Page 1
Instructions For Use
Page 2
TABLE OF CONTENTS
Contents of Package 1
Before You Use EmbaGYN
™
1
Contraindications, Warnings and Precautions 2-3
Indications For Use 4
Treating Urinary Incontinence 5
How To Set Up And Use EmbaGYN
™
6-9
EmbaGYN
™
“Smart Features” 10
EmbaGYN
™
Controls 11-14
Screen Displays 15-16
Stress Incontinence Program 17-18
Battery Use 19-20
EmbaGYN
™
Cleaning And Storage 20
Other Programs 21-22
Urge Incontinence Program 21
Mixed Incontinence Program 21-22
Tone Program 22
Troubleshooting 23
Patient Daily Diary 24
Returns And Replacement 25
Limited Warranty 26-28
Disclaimer 29
Product Specifications 30
Program Settings 31
IMPORTANT: Read this manual carefully before starting to use your
EmbaGYN™ Pelvic Floor Exerciser. INAPPROPRIATE OR INCORRECT USE COULD
BE UNSAFE.
Caution: U.S. Federal Law restricts this device to sale by or on the order of a
licensed healthcare practitioner.
Support
Customer Support is available Monday through Friday 9 am to 5 pm GMT.
Call TensCare: +44 (0) 013 7272 3434
Email: sales@tenscare.co.uk
To report a serious problem or adverse experience related to the use of
EmbaGYN™ Pelvic Floor Exerciser, call TensCare.
Page 3
CONTENTS OF PACKAGE
• EmbaGYN™ Control Unit
• EmbaGYN™ Trainer
• Connecting lead wire
• Four AA batteries
• Instruction booklet
• Patient daily diary
• Storage pouch
Before you use EmbaGYN™ for the first time
An examination of the vaginal tissue should be completed prior to initial
treatment to rule out any contraindications, establish the baseline tissue
condition and assess the physiology discussed below. Pelvic floor stimulation may not be successful if the urethra has excessive scarring or if there
is significant denervation of the pelvic floor. The neuromuscular structures
involved in urine storage must also be at least partially preserved. Patients
with intact sacral reflex arcs and some innervation of the pelvic floor may
benefit from pelvic floor stimulation.
The EmbaGYN unit must only be used in accordance with the advice of your
treating physician. Be sure to read the instructions included in this booklet
to supplement the information provided to you by your physician.
CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS
Contraindications
Should not be used if you have any of the following conditions:
• If you have a heart pacemaker or a heart rhythm problem
• If you are pregnant or trying to become pregnant
• If you have been diagnosed or treated for cervical, or any pelvic, cancer
• If you have, or have had epilepsy
• While driving, or during any activity in which involuntary muscle
c
ontractions may put the user at undue risk of injury
• If you have:
• An active urinary tract infection
• Recent history of vaginal bleeding between menstrual periods
• Infections or lesions in the area of electrode placement
• Diminished sensory perception
• Inability to understand the directions of use or operate the device correctly
• History of urinary retention or post-void residual volume greater than 200 cc
If any discomfort occurs when inserting the trainer consult your treating physician.
Warnings
Review the following warnings before using:
• The patient should discontinue use and immediately consult the clinician if
irritation, pain or unusual bleeding occurs.
• Keep out of reach of children.
• Do not use in water (for example,while bathing) or device may shock user.
This equipment is not rated for use while immersed or under dripping water.
• Do not use simultaneously with high frequency hospital diagnostic/therapeut
ic equipment. Doing so may result in burns at the site of the electrodes
and possible damage to the device.
1 2
Page 4
• Do not use simultaneously with patient monitoring equipment such as EKG
Precautions
Review the following precautions before using:
• It is not recommended to use device while under the influence of alcohol or
other substances, such as sleeping pills or tranquilizers, which could affect
the patient’s ability to operate the system correctly.
• Removing or inserting the electrode while the system is on could result in
discomfort.
• Use while operating hazardous equipment, machinery or motorized
vehicles could cause abrupt changes in stimulation which can startle the
patient and create a hazard.
