SIS M250 User manual

SIS MACHINES
TECHNICAL OPERATING MANUAL_M250/M250MA_v2.2
This operating manual is downloadable from https://siselectromed.com/
Due to periodic revisions, always check that you are reading the most up to
date version of this manual.
PLEASE READ THIS MANUAL CAREFULLY BEFORE USING THE SIS
EQUIPMENT FOR CORRECT AND SAFE OPERATION.
Page . SIS ANUFACTURING LTD, NZ. JULY 2020.

SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
CONTENTS
SECTION PAGE
DELIVERY AND UNPACKING_ _ _ __ _ _ _ _ _ _ _ _ _ _ _ _ 4
WARNING FOR BIOLOGICAL APPLICATIONS _ _ _ _ _ _ _ 4
DEVICE DESCRIPTION _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 4
POWER SOURCE _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 5
ELECTRODE CABLE CONNECTION _ _ _ _ _ _ _ _ _ _ _ _ 5
KEYPAD CONTROLS AND OPERATION _ _ _ _ _ _ _ _ _ _ 6-7
APPLICATIONS_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 6
SIS electrodes_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 7-8
Connection of electrode cable to electrodes _ _ _ _ _ _ 7
Infection treatments_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 9
Direct Current (DC) Electrotherapy _ _ _ _ _ _ _ _ _ _ _ 10-11
DC electro-acupuncture_ _ _ _ _ _ _ _ _ _ _ _ _ _ 11
DC battlefield electro-acupuncture (BFA)_ _ _ _ _ 11-12
Transcranial DC stimulation (tDCS)_ _ _ _ _ _ _ _ 12
Low intensity DC current microcurrent electrical
neuromuscular stimulation ( ENS) _ _ _ _ _ _ _ _
12-13
Scar pain treatment _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 13
Ionic solution medication iontophoresis_ _ _ _ _ _ 13-14
Cell apoptosis stimulation_ _ _ _ _ _ _ _ _ _ _ _ _ 14-15
Laboratory and research use_ _ _ _ _ _ _ _ _ _ _ 15
AUDIO AND VISUAL ALERTS_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 16
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
ELECTROTHERAPY ELECTRODE↔SKIN CONTACT _ _ _ 17-18
CONTRAINDICATIONS AND SAFETY_ _ _ _ _ _ _ _ _ _ _ _ 19
EDICAL DISCLAI ER _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 20
WATER TREAT ENT_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _21
AINTENANCE _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 22
WARRANTY_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _23
Returns, Disposal _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _24
DEVICE SPECIFICATIONS _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 25
ANUFACTURER'S DECLARATION_ _ _ _ _ _ _ _ _ _ _ _ _26
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
DELIVERY AND UNPACKING
Please unpack the shipping package carefully and inspect contents
immediately on receipt. Check that all ordered equipment is included in the
shipping box and notify SIS anufacturing Ltd New Zealand immediately of
any missing items from your order.
Visible damage or tampering to shipping boxes must be recorded before
signing the delivery receipt. Please take photographs of any received
damaged items. Report the damage or tampering immediately to the shipping
carrier. You must also notify SIS anufacturing Ltd immediately of any
received damaged or tampered items or of any lost shipments.
WARNING FOR BIOLOGICAL APPLICATIONS
THE SIS ACHINES ODELS 250/ 250 A ARE ELECTRONICALLY
CALIBRATED WITH EXTRE E PRECISION FOR THERAPEUTIC
BIOLOGICAL ELECTRICAL STI ULATION IN CO BINATION WITH THE
SIS SILVER-NYLON ELECTRODES. USE OF OTHER ELECTRODES CAN
CAUSE ADVERSE AND UNPREDICTABLE BIOLOGICAL EFFECTS. FOR
OTHER BIOLOGICAL ELECTRICAL STI ULATION APPLICATIONS, IF SIS
SILVER-NYLON ELECTRODES ARE NOT USED, ONLY USE SURFACE,
INSERTED OR I PLANTED ELECTRODES APPROVED FOR BIOLOGICAL
CONTACT AND EDICAL/THERAPEUTIC APPLICATIONS. READ THE
CONTRAINDICATIONS AND SAFETY INSTRUCTIONS IN THIS ANUAL
BEFORE USING THIS EQUIP ENT.
