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Instructions for use

PST 500 U

Mobile operating table

ENGLISH

en-US

Read the instruction manual carefully before using the product 
and keep it safe for future reference.

Summary of Contents for 4080300

Page 1: ...Instructions for use PST 500 U Mobile operating table ENGLISH en US Read the instruction manual carefully before using the product and keep it safe for future reference ...

Page 2: ...This page is intentionally blank ...

Page 3: ...t at www trumpfmedical com Information about the document Original instruction manual This instruction manual is included in paper form in the scope of the product supply This document applies to the following sales units Supporting documents The operating table can be custom assembled using various Trumpf Medizin Systeme products The instructions for use of all the products used then apply Sectio...

Page 4: ...Mobile operating table 4 4990824_030_02 2071995 12 DEC 2019 This page is intentionally blank ...

Page 5: ...e product is used The instruction manual must be easily accessible in full to all users of the product at all times The figures in the instruction manual are highly simplified and are intended to provide a basic understanding Residual dangers that may occur while using the product are identified in the document with a signal word The safety measures required and potential consequences of failing t...

Page 6: ...Mobile operating table 6 4990824_030_02 2071995 12 DEC 2019 This page is intentionally blank ...

Page 7: ...7 3 Emergency unlocking of the parking brake 19 2 7 4 Failure of the operating table s electrical functions 19 2 8 Information notices 20 2 8 1 Safety instructions 20 2 8 2 Position and meaning 20 3 Unpacking the operating table 23 4 Summary 26 4 1 Operating table and equipment 26 5 Description 27 5 1 Overview of the operating table 27 5 2 Summary of control modules 29 5 2 1 Column keypad 29 5 2 2...

Page 8: ...mary of how to use the operating table 54 6 4 Charging the batteries external power supply 55 6 5 Connecting disconnecting the equipotential bonding cable 56 6 6 Attach cladding protection 56 6 7 Attaching the tabletop section to the operating tabletop 57 6 8 Attaching accessories to the side rail 57 6 9 Operating states 58 6 9 1 Switch on the operating table 58 6 9 2 Switching off the operating t...

Page 9: ...1 Disposal 79 12 Technical data 80 12 1 Device data 80 12 2 Electromagnetic compatibility 81 13 Product certification 84 13 1 European Union 84 14 Accessories 85 14 1 Manufacturer Trumpf Medizin Systeme 85 14 2 Third party manufacturers 90 15 Combinations of operating table and tabletop sections 91 ...

Page 10: ...Contents 10 4990824_030_02 2071995 12 DEC 2019 This page is intentionally blank ...

Page 11: ...alified service technicians Initial operation by the operator Repair and disposal of the operating table must be performed by qualified service technicians as required Normal use includes sections 1 2 1 4 1 5 1 6 and 1 7 1 2 Intended purpose The medical device PST 500 is a mobile and configurable operating table which is intended to be used in combination with specific tabletop sections pads and a...

Page 12: ... a weight of 454 kg 1000 lbs can be positioned on the PST 500 operating table Depending on the tabletop sections used the approved patient weight may be reduced to 135 kg 297 lbs The conditions for the various loads on the operating table are specified in section 5 11 1 5 User definition The PST 500 operating table may be used and operated only by qualified staff The training of the staff is perfo...

Page 13: ...ransport The operating table must be stored and transported in the following conditions 1 8 Service life The service life with normal use is 10 years Temperature 20 C to 60 C 4 F to 140 F Air humidity 10 to 95 Atmospheric pressure 540 mbar to 1060 mbar 54 kPa to 106 kPa fragile contents top keep dry ...

Page 14: ...ormity Pads Control modules Tabletop sections The tabletop sections are designed by Trumpf Medizin Systeme for use in conjunction with the operating table to enable or support its intended purpose The tabletop section is fastened to hook coupling points at the head or foot end of the operating tabletop and extends the positioning surface for the patient Product designation Part number Document num...

