OPERON B810 Service and Parts Manual

SERVICE AND PARTS MANUAL 70-000-0027 Related Publications: OPERON B 810 Installation and Operator Manual 70-001-0026 OPERON B 810 Uncrating Instructions 60-000-0002

NOTE

NOTE

The service and parts manual is meant to be used as a reference in performing preventative and corrective maintenance on the OPERON B 810 surgical table. The successful completion of a factory training program is required to properly and effectively troubleshoot, repair, and maintain the OPERON B 810 surgical table. BERCHTOLD Corporation assumes no liability for table performance when used with accessories designed by others for use on the OPERON B 810 surgical table or damage to the OPERON B 810 surgical table resulting from the use of accessories designed by others.

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 60601-1. Medical Electrical Equipment OPERON® is a registered trademark of BERCHTOLD CORP.

OPERON B 810 SURGICAL TABLE TABLE OF CONTENTS

TABLE OF CONTENTS SPECIAL SAFETY INSTRUCTIONS... S-1 SAFETY SYMBOLS ... S-1 USE CONDITIONS... S-1 POWER SUPPLY ... S-1 PINCH POINTS... S-1 LOAD CAPACITY... S-2 PATIENT POSITIONING ... S-3 PATIENT ORIENTATION ... S-3 OPERATION ... S-3 TABLE MOVEMENT WITH PATIENT ... S-3 PRIMARY HAND PENDANT FUNCTIONS ... S-3 AUXILIARY HAND PENDANT... S-3 HEADREST ... S-4 REMOVABLE LEG SECTION... S-4 ACCESSORIES DESIGNED BY OTHERS ... S-4 RADIOLUCENT TABLE TOP AND PADS ... S-4 FOOTSWITCH (OPTIONAL)... S-4 HYDRAULIC SYSTEM... S-4 HOLLOW PLUGS... S-4 HYDRAULIC FLUID... S-4 ELECTROMAGNETIC INTERFERENCE... S-5 ELECTRICAL SYSTEM... S-5 SERVICE PROGRAM... S-5 CLEANING AND DISINFECTION ... S-6 WARNING LABELS ... S-6 GENERAL INFORMATION...1-1 GENERAL DESCRIPTION ...1-1 RADIOLUCENT TABLE TOP AND PADS ...1-1 INTERCHANGEABLE HEADREST ...1-1 POWER SUPPLY ...1-2 FUSES...1-2 FLOOR LOCK SYSTEM ...1-3 PRIMARY HAND PENDANT...1-3 PRIMARY HAND PENDANT INDICATORS ... 1-4 PRIMARY HAND PENDANT FUNCTIONS ... 1-5 FOOTSWITCH (OPTIONAL)...1-6 MANUAL FOOT PUMP ...1-6 AUXILIARY HAND PENDANT...1-7 AUXILIARY PENDANT STORAGE...1-7 OPERATING INSTRUCTIONS...2-1 PINCH POINTS...2-1 ELECTROMAGNETIC INTERFERENCE...2-1 LOAD CAPACITY...2-1 70-000-0027

Rev. 1 i

OPERON B 810 SURGICAL TABLE TABLE OF CONTENTS PATIENT ORIENTATION... 2-2 NORMAL ORIENTATION... 2-2 REVERSE ORIENTATION ... 2-2 PATIENT POSITIONING ... 2-2 TABLE MOVEMENT WITH PATIENT ... 2-3 OPERATION ... 2-3 HAND PENDANT OPERATION ... 2-4 FUNCTION PRIORITY ... 2-5 TABLE MOVEMENT LIMITS... 2-5 SOFTWARE-CONTROLLED LIMITS ... 2-5 USER-CONTROLLED LIMITS... 2-7 HEADREST ... 2-7 REMOVABLE LEG SECTION... 2-8 FOOTSWITCH (OPTIONAL)... 2-8 BACKUP INSTRUCTIONS ... 3-10 PRINCIPLES OF OPERATION... 4-1 HYDRAULIC SYSTEM... 4-1 HYDRAULIC POWER UNIT ... 4-1 HYDRAULIC MANIFOLDS ... 4-1 COLUMN MANIFOLD... 4-2 TABLE TOP DISTRIBUTION BLOCK ... 4-2 FLOOR LOCK MANIFOLDS... 4-3 FLOOR LOCK SYSTEM OPERATION... 4-3 FLOOR LOCK QUICK DISCONNECT ... 4-4 MANIFOLD VALVE DESCRIPTION... 4-5 MANIFOLD VALVE OPERATION ... 4-6 COLUMN HYDRAULICS ... 4-6 GENERAL INFORMATION... 4-6 OPERATION ... 4-8 HEIGHT UP AND DOWN... 4-8 TILT LEFT AND RIGHT... 4-8 TRENDELENBURG AND REVERSE TRENDELENBURG... 4-8 TABLE TOP HYDRAULICS... 4-9 HOLLOW PLUGS AND SEALS ... 4-11 USING HOLLOW PLUGS AND WASHERS TO SECURE HYDRAULIC LINES ... 4-11 HOLLOW PLUG TORQUE SPECIFICATIONS... 4-12 HYDRAULIC FLUID... 4-12 ELECTRICAL SYSTEM ... 4-13 CPU AND AUXILIARY BOARD... 4-13 CONNECTOR BOARD... 4-15 EXTENSION BOARD... 4-16 POSITION SENSORS AND SWITCHES... 4-16 TILT AND TRENDELENBURG SENSORS... 4-17 SLIDE SENSOR ... 4-17 KIDNEY SWITCH ... 4-18 AUXILIARY PENDANT SWITCH... 4-18