• Do not use in close proximity (e.g. <3ft.) to transmitting cellular (wireless)
telephones or two-way radios. This equipment may produce instability in
the stimulatory output. Sudden unexpected changes in output could startle
the patient and create a hazard.
• Use while sleeping is not recommended.
• The patient should discontinue use and consult a clinician if a significant
change in the stimulation sensation occurs without changing the intensity
settings. It is normal to feel a difference in sensation when changing
pos
itions during stimulation.
• Caution should be used following recent surgical procedures when muscle
contraction may disrupt the healing process.
EMBAGYN™ INDICATIONS FOR USE
Your physician has prescribed the use of the EmbaGYN™ Pelvic Floor
Exerciser for the treatment of your urinary incontinence symptoms.
EmbaGYN is indicated for the rehabilitation and strengthening of weak
pelvic floor muscles in the treatment of stress, urge, and mixed urinary
incontinence.
It is recommended that EmbaGYN be used once a day at the same time each
day for 20 minutes.
Each patient and situation is different. Your physician may determine that a
different regimen is more appropriate for you.
Please follow the instructions for use given to you by your physician.
Initial fitting and treatment
Please note that it is very important to obtain the advice of your treating
physician, BEFORE you start using EmbaGYN.
The initial electrode fitting and the treatment session should be done under
medical supervision.
3 4
monitors without investigating the possibility of output from the device
causing erroneous monitor readings.
• Do not carry batteries in a pocket, purse, or any other place where the
terminals could become short circuited, (e.g. by way of a coin or paperclip).
Intense heat could be generated and injury may result.
• The long term effects of chronic electrical stimulation are unknown.
• Do not use with products other than those recommended by
TensCare.
Page 5
5 6
TREATING URINARY INCONTINENCE
Your physician has prescribed the EmbaGYN™ Pelvic Floor Exerciser to help
strengthen your pelvic floor muscles to treat your urinary incontinence. This
loss of bladder control is a common issue for women that may lead to
discomfort and embarrassment. Some women experience an occasional
dribble or minor urine leaks, while others have urges so sudden that they wet
their clothes. Fortunately, the condition is treatable.
One in three women in the U.S. suffers from the problem of urinary incontinence.
There are three basic types of urinary incontinence (UI).
Stress incontinence
– occurs when you put stress on your bladder by
coughing, sneezing, laughing, or exercising.
Urge incontinence
– sometimes called “overactive bladder” – is caused by
involuntary contractions of the bladder muscle that cause sudden, intense
urges to urinate.
Mixed Incontinence
– includes symptoms of both stress and urge
incontinence.
Treatment for UI may entail exercise, drug therapy, or even surgery.
The EmbaGYN Pelvic Floor Exerciser produces a mild electrical stimulation. It
exercises and strengthens the muscles of the pelvic floor by sending a gentle
electrical pulse through the EmbaGYN Trainer. In time, this helps you to regain
your muscle control and improve your symptoms and minimize leakage.
EmbaGYN is most commonly used for stress incontinence, however the
EmbaGYN Control Unit also has modes for urge incontinence, mixed
incontinence, as well as a tone mode; information on these modes is located
at the back of this booklet (see page 21).
You should experience the sensation of a muscular contraction in the vagina
when using EmbaGYN. For best results, try to contract the pelvic floor muscles
by performing kegel exercises along with your use of EmbaGYN and to sustain
the contraction into the rest interval. If possible, link the contraction to your
breathing in order to achieve a gentle rhythm.
HOW TO SET UP AND USE EMBAGYN
™
Setting up and using the EmbaGYN
™
Pelvic Floor Exerciser is very simple.
Step 1: Before you use EmbaGYN for the first time, clean the Trainer gently
with soap and water (do not immerse).
Step 2: Insert two AA batteries into the Control Unit (see “Inserting the
Batteries” page 19 ). To test that the batteries have been inserted correctly
and that the unit is working, press and hold the “ON”
button for three seconds. The screen will light up and
you will hear a beep.
