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Safety

Instruction manual Operating table TruSystem 7000 – 1 730 263 – 11/2016

1.2

Safety instructions

Safety information is defined as measures to protect the user and

patient from dangers than might occur when using the operating

table.

The medical device is subject to special precautions regarding the

electromagnetic compatibility (EMC). Installation and

commissioning must be done in accordance with the EMC notes

specified in this user manual. See section 24.3 on page 99 and

section 28 on page 104.
In critical situations during surgery, changing the patient's position

by means of operating table movements (level position,

Trendelenburg) may be necessary to facilitate lifesaving measures.

In the rare event that an operating table fails during surgery,

alternate measures may need to be taken to reposition the patient.

These measures include supporting the patient with additional pads

or transferring the patient from the operating table.

NOTE

Refers to a potential

detriment

, i.e. undesired states or

consequences could occur if the corresponding information is not

followed.

WARNING!

Risk of personal injury. Patient hazard due to changes to the

product!

Changes to the medical device are prohibited! The manufacturer

will not be held liable if changes are made to the operating table.

WARNING!

Risk of personal injury. Patient hazard due to malfunction!

Given the present state of the art on the market, the possibility of

an operating table malfunction cannot be fully excluded. While

very unlikely, there does exist a possibility that the motorized table

functions may fail during surgery.

Содержание 1604786

Страница 1: ...TruSystem 7000 Operating Table Instruction manual...

Страница 2: ...e we reserve the right to make changes to the format equipment and technology at any time Reprinting copying or translating this document in whole or in part is forbidden without the express written p...

Страница 3: ...1841046 TruSystem 7000 V 1841050 Operating table TruSystem 7000 U 1604788 TruSystem 7000 MBW 1841048 TruSystem 7000 MBW V 1841082 Operating table TruSystem 7000 U MB 1604786 TruSystem 7000 U14 MBW 206...

Страница 4: ...4 Instruction manual Operating table TruSystem 7000 1 730 263 11 2016...

Страница 5: ...n 23 2 1 Proper use of the equipment 25 2 2 Key performance feature 25 3 Unpacking and Setting up the Operating Table 26 4 Operating Table Overview 28 4 1 Two part table top 28 4 2 One part table top...

Страница 6: ...n extension and leg sections 66 18 1 3 Operating table top with seat section extension and upper back section 67 18 1 4 Operating table top with Carbon 600 table top segment 67 18 1 5 Operating table...

Страница 7: ...rive operating table version MB MBW 90 21 6 Operating table lock braking jacks extended 91 21 7 Emergency release of the running gear of the operating table unlock 92 22 Emergency Mode 93 23 Care Clea...

Страница 8: ...or death Safety instructions without a warning symbol indicate risk of material damage DANGER WARNING CAUTION NOTICE NOTE In the safety information the keywords are located in the title field with th...

Страница 9: ...erious injuries if the appropriate precautionary measures are not taken CAUTION Risk of personal injury Refers to a potential danger that can result in minor or moderate injury if the appropriate prec...

Страница 10: ...n the rare event that an operating table fails during surgery alternate measures may need to be taken to reposition the patient These measures include supporting the patient with additional pads or tr...

Страница 11: ...proper handling The TruSystem 7000 operating table is to be used only for the intended purposes specified under Proper use of the equipment with the materials specified under Proper use of the equipme...

Страница 12: ...f personal injury Risk of crushing by moving parts Familiarize yourself with its operating functions before using the product Risk of injury due to overhanging parts Maintain proper distance CAUTION R...

Страница 13: ...l injury Hazard to the patient Always keep the operating table in an operational charged state so that it is ready immediately in case of power supply failure Fully charge the operating table prior to...

Страница 14: ...ed Remove cables prior to relocating the table CAUTION Risk of personal injury The anti static properties of the operating table top comply with the legal requirements Meeting this requirement require...

Страница 15: ...es Make sure the patient does not come into contact with damp towels or pads Only use dry materials The electrically motorized operating table functions can be interrupted when high frequency surgical...

Страница 16: ...urely and do not drop it CAUTION Risk of personal injury Incorrect loading can break the section segments off the operating table or cause the operating table to tip over Do not climb onto or down fro...

Страница 17: ...cts lying below it or it may even make contact the floor if it is set in an extreme position Users should be aware of the fact that there exists a risk of crushing injuries to both the patient and the...

