CHATTANOOGA INTELECT REF 2082 (01) PDF MANUAL

FREE ENGLISH CHATTANOOGA INTELECT REF 2082 (01) PDF USER GUIDE

FREE ENGLISH CHATTANOOGA INTELECT REF 2082 (01) PDF USER MANUAL

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FREE ENGLISH CHATTANOOGA INTELECT REF 2082 (01) PDF OWNER MANUAL

FREE ENGLISH CHATTANOOGA INTELECT REF 2082 (01) PDF REFERENCE GUIDE

FREE ENGLISH CHATTANOOGA INTELECT REF 2082 (01) PDF INSTRUCTION GUIDE

FREE ENGLISH CHATTANOOGA INTELECT REF 2082 (01) PDF REFERENCE MANUAL

FREE ENGLISH CHATTANOOGA INTELECT REF 2082 (01) PDF INSTRUCTION MANUAL

FREE ENGLISH CHATTANOOGA INTELECT REF 2082 (01) PDF OPERATING INSTRUCTIONS

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CHATTANOOGA INTELECT REF 2082 (01) PDF SUMMARY:

What are the operator qualifications for the Intelect RPW?

The Intelect RPW is intended for use only by medical specialists who are qualified and instructed in a clinical environment. These specialists should have practical knowledge of medical procedures, applications, and the technology, as well as experience treating the listed indications. Operators should also have basic physical and cognitive abilities including vision, hearing, literacy, and function of the upper extremities. The target demographic is between 18 and 65 years of age.

What training must operators of the Intelect RPW have?

Operators must be adequately trained in using the system safely and efficiently. A documented, cross-functional review must be performed to ensure instructions are understood. The training must include:

Operation and designated use of the instrument with practical exercises.
Mode of effect and function of the unit and the applied energies.
Settings of all components.
Indications for use of the unit.
Contraindications and side effects of the therapy waves.
Explanation of the warning notes in all operating statuses.
Instructions on how to maintain the unit.

What is the intended use of the Intelect RPW?

The Intelect RPW is intended for use in predominately non-sterile medical sites to treat indications with radial, pneumatically generated, low energy acoustic waves (shock waves) or pressure pulses. It is a compressed air operated ballistic shock wave generator. The kinetic energy of a projectile accelerated by compressed air is converted into sound energy when the projectile strikes a shock transmitter, which then transmits the acoustic pulse to the target tissue. The pressure pulse propagates radially within the tissue and has a therapeutic effect.

What is the general information about the Intelect RPW unit?

The Intelect RPW unit and its components meet the currently valid safety standards and comply with IEC 60601-1 and medical product regulations. The unit and its external components are safe if used properly, but can pose dangers if not. Anyone operating the unit must be aware of the potential dangers before beginning work.

What features are available on the Intelect RPW unit?

The Intelect RPW unit has the following features:

Clear Touch Screen LCD: Allows the operator to select options on the screen, guides the operator through the setup process, provides continuous feedback, and allows the operator to turn on the unit by pressing the LCD.
Clinical Protocols: Provides an efficient approach for setting up a treatment using preset parameters.
Quick Link Indications: Allows the user to select specific clinical indications and apply the most common therapy. All modalities are editable.
User Protocols: Allows the user to set, save, and change the parameters of each program to meet patients’ needs. Up to 200 user protocols can be created.
Screen Saver: Reduces LCD screen burn-in by activating after 10 minutes of inactivity. The user can return to the Home screen by pressing the touch screen or any button.
Realtime Clock: Keeps track of date and time even when the unit is off or unplugged.
Intensity Ramping: Gradually increases the intensity from 1.4 bar to the set intensity via the Ramp button. The intensity increases to the full preset number of bars after one-third of the pulses have been given. This feature can help acclimate patients to the pressure.

What is the meaning of the symbols in the PDF?

The precautionary instructions are indicated by specific symbols. The definitions of these symbols are:

CAUTION: Explains possible safety infractions that could cause minor to moderate injury or equipment damage.
WARNING: Explains possible safety infractions that could cause serious injury and equipment damage.
Explosion Hazard: Explains possible safety infractions if the equipment is used in the presence of flammable anesthetics.
DANGER: Explains imminently hazardous situations that could result in death or serious injury.
Dangerous Voltage: Informs the user of possible hazards resulting from the electrical charge delivered to the patient or operator.
NOTE: Indicates helpful information.

What are the cautions for the D-20mm and D-35mm transmitters?

For the D-20mm transmitter, avoid using it with pressure levels exceeding 3 bars on the screen when not applying on a non-impact surface (body). The handset is at risk of damage. For the D-35mm transmitter, avoid pressure over 3 bars on the screen at all times. The handset is at risk of damage.

What are the steps for preparing the unit for therapy?

The PDF provides the following instructions :

Plug the power cord into the wall socket and the back of the unit.
Turn the unit on by touching the LCD display.
Install the applicator and transmitter.
Select the correct transmitter for the application.
If necessary, adjust the treatment parameters based on the treatment protocol.

How do you prepare a patient for therapy?

The PDF provides the following instructions :

Position the patient so that the area to be treated is easily accessible.
Apply a thin layer of ultrasound gel to the treatment area.
Consider the patient’s sensitivity level to pressure and adjust the treatment parameters accordingly.

What is the basic operation for the Intelect RPW?

The basic operation involves the following steps :

Turn on the unit.
Select a treatment protocol.
Adjust the treatment parameters as needed.
Apply ultrasound gel to the treatment area.
Position the handpiece on the treatment area.
Start the therapy.
Monitor the patient’s response to therapy.
Complete the therapy session.

How do you start therapy?

Therapy can be started from the Home Screen :

Select “Start Therapy” on the Home screen .
The unit will then go to the Edit Treatment screen where the user can adjust treatment parameters .
After adjusting the parameters, select “Start” to begin therapy .

What is the Home Screen?

The Home Screen is the first screen the user sees after turning on the unit . It provides access to the main functions and settings of the device .

What is the Edit Treatment Screen?

The Edit Treatment screen allows the user to adjust various treatment parameters such as intensity, frequency, and number of pulses .

What is the Select Transmitter Screen?

The Select Transmitter screen allows the user to choose the correct transmitter for the treatment .

What are Quick Link Indications?

Quick Link Indications allow the user to select specific clinical indications and apply the most common therapy for the selected indication . All modalities can be edited to customize the treatment .

How do you use the ramp button?

The ramp button allows the user to gradually increase the intensity of the treatment . This feature is useful when a gradual increase is preferred. When turned on, the intensity increases to the full preset level after one-third of the pulses have been given. The ramp button can also be used to stop the ramping process .

How do you stop therapy using the STOP button?

Press the STOP button during therapy to immediately stop the treatment .

How do you pause therapy using the PAUSE button?

Press the PAUSE button to pause therapy . To resume, press the PAUSE button again .

How do you pause therapy using the trigger button?

Press the trigger button on the handpiece to pause therapy . To resume, press the trigger button again .

How do you complete a therapy session?

The therapy session is completed when the programmed number of pulses has been delivered . The unit will stop automatically when all the pulses are delivered .

How are Clinical Protocols used?

Clinical Protocols are an efficient way to set up treatments using preset parameters . They provide guidance for commonly treated conditions .

How do you retrieve, delete, and save User Protocols?

Retrieving User Protocols: Select “User Protocols” from the menu and select the desired protocol .
Deleting User Protocols: Select “User Protocols”, choose the protocol to delete, and select the delete option .
Saving New User Protocols: After setting up a treatment, select the “Save” option and enter a name for the protocol .
Editing Existing User Protocols: Select “User Protocols,” select the protocol to edit, and adjust the parameters as desired. Then save the changes .

What is the Anatomical Graphics Library?

The Anatomical Graphics Library is a resource that provides images and information about anatomical structures .

What is the Handpiece Placement Library?

The Handpiece Placement Library is a resource that provides guidance on the correct placement of the handpiece for various treatments .

How do you view rationale and contraindications?

Viewing Rationale: Select the “Rationale” option in the Clinical Resources section to view the rationale behind a specific treatment .
Viewing Contraindications: Select the “Contraindications” option in the Clinical Resources section to view the contraindications for a specific treatment .

How do you use the Patient Card?

The Patient Card is a clinical resource that allows the user to manage patient treatment information :

Viewing and Retrieving Treatments: Select “Patient Card”, choose the patient, and view or retrieve saved treatments .
Editing the Pain Profile: Select “Patient Card,” choose the patient, and edit the pain profile .
Saving Treatments: After completing or adjusting a treatment, select “Save to Patient Card” and choose a patient .
Erasing Patient Card: Select “Patient Card” and choose the option to erase a card .

What are the Unit Settings?

Unit Settings allows the user to customize the device settings :

Adding and Changing the Clinic Name: Select “Unit Settings” and choose the option to change or add the clinic name .
Increasing and Decreasing the Unit Volume: Select “Unit Settings” and choose the option to adjust the volume .
Setting the Date and Time: Select “Unit Settings” and choose the option to set the date and time .
Resetting Unit Settings: Select “Unit Settings” and choose the option to reset to default settings .
Resetting Default Protocols: Select “Unit Settings” and choose the option to reset default protocols .
Changing Languages: Select “Unit Settings” and choose the option to change the language .
Editing the Default Transmitters for Channels: Select “Unit Settings” and choose the option to edit default transmitters for channels .
Resetting the Pulse Counter: Select “Unit Settings” and choose the option to reset the pulse counter .

What are some treatment tips?

Position the handpiece so that it is in full contact with the skin . Apply even pressure, and avoid excessive force during treatment .

How do you position the handpiece?

The handpiece should be positioned directly over the treatment area with full contact on the skin . Apply even pressure and avoid excessive force .

What should you do if the unit displays an error?

Refer to the Error Codes and Descriptions in the troubleshooting section of the PDF. If the error persists, contact service .

How do you maintain the Intelect RPW?

Routine maintenance includes cleaning and disinfection of the unit and its components after each use . The water bottle should be removed, refilled, and replaced when needed . The projectile and guide tube should be replaced after a certain number of pulses, following the instructions provided in the PDF . Safety inspections should be performed periodically .

