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Lotus Max System Safety

This job aid covers system safety with the Lotus Max system.

Lotus Max: System Safety LUMINOS Lotus Max Table of content 1. General safety information ................................................................................................................. 3 1.1. Trained users ..................................................................................................................................... 3 1.2. Pictograms ........................................................................................................................................ 3 1.3. Laws and regulations ......................................................................................................................... 4 1.4. Explosion protection .......................................................................................................................... 5 1.5. Fire safety ......................................................................................................................................... 5 1.6. Information about the software .......................................................................................................... 6 1.7. Checks, tests ..................................................................................................................................... 8 1.8. Error messages and status indicators ................................................................................................... 9 2. Personal safety measures ................................................................................................................... 9 2.1. Warning signs .................................................................................................................................... 9 2.2. Information about unit movements .................................................................................................... 9 2.3. Danger of crushing .......................................................................................................................... 12 2.4. Abnormal movements ...................................................................................................................... 12 2.5. Dead man´s grip .............................................................................................................................. 12 2.6. Collision protection .......................................................................................................................... 12 2.7. Red emergency STOP buttons ........................................................................................................... 12 2.8. Emergency SHUTDOWN button (installed on-site) .............................................................................. 15 2.9. Power failure ................................................................................................................................... 16 2.10. Implanted devices ............................................................................................................................ 16 2.11. Maximum weight ............................................................................................................................ 16 2.12. Equipment damage.......................................................................................................................... 18 2.13. Danger zones/danger points ............................................................................................................. 20 2.14. Grip locations .................................................................................................................................. 25 2.15. Safety during patient examination .................................................................................................... 26 2.16. Radiation protection ........................................................................................................................ 31 2.17. Reducing radiation with C.A.R.E. ....................................................................................................... 38 2.18. Information about dose measurement .............................................................................................. 39 3. General safety information ............................................................................................................... 43 3.1. Protection against electric shock ....................................................................................................... 43 SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Healthineers Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 3.2. Electromagnetic compatibility (EMC) ................................................................................................ 44 3.3. Maintenance plan ............................................................................................................................ 45 3.4. Combination with other products/components .................................................................................. 51 3.5. Installation recommendations .......................................................................................................... 53 3.6. Installation, repair, or modifications .................................................................................................. 53 3.7. Cleaning and disinfection ................................................................................................................. 54 3.8. Product service life .......................................................................................................................... 58 3.9. Disposal .......................................................................................................................................... 58 SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 1. General safety information The organization responsible for the safety of the medical device according to IEC 60601 ff. is the user or the operator/operating company of the device. H. 1.1. Trained users CAUTION Operation of the system by untrained users Risk of incorrect diagnosis or treatment due to misinterpretation of image information  The system must only be used by persons with the necessary specialist knowledge, for example, physicians, trained radiologists, or trained technologists, after an appropriate application training. 1.2. Pictograms Alternating current Equipotential bonding Caution: Read Operator Manual Caution: Laser SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Pushing prohibited Off O. On Attention: Hot surface (at the X-ray tube) SSS Degree of protection type B 1.3. Laws and regulations The statutory regulations of the respective country must be followed. If legally binding regulations govern the installation and/or the operation of the product, it is the responsibility of the installer or the operator to observe these regulations. Modifying the medical product is not permitted. Country-specific regulations The legally established country-specific regulations must be followed in all countries. Deviating from this Operator Manual, values may be set according to country-specific regulations. Regulations in the EU Due to the Medical Device Directive 93/42/EWG, LUMINOS Lotus Max complies with the standards of the EN 60 601-1 series. Additional national regulations SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 To ensure safety for operators, patients, and third parties, we recommend compliance with the regulations listed here to the extent that local national laws allow. USA and Canada Corresponding to the Medical Device Directive in the EU, LUMINOS Lotus Max complies in the U.S.A. and Canada with the applicable standards. Federal law stipulates that this system may only be sold to a physician or by order of a physician. This system is intended for use in radiographic and radioscopic examinations and under the guidance of a trained health care professional. 1.4. Explosion protection LUMINOS Lotus Max is not designed for operation in explosion-endangered areas. CAUTION The system is not designed for operation in explosion-endangered areas. It does not fulfill the requirements for AP/APG classification. Danger of explosion!  Do not use the system where explosive atmospheres can arise. AP Only products with the AP mark (AP = anesthetics test) may be used in explosion-endangered areas. 1.5. Fire safety In the event of a fire 1. Shutdown the entire system immediately, that is, disconnect the system from the main power supply. 2. Press the emergency SHUTDOWN button or actuate the main or disconnecting switch. 3. Use a CO2 fire extinguisher. Do not use water! H. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 CAUTION Fire inside or in the vicinity of the system Risk of injury of patient and personnel and damage to property. Risk of inhalation of fumes from burning plastic.  Switch off the system in the event of fire.  Help the patient to escape from the system.  Make sure that you know where the escape routes are.  Make sure that you know where the fire extinguishers are located and familiarize yourself with the use of them. 4. Contact Customer Service before performing any refurbishing work and before starting the system up again. 1.6. Information about the software Network security CAUTION Unauthorized access to the system Hazards up to and including loss of patient data and non-operational system  The hospital/clinic is responsible for network security at the site.  Set up firewalls and user account password protections.  Do not allow users to change configuration files.  