Page 15: ...roducts the operator is responsible for this combination Trumpf Medizin Systeme accepts no responsibility for the combination of the operating table with third party products The guarantee warranty for products from Trumpf Medizin Systeme may become void in the event of combination with third party products Leg section four parts spreadable H V U 1853829 4990133 Pad leg section four parts H B 1851...

Page 16: ... is operational and in an appropriate state and the user must further have read the instructions for use as well as other attached safety relevant information and maintenance instructions The instructions for use and the instructions provided with the medical device must be stored in a way that ensures that the user can access the information required for using the medical device at any time The o...

Page 17: ...alfunctions of the operating table Examples of potential sources of interference Electronic control gear ECG for fluorescent lamps HF surgical devices Wireless remote control for other devices e g monitors Very bright indoor lighting 2 7 What to do in the event of a malfunction In the event of a malfunction the operating table has the following functions available depending on the problem that has...

Page 18: ...e no faults To do this switch the operating table off and back on again Hold the off button down for at least 3 seconds 2 7 2 Reset If the operating table reacts unexpectedly to a control switch off the operating table and switch it back on If you cannot even switch it off press the reset button 1 Push through the red circle on the information notice and press the 38 key below it The operating tab...

Page 19: ...e emergency unlock 1 Push through the red circle on the information notice and press the 39 key below it The jack props in the wheels are retracted and the operating table is freely mobile It is possible that the operating table can only continue to be used to a limited degree 2 Notify the Technical Customer Service 2 7 4 Failure of the operating table s electrical functions According to the curre...

Page 20: ...product A damaged illegible or missing device label information notice must be replaced immediately Observe the information notices on the product The information notices must not be altered or removed 2 8 2 Position and meaning 50 Head end of the operating table 51 Foot end of the operating table 1 8 4 5 10 10 12 12 6 9 7 16 3 13 14 11 48 49 15 2 No Information notice Meaning 1 Operating table na...

Page 21: ... key Switch the operating table off B Emergency unlock key Release the operating table s parking brake 10 Connection socket for the cable remote control and foot control 11 A WARNING B Before transporting the patient lower the operating table so that the information notice is completely covered 12 Positioning aid for the extension adapter 1850992 13 UL mark No Information notice Meaning B A B A ...

Page 22: ...r Trumpf Medizin Systeme material number Serial number Medical product The device conforms to Regulation EU 2017 745 concerning medical devices All round splash protection The product must be disposed of at a suitable disposal facility for the recycling of electrical and electronic devices in accordance with the requirements of Directive WEEE II 2012 19 EU and country specific regulations Caution ...

Page 23: ...m environment or vice versa moisture can form inside the operating table and cause a short circuit After delivery leave the operating table for at least 12 hours in the environment in which it will be used before switching it on for the first time Unpack the operating table in a room with a level floor and sufficient open space 1 Position the pallet so that clearance of around 3 30 m 10 83 ft A is...

Page 24: ...he front section E and position it as the second part of the ramp on the front of the pallet Push the ramp up to a closed area on the pallet 6 Remove both side sections 4 screws F each 7 Release the tensioning straps G around the operating table and remove them together with the wooden bases H 8 Remove the wooden securing blocks I from the wheels 2 screws each D E F G H I ...

Page 25: ...is press the key i53 on the column keypad 12 Activate the operating table s parking brake To do this press the key i45 on the column keypad 13 Dispose of the pallet ramp and packing material in an environmentally responsible manner 14 Charge the batteries in the operating table 15 Before using the products for the first time they must first be cleaned and disinfected according to the hygiene speci...

Page 26: ...table can be custom assembled using various Trumpf Medizin Systeme products The approved products are listed in Section 2 1 Example 17 Operating tabletop 18 Operating table column 19 Running gear 20 Tabletop section 21 Accessories 22 Remote Control 23 2 part cladding protection 18 17 20 21 20 19 21 22 23 ...