How do you clean and disinfect the Intelect RPW?

Use a soft cloth or sponge with a mild detergent to clean the unit . Disinfect with an appropriate disinfectant solution . Avoid using abrasive cleaning agents .

What should you do before using the Intelect RPW?

Before using the Intelect RPW, you must read and understand all the information provided in the manual. Familiarity with the information in the manual is essential for efficient and optimal use of the system, to avoid dangers to persons and the equipment, and to obtain good treatment results.

What is an essential prerequisite for operating the Intelect RPW?

Knowledge of the content of the manual is an essential prerequisite for operating the Intelect RPW.

What should you not do when operating the Intelect RPW?

Do not operate the Intelect RPW in conjunction with any other devices. Do not operate this unit in an environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner.

What can affect medical electrical equipment?

Portable and mobile RF communications equipment can affect medical electrical equipment.

What should be routinely checked before each use of the Intelect RPW?

The unit should be routinely checked before each use to determine that all controls function normally (e.g., the STOP button ends treatment, the START button causes the treatment to begin, the trigger button on the handpiece causes the transmitter to pulse, etc.), especially that up and down arrow buttons adjust the number of pulses the transmitter emits.

What should you not use to operate the buttons on the control panel?

Do not use sharp objects such as a pencil point or ballpoint pen to operate the buttons on the control panel as damage may result.

What temperatures should the unit be transported and stored in?

This unit should be transported and stored in temperatures between 0 °C and 60 °C (32 °F and 140 °F) to prevent damage to the unit or its components.

How should you handle radial pressure wave treatment accessories?

Handle radial pressure wave treatment accessories with care. Inappropriate handling of the accessories may adversely affect their characteristics.

What should you inspect before each use?

Inspect cables, associated connectors, and accessories before each use.

What accessories should you use with the unit?

Do not use accessories other than those supplied with the unit, or recommended by DJO. The safety of other products has not been established, and their use could result in injury to the patient and degrade minimum safety.

What should you consult to determine the distance of separation for all equipment operating near the Intelect RPW?

To determine the distance of separation for all equipment operating near the Intelect RPW, consult the EMC tables applicable to the other equipment.

Who is the Intelect RPW to be used by, and sold to?

This equipment is to be used by, and sold to, a trained clinician only under the prescription and supervision of a licensed practitioner.

Who should operate the unit and its applicators?

Only users trained in the use of radial pressure wave therapy should operate the unit and its applicators.

What does the Power On/Off button not do?

The Power On/Off button is considered a “soft” switch and does not isolate the unit from mains power when the unit is turned off.

What must you do to isolate the unit from mains power?

You must disconnect the male end of the power supply cord from the electrical outlet (mains power supply) in order to isolate it.

What is the Intelect RPW not intended for the treatment of?

The Intelect RPW is not intended for the treatment of kidney stones.

What should you do to the caster locks during treatment and storage?

Depress the tabs of the caster locks to prevent the front wheels from moving during treatment and storage.

When should you disconnect the power supply cord?

Disconnect the power supply cord before removing covers on this equipment.

Who should service the unit?

Refer the servicing of this unit to qualified service personnel.

What is the equipment capable of producing?

This equipment has an output that is capable of producing a physiological effect.

When can grounding reliability be achieved?

Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “Hospital Only” or “Hospital Grade”.

What special precautions does medical electrical equipment need regarding EMC?

Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the manual.

What can this unit radiate?

This unit can radiate radio frequency energy.

What can happen if the unit is not installed and used in accordance with the instructions?

If not installed and used in accordance with the instructions, the unit may cause harmful interference to other devices in the vicinity.

How can you determine if harmful interference is occurring to other devices?

Harmful interference to other devices can be determined by turning this equipment on and off.

What should you do if there is interference from the Intelect RPW?

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 to which the other device(s) are connected, and consult the factory field service technician for help.

What should you do when operating this unit adjacent to or stacked with other equipment?

Care must be taken when operating this unit adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Intelect RPW should be observed to verify normal operation in the configuration in which it will be used.

What should you try to minimize when using the Intelect RPW with other equipment?

Try to minimize electromagnetic or other interference by not using other equipment in conjunction with it.

What accessories should you use with the Intelect RPW?

Use only accessories that are specially designed for this unit. Do not use accessories manufactured by other companies on this unit.

What may result from using other accessories or cables than those specified?

The use of other accessories or cables (other than those specified) may result in increased emissions or decreased immunity of this unit.

What may result from using controls or adjustments or performance of procedures other than those specified?

Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to radial pressure wave energy.

How should you make certain that the unit is electrically earthed?

Make certain that the unit is electrically earthed by connecting only to a earthed electrical service receptacle, conforming to the applicable national and local electrical codes.

Where should this device be kept?

This device should be kept out of the reach of children.

Should you leave a patient unattended during radial pressure wave therapy?

Do not leave patient unattended during radial pressure wave therapy.

What can result from improper installation, operation, or maintenance of the radial pressure wave system?

Improper installation, operation, or maintenance of the radial pressure wave system may result in malfunctions of this unit or other devices.

What should you do in case of display failure or other obvious defects?

In case of display failure or other obvious defects, switch the unit off immediately by means of the power on/off button, disconnect the power cord from the power outlet, and notify a certified service technician.

What may result from adjustments or replacement of components?

Adjustments or replacement of components may result in the equipment failing to meet the requirements for interference suppression.

How should the unit be stored if it cannot be installed immediately after delivery?

If the unit cannot be installed immediately after delivery, the unit and its external components or accessory elements must be stored in their original packaging in a dry place.

Where should you not store or operate the unit?

Do not store or operate the unit in a dusty environment.

Where should you keep all line cords?

Keep all line cords away from the unit cables. Do not store or coil line cords where they can come close to the cables on an operating radial pressure wave unit.

How should the power cord be positioned?

Position the power cord in such a way that it does not present a tripping hazard.

Is this equipment designed to prevent the ingress of water or liquids?

This equipment is not designed to prevent the ingress of water or liquids.

What can the ingress of water or liquids cause?

Ingress of water or liquids could cause malfunction of internal components of the system and therefore create a risk of injury to the patient.

How should you remove the applicator?

Remove the applicator by pulling the cable connector only. DO NOT remove by pulling the cable.

What should you do to remove the cable from the applicator?

To remove the cable from the applicator, make certain the power is off. Hold the applicator while removing the cable to prevent the applicator from dropping to the floor.

What should you do while the patient is receiving therapy?

Observe the patient at all times during therapy.

What can happen if the unit is operated at pressures higher than 3 bar without an impact surface?

Operating the unit at pressures higher than 3 bar without an impact surface can result in damage to the handset.

What should you do if an Error message or Warning appears beginning with a 2 or 3?

In the event that an Error message or Warning appears beginning with a 2 or 3, immediately stop all use of the unit and contact the dealer or DJO for service. Errors and Warnings in these categories indicate an internal problem with the unit that must be tested by DJO or a Field Service Technician certified by DJO before any further operation or use of the system. 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 system.

How often should the water bottle be emptied?

Empty the water bottle at least once weekly or if it is half full.

Where should treatment never be given?

Treatment should never be given in the area of metal implants.

Where should you place the unit during treatment and storage?

Place the unit on a flat surface during treatment and storage to prevent tipping and rolling.

What can happen to the surface of the transmitter?

The surface of the transmitter can become hot.

What can extended skin contact with the transmitter cause?

Extended skin contact can cause minor burns.

How long should you interrupt therapy to allow the transmitter to cool?

Interrupt therapy after a maximum of 6000 pulses to allow the transmitter to cool.

What must the operator monitor during the treatment session?

The operator must monitor the temperature of the transmitter during the treatment session.

How many pulses should you apply to the same spot?

Do not apply more than 300 pulses to the same spot.

What should you replace fuses with?

For continued protection against fire hazard, replace fuses only with ones of the correct type and rating.

What may be adversely affected during treatment with radial pressure wave?

The function of certain implanted devices (e.g., pacemakers) may be adversely affected during treatment with radial pressure wave.

What should you do if there is doubt about using the unit on a patient with an implanted device?

In case of doubt, the advice of a licensed practitioner in charge of the patient should be sought.

What may be adversely affected when in close proximity to radial pressure wave equipment?

Other equipment, including patient connected devices, may be adversely affected when in close proximity to radial pressure wave equipment.

When should patients not be treated with radial pressure wave?

Patients should not be treated with radial pressure wave when they have reduced thermal sensitivity over the proposed area of treatment, unless the physician in charge of the patient is notified.

Should treatment be given through clothing?

Treatment should not be given through clothing, although it is permissible to administer treatment through a dressing in pulsed modes.

What should be removed prior to treatment?

Remove hearing aids prior to treatment.

What should you check before each use?

Before each use, check the condition of the housing and the insulation of the applicator and power supply cable. Also make sure that the cables have been routed correctly.

What must happen if the unit is not safe for operation?

If the unit is not safe for operation, then it must be repaired by certified service personnel and the operators must be informed of the dangers posed by the unit.

What should you do to prevent electrical shock?

In order to prevent electrical shock, unplug the power plug from the socket before cleaning or disinfecting the unit.

Under what circumstances may liquid penetrate the openings on the unit?

Under no circumstances may liquid penetrate the openings on the unit (e.g. the connecting sockets of the cables).

What should you not use to clean or disinfect the unit?

Do not use cleaning or disinfectant sprays.

Can the unit and cables be sterilized using steam or gas?

The unit and cables may not be sterilized using steam or gas.

What should you never clean the unit with?

Never clean the unit with abrasives, disinfectants or solvents that could scratch the housing or damage the unit.

Who should perform repairs on the unit?

Do not perform unauthorized repairs under any circumstances. The unit’s components are under pressure and subject to high voltage.

Where should shock waves not be applied?

Shock waves must not be applied to target areas located above air filled tissue (lungs), nor to any regions near large nerves, vessels, the spinal column or head.