Update virus protection software as required. Please Note: The following are changes to the network that may introduce new risks:  Network configuration change;  Connection of additional systems or equipment to the network  Disconnection of systems or equipment from the network  Update or upgrade of equipment connected to the network Please note the following information relating to cybersecurity:  Appropriate physical access controls shall be implemented  Cables shall be protected from interception, interference, and damage  Maintenance and inspection of devices shall only be carried out by authorized personnel SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054  External personnel who perform maintenance or service work shall be accompanied at all times  Devices shall be secured with physical locking cables or securely locked away  The system shall lock down automatically or terminate the session after exceeding a reasonable defined idle time limit  Applications shall log off the user or terminate the session after exceeding a reasonable defined idle time limit  Malicious software shall not be created, downloaded, or distributed on purpose  User accounts shall only be assigned to and used by individual persons  For each account a different password shall be used  IP addresses assigned to systems shall be logged  Device log data shall be continuously analyzed  Device log data shall be stored for a reasonable time period  Devices shall be placed in network zones which fulfill and are appropriate for their information security requirements  The system must be used by persons with necessary specialist knowledge after training supplied by Siemens Healthineers Representative  The hospital is responsible for authorized access to the system  We recommend installing the system in a separate examination room with a door controller  The system can be connected to the internal network. The hospital is responsible for network security at the site  The Device Guard built into Windows 10 is used to prevent unauthenticated software from being executed in the system  The firewall built into Windows 10 is used to block network connections through illegal ports  The security service is used to encrypt/decrypt important files  The corespot service is used to enhance the security of the operating system  Normal users shall use a unique ID and password to log into the system  The system allows access in a special mode without authentication to enable examination in the event of an emergency. For this special mode no password is set  The system has basic requirements on the length/complexity/expiry time of the password  The system predefines several user roles, and users can only access the functions defined in their roles  The system has been tested before its launch, making sure that there are no software security vulnerabilities.  The major 3rd party software used by the system has been registered to the Siemens Healthineers SVM service to monitor security vulnerabilities that may be found in future.  Siemens Healthineers will analyze vulnerability notifications from SVM in a timely manner and take appropriate measures according to their severity.  Siemens Healthineers will provide timely patches or mitigations for serious software security vulnerabilities. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054  Siemens Healthineers releases a security patch for the system regularly (90 days) to repair general security vulnerabilities. Third-party software Only software authorized by Siemens Healthineers for use with this product may be used. CAUTION Use of unapproved or manipulated software or hardware components Risk of malfunctions posing a hazard to patients and equipment  Only use software or hardware components approved by Siemens Healthineers.  Perform repairs only with our expressed written approval. Software installed inside the Virtual Workstation is exempt from this rule. H. Copyright The system and user software used in this product is protected by copyright. DICOM conformity The digital imaging system is DICOM-conform. The “DICOM Conformance Statement” is available on request from Siemens Healthcare or via the Siemens Healthineers Internet homepage. Data security Personal data are subject to data protection.  Please observe the relevant legal provisions. 1.7. Checks, tests Before the system is used for examinations, the user must ensure that all safety-relevant devices function correctly and that the system is ready for operation. Important functional tests and checks must be made at certain time intervals. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 1.8. Error messages and status indicators The system displays warnings and error messages as well as information about current system status on the screen. It gives information on how to proceed in each situation. For further details, refer to the Operator Manual of the FLUOROSPOT Compact imaging system. 2. Personal safety measures 2.1. Warning signs Special danger points are marked on the unit with a warning sign: Danger of crushing These warning signs indicate possible danger of crushing for the patient and examiner. Cardiopulmonary resuscitation This warning sign shows the position of the patient table in cardiopulmonary resuscitation (CPR) with pressure compression up to 500N (50 kg). Risk of collision However, under certain circumstances, additionally installed components, for example lead protective screens, lamps, auxiliary equipment, and so on, can cause collision with the system. To protect these components and to protect the patient, such components are provided with the warning sign shown on the left. We can provide you with these warning signs. Customer Service will also attach them to additionally installed components on request. General danger Caution always observe the Operator Manual! This warning notice indicates that special instructions can be found in the Operator Manual. Please read the Operator Manual. 2.2. Information about unit movements Because of the possible speed of movement of the system, it must be operated with particular care. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Unit movements should be started only if neither a patient nor a third party may be endangered and if no object may hinder unit movements. However, if an object (for example seat) was hindering a movement direction (for example, during a down movement) or the height of the detector unit or the X-ray tube H. was manually readjusted, the alignment control must be readjusted. If this alignment is not performed, no acquisitions are possible! CAUTION System movements cause collision. Risk of injury or system damage  Perform system movements only when it is certain that neither the operator, the patient, third parties nor pieces of equipment can be endangered by these movements.  Remove any objects or accessories, for example injector or infusion stand, from the collision area.  Make sure you are standing outside the dangerous area.  Always watch the patient when performing system movements. CAUTION Touching the telescoping column during movement. Risk of crushing  Do not place your hands on moving or rotating parts.  Use the provided hand grips to move ceiling-suspended parts.  Whenever this is not possible, pay special attention to all crush zones on the column especially those involving the hands or fingers. CAUTION SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Movement without intentional activation of control elements. Risk of collision, risk of injury to patient or operator, risk of damage to the system  If movement does not stop, press the nearest emergency STOP button. WARNING Movement without intentional activation of control elements. Risk of collision, risk of injury to patient or operator, risk of damage to the system  Do not load the remote console with any objects, accessories, folders, or documents.  If movement does not stop, press the nearest emergency STOP button. WARNING Unintentional activation of control elements for movements. Collision of tube with patient, operator, or equipment when table is in vertical position  Observe the workflow for free exposure:  Select Acq. mode: free exposure  Rotate tube  Tilt stand and move to correct SID  Position the patient under the tube  Check patient and stand  Do not let patient stay in stand area during absence of operator SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 2.3. Danger of crushing The patient and operating personnel must use only the handles which are intended for the proper handling of the equipment or positioning of the patient. Where it is not possible, you must pay attention to possible risks of injury by crushing in the vicinity of moving parts. 1. Pay special attention to the risks of crushing fingers and hands between moving parts and their guide openings. 2. Before performing unit movements, make certain that the patients do not grasp the frame of the tabletop. 2.4. Abnormal movements If any part of the system moves although movement was not released, there might be a fault. Example: The ceiling-suspended X-ray tube moves down by itself.  Shut down your system and call Customer Service. 2.5. Dead man’s grip All unit movements are controlled with a dead man's grip (DMG), that is, movements are performed only while the operating element is being actuated. In the event of danger, the movement can be stopped immediately by releasing the operating element. 2.6. Collision protection The LUMINOS Lotus Max system has a collision control device comprising all motor driven moving components like tube support, detector support, tabletop and wall stand. Attention: When clinical protocols are used in which the tube was programmed in the collision zone of the table, collisions of the tube and the table are possible. Never leave the system unattended during system movements. H. 2.7. Red emergency STOP buttons Triggering STOP STOP If a malfunction of a unit movement causes an emergency, danger to the patient, to operating personnel, or to the unit, do the following: SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054  Press one of the red emergency STOP buttons immediately. All system drives are shut down and movements are stopped immediately. Movement can only be continued when STOP is canceled. Radiation, fluoroscopy, and acquisition are interrupted, but can be released again if you press the fluoroscopy or exposure release pedal again, even without canceling STOP. Injections are interrupted but can be continued without canceling STOP. Canceling STOP Only when the cause of the danger has been unequivocally identified and remedied, can the emergency STOP button be disengaged.  