Page 27: ...wn Back section up back section down Beach chair position The patient orientation on the operating table is adjusted electrically This means that the operation of the operating table is identical for the inverse and normal patient position All functions are automatically carried out on the correct side The operating table is operated as standard with the remote control or via the column keypad Oth...

Page 28: ...tension adapter is available as an optional accessory from Trumpf Medizin Systeme 33 Bearing for the extension adapter The extension adapter is available as an optional accessory from Trumpf Medizin Systeme 34 Column keypad 35 Control unit connector socket with cover head and foot end 36 Equipotential bonding cable connector pin 37 Connector socket for power cable 38 Shutdown key operating table r...

Page 29: ...ntally activated The OFF key is excluded from the key lock 44 Directional movement wheel The wheel assists the user when the operating table is being moved forward or sideways 45 Equipotential bonding cable 46 Mains power cable 47 LED strip indirect floor lighting 48 Lever The lever acts as a securing device and prevents the accessory from slipping from the side rail 49 Stop The stop acts as a sec...

Page 30: ...on i6 Lower function i7 Trendelenburg function i8 Anti Trendelenburg function i9 Left tilt function i10 Right tilt function i11 Level position function Status display next to the key i12 Leg section up function i13 Leg section down function i14 Back section up function i15 Back section down function i16 Head end longitudinal slide function i17 Foot end longitudinal slide function i20 Activate emer...

Page 31: ...function i6 Lower function i7 Trendelenburg function i8 Anti Trendelenburg function i9 Left tilt function i10 Right tilt function i12 i13 i14 i15 i16 i17 i32 i33 i3 i24 i25 i3 Inverse patient orientation function i12 Leg section up function i13 Leg section down function i14 Back section up function i15 Back section down function i16 Head end longitudinal slide function i17 Foot end longitudinal sl...

Page 32: ...6 i7 i5 Raise function i6 Lower function i7 Trendelenburg function i8 Anti Trendelenburg function i9 Left tilt function i10 Right tilt function i13 i12 i32 i33 i15 i14 i17 i16 i25 i24 i12 Leg section up function i13 Leg section down function i14 Back section up function i15 Back section down function i16 Head end longitudinal slide function i17 Foot end longitudinal slide function i24 Select the l...

Page 33: ...ails The operating tabletop is equipped with side rails Accessories can be attached to the side rails The accessories approved by Trumpf Medizin Systeme are listed in Section 2 1 The accessories must be taken into account along with the patient s weight see Section 5 11 The side rails on the operating tabletop are equipped at the end with a securing device 48 49 The securing device prevents loose ...

Page 34: ... 46 The operating table must be connected to the power supply using the original mains power cable from Trumpf Medizin Systeme The mains power cable is indicated with a label A 5 6 Cladding protection Objects on the running gear that could touch the cladding of the operating table column may block the adjustment range of the operating table column The cladding parts may bump into the objects and b...

Page 35: ...re given using the keys for the back section i14 i15 Normal patient orientation default setting The patient lies with their head at the head end of the operating tabletop After the operating table has been switched on normal patient orientation is always automatically activated Inverse patient orientation The patient lies with their head at the foot end of the operating tabletop The patient orient...

Page 36: ...s the foot end A or head end B of the patient 5 7 6 Back section The back section is moved electrically upward A or downward B 5 7 7 Leg section joint The joints are inclined electrically upward A or downward B The joints can only be moved together with the column keypad With the remote control when the normal patient orientation is selected the right and left joints can be moved independently of ...

Page 37: ...on is positioned horizontally Leg section function The leg section is positioned horizontally 5 7 9 Flex down flex up The operating tabletop folds electrically between the seat and back section In the flex down position A both ends of the operating tabletop are moved downward reverse Trendelenburg function and back section down In the flex up position B both ends of the operating tabletop are move...