Where should the operator not use radial pressure wave?

The operator should not use radial pressure wave over the heart in order to prevent theoretical cardiac signal interference.

How must the unit be installed?

The unit must be installed so that there is no danger to the patient, the operator, or other persons.

What should you read before operating the unit?

Read the safety instruction and contraindications.

What is an explosion hazard when using the Intelect RPW?

Explosion hazard if the Intelect RPW is used in the presence of flammable anesthetics mixture with air, oxygen, or nitrous oxide.

What may the Intelect RPW unit contain?

The Intelect RPW unit may contain Di (2-ethylhexyl) phthalate (DEHP) and bisphenol-A (BPA).

What are some preventative measures to take when using PVC devices containing DEHP?

As a preventative measure, use PVC devices that do not contain DEHP, or devices made of other materials such as ethylene (EVA), silicone, polyethylene, or polyurethane for all clinical procedures. Avoid using DEHP-leaching PVC when performing all clinical procedures on male neonates, pregnant women who are carrying male fetuses, or peripubertal males.

What are some properties of BPA?

BPA is considered an Unclassifiable Carcinogen and a suspected Endocrine disruptor which may interfere with or block hormones. BPA is highly toxic if swallowed, absorbed through the skin, or inhaled.

Are the effects of BPA and DEHP known in the concentrations present in the unit and its applicators?

The effects of BPA and DEHP are not known in the concentrations present in the unit and its applicators.

What should you do in case of damage from transport that could endanger personal safety?

In case of damage from transport that could endanger personal safety, the unit must not be connected to the mains power supply before inspection is complete.

What should you adhere to regarding high powered radio frequency fields?

Adhere to rules, regulations, and ordinances that may vary from location to location concerning the appropriate use of high powered radio frequency fields.

What may happen in case of improper or unauthorized use of the unit?

In case of improper or unauthorized use of the unit, the operator, the patient or other persons may be subjected to the danger of electric shock due to high voltage produced by the unit, the danger of influence on active implantations by magnetic fields produced by the unit and the danger of being burned due to erroneously positioned handset or false parameters such as the duration of treatment, power output or operating mode.

What should you do before operating the unit?

Before operating the unit, read the instruction manual carefully and observe the information contained therein. Pay special attention to the list of contraindications. Refer to “Safety Instructions” , “Contraindications”, and “Additional Precautions”.

What should you verify before operating the unit each time?

Verify that the unit has been correctly connected to the Mains Power Supply. The handset connection cable is connected properly and is not cross-routed (which may cause capacitive short circuits). Only accessories approved by the manufacturer are connected. The handset is positioned according to the doctor’s instructions (to be checked by the doctor or physiotherapist if applied by assisting personnel).

What should you verify with the patient before using the unit?

Before using the unit, speak with the patient to verify that the patient is in a comfortable position during the entire treatment. That the patient is comfortable before and during treatment.

What should you determine before using the unit?

Determine the maximum nominal output power of the respective accessory in order to avoid overheating the tissue.

What should you verify at regular intervals during the treatment?

Verify that the unit is functioning properly. Verify if the patient feels well.

What should you ask the patient after the treatment?

After the treatment, ask the patient about the tolerance of the treatment.

Who should inspect the treatment environment?

The treatment environment should be inspected by a licensed practitioner.

What parts of the body should be unclothed during treatment?

The affected parts of the body should be unclothed during treatment, since accumulation of moisture on the skin or in folds can cause local overheating of the skin. This is especially important in the event that the patient is wearing clothing made of moisture-resistant fabric such as silk or synthetic fibers.

How should the output power be set?

The output power must always be set according to the subjective response of the patient.

What kind of patients should you take particular care with?

Particular care is to be taken with patients who have a reduced capacity for heat perception.

What can result from improper installation, operation or maintenance of the radial pressure wave unit?

Improper installation, operation or maintenance of the radial pressure wave unit may result in malfunctions of this unit or other devices.

What should you make sure of before connecting the unit?

Before connecting the unit, make sure that: The voltage rating on the safety label corresponds to the available system voltage. The frequency rating on the rating plate corresponds to the system frequency. An earthed socket outlet with earthing contact is available for connecting the unit. The routing of the power cable from the unit to the socket outlet with earthing contact does not pose a danger for personnel or the patient.

What should you make certain of regarding electrical earthing?

Make certain that the unit is electrically earthed by connecting only to a earthed electrical service receptacle, conforming to the applicable national and local electrical codes.

When should you connect the unit to the Mains Power Supply?

Do not connect the unit to the Mains Power Supply until the following requirements have been met: Before putting the unit into operation, check to make sure that the handset connection cable and the transmitters are undamaged and have been connected correctly to the unit.

When should you clean and disinfect the unit?

Clean and disinfect the unit only when the Mains Power Supply is deactivated (power switch off, power plug disconnected).

How should you clean and disinfect the unit?

Clean and disinfect the unit only by means of disinfection by wiping. Disinfecting by spraying can damage the unit due to penetrating moisture.

What should you never clean the unit with?

Never clean the unit with abrasives, disinfectants, or solvents that could scratch the housing or damage the unit.

Who should perform service work on the unit?

Never perform unauthorized service work. All service work must be performed only by service technicians who have been authorized by the manufacturer.

What is the procedure for deactivating Myofascial Trigger Points (MTrP) using Radial Pressure Wave Therapy?

Triggers are localized at the low energy level (approximately 2 bar) by passing the transmitter over the muscle region being treated (increased sensitivity to pain) and then deactivated using a higher energy level (approximately 3 bar). This method involves initially identifying sensitive areas with low energy and then applying higher energy to deactivate the trigger points. This two-step approach ensures targeted and effective treatment.

What are some general contraindications for using the Intelect RPW unit?

The Intelect RPW unit is contraindicated for use in several conditions and situations. These include pregnancy, both confirmed and potential, due to the risk to the developing fetus. It’s also contraindicated for individuals with blood disorders such as haemophilia, or those on anticoagulant medications, due to the increased risk of bleeding. Acute inflammations, swollen or infected tissues, skin eruptions, and other acute tissue lesions are also contraindications. Further contraindications include areas affected by polyneuropathy, usually associated with diabetes, and areas recently treated with cortisone injections, with a recommended waiting period of at least 6 weeks. Patients with a history of hemorrhages, malignant tumors (diagnosed or undiagnosed), and swellings that still feel warm should also not be treated. Treatment over implants, removed implant areas, damaged implants, metal inclusions, superficial endoprosthesis, and metal implants is also contraindicated. Severe arterial obstructions, gynecological disorders involving acute inflammation, deep vein thrombosis, phlebitis, varices, arterial disease, and circulatory insufficiency are further reasons to avoid treatment. Other contraindications include treatment over eyes, reproductive organs, cardiac pacemakers, defibrillators, cochlear implants, bone growth stimulators, deep brain stimulators, spinal cord stimulators, and other nerve stimulators, open lamina, carotid sinuses, cervical stellate ganglion, or the Vagus nerve. Direct application over cancerous tumors or lesions, neoplastic tissues, or space-occupying lesions, occlusive vascular diseases, systemic or local infections, and areas above air-filled tissue or near large nerves, vessels, the spinal column, or the head are also contraindicated. This extensive list of contraindications highlights the need for a thorough examination and diagnosis before using the device.

What are some additional precautions to consider when administering radial pressure wave treatment?

When administering radial pressure wave treatment, several precautions should be taken. Treatment should be applied with caution over bone where minimal soft tissue is present due to the risk of injury. Hearing aids should be removed to avoid interference. There is also a possibility that the unit’s operation could adversely affect the function of other patient-connected equipment, necessitating that a maximum distance be maintained between units to minimize potential interactions. The risk of bleeding is increased due to the rise in blood flow from the treatment, so care must be used when treating patients with bleeding disorders. The intensity level and skin response should be monitored frequently during treatments. Always apply the transmitter on the skin with small circular movements. Radial pressure wave therapy should never be used on the head. Treatment should not be applied directly in an area with a metal implant. Patients with active autoimmune diseases may not respond positively to the treatment.

What are some common side effects that could occur after treatment with Radial Pressure Wave therapy?

Common side effects following Radial Pressure Wave therapy include reddening, swelling, pain, hematoma, petechiae, and skin lesions, especially after previous cortisone therapy. These side effects are generally expected to diminish within 5 to 10 days.

When should a treatment not be repeated after side effects occur?

A treatment should not be repeated until the previous side effects have diminished. This is crucial to allow the body to recover and to avoid exacerbating any negative reactions.

What is the recommended procedure for unpacking the Intelect RPW unit?

The unpacking process for the Intelect RPW unit involves several steps. First, the transport packaging should be positioned so that the arrows are pointing upward. Then, the safety bands need to be removed from the transport packaging. Next, the transport packaging should be removed upward. After that, any remaining foam material should be taken out. Finally, the unit should be lifted from the lower packaging element using at least two people due to its weight.

What steps should be taken to inspect the unit immediately after unpacking?

After unpacking, several steps should be taken to inspect the unit. First, verify the delivery documents to ensure that the delivery is complete. Then, check the external components and accessories for any possible damage that may have occurred during transport. Verify that all components are present, including the Intelect RPW unit, Intelect RPW CD User Manual, Intelect RPW Quick Start Guide, Conductor™ Transmission Gel, and the standard accessory kit, which includes the R-SW Handpiece Applicator, Projectile, R15 – 15 mm ESWT Transmitter, D20-S D-ACTOR® 20 mm Transmitter, Sealing Set, Guide Tube, Cleaning Brush, and power cord. Finally, retain the original packaging as it may be useful for future equipment transport. It is important to note that if there is damage from transport that could endanger personal safety, the unit must not be connected to the Mains Power Supply before inspection is complete.

What are some important requirements for the installation location of the unit?

The installation location must be large enough to allow the unit to be operated from the front, even if the handpiece is inconveniently positioned. The unit must be installed in a manner that ensures there is no danger to the patient, the operator, or any other persons. Additionally, the unit should not be stored or operated in a dusty environment.

