OPERON MOT Operating Manual Feb 2015

OPERON® Mobile operating tables

Table of Contents

1 General ... 6 1.1 About this user manual ... 6 1.2 Definition of symbols used ... 6 1.3 Liability limitation ... 8 1.4 Copyright protection ... 8 1.5 Warranty provisions ... 9 1.6 Customer service ... 9 1.7 CE certificate ... 9 2 Design and function ... 10 2.1 Overview ... 10 2.2 Brief description ... 10 2.3 Controls ... 11 2.4 Points with increased pinching hazard ... 11 2.5 Scope of delivery ... 12 2.6 Accessories ... 12 3 Installation and initial start-up ... 13 3.1 Prerequisites at the installation site ... 13 3.2 Unpacking and installing ... 14 3.3 Attaching the pads ... 16 3.4 Connecting the hand pendant ... 17 3.5 Connecting the foot control (optional) ... 17 3.6 Connecting the power supply ... 18 3.6.1 Connecting the potential equalization ... 19 3.7 Checks before initial start-up ... 19 4 Operation ... 21 4.1 Safety instructions for operation ... 21 4.2 Patient positioning ... 22 4.3 Configuration options (excerpt) ... 23 4.4 Software-controlled limits of the OR table ... 23 4.5 Switching the hand pendant on and off ... 26 4.6 Checking the battery charge ... 27 4.7 Locking and unlocking the OR table ... 28 4.8 Setting reverse orientation ... 28 4.9 Moving the OR table (InstaDrive™, optional) ... 30 4.9.1 Conditions ... 30 4.9.2 Moving the table without InstaDrive ... 32 4.9.3 Moving the table using InstaDrive ... 32 4.10 Changing the module position and height of the OR table ... 33 4.11 Changing patient position ... 35 4.12 Leveling the OR table ... 36 4.13 Using preset positions ... 37 3

OPERON® Mobile operating tables

Table of Contents 4.14 Operating the foot control (optional) ... 38 4.15 Adjusting the head rest ... 39 4.16 Exchanging modules ... 40 4.17 Tasks after use ... 42 4.17.1 Charging the batteries ... 49 5 Technical Data ... 50 5.1 Dimension sheets ... 51 5.2 Patient positioning ... 53 5.2.1 Patient weight and size ... 53 5.3 Motion range limits ... 54 5.4 General information ... 57 5.5 Connection loads ... 58 5.6 Emissions ... 59 5.7 Classification ... 59 5.8 Load capacity ... 59 5.9 Operating conditions ... 60 5.10 Operating fluids ... 60 5.11 Model plate ... 60 6 Safety ... 62 6.1 Intended use ... 62 6.2 Fundamental dangers ... 63 6.3 General risks at the workplace ... 63 6.4 Dangers from electrical energies ... 64 6.5 Dangers from the hydraulics ... 65 6.6 Danger due to mechanical parts ... 66 6.7 Note on X-ray exposures ... 66 6.8 Responsibility of the operator ... 67 6.9 Personnel requirements ... 69 6.9.1 Qualifications ... 69 6.9.2 Unauthorized persons ... 70 6.9.3 Instruction ... 71 6.9.4 Personal protective equipment ... 71 6.9.5 Environmental protection ... 72 6.9.6 Signage and labels ... 72 6.9.7 Warnings on the device ... 73 6.9.8 Spare parts ... 74 6.9.9 Securing device against switch-on ... 74 7 Transport, packaging and storage ... 76 7.1 Transport safety instructions ... 76 7.2 Transport inspection ... 76 7.3 Symbols on the packaging ... 76 7.4 Transport ... 77 7.5 Storage ... 77 4

OPERON® Mobile operating tables

Table of Contents 8 Maintenance ... 79 8.1 Safety instructions for maintenance ... 79 8.2 Maintenance schedule ... 79 8.3 Measures after completed maintenance ... 81 9 Malfunctions ... 82 9.1 Malfunction indicators ... 82 9.2 Table of malfunctions ... 82 9.3 Troubleshooting tasks ... 83 9.4 Using the emergency hand pendant ... 85 9.4.1 Emergency hand pendant OPERON® D 850 ... 85 9.4.2 Emergency hand pendant OPERON® D 820, D 760 ... 86 10 Disassembly and disposal ... 88 10.1 Safety instructions for disassembly and disposal ... 88 10.2 Disassembly ... 88 10.3 Disposal ... 89 11 Appendix ... 90 11.1 Information on electromagnetic compatibility (EMC) ... 90 11.2 Guidelines and manufacturer's declaration – Electromagnetic emissions ... 90 11.3 Guidelines and manufacturer's declaration – Electromagnetic interference immunity ... 90 Index ... 92

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OPERON® Mobile operating tables

General

1 General 1.1 About this user manual This manual provides important instructions on how to handle the device. For safe operation, observe all safety and operating instructions. Local accident prevention and general safety regulations also apply. Read this manual thoroughly before beginning any work! The manual is considered part of the equipment and must be kept in the vicinity of equipment at all times for reference by personnel. If the device is passed to a third party, this manual must accompany it. The illustrations in this manual are intended to provide a better understanding of the device; they are not necessarily drawn to scale and may deviate slightly from the actual version of the device.

