Nu-Tek Levator Elite LE9011 User manual

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Levator Elite LE9011
Nu-Tek® Levator Elite
Single Channel EMG, EMS & ETS
• EMG Triggered Stimulation (Passive +Active), Muscle
Stimulation and EMG Modes
• One channel EMG and One channel EMS stimulation
• One channel ETS with stimulation on one channel
• Nu-Tek scale scoring for Pelvic Floor Muscle and used as
an assessment tool
• Programs for Incontinence treatment, Pelvic floor muscle
development and neuromuscular Rehabilitation
• User programs for EMG/ETS (1 phase) and STIM (up to 5
stimulation phases) mode
Application:
• Promote continence
• Improve Pelvic floor Exercise
• Re-educate the Pelvic muscles
NULEADPATRD Nu-Tek Patient Lead- Red
NULEADEARTH Nu-Tek Earth Lead - Black
ACPROBEV Incontinence Probe - Vaginal
ACF35050 AllCare Electrodes - 5cm x 5cm - Square-
Self Adhesive
Standard Accessories:
NUSOFTWARE Nu-Tek Biofeedback Soware
ACPROBEA Incontinence Probe - Anal
ACF35090 AllCare Electrodes - 5cm x 9cm - Rectangle
- Self Adhesive
ACF350R AllCare Electrodes - 5cm - Round
- Self Adhesive
Optional Accessories:
Specifications:
Power Supply: 1.5V AA baeries, 6V
Low Voltage Warning: ≤4V±0.2V
Dimensions: 139mm×68mm×33mm (L*W*H)
Weight: 156g (without baeries)
EMG: One Channel:
EMG Range: 0.2 to 2000μV
Sensitivity: 0.1μV
Accuracy: 4% of μ V reading, +/- 0.3μV at 200 Hz
Work/Rest Periods: 2-99 seconds
STIM: One Channel:
Stimulation Intensity: 90V±10V (V max), Adjustable from 0 to
90mA (on 1000Ω)
Pulse Width: 50-450μS (2% accuracy)
Pulse Rate: 2-100Hz (2% accuracy)
Work/Rest periods: 1-99 seconds
Ramp Time (up and
down): 0.1-9.9 seconds
Treatment Time: 1-99 minutes
Programs Pre-set: 11 Customs:3
Code: Description:
NULEVATOR Nu-Tek® Levator Elite

Nu-Tek Levator Elite
User Manual
www.nutekmedical.com

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Nu-Tek Levator Elite User Manual
Table of Contents
Contents
Warnings--------------------------------------------------------------------------
Introduction----------------------------------------------------------------------
Contra-Indication and Precautions-----------------------------------------
Keypad Layout-------------------------------------------------------------------
Lead / Electrode connection Assembly-----------------------------------
Quick start instructions--------------------------------------------------------
Clinical Mode - Program - Phase--------------------------------------------
EMG mode operation--------------------------------------------------
Examples of EMG treatment-----------------------------------------
EMG Parameters--------------------------------------------------------
EMG and ETS Threshold----------------------------------------------
EMG in patient mode -------------------------------------------------
EMG measurement-----------------------------------------------------
Conditions respond to EMG-----------------------------------------
STIM mode operation-------------------------------------------------
STIM Parameters--------------------------------------------------------
ETS mode operation---------------------------------------------------
ETS Parameters---------------------------------------------------------
Data Report for progress-----------------------------------------------------
System setting----------------------------------------------------------------
Statistics--------------------------------------------------------------------------
More about EMG statistics----------------------------------------------------
Electrodes Types and Tips----------------------------------------------------
Care, Maintenance, Accessories and Disposal--------------------------
Specications--------------------------------------------------------------------
Information regarding Electromagnetic
compatibility and interference (EMC)------------------------------------
Trouble shooting---------------------------------------------------------------
Warranty--------------------------------------------------------------------------
Appendix-program------------------------------------------------------------
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Issue Date: 06/05/2016 Document Number: LE9011-Rev. V1.1 2016
c
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Nu-Tek Levator Elite User Manual
Warnings
※This device must be used with the guidance of a Physiotherapist or Doctor.
※Type BF equipment, Continuous Operation.
※Do not immerse device into water or any other substance.
※Do not use the device in the presence of a ammable anaesthetic gas
mixture and air or with Oxygen or Nitrous Oxide.
※This device uses 4 x AA Batteries. If using rechargeable Nickel Metal
Hydride batteries, be sure to use a CE approved battery charger. Never
connect it directly to a battery charger or to any other mains powered
equipment.
※To avoid the eects of electromagnetic interference, never use the device
in the EMG mode, within 4 metres of a mobile telephone or near any
other powerful radio interference producing equipment that causes
electrical sparks etc. In the EMG mode, the device may be susceptible to
strong interfering radio type emissions that may lead to temporally
increased EMG microvolt readings. The reading will immediately return
to the correct value when the interference ceases. (Remember that a
relaxed muscle should read below 4μV).
※Patient electrodes including all skin surface electrodes, vaginal and rectal
probe are for single patient use only!
※Do not use stimulation on your facial area unless you are under strict
guidance from a qualied clinician.
※Application of electrodes near the thorax may increase the risk of cardiac
brillation.
※Operation in close proximity (e.g. 1m) to a shortwave or microwave
therapy equipment may produce instability in the stimulator output.
※Simultaneous connection of a patient to a high frequency surgical
equipment may result in burns at the site of the stimulator electrodes
and possible damage to the stimulator.
※No modication of this equipment is allowed!
※Keep the device out of reach of children
※Skin irritation from the electrode gel and electrode burns are potential
adverse reactions. If skin irritation occurs, discontinue use and consult
your physician.
※Do not apply stimulation over the patient's neck because this could cause
severe muscle spasms resulting in closure of the airway, diculty in
breathing, or adverse eects on heart rhythm or blood pressure.
※Do not apply stimulation in the presence of electronic monitoring
equipment (e.g., cardiac monitors, ECG alarms), which may not operate
properly when the electrical stimulation device is in use.
Device name: Nu-Tek Levator Elite Model number: LE9011