What should you do if the unit cannot be installed immediately after delivery?

If the unit cannot be installed immediately after delivery, it, along with its external components and accessories, must be stored in the original packaging in a dry place.

What are the basic components of the Intelect RPW unit according to the front view?

According to the front view, the basic components of the Intelect RPW unit are the User Interface, Handpiece, Handpiece connection cable, Locking caster, Non-locking castors, IEC Connector for Power Cord, Storage Bin, Grab Bar, and Swivel Console.

What are the basic components of the Intelect RPW unit according to the rear view?

According to the rear view, the basic components of the Intelect RPW unit are the Expansion Port (for Service Use only), Transmitter Storage Compartment, Handpiece, Cable, and Gel Tray, Output Sockets, and Cable Storage Hooks.

What are the components of the user interface of the Intelect RPW unit?

The user interface of the Intelect RPW unit consists of the Power On/Off Button, Liquid Crystal Display (LCD) and Touch Screen, Clinical Resources Button, START Button, PAUSE Button, Multimedia Card (MMC) Port, Patient Data Card Port, STOP Button, and Power LED.

What do the software symbols on the Intelect® RPW display?

The software symbols on the Intelect® RPW display various functions and parameters. These include the Edit Treatment Screen, which likely allows users to modify treatment settings. There are also symbols for navigation, such as the Up Arrow (Increase) and Down Arrow (Decrease) for adjusting values, Touch and Slide Left/Right to Increase/Decrease, and Back (Return to Previous Screen) for navigating menus. The Home Screen symbol returns users to the main display. Additionally, there are cursor movement symbols for moving the cursor left or right. The Accept/Select (Parameters) symbol confirms selected settings. The Cancel symbol allows users to return to the previous screen. The symbols to Change Text to Upper or Lower Case indicate text editing capabilities. The unit also displays whether radial pressure wave energy or massage therapy is being emitted, indicates a Pause, and shows the Transmitter Type, Number of Pulses, and Pulse Frequency.

What should be done with accessories and cords during treatment?

During treatment, it is important to keep all accessories and their cords separated. This is achieved by using the hook located on the side of the unit. If accessories or their cords come into contact with each other during treatment, it can result in improper stimulation, skin burns, or damage to the cord or accessory. This precaution ensures the safe and effective operation of the device.

What are the components of the handpiece?

The handpiece of the Intelect® RPW consists of several key components. These include the 20 mm Insert (Transmitter), which is the part that delivers the therapy. The Front Cap and Rear Cap secure the transmitter in place. The Shaft is the body of the handpiece. The Handle allows the user to hold and maneuver the handpiece. The Trigger Button activates the device. The Vibration Absorber Cushion helps reduce vibrations during use. The Cable connects the handpiece to the main unit.

What are the ambient temperature, relative humidity, and air pressure requirements for the Intelect® RPW during operation?

The Intelect® RPW has specific environmental requirements for optimal operation. The ambient temperature should be between +10 °C to 35 °C (50 °F to 95 °F). The relative humidity must be within the range of 5% to 90%. The air pressure should be between 500 hPa to 1060 hPa. Maintaining these conditions ensures that the device operates safely and effectively.

What is the power consumption of the different models of the Intelect® RPW?

The Intelect® RPW comes in different models, each with varying power consumption. Model 2082 consumes 840 VA of power. Model 2073 consumes 780 VA. Model 2074 consumes 610 VA.

What is the input voltage and frequency for each model of the Intelect® RPW?

The input voltage and frequency requirements vary by model. Model 2082 operates at 100 V ~, 50/60 Hz. Model 2073 operates at 120 V ~, 60 Hz. Model 2074 operates at 230 V ~, 50 Hz.

What is the pressure vessel volume of the Intelect® RPW?

The pressure vessel volume of the Intelect® RPW is 31 liters. This indicates the amount of compressed air that the device can hold.

What are the mode options for the Intelect® RPW?

The Intelect® RPW offers two mode options: Single or Continuous. This allows clinicians to choose the appropriate mode based on the treatment requirements.

What is the range of the compressed air output for the Intelect® RPW?

The compressed air output of the Intelect® RPW ranges from 1.4 to 5 bar. This indicates the force of the air used to generate the pressure waves.

What is the power increment setting for the Intelect® RPW?

The power increment setting for the Intelect® RPW is 0.2 bar. This means that the power output can be adjusted in increments of 0.2 bar.

What are the power indications for the Intelect® RPW?

The Intelect® RPW provides indications for both maximum and average power. This allows the user to monitor the power levels being delivered during treatment.

What is the pulse amplitude of the Intelect® RPW?

The pulse amplitude of the Intelect® RPW is approximately 2 mm at 3 bar when idling (without coupling). This is the distance the impact body moves during the delivery of a single pulse.

What is the pulse width of the Intelect® RPW?

The pulse width of the Intelect® RPW is approximately 6 to 12 ms. This is the duration of a single pressure wave pulse.

What is the pulse frequency of the Intelect® RPW?

The pulse frequency of the Intelect® RPW ranges from 0.5 to 21 Hz. This is the rate at which pressure waves are delivered.

What type of fuses does the Intelect® RPW use?

The Intelect® RPW uses two 6.3 A Time Lag 5 x 20 mm fuses. These fuses are not user-serviceable, and if they need replacement, a qualified technician should handle the task.

What is the electrical class of the Intelect® RPW?

The Intelect® RPW is classified as CLASS I equipment. This indicates the level of protection against electric shock.

What is the electrical type (degree of protection) of the Intelect® RPW?

The Intelect® RPW is classified as TYPE B equipment, indicating the degree of protection against electric shock.

What is the regulatory risk class of the Intelect® RPW?

The regulatory risk class of the Intelect® RPW is IIa according to MDD 93/42/EEC. This classification is based on the risk level associated with the device according to European medical device regulations.

What are the dimensions of the Intelect® RPW?

The Intelect® RPW has specific dimensions. Its width is 420 mm (16.5"), its depth is 410 mm (16.14"), and its height is 1143 mm (45"). These dimensions can be used to consider the space needed for the unit.

What is the standard weight of the Intelect® RPW with one handset?

The standard weight of the Intelect® RPW, including one handset, is 32.66 kg (72 lbs). This is useful for understanding the portability of the equipment.

How can I view the software version of the Intelect® RPW?

To view the software version, you must press the Unit Settings button on the Clinical Resources screen. The software version number will appear at the top of the screen.

What are the ambient temperature, relative humidity, and air pressure requirements for the Intelect® RPW during transport and storage?

During transport and storage, the Intelect® RPW has specific environmental requirements. The ambient temperature should be between 0 °C to 60 °C (32 °F to 140 °F). The relative humidity should be between 30% to 75%. The air pressure should be within 500 hPa to 1060 hPa.

What safety standards does the Intelect RPW meet?

The Intelect RPW has been designed to meet the requirements of IEC/EN 60601-1, 60601-1-2, and 60601-1-4. These standards ensure the safety and effectiveness of medical devices.

What should I pay special attention to when using the Intelect® RPW?

When using the Intelect® RPW, you should pay special attention to the list of contraindications. You should also refer to the “Safety Instructions”, “Contraindications”, “Additional Precautions”, and “Personal Safety” sections in the documentation. These resources contain vital information for safe usage of the device.

What are the technical data for the R-SW Handpiece?

The R-SW Handpiece has specific technical specifications. Its compressed air output is 1.4 to 5 bar. The frequency range is 0.5 to 21 Hz. The operating ambient air temperature is +10° C to 35° C (50° F to 95° F). The storage and transport temperature should be 0° C to 60° C (32° F to 140° F), and it should be frost-free. The ambient air pressure should be 500 to 1060 hPa. The air humidity should be 5 to 90% (non-condensing). The handpiece weighs 510 g (1.12 lb). Its protection against water ingress is IPX0.

How can I get technical data on specific transmitters?

To get technical data on specific transmitters, press the Transmitter Information button on the Select Transmitter screen. This screen can be accessed on page 41 in the documentation.

What do the markings on the Intelect RPW system indicate?

The markings on the Intelect RPW system indicate that it conforms to the highest applicable standards of medical equipment safety and electromagnetic compatibility. The markings can include: compliance with Directive 93/42/EEC; compliance with 21CFR 1040.10 & 1040.11; and adherence to IEC/EN 60601-1, IEC 60601-1-2, 60601-1-4, and 60601-1-6 standards. These markings assure the user of the device’s regulatory compliance.

What does the symbol with a trash can with an X through it indicate?

The trash can symbol with an X through it indicates that the device should not be disposed of as municipal waste. It is a reminder to comply with Council Directive 2002/96/EC regarding Waste Electrical and Electronic Equipment (WEEE). You should contact your local distributor for information on proper disposal of the unit and accessories.

Who is this equipment intended to be used by?

This equipment is intended to be used by and sold to trained clinicians only under the prescription and supervision of a licensed practitioner (U.S. only). This underscores that proper training is necessary to safely and effectively operate the device.

What does the unit produce?

The unit produces radial pressure wave (shockwave) energy. This energy is used for therapeutic purposes.

What does the “Contents under pressure” symbol indicate?

The “Contents under pressure” symbol indicates that the device contains pressurized components. This should be noted for safety during usage and maintenance of the device.

What does the “Functional Earth (Ground)” symbol indicate?

The “Functional Earth (Ground)” symbol indicates the grounding point of the device. It is a safety feature that ensures the device is properly grounded.

Is the unit and its accessories latex-free?

Yes, the unit and its accessories are latex-free. This is an important consideration for patients and clinicians with latex sensitivities or allergies.

How are pressure waves generated in this device?

Pressure waves are generated by the collision of solid bodies with an impact speed of a few meters per second (approx. 5 – 20 m/s). A projectile is accelerated using compressed air and then abruptly slowed down by hitting an impact body. This causes the impact body to transfer kinetic energy to the tissue.

How does the pressure wave travel through the tissue?

The pressure waves emanate from the application point of the impact body and travel radially into the adjacent tissue. The energy density decreases with increasing distance from the application point. The strongest effect is at the application point.