Страница 18: ...trained by Trumpf Medical Trumpf Medical will not be held liable for damage of any kind arising from the failure to perform inspections or as a result of inadequate repairs or maintenance or modifica...

Страница 19: ...g table NOTE Dispose of any remaining cleaning and disinfection materials and any associated residues in a safe and environmentally compatible manner Note recycling possibilities for batteries that ha...

Страница 20: ...ial bonding cable Head end on the running gear D Connector socket for power cable On the cover of the connector socket at the head end on the running gear E 2x 10 AT fuses On the cover of the connecto...

Страница 21: ...n the running gear in the running gear recess next to the software label only for operating table version MBW Identifier of operating table with motorized drive mode and radio module Foot end on the r...

Страница 22: ...able weight of 660 lbs 300 kg consists of the operating table weight itself plus the weight of the connected section segments Foot end on the running gear in the running gear recess next to the radio...

Страница 23: ...e easily accessible for all product users at all times This operating table is safe to use Residual risks are addressed in the respective sections of this manual Pay attention to this information Glos...

Страница 24: ...perating table top are also part of the operating table Column keypad Control keypad on head end of the column Two part table top The table top is made up of a seat section and a lower back section Th...

Страница 25: ...m to the patient transfer unit The rails located below the back section at the interior sides of the bars are intended only for the support of X ray cassettes size 14 inch 35 56 cm Positioning of the...

Страница 26: ...4 Remove the box fasteners below at the pallet 5 Lift the box upward and remove it 6 Remove the scope of delivery notice 7 Take off the straps 8 Remove the securing beams 10 Switch on the operating ta...

Страница 27: ...release of the keypad is indicated by an acoustic signal and the associated indicator lights up The keypad is released for operation for 10 seconds 15 On the column keypad press the LOCK key until an...

Страница 28: ...rview 4 1 Two part table top The TruSystem 7000 operating table has a two part table top with two motor driven joint pairs leg and back section joints and a rigid coupling point Operating table moveme...

Страница 29: ...1 Support for the extension adapter 12 Control unit connector socket head and foot ends 13 Running gear 14 Connector pin for equipotential bonding cable 15 Connector socket for power cable 16 Wheel 17...

Страница 30: ...263 11 2016 4 2 One part table top The TruSystem7000 U14 operating table has a one part table top with two motor driven joint pairs leg and back section joints The traveling movements of the operatin...

Страница 31: ...ion adapter 12 Control unit connector socket head and foot ends 13 Running gear 14 Connector pin for equipotential bonding cable 15 Connector socket for power cable 16 Wheel 17 Fifth wheel for running...

Страница 32: ...50 Hz Max power 700 VA F Operating mode Continuous operation with intermittent load 2 min ON 8 min PAUSE G The device is declared compliant in accordance with the Council Directive 93 42 EEC concerni...

Страница 33: ...m overload limit end position or level position of selected adjustment range reached Single tone Confirmation of operating procedure e g Key lock canceled Double tone Level position reached Double ton...

Страница 34: ...own see section 23 page 94 and is radiolucent Furthermore the pad is latex free and breathable The pad allows pressure necrosis inhibiting positioning of the patient Medically trained personnel must e...

Страница 35: ...truction manual Operating table TruSystem 7000 1 730 263 11 2016 35 pad plate Place the pad on the pad plate press down across the length of the hook and loop fastener and check that it is securely at...

Страница 36: ...on of the graphic representation shows the functions of the operating table with the functions of the operating table column below viewed from the head end The keys for the adjustment functions are id...

Страница 37: ...Tilt right i11 Level position indicator Level position i12 Leg section joint up i13 Leg section joint down i14 Back section joint up i15 Back section joint down i16 Longitudinal travel toward head end...

Страница 38: ...mn keypad is locked A locked key was pressed on the keypad Direct operation of the operating table using the column keypad is not possible Press button i53 The keypad is released for operation for 10...

Страница 39: ...ed manually Block the defective operating table from use for subsequent surgeries Contact Technical Customer Service Locking jacking up i45 illuminated green The operating table is jacked up flashes g...

Страница 40: ...s charging Establish external power supply connection for operating table flashes red Operating table battery is discharged Electricalfunctions are severely limited Operating table shutdown pending Es...