1.2 Definition of symbols used Warnings

Symbols are used to indicate warnings in these instructions. A signal word that reflects the extent of the danger precedes each warning. Observe all warning notices and exercise extreme caution to prevent accidents, injuries and property damage.

DANGER Indicates an immediately dangerous situation that, if not avoided, will result in death or serious bodily injury.

WARNING Indicates a possibly dangerous situation that, if not avoided, can result in death or serious bodily injury.

CAUTION Indicates a possibly dangerous situation that, if not avoided, can result in moderate or minor injuries.

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OPERON® Mobile operating tables

General

CAUTION Indicates a possibly dangerous situation that, if not avoided, can result in damage to property.

Tips and recommendations

NOTICE Highlights useful tips, recommendations, and information for efficient, trouble-free operation.

Special safety notices

To draw attention to particular dangers, the following symbol is used in combination with safety notices:

DANGER Risk of electrocution! Indicates life-threatening situations resulting from electrical current. Disregarding the safety notice can result in serious injury or death. All work must be performed exclusively by skilled electricians.

Other marks

To draw attention to operating instructions, results, listings, references, and other elements, the following marks are used in this manual. Mark

Description

1,2,3….

Step-by-step instructions

→

Results of steps performed

↺

References to sections and related documents

¡

List without defined sequence

[Button]

Controls (e.g., button, switch) Display element (e.g., signal lights)

"Display"

Screen elements (e.g., buttons, layout, and function keys)

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OPERON® Mobile operating tables

General

1.3 Liability limitation All specifications and notices in this manual have been compiled with consideration for applicable standards and regulations, the current state of technology, and our many years of experience and knowledge. The manufacturer assumes no liability for damages resulting from ¡ Non-compliance with the manual. ¡ Improper operation. ¡ Work performed by untrained personnel. ¡ Unauthorized modifications. ¡ Technical changes. ¡ Installation of non-approved spare parts. ¡ Performance of unauthorized installation and maintenance work. Explanations and illustrations presented herein may deviate from the actual product delivered in the case of special models, additional options or the latest technical changes. Furthermore, all obligations agreed to in the delivery contract, the general terms and conditions, the manufacturer's delivery terms, and any regulations legally valid at the time the contract is concluded apply. We reserve the right to make technical modifications to improve and further develop the product.

1.4 Copyright protection Treat this manual as confidential. It is exclusively for the use of persons handling the device. This manual may not be transferred to third parties without written approval from BERCHTOLD.

NOTICE The specifications, text, drawings, pictures and other illustrations contained herein are protected by copyright and are subject to industrial property rights. Improper application is punishable by law. Making photocopies of any type or form, including excerpts hereof, as well as using and/or sharing the content of this manual requires written consent from BERCHTOLD. Violators will be liable for damages. Further claims remain reserved.

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OPERON® Mobile operating tables

General

1.5 Warranty provisions The warranty provisions and general terms and conditions may be reviewed and downloaded from the Internet (back of manual).

1.6 Customer service For technical questions, contact BERCHTOLD Technical Customer Service. To find out who your contact is, call, fax, e-mail or contact us via the website at any time ( back of manual). We are also always interested in feedback from you with a view toward improving our products.

1.7 CE certificate The device meets the requirements of the EU directive on medical products 93/42/EEC. You will find the CE certificate on the Type plate.

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OPERON® Mobile operating tables

Design and function

2 Design and function 2.1 Overview

1

Head rest

5

Column

2

Back plate

6

Floor stand including cover

3

Hand pendant

7

Leg plate

4

Center module

8

Pad

2.2 Brief description The OPERON® MOT operating table is a battery-driven, mobile OR table with a number of adjustment options for positioning the patient. It assists in positioning the patient before and during surgery. The hand pendant can be used to move the OR table via InstaDrive™ (optional). The OR table is locked using 4 base control cylinders. The various modules of the OR table can be adjusted using the hand pendant and be individually configured by the user.

