The document provides a user manual for the InWave pelvic muscle stimulator. It describes how to set up the electrodes, program treatment modes for stress or urge incontinence, and operate the device safely. Treatment involves 15-20 minute daily sessions for 1-3 months to strengthen pelvic floor muscles. The device is intended to treat urinary incontinence but should not be used by pregnant women or those with infections or device contraindications.
Neurodyn Aussie Sport is electric current application equipment for applying electrical current via electrodes in direct contact with the patient. It is a transcutaneous neuromuscular stimulator which uses microcomputer technology, that is, it is controlled by a computer, and is operated by touch screen. All the information related to the parameters selected by the physiotherapist will be shown in the alphanumeric liquid crystal display.
Neurodyn Aussie Sport stimulator produces AUSSIE CURRENT (also called Australian Current), a “new generation” of electrical current for stimulation with some advantages on the traditional methods of stimulation (Russian, Interferential, TENS e FES). This technique is non-invasive, non-addictive, and without undesirable side effects.
Neurodyn Aussie Sport is electric current application equipment for applying electrical current via electrodes in direct contact with the patient. It is a transcutaneous neuromuscular stimulator which uses microcomputer technology, that is, it is controlled by a computer, and is operated by touch screen. All the information related to the parameters selected by the physiotherapist will be shown in the alphanumeric liquid crystal display.
Neurodyn Aussie Sport stimulator produces AUSSIE CURRENT (also called Australian Current), a “new generation” of electrical current for stimulation with some advantages on the traditional methods of stimulation (Russian, Interferential, TENS e FES). This technique is non-invasive, non-addictive, and without undesirable side effects.
ShuntCheck is an aid to the detection of flow in implanted cerebrospinal fluid (CSF) shunts. ShuntCheck includes Micro-Pumper, a component which may be used to temporarily increase CSF flow in suspected non-flowing, patent shunts during the ShuntCheck test. ShuntCheck cannot alone diagnose CSF shunt function or malfunction. The clinical diagnosis of CSF shunt function or malfunction, incorporating the flow information from ShuntCheck, should be made only by a qualified neurosurgeon.
Estimulación cardiaca sin cables
08/10/2015 13:30-15:00h Casa del Corazón, Madrid
http://marcapasossincables.secardiologia.es
#marcapasossincables
La estimulación sin cables: resultados a medio plazo
Dr. Lluís Mont Girbau, Hospital Clínic (Barcelona)
@Montgirbau
Neuro-Stim System Neurostim FDA K140530 Electro Acupuncture Devicemcalipo
Neuro-Stim Electro Acupuncture device and Electro Acupuncture Stimulator. The Electro Auricular Device or PENS (Percutaneous Electrical Nerve Stimulation). Neurostimulation pain therapy medical devices deliver a therapeutic electrical signal into auricular nerves to help release endorphins and provide pain relief.
https://www.laserspineinstitute.com/spinal_orthopedic_procedures/neurostim/
Electrical cardiac pacing for the management of bradyarrhythmias
was first described in 1952, and permanent transvenous pacing
devices were introduced into clinical practice in the early 1960s.
ShuntCheck is an aid to the detection of flow in implanted cerebrospinal fluid (CSF) shunts. ShuntCheck includes Micro-Pumper, a component which may be used to temporarily increase CSF flow in suspected non-flowing, patent shunts during the ShuntCheck test. ShuntCheck cannot alone diagnose CSF shunt function or malfunction. The clinical diagnosis of CSF shunt function or malfunction, incorporating the flow information from ShuntCheck, should be made only by a qualified neurosurgeon.
