TRUMPF

TITAN Operating Table User Manual No. 1 July 2005

User Manual

60 Pages

File Type: PDF

File Size: 1.32 MB

File Name: TRUMPF - 1-258761 - TITAN Operating Table User Manual No. 1 July 2005.pdf

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Page 1

TITAN Operating table User Manual

This is a medical product of class I according to appendix IX of the Medical Product Directive (MDD) 93/42/EEC of 14 June 1993. The manufacturer declares that the device is compliant with the fundamental requirements according to Appendix I of MDD, and that a conformity assessment procedure is performed as required for Class I products according to Appendix VII of MDD. This is documented by the CE symbol.

TRUMPF Medizin Systeme GmbH Postfach 24 44 D-07310 Saalfeld Germany TRUMPF Medizin Systeme GmbH Carl-Zeiss-Straße 5 D-07318 Saalfeld Germany Sales and Distribution

Service

Phone

+49 3671 586-0

Telefax

+49 3671 586-166

Phone

+49 3671 586-172 +49 3671 586-176

Telefax

+49 3671 586-175

We are constantly working on further developments. Therefore, please understand that we must reserve the right to change the scope of the delivery in respect of the form, equipment and technology at any time. Reprinting, copying or translating this document, in whole or in part, is forbidden without the express written permission of TRUMPF Medizin Systeme GmbH! All rights under the copyright laws are expressly reserved by TRUMPF Medizin Systeme GmbH. Within the bounds of the legal requirements, the manufacturer is only then responsible for the technical safety characteristics of this apparatus if the maintenance, repairs and modifications to this apparatus are performed by him or by someone appointed by him and in accordance with his instructions.

ATTENTION! This user manual applies to the following sales units: TITAN operating table ... 4 544 260 Cable remote control TITAN ... 1 246 219 IR remote control TITAN ... 1 246 218 Mobile charger... 4 544 122 Wall-fitting charger 230 ... 4 544 123 Wall-fitting charger 24 ... 4 544 139

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Contents

Contents 1 1.1 1.2 1.3

1.4

2 2.1

Important Information Proper Use of the Equipment... 3 Explanation of Symbols... 4 Safety Instructions... 4 General... 5 Changing position... 5 Electricity... 6 Environmental Protection... 7 Protection against Infection... 7 Glossary... 7 Two-key operation... 8 Acoustic signals... 8 Zero Position... 8 Coupling points... 8 Special features... 8

2.3 2.4

Preparatory Work Condition on Delivery... 9 Packaging... 9 Unpacking... 9 Sequence... 9 Installation... 10 Connecting... 11

3 3.1

Charging devices for the IR remote control Charging Readiness... 12

4 4.1 4.2

Control Units Priorities... 13 Operating the Column... 14 Head position... 15 Operating fault... 15 Cable and IR remote control, 1 246 219 / 1 246 218... 16 Connecting the cable remote control... 16 Ready for IR remote control... 16 Functions... 17 Indicators... 18

2.2

4.3

5.1 5.2

Description of the Power Supply Power supply... 19 Duration of use... 19 Charging the batteries... 20 Maintenance Charging... 20 AP Safety... 20 Electrical Safety... 20 Readiness for use with external power supply (mains)... 21 Readiness for use with internal power supply (battery)... 22 Switching on... 22 Standby... 22 Switching off... 22

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Contents 6 6.1 6.2 6.3

7 7.1

7.2 7.3 7.4

7.5

7.6

Travel Modes Free-Wheel (unlocking)...23 Emergency release...24 Directional travel...25 Travel mode...26 Brake...27 Locking...27 Release...27 Operating Table Top TITAN coupling points...28 Definition...28 Overview of coupling variants...29 Coupling Double clamp...30 Uncoupling Double clamp...30 Coupling Single clamp...31 Uncoupling Single clamp...31 Components...32 Coupling points...32 Radiolucence...33 Loading capacity...33 Operating table...33 Standard rails...36 Patient positioning...36 Table top settings...37 Zero position...37 Tilting...38 Anti-/Trendelenburg...39 Raise/lower table...39 Longitudinal displacement...40 Back section...42 Back section joint...43 Leg section joints...44 Exchanging sections...45 Flex/Reflex...46 Using electrical equipment...46 Connecting socket...46