Rev. 1 ii

70-000-0027

OPERON B 810 SURGICAL TABLE TABLE OF CONTENTS POWER SUPPLY SYSTEM ... 4-19 BATTERIES ... 4-19 BATTERY REPLACEMENT ... 4-20 POWER INPUT SYSTEM ... 4-21 LEFT POWER CENTER... 4-21 RIGHT POWER CENTER... 4-21 CONTROL PENDANTS ...4-22 PRIMARY HAND PENDANT ... 4-22 AUXILIARY HAND PENDANT... 4-23 BASE WIRING...4-23 BASE, COLUMN, AND TOP ELECTRICAL CONNECTIONS... 4-24 MECHANICAL SLIDE SYSTEM ...4-27 TIMING BELT TESTING AND ADJUSTMENT ... 4-1 CIRCUIT DIAGRAMS...5-1 SERVICE PROGRAM ...6-1 INTRODUCTION...6-1 CPU DESCRIPTION ...6-1 HOW TO USE THE SERVICE PROGRAM...6-2 CONNECT TO THE TABLE ... 6-2 LAUNCH THE SERVICE PROGRAM ... 6-2 THE HAND PENDANT GRAPHIC ... 6-4 THE SERVICE PROGRAM MENUS... 6-4 FILE MENU ... 6-4 VIEW MENU ... 6-5 CHOOSE CPU MENU ... 6-5 LOAD DATA MENU... 6-5 FREE ACCESS MENU ... 6-5 OPEN FILE BUTTON... 6-5 SAVE FILE BUTTON... 6-5 COPY TO BUTTON ... 6-5 PRINT SYSTEM SETTINGS BUTTON ... 6-6 COM BUTTON ... 6-7 LOAD DEFAULT SETTINGS BUTTON ... 6-7 DEVICE SETTINGS BUTTON ... 6-7 Motor Tab ... 6-9 Valve Tab... 6-10 Sensor Tab ... 6-10 ACCU Tab ... 6-13 Movements Tab ... 6-14 Table Info Tab ... 6-15 SYSTEM INFO BUTTON ... 6-16 CYCLE TEST BUTTON... 6-18 CPU ERROR CODES...6-20 TROUBLESHOOTING ...6-25 BATTERIES AND CHARGE INDICATORS ...6-27 INTRODUCTION... 6-27 NO AC DETECTED... 6-27 AC DETECTED ... 6-28 ELECTRICAL PARAMETERS ...6-29 70-000-0027

Rev. 1 iii

OPERON B 810 SURGICAL TABLE TABLE OF CONTENTS SUPPLY VOLTAGE ... 6-29 PERIODIC MAINTENANCE... 7-1 ELECTRICAL INSPECTION... 7-1 HYDRAULIC SYSTEM OPERATION ... 7-1 GROUND CONTINUITY/LEAKAGE CURRENT ... 7-1 FLEXIBLE HYDRAULIC LINES... 7-1 HYDRAULIC FLUID LEVEL ... 7-1 FASTENERS AND RETAINING CLIPS... 7-2 CLAMPS AND ACCESSORIES ... 7-2 STRUCTURAL INTEGRITY OF THE TABLE ... 7-2 CLEANING AND DISINFECTION... 7-2 STAINLESS STEEL SURFACES ... 7-2 CLEANING METHODS ... 7-2 CLEANING AGENTS ... 7-2 REMOVING STAINS... 7-3 APPLYING DISINFECTANTS... 7-3 PAINTED SURFACES... 7-3 CONDUCTIVE ITEMS ... 7-3 HAND PENDANTS... 7-3 PARTS ... 8-2 INTRODUCTION ... 8-1 FASTENER TORQUE REQUIREMENTS ... 8-1 DRAWING INDEX ... 8-1

Rev. 1 iv

70-000-0027

OPERON B 810 SURGICAL TABLE TABLE OF CONTENTS

TABLE OF FIGURES FIGURE S-1 FIGURE S-2 FIGURE S-3 FIGURE 1-1 FIGURE 1-2 FIGURE 1-3 FIGURE 1-4 FIGURE 1-5 FIGURE 1-6 FIGURE 1-7 FIGURE 1-8 FIGURE 1-9 FIGURE 1-10 FIGURE 1-11 FIGURE 2-1 FIGURE 2-2 FIGURE 2-3 FIGURE 2-4 FIGURE 2-5 FIGURE 2-6 FIGURE 2-7 FIGURE 2-8 FIGURE 2-9 FIGURE 2-10 FIGURE 2-11 FIGURE 3-1 FIGURE 3-2 FIGURE 4-1. FIGURE 4-2. FIGURE 4-3. FIGURE 4-4. FIGURE 4-5. FIGURE 4-6. FIGURE 4-7. FIGURE 4-8. FIGURE 4-9. FIGURE 4-10. FIGURE 4-11. FIGURE 4-12. FIGURE 4-13. FIGURE 4-14. FIGURE 4-15. FIGURE 4-16.

MAXIMUM WEIGHT LOCATION ... S-2 PATIENT SAFETY WARNING LABEL ... S-6 FUSE LABEL... S-6 OPERON B 810 SURGICAL TABLE ...1-1 BASE COMPONENTS ...1-2 PRODUCT IDENTIFICATION AND FUSE INFORMATION LABEL ...1-3 PRIMARY HAND PENDANT AND FOOTSWITCH CONNECTOR BOX...1-3 PRIMARY HAND PENDANT INDICATORS...1-4 PRIMARY HAND PENDANT FUNCTIONS...1-5 FOOTSWITCH...1-6 DEPLOYING FOOT PUMP PEDAL ...1-6 LOCKING FOOT PUMP PEDAL FOR USE...1-6 AUXILIARY HAND PENDANT ...1-7 LOCATION OF AUXILIARY PENDANT AND DRAWER ...1-7 PINCH POINTS...2-1 NORMAL TABLE ORIENTATION ...2-2 REVERSE TABLE ORIENTATION ...2-2 NORMAL PERINEAL POSITION ...2-3 REVERSE PERINEAL POSITION...2-3 HAND PENDANT POWER-ON INDICATORS...2-4 HEADREST ...2-7 ALIGNING THE LEG SECTION FOR INSTALLATION ...2-8 LEG SECTION ...2-8 ASSEMBLED LEG SECTION...2-8 FOOTSWITCH...2-9 BACKUP SYSTEMS ...3-10 AUXILIARY HAND PENDANT ...3-10 HYDRAULIC POWER UNIT ON MAIN ELEVATING COLUMN ...4-1 COLUMN MANIFOLD ...4-2 DISTRIBUTION BLOCK...4-2 FLOOR LOCK MANIFOLD ...4-3 FOOT LOCK MANIFOLD LOCATION IN BASE...4-3 FLOOR LOCK SYSTEM OPERATION ...4-4 FLOOR LOCK QUICK DISCONNECT...4-5 MANIFOLD VALVE ...4-5 COLUMN CYLINDER SCHEMATIC...4-7 LIFT TUBES/CYLINDERS...4-8 TILT CYLINDER AND UPPER LIFT TUBE ...4-8 TILT OPERATION ...4-8 MANIFOLD AND SOLENOIDS...4-9 HOSE ROUTING ...4-9 LEFT SIDE FRAME CYLINDERS ...4-10 RIGHT SIDE FRAME CYLINDERS ...4-10