Step 3: Insert the two prongs of the lead wire into the
matching receptacle end of the EmbaGYN Trainer wire.
Step 4: Plug the USB port end of the lead wire directly
into the bottom of the EmbaGYN Control Unit as shown.
Page 6
7 8
Step 5: Before you insert the EmbaGYN Trainer,
empty your bladder (urinate), and make sure
the EmbaGYN Control Unit is switched OFF.
Step 6:
You may want to lubricate theEmbaGYN Trainer with water or a
water-based vaginal lubricant such as K-Y® jelly*.
Step 7: After the wires are securely connected,
insert the Trainer into the vagina, in the same
way you would a tampon, until only the flange
at the end is visible. The Trainer will naturally
position itself with the widest part of the
flange vertically (see diagram).
Note: The flange should not be inserted into the vagina and should remain outside of
the vagina at all times.
It is important to relax and choose a comfortable position – such as a semireclined pose – or to lie down on a bed or couch when performing this step.
Step 8: Turn EmbaGYN ON by pressing the ON button
( ) for three seconds. When the unit is switched ON
an audible “beep” will be heard.
*K-Y Jelly is a registered trademark of Johnson & Johnson
Step 9: Press the P button on the unit to select the
program that was recommended by your physician.
Treatment programs include Stress, Urge, and Mixed,
as well as a Tone program for continued periodic
maintenance after you have reached your goal.
For assistance with program selection,
see Preset Program section on page 21.
Note: EmbaGYN will default to the Stress Mode the first time the unit is
turned on.
Step 10: After insertion, adjust the strength by
pressing the strength up ( ) button. The selected
intensity will appear on the display. Begin to
increase the strength to a level where you feel the
sensation but is not overly painful. You may not feel
any sensation until the strength reaches a certain
level. This level may vary based on individual use and
any pre-existing physical conditions, but stimulation
occurs as soon as the strength is registered above 0.
Note: It is important to be conservative upon initial use. As long as you can feel
the contraction, EmbaGYN is working. You can build up the strength slowly over a
number of days.
During use you may feel cramping. If this happens, stop using the EmbaGYN
until the cramping goes away, then start again using a lower strength and a
shorter treatment time. As your pelvic floor begins to strengthen, it will be
possible to maintain the stimulation for a longer duration.
TRAINER FLANGE
Page 7
9 10
Step 11: To decrease intensity, press the strength
down ( ) button. See “Preset Programs” on page 17
for further details on how to use these buttons for
selecting the proper strength for you.
NOTE: EmbaGYN
™
cycles between active stimulation
and periods of rest to allow your muscles to recover
between contractions. It is normal to feel the stimulation ramp down, stop
briefly, and then ramp back up again during treatment. (During the “rest”
period, the strength display flashes “000”.)
Step 12: The length of each session is automatically set at 20 minutes.
This
time can be adjusted (see “Time Selection Button” on page 14 ) if your
physician recommends a longer or shorter session.
Step 13: When the timer reaches zero, your session is complete. Press and
release the OFF button once to turn off the power, or it will automatically turn
off.
Step 14: Remove the EmbaGYN Trainer from your vagina by grasping the
trainer flange and gently pulling outward. It is important that you do not pull
from the wires, as it may become disconnected at the two-prong connection.
Step 15: Wash and thoroughly dry the EmbaGYN Trainer before placing it and
the EmbaGYN Control Unit into the storage pouch.
Note: As with any new exercise regimen, with the first few sessions your muscles
may be a bit sore the next day.
Note: EmbaGYN™ has a Usage Memory that records the length of each session
and the strength level you used. The next time you turn on the unit, it will
default to the mode last used but at half strength. Thus, it may be beneficial
for you to adjust the intensity to the desired setting for your next treatment
session prior to turning off the EmbaGYN Pelvic Floor Exerciser.
