Chattanooga Intelect RPW User Manual Download Page 24

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CONTRAINDICATIONS

Intelect® RPW

•

Occlusive vascular disease, such as arteriosclerosis obliterans

and thromboangitis obliterans, in which organic occlusion

and ischemia are evident.

•

In the presence of systemic or local infection (sepsis,

Osteomyelitis, tuberculosis) or if the patient has an elevated

temperature.

•

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.

GENERAL (CONTINUED)

Summary of Contents for Intelect RPW

Page 1: ...User Manual Operation Installation Instructionsfor IntelectRadialPressureWave RPW REF 2082 100V REF 2073 120V REF 2074 230V ...

Page 2: ...ONS 19 General 19 ADDITIONAL PRECAUTIONS 21 General 21 Possible Side Effects 21 SETUP 22 Unpacking the Unit 22 Inspection 22 Requirements for Installation 23 Requirements for the Installation Location 23 NOMENCLATURE 24 Front View 24 Rear View 25 User Interface 26 Software Symbols 27 Accessories 28 Handpiece 28 SPECIFICATIONS 29 Unit Specifications 29 Operating Data and Ratings 29 Radial Pressure ...

Page 3: ...s 50 Retrieving User Protocols 50 Deleting User Protocols 50 Saving New User Protocols 51 Editing Existing User Protocols 52 Using Clinical Resources Educational Libraries 53 Anatomical Graphics Library 53 Handpiece Placement Library 54 Viewing Rationale 56 Viewing Contraindications 56 Using Clinical Resources Patient Card 57 Viewing and Retrieving Treatments from the Patient Card 57 Editing the P...

Page 4: ...tions 81 Service 82 Warranty Repair Out of Warranty Repair 82 ACCESSORIES 83 Standard Accessories 83 Optional Accessories 83 WARRANTY 84 APPENDIX A EMC TABLES 85 Table 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions 85 Table 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity 86 Table 3 Recommended Separation Distances between Portable and Mobile RF Communication...

Page 5: ...y treatment to a patient the user of this equipment should read understand and follow the information contained in this manual for each mode of treatment available as well as the indications contraindications warnings and precautions Consult other resources for additional information regarding the application of radial pressure wave treatment Operator Qualifications The Intelect RPW is intended ex...

Page 6: ... propagates radially within the tissue and has a therapeutic effect on areas of the tissue NOTE Medical devices operating on the basis of the above principle are generally referred to as extracorporeal shock wave systems in modern medical literature Stay current with the latest clinical developments in the field of radial pressure wave treatment Observe all applicable precautionary measures for tr...

Page 7: ...the D 20mm transmitter with pressures levels exceeding 3 Bars on screen when not applying on a non impact surface body Handset is at risk for damage Caution D 35mm Avoid pressure over 3 Bars on screen at all times with D 35mm Transmitter Handset is at risk for damage ...

Page 8: ...components before beginning work Please read and observe all safety instructions in this manual The following features are available on the Intelect RPW unit Clear Touch Screen LCD Allows the operator to select an option on the screen by simply touching it Guides the operator through the setup process providing continuous feedback about treatment settings Gives the operator optimal visibility duri...

Page 9: ...d time even when the unit is turned off or unplugged Intensity Ramping Ramping the intensity via the Ramp button on the Home and Edit Treatment screens allows the unit to gradually increase the intensity from 1 4 bar to the set intensity This feature is useful in treating conditions in which a build up of intensity is preferred over giving the patient the full intensity from the beginning of the t...

Page 10: ...amage Text with an Explosion Hazard indicator will explain possible safety infractions if this equipment is used in the presence of flammable anesthetics NOTE Throughout this manual NOTE may be found These Notes are helpful information to aid in the particular area or function being described PRECAUTIONARY DEFINITIONS Explosion Hazard Text with a DANGER indicator will explain possible safety infra...

Page 11: ...in an unshielded manner Portable and mobile RF communications equipment can affect medical electrical equipment CAUTION 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 d...

Page 12: ...ment Refer the servicing of this unit to qualified service personnel This equipment has an output that is capable of producing a physiological effect Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked Hospital Only or Hospital Grade Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into ...

