Operators Guide
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PATHWAY™ CTS 2000 CONTINENCE EVALUATION and TRAINING SYSTEM OPERATOR’S GUIDE
Copyright © 2002 The Prometheus Group One Washington Street, Suite 303 Dover, New Hampshire 03820
FOR ASSISTANCE, CALL YOUR LOCAL SALES REPRESENTATIVE, DISTRIBUTOR, OR THE PROMETHEUS GROUP AT 800.442.2325 IN THE U.S. AND CANADA OR 603.749.0733 INTERNATIONAL. FOR TELEPHONE TECHNICAL SUPPORT CALL 800.272.8492 IN THE U.S. AND CANADA OR 603.742.6053 INTERNATIONAL. WEBSITE: www.theprogrp.com E-MAIL: [email protected]
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CONTENTS Pathway™ CTS 2000 Continence Evaluation and Training System Equipment and Accessories Include: One Pathway™ CTS 2000 Module consisting of one channel of vaginal or rectal intracavity EMG or external pelvic muscle EMG, one channel of accessory muscle EMG, one channel of vaginal or rectal intracavity Electrical Stimulation and two channels of vaginal or rectal intracavity Pressure Manometry; One Active Matrix Color Notebook or SVGA Color Desktop Computer System with Color Inkjet Printer; One #2583 Pathway™ Preamplifier; Four packets of #6750 Pathway™ Electrodes; Four packets of #6801 Easytrode™ Pregelled Electrodes; One #5338 6’ Electrode Lead Wire Set; Four #6330 Pathway™ Vaginal EMG/Stimulation Sensors; Two #6340 Pathway™ Rectal EMG/Stimulation Sensors; Two #6420 Pathway™ Vaginal Silicon Pressure Sensors; Two #6425 Pathway™Rectal Silicon Pressure Sensors; One #8402 Computer Serial Interface Cable, One Synergy™ 3-Dimensional Software Program; Ten #4102 Patient Information Handouts; Ten #4632 3-Day Bladder Control Diaries; Operator’s Guides.
Pathway™ and Synergy™ are trademarks of The Prometheus Group. The Pathway™ CTS 2000, Synergy™ 3-Dimensional Software and this manual are Copyright © 2002, The Prometheus Group.
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INDICATIONS FOR USE: * Urinary Incontinence : Stress, Urge and Mixed Incontinence * Neuromuscular Reeducation CONTRA-INDICATIONS * Active Infection or Genital Disease * Severe Pelvic Pain * Pregnancy * Postpartum or Post Surgical (6 weeks) * Atrophic Vaginitis * Dyspareunia * Menstrual Period * Pacemaker or Cardiac Arrhythmia * Presence of Any Known Malignancy * History of Severe Urine Retention * Prolapse * Diminished sensory perception Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed medical practitioner, licensed by law in the state in which they practice. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician when used for the treatment of incontinence. Caution: Use only electrodes from The Prometheus Group with your Pathway™ EMG device. Any other electrode may not be compatible with the Pathway™ device. Warnings: • Be sure to read this operator's guide before using this device. • Do not put this device underwater or get device wet. It could damage the device. • Do not connect any preamp, lead wire, or electrode to a wall outlet. • Do not leave electrodes attached when device is not in use. • Do not use while sleeping. • Do not use during intercourse. • Do not use with any other object in vagina or rectum. • Do not keep electrode in vagina or rectum for extended periods. • Never operate machinery including automobiles during stimulation. • Discontinue use if bleeding develops. Precautions: • The Pathway™ CTS-2000 should only be used with Pathway™ perineometer sensors. • Be sure stimulation is off while inserting or removing electrodes. Adverse effects • Skin irritation beneath or around electrode sites may develop. 3
TABLE OF CONTENTS PHYSICAL
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Front Panel Back Panel
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MECHANICAL