8 8.1 8.2 8.3

Care, Cleaning and Disinfection Control units and charging devices...47 Column/running gear...47 Operating table top...48

9 9.1 9.2 9.3 9.4

Technical data Conditions for Operation, Storage and Transport...49 TITAN operating table...49 Charging devices...50 Fitments and operating table components...51

Troubleshooting...52

Service and Maintenance...54

Scrap disposal...54

Overview: TITAN operating table...55

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Important Information

Important Information Products from TRUMPF Medizin Systeme GmbH are manufactured to give a long and trouble-free service life. Development, design and production by TRUMPF Medizin Systeme GmbH have been certified in accordance with DIN ISO 9001. This guarantees: • highest quality and a long service life, • easy operation, • functional design and • optimisation for the intended purpose. The TITAN operating table fulfils the requirements of the Medizinproduktegesetz MPG (Law on Medical Products) and bears the CE sign. Please read this user manual carefully from the beginning, in order to familiarise yourself step-by-step with the many and varied functions. A comprehensive system of electronic sensors actively ensures safety while the TITAN is being used. Reference is made to any residual dangers at the appropriate points in the manual. Please observe the following instructions!

1.1

Proper Use of the Equipment The TITAN operating table, in conjunction with the stated operating table components is intended for the following purposes: • Holding patients during the operation: - induction of anaesthesia - operation - recovery from anaesthesia • Transporting the patient on the tabletop: - from a patient transfer unit to the operating theatre - from the operating theatre to the patient transfer system • The operating table must be covered with sterile material before use. Intended use includes following the instructions in this user manual. Any other use of the operating table is regarded as incorrect usage. The supplier/manufacturer is not liable for damage to property or injury to persons resulting from incorrect operation of the table or putting it to an improper use.

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Important Information 1.2

Explanation of Symbols Important information in this user manual is marked with symbols and keywords. Keywords such as WARNING, CAUTION or ATTENTION indicate the level of danger involved. The symbols emphasise the message visually. Additional symbols can indicate injury hazards or danger to life and limb. The measures to prevent dangers arising must be implemented without fail! WARNING! Danger to life and limb (for example electric shock)! Risk of serious injuries and damage to property. CAUTION! Risk of injury and damage to property. ATTENTION! Risk of damage to property. NOTE! Useful additional information and tips.

1.3

Safety Instructions In critical situations during operations, it may become absolutely necessary to change the position of the patient by changing the position of the operating table (zero position, Trendelenburg) in order to aid life-saving actions. WARNING! Hazard to the patient! A functional failure of the operating table cannot be completely excluded with the current commercially available state of the art. In this rare case, the motor-driven operating table functions are no longer available during the operation. If the electrical operating table functions fail, the position of the patient can only be changed by using suitable ancillary equipment (for example placing pads underneath the patient) or by removing the patient from the operating table.

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Important Information Please observe the following instructions: General

• Keep a log book for medical apparatus! All services, inspections and repairs are to be documented in this book. • All repairs must be performed in accordance with the safety regulations as per DIN VDE 0750-1/IEC 601-1! • Within the bounds of the legal requirements, the manufacturer is only then responsible for the technical safety characteristics of this apparatus if the maintenance, repairs and modifications are performed by him or by someone appointed by him and in accordance with his instructions. • TRUMPF Medizin Systeme GmbH is not liable for damage of any kind arising from the failure to perform inspections or through inadequate repairs, modifications or maintenance. • The pads specially developed by TRUMPF enable the patient to be positioned in a manner that inhibits the development of pressure necroses. Trained personnel have to eliminate the residual risk by active decubitus prophylaxis when positioning the patient. • The edges of the pads are flush when the operating table components have been attached properly. • Take note of the danger points and risks indicated by the pictograms on the operating table. • Always place the operating table in the zero position before a patient is laid on the tabletop! • Released elements may move autonomously. Check that fixing screws are seated tightly. • Check that all electrical and mechanical functions/parts of the operating table, including accessories are undamaged and in good working order before using them.Defective or damaged products must not be used. • Accessories with removable pads must not be carried by the pads.