What are the applications of Intelect® RPW units?

Intelect® RPW units are used for a wide range of applications in hospitals and private practices by doctors and physiotherapists. This highlights the broad utility of the device in medical and therapeutic settings.

How do I replace the transmitter?

To replace the transmitter, follow these steps:

Unplug the unit.
Unscrew the rear cap by turning it counterclockwise while holding the handpiece.
Unscrew the front cap by turning it counterclockwise while holding the rear cap.
Remove and replace the O rings on the transmitter if necessary.
Press the transmitter and spacers through the front cap.
Press the front cap onto the rear cap and turn the rear cap clockwise to tighten it.
Fit the rear cap onto the handpiece and turn it clockwise while holding the handpiece, tightening until snug.
Align the red dot on the connector with the red dot on the socket and press the connector into the socket.
Use the cable hook on the side of the unit to store the applicator cable.

What precautions should be taken when installing the applicator?

When installing the applicator, avoid cross-threading the two caps. Do not cross cables. Before removing the cable from the handpiece, ensure the power is off, and hold the handpiece to prevent it from dropping. Also, observe the patient at all times during therapy.

How do I prepare the unit for therapy?

Make sure that the voltage rating on the serial decal conforms to the system voltage of the building. Install the required transmitter into the handpiece. Plug the handpiece cable into the socket on the back of the unit and attach the connecting cable in the cable hook on the side of the unit. Check the condition of the housing and the insulation of the handpiece, handpiece connection cable, and the power supply cable, making sure that the cables have been routed correctly. Insert the power cord plug into an earthed socket outlet. Depress the tabs of the caster locks to prevent the front wheels from moving. The unit and the handpiece must be positioned so that there is no danger of personal injury. Read and observe the safety instructions and the list of contraindications before putting the unit into operation. Make certain that the unit is electrically earthed by connecting only to an earthed electrical service receptacle.

How do I prepare the patient’s skin for therapy?

Thoroughly wash the skin on which you intend to administer therapy with mild soap and water or alcohol wipe. Dry the skin thoroughly. Apply the coupling gel generously to the target area on the patient.

How do I connect the power supply cord?

Connect the male end of the power supply cord to an appropriate electrical outlet. Connect the female end of the power supply cord into the IEC connector on the side of the unit.

How do I turn on the unit?

Press the Power On/Off button or touch the LCD.

What happens when the Power On/Off button is pressed or the LCD is touched?

Three quick beeps sound, the blue LED illuminates, and the Home Screen displays.

How do I view parameter options and make selections?

The operator can view parameter options on the display and make selections by pressing the buttons directly on the LCD.

What information does the LCD provide during treatments?

The LCD provides continuous information during the treatments concerning intensity and the number of pulses given.

How are parameters adjusted?

Parameters are adjusted using the and buttons.

How can the output be stopped?

The output can be stopped by the user by pressing the PAUSE or STOP buttons located on the Operator Interface.

What methods are available to begin a treatment session?

The Intelect RPW offers the following methods from which you can begin a treatment session: Quick Link Indications, Home screen, Clinical Protocols, User Protocols, and Patient Card.

What is the purpose of the Home screen?

The Home screen serves as the main treatment screen.

How can I increase or decrease the output power during therapy on the Home screen?

You may increase or decrease the output power (in bars) during therapy on the Home screen by using the and buttons.

How do I access the Edit Treatment screen?

On the Home Screen, press the button.

How do I increase parameters on the Edit Treatment screen?

Increase the parameters on the Edit Treatment screen by pressing the button.

How do I decrease parameters on the Edit Treatment screen?

Decrease the parameters by pressing the button.

How else can I increase and decrease parameters?

You may also increase and decrease parameters by pressing and sliding the button either left or right.

How do I select between Single or Continuous mode?

Press the Mode button to select either Single or Continuous.

When are pulse frequency parameters not available?

Pulse Frequency parameters are not available when Single mode is selected.

How do I turn the ramping feature on or off?

Press the Ramp button to turn the ramping feature on or off.

How do I select the transmitter for treatment?

Press the Handpiece/Transmitter button to select the transmitter for treatment. See “Select Transmitter Screen” for more information on this feature.

How do I return to the previous screen?

Press the button to return to the previous screen.

How do I return to the Home screen?

Press the button to return to the Home screen.

How do I access the Select Transmitter screen?

On the Edit Treatment screen, press the Handpiece/Transmitter button.

How do I select a transmitter?

Press the transmitter to highlight it, or press the and buttons to scroll through a list of the available transmitters.

How do I display technical details of the transmitter?

Press the Transmitter Information button to display technical details of the transmitter.

How do I accept the highlighted selection on the Select Transmitter screen and return to the Edit Treatment screen?

Press the button to accept the highlighted selection and return to the Edit Treatment screen.

How do I return to the previous screen from the Select Transmitter screen?

Press the button to return to the previous screen.

How do I return to the Home screen from the Select Transmitter screen?

Press the button to return to the Home screen.

How do I access specific pre-programmed indications?

By pressing the Quick Link Indications button on the Home screen.

What is the purpose of the Quick Link Indications screen?

It provides pre-programmed indications, for general reference only, which aid in selecting the proper output and handpiece placement for particular indicated patient syndrome diagnoses.

How do I use the Quick Link Indications screen?

On the Home screen, press the Quick Link Indications button. Then, click one of the buttons on the Quick Link Indications screen. The Home screen displays with the pre-set parameters for the indication you selected to begin treatment.

How do I set the appropriate output power for therapy on the Home screen?

On the Home screen, press the and buttons to set the appropriate output power (in bars) for therapy.

How do I begin treatment after setting the output power?

Press the START button on the User Interface to begin treatment. Then, press the trigger button on the handpiece to activate the handpiece. The unit begins emitting radial pressure wave energy.

What does the unit display when the START button is pressed?

When the START button is pressed, the icon displays.

What is the purpose of the Ramp button?

The Ramp button turns the ramping function on and off.

What is the purpose of the ramping function?

Ramping the intensity serves to acclimate the patient to the pressure of the output instead of administering the full output all at once. When pressed, the Ramp button allows the unit to gradually increase the intensity from 1.4 bar to the set intensity.

When is the ramping feature not available?

The ramping feature is not available while a treatment session is in progress.

How do I use the ramping feature?

Set the intensity on the Home screen. Press the Ramp button so that it reads “On.” When the START button and the trigger button on the handpiece are pressed, notice that the progress bar gradually increases to the set intensity. The full intensity is reached when one-third of the pulses have been given to the patient.

What happens if the PAUSE button or the trigger button on the handpiece is pressed to pause the treatment before the intensity has fully ramped?

The ramping feature continues when treatment resumes.

How do I stop the ramping feature during a treatment session?

Press the Ramp button (the Ramp button will read “Ramp Off”).

What happens when the Ramp button is pressed before the intensity is fully ramped?

The intensity level is set at that level.

How do I stop therapy?

Press the STOP button on the User Interface.

What occurs when the STOP button is pressed?

The applicator stops emitting radial pressure wave energy, the message “Treatment has been stopped by user. Touch anywhere to continue . . .” appears, and the unit sounds three long tones.

What happens after pressing the STOP button and touching the screen?

The Treatment Complete screen displays.

What options are available on the Treatment Complete screen?

You can save the current parameters to a patient card, save the current parameters as a user protocol, or start over with the same treatment.

How do I save the current parameters to a patient card?

Press the Save to Patient Card button and follow the instructions on page 61, beginning with step 2.

How do I save the current parameters as a user protocol?

Press the Save Protocol button and follow the instructions on page 51 beginning with step 4.

How do I start over with the same treatment?

Press the Run this Treatment button. You are returned to the Home Screen with the same parameters displayed.

How do I pause therapy?

Press the PAUSE button on the User Interface.

What occurs when the PAUSE button is pressed?

The applicator stops emitting radial pressure wave energy and the (pause) symbol displays and blinks.

How do I resume therapy after pausing?

Press the PAUSE or START buttons on the User Interface.

How can therapy be interrupted?

Therapy can be interrupted at any time by pressing the trigger button on the handpiece. When the trigger button is pressed, the applicator stops emitting radial pressure wave energy and the symbol continues to display. This allows the user to temporarily halt the treatment as needed.

How can therapy be resumed after being paused?

To resume therapy, press the trigger button on the handpiece. This will restart the radial pressure wave emission and continue the treatment session.

What happens when the unit has completed the set number of pulses?

When the unit has completed the set number of pulses, the applicator stops emitting radial pressure wave energy. Additionally, the message “Treatment has completed. Touch anywhere to continue . . .” is displayed, and the unit sounds three long tones. This indicates that the programmed treatment session has concluded.

What are the options after a treatment session is complete?

After a treatment session is complete, you have several options: you can save the current parameters to a patient card, save the current parameters as a user protocol, or start over with the same treatment. This flexibility allows you to manage treatment data effectively.

How do you save current parameters to a patient card?

To save the current parameters to a patient card, press the Save to Patient Card button and follow the instructions on page 61, beginning with step 2. This is useful for tracking individual patient treatment parameters.

How do you save current parameters as a user protocol?

To save the current parameters as a user protocol, press the Save Protocol button and follow the instructions on page 51 beginning with step 4. Saving user protocols is helpful for treatments that are used frequently.

How do you start over with the same treatment after a session is complete?

To start over with the same treatment, press the Run this Treatment button. This will return you to the Home Screen with the same parameters displayed, allowing you to immediately repeat the treatment.

What is the first step when using clinical protocols?

Make sure the MMC labeled “RPW Clinical Resource Library” is inserted into the MMC port. This step is crucial for accessing the clinical protocol database.

What is the second step when using clinical protocols?

On the Home screen, press the Clinical Protocols button. The Clinical Protocols screen displays. This will navigate you to the appropriate section for selecting protocols.

What is the third step when using clinical protocols?

Press the specific body area on the front or back image to select the desired body area to treat. The screen unique to the area of the body you pressed displays. This allows you to select specific protocols based on the body part being treated.