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Intracavity #6330 Pathway™ Vaginal EMG/Stimulation Sensor and #6340 Pathway™ Rectal EMG/Stimulation Sensor External pelvic EMG or accessory muscle EMG #5338 6’ Electrode Lead Wire Set Accessory EMG channel. Input for the #2583 Pathway™ Preamplifier Intracavity #6420 Pathway™ Vaginal Silicon Pressure Sensor and #6425 Pathway™ Rectal Silicon Pressure Sensor
OPERATION
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Start-up Windows Icon Opening Screen EXIT to Windows Icon UTILITIES Button COM Ports RealTime Mode START HERE Button EXIT TO MAIN MENU EDIT PATIENT ADD PATIENT Patient Demographic Information INTAKE QUESTIONNAIRE BLADDER CONTROL DIARY Application Protocols PAUSE RESET MODIFY PROTOCOL Screens Channels Display Type Templates Animations Timing 3D Goals On-Line Statistics Ranges Colors Names Stim Menu
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CLICK HERE WHEN FINISHED MODIFYING PROTOCOL Save Protocol Patient Protocol Show Patient Protocols Delete Protocol File Create Link Protocol START COLLECTING DATA EXIT TO MAIN MENU REPORTS/REPLAY Button Choose a PATIENT Delete Highlighted Patient Patient Saved Sessions Delete Session Compare Sessions REPORTS Graph Types Summary Session Statistics Detailed Session Statistics Insertions and Attachments Insertions Page Header Demographic Information Notes, Interpretations, Rx Attachments Intake Questionnaire Bladder Diary Home Program HIDE MENU Command Line Print Print Preview MR and TR Series Download View the MR and TR Series Downloaded Data Delete the MR and TR Series Downloaded Data Filename View the Reports Menu Exit and Return to Opening Screen ZOOM Undo Zooming Expand Vertically and Compress Vertically Add a Marker Delete a Marker MARKER Adjust Mode REPLAY TECHNICAL SPECIFICATIONS
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34-36 35 35-36 36 36 36-38 38-39 39 40-41 42 43 43 43 43-44 45 46 46-47 47 47-48 48 48-49 49 49-50 50 50 50-51 51 51 51 51 52 52 52 52 52 52 52-53 53 53 53 53 53 53 54
PHYSICAL The Front Panel
EMG A/STIM Primary EMG channel and Stimulation channel. Input for the intracavity #6330 Pathway™ Vaginal EMG/Stimulation Sensor, the intracavity #6340 Pathway™ Rectal EMG/Stimulation Sensor or the external pelvic muscle EMG and accessory muscle EMG #5338 6’ Electrode Lead Wire Set. EMG B Accessory muscle EMG channel. Input for #2583 Pathway™ Preamplifier. PRESSURE C Primary Pressure Manometry channel. Input for the intracavity #6420 Pathway™ Vaginal Silicon Pressure Sensor or the intracavity #6425 Pathway™ Rectal Silicon Pressure Sensor. PRESSURE D Secondary Pressure Manometry channel. Input for the intracavity #6420 Pathway™ Vaginal Silicon Pressure Sensor or the intracavity #6425 Pathway™ Rectal Silicon Pressure Sensor. L.E.D. POWER INDICATOR Indicates whether the Pathway™ CTS 2000 power is on or off. Power must be on (L.E.D. illuminated) to operate the Pathway™ CTS 2000. 6
The Back Panel
COMPUTER INTERFACE Interfaces the Pathway™ CTS 2000 to the laptop or desktop computer using the #8402 Computer Serial Interface Cable. The male end of the cable is connected to the Pathway™ CTS 2000 and the female end to the computer. Connect the female end to the 9 pin male output in the back of the computer. This output is labeled Serial, Com or 10101 on the computer. POWER OUTPUT Connects the Pathway™ CTS 2000 to a standard 110V power wall outlet. CAUTION: USE ONLY THE PATHWAYTM POWER TRANSFORMER SUPPLIED WITH THIS UNIT. POWER ON/OFF SWITCH Turns the power on and off to the Pathway™ CTS 2000. Power on is represented by the top portion of the switch depressed with the L.E.D. illuminated on the front panel.
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MECHANICAL Intracavity #6330 Pathway™ Vaginal EMG/Stimulation Sensor and #6340 Pathway™ Rectal EMG/Stimulation Sensor.