To do so, turn clockwise and pull the red emergency STOP button. In case of a system failure, press the emergency STOP button and unlock it again. The system is reinitialized. H. Where are the emergency STOP buttons? You find the emergency STOP buttons in the following locations: STOP STOP On the unit SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 STOP tr # SIEMENS. Healthineers .. " On the remote-control console STOP On the wall stand (The emergency STOP buttons are located at both sides of the wall stand.) SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 2.8. Emergency SHUTDOWN button (installed on-site) Use this shutdown method only in an extreme emergency because it is an uncontrolled process! Consequences:  All unit movements are interrupted.  Radiation is turned off.  The current system program is interrupted.  Current operating sequences are interrupted and cleared.  All current acquisition data are cleared unless they have been saved to nonvolatile memory. Data could be lost, for example unsaved images, exporting and filming jobs, and so on. The tube cooling system is also disconnected from the power supply, and the tube can overheat. If a flat detector is used, it is also disconnected from the power supply. After the power has been switched on again, an additional waiting time is required to ensure optimum image quality. An emergency power supply, if one is connected, will not be activated when emergency SHUTDOWN is pressed. The UPS of the imaging system is also not activated. H. Shutdown in an emergency Only exclusively if there is danger for patients, operators, third parties or the unit: CAUTION Shutdown using the emergency SHUTDOWN button (if installed) Risk of data loss and/or damage to tube due to lack of cooling  Use the emergency SHUTDOWN button only in case of emergency or when the system cannot be switched off normally.  Press the on-site emergency SHUTDOWN button. The entire system is disconnected from the power supply. Switching on again Only if the cause of the danger has been unequivocally identified and remedied, the emergency SHUTDOWN button can be released, and the system operated again. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 1. In all other cases, for example system malfunction, contact Customer Service. 2. If the stop function does not respond normally, immediately activate an emergency shutdown to turn off the entire system. If this happens, you may not continue to use the system. Contact the Customer Service. 2.9. Power failure If the power network at the site is very unstable, it may be advisable to install an uninterruptible power supply to prevent data loss. Contact Siemens Healthineers for more information. H. With UPS for imaging system (Uninterruptible Power Supply) 1. In case of a short power failure, please try to switch on the system after some seconds. 2. If it was possible to switch on the system, please wait until the system is ready. 3. Then continue working or rescue the patient. 4. If it was not possible to switch on the system or if the patient has collapsed, remove the patient immediately. 2.10. Implanted devices WARNING Examination or treatment of patients with implanted devices such as pacemakers or neuro- stimulators External influences (e.g. during pulsed fluoroscopy) can cause malfunctions in the implanted device.  Find out whether there are known external influences upon the implanted device by the X-ray system (e.g. by checking the technical data or the operator manual of the implanted device). 2.11. Maximum weight CAUTION SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Too much weight on system components Risk of damage or patient injury  Observe the maximum allowable patient weight including the weight of the accessories. The permissible patient weight with which you can load your tabletop is max ... kg stated on the label on the tabletop and in the technical data. It is important that the load is distributed uniformly over the tabletop. Otherwise there is a risk of material deformation and system malfunction. The patient weight includes any parts permanently or loosely connected with the patient, such as equipment, prostheses, implants, plaster casts. Example of incorrect use with uneven weight distribution: A patient with a maximum weight sitting at the end of a fully extended tabletop. Accessory load In addition, 30 kg can be attached to any accessory rail or to all accessory rails in total. This value includes all accessories, for example injector and radiation protection devices! In the interest of safety of operation for the patient and unit, the permitted patient weight and accessory weight must not be exceeded. Maximum load 25kg The component, for example tabletop or accessory, must not be loaded with more weight than indicated. Approved loading of the tabletop All technical specifications represent typical values unless specific tolerances are provided. Patient Performance figures and restrictions up to 150 kg  Full speed 150 - 180 kg  All movements possible  All speeds reduced up to 20% Restriction of movement range:  Table longitudinal ± 40 cm  Table transverse: between center and ± 7.5 cm (operator side) SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Restriction for patient position:  Patient prone or supine position, centered on the table 180 - 230 kg  Table-tilt -15°/+90°; reduced speed  Lift range not limited, reduced speed  Tabletop: Centered in both directions; no movement allowed Restriction for patient position:  Patient prone or supine position, centered on the table 230 - 300 kg  Table tilt -15°/+45°; reduced speed.  Tabletop: Centered in both directions; no movement allowed  Table height adjustments are possible with reduced speed.  Restriction for patient position:  Patient prone or supine position, centered on the table 300 kg  Maximum patient weight Approved loading of the footrest This warning sign indicates that the footrest can be loaded with a maximum max. 230kg weight of 230 kg. All technical specifications represent typical values unless specific tolerances are provided. Patient Performance figures and restrictions Up to 150 kg  Table tilt: -90° to +90°  Patient must be secured with shoulder supports and foot holder ≤ 182 kg  Table tilt: -45° to +90°  Patient must be secured with shoulder supports and foot holder ≤ 230 kg  Table tilt: -15° to +90°  Patient must be secured with shoulder supports or foot holder 2.12. Equipment damage WARNING - SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Collision causes damage to system Injury of persons  Report severe collisions to Siemens service so that the system can be inspected. Avoiding equipment damage 1. Before starting system movements, especially lowering, and tilting the table, make sure that the movement range is free of obstructions. 2. Move monitor support systems, operating consoles, gurneys, beds, and instrument tables out of the tilting range of the table. 3. Remove chairs, steps, stands, waste containers, and similar objects from the movement area. (No collision monitoring.) 4. Do not place any objects or consumable material on the cover of the table support, on the detector cover and on the longitudinal guides of the stand carriage. Considerable forces which can damage these objects in the area of movement of the systems occur during movements of the tabletop. 5. Do not place any loose objects anywhere on the table. These objects could fall when the table is tilted, causing injury or damage. 6. Do not stand at any place on the covers of the table support. The covers can be deformed. Components located underneath them can be damaged and thus lead to operating disturbances. 7. Do not place any objects on the operating areas of the control consoles and the tableside control. Do not place folders next to the operating area of the control consoles and next to the tableside control. Folders falling might cause unwanted system movements. H. 8. In vertical table positions do not use the following system parts as a seat or support:  Stand column  Tube assembly support arm  Tube assembly cover  Primary collimator  Compression device. This unallowed loading can lead to material breakage and damage to bearings. 9. Do not place contrast medium cups or open containers with liquid or pasty contents on the unit, on the remote console or on the control cabinets. Contrast medium can spill, leak, or overflow into system parts and lead to operational disturbances of the unit or to misinterpretation of exposures. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 10. When storing contrast medium in the cup holder on the compression carriage, use only cups with a maximum volume of 0.25 liters. Use only cups made of unbreakable material, that is under no circumstances glass or porcelain. 11. Remove contrast medium traces immediately! 2.13. Danger zones/danger points The positions marked in the following illustrations show danger zones in which patients or operating personnel could suffer injury by crushing or colliding:  Due to the mobility of the stands, there is a danger of injury in certain areas during unit movements.  Make sure that there are neither persons nor objects in the swivel or rotation range of the stands.  Make sure that there are neither persons nor objects in the lifting and rotation range of the patient table.  Make sure that the knees of sitting staff members are not in an area under a stand or the patient table.  Avoid standing or sitting immediately adjacent to the system.  If it is necessary to position the patient with legs or knees under the crossbeam at the head or foot end of the table, avoid system movements.  Make sure that, during system movements, no one is in the area between unit base and table.  