OPERON B810 Operating and Installation Manual Rev 1 March 2003

OPERON B 810 SURGICAL TABLE DESCRIPTION OF SYMBOLS

INSTALLATION AND OPERATOR MANUAL 60-001-0220 Rev. 1 ECO 20427(3/2003) New Manual Release Related Publications: Berchtold B 810 Uncrating Instructions 60-000-0002 Berchtold B 810 Service and Parts Manual 60-000-0001

DESCRIPTION OF SYMBOLS & NOTES IN MANUAL The following symbols with related notes appear in this manual.

“WARNING” NOTES ALERT THE USER TO THE POSSIBILITY OF PERSONAL INJURY.

“Caution” notes alert the user to the possibility of damage to the equipment, or to the possibility of effects on the patients or users that may not result in serious injury, but about which the user should be aware.

NOTES” ALERT THE USER TO PERTINENT FACTS AND CONDITIONS.

This manual contains proprietary information of Berchtold Corp. It shall not be reproduced in whole or in part without the written permission of Berchtold Corp. ETL/CETL LISTED TO IEC 601-1. MEDICAL ELECTRICAL EQUIPMENT OPERON™ IS A REGISTERED TRADEMARK OF BERCHTOLD CORPORATION.

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OPERON B 810 SURGICAL TABLE TABLE OF CONTENTS TABLE OF CONTENTS DESCRIPTION OF SYMBOLS

A-1

SAFETY INSTRUCTIONS

S-1

USE CONDITIONS

S-1

POWER SUPPLY

S-1

PINCH POINTS

S-1

CONTROL PENDANTS

S-1

LOAD CAPACITY

S-1

ACCESSORIES DESIGNED BY OTHERS

S-2

PATIENT POSITIONING

S-2

OPERATION

S-2

INSTALLATION INSTRUCTIONS

1-1

ELECTRICAL POWER REQUIREMENTS

1-1

ENVIRONMENTAL REQUIREMENTS

1-1

TOOLS REQUIRED

1-1

UNPACKING

1-2

INSTALLATION

1-4

Installing Pads

1-4

Installing the Headrest

1-4

To Install the Headrest:

1-4

To Remove the Headrest:

1-4

CHECKS AND ADJUSTMENT

1-5

FUSES (Mains AC)

1-5

GENERAL INFORMATION

2-1

GENERAL DESCRIPTION

2-1

RADIOLUCENT TABLE TOP AND PADS

2-1

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OPERON B 810 SURGICAL TABLE TABLE OF CONTENTS INTERCHANGEABLE HEADREST

2-1

POWER SUPPLY

2-1

FUSES

2-2

FLOOR LOCK SYSTEM

2-2

PRIMARY HAND PENDANT

2-3

Primary Hand Pendant Indicators

2-4

Primary Hand Pendant Functions

2-5

FOOTSWITCH (Optional)

2-6

MANUAL FOOT PUMP

2-6

AUXILIARY HAND PENDANT

2-8

AUXILIARY HAND PENDANT DRAWER

2-8

TECHNICAL DATA

2-9

OPERATING INSTRUCTIONS

3-1

PINCH POINTS

3-1

LOAD CAPACITY

3-2

PATIENT ORIENTATION

3-2

PATIENT POSITIONING

3-3

TABLE MOVEMENT WITH PATIENT

3-4

OPERATION

3-4

FUNCTION PRIORITY

3-6

TABLE MOVEMENT LIMITS

3-6

Software-Controlled Limits

3-6

User-Controlled Limits

3-7

HEADREST

3-8

REMOVABLE LEG SECTION

3-8

FOOTSWITCH (Optional)

3-9

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OPERON B 810 SURGICAL TABLE TABLE OF CONTENTS BACKUP INSTRUCTIONS OPERATOR TROUBLESHOOTING GUIDE OPERATOR MAINTENANCE

4-1 4-2 5-1

PERIODIC MAINTENANCE

5-1

CLEANING AND DISINFECTION

5-2

STAINLESS STEEL SURFACES

5-2

Cleaning Methods

5-2

Cleaning Agents

5-2

Removing Stains

5-2

Applying Disinfectants

5-2

PAINTED SURFACES

5-2

CONDUCTIVE ITEMS

5-3

HAND PENDANTS

5-3

PARTS AND ACCESSORIES

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5-3

Rev 1 iii

OPERON B 810 SURGICAL TABLE TABLE OF CONTENTS FIGURES FIGURE S-1. MAXIMUM WEIGHT LOCATION

S-2

FIGURE 1-1. SHIPPING CONTAINER

1-2

FIGURE 1-2. REMOVING SHIPPING CLAMPS

1-3

FIGURE 1-3. PAD SET

1-4

FIGURE 1-4. LOCKING LEVERS

1-4

FIGURE 1-5. HEADREST

1-4

FIGURE 2-1. B 810 SURGICAL TABLE

2-1

FIGURE 2-2. BASE COMPONENTS

2-2

FIGURE 2-3. PRIMARY HAND PENDANT AND FOOTSWITCH CONNECTOR BOX

2-3

FIGURE 2-4. PRIMARY HAND PENDANT INDICATORS

2-4

FIGURE 2-5. PRIMARY HAND PENDANT FUNCTIONS

2-5

FIGURE 2-6. FOOT SWITCH

2-6

FIGURE 2-7. MANUAL FOOT PUMP

2-6

FIGURE 2-8 REMOVING THE FOOT PUMP PEDAL

2-6

FIGURE 2-9 LOCKING THE FOOT PUMP PEDAL FOR USE

2-6

FIGURE 2-10. LOCATION OF AUXILIARY HAND PENDANT AND DRAWER

2-8

FIGURE 3-1. PINCH POINTS

3-1

FIGURE 3-2. NORMAL TABLE ORTIENTATION

3-2

FIGURE 3-3. REVERSE TABLE ORIENTATION

3-3

FIGURE 3-4. NORMAL PERINEAL POSITION

3-3

FIGURE 3-5. REVERSE PERINEAL POSITION

3-3

FIGURE 3-6 HEADREST

3-8

FIGURE 3-7 ALIGNING THE LEG SECTION FOR INSTALLATION

3-8

FIGURE 3-8. LEG SECTION

3-8

FIGURE 3-9 ASSEMBLED LEG SECTION

3-9

FIGURE 3-9. FOOTSWITCH

3-9

FIGURE 4-1.BACKUP SYSTEMS

4-1

FIGURE 4-2 AUXILIARY HAND PENDANT

4-1

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OPERON B 810 SURGICAL TABLE TABLE OF CONTENTS TABLES TABLE 2-1. TECHNICAL DATA