Estimulación cardiaca sin cables
08/10/2015 13:30-15:00h Casa del Corazón, Madrid
http://marcapasossincables.secardiologia.es
#marcapasossincables
La estimulación sin cables: resultados a medio plazo
Dr. Lluís Mont Girbau, Hospital Clínic (Barcelona)
@Montgirbau
Neuro-Stim System Neurostim FDA K140530 Electro Acupuncture Devicemcalipo
Neuro-Stim Electro Acupuncture device and Electro Acupuncture Stimulator. The Electro Auricular Device or PENS (Percutaneous Electrical Nerve Stimulation). Neurostimulation pain therapy medical devices deliver a therapeutic electrical signal into auricular nerves to help release endorphins and provide pain relief.
https://www.laserspineinstitute.com/spinal_orthopedic_procedures/neurostim/
Electrical cardiac pacing for the management of bradyarrhythmias
was first described in 1952, and permanent transvenous pacing
devices were introduced into clinical practice in the early 1960s.
Hướng dẫn sử dụng Testo 435
https://testostore.vn/san-pham/dong-ho-do-da-nang-testo-435-3/
https://testostore.vn/danh-muc/do-ap-suat/may-do-ap-suat-vi-sai/
Hướng dẫn sử dụng máy đo nhiệt độ bề mặt Testo 435-3Tenmars Việt Nam
Hướng dẫn sử dụng máy đo nhiệt độ bề mặt Testo 435-3
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Hướng dẫn sử dụng testo 435-3
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Hướng dẫn sử dụng Testo 435-3
https://testostore.vn/san-pham/dong-ho-do-da-nang-testo-435-3/
https://testostore.vn/danh-muc/do-ap-suat/may-do-ap-suat-vi-sai/
Hướng dẫn sử dụng máy đo đa năng Testo 435 đo nhiệt độ độ ẩm, đo áp suất, tốc độ gió...
Máy đo áp suất đa năng Testo 435: https://testostore.vn/san-pham/dong-ho-do-da-nang-testo-435-3/
Máy đo nhiệt độ bề mặt: https://testostore.vn/danh-muc/do-nhiet-do-do-am/do-nhiet-do-be-mat/
Website: testostore.vn
Hotline: 0914222214
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This manual is written for the PC-200 Spot-Check Monitor.
The manual describes, in accordance with the Spot-Check Monitor’s features and requirements, the main
structure, functions, specifications, correct methods for transportation, installation, usage, operation,
repair, maintenance and storage, etc. as well as the safety procedures to protect both the user and
equipment. Refer to the respective chapters for further details.
The manual is published in English and Creative has the ultimate right to explain the Manual.
For the user's convenience, we provide the latest version of PC software for the Spot-Check Monitor,
which can be downloaded from our website (www.creative-sz.com). Please consult the manufacturer or
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Schwinn 430 elliptical trainer User ManualEllipticalHUB
This is the User manual for Schinn 430 (2013). For detail review of this machine, please visit: https://www.ellipticalhub.com/schwinn-430-elliptical-trainer
The NEUROMOVE is a neurological re-learning tool, a therapy device, which has been proven to help stroke and other patients recover lost movement. Once a stroke has occurred, the brain loses neurons which cause limb weakness or paralysis. The NeuroMove can train healthy neurons to assume functions lost by damaged brain cells; a concept known as Neuroplasticity. This rehabilitation tool can be used even when there is no muscle movement available. It is sophisticated enough to use in the clinic, yet simple enough for patients to use at home. Thirty minutes a day in four to five months can provide dramatic results.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
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Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
2. InWave
Table of Contents
Contact Information / Customer Service / Supplies / Support ........................ 4
About the InWave ........................................................................................... 5
Safety Information .......................................................................................... 6
Sensor and Lead Wire Setup ........................................................................... 9
Programming Instructions ............................................................................... 12
Preprogrammed Modes ................................................................................... 13
Controls........................................................................................................... 15
Operating Instructions..................................................................................... 16
Indications, Contraindications and Warnings………………………..17, 19, 21
Precautions and Adverse Reactions…………………………………..18, 20, 22
Troubleshooting .............................................................................................. 23
Specifications and Accessories ....................................................................... 24
Sensor, Batteries, and Cleaning ...................................................................... 25
Warranty ......................................................................................................... 26
3
3. Zynex Medical
Painezee
Contact Information
1-866-940-7030
0091-9030022402
CUSTOMER SERVICE
Supplies:
To order more electrodes or other accessories
Technical Support:
Questions or problems with using your device
Device Return:
Order a postage paid return envelope to return your
device at no charge
MAIN OFFICE
Billing Questions:
1-800-495-6670
0091-9030022402
Questions regarding insurance benefits and
covered benefits for Durable Medical Equipment
(DME) or questions about an Explanation of
Benefits form you received in the mail
FAX NUMBER
1-800-495-6695
MAILING ADDRESS
Zynex Medical, Inc.