Be careful when working with the attached footrest. There is a risk of collision with the extended cone when the tabletop and/or the – longitudinal carriage are moving.  Be aware of the danger zone between patient table and detector tray. WARNING Unintended overtravel when tilting or lowering the table Crushing of patient or operator seated next to the table (for example, a wheelchair patient)  Avoid movements when somebody is within the dangerous movement zone.  Table movements do not stop immediately when the control elements are released.  Most axes perform a short overtravel movement. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Danger points Risk of injury by crushing or collision = ..... Unit in horizontal position SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Unit in vertical position - between -90° and +90° If the patient is in the danger zone, always make sure that the operating personnel is in the room and within reach of an emergency stop. If the operating personnel leaves the room or moves out of reach of an emergency stop, the patient must be moved out of the danger zone. User is working directly at device during lift or tilting movement. At the point where the distance to the floor is lower than 12 cm, the user can be injured, for example, on the foot. H. H. Additional danger zone SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 O O O OO Examinations with patient sitting on the footrest WARNING - Downward movement of tube assembly during examinations with patient sitting on the footrest. Danger of crushing the patient (knee, hand) with the compression unit  Pay special attention to the danger zone (1) between the compression unit and the sitting patient. Tube support O O SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Wallstand -Tf- Pay attention to squeezing between floor and front unit. Downward movement stops at 12-cm distance to floor. Movement can be reactivated with slower speed. H. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 CAUTION Lowering the detector of the wall stand onto a seated patient Crushing of patient seated with legs under the detector (for example, a wheelchair patient)  Do not move the detector while a patient is seated near the wall stand.  Move the patient away from the wall stand first. Wallstand with pulled out detector/cassette tray 7 O O 0 r 2.14. Grip locations When handling the system correctly and when positioning the patient, operators, and patients must use only the grip locations provided for this purpose. H. The following grip locations are provided:  One hand grip rail (front or back)  Two hand grips (front and back)  One protection strip (at the head end) SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Grip attachment  Make sure that the hand grip rail, the hand grips, and the protection strip are always attached. Please Note: If these grip locations cannot be used:  Pay special attention to the mentioned possibilities of crushing between moving parts and their guide openings.  Make sure during the examination that the patient does not hold on to the edges of the patient table under any circumstances. 2.15. Safety during patient examination Patient positioning  All safety-related equipment must be installed and functioning. The hand grip strip, protection strip, hand grip, footrest, foot holder, compression belt, and shoulder support.  The hands, arms, legs, head, and hair of the patient must not extend unsecured beyond the edge of the tabletop.  Observe the patient while moving the tabletop and during system movements and take care that any catheter is correctly located.  In examinations with the table tilted up vertically, the footrest serves for an adjustable step or seat.  Make sure that the footrest is locked together with the tabletop on both sides.  Check the firm location of the footrest. WARNING Hand grips loosen or are not used Injury of patient due to falling  Check that the patient hand grips on the table are in the right position.  Ensure that hand grips are tightened prior to use.  Make sure that the patient uses the hand grips during system movements or when turning over.  Use other positioning aids for immobilizing weak or very unstable patients. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 CAUTION Hair, clothes and tubes or cables caught in table. Risk of patient injury  Make sure that hair, clothes and tubes or cables cannot be caught in the table before initiating system movements.  Press emergency stop immediately if something gets caught. Patient positioning with unit in vertical position During examinations with the unit in the vertical position, there is a risk of crushing to the patient if the X-ray system (stand with tube unit and receptor unit with flat detector) is moved longitudinally. 1. Position the X-ray system in the approximate acquisition position. 2. Move the patient to the acquisition position. 3. Set the X-ray system to object height. Always watch the patient during this movement. Motor-driven remote compression  Take special care for the applied compression forces, especially in the case of sick, elderly, and frail patients (for example, infants).  There is an increased risk of crushing and injury for the patient.  Furthermore, there are considerable mechanical shearing forces with risk of damage between the compression cone and attached accessories by collision during the motor- driven tabletop movement. Safety device SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 (1) Switch rail between tabletop and stand On activation of the safety device (shutdown device), all system movements stop and are blocked. If it is not possible to remove the obstruction causing the problem, call the Siemens Healthineers Uptime Services. Movements are possible again only after the safety device has been deactivated. Patient rescue In case of, for example power failure, motorized system movements are not available. However, you can move parts of the system manually. CAUTION Patient is caught between compression cone and patient table during a power failure Risk that the patient cannot be removed from the patient table.  To rescue or release the patient from the system, proceed as described in the following. During the following steps, make sure that the patient is not crushed! H. Personnel  Use enough personnel for the rescue. Accessories  Remove any accessories obstructing the rescue. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 If the patient is compressed with the cone 1. Press down the hinge and hold the cone at the same time. The cone will spring back from the patient. 2. Take care that the hinge does not press into the side of the patient after it releases. If shoulder supports or foot holder are loosened in Trendelenburg position, then take care that the operating personnel secure the patient sufficiently. Get the aid of sufficient personnel for the rescue of the patient. H. Immobilization WARNING Table tilted in Trendelenburg (head-down) position Patient slides off table head-first  Use shoulder supports to prevent the patient from sliding off the table.  If the table must be tilted more than 15° Trendelenburg (head-down), use the foot holder in addition to the shoulder supports.  Loosen any fixtures. Mattress In difficult cases, you may have to rescue the patient along with the mattress. 1. Lift the mattress at the foot end to unfasten the hook and loop fastener or velcro fastener. 2. Put some paper or cloth between tabletop and mattress so that the Velcro does not fasten again. 3. Unfasten safety straps, if applicable. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 4. Pull the mattress with the patient from the tabletop at head end or foot end of the table (depending on room situation and accessibility). Correct image orientation – patient orientation It is the responsibility of the operator to ensure correct image orientation on the monitor or film. CAUTION Image is incorrectly flipped due to incorrect patient position information or right/left labeling. Risk of incorrect diagnosis or treatment because of left/right or up/down confusion  The examiner is responsible for using the image orientation functions and interpreting the images correctly.  Make sure that the R/L labels have been placed correctly.  Compare the patient position data with the anatomic view when diagnosing images to exclude any errors.  If necessary, use lead letters or similar devices during acquisition. Visual contact to patient The operator of the X-ray system must ensure that there is visual and acoustic contact with the patient. Thus, the operator always remains informed about the condition of the patient. Room lighting According to DIN 6868- 157 (valid in Germany), the lighting in rooms in which diagnoses are made on image display devices (monitors) must fulfill the following requirements:  The lighting must be adjustable and glare-free.  The setting of the illuminance must be reproducible (for example, dimmer with scale).  No mirroring or reflections of windows, lights, view boxes, and so on, must occur in the operating position of the monitors. Prerequisites for diagnosis and treatment planning The FLUOROSPOT Compact imaging system software has been designed and tested for use in diagnosis and treatment planning based on digital radiographic X-ray images and series. To ensure that the imaging system produces images suitable for these purposes, the monitor must meet certain criteria for image quality. Checks Image quality can deteriorate over time because of aging and normal wear or damage of the monitor and other components.  The image quality must be checked at regular intervals (once per month) after installation. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054  Thus, you make sure that the system is still suitable for use in diagnosis and treatment planning. For further information, refer to Maintenance plan. The operator must ensure that qualified personnel are chosen and that the criteria for image quality specified in the installation and maintenance instructions are fulfilled. H. Test images Test images for calibration of the monitor and to test the quality output of the laser camera, are stored in the system. For further information, refer to the FLUOROSPOT Compact Operator Manual. Displays Please observe the following information:  The operating indicator must light up.  