Clinicians Guide
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Pathway STM-10 Operator's Guide
Clinician Version 52_017a EN
Pathway STM-10 Operator's Guide
Clinician Version 52_017a EN
Indications for use: • Urinary Incontinence: Stress, Urge, and Mixed Incontinence • Neuromuscular Reeducation
PATHWAY STM-10 OPERATOR’S GUIDE - FOR THE CLINICIAN -
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
Your Pathway STM-10 kit Contains: (1) Pathway STM-10 device (1) 9 volt alkaline battery (1) carrying case (1) Pathway STM-10 Operator’s Guide; For the Clinician (1) Pathway STM-10 Operator’s Guide; For the Patient
In this Operator’s Guide: Indications for Use/Contra-indications …………………………………….. Cautions/Warnings …………………………………….. Precautions/Adverse Effects …………………………………….. Connecting to Your Pathway STM-10 Device ………………………… Using Your Pathway STM-10 Device ………………………… The Interface ………………………… Programming the Treatment Session ………………………… Viewing/Clearing Patient Compliance ………………………… General Instructions ………………………… Treatment Protocols and Guidelines ………………………… Care and Maintenance ……………. Changing the Battery in your STM-10 Device ……………. Caring for your Pathway STM-10 Device ……………. Sensor Care and Maintenance ……………. Technical Specifications ……………………………………. Warranty …………………………………….
2 2 2 3 3 3 4 5 6 7 8 8 8 8 9 10
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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: • STM-10 should only be used with Pathway Vaginal or Rectal EMG/Stim Perineometer Sensors. • Always turn off the device before removing a Pathway Vaginal or Rectal EMG/Stim Perineometer Sensor. Adverse Effects: • Skin irritation beneath or around the electrode sites may develop.
FOR ASSISTANCE CONTACT YOUR LOCAL SALES REPRESENTATIVE, DISTRIBUTOR, OR THE PROMETHEUS GROUP AT 800-442-2325 IN THE US AND CANADA OR AT 603-749-0733. FOR TECHNICAL ASSISTANCE, CALL THE PROMETHEUS GROUP TECH SUPPORT LINE AT 800-272-8492 IN THE US AND CANADA OR AT 603-742-6053. Pathway is a registered trademark of The Prometheus Group. The STM-10 and this manual are Copyright (c) 2002, The Prometheus Group. Page 1 of 12
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Pathway STM-10 Operator's Guide
Clinician Version 52_017a EN
Connecting to Your Pathway STM-10 Device
Pathway STM-10 Operator's Guide
Clinician Version 52_017a EN
Using Your Pathway STM-10 Device: Programming the Treatment Session 1.
Simultaneously press the UP ARROW button and press the ON/OFF button to turn the unit on in programming mode.
Note: For each treatment option, the last treatment option saved is always the first to be displayed. 2.
Fixed Session Time Selection (min): 5, 10, 15, 20, 25, 30
Figure 1
If the UP ARROW or DOWN ARROW button is not pressed for 7 seconds, the SESSION TIME will be stored and the next programmable treatment option will be displayed.
Plug the Pathway Vaginal or Rectal EMG/Stim Perineometer Sensor into the connector at the top end of the device as shown above in Figure 1. 3.
Using Your Pathway STM-10 Device: The Interface Indicates DUTY CYCLE is being displayed. DUTY CYCLE is the session ON/OFF time of stimulation, represented in seconds.
Indicates SESSION TIME is being displayed. The SESSION TIME is the treatment time for each session represented in
Select the desired treatment SESSION TIME by pressing the UP ARROW button or DOWN ARROW button until the desired SESSION TIME is displayed on the screen.
Select the desired treatment DUTY CYCLE by pressing the UP ARROW button or DOWN ARROW button until the desired DUTY CYCLE is displayed on the screen. Fixed Duty Cycle Selection (on/off) (s): 5/5, 5/10, 10/10, 10/20, Continuous (C) If the UP ARROW or DOWN ARROW button is not pressed for 7 seconds, the DUTY CYCLE will be stored and the next programmable treatment option will be displayed.
4.
Select the desired treatment FREQUENCY by pressing the UP ARROW button or DOWN ARROW button until the desired FREQUENCY is displayed on the screen. Fixed Frequency Selection (Hz): 12.5(12), 50, 100, 200, 12:50
Indicates TIME USED is being displayed. TIME USED represents the total time for all cumulative treatment sessions.
