Mettler Electronics Sys*Stim 294 User manual

Sys*Stim®294
Instruction Manual
®
1333 South Claudina Street • Anaheim, CA 92805, U. S. A.
Toll Free: (800) 854–9305 • Telephone: [phone] • FAX: [phone]
Web Site: http://www.mettlerelectronics.com • Email: [email protected]
IR7–98 Rev.F_09/13/17
Copyright © 1999-2017 by Mettler Electronics Corp.—Anaheim, CA

Mettler Electronics Corp.— Rev.F_09/13/17
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Sys*Stim 294 Instruction Manual— Rev.F_09/13/17
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Table of Contents
Section Title Page
1 Introduction 5
1.1 Introduction to the Sys*Stim 294 5
1.2 Introduction to this Manual 6
1.3 Safety Precautions 6
1.4 Caution 7
1.5 Shipping Damage 7
1.6 Package Contents 7
1.7 Limited Warranty 7
2Symbol Glossary and List of Abbreviations 9
2.1 Symbol Glossary 9
2.2 Treatment Status Indicator Icons 11
2.3 List of Abbreviations 12
3Installation 13
3.1 Installation Instructions 13
3.2 EMC Guidance 14
4Operating Instructions 19
4.1 A Note About Electrodes 19
4.2 General Operating Instructions 20
4.3 Stimulation Set-up Procedure 21
4.4 Electrode Positioning 25
5Indications, Contraindications, Precautions and Adverse
Reactions
29
5.1 Indications for Neuromuscular Electrical Stimulation 29
5.2 Contraindications for Neuromuscular Electrical Stimulation 29
5.3 Warnings for Neuromuscular Electrical Stimulation 30
5.4 Precautions for Neuromuscular Electrical Stimulation 30
5.5 Side Effects/Adverse Reactions for Neuromuscular Electrical
Stimulation
31
6Maintenance and Troubleshooting 33
6.1 Cleaning the Sys*Stim 294 33
6.2 Routine Maintenance 33
6.3 Troubleshooting the Sys*Stim 294 33
7 References 35
8 Specifications 37
8.1 General Specifications 37
8.2 Waveform Specifications 37
8.3 Amplitude Modulation Specifications 41
9Accessories 43
9.1 Ordering Information 43
9.2 Sys*Stim 294 Accessories 43

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List of Figures
No. Title Page
1.1 Sys*Stim 294 5
3.1 Sys*Stim 294, Back view—Mains Power Switch and Line Cord connection 13
3.2 Sys*Stim 294, Front View—Electrode Cable Connections 14
4.1 Front membrane panel and LED indicators 19
4.2 Electrode Sizes and Current Density 20
4.3 Quadpolar Electrode Placement Technique 25
4.4 Bipolar Electrode Placement Technique 26
4.5 Monopolar Electrode Placement Technique 26
4.6 Using the Pencil Electrode 27
8.1 Interferential Waveform 37
8.2 Premodulated Waveform 38
8.3 Medium Frequency (Russian) Waveform 39
8.4 Biphasic Waveform 39
8.5 High Volt Waveform 40
8.6 Microcurrent Waveform 40

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Section 1: Introduction
1.1 Introduction to the Sys*Stim 294
Thank you for purchasing the Sys*Stim 294 four-channel neuromuscular stimulator. The
microprocessor controlled Sys*Stim 294 provides interferential, premodulated, medium
frequency, symmetrical biphasic, high volt and microcurrent waveforms with enhanced
reliability and ease of use.
The four–channel Sys*Stim 294 allows you to utilize up to four different waveforms using
four channels simultaneously. You can choose between several different amplitude
modulation options such as the surge, reciprocation and vector rotation. The interferential
and premodulated modes offer frequency modulation as well as a static frequency option.
Figure 1.1— Sys*Stim 294
The membrane panel provides both tactile and audio feedback when buttons are pressed.
Blinking LED’s guide you through the easy setup routine. The new Treatment Status
Indicator shows you which stimulation waveform has been chosen for treatment. The
status display moves when treatment output is active.
Large, soft-touch control knobs make adjusting stimulation intensity easy to accomplish
with no guesswork involved. Two LED output displays allow you to monitor two
channels simultaneously. These also allow you to adjust both channels of an interferential
protocol simultaneously while monitoring the current.
The Sys*Stim 294 can provide electrical stimulation from four channels. Add the optional
treatment cart to create a mobile treatment center for your office.