Please always keep the ventilation slots of the monitors unobstructed. Do not touch the surface of the screen using sharp, pointed objects. Do not open the display under any circumstances. Monitors are suitable for medical online diagnosis only, if special measures to assure image quality are adopted (especially determining the brightness and contrast values). In case of doubt, film images on a hardcopy camera, if you want to make a diagnosis. Siemens Healthineers undertakes no liability for diagnoses, which are performed on H. H. monitors of other vendors. Use of hardcopy cameras Only hardcopy cameras approved by Siemens Healthineers may be used. Approvals by Siemens Healthineers refer to DICOM image type XA. Siemens Healthineers does not accept any liability for diagnoses made based on images from non-approved hardcopy cameras. 2.16. Radiation protection The X-ray equipment LUMINOS Lotus Max with radiation protection complies with IEC 60601-1- 3:2008 and IEC 60601-2-43:2010. Mode of operation: Continuous Important information SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 The automatic format collimation system for acquisition and fluoroscopy modes, pulsed fluoroscopy, CAREPROFILE and CAREPOSITION as well as the automatic dose rate control including CAREFILTER help reduce the radiation dose to the patient and examiner considerably. For radiation dose indication during normal use of the equipment, the system is equipped with a measurement system based on an ionization chamber calibrated in air kerma area product. Measures for reducing radiation exposure Please pay attention to the fact that the air kerma is increased by the following settings:  Higher kV  Higher mAs  Higher ms  Smaller SID  Selection of Fluoro curves 1 to 3 in OGP  Higher frame rate  Change of zoom status: zoom 0 --> zoom 3 Please observe the following: Radiation may be released only by authorized operators or persons with proper authorization to apply ionized radiation. Fluoroscopy 1. Release fluoroscopy for as short a time as possible, use the LIH function! 2. Use the dose-saving fluoroscopy with CAREVISION! 3. Collimate radiation-free in the LIH image. You can also set the filter diaphragms in the LIH image without radiation: CAREPROFILE 4. Position the patient radiation-free in the LIH image: CAREPOSITION. 5. If possible, ensure the best possible protection of the patient during acquisitions in the vicinity of the reproductive organs (use gonadal shields, lead-lined rubber covers). 6. Keep the radiation field as small as possible without reducing the active measuring field. 7. Remove all radiopaque parts from the radiographic field, if possible. 8. Set the X-ray tube voltage as high as possible (not forgetting the image quality; the optimum is 63 kV for iodine contrast). 9. Set the X-ray tube to skin distance as large as is reasonable for each examination. A larger focal spot to skin distance leads to a lower air kerma. The maximum air kerma of 2 Gy must not be exceeded. Recommendation: Change the projection and the air kerma entrance area. H. Radiation protection for the patient 1. If possible, ensure the best possible protection of the patient during acquisitions in the vicinity of the reproductive organs (use gonadal shields, lead-lined rubber covers). 2. Keep the radiation field as small as possible without reducing the active measuring field. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 3. Remove all radiopaque parts from the radiographic field, if possible. 4. Set the X-ray tube voltage as high as possible (not forgetting the image quality; the optimum is 63 kV for iodine contrast). 5. Set the X-ray tube to skin distance as large as is reasonable for each examination. A larger focal spot distance leads to a lower air kerma. Radiation protection for the examiner CAUTION Failure to observe radiation protection regulations Unnecessary radiation exposure to personnel  This system produces X-rays.  Wear protective clothing such as lead aprons.  Monitor radiation exposure using personal dosimeters. 1. If possible, release the acquisition series in the control room. 2. Stay in the examination area as short as possible. 3. If the exposure is to be released in the examination room, use an additional radiation shield (protection for upper and lower body) or radiation-proof window. These measures contribute greatly to your personal radiation protection. 4. If the protective shields are not used, wear radiation protection clothing with a 0.25 mm lead layer or similar clothing. 5. Keep the maximum distance from the source of radiation. 6. Check your personal dose by wearing a radiation monitoring badge or a pen dosimeter. Switching off in an emergency If a problem, for example a defect, occurs during the examination and radiation can no longer be interrupted by letting go of the radiation release button:  Press the nearest emergency STOP button. Avoiding unwanted radiation  Before starting system movements, make sure that the foot switch for fluoroscopy and radiography in the examination room is not in the travel range of the receptor system. CAUTION SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Tube is not directed toward the detector during acquisition Unwanted radiation exposure  Use the free exposure mode with care.  Check that the tube is active and use the light marker for positioning before releasing X-ray. Radiation protection zones Position and dimensions of the main operating area: Horizontal patient table (1) 2 108 200 90 (1) Focus point (2) Reference axis 60- -60- Main operating area Dimensions in cm Position and dimensions of the main operating area: Vertical patient table SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 ol 200 140 108 40 60 60 Main operating area Dimensions in cm SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Stray radiation in the main operating area According to IEC 60601-1-3:2008 and IEC 60601-2-54:2009 200. (1) 190 - 180- 170. 160 - 150 140- 130 120 110 100 90 80 70 60 50 40 30 20 10 (2) O 1000 2000 000 o- Characteristic A and B: horizontal/vertical 110 kV, 3 mA, Control Fluoro (Service mode) (1) cm above floor (2) μGy/h (Air Kerma Rate) (1 200 190 180 170 160 150 140 130 120 110 100 90 + 80 70 60 50 40 30 20 10 0 (2) 100 200 300 400 SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Characteristic C and D: horizontal/vertical 75 kV, 13 mA (Antiisowatt) (1) cm above floor (2) μGy/h (Air Kerma Rate) Main operating areas The following locations are permitted for the operator and the patient: (1) Patient table in 0° position (1) The operator may stand anywhere in the room. (2) The patient must not stand behind the unit base (1). (2) Patient table in 90° position (1) The operator may stand anywhere in the room. (2) The patient must not stand behind the patient table (2). SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 2.17. Reducing radiation with C.A.R.E. The C.A.R.E. package (Combined Applications to Reduce Exposure) comprises:  CAREFILTER  CAREPROFILE  CAREPOSITION  CAREVISION  CAREWATCH Please contact your Siemens Healthineers sales engineer for information about C.A.R.E. radiation protection. CAREFILTER The CAREFILTER function comprises various copper filters. They filter out the low-energy components of the X-ray spectrum that are not necessary to make the image. This causes hardening of the beam, reducing not only the air kerma for the patient but also the scattered radiation for the examiner. Automatic dose rate control calculates the water equivalent of the patient from the current kV/mA values and the pulse width. The additional copper filter is automatically moved in or out of the beam path as a function of this value during acquisition if the image quality becomes unacceptable because of a very high patient density. The CAREFILTER function is automated and cannot be operated manually. CAREPROFILE With CAREPROFILE, the positions of the multileaf collimator and the filter diaphragms are displayed graphically in the last fluoroscopic or acquisition image. In this way, you can change the collimation without additional radiation release. CAREPOSITION CAREPOSITION allows you to reposition the patient with the aid of the last fluoroscopic image (LIH) without additional fluoroscopy. CAREVISION With CAREVISION, you have at your disposal a selection of fluoroscopy modes with different pulse rates that you can use to reduce the patient dose considerably. CAREWATCH SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 With a dose measuring chamber (mandatory in some countries), the dose-area product and the patient dose (air kerma) are shown on the data display and on the system console and recorded in the examination data. The dose measuring chamber must be calibrated at regular intervals. This calibration is done under the terms of a service contract. If you do not have a service contract, Customer Service or the manufacturer can calibrate the dose measuring chamber. H.  During fluoroscopy or acquisition The current values of the patient dose rate  Without radiation The accumulated values of the patient dose or the relative patient dose in percent (%) related to a configurable limiting value (usually 2 Gy) (configurable. Contact your Siemens Healthineers representative, if you prefer a different display.) As well as:  Permanently The accumulated dose-area product If the dose-area product exceeds a certain limit value, radiation injury (initially reddening of skin) can occur on the patient. This information allows the examiner to avoid radiation injury, for example by changing H. the angulation. Display data During digital fluoroscopy and when a Fluoro LIH image or Fluoro loop is displayed, the following system parameters are displayed in the control area of the live monitor and on the Touchscreen:  Cu filter for fluoroscopy  Cu filter for exposure  Dose-area product in μGycm² (With dose-area product meter only )  Dose or dose rate during fluoroscopy  Error text  Door open display  Emergency power supply  X-ray disable display 2.18. Information about dose measurement To provide you with perfect image quality for your daily work without additional operating effort, we install the most frequently used organ programs (preferred organ programs) in the factory. