Trios Table Base Ref 7803xx Owners Manual Rev B

Table of Contents 1

Important Notices ... 1 1.1 Trademarks ... 4 1.2 Disposal of Electrical Components... 5

2

Introduction ... 6 2.1 General Description ... 6 2.2 Intended Use ... 7 2.3 User Profile ... 7 2.4 Training Requirements ... 7 2.5 Conditions of Use ... 7 2.6 Product Lifetime ... 8 2.7 Specifications ... 8 2.8 Shipping and Storage ... 8 2.9 Glossary of Terms... 9

3

Component Identification ...11 3.1 Table Orientation... 11 3.2 Head-End Column of the Trios® Table Base ... 12 3.2.1 Base of the Head-End Column ... 13 3.2.2 Pivot Assembly ... 14 3.2.3 IntelliPendant® ... 15 3.2.4 Auxiliary Control Panel ... 15

3.3 Foot-End Column of the Trios® Table Base ... 16 3.3.1 Optional Advanced Control Pad System™ ... 17

3.4 Model Number and Serial Number ... 17

4

Basic Operation...18 4.1 Control Operation ... 18 4.2 Emergency Stop ... 19 4.3 Auxiliary Control Panel ... 20 4.4 Floor Locks ... 21 4.4.1 IntelliPendant® Activated Floor Lock Override ... 21 4.4.2 Manual Floor Lock Override ... 21

4.5 Moving the Trios® Table Base ... 22 4.6 IntelliPendant® ... 22 4.6.1 Table Functions ... 25

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4.6.2 Defined Function and Setting Symbols ... 26 4.6.3 Return to Level ... 28 4.6.4 Soft Key Functions and Settings ... 28

4.7 Configuration of Trios® Table Base for Transport or Storage... 35 4.8 Indicator Lights ... 39 4.8.1 Level Indicator Light... 39 4.8.2 180 Degree Rotation Lock... 40

4.9 Traction Pulley Assembly ... 41

5

Inspection ...42 5.1 Acceptance and Transfer ... 42 5.2 Pre-Procedure/Post-Procedure ... 42 5.3 Semi-Annual Preventative Maintenance ... 42 5.4 Product Lifetime ... 42

6

Installing and Removing a Table Top ...43 6.1 Preparing the Table Base for Table Top Installation ... 43 6.2 Installing the Table Top on the Table Base ... 44 6.3 Removing the Table Top from the Table Base ... 51

7

Function Check ...53 7.1 General Table Base Function Checks ... 53 7.2 Floor Lock Checks ... 54 7.3 IntelliPendant® Function Checks ... 54 7.4 Battery Operation Checks ... 55

8

Cleaning, Storage, and Maintenance ...56 8.1 Cleaning and Disinfecting ... 56 8.1.1 Trios® Table Base Exterior ... 56

8.2 Storage ... 56 8.3 Maintenance ... 57 8.3.1 Battery Maintenance... 57 8.3.2 Preventative Maintenance... 57

9

Electrical System ...58 9.1 Description ... 58 9.2 Detachable Power Cord ... 58 9.3 Power/Standby Switch ... 58 9.4 Power/Charging Indicator ... 58

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9.5 Circuit Breakers ... 59 9.6 Emergency Stop Button ... 59 9.7 IntelliPendant® ... 59 9.8 Battery System ... 59 9.8.1 Charging the Batteries ... 60 9.8.2 Replacing the Batteries ... 60

10 Troubleshooting ...61 10.1 Electrical System ... 61 10.2 Base ... 61 10.3 Hand Pendant ... 61 10.4 Manual Floor Lock Override ... 62

11 Software Troubleshooting ...63 12 Technical Support ...68 12.1 Contact for Parts and Service ... 68 12.2 Order Replacement Parts ... 68 12.3 Return Damaged Parts ... 68 12.4 Send a Part for Repair ... 68 12.5 Warranty... 69 12.6 European Union EC Representative

... 69

13 Appendix ...70 13.1 Electromagnetic Emissions ... 70 13.2 Electromagnetic Immunity ... 71 13.3 Recommended Separation Distances... 73