70-000-0027

Rev. 1 v

OPERON B 810 SURGICAL TABLE TABLE OF CONTENTS FIGURE 4-17. FIGURE 4-18. FIGURE 4-19. FIGURE 4-20. FIGURE 4-21. FIGURE 4-22. FIGURE 4-23. FIGURE 4-24. FIGURE 4-25. FIGURE 4-26 FIGURE 4-27. FIGURE 4-28. FIGURE 4-29. FIGURE 4-30. FIGURE 4-31. FIGURE 4-32. FIGURE 4-33. FIGURE 4-34. FIGURE 4-35. FIGURE 4-36. FIGURE 4-37. FIGURE 4-38. FIGURE 4-39. FIGURE 4-40. FIGURE 4-41. FIGURE 4-42. FIGURE 4-43. FIGURE 4-44. FIGURE 4-45. FIGURE 4-46. FIGURE 4-47. FIGURE 4-48. FIGURE 5-1. FIGURE 5-2. FIGURE 5-3. FIGURE 6-1. FIGURE 6-2. FIGURE 6-3. FIGURE 6-4. FIGURE 6-5. FIGURE 6-6. FIGURE 6-7. FIGURE 6-8. FIGURE 6-9.

Rev. 1 vi

BACK AND LEG CYLINDERS ... 4-10 KIDNEY CYLINDERS... 4-11 HOLLOW PLUGS AND WASHERS... 4-11 SECURING HYDRAULIC LINES ... 4-12 CPU LOCATION ON COLUMN ... 4-13 CPU BOARD CONNECTIONS... 4-14 AUXILIARY BOARD CONNECTIONS ... 4-14 CONNECTOR BOARD... 4-16 EXTENSION BOARD CONNECTIONS... 4-16 TILT, TRENDELENBURG, AND SLIDE SENSOR LOCATIONS ... 4-17 SLIDE SENSOR ... 4-18 KIDNEY SWITCH... 4-18 AUXILIARY DRAWER SWITCH ... 4-18 POWER SUPPLY SYSTEM ... 4-19 BATTERY CHARGER CONNECTION AT POWER SUPPLY ... 4-20 BATTERY TERMINAL IDENTIFICATION... 4-20 POWER CENTERS ... 4-21 DC FUSE IDENTIFICATION ... 4-21 LEFT POWER CENTER... 4-21 RIGHT POWER CENTER ... 4-22 PROTECTIVE COVER ON AUXILIARY HAND PENDANT ... 4-23 WIRING CONNECTIONS AT THE BACK OF THE DC POWER CENTER... 4-24 BASE HEAD-END WIRING CONNECTIONS... 4-25 BASE COLUMN AREA WIRING CONNECTIONS... 4-25 BASE COLUMN RIGHT WIRING CONNECTIONS... 4-25 BASE FOOT END RIGHT WIRING CONNECTIONS ... 4-26 BASE FOOT END RIGHT WIRING CONNECTIONS ... 4-26 TOP OF COLUMN WIRING CONNECTIONS... 4-26 COLUMN HEAD SIDE CONNECTIONS ... 4-27 COLUMN LEFT SIDE CONNECTIONS... 4-27 SLIDE MECHANISM COMPONENTS... 4-28 DRIVE BELT TENSION TESTING AND ADJUSTMENT ... 4-1 C8 HYDRAULIC SCHEMATIC... 5-2 WIRING DIAGRAM... 5-3 BASE WIRING DIAGRAM (DWG. 306886) ... 5-8 OPERON B 180 SURGICAL TABLE MOVEMENTS ... 6-1 PC CONNECTION... 6-2 LOGIN FORM ... 6-2 SERVICE PROGRAM MAIN MENU SCREEN PENDANT INDICATORS ... 6-3 SERVICE PROGRAM MAIN MENU SCREEN MENU OPTIONS... 6-3 FILE MENU OPTIONS ... 6-4 WINDOWS FILE OPEN SELECTION SCREEN... 6-5 WINDOWS FILE SAVE SCREEN ... 6-5 SYSTEM SETTINGS SCREEN ... 6-6

70-000-0027

OPERON B 810 SURGICAL TABLE TABLE OF CONTENTS FIGURE 6-10. COM OPTIONS SETTING FORM...6-7 FIGURE 6-11. DEVICE SETTING FORM TABS ...6-8 FIGURE 6-12. MOTOR SETTINGS FORM ...6-9 FIGURE 6-13. VALVE SETTINGS FORM...6-10 FIGURE 6-14. SENSOR SETTING FORM...6-12 FIGURE 6-15. ACCU (BATTERY) DISPLAY SETTING FORM ...6-13 FIGURE 6-16. MOVEMENTS SETTING FORM ...6-15 FIGURE 6-17. TABLE INFO FORM ...6-16 FIGURE 6-18. SYSTEM INFO DISPLAY...6-17 FIGURE 6-19. PRINT PREVIEW AND PRINTED REPORT FORMAT...6-17 FIGURE 6-20. CYCLE TEST FORM ...6-19 FIGURE 6-21. COMPONENT LOCATIONS ...6-25 FIGURE 6-22. BATTERY LED INDICATORS...6-27 FIGURE 7-1. HYDRAULIC OIL FILL LEVEL ...7-1

70-000-0027

Rev. 1 vii

OPERON B 810 SURGICAL TABLE TABLE OF CONTENTS

TABLE OF TABLES TABLE 1-1. TABLE 2-1. TABLE 4-1 TABLE 4-2 TABLE 4-3 TABLE 4-4 TABLE 4-5 TABLE 4-6 TABLE 4-7 TABLE 4-8 TABLE 6-1. TABLE 6-2. TABLE 6-3. TABLE 6-4. TABLE 6-5. TABLE 6-6. TABLE 6-7. TABLE 7-1. TABLE 8-1

Rev. 1 viii

TECHNICAL DATA ... 1-8 SOFTWARE-CONTROLLED LIMITS ... 2-6 MANIFOLD VALVE OPERATING SPECIFICATIONS... 4-6 COLUMN SOLENOIDS ... 4-7 HOLLOW PLUG TORQUE SPECIFICATIONS ... 4-12 CPU POWER CONNECTORS ... 4-15 WIRING HARNESS APPLICATIONS ... 4-15 BLADE FUSES ... 4-21 BASE WIRING COLOR CODES ... 4-23 BASE ELECTRICAL CONNECTIONS LOCATIONS... 4-24 SENSOR PARAMETERS... 6-12 ACCU (BATTERY) SETTING PARAMETERS... 6-13 OPERON B 810 ERROR CODES ... 6-20 TROUBLESHOOTING GUIDE ... 6-26 LED AND TABLE STATUS FOR NO AC POWER DETECTED ... 6-28 LED AND TABLE STATUS FOR AC POWER DETECTED ... 6-29 ELECTRICAL PARAMETERS... 6-29 RECOMMENDED MAINTENANCE SCHEDULE ... 7-1 GENERAL FASTENER TORQUE SPECIFICATIONS... 8-1

70-000-0027

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.