Plot No: 6, Green Avenues,
9990 Park Meadows DriveNizampet Road,
Opp: Bhavysa Anandham,
Kukatpally, Hyderabad - 500090
Lone Tree, CO 80124-6739
Andhra
USA Pradesh, India
info@zynexmed.com
info@painezee.com
EMAIL
WEBSITE
www.zynexmed.com
www.painezee.com
4
4. About the InWave
The InWave is a multiple-mode stimulator which allows users a choice of
treatment options. The InWave causes muscle contractions which exercise and
strengthen the pelvic floor muscles.
Stress Incontinence Treatment
The output delivers electrical impulses at a frequency of 50 Hz, which produce
smooth, even muscle contractions. This type of stimulation exercises and
strengthens the pelvic floor muscles, which aids in the control of stress
incontinence.
Stimulation can be set to 3 or 5 second duration, with a resting period of 5 or
10 seconds between contractions.
Default treatment time is 15 minutes.
Urge Incontinence Treatment
The output delivers electrical impulses at a frequency of 12.5 Hz, which
produce a series of short, rapid contractions. This type of stimulation aids in
the relaxation of involuntary muscle contractions which cause urge
incontinence.
Stimulation can be set to 6 or 10 second duration, with a resting period of 3 or
10 seconds. Default treatment time is 20 minutes.
Mixed Incontinence Treatment
Mixed treatment modes consist of a 2, 5, or 10 minute stress treatment
followed by a 2, 5, or 10 minute urge treatment. This combination of
stimulation types aids in both stress and urge incontinence in the manners
mentioned above.
Caution: Federal law restricts this device to sale by or on the order of a
licensed healthcare practitioner.
5
5. Safety Information
Equipment Classification
As per the International Electrotechnical Commission standard IEC
60601-1, and the European standard EN 60601-1, Medical Electrical
Equipment, General Requirements for Basic Safety and Essential
Performance, the InWave is classified as follows:
Type BF Equipment
A Type BF piece of equipment is one that provides a particular degree
of protection against electric shock, particularly regarding allowable
leakage current. Type BF applied part is one that is floating above
ground and is isolated from all other parts of the equipment.
Medical Device Directive (MDD) Classification
The InWave is a Class IIa medical device per the European Medical
Device Directive.
Internally Powered Equipment
The InWave is powered by an internal, 9 VDC, MN1604, battery, so
it is classified as Internally Powered Equipment.
Electromagnetic Compatibility
Conforms to IEC 60601-1-2.
Temperature
Operating temperature range: 0° - 40° C (32° - 104° F)
Storage temperature range: -20° - 70° C (-4° - 158° F)
Water Ingress
Ordinary equipment. This device does not have protection against
ingress of water.
Flammable Anesthetics
This device is not suitable for use in the presence of a flammable
anesthetic mixture with air, or in the presence of a flammable
anesthetic mixture with oxygen or nitrous oxide.
6
6. Safety Information
Mode of Operation
This device is suitable for continuous operation.
Symbols
Safety symbols shown on the device above are defined below.
On/Standby. This symbol indicates that the labeled switch
electronically cycles the DC power on and off for part of the
equipment.
General Warning Sign.
Follow warnings stated in the
instruction manual to prevent potential hazards.
Refer to Instruction Manual/Booklet. The operator must read,
understand, and follow all instructions in the accompanying
document including all warnings, cautions, and precautions
before using this medical device.
Type BF Equipment. This symbol indicates that the patient
applied parts (electrodes) are Type BF (floating from ground)
offering the user a specific level of safety.