Страница 41: ...i Reverse Trendelenburg i9 Tilt left i10 Tilt right i11 Level position i12 Leg section joint up i13 Leg section joint down i14 Back section joint up i15 Back section joint down i16 Longitudinal travel...

Страница 42: ...le i5 Lift i6 Lower i7 Trendelenburg i8 Anti Reverse Trendelenburg i9 Tilt left i10 Tilt right i11 Level position i12 Leg section joint up i13 Leg section joint down i14 Back section joint up i15 Back...

Страница 43: ...fluorescent lamps RF surgical devices wireless remote controls for other devices for example monitor very bright interior lights WARNING Risk of personal injury Hazard to patients caused by malfunctio...

Страница 44: ...e connected The battery charge status can be seen on the indicator a1 on the column keypad Observe the indicator while using the operating table 8 2 External power supply line connection The operating...

Страница 45: ...tures of anesthetics and air 4 Indicators i1 and a3 on the column keypad light up After a few seconds an audible signal sounds The operating table is only ready for use once the signal tone has sounde...

Страница 46: ...s out and an audible signal sounds 2 Pull the power cable plug from the connector socket on the running gear 1 WARNING Risk of explosion due to flammable gas mixtures There is a risk of explosion in c...

Страница 47: ...n external power supply to the operating table see section 8 2 on page 44 Indicator a3 on the column keypad lights up Indicator a1 on the column keypad flashes green within 1 minute after plugging in...

Страница 48: ...few seconds The operating table is only ready for use once the signal tone has sounded Indicator i1 lights up continuously when the operating table is switched on The operating table is always switche...

Страница 49: ...ithout the operating table controls being used 1 Disconnect the operating table from the power supply see section 8 2 on page 44 2 Press key i2 on the column keypad or remote control for more than 2 s...

Страница 50: ...ction site between the operating table top and additional equipment The different combinations allow the operating table to be assembled in an individual and mechanically safe fashion 12 2 Overview Th...

Страница 51: ...mechanism not on all side rails Accessory parts with a rigid clamp without a movable claw can be slid onto the side rail only on the side with a movable locking mechanism A The clamp will then push b...

Страница 52: ...tion on the operating table top Coupling point Head end 21 Attachment S 9 By default the head section is attached to the lower back section Foot end 22 Motor operated joint with fixing point L 5 By de...

Страница 53: ...int Head end 21 Motor operated joint with fixing point M 7 By default the upper back section or the top section is attached to the seat section Foot end 22 Motor operated joint with fixing point L 5 B...

Страница 54: ...extension unit the user manual of the extensions adapter must be followed Restrictions regarding the extension table The extensions adapter is automatically recognized by the operating table and for...

Страница 55: ...ts of the operating table top 3 Pull the section segment A away from of the operating table top The hooks must be guided precisely into the recesses of the fixtures 4 Check that the section segment is...

Страница 56: ...l section segment with release button is the single joint head section closed section segment Attaching the section segment 1 For a closed section segment bring the joints on the operating table top t...

Страница 57: ...table top until it can be lifted out of the fixing points on the operating table top 14 3 Section segment with release handle A typical section segment with a handle is the one part leg section closed...

Страница 58: ...ntil the locking bolts engage securely on the hooks The hooks must be guided precisely into the recesses of the fixtures Removingthesection segment 1 Pull the right and left handles C on the section s...

Страница 59: ...ok the accessory part A with the claw obliquely from above into the side rail 3 Turn the locking handle on the clamp to tighten The clamp closes CAUTION Risk of personal injury Risk of injury due to i...

Страница 60: ...able Top 60 Instruction manual Operating table TruSystem 7000 1 730 263 11 2016 Removing the accessory 1 Release the locking handle from the clamp The clamp opens 2 Tip the accessory A slightly upward...

Страница 61: ...egion between the struts of the end of the section segment and the cladding of the operating table column The X ray area is dependent on the longitudinal travel of the operating table top The column a...

Страница 62: ...and securely on the operating table top so that the weight is evenly distributed over the operating table top The patient s arms or legs must not extend beyond the end of the operating table top in th...

Страница 63: ...olumn keypad must match the patient s head position Attention the adjustment areas for the inverse and normal patient position may be different because the function is executed in accordance with the...