SPECIAL SAFETY INSTRUCTIONS SAFETY SYMBOLS This manual uses special symbols to help alert you to important safety information:

WARNING

CAUTION

NOTE

This symbol identifies a WARNING. A warning indicates that the procedure in the following text involves actions that could cause harm or death to an individual if certain precautions are not taken. The warning text always provides specific information on what you must do to avoid the risk. This symbol identifies a CAUTION. A caution indicates that the procedures in the following text involve actions that could cause damage to the equipment, including the failure to operate. The caution text always provides specific information on what you must do to avoid the risk. This symbol identifies a NOTE. A note contains information that can help you perform the procedure in the following text more effectively.

USE CONDITIONS WARNING — POSSIBLE EXPLOSION HAZARD: Do not operate the table in the presence of flammable anesthetics. The OPERON B 810 table is designed for use in nonhazardous anesthetizing locations.

WARNING

PINCH POINTS WARNING

CAUTION

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. 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.

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 column shield 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 2-1 for details.

POWER SUPPLY WARNING

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.

70-000-0027

Rev. 1 S-1

OPERON B 810 SURGICAL TABLE SPECIAL SAFETY INSTRUCTIONS LOAD CAPACITY This table has a patient lifting and articulation capacity of 600 lb (273 kg). Positioning and constraints are discussed on page S-3. Do not exceed this maximum load in service. See FIGURE S-1.

WARNING

NOTE — The use of some positioning capabilities or table 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. 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.

NOTE

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.

The table load capacity is 400 lb (181 kg)) when the beach chair accessory is installed on the table. The table load capacity is 300 lb (136 kg) when the fracture attachment unit is installed on the table.

D etachable Leg S ection

In n ormal orien tation, the

In reverse orien tation, the

patien t’s pelvis must n ot exten d

patien t’s pelvis must n ot exten d

beyon d the en d of the S EAT S ection for full side capability

beyon d the en d of the BACK S ection for full side capability

S eat S ection

Kidn ey Elevator

Headrest

Primary Han d Pen dan t Receptacle

Footswitch Receptacle Primary Han d Pen dan t

Man ual Foot Pump Pedal

Warn in g Label

Back S ection

F loor Feet

Located on this en d of Base: Power En try Module, Fuses, an d Auxiliary Pen dan t D rawer

FIGURE S-1 MAXIMUM WEIGHT LOCATION

Rev. 1 S-2

70-000-0027

OPERON B 810 SURGICAL TABLE SPECIAL SAFETY INSTRUCTIONS 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

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 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.

WARNING

WARNING

WARNING — POSSIBILITY OF TIPPING: If FULL SLIDE FORWARD IS REQUIRED, the patient’s 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. WARNING — 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 the normal perineal position.

Full articulation and full slide in either direction can be safely achieved with a 600lb (273kg) patient if these steps are followed.

CAUTION

TABLE MOVEMENT WITH PATIENT WARNING

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

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.

PRIMARY HAND PENDANT FUNCTIONS WARNING

WARNING

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.

OPERATION WARNING

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.

70-000-0027

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.

AUXILIARY HAND PENDANT

PATIENT ORIENTATION WARNING

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.

WARNING

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.

Rev. 1 S-3

OPERON B 810 SURGICAL TABLE SPECIAL SAFETY INSTRUCTIONS

CAUTION

CAUTION — The auxiliary hand pendant does not have the following functions: FLEX, CHAIR, RETURN TO LEVEL, or SLIDE. This pendant is intended to be used for completing procedures, followed by charging the batteries or servicing the table.

HEADREST WARNING

WARNING

WARNING

FOOTSWITCH (OPTIONAL) 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 25 lbs. WARNING — When articulating the headrest, be sure that the locking mechanism engages completely, and does not hang in between positions. Until the locking mechanism engages, the headrest may move when a load is applied.

CAUTION

WARNING

CAUTION

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.

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.

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.

HYDRAULIC SYSTEM

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

REMOVABLE LEG SECTION WARNING

CAUTION

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.

WARNING – POSSIBILITY OF INJURY: The hydraulic system must be kept free of contamination. Contamination can cause the hydraulic system to fail, resulting in personnel or injury or equipment damage. CAUTION – The hydraulic system on the OPERON B 810 surgical table contains micro-hydraulic valves, which are very sensitive to contamination. Only a qualified, trained service technician should open the hydraulic system, and only after all other repair procedures have been tried. Always use clean tools, and cover or wrap any loose hydraulic lines with clean plastic bags.

HOLLOW PLUGS CAUTION

CAUTION – Do not over tighten the hollow plugs. Over tightening can cause the seals to deform and leak.

RADIOLUCENT TABLE TOP AND PADS CAUTION

Rev. 1 S-4

CAUTION — The anti-static properties of the table depend on the use of the recommended mattress. Compromise of the anti-static properties could expose the patient or OR personnel to an electrostatic shock. It could also deliver a shock to the table’s electronics that could damage or destroy critical components.

CAUTION

CAUTION — Hollow plugs used in the hydraulic system have different torque values than the mechanical fasteners. See Table 4-3 for hollow plug torque requirements.

HYDRAULIC FLUID CAUTION

CAUTION – Do not mix hydraulic fluid types. Other hydraulic fluids can be incompatible with the seals in the OPERON B 810 table and can cause equipment failure or reduce the service 70-000-0027

OPERON B 810 SURGICAL TABLE SPECIAL SAFETY INSTRUCTIONS life. (See drawing 306762 for correct fluid designation.) ELECTROMAGNETIC INTERFERENCE WARNING

SERVICE PROGRAM CAUTION

WARNING — When using the table in the vicinity of high-frequency surgical equipment, such as cardiac defibrillators and cardiac defibrillator monitors, refer to the equipment manufacturers’ instructions to ensure compatibility issues are considered.

