OPERON D800 and D700 series Operator Manual Sept 2019

Manufactured by: BERCHTOLD GmbH & Co. KG Ludwigstaler Straße 25 78532 Tuttlingen – Germany

Distributed by:

© BERCHTOLD Corporation 1950 Hanahan Road Charleston, SC 29406 www.BERCHTOLD.biz Phone: 843-569-6100 Phone: 800-243-5135 Fax: 843-569-6133

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Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

Table of Contents

1 General ... 6 1.1 About this user manual ... 6 1.2 Definition of symbols used ... 7 1.3 Liability Limitation ... 9 1.4 Copyright protection ... 9 1.5 Warranty provisions ... 10 1.6 Customer service ... 10 1.7 UL Listing ... 10 2 Design and function ... 11 2.1 Overview ... 11 2.2 Brief description ... 12 2.3 Controls ... 12 2.4 Points with increased pinching hazard ... 12 2.5 Scope of delivery ... 13 2.6 Accessories ... 14 3 Installation and initial start-up ... 15 3.1 Prerequisites at the installation site ... 15 3.2 Unpacking and installing ... 16 3.3 Attaching the pads ... 20 3.4 Connecting the hand pendant ... 21 3.5 Connecting the foot control (optional) ... 21 3.6 Connecting the power supply ... 22 3.6.1 Connecting the potential equalization ... 23 3.7 Checks before initial start-up ... 24 4 Operation ... 25 4.1 Safety instructions for operation ... 25 4.2 Patient positioning ... 26 4.3 Software-controlled limits of the OR table ... 26 4.4 Switching the hand pendant on and off ... 29 4.5 Checking the battery charge ... 31 4.6 Locking and unlocking the OR table ... 32 4.7 Setting reverse orientation ... 33 4.8 Movement of the OR Table (on casters) ... 35 4.8.1 Conditions for Repositioning Table with Patient ... 36 4.8.2 Moving the table without InstaDrive™ (without patient) ... 37 4.8.3 Moving the table using InstaDrive™ (without patient) ... 37 4.9 Attaching the InstaDrive™ Arc Docking System (Optional) ... 38 4.10 Position and height adjustment for the OPERON® Table Sections table ... 40

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Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

Table of Contents 4.11 Adjusting patient position ... 41 4.12 Leveling the OR table ... 42 4.13 Using preset positions ... 44 4.14 Operating the foot control (optional) ... 45 4.15 Adjusting the head rest ... 45 4.16 Exchanging table sections ... 47 4.17 Tasks after use ... 51 4.17.1 Charging the batteries ... 58 4.18 Hand pendant care ... 58 5 Technical Data ... 63 5.1 Dimension sheets ... 64 5.2 Patient positioning ... 68 5.2.1 Patient weight and size ... 68 5.3 Motion range limits ... 68 5.4 General information ... 72 5.5 Connection loads ... 73 5.6 Emissions ... 74 5.7 Classification ... 74 5.8 Load capacity ... 74 5.9 Operating conditions ... 74 5.10 Operating fluids ... 75 5.11 Product Label ... 75 6 Safety ... 77 6.1 Intended use ... 77 6.2 Fundamental dangers ... 78 6.3 General risks at the workplace ... 78 6.4 Danger due to mechanical parts ... 79 6.5 Note on X-ray exposure ... 79 6.6 Responsibility of the Device Owner ... 80 6.7 Personnel requirements ... 82 6.7.1 Qualifications ... 82 6.7.2 Unauthorized persons ... 83 6.7.3 Instruction ... 84 6.7.4 Personal protective equipment ... 84 6.7.5 Environmental protection ... 85 6.7.6 Signage and labels ... 86 6.7.7 Warnings on the device ... 86 6.7.8 Spare parts ... 88 6.7.9 Securing device during maintenance ... 88 7 Transport, packaging and storage ... 90 7.1 Transport safety instructions ... 90 7.2 Transport inspection ... 90 7.3 Symbols on the packaging ... 91 4

Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

Table of Contents 7.4 Transport ... 91 7.5 Storage ... 92 8 Maintenance ... 93 8.1 Safety instructions for maintenance ... 93 8.2 Maintenance schedule ... 93 8.3 Measures after completed maintenance ... 95 9 Malfunctions ... 96 9.1 Malfunction indicators ... 96 9.2 Table of malfunctions ... 96 9.3 Troubleshooting tasks ... 97 9.4 Using the Auxiliary hand pendant ... 99 9.4.1 Auxiliary hand pendant D 850 ... 100 9.4.2 Auxiliary hand pendant D 820, D 760 ... 100 10 Disassembly and disposal ... 102 10.1 Safety instructions for disassembly and disposal ... 102 10.2 Disassembly ... 102 10.3 Disposal ... 103 11 Appendix ... 104 11.1 Information on electromagnetic compatibility (EMC) ... 104 11.2 Guidelines and manufacturer's declaration – Electromagnetic emissions ... 104 11.3 Guidelines and manufacturer's declaration – Electromagnetic interference immunity ... 105 Index ... 107