Страница 64: ...ied with The specifications are contained in the user manual of the products The specified values are valid for the uniform loading distributed load of the operating table top Special cases WARNING Ri...

Страница 65: ...ion Only the flashing evasive movement is permitted on the operating table Example When checking the operating table load the electronics detects a head end overload of the operating table The warning...

Страница 66: ...ating table top 2 A seat section extension 30 and leg sections 29 are attached at the foot end of the operating table top 3 Patient orientation on the operating table top is as normal Permissible load...

Страница 67: ...top segment 32 Carbon 600 table top segment 33 X RAY head positioning accessory 1 No section segment is necessary at the head end of the operating table top 2 A Carbon 600 table top segment 32 with X...

Страница 68: ...foot end of the operating table top 2 Patient orientation on the operating table top is as normal Permissible load 18 1 7 Operating table top with shoulder chair 36 Shoulder chair 37 Head positioning...

Страница 69: ...ient weight 496 lbs 225 kg Patient weights of up to 496 lbs 225 kg are possible with the head positioning accessory retracted The operating table functions can be used without limitation 353 lbs 160 k...

Страница 70: ...le top is as normal Permissible load Attention additional accessories reduce the permissible patient weight 1000 lbs 450 kg Patient weights of up to 1000 lbs 450 kg are possible under the following co...

Страница 71: ...eg sections 32 Carbon 600 table top segment 33 X RAY head positioning accessory 1 Leg sections 29 are attached at the head end of the operating table top 2 A Carbon 600 table top segment 32 with X RAY...

Страница 72: ...d Attention additional accessories reduce the permissible patient weight 18 2 5 Operating table top with extension unit 35 Extension unit 1 The extension unit 35 is attached at the foot end of the ope...

Страница 73: ...amage when permissible loads are exceeded Irrespective of the permissible loads of the individual side rails the total torque on one side about the longitudinal axis of the operating table must not ex...

Страница 74: ...ance l 3 94 10 cm 7 87 20 cm 11 81 30 cm 15 75 40 cm 19 69 50 cm 22 0 lbs 10 kg 7 4 lbf ft 10 Nm 14 8 lbf ft 20 Nm 22 1 lbf ft 30 Nm 29 5 lbf ft 40 Nm 36 9 lbf ft 50 Nm 44 1 lbs 20 kg 14 8 lbf ft 20 N...

Страница 75: ...nctions on the operating table Adjusting the function Hold down the function key on an operating unit until the desired position is reached Function stops in the following situations The key is releas...

Страница 76: ...ng table equipment single jointed head section or double jointed head section on the two part table top head end upper back section and head section single joint or head section double joint head end...

Страница 77: ...ng the head position The head position of the patient must always match the display on the column keypad The operating table top can be set up in the inverse direction for certain patient positions wh...

Страница 78: ...ble in such a manner that they do not collide with other accessories section segments or the operating table during positioning 3 Press key i11 The final level position is indicated when an acoustic s...

Страница 79: ...is smaller The reverse Trendelenburg position needs to be reduced if a larger setting range is required Adjusting the function Press key i9 or i10 For safety reasons the tilt function stops automatica...

Страница 80: ...and stop the function before a hazardous situation arises Clear the area beneath the operating table top move the table top to a higher lift position or raise the corresponding section segments leg ba...

Страница 81: ...atient s weight For heavy patients the adjustment range is smaller If a larger adjustment range is required the inclination of the operating table top must be reduced 4 Longitudinal travel is restrict...

Страница 82: ...ent range of the joints is automatically restricted or locked in the following situations 1 The joints can not be adjusted individually if a closed section segment is attached The closed section segme...

Страница 83: ...essory if it is attached to two joints simultaneously e g colonoscopy roll 2 Arrange accessories on the operating table in such a manner that they do not collide with other accessories section segment...

Страница 84: ...position the back section joints 7 are controlled by the keys for the functions of the leg sections Limitations The adjustment range of the joints is automatically restricted or locked in the followi...

Страница 85: ...table top bends between the seat section and the back section of the table top Flex Reverse Trendelenburg function and back section joints down Reflex Trendelenburg function and back section joints up...

Страница 86: ...for the Tilting Trendelenburg and Longitudinal travel functions The respective function stops automatically upon reaching the newly set position For any further adjustment briefly release the functio...