2-9

TABLE 3-1. FUNCTION CONFLICTS

3-6

TABLE 3-2. SOFTWARE-CONTROLLED LIMITS

3-6

TABLE 3-3. USER-CONTROLLED LIMITS

3-7

TABLE 4-1 OPERATOR TROUBLESHOOTING GUIDE

4-2

TABLE 5-1. RECOMMENDED MAINTENANCE SCHEDULE

5-1

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OPERON B 810 SURGICAL TABLE

SPECIAL SAFETY INSTRUCTIONS - IMPORTANT THE SAFETY INSTRUCTIONS THAT FOLLOW APPEAR WITHIN THE MANUAL. READ THEM CAREFULLY BEFORE OPERATING THE UNIT AND FOLLOW INSTRUCTIONS. USE CONDITIONS WARNING — POSSIBLE EXPLOSION HAZARD: Do not operate the table in the presence of flammable anesthetics. The Berchtold B 810 table is designed for use in non-hazardous anesthetizing locations. POWER SUPPLY WARNING — ELECTRICAL HAZARD: Repeated breaker tripping or fuse replacement may indicate a ground fault or overload condition. The table will not operate reliably under such a condition and may be electrically unsafe. Do not use the table until this condition is corrected. PINCH POINTS WARNING — Cutting or crushing injury may occur if any part of a patient or staff member is caught in a pinch point when the table is articulated. WARNING — Damage to the table or object may occur if any foreign object, accessory, clamp, etc., is in a table pinch point when a table function movement is initiated. Pinch points include, but are not limited to: • Kidney elevator to seat channels • Kidney elevator to seat top • Kidney elevator to back section • Back section to side shields • Leg section to side shields • Leg section to column shield • Leg section to base cover • Leg section to seat section • Back section link to seat channel • Column shields to base cover • Side shields to column shields (in tilt) • Floor feet to base • Floor feet to floor • Base to floor • Headrest to back section 60-001-0220

This list is not all-inclusive because pinch points can be created by the attachment of accessories. Always check that the patient and staff are clear of pinch points before and while the table is in motion. Refer to FIGURE 3-1 for details. CONTROL PENDANTS NOTE — The primary hand pendant can be configured for normal or reverse patient orientation by pressing the NORMAL or REVERSE buttons on the pendant. This reverses all functions except floor locking, table up/down, and Kidney up/.down. CAUTION — The auxiliary hand pendant is configured for normal orientation and does not have the following functions: FLEX, REFLEX, AND RETURN TO LEVEL. This pendant is intended to be used along with the manual foot pump for completing procedures, followed by charging the batteries or servicing the table. LOAD CAPACITY This table has a patient lifting and articulation capacity of 600 Ibs. (273 kg). Positioning and constraints is discussed in section S-2. Do not exceed this maximum load in service. See FIGURE S – 1. WARNING — Overloading may result in tipping of the table or failure of the table sections to move. Do not exceed the maximum load in service. NOTE — The use of some accessories will put additional restrictions on patient weight. Accessories provided by Berchtold Corp., when used as intended, are designed to perform safely with the patient loads for which this table was designed.

Rev 1 S-1

OPERON B 810 SURGICAL TABLE

SPECIAL SAFETY INSTRUCTIONS seat section. The patient’s legs may be placed on a leg extension attached to the end of the leg section. Reversed Patient Orientation - The Patient's pelvis should not be extended beyond the back section. The patient’s legs may be placed on a leg extension attached to the end of the back section. Full articulation and full slide in either direction can be safely achieved with a 600lb(273kg) patient if these steps are followed.

A Berchtold Corporation accessory that puts additional restrictions on patient weight, when used as intended, will be clearly labeled to indicate the maximum allowed loads. ACCESSORIES DESIGNED BY OTHERS Berchtold Corporation assumes no liability for table performance when used with accessories designed by others for use on Berchtold equipment, or damage resulting to Berchtold equipment resulting from the use of accessories designed by others.

OPERATION WARNING — The table should always be locked to the floor whenever a patient is on the table or being transferred to or from the table. This is accomplished by extending the table’s feet by activating the FLOOR LOCK function. This table is not intended for patient transport.

PATIENT POSITIONING WARNING — POSSIBILITY OF TIPPING: Table stability may be compromised if patients are positioned beyond the following limits: Normal Patient Orientation The patient's pelvis should not be extended beyond the end of the In Normal Orientation, The patient’s pelvis must not extend beyond the end of the SEAT Section for full slide capability Seat Section

Detachable Leg Section

Footswitch Receptacle

Kidney Elevator

In Reverse Orientation, the patient’s pelvis must not extend beyond the end of the BACK Section for full slide capability. Back Section

Headrest

Primary Hand Pendant

Primary Hand Pendant

Manual Foot Pump Pedal

Floor Feet

Located on this end of Base Power Entry Module, Fuses, and Auxiliary Pendant Drawer

FIGURE S – 1. MAXIMUM WEIGHT LOCATION

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OPERON B 810 SURGICAL TABLE INSTALLATION INSTRUCTIONS INSTALLATION INSTRUCTIONS

ENVIRONMENTAL REQUIREMENTS WARNING— The batteries are sealed to prevent spilling of the acid electrolyte. If punctured and contact is made with the acid, flush with cold water for 15 minutes.

These instructions provide the information necessary to unpack and install the Berchtold B 810 Surgical Table. ELECTRICAL POWER REQUIREMENTS

WARNING— Although the batteries are sealed to prevent spilling, they are vented to allow for normal outgassing. Because of this, the table should not be used in a room that has no ventilation system.