ELECTRICAL SYSTEM WARNING

WARNING

WARNING

WARNING – When servicing the table, turn power off or remove the appropriate fuses to prevent personal injury. If power is required, use care to avoid contact with live parts. WARNING – Even a “dead” battery can contain enough power to cause a serious shock or explosive spark. Always disconnect the battery charger plug at the power center before disconnecting cables. WARNING – The batteries contain acid, which can cause serious burns. While the batteries are sealed, a dead battery may be damaged and may leak. Always handle batteries in a way that will prevent acid from spilling on your skin or clothes.

70-000-0027

CAUTION

CAUTION

CAUTION

CAUTION —The Service Program will allow you to set motor parameters outside the min. and max. values of 100 to 1000. Setting the parameters to the extreme min. or max. value could lead to damage to the table or its components, including a failure to operate. Always double check your settings before clicking on “Save Parameters”. CAUTION —The Service Program will allow you to set valve parameters outside the min and max range of 100300MSec. This could lead to damage to the table or its components, including a failure to operate. Always double check your settings before clicking on “Save Parameters”. CAUTION —The Service Program will allow you to set sensor parameters outside the min and max range shown in TABLE 6-1. This could lead to damage to the table or its components, including a failure to operate. Always double check your settings before clicking on “Save Parameters”. CAUTION —The Service Program will allow you to set ACCU (battery) parameters outside the ranges shown in TABLE 6-2. This could lead to false readings on the (physical and graphic) pendant LEDs, including a failure to operate. Always double check your settings before clicking on “Save Parameters”.

Rev. 1 S-5

OPERON B 810 SURGICAL TABLE SPECIAL SAFETY INSTRUCTIONS CLEANING AND DISINFECTION WARNING

WARNING — Unplug the power cord before cleaning the table if cleaning liquids will be used near the power cord receptacle. Under no circumstances should steam or extremely hot water (over 150°F/66°C) be used to disinfect or clean the table. Elevated temperatures and high humidity will weaken the hydraulic lines and result in failure of the hydraulic system and increased leakage currents. Do not clean this table in automatic cart washing equipment. Use of high-pressure water guns could lead to an electrical malfunction and must be avoided.

CAUTION

CAUTION — Failure to thoroughly dry the surface after cleaning may result in rust.

WARNING LABELS FIGURE S-2 shows the patient safety warning label attached to the table. The label is located on the base at the foot end.

Dwg. 306651

Drawing 306651 Rev. 1

FIGURE S-2 PATIENT SAFETY WARNING LABEL WARNING

WARNING — Always replace fuses with fuses of the same voltage and current rating. Failure to use the correct fuse could cause a fire and injury to the patient or OR personnel.

FIGURE S-3 shows the product information label attached to the top of the column on the head side of the table. The product information label also contains fuse replacement information.

FIGURE S-3 FUSE LABEL

Rev. 1 S-6

70-000-0027

OPERON B 810 SURGICAL TABLE GENERAL INFORMATION GENERAL INFORMATION GENERAL DESCRIPTION The Berchtold OPERON B 810 surgical table is a remote controlled, full-function design offering a high level of patient positioning and imaging flexibility to the surgical team. The table can be activated 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. An electric motor with a belt driven screw is used to slide the table top head to foot. Hydraulic cylinders are used to articulate the table's sections. Hydraulic pressure is provided by a motor Leg Section

Seat Section

Footswitch Receptacle

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 (FIGURE 1-1): • Headrest • Back Section • Kidney Elevator • Seat Section • Leg Section A leg extension can be added to extend the tabletop surface. Kidney Elevator

Back Section

Headrest

Primary Hand Pendant Receptacle

Primary Hand Pendant

Manual Foot Pump Pedal

Floor Feet

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

FIGURE 1-1 OPERON B 810 SURGICAL TABLE RADIOLUCENT TABLE TOP AND PADS CAUTION

CAUTION — The anti-static properties of the table depend on the use of the recommended mattress. Compromise of the anti-static properties could expose the patient or OR personnel to an electrostatic shock. It could also deliver a shock to the table’s electronics that could damage or destroy critical components.

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.

70-000-0027

CAUTION

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 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.

Rev. 1 1-1

OPERON B 810 SURGICAL TABLE GENERAL INFORMATION POWER SUPPLY WARNING

NOTE

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. 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

The locations of the primary Power Supply components are shown in FIGURE 1-2. 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

Pendant Drawer

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 lit, the table senses AC power and activates the battery charging system. If AC is present, the battery charging system is activated whether the ON/OFF switch on the base is in the ON or OFF position. The table can remain plugged into AC indefinitely without damaging the batteries. The battery indicator on the primary hand pendant displays the battery charge status. This display has three sections: green (full charge), yellow (low charge) and red (recharge). Only one color will be activated at a time.

NOTE

NOTE — In the unlikely event of a control pendant failure, the table movements can be stopped by switching the breaker on the base to the off (down) position.

Power Entry Cover Fuse Drawer, AC Mains Fuses (F1 and F2) 2 @ 5 X 20mm 8A Time Delay

Manual Foot Pump Pedal

Charging Indicator Grounding Post Fuse Cover DC Battery, Pump and Pendant Fuses 3 ATO Fuses: 3 @ 20 A (PN 304849)

Floor Feet

ON/OFF Switch (20 Amp Circuit Breaker)

Power Cord Receptacle

Caster

FIGURE 1-2 BASE COMPONENTS F2. These fuses protect against current surges in the AC (mains) line.

FUSES Two sets of fuses are accessible without removing the base covers.

The first set, located within the receptacle for the power cord, contains two fuses labeled F1 and

Rev. 1 1-2

The second set, located behind the hinged door next to the ON/OFF switch, contains three fuses. Two of these fuses protect against surges in the DC circuitry; one fuse serves as a spare. Fuses F3 and F4 are 20 Amp rated. 70-000-0027

OPERON B 810 SURGICAL TABLE GENERAL INFORMATION In addition to the fuses, the ON/OFF switch serves as a circuit breaker with a 20 Amp rating.

