TruSystem 7000 Operating Table Instruction Manual Nov 2016

Translation of the original German instruction manual CE mark/Conformity: This is a Class I medical device according to the Council Directive 93/ 42/EEC concerning medical devices and is compliant with the Directive version currently in force at the time of product sale. The manufacturer declares the conformity of this product with the essential requirements of the Council Directive 93/42/EEC concerning medical devices according to Appendix I, as well as the implementation of an assessment procedure required for Class I product conformity under Appendix VII and documents this with the CE mark. ETL mark: Intertek tested the product for the USA and Canada. ETL classification regarding risk of electric shock and fire, as well as mechanical hazard in accordance with ULSTD 60601-1; CAN/CSA STD C22.2 NO.601.1.

Manufacturer and distributor

TRUMPF Medizin Systeme GmbH + Co. KG Carl–Zeiss–Straße 7–9 07318 Saalfeld Germany www.trumpfmedical.com Telephone +49 3671 586–41911 Fax +49 3671 586–41175 Email [email protected]

Sales and Technical Customer Service

TRUMPF Medical Systems, Inc. 1046 LeGrand Blvd. Charleston, SC 29492 United States Telephone +1 888 474 9360

We at Trumpf Medical are constantly developing our products. Therefore, 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 permission of TRUMPF Medizin Systeme GmbH + Co. KG. TRUMPF Medizin Systeme GmbH + Co. KG expressly reserves all rights under copyright law. Within the bounds of the legal requirements, the manufacturer is responsible for the technical safety characteristics of this apparatus only 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.

© TRUMPF Medizin Systeme GmbH + Co. KG

Revision level: 24/11/2016 Document number: 4990043_030_00

This instruction manual applies to the following sales units: Name

Mat. no.

TruSystem 7000

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)

2065385

TruSystem 7000 U14 (MBW) V

2065386

Pad table top TS7000 B

1753616

Pad table top TS7000 URO B

1960742

Pad TS7000 U14 B

2065417

Pad TS7000 U14 URO B

2065670

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

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

Contents

Contents 1 1.1 1.2 1.2.1 1.2.2 1.2.3 1.2.4 1.2.5 1.2.6 1.2.7 1.2.8 1.3

Safety... 8 Definitions...8 Safety instructions... 10 General... 11 Electricity... 13 High-frequency (HF) surgery devices and defibrillators... 15 Pad... 15 Transport/Repositioning... 16 Maintenance/Repair... 18 Protection against infection... 18 Environmental protection... 19 Pictograms on the product... 19

2 2.1 2.2

Important Information... 23 Proper use of the equipment... 25 Key performance feature... 25

3

Unpacking and Setting up the Operating Table... 26

4 4.1 4.2 4.3 4.4

Operating Table Overview... 28 Two-part table top... 28 One-part table top... 30 Model plate... 32 Acoustic signals (factory state)... 33

5

Pad... 34

6 6.1 6.1.1 6.1.2 6.2

Control Units... 36 Column keypad... 36 Overview of functions... 36 Optical indicators... 38 Remote control... 41

7

Malfunction Caused by other Devices... 43

8 8.1 8.2 8.3

Power Supply... 44 Internal power supply... 44 External power supply (line connection)... 44 Charging the operating table... 47

9

Equipotential Bonding... 48

10

Switching the Operating Table On and Off... 48

11

Reset... 49

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

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Contents 12 12.1 12.2 12.3 12.3.1 12.3.2

Coupling Points... 50 Definition...50 Overview...50 Coupling points on the operating table top...52 Two-part table top...52 One-part table top...53

13

Using the Operating Table as an Extension Table... 54

14 14.1 14.2 14.3

Attaching the Section Segment to the Operating Table Top... 55 Section segment without additional locking...55 Section segment with release button...56 Section segment with release handle...57

15

Attaching Accessories to the Operating Table Top... 59

16

Radiolucence... 61

17

Patient Positioning... 62

18 18.1 18.1.1 18.1.2

18.2.4 18.2.5 18.3

Load Capacity... 64 Two-part table top...66 Operating table top with head section and leg sections...66 Operating table top with head section, seat section extension and leg sections...66 Operating table top with seat section extension and upper back section...67 Operating table top with Carbon 600 table top segment...67 Operating table top with Carbon 1200 table top segment...68 Operating table top with extension unit...68 Operating table top with shoulder chair...68 One-part table top...70 Operating table top with head section, upper back section and leg sections...70 Operating table top with Carbon 600 table top segment and leg sections...71 Operating table top with Carbon 1200 table top segment...72 Operating table top with extension unit...72 Side rails...73

