Athena Feminine Technologies E03946PS3 Pelvic Muscle Trainer (433.9MHz Tx) User Manual

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Document ID	739327
Application ID	e+RGlfmipTedMpvMED2JJw==
Document Description	User Manual
Short Term Confidential	No
Permanent Confidential	No
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Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	132.29kB (1653659 bits)
Date Submitted	2006-12-15 00:00:00
Date Available	2006-12-15 00:00:00
Creation Date	2006-10-26 11:50:13
Document Lastmod	2006-10-26 11:52:06
Document Title	User Manual

Athena Pelvic Muscle Trainer”
INSTRUCTIONS
The Athena Pelvic Muscle TrainerTM (PMT) is a myostimulation device that
treats urinary incontinence in women. It has been shown to be effective in
strengthening the pelvic floor muscles that can control incontinence. This is a
single-user device and should not be shared,
This manual explains how the Athena PMT treats incontinence, shows the
parts of the PMT, and reviews the use and care of your new Athena PMT.
CAUTION: Federal law (U.S.) restricts this device to sale by or on the order of
a physician.
Athena Pelvic Muscle TrainerTM
The Athena Pelvic Muscle TrainerTM (PMT) is an intravaginal pelvic floor
exerciser that strengthens the pelvic floor muscles to aid in the control of
urinary incontinence (U1) in women. The Athena PMT is a single-user
device and should be used by the prescribed patient only.
Description of the Pelvic Muscle TrainerTM
- The Athens Pelvic Muscle TrainerTM is an intravaginal exerciser
constructed of medical»grude plastic and one electrode pair.
- The “trainer” is not tethered, and is controlled through a radio
frequency (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 ergonomically designed for use by a single person.
WARNINGS
~ Do not use in water or while bathing or swimming,
- Keep out of the reach of children,
- Do not use simultaneously with high frequency hospital equipment (eg.
diathermy equipment). It may result in bums at the site of the electrodes and
possible damage to the trainer.
- Do not use if you have a pacemaker,
CAUTION: Federal law (USA) restricts this device to sale by or
on the order ofa physician.
2.
PRODUCT DESCRIPTION
The Athena Pelvic Muscle TrainerTM has two parts:
1. Wireless Controller with PMT Trainer storxge cradle
PMT Trainer Storage Cradle Two—Color LED Status
(Store PMT here be een uses.) Light‘ (Yellow when
processing a command,
Green when operating a
Intensity Level Dial (equesfied level)
(Controls strength of
contractions.)
START Button
(Press after insertion.)
Frequency
Adjustment
Switch
50 Hz: Stress Incontinence
lZASI-lz: Urge Incontinence
(see page 10)
Stop Button
(Turns ofi‘deviee in an
emergency.)
2" PMT Tram" /Eye1er (To insen dental floss for easy removal)
Electrode Pair
USING YOUR THENA PE C MUSCLE TRAI R
Initial Treatment
The initial treatment with the Athena PMT should be done under medical supervision. Ynu
will then he sent home to use the Athena PMT on your ovm for a period of two to 14
weeks. it Is very imponant that you follow the instructions as direcled by your physician,
Much like modieatton, ifyou don‘t do the treatments, you will not experience improve
menl.
Ifyou miss an: or lwo lreaimems, dun”! be alarmed. But ifycu miss several in a row, call
the physieian 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 heen any
changes in your hladtler activity to determine what would be best for you.
Using the Athena PMT every day, as direcwd, is like daing exercise on a mgular basis. It‘
wrllpmdnae the best and most rapid results
Precautions
l. The PMT trainer shuuld not remain inserted in Ihe vagina when the uni
Z. The PMT should not be used while:
. sleeping,
. anything else is in your vagina such as a tampon or
diaphragm; or are engaging in sexual interooutse.
- engaging in any activity that eould immerse the PMT in water while operating
eg. swimming, bathing
. driving a motor vehicle.
. menstruating.
3. Discontinue treatments and contact your physician if you:
. feel any pain.
0 notice abnormal vaginal discharge, initatton to the tissue, or vaginal
bleeding not assoeiated with your usual menstrual cycle.
. experience bun-ling when you urinate or other symptoms associated with a
urinary infection.
. develop any lesions on your perineum (any humps or sores appear around the area
where you inserl lhe Athena PMT).
Gett g started
Refine the PM cart be used, batterier must be installed“
1. bansen the screw on the buck ofthe wireless controller using a screw
driver or coin and remove hattery cover.
2. Install the three supplied AAA batteries as indicated by the marking inside
the battery cumpartment. The negative pan uf the battery goes toward the spring,
1 Replace the battery cover and tighten the screw.
TEST MODE PROCEDURE
4, To make sure the hatteries are in currently and tire trainer is communicating with the cradle,
rennve the trainer from the cradle (the LED light will he flashing yellow)
5, Press the STOP button (the yellow LED will remain steady and then turn ufl)
6 Replace the trainer in the cradle. (The LED ligit will turn green and then
turn om.