See FIGURE 1-2 for the fuse locations. See FIGURE 1-3 for the product identification and fuse information label

Fuse Information

FIGURE 1-3 PRODUCT IDENTIFICATION AND FUSE INFORMATION LABEL activating the FLOOR LOCK function to operate Two in-line 250V/0.6A fuses protect various any other pendant functions. This ensures that components on the AC line. One fuse, located the table base will not move while the tabletop is near the head side of the column protects the articulating. CPU from power surges (FIGURE 4-41). The second fuse, located on the right side of the The primary hand pendant plugs into the right column, is in the line between the AC mains and side of the remote control connector box, which the transformer. One spare fuse is included is located on the left side of the table (FIGURE inside the base cover. 1-4). Insert the pendant so the red dot on the connector aligns with a red dot on the socket in FLOOR LOCK SYSTEM the Primary Hand Pendant Connector Box. Four self-stabilizing floor feet compensate up to 0.25'' (6 mm) for unlevel floors. The floor feet NOTE — The ON/OFF function can be lowered (locked) or raised (unlocked) on the control pendant can be NOTE using the control pendant. When the floor feet used to stop the table while in are raised, the table rests on four non-conductive motion. casters. PRIMARY HAND PENDANT A primary hand pendant controls all table functions. The floor feet must be locked by

Footswitch Receptacle

Pendant Receptacle

FIGURE 1-4 PRIMARY HAND PENDANT AND FOOTSWITCH CONNECTOR BOX

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Rev. 1 1-3

OPERON B 810 SURGICAL TABLE GENERAL INFORMATION Primary Hand Pendant Indicators See FIGURE 1-5 for the location of the indicators 1.

2.

Aux. Pendant (amber) — Auxiliary hand pendant is active. The primary hand pendant will still be enabled if the auxiliary hand pendant is active. SERVICE (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, use the auxiliary hand pendant and the manual foot pump (if necessary) to articulate the table until the malfunction can be repaired.

4. 5. 6.

2

3

NOTE — If the SERVICE indicator lights, call your local Berchtold Corporation Service Representative.

NOTE

3.

1

REVERSE (amber) — Indicates reverse orientation of controls. FLOOR UNLOCK ² — Floor feet are raised so table is mobile. FLOOR LOCK ± — Floor feet are lowered so table is locked in place. BATTERY — LEDs indicate the charge status of the batteries:

4

5

•

7.

Green — Full to medium charge. Normal Operation. • Yellow — Low charge. Table still operates normally, but batteries should be charged at the first opportunity. • Red (steady) — Recharge battery. Pump motor is shut off and manual foot pump must be used. • Red (flashing) — Auxiliary pendant must be used. Recharge battery immediately! ON  (Backlight) — Control pendant is active.

NOTE

Rev. 1 1-4

NOTE — In the event of a primary hand pendant failure, use the auxiliary hand pendant and foot pump to complete the procedure and contact your local Berchtold Corporation Service Representative.

7 6

FIGURE 1-5 PRIMARY HAND PENDANT INDICATORS

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OPERON B 810 SURGICAL TABLE GENERAL INFORMATION Primary Hand Pendant Functions WARNING

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.

2.

TABLE v — Raises and lowers the entire tabletop.

LEG v — Raises and lowers the leg section. TREND/REV TREND (Trendelenburg) — Tilts the entire tabletop about the transverse axis. 5. SLIDE FOOT/SLIDE HEAD — Slides the table top toward 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 — Combines back down with reverse Trendelenburg to form an inverted V (jackknife position). 9. CHAIR – Combines back up, Trendelenburg, and leg down functions to form a chair-like support. The three functions operate in a repeating sequence until the back section reaches 80° relative to the seat section and the leg sections reach 105° degrees relative to the seat section. 10. LEVEL — Moves the table to a horizontal position that is within 1 degree of level. This function should be used prior to the Flex and Chair Functions. 11. ORIENTATION NORMAL/REVERSE — In REVERSE mode, the buttons function in reverse. CHAIR is disabled in Reverse Orientation. Table up/down, floor lock/unlock, and kidney up/down are not reversed. 12. FLOOR UNLOCK / LOCK — Raises (unlocks) or lowers (locks) the floor feet.

NOTE — If AC power is not present, the auto-shutdown feature will turn the control pendant off after about 120 minutes of non-use. To reactivate the pendant, press any function button. If AC is present, the auto-shutdown feature is disabled, and the hand pendant remains on until it is turned off.

NOTE

1

2 3

3. 4.

NOTE

NOTE: — The power switch on the base of the table must be in the ON position before the hand pendant will operate.

4 5 6 7 8

9

10 11 12

13

FIGURE 1-6 PRIMARY HAND PENDANT FUNCTIONS

13. ON/OFF — Turns the primary hand pendant on and off. The pendant will be backlit when activated.

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Rev. 1 1-5

OPERON B 810 SURGICAL TABLE GENERAL INFORMATION FOOTSWITCH (OPTIONAL) A footswitch control is available for procedures where the surgeon is normally seated at the pelvic end of the patient (FIGURE 1-7). Footswitch functions include: • Trendelenburg/Reverse Trendelenburg • Tilt Left/Tilt Right • Table Up/Down 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 1-4 for location of connector.

FIGURE 1-8 DEPLOYING FOOT PUMP PEDAL 2.

Table Up/ Table Down

3.

Rotate the pedal clockwise until it can be pulled out farther. Extend the pedal until it snaps into position (FIGURE 1-9).

Tilt Left/ Tilt Right Reverse Trendelenburg

FIGURE 1-7 FOOTSWITCH Pressing one of the footswitch controls turns the table on and places it in “controls active” status. However, none of the functions will operate unless the floor locks are set. The floor locks must be operated through the hand pedant.

Retracted Position Locking Dimple

1. Rotate Pedal Clockwise

MANUAL FOOT PUMP The manual foot pump is used to provide hydraulic pressure when there is no electric power to operate the hydraulic pump. This could occur due to any of the following conditions: •

Battery power is low as indicated by a steady or flashing red battery light on the hand pendant. • A combined failure of the battery and AC mains power supplies. • A failure of the table’s hydraulic pump or the electrical system that powers the hydraulic pump. The manual pump pedal is located at the head end of the base. To use the manual foot pump: 1.

Pull the foot pedal straight out as far as it will go (FIGURE 1-8).

FIGURE 1-9 LOCKING FOOT PUMP PEDAL FOR USE 4.

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. 2. 3.

Rev. 1 1-6

Continue to Pull Out Until Pedal Locks

Push the pedal back into the table until the end is close to the base cover. Rotate the pedal counterclockwise until the end aligns with the hole in the base cover. Continue to push the pedal into the table until it snaps into the retracted position.

70-000-0027

OPERON B 810 SURGICAL TABLE GENERAL INFORMATION AUXILIARY HAND PENDANT The yellow auxiliary hand pendant (FIGURE 1-10) is located in the auxiliary hand pendant control drawer in the head end of the base (FIGURE 1-11).