Refer to the instructions for use enclosed with each sealed sensor bag. Make certain the jack is pushed fully into the EMG A/STIM channel. External pelvic EMG or accessory EMG #5338 6’ Electrode Lead Wire Set.
Snap the two white and one green lead wires onto the #6801 Easytrode™ Pregelled Electrodes. Remove the #6801 Easytrode™ Pregelled Electrodes individually. For external pelvic muscle, place the two white (active) lead wires at the 3 and 9 o’clock positions around the anus. Place the green (reference) lead wire over the ischial tuperosity or buttocks muscle. For accessory muscles such as abdominals, adductors and gluteals, prepare the skin with an alcohol pad to avoid high impedance artifact and wipe dry with a tissue or cloth. Place the two white lead
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wires side-by-side over the bulk of the muscle. Place the green lead wire above or below the two white wires. Make certain the jack is pushed fully into the EMG A/STIM channel. Accessory EMG channel. Input for the #2583 Pathway™ Preamplifier.
Accessory muscles such as abdominals, leg adductors and gluteals are commonly monitored by placing the active electrodes over the bulk of the muscle. The #2583 Pathway™ Preamplifier has three female snaps; two labeled ACT (active) and one labeled GND (ground). Prepare the skin with an alcohol pad to avoid high impedance artifact. Wipe dry with a tissue or cloth. Snap the #2583 Pathway™ Preamplifier onto one of the #6750 Pathway™ Electrodes taking care to orient the snaps correctly. Make sure all three snaps are secure. Carefully remove the backing of the #6750 Pathway™ Electrode and place the two labeled ACT over the bulk of the muscle with the length of the electrode parallel with the muscle fibers. Make sure the plug is seated fully into EMG B.
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Intracavity #6420 Pathway™ Vaginal Silicon Pressure Sensor and #6425 Pathway™ Rectal Silicon Pressure Sensor.
Refer to the instructions for use enclosed with each sealed sensor bag. After insertion, inflate the sensor by using the pressure syringe provided. Open the syringe valve fully and then twist the syringe clockwise onto the end of the sensor tube. Depress the syringe valve until the #6420 Pathway™ Vaginal Silicon Pressure Sensor is filled with 5ml of air or the #6425 Pathway™ Rectal Silicon Pressure Sensor is filled with 3ml of air. Rotate the syringe counterclockwise to unseat and rotate the end of the sensor tube clockwise into PRESSURE C or PRESSURE D. Make sure the fitting is secure so that there is an air-tight seal.
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OPERATING THE PATHWAY™ CTS 2000 CONTINENCE EVALUATION and TRAINING SYSTEM Interface the Pathway™ CTS 2000 and computer as described in the PHYSICAL section. For tutorial purposes, plug the #5338 6’ Electrode Lead Wire Set into EMG A/STIM, the #2583 Pathway™ Preamplifier into EMG B, and a properly inflated #6420 Pathway™ Vaginal Silicon Pressure Sensor or #6425 Pathway™ Rectal Silicon Pressure Sensor into PRESSURE C. Prepare the skin of the left and right forearm flexor area and, using the #6801 Easytrode™ Pregelled Electrodes and the #6750 Pathway™ Electrodes, place EMG A/STIM on the left forearm and EMG B on the right. Power the Pathway™ CTS 2000 and the computer (if a laptop, wall power is preferred over battery power for longer time usage). Once the computer has completed its start-up procedures and the Windows Icon screen appears use the mouse or mouse keypad to position the mouse arrow on the Synergy 3-D Icon and double click the left mouse button.
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BOOT-UP SCREEN
The Boot-Up or Opening screen consists of the Synergy™ 3-Dimensional Software and The Prometheus Group™ logos with four Main Menu buttons in the lower left portion of the screen (EXIT, UTILITIES, START HERE, REPORTS/REPLAY). The computer specifications and recommendations, software version, Technical Support phone number, company website and e-mail, are located in the lower right portion of the screen. Every thirty days the Pathway™ CTS 2000 performs an automatic system check and calibration. Any malfunction will be documented in the lower right portion of the screen. Call the Technical Assistance number on the screen.