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Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

General

1 General This OPERON® Surgical Mobile Operating Table Operator Manual covers models D860, D850, D830, D820, D770, D760

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. The user should be aware of the difference between table operation for tables with software versions prior to 8.040 All D860, D830, and D770 tables, and D850, D820, and D760 tables starting with the following S/Ns contain software 8.040. D850 S/N 35-XXXXX-V-10841, D820 S/N 34-XXXXXV-10355, D760 S/N 33-XXXXX-V10254. Older tables that have been upgraded to S/W 8.040 are identified by a label annotating S/W 8.040next to the S/N label and on the CPU.

NOTICE 1. Illustrations in this manual, although potentially different from your specific OPERON® Surgical Mobile Operating Table model, are valid for all tables covered by this manual.

NOTICE If you have any questions regarding this manual or if it applies to your table, please call BERCHTOLD Technical Service at 800-243-5135

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Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

General

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.

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

Tips and recommendations

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Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

General

NOTICE Highlights useful tips, recommendations, and information for effi- cient, 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 cur- rent. Disregarding the safety notice can result in serious injury or death. All work must be performed exclusively by skilled electri- cians.

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"

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

Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

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 in- dustrial 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. 9

Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

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 Service at 800-243-5135, Option 2. To contact BERCHTOLD via web, visti: http://www.berchtoldusa.com/contact-us Mailing Address: BERCHTOLD 1950 Hanahan Road Charleston, SC 29406 Phone: 843-569-6100 Phone: 800-243-5135 Fax: 843-569-6133 E-Mail [email protected] We are also always interested in feedback to improve our products.

1.7 UL Listing This device is safety listed to ANSI/AAMI 60601-1, IEC 60601-2-46, and UL file E347014.

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Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

Design and function

2 Design and function 2.1 Overview

1. Head rest

5. Column 11

Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

Design and function 2. Back section

6. Floor stand including cover

3. Hand pendant

7. Leg section

4. Center section

8. Pad

2.2 Brief description The OPERON® Surgical Mobile Operating Table is a battery-driven, and has 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 sections of the OR table can be adjusted using the hand pendant and be individually configured by the user.

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.

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Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

Design and function

1. Kidney elevator (optional)/seat section

6. Side cover/column head cover (during tilting)

2. Kidney elevator (optional)/ section frame

7. Telescope cover/base cover

3. Kidney elevator (optional)/back 8. Base section 4. Head rest at back section

9. Foot pump handle/floor

5. Back and leg plate connection, 10. Split leg section, split leg section frame Leg sections/telescope cover

2.5 Scope of delivery OPERON® MOT OR Table

Contents of the small carton: ¡ Hand pendant 13

Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

Design and function ¡ Head rest ¡ Power cord ¡ Operating manual CAUTION! Depending on scope of delivery, optional accessories may be shipped in separate boxes!

2.6 Accessories CAUTION 1. Adding accessories may reduce the motion limits of the OR table. 2. If you are unsure about the capability of any accessory with your BERCHTOLD OPERON® Surgical Mobile Operating Table, contact BERCHTOLD Technical Service at 800-243-5135, Option 2. Some accessories have not been tested with the OPERON® Surgical Mobile Operating Table and can induce unsafe conditions.

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. Only use accessories approved by the manufacturer.

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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Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

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 all fasteners. 5. Secure components from falling or over balancing. 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 ¡ Ensure that the OR table is easily accessible from all sides. ¡ Lighting is sufficient. ¡ Ventilation is sufficient. ¡ Power supply is available. ¡ Escape routes and life-saving equipment are freely accessible.

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Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

Installation and initial start-up ¡ A maximum relative humidity of 95% is ensured. ¡ Humidity is less than or equal to 95% ¡ 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. See section 11.3.

3.2 Unpacking and installing 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 ¡ Pliers

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Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

Installation and initial start-up

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.

NOTICE Contact the manufacturer prior to unpacking, otherwise the war- ranty 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.

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Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

Installation and initial start-up

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

1. Using two persons, secure the OR table and carefully roll it down the ramp.

WARNING 1. Risk of pinching or crushing from OR table over balancing! Attach module

CAUTION Risk of pinching on section frame!

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Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

Installation and initial start-up

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

CAUTION Risk of section detachment and patient/user injury is possible if the section is not securely locked. If the green markings on both sides of the section frame are not visible, the section is NOT com- pletely locked into place.

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Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760

Installation and initial start-up

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. 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 sec- tion and unhook the Velcro fastener.

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