EMBAGYN™ “SMART FEATURES”
EmbaGYN™ Pelvic Floor Exerciser is designed with state-of-the art electronic
features including:
• Controllable Stimulation
The strength of the stimulation is under your control. You can gradually
increase or decrease the intensity whenever you want to make sure the
stimulation always feels comfortable.
• Easy Start – One Touch Memory
The EmbaGYN has intelligent memory that enables the unit to remember the
last settings you used, and return to similar settings at your next use.
• Usage Memory
EmbaGYN also has Usage Memory that records the length of each session and
the strength level you used. This can help you keep track of your progress.
To activate hold down the Time Selector and strength UP buttons together for
3 seconds. The screen will show the time in hours (to the nearest hour) and
strength in mA. Hold down Time Selector and strength DOWN button together
for 3 seconds to reset the memory to zero.
• Automatic Safety Shutoff
This feature automatically turns the device off after 20 minutes of use to
protect the pelvic floor muscles from being overworked. If your physician
recommends sessions that are longer than 20 minutes, you can adjust the
device to override the safety shutoff and allow a longer session.
Page 8
11 12
EMBAGYN™ CONTROLS
Memory Start
If you turned the unit off before completing the session, it will automatically
start in the program you used last, at about
5
0
% of the strength level you
were using. This way you can adjust the strength comfortably for each new
session.
Strength UP( ) Button
To increase strength: Press and hold the Strength UP
button until your desired strength is displayed on the
screen. You may not feel any initial sensation, as it is
a gentle increase of intensity. To increase the strength,
press and release the button until you reach your
required level. The strength will increase in 0.5
increments up to a maximum of 100.
Strength DOWN ( ) Button
To decrease strength: Press and hold the Strength
DOWN button until the desired strength is achieved.
To decrease the strength, press and release the
button until you reach your desired level.
ON ( ) Button
To turn EmbaGYN ON: Press and hold the ON
button for three seconds. When the unit turns on,
you will hear a beep.
Note: The first time you use the EmbaGYN Pelvic Floor
Exerciser, it will be set for the Stress program.
Page 9
13 14
Program ( ) Button
EmbaGYN has four preset programs.
The fir
st time you use the device, it will
automatically be set to the Stress Program.
To change the program, simply press the “P” button.
The screen will show the program selected. The next
time you turn the device on, it will automatically
display the last program you used.
Lock Button
The Lock button can be used to lock all the controls
except for the strength down and OFF buttons. This
way you won’t accidentally change the settings while
you use the unit, but you still have the ability to
decrease the strength at any time. To lock the unit,
press and hold down the Lock button for three
sec
onds until LOCK is displayed on the screen.
To unlock the unit, simply repeat.
T
ime Selector ( ) Button
The EmbaGYN Pelvic Floor Exerciser counts down
t
he minutes of your session. This countdown is
displayed on the screen. When the count reaches
zero, the unit will automatically turn off.
Each time you switch on the EmbaGYN, the time selector will be set at 20
minutes. Your physician may advise you to use EmbaGYN for a shorter or
a longer period. You can change the length of your program by repeatedly
pressing and releasing the Time Selector button. This allows you to select a
program length of 10, 20, 30, 45, 60, or 90 minutes or continuous time (i.e.,
until you turn it off manually). The length of time that you have selected will
be displayed on the screen.
To PAUSE the session – in case you need to suspend the treatment
session and resume later – hold down the Time Selector button for three
seconds. The display will read “PAUSE”.
To return to the main screen, press any other key and you will return to the
settings where you left off.
Only adjust the Timer in accordance with the advice of your treating physician.
OFF ( ) Button
To turn EmbaGYN OFF: Press the OFF button.
Y
ou will hear a double beep.
NOTE: Always make sure the unit is OFF before
removing the EmbaGYN Trainer from your vagina.
Lock
Button
Page 10
15 16
SCREEN DISPLAYS
The screen lights up whenever a button is pressed.
U
SAGE MEMORY
EmbaGYN
™
has a usage memory that remembers the average strength and
the length of time of your session.