The EXIT button allows you to leave the Synergy™ 3-Dimensional Software program and return to the Windows Icon screen by positioning the mouse arrow on the EXIT button and clicking once on the left mouse button.
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Position the mouse arrow on the UTILITIES button and single click the left mouse button.
The Pathway™ CTS 2000 is preset to the correct COM Port (usually COM 1) for each computer configuration and the RealTime Mode is preset to Live Data. Live Data means that you are acquiring and displaying the patient’s EMG, Pressure or Stimulation signals. The RealTime Mode also has a Demo option. Demo means that the Synergy™ 3-Dimensional Software automatically displays a preprogrammed or “dummy” signal. The Demo option is quite useful as an aid to learn the software without patient involvement. Stimulation menus and stimulation protocols (single or linked) cannot be accessed or run in the Demo mode. To change from Live Data to Demo simply place the mouse arrow inside the circle next to Demo and single click the left mouse button. To accept this change place the mouse arrow inside the OK button and single click the left mouse button. To NOT accept use the Cancel button in the same manner. The Transfer Patient Files button allows patient data files to be transferred from another file directory to this program. Access this option by placing the mouse arrow inside the Transfer Patient Files button and single click the left mouse button. A prompt will then appear asking for the drive location and filename of the patient data files. The Manual Calibration button performs the system check and calibration at any time. For purposes of this tutorial and to make full use of system capabilities, the Live Data option will be used. Select Live Data and click on OK. 13
Position the mouse arrow on the START HERE button and single click the left mouse button.
The RealTime screen is used to acquire and display patient signals or “dummy” signals using embedded or modified protocols and to add or edit patient information. Note that most buttons and headers on this screen are currently “grayed out” (not active) while the EXIT TO MAIN MENU button, Patients: header with the pull-down list, ADD PATIENT button and EDIT PATIENT button are bold (active). This is to establish a hierarchy and guide to the menu structure by only activating certain headers and buttons when access is required.
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If you place the mouse arrow in the EXIT TO MAIN MENU button and single click the left mouse button you will return to the Boot-Up or Opening screen.
Place the mouse arrow on the down arrow button under the Patients: header and single click the left mouse button. Notice this activates a pull-down list with a fictitious patient named Jane Doe. Place the mouse arrow on Jane Doe (Doe; Jane) and single click the left mouse button. This is the method by which you would select an existing patient from the Patients: pull-down list to either EDIT PATIENT information or acquire and display patient signals. Note that selecting an existing patient activates the Application Protocols: header with pull-down list and the Show Patient Protocols button to select a Protocol for signal acquisition and display.
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To add a new patient to the Patients: pull-down list, place the mouse arrow on the ADD PATIENT button and single click the left mouse button. This will activate the Patient Demographic Information page.
The first and last name of the new patient are the only required entries for addition to the pull-down list. Use the tab key on the keyboard to advance the cursor to a new field. For purposes of this tutorial add the minimum of a real or fictitious patient name.
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Note two additional patient information options on this page: INTAKE QUESTIONNAIRE and BLADDER CONTROL DIARY. Place the mouse arrow on the INTAKE QUESTIONNAIRE button and single click the left mouse button.
The INTAKE QUESTIONNARIE consists of five pages of multiple choice and fill-in questions. This questionnaire is an excellent tool for profiling the patient’s incontinence history. To make a multiple choice selection place the mouse arrow inside the circle next to your choice and single click the left mouse button. To correct an incorrect choice simply click on the correct choice. For check-off boxes place the mouse arrow inside the box and single click the left mouse button on the appropriate box or boxes. To correct an incorrect choice click on the incorrect choice. For fill-in questions place the mouse arrow inside the fill-in area and single click the left mouse button. This will activate a cursor and allow you to type in the entry. Use the Backspace button on the keyboard to erase the entry in case of error. To activate the next page place the mouse arrow inside the NEXT button and single click the left mouse button. To activate previous pages use the BACK button. Once complete click on the SAVE AND EXIT button. The INTAKE QUESTIONNAIRE will be saved under the patient’s name and can be viewed and printed as a single document or as part of an integrated report by accessing the REPLAY/REPORTS button on the Boot-Up or Opening screen.