Page 38: ...ng tabletop are not detected by the operating table In this case the function must be stopped by the user before a collision occurs The movement ranges are only monitored with the following operating table equipment Different operating table equipment and accessories on the side rails are not monitored with regard to collisions In this case incorrect warning messages or no warning message may occu...

Page 39: ...s not light up The operating table is switched off Switch on the operating table if necessary The display lights up green The key lock has been released The keypad automatically locks 10 seconds after the last key has been pressed No action required The display flashes green In addition tothe flashing display i53 a single tone is emitted A key has been pressed while the key lock is active Release ...

Page 40: ...he display lights up green Patient orientation is inverted The display corresponds to the head position of the patient on the operating tabletop No action required The display lights up green The operating table is in the level position No action required The display flashes green The level position of the operating table is incomplete Not all functions have been moved to the level position Notify...

Page 41: ... operating table is connected by the power cable to the external power supply No action required The display lights up red An error has occurred with the operating table The operating table can only be used to a limited degree Notify the Technical Customer Service Display Status Meaning Action a1 a1 a3 a4 Display Status Meaning Action All bars light up green The batteries are fully charged No acti...

Page 42: ... No action required Display Status Meaning Action 41 41 Display Status Meaning Action A two digit number is displayed The number represents an error Notify the Technical Customer Service 40 Display Status Meaning Action The LED strips on the running gear flash green The parking brake on the operating table has been activated Aftercompleting the function the LED strip lights up green for approximat...

Page 43: ...floor lighting off Display Status Meaning Action 47 47 47 No Sound Meaning 1 Ascending tone sequence The operating table is switched on 2 Descending tone sequence The operating table is switched off 3 Single tone The parking brake on the operating table is being released The parking brake on the operating table is being activated The end position of the function in question has been reached The le...

Page 44: ... operating table other than that described in these instructions for use The load comprises the weight of the patient and the net weight of the accessories An additional accessory on the operating tabletop therefore reduces the permissible patient weight The net weight of the accessory must be deducted from the permissible patient weight Regardless of the load on the operating table the load on th...

Page 45: ... is listed in Section 15 under the respective item number Orientation Weight Restriction Chapter Foot end Head end Leg section Item 58 or 62 Head section Item 59 or 60 Normal 454 kg 1000 lbs Yes 5 11 2 1 Leg section Item 56 57 58 or 62 Head section Item 59 or 60 Normal 360 kg 793 lbs None 5 11 2 2 Seat section extension Item 61 None Normal 300 kg 661 lbs None 5 11 3 Leg section Item 56 57 or 58 Un...

Page 46: ...head section H U V 1769761 Item Product designation Part number 58 Single part leg section H U V 1739969 62 Universal section H V U 2072445 454 kg 1000 lbs Patient weights of up to 454 kg 1000 lbs are permitted under the following conditions 1 The longitudinal travel of the operating tabletop must be in the level position 2 The operating tabletop must be inclined by no more than 15 around the late...

Page 47: ...ng table is switched to inverted 360 kg 793 lbs Patient weights of up to 360 kg 793 lbs are possible without limiting the operating table functions Attention Additional accessories on the operating table reduce the permissible patient weight 61 56 57 58 Item Product designation Part number Seat section extension 61 Seat section extension H V U 1909820 Leg section 56 Leg section four parts spreadab...

Page 48: ... kg 595 lbs are possible without limiting the operating table functions Attention Additional accessories on the operating table reduce the permissible patient weight 53 Item Product designation Part number 53 Table top segment Carbon1200 H V 1850989 160 kg 352 lbs Patient weights of up to 160 kg 352 lbs are possible in the normal patient orientation Normal patient orientation is active on the oper...

Page 49: ...of up to 160 kg 352 lbs are permitted Longitudinal travel of the operating tabletop towards the head end of the patient is restricted by 100 mm Attention Additional accessories on the operating table reduce the permissible patient weight 160 kg 352 lbs Patient weights of up to 160 kg 352 lbs are possible without limiting the operating table functions 63 Item Product designation Part number 63 Shou...