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The Sys*Stim 294 was certified by Intertek Testing Services to meet the requirements for
ETL Listing per the following standards:
UL 2601-1-UL Standard for Safety–Medical Electrical Equipment, Part 1:
General Requirements for Safety Second Edition.
CAN/CSA C22.2 NO 601.1 – Medical Electrical Equipment – Part 1:
General Requirements for Safety
IEC60601-2-10 – Safety of Nerve and Muscle Stimulators
In addition, the Sys*Stim 294 meets the following standards for radio frequency emissions:
EN 60601-1-2
EN–55011 (CISPR–11)
Mettler Electronics Corp. has been certified by VTT Expert Services LTD to be compliant
with EN ISO 13485:2003 and MDD 93/42/EEC Annex II requirements. In addition, Mettler
is certified by DQS Medizinprodukte GMBH to be compliant with ISO 13485:2003
(CMDCAS) Canadian Medical Device requirements.
1.2 Introduction to This Manual
Read the contents of this manual before treating patients with the Sys*Stim 294.
This manual has been written to assist you with the safe operation of the Sys*Stim 294. It is
intended for use by the owners and operators of the Sys*Stim 294. The goal of this manual
is to direct the correct operation and maintenance of this unit.
The specifications and instructions presented in this manual are in effect at the time of its
publication. These instructions may be updated at any time at the discretion of the
manufacturer. Please fill in the warranty card to assure that you will be updated on
changes should that become necessary. You may also go to our website at,
http://www.mettlerelectronics.com/product-registration/ , to register your product.
1.3 Safety Precautions
The Sys*Stim 294 operates with high voltages. Qualified biomedical technicians with
training in neuromuscular stimulator service should perform servicing of the Sys*Stim 294
or it should be returned directly to the factory. To maximize safety during use, the unit
should be plugged into a grounded wall outlet. General safety guidelines for medical
electronic equipment should be followed.
Service may be obtained from the manufacturer by sending the Sys*Stim 294 in its original
shipping container to Mettler Electronics Corp., 1333 South Claudina Street, Anaheim, CA
92805, ATTN: Service Department. (Telephone toll free: (800) 854–9305, Email:
[email protected], Alternate telephone number: 1 (714) 533–2221)
NOTE: All warranty repairs must be performed by Mettler Electronics Corp. or by a
service facility authorized by Mettler Electronics to perform warranty repair work.
A service manual for the Sys*Stim 294 is available from Mettler Electronics Corp. for a
nominal charge.

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1.4 Caution
Federal law restricts the sale of this device to, or on the order of, a physician, dentist,
veterinarian or any other practitioner licensed by law of the state in which he practices.
Use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous exposure to electrical energy. The electric energy delivered
by this device may possibly be lethal. Treatment should be administered only under the
direct supervision of a health care professional.
1.5 Shipping Damage
Your new Sys*Stim 294 is shipped complete in one carton. Upon receipt, please inspect the
carton and the unit for visible and hidden damage. If you discover any damage, hold all
shipping materials, including the carton, and call the shipping agent who delivered the
unit. They are responsible for all damage in transit; therefore, all claims should be filed
directly with them. The factory will not be responsible for any damage in shipment, nor
allow any adjustments unless proper formal claim has been filed by the receiver against
the carrier.
The carton in which your new Sys*Stim 294 was received is specially designed to protect
the unit during shipping. Please retain all shipping materials in the event that you will
need to return your unit for servicing. NOTE: All warranty repairs are to be performed by
Mettler Electronics Corp. or an authorized Mettler Electronics warranty repair center.
1.6 Package Contents
Your new Sys*Stim 294 comes complete with all the necessary components to perform
neuromuscular electrical stimulation. Below is a list of items that are included in the
shipping carton.
1. Sys*Stim 294
2. Four electrode cable sets, (ME 2260)
3. Two gray pin to banana adapters, (ME 2027)
4. One package each EZ Trodes, 2" diameter (ME 2221) and 2.75" diameter (ME 2222)
5. Detachable U.L. listed, hospital–grade line cord, (ME 7293)
6. Instruction Manual, Electrical Stimulation & Ultrasound Pocket Guide and Warranty Card
1.7 Limited Warranty
The Sys*Stim 294 neuromuscular electrical stimulator is warranted against defects in
materials and workmanship for a period of two years from date of purchase. During the
applicable warranty period Mettler Electronics Corp. will, at its discretion, either repair or
replace the Product without charge for these types of defects.
For service under this warranty, the Product must be returned by the buyer within the
applicable warranty period to Mettler Electronics Corp. Shipping charges to Mettler
Electronics Corp. under this warranty must be paid by the buyer. The buyer must also
include a copy of the sales receipt or other proof of the date of purchase. If the Product