7
7. Waste Electrical and Electronic Equipment (WEEE). This
product may contain substances known to be hazardous to the
environment or to human health. It should be disposed of
properly (for example, at your local waste collection
administration or recycling plant) and in accordance with local
ordinances.
Service and Calibration
Do not remove the cover. There are no user serviceable parts. Refer all
service to authorized personnel. No modification of the equipment is
allowed.
No preventative inspections are required. Factory testing and calibration
ensure equipment accuracy and response. Contact Zynex Medical for
factory re-calibration if necessary.
8
8. InWave
Sensor and Lead Wire Setup
Step 1
Open the sensor package and remove the sensor. Remove the
electrode wire from the packaging, and unbundle the wire.
Note: Only Zynex Medical sensors are approved for use with the
InWave. P/N 400015 are provided standard.
Step 2
Insert the lead wire pin connectors into the sensor connectors as
shown below.
Sensor
Connections
Lead Wire
9
9. InWave
Electrode and Lead Wire Setup (continued)
Step 3
Insert vaginal sensor as shown below. If needed, a small amount of
water-based lubricant can be applied to the tip of the sensor to aid
in insertion. Initial placement of the vaginal sensor and selection of
the treatment program should be performed under the guidance of a
physician. Note: Overuse of a lubricant can cause lack of
stimulation, and lead to ineffective treatment. In order to avoid
treatment interruption, it may be necessary to empty the bladder and
bowels before starting a treatment session.
See the directions included with the sensor for further information.
Note: The vaginal sensors are for single patient use only.
10
10. InWave
Electrode and Lead Wire Setup (continued)
Step 4
Plug the lead wire into the top of the device.
Step 5
Proceed to page 16 to start treatment or page 12 to program device.
Electrode
Connector
11
11. InWave
Device Programming Instructions
Turn device on by pressing the black On/Standby button
1.
2.
3.
Select the desired Modality by pressing the “STRESS”, “URGE”, or
“MIX” button once.
Press the “+” or “-” portions of the Program button until the arrow on the
LCD is next to the desired program.
Press the Treatment Timer button until the desired treatment time is set on
the screen.
The InWave is now ready to use.
On /
Standby
Button
Modality
Buttons
Treatment
Timer Button
12
12. InWave
Preprogrammed Modes
Stress Incontinence Treatment (50 Hz Frequency, 200 µSecond Pulse Width)
Program
Description
5/10
The output signal ramps up to the level set by the user over a
period of 1 second. The output stays on for the remainder of
the 5 second on time, then ramps down to zero over a period of
1 second. The output stays off for the remainder of the 10
second off time. This cycle repeats for the duration of the
treatment time. (Default is 15 minutes.)
3/10
The output signal ramps up to the level set by the user over a
period of 1 second. The output stays on for the remainder of
the 3 second on time, then ramps down to zero over a period of
1 second. The output stays off for the remainder of the 10
second off time. This cycle repeats for the duration of the
treatment time. (Default is 15 minutes.)
5/5
The output signal ramps up to the level set by the user over a
period of 1 second. The output stays on for the remainder of
the 5 second on time, then ramps down to zero over a period of
1 second. The output stays off for the remainder of the 5
second off time. This cycle repeats for the duration of the
treatment time. (Default is 15 minutes.)
Urge Incontinence Treatment (12.5 Hz Frequency, 600 µSecond Pulse Width)
Program
Description
10/3
The output signal ramps up to the level set by the user over a
period of 1 second. The output stays on for the remainder of
the 10 second on time, then ramps down to zero over a period
of 0.5 seconds. The output stays off for the remainder of the 3
second off time. This cycle repeats for the duration of the
treatment time. (Default is 20 minutes.)
6/3
The output signal ramps up to the level set by the user over a
period of 1 second. The output stays on for the remainder of
the 6 second on time, then ramps down to zero over a period
of 0.5 seconds. The output stays off for the remainder of the 3
second off time. This cycle repeats for the duration of the
treatment time. (Default is 20 minutes.)