Changing position

WARNING! Risk of tipping over! The operating table with patient only unlock or move in compliance with the conditions on page 23! • Secure the patient before adjusting the operating table. The patient must be actively supported when the position is adjusted. • Every change of position, whether executed by motor power or manually, must be performed in a controlled and responsible manner.

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Important Information • Pay close attention to all electrically assisted functions and movements in order to exclude the possibility of - a risk to the patient arising - damage occurring to the equipment, the operating table top or to the furnishings. • When approaching the zero position, inclined patient positions may become steeper than they were before the movement commenced! Only approach the zero position if there is no risk of collision. Watch the approach to the zero position carefully until the end position has been reached. • Pay particular attention during downward movement, as the tabletop may collide with operating accessories lying below it, or it may even contact the floor if it is in an extreme position. In addition, beware of the risk of crushing injuries to persons. Electricity

• Get a qualified electrician to check the electrical safety of the TITAN operating table and the power supply every year! We recommend an annual general safety check by TRUMPF Medizin Systeme GmbH customer service. • The electrically conductive properties of the operating table top comply with the legal requirements if the pads supplied are used and properly secured. • Please perform the recommended care and cleaning of the pads in order to maintain their electrically conductive properties as per DIN EN 60601-1. • Always keep the storage batteries in a state of operational readiness (charged). • The TITAN operating table may only be used with the potential equalisation connected and on an electrically conductive flooring. • The connection for the potential equalisation line on the column head complies with DIN EN 60601-1 (VDE 0750-1). • Power pack cable and potential equalisation line: - Do not crush or runover with castors! - Do not continue to use damaged lines or cables! - Remove before relocating the apparatus. • If devices are attached to the table, they must not have any detrimental effects on safety. In accordance with DIN EN 60601, the regulations of the manufacturer of the device concerned must be observed when it is used on or near operating table tops (e. g. defibrillators, defibrillator monitors, high-frequency surgical devices etc.). • The use of HF surgical devices can lead to operating functions being interrupted.

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Important Information Environmental Protection

• Dispose of all left over cleaning materials and disinfectants and any residues thereof in a safe manner which does not harm the environment! • Utilise the facilities available for recycling batteries which are no longer serviceable. • Ensure that this document is disposed of in a way which does not harm the environment.

Protection against Infection

• Comply with all the stipulations concerning cleaning/ disinfection and sterilisation. Follow the instructions in this manual concerning cleaning, disinfection and sterilisation procedures and the substances to be used. • The operating table and the fitments for patient positioning must be covered with sterile material before use. • Devices and fitments must be cleaned and disinfected before being handed over to service technicians for maintenance and repair work. • Pads which no longer fulfil the requirements concerning hygiene and protection against infection must be replaced.

1.4

Glossary The following terms and abbreviations are used in this user manual:

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Text written in ITALICS

Key designations and inscriptions on the equipment

Number in brackets [50]

Number code for illustrations (Referencing graphics to text)

Fitments

Head/leg sections etc.

Column keypad

Operating keypad on the column

Remote control

Cable and IR remote control

Standard rail

Fixing rails for accessories

Coupling point

Separable joints between the fitments

AP area

Area subject to special conditions as per DIN VDE 0100-710

Zone M

Zone classification as per DIN VDE 0100-710

Identification of the apparatus protection type for apparatus which may be used in the AP area of zone M

Important Information Two-key operation

Press two keys at the same time in the case of - additional equipment with motorised drive operated from the remote or manual control keypads the appropriate + function key

7.24

- selecting functions on the column keypad 2.27

the appropriate

+ function key

Acoustic signals

Zero Position

Error

1x1 s A continuous signal if actuation is constantly incorrect.

Indication

1x0,2 s

Confirmation

2x0,2 s

In the zero position - the section elements are in a horizontal position or above the tabletop, - the additional tabletop movement is reset to zero, - the longitudinal displacement and tilting are in their central positions and - the Anti-/Trendelenburg position is horizontal. Reaching the zero position is confirmed by an acoustic signal.

Coupling points

Joint between the operating table top and the fitments.

Special features

Sections marked with * (star) are available optionally!