Page 13: ...t the unit is electrically earthed by connecting only to a earthed electrical service receptacle conforming to the applicable national and local electrical codes This device should be kept out of the reach of children Do not leave patient unattended during radial pressure wave therapy Improper installation operation or maintenance of the radial pressure wave system may result in malfunctions of th...

Page 14: ...e 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 Empty the water bottle at least once weekly or if it is half full For instructions on removing and replacing the water bottle see page 75 Treatment should never be given in the area of metal implants Place the unit on a flat surface ...

Page 15: ...tion then it must be repaired by certified service personnel and the operators must be informed of the dangers posed by the unit In order to prevent electrical shock unplug the power plug from the socket before cleaning or disinfecting the unit Under no circumstances may liquid penetrate the openings on the unit e g the connecting sockets of the cables Therefore do not use cleaning or disinfectant...

Page 16: ...ures Avoid using DEHP leaching PVC when performing all clinical procedures on male neonates pregnant women who are carrying male fetuses or peripubertal males The Intelect RPW unit may contain bisphenol A BPA which is a building block of polycarbonate plastic used to make numerous consumer products baby bottles 5 gallon water bottles etc This chemical is considered an Unclassifiable Carcinogen and...

Page 17: ... positioned according to the doctor s instructions to be checked by the doctor or physiotherapist if applied by assisting personnel Before using the unit speak with the patient to verify The patient is in a comfortable position during the entire treatment That the patient is comfortable before and during treatment That the patient understands what to expect during and after treatment Before using ...

Page 18: ...ystem 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 WARNING WARNING Make certain that the unit is electrically earthed by connecting only...

Page 19: ...e unit only when the Mains Power Supply is deactivated power switch off power plug disconnected Clean and disinfect the unit only by means of disinfection by wiping Disinfecting by spraying can damage the unit due to penetrating moisture Never clean the unit with abrasives disinfectants or solvents that could scratch the housing or damage the unit Never perform unauthorized service work All servic...

Page 20: ...e no longer able to produce generator potential and can thus no longer send out any pain signals Shock waves stimulate nociceptors which in turn release a high amount of neural pulses As described by the Gate Control Theory transmission of these pulses to the central nervous system is inhibited Owing to the mode of action of shock waves the chemical environment of the cells is changed by free radi...

Page 21: ...bed in the hypothesis towards associative pain memory for instance Pulsed Radial Pressure Wave Introduction Pulsed radial pressure wave equipment delivers the energy in pulses or bursts of radial pressure wave energy The pulses are typically 6 to 12ms in duration pulse width and are repeated with a frequency of 0 5 to 21 Hz pulse frequency As with other modalities such as ultrasound it is found th...

Page 22: ...ensitivity to pain and then deactivated using a higher energy level approximately 3 bar Activation of Muscle and Connective Tissue Increasing Circulation Promotes blood flow through the tissue and boosting metabolism Pulse Vibration Massage Soothing relief from muscle strain and stress Disorder of Tendon Insertions Plantar Fasciitis Heel Pain or Heel Spur Plantar Fasciitis is an inflammatory condi...

Page 23: ...ry and nervous function in the polyneuropathic area Cortisone therapy Wait minimum 6 weeks after local cortisone injection before treatment with radial pressure waves Patients with hemorrhages or risk of hemorrhage Patients with malignant tumors and undiagnosed tumors Swellings that still feel warm Implants areas where implants have been removed damaged implants and metal inclusions Over superfici...

Page 24: ...anic occlusion and ischemia are evident In the presence of systemic or local infection sepsis Osteomyelitis tuberculosis or if the patient has an elevated temperature 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 GENERAL CONTINUED ...

Page 25: ...of the heated tissues Care therefore should be used in treating patients with therapeutic radial pressure wave treatment who have bleeding disorders Frequent monitoring of intensity level and skin response should occur during all treatments Always apply the transmitter on the skin with small circular movements Never use Radial Pressure Wave therapy on the head Do not treat direct in an area with a...

Page 26: ... delivery documents to make sure that the delivery is complete 2 Check the external components and accessories for possible damage due to transport UNPACKING THE UNIT DANGER 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 3 Verify that the packaging contains the following Intelect RPW unit I...