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Nu-Tek Levator Elite User Manual
Introduction
The Nu-Tek Levator Elite combined EMG [electromyography] and
Neuromuscular Stimulation is a simple to use advanced product for reducing
incontinence in females with urinary incontinence. The device has been
developed to enhance and support the Clinician, to assist the end user at
home to learn more about their Pelvic muscle and above all to improve their
Pelvic Muscle strength and their incontinence therapy.
The Nu-Tek Levator Elite: EMG Biofeedback measures the Pelvic contraction,
and assists users to maximise Pelvic oor exercises, after periodic training, it
also helps to assess the pelvic oor muscle condition, quantify the need for
further treatment and evaluate report on the patient’s progress. Muscular
Stimulation improves blood circulation, capillary bed density and strengthens
the Pelvic oor muscles. EMG triggered stimulation facilitate those with
accid muscles; ETS helps reduce the symptoms in Genuine Stress
incontinence in some patient’s and is being used more frequently by
clinicians for this condition
For the end user, in patient mode, a simple and easy to understand EMG
Biofeedback bar graph displays the Nu-Tek pelvic muscle strength
grading on a scale of 1 to 6, and assists the user to meet their pre-set targets.
In the therapy mode, the EMG graph can be changed to a waveform format,
as viewed on the LCD screen of the device or using the Nu-Tek software
link on a desk top or laptop computer . The waveform can be used to
help analyse the patient’s condition. Periodically the doctor or therapist will
be able to download newly developed programs for Muscle Stimulation, EMG
Biofeedback and EMG- TRIGGERED STIMULATION. This helps this unique
product to keep abreast of any clinical trials where the conclusion is that a
specic program or program set may assist in enhancing the treatment of
continence. The Nu-Tek Levator Elite has 3 clinical modes: EMG, ETS, and
STIM. Each of these modes has custom programs. The device also includes
pre-set EMG and STIM programs: there are 20 pre-set Pelvic muscle
stimulation programs: Genuine Stress, Urge, Frequency, weekly maintenance.
Lack of sensation, rectal stimulation and several other Patient conditions. One
pre-set EMG program for assessment. The custom program has a diverse
range of parameters that can be programmed by the patient or therapist to
meet individual user conditions. Any one of the pre-set or custom programs
can also be selected freely by the user. The essential performance of the
device are free from the production of unwanted or excessive stimulation
output and free from the display of incorrect numerical values associated
with measure to be performed.

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Nu-Tek Levator Elite User Manual
Customer Care
We welcome constructive comments regarding our equipment particularly
those that might help us to improve existing features, add new ones and / or
develop new products for the future.