What is the fourth step when using clinical protocols?

If applicable, press the and buttons to scroll through the pages of protocols. This is useful when there are multiple pages of protocols for a selected body area.

What is the fifth step when using clinical protocols?

Press the protocol to highlight it, or press the and buttons to scroll through the list. This lets you select a specific protocol from the available options.

What is the sixth step when using clinical protocols?

Press the button to accept the highlighted selection. The suggested parameters, transmitter, and placement information displays. This provides details about the selected protocol before starting treatment.

What is the seventh step when using clinical protocols?

To select this protocol and begin treatment, press the button. The Home screen displays and you can begin treatment. This confirms the protocol selection and takes you to the screen to initiate treatment.

What should be done if you want to change the protocol?

If you want to change the protocol, press the Alternate Protocol button. The next Clinical Protocols screen displays, allowing you to choose another protocol.

What is the ninth step when using clinical protocols?

Press the button. The Home screen displays with the new parameters. This will return you to the home screen with the new protocol’s parameters set up.

What is the tenth step when using clinical protocols?

Press the and buttons to set the appropriate output power for treatment. This is important for customizing the treatment to the individual patient’s needs.

What is the eleventh step when using clinical protocols?

Press the EDIT button to change the parameters. This allows for manual adjustments to the treatment settings.

What is the twelfth step when using clinical protocols?

Press the START button to begin treatment. This will initiate the treatment process using the selected parameters.

What is the thirteenth step when using clinical protocols?

Press the trigger button to activate the handpiece. This will start the radial pressure wave emission and begin the treatment session.

How many user protocols can be created?

The Intelect RPW unit allows you to tailor a protocol according to the requirements of a patient, and you may create up to 200 user protocols. This allows for substantial customization and saving of frequently used treatment setups.

How do you retrieve a user protocol?

On the Home screen, press the User Protocols button. The User Protocols screen displays.
Press the Retrieve Protocol button. The Retrieve Protocol screen displays.
Press or scroll to the desired user protocol to view the treatment parameters.
Press to select the highlighted protocol. You are returned to the Home screen to begin treatment. This allows easy access to previously saved user protocols.

How do you delete a user protocol?

To delete the highlighted user protocol, press the Delete button on the Retrieve Protocol screen. A message displays to verify the deletion.
Press the Yes button to delete the user protocol. You are returned to the Retrieve Protocol screen. Note: If you press Yes, the user protocol name and parameters will be permanently removed from the unit.
Press the No button to keep the user protocol and return to the Retrieve Protocol screen. This procedure is useful for maintaining the user protocol list.

How do you save a new user protocol?

Set up treatment parameters by completing the steps listed in “Starting Therapy” on pages 40-42, but do not press the START button.
On the Home screen, press the User Protocols button. The User Protocols screen displays.
Press Save Protocol. The Save Protocol screen displays.
To create a name for the new protocol, press the Save Protocol as a New Name button. The Keyboard screen displays.
Type the name of the new protocol. The name of the new protocol can be up to 25 alpha-numeric characters.
Press the button to save the name of the protocol. A message displays briefly to confirm the protocol was saved. Press anywhere on the screen. The Home screen displays the parameters of the user protocol you just saved. This procedure allows for saving customized treatment settings for later use.

How do you edit existing user protocols?

To edit the treatment parameters of a previously saved user protocol, press to highlight, or scroll through the list of user protocols and highlight the appropriate user protocol.
Press the button to save the new treatment parameters. A message displays to confirm the overwriting of the old parameters. If you press Yes, a message displays briefly to confirm the protocol was saved and the Home screen displays the parameters of the user protocol you just saved. If you press No, you are returned to the Save Protocol screen. This allows for easy modification of existing user protocols.

How do you access the Anatomical Graphics Library?

Make sure the MMC labeled “SWD Clinical Resource Library” is in the MMC port.
On the Clinical Resources screen, press the Anatomical Graphics Library button. The Anatomical Graphical Library screen displays.
Press the button of the body area on which you intend to administer therapy. The screen that corresponds to the body area you selected displays. For example, you may have pressed the back of the neck which would cause the Neck: Page 1 of 2 screen to display.
If available, press the icon to display additional pathological images. This library provides anatomical visuals that help in understanding treatment areas and conditions.

How can the Educational Libraries be accessed?

The Educational Libraries can be accessed by pressing the button with the icon (Clinical Resources button) located below the touch screen display. The Clinical Resources screen allows you access to the Educational Libraries, Patient Card management, and Utilities screens. This is the main entry point for accessing the various educational resources of the device.

What can you do with the Anatomical Images section of the library?

Press a button on the left side of the screen (Anatomical Images) to display a list of either muscles or bones that make up the area.
Press the button to return to the previous screen. This section of the library is useful for identifying the specific anatomical structures relevant to the treatment.

What can you do with the Pathological Images section of the library?

Press a button on the right side of the screen (Pathological Images) to display an illustration of a common disorder associated with the body area.
Press the button to return to the previous screen. This provides visual guidance for conditions that may be treated with radial pressure wave therapy.

How do you access the Handpiece Placement Library?

On the Clinical Resources screen, press the Handpiece Placement Library button. The Select Treatment Area screen displays.
Press the body area on which you intend to administer therapy. The screen that corresponds to the body area you selected displays. For example, if you press the foot, the Hand Piece Placement: Foot displays.
Press one of the handpiece placement thumbnails to view the entire picture of the handpiece placement. The Handpiece Placement screen displays.
Press the button to return to the previous screen.
Press the button to return to the Home screen. This library offers visual guides for proper handpiece placement during treatment.

How do you view the rationale for shockwave therapy?

On the Clinical Resources screen, press the Shockwave Rationale button. The Shockwave Rationale screen displays.
Press the and buttons to scroll through the information.
Press the button to return to the previous screen.
Press the button to return to the Home screen. This provides an overview of the radial pressure wave therapy and its applications.

How do you view contraindications for shockwave therapy?

On the Clinical Resources screen, press the Contraindications button. The Contraindications screen displays.
Press the and buttons to scroll through the information.
Press the button to return to the previous screen.
Press the button to return to the Home screen. This displays the list of conditions for which radial pressure wave therapy is not recommended.

How do you view and retrieve treatments from the Patient Card?

To view and retrieve treatments from the Patient Card, first, press the Patient Card button on the Clinical Resources screen. This action will take you to the Patient Card screen where the treatment data is stored. Next, use the up and down buttons to scroll through the list of treatment sessions. As you scroll, the treatment parameters for the highlighted session will be displayed at the top of the screen. If there are multiple pages of treatment sessions, you can continue scrolling using the up and down buttons. Once you have located the desired treatment session, press the select button. This will display the treatment parameter screen. Now, you can review the treatment parameters before starting the session. Finally, press the Run this Treatment button to begin the treatment.

How do you edit the pain profile?

To edit the pain profile, start by pressing the Edit Pain Profile button on the Clinical Resources screen. This will bring you to the Edit Pain Profile screen where you can input pain information. In the Pain Before Treatment section, select either a Numeric or Visual pain scale. Adjust the pain level using the decrease button to reduce the amount of pain on the scale and the increase button to increase it. Next, press the Pain Type button to bring up the Select Pain Type Before Treatment screen. Here, you can select the appropriate pain type or use the up, down, and select buttons to choose the correct option. This will return you to the Edit Pain Profile screen with the selected pain type. To specify the location of pain, press the Edit Pain Map button. This will display the Pain Map Before Treatment screen, where you can press the body area where you intend to administer therapy, with a purple shading appearing in the areas you press. If you make a mistake, press the Clear button to remove all previously selected areas. Press the return button to go back to the previous screen. In the Pain After Treatment section, repeat the previous steps to record pain after treatment. To choose the specific body area to treat, press the Treatment Area screen. This will display the Select Treatment Area screen, where you can press the desired body area on the front or back image. This action returns you to the Edit Pain Profile screen. Finally, press the Save to Patient Card button to save the pain information to the patient’s card. After saving, press the return button to return to the Clinical Resources screen, and then again to return to the Home screen.

How do you save treatments to the Patient Card?

When a treatment time expires or if you stop a treatment using the STOP button, the unit will give you the option to save the treatment to a patient card. To do so, press the Save to Patient Card button when prompted. Then, you need to follow the same steps as you would for editing the pain profile. Once you press the Save to Patient Card button, you will briefly see the message “Treatment has been saved for (patient name)”.

How do you erase a Patient Card?

To erase a Patient Card, first insert the patient card that you want to erase into the Patient Data Card Port. Then, press the Erase Patient Card button. A message will appear to verify the deletion. If you do not want to erase the card, press the No button, and you will be returned to the Clinical Resources screen. If you are sure you want to erase the card, press the Yes button, which will permanently remove all data on the card. Once the data is erased, you will be returned to the Clinical Resources Screen.

How do you add and change the clinic name?

To add or change the clinic name, navigate to the Clinical Resources screen and press the Unit Settings button. This will display the Unit Setup screen. On the Unit Setup screen, press the Clinic Name button, which will display the Keyboard screen. Use the keyboard to type the new clinic name; the name can be up to 25 alphanumeric characters. To save the new name and return to the Unit Settings screen, press the accept button. If you wish to delete the new information and return to the Unit Settings screen, press the delete button.

How do you increase and decrease the unit volume?

To adjust the unit’s volume, go to the Clinical Resources screen and press the Unit Settings button to access the Unit Settings screen. Once there, press the Volume button repeatedly until the desired volume level is reached. Each press of the volume button will produce a tone at the current volume level. Note that the volume level will remain unchanged even after the unit is powered off. The version number of the software will be displayed at the top of the Unit Settings screen.

How do you set the date and time?

To set the date and time, press the Unit Settings button on the Clinical Resources screen to access the Unit Settings screen. Then, press the Set Date and Time button to display the Set Date and Time screen. Use the up and down buttons to adjust the year, month, day, hour, and minute. Once you have set the correct date and time, press the accept button to save the settings and return to the Unit Settings screen.

How do you reset unit settings?