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Preparatory Work

2.1

Condition on Delivery Packaging

The TITAN operating table system is supplied in a carton on a pallet. The ordered fitments, individually packed, also lie on the pallet. Package dimensions: Length 1940 mm Width 800 mm Height 1250 mm Weight: TITAN 275 kg plus the weight of the other items in the consignment. NOTE! The packaging is not weatherproof. Store in accordance with the instructions in the technical data.

2.2

Unpacking Sequence

Unpack in a room with a level floor and with sufficient free space for the apparatus to be rolled off the pallet. Unpack in the following sequence of stages: 1,5 m

1. Place the pallet in a position where there is a free space of approx. 1.5 x 5 m available. 2. Open the top of the carton. 3. Pull the two-part ramp out in an upward direction and place it at the front end of the pallet. 4. Free the bottom of the carton from the pallet. 5. Pull the carton off in an upward direction. 6. Remove the delivered parts. 7. Take off the tension bands. 8. Remove the wooden chocks.

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Preparatory Work 9. Press the UNLOCK key on the column keypad for at least 1 second. 2.20

The operating table is now unlocked. CAUTION! Risk of tipping over! Do not allow the operating table to fall over the edge of the pallet. Run the TITAN off the pallet and down the ramp under the control of at least two persons! 10. Move the TITAN carefully off the pallet, down the ramp and to a flat surface. Press the LOCK key on the column keypad for at least 1 second. 2.22

The operating table is now locked. 11. Dispose of the palette, ramp and packing material in a way that safeguards the environment.

2.3

Installation 1. Press the UNLOCK key on the column keypad for at least 1 second 2.20

and push the operating table to its intended location. 2. Set the TITAN down safely in its designated position. 3. Press the LOCK key on the column keypad for at least 1 second. 2.22

The operating table is now locked.

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Preparatory Work 2.4

Connecting ATTENTION! Take note of the mains voltage! Only connect the operating table to an AC voltage corresponding to that shown on its type plate. When disconnecting the power supply, first separate the power cable from the mains network, only then disconnect the cable from the operating table. Connecting to the mains supply:

4.1

4 4.2

2.25

1. Connect the connecting pin [4.1] on the operating table via a potential equalisation cable to the potential equalisation system in the operating theatre. 2. Insert the power supply cable [4.2] into the socket on the TITAN running gear [4]. 3. Insert the power cable plug into an earthed socket. 4. Check that the power supply is connected on indicator of the column keypad. The indicator [2.25] must light up. 5. Operating table is ready for use. CAUTION! Danger of tripping over! Watch out for the power supply and potential equalisation cables, particularly in the vicinity of the operating table. Stop using any cable if it shows signs of crushing or if the insulation is damaged.

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Charging devices for the IR remote control

Charging devices for the IR remote control The charging device is available in two designs for two different supply voltages. - Table charger with connecting cable [5] 4 544 122 for 230 V/ 50/60 Hz - Wall-fitting charger with connecting cable [6] 4 544 123 for 230 V/ 50/60 Hz 4 544 139 for 24 V AC/DC

The table charger [5] can be placed on any table in any position. The rear side of the wall charging device [6] must be screwed to a wall with 2 screws. The charging devices for 230 V can be used at any earthed socket. The low voltage charging device 4 544 139 is connected to a switchable 24 V supply by a plugless connecting line. Device types 4 544 122 and 4 544 123 are disconnected from the power supply by pulling out the mains plug. All these charging devices are maintenance free.

3.1

Charging Readiness 5.2

If the devices have been connected to the mains, a green LED [5.1]/[6.1] on the device will indicate readiness for charging. The charging devices do not have any operating elements. The 9 V NiMH storage battery located in the IR remote control is recharged safely and inductively (non-contact) by inserting it into the retainer pocket [5.2]/[6.2].

5.1 5

6.2 6

NOTE! Place the IR remote control in the charger with the control side facing forwards.

6.1

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Control Units

Control Units The following cable connected control units can be connected to the TITAN operating table: • Cable remote control [7] or • Foot control The operating table can be operated by more than one control unit at the same time: • Column keypad [2] • IR Remote control • Cable remote control [7] or • foot control

4.1

Priorities Entries keyed into the individual control units are accepted in the following order of priority: 1. 2. 3. 4.

Column keypad Cable remote control Foot control IR remote control

Simultaneously pressing several keys leads to acoustic error signals or to functions being executed in order of priority.