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is returned without proof of the date of purchase, it will be serviced as an out–of–
warranty product at Mettler Electronics Corp.'s prevailing service rates.
Alteration, misuse, or neglect of the Product voids this warranty. Except as specifically
set forth above, Mettler Electronics Corp. makes no warranties, express or implied,
including without limitation any implied warranty of merchantability or fitness for a
particular purpose, with respect to the Product. If any implied warranties apply as a
matter of law, they are limited in duration to one year.
Mettler Electronics Corp. shall not be liable for any indirect, special, consequential or
incidental damages resulting from any defect in or use of the Product.
Any legal action brought by the buyer relating to this warranty must be commenced
within one year from the date any claim arises and must be brought only in the state or
federal courts located in Orange County, California.
Some states do not allow limitations on how long an implied warranty lasts, or the
exclusion or limitation of incidental or consequential damages, so the above limitations or
exclusions may not apply to the buyer. This warranty gives the buyer specific legal rights,
and the buyer may also have other rights which vary from state to state.

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Section 2—Symbol Glossary
and List of Abbreviations
2.1 Symbol Glossary
Electrical Stimulation Selector
Time display
1
5. 0 0
min s

Time display LED’s. Displays treatment time and numeric values for
frequency, phase duration, on/off times and alphanumeric error codes.
s
 s
Hz

These LED’s will illuminate to prompt the clinician to input either time
in seconds (s), microseconds (μs), or frequency (Hz). The time or the
frequency will be displayed in the numeric time display.
Treatment Status Indicator
12
34

Channel display indicator and selector
1
Numeric keypad for time, frequency or phase duration entry.
Starts treatment and stimulation output.
Stops treatment for the treatment displayed in timer window or acts as
an “Enter” button during treatment setup.
Stops all stimulation output.
Interferential waveform selector—LED is illuminated when this function
is activated.
Premodulated waveform selector—LED is illuminated when this
function is activated.
Medium frequency waveform selector—LED is illuminated when this
function is activated.

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Symmetrical biphasic waveform selector—LED is illuminated when this
function is activated.
High volt waveform selector—LED is illuminated when this function is
activated.
Microcurrent waveform selector—LED is illuminated when this function
is activated.
 s
Phase duration control selector—Press this button during a biphasic
treatment to display phase duration.
Hz
Frequency control selector—Press this button during a stimulation
treatment to display frequency.
+
–
Polarity selector for high volt and microcurrent waveforms.
Amplitude modulation (Vector rotation), used for interferential
waveform only.
Continuous stimulation selector
Surge selector to set on and off times
Reciprocation selector, use for channel pairs 1 & 2 or 3 & 4.
Stimulation output displays
000
LED’s that display the output intensity during a treatment. When the
unit is in the “Hold” mode for electrical stimulation, “--- ---“ will be
displayed.
1324
LED indicators are lit to define which output intensity is being
displayed in the two windows.
Vm
A

A
mA
LED indicators are lit to show the measurement units of the output
intensity being displayed in the window.
Output intensity control knob, rotate knob clockwise to increase output
and counterclockwise to decrease output.
IMains On.