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Measurement configuration The phantom consists of a 20 cm thick rectangular block of polymethylmethacrylate (PMMA) with side lengths greater than or equal to 25 cm. The phantom should be positioned on the tabletop as closely as possible to the X-ray image receptor. The measurement detector should be placed midway between the phantom’s focus and entry surface. The measurement values are then calculated for the location of the patient entry reference point (30 cm above the patient support). Deterministic effects At the Air Kerma rate of 13,86 mGy/min at the reference point, a reference dose of 2 Gy is reached after 8658 s fluoroscopy. Deterministic effects are probable at this dose (2 Gy). Fluoro programs With SID 115 cm OGP OGP that is linked to the Fluoro "automatic 2" Program Set "CP high dose Low dose and Standard" Fluoro Fluoro Fluoro "automatic "automatic curve 3" 1" "CP "CP_Paediat Standard" ric” Dose 32 32 32 32 32 32 32 32 45 32 level [nGy/p] Dose 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 rate index Zoom 0 0 0 0 3 3 3 3 3 0 Collimat 25 x 25 x 25 x 25 x 14.3 14.3 x 14.3 x 14.3 x 14.3 x 25 x 25 ion 25 25 25 25 x 14.3 14.3 14.3 14.3 [cm²] 14.3 Grid yes yes yes yes yes yes yes yes yes no Copper 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.3 [mm] Pulse 3 7.5 10 15 3 7.5 10 15 15 3 rate [p/s] U [kV] 73 73 73 73 82.3 73.8 73 75.5 81 80.5 SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 I [mA] 46.6 33.5 30.2 26.6 72.8 74.9 72.8 53 51.5 13.9 Pulse 8.8 7.9 7.8 7.9 10 10 9.9 10 10 8.3 width [ms] Measuring 3 fields 3 fields 3 fields 3 fields circle circle circle circle circle circle fields (l, m, (l, m, (l, m, (l, m, (cente (center) (center) (center) (center) (center) r) r) r) r) r) Air 1,64 2.50 2.95 3.92 4.14 7.54 9.32 11.36 13.86 0.45 kerma rate (30cm above tabletop ) [mGy/mi n] Dose 72 110 130 172.5 182 332 410 500 610 20 rate [μGy/s] With SID 115 cm OGP OGP that is linked to the Fluoro "automatic 2" Program Set "CP high dose Low dose and Standard" Fluoro Fluoro Fluoro "automati "automatic curve c 3" 1" "CP "CP_Paedia Standard" tric” Dose 32 32 32 32 32 32 32 32 45 32 level [nGy/p] Dose 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 rate index Zoom 0 0 0 0 3 3 3 3 3 0 Collimat 25 x 25 x 25 x 25 x 25 14.3 x 14.3 x 14.3 x 14.3 x 14.3 x 25 x 25 ion 25 25 25 14.3 14.3 14.3 14.3 14.3 [cm²] Grid yes yes yes yes yes yes yes yes yes no Copper 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.3 [mm] Pulse 3 7.5 10 15 3 7.5 10 15 15 3 rate [p/s] SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 U [kV] 73 73 73 73 92.3 81.5 80.5 84.3 90 83.5 I [mA] 73.9 48.7 44 38.1 70.7 72.8 72.8 50.8 50.1 13.9 Pulse 9.9 8.8 8.7 8.9 10 10 10 10 10 8.3 width [ms] Measuring 3 fields 3 fields 3 fields 3 fields circle circle circle circle circle circle fields (l, m, (l, m, (l, m, (l, m, (center) (center) (center) (center) (center) (center) r) r) r) r) Air 1.46 2.11 2.48 3.26 2.91 5.02 6.44 7.72 9.27 0.23 kerma rate (30cm above tabletop ) [mGy/mi n] Dose 45 65.1 76.5 100.8 90 155 199 238.5 286.5 7 rate [μGy/s] RAD 80 kW Highest dose Example RAD1 Example RAD2 - Measuring fields l,r m Techniques 3-point 3-point 1-point 1-point Collimation [cm²] 25 x 25 25 x 25 25 x 25 25 x 25 SID [cm] 115 115 115 115 Grid yes yes yes yes Copper [mm] 0 0 0 0 U [kV] 79 150 109 70 Q [mAs] 40 200 3.5 46.1 t [ms] 40 500 10.8 56.8 Focus big big small big Power 100% 100% 80% 80% DAP (System) [μGy 100.70 1363.03 15.33 93.57 x m²] Organ programs To optimize operation, protocols (Organ Programs - OGPs) for the most common standard examinations are delivered with the system. In general, these protocols can be taken as examples to derive individual protocols for more specific examinations. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 For editing protocols, refer to the chapter PEX editor in the FLUOROSPOT Compact Operator Manual.  Normal dose OGP: Default Fluoro program set CP_Standard "Automatic 2"  Low dose OGP: Default Fluoro program set CP_Standard "Automatic 1 3. General safety information 3.1. Protection against electric shock Attention: To avoid the risk of electric shock, a protective conductor must be implemented when connecting this device to mains power. Power supply For all products that are operated within an X-ray system, the power supply must be made through a contactor or other multipole circuit breaker installed on-site. The room installation must comply with DIN VDE 0100-710 or the corresponding national regulations. Injector connector When the injector is removed from the table, the adapter must also be removed from the connector on the table for safety reasons. Power outlet The country-specific multipurpose power outlet on the patient table is not switched off and on with the system. Only devices which accord to IEC 60601-1 must be connected. Covers If socket covers (especially those of the operating modules) are damaged, they must be replaced. In the event of defects, for example, if a covering cap has broken off, call Customer Service. Protection class The system belongs to protection class I with a type B applied part according to IEC 60601-1. Protection against ingress of liquids:  Foot switches: IPx8 = Protection against long periods of immersion under pressure  Tableside control panel: IPx3 = Protected against spraying water SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054  Control Room Module: IP22 = Protection against contact with any large area by hand and against solid foreign bodies with Ø > 12 mm; Protection against diagonal water drips (up to a 15° angel)  Rest of the system: IPx0 = No special protection Protection class IPx3 is only valid if the tableside control panel is originally built into the table. When it is removed or replaced, protection class IPx3 may not be met anymore. H. Equipotential bonding Systems for which equipotential bonding is recommended must only be operated in medical facilities where supplemental equipotential bonding has been installed and tested according to the specifications in DIN 57107/VDE 0107/6.81 section 5 (Federal Republic of Germany) or the relevant local and federal regulations. Attention: To avoid the risk of electrical shock, a protective conductor must be implemented. H. Opening the units Only authorized service personnel are permitted to open the units. 3.2. Electromagnetic compatibility (EMC) CAUTION Radio interference from the system affects nearby equipment Risk of malfunction of nearby equipment.  Reorient or relocate the equipment or system or shield its location.  Test the operation of the equipment in its new location. CAUTION SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Electromagnetic interference or a defect in the system Deterioration of the image quality  Remove the source of interference (for instance, a mobile phone or an electric device) from the area.  Shut down the system and turn it on again. Pay attention to error messages during restart. 3.3. Maintenance plan WARNING Wear or material fatigue in the system or accessories Risk of injury or system damage  Follow the maintenance guidelines to maintain safety and proper function of the system.  Check accessories for wear before use. CAUTION Image artifacts due to unperformed maintenance Incorrect diagnosis basis  Check that the image quality criteria described in the installation and maintenance manual are met before using the system.  Maintenance work should be performed by trained technical personnel only.  Purchasing a maintenance contract will keep the system in optimum condition. H. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 This maintenance plan includes the required tests according to IEC 62353. Periodic maintenance Periodic maintenance includes:  Safety inspection  Preventive maintenance  Quality and function tests  Replacement of safety-relevant parts subject to wear This work may be performed only by qualified and authorized service engineers. Qualified in this context means that the engineers have been trained accordingly or have acquired the necessary experience in practice. Authorized means that the engineers have been authorized by the operator of the system to perform maintenance work. Prior to the first system startup, we recommend that you name a staff member who will be responsible for ensuring that routine checks and preventive inspection and maintenance work are performed. This employee must archive all certificates in the folder for the "Technical Documentation". In addition to our repair service, Siemens Healthineers also offers you a complete range of services for preventive inspection and maintenance of your system. These services can be called on as required or agreed in a flexibly drafted service contract. If you have not received a quotation from our UPTIME Services service organization, please contact the Siemens Healthineers representative responsible for your facility. Safety inspection The following checks are intended to ensure the safety of the system. Where appropriate, preventive measures must be adopted, or repairs performed. For the most part, the points to be checked are prescribed by laws and standards. Maintenance interval: 24 months for the entire system Listing of work steps to be performed Object or function Reason What is checked General checks Overall system Safety of patients and personnel Visual check of the system (cover panels) for damage and sharp edges. Cables and how cables are Protection of patient and Visual check of cables and how cables laid personnel against electric shocks are laid for safety deficiencies. Accessories Safety of patients Check for safety deficiencies. