Athena Feminine Technologies E03946001 Remote Control for Medical Device User Manual Physician inst compiled pmd

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Athena Pelvic Muscle Trainer™
PHYSICIAN
INSTRUCTIONS FOR USE
CAUTION: Federal law (USA) restricts this device to sale by or on the
order of a physician
ATHENA Pelvic Muscle Trainer™ (PMT)
Athena Pelvic Muscle Trainer™
Warranty and Disclaimer
Product Specifications
Cleaning the PMT
Assessing and Achieving Success
Recommended Treatment Protocol
Initial Treatment Checklist
Initial Fitting and Treatment
Directions for Use
Clinical Information
Diagram
Product Description
Introduction
16
15
14
13
12
11
10
Table of Contents
References
CAUTION: Federal law (USA) restricts this device to sale by or on the order of
a physician.
2.
ATHENA Pelvic Muscle Trainer™ (PMT)
ATHENA Pelvic Muscle Trainer™ (PMT)
INTRODUCTION
The Athena Pelvic Muscle Trainer™ (PMT) is a vaginal myostimulator
that induces the pelvic muscles to contract and relax, similar to Kegel
exercises. The system consists of a vaginal trainer (PMT trainer) with a
sealed battery and a wireless controller to adjust the strength of the
contractions while the PMT trainer is in use. The PMT trainer is housed
in a cradle in the wireless controller. It is necessary for the patient to
return the PMT trainer to the cradle in the wireless controller after each
use in order for the system to function correctly.
Studies of other devices over the past 20 years have shown that pelvic
floor myostimulation and neuromuscular reeducation can be up to 60% to
90 % effective in reducing or eliminating urinary incontinence. This
manual provides an overview of pelvic floor stimulation and complete use
instructions for the Athena Pelvic Muscle Trainer (PMT).
Pelvic Floor Stimulation is a treatment for incontinence.
Pelvic floor stimulation is a simple, low-risk treatment for incontinence
resulting from lax pelvic floor muscles or a hyperactive bladder. An
electrical current activates sensory nerve fibers that can facilitate or
inhibit a sensory-motor response.
When used consistently, pelvic floor myostimulation has been clinically
documented to have the following prolonged therapeutic effects:
1. Strengthening of the pelvic floor muscles.
2. Inhibiting the detrusor muscle through reflexive mechanisms.
For best results, the Athena Pelvic Muscle Trainer™ should be used
twice a day. Other regimes may be appropriate for some patients.
3.
ATHENA Pelvic Muscle Trainer™ (PMT)
PRODUCT DESCRIPTION
The Athena Pelvic Muscle Trainer™ (PMT) is an intravaginal pelvic floor
exerciser that provides myostimulation and neuromuscular reeducation
for the purpose of rehabilitation of weak pelvic floor muscles to aid in the
control of urinary incontinence (UI) in women. This is a single-user
device and should be used by one patient only.
The Athena Pelvic Muscle Trainer™ is an intravaginal exerciser
constructed of medical-grade plastic, and has one electrode pair.
The trainer is not tethered and is controlled through a radio fre
quency (RF) signal from the wireless controller.
The electrodes are designed to deliver current to stimulate the pel
vic floor muscles to perform Kegel-like contractions.
The exerciser is reusable and ergonomically designed.
Description of the Pelvic Muscle Trainer
•
•
•
•
The Athena Pelvic Muscle Trainer has two parts:
1. Wireless Remote Control with PMT trainer storage cradle
2. PMT Trainer
4.
ATHENA Pelvic Muscle Trainer™ (PMT)
Federal Communications Commision (FCC) Compliance Notices:
Pelvic Muscle Trainer (Wireless Control Unit)
FCC ID: RMLE03946001
This device complies with Part 15 of the FCC Rules. Operation is subject
to the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
Warning - Any changes or modifications not expressly approved by the
party responsible for compliance (i.e. Athena Feminine Technologies) could
void the user's authority to operate this equipment.
This unit was authorized under the FCC Certification Procedure
Pelvic Muscle Trainer (Trainer Unit)
Athena Feminine Technologies
ATHENA PMT-II
This device complies with Part 15 of the FCC Rules. Operation is subject
to the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
Warning - Any changes or modifications not expressly approved by the
party responsible for compliance (i.e. Athena Feminine Technologies) could
void the user's authority to operate this equipment.
P/D 1700
Rev.3/01/04
This unit was authorized under the FCC Declaration of Conformity
Procedure.
Responsible Party:
Athena Feminine Technologies
179 Moraga Way
Orinda, CA 94563
(925) 254-2121
17.
ATHENA Pelvic Muscle Trainer™ (PMT)
REFERENCES
• Berghmans LCM, Hendriks HJM, Bo K et al. (1998). Conservative
treatment of stress urinary incontinence in women: a systematic review of
randomized clinical trials. Br J Urol, 82:181-191.
