Triton Traction Model 4749 and 4798 User Manual

TABLE OF CONTENTS Foreword... 1

Product Description... 1

About traction therapy... 2-8

Precautionary Instructions... 2 Cautions... 3-4 Warnings... 4-5 Dangers... 5 Overview of Traction Therapy... 6 Common Terms... 6 Indications... 7 Contraindications... 7

Nomenclature... 8-13

Base Unit - Front View... 8-9 Base Unit - Rear View... 10-11 LCD Base... 12 Symbol Definitions... 13

specifications... 14-16

Traction Unit Dimensions and Specifications... 14 sEMG Module Dimensions and Specifications... 15 Description of Device Markings... 16

setup... 17-23 Contents of Carton... 17 Mounting Unit on Table... 18 Attaching the Patient Switch Hook... 19 Installing the sEMG Module... 20 Removing the sEMG Module... 21 Initial Unit Setup... 22-23

Operation... 24-48

Patient Preparation... 24-25

Triton® Traction Operating Controls - Home Screen... 26-28 Operating Controls - Treatment Screen... 29-32 sEMG Traction Treatment... 33-35 Starting, Pausing and Stopping Treatment... 36-37 Saving Treatment to a Patient Data Card... 38-40 Retrieving Data from Existing Patient Data Card... 41 Erasing Patient Data Card... 42 User Protocols... 43-44 Clinical Protocols™... 45-46 Multimedia Card (MMC) Graphics Library... 47 DTS Pull Patterns (If Applicable)... 48

accessories... 49-50 troubleshooting... 51-54

Troubleshooting... 51-52 Error Messages... 53-54

Maintenance... 55-56

Cleaning... 55 Preventative Maintenance Schedule... 55 Calibration Requirements... 55 Service... 56

Warranty... 57

FOREWORD

Triton® Traction

This manual has been written for the operators of the Triton traction unit. It contains general instructions for operation, precautionary instructions, and maintenance recommendations. In order to obtain maximum life and efficiency from your Triton traction unit, and to assist in the proper operation of the unit, read and understand this manual thoroughly. The specifications put forth in this manual were in effect at the time of publication. However, owing to DJO, LLC's policy of continuous improvement, changes to these specifications may be made at any time without obligation on the part of DJO, LLC. Before administering any treatment to a patient, you should become acquainted with the operating procedures, as well as the indications, contraindications, cautions, warnings, and dangers. Consult other resources for additional information regarding the application of traction therapy.

Product Description

The Triton traction unit is a simple to use digital touch screen user interface traction unit that offers static, intermittent, and cyclic traction with user definable hold, rest, and treatment times. An optional sEMG Module and DTS software upgrade are available for separate purchase. Patient Pain Profiles are recorded before and after treatment with a Numeric Pain Scale, VAS (Visual Analog Scale), and Pain Map for each patient. Once treatment parameters are customized for a patient, clinicians can store them as either the default user protocol or as one of twenty user defined protocols. The Triton traction unit contains a Patient Data Card port, providing access to store the above session parameters on Patient Data Cards. Information may be transferred to a PC via the optional Patient Data Management System. The PC software is designed to allow easy access to patient data and printing of reports as well as adding session notes to the Patient Data Card. This equipment is to be used only under the prescription and supervision of a licensed practitioner.

©2009 DJO, LLC Vista, California, USA. Any use of editorial, pictorial, or layout composition of this publication without express written consent from DJO, LLC is strictly prohibited. This publication was written, illustrated, and prepared for distribution by DJO, LLC.

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ABOUT TRACTION THERAPY

Triton® Traction

Precautionary INSTRUCTIONS NOTE: Throughout this manual “NOTE” may be found. These Notes are helpful information to aid in the particular area or function being described.

The precautionary instructions found in this section and throughout this manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment. The definitions of these symbols are as follows:

Explosion Hazard Text with an “Explosion Hazard” indicator will explain possible safety infractions if this equipment is used in the presence of flammable anesthetics.

CautionText with a “CAUTION” indicator will explain possible safety infractions that could have the potential to cause minor to moderate injury or damage to equipment.