DEVICE DESCRIPTION
The SIS machines 250/ 250 A models are designed for electromedical,
nanoampere to low milliampere direct current (DC) electrotherapy
applications, and for low intensity (amperage) DC silver iontophoresis
stimulation (SIS) when used with SIS electrodes. The 250 A model can be
used for liquid medication intophoresis, and for cell apoptosis stimulation.
The 250/ 250 A models are also designed for use as a nanoampere to
low milliampere ( 250 A only) constant current generators for non-medical,
non-therapeutic, non-diagnostic, research, laboratory and experimental
purposes, including Life Sciences, and water treatment.
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
. POWER SOURCE
The 250/ 250 A is powered by replaceable AAA type batteries.
Rechargeable batteries can be used and do not compromise the correct
function of the device. Refer to section 15. DEVICE SPECIFICATIONS for
further information.
Do not use zinc-carbon batteries that can leak and damage the device.
. . INSERTING AAA BATTERIES
A. POWER OFF the device if it is operating.
B. Remove the shockproof silicon cover from the casing.
C. Remove the battery compartment cover.
D. Insert 3×AAA batteries. Ensure correct polarity of the batteries—follow
the battery diagram and polarity symbols inside the battery
compartment.
E. Replace the battery compartment cover.
F. Replace the shockproof silicon cover over the casing.
2. ELECTRODE CABLE CONNECTION
2. . CONNECTION OF ELECTRODE CABLE (HARNESS)
Unplug the Seal Cap from the connection socket (Jack) in the top end panel
of the device. Insert the cable connector plug all the way into the connection
socket. Screw tighten the Locking Ring on the cable connector plug to the
socket; DO NOT use excessive force.
2.2. CABLE TESTING
Perform a cable connection and integrity test from the CABLE TEST screen
before each application.
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
3. KEYPAD CONTROLS AND OPERATION
POWER
ON OFF
Power device ON, 2 seconds hold.
Power device OFF, 5 seconds hold.
ain
Operating
Screen
Output CURRENT and STATUS displayed
PROGRAM Access ain
enu
scroll
through ain
enu options
EXIT
PROGRAM
to select
Return to ain Operating Screen
STIM DATA
Output Current and Voltage
and measured bioelectric
data
PROGRAM
or 
return to
ain enu
STATISTICS Electrode stimulation
efficiency data
CABLE TEST
Instructions
PROGRAM
Instructions 2
PROGRAM
Result:
PASSED
or
FAILED
DISPLAY

AUTO-OFF (DEFAULT) or
ALWAYS ON
TIMER Session duration data
MONITORING 
AUTO (DEFAULT) or OFF
POLARITY 
AUTO (DEFAULT) or OFF
ABOUT Information about device
DISPLAY
Sound turned ON or OFF, 2 seconds hold.
OLED display turned ON or OFF, 1 second hold, when DISPLAY set to
AUTO-OFF (DEFAULT).
The default device settings after powered on are OLED display and sound
turned on.
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
If no keypad input is detected during normal STATUS: OK operation and the
AUTO-OFF default DISPLAY setting has not been changed to ALWAYS ON,
then the display turns off after 2 minutes for power saving.
At any time when the menu is accessed, if no user input is detected after 2
minutes, the device automatically powers off.
The red BATTERY CHARGE LED flashes every 5 seconds while the device
is operating; the LED is not under user control.
APPLICATIONS
4. SIS electrodes
NOTE: Position and secure the SIS electrodes to the body first, and then
connect the SIS electrode cable to the two SIS electrode wires.
NOTE: Read and follow the INSTRUCTIONS FOR USE (IFU) on the IFU card
included in each SIS electrode pack.
4. . Electrode size
4. . . INTERNAL INFECTIONS
The SIS (+)positive electrode must completely 'cover' a target internal organ
or other anatomical structure or area. The electrode must be at least the
same size or slightly larger than the target internal organ or other anatomical
structure as it would be seen two dimensionally in a diagnostic X-ray/CAT
scan/ RI scan/ultrasound taken from the position and anatomical plane of
the electrode on the body surface.
The SIS (-)return electrode should be (approximately) the same size or larger
than the SIS (+)positive electrode.