Page 27: ...ently There is no need to plug the power cord into an isolated circuit for the proper function of this unit The unit must be installed so that there is no danger to the patient the operator or other persons Therefore you must read the Safety Instructions on pages 6 12 and the following information REQUIREMENTS FOR INSTALLATION DANGER WARNING If the unit cannot be installed immediately after delive...

Page 28: ...LATURE 24 1 User Interface see page 26 2 Handpiece 3 Handpiece connection cable 4 Locking caster 5 Non locking castors 6 IEC Connector for Power Cord 7 Storage Bin 8 Grab Bar 9 Swivel Console FRONT VIEW 1 4 3 5 2 9 8 7 6 ...

Page 29: ...Intelect RPW NOMENCLATURE 25 REAR VIEW 1 Expansion Port for Service Use only 2 Transmitter Storage Compartment 3 Handpiece Cable and Gel Tray 4 Output Sockets 5 Cable Storage Hooks 1 4 3 5 2 ...

Page 30: ...R INTERFACE 1 Power On Off Button 2 Liquid Crystal Display LCD and Touch Screen 3 Clinical Resources Button 4 START Button 5 PAUSE Button 6 Multimedia Card MMC Port 7 Patient Data Card Port 8 STOP Button 9 Power LED 1 2 6 8 4 3 5 7 9 ...

Page 31: ...ase Back Return to Previous Screen Display the Home Screen Move the cursor to the left one space Move the cursor to the right one space Accept Select Parameters Cancel and Return to Previous Screen Change Text to Upper Case Change Text to Lower Case Radial pressure wave energy is being emitted Massage therapy is being emitted Pause Transmitter Type Number of Pulses Pulse Frequency ...

Page 32: ...on the side of the unit Accessories or their cords in contact with each other during treatment could result in improper stimulation skin burns or damage to the cord or accessory Handpiece 1 20 mm Insert Transmitter 2 Front Cap 3 Rear Cap 4 Shaft 5 Handle 6 Trigger Button 7 Vibration Absorber Cushion 8 Cable 6 5 2 1 3 4 8 7 WARNING ...

Page 33: ...5 bar Power Increment Settings 0 2 bar Power Indication maximum and average power Pulse Amplitude approx 2 mm at 3 bar idling without coupling Pulse Width approx 6 12 ms Pulse Frequency 0 5 21 Hz Fuses Two 6 3 A Time Lag 5 x 20 mm not user serviceable Electrical Class CLASS I Electrical Type Degree of Protection TYPE B Protection against water ingress IPX0 Regulatory Risk Class IIa according to MD...

Page 34: ...urces screen The version number of the software appears at the top of the screen Transport and Storage Conditions Ambient temperature 0 C to 60 C 32 F to 140 F Relative Humidity 5 to 90 NC non condensing Air Pressure 500 hPa to 1060 hPa Safety The Intelect RPW has been designed to meet the requirements of IEC EN 60601 1 CAN CSA STD C22 2 No 601 1 UNIT SPECIFICATIONS CONTINUED ...

Page 35: ...20 Additional Precautions on page 21 and Personal Safety on page 13 R SW Handpiece Technical Data Compressed Air Output 1 4 5 bar Frequency 0 5 21 Hz Ambient Air Temperature See Unit Specifications page 29 To get technical data on specific transmitters press the Transmitter Information button on the Select Transmitter screen page 41 APPLICATOR SPECIFICATIONS ...

Page 36: ...ld to a trained clinician only under the prescription and supervision of a licensed practitioner U S only Unit produces radial pressure wave shockwave energy Contents under pressure The unit and its accessories are latex free Safety agency symbol indicating device meets general safety requirements for medical electrical equipment Ambient temperature 10 C to 35 C 50 F to 95 F Relative Humidity 5 to...

Page 37: ...tes the treatment Clinical Resources to access the Educational Libraries This icon is located directly above the treatment pause button and allows access to the clinical library MMC multimedia card This icon is located above the patient data card port and allows for software upgrades PATIENT CARD patient data card This icon is located below the multimedia card port and allows for patient treatment...

Page 38: ...and travel radially into the adjacent tissue The energy density of the induced pressure wave quickly drops with increasing distance from the application point by a proportion of 1 r so that the strongest effect is at the application point of the applicator It appears that the principle of action is so universal that a multitude of very different indications respond positively to shock wave therapy...