19 19.1 19.2 19.3 19.4 19.5 19.6 19.7 19.8 19.9 19.10

Controlling the Operating Table... 75 Key release...77 Selecting the head position...77 Level position...78 Tilt...79 Anti (Reverse)-Trendelenburg/Trendelenburg...79 Lift/lower...80 Longitudinal travel...81 Leg section joints...82 Back section joints...84 Flex/Reflex...85

18.1.3 18.1.4 18.1.5 18.1.6 18.1.7 18.2 18.2.1 18.2.3

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

Contents 20

Configuration... 86

21 21.1 21.2 21.3 21.4 21.5 21.6 21.7

Travel Behavior... 87 Requirements for unlocking, rotating, and moving the operating table... 87 Unlocking the operating table (releasing the brake)... 88 Freewheel... 89 Running gear assistance (directional travel, turning the operating table)... 89 Traction drive (operating table version MB/MBW)... 90 Operating table lock (braking jacks extended)... 91 Emergency release of the running gear of the operating table (unlock)... 92

22

Emergency Mode... 93

23

Care, Cleaning and Disinfection... 94

24 24.1 24.2 24.3

Technical Data... 96 Conditions for operation, storage and transport... 96 Operating table... 97 Cables... 99

25

Troubleshooting... 100

26

Maintenance and Repair... 102

27

Disposal... 103

28

EMC-Verification... 104

29

Information on Ordering Additional Equipment for the Operating Table... 107

30

Radio License (only for Operating Table Version MBW)... 108

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Safety

1

Safety

1.1

Definitions The following keywords and symbols are used in this instruction manual to indicate hazards and important information: Warning symbol

In the safety information, the warning symbol is located in the title field with the colored background, to the left of the signal word (DANGER, WARNING, CAUTION). Safety information with a warning symbol indicates a risk of personal injury. Follow the safety information to reduce risk of injuries or death. Safety instructions without a warning symbol indicate risk of material damage.

Keyword

DANGER WARNING CAUTION NOTICE NOTE

Additional symbol

In the safety information the keywords are located in the title field with the color background. They follow a specific hierarchy and, in conjunction with the warning symbol, indicate the severity of the hazard or the type of information. See the explanations on page 8 and page 9. The additional symbols in the safety information are located to the left, under the title field with the colored background. They should indicate the potential hazard. Example: Crushing hazard

DANGER! Risk of personal injury. Refers to an imminent danger that will result in death or serious injuries if the appropriate precautionary measures are not taken.

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

Safety

DANGER! Risk of personal injury. Refers to an imminent danger that will result in death or serious injuries if the appropriate precautionary measures are not taken.

WARNING! Risk of personal injury. Refers to an imminent danger that can result in death or serious injuries if the appropriate precautionary measures are not taken.

WARNING! Risk of personal injury. Refers to an imminent danger that can result in death or serious 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 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 precautionary measures are not taken.

NOTICE Risk of material damage. Refers to a potential danger that can lead to material damage if the appropriate precautionary measures are not taken.

NOTICE Risk of material damage. Refers to a potential danger that can lead to material damage if the appropriate precautionary measures are not taken.

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Safety

NOTE Refers to a potential detriment, i.e. undesired states or consequences could occur if the corresponding information is not followed.

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.

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. 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.

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. 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.

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

Safety 1.2.1

General

WARNING! Risk of personal injury due to improper handling. This instruction manual must be • read and understood in full by the operating personnel, especially the section “Important Information”, prior to start-up or, if appropriate, communicated by means of an in-house training session taking the level of professional training into account, • strictly adhered to, • and readily accessible at the place of use of the product.

WARNING! Risk of personal injury due to improper 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 equipment”! • at the values specified under “Technical Data”!