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OPERON® Mobile operating tables

Design and function

2.3 Controls NOTICE Functional descriptions of the controls and indicator lights are found in the “Operation” chapter.

2.4 Points with increased pinching hazard NOTICE The following list of pinch points is not comprehensive. Attaching accessories creates others.

1

Kidney elevator (optional)/ seat plate

6

Side cover/column head cover (during tilting)

2

Kidney elevator (optional)/ module frame

7

Telescope cover/base cover

3

Kidney elevator (optional)/ back plate

8

Base

4

Head rest at back plate

9

Foot pump handle/floor

5

Back and leg plate connection, split leg plates/module frame

10

Split leg plates, Leg plates/telescope cover

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OPERON® Mobile operating tables

Design and function

2.5 Scope of delivery OPERON® MOT OR Table

Contents of the small carton: ¡ Hand pendant ¡ Head rest ¡ Power cable ¡ Operating manual NOTICE! Other additional optional accessories (depending on scope of delivery)

2.6 Accessories NOTICE Damage resulting from accessory use! ü Attaching accessories changes the geometry of the table and increases the risk of collision because crash prevention no longer operates to its fullest extent. 1. Use only accessories approved by the manufacturer. 2. Pay attention to altered motion limit ranges resulting from the use of accessories.

NOTICE For a full list of available accessories, see the accessories catalog (on request or via the Internet from www.BERCHTOLD.biz)

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OPERON® Mobile operating tables

Installation and initial start-up

3 Installation and initial start-up Improper installation and initial start-up

WARNING Risk of injury due to improper installation and initial start-up! Improper installation and initial start-up can cause severe injury or damage. 1. Before beginning installation, ensure there is adequate space. 2. Use caution when handling open, sharp-edged components. 3. Keep the installation site clean and organized. Components and tools lying around loose or atop one another are accidents waiting to happen. 4. Install components properly. Comply with specified torques for screws. 5. Secure components from falling or toppling over. ð Before initial installation, do the following: 6. Ensure that all installation work was performed according to the information and instructions in this operating manual and is complete. 7. Ensure that no one is in the hazard zone.

3.1 Prerequisites at the installation site When setting up the OR table, ensure the following: ¡ The installation site is level. ¡ Ensure the OR table will stand securely. ¡ Use the OR table only in rooms for medical purposes (according to VDE 0100-710 or IEC 60364-7-10). ¡ The OR table is easily accessible on all sides. ¡ Lighting is sufficient. ¡ Ventilation is sufficient. ¡ Power supply is available. ¡ Escape routes and life-saving equipment are freely accessible. ¡ A maximum relative humidity of 95% is ensured. 13

OPERON® Mobile operating tables

Installation and initial start-up ¡ The OR table is not exposed to an explosive atmosphere. ¡ The OR table is not exposed to a corrosive atmosphere. ¡ The OR table is not exposed to direct sunlight. ¡ Ambient heat sources cannot add external heat. ¡ There are no sources of dust. ¡ Fire prevention measures have been taken. ¡ The OR table is not exposed to vibration/oscillation. ¡ The flooring is resistant to solvents, impervious to liquids, antistatic and easy to clean. ¡ There are no machines nearby that would cause electrical or electromagnetic interference.

3.2 Unpacking and installing Personnel:

¡ Manufacturer and/or authorized representative

Protective equipment:

¡ Protective clothing ¡ Protective gloves ¡ Safety boots

Special tools:

¡ Spirit level ¡ Protractor ¡ Measuring tape ¡ Wrench 11 mm ¡ Wrench 14 mm ¡ Wire cutters ¡ Flat screwdriver ¡ Pincer

CAUTION Risk of injury due to improper unpacking! ü Improper handling, such as attempting to lift the table by the top segments, can cause injury and seriously damage the OR table. 1. Be sure to follow the unpacking instructions in the order specified.

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OPERON® Mobile operating tables

Installation and initial start-up

NOTICE Contact the manufacturer prior to unpacking, otherwise the warranty is void. See page 2 for the address.

1. Cut through the straps (2) on the transport container (3) and remove the top covers (1). 2. Remove the ramp (wood cover) from the transport container. 3. Carefully cut and remove all straps and the upper cross bracing. 4. Carefully remove the plastic wrapping from the OR table. 5. Check the contents of the carton for completeness. 6. Loosen and remove the wing nuts (4). 7. Loosen and remove transport clamps and straps.

Attach ramp 1. Position the ramp (2) at the side of the pallet and secure it tightly with the wing nuts (1).

Roll the OR table down the ramp

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OPERON® Mobile operating tables

Installation and initial start-up 1. Using two persons, secure the OR table and carefully roll it down the ramp.

WARNING Risk of pinching or crushing from OR table toppling over!

Attach module

CAUTION Risk of pinching on module frame!