To activate the Usage Memory, hold down both the
Time
Selector ( ) and strength up ( ) buttons
together for three seconds.
The screen will show the strength and the time in
u
nits of 10 minutes. To reset the memory to zero,
hold down the Time Selector ( ) button and strength
down ( ) button together for three seconds.
LEADS ALARM
EmbaGYN monitors the contact between you, the
T
rainer, and the EmbaGYN Control Unit. If either
of these go outside of a standard range, while the
strength is above 20.0, the unit will flash “LEADS”,
beep three times, and return strength to zero.
The mos
t common causes are:
• Poor contact with your vaginal walls.
• A broken lead wire.
• A faulty connection at the USB port or at the dual trainer connectors.
If the LEADS alarm sounds, make sure the wires are connected properly.
If
that doesn’t solve the problem:
• Change the position of the trainer in the vagina; or
• Change your body position; or
• Add lubrication to the EmbaGYN Trainer so that it can make a better
contact with the vaginal tissue.
If you have taken the above steps above and the alarm still shows, please
refer to Troubleshooting section for further information.
Page 11
17 18
STRESS INCONTINENCE PROGRAM
There are three basic types of urinary incontinence – Stress, Urge, and Mixed.
Although EmbaGYN is most commonly used for stress incontinence, the
EmbaGYN
™
Pelvic Floor Exerciser also has preset treatment programs for the
others. EmbaGYN also has a fourth preset program for toning, to keep your
pelvic floor muscles toned after you’ve reached your treatment goal. Each
program produces a slightly different sensation and cycle of stimulation.
Stress incontinence occurs when you exert your bladder by coughing,
sneezing, laughing, or by physical exertion. The Stress Incontinence program
uses gentle stimulation to strengthen the muscles of the pelvis.
Once strength improves, these muscles are better able to resist urinary
leakage caused by stress to the bladder.
When you use EmbaGYN to treat stress incontinence, the muscles must
contract in order to give a benefit. You should experience the sensation of a
muscular contraction in the vagina when using EmbaGYN. Your natural reac
tion will be to pull your muscles in and up. This is good, because it exercises
and strengthens the muscles.
Set the strength level to that prescribed by your physician. If you experience
discomfort, then reset the intensity down one step. Don’t “overdo” it early on.
As long as you can feel the contractions, EmbaGYN is working properly.
Your muscles may be sore the next day – the same reaction you would get
with any new exercise – and you may need to stop using your EmbaGYN for
a day or two until the soreness goes away, then start again using a lower
strength and shorter treatment time. As the pelvic floor muscles get stronger,
you will be able to increase your strength level and time.
For best results, try to contract your pelvic floor muscles while you use the
EmbaGYN and try to hold the contraction into the rest interval. Matching the
rhythm of your breathing with the contractions may help you relax.
NOTE: EmbaGYN™ cycles between active stimulation and periods of rest. It is normal
to feel the stimulation ramp down, stop briefly, and then ramp back up again during
treatment.
EmbaGYN™ must only be used as directed by your physician.
The preset programs are guidelines only, and may be modified to conform
to your physician’s recommendations. Use EmbaGYN for the time period
directed by your physician.
It is important to use EmbaGYN at the same time each day, and to use the
patient daily diary that is supplied in the packaging to keep a record of any
leakage or wetting episodes so that you can monitor your progress over time.
Display reads “STRES”
Page 12
19 20
BATTERY USE
Inserting the Batteries
Open the battery cover:
Press down in center of battery
c
over and slide the cover
downwards in the direction of
the raised arrows.
Insert the batteries in the direction shown inside the case. Make sure that the
ribbon goes behind the batteries, which makes them easier to remove later.
When the batteries are running low, a low battery indicator will show on the
screen (battery symbol) and the display will begin to fade. The intensity of
your workout, however, will stay the same until the battery runs out and the
unit shuts off.
Battery removal and replacement:
When the batteries need to be changed the low battery sign, “BATT”, will
be displayed on the screen. To remove batteries, pull gently on the ribbon
behind them. Remove batteries from your EmbaGYN unit if the unit is unlikely
to be used for a long period.