7. The PMT trainer is now ready fur use.
Nata: Always return the trainer to the cradle when it it not in user
Cleaning the PMT Trainer
Wash the PMT trainer prior to initial use and after every use.
Before cleaning the PMT trainer remove any floss used during the session
Use a mild strap and water. Snap that is free ofdeodomnts, fragrance and dyes rs recommended.
You may put the trainer under running water but do rtat immerse camplzlely‘ in water
The PMT trainer can be air-dried or wiped off with a lint-flee cloth.
Be sure that the PMT trainer is clean and dry before replacing in the cradle.
frhfi
me
To prepare the trainer for use, wash and dry it. Add floss for easy removal
ifdesired. Then return it (cl lhe cradle.
l.
Set the frequency switch to 12.5 Hz for urge incontinence or 50 Hz for siress
incontinence. (See page ID) For mixed incontinence set one sessiun at 12.5 Hz and the other
session 31. 50 Hz.
Set the intensity dial to 5. .
Remove the PMT trainer from ihe cradle. The LED siatus light will blink yellow. [gal
Recline comfonahly and insert the trainer as you would a tampon
- Use a waier-hased luhricant jelly ifneeded (not pelmleum jelly)
Push the geen START Button to start the PMT, The LED Slams Lig‘lt will turn
solid yellow until it has reached lhe strength MS and will then turn solid
green,
lfyou do not feel anything, increase the dial by 2 clicks (from 5 to 7) and wait fur the high to
turn geen again. Keep doing this until a comfortable pulse can be felt. It shuuld never
be uncomfonahlel
Lie back and relax for l5 minutes while the PMT does pelvic floor exercises for you.
The PMT will rurn off aher is minutes and the green light will go out. Remove lhe PMT trainer,
wash and dry it (see page 5 for cleaning insiruetions) and replace it in the cradle for the next use.
The light will flash iwice every minule to remind you to replace the trainer in the cradle.
Leave the intensity dial on the setting you were using. lt will automatically adjust to this level the
next time you use the PMT.
Note: The stimulation should always be at a cumforlable level. Ifyml feel any discomfoll,
turn the intensity dnwn sliylily until cumfonahle. it is flat necessary or beneficial to slimulale
at levels higher than lhnse which are comfuflflhler
Regu r use
1. insert the PMT Trainer into your vagina.
2. Press the green START Button. The light will be constant yellow. Your 15
minute session will start.
3. The pm trainer will automatically slowly adjust to the setting
you previously used and |he LED will turn solid green once it has been reached.
4. The green light will turn nffat the end nfthc session,
5. Afier use, remove the floss ifused. wash, dry, and replace in the cradle,
IMPORTANT
Read Before Using
- The PMT trainer is best used when lying duwn er in a reclining chair.
' The PMT lrainer slowly increases in intensity and is indicated by the yellow LED.
fiendtkanhen starting lo use it.
- The PMT trainer starts to work unly after you press the green START button.
' The PMT will automatically adjust to the level Seton the dial.
- If you want to weaken or strengthen the contractions, use the intensity dial on the PMT
wireless controller to adjust the strength as appropriate. Adjust slowly (I to 2 clicks) tn
find the approprialc strength,
' The PMT lrainer will automatically tum off afier each lS-minule session.
' The STATUS LED LIGHT:
The blinking light on the PMT wireless controller tells you that the PMT trainer is
waiting for a command. it will remain solid YELLOW after you push the START
Button unlil it reaches lhe strength set an lhe dial. Then the LED will be sulid GREEN
when it is operating at the strength requested. The Green light will go out at the end or"
the session. ll will then blink twice every minule until the trainer is returned [0 the
cradle.
' lfyou need to remove lhe PMT [miner hefure the end of the session, push the button
marked STOP. Wait for the LED to turn off and remove the PMT trainer.
- The PMT trainer must be returned to the cradle for storage to function properly.
- To increase the efl'ectiveness of the contractions. you can physically contracl your pelvic
muscles when you feel the PMT lraincr commotion, although this is not necessary for
succnss.
~ lfyou have difficulty removing the PMT trainer from the cradle insert a piece of dental
floss through the eyelet and tie it to form t loop. Then pull it out.
7.
QUESTIONS AND ANSWERS
. When I lry lhe lest made the yellow light does't blink when the trainer is removed from the
cradle.
Check lo make sure that you have fresh batteries and thal the halteries are inserted Carmelly,
. isuddeuly can‘t feel the PMT trainerwheu Pm using it, What should i do?