If the UP ARROW or DOWN ARROW button is not pressed for 7 seconds, the FREQUENCY will be stored. Indicates stimulation FREQUENCY is being displayed. The stimulation FREQUENCY is calibrated in Hz.
DISPLAY for viewing SESSION TIME, DUTY CYCLE, TIME USED, FREQUENCY, and stimulation
Press to turn the unit ON and OFF at any time during operation.
Note: The selection of 12:50 consists of a session at 12.5Hz directly followed by a session of 50Hz. At the end of the 12.5Hz session, the unit will go to 0mA and await adjustment of stimulation for the 50Hz treatment. The programmed session time and duty cycle apply to each of the sessions. 5.
The treatment session is now programmed with 0 mA stimulation amplitude displayed. If a treatment session is desired, begin and adjust the stimulation amplitude as described in Using Your Pathway STM-10 Device: General Instructions. When the treatment session is completed and the device is turned OFF, all programmed treatment options will be saved.
6.
If a treatment session is not desired, turn the device OFF by pressing the ON/OFF button. When the unit is turned OFF, all programmed treatment options will be saved.
Press to increase stimulation AMPLITUDE and to perform programming operations as defined in this guide.
Figure 2
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Press to decrease stimulation AMPLITUDE and to perform programming operations as defined in this guide.
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Pathway STM-10 Operator's Guide
Clinician Version 52_017a EN
Pathway STM-10 Operator's Guide
Clinician Version 52_017a EN
Using Your Pathway STM-10 Device: Viewing/Clearing Patient Compliance 1.
Simultaneously press the DOWN ARROW button and press the ON/OFF button to turn the device on in compliance mode.
2.
Patient compliance TIME USED is displayed on the screen in Hours:Minutes.
3.
To CLEAR the patient compliance TIME USED, press the UP ARROW button or the DOWN ARROW button. CLR will FLASH on the display, indicating that you have selected to CLEAR the TIME USED. If the UP ARROW or DOWN ARROW is not pressed for 7 seconds, TIME USED will be CLEARED.
Note: Pressing the UP ARROW button or the DOWN ARROW button while CLR is flashing will toggle the display back to TIME USED and the TIME USED will not be cleared. 4.
5.
6.
Whether clearing or not clearing the TIME USED, if the UP ARROW button or the DOWN ARROW button is not pressed for 7 seconds, the TIME USED will be stored. The last programmed treatment session is now active with 0 mA stimulation amplitude displayed. If a treatment session is desired, begin and adjust the stimulation amplitude as described in Using Your Pathway STM-10 Device: General Instructions.
If a treatment session is not desired, turn the device OFF by pressing the ON/OFF button.
1.
Connect the Pathway Vaginal or Rectal EMG/Stim Perineometer Sensor to the Pathway STM-10 device as described in Connecting to Your Pathway STM-10 Device.
2.
The Pathway Vaginal or Rectal EMG/Stim Perineometer Sensor should be cleaned and prepared with a water-based lubricating jelly and inserted into the vagina or rectum. Be sure to read the Instructions for Use provided with each sensor for additional information on using and fitting the Pathway Vaginal or Rectal EMG/Stim Perineometer Sensors.
3.
Turn the Pathway STM-10 device ON by pressing the ON/OFF button.
Note: The treatment session is defined by those treatment options saved during the last programming activity of the device. If the device has never been programmed these values are the factory default. Warning: Do not begin stimulation until after the sensor is properly connected to the Pathway STM-10 device and inserted into the vagina or rectum. 4.
The stimulation amplitude is presently displayed at 0 ma. Begin stimulation by pressing the UP ARROW button. This button increases the amplitude of the stimulation. Continue to increase the amplitude of the stimulation by continually pressing the UP ARROW button.
Note: When stimulation is active ON is displayed. Note: Pressing the UP ARROW increases the stimulation amplitude in 1 mA increments. Pressing and holding down the UP ARROW button will allow the amplitude to be adjusted more quickly in 1 mA increments. Decrease the amplitude of the stimulator by pressing the DOWN ARROW button. Note: Pressing the DOWN ARROW decreases the stimulation amplitude in 1 mA increments. Pressing and holding down the DOWN ARROW will allow the amplitude to be adjusted more quickly in 1 mA increments. Note: During stimulation amplitude adjustment, constant stimulation is delivered. Caution: Always exercise caution when increasing the amplitude setting. 5.