Battery type:
ONLY use either AA alkaline batteries or NiMH AA rechargeable batteries. DO
NOT mix batteries of different types. Do not try to recharge alkaline batteries.
Properly dispose of used batteries, as batteries
should not
be disposed of with household waste.
Warning:
• Keep batteries out of the reach of small children
• If battery leakage occurs and comes in contact with the skin or eyes, wash
thoroughly with lots of water.
• Do not attempt to revive alkaline batteries by heating, charging or other means
• Never put batteries in a fire nor try to disassemble them
EMBAGYN™ CLEANING AND STORAGE
Cleaning the Trainer
It is important to clean the EmbaGYN Trainer after each use to prevent
b
acterial growth that could possibly lead to an increased risk for infection.
Wash the trainer with warm soapy water and then wipe the trainer with an
alcohol wipe, and dry thoroughly. DO NOT immerse the trainer under water,
or in boiling water, as this will damage it.
The Trainer that is supplied with the EmbaGYN
™
Pelvic Floor Exerciser is
intended strictly for one person’s use. Do not let anyone else use your EmbaGYN.
Cleaning the EmbaGYN™ Control Unit
Clean the EmbaGYN Control Unit weekly with a cloth or paper towel dampened
with soapy water, but DO NOT immerse it under water. Dry it with a clean cloth
and make sure it is fully dry before storing the unit in its pouch.
Storing Your EmbaGYN
™
Pelvic Floor Exerciser
• Store EmbaGYN in its pouch.
• Do not store at high temperatures or in damp conditions.
• Do not store or use near a microwave oven.
• Remove batteries if storing for more than 30 days.
Page 13
21 22
Set the strength level to that prescribed by your physician. If you experience
discomfort reset the intensity down one step. Don’t “overdo” it early on. As
long as you can feel the contractions, EmbaGYN is working properly. You can
build up slowly over a number of sessions.
Your muscles may be sore the next day – the same reaction you would get
with any new exercise – and you may need to stop using your EmbaGYN for
a day or two until the soreness goes away, then start again using a lower
strength and shorter treatment time. As the pelvic floor muscles get stronger,
you will be able to increase your strength level and time.
For best results, try to contract your pelvic floor muscles while you use the
EmbaGYN and try to hold the contraction into the rest interval. Matching the
rhythm of your breathing with the contractions may help you relax.
Once the pelvic floor has been strengthened using EmbaGYN, it is important
for you to continue to exercise these muscles. This is why EmbaGYN features
a “tone” program as well.
TONE
The Tone program helps maintain your muscle tone
after you have reached your desired results. You
will feel a repeated drawing in, and then releasing,
of the pelvic floor muscles. With your physician’s
approval, use the Tone program two to three times
each week, or as often as you need, to keep the
results you achieved with your original program.
Other Programs
URGE INCONTINENCE
Urge incontinence – sometimes called “overactive
bladder” – is caused by involuntary contractions
of the bladder muscle. This results in sudden
urges to urinate and involuntary urine loss. The
Urge Incontinence program reduces these bladder
contractions.
The Urge Incontinence program works differently from the Stress program.
Instead of feeling contractions, you will feel a longer and softer stimulation of
the pelvic floor. As long as you can feel the stimulation, the treatment is working.
You may need to increase the strength during the treatment session.
MIXED INCONTINENCE
Use the Mixed Incontinence program if you have
both stress and urge incontinence symptoms, or
if directed by your physician. This program uses a
strength level midway between the Urge program
and Stress program.
The Mixed Incontinence program exercises the
pelvic floor muscles, and requires these muscles to contract. You should
experience the sensation of a muscular contraction in the vagina when using
EmbaGYN.