You may not feel the PMT for a number of reasons
Your session may be over. Check to see irthe LED lighl has lumed air,
The pm may have lumed ofl‘ (see question 5).
The PMT lminer may have moved out ofoomaot with lhe ouneet nerves. To remedy this.
simply hire the tip ofyour finger and move lhe PMTuntil you can feel the Contractions again.
t Can I let ulhers try my Athena m1?
No, lhe PMT is by prescription for single palienl use only.
. How do I turn it on once 1 inserl it?
Press lhe greenSTART button
t How do i slop ii ill need to before the 15 minules are up?
Press the re_d STOP Buttun
. The PMT doesn‘l turn on when I press the START huttnn.
What should “in?
To enhance battery life, the PMT is designed to mm ofi sfier 2 minutes iflhe START button is ncl
pushed. To reset, place the PMT trainer back into lhe cradle, remove, insert into lhe vsginu and
press the START button wilhin 2 minutes,
t What tan 1 do ill Em too dry to insert the PMT trainer?
Ynu may use a vaginal lubricant when inserting the PMT. Use a water-based lubricanl, (191
pelroleum jelly.
. What will the sfimulat‘ion feel like?
The slimulation will feel like a flutter nr gentle pulsating commotion of the muscles.
Each time you use lhe Athena PMT, you should try lo use it at u high enough intensity to feel
cmntmcticns. As your muscles get stronger you may wanl lo gradually increase the intensity so that
you use the strongest stimulation that is cumforlable for you. However, moving lo higher levels of
intensity shuuld not be a goal. Most women achieve results staying at abnut the some setting during
the entire time they use the PMT. NEVER use it at an intensity that is uncomfortable or paiufill,
RECOMMENDED TREA M NT PROTOCOL
Achieving Success
it is important to establish goals and guidelines with your physieian for determining success.
Frequently a palient‘s perception ofsuocess does not correlate with what is aetually happening.
By setting reasonable and mutually agreeable goals for “significant improvement," you will
establish an aeceptahle measure ofsuccess.
when used as recommended, most patients suffering from urge incontinence will see improve-
ment in 3 to 4 weeks. Patients with stress incontinence, or incontinence associated with
sphinctar weaknass, usually see significant improvement in 8 lo 12 weeks. Asinndard 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 improve»
menl.
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 your Athena PMT on a pertodic basis even fitter
your goal is reached. This will ensure that the pelvic muscle stays slrorlg and will help to
prevent future problems. Check with yum doctor.
CUSTOMER CARE
Working with our customers lo help them achieve the maximum results from their Alhena
Pelvic Muscle Trainerm is our main priority, Feel free to chill us.
Before you call:
" Check to make sure the batteries in lhe oonlroller are installed correctly.
, Confirm that lhe PMT Trainer is walking correctly by repeating the initial set up
test mode procedure. (page 5. Gening Staned. steps 4-6)
For more information on the Allrena PMT, We use, answers to questions and resources
for incontinence information Visit our website at wwwrnlhenai‘lmoln
lfyou still have questions please oall our customer oareline:
866-308-4436 (M-F. 9100.3.m, lo 4:00 prln. PST)
Urge and Stress Incontinence
Cheek with your physician for rhe eorrecl seizings for you.
suess ineonlinence is defined as he leaking ofurine when a pressure is exerted on the
bladder. such as when laughing, sneezing or coughing. If you have ihis kind ofineonri-
nenee you should probably use the PMT Trainer set on so Hz.
ngLlucnminem is present when you know you have to go to the balhmom bill are
unable to make it on time It is sometimes referred to as "garage door incontinence“ since
some women hwnlunnnly empry rheir bladder v/nzm urey arrive honre instead orheing
able lo hold it until they reach lhe balhreom. lfyou have this kind ofinwntinence you
should probably use lhe PMT Trainer set an 12.5 Hz.
Mixed Incontinence
lryou have both kinds of incontinence, known as mixed incaminence, you might use one
setting in the moming and anuther in rhe evening.
10r
PATIENT LOG
Remember, consistency connts!
To ranciv: maximum benefits. use the Athcna PMT as prescribed by your physician. Regular
use ofthc PMT is necessary for improvcmcm. Talk: an active pan in lhe treatment and he as
msiatenl as pcssiblm
P Menstrual Cycle
114
I DICATIONS FOR USE
The Athena Pelvic Muscle TrainerTM is intended to provide myosttmulation and neummus~
eular reeducalion for the purpose of rehabililztinn of weak pelvic floor muscles in the
treatment oistress, urge hind mixed urinary ineontinenee in women.
This therapy may he appropriate tiyeu:
. expelienc: incontinence due to weak pelvic lioor museles,
. are willing tn enmply with the therapy program on a consistent basis.