Page 50: ... and foot B end depends on the position of the operating tabletop in the longitudinal orientation If the operating tabletop is moved in the direction of the foot end the X ray area at the foot end of the operating tabletop increases If the operating tabletop is moved in the direction of the head end the X ray area at the head end of the operating tabletop increases The instructions for use of the ...

Page 51: ...on The operating table is equipped with batteries and can be operated without a mains power connection If the batteries are fully charged the electrical functions on the operating table can be used for several days The battery status is visible from the display a1 on the column keypad and the display 41 on the running gear When the batteries are empty the LED strip 47 on the running gear also ligh...

Page 52: ...ipotential bonding compensates for different electrical potentials between live parts that may be touched in the area around the patient and protects against electrical discharges The connecting pin 36 for the equipotential bonding is located at the head end on the running gear 36 ...

Page 53: ...ng forces that have developed will be eliminated Check the operating table to ensure it is functional and intact before use The use of faulty or damaged products is prohibited 6 2 Selection of functions The operating table can be adjusted using the following control units Column keypad Remote control Foot control The commands of the individual control units are listed in the following sequence 1 C...

Page 54: ...d by default so that the functions on the operating table cannot be accidentally activated To release the key lock Press the i53 key on the column keypad The keys are released for 10 seconds 6 3 Summary of how to use the operating table The operating table is fitted with tabletop sections and accessories according to the procedure planned Before the patient is transferred the operating table must ...

Page 55: ...r cable from Trumpf Medizin Systeme only Do not extend the mains power cable on the operating table Connecting the cable 1 Flip up the connector socket cover 37 on the running gear and insert the power cable plug 46 into the connection socket 2 Route the cable to the socket so that no one can trip or fall over it 3 Plug the connector of the mains power cable into a grounded power socket in the roo...

Page 56: ...Attach cladding protection CAUTION Risk of crushing injury to fingers Do not place fingers between the two parts of the cladding protection The magnets may attract the two parts together 1 Pull the two parts of the cladding protection apart 2 Place one part of the cladding protection at the head and one at the foot on the running gear as shown in the image 3 Bring the two parts of the cladding pro...

Page 57: ...ly lock 4 Check that the tabletop section is securely fastened to the operating tabletop It must not be possible to pull the tabletop section from the operating tabletop Removing the tabletop section 1 Release the interlock To do this press the knob A on the side or handle under the tabletop section and keep it pressed 2 Lift the tabletop section a little and push it towards the operating tabletop...

Page 58: ...e operating table 6 10 1 Safety instructions Securely attach the patient to the operating table with the appropriate accessories for example using straps Carry out all patient repositioning in a controlled and responsible manner Monitor all of the operating table s motorized movements to prevent the patient being endangered or material damage occurring as a result of a collision Stop the function ...

Page 59: ... on the column keypad Remote control with display The patient orientation is set via the menu in the remote control s display button A Consult the remote control s instruction manual for more information 6 10 3 Lift NOTICE Danger of collisions when lowering the operating tabletop When lowering the operating tabletop collisions may occur with the running gear the floor furnishings or devices locate...

Page 60: ...e operating tabletop When lowering the operating tabletop collisions may occur with the operating table column the floor furnishings or devices located below the operating tabletop Monitor the operating table s movement and stop the function before any potential collision Pay particular attention to lowered tabletop sections Move the operating tabletop further upward Move the tabletop section in q...

Page 61: ...tions The longitudinal travel is locked when the extension adapter is attached to the operating tabletop If the leg section or back section is tilted downward longitudinal travel may be restricted The adjustment range depends how far the leg section or back section is tilted downward If a larger adjustment range is required the leg section or back section must be moved upward The longitudinal slid...

