TensCare EmbaGYN User manual

Instructions For Use

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: [phone]
Email: [email protected]
To report a serious problem or adverse experience related to the use of
EmbaGYN™ Pelvic Floor Exerciser, call TensCare.
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

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 stimula-
tion 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
contractions 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/thera-
peutic equipment. Doing so may result in burns at the site of the electrodes
and possible damage to the device.
1 2

• Do not use simultaneously with patient monitoring equipment such as EKG
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.
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
positions 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

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.
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