Display reads “URGE”
Display reads “MIXED”
Display reads “TONE”
Page 14
23 24
TROUBLESHOOTING
If you have problems with the operation of your EmbaGYN™ Pelvic Floor
Exerciser, follow these directions:
Fading display or no display
–
The display will begin to fade as the batteries run low, and there will be
nothing on the display when there is no power left in the batteries. Make sure
the batteries are charged and inserted correctly. If necessary, replace them.
(For more information, see “Battery Use” on page 19)
Controls won’t work
–
The unit may be on LOCK, in which case the display will read “LOCK”. Hold
down the Lock button on the side for three seconds. If “LOCK” is not showing
on the display, remove and replace the batteries.
No sensation / No leads alarm –
If you feel no sensation when you use EmbaGYN, first try increasing the
strength level according to instructions. If that does not work, dampen your
hand with water and a little table salt. Holding the Trainer in your hand,
increase the strength gradually. If you don’t feel anything, the unit may need
to be replaced.
NOTE: If you are able to feel the sensation in your hand but not in your vagina, you
may have nerve damage. Stop using EmbaGYN and call your physician
PATIENT DAILY DIARY
The Patient Daily Diary will help you keep track of your EmbaGYN™ sessions
and your results. Bring the diary with you to your physician appointments,
so your physician can monitor your progress and adjust your EmbaGYN
treatment regimen if necessary.
Page 15
25 26
CUSTOMER SUPPORT
LIMITED WARRANTY AND DISCLAIMER
LIMITED WARRANTY
This Limited Warranty is expressed for the sole benefit of the person purchasing
the unit for use of the device and is intended for one single user only and is
not transferrable. For the purpose of this Limited Warranty, Purchaser shall
mean consumer other than for purpose of resale. Misuse of the product shall
render this warranty as void.
Duration of the Warranty:
If you still have any issues with your EmbaGYN™ Device after reading this
manual please contact us .
Customer Support by phone at: 1-866-735-8423
or by email at: Support@RenoviaInc.com
and a customer representative will be happy to assist you.
TensCare warrants products, components, and accessories to be
free from defect in workmanship and materials for a period of
ninety (90) days from the date of purchase. Batteries are not
included in this warranty.
During the Warranty Period, TensCare shall, at its option, replace or repair
products found or shown to be defective at no expense to the Purchaser.
Extent of Warranty Coverage: This warranty applies to EmbaGYN™ Pelvic
Floor Exerciser medical device and its components (i.e., EmbaGYN
replacement Trainer and lead wires only
TensCare is not liable for defects due, in its judgment, to abuse, lack of
proper maintenance, storage, negligence, accident, or misuse by the
Purchaser. Further, any of the foregoing acts or events shall void this
warranty with respect to both the device and/or components and TensCare
shall have no further responsibility with regards thereto.
).
Page 16
27 28
TensCare's sole obligation in the case of any breach of the Limited
• Has been repaired or modified by the purchaser or which has been
subjected in whole or in part, to misuse, misapplication, abuse,
neglig
ence, alteration, inappropriate storage, freight damage,
accident, tampering, or failure to seek and obtain repair in a
timely manner.
• Has not been installed, used, or properly cleaned and maintained
as required in the product Instruction Manual and related printed
material for the applicable product;
• Is not an authorized EmbaGYN part or accessory.
Warranty set forth above shall be, at TensCare's option, to repair or
replace the Product or parts of the Product without charge to Purchaser.
• Replacement Authorization Number from TensCare or authorized agent
must be received prior to the return of an EmbaGYN pelvic floor exerciser or
part and only items having a replacement authorization number shall be
replaced.
• EmbaGYN Control Unit – the warranty covers defects within a period
of 90 days after purchase. In order to recover under the Limited
Warranty, see Returns and Replacement Section and provide the
following :
• Description setting forth the problem in reasonable detail
prior to expiration of warranty period.
• Evidence of purchase.
• Obtain a Return Authorization Number.
• It is the purchaser’s responsibility to package the product safely for
transportation, as TensCare will not be responsible for damage due
to improper packaging or shipment.