Page 62: ... the following situations Depending on the longitudinal travel the downward adjustment range of the joints may be restricted If a larger adjustment range is required longitudinal travel must be changed The leg section function is locked when the extension adapter is attached to the operating tabletop The adjustment range of the leg section differs for normal and inverted patient orientation See al...

Page 63: ... In this case when the leg sections are spread and above one another there is a risk of the right leg section colliding with the left leg section Stop the function before any collision and adjust the leg sections so that they are not on top of each other 6 10 11 Flex down flex up The function can only be selected with the remote control Flex down Press the i32 key on the remote control Flex up Pre...

Page 64: ...g table cannot be moved anymore 6 12 Releasing the parking brake and moving the operating table 1 Set the operating tabletop tilt to horizontal i9 i10 key 2 Move the longitudinal travel of the operating tabletop to the level position i16 i17 key 3 Lower the operating tabletop until the information notice 11 on the cladding is completely hidden i6 key 4 If the leg sections on the operating table ar...

Page 65: ...rip the operating table by the operating tabletop s side rails and move it If the patient weighs 160 kg 352 lbs or more the operating table must be moved by 2 or more people If the patient is moved head first a second person must generally accompany the operating table at the patient s head end for safety reasons 6 13 Switching the floor lighting on off The floor lighting can only be switched on a...

Page 66: ...ions of the medical facility as well as the applicable regulations of the state or country Cleaning the operating table with a high pressure cleaner steam cleaner or water jet is prohibited The operating table must not be cleaned mechanically Cleaning is carried out by hand using suitable utensils 7 2 Cleaning and disinfecting agents CAUTION Cleaning and disinfecting agents can cause rashes or irr...

Page 67: ...ion of the cleaning agents and disinfectants The concentration of the disinfectant affects the exposure time The disinfectant used must be allowed to work undisturbed Do not wipe off The operating table must not be dried by the direct effect of heat Lift carry or move the tabletop sections with care Work with an additional person if necessary Never remove multiple tabletop sections or heavy unwiel...

Page 68: ...eight of the operating table with the i5 or i6 key so that the work does not strain your back 7 Pull the mains power cable plug from the socket i11 i11 i5 i6 1 Prepare the operating table as described in Section 7 4 Wear the required personal safety equipment 2 Remove coarse dirt from the operating table using suitable means 3 Prepare the cleaning solution Note the concentration of the cleaning ag...

Page 69: ...the prepared resting surface 7 Clean all residues from the uppermost side of the pad Wipe the sides of the pad again 8 Leave the pads on the resting surface until dry Also ensure that the Velcro tape is completely dry 9 Wipe the surface of the operating tabletop and the individual tabletop sections so there are no residues 10 Wipe the side rails on the operating tabletop and the tabletop sections ...

Page 70: ...able all the way up and wipe thoroughly with a cleaning agent Then move the hook couplings all the way down and clean again so there are no residues 14 Remove the individual tabletop section at the head end of the operating table and place it with the clean dry side facing downwards on the prepared resting surface 15 Clean the uppermost side and the hook couplings of the tabletop section so there ...

Page 71: ...no residues 19 Extend the operating tabletop with the i17 key all the way to the foot end 20 Clean the extended operating tabletop from underneath so there are no residues 21 Move the operating tabletop with the i5 key all the way up 22 Clean the bellows and sheet metal casing from all sides so there are no residues i17 i17 i17 i17 i5 ...

Page 72: ... are completely dry can the disinfection process begin 1 Prepare a suitable disinfectant and disinfection method During disinfection ensure that all surfaces are adequately wetted at all times 2 Prepare an additional resting surface for the padding Disinfect the resting surface Note the disinfectant s exposure time 3 The padding and tabletop sections are still on the disinfected resting surface Di...

Page 73: ... table including the tabletop sections Allow the surface to dry 8 Once the underside of the padding is dry place the padding with the disinfected side facing downward on the additionally disinfected resting surface 9 Disinfect the uppermost side of the pad 10 Attach the pad to the dried tabletop sections on the operating table 11 Disinfect all padding edges again 12 Disinfect the side rails ...