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 System radiation protection Protection of patient and Check unit radiation safety devices as devices personnel against radiation well as any additional safety devices injuries that are configured, e.g. lower body radiation shield, upper body radiation shield, ceiling-mounted radiation shield, for installation and for damage. Operator documents Protection against incorrect Check for the presence of operator operation and thus protection of documents. patients, personnel, and unit Warning notices Protection against incorrect Check for presence of the required operation and thus protection of warning labels visible to the user for patients, personnel, and unit operation of the system. Insertable fuses Protection of patients, personnel, Check all insertable fuses that are and unit accessible without tools to determine whether manufacturer data (nominal value and switch-off characteristics) are met. User interfaces Protection against incorrect Check for legibility and operating operation and thus protection of symbols. patients, personnel, and unit Electrical checks Electrical safety Protection of patient and  Measurement of ground wire personnel against electric shocks resistance  Device leakage current measurement  Patient leakage current measurement of the complete system per national regulations. Mechanical checks Wall and floor mounting Protection of patients, personnel, Mounting (visual check) and unit Pull and support cables Protection of patients, personnel, Check for wear and fraying. and unit Chain drives Ensure power transmission and Check for wear, tension, ease of safety functions movement and function of the guide rollers. System movements Safety of the system latching Check of brake holding and end stops. (manual) mechanisms Movable components Protection of patients, personnel, Cable lead-in, movement behavior and unit and, if applicable, brakes. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Accessories Safety of patients, personnel Check for functionality and for good condition. User interfaces Protection against incorrect Check for damage. operation and thus protection of patients, personnel, and unit Safety-relevant parts Protection of patients, personnel, Check for damage. subject to wear and unit Function check Emergency stop devices Preventing the first malfunction Switch-off of system functions after caused by application errors and activating the emergency stop device. collapsing patients Control devices and Inform the operator about The functions of the following warning indicators relevant system conditions and displays: overload situations  Radiation  X-ray tube load  Blocking  Unit movements at the collision limit System movements Protection of patients, personnel, Safety shutdown of the movements (motorized) and unit Collision protection Prevent damage to unit Automatic shutdown of system components movements in the collision zone (for example ceiling, wall, floor) Function test Prevent damage to unit Final function test of all components components Preventive maintenance The purpose of preventive maintenance is to reduce unforeseen failures to a minimum. Thus, the prerequisites for the system to meet the assured characteristics in the long term are created. The effects of different operating conditions (full or partial load operation, temperature, size of dust particles, humidity, gases, vapors) are checked and the condition of parts subject to wear is determined by recording and analyzing characteristic values. Preventive measures must be adopted, or repairs must be undertaken as appropriate. The specified maintenance intervals correspond to the minimum requirements. Compliance with stricter national legislation may be necessary. Maintenance interval: 24 months for the entire system. Listing of work steps to be performed Object or function Reason What is checked Overall system Preventive measures to avoid:  Check of operating data SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054  Safety risks  Check of cables, cable routing  Overheating and cable connections for  Wear and tear damage  Image artifacts  Cleaning contrast medium, blood, disinfectants from areas not accessible to the customer  Inspection and cleaning of coolant and air circulation passageways  Inspection and cleaning of optical transmission paths  Removal of foreign objects, for example positioning aids and injection needles  Touch-up of paint to prevent corrosion and infection  Check of measurement values with tolerance ranges  Check of the movement forces  Check of the drive characteristics, acceleration, and deceleration movements  Measures to ensure that all components move smoothly  Check and analysis of points of friction  Reading and analyzing the error log files  Repairing minor damage Quality and function tests Quality and function tests are used to check whether the system meets the assured characteristics. Image quality tests determine differences from the original status (for example resolution, contrast range, minimum contrast, image signal and, if applicable, check of Digital Subtraction Angiography). If there are differences, preventive measures must be taken or repairs performed, whenever is appropriate. Maintenance interval: 24 months for the entire system Listing of work steps to be performed SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Object or function Reason What is checked Overall system Optimum operation based on the Interaction of all system components specifications listed in the data according to the assured sheet characteristics Power line connection Unrestricted power input from Internal line impedance the line power source for the purpose of maximum system load. (The power input can be limited by oxidation and corrosion, which can result in exposure fluctuations and system shutdowns.) Vacuum components: Assuring the system Image quality  X-ray tube specifications (vacuum assembly components are subject to aging) Beam geometry, centering, Observance of the specifications Centering the central beam onto the beam collimation and legal regulations* to center of the image receptor. minimize radiation exposure of Coincidence of radiation field size and patient and personnel image receptor size or light field size and radiation field size. Radiation dose Compliance with specifications Check of dose rate/cutoff dose† and legal requirements* to during minimize radiation exposure of  Fluoroscopy (DL) patient and personnel  Acquisition in all operating modes Detail recognition Compliance with specifications Resolution† during and legal requirements* Ensuring  Fluoroscopy (DL) image quality  Acquisition in all operating modes Image contrast Compliance with specifications Minimum contrast and dynamic and legal requirements* range† during Ensuring image quality  Fluoroscopy (DL)  Acquisition in all operating modes DSA device† Compliance with specifications DSA scene: contrast sensitivity, and legal requirements* dynamic range, taking the logarithm, Ensuring image quality subtraction, artifacts Tomo device† Compliance with specifications Accuracy of the tomographic height, and legal requirements* resolution, shape and course of the Ensuring image quality tomographic pattern, blurring Image display Compliance with specifications Brightness, focus and the geometry of and legal requirements* the configured monitors Ensuring image quality SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Image artifacts Compliance with specifications Image display for intolerable image and legal requirements* Ensuring artifacts in all existing application image quality techniques Dose measurement Maintenance of specifications Accuracy of the display device† Image documentation Compliance with specifications Gray scale reproduction, geometric systems and legal requirements* imaging characteristics, resolution, Ensuring image quality optical density, artifacts * DHHS and country-specific regulations must be observed † Depending on the system configuration Safety-relevant parts subject to wear Safety-relevant parts which are subject to wear must be replaced in periodic intervals. 3D V ceiling stand Object or function Reason What is replaced? Interval 3D Wear can cause springs Spring-loaded 8 years to break and the mechanism with steel support cable to split or cables fray. 3.4. Combination with other products/components To ensure the necessary safety, only products or components expressly approved by Siemens Healthineers, may be used in combination with the system. Interfaces Accessories connected to the analog or digital interfaces must be certified according to the respective IEC standards. Example: IEC 60950-1 for Information Technology Equipment and IEC 60601-1 for Medical Equipment. The person connecting additional equipment to the medical device is configuring the system and is therefore responsible for ensuring that the current system configuration complies with the relevant standards (for example system standard IEC/EN 60601-ff and/or H. other applicable standards). In case of doubt, please consult your local contact person. Furthermore, all configurations shall comply with the valid version of the system standard IEC 60601-1. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Everybody who connects additional equipment to the signal input part configures a medical system and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC 60601-1. If in doubt, consult the technical service department or your local representative Display ceiling suspension (DCS) Example WARNING - SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Display not properly mounted in suspension system. Electrical shock, injury of persons  The customer is responsible for mounting non-Siemens-provided displays properly in the suspension system. This includes proper grounding, cabling and fixation of the displays using the provided equipment.  