Page 39: ...cement do the following 1 Unplug the unit 2 Unscrew the rear cap by turning it counterclockwise and holding the handpiece 3 Unscrew the front cap by turning it counter clockwise and holding the rear cap 4 Remove and replace the O rings on the transmitter if necessary 5 Press the transmitter and spacers through the front cap INSTALLING THE APPLICATOR ...

Page 40: ...ece and turn it clockwise and holding the handpiece Tighten until snug 8 Align the red dot on the connector with the red dot on the socket and press the connector into the socket 9 Use the cable hook on the side of the unit to store the applicator cable INSTALLING THE APPLICATORS CONTINUED CAUTION Do not cross thread the two caps with tightening ...

Page 41: ...S CONTINUED WARNING Do not cross cables To remove the cable from the handpiece make certain the power is off Hold the handpiece while removing the cable to prevent the handpiece from dropping to the floor Observe the patient at all times during therapy ...

Page 42: ...ndpiece connection cable and the power supply cable Also make sure that the cables have been routed correctly Insert the power cord plug into an earthed socket outlet There is no need to plug the power cord into an isolated circuit for the proper function of this unit Position the device such that it is not difficult to disconnect the power cord plug from the outlet in case of emergency Depress th...

Page 43: ...tient s skin for therapy you will allow more energy to reach the targeted areas and reduce the risk of skin irritation To prepare the patient s skin for therapy do the following 1 Thoroughly wash the skin on which you intend to administer therapy with mild soap and water or alcohol wipe 2 Dry the skin thoroughly 3 Apply the coupling gel generously to the target area on the patient ...

Page 44: ...or the LCD is touched three quick beeps sound the blue LED illuminates the Home Screen displays The Operator Interface consists of buttons with a touch screen liquid crystal display LCD The operator is able to view parameter options on the display and make selections by pressing the buttons directly on the LCD The LCD provides continuous information during the treatments concerning intensity and t...

Page 45: ...The Home screen serves as the main treatment screen After the treatment parameters have been selected you may increase or decrease the output power in bars during therapy on the Home screen by using the and buttons Edit Treatment Screen 1 On the Home Screen press the button The Edit Treatment screen displays 2 Increase the parameters on the Edit Treatment screen by pressing the button 3 Decrease t...

Page 46: ...rn the ramping feature on or off For more information on the ramping feature see pages 44 45 7 Press the Handpiece Transmitter button to select the transmitter for treatment See Select Transmitter Screen for more information on this feature 8 Press the button to return to the previous screen 9 Press the button to return to the Home screen Select Transmitter Screen 1 On the Edit Treatment screen pr...

Page 47: ...o return to the Home screen Quick Link Indications By pressing the Quick Link Indications button on the Home screen you can access specific pre programmed indications for general reference only which aid in selecting the proper output and handpiece placement for particular indicated patient syndrome diagnoses 1 On the Home screen press the Quick Link Indications button The Quick Link Indications s...

Page 48: ...g that condition Starting Therapy from the Home Screen 1 On the Home screen press the and buttons to set the appropriate output power in bars for therapy 2 Press the START button on the User Interface to begin treatment When the START button is pressed the icon displays 3 Press the trigger button on the handpiece to activate the handpiece The unit begins emitting radial pressure wave energy ...

Page 49: ... not available while a treatment session is in progress 1 For example on the Home screen set the intensity to 3 8 bar 2 Press the Ramp button so that it reads On 3 When the START button and the trigger button on the handpiece are pressed notice that the progress bar gradually increases to the 3 8 bar setting The full intensity is reached when one third of the pulses have been given to the patient ...

Page 50: ...nsity or if the intensity level is being achieved by the patient s response 1 After completing steps 1 2 on page 44 press the START button and the trigger button on the handpiece Notice that the progress bar gradually increases 2 When the Ramp button is pressed before the intensity is fully ramped the intensity level is set at that level For example if you set the intensity at 3 8 bar and you pres...

Page 51: ...follow the instructions on page 61 beginning with step 2 If you choose 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 If you choose to start over with the same treatment press the Run this Treatment button You are returned to the Home Screen with the same parameters displayed Pausing Therapy Using the Pa...