To reset the unit settings, which includes language, volume, and clinic name, go to the Unit Settings screen and press the Reset Unit Settings button. A reset message will then display on the screen. Touch anywhere on the LCD screen to confirm the reset, and you will be returned to the Unit Settings screen.

How do you reset default protocols?

To reset all user protocols to their default parameters, press the Reset Default Protocols button on the Unit Settings screen. A message will appear to verify the reset. If you do not wish to reset the protocols, press the No button, and you will be returned to the Unit Settings screen. If you wish to proceed with the reset, press the Yes button, which will permanently remove any user protocols you may have created, and you will be returned to the Unit Settings Screen.

How do you change the language?

To change the language, navigate to the Unit Settings screen and press the Language button. This will display the Language screen. Use the up and down buttons to scroll through the available languages. Press the language you want to select to highlight it, or use the up and down buttons to scroll through the list. Once the language is highlighted, press the accept button to confirm your selection. You will then return to the Unit Setup screen and all the buttons will be displayed in the newly selected language.

How do you edit the default transmitters for channels?

To edit the default transmitters for channels, start by going to the Unit Settings screen and pressing the Ch1 Default Transmitter button. The Select Transmitter screen will then appear. Press the desired transmitter to highlight it, or use the up and down buttons to scroll through the list of available transmitters. If you want to see technical information about the transmitter, press the Transmitter Information button. To accept the highlighted transmitter and return to the Edit Treatment screen, press the accept button. To go back to the previous screen without making changes, press the return button.

How do you use a second handpiece during therapy?

If you choose to use a second handpiece during therapy, repeat steps 1-5 for the Ch2 Default Transmitter button.

What does the Pulse Counter function do?

The Pulse Counter function allows the unit to track the number of pulses for the transmitters for maintenance purposes. After a certain number of pulses, the projectile must be replaced.

How does the pulse counter track the pulses?

The pulse counter monitors the number of pulses for a transmitter that is connected to the same socket for each therapy session. For example, if you keep the R-SW connected to Channel 1, the pulse counter tracks the number of pulses for the R-SW in Channel 1. The pulse counter will also monitor the number of pulses for a different transmitter as long as it is always connected to the same socket.

What happens if you swap the sockets and transmitters?

The unit cannot track the number of pulses if the sockets and transmitters are swapped (i.e., the R-SW is connected to Channel 2). Therefore, you must connect the transmitters to the same sockets each therapy session in order for the pulse counter to be accurate.

When should projectiles and guide tubes be changed?

Projectiles and guide tubes should be changed after 1,000,000 pulses.

How do you display the pulse count?

On the Unit Settings screen, press the Pulse Counter button. The Pulse Counter screen displays.
Press the Reset button beside the desired transmitter to reset the counter to zero.
Press the Reset All button to reset all the pulse counters to zero.

How do you start and stop shock wave application?

The applicator is placed over the previously diagnosed pain region. To start and stop shock wave application, the trigger button provided on the applicator must be pressed.

What are some things to keep in mind when applying shock waves?

Do not apply more than 300 pulses to the same spot.
Avoid pressing the transmitter into the treatment area with excessive pressure. Excessive pressure is not needed for effective and successful treatment.
Stop treatment after a maximum of 6000 pulses.

How do you position the handpiece like a pen?

The handpiece is held behind the rear cap. This way of holding the applicator is recommended for tactile treatment.

How do you position the handpiece like a bar?

The handpiece is grasped with the entire hand behind the rear cap. This way of holding the applicator is recommended for the treatment of pain regions covering relatively large areas.

How do you hold the handpiece when treating pain confined to specific points?

Use both hands to hold the handpiece.

What can happen if the unit is operated at pressures higher than 3 bar without an impact surface?

Operating the unit at pressures higher than 3 bar without an impact surface can result in damage to the handset.

What does error code 100 mean?

The Patient Card button was pressed, but no valid treatments were found on the Patient Card.

What does error code 101 mean?

The Save to Patient Card button was pressed, but there is no Patient Card inserted.

What does error code 102 mean?

The Save to Patient Card button was pressed, but the card that is currently inserted in the Patient Data Card Port is not a valid patient data card.

What does error code 103 mean?

The Save to Patient Card button was pressed, but the card that is currently inserted in the Patient Data Card Port is full.

What does error code 104 mean?

The Save to Patient Card button was pressed, but there is already a treatment by that name on the Patient Card.

What does error code 105 mean?

No patient name was entered when the Save to Patient Card button was pressed.

What does error code 106 mean?

No protocol name was entered when attempting to save a protocol.

What does error code 107 mean?

The Retrieve Protocol button was pressed, but no user protocols have been set up in the unit.

What does error code 108 mean?

The protocol cannot be saved because the unit has the maximum number of protocols already saved.

What does error code 109 mean?

The MMC is being accessed, but there is no MMC inserted into the MMC port.

What does error code 110 mean?

The user is attempting to update the unit’s software, but the MMC inserted into the MMC port is not a software update MMC.

What does error code 111 mean?

There was an error encountered when attempting to update the control board software.

What does error code 112 mean?

There was an error encountered when attempting to update the interface board software.

What does error code 113 mean?

The treatment being accessed on the Patient Card is a traction type of treatment.

What does error code 114 mean?

The treatment being accessed on the Patient Card is an electrotherapy type of treatment.

What does error code 115 mean?

The treatment being accessed on the Patient Card is a continuous passive motion (CPM) type of treatment.

What does error code 116 mean?

The treatment being accessed on the Patient Card is a shortwave diathermy type of treatment.

What does error code 117 mean?

The treatment being accessed on the Patient Card is an un-known type of treatment.

What does error code 118 mean?

A button was pressed that accessed the MMC card (e.g., Radial Pressure Wave Rationale, Contraindications, etc.), but the MMC inserted into the MMC port is not the correct MMC.

What does error code 119 mean?

The Delete button was pressed while a default (factory) protocol was highlighted.

What does error code 121 mean?

The START button was pressed, but a handpiece cable is not connected to any output socket.

What does error code 122 mean?

The START button was pressed, but a handpiece cable is not connected to the Channel 1 output socket.

What does error code 123 mean?

The START button was pressed, but a handpiece cable is not connected to the Channel 2 output socket.

What does error code 124 mean?

The user is attempting to use the wrong transmitter for the selected protocol.

What does error code 125 mean?

The transmitter in Channel 1 has reached one million pulses.

What does error code 126 mean?

The transmitter in Channel 2 has reached one million pulses.

What does error code 127 mean?

The handpiece cable has become disconnected from the output socket during a therapy session.

What should you do if an error message or warning appears beginning with a 2 or 3?

What could happen if you use a unit that indicates an error or warning beginning with a 2 or 3?

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 system.

What should you do if there is a display failure or other obvious defects?

In case of display failure or other obvious defects, switch the unit off immediately by means of the Power On/Off button and notify a certified service technician.

Who is responsible for the safety and reliability of the unit?

As the manufacturer, DJO is responsible for the safety and reliability of the unit only if it is used in accordance with this user manual.

Who is allowed to perform safety inspections, maintenance, repairs, and modifications?

Safety inspections, maintenance, repairs, and modifications may be performed only by a certified service center or field technician certified by DJO.

What should you keep in mind when cleaning the unit?

Unplug the unit and remove the handpiece cable from the socket on the unit.
Wipe off excess coupling gel from the transmitter.
Clean the base unit using a soft, clean cloth dampened with water and a mild antibacterial detergent. Avoid the use of abrasive materials and cleaning solvents.

How do you clean the R-SW handpiece after each patient use?

Clean the R-SW handpiece (remove the front and rear caps first) using a soft, clean cloth dampened with alcohol, an alcohol-based surface cleaning wipe, or a mild antibacterial detergent. Avoid the use of abrasive materials and cleaning solvents.

How do you clean the handle?

Remove the protective cushion by pulling it up and off the handle. Use a soft, clean cloth dampened with water or a mild antibacterial detergent to wipe off the handle. Avoid the use of abrasive materials and cleaning solvents.

What should you do before operating the unit again after cleaning?

Wait until the unit is completely dry before operating it again.

How do you clean the transmitters?

It is recommended that the transmitters be cleaned with an ultrasound cleaning bath designed for disinfecting heat-sensitive, reusable medical instruments. If an ultrasonic bath is unavailable, clean parts under running water and wipe with an alcohol-based surface cleaner wipe, or spray with alcohol-based surface cleaner and wipe with a soft, clean cloth. When cleaning the transmitter, push aside the spacer ring so that the interior cavity can be cleaned.

Is the clear plastic impedance adapter reusable?

The clear plastic impedance adapter is for single patient use only and should be discarded.

How do you re-assemble the transmitter and handpiece?

Re-assemble the transmitter and handpiece by reversing the procedures for disassembly.

When should you empty the water bottle?

You must empty the water bottle at least once a week and when the bottle is half full.

How do you empty the water bottle?

Unplug the unit from the Mains Power.
Pull out the drawer.
Slide the water bottle out of the holding bracket.
Hold the cap, turn the bottle counter clockwise, and remove the cap.
Empty the contents of the bottle.
Replace the bottle by holding the cap and turning the bottle clockwise.
Slide the water bottle back into the holding bracket.
Push in the drawer.

When should you change the projectiles and guide tubes?

Projectiles and guide tubes should be changed after 1,000,000 pulses.

How do you change the transmitter?

Unplug the unit and remove the handpiece cable from the socket on the unit.
Unscrew the rear cap by turning it counterclockwise and holding the handpiece.

How should portable and mobile RF communications equipment be used in relation to the Intelect RPW?

Portable and mobile RF communications equipment should not be used any closer to any part of the Intelect RPW, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

How is the recommended separation distance calculated for the Intelect RPW with regards to conducted RF?

The recommended separation distance (d) is calculated using the formula d = 3.5√P, where P is the maximum output power rating of the transmitter in watts (W), for conducted RF with a frequency of 150 kHz to 80 MHz.

How is the recommended separation distance calculated for the Intelect RPW with regards to radiated RF at 80 MHz to 800 MHz?

