instructions 2 enze ‘SPR2-130.621.19.01.02Safety General Information Using the operating instructions Information on the text format These operating instructions include text styles and graphics that make it easier to understand the text The following types of text are used: Instructional text guides you in the proper use of your system. © This text is preceded by a giamond, Lists: 1 This text is preceded by a square Explanatory text reinforces an instructional text or a list with additional points, This text is preceded by 3 dash References refer you to further explanations in another section of your operating instructions im @ separate document. > This text is preceded by an arrow. Notice is used two different ways: refers to safety information which doss not involve immediate danger I contains @ summary of the most important information in a text This text is highlighted in gray. SIREMOBIL Compact L ‘SPR2-130,621.19.01.02Safety Information is text which gives additional, useful explanations. al This text is preceded by the information pietogram and is italicized. Identification of safety warnings ‘Throughout the operating instructions, safety-related information is offset by a black frame and potential hazards are identified as follows Warning Warnings are information provided with special emphasis when there is the po- tential for personal injury to operator or patient Caution Cautions are information provided with special emphasis when there is the po- tential for damage to the equipment. Supplements to the operating instructions ‘© Please note the supplement to the operating instructions made necessary by further technical developments. © These may be found in the Supplement Register. Values All values are typical values unless specific tolerances are indicated Pictograms This pictogram is used to indicate equipotential bonding. Aone Operating Instructions ‘SPR2-130.621.19.01.02Safety Proper use of the product Proper use of this product presupposes that the user has the required training ‘and knowledge of the operating instructions. ‘The operating instructions must be reviewed in detail prior to starting up the sys tem. ‘The installer and operator are responsible for complying with all local regulations regarding the installation and operation of the system. ‘The user must be trained in the proper operation of the product. Instruction is to be repeated at predetermined intervals. We recommend simulating emergency conditions during training so that appro- priate corrective measures can be tought. Laws and regulations CE Mark ‘This product is identified by the CE mark in compliance with regulation 93/42/ EWG of the EEC dated June 14, 1993 pertaining to medical devices. National regulations In all countries, the legally established regulations are to be observed. Values other than those indicated in these operating instructions may be pro- grammed where required by local country-specific regulations. Legally required tests Al legally required tests must be performed at the prescribed time intervals: 2.9, constancy test accarding to the X-ray ardinance (816 ROV) in the Federal Republic of Germany = 8. g. tests based on DHHS guidelines (Department of Health and Human Services) where applicable SIREMOBIL Compact L SPR2-130.621.19.01.02 BozeSafety Software The operating and applications software used in this system is copyright protect ed Only software released by Siemens for this system may be used. Warning Use of unreleased software andlor modifications to software can lead to sys- tem malfunctions which, in turn, may result in injury to the patient andior dam: age to the equipment Data protection Person-specific data is subject to data protection. ‘© Ensure compliance with all applicable laws and regulations, Disposal There may be local regulations governing the disposal of your system. ‘© To avoid environmental damage and/or personal injury, we recommend that, you cansult Siemens customer service prior to removing the praduct from ser~ vice. © Batteries must be disposed of in an environmentally safe manner. (Operating Instructions ‘SPR2-130.621.19.01.02Safety Operating safety and safety precautions Installation and start-up Modifications or upgrades to the system must comply with federal or local regu- lations as weil es generally recognized technical standards ‘As manufacturer, SIEMENS will not be held 1 reliability and performance of the system if ponsible for the safety features, i the system is used in a manner other than that specified in the operating in- structions, installation, upgrades, resetting or repairs are performed by personnel not au- thorized by Siemens. 1D components affecting product safety are not replaced with original Siemens spare parts. 