WARNING! Risk of personal injury due to improper handling. • All work with or on the operating table (set up, commissioning, operation, maintenance, decommissioning, transport, and disposal) may be performed only by trained staff. • Follow the relevant instruction manuals for the proper and safe use of additional equipment. • Use of the operating table tops is permissible in combination with other Trumpf Medical products. The instruction manuals for the products used must be observed and followed for their use.

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Safety

CAUTION! Risk of personal injury. Hazard to the patient due to improper attachment! Check that the section segments and accessories are securely fastened to the operating table before each use. Spontaneous movement may occur and loose elements may slip out! Loosen control units for adjustment purposes only. Clamp them down immediately thereafter! Always check that fastening elements are secured properly.

CAUTION! Risk of 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! Risk of personal injury. Hazard to the patient due to damaged product. Check that all electrical and mechanical functions/parts of the operating table, including accessories, are undamaged and in good working order before start-up. Defective or damaged products may not be used!

NOTE The manufacturer will not be held liable if • additional components or other accessories that do not meet the manufacturer's specifications are installed or used with this product, • installed safety equipment is removed.

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

Safety 1.2.2

Electricity

WARNING! Risk of personal injury. Position the operating table such that the detachable plug or device couplers are easily accessible. The operating table may only be connected to a power supply with protective conductor. This reduces the risk of electric shock.

WARNING! Risk of personal injury. Have the operating table and power supply electrical safety checked once a year by an electrician. We recommend an annual general safety inspection by TRUMPF Medical Systems, Inc., Technical Customer Service.

WARNING! Risk of personal 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 first use.

WARNING! Risk of personal injury. An extension cord cannot be used with the power cable at the operating table, otherwise, in case of a fault, the permitted patient leakage current threshold for cardiac surgery (applied part CF according to IEC 60601–1) will be exceeded. The fault occurs when the protective conductor is interrupted by a damaged power cable. The operating table must only be connected to the power grid using the original power cord from Trumpf Medical. In addition, the supply voltage must be respected. The operating table must only be connected to the supply voltage indicated on the nameplate.

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

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Safety

WARNING! Risk of personal injury. When used on an electrically conductive floor, the operating table may be used only if connected to an equipotential bonding cable. The equipotential bonding cable connection location on the operating table is in accordance with IEC 60601–1.

CAUTION! Risk of personal injury and material damage. Ensure that the power cable and equipotential bonding cable are not crushed or driven over. Stop using cables if damaged. If there are concerns regarding the safety of the power or equipotential bonding cable, use the internal power supply (battery) only until the corresponding cable can be replaced. 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 requires the use of the pads supplied with the product, which must be properly secured.

NOTICE Risk of material damage to the electronics due to condensation. There is a risk of condensation forming during transport, which could potentially damage electronic components. After delivery of the operating table, it is important to wait a certain period of time before it is switched on or connected to an external power source (at least 12 hours is recommended). Place the operating table in an environment with the same ambient temperature and relative humidity as the room where the table will be used (see page 96). The batteries must be completely recharged after a significant change in temperature or humidity.

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

Safety 1.2.3

High-frequency (HF) surgery devices and defibrillators

WARNING! Risk of personal injury. The operating table is suitable for the use of HF surgical equipment, defibrillators, and defibrillator monitors. Please follow the manufacturer's instruction manual and safety information for the equipment. Trumpf Medical operating tables are electrically conductive in accordance with currently applicable IEC 60601-1 regulations. When high-frequency surgery devices, defibrillators, and defibrillator monitors are used, the patient runs the risk of burns if safety precautions are not followed. • Risk of burns to patient! Position the patient on the operating table isolated from metal parts (operating table, accessories) and conductive pads or tubes. • 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 devices are used simultaneously. 1.2.4

Pad

CAUTION! Risk of personal injury. • The pads and cover retain the patient's body heat, thereby preventing body temperature from falling due to heat diffusion. • The pads can be removed. Use the appropriate Trumpf Medical pads only! Do not position the patient on the operating table without a pad. • Lift the patient into the desired position on the operating table; do not drag the patient over the pads. After each change of position, lift the patient's appropriate body parts. Any wrinkles or shearing forces that have developed will be eliminated. • Do not stick any sharp-edged objects into the pad. Avoid placing sharp objects on the pad. Do not attach any adhesive foil! • For accessories with removable pads, do not carry the accessories by the pad. They may come detached from the pad and fall downward.