• Blaivas JG, Appell RA, Fantl JA et al. (1997). Standards of efficacy for
evaluation of treatment outcomes in urinary incontinence: recommendations of
the Urodynamic Society. Neurourol Urodyn, 16(3):145-7
• Bo K, Talseth T, Holme I. (1999). Single blind, randomised controlled trial of
pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in
management of genuine stress incontinence. Br Med J, 318:487-493.
• Dumoulin C, Seaborne DE, DeGirardi CQ et al. (1995). Pelvic-floor
rehabilitation, Part 2: Pelvic-floor reeducation with interferential currents and
exercise in the treatment of genuine stress incontinence in postpartum
women—a cohort study. Phys Ther, 75(12):1075-1081.
• Gallo M, Sasso KC. (1997). Key components of patient education for pelvic
floor electrical stimulation in the treatment of urinary incontinence. Urol Nurs,
17(1):10-16.
• Luber KM, Wolde-Tsadik G. (1997). Efficacy of functional electrical
stimulation in treating genuine stress incontinence: a randomized clinical trial.
Neurourol Urodyn, 16:543-551.
• Sand PK, Richardson DA, Staskin DR et al. (1995). Pelvic floor electrical
stimulation in the treatment of genuine stress incontinence: a multicenter,
placebo-controlled trial. Am J Obstet Gynecol, 173:72-79.
• Siegel SW, Richardson DA, Miller KL et al. (1997). Pelvic floor electrical
stimulation for the treatment of urge and mixed urinary incontinence in women.
Urology, 50(6):934-940.
• Shumaker SA, Wyman JF, Uebersax JS et al. (1994). Health-related
quality of life measures for women with urinary incontinence: the Incontinence
Impact Questionnaire and the Urogenital Distress Inventory. Continence
Program in Women (CPW) Research Group. Qual Life Res, 3(5):291-306.
• Stuart N, Elixhauser A. (1998). Review of the Clinical Literature on Pelvic
floor electrical stimulation for Urinary Incontinence. MEDTAP International,
Inc.
• Yamanishi T, Yasuda K, Sakakibara R et al. (1997). Pelvic floor electrical
stimulation in the treatment of stress incontinence: an investigational study
and a placebo controlled double-blind trial. J Urol, 158:2127-2131.
16.
ATHENA Pelvic Muscle Trainer™ (PMT)
PMT Trainer
Stop Button
Turns off
device
ON Button
PMT Trainer Storage Cradle
Eyelet to insert dental floss for easy removal
Electrodes
Wireless Controller
Set Level Dial:
Frequency
Adjustment
Switch
12.5Hz or 50Hz
5.
ATHENA Pelvic Muscle Trainer™ (PMT)
WARRANTY AND DISCLAIMER
ATHENA Pelvic Muscle Trainer™ (PMT)
Athena Feminine Technologies warrants the Athena Pelvic Muscle
Trainer for a period of one year from the date of purchase to be free
from defects in workmanship and material and in material compliance
with all published product specifications in effect on the date of shipment.
During the warranty period, Athena Feminine Technologies shall, at its
option, replace any products shown to Athena Feminine Technologies to
be defective at no expense to the purchaser. The foregoing remedies
shall be the purchaser’s sole and exclusive remedies under this warranty.
CLINICAL INFORMATION
Indications for Use
The Athena Pelvic Muscle Trainer is intended to provide
electrical stimulation and neuromuscular reeducation for the
purpose of rehabilitation of weak pelvic floor muscles for
the treatment of stress, urge, and mixed urinary incontinence in women.
Contraindications
Batteries
The Athena PMT Trainer contains a sealed battery compartment for
your safety. The battery has a life of about two years. When it needs a
replacement mail the PMTTrainer to:
BATTERY REPLACEMENT
Athena Feminine Technologies
179 Moraga Way
Orinda, CA 94563
The Athena PMT Wireless Controller runs on four AAA batteries. To
replace the batteries loosen the small screw on the back of remote,
remove the cover and replace the batteries.
Contact Athena Customer Support at 1-866-308-4436 or visit us online at
www.athenaft.com
This therapy is not appropriate if a patient:
• has a neurological deficiency that does not permit proper sensory perception or stimulation.
• is currently pregnant or attempting to get pregnant.
• has a cardiac pacemaker or a history of heart rate or conductive
disturbance.
• has an anatomical vaginal structure that does not permit proper
and complete placement of the trainer.
• has irregular menstrual cycles.
• has urinary or vaginal infections, localized lesions, or other
undiagnosed symptoms.
• has a history or symptoms of urinary retention.
Warnings
In the event the purchaser makes any modifications or alterations to the
product, the foregoing warranties shall be void and of no future force or
effect.