1D electrical wiring in the rooms containing the system does not met the specifi- cations of DIN VDE 0107 or other local regulations. If desired, we will provide the technical documentation regarding the system. However, this does not imply an authorization for repairs to be performed by non Siemens technical personnel We cannot be held responsible for repairs made without our express written con- sent When any work is performed on the system, we would recommend that you ob- tain a certificate indicating the nature and scope of the work performed. The cer- tificate should specify the changes made to nominal data ar the 1ype of work performed, including date, company name and signature. Maintenance In the interest of safety for patients, operators and third parties, itis tecommend- ‘ed that the operating safety and function of the equipment be maintained by in- spections every 12 months. Tests should be performed at shorter intervals ifthe system is subject to above-average use. Service should be performed by trained technical personnel only. If you do not have a service contract, contact Siemens customer service. Ensure compliance with federal or local regulations requiting more frequent in- spections and maintenance, SIREMOBIL Compact L ‘SPR2-730,627.19.01.02Safety Activation: Unlocking: System operation with line voltage supply In case of danger to the patient, operator or system, disconnect the system from the main power source. The entire system will be shut down and taken of thereby 2 shutting off radiation ‘2 interupting the current system program interrupting and deleting current operating sequences deleting all image information not stored on a hard disk. Only after the cause of the hazardous situation has been clearly identified and remedied may the system be reconnected to the line voltage. In all other cases, 2.9. for malfunctions, notify Siemens customer service immediately, EMERGENCY STOP © Please press the red EMERGENCY STOP bution (arrow! on the electronics unit of the SIREMOBIL Compact L basic unit immediately i a dangerous situ ation results from motorized movements, ~ The motorized vertical movement will then be disabled immediately ~ All other system functions are not affected by this Unlock the button only after the danger has clearly been eliminated. ‘© You can unlock the button by turning it gently clockwise. Switch over to emergency power If there is a network interruption longer than 8 msec, the SIREMOBIL can switch off. In this case, the system must be restarted after being switched to emergen: cy power. Boi Operating Instructions SPR2-130.621.19.01.02Safety Equipotential bonding Systems which require eqiotentil bonding may olybe overated in medio Y sires whorothesupsomenta equseterta sordag has o8en etal sndest tc according othe specications n OINSTIGPNDE OT07I6.8 section So the Telvant lal and federal epuatons Cardiac and cranial examinations v @ Ifthe system is used slone or with ether units for cardiac or cranial examine. tions, an additional conductive connection between the unit and a point of po: tential equalization, @.g. the tabletoo, must be made. ‘© Only then should the patient be connected to the device. Use in connection with high frequency surgical equipment ‘The following regulations for use must be observed! Q IECITR 1289-1 / 07.94 High frequency surgical equipment - Part 1: Operation a IEC/TR 1289-2 /08.94/ High frequency surgical equioment - Part 2: Maintenance SIREMOBIL Compact L SPR2-130.621.19.01.02 SezSafety Points of injury Fig 1 W] Points of injury for operators Warning er the When the C-arm is positioned as in Fig, 2, please watch your feet when: C-atm is being lowered. This is important since there is no clearance between the I. and the floor with the C-arm lowered fully (see Fig. 2) For the same reason, please also make sure that the footswitch is not located underneath the |,|, Otherwise maximum lowering of the C-arm could result in contact between the |.|. and the faotswitch, causing accidental release of radiation 9 injury for pati VY Poin Operating Instructions SPR2-130.821.19.01.02 10Safety The high maneuverability of the C-arm may cause the image intensifier or single-tank to collide with the patient or the patient table, when the SIRE! Compact L is nat operated as specified For unfavorable positioning of the unit, collision can also take place between the image intensifier/single-tank and the unit base, This can cause damage to the components affected ‘The system should be moved only manually, by the handles provided for this purpose. Whenever exceptions must be made, note the points of patential injury between the movable system parts and their guide openings. The system areas marked in the drawings indicate points of crushing or impact hazards for the patient or the operator. /OBIL Make sure the brakes are applied after adjusting the C-arm position. Collisions Please take special care when moving or transporting the unit that the system parts do not strike against an obstruction, This could also result in an impairment of the image quality under certain circumstances. SIREMOBIL Compact L SPR2-130.621.19.01.02 MaseSafety Malfunctions If the systern malfunctions, call SIEMENS customer service. Malfunctions or error messages Q All sy During routine operation, the