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O Mains Off.
Attention, consult instruction manual.
Symbol for “Consult instructions for use.”
Type BF Equipment—Class I
IPX0 Not suitable for use in the presence of a flammable anaesthetic mixture
with air or with oxygen or nitrous oxide.
CE Mark
2.2 Treatment Status Indicator Icons
Stimulation selected, waiting for waveform type to be selected.
Interferential waveform selected. Display will move to the right when
the outputs are active.
Interferential vector rotation control selected. Display appears to rotate.
Premodulated waveform selected. Display will move to the right when
the outputs are active.
Medium frequency (Russian) waveform selected. Display will move to
the right when the outputs are active.
Biphasic waveform selected. Display will move to the right when the
outputs are active.
High volt waveform selected. Display will move to the right when the
outputs are active.

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Microcurrent waveform selected. Display will move to the right when
the outputs are active.
2.3 List of Abbreviations
Hz — Hertz (pulses per second)
LED — Light Emitting Diode
A — Microampere (1 x 10-6 ampere)
s — Microsecond (1 x 10-6 second)
mA — Milliampere (1 x 10-3 ampere)
ms — Millisecond (1 x 10-3 second)
min — Minutes
s — Seconds
S/N — Serial Number

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Section 3—Installation
3.1 Installation Instructions
1. Connect the line cord to the back of the Sys*Stim 294. (See Figure 3.1)
2. Plug the line cord (ME 7293) into a grounded wall outlet that is rated between 90–240
VAC, 50–60 Hz. Your power supply must match the voltage requirements listed on the
serial number label of your device. Do not connect the Sys*Stim 294 to a power
supply rated differently than that described above.
3. The line cord comes equipped with a standard 3–prong plug. This plug provides
grounding for the Sys*Stim 294. Do not defeat its purpose by using 3–to–2 prong
adapters or any other means of attaching to a wall outlet.
4. Plug the electrode cables (ME 2260) into the electrode cable connections as seen in
Figure 3.2.
5. The Sys*Stim 294 may be susceptible to interference originating from shortwave
diathermy units operating in close proximity to it. Avoid operating the Sys*Stim 294
adjacent to and simultaneously with operating shortwave devices.
6. Do not use sharp objects to operate the membrane panel switches. If the tough outer
layer of the membrane is broken, moisture may leak into the switches resulting in
switch failure.
7. Once you have verified proper functioning of your Sys*Stim 294, using the instructions
in Section 4, please fill in the enclosed self–addressed Warranty Registration Card and
mail it to Mettler Electronics.
Mains Power Switch
Line Cord Connection
Figure 3.1— Sys*Stim 294, Back View—
Mains Power Switch and Line Cord Connection

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Electrode Cable Connections
Figure 3.2— Sys*Stim 294, Front View—
Electrode Cable Connections
3.2 EMC Guidance
CAUTION: Medical Electrical Equipment needs special precautions regarding Electromagnetic
Compatibility (EMC) and needs to be installed and put into service according to the EMC
information provided in the following tables.
Portable and mobile Radio Frequency (RF) communications equipment can affect Medical
Electrical Equipment.
Accessories: Hospital Medical grade power cord of a maximum length of 120 inches
WARNING: The use of accessories, other than those specified, except those supplied or sold by Mettler
Electronics Corp., as replacement parts for internal or external components, may result in
increased EMISSIONS or decreased IMMUNITY of the Sys*Stim 294.
Guidance and manufacturer’s declaration – electromagnetic emissions
The Sys*Stim 294 is intended for use in the electromagnetic environment specified below. The customer or
the user of the Sys*Stim 294 should assure it is used in such an environment.
Emissions Test Compliance Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1 The Sys*Stim 294 must emit electromagnetic energy in order to
perform its intended function. Nearby electronic equipment
may be effected.
RF emissions
CISPR 11
Class B The Sys*Stim 294 is suitable for use in all establishments other
than domestic and those directly connected to the public low-
voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions
IEC 61000-3-2
Applicable
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Applicable

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Guidance and manufacturer’s declaration – electromagnetic immunity
The Sys*Stim 294 is intended for use in the electromagnetic environment specified below. The customer or
the user of the Sys*Stim 294 should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance level Electromagnetic environment —
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
±2 kV for power
supply lines
±1 kV for
input/output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
±2 kV common mode
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 seconds
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 seconds
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
Sys*Stim 294 requires continued
operation during power mains
interruptions, it is needed that the
Sys*Stim 294 be powered from an
uninterruptible power supply.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
NOTE UTis the A.C. mains voltage prior to application of the test level.