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Trios® Table Base Owner’s Manual

1 Important Notices CAUTION: To ensure safe operation of the equipment, please READ THESE INSTRUCTIONS COMPLETELY and keep this manual readily available for future reference. Carefully observe and comply with all warnings, cautions and instructions placed on the equipment or described in this manual. NOTE: This device is intended for use by trained personnel only. To schedule an in-service,

please contact your domestic Mizuho OSI sales representative, or call 1-800-777-4674 inside the USA or +1-510-429-1500 outside the USA. NOTE: The application techniques outlined in these instructions are the manufacturer’s

suggested techniques. The final disposition of each patient’s care as related to the use of this equipment rests with the attending surgeon. In this manual, the following symbols are used: Symbol

Meaning This symbol indicates an authorized representative in the European Community. This symbol indicates the Manufacturer of the device.

This symbol indicates the Date of manufacture. NOTE:

This symbol indicates a comment or instruction of importance. This symbol is to signify CAUTION. It is intended to alert the user to consult the documentation for safety-related information such as warnings and precautions that cannot, for a variety of reasons, be presented on the device itself. This WARNING symbol is intended to alert the user of important operation, maintenance, or safety instructions. This symbol indicates proper disposal instructions. This symbol indicates a product number. This symbol indicates a serial number. This symbol indicates that you must read the owner’s manual before use. This symbol indicates that you are advised to refer to the owner’s manual before use. This symbol indicates an external ground stud that is required to be connected to earth ground (via equipotential connector/busbar) when the AC power cable is not connected to a protective earth ground hospital grade AC outlet in your operating room or facility.

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This symbol indicates this equipment is an applied part TYPE B in accordance with IEC 60601-1 and is generally suitable for applications involving external or internal contact with the patient, excluding the heart. The patient circuit is connected to protective earth and this equipment should be connected only to hospital grade AC outlets with a protective earth ground. This symbol indicates that a Warning exists related to actions to be taken, and the owner’s manual must be read before use. This symbol identifies a Power/Standby switch.

This symbol represents an Emergency Off.

This symbol identifies a Hand Pendant Connector.

This symbol indicates table level.

This symbol indicates table rotation.

This symbol indicates Up-Down movement.

These two symbols indicate a two-step rotation unlock process: lift up, then pull down.

This symbol indicates pulley for weighted traction.

This symbol indicates positive and negative terminals for proper attachment of battery cables. This symbol indicates Warning, dangerous voltage (related to battery safety).

This symbol indicates Do not touch, housing energized (related to battery safety).

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WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

WARNING: Proper preoperative and intra-operative procedures must be followed to prevent venous stasis and pooling, pressure sore development, neuropathy, improper electro-surgical tissue grounding, hypertension/hypotension, and hypothermia.

WARNING: This symbol indicates an external ground stud that is required for use when the AC power cable is not connected to a protective earth ground hospital grade AC outlet in your operating room or facility. To protect the patient, hospital staff, and the table from possible electrical hazards, an external ground wire connection is required between the external ground stud and earth ground (via equipotential connector/busbar) when the table is in use under battery power.

WARNING: Medical electrical equipment needs special precautions regarding Electromagnetic Compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this manual.

WARNING: Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.

WARNING: The equipment or system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used.

WARNING: The use of accessories, transducers, and/or cables other than those specified, with the exception of those sold by Mizuho OSI as replacement parts for internal components, may result in increased emissions or decreased immunity of the equipment or system.

WARNING: The weight capacity of the Trios® Table Base is table top specific. Use of the Trios Surgical Table System (Base with any of the compatible table tops) with patients exceeding the table top specific weight capacity could result in damage to the table, possible injury to the patient, or harm to the healthcare professionals. ®

WARNING: The table tops will only support the specified patient weight when installed patient side up (Patient Weight Limit label and Fixed Table Top Handles are visible) to the Tower installed on the underside of the Crossbar or directly to the Crossbar, as described in Section 6. Placing a patient on a table top that is not installed as described could result in damage to the table, possible injury to the patient, or harm to the healthcare professionals.