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Nu-Tek Levator Elite User Manual
Contra-Indications and Precautions
STIM: Neuromuscular Stimulation (NMS)
Before using this device you must rst seek the advice of your doctor or
therapist.
Neuromuscular Stimulation should not be used by:
※Patients tted with demand style cardiac pacemakers
※During pregnancy (unless medically advised)
※Patients with undiagnosed pain conditions
※Do not place electrodes:
- Over carotid sinus nerves
- Over larynx or trachea
- Inside mouth
- On anaesthetised or desensitised skin
- Do not drive a vehicle while the device is stimulating and attached to
your body
※Skin irritation from the treatment of NMS or EMG itself does not generally
occur. However, rubber electrodes may irritate some skin types, therefore;
in this case we recommend using hypoallergenic self adhesive electrodes.
※The patient should only use the device for what it was prescribed for
※Do not immerse the device in water or any other liquid substance
※Do not use stimulation on your facial area unless you are under strict
guidance from a qualied clinician
EMG
There are no precautions when using EMG unless used for pelvic oor
exercising or assessment. In this case EMG should not be used:
※During menstrual period
※Inammation or infection in the vaginal area or urinary tract.
※With patients who have diminished mental capacity or physical
competence who cannot handle the device properly.
※The absence of sensation due to denervation of the pelvic oor.
※In children - when using internal probe.

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Nu-Tek Levator Elite User Manual
Keypad Layout
1
3
2
4
6
5
1. ON/OFF: press to power on or switch othe device.
2. ESC: press to nish the session (program) or the settings, or return to
previous menu.
3. THRS+ and THRS-: adjust the EMG threshold level (ETS target) and adjust
the other parameters and settings.
4. mA+ and mA -: start the STIM or ETS phase, increase or decrease the
stimulation intensity.
5. OK: press to complete selection
6. , , , : select mode in main menu, or switch parameter and settings.

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Nu-Tek Levator Elite User Manual
Lead / Electrode Connection Assembly
USB cable: Connection to the PC
REF: Reference wire (REF) for precise EMG measurement
CH: dual conductor lead wire for STIM or EMG
Note: The REF EMG lead / electrode is only required for EMG and ETS and
NOT for Neuromuscular stimulation.
The lead wires, electrodes, vaginal probe and REF wires are supplied
as part of the kit.
EV

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Nu-Tek Levator Elite User Manual
Quick Start Instructions
1. Insert four AA batteries
Remove battery cover. Insert batteries as labelled inside the battery
compartment and then replace the back cover.
2. Insert lead wire
Insert the lead wire/s into the sockets of the device. The round black EMG
reference lead wire connects to the round black socket in the top of the
unit; the red stimulation lead wire connects to the red socket.
IMPORTANT! If you don’t use the round EMG reference wire (REF), your
EMG and ETS results will be inaccurate.
3. Skin electrodes/probe placement
When using the EMG or ETS phase, connect the EMG reference lead wire
to a surface skin electrode and place it appropriately on the body, making
sure the skin is free from grease and dirt; repeat the above procedure with
the other two skin electrodes. If using a probe, place the single surface
skin electrode on the thigh area and then insert the probe.
4. Turn on Levator Elite by pressing the ON/OFF button once for 3 seconds.
Note: This product has a Patient Mode which we suggest the general
public use and a Therapy Mode which is more practical for the Clinician.
Selecting the Therapy Mode requires a password. When selected the
Patient Mode, the product would be locked. The details setting method
refer to“Change using mode”of page 27. In Patient Mode, you can not
select the therapy program and set the parameters of the custom
program.
5. The EMG, the Patient Mode uses the Nu Tek bar graph; the Therapy Mode
uses a line graph.
6. There are pre-set (ready to use) programs and custom programs (which
can be adjusted by the patient or therapist in Therapy Mode). The
parameters of pre-set programs can not be changed.
Note: Individual custom programs set for the patient should ideally be
under the guidance of a doctor or therapist in Therapy Mode.
Using the circular button black arrow keys navigate to select EMG and press
the OK button. The screen displays Training Program and Assessment
Program. In Assessment Program, there is only one preset program: Threshold
= 30μV, WIDE Filter, ABOVE Biofeedback sound, Work time = 5s, Rest time =
5s, and 5 Trials, AUTO threshold is advised to be used to see the treatment
progress during periodic training. In the Training program, there are two
custom programs, you can select all the EMG Biofeedback parameters by
using the up and down black arrow keys, and change settings by using the
THRS+ and THRS- buttons. In Patient Mode, the program, work time, rest
time,trial and A/M threshold can not be adjust.