10/10
The output signal ramps up to the level set by the user over a
period of 1 second. The output stays on for the remainder of
the 6 second on time, then ramps down to zero over a period
of 0.5 seconds. The output stays off for the remainder of the 3
second off time. This cycle repeats for the duration of the
treatment time. (Default is 20 minutes.)
13
13. Mixed Incontinence Treatment
Program
Description
10:10
A 10 minute “5/10” Stress program is run, followed by a 10
minute “10/3” Urge program. This cycle repeats for the
duration of the treatment time. Default treatment time is 20
minutes.
5:5
A 5 minute “5/10” Stress program is run, followed by a 5
minute “10/3” Urge program. This cycle repeats for the
duration of the treatment time. Default treatment time is 20
minutes.
2:2
A 2 minute “5/10” Stress program is run, followed by a 2
minute “10/3” Urge program. This cycle repeats for the
duration of the treatment time. Default treatment time is 20
minutes.
The InWave should be used daily for 15 to 20 minutes per session, for 1 to 3 months,
or as directed by a physician.
14
14. InWave
Device Controls
Display
Attach Lead Wire Here
Lead Wire
Connector
Turns Unit On/Off
On/Standby
Button
Cycles Through Programs
Adjusts Treatment Intensity
Program Select Button
Up and Down Button
Unlocks Control Buttons
Unlock Button
STRESS, URGE, MIX
Modality Buttons
Adjusts Treatment Times
Treatment Timer Button
15
15. InWave
Device Operating Instructions
Start Treatment:
Before starting treatment, the sensor must be inserted and the lead wire must
be connected to the InWave. See pages 9-11 for instructions.
1.
Turn the InWave on by pressing the On/Standby button once, and set the
desired program using the Modality and Program buttons.
2.
Increase the stimulation level by pressing the upper portion of the Intensity
button until a strong but comfortable stimulation level is felt.
NOTE: Output increases in 1/2 mA increments up to the 4 mA level, then
increases in increments of 1 mA.
3.
Once the desired level of stimulation is set, the InWave will automatically
shut off after the preset treatment time (shown on the display.) If the
Treatment Timer has been set to, “No Timer,” then the InWave will need
to be shut off manually. Refer to Programming Instructions on page 12 to
adjust the Treatment Timer.
4.
To turn off the InWave manually, press the On/Standby button.
Note: If “Check Connections!” message is displayed on the screen, see “Display Alerts”
below.
During Treatment:
IMPORTANT: Button controls lock after 20 seconds of inactivity. To unlock
button controls, press the Unlock button.
Increase Intensity:
To increase the intensity, press the upper potion of the Intensity button until
the desired level of stimulation is felt.
Decrease Intensity:
To decrease the intensity, press the lower portion of the Intensity button until
the desired level of stimulation is felt.
Display Alerts:
Check Connections: The lead wire and/or the sensor may not be attached
properly. Check all connections and try again (see page 23). If the problem
persists, call Technical Support (see page 4).
Low Battery: Replace the battery immediately.
Locked: The stimulation level and mode cannot be changed until the Unlock
button is pressed.
16
16. InWave
Indications for Use
Stress Incontinence Mode
Please read the InWave User’s Manual before using the InWave pelvic
muscle stimulator.
CAUTION: Federal law restricts this device to sale by or on the order of a
licensed healthcare practitioner. This device should only be used under medical
supervision for adjunctive therapy for the treatment of medical diseases and
conditions.
Indications
The Zynex Medical InWave is intended to provide electrical stimulation
and neuromuscular re-education for the purpose of rehabilitation of weak
pelvic floor muscles for the treatment of stress, urge, and mixed urinary
incontinence in women.
Contraindications
This InWave should not be used in the presence of the following:
-Where there is a tendency to hemorrhage following acute trauma or
fracture.
-Following recent surgical procedures when muscle contraction may
disrupt the healing process.
-Over the menstruating or pregnant uterus.
-Over areas of the skin which lack normal sensation.