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WARNING: The Trios® Table Base is to be used by personnel that receive training from either Mizuho OSI or from someone qualified by the medical facility to provide this training. Failure to comply with this requirement may result in damage to the device, possible injury to the patient, or harm to the healthcare professionals.

WARNING: Before and after each use, inspect the Trios® Table Base and its components for possible damage, excessive wear, or non-functioning parts. Carefully inspect all critical, accessible areas, joints, and all moving parts for possible damage or non-function. Damaged or defective parts should not be used or processed. Contact Mizuho OSI Services for repair or replacement (see Section 12).

WARNING: The Trios® Table Base should not be operated in the presence of flammable anesthetics, volatile substances, or other explosive gases, liquids, or atmospheres.

WARNING: Use of components not manufactured or recommended by Mizuho OSI may result in harm to the patient, the device, or the healthcare professionals.

CAUTION: As outlined in the AORN Recommended Practices for Positioning a Patient in the Perioperative Setting, following the positioning of the patient, an assessment of the patient’s alignment, tissue perfusion, and skin integrity should be completed. All contact points of the patient with the table pads should be monitored during the procedure.

CAUTION: No modification of the Trios® Table Base or its components is allowed. Any modification to the equipment may result in damage to the table, possible injury to the patient, or harm to the healthcare professionals. NOTE: If the integrity of the AC power source is in doubt, the equipment shall be operated from

its internal electrical power source (battery). NOTE: If high-frequency surgical equipment, cardiac defibrillators, or cardiac defibrillator

monitors are to be used with the Trios® Surgical Table System, refer to the instructions for use provided by the manufacturer of those devices. Potential hazards that must be considered include, but are not limited to patient burns, explosion hazards, or electric shock of the patient or operator.

1.1 Trademarks Trios® and IntelliPendant® are registered trademarks of Mizuho OSI. Advanced Control Pad System™ is a trademark of Mizuho OSI. O-arm® is a registered trademark of Medtronic Inc. Tempur® is a registered trademark of Tempur-Pedic North America, Inc. Patents Pending

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1.2 Disposal of Electrical Components

In accordance with the European Union Waste Electrical and Electronic Equipment (WEEE) Directive, all electrical components, batteries, and carbon composite components must be disposed of in accordance with local regulations or returned to Mizuho OSI for proper disposal. Please contact Mizuho OSI Services at 1-800-777-4674 inside the USA or +1-510-429-1500 outside the USA for further information regarding this requirement.

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2 Introduction 2.1 General Description The Trios® Table Base is the primary component of the Trios® Surgical Table System and is designed to be used with multiple interchangeable table tops. The Trios® Surgical Table System provides the flexibility to position patients for a variety of surgical or radiographic imaging procedures. The Trios® Table Base provides the foundation on which a table top may be mounted, creating a surgical platform free of any obstructions when used with a fluoroscopic C-arm or the O-arm®. The Base is designed for use with the following procedure-specific table tops currently offered: Trios® Spinal Surgery Top, Trios® Radiolucent Imaging Top, and Trios® Orthopedic Trauma Top. The Trios® Table Base has electrically powered positioning and operating functions, which are controlled by means of the IntelliPendant®. The IntelliPendant® provides a visual status display for the Floor Locks, optional Advanced Control Pad System™ (ACP), Battery Status, Height Status, Trendelenburg/ Reverse Trendelenburg Angle, and Lateral Tilt Angle. The Base may also be retracted for storage (see Section 4.7). The Base can be operated under AC power or internal batteries. The product life of the Trios® Table Base is ten (10) years when used and maintained as outlined in this manual.