Page 52: ...completed the set number of pulses the applicator stops emitting radial pressure wave energy the message Treatment has completed Touch anywhere to continue the unit sounds three long tones If you choose 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 If you choose to save the current parameters as a...

Page 53: ...nd buttons to scroll through the pages of protocols 5 Press the protocol to highlight it or press the and buttons to scroll through the list 6 Press the button to accept the highlighted selection The suggested parameters transmitter and placement information displays 7 To select this protocol and begin treatment press the button The Home screen displays and you can begin treatment USING CLINICAL P...

Page 54: ...on The next Clinical Protocols screen displays 9 Press the button The Home screen displays with the new parameters 10 Press the and buttons to set the appropriate output power for treatment 11 Press the EDIT button to change the parameters 12 Press the START button to begin treatment 13 Press the trigger button to activate the handpiece USING CLINICAL PROTOCOLS CONTINUED ...

Page 55: ...otocols screen displays 2 Press the Retrieve Protocol button The Retrieve Protocol screen displays 3 Press or scroll to the desired user protocol to view the treatment parameters 4 Press to select the highlighted protocol You are returned to the Home screen to begin treatment Deleting User Protocols 1 To delete the highlighted user protocol press the Delete button on the Retrieve Protocol screen A...

Page 56: ...e steps listed in Starting Therapy on pages 40 42 but do not press the START button 2 On the Home screen press the User Protocols button The User Protocols screen displays 3 Press Save Protocol The Save Protocol screen displays 4 To create a name for the new protocol press the Save Protocol as a New Name button The Keyboard screen displays 5 Type the name of the new protocol The name of the new pr...

Page 57: ... saved user protocol press to highlight or scroll through the list of user protocols and highlight the appropriate user protocol 2 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 ...

Page 58: ...rary button The Anatomical Graphical Library screen displays 2 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 3 If available press the icon to display additional pathological images The Educati...

Page 59: ...utton to return to the previous screen Handpiece Placement Library The Handpiece Placement Library serves as a guideline for the placement of transmitters for radial pressure wave treatment 1 On the Clinical Resources screen press the Handpiece Placement Library button The Select Treatment Area screen displays 2 Press the body area on which you intend to administer therapy The screen that correspo...

Page 60: ...nt thumbnails to view the entire picture of the handpiece placement The Handpiece Placement screen displays 4 Press the button to return to the previous screen 5 Press the button to return to the Home screen USING CLINICAL RESOURCES EDUCATIONAL LIBRARIES CONTINUED ...

Page 61: ...ion 3 Press the button to return to the previous screen 4 Press the button to return to the Home screen Viewing Contraindications Pressing the Contraindications button displays a list of conditions for which radial pressure wave therapy is contraindicated 1 On the Clinical Resources screen press the Contraindications button The Contraindications screen displays 2 Press the and buttons to scroll th...

Page 62: ...eatment data stored on the patient card 1 On the Clinical Resources screen press the Patient Card button The Patient Card screen displays 2 Press the and buttons to scroll through the treatment sessions The treatment parameters for the highlighted treatment display at the top of the screen 3 Press the and buttons if the number of treatment sessions extend beyond one page 4 Press the button to sele...

Page 63: ...ment Pain Map after treatment Treatment Area 1 On the Clinical Resources screen press the Edit Pain Profile button The Edit Pain Profile screen displays 2 In the Pain Before Treatment section press to select either a Numeric or Visual pain scale 3 Press the button to decrease the amount of pain on the scale 4 Press the button to increase the amount of pain on the scale 5 Press the Pain Type button...

Page 64: ... the areas you press 9 Press the Clear button to remove all the areas previously selected in the previous step 10 Press the button to return to the previous screen 11 In the Pain After Treatment section repeat steps 2 10 12 Press the Treatment Area screen The Select Treatment Area screen displays 13 Press the specific body area on the front or back image to select the desired body area to treat Yo...

Page 65: ... the Save to Patient Card to save the pain information to the patient s card 15 Press the button to return to the Clinical Resources screen 16 Press the button to return to the Home screen USING CLINICAL RESOURCES PATIENT CARD CONTINUED ...