If the UP ARROW or DOWN ARROW button is not pressed for 7 seconds, the treatment session will begin at the last selected amplitude.
Note: During the treatment session, the ON TIME of the cycle is counted down on the display. During the OFF TIME of the cycle, the OFF TIME is counted down on the display. When stimulation is active ON is displayed. If stimulation has been chosen to be Continuous, during the treatment session “ON C” is displayed, and there is no count down. Using Your Pathway STM-10 Device: General Instructions
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Pathway STM-10 Operator's Guide
6.
7.
Clinician Version 52_017a EN
Pressing the UP ARROW or DOWN ARROW button at any time during the treatment will revert the device to constant stimulation, displaying the present stimulation amplitude, and allowing stimulation amplitude adjustment. Press the UP ARROW or DOWN ARROW button a second time to change the stimulation amplitude as described above. When the prescribed treatment time is over, the stimulation will automatically end and the STM-10 device will turn OFF.
Pathway STM-10 Operator's Guide
Clinician Version 52_017a EN
It is generally recommended that follow-up visits take place at least every four weeks to evaluate progress, adjust the parameters and solve any patient problems. It is important that there is proper patient selections and compliance with the treatment programs. Assessment by a digital vaginal examination should be conducted and the patient's ability to hold a contraction should be measured. Treatment Time
Note: If you are in the 12.5Hz session of a linked 12:50 treatment, the stimulation will automatically end and the STM-10 device will be at 0ma amplitude, awaiting the adjustment of stimulation for the 50Hz treatment. At the end of the 50Hz session the STM-10 device will automatically turn OFF. 8.
Condition Mild Moderate Severe
Weeks 1-8 1-10 1-16
Treatment Time 15/30 minutes 15/30 minutes 15/30 minutes
Sessions/Day 1 or 2 1or 2 1 or 2
Press the ON/OFF button to turn OFF the STM-10 at any time during use.
Note: If you are in the 12.5Hz session of a linked 12:50 treatment and the ON/OFF button is pressed, the stimulation at 12H.5Hz will end and the STM-10 device will be at 0ma amplitude, awaiting the adjustment of stimulation for the 50Hz treatment. Press the ON/OFF button during the 50Hz treatment and the STM-10 device will turn OFF.
The length of the treatment session is chosen to correspond with the above suggested treatment table, however, the session length should be adjusted accordingly using the following guidelines: Guideline To decrease muscle fatigue
Action Decrease session length
Warning: Always turn the stimulator OFF before removing the sensor. Amplitude Adjust to strong contractions but not uncomfortable. Allow a few minutes before final adjustment. Frequency The treatment frequency is contingent on the diagnosis. The following diagnosis corresponds to the following treatment frequencies: Diagnosis Stress Urinary Incontinence Urge Urinary Incontinence
Frequency 50 Hz – 100 Hz 12.5 Hz
Duty Cycle The duty cycle is chosen based on the ability to allow the muscle to recover, which is determined by the clinician using the following guidelines: Guideline Strong Muscle Strength Weak Muscle Strength Induce Fatigue Using Your STM-10 Device: Treatment Protocols and Guidelines
Treatment Duty Cycle 1:1 ratio 1:2 ratio (C) Continuous
Care and Maintenance: Changing the Battery in your STM-10 Device
It is suggested that all patients keep both a treatment (exercise) and voiding log during the program.
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Pathway STM-10 Operator's Guide
Clinician Version 52_017a EN
When the battery is low and needs to be replaced your STM-10 Device will FLASH LO BATT and then proceed to automatically turn OFF. This feature disables the ability to use the device with low battery power. To replace the battery, remove the battery door at the back of the device and remove the low battery. Insert a new battery with respect to the labeling inside the battery compartment, making sure to place the positive terminal with the positive terminal labeling. After inserting the new battery, place the battery door back on the device. Note: This unit must never be plugged into an electrical outlet or used with a 9-Volt adapter.
Care and Maintenance: Caring for Your Pathway STM-10 Device The only maintenance necessary on your Pathway STM-10 is occasional cleaning.