15.
Review the following warnings with your patient:
„
Do not use in water or while bathing.
„
Keep out of the reach of children.
„
Do not use simultaneously with high-frequency hospital
equipment (e.g. diathermy equipment). It may result in burns
at the site of the electrodes and possible damage to the trainer.
6.
ATHENA Pelvic Muscle Trainer™ (PMT)
DIRECTIONS FOR USE
ATHENA Pelvic Muscle Trainer™ (PMT)
Precautions
•
•
•
•
7.
For best results, the patient should use the PMT twice a day during the
treatment period. If this is not possible, the stimulation can still be
effective, but improvement may take longer.
For Best Results
feels any pain .
notices abnormal vaginal discharge, irritation to the tissues,
or vaginal bleeding not associated with the usual menstrual
cycle.
experiences burning when she urinate or other symptoms
associated with a urinary infection.
develops any lesions on her perineum .
3. The patient should discontinue treatments and contact physician if
patient:
•
•
2. The PMT should not be used while patient:
• is sleeping.
• has anything else in her vagina such as a tampon, diaphragm
or is engaging in sexual intercourse.
• is engaging in any activity that could place the PMT in
contact with water (e.g. swimming, bathing).
is driving a motor vehicle.
is having her menstrual period.
1. The PMT trainer should not remain inserted when the unit is not in
use.
Review the following precautions with your patient:
PRODUCT SPECIFICATIONS
Specifications
Complies with IEC-601-1
Mode of Operations: Intermittent
Equipment not suitable for use in the presence of a flammable anaesthetic
mixture with air or oxygen or nitrous oxide.
IPX7 rating (protected from dust and liquid ingress)
ATTENTION
TYPE BF EQUIPMENT
NON-IONIZED RADIATION
Electrical Properties
Output Current: 0-70mA
Pulse Width: 200uS at 1%
Frequency: 12.5Hz and 50 Hz
Power Source: PMT trainer: One- 3.6 volt lithium battery
Wireless controller: Four- AAA batteries
Output Type: Constant voltage over range of 100 to 1000 Ohms
Output Isolation:>100 meg Ohms
Transportation and Storage
Ambient temperature range: -40 degrees C to 70 degrees C.
(-40 degrees F to 158 degrees F)
Relative Humidity range: 10% to 100% including condensation
Atmospheric pressure range: 500hPa to 1060hPa. (7.25 PSI to
15.36 PSI)
Environmental
Please dispose of according to local regulatory standards in your area.
14.
ATHENA Pelvic Muscle Trainer™ (PMT)
Initial Fitting and Treatment
1. Instruct the patient to clean the exerciser per “Cleaning
the PMT” instructions ( page 13) prior to initial placement.
2. The patient should be placed in standard lithotomy position.
3. If the patient does not have sufficient lubrication of her
own, apply water or a water-based lubricant such as K-Y
Jelly to the PMT trainer. Do not use a petroleum-based
product as it will have a deleterious effect on the exerciser
and will limit the flow of stimulating current.
4. Remove the PMT trainer from the cradle and show the
patient how to thread a piece of dental floss through the
eyelet in the PMT trainer. The patient should tie the floss
to create a loop. This will allow for easy removal.
5. Instruct the patient to set
switch to either
12.5Hz (urge) or
50 Hz (stress) incontinence.
(For mixed incontinence,
vary the level by session)
6. SHOW THE PATIENT HOW TO PLACE THE UNIT BACK
INTO THE CRADLE. The PMT trainer is controlled
through a magnet in the cradle. Putting it back into the
cradle will set the unit to the start position.
8.
ATHENA Pelvic Muscle Trainer™ (PMT)
CLEANING THE PMT
Review the cleaning instructions with the patient:
1. Wash the PMT trainer prior to initial use and after every use. Use
water and a mild soap. Soap that is free of deodorants, fragrance
and dyes is recommended. Do not immerse in water.
2. The PMT trainer can be air-dried or wiped off with a lint-free
cloth.
3. Be sure that the PMT trainer is clean and dry before replacing in
the cradle.
4. Should the PMT trainer develop an odor, wear out, or become
discolored, it should be replaced.
•
The Athena PMT is most effective when used twice every day.
Notes on Use
•
If the contractions seem to stop during a session, the patient
should gently use her fingertip to reposition the PMT trainer.
13.
ATHENA Pelvic Muscle Trainer™ (PMT)
Assessing Success
To assess treatment success, we recommend that the patient keep a
one week voiding diary prior to treatment and immediately following
treatment. We also recommend a follow-up visit at week two of
treatment to verify compliance and to address any concerns. You may
wish to have the patient complete a voiding diary midway through
treatment and evaluate progress with a patient visit between weeks six
and eight of treatment.