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From the Patient Demographic Information page position the mouse arrow on the BLADDER CONTROL DIARY button and single click the left mouse button.
Fill in or correct the choices in the same manner as the Intake Questionnaire. The BLADDER CONTROL DIARY is based on the results of The Prometheus Group’s 3 Day Bladder Control Diary patient handout. Once completed, click on the SAVE AND EXIT button. Multiple BLADDER CONTROL DIARIES can be stored under the patient’s name and can be viewed, compared (up to three) and printed as a single document or as part of an integrated report by accessing the REPLAY/REPORTS button on the Boot-Up or Opening screen. From the Patient Demographic Information page click on OK. This will return you to the RealTime screen with the newly added patient’s name in the pull-down list box. Now clicking on the down arrow under the Patients: header reveals Doe; Jane and the newly added patient. NOTES: 1) No more than one patient can appear in the pull-down list box after you have selected a patient. This protects patient privacy. 2) If you acquire an extensive patient list, type in the first letter of the patient’s last name in the box, click the down arrow under the Patients: header and last names beginning with the letter typed will appear.
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To add or change patient information, select a patient and then click EDIT PATIENT. This will activate the Patient Demographic Information page. NOTES: While the Edit Patient Information section can be changed, the saved INTAKE QUESTIONNAIRE or BLADDER CONTROL DIARY cannot. You can add subsequent BLADDER CONTROL DIARIES but there is only one INTAKE QUESTIONNAIRE per patient. When a patient’s name appears in the pull-down list box, the Application Protocols: header, the down arrow under this header and the Show Patient Protocols button become active. This part of the menu structure is used to acquire and display the the patient’s EMG, Pressure or Stimulation signals (Live Data only) or present Demo signals. Place the mouse arrow on the down arrow under the Application Protocols: header and click.
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This will display five of the eighteen embedded Application Protocols. Placing the mouse arrow on the down arrow button of the protocol file and continuously clicking moves you down the protocol list. Similarly, the up arrow button moves you up the protocol list. An Application Protocol is defined as an evaluation or training display that would be utilized with many patients. The embedded Application Protocols are: dual, area, 10W20R10T, 2EMGs.pro dual, area, 10W20R10T, EMGA, PressureC.pro dual, area, 2W4R10T, 2EMGs.pro dual, area, 2W4R10T, EMGA, PressureC.pro dual, area, resting, 2EMGs.pro dual, area, resting, EMGA, PressureC.pro resting, 2W4R10T, 10W20R10T, 2EMGs.prl resting, 2W4R10T, 10W20R10T, EMGA, PressureC.prl resting, 2W4R10T, 10W20R10T, PressureC.prl single, area, 10W20R10T, PressureC.pro single, area, 2W4R10T, PressureC.pro single, area, resting, PressureC.pro single, stim, 100Hz, 5on10ff, 15min.pro single, stim, 100Hz, 5on5off, 15min.pro single, stim, 12.5Hz, 5on10off, 15min.pro single, stim, 12.5Hz, 5on5off, 15min.pro single, stim, 200Hz, 5on10ff, 15min.pro single, stim, 200Hz, 5on5off, 15min.pro single, stim, 50Hz, 5on10off, 15min.pro single, stim, 50Hz, 5on5off, 15min.pro Definitions: dual-split screen display, two graphical displays. single-single screen display, one graphical display. area-scrolling graph with area beneath the scroll filled-in. 10W20R10T or 2W4R10T-describes the work (contract), rest (relax) and number of trials (repetitions) to the patient’s evaluation or training program. For example, 10W20R10T means 10 seconds of work, 20 seconds of rest for 10 trials. resting-describes a continuous (non work/rest) display of patient activity. 2EMGs-EMG A and EMG B are the active channels. EMGA, PressureC-EMG A and PRESSURE C are the active channels. PressureC-PRESSURE C is the active channel.
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