Pathway STM-10 Operator's Guide
Pathway STM-10 Technical Specifications Stimulation • • • • • • • • • •
Pulse amplitude (mA): 1 - 60 Pulse Rate (Hz): 12.5/50/100/200 Cycle (on/off) (S): 5/5, 5/10, 10/10, 10/20, Continuous (C) Ramp Up (S): 2 fixed Ramp Down (S): 1 fixed Pulse width (uS): 300 Charge per pulse (uC): 17 Power source: 9V alkaline battery Dimensions (in): 4.75 x 2.5 x 1 Weight (oz): 4.2 (5.8 w/ 9V alkaline battery)
Your Pathway STM-10 can be easily cleaned by wiping gently with a soft cloth or sponge dampened with water. This will remove the dust and dirt that naturally accumulates. A good quality rubbing alcohol may be used to remove stains or adhesives that stick to the case.
Compliance
Do not use strong household cleaners, as they may damage the plastic parts.
Electromagnetic Compatibility
Do not immerse the Pathway STM-10 in liquid. Excessive moisture may damage the internal electronic components.
Clinician Version 52_017a EN
•
Compliance Use Timer: hours:minutes (99:59 max)
This device has been tested in accordance to EN60601-1-2: 1993.
Care and Maintenance: Pathway EMG/Stim Perineometer Sensor Care Instructions The Pathway Vaginal or Rectal EMG/Stim Perineometer Sensors are single patient multiuse products. The electrode life expectancy depends upon use and care but should typically last several months. The sensor should be washed with a pure mild soap and warm water. Then thoroughly rinse the sensor with warm water and air dry. The sensor should be kept in the original resealable bag between uses. If the sensor becomes worn or develops an odor, immediately stop using and replace. Be sure to read the Instructions for Use provided with each sensor for additional instructions regarding care and maintenance of your Pathway Vaginal or Rectal EMG/Stim Perineometer Sensors.
Warranty
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Pathway STM-10 Operator's Guide
Clinician Version 52_017a EN
Pathway STM-10 Operator's Guide
Clinician Version 52_017a EN
The Prometheus Group warrants equipment of its own manufacture to be free from defects in material and workmanship as follows: One year from the date of shipment to the original purchaser, subject to the terms, conditions, limitations , and exclusions specified herein. 1.
Service: The Prometheus Group of New Hampshire, Ltd., hereafter “The Prometheus Group”, shall provide, for the term of this warranty, repair of defective “Pathway” units. This warranty shall include all parts and labor charges. The purchaser must obtain a Return Authorization Number and must return the defective unit, at the purchaser’s own expense to The Prometheus Group. The Prometheus Group may, at its option, repair and return the unit or provide a replacement unit. Should The Prometheus Group elect to provide a replacement unit, then this warranty is automatically transferred to the replacement unit. The Prometheus Group shall return, at The Prometheus Group’s own expense, the repaired or replacement “Pathway” unit.
2.
Exclusions: The following conditions are excluded from service under this warranty: A. B.
C. D.
3.
Preventative maintenance. Preventative maintenance, defined as maintenance performed for the purpose of preventing a malfunction, is excluded from service under this warranty. Repair of damage or malfunction of “Pathway” equipment resulting from abuse, accident, modification, or other cause other than normal usage, including but not limited to operator error, failure of other user-supplied equipment, and equipment operation in excess of design specifications is excluded from service under this warranty. Loss due to fire, flood, robbery, burglary, theft, vandalism, radioactive contamination, or other natural disasters or Acts of God is excluded from service under this warranty Replacement of batteries, accessories and expendables such as electrodes, are excluded from service under this warranty.
Limitation of Remedy: The Prometheus Group shall not be liable for any damages caused by the delay in furnishing warranty services or other performance under this warranty. The service warranty expressed in paragraph 1 represents the sole and exclusive remedy for any warranty clams under expressed or implied warranties, including without limitation any warranty of merchantability or fitness. This warranty specifically limits the liability of The Prometheus Group, including liability for negligence claims by users and disclaiming any other claims of non-performance by The Prometheus Group. In no event shall The Prometheus Group be held liable for any incidental or consequential damages of any kind.
Assignment: This warranty shall not be assigned by the purchaser without prior written consent of The Prometheus Group. The warranty shall be binding upon all of the parties and their successors and assigns.
Notes:
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