WarningText with a “WARNING” indicator will explain possible safety infractions that will potentially cause serious injury and equipment damage.

DangerText with a “DANGER” indicator will explain possible safety infractions that are imminently hazardous situations that would result in death or serious injury.

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ABOUT TRACTION THERAPY

Triton® Traction

• Do not operate the unit when connected to any unit other than

• Read, understand, and practice the precautionary and operating

Chattanooga devices. Do not use devices manufactured by other companies on Chattanooga equipment. DJO, LLC is not responsible for any consequence resulting from using products manufactured by other companies. • Handle the unit with care. Inappropriate handling of the unit may adversely affect its characteristics. • Before each use, inspect the Traction Cord for wear. Prolonged wear on the cord will cause it to break, which may cause sudden release of traction pressure on a patient. • Inspect lead wires and associated connectors for signs of damage before each use. Replace damaged lead wires immediately before any treatment is applied. • Always test the Patient Interrupt Switch cable before each use for proper operation. • Do not use sharp objects such as a pencil point or ballpoint pen to operate the buttons on the Touch Screen base as damage may result. • Do not remove the cover. This may cause unit damage, malfunction, electrical shock, fire, or personal injury. There are no user-serviceable parts inside the unit. If a malfunction occurs, discontinue use immediately, disconnect the Mains Power Cord from the outlet, and consult the dealer for repair service. • Do not disassemble, modify, or remodel the unit or accessories. This may cause unit damage, malfunction, electrical shock, fire, or personal injury. • Do not use the traction unit near devices such as X-ray units or diathermy units. These units may emit high frequency noise that may affect the operation of the unit.

instructions. Know the limitations and hazards associated with using sEMG, DTS Pull Patterns and the Triton traction unit. Observe the precautionary and operational decals placed on the unit. • DO NOT operate this unit in an environment where other devices are being used that intentionally radiates electromagnetic energy in an unshielded manner. Portable and mobile RF communications equipment can affect Medical Electrical Equipment. • This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. Harmful interference to other devices can be determined by turning this equipment on and off. Try to correct the interference using one or more of the following: reorient or relocate the receiving device, increase the separation between the equipment, connect the equipment to an outlet on a different circuit from that which the other device(s) are connected and consult the DJO, LLC Service Department for help. • This unit should be operated, transported, and stored in temperatures between -18 °C and 60 °C (0° F and 140° F). • The unit should be routinely checked before each use to determine all controls function normally. • Do not use electrodes that have been previously used as the electrodes used with this unit are designed for single use only.

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ABOUT TRACTION THERAPY

Triton® Traction

• This device should only be used under the continued supervision of a

• Do not use the Clevis as a handle to pick up or carry the unit. • Do not permit any foreign materials or liquids to enter the unit. Take

licensed practitioner.

• Care must be taken when operating this unit adjacent to or

care to prevent any foreign materials including, but not limited to, inflammables, water, and metallic objects from entering the unit. These may cause unit damage, malfunction, electrical shock, fire, or personal injury. • If you have difficulty operating the unit after carefully reviewing this operator’s guide, contact your DJO, LLC dealer for assistance. • Failure to use and maintain the traction unit and its accessories in accordance with the instructions outlined in this manual will invalidate your warranty. • The Patient Interrupt Switch is essential for the functioning of the unit. If it is not connected, or if it is malfunctioning, the unit will not work. • A licensed practitioner experienced with traction therapy must be familiar with all instructions contained in this manual before administering traction therapy. Do not attempt to become familiar with the Triton traction unit while administering traction therapy on a patient. • In the event of a loss of power to the unit or when quick release is needed, traction tension should only be released by having the patient move towards the traction head to release the tension on the rope. Once the tension on the rope has been released, loosen the patient harness adjustment straps.