Page 74: ...ey all the way to the head end 14 Disinfect the extended operating table from underneath 15 Extend the operating tabletop with the i17 key all the way to the foot end 16 Disinfect the extended operating table from underneath 17 Move the operating tabletop with the i5 key all the way up i16 i16 i17 i17 i17 i17 i5 ...

Page 75: ... sides 19 Disinfect the running gear from above 20 Disinfect and attach the cladding protection 21 Check the pad for cracks or other visible damage Damaged padding must not be reused 22 Plug the plug on the mains power cable back in the socket 23 Protect the operating table from contamination using suitable materials ...

Page 76: ...key switch on key and simultaneously press the function key required The tilt or longitudinal travel function is not carried out when the key is pressed A warning tone sounds The parking brake on the operating table has been released In this state not all of the adjustment functions are available Activate the operating table s parking brake i45 key No operating table function is carried out when a...

Page 77: ...rning tone sounds during the level position function if the left and right leg sections are moving away from each other When the leg sections are spread and above one another there is a risk that the right leg section will collide with the left leg section The audible signal is a warning tone and does not indicate an error An audible signal sounds when the operating table is being moved The functi...

Page 78: ...alified service technicians only The contact details of service technicians can be obtained from the Technical Customer Service at Trumpf Medizin Systeme Trumpf Medizin Systeme recommends concluding a maintenance agreement so that maintenance can be carried out promptly and reliably 10 Repair The products must be repaired only by qualified service engineers The contact details of service technicia...

Page 79: ...ease contact the Technical Customer Service at Trumpf Medizin Systeme your local dealer or the appropriate national authority In addition to regional disposal faulty or obsolete products can be returned to Trumpf Medizin Systeme Trumpf Medizin Systeme will ensure environmentally sound disposal Detailed information about returns is provided by the Technical Customer Service at Trumpf Medizin System...

Page 80: ...rating table equipment Adjustment range of the functions Lift 550 mm 21 65 in Trendelenburg 35 35 Tilt 25 to the left 25 to the right Longitudinal slide 400 mm 15 75 in 200 mm 7 87 inch in each direction starting from the level position Leg section joint angles relative to the seat section 90 upward 105 downward The figures refer to normal patient orientation Back section joint angles relative to ...

Page 81: ...itals CISPR 11 Class A When used in domestic situations for which Class B is normally required according to CISPR 11 this device may not provide adequate protection from radio services If necessary users must take remedial measures such as the relocation or realignment of the device Key performance features according to IEC 60601 1 The operating table maintains the position set by the user A chang...

Page 82: ...re that it is used in such an environment Immunity testing IEC 60601 1 test level Compliance level Electromagnetic environment guidelines Electrostatic discharge ESD according to IEC 61000 4 2 8 kV contact discharge 15 kV air discharge 8 kV contact discharge 15 kV air discharge The floor should be made of wood or concrete or should be covered with ceramic tiles If a floor is covered with synthetic...

Page 83: ...he electromagnetic environment described below The operator or user must ensure that it is used in such an environment Immunity test IEC 60601 1 test level Compliance level Conducted RF disturbance variables as per IEC 61000 4 6 3 V 0 15 MHz 80 MHz 6 V in the ISM band between 0 15 MHz and 80 Mhz a 3 V 0 15 MHz 80 MHz 6 V in the ISM band between 0 15 MHz and 80 Mhz a Radiated RF disturbance variabl...

Page 84: ...rocedure required for Class I devices shall be carried out in accordance with Article 52 7 taking into account a quality management system in accordance with Annex IX Chapter 1 The manufacturer confirms conformity with the CE marking 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE band 5 Pulse modulation 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE band 1 3 4 ...