• Upon receipt of the returned product, TensCare will inspect it and
either repair the product or send a replacement at the discretion of
TensCare
• It is the Purchaser’s obligation to comply with the warranty and
return instructions set forth either by TensCare or its authorized
agent.
Procedure to Obtain Warranty Performance – Contact TensCare by mail or
phone (see Customer Support section) prior to sending device. A return
authorization number must be obtained prior to return of any device.
This Limited Warranty is voided immediately as to any EmbaGYN which:
Page 17
29 30
Disclaimer of Warranties and Limitation of Liability.
PRODUCT SPECIFICATIONS
Maximum Intensity 50V zero to peak. Setting 0-100 in steps of 0.5
OC cutout below 160 Ohm. Constant current 160-470 Ohm
470-2000 Ohm constant voltage
Channels Single
Waveform Asymmetrical rectangular
Max Pulse energy *Total output limited to 25uC per pulse
Power 2 x AA Alkaline OR 2 x AA NiMH
Battery life At least 15 hours at 50mA 300uS 50Hz
Adjustable Timer 10, 20, 30 45, 60, 90 min defaults to 20 min
Pause button “Clock” key when running
Output plug Fully shielded: touch-proof mini USB
Weight 90 gms without batteries
Dimensions 110 x 53 x 30 mm
Safety Classification Internal power source.
Type BF Designed for continuous use.
No special moisture protection.
En
vironmental Operating: Humidity: 20% - 65% RH
Storage Humidity: 10 to 90% RH
Temperature range: 0°C to 55°C
Temperature range 0°C to 35°C
The electrical specifications are nominal and subject to variation from the listed
values due to normal production tolerances .
TENSCARE MAKES NO WARRANTIES, EXPRESS OR IMPLIED, IN FACT OR IN
LAW, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. TO THE
EXTENT THAT THE APPLICABLE JURISDICTION LIMITS TENSCARE'S ABILITY
TO DISCLAIM ANY IMPLIED WARRANTIES, THIS DISCLAIMER SHALL BE
EFFECTIVE TO THE MAXIMUM EXTENT PERMITTED.
No Liability for Consequential Damages.
UNDER NO CIRCUMSTANCES SHALL TENSCARE,
ITS DIRECTORS, OFFICERS, EMPLOYEES, OR AGENTS BE LIABLE TO BUYER OR
THER PARTY FOR INDIRECT, CONSEQUENTIAL, SPECIAL, INCIDENTAL,
ANY O
PUNITIVE, OR EXEMPLARY DAMAGES OF ANY KIND (INCLUDING LOST
REVENUES OR PROFITS OR LOSS OF BUSINESS) RESULTING FROM THE
FURNISHING, PERFORMANCE, OR USE OF ITS PRODUCTS DUE TO A BREACH
OF CONTRACT, BREACH OF WARRANTY, OR THE NEGLIGENCE OF TENSCARE
OR ANY OTHER PARTY, EVEN IF TENSCARE IS ADVISED BEFOREHAND OF THE
POSSIBILITY OF SUCH DAMAGES.
Page 18
31 32
PROGRAM SETTINGS
Device Output Parameters and Waveform
The waveform below illustrates a typical output waveform from the EmbaGYN
device:
Max Pulse Energy: 23 µC
Use special precautions regarding EMC according to
the information provided below.
• Other portable and mobile RF communications equipment
can affect performance.
• Do not use when adjacent to or stacked with other
electrical equipment.
Program Hz Pulse Ramp Up & Plateau Off Default Program
Width (µS) Down (Sec) (Sec) (Sec) Duration (Min)
STRESS 50 300 1 5 10 20
URGE 10 200 1 5 10 20
MIXED 20 250 2 5 10 20
TONE 35 250 2 3 6 20
EMB-1001 10/12
TensCare
Tel: +44 (0) 013 7272 3434
Email: sales@tenscare.co.uk
www.tenscare.co.uk
Page 19
TensCare
Tel: +44 (0) 013 7272 3434
Email: sales@tenscare.co.uk
www.tenscare.co.uk
Loading...