stacked with other equipment. Potential electromagnetic or other interference could occur to this or other equipment. Try to minimize this interference by not using other equipment (i.e. cell phones, etc.) in conjunction with it. • Use of controls or adjustments or performance of procedures other than those specified herein may result in a hazardous traction related injury. • Before connecting the unit to an electrical outlet, make certain the unit is electronically grounded by connecting only to a grounded electrical service receptacle conforming to the applicable national and local electrical codes. • Do not use a damaged Mains Power Cord. Using a damaged Mains Power Cord may cause unit damage, malfunction, electrical shock, fire, or personal injury. If the Mains Power Cord becomes damaged, discontinue use immediately and contact the dealer for replacement of the Mains Power Cord. • To prevent electrical shock, disconnect the unit from the power source before attempting any maintenance procedures. • This device should be kept out of the reach of children. • Always hand tighten the Lock Knob securely to avoid any slippage. • The Patient Interrupt Switch must be in the patient’s grasp throughout the traction therapy. • Do not apply external pressure (heat or cold) to the electrode sites during therapy. • Dispose of all products in accordance with local and national regulations and codes.

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ABOUT TRACTION THERAPY

Triton® Traction

• Use only tables, stands, power cords and accessories that are specially

• Handle, clean, and dispose of components and accessories that have

designed for the Triton traction unit. Do not use accessories manufactured by other companies on the Triton traction unit. DJO, LLC is not responsible for any consequence resulting from using products manufactured by other companies. The use of other accessories or cables may result in increased emissions or decreased immunity of the Triton traction unit. • Do not use other accessories other than those supplied with the system or recommended by DJO, LLC. The safety of other products has not been established, and their use could result in injury to the patient. • To prevent accidental disengagement, this unit must be securely attached to the mounting surface of the pedestal or traction stand. It is the responsibility of the user to verify the adequacy of the installation before use in therapy. • Do not apply electrodes over broken or compromised skin (e.g., sunburn, cuts, acne) due to increased risk of skin reactions. • Do not plug lead wires into power outlets such as wall sockets and line cord receptacles. Doing so could result in severe shock or burns whether or not the lead wires are attached to the unit. • In the event that an Error message or Warning appears beginning with a 2 or 3, immediately stop all use of the system and contact the dealer or DJO, LLC for service. Errors and Warnings in these categories indicate an internal problem with the unit that must be tested by DJO, LLC or a Field Service Technician certified by DJO, LLC before any further operation or use of the unit. Use of a unit that indicates an Error or Warning in these categories may pose a risk of injury to the patient, user or extensive internal damage to the unit. • Disconnect the traction unit from the power source before attempting any maintenance, installation, removal, or replacement procedures to prevent electrical shock and possible damage to the unit. • The traction unit should only be used by a qualified licensed practitioner in a position of supervision during therapy. For that reason, do not attempt to put yourself in traction with this unit.

come in contact with bodily fluids according to National, Local and Facility rules, regulations and procedures. • Do not connect the unit to an electrical supply without first verifying that the power supply is the correct voltage. Incorrect voltage may cause unit damage, malfunction, electrical shock, fire, or personal injury. Your unit was constructed to operate only on the electrical voltage specified on the Voltage Rating and Serial Number plate. Contact your DJO, LLC dealer if the unit is not properly rated. • Should Traction Cord fray or damage to the Traction Cord or knot be apparent from visual inspection, immediately stop use of the unit and contact the Dealer or DJO, LLC for service. • Do not attempt to repair the Traction Cord. • An improperly tied knot may result in injury. Do not attempt to re-tie the knot unless properly trained. • Not for use in the presence of flammable anesthetics.

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ABOUT TRACTION THERAPY

Triton® Traction

OVERVIEW OF TRACTION THERAPY Effects of Traction Therapy The Triton traction device provides a treatment in static, intermittent, and cyclic distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). Therapeutic distraction can be applied in a variety of programmable patterns, cycles and functions.

Static Traction Therapy This term denotes that a steady amount of traction is applied for periods from a few minutes up to 99 minutes. The shorter duration is usually coupled with more tension. Static lumbar traction is most effective if a split table is utilized to reduce friction. It is important that it is the type that maintains constant tension. This way, any slack developed as the patient relaxes during the traction therapy is automatically taken up and the desired amount of traction is maintained. Static traction is sometimes referred to as sustained traction.

COMMON TERMS Progressive Traction Progressive traction refers to a traction phase during the treatment when the tension gradually increases.