Page 66: ...g the STOP button the unit gives you the option of saving the treatment to a patient card 1 Press the Save to Patient Card button when prompted 2 Follow steps 2 13 on pages 58 60 3 When you press the Save to Patient Card button the message Treatment has been saved for patient name briefly displays USING CLINICAL RESOURCES PATIENT CARD CONTINUED ...

Page 67: ...e Patient Data Card Port 2 Press the Erase Patient Card button A message displays to verify the deletion Press the No button if you do not want to erase all the information on the Patient Card You are returned to the Clinical Resources screen Press the Yes button to erase all the information on the Patient Card NOTE By pressing the Yes button you will permanently remove all data on the Patient Car...

Page 68: ... protocol and return to the Unit Settings screen 5 Press the button to delete the new information you may have entered and return to the Unit Settings screen Increasing and Decreasing the Unit Volume On the Unit Settings screen press the Volume button repeatedly until the appropriate volume level displays Each time you press the Volume button a tone sounds at the volume level displayed The volume ...

Page 69: ...ings you entered and return to the Unit Settings screen Resetting Unit Settings This button resets settings such as the language volume and clinic name back to the original factory defaults 1 On the Unit Settings screen press the Reset Unit Settings button The reset message displays 2 Touch anywhere on the LCD You are returned to the Unit Settings screen Resetting Default Protocols 1 To reset all ...

Page 70: ...essing the Yes button you will permanently remove user protocols you may have created You are returned to the Unit Settings Screen Changing Languages 1 On the Unit Settings screen press the Language button The Language screen displays 2 Press the and buttons to scroll through the pages of available languages 3 Press the language to highlight it or press the and buttons to scroll through the list 4...

Page 71: ...e Ch1 Default Transmitter button The Select Transmitter screen displays 2 Press the transmitter to highlight it or press the and buttons to scroll through a list of the available transmitters 3 Press the Transmitter Information button to display technical details of the transmitter 4 Press the button to accept the highlighted selection and return to the Edit Treatment screen 5 Press the button to ...

Page 72: ...ep 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 However 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 co...

Page 73: ...Intelect RPW 69 OPERATION USING CLINICAL RESOURCES UNIT SETTINGS CONTINUED 3 Press the Reset All button to reset all the pulse counters to zero ...

Page 74: ...ter a maximum of 6000 pulses Positioning the Handpiece Position the handpiece on the part of the body to be treated according to the medical indication Holding the Handpiece as a Pen The handpiece is held behind the rear cap This way of holding the applicator is recommended for tactile treatment Holding the Handpiece as a Bar The handpiece is grasped with the entire hand behind the rear cap This w...

Page 75: ...Intelect RPW 71 OPERATION TREATMENT TIPS CONTINUED Using Both Hands to Hold the Handpiece This way of holding the applicator is recommended for the treatment of pain confined to specific points ...

Page 76: ... the unit Refer to page 51 for more information about saving user protocols 108 The protocol cannot be saved because the unit has the maximum number of protocols already saved Error Code Description 109 The MMC is being accessed but there is no MMC inserted into the MMC port 110 The user is attempting to update the unit s software but the MMC inserted into the MMC port is not a software update MMC...

Page 77: ... transmitter in Channel 1 has reached one million pulses 126 The transmitter in Channel 2 has reached one million pulses 127 The handpiece cable has become disconnected from the output socket during a therapy session WARNING WARNING 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...

Page 78: ...oupling gel from the transmitter 3 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 4 After each patient use clean the R SW handpiece remove the front and rear caps first page 28 Use a soft clean cloth dampened with alcohol an alcohol based surface cleaning wipe or a mild antibacterial dete...

Page 79: ...sed surface cleaner and wipe with a soft clean cloth 8 When cleaning the transmitter push aside the spacer ring so that the interior cavity can be cleaned 9 Re assemble the transmitter and handpiece by reversing the procedures in steps 4 and 3 MAINTAINING THE INTELECT RPW CONTINUED Hand piece Maintenance Frequent cleaning is recommended After everyday of usage Technique Please use cleaning brush p...