Table Up

Table Down

Back Up

Back Down

Leg Up

Leg Down

Tilt Left

Reverse Trend Tilt Right

Kidney Up

Kidney Down

Feet Unlock

Feet Lock

Trendelenburg

CAUTION

NOTE

CAUTION — The auxiliary hand pendant does not have the following functions: FLEX, CHAIR, RETURN TO LEVEL, and SLIDE. This pendant is intended to be used for completing procedures, followed by charging the batteries or servicing the table. NOTE — Activating the Feet Lock function with the auxiliary hand pendant and foot pump will require a large number of pumps to engage the locking feet.

AUXILIARY PENDANT DRAWER Do this to use the auxiliary control pendant: 1. Pull the finger tab to open the door and slide the pendant out (FIGURE 1-11). • •

Removing the pendant activates a switch that turns the auxiliary pendant on. Activating the auxiliary hand pendant does NOT disable the primary hand pendant.

FIGURE 1-10 AUXILIARY HAND PENDANT Use the auxiliary control pendant when: • •

Auxiliary Control Pendant

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

WARNING

WARNING

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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.

FIGURE 1-11 LOCATION OF AUXILIARY PENDANT 2. 3.

Press and hold the desired function button. Operate the manual foot pump until the table top is in the desired position.

NOTE

NOTE — Cord and auxiliary hand pendant should be placed in separate compartments as labeled..

When the procedure is complete, do this to stow the auxiliary hand pendant: 1. Carefully fit it and the cord into the compartment. 2. Close the door firmly. 3. If deployed, stow the foot pump handle.

Rev. 1 1-7

OPERON B 810 SURGICAL TABLE GENERAL INFORMATION TABLE 1-1. Electrical Power Requirements:

TECHNICAL DATA 115 V AC +/-10% 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 8000 ft.

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

76 inches (1930 mm)

Width

21 inches (533 mm); excluding the side rails.

Weight

Approximately 715 lbs. (325 kg)

Height

28 to 48 inches (711 mm to 1219 mm)

Head Section

9” X 21”

Back Section

20.0” X 21”

Seat Section

20.5” X 21”

Kidney Elevator

3” X 21”

Leg Section

18.5” X 21”

Range of Motion: Trendelenburg

Up to 30°

Reverse Trendelenburg

Up to 30°

Lateral Tilt

Up to 20° right or left

Back Section

From 45° below horizontal to 80° above horizontal

Kidney Elevator

Extendable up to 3 inches (76 mm)

Leg Section

From 2° above horizontal to 105° below horizontal

Headrest

Adjustable from 90° below horizontal to 90° above horizontal in 15° increments

Longitudinal Slide

12 inches (305mm) total

Flex

225°

Chair

Leg Section 105°, Back Section 80° relative to the Seat Section, which may be up to 30° in the Trendelenburg position.

Load Capacity: Lifting and Articulation

600 lbs. (273 kg)

If you need assistance, call Berchtold Technical Service at 800-243-5135.

Rev. 1 1-8

70-000-0027

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

CAUTION

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. Side shields to column shields (in tilt) 7. Column shields to base cover 8. Base to floor 9. Floor feet to base 10. Floor feet to floor 11. Leg section to column shield 12. 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 OPERON B 810 table, pinch or crushing points exists (FIGURE 2-1). 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. Leg Section

Seat Section

1 2

Floor Feet

11

Headrest

3

4

5

12 Side Shield Column Shield Base Covers Base

Back Section

Kidney Elevator

6 7

10 9

8

FIGURE 2-1 PINCH POINTS If the integrity of the external protective earth ELECTROMAGNETIC INTERFERENCE conductor arrangement is in doubt, the surgical table WARNING — When using the table should be operated from its internal electrical power in the vicinity of high-frequency source (batteries) until the situation is corrected. The WARNING surgical equipment, such as cardiac batteries require charging at least once a week. If the defibrillators and cardiac integrity of the external protective earth conductor defibrillator monitors, refer to the arrangement is in doubt, and the batteries are not equipment manufacturers’ charged, operate the surgical table with the manual instructions to ensure compatibility foot pump and the auxiliary hand pendant until the issues are considered. situation is corrected. 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. 70-000-0027

LOAD CAPACITY WARNING

WARNING — Overloading may result in tipping of the table or failure of the table sections to move. Do not exceed the maximum load.

Rev. 1 2-1

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS The patient lifting and articulation capacity is 600 lbs (273 kg). This means that a 600 lb patient can be moved into any of the standard procedural positions. PATIENT ORIENTATION WARNING

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 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.

FIGURE 2-3 REVERSE TABLE ORIENTATION PATIENT POSITIONING WARNING

WARNING — POSSIBILITY OF TIPPING: If FULL SLIDE FORWARD IS REQUIRED, the patient’s 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.

When the patient is placed in the Lithotomy position on the seat section, the following precautions must be followed to ensure safety and stability: FIGURE 2-2 NORMAL TABLE ORIENTATION Reverse Orientation 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.

Rev. 1 2-2

•

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

WARNING

WARNING — 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 the normal perineal position.

NOTE

NOTE: — The tabletop may be slid towards the foot end of the table (full slide forward) without compromising stability.

70-000-0027

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS

WARNING

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: •

FIGURE 2-4 NORMAL PERINEAL POSITION 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.

CAUTION

Alternate Perineal Cutout Back Section

Leg Section

FIGURE 2-5 REVERSE PERINEAL POSITION The table must be securely locked to the floor and not mobilized while the patient is in this position.

NOTE

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. • Immediately lock the table when the new location is reached. OPERATION

NOTE: — The tabletop may be slid towards the head end of the table (full slide reverse) without compromising stability.

TABLE MOVEMENT WITH PATIENT WARNING

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.

NOTE

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.

If desired, plug the table’s power cord into a mains power source. 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 lit, the table senses mains AC and activates the battery charging system. Battery

70-000-0027

Rev. 1 2-3

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS charging will occur whether the ON/OFF switch on the base is in the ON or OFF position. The table can remain plugged into AC indefinitely without damaging the batteries. HAND PENDANT OPERATION The table may be activated by pressing the hand pendant ON button or by pressing any of the hand pendant function buttons. If you activate the table by pressing the ON button, the hand pendant LEDs for the SERVICE, LOCK/UNLOCK, and all Battery levels will illuminate briefly. This is a self-test function. If there is a problem with the hand pendant, the connection to the table, or any of the table functions, the SERVICE LED will remain on. If there are no problems, all LEDs except the current floor lock and battery status displays will turn off, and the function buttons will become back lit to indicate that the table is in a “controls active” status (FIGURE 2-6).