- understand how la use the Athena pm as described in this instruction booklet.
- are generally in good health.
Contraindications (When to not use the device)
This rherapy may m be appropriate ifycu:
- have n neurologieai deficiency that does not permit proper sensory percep-
tion or stimulalim'l (have areas uf numbness that might interfere with your
feeling the stimulation).
are currently pregnant or altempling to get pregnant.
have a cardiac pacemakn ora history ofheart rate or conductive distubancc.
hnye irregular menstrual eyoles.
have urinary or vaginal infeetions.
have a history of urinary retention. or eurrent symptoms.
Your physician will determine iflhis device is appropriate for you.
12.
PRODUCT SPECIFICATIONS
Specifications
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL
yWWQ HAZARDS ONLY IN ACCORDANCE WITH UL60601-l , IECGOSOl-L
A e®nr CAN/C221No. 601.1
55m Modeopocmio :Cominuous
Equipment not suitable for use in die presence urn flsmmslsle nnnesrlrerie
mixture with air or oxygen or nilmus oxide.
lPXO mling (no protection from dust and liquid ingress)
«fl» NON-IONIZED RADIATION
E TYPE BF EQUIPMENT
Electricnl Properlies
Outpul Current: D~70mA
Pulse Width: ZDOuS at 1%
Frequency. 2 SH: and 50 Hz
Fewer Source: PMT trainer: One- 3.6 voll lithium battery
wireless controller: Four— AAAbarleries
ourpur Isulallun:>[00 meg Ohms
Transpanaiinn and Slorage
Ambient temperature range: 40 degrees C re 70 degrees c. (40 degrees Flo 158
degrees F)
Rclmivc Humidity range: “We to [00% including condensation Aunospherie
pressure rangc: SOOhPa tn lDéDhPa. (7,25 PS[ to 15.36 PSI)
Environmenul
Please dispose ofaccording to local regulamry srandnrds in your area
Palent Pending
Assembled in Chin:
13.
Federal Communications Commission (FCC) compliance Notice:
Pelvic Muscle Trainer (Wireless Control Unit)
Warning: Changes or modifications to this unit not expressly approved by the party
responsible for compliance could void the user's authority to operate the equipment
NOTE. This equipment has been tested and found to comply with the limits for a
Class B digital device. pursuant to Part 15 of the FCC Rules. These limits are
designed to provide reasonable prolection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instmctions, may cause harmful
interference to radio communications
However, there is no guarantee that interference will not occur in a particular
installation If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following
measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help
Pelvic Muscle Trainer (Trainer Unit)
This device complies with Part 15 of the FCC Rules. Operation is subject to the
followtng two Conditions‘ (1) This device may not cause harmful interference and
14.
(2) This device must accept any interference received, including interference that may
cause undesired operation.
Warning. Changes or modifications to this unit not expressly approved by the party
responsible for compliance could void the user’s authority to operate the equipment.
NOTE. This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to Part is of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instructions, may cause harmful
interference to radio communications.
However, there is no guarantee that interference will not occur in a particular
installation If this equipment does cause harmful interference to radio or television
reception. which can be detennined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following
measures
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
~ Connect the equipment into an outlet on a Circuit different from that to which the
receiver is connected
- Consult the dealer or an experienced radio/T V technician for help
Athena Feminine Technologies, inc.
Responsible Party:
Athena Feminine Technologies, Inc
21 Orinda Way, C246
Orinda, CA 94563
(925) 254-2121
15.
WARRA TY AND DISCLAIMER
Athena Feminine Teehnoiogies. ine. warrants the Athena Pelvic Musele Trainer for a period ofone
year from the date of purchase to he 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, irte. shall. at its option, replaoe any
products shown to Athena Feminine Technologies to be defective at no expense to the purchaser.
The foregoing remedies shall be die purchaser‘s sole and exclusive remedies under this warranty.
In the event the purchaser makes any modifieatiens or allemlions to the product the foregoing
warranties shall be void and uf no future force or effect.
Warning: This is a medical device that may break if it is dropped or misused, Athena Feminine
Technologies takes no responsibility For devices that are returned in hroken cnnditinn.
Batteries
The Athena PMT trainer contains a sealed battery compartment fur your safety. The battery has a
life ofahout lwu years. When it needs a replacement call 1-866-303-4436 for funher instmetions,
The WWI“ runs on three AAA bimelies. Tu replace the batteries,
loosen the small screw an the back of remote. remove the cover and replace the batteries.
Contact Athena Customer CHE at 866-308-4436 or visit us at our Website: wwwmhenaficom
if
Athena Feminine Technologies, Inc.
21 Orinda Way, C246
Orinda, CA 94563
1-866-308-4436
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