WARNING — Do not operate this table in the presence of flammable anesthetics. This surgical table is designed for use in non-hazardous anesthetizing locations. NOTE — This table has been designed to be connected to circuits installed in accordance with NFPA 70 — National Electrical Code. The user should also be familiar with NFPA 99 — Health Care Facilities. Consult these references if you have any doubt about the compliance of the user’s maintenance program or electrical system with code requirements.

CAUTION — The batteries contain LEAD, and if replaced, need to be recycled in accordance with local environmental regulations. CAUTION — Do not expose the table to steam or heat sources, or place the table where it may be exposed to unusually high temperatures. CAUTION — Allow the table to reach room temperature prior to operation if the table was exposed to excessively hot or cold conditions during transport or storage.

NOTE — This table is classified as Class 1, Type B equipment in its type and degree of protection against electrical shock. The BERCHTOLD B 810 table is completely battery-operated and only requires AC power for battery charging, although it may also be operated directly from AC power. The power supply must be a 120V (+-10%) AC, 50/60 Hz, 6 Amp. The table is provided with a 14-ft. (4.27 m), 16 AWG, three-conductor power cord terminated with a hospital grade, threeprong plug. Attachment of a plug of alternate design, if required, is the responsibility of the customer. The BERCHTOLD B 810 contains two (2) 12V 28amp-hour Sealed Lead Acid (SLA) batteries. The batteries are connected in series to provide 24V for the table’s electrical system. The batteries are fused to prevent high discharge due to a power short. The charging system is designed to allow the table to be connected to AC indefinitely without overcharging or damaging the batteries. Other than periodic charging, the batteries do not require maintenance.

60-001-0220

See “TECHNICAL DATA” in Section 2 for the appropriate environmental conditions for the Berchtold B 810 table. Store the table in a cool, dry place. Do not subject the table to environmental conditions in excess of those specified in table 2. TOOLS REQUIRED The following tools are required: • • • • • • •

Level Angle indicator Tape measure 11 & 14mm socket wrench Diagonal cutters Flathead screwdriver Pliers

Rev 1 1-1

OPERON B 810 SURGICAL TABLE INSTALLATION INSTRUCTIONS UNPACKING WARNING — POSSIBILITY OF INJURY: This table weighs approximately 715 pounds (325 kg). At least two persons are required to remove the table from its shipping container. WARNING — POSSIBILITY OF INJURY: Do not attempt to lift the table by its top sections. Failure to follow uncrating instructions in the order given will result in difficulty in removing the table from the skid and possible personal injury. NOTE — Warranty shall be void if customer fails to call Berchtold Corporation Sales Representative before unpacking. 1. Cut the strapping around the shipping box and remove the top cover. 2. Remove the ramp from the box. 3. Remove the staples around the bottom perimeter of the shipping box with the screwdriver and the pliers. Remove the cardboard cartons from the wooden skid; there is an inner carton and an outer carton. See figure 1. Carton

Top Cover

4. Cut and remove all strapping and top bracing frames. Be careful not to mar finish. Remove the plastic bag covering the table. 5. Check contents of smaller carton: A. B. C. D.

Primary Hand Pendant Headrest Power Cord Installation and Operator Manual

6. Remove primary hand pendant from the smaller carton. Plug pendant into receptacle on the right side of the remote control box located on the left side of the table’s column, aligning the red dots on the connectors. See figure 3. 7. Place the On/Off switch located on the base in the ON position. It is not necessary to plug in the power cord. 8. Press the ON button on the primary hand pendant. The pendant will turn on and illuminate. NOTE — If battery indicator on the primary hand pendant is green or yellow, it is not necessary to use the manual foot pump or plug the table into AC. If battery indicator is red, the table can be plugged into AC; or when using the auxiliary hand pendant, follow the manual foot pump procedure outlined in the Installation and Operators Manual. NOTE — The primary hand pendant will automatically turn off after 90 seconds if a table function is not selected and the table is not plugged into AC. To reactivate the pendant, press either the pendants ON button or a function button to move the selected function.

Staples

9. Press the LOCK Button on the primary hand pendant to extend the locking cylinders. The LOCK LED on the primary hand pendant will illuminate.

FIGURE 1-1 SHIPPING CONTAINER

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OPERON B 810 SURGICAL TABLE INSTALLATION INSTRUCTIONS 10. Remove the four sets of lag screws, washers, and wooden clamps that retain the floor feet. See figure 2. 11. Align ramp on either side of skid and insert 1/2” hex head bolts. Bolts are taped to the outside of the instruction manual package, inside the cardboard shipping carton. 12. Press the UNLOCK button on the pendant. This will raise the feet and allow the casters to rest on the skid.

CAUTION — Do not attempt to lift the table by its seat section or siderails. Do not allow the table to drop off the ramp, as this can damage the casters. WARNING — POSSIBILITY OF TIPPING: The table will roll freely. At least two people are required to roll the table down the ramp. 13. Slowly move the table down the ramp.

FIGURE 1-2. SHIPPING CLAMPS AND RAMP

Ramp

60-001-0220

Bolt to secure ramp to skid. Bracket is shipped secured to ramp. Two (2) brackets per ramp.

Shipping clamps, Four (4) total, one (1) per corner. Each clamp secured to skid with two (2) 11mm or 14mm Bolts.

Rev 1 1-3

OPERON B 810 SURGICAL TABLE INSTALLATION INSTRUCTIONS INSTALLATION

To Install the Headrest:

Installing Pads

1. Slide the headrest into its location as far as possible, until you hear the locks engage.

The tabletop is fitted with a matching set of conductive radiolucent pads.

2. Pull the headrest towards you to ensure that it is locked into place.

FIGURE 1-5. HEADREST FIGURE 1-3. PAD SET To install the pads, align them with the edge of the tabletop and press down. Velcro tape will hold the pads in place. To remove the pads, peel them from the tabletop by pulling up at one corner. If pad replacement is necessary, replace with Berchtold replacement pads. Cleaning instructions are outlined in Section 5, Operator Maintenance.

To Remove the Headrest: 1. Depress the two locking levers on the underside of the table, simultaneously pulling the headrest away from the table. 2. Grasp the headrest on each side and remove.

Installing the Headrest The headrest can be installed at either end of the table. Attach headrest to back/seat section for standard table set-up.