Page 85: ...dapter for head positioning 1739994 4990098 Adapter for KIRSCHNER bow 1218837 4990273 Adapter for KIRSCHNER bow single 4544784 4990273 Slider for plaster board 1386129 4990194 Spindle traction mechanism adapter 1593159 4990224 Adapter X RAY 3 joint wide 1430024 4990190 Adapter X RAY double joint wide 1312735 4990190 Adapter X RAY wide 1312733 4990190 Extension pad II pair 1594041 4990223 Anesthesi...

Page 86: ...ion pan 1218883 4990258 Condyle fixation device 1434382 4990261 Connector bracket 4544728 4990249 Connector bracket single 1254739 4990295 Single connector bracket offset 1305449 4990295 Connector bracket with joint 4544729 4990295 Connector bracket with joint short 4544733 4990295 Counter traction post for upper arm positioning 4544765 4990275 Counter traction post 1218835 4990198 Counter tractio...

Page 87: ...ingle 4549730 4990251 Head collar flat 20 1256701 4990175 Helmet for shoulder surgery 1296096 4990188 Horseshoe shaped head rest COMFORT 1537214 4990212 Horseshoe shaped head rest single piece 4549731 4990252 Horseshoe shaped head rest dual piece 4549732 4990253 Head rest X RAY 1300662 4990190 Head section X RAY narrow T 1424588 4990190 Head section X Ray wide 1297207 4990190 Head section X Ray wi...

Page 88: ...18828 4990299 Leg restraint dual piece 1218829 4990299 Meniscus positioning device 4544791 4990264 MIS Hip Device 1574732 4990215 Neuroadapter Carbon wide 1435067 4990058 Padded cuff 1358558 4990241 Pad protection 1756164 4990037 Padded roll 80 mm 1297245 4990297 Swivel side support pad 4544192 4990176 Transfer leg section 1876708 4990054 Transfer leg section pad 1891246 4990054 Pad transfer leg s...

Page 89: ...0185 Arm restraint with Velcro fastener 4544703 4990240 Swivel adapter X RAY 1317786 4990190 Traction boot 1574733 4990214 Traction boot for children 1610541 4990214 Traction unit for upper arm positioning 4544766 4990276 Component transport trolley short 1504926 4990339 Universal strap and hand restraint 1346755 4990241 Universal lateral support height adjustable 4544719 4990247 Universal Seat OT...

Page 90: ...009875 Arm support with trigger U 2013863 Arm support with trigger pad 2013865 Shoulder chair H with support 2065800 Skull pins for adults 4145420 Skull pins for children 4145421 Sterilization wire mesh basket 1 2 1215712 Sterilization wire mesh basket 1 1 1215760 Bilateral hook trolley 1218493 Unilateral hook trolley 1218503 Surgeon s double mounting step 220 440 1218784 Clamp for leg holder 1228...

Page 91: ...of the operating table with the products listed has been tested by Trumpf Medizin Systeme and subjected to a declaration of conformity The following illustration shows the tabletop sections that can be attached at the head or foot end of the operating table The possible configuration of the operating table is defined by the hook couplings The hook coupling type is specified on each tabletop sectio...

Page 92: ...9 Pad TTS Carbon one part B 1873466 54 Carbon 600 tabletop section H V 1739992 Pad TTS Carbon 600 H B 1770133 55 Single part lightweight leg section H V 2012543 Pad leg section single part lightweight H B 1783522 56 Leg section four parts spreadable H V U 1853829 Pad leg section four parts H B 1851579 57 Two part leg section spreadable H U V 1739991 Pad leg section two parts H B 1809671 58 Single ...

Page 93: ...U V 1853828 Pad head section H B 1764878 60 Single joint head section H U V 1769761 Pad head section H B 1764878 61 Seat section extension H V U 1909820 Pad seat section extension H B U 1909819 62 Universal section H V U 2072445 Universal plate pad H B 2072448 63 Shoulder chair H 2009875 Item Product designation Part number ...

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