Berchtold Operon D860 User manual

OPERON
Operator Manual
Surgical Mobile Operating Table Models D860, D850, D 830, D820,
D770, D760
Read the instructions before beginning any work!

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: [phone]
Phone: [phone]
Fax: [phone]
2

1General ............................................................................................. 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
2Design 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
3Installation 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
4Operation ....................................................................................... 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 pa-
tient) ............................................................................. 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
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
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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
5Technical 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
6Safety .............................................................................................. 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
7Transport, packaging and storage ............................................. 90
7.1 Transport safety instructions ................................................... 90
7.2 Transport inspection ............................................................... 90
7.3 Symbols on the packaging ................................................... 91
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
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7.4 Transport ................................................................................. 91
7.5 Storage ................................................................................... 92
8Maintenance .................................................................................. 93
8.1 Safety instructions for maintenance ................................... 93
8.2 Maintenance schedule ........................................................ 93
8.3 Measures after completed maintenance ........................... 95
9Malfunctions ................................................................................... 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 – Electromag-
netic emissions ...................................................................... 104
11.3 Guidelines and manufacturer's declaration – Electromag-
netic interference immunity ............................................... 105
Index ............................................................................................. 107
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
Table of Contents
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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 consid-
ered part of the equipment and must be kept in the vicinity of equip-
ment 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 ta-
bles, 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-XXXXX-
V-10355, D760 S/N 33-XXXXX-V10254. Older tables that have been up-
graded 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
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
General
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1.2 Definition of symbols used
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.
Warnings
Tips and recommendations
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
General
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NOTICE
Highlights useful tips, recommendations, and information for effi‐
cient, trouble-free operation.
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.
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)
Special safety notices
Other marks
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
General
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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 ac-
tual 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 manufactur-
er's delivery terms, and any regulations legally valid at the time the con-
tract is concluded apply. We reserve the right to make technical modifi-
cations 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.
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
General
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1.5 Warranty provisions
The warranty provisions and general terms and conditions may be re-
viewed 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: [phone]
Phone: [phone]
Fax: [phone]
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.
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
General
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2 Design and function
2.1 Overview
1. Head rest 5. Column
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
Design and function
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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 ta-
ble is locked using 4 base control cylinders. The various sections of the OR
table can be adjusted using the hand pendant and be individually con-
figured 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.
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
Design and function
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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
section
8. Base
4. Head rest at back section 9. Foot pump handle/floor
5. Back and leg plate connection,
split leg section frame
10. Split leg section,
Leg sections/telescope cover
2.5 Scope of delivery
Contents of the small carton:
¡Hand pendant
OPERON® MOT OR Table
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
Design and function
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¡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 Operat-
ing Table, contact BERCHTOLD Technical Service at
800-243-5135, Option 2. Some accessories have not
been tested with the OPERON® Surgical Mobile Operat-
ing Table and can induce unsafe conditions.
NOTICE
Damage resulting from accessory use!
üAttaching accessories changes the geometry of the ta-
ble and increases the risk of collision because crash pre-
vention 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)
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
Design and function
14

3 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 compo-
nents.
3. Keep the installation site clean and organized. Compo-
nents and tools lying around loose or atop one another
are accidents waiting to happen.
4. Install components properly. Comply with specified tor-
ques for all fasteners.
5. Secure components from falling or over balancing.
ðBefore initial installation, do the following:
6. Ensure that all installation work was performed accord-
ing 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.
Improper installation and
initial start-up
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
Installation and initial start-up
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¡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 electro-
magnetic 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
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
Installation and initial start-up
16

CAUTION
Risk of injury due to improper unpacking!
üImproper 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.
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
Installation and initial start-up
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1. Position the ramp (2) at the side of the pallet and secure it tightly with
the wing nuts (1).
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 balanc-
ing!
CAUTION
Risk of pinching on section frame!
Attach ramp
Roll the OR table down the
ramp
Attach module
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
Installation and initial start-up
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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.
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
Installation and initial start-up
19

3.3 Attaching the pads
CAUTION
Risk of injury if incorrect pads are used!
üUsing incorrect pads can compromise their antistatic
properties during radiation. This can cause an electro-
static shock that can seriously injure the patient and per-
sonnel and severely damage critical components.
1. Use only antistatic, conductive, and radiolucent pads.
2. The pads should be initially installed only by the manu-
facturer'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.
Operator Manual Surgical Mobile Operating Table Models D860, D850, D 830, D820, D770, D760
Installation and initial start-up
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