SERVICE Led Lights then goes out Function Indicator Back Lighting Glows

Lock or Unlock Status LED stays lit Battery Status LED stays lit

FIGURE 2-6 HAND PENDANT POWER-ON INDICATORS To conserve battery power, the hand pendant will automatically go into SLEEP MODE (backlighting will turn off) after two hours of non-use. This period can be changed through the table’s Service Software Program, which is described in the “Service Program” section of this manual. If you activate the hand pendant from the SLEEP MODE by pressing any of the function buttons (other than the ON button), the self-test will be performed after the button is released. To actuate the function associated with the button it must be pressed a second time after “awakening” the hand pendant. If the floor legs are NOT locked, the back lighting will come on and the hand pendant will go into “controls active” status, the feet will automatically descend and lock.

Rev. 1 2-4

To operate any hand pendant function, press and hold the button for the action desired. If you press the floor lock or unlock function, you do not have to hold the button until the function is complete. Once started, the floor locking or unlocking action will be completed automatically. Each articulation has a software controlled limit. You can stop any motion by releasing the function button or you can hold the button until it reaches the limit set for that function, and the movement will stop automatically. 1.

Press the ON button on the control pendant to activate the control pendant 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. 4. When the desired position has been reached, release the function button 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.

2. 3.

Is the ON/OFF switch on the base of the table in the OFF position? • Turn the switch to the ON position. Is the yellow UNLOCK indicator lit? • Lock the floor feet. Is the battery status LED red and flashing or steady? •

4.

Use the manual foot pump or plug in the table. Plugging in the table will allow normal use and also recharge the batteries. • Use the auxiliary pendant and foot pump to complete the operation. Is the red SERVICE LED lit? •

A lit SERVICE LED 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 as return to level, will be disabled but the other functions will remain enabled. Only a catastrophic failure of the main processor will light the SERVICE LED and disable all table functions. Always contact Berchtold Service if the SERVICE LED is lit. 70-000-0027

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS Function Priority When a function is selected using either, the primary hand pendant or optional footswitch, the table will stop performing any function that was in progress. To resume the motion, you must release the function (or footswitch) button and press it again. You can press only one button at a time. If you press more than one button at the same time, neither will work. If you press a second button while one function is operating, the function will stop. To restart the function, you must release the function button and press it again. Table Movement Limits Due to the OPERON B 810 table’s extensive articulation range, some functions can not be

70-000-0027

combined at their maximum capability. These interfering functions are limited in two ways: by the table software and by the user. Each table movement has a speed limit that is based on a percentage of the hydraulic pump power applied. These speed limits help to ensure smooth table movements and enhance patient safety. Software-Controlled Limits The software controls limit the functions described in Table 2-1. If the Operon B 810 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.

Rev. 1 2-5

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS TABLE 2-1. 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 Trendelenburg and Reverse Trendelenburg

Tilt Left and Tilt Right

Back angle Leg angle

Slide Height

Rev. 1 2-6

Limits Back section to maximum of 26° above horizontal ± 30 ° except: When Tilt Right is:

Max Trend angle is:

0° to 5° 5.1° to 10° 10.1° to 20° When Tilt Left is: 0° to 10° 10.1° to 20° When Leg angle is: >65° >90° When Back down angle is: >30° When table Height is: <31” 31”<Height<40” AND Leg >65°

30° 30° 22°

Max Reverse Trend angle is: 30° 15° 15°

30° 22°

30° 22°

30° 30°

10° Disabled

15°

30°

15° 15°

15° 5°

Max Tilt Right is: 20° 10°

Max Tilt Left is: 20° 10°

20° 5° 5°

20° 20° 10°

Disabled

Disabled

Max Back angle is 80°

Min Back angle is 30°

± 20 ° except: When Trend is: 0° to 20° >20° When Rev Trend is 0° to 15° 15° to 22° >22° When Leg down is >65° If Height is <31”

+2°, -105° except If Reverse Trend is Max Leg up angle is Max Leg down angle is >10° 2° 65° If table Height is <31” 2° 65° If Tilt (right or left) is >5° 2° 65° Height < 31” AND Slide is Max Forward (leg end) 2° 97° Slide Function is disabled if: Trendelenburg or Reverse Trendelenburg angles >15° Leg Down > 65° AND Height <31” If Leg down angle Max Height is Min Height is is >65° 46” 31”

70-000-0027

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS User-Controlled Limits

locking mechanism is not engaged.

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.

CAUTION

Some collisions are possible when combining multiple articulations, particularly at low table heights. When combining functions, you must monitor the table’s position to ensure collisions are avoided. HEADREST WARNING — Do not mount knee crutches or leg holders 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 25 lbs.

WARNING

WARNING — When articulating the headrest, be sure that the locking mechanism engages completely, and does not hang in between positions. Until the locking mechanism engages, the headrest may move when a load is applied.

WARNING

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

Back Section

15° Release Bar

90°

FIGURE 2-7 HEADREST To raise and lower the headrest: 1. Release the locking mechanism by pulling out the release bar on the right underside of the headrest. 2. When the headrest is properly positioned, release the bar.

WARNING

70-000-0027

WARNING — When releasing the locking mechanism, support the headrest, as it will fall freely if the Rev. 1 2-7

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS REMOVABLE LEG SECTION

WARNING

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. Partially Inserted

Pivots Level

Latches

FIGURE 2-10 ASSEMBLED LEG SECTION 5.

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. 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

Fully Inserted

FIGURE 2-8 ALIGNING THE LEG SECTION FOR INSTALLATION 3. 4.

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 (FIGURE 2-9 and FIGURE 2-10). Leg Section

Seat Section

Seat Section

NOTE

NOTE

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. NOTE — to operate the footswitch control, the floor feet must be locked.

NOTE — It is not necessary to press the primary hand pendant ON/OFF switch when operating the footswitch control. The primary hand pendant can not be operated simultaneously with 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. (See FIGURE 2-11.)

Leg Section Pivots

FIGURE 2-9 LEG SECTION

Rev. 1 2-8

70-000-0027

OPERON B 810 SURGICAL TABLE OPERATING INSTRUCTIONS NOTE

Table Up/ Table Down Tilt Left/ Tilt Right Trendelenburg/ Reverse Trendelenburg

FIGURE 2-11 FOOTSWITCH

70-000-0027

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.

Rev. 1 2-9