Figure 1: Trios® Table Base

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2.2 Intended Use With a table top mounted on the Trios® Table Base, an electrically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized. The Base with a table top mounted is intended for use during surgical procedures, including radiographic imaging during such procedures. The Base with a table top mounted should not be used for patient transport. The table tops, when mounted on the Trios® Table Base, provide a platform designed to support and position adult and pediatric patients falling within the maximum weight limit allowed for each top as listed below: 

Trios® Spinal Surgery Top:

650 lbs (295 kg)



Trios® Radiolucent Imaging Top:

650 lbs (295 kg)



Trios® Orthopedic Trauma Top:

500 lbs (227 kg)

2.3 User Profile The Trios® Surgical Table System is suitable for use by health care professionals, including but not limited to surgeons, radiologists, anesthesiologists, circulating nurses, surgical technicians, biomedical technicians, and radiology technicians.

2.4 Training Requirements Before using the Trios® Surgical Table System, the user must read the NW0785 Trios® Table Base Owner’s Manual. Depending on the table top(s) used, the user must also read the corresponding Owner’s manual(s) listed below: NW0786 Trios® Spinal Surgery Top Owner’s Manual NW0787 Trios® Radiolucent Imaging Top Owner’s Manual NW0816 Trios® Orthopedic Trauma Top Owner’s Manual It is required that personnel using the Trios® Surgical Table System receive training by either Mizuho OSI or by someone qualified by the medical facility to provide this training.

WARNING: Failure to ensure training prior to use of this device may cause harm to the patient, healthcare professional, or the device.

2.5 Conditions of Use The Trios® Table Base may be used several times throughout the day and night in medical facilities; e.g. hospitals, and outpatient surgery/imaging centers. The Trios® Table Base will be used in an operating room or other treatment room, and may be rolled between rooms. It shall not be used for patient transport.

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2.6 Product Lifetime The product’s service lifetime is defined as 10 years. At the time of delivery, your product fulfills existing regulations and standards. However, despite proper use, routine inspection, prescribed service, maintenance and repairs, the product is subject to aging and wear. Therefore, Mizuho OSI cannot guarantee the product’s safety after ten (10) years and recommends your product be taken out of service. For product warranty information, see Section 12.5.

2.7 Specifications The Trios® Table Base has the following specifications: 

When used with each of the procedure-specific table tops, the Trios® Table Base provides the platform on which these table tops are designed to mount. The maximum patient load is table top specific.



Height range of the Base is 33 inches (83.8 cm) to 50.7 inches (128.8 cm).



Width of the Base is 32 inches (81.3 cm).



Maximum length of the Base is 110 inches (279.4 cm), with a retracted length of 68 inches (172.7 cm) for storage.



Lateral Tilt (left/right) is 25 degrees, and Trendelenburg/Reverse Trendelenburg is 11 degrees.



Input power requirement is 100-240 VAC, 50/60 Hz, as indicated on the table label.



The table may also be operated under battery power. The expected working life of a fully charged battery is two normal procedures.



The Base is IPX4 rated per IEC 60529.



Operating environment – 68 °F (20 °C), relative humidity 50%, atmospheric pressure 75-105 kPa.



Class 1 Equipment; Type B per IEC 60601-1.



The Base is not suitable for use with flammable anesthetic gas mixtures.



This device is rated for a duty cycle of 4% (2.5 minutes on, 60 minutes off).

2.8 Shipping and Storage If required to be transported, the Trios® Table Base must be transported using the appropriate shipping crate. Unpacking instructions were included with the original shipping crate and should be included on the outside of the crate if the Trios® Table Base must be transported. When not in use, the Trios® Table Base should be stored in a clean, dry environment. The following conditions are required of the shipping and/or storage environment: 

Ambient temperature -4 °F (-20 °C) to 122 °F (50 °C)



Relative humidity from 10% to 95%, non-condensing



Atmospheric pressure from 75 to 105 kPa

When in storage, the table cover provided with each respective table top serves as a dust cover and should be used. Also, to ensure that the battery is always fully charged and ready for use, store the Base connected to the AC power that matches the ratings on the manufacturer’s label located on the Head-End base cover.

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2.9 Glossary of Terms This glossary of terms assumes that the patient is oriented with his or her head at the Head-End of the table and his or her feet at the Foot-End of the table. The functions of the IntelliPendant® and Auxiliary Control Panel are oriented for this position. Term

Description

Head-End

Refers to the end of the Base where the Power Cord, Power Switch, and Control Panel are located.