2.1

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2.16

NOTE! Functions are only executed if the keys are kept held down. If the key is released, the function also stops. Two key operation is necessary on the column keypad. Exceptions: The selection of the head end can be made directly with keys REVERSE [2.1] and NORMAL [2.16].

Control Units 4.2

Operating the Column 2 2.5

2.2

2.4 2.1

2.26

2.15

2.28

2.25

2.10

2.12

2.11

2.13

2.9

2.14

2.8

2.29 2.3

2.27

2.7

2.6 2.24

2.23 2.22

[2] [2.1] [2.2] [2.3] [2.4] [2.5] [2.6] [2.7] [2.8] [2.9] [2.10] [2.11] [2.12] [2.13]

Column keypad Select head position left -REVERSEIndicator: head position left Longitudinal displacement to foot end Back section, up Leg section, up Longitudinal displacement to head Leg section, down Back section, down Tilting, left Trendelenburg Raise table top Anti-Trendelenburg Lower tabletop

[2.15] [2.16] [2.17] [2.18] [2.19] [2.20] [2.21] [2.22] [2.23] [2.24] [2.25] [2.26] [2.27] [2.28]

[2.14]

Tilting, right

[2.29]

2.16

2.21

2.17 2.20

2.19

2.18

Indicator: head position right Select head position right -NORMALIndicator: TITAN switched on Power-on key, green Zero position Unlock operating table Indicator: TITAN locked Lock operating table Indicator: batteries must be recharged Indicator: batteries charging Indicator: power supply connected Indicator: operating fault Power-off key, orange Indicator: extended longitudinal displacement range Indicator: not in use

NOTE! The individual functions on the column keypad can only be executed with two-key operation. Press the green ON key [2.18] and also the desired function key! Only the head position can be selected directly.

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Control Units Head position 2.15

2.2

2.1

2.16

WARNING! Risk to the patient! Check that the head position of the patient corresponds to that shown on the display [2.2] or [2.15]. If it does not correspond with the indicators, then you must switch over with the REVERSE or NORMAL [2.1]/[2.16] key! If the patient is lying the other way round on the tabletop (head on the leg section end) and no end correction has been made, then the following table movements will be executed at the wrong end: - Trendelenburg - Tilting - Longitudinal displacement - Leg sections - back section These table movements will be executed correctly after the head position has been changed over with the REVERSE [2.1] or NORMAL [2.16] key.

Operating fault 2.26

Signal

Functional disturbances are shown on a display on the column keypad of the TITAN operating table. The different colours of the display have the following meanings:

Meaning

Remedy

Error Operating table available for restricted use

Press zero key. The operating table becomes fully functional once more when the zero position has been reached and the indicator light has gone out. Call Service if the indicator light does not go out.

Error Operating table available for restricted use

Press zero key. The operating table becomes fully functional once more when the zero position has been reached and the indicator light has gone out. Call service!

- Indicator: orange - Indicator: orange - Acoustic signal when function is selected

- Indicator: red

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Control Units 4.3

Cable and IR remote control, 1 246 219 / 1 246 218 Connecting the cable remote control

Insert the plug [7.28] of the cable remote control into one of the connector sockets [3] next to the column keypad.

The cable remote control is ready to function when the TITAN is switched on. If not, press the ON key the column keypad [2]. The cable remote control is supplied with power by the connecting cable. It does not contain any batteries.

7.28

Ready for IR remote control

ATTENTION! Do not use alkaline or zinc-carbon batteries as substitutes for defective batteries! Replace with NiMH (9 V/170 mAh) batteries only! The batteries must be removed from the IR remote control, if the operation table is shut down for a longer period! The IR remote control is supplied with power by its own battery. Recharging the batteries NOTE! Place the IR remote control in the charger with the control side facing forwards. Always insert the IR remote control into the charger after use. This ensures that the unit will be ready for use. If the green indicator on the charging device lights up, it is ready for operation. IR number The transmitter of the IR remote control is assigned to the receiver in the column by an infrared code. NOTE! There is a specific IR remote control with a matching infrared code for each column. The column and IR remote control therefore each carry an IR number for identification. The IR number is located as follows Column: type plate IR remote control: rear side These IR numbers must be identical.

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