Achieving Success
It is important to establish goals and guidelines for determining success
with the patient. Frequently a patient’s perception of success does not
correlate with objective findings. By setting reasonable and mutually
agreeable goals for “significant improvement,” you will establish an
acceptable measure for success.
When used for the recommended twice-daily, 15-minute sessions,
typically most patients suffering from urge incontinence will see
improvement in three to four weeks. Patients with stress incontinence,
or incontinence associated with sphincter weakness, usually see
significant improvement in six to eight weeks. A standard treatment
program for pelvic floor stimulation is 12 to14 weeks.
If the problem is not resolved in the treatment period and the patient
continues to show improvement, continue the therapy twice a day until
there is no further improvement.
It is recommended that patients continue to use the Athena PMT on a
periodic basis even after the goal is reached. This will ensure that the
pelvic muscles stay strong and will help to eliminate any further
problems.
12.
ATHENA Pelvic Muscle Trainer™ (PMT)
7. Remove the PMT trainer from the cradle. Insert the PMT
trainer into the patient‘s vagina until it meets resistance from
the cervix or cul-de-sac. Make sure the dial is initially set to 0.
8. When the correct position is reached, press the ON button to
start the session. Slowly rotate the dial to increase the strength
of the stimulation until it is comfortable for the patient. Future
sessions will automatically go to the setting last used by the
patient.
9. The patient should be asked to contract her pelvic muscles
tightly in order to prevent the PMT trainer from being easily
removed from the vagina. Concurrently, you should request
the patient to place her finger(s) on the end tip of the PMT
trainer and gently move or rotate until she feels a muscle contraction. In most cases, she will feel a slight pushing forward
on the PMT trainer. If no contraction is felt and the exerciser
is easily dislocated, perform a pelvic exam in order to locate
the appropriate muscles; once identified, position the exerciser.
10. If the patient has difficulty holding the exerciser within the
vagina, treatment should be prescribed for a supine position.
11. Have the patient practice inserting the PMT trainer on her own
to make sure she does it correctly.
Note: The stimulation should always be at a comfortable level. If
the patient expresses discomfort, turn the intensity down slightly
until comfortable. It is not necessary or beneficial to stimulate
at levels higher than those determined above.
9.
ATHENA Pelvic Muscle Trainer™ (PMT)
8.
7.
6.
5.
4.
3.
2.
1.
The PMT will begin to stimulate with an on/off cycle of 2.5 seconds on and
2.5 seconds off, thus inducing pelvic muscle contractions.
Slowly increase the intensity dial until the patient feels a comfortable sensation. Once the level is set it will automatically increase to that level in future
sessions. Therefore, the patient will not have to set the level each time it is
used.
When the PMT trainer is in the right position, push the ON button and the
session will begin.
Remove the PMTtrainer from the cradle and insert it into the vagina.
If needed, use vaginal lubricant to allow for easier insertion.
Have the patient lie down.
Set the controller to either 12.5Hz or 50Hz and the dial to 0. Return the PMT
trainer to cradle.
Show patient how to insert floss for PMT trainer removal string.
Show patient how to clean PMT trainer.
INITIAL TREATMENT CHECKLIST
9.
10. If necessary, further adjust the level to meet the patient’s needs. More sensitive patients may need a lower setting. Older patients may require a much
higher setting.
11. The Athena PMTtrainer will automatically shut off after 15 minutes of use. If
a shorter treatment is desired, the PMT may be turned off at any time by
pressing the STOP button on the wireless controller.
12. Remove the PMT trainer. Clean as per the “Cleaning the Athena PMT”
instructions (page 13).
13. After the PMT trainer is dry, store the probe in the storage cradle on the
wireless controller.
10.
ATHENA Pelvic Muscle Trainer™ (PMT)
RECOMMENDED TREATMENT PROTOCOL
You may prefer to prescribe the use of 12.5 Hz for patients with urge incontinence, as some studies support the use of lower frequency for optimal inhibition
of bladder contractions. Similarly, you may prefer to prescribe 50 Hz for patients
with pure stress incontinence. Patients with mixed incontinence can alternate
between the two channels from session to session. ( For example, 12.5 Hz in the
morning and 50 Hz in the evening.)
To receive maximum benefits, most patients should use the Athena PMT for 15
minutes, twice a day. Regular use of the PMT is necessary for improvement to
occur. Encourage the patient to take an active part in the treatment and to try to
be as consistent as possible in use.
When used consistently, patients with urge incontinence should show improvement in three to four weeks. Those with stress incontinence should show
improvement in 12 to 14 weeks.
P Menstrual Cycle
Missed
Done
The following chart is also provided in the patient instructions. It may help the
patient towards the consistency needed for improvement. There are spaces on
the patient’s page to write the goal of treatment, as well as any special instructions that you might have.
11.

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