Foot-End

Refers to the end of the Base opposite the Head-End.

Column

Refers to each of the two main column structures of the Base used to support the table top.

Retractable Center Beam

The Retractable Center Beam connects to the Head-End and the Foot-End Columns. The Beam retracts, allowing the table to be transported or stored in a smaller configuration.

Floor Locks Unlocked

Refers to the table casters being fully free to rotate. The button on the IntelliPendant® and the Auxiliary Control Panel used to unlock the Floor Locks is labeled .

Floor Locks Locked

Refers to the table casters being fully locked. The button on the IntelliPendant® and the Auxiliary Control Panel used to lock the Floor Locks is labeled .

Left Side of the Base

Refers to the left side of the Base (as you stand at the Head-End and look towards the Foot-End). The button on the IntelliPendant® and the Auxiliary Control Panel used to laterally tilt (roll) the table top to the left is labeled

Right Side of the Base

.

Refers to the right side of the Base (as you stand at the Head-End and look towards the Foot-End). The button on the IntelliPendant® and the Auxiliary Control Panel used to laterally tilt (roll) the table top to the right is labeled

.

Raise the Table

Refers to raising the height of the table top. The button on the IntelliPendant® and the Auxiliary Control Panel used to raise the height of the table top is labeled .

Lower the Table

Refers to lowering the height of the table top. The button on the IntelliPendant® and the Auxiliary Control Panel used to lower the height of the table top is labeled .

Trendelenburg

Refers to lowering the height of the Head-End of the table top relative to the FootEnd of the table top. The button on the IntelliPendant® and the Auxiliary Control Panel used to lower the Head-End is labeled .

Reverse Trendelenburg

Refers to lowering the height of the Foot-End of the table top relative to the HeadEnd of the table top. The button on the IntelliPendant® and the Auxiliary Control Panel used to lower the Foot-End is labeled .

Table Motion

Any one of the three motions: Height, Lateral Tilt, or Trendelenburg.

Return to Level

Refers to the motion of the table required to return the table to the neutral position. When the Return to Level function is activated, the Lateral Tilt Angle returns to 0 degrees, and the Trendelenburg/Reverse Trendelenburg Angle returns to 0 degrees. The button on the IntelliPendant® and the Auxiliary Control Panel used to return the table to the neutral position is labeled .

Home Position

The position of the Trios® when the table top is level head-to-foot and side-to-side, and the height of the table top is 37 inches (94 cm) above the floor.

Hospital Grade AC outlet

Refers to specially designated outlets (receptacles) that include additional grounding reliability, assembly integrity, strength, and durability. A hospital grade outlet in the United States may be indicated by a green colored dot on the face of the outlet.

Slide Assembly

The Slide Assembly at the Head-End Column adjusts superiorly or inferiorly to accommodate for the length adjustments needed when using Trendelenburg and Reverse Trendelenburg.

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Traction Pulley Assembly

The Traction Pulley Assembly allows for weighted traction to be pulled by guiding the use of a traction rope.

Advanced Control Pad The Advanced Control Pad System™ provides user-selectable, pressure point System™ (ACP) stimulation to the patient’s hips, thighs, and chest when positioned prone. The ACP Hip Pads have built-in cells that alternate between inflating and deflating with air. Table Top

The patient support surface or frame on which patient support accessories are attached. The Trios® Table Base is designed for use with three (3) table tops: Trios® Spinal Surgery Top, Trios® Radiolucent Imaging Top, and Trios® Orthopedic Trauma Top.

Prone (Patient) Position

A body position in which the patient lies face down on a table top.

Supine (Patient) Position

A body position in which the patient lies face up on a table top.

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3 Component Identification 3.1 Table Orientation The Trios® Table Base is described as having a Head-End and a Foot-End. The Head-End of the Base provides the port to which the Hand Pendant is connected and the 180 Degree Rotation Lock handle. The end opposite to it is identified as the Foot-End (Figure 2). Each end also contains a Crossbar with mounting posts that allows for the attachment of a table top. With a table top installed, the patient should be positioned with his or her head oriented towards the Head-End of the Base.