Page 80: ...l To do this do the following 1 Unplug the unit from the Mains Power 2 Pull out the drawer 3 Slide the water bottle out of the holding bracket 4 Hold the cap turn the bottle counter clockwise and remove the cap 5 Empty the contents of the bottle 6 Replace the bottle by holding the cap and turning the bottle clockwise MAINTAINING THE INTELECT RPW CONTINUED ...

Page 81: ...ile and Guide Tube Projectiles and guide tubes should be changed after 1 000 000 pulses To change the transmitter do the following 1 Unplug the unit and remove the handpiece cable from the socket on the unit 2 Unscrew the rear cap by turning it counterclockwise and holding the handpiece MAINTAINING THE INTELECT RPW CONTINUED ...

Page 82: ...le may be laying inside the handle 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 NOTE Make certain that the entire projectile is retrieved It may have broke apart during use MAINTAINING THE INTEL...

Page 83: ...projectile 9 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 NOTE Wait until the cleaned components are dry before continuing with step 10 10 Clean the inside of the shaft tube with the cleaning brush provided with hand piece kit Cleaning should be perfo...

Page 84: ...of the shaft until it hits the stop 12 Insert the new guide tube into the shaft NOTE Make certain to insert the end of the guide tube without the holes into the shaft 13 Press the guide tube into the shaft until it seats 14 Insert the new projectile into the guide tube MAINTAINING THE INTELECT RPW CONTINUED ...

Page 85: ... loosen the shaft with your hand 17 Reattach the rear cap by turning it clockwise and holding the handpiece 18 Plug in the unit and connect the handpiece cable to the output socket on the unit 19 Reset the pulse counter by following the steps beginning on page 67 MAINTAINING THE INTELECT RPW CONTINUED DANGER If the unit is not safe for operation it must be repaired by a certified service technicia...

Page 86: ...ion the following areas of potential damage Correct function of indicators Display of operating modes NOTE It is the responsibility of the health care facility to verify that the unit complies with the facility local and national Earth Leakage limits MAINTAINING THE INTELECT RPW CONTINUED DANGER Under no circumstances may liquid penetrate the openings on the unit e g the connecting sockets of the ...

Page 87: ...arranty or repair please contact the selling dealer or your local DJO customer service NOTE The unit was calibrated during the manufacturing process and is ready to be placed into service upon delivery MAINTAINING THE INTELECT RPW CONTINUED Do not perform unauthorized repairs under any circumstances Return unit to DJO for servicing Council Directive 2002 96 EC concerning Waste Electrical and Elect...

Page 88: ...ansmitter 1 28742 Red Sealing Sleeve 1 REF Description Qty 28668 Intelect RPW CD User Manual 1 28671 Intelect RPW Quick Start Guide 1 4248 Conductor Transmission Gel 250 ml 8 5 oz bottle 1 28700 Standard Accessory Kit that Includes the following 1 28699 D ACTOR R SW Handpiece Applicator 1 28736 Projectile 3 17638 R15 15 mm ESWT Transmitter 1 28724 D20 S D ACTOR 20 mm Transmitter 1 28737 Sealing Se...

Page 89: ...not limited to the failure to provide reasonable and necessary maintenance or any use that is inconsistent with the Product User s Manual DJO LLC is not responsible for injury or damage resulting from modifications or service performed by non authorized DJO LLC service personnel COMPANY SHALL NOT BE LIABLE IN ANY EVENT FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES Some areas do not allow the exclusion o...

Page 90: ...t Guidance RF emissions CISPR 11 Group 1 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 RF emissions CISPR 11 Class A The Intelect RPW is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply net...

Page 91: ... 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the Intelect RPW requires continued operation ...

Page 92: ...RER S DECLARATION ELECTROMAGNETIC IMMUNITY CONTINUED The Intelect RPW unit is intended for use in the electromagnetic environment specified in the table below The user of the Intelect RPW unit should assure that it is used in such an environment NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is aff...

Page 93: ...nt electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Intelect RPW as recommended below according to the maximum output power of the communications equipment For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation a...

Page 94: ...28668_H English DJO France SAS Centre Européen de Frêt 3 rue de Béthar 64990 Mouguerre France T 1 800 592 7329 USA T 1 317 406 2209 F 1 317 406 2014 chattgroup com 2017 DJO LLC All rights reserved 0086 ...

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