The recommended separation distance (d) is calculated using the formula d = 3.5√P, where P is the maximum output power rating of the transmitter in watts (W), for radiated RF with a frequency of 80 MHz to 800 MHz.

How is the recommended separation distance calculated for the Intelect RPW with regards to radiated RF at 800 MHz to 2.5 GHz?

The recommended separation distance (d) is calculated using the formula d = 7√P, where P is the maximum output power rating of the transmitter in watts (W), for radiated RF with a frequency of 800 MHz to 2.5 GHz.

What should be done if the measured field strength in the location where the Intelect RPW is used exceeds the applicable RF compliance level?

If the measured field strength in the location where the Intelect RPW is used exceeds the applicable RF compliance level, the Intelect RPW should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Intelect RPW.

What is the maximum field strength for the Intelect RPW over the frequency range of 150 kHz to 80 MHz?

Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

What is the recommended separation distance for the Intelect RPW with a transmitter rated at 0.01 W in the 150 kHz to 80 MHz range?

The recommended separation distance is 0.12 meters.

What is the recommended separation distance for the Intelect RPW with a transmitter rated at 0.01 W in the 80 MHz to 800 MHz range?

The recommended separation distance is 0.12 meters.

What is the recommended separation distance for the Intelect RPW with a transmitter rated at 0.01 W in the 800 MHz to 2.5 GHz range?

The recommended separation distance is 0.23 meters.

What is the recommended separation distance for the Intelect RPW with a transmitter rated at 0.1 W in the 150 kHz to 80 MHz range?

The recommended separation distance is 0.38 meters.

What is the recommended separation distance for the Intelect RPW with a transmitter rated at 0.1 W in the 80 MHz to 800 MHz range?

The recommended separation distance is 0.38 meters.

What is the recommended separation distance for the Intelect RPW with a transmitter rated at 0.1 W in the 800 MHz to 2.5 GHz range?

The recommended separation distance is 0.73 meters.

What is the recommended separation distance for the Intelect RPW with a transmitter rated at 1 W in the 150 kHz to 80 MHz range?

The recommended separation distance is 1.2 meters.

What is the recommended separation distance for the Intelect RPW with a transmitter rated at 1 W in the 80 MHz to 800 MHz range?

The recommended separation distance is 1.2 meters.

What is the recommended separation distance for the Intelect RPW with a transmitter rated at 1 W in the 800 MHz to 2.5 GHz range?

The recommended separation distance is 2.3 meters.

What is the recommended separation distance for the Intelect RPW with a transmitter rated at 10 W in the 150 kHz to 80 MHz range?

The recommended separation distance is 3.8 meters.

What is the recommended separation distance for the Intelect RPW with a transmitter rated at 10 W in the 80 MHz to 800 MHz range?

The recommended separation distance is 3.8 meters.

What is the recommended separation distance for the Intelect RPW with a transmitter rated at 10 W in the 800 MHz to 2.5 GHz range?

The recommended separation distance is 7.3 meters.

What is the recommended separation distance for the Intelect RPW with a transmitter rated at 100 W in the 150 kHz to 80 MHz range?

The recommended separation distance is 12 meters.

What is the recommended separation distance for the Intelect RPW with a transmitter rated at 100 W in the 80 MHz to 800 MHz range?

The recommended separation distance is 12 meters.

What is the recommended separation distance for the Intelect RPW with a transmitter rated at 100 W in the 800 MHz to 2.5 GHz range?

The recommended separation distance is 23 meters.

How can the recommended separation distance be estimated for transmitters with maximum output power not listed in the table?

The recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

How do you remove the shaft from the handpiece of the Intelect RPW?

Unscrew the shaft from the handpiece by turning it counterclockwise. Use the supplied 22 mm open-face wrench if necessary. Then remove the shaft from the handpiece housing.

How do you remove the projectile from the handpiece?

Place your hand over the hole in the handle and turn it over so that the projectile falls out in your hand. If the projectile is in the shaft, place your hand over the open end of the shaft and turn it over so that the projectile falls out in your hand.

What should you check when retrieving the projectile?

Make certain that the entire projectile is retrieved. It may have broken apart during use.

How do you remove the guide tube from the shaft?

Slide the long end of the hex wrench through the hole in the guide tube. While holding the shaft with one hand, pull the guide tube out of the shaft with the other hand.

What should you do with the used projectile?

Dispose of the used projectile.

How should you clean the outside of the shaft, transmitter, and screw cap?

Clean the outside of the shaft, transmitter, and screw cap using a soft, clean cloth dampened with water or a mild antibacterial detergent. Avoid the use of abrasive materials and cleaning solvents.

How should you clean the inside of the shaft?

Clean the inside of the shaft with the cleaning rod and brush.

When should you replace the red sealing sleeve?

If necessary, replace the red sealing sleeve by pressing it into the opening of the shaft until it hits the stop.

How do you insert the guide tube into the shaft?

Insert the new guide tube into the shaft, making certain to insert the end of the guide tube without the holes into the shaft. Then, press the guide tube into the shaft until it seats.

How do you insert the new projectile?

Insert the new projectile into the guide tube.

How do you reattach the shaft to the handle?

Insert the shaft into the handle and turn clockwise until snug. Use one hand to hold the handle and the other hand to tighten the shaft into the handle using the 22 mm open face wrench. Tighten the shaft so that you are not able to loosen the shaft with your hand.

How do you reattach the rear cap?

Reattach the rear cap by turning it clockwise and holding the handpiece.

After reassembling the handpiece, what should you do before use?

Plug in the unit and connect the handpiece cable to the output socket on the unit. Reset the pulse counter by following the steps beginning on page 67.

Who should repair the unit if it is not safe for operation?

If the unit is not safe for operation, it must be repaired by a certified service technician, and the operators must be informed of the dangers posed by the unit.

Who is responsible for performing safety inspections on the Intelect RPW?

Safety inspections must be performed by persons who, based on training, knowledge, or practical experience, are capable of conducting the inspections correctly and independently.

What areas of potential damage should be checked during daily visual inspections of the unit?

During daily visual inspections of the unit, pay particular attention to the following areas of potential damage: Deformation of unit housing, power cable damage, handpiece connection damage, and handpiece cable damage.

What should be checked during the daily functional test of the Intelect RPW?

During the daily functional test, check for the correct function of indicators and the display of operating modes.

Who is responsible for verifying that the unit complies with the facility, local, and national Earth Leakage limits?

It is the responsibility of the health care facility to verify that the unit complies with the facility, local, and national Earth Leakage limits.

What precautions should be taken when cleaning the Intelect RPW unit?

Under no circumstances may liquid penetrate the openings on the unit. Do not use cleaning or disinfectant sprays. The unit, handpiece, and cables may not be sterilized using steam or gas. Never clean the unit with abrasives, disinfectants, or solvents that could scratch the housing or LCD or otherwise damage the unit. To prevent electrical shock, unplug the power plug from the power outlet before cleaning or disinfecting the unit.

When should the Intelect RPW unit be recalibrated?

The Intelect RPW unit must be recalibrated if it is not operating within specifications after routine maintenance and safety inspections have been performed.

Who should perform repairs or recalibration on the Intelect RPW?

It is recommended that all DJO radial pressure wave treatment products be returned to the factory or a certified servicing dealer for repairs or recalibration.

What should be done if the Intelect RPW unit requires service, warranty, or repair?

Contact the selling dealer or your local DJO customer service.

What should you not do under any circumstances when operating the Intelect RPW?

Do not perform unauthorized repairs.

What does the WEEE directive indicate?

The WEEE directive indicates a requirement not to dispose of WEEE as municipal waste. Contact your local distributor for information regarding disposal of the unit and accessories.

What is included in the standard accessories kit for the Intelect RPW?

The standard accessories kit includes the following: R-SW Handpiece Applicator, Projectile, R15 – 15 mm ESWT Transmitter, D20-S D-ACTOR® 20 mm Transmitter, Sealing Set, Guide Tube, and Cleaning Brush.

What power cords are included?

One of the following power cords: US, Switzerland, UK, India, Israel, Denmark, Australia, EU, Japan.

What is included in the optional revision kit?

The revision kit includes a replacement guide tube and 2 projectiles.

What is included in the V-ACTOR® hand piece applicator Kit?

The V-ACTOR® hand piece applicator Kit includes the following: V25 V-ACTOR® 25 mm Vibration Transmitter, V40 V-ACTOR® 40 mm Vibration Transmitter, and a Red Sealing Sleeve.

How long is the warranty for the Intelect RPW?

The warranty for the Intelect RPW is three years from the date of original consumer purchase.

How long is the warranty for accessories?

The warranty period for accessories is 365 days or 5 Million Shocks.

What is not covered under the Intelect RPW warranty?

The warranty does not cover: replacement parts or labor furnished by anyone other than the Company, the selling dealer or a certified Company service technician; defects or damage caused by labor furnished by someone other than Company, the selling dealer or a certified Company service technician; any malfunction or failure in the Product caused by product misuse, including, but not limited to, the failure to provide reasonable and necessary maintenance or any use that is inconsistent with the Product User’s Manual.

What must be done to obtain service under the Intelect RPW warranty?

To obtain service under the warranty, a written claim must be made within the warranty period to the Company or the selling dealer, and the Product must be returned to the Company or the selling dealer by the owner.

What is the electromagnetic environment guidance for the Intelect RPW unit with regards to RF emissions?

The Intelect RPW uses RF energy only for its internal function, therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

What is the electromagnetic environment guidance for the Intelect RPW unit with regards to its suitability of use?

The Intelect RPW is suitable for use in all establishments, other than domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

What is the electromagnetic environment guidance for the Intelect RPW unit with regards to Electrostatic discharge (ESD)?

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

What is the electromagnetic environment guidance for the Intelect RPW unit with regards to Mains power quality?

Mains power quality should be that of a typical commercial or hospital environment.

What is the electromagnetic environment guidance for the Intelect RPW unit with regards to power frequency magnetic fields?

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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