Make sure that external cables do not create an additional risk of injury. Siemens Healthineers is not responsible for injuries resulting from improper installation of foreign display monitors. 3.5. Installation recommendations  Interlocks must not be present on the doors of the room containing the interventional X- ray equipment. No other measures, whether or not employed for radiation protection, should be able to cause the interruption of irradiation or any other disturbance of a procedure in progress, unless the operator has the means to prevent such action from occurring during the procedure.  All emergency stop controls in the system must be protected against accidental actuation.  Sufficient space must be available around the patient support for the unimpeded conduct of CPR.  One or more warning lights must be present to indicate the loading state to persons at all positions in the room containing the interventional Xray equipment.  Appropriate warning lights to indicate the loading state must be present adjacent to doors opening into the procedure room when warning lights within the procedure room are not visible. 3.6. Installation, repair, or modifications Modifications of or additions to the product must be made in accordance with the legal regulations and generally accepted engineering standards. Siemens Healthineers does not accept responsibility for the safety features and for the reliability and performance of the equipment as the manufacturer, assembler, installer, or importer, in the following cases:  Installation, equipment expansions, readjustments, modifications, or repairs are not carried out by persons authorized by us to do so.  Components affecting safe operation of the product are not replaced by original spare parts in the event of a malfunction. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054  The electrical installation of the room does not meet the requirements of the VDE regulation or the corresponding national regulations.  The product is not used in accordance with the Operator Manual. Technical documents On request we can provide you with technical documents for the product for a charge. This does not imply authorization to undertake repairs. We recommend that you obtain a report indicating the nature and the extent of the work performed from the persons carrying out such work. The report should include all changes in rated parameters or operating ranges and the date, the name of the company and a signature. We accept no responsibility for repairs performed without our express written approval. H. H. Installation All information and installation requirements contained in the service documentation require strict adherence. If you should require additional information, please contact the qualified people specified by the manufacturer. 3.7. Cleaning and disinfection CAUTION Use of harsh cleaning agents, liquids, or sprays. Risk of electrical hazard or damage to the system  Use only substances for cleaning and disinfection which are recommended.  Do not let cleaning liquids seep into the openings of the system (e.g. air openings, gaps between covers).  Observe the cleaning and disinfection instructions. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 CAUTION Inadequate cleaning and disinfection. Risk of infection  Clean and disinfect all contaminated surfaces and all parts which may come (or have come) into contact with patient after each examination.  Use the recommended cleaning agents and disinfectants.  Protect the portable detector with a single-use plastic bag. Cleaning Preparations  Clean all contaminated parts and all parts that may come or have come into contact with the patient, directly or indirectly. When cleaning and disinfecting, use suitable gloves for your own protection. H. Equipment 1. Only use water or a lukewarm diluted household cleaning agent solution. i The use of other than the recommended cleaning agents can result in damage to the equipment. Plastics 2. Wipe system parts with a damp cloth (squeeze out wet cloth before using it) until all contaminations are removed. 3. Remove any watery residues immediately.  Use only special plexiglass cleaning agents, dishwashing detergent, soapy water, or laundry detergent. Harsh cleaning agents, such as TCE, acetone, alcohol, and cleaning agents containing any of these agents may cause hairline cracks and eventually breakage even under a small load. H. Parts mounted above the patient  Remove dust on parts mounted above the patient regularly. Ventilation slots  Keep the ventilation slots of all components unobstructed. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 CAUTION Objects on top of the generator cabinet block ventilation. Generator becomes inoperable because it is too warm.  Do not store objects on top of the generator cabinet. Generator cabinet CAUTION Cleaning liquids drip into the generator cabinet. Electrical parts are damaged.  Make sure that no liquids are used at the top of the generator cabinet.  Clean the generator cabinet covers very carefully, making sure that no liquid seeps into the cabinet. Displays, touchscreens  Clean the touchscreens regularly because they become dirty with fingerprints. Liquid-crystal displays (LCD) are very sensitive to mechanical damage. Do not spray the displays directly. Avoid scratches and shocks. H. Remove drops of water immediately, longer contact with water discolors the surface. 1. Remove immediately any contamination, for example, contrast medium stains. 2. Use only a water damp cloth without any cleaning agents. 3. Wipe the screen. 4. Dry it with a soft cotton cloth. Mobile detector Recommendations: 1. Use low concentrated chemicals, at maximum with the concentration written in the PTS. 2. Clean the back of the detector first so that it has more time to dry while the front is being cleaned. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 3. Every cleaning should be followed by a rising (wipe soak with water). It is to remove the chemicals rapidly and reduce exposure time. The charge contact plate on the back of the detector must be completely dry before the detector is returned into the Bucky tray. Otherwise, the detector will not charge sufficiently, and the charge contact surfaces may corrode. H. Accessory parts Please Note: For some accessory parts, there are special instructions on cleaning in the corresponding chapters. Unless special instructions are given there, the equipment cleaning instructions are valid. Disinfection To disinfect surfaces, we recommend solutions of common surface disinfectants based on aldehyde and/or amphoteric surfactants. Some substances contained in disinfectants are known to be hazardous to health. Their concentration in the air must not exceed the legally defined limit. Follow the manufacturer’s instructions when using these disinfectants. H. The following active ingredient classes can be used:  Guanidine derivatives  Peroxide compounds  Organic acids The following products should not be used:  Virex TB  Terralin  All alcohol-based products  All phenol-based products  All chlorine-releasing products The safety data sheets of the manufacturer provide detailed information on the composition of the disinfectants. Disinfecting 1. Disinfect all parts that can, directly or indirectly, come or have come into contact with the patient. 2. In addition, observe the hygiene plan of your hospital. 3. Disinfect the system by wiping only. Sterilization The system does not require sterilization. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 3.8. Product service life Our medical engineering products are designed for operation under average conditions in accordance with the Operator Manual for a useful life of 10 (ten) years. If the products are operated for longer than this time, additional checks and possibly repairs beyond the usual maintenance procedures may be necessary to ensure the functional integrity and operating safety of these products. Please talk to your Siemens Healthineers Representative about these measures early enough! 3.9. Disposal On disposing of the complete system or parts thereof, currently valid environmental legislation must be observed. Examples of environmentally relevant components are:  Accumulators and batteries  Transformers  Capacitors  Flat panel monitors  Phantoms For details contact your local Customer Service representative or your Siemens Healthineers regional office. Please Note: System components which are hazardous to persons or the environment must be disposed of with care and in compliance with legally binding ordinances. For all countries of the EU: In the member states of the European Union (EU), Siemens Healthineers will take back and will dispose of the packing material of your system. Products bearing this symbol are subject to EC directive 2002/96/EC on waste electrical and electronic equipment (WEEE), amended by 2003/108/EC. This directive determines the framework for the return and recycling of used equipment as applicable throughout the EU. For details about return and disposal of the product or its components or accessories please contact your local Customer Service or your Siemens Healthineers regional office. SIEMENS Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Healthineers Master Template Effective Date: 5 MAR 2020 | HOOD05162003074494 Job Aid Effective Date: 4 May 2020 I HOOD05162003188054 Job Aid Lotus Max: System Safety Effective Date: 05/04/2021 I HOOD05162003188054 Please note that the learning material is for training purposes only! For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively “Operator Manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator's Manual shall be used as your main reference, for relevant safety information like warnings and cautions. Note: Some functions shown in this material are optional and might not be part of your system. Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. Copyright © Siemens Healthcare GmbH 2020 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84-0 siemens-healthineers.com SIEMENS Healthineers Unrestricted