1. Carefully slide the module onto the bracket until it snaps into place. The green markings (1) on the side of the module frame are visible. 2. Make sure the module is seated firmly. CAUTION! If the green marking on the module frame is not visible, then the module is not completely locked in place.

CAUTION Risk of injury from locking!

3.3 Attaching the pads CAUTION Risk of injury if incorrect pads are used! ü Using incorrect pads can compromise their antistatic properties during radiation. This can cause an electrostatic shock that can seriously injure the patient and personnel and severely damage critical components. 1. Use only antistatic, conductive, and radiolucent pads. 2. The pads should be initially installed only by the manufacturer's technicians. Personnel:

¡ Manufacturer ¡ Medical specialists

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OPERON® Mobile operating tables

Installation and initial start-up 1. To attach the pads, align them flush with the edge of the table. 2. Press the pads down. ¡ The pads are held in place with Velcro strips. NOTICE! Sample design. Pad shapes and variants can differ depending on the scope of delivery.

NOTICE Removing pads! To remove pads, slide your hand between the pad and base plate and open the Velcro fastener.

3.4 Connecting the hand pendant

1. Attach the hand pendant to the control sleeve by connecting the cable (1) and the jack (3). To do so, open the protective cap (2). Align the red dots on the plug connections.

3.5 Connecting the foot control (optional) 1. Attach the foot control (optional) to the control sleeve by connecting the cable and the jack. Align the red dots on the plug connections. ¡ See Section 3.4 on connecting the hand pendant.

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OPERON® Mobile operating tables

Installation and initial start-up

3.6 Connecting the power supply Electrical current

WARNING Risk of injury by electrical current! ü Touching live components may cause injury due to electrical shock. Damage to insulation or individual components can cause injury. 1. Electrical work is to be performed by skilled electricians only. 2. If insulation is damaged, immediately cut off the power supply and initiate repairs. 3. Do not touch plug with wet hands. 4. Disconnect the power supply by pulling out the plug; never pull on the cable. 5. Route the cable so that it cannot be bent, clamped or run over. 6. Make sure no one can trip over the cable. 7. Do not use an extension cord or multi-outlet power strip. 8. Keep an eye on the power cord when table is moving. 9. Never bypass or deactivate fuses. Make sure the amperage is correct when changing fuses. ð Keep conductive parts away from humidity. It can cause a short circuit.

Personnel:

¡ Medical personnel

Overview of IEC connectors ¡ The indicator light (charge display) is lit, the batteries are charging. 1. Main switch 2. Fuses 3. Socket for the power supply 4. Ground/potential equalization 5. Indicator light (charge display)

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OPERON® Mobile operating tables

Installation and initial start-up

NOTICE Make sure to ground (4) any additional components used.

3.6.1 Connecting the potential equalization Establish potential equalization

Connect the potential equalization cable to the potential equalization pin of the mobile OR table. Connect the other end of the potential equalization cable to the potential equalization pin of the operating room.

NOTICE An authorized service technician must check the electrical conductivity of the product annually.

3.7 Checks before initial start-up NOTICE At storage temperatures below 10° and above 38° the hydraulic fluid can contract/expand too much, adversely affecting the storage modules. This situation resolves itself once the OR table reaches room temperature. Personnel:

¡ Manufacturer 1. Make sure that all accessories and attachments are removed from the packing material. 2. Visually inspect the OR table to ensure that all straps, spacers and other packing materials have been removed. 3. Ensure that the supply voltage is 110/120 V AC 60 Hz or 230 V AC 50 Hz. 4. Check all motion limits (“Motion range limits” section) and all functions (“Operation” section) of the OR table. 5. Check the function of the emergency hand pendant (“Emergency hand pendant” section) and the foot pump ("Operating the foot pump” section). 19

OPERON® Mobile operating tables

Installation and initial start-up 6. Visually check for leaking hydraulic fluid, especially under the base and at the column head covers. If there is a leak, contact the manufacturer (see page 2 for address).

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OPERON® Mobile operating tables

Operation

4 Operation 4.1 Safety instructions for operation Risk of crushing or pinching

WARNING Risk of injury from crushing or pinching at pinch points! ü When moving or repositioning the OR table, the operator or patient can sustain a pinching or crushing injury at a pinch point. 1. Point out pinch points to OR personnel and instruct them accordingly. 2. Ensure there is enough distance between persons and pinch points when the table is being moved. 3. Do not reach into or handle moving parts during use.

CAUTION Material damage from objects on the base cover of the OR table! Objects lying on the base cover can end up in the telescope cover when the OR table is being repositioned and cause massive damage. 1. Never place objects on the base cover.

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