FIGURE 1-4. LOCKING LEVERS Locking levers are located on the underside at the end of the back and leg sections, and are used to secure the headrest. The levers have two positions, locked and unlocked.

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Rev 1 1-4

OPERON B 810 SURGICAL TABLE INSTALLATION INSTRUCTIONS CHECKS AND ADJUSTMENT WARNING — The installation checkout is necessary to ensure that handling during shipment did not damage the table. NOTE — If the table was stored where the ambient temperatures were significantly hotter or colder in storage than 50° to 100° Fahrenheit (10° to 38° Celsius), the table’s hydraulic fluid may have expanded or contracted enough to affect the positions of table sections. This situation will correct itself as the table warms or cools to room temperature After carefully uncrating the table, perform the following checks: 1. Be sure that all accessories and attachments have been removed from packing material. 2. Examine table to be sure that all straps, shims, and other packaging materials have been removed. 3. Verify that the AC line voltage (mains) is within the range of 108-132VAC.

• • • • •

Kidney elevator raises 3'' (76 mm) above table surface and retracts properly. Trendelenburg and reverse Trendelenburg allows movement to 30° above and below horizontal. Flex position enables formation of an inverted “V” of 225°. Reflex position enables formation of a 80° “V”. Auxiliary control pendant and manual foot pump operate correctly.

5. Inspect exterior surfaces for presence of hydraulic fluid, especially under the base and side panels. If a leak is evident, contact the manufacturer. 6. It is recommended the batteries are fully charged overnight before introducing table into service. The charging system is activated when the table is plugged into mains AC power (hospital receptacle) and the green charging indicator lamp next to the plug is illuminated. AC FUSES (Mains AC) The table has been supplied with two 6-amp 5x20mm time delay fuses in the power cord receptacle.

4. Operate the table to confirm the articulation range of all functions. Follow the checklist below: • •

• • • •

Table locking system engages and disengages properly and immobilizes table properly. Tabletop travels from a minimum height of 28'' (711 mm) to a maximum of 48” (1219 mm) (without pads). Slide forward and reverse moves tabletop through 12'' (305 mm) of travel. Tabletop tilts right and left 20°. Leg section adjusts from 2° above horizontal to a minimum of 105° below horizontal. Back section adjusts from 80° above horizontal to 45° below horizontal.

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Rev 1 1-5

OPERON B 810 SURGICAL TABLE GENERAL INFORMATION GENERAL INFORMATION GENERAL DESCRIPTION The Berchtold table is a remote controlled, full-function surgical table offering a high level of patient positioning and imaging flexibility to the surgical team. The table can be powered by AC power through the power cord (input range of 115V ±10%), or by battery power which requires no power cord, except when charging the batteries. Hydraulic cylinders are used to articulate the table's sections. Hydraulic pressure is provided by a motor driven pump during normal use, and by a manual foot pump in manual back-up mode. A hand-held control pendant is used to control table positions. The tabletop is divided into the following sections: Headrest, Back Section, Kidney Elevator, Seat Section, and Leg Section. A leg extension can be added to extend the tabletop surface. RADIOLUCENT TABLE TOP AND PADS The tabletop surface is made from electrically conductive radiolucent panels. The table is fitted with a matching set of conductive radiolucent pads. Velcro tape holds the pads in place.

CAUTION — Protect the top and bottom surfaces from nicks and scratches. Scratches more than 0.005 inches (127 microns) deep may appear on x-rays. Damaged or scratched panels should be replaced if x-ray quality is affected. Each table section has a cassette channel that can accommodate x-ray cassettes up to 14'' x 17'' (356 x 432 mm). INTERCHANGEABLE HEADREST The tabletop has perineal cutouts in both the seat and back sections. The back/seat pad can be reversed to expose the desired cutout. The headrest can be interchanged to allow for normal and reversed patient orientation. See FIGURE 2 – 1. POWER SUPPLY WARNING — Repeated breaker tripping or fuse replacement may indicate a ground fault or overload condition. The table will not operate reliably under these conditions, and may be electrically unsafe. Do not use the table until these conditions are corrected.

Primary Hand Pendant Receptacle Primary Hand Pendant

FIGURE 2-1. BERCHTOLD B 810 SURGICAL TABLE

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OPERON B 810 SURGICAL TABLE GENERAL INFORMATION Auxiliary Hand Pendant Drawer

Power Entry Cover

5x20mm 6A Fuse Drawer, Time delay

Manual Foot Pump Pedal

AC Mains Fuses (2) Charging Indicator Grounding Post

4 ATO Fuses (2) 20A (2) 2A Fuse Cover DC Battery, Pump And Solenoid Fuses (4)

Floor Feet Power Cord Receptacle

Caster

ON/OFF Switch FIGURE 2-2. BASE COMPONENTS NOTE — Recharge the batteries as indicated by the battery indicator on the control pendant. For longevity, it is good practice to charge the batteries at least once a week When the table is plugged into a 120VAC receptacle, it is powered by AC (mains). When the power cord is not plugged in, the batteries provide power to the table. In either case, the ON/OFF switch on the base must be ON to articulate any table sections. When the ON/OFF switch on the base is OFF, the table's electronics and pump motor are isolated from the power supply and the batteries, regardless of the pendant used. When the charge indicator lamp near the power cord receptacle is illuminated, AC power is sensed by the table and the battery charging system is activated. If AC is present, the battery charging system is activated whether the ON/OFF switch on the base is ON or OFF. The table can remain plugged into AC indefinitely without damaging the batteries. The battery indicator on the primary hand pendant displays Battery charge status. This display has three sections: green (full charge), yellow (low charge) and red

60-001-0220

(recharge). Only one color will be activated at a time. NOTE — In the unlikely event of a control failure, the table movements can be stopped by switching the breaker on the base to the off (down) position. FUSES There are two sets of fuses that are accessible without removing the base covers. The first set contains two fuses that are located within the receptacle for the power cord. These fuses protect against current surges in the AC (mains) line. The second set contains four fuses that are located behind the hinged door next to the ON/OFF switch. These fuses protect against surges in the DC circuitry. See FIGURE 2 – 2. FLOOR LOCK SYSTEM Four self-stabilizing floor feet compensate up to 1/4'' (6 mm) for unlevel floors. The floor feet can be lowered (locked) or raised (unlocked) using the control pendant. When the floor feet are raised, the table rests on four non-conductive casters. Rev 1 2-2

OPERON B 810 SURGICAL TABLE GENERAL INFORMATION PRIMARY HAND PENDANT A primary hand pendant controls all table functions. The floor feet must be locked by activating the FLOOR LOCK function to operate the other pendant functions. This ensures that the table base will not move while the tabletop is articulating.

dot on the connector aligns with a red dot on the socket in the Primary Hand Pendant Connector Box. See FIGURE 2 – 3 for the location. NOTE — The On/Off function on the control pendant may be used to stop the table while in motion.

