Table of Contents
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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
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.
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for the first time
™
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.
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