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Guidance and manufacturer’s declaration – electromagnetic immunity
The Sys*Stim 294 is intended for use in the electromagnetic environment specified below. The customer or
the user of the Sys*Stim 294 should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance
level
Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 GHz
3 V/m
80 MHz to 2,5 GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of the Sys*Stim 294, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
d= 1,2√P
d= 1,2√P80MHz to 800 MHz
d= 2,3√P800MHz to 2,5 GHz
where Pis the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and dis the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the Sys*Stim 294 is used exceeds the applicable RF compliance level above, the Sys*Stim 294 should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Sys*Stim 294.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Recommended separation distances between
portable and mobile RF communications equipment and the
Sys*Stim 294
The Sys*Stim 294 is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the Sys*Stim 294 can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Sys*Stim 294 as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d= 1,2√P
80 MHz to 800 MHz
d= 1,2√P
800 MHz to 2,5 GHz
d= 2,3√P
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P
is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Guidance and manufacturer’s declaration
No. Mode of Operation Essential Performance
Degradation Allowed
1 Unit tested to 230
VAC for CE
Unit tested to 120
VAC for US/Canada
Unit designed to be failure safe in
abnormal condition
2 Unit has four
stimulation channels
Reset allowed as long as failure safe

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Section 4—Operating
Instructions
1 5. 0 0
min s
s
 s
Hz
1324
1 - 15 Hz
80 - 150 Hz
1 - 150 Hz
Hz - Hz
12
Hz
Hz
 s
Hz
Hz
+
–
+
–
123
456
789
0
12
34
0
00 000
VmA  A
mA
Stim Channels
Timer Functions
Start Hold /
Enter
Stop All Output
Stim Setup
Sweep Frequency
Interferential Amplitude
Modulation
Premodulated
Medium
Frequency
Biphasic
High Volt
MicroCurrent
Phase
Duration Frequency
Polarity Frequency
Polarity Frequency
Continuous
Surge
Reciprocation
Stim
Output
WARNING: Hazardous electrical output. This
equipment is for use by qualified personnel.
Use electrode cable set ME 2260.
!
SYS STIM 294
*
®
Figure 4.1—Front membrane panel and LED indicators
4.1 A Note About Electrodes
To ensure safe operation of the Sys*Stim 294, follow the recommendations listed below:
1. We strongly encourage careful maintenance of the electrode system. This includes the
lead wires as well as the pads themselves. Worn cables and/or poor pads (or the
wrong sized pads) can have a significant impact upon treatment results.
2. For best performance, use Mettler Electronics’ brand electrodes.
3. Do not exceed the number of recommended uses listed on the instructions for EZ
Trodes or other reusable self–adhesive electrodes.
4. Make sure that the entire surface of the electrode is contacting the patient.
5. Do not use moist hot packs to secure electrodes.
6. To avoid skin irritation due to high current density, do not use electrodes smaller in
surface area than the 2" diameter EZ Trode®self-adhesive electrode (ME 2221).
7. Do not use conductive carbon electrodes with this product.
8. Whenever clinically possible, utilize the largest possible pads to reduce local increases
in current density. In situations where small pads are required, use the lowest
stimulation intensity necessary to achieve the desired clinical results.

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The table below illustrates the relationship between electrode diameter and current
density. As you can see the current density increases rapidly when diameter decreases.
Diameter
inches
Surface Area
Square inches
Current Density
mA/sq in (for 10mA)
1.25 1.2 8.2
2.00 3.1 3.2
3.00 7.1 1.4
1.25 inch
diameter
2.00 inch
diameter
3.00 inch
diameter
Figure 4.2—Electrode Sizes and Current Density
4.2 General Operating Instructions:
Before you start.
a) Review precautions, contraindications and side effects/adverse reactions
listed in Section 5.
b) Use Mettler Electronics electrodes to ensure safe and effective operation.
c) Verify connection of the line cord to a grounded wall receptacle and the
Sys*Stim 294.
d) For electrical stimulation connect electrode cables (ME 2260) into the electrode
connections for the channels that are going to be used.
e) Note: Descriptions of the symbols used on controls are in Section 2.