The primary hand pendant plugs into the right side of the remote control connector box, which is located on the left side of the table. Insert the pendant such that the red

Primary Hand Pendant

FIGURE 2-3. PRIMARY HAND PENDANT AND FOOTSWITCH CONNECTOR BOX

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OPERON B 810 SURGICAL TABLE GENERAL INFORMATION Primary Hand Pendant Indicators 1. DWR (orange) — Auxiliary hand pendant drawer is open. THE PRIMARY HAND PENDANT WILL STILL BE ENABLED IF THE AUXILIARY HAND PENDANT DRAWER IS OPEN. 2. SERV (red) — Table malfunction. It is likely that most of the functions still work properly and can still be controlled from the primary hand pendant. If the control pendant is not working, however, use the auxiliary hand pendant and the manual foot pump to articulate the table until the malfunction can be repaired. NOTE — If the SERV indicator lights, call your local Berchtold Corporation. Service Representative. 3. REV (orange) — Indicates reverse orientation of controls. 4. FLOOR UNLOCK ² — Floor feet are raised so table is mobile. 5. FLOOR LOCK ± — Floor feet are lowered so table is locked. 6. BATTERY — Indicates charge status of the batteries: ¾ Green — Full to medium charge. Normal Operation. ¾ Yellow — Low charge. Table still operates normally, but batteries should be charged at the first opportunity. ¾ Red (flashing) — Recharge battery. Pump motor is shut off and manual foot pump must be used. ¾ Red (steady) — Auxiliary pendant must be used. Recharge battery immediately!

FIGURE 2 - 4. PRIMARY HAND PENDANT INDICATORS

7. ON  (green) — Control pendant is activated. See FIGURE 2 – 4. For location of indicators

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OPERON B 810 SURGICAL TABLE GENERAL INFORMATION Primary Hand Pendant Functions WARNING — The primary hand pendant is configured for normal patient orientation. If the patient is reversed, the Back function must be used to raise or lower the patient's legs and the Leg function must be used to raise or lower the patient's back. Trendelenburg, tilt and slide functions are also reversed if the patient is in reverse orientation. 1. BACK v — Raises and lowers the back section.

12. ON/OFF — Turns the primary hand pendant on and off. The pendant will be backlit when activated. NOTE — After 90 seconds of nonuse, and if AC power is not sensed as being present, the auto-shutdown feature will turn the control pendant off. If AC is sensed as being present, the auto-shutdown feature is disabled. To reactivate the pendant, press the pendant's ON button, or press any function button to move the selected function.

2. Table v — Raises and lowers the entire tabletop. 3. LEG v — Raises and lowers the leg section. 4. TREND/REV TREND (Trendelenburg) — Tilts the entire tabletop about the transverse axis. 5. REV SLIDE/FWD SLIDE — Slides the table top toward the head and away from the head. 6. TILT LEFT/TILT RIGHT — Tilts the entire tabletop about the head to foot axis. 7. UP KIDNEY/DOWN KIDNEY — Raises and lowers the kidney elevator. 8. FLEX/REFLEX — Flex combines Back Down with Reverse Trendelenburg to form an inverted V (jackknife position). Reflex combines Back Up and Trendelenburg. 9. LEVEL — Moves the table back into a horizontal level position. To within 1 degree of level. 10. ORIENTATION NORM/REV — In REV mode, the buttons function in reverse. REFLEX is disabled in Reverse Orientation. Table up/down, Floor Lock/Unlock, and Kidney up/down are not reversed. 11. FLOOR ² / ± — Raises (unlocks) or lowers (locks) the floor feet. 60-001-0220

FIGURE 2 – 5 PRIMARY HAND PENDANT FUNCTIONS

Rev 1 2-5

OPERON B 810 SURGICAL TABLE GENERAL INFORMATION FOOTSWITCH (OPTIONAL)

To use the manual foot pump:

A Footswitch control is available for procedures where the surgeon is normally seated at the pelvic end of the patient. Footswitch functions include: Trendelenburg/Reverse Trendelenburg, Table Up/Down, and Tilt Left/Tilt Right. The footswitch is connected into the Remote Control Connector Box by aligning the red dot on the footswitch connector with the red dot on the socket in the Remote Control Connector Box. See FIGURE 2 – 3 for location of connector.

1. Pull the foot pedal straight out as far as it will go. See figure 2-8.

Pull pedal straight out FIGURE 2-8 REMOVING FOOT PUMP PEDAL 2. Rotate the pedal clockwise until the pedal can be pulled out further. Extend the pedal until it snaps into position. See figure 2-9. FIGURE 2-6. FOOTSWITCH MANUAL FOOT PUMP

Note the retracted position locking dimple

The manual foot pump is used to provide hydraulic pressure when: • • •

the red battery indicator is lit, either flashing or steady the auxiliary control pendant is used a power failure necessitates its use.

The manual pump pedal is located at the head end of the base. See figure 2-7. 1. Rotate Lever clockwise

2. Pull Lever out until it locks

FIGURE 2-9 LOCKING FOOT PUMP PEDAL FOR USE FIGURE 2-7 MANUAL FOOT PUMP 60-001-0220

Rev 1 2-6

OPERON B 810 SURGICAL TABLE GENERAL INFORMATION 3. To articulate the table, press and hold the desired function button on the auxiliary control pendant (see next section) and operate the manual pump with your foot. For best results, depress the pump pedal completely, making full strokes, at the rate of about one stroke per second. To re-insert the pump pedal: 1. Push the pedal back into the table until the end is close to the base cover 2. Rotate the pedal counterclockwise until the end aligns with the hole in the base cover. 3. Continue to push the pedal into the table until it snaps into the retracted position.