Intermittent Traction Therapy This form of traction alternates traction tension between tension levels - Maximum and Minimum - every few seconds throughout the timed treatment. It is also most effective if a split table is used to reduce friction when giving lumbar traction. In the progressive and regressive phases, the traction unit pulls to the calculated tension, holds for the set hold time, then drops to 50% of the tension level, holds the set rest time and then repeats this step for the number of steps selected. However, once the minimum level is reached, the traction unit uses the minimum level for the rest time.

Regressive Traction Regressive traction refers to a traction phase during the treatment when the tension gradually decreases. TX (Traction) TX (Traction) refers to the type of traction used during a treatment. There are three modes to choose from: Static, Intermittent or Cyclic Traction Mode. Steps The term “step” refers to the increment in which the traction tension is either increased or decreased during therapy.

Cyclic Traction Cyclic traction refers to progressive and regressive phases of the traction program being repeated continuously throughout the entire course of the traction treatment.

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ABOUT TRACTION THERAPY

Triton® Traction

INDICATIONS

CONTRAINDICATIONS

The Triton traction device provides traction and mobilization of skeletal structures and skeletal muscles.

Traction is contraindicated for the following: • Structural disease secondary to tumor or infection

The Triton traction device may be used to relieve peripheral radiation/ sciatica and pain associated with: • Protruding discs • Bulging discs • Herniated discs • Degenerative disc disease • Posterior facet syndrome • Acute facet problems • Radicular pain • Prolapsed discs

• Patients with vascular compromise • Any condition for which movement is contraindicated

• Spinal root impingement • Hypomobility • Degenerative joint disease • Facet syndrome • Compressions fracture • Joint pain • Discogenic pain

• Patients with acute strains, sprains, and inflammation which would be aggravated by traction therapy • Patients with joint instability of the spine • Pregnancy • Osteoporosis • Hiatus hernia

The Triton traction device achieves these effects through mechanical traction of intervertebral discs, that is, unloading due to distraction and positioning.

• Claustrophobia • Cardiac or pulmonary problems

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NOMENCLATURE

Triton® Traction

base unit- front view The Base Unit serves to house the mechanical and electrical components that provide the actual traction tension for the Triton traction unit under the electronic control and supervision of the Controller.

Touch Screen User Interface

Traction Cord

Patient Interrupt Switch Receptacle

Traction Cord To prevent wear and fraying, the unit should be mounted facing toward the desired direction of pull so that the Traction Cord does not contact the side of the slot from which it extends.

Clevis Attachment Slots

sEMG Lead Wire Receptacle (Model 4798 or with sEMG Module P/N 4766)

• Should Traction Cord fray or damage to the Traction Cord or knot be apparent from visual inspection, immediately stop use of the unit and contact the Dealer or DJO, LLC for service. • Do not attempt to repair the Traction Cord. • An improperly tied knot may result in injury. Do not attempt to retie the knot unless properly trained.

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NOMENCLATURE

Triton® Traction

base unit- front view (continued) Accessory Clip The Accessory Clip allows you to attach the desired accessory (i.e., Spreader Bar or traction harnesses) to the unit.

Patient Interrupt Switch Receptacle The Patient Interrupt Switch Receptacle is located on the front of the unit.

Clevis Attachment Slots The Clevis Attachment Slots serve as a connection point for other traction apparatus (not included), such as cervical or wrist.

• The Patient Interrupt Switch is essential for the functioning of the unit. If it is not connected, or if it is malfunctioning, the unit will not work. sEMG Lead Wire Receptacle (Model 4798 or with sEMG Module P/N 4766) The sEMG lead wire connection is located on the front of the unit.

• Do not use the Clevis as a handle to pick up or carry the unit.

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NOMENCLATURE

Triton® Traction

base unit- rear view The rear view of the base unit is the site of electric current control and surge protection, and serves as a connection point for both the traction controls and safety features of the Triton traction unit.

Screen Contrast Control

Lock Knob

Mains Power Cord Receptacle

Power On/Off Switch The Power On/Off Switch is a toggle switch located on the back of the unit. This switch controls the flow of electricity from the outlet to the unit.

