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

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Athena Pelvic Muscle Trainer™
PATIENT
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™
Pelvic Muscle Stimulation
Indications for Use
Product Description
Introduction
Table of Contents
Instructions for Use
Diagram/ Warnings
Product Specifications
Recommended Treatment Protocol
PATIENT DIARY/LOG
15
14
13
12
10
10
11
Warranty and Disclaimer
16
Initial Treatment
Overview of PMT Use
Precautions
Cleaning the PMT
Directions for Home Use
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 mild electrical vaginal
stimulator that treats urinary incontinence in females. It has been
shown to be effective in strengthening the pelvic muscles that can
control incontinence. This is a single-user device and should not be
shared.
This manual discusses how the Athena PMT treats incontinence,
shows you the parts of the PMT, and explains how to use and care for
your new Athena PMT.
Why Incontinence Occurs
Incontinence can occur for many reasons. One of the most common
causes is the weakening of the pelvic muscle. The pelvic muscle is
like a hammock that holds up the bladder and other organs.
When this muscle is weak it may not hold up the bladder correctly and
may allow urine to leak. Strengthening the pelvic muscle can often help
control incontinence.
3.
ATHENA Pelvic Muscle Trainer™ (PMT)
Pelvic Muscle Stimulation
Many studies have shown that one way to strengthen weakened
muscles is to apply mild myostimulation to them. This causes the
muscles to contract, making them stronger in the same way physical
exercise does.
Contracting the muscles in the floor of the pelvis voluntarily is called
the Kegel exercise. The Athena PMT causes the pelvic floor
muscles to contract, similar to the way they are contracted when
doing the Kegel exercise. The difference between the two is that the
Athena PMT causes the muscles to contract for you, by applying
gentle myostimulation to them. You can then lie back and exercise
with little voluntary effort.
Studies of other devices during the last 20 years have shown that
intra-vaginal myostimulation of weakened muscles in the pelvic floor
can lead to control of the most common forms of incontinence in
females up to 60% to 90% of the time. Because of its effectiveness
and lack of side effects, intravaginal myostimulation is an ideal first
choice of treatment for urinary incontinence in women.
What will the stimulation feel like?
The stimulation will feel like a gentle pulsating contraction of the
muscles. It may feel like a flutter at lower settings. Each time you
use the Athena PMT you should try to use it at a high enough
intensity to feel contractions. As your muscles get stronger you may
want to gradually increase the intensity so that you use the strongest
stimulation that is comfortable for you. NEVER turn it up to an
intensity that is uncomfortable or painful.
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)
Indications for Use
The Athena Pelvic Muscle Trainer is intended to provide
myostimulation 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.
This therapy may be appropriate if you:
• experience incontinence due to weak pelvic floor muscles.
• are willing to comply with the therapy program on a consistent basis.
• understand how to use the Athena PMT as described in this
instruction booklet.
are generally in good health.
•
Contraindications (When you should not use the device)
This therapy is not appropriate if you:
• have a neurological deficiency that does not permit proper
sensory perception or stimulation (have areas of numbness that might interfere with your feeling the
stimulation).
• are currently pregnant or attempting to get pregnant.
• have a cardiac pacemaker or a history of heart rate or
conductive disturbance.
• have irregular menstrual cycles.
• have urinary or vaginal infections.
• have a history of urinary retention, or current symptoms.
Your physician will determine if this device is appropriate
for your use.
5.
ATHENA Pelvic Muscle Trainer™ (PMT)
PRODUCT DESCRIPTION
Description of the Pelvic Muscle Trainer™
The Athena Pelvic Muscle Trainer™ (PMT) is an intravaginal pelvic
floor exerciser that strengthens the pelvic muscles to aid in the
control of urinary incontinence (UI) in women. This is a single-user
device and should be used by one person only.
•
•
•
•
The Athena Pelvic Muscle Trainer™ is an intravaginal exerciser
constructed of medical-grade plastic and has one electrode pair.
The probe is not tethered and is controlled through a radio fre
quency (RF) signal from the wireless controller.
The electrodes are designed to deliver myostimulation to the pelvic
floor muscles to induce Kegel-like contractions.
The exerciser is only reusable by a single person and is
ergonomically designed.
The Athena Pelvic Muscle Trainer has two parts:
1. Wireless Controller with PMT trainer storage cradle
2. PMT Trainer
6.
ATHENA Pelvic Muscle Trainer™ (PMT)
WARRANTY AND DISCLAIMER
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.
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 PMT Trainer 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 at our
website www.athenaft.com
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.
ATHENA Pelvic Muscle Trainer™ (PMT)
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.
Stop Button
(Turns off device)
PMT Trainer Storage
Cradle
Electrodes
Eyelet to insert dental floss for easy removal
ATHENA Pelvic Muscle Trainer™ (PMT)
PMT Trainer
Wireless Controller
Set Level Dial:
Frequency
Adjustment
Switch
(12.5Hz or 50Hz)
Warnings
„
„
„
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.
7.
ATHENA Pelvic Muscle Trainer™ (PMT)
INSTRUCTIONS FOR USE
Initial Treatment
The initial treatment with the Athena PMT will be done under
medical supervision. You will then be sent home to use the Athena
PMT on your own for a period of two to 14 weeks. It is very
important that you follow the instructions as directed by your
physician. Much like medication, if you don’t do the treatments,
you will not experience improvement.