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OPERON B 810 SURGICAL TABLE GENERAL INFORMATION AUXILIARY HAND PENDANT The yellow auxiliary hand pendant is located in the auxiliary hand pendant control drawer on the head end of the base. Use the auxiliary control pendant when: • •

the primary hand pendant will not function the batteries are nearly discharged, AC is not available, and the table must be mobilized.

See FIGURE 2-10 for location of the Auxiliary Hand Pendant and drawer. WARNING — The auxiliary hand pendant is configured for normal patient orientation. If the patient is reversed, the Back function must be used to raise or lower the patient's legs and the Leg function must be used to raise or lower the patient's back. Trendelenburg, tilt and slide functions are also reversed with respect to the patient’s orientation. WARNING — The auxiliary hand pendant functions will operate regardless of whether the floor feet are locked or unlocked. If the floor feet are unlocked, the table may roll when the manual pump is operated.

CAUTION — The auxiliary hand pendant does not have the following functions: FLEX, REFLEX, AND RETURN TO LEVEL. This pendant is intended to be used along with the manual foot pump for completing procedures, followed by charging the batteries or servicing the table. AUXILIARY CONTROL DRAWER To remove the auxiliary control pendant, pull the finger pull-tab and slide the drawer open. When the drawer is open, power is provided to the auxiliary pendant. Opening the auxiliary hand pendant drawer does NOT disable the primary hand pendant. NOTE — When the auxiliary hand pendant is in use, the pendant drawer may be partially closed to prevent fluids from entering the drawer. The manual foot pump must be used to provide hydraulic pressure when the auxiliary hand pendant is used. To use the auxiliary hand pendant, press and hold the desired function button, while operating the manual foot pump. See FIGURE 2 - 10. For location of Auxiliary Hand Pendant Drawer.

FIGURE 2 – 10 LOCATION OF AUXILIARY PENDANT AND DRAWER

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OPERON B 810 SURGICAL TABLE GENERAL INFORMATION TABLE 2-1. TECHNICAL DATA Electrical Power Requirements

120V AC, 50/60 Hz, 6A, Single-phase.

Environmental and Storage Requirements: Operation

Ambient temperature range of 50 to 100° F (10 to 38°C), relative humidity range of 10% to 95%, at altitudes from sea level to 8000ft.

Transport and Storage

Ambient temperature range of –30 to +150°F (34 to 66°C) relative humidity range of 0% to 95% at altitudes from sea level to 50,000 ft.

Table Top

Radiolucent and conductive carbon fiber panels conform to 21 CFR Subchapter J, Radiation Control for Health and Safety Act of 1968.

Dimensions: Length Width Height Weight Range of Motion: Trendelenburg Reverse Trendelenburg Lateral Tilt Back Section

76 inches (1930 mm) 21 inches (533 mm); excluding the side rails. 28 to 48 inches (711 mm to 1219 mm) Approximately 715 lbs. (325 kg)

Longitudinal Slide Flex Reflex

Up to 30° Up to 30° Up to 20° right or left From 45° below horizontal to 80° above horizontal Extendable up to 3 inches (76 mm) From 2° above horizontal to 105° below horizontal Adjustable from 90° below horizontal to 90° above horizontal in 15° increments 12 inches (305mm) total 225° 80°

Load Capacity: Lifting and Articulation

600 lbs. (273 kg)

Kidney Elevator Leg Section Headrest

Berchtold Corp. will make upon request, circuit diagrams, component part lists, descriptions, and other information needed to assist service personnel in the maintenance and repair of the B 810 Surgical Table. The service and parts manual, pt # 60-000-0001, can be ordered by calling the phone number on page 5-3.

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Technical assistance can also be obtained by calling the number on page 5-3.

Rev 1 2-9

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS This list is not all-inclusive because pinch points can be created by the attachment of accessories. Always ensure that the patient and staff are clear of all pinch points before moving the table or while the table is in motion.

OPERATING INSTRUCTIONS PINCH POINTS WARNING — Cutting or crushing injury may occur if any part of a patient or staff member is caught in a pinch point when the table is articulated.

Pinch points include but are not limited to: 1. Kidney elevator to seat top 2. Kidney elevator to seat channels 3. Kidney elevator to back section 4. Headrest to back section 5. Back section link to seat channel 6. Back section to side shields 7. Side shields to column shields (in tilt) 8. Column shields to base cover 9. Base to floor 10. Floor feet to base 11. Floor feet to floor 12. Leg section to base cover 13. Leg section to column shield 14. Leg section to side shields 15. Leg section to seat section.

CAUTION — Damage to the table or object may occur if any foreign object is caught in a table pinch point when the table is articulated. Due to the variety of table positions attainable with the Berchtold B 810 table, pinch or crushing points exists. The OR staff must be trained to ensure that body parts or surgical apparatus are not caught in pinch points when the table is operated.

1

2

3

15

5 14

4

6

Shield 7 13 12

11

8

10

9

FIGURE 3 – 1. PINCH POINTS 60-001-0220 3-1

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS WARNING — When using the table in the vicinity of high-frequency surgical equipment, such as cardiac defibrillators, and cardiac defibrillator monitors, refer to the manufacturers’ instructions to ensure compatibility issues are considered. This surgical table has been tested to EN 60601-1-2 to ensure proper electromagnetic compatibility. Other products used in the vicinity of the surgical table should also comply with this standard. If they do not comply, interference between products resulting in unintended responses may occur. Please contact the appropriate manufacturer(s) if any problems arise. If the integrity of the external protective earth conductor arrangement is in doubt, the surgical table should be operated from its internal electrical power source (batteries) until the situation is corrected. The batteries require charging at least once a week. If the integrity of the external protective earth conductor arrangement is in doubt, and the batteries are not charged, operate the surgical table with the manual foot pump and the auxiliary hand pendant until the situation is corrected.