sys sm functions are automatically checked each time the sys sm is continuously monitored. When an error occurs, the system is blocked and the error is displayed on the sys- Temporary error messages e.g. No. 5080, can be removed by pressing any key on the basic system (with the exception of the lifting column and the ony off swite Error messages 6090, 7309 and 7409 are tempor. serve to warn the operator that further use of the system may lead te unnec. essary radiation exposure for the operator and the patient. repeatedly, switch off the system and notify customer service. I errors 0¢ Have the following information ready: Error number Operating mode selected Wes r activated when the er — Is the error related to an operating pr 1D Error messages such as No. 5015 ages are displayed, radiation can n service immediately. ‘be removed. When these longer be released. Notify. (Operating instructions ‘SPR2-130.621.19.01.02Safety Fire protection @ Incase of fire, switch the system OFF and disconnect the system from the power source. ‘© Then immediately activate the on-site emergency shutdown, mains or discon: ect switch, Warning Poisonous gases or fumes can result from a burning or smoldering fire. We recommend that al official satety personnel be instructed in handling fire emergencies in advance. © Please contact Siemens customer service prior to restarting the system, ifthe system requires refurbishing due to fire damage. Explosion protection ]_ The C-arm including the image intensifier and X-ray tube assembly have been de- signed according to the specifications for systems with the Anesthetics test (AP) 2 stated in DIN IEC 601 part 1/VDE 0750 part 1 section 6, and are identified by the symbol {on a green triangle) to the left Warning If the image intensifier housing or single tank generator are damaged, the sys- tem may no longer be operated. LT AP systems may be installed and started-up only by the manufacturer or autho rized third parties. SIREMOBIL Compact L SPR2-130.621.19.01.02 1BazeSafety Overload protection Prolonged continuous radiation at maximum tube load is permissible during fluoroscopy. However, this can cause the X-ray tube assembly to heat up. For this reason, the SIREPHOS X-ray tube assembly has a thermal monitor. If the temperature rises to 2 50°C = the temperature indicator glows on the system operating panel. a selected high contrast characteristic curve is reset when fluoroscopy is completes. — the characteristic curve will be changed from S2toS1 HC2 to HCI 1OD to HCI — the high contrast characteristic curve can be reselected. If the temperature rises to 2 60°C —_ the system will switch to another characteristic curve during radiation release, The characteristic curve will be switched from $2 toS1 HC2 toHC1 IOD to HCI Selection of characteristic curves $2, HC2 and IOD will no longer be pos- sible. If the temperature rises to 2 70°C the temperature display on the system operating console will begin fiash- ing. = Radiation will be switched off and will no longer be possible. the temperature drops back below 50°C — the previously selected curve will automatically be reselected Warning To avoid bums, the tube assembly housing must not come in contact with the patient's skin at a temperature of > 50°C. ‘Operating instructions SPR2-130 621.19,01.02Safety Correct image orientation Correct image orientation on the monitor andlor fim is the responsibilty of the operator. Correct orientation of image and patient data Correct orientation of image and patient data when saving images is the respon- sibility of the operator. Make sure to press the “NEXT-PAT” key and to enter the new patient name prior to beginning work on the next patient. Electromagnetic compatibility This medical device complies with the recommended standard for electromag- netic compatibility (EMC). Please be advised that other mobile electronic devices, e.g. cellular telephones, exceeding the established emissions limits in the EMC standard may disrupt the functions of your medical device. Protecting the system from fluids Do not allow fiuids to enter the system either during normal operation or during cleaning and disinfection as this may damage the system or cause a system mal- function. ‘SIREMOBIL Compact L ‘SPR2-130,627.18.01.02 1B azSafety Checks and inspections Daily checks Prior to the examination ‘The user must check that all safety-related devices are functional and that the system is ready to operate. © Check the function of the foot brakes and the system steering © Check the counter-balance after releasing the brake Visually inspect all indicators and signal lamps, Visually inspect the |.