Figure 2: Trios® Table Base NOTE: The maximum weight capacity for this table system is specific to each table top as noted

in the respective Owner’s Manuals and on the safety labels found on the table tops themselves.

WARNING: Use of the Trios® Table Base and a procedure-specific table top with a patient exceeding the maximum patient weight capacity noted could result in damage to the table, possible injury to the patient, or harm to the healthcare professionals.

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3.2 Head-End Column of the Trios® Table Base The Head-End Column of the Trios® Table Base contains several key controls necessary to operate the Base correctly, as well as important indicator lights and product identification information. Features found on Head-End Column include the 180 Degree Rotation Lock Handle, Emergency Stop button, Auxiliary Control Panel, Hand Pendant Rails, and the Traction Pulley (Figure 3).

Figure 3: Head-End Column of the Trios® Table Base

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3.2.1 Base of the Head-End Column The inside base of the Head-End Column is equipped with the following electrical features (Figure 4): 

Power/Standby Switch



Power Cord Receptacle



Two Reset Button Circuit Breakers



External Ground Stud



Battery Indicator LED



AC Power Indicator LED



Connection Port for diagnostics and service Reset Button Circuit Breakers

Power/Standby Switch

Battery Indicator LED

Service Port

External Ground Stud

Power Receptacle

AC Power Indicator LED

Figure 4: Head-End Column, Inside Base

If the table is running on AC power, the Power/Standby Switch and AC Power Indicator LED will be illuminated green. The Battery Indicator LED will either be illuminated green, indicating batteries are fully charged, or yellow, indicating batteries are charging.

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3.2.2 Pivot Assembly The Head-End Pivot Assembly is equipped with the following two indicator lights (Figure 5): 

180 Degree Rotation Lock indicator light



Level indicator light 180 Degree Rotation Lock Handle

180 Degree Rotation Lock Indicator Level Indicator

Hand Pendant Rails

IntelliPendant®

Traction Pulley Release Button Emergency Stop Button

Traction Pulley

Figure 5: Pivot Assembly of the Head-End Column

The Head-End Pivot Assembly also features the 180 Degree Rotation Lock Handle, the Emergency Stop button, the Traction Pulley, and the Hand Pendant Rails.

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3.2.3 IntelliPendant® The Trios® Table Base functions are controlled by the single hand pendant referred to as the IntelliPendant® (Figure 12). The graphical display of the IntelliPendant® provides real time information about the table’s position: Height, Trendelenburg/Reverse Trendelenburg angle, and Lateral Tilt angle. The IntelliPendant® also informs the user of the table’s status for Power, ACP Setting, and Floor Locks. The table’s functions and settings, which include Memory Position, Advanced Control Pad System™ Cycles, Floor Lock Override, and Storage Configuration, are managed using the IntelliPendant®. When the table is in use, the current Height is identified on the display screen in inches/centimeters. The angle of Trendelenburg/Reverse Trendelenburg and Lateral Tilt is displayed in degrees. Detailed instructions for utilizing the IntelliPendant® are provided in Section 4.6.

3.2.4 Auxiliary Control Panel The Auxiliary Control Panel (Figure 11) is intended to provide a second option for controlling primary table motions and the Floor Lock function. The Auxiliary Control Panel may be utilized to control table Height, Trendelenburg/Reverse Trendelenburg, Lateral Tilt, and Floor Lock operation. NOTE: Should the IntelliPendant® stop functioning, the Auxiliary Control Panel will allow the user

to execute the basic motions of the table and lock/unlock the Floor Locks. Detailed instructions for utilizing the Auxiliary Control Panel are provided in Section 4.3.

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3.3 Foot-End Column of the Trios® Table Base The Foot-End Column of the Trios® Table Base contains a second 180 Degree Rotation Lock indicator light (Figure 6). 180 Degree Rotation Lock Indicator

Figure 6: Foot-End Column of the Trios® Table Base

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