If you miss one or two treatments don’t be alarmed. But if you
miss several in a row, call the physician or clinic for a possible
revision in your treatment regimen. They will review how far you
have progressed in your treatment regimen and whether there have
been any changes in your bladder activity to determine what would
be best for you.
Note: Using the Athena PMT every day, as directed, is like doing
exercise on a regular basis. It will produce the best and most rapid
results.
Note: The stimulation should always be at a comfortable
level. If you feel any discomfort, turn the intensity down
slightly until comfortable. It is not necessary or beneficial to stimulate at levels higher than are comfortable.
8.
ATHENA Pelvic Muscle Trainer™ (PMT)
RECOMMENDED TREATMENT PROTOCOL
Achieving Success
It is important to establish goals and guidelines with your physician for
determining success. Frequently a patient’s perception of success
does not correlate with what is actually happening. By setting reasonable and mutually agreeable goals for “significant improvement,” you
will establish an acceptable measure for success.
When used for the recommended 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 to 14 weeks.
If the problem is not resolved in the treatment period and you continue
to show improvement, your physician may recommend that you continue the therapy until there is no further improvement.
Assessing Success
To assess treatment success, you might keep a one week voiding diary
prior to treatment and immediately following treatment. You might
also want to make milestones on your chart, i.e. fewer pads used, dry
day, etc.
Continuing Success
It is recommended that you continue to use the Athena PMT on a
periodic basis even after the goal is reached. This will ensure that
the pelvic muscle stays strong and will help to eliminate any further
problems.
13.
PATIENT DIARY/LOG
ATHENA Pelvic Muscle Trainer™ (PMT)
Menstral Cycle
Missed
Done
To receive maximum benefits you should use the Athena PMT as prescribed
by your physician. Regular use of the PMT is necessary for improvement to
occur. Take an active part in the treatment and try to be as consistent as
possible.
12.
ATHENA Pelvic Muscle Trainer™ (PMT)
•
•
•
•
•
•
•
•
•
THE PMT TRAINER MUST BE RETURNED TO THE
CRADLE TO FUNCTION PROPERLY.
Return the PMT trainer to its spot in the controller cradle.
Wash the PMT trainer with warm water and soap, then dry.
If you need to take the PMT trainer out before the end
of the session, use the STOP button. Then remove the
PMT trainer.
The PMT will automatically turn off after a 15-minute
session.
If you want to lessen or strengthen the contractions, use the
dial on the PMT wireless controller to adjust the strength as
appropriate.
It will automatically adjust to the level of your previous
session.
The device starts to work when you press the ON button.
The Athena PMT is inserted into the vagina for 15-minute
sessions. It is best used when lying down or in a reclining
chair.
Overview of PMT Use
•
To increase the effectiveness of the contractions, physically
contract your pelvic muscles when you feel the PMT trainer
contraction.
9.
ATHENA Pelvic Muscle Trainer™ (PMT)
Precautions
The PMT trainer should not remain inserted when the unit is not in use.
The PMT should not be used while you:
• are sleeping.
• have anything else in your vagina such as a tampon, diaphragm or are engaging in sexual intercourse.
• are engaging in any activity that could place the PMT in
contact with water e.g. swimming, bathing
are driving a motor vehicle.
are having your menstrual period.
•
•
Discontinue treatments and contact your physician if you:
• feel any pain.
• notice abnormal vaginal discharge, irritation to the tissues, or
vaginal bleeding not associated with your usual menstrual
cycle
• experience burning when you urinate or other symptoms
associated with a urinary infection.
• develop any lesions on your perineum (any bumps or sores
appear around the area where you insert the Athena PMT).
CLEANING THE PMT
1. Wash the PMT trainer prior to initial use and after every use.
Use a mild water and 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.
10.
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ATHENA Pelvic Muscle Trainer™ (PMT)
DIRECTIONS FOR HOME USE
Remove the PMT trainer from the cradle and thread a piece of
dental floss through the eyelet. Tie floss together to form a loop.
This loop allows for easy removal.
Place the PMT trainer back into the cradle (this is important for
proper PMT functioning).
Empty your bladder before beginning a session.
Find a comfortable place to lie or recline for the 15-minute session.
Set the switch on the wireless controller to either 12.5Hz or 50Hz,
as directed by your physician.
Remove the PMT trainer from the cradle and insert it like you
would a tampon.
Lie back and relax. Push the ON button. The PMT will automatically slowly adjust to the level set by your physician.
You will begin to feel a sensation and then small contractions.
If you do not feel any contractions within 2 or 3 minutes, gently take
the tip of your finger and reposition the PMT trainer slightly until
you feel the muscle contracting.
If you want to change the contraction level, use the dial on the
wireless controller. Increase the level slowly to avoid over-stimulating the muscle.
If at any time during the cycle you need to remove the PMT trainer,
press the STOP button and then remove it.
After 15 minutes the contractions will stop.
Use the floss to remove the PMT trainer. You may also remove
the trainer by standing up and gently squeezing your pelvic muscle.
Wash the PMT trainer with warm water and soap. DO NOT
IMMERSE IN WATER
Return the PMT trainer to its proper place in the cradle. IF THE
PMT TRAINER IS NOT RETURNED TO THE CRADLE, IT
WILL NOT WORK THE NEXT TIME.
Once replaced in the cradle, it is now ready for your next use.
11.

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