-Irregular menstrual cycles.
-Urinary or vaginal infection.
-History of urinary retention or current symptoms.
Warnings
The long-term effects of chronic electrical stimulation are unknown.
Safety has not been established for the use of the InWave during
pregnancy.
The device is capable of generating currents and voltages in excess of 10
mA RMS and 10 V RMS, respectively. A yellow LED indicator is
provided next to the lead wire connector to show that the unit is delivering
energy for any non-zero value of stimulation output (0.5 to 80 mA).
Discontinue use of this device in the event of pain or bleeding.
Do not use this device in water.
Do not insert the lead wires into a mains power supply.
17
17. InWave
Precautions and Adverse Reactions
Stress Incontinence Mode
Precautions
Stimulation settings should be based on the guidance of the prescribing
practitioner.
This device should be kept out of the reach of children.
This device should only be used with the leads and vaginal sensor
recommended for use by the manufacturer.
This device should not be used while driving, operating machinery, or
during any activity in which involuntary muscle contractions may put the
user at risk of injury.
Caution should be exercised when this device is used by patients with
pacemakers and heart rhythm problems.
Do not use this device while under the influence of drugs or alcohol.
Do not insert or remove the vaginal sensor while the device is ON.
Do not use this device while in the close proximity of wireless devices.
Use this device only as directed.
Do not immerse the unit in water or any other liquid.
The vaginal sensor should not remain inserted in the vagina when the unit
is not in use.
This device should not be used while sleeping or when anything else is in
the vagina, such as a diaphragm or tampon.
Adverse Reactions
Skin irritation and electrode burns are potential adverse reactions.
Safety References
Zynex Medical, Inc. is only responsible for the safety, reliability and function
of the device when repairs and adjustments have been made by persons
authorized by Zynex Medical, Inc., and the device is used in accordance with
the user’s manual. Repairs and technical safety tests shall only be performed
by authorized personnel.
18
18. InWave
Indications for Use
Urge Incontinence Mode
Please read the InWave User’s Manual before using the InWave pelvic
muscle stimulator.
CAUTION: Federal law restricts this device to sale by or on the order of a
licensed healthcare practitioner. This device should only be used under medical
supervision for adjunctive therapy for the treatment of medical diseases and
conditions.
Indications
The Zynex Medical InWave is intended to provide electrical stimulation
and neuromuscular re-education for the purpose of rehabilitation of weak
pelvic floor muscles for the treatment of stress, urge, and mixed urinary
incontinence in women.
Contraindications
This InWave should not be used in the presence of the following:
-Where there is a tendency to hemorrhage following acute trauma or
fracture.
-Following recent surgical procedures when muscle contraction may
disrupt the healing process.
-Over the menstruating or pregnant uterus.
-Over areas of the skin which lack normal sensation.
-Irregular menstrual cycles.
-Urinary or vaginal infection.
-History of urinary retention or current symptoms.
Warnings
The long-term effects of chronic electrical stimulation are unknown.
Safety has not been established for the use of the InWave during
pregnancy.
The device is capable of generating currents and voltages in excess of 10
mA RMS and 10 V RMS, respectively. A yellow LED indicator is
provided next to the lead wire connector to show that the unit is delivering
energy for any non-zero value of stimulation output (0.5 to 80 mA).
Discontinue use of this device in the event of pain or bleeding.
Do not use this device in water.
Do not insert the lead wires into a mains power supply.
19
19. InWave
Precautions and Adverse Reactions
Urge Incontinence Mode
Precautions
Stimulation settings should be based on the guidance of the prescribing
practitioner.
This device should be kept out of the reach of children.
This device should only be used with the leads and vaginal sensor
recommended for use by the manufacturer.
This device should not be used while driving, operating machinery, or
during any activity in which involuntary muscle contractions may put the
user at risk of injury.
Caution should be exercised when this device is used by patients with
pacemakers and heart rhythm problems.
Do not use this device while under the influence of drugs or alcohol.
Do not insert or remove the vaginal sensor while the device is ON.