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

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Safety 1.2.5

Transport/Repositioning

CAUTION! Risk of personal injury. Occupational safety for personnel: Given their heavy weight, when lifting or carrying the section segments and accessories, or when manually moving the operating table with or without a patient, take extra care not to strain your back! Work with an additional person if necessary. Never couple or uncouple multiple section segments or heavy, unwieldy accessories at the same time! Hold the component securely 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 from the operating table over the back sections or attached section segments. Patients may only get on or off in the area of the support column, using the seat section. Do not sit on the back section or other attached table section segments.

CAUTION! Risk of personal injury. Hazard to the patient! • Always move the operating table to the level position before placing a patient on the table top. • Secure the patient on the operating table (e.g., by using straps), and provide active support to the patient when making adjustments to the operating table!

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

Safety

CAUTION! Risk of personal injury and material damage. Risk of collision when adjusting the operating table! Perform all patient repositioning in a controlled and responsible manner! Pay close attention to all electrically supported operating table functions and movements, up to the final position, to rule out any hazard to the patient and material damage to the operating table, equipment or furnishings. Care must be taken to avoid collisions. The operator must take care to interrupt any function that poses this risk. Pay close attention that no surgical draping, tubing or other objects can be touched and pinched by movable parts. Pay particular attention to the operating table when lowering, since the table top may collide with objects 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 staff. Extreme care should be taken to avoid these risks.

CAUTION! Risk of personal injury and material damage. Hazard to the patient! • Continually monitor the patient's position. When moving to level position on the operating table, larger patient incline positions can occur compared to the initial position. Select the Level position function only if there is no possibility of collisions! Monitor the movement to level position up to the final position. • Risk of physical injury due to the operating table tipping over! Moving the operating table with a patient positioned on it is only permitted if specific conditions are met (see page 87). • Danger of collision! Be especially careful when transporting the operating table! Be careful to avoid collisions with nearby persons or furniture to prevent damage to the table!

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

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Safety 1.2.6

Maintenance/Repair

NOTE • Always retain and fill out a log book for this medical equipment! All servicing, inspections, and repairs are to be documented in this log book. • All repairs have to comply with the safety regulations in IEC 60601–1. • The manufacturer is only responsible, within the bounds of the legal requirements, for the technical safety characteristics of this device, if the maintenance, repairs and modifications to this apparatus are performed by Trumpf Medical service technicians or by personnel authorized and 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 modifications to the product. • To ensure safe use of the operating table, Technical Customer Service must be ordered immediately if there are leaks in the running gear hydraulics system (loss of hydraulic fluid). 1.2.7

Protection against infection

CAUTION! Risk of infection. • Comply with all the stipulations concerning cleaning and disinfection (see page 94). Follow all cleaning and disinfection procedures and use only the disinfectants described in this instruction manual! • Devices and equipment must be cleaned and disinfected before being handed over to service technicians for maintenance and repair work. • Replace pads that no longer meet infection prevention and hygiene requirements.

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

Safety 1.2.8

Environmental protection

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 have become unserviceable. • Follow this document for environmentally friendly disposal (see page 103).

1.3

Pictograms on the product The TruSystem 7000 operating table is equipped with pictograms. The pictograms contain information regarding the operating table or indicate specific dangers at the marked positions. Follow the other pictograms on the section segments and accessories.

WARNING! Risk of personal injury. Note the hazard locations and risks indicated by the pictograms on the operating table.

NOTE All pictograms (adhesive labels) on the device must be complete and legible! They may not be – moved – changed – removed or – covered by other objects. Damaged or missing pictograms are to be replaced according to the specifications. The following pictograms are located on the operating table:

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

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Safety

Item Pictogram

Meaning

Position

[A]

Model plate

Foot end on the running gear in the running gear recess

[B]

Operating table name

On the right side on the topmost cover panel

[C]

Connector pin for equipotential 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 connector socket, at the head end on the running gear

[F]

Connector socket for wired remote control

Under the seat section on the column head (both sides)

[G]

Before retracting the floor jacks, lower On the right and left side of the the patient table lift until the pictogram column is covered.

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