Страница 87: ...n see page 80 2 Set the operating table top tilt to horizontal see page 79 When the operating table top tilt is greater than 10 10 the lowering of the operating table by the operating table software i...

Страница 88: ...e indicator illuminates on the column keypad according to the function selected The appropriate status pictograms are visible in the remote control display On the remote control the available buttons...

Страница 89: ...the additional wheel 17 3 in the middle under the running gear is extended Indicator i52 on the column keypad lights up The appropriate status pictograms are visible in the remote control display 21...

Страница 90: ...ion drive can be set individually refer to section 20 on page 86 1 Set running gear assistance refer to section 21 4 on page 89 The travel direction keys are visible on the remote control 2 Press and...

Страница 91: ...the column keypad lights up The appropriate status pictogram is visible in the remote control display NOTICE Risk of material damage Risk of collisions The drive unit only supports directional moveme...

Страница 92: ...se 18 at the head end of the running gear until the operating table is completely jacked down All jack props 36 are immediately retracted The appropriate status pictograms are visible in the remote co...

Страница 93: ...on manually for the individual functions The running gear functionality is disabled The emergency mode must only be activated in case of a serious malfunction of the operating table Please contact TRU...

Страница 94: ...pad plate and the underside of the pad CAUTION Risk of personal injury Risk of injury due to uncontrolled movements Always disconnect and isolate the operating table from the external power supply be...

Страница 95: ...tants for plastic parts and pads Alcohol based solutions can damage these surfaces Follow the product manufacturer s instructions when using a disinfectant After cleaning and disinfecting use a dry cl...

Страница 96: ...ms The requirements for the operation of the operating table are as follows Pictogram Meaning Temperature range for storage and transport 5 F to 131 F 15 C to 55 C Air humidity for storage and transpo...

Страница 97: ...ight Two part table top 45 x 21 5 x 3 6 1143 x 545 x 90 mm One part table top 29 5 x 21 5 x 3 6 748 x 545 x 90 mm Weight Two part table top 551 lbs 250 kg One part table top 507 lbs 230 kg Maximum tab...

Страница 98: ...joints Angle specifications in relation to the seat plate 90 upwards 105 downwards Back section joints Angle specifications in relation to the seat plate Two part table top 90 upwards 45 downwards On...

Страница 99: ...tch length 3 3 yd 3 m The cable is permanently connected to the foot switch and cannot be removed Cables sold as spare parts by the manufacturer of the operating table Other accessories and other cabl...

Страница 100: ...le at the moment or not permitted No response when pushing button the battery status display on the column keypad flashes Discharge the operating table Operate the operating table with line power and...

Страница 101: ...osition The operating table drive mode does not operate with wired remote control Power cable connected to the operating table Disconnect the operating table from the line power Leg sections not adjus...

Страница 102: ...iately if there are leaks in the running gear hydraulics system loss of hydraulic fluid Please contact the Technical Customer Service at TRUMPF Medical Systems Inc if you require technical support or...

Страница 103: ...e national authority Trumpf Medical will take back your old equipment or products that are defective or no longer used Please contact Technical Customer Service in Saalfeld for more information When t...

Страница 104: ...s per IEC 61000 3 2 Class A Voltage fluctuation flicker emissions in accordance with IEC 61000 3 3 Compliant Table 2 according to IEC 60601 1 2 2007 Guidelines and manufacturer s declaration electroma...

Страница 105: ...period The supply voltage quality should correspond to that in a typical business or hospital environment If the user of the TruSystem 7000 operating table requires continued operation during interru...

Страница 106: ...recommended safe distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b I...

Страница 107: ...above mentioned device can contribute towards avoiding electromagnetic interference by observing the minimum distance between portable and mobile HF telecommunication devices transmitters and the abov...

Страница 108: ...th the FCC ID TYOJN5148M0 or the IC ID 7438A CYO5148M0 Contains Industry Canada ID IC 7438A CYO5148M0 or 20829 0ANY2400SC1 Contains FCC ID TYOJN5148M0 or 2AGCQANY2400SC1REV0 To comply with FCC s RF ra...

Страница 109: ......

Страница 110: ...0 Fax 49 89 80907 40020 Subsidiaries and Branch Offices France TRUMPF Syst mes M dicaux United Kingdom TRUMPF Medical Systems Ltd Italy TRUMPF MED ITALIA s r l United States of America TRUMPF Medical...

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