Do not use this device while in the close proximity of wireless devices.
Use this device only as directed.
Do not immerse the unit in water or any other liquid.
The vaginal sensor should not remain inserted in the vagina when the unit
is not in use.
This device should not be used while sleeping or when anything else is in
the vagina, such as a diaphragm or tampon.
Adverse Reactions
Skin irritation and electrode burns are potential adverse reactions.
Safety References
Zynex Medical, Inc. is only responsible for the safety, reliability and function
of the device when repairs and adjustments have been made by persons
authorized by Zynex Medical, Inc., and the device is used in accordance with
the user’s manual. Repairs and technical safety tests shall only be performed
by authorized personnel.
20
20. InWave
Indications for Use
Mixed Incontinence Mode
Please read the InWave User’s Manual before using the InWave pelvic
muscle stimulator.
CAUTION: Federal law restricts this device to sale by or on the order of a
licensed healthcare practitioner. This device should only be used under medical
supervision for adjunctive therapy for the treatment of medical diseases and
conditions.
Indications
The Zynex Medical InWave is intended to provide electrical stimulation
and neuromuscular re-education for the purpose of rehabilitation of weak
pelvic floor muscles for the treatment of stress, urge, and mixed urinary
incontinence in women.
Contraindications
This InWave should not be used in the presence of the following:
-Where there is a tendency to hemorrhage following acute trauma or
fracture.
-Following recent surgical procedures when muscle contraction may
disrupt the healing process.
-Over the menstruating or pregnant uterus.
-Over areas of the skin which lack normal sensation.
-Irregular menstrual cycles.
-Urinary or vaginal infection.
-History of urinary retention or current symptoms.
Warnings
The long-term effects of chronic electrical stimulation are unknown.
Safety has not been established for the use of the InWave during
pregnancy.
The device is capable of generating currents and voltages in excess of 10
mA RMS and 10 V RMS, respectively. A yellow LED indicator is
provided next to the lead wire connector to show that the unit is delivering
energy for any non-zero value of stimulation output (0.5 to 80 mA).
Discontinue use of this device in the event of pain or bleeding.
Do not use this device in water.
Do not insert the lead wires into a mains power supply.
21
21. InWave
Precautions and Adverse Reactions
Mixed Incontinence Mode
Precautions
Stimulation settings should be based on the guidance of the prescribing
practitioner.
This device should be kept out of the reach of children.
This device should only be used with the leads and vaginal sensor
recommended for use by the manufacturer.
This device should not be used while driving, operating machinery, or
during any activity in which involuntary muscle contractions may put the
user at risk of injury.
Caution should be exercised when this device is used by patients with
pacemakers and heart rhythm problems.
Do not use this device while under the influence of drugs or alcohol.
Do not insert or remove the vaginal sensor while the device is ON.
Do not use this device while in the close proximity of wireless devices.
Use this device only as directed.
Do not immerse the unit in water or any other liquid.
The vaginal sensor should not remain inserted in the vagina when the unit
is not in use.
This device should not be used while sleeping or when anything else is in
the vagina, such as a diaphragm or tampon.
Adverse Reactions
Skin irritation and electrode burns are potential adverse reactions.
Safety References
Zynex Medical, Inc. is only responsible for the safety, reliability and function
of the device when repairs and adjustments have been made by persons
authorized by Zynex Medical, Inc., and the device is used in accordance with
the user’s manual. Repairs and technical safety tests shall only be performed
by authorized personnel.
22
22. Troubleshooting
Problem
Solution
Unit stays on even
after treatment ends.
Hold Off button down for 2 seconds to shut unit off.
Otherwise unit will shut off automatically after 5
minutes of no stimulation. Alternatively you can start
a new treatment session after the last one ends.
Cannot increase level
from its current setting.
Press and release Unlock button to unlock this safety
feature. Then increase stimulation to the desired level
of intensity. Intensity level is always locked after 20
seconds of key press inactivity.
Display shows “Check Check to see that the sensor is properly inserted.