PATIENT ORIENTATION WARNING — Before positioning the table, be sure the correct table orientation is selected as indicated by the NORM or REV indictor on the primary control pendant. Improper orientation will result in reverse functioning and potential patient injury. NORMAL ORIENTATION is defined as follows: •

The head end is the end where the manual pump is located.

•

The perineal cutout in the seat section is exposed

•

Left and right refer to the patients left and right.

LOAD CAPACITY WARNING — Overloading may result in tipping of the table or failure of the table sections to move. Do not exceed maximum load. The patient lifting and articulation capacity is 600 Ibs. (273 kg). This means that a 600 Ib. patient can be moved into any of the standard procedural positions.

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FIGURE 3-2 NORMAL TABLE ORIENTATION

Rev 1 3-2

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS REVERSE ORIENTATION is defined as follows: •

The head end is opposite the manual pump.

•

The back/seat pad is reversed to expose the perineal cutout in the back section.

•

The headrest is removed and the optional leg extension or fem-pop board is installed into the back section.

•

Left and right refer to the patients left and right.

When the patient is placed in the Lithotomy position on the seat section, the following precautions must be followed to ensure safety and stability: •

The table must be securely locked to the floor and not mobilized while the patient is in this position.

•

The leg section may be removed from the table. If it is left on the table, use caution when raising the leg section while the patient is in this position. NOTE: — The tabletop may be slid towards the foot end of the table (full slide forward) without compromising stability.

FIGURE 3-4 NORMAL PERINEAL POSITION

FIGURE 3-3 REVERSE TABLE ORIENTATION

For OB/GYN, cystoscopy, and endo/urology procedures using a C-Arm, the patient may be reversed with the pelvis positioned on the back section over the alternate perineal cutout.

PATIENT POSITIONING WARNING — POSSIBILITY OF TIPPING: If FULL SLIDE FORWARD IS REQUIRED, the patients pelvis must always be located over the seat section when in normal orientation. Utilizing full forward slide while the patient’s pelvis is on the leg section can impair table stability and result in patient injury or equipment damage.

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FIGURE 3-5 REVERSE PERINEAL POSITION

Rev 1 3-3

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS The table must be securely locked to the floor and not mobilized while the patient is in this position. NOTE: — The tabletop may be slid towards the head end of the table (full slide reverse) without compromising stability TABLE MOVEMENT WITH PATIENT WARNING — If the table needs to be moved with a patient on the table, it is very important to follow the following instructions to prevent patient injury or equipment damage. WARNING — The table should not be used to transport a patient over a long distance. This procedure is only meant for repositioning the table in the surgical suite. Certain ENT, Neuro, and Ortho procedures require that the table be moved after anesthetizing the patient. If this is required, the following steps must be followed: •

Be sure that the patient is properly secured to the table with straps.

•

Center the patient over the main lift column.

•

Lower the table to its lowest point.

•

Check the floor for and remove objects that may interfere with moving the table, such as power cords or table accessories.

•

Have at least one person at each end of the table.

•

Unlock the table.

•

When moving the table, the people at each end must use a lateral force in the direction of motion; do not lift up on a section or push down on a section.

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•

Immediately lock the table when the new location is reached.

OPERATION CAUTION — Storage of clamps, accessories, etc., on the base cover may result in damage to lift column shields and prevent proper elevation or descent of the table. NOTE — The table can be operated with or without the power cord connected to the mains inlet receptacle. Plug in the power cord if the batteries need recharging. The table may be operated while the batteries are charging. Plug the power cord into mains inlet receptacle, i.e., the hospital receptacle. When the table is plugged in via the power cord, it is powered by mains AC. When the power cord is not plugged in, the batteries provide power to the table. In either case, the ON/OFF switch on the base must be ON to articulate any table sections. When the ON/OFF switch on the base is OFF, the table’s electronics and pump motor are isolated from the power supply and the batteries. When the charge indicator lamp near the power cord receptacle is illuminated, mains AC is sensed by the table and the battery charging system is activated. If AC is present, the battery charging system is activated whether the ON/OFF switch on the base is ON or OFF. The table can remain plugged into AC indefinitely without damaging the batteries. 1. Press the ON button on the control pendant to activate the control pendant NOTE — The control pendant will automatically turn off after 90 seconds if a table function is not selected and AC is not sensed as being present. If AC is sensed as being present the auto-shutdown feature is disabled. To reactivate the pendant, press either the pendant’s ON button or a function button to move the selected function.

Rev 1 3-4

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS 2. Press FLOOR LOCK to lower the floor feet. The green LOCK indicator on the control pendant will light when the floor feet are locked. 3. Select the desired function by pressing and holding the appropriate function switch.

as return to level, will be disabled while the individual functions will be enabled. Only a catastrophic failure of the main processor will light the SERV LED and disable all table functions. Always contact Berchtold Service if the SERV indicator is lit.

NOTE — Any two functions (except opposing functions, i.e. Flex, reflex, RTL and Feet Lock/Unlock) may be operated simultaneously. If two opposing function switches are pressed, the second function will not activate until the first function is deactivated. 4. When the desired position has been reached, release the function switch to stop movement. 5. After the patient has been transferred from the table, press FLOOR UNLOCK to raise the floor feet and allow table transport. The yellow UNLOCK indicator on the control pendant will light when the floor feet are unlocked. If the table functions do not operate, check the following: 1. Is the On/Off switch on the base in the OFF position? • Turn the switch to the ON position. 2. Is the yellow UNLOCK indicator lit? • Lock the floor feet. 3. Is the red battery indicator flashing or steady? • The motor-driven pump has been disabled. Use the manual foot pump or plug in the table to recharge the batteries. 4. Is the red SERV indicator lit? • A lit SERV indicator indicates that service is required, but may not disable a table function or functions, depending on the failure. If a failure occurs that can allow an unsafe operation, the specific function, such 60-001-0220

Rev 1 3-5

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS more than two functions may be operated simultaneously.

FUNCTION PRIORITY When a function is selected, using either the primary hand pendant or optional footswitch, that function has priority over any other function with which it conflicts. Functions, which are independent in operation, may be operated simultaneously by pressing the desired functions on the control pendant. No

FUNCTION Table Up Back Up Leg Up Trendelenburg Slide Forward Tilt Left Kidney Up Floor Lock Floor Unlock Flex Reflex Return to level

Floor Lock, Floor Unlock, Return to Level, Flex, and Reflex cannot be operated simultaneously with other functions. Table 31 shows the function conflicts for the Berchtold B 810 table.