Power On/Off Switch

Data Port (Factory use Only)

Mains Power Cord Receptacle The Mains Power Cord Receptacle accepts the Mains Power Cord (female end).

Serial Number and Electrical Rating Plate

Screen Contrast Control The Screen Contrast Control is used to set a comfortable viewing of brightness of the Touch Screen User Interface. Functional On Monochrome Units Only.

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NOMENCLATURE

Triton® Traction

base unit- rear view (continued) Lock Knob The Lock Knob is used to clamp the Triton traction unit to the base (i.e. pedestal, traction stand).

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NOMENCLATURE

Triton® Traction

LCD Base (1) LED Indicator (Power On/Off) This indicator will illuminate when the unit is powered on. NOTE: The LED indicator will blink when the unit goes in screen saver mode (the screen will go blank after twenty minutes of inactivity). Simply touch the screen to reactivate. (2) Clinical Resources This button allows you to access the following features of the traction unit: • Patient Card • Protocols • Patient Card (Patient Name) • Retrieve Protocol • Edit Current Pain Profile • Save Protocol • Edit/Save Completed Pain Profile • Clinical Protocols™ • Erase Patient Card • Utilities • Unit Settings (3) Stop This button will stop the treatment program. Traction tension slowly decreases to zero. (4) Pause This button will pause the treatment program. Traction tension slowly decreases to zero. Press the pause button again to resume treatment program and traction tension. (5) Start Touch this button to start the treatment program. (6) Patient Data Card Port Access port to insert a Patient Data Card to save and retrieve patient treatments. (7) Multimedia Card (MMC) Port Access port to insert a MMC Card to display traction techniques and the anatomical library.

The LCD Base serves as a programming terminal during the selection of the traction parameters, as well as a display showing all the factors affecting the traction during therapy. Traction parameters are selected with the buttons on the LCD Base and the Touch Screen User Interface. The Touch Screen and beeper make various audio and visual indications, and warn the operator when unsuitable parameters are chosen.

1

2

4

3

5

6 7

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NOMENCLATURE

Triton® Traction

symbol definitions Below are the definitions for all of the Symbols used on the Triton traction unit hardware and software. Study and learn these symbols before any operation of the unit. System Hardware Symbols Contrast Control

Stop Treatment

On/Off Switch

Pause Treatment

Data Port (Factory Use Only)

Start Treatment

Lock/ Unlock Lock Knob

System Software Symbols Patient Card/ Multi-Media Card (MMC)/ DTS Software Upgrade Card Patient Interrupt Switch

Move UP

Move DOWN Accept and Return

Clinical Resources Cancel

sEMG Lead Wires Back Forward Home

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SPECIFICATIONS

Triton® Traction

traction UNIT DIMENSIONS and specifications

Meets Directive 93 /42 /EEC IEC/UL/EN: 60601-1 60601-1-2

Width...24 cm (9.5 in) Depth... 45 cm (17.5 in) Height...45 cm (17.5 in)

Certified to CAN/CSA Standard C22.2 No. 601.1-M90w/A2

Weight Standard Weight...14 kg (30 lbs) Shipping Weight...18 kg (40 lbs) Power Voltage...100V-240V (50/60Hz) Duty Cycle... Continuous Operation Power Consumption...75 VA Current Consumption...3.2 Amps Max Electrical Class... Class I Traction Electrical Type...Type B

Height

sEMG Electrical Type... Type BF Traction Modes Static, Intermittent, Cyclic, and their combinations. Traction Type: Mechanical LCD Display: High contrast color touch screen Traction Tension Parameters Traction Period Hold Period Rest Period Traction Tension Progressive and Regressive Steps

Minimum 1 minute 0 seconds 0 seconds 0 kg (0 lb/0 N)

Maximum Increments 99 minutes 1 minute 99 seconds 1 second 99 seconds 1 second 90 kg (200 lb/890 N) 1 kg (1 lb/5 N)

1 step

9 steps

1 step

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Dep

th

th Wid

SPECIFICATIONS

Triton® Traction

sEMG module DIMENSIONS and specifications Width... 16.83 cm (6.63 in) Depth... 7.62 cm (3 in) Height...4.13 cm (1.63 in) Input Impedance... > 1,000,000 ohm Input Sensitivity... < 1.0 µV RMS