Connections”
(Remove and re-insert the sensor if necessary to
(Electrode alarm).
establish a better electrical contact.) Verify that the
sensor is correctly connected to the lead wire and that
the lead wire is correctly connected to the InWave.
Connect the bare metal pins of the lead wire together
to short-circuit the output. If the electrode alarm ceases
the problem is with the sensor connection integrity.
Removing and re-inserting the sensor may establish a
better electrical contact.
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23. InWave
Specifications and Accessories
Stress Incontinence Mode
Amplitude:
Frequency:
Pulse Width:
Stress Modes:
On Time:
Off Time:
Ramp Up Time:
Ramp Down Time:
Waveforms:
0-80 mA
50 Hz
200 µseconds
5/10, 3/10, 5/5
3 or 5 seconds
5 or 10 seconds
1 second
1 second
Symmetrical biphasic
Urge Incontinence Mode
Amplitude:
Frequency:
Pulse Width:
Urge Modes:
On Time:
Off Time:
Ramp Up Time:
Ramp Down Time:
Waveform:
0-80 mA
12.5 Hz
600 µseconds
10/3, 6/3, 10/10
6 or 10 seconds
3 or 10 seconds
1 second
0.5 seconds
Symmetrical biphasic
Mixed Incontinence Mode
Amplitude:
Frequency:
Pulse Width:
Mix Modes:
On-Time:
Off-Time:
Ramp Up:
Ramp Down:
Waveforms:
0-80 mA
12.5 Hz and 50 Hz
200 µseconds and 600 µseconds
10:10, 5:5, 2:2
3, 5, 6, or 10 seconds
3, 5, or 10 seconds
1 second
0.5 or 1 second
Symmetrical biphasic
Other Specifications
Treatment timer:
5 to 25 minutes, in 5 minute increments.
Compliance meter:
Records total usage time in minutes and number of times
used.
Dimensions:
2.9 x 4.6 x 1.0 in.
Weight:
5.8 oz. including battery
Warranty:
5 year manufacturer’s warranty on materials and
workmanship. Accessories excluded.
Accessories
Lead wire:
104204, lead wire, gray.
Sensor:
400015, vaginal sensor.
Battery:
130010, battery, 9 Volt, alkaline, MN1604.
24
24. InWave
Sensor, Batteries, and Cleaning
Sensor Use
The InWave is intended to be used with a re-usable vaginal sensor. Before and
after each use, clean the sensor with mild soap and water, and dry the sensor.
Store the sensor in a safe location when not in use.
Follow directions of the prescribing physician.
Note: The vaginal sensors are for single patient use only.
Battery Power
One 9 Volt alkaline battery is used to power the InWave. The battery
compartment on the back of the device opens by sliding the cover downwards.
Rechargeable batteries are not recommended since they have only a short
usage time and cannot be charged while in the InWave.
Battery replacement is indicated by the battery icon in the display. Replace
with a new 9 Volt alkaline battery.
The InWave operates normally even if the 9 Volt battery is inserted with
reverse polarity.
Please dispose of used batteries properly.
Device Cleaning
The InWave case and display window can be cleaned by lightly applying mild
soap to a damp soft cloth or paper towel and using it to wipe the surfaces clean.
Allow the unit to dry thoroughly before using. Do not spray cleaning solutions
directly onto the unit, or immerse it in water or other liquids.
25
25. InWave
Warranty Information
The InWave device is warranted to be free from defects in material,
workmanship, and structural integrity when subjected to normal domestic use
and service for five years after the original purchase.
During that time, Zynex Medical, Inc will repair or replace, at its sole
discretion, the InWave device that has been used in a standard manner. This
warranty does not cover misuse or use contrary to the operating instructions
supplied.
Warranty obligations are limited to replacement or repair of defective parts and
components, at the option of Zynex Medical, Inc. This Warranty is only valid
for the original purchaser of this product and will not be honored if the product
ownership is transferred or is resold.
To obtain warranty service, please contact Technical Support at the number
listed on page 4 of this manual.
26