TABLE 3-1 FUNCTION CONFLICTS CONFLICTING FUNCTION Table Down Back Down Leg Down Reverse Trendelenburg Slide Reverse Tilt Right Kidney Down All other functions.

TABLE MOVEMENT LIMITS

SOFTWARE-CONTROLLED LIMITS

Due to the Berchtold B 810 table’s extensive articulation range, some functions can not be combined at their maximum capability. These interfering functions are limited in two ways; by the table software and by the user. These are described in the following 2 paragraphs.

The software controls limit the functions described in Table 3-2. If the Berchtold table is positioned according to “POSITION OF FUNCTION”, the software prevents movement beyond the range specified by “RESULTING FUNCTION LIMIT”. The user cannot override these limits using the control pendant.

TABLE 3-2. SOFTWARE-CONTROLLED LIMITS POSITION OF FUNCTION RESULTING FUNCTION LIMIT Back section raised over 26°

Kidney elevator cannot be operated

Any raising of the kidney elevator

Limits the Back section to 26° above horizontal

Trendelenburg and Reverse Trendelenburg

+-30 degrees

Tilt Left and Tilt right

+- 20 degrees

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Rev 1 3-6

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS USER-CONTROLLED LIMITS CAUTION — Watch the table at all times while performing multiple articulations. Stop table movements before collisions occur. Failure to do so could result in damage to the table. The user must limit the functions described in Table 3-3. If the BERCHTOLD B 810 table is positioned according to “POSITION OF FUNCTION”, the user must not exceed table movements specified

by “RESULTING FUNCTION LIMIT”. If the user exceeds these limits using the control pendant, portions of the table will collide, possibly resulting in table damage. This list is not all-inclusive. Numerous collisions are possible when combining multiple articulations, particularly at low table heights. When combining functions, the user should monitor the table’s position to ensure collisions are avoided.

TABLE 3.3. USER-CONTROLLED LIMITS POSITION OF FUNCTION

RESULTING FUNCTION LIMIT

To prevent interference of the leg section with column covers: Slide fully towards the head section

Leg section limited to 100° below horizontal

Leg section completely lowered

Slide to head section limited to 10.5” (267mm)

Leg Section lowered 90˚

Height below 29.5” (749.3 mm)

To prevent interference of the side frame with the column covers and bellows: Table at lowest height (28”) to 31”

Combination of Reverse Trendelenburg and Tilt Right limited: Reverse Trend = 30°, Tilt Right limited to 15° Tilt Right = 20°, Reverse Trend limited to 25°

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Rev A 3-7

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS HEADREST WARNING — Do not mount knee crutches or legholders to the headrest side rail. The headrest should only be used for supporting the head or feet. Do not lean on the headrest. The headrest has a weight limit of 25lbs. WARNING — Be sure that when articulating the headrest, the locking mechanism ends up properly engaged, and not in between positions. The headrest may move when load is applied until the locking mechanism engages.

REMOVABLE LEG SECTION WARNING — Failure to securely lock the leg section into place may result in patient injury. Always check the retention of the leg section upon installation. Install the leg section as follows: 1.

Using the pendant, activate LEG UP until the leg section pivots are horizontal.

2.

To align the leg section for installation, place the leg section posts into the pivots at a –45 degree angle as shown in figure 3-7.

The table headrest can be latched in any position from 90° above horizontal in 15° increments.

FIGURE 3-7 ALIGNING THE LEG SECTION FOR INSTALLATION FIGURE 3-6. HEADREST To raise and lower the headrest, release the locking mechanism by pulling out the release bar on the right underside of the headrest. When the headrest is properly positioned, release the bar.

3.

Once the leg section is aligned, lift to a horizontal position and insert the leg section into the pivots. Slide the leg section towards the seat section until it comes to a stop and the locks snap into place. See figures 3-8 and 3-9.

WARNING — When releasing the locking mechanism, support the headrest, as it will fall freely if the locking mechanism is not engaged.

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Rev A 3-8

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS FIGURE 3-8 LEG SECTION Attempt to pull the leg section away from the table to make sure that it is retained. If not, push evenly until the locks engage.

FIGURE 3-9 ASSEMBLIED LEG SECTION FIGURE 3-9. FOOTSWITCH To remove the leg section: 1. Bring the leg section to a level position, i.e. parallel to the floor. 2. Depress the latches to release the locking mechanism and pull back evenly.

FOOTSWITCH (OPTIONAL) CAUTION — The Footswitch’s electrical connections are resistant to fluid intrusion, but if fluid drainage is anticipated, the footswitch should be protected by wrapping it with a clear disposable footswitch bag. This will reduce the need to disinfect the footswitch. .

The footswitch plugs into the left connector on the receptacle box, which is located on the left side of the table. Align the red dot on the footswitch connector with the red dot on the mating connector on the left side of the connector box. NOTE — To avoid inadvertent actuation, the footswitch should be disconnected for procedures that do not require its use. The footswitch will not operate if the red battery indicator is lit, either flashing or steady To operate the table, select the desired function by pressing the appropriate side of the rocker switch. Pressing the opposite side of the rocker will reverse the direction of travel. Releasing the rocker switch will stop table movement.

NOTE — To operate the footswitch control, the floor feet must be locked. NOTE — It is not necessary to press the primary hand pendant’s ON/OFF switch when operating the footswitch control. The primary hand pendant can not be operated simultaneously with the footswitch

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Rev A 3-9

OPERON B 810 SURGICAL TABLE BACKUP INSTRUCTIONS BACKUP INSTRUCTIONS It is highly recommended that all operators become familiar with the following backup instructions and with the operation of the auxiliary hand pendant and manual foot pump before using the table.

NOTE: — When using the auxiliary hand pendant, press and hold the button while operating the foot pump.

FIGURE 4-1 BACKUP SYSTEMS

FIGURE 4-2 AUXILIARY HAND PENDANT

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Rev 1 4-1