Width

Frequency Range... 15Hz - 1000Hz with CMMR of > 120 dB CMMR at 50/60 Hz > 180 dB Weight... 146 g (5.2 oz) Product Type

th

Internally Powered...Triton Traction Unit

Dep

Electrical Class... Class I

Height

Electrical Type... Type BF For Continuous Operation Regulatory Compliance Meets Directive 93 /42 /EEC IEC/UL/EN: 60601-1 60601-1-2 Certified to CAN/CSA Standard C22.2 No. 601.1-M90w/A2

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SPECIFICATIONS

Triton® Traction

description of device markings The markings on the Triton traction unit are your assurance of its conformity to the highest applicable standards of medical equipment safety and electromagnetic compatibility. One or more of the following markings may appear on the device: This product complies with WEEE Directive 2002/96/EG (waste electrical and electronic equipment). Separate collection for electrical and electronic equipment.

Meets Directive 93 /42 /EEC IEC/UL/EN 60601-1, 60601-1-2

Certified to CAN/CSA Standard C22.2 No. 601.1-M90w/A2

Refer to Instruction Manual/Booklet

Type B Equipment

Type BF Equipment

Protective Earth

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SETUP

Triton® Traction

contents of carton NOTE: When shipping the unit back to the dealer or factory, make certain the original packaging is used. If the original packaging is not available, contact DJO, LLC to obtain the following packaging materials for shipment:

Remove the Triton traction unit and all accessories from the shipping cartons. Visually inspect for damage. Report any damage to the carrier immediately. Contents of Cartons:

48059 48093 48094 48092 48095

Model 4749 - Triton Traction Unit • Triton Traction Unit • Patient Data Cards (5) • Patient Interrupt Switch - 2.75 m (9 ft) in cable length, shielded, 26 AWG • Patient Interrupt Switch Hook Kit • Mains Power Cord - 203 cm (80 in) in cable length, shielded, 18 AWG • User Manual (CD-ROM)

Inner Pack Box Top Left Inner Pack Right Inner Pack Shipping Box Shipping Bag

Any damage sustained from improper packaging may render the warranty null and void.

Model 4798 - DTS Traction Unit • Triton DTS Traction Unit • Patient Data Cards (5) • sEMG lead wire - 2.44 m (8 ft) in cable length, unshielded, 24/28 AWG • (4) Dura-Stick II Electrodes - 3 cm (1.25 in) Round • (4) Dura-Stick II Electrodes - 5 cm (2 in) Round • Patient Interrupt Switch - 2.75 m (9 ft) in cable length, shielded, 26 AWG • Patient Interrupt Switch Hook Kit • Mains Power Cord - 203 cm (80 in) in cable length, shielded, 18 AWG • User Manual (CD-ROM)

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SETUP

Triton® Traction

Mounting Unit on table The Triton traction unit was designed to be utilized with Chattanooga traction tables:

1. To secure the traction unit to the mounting surface, first loosen the Clamp Knob by turning to the left. Fit the unit to the mounting surface, then turn the Clamp Knob to the right, tightening the clamp and securing the unit in place. 2. Remove the cover on the back of the unit and connect the Mains Power Cord (female end) to the Mains Power Cord Receptacle. 3. Verify that there is a good connection between the Mains Power Cord and the Mains Power Cord Receptacle. Always make certain that the Mains Power Cord is properly plugged into the unit. 4. Check the voltage rating on the serial plate located on the back of the unit. Plug the Mains Power Cord into a 100V-240V AC outlet, as required. Replace the cover on the back of the unit.

• Do not operate the unit when connected to any unit other than Chattanooga devices. Do not use devices manufactured by other companies on Chattanooga equipment. DJO, LLC is not responsible for any consequence resulting from using products manufactured by other companies.

• To prevent accidental disengagement, this unit must be securely attached to the mounting surface of the pedestal or traction stand. It is the responsibility of the user to verify the adequacy of the installation before use in patient therapy. NOTE: The Triton traction unit should be mounted facing the direction of pull so the Traction Cord does not contact the side of the slot from which it extends.

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