| housing and the housing of the single tank generator, For cardiac or cranial examinations ‘® You have to establish an additional conductive connection between the ‘system and 2 point of potential equalization, e.g. the patient table, prior to the ‘examination, During the examination ‘© Check the patient supports on the patient tabl ‘© When moving the system, remove any obstacles on the floor that may block the wheels. The radiation ON indicator on the system control pane! and the signat lamps on the monitor trolley must glow as long as radiation is activated. Warning Switch the system “OFF” immediately if a live image appears on the monitor or the radiation indicator glows although the radiation release switch is not activated Notify Siemens customer service immediately. 16 aie Operating Instructions SPR2-130.621.19.01.02Safety Monthly checks © Run a check of the automa’ dose rate control This simple procedure will allow you to check ine automatic dose function without an object in the beam path con © Open the iris and slot diaphragms to maximum aperture. © Press the dose rate control “Stop” function © Select 110 kV with the +/- keys Release radiation ~ The monitor image is overexposed © Release the dose rate control “Stop” function © Release radiation ‘The monitor image should t be overexposed. ALkV value of $45 kV must be displayed. Checking the EMERGENCY STOP function for motor-driven system movements: © Switch the system on © Move the lifting column ‘© Press the EMERGENCY STOP button Lifting column movement is not possible © Unlock the EMERGENCY "EMERGENCY STOP” ‘OP button again as described in the chapter SIREMOBIL Compact L SPR2-130.621.19.01.02Safety Radiation protection Important points to remember ‘Automatic dose rate contra! contributes considerably to the reduction of radiation exposure for the patient and the operator. However, please achere tothe folowing recommendations to keep the absorbed dose as low as possible forthe patient © Colimate the exposure field as small as possible {use the slot and irs diaphragms) o Keep the fluoroscopic time as short as possibie 0 Protect the patient using gonadal shields or lead-lined rubber covers when using radiation for examinations near the reproductive organs, ‘Wear protective clothing when working in the examination area Use a radiation monitoring badge or a pen dosimeter Maintain the maximum possible distance from the source of radiation Maintain tne maximum possible facus - skin distance Oo uo Be aware that certain materials can lead to increased dose exposure e., parts of an operating room table) when located in the beam path Operating Instructions SPR2-130.621.19.01.02Safety Location and size of the critical examination region (according to DIN EN 60601-1-3 t : ae CLL | 8 th 2 8 | g eke iAP ! [go —+|-- 35+! -—60——! Vertical beam Focus 170 cm above floor Important examination region Dimensions in em SIREMOBIL Compact SPR2-130.621.19.01.02, DassSafety Maximum scatter radiation in the critical examination region Wem/7" Ul 23.m/9" LA. Wem/7" Uh 23.em/9" Ll. The values are valid for flu characteristic curve and 25 25x16 [em] water phantom, directly a Interrupting radiation for all operating modes The hand and foot switches are designed as push button switches. Radiation is interrupted after the last image is stored when releasing either oper ating element Safety information regarding accessories Combinations with other systems In the interests of safety, only the products / components expressly released by SIEMENS AG, Medica! Engineering Group, may be used with this system. Components that are brought into the beam path (e.g. operating table) will atten uate radiation and degrade image quality Original accessories To ensure product safety, use only original approved by Siemens, ‘The operator is responsible for any damages caused when accessories not ap- proved by Siemens are used ssories 20 Operating Instructions SPR2-130.621.19,01.02Safety Cleaning and disinfection a Warning ‘Switch OFF the system and disconnect the line voltage plug prior to cleaning, Caution Never spray the system with cleaning solutions. Do not allow fluids or cleaning solutions to seep into the system since this may cause damage to the equipment, System parts Al parts coming in contact with patients must be cleaned prior to each use © Clean the parts with a damp cloth '@ For cleaning, use water or a lukewarm solution of water and a commercially availaole cleaner. © Do not use abrasive cleaners or organic solvents or cleansers containing ben Zine, alcohol, spot removers, etc., due to possible material incompatibility ‘SIREMOBIL Compact L ‘SPR2-130.621.19.01.02 DezeSafety Monitor screen Caution Do not use acids or alkaline solutions to clean the screen since this may damage the monitor screen, Monitors with anti-glare, non-reflective surfaces should only be cleaned with a soft cloth, Monitors should be cleaned at least every ‘other month Clean the monitor screen with a cotton cloth dampened with water. ‘© Remove stubbom stains with a mixture of 2/8 water and 1/8 alcohol © Immediately dry aff the monitor sereen with a soft cotton cloth © Wipe off contrast agent spots as soon as possible Keyboard ‘© Wipe off the keyboard with a clean, damp cloth ony. © For cleaning, use @ solution of 2/3 water and 1/3 alcoho! Do not pour the solution onto the keyboard. Operating Instructions SPA2-130.621.19.01.02