4. .2. SURFACE INFECTIONS
Use an SIS electrode size that most closely matches the dimensions of the
opposite sides of the area of the infection, where the electrodes will be
positioned. For example, for an area of infection that can be totally contained
within a 2cm×10cm rectangle, the 4.75cm diameter⌀ round SIS electrodes
should be applied next to the 2cm length sides of the infected area, or the
10cm×15cm SIS electrodes should be applied across the 10cm length sides.
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
NOTE: Do not use over-sized SIS electrodes. The 250/ 250 A can more
accurately monitor electrode↔skin contact the smaller the electrode size.
4.2. Securing SIS electrodes
The contact of the entire surface of an electrode placed onto non-damaged
skin should be as uniform as possible to surface anatomy geometry.
NOTE: The silver-nylon side of an SIS electrode is the active surface that
contacts the body.
Use adhesive fixation tape, stretch strap, bandages or other emergency
means to secure the electrode to the body; adhesive tape should extend
beyond all edges of the electrode.
! IMPORTANT INFORMATION:
RECOMMENDED ELECTRODE LIFETIME FOR SEVERE INFECTION :
SIS (+)POSITIVE (RED WIRED) ELECTRODE: 2-24 HOURS
SIS (-)RETURN (BLACK WIRED) ELECTRODE: 2-48 HOURS
4.3. Connection of electrode cable to electrodes
●The SIS electrode that is connected to the red wire of the electrode
harness is the SIS (+)positive electrode.
●The SIS electrode that is connected to the black wire of the electrode
harness is the SIS (-)return electrode.
Insert the two gold metal 'banana plugs' at the ends of the black and red wires
of the electrode cable into the two white plastic connectors at the ends of the
SIS electrode wires; insert the 'banana plugs' all the way in until they are no
longer visible.
NOTE: Do not tape the connections of the electrode cable to the electrode
wires as doing so can cause excessive mechanical force on the cable
connection to the electro-stimulator.
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
5. Infection treatments
! NOTE: The SIS machines 250/ 250 A can be targeted at almost any
infected anatomical structure or location. However, the devices cannot
determine the type of microbe(s) present; standard diagnostics and
differentiating information based on anatomical location, clinical signs,
presentation and/or laboratory testing must be applied.
5. . Electrode positioning
Diagrams of typical SIS electrode positionings for common infections are
available from: https://siselectromed.com/applications
NOTE: Avoid positioning electrodes over bones wherever possible.
5. . . INTERNAL INFECTION
A. Position the SIS (+)positive electrode onto intact skin skin directly over
the target infected organ or other anatomical structure.
B. Position the SIS (-)return electrode onto intact skin on the opposite
anatomical surface of the body to the SIS (+)positive electrode so that
the target infected organ or other anatomical structure is aligned bet ween
the two SIS electrodes.
5. .2. SURFACE INFECTION
A. Position the SIS (+)positive and (-)return electrodes on opposite side s
across and as close as possible to the target infected area ; do not place
electrodes on the infected area.
6. OUTPUT CURRENT
Adjust and PROGRA the output CURRENT for either a bacterial or
viral infection treatment:
➔B acteri al infection treatment or in vitro anti-bacterial effect: use the
default output CURRENT setting of 2.5 microAmps.
➔V iral infectio n treatment or an in vitro anti-viral effect: adjust the output
CURRENT to 7.5 microAmps.
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
7. Direct Current (DC) Electrotherapy
The 250 ( 250 A) is a multirole microcurrent (and milliampere) electro-
stimulator.
If necessary, use the alligator clip adapters supplied with the SIS machine to
convert the 250/ 250 A electrode harness for connection to many other
electrodes. Insert the gold 'banana plugs' at the ends of the black and red
wires of the electrode harness into the plastic connector ends of the adapters.
7. . OUTPUT CURRENT POLARITY
(+)positive conventional current polarity is produced by the 250/ 250 A.
The black-wired ‘banana plug’ of the electrode cable is the conventional
(-)negative terminal (electrode). The red-wired ‘banana plug’ is the
conventional (+)positive terminal (electrode). That is, there is a galvanic cell
polarity current flow out of the device.
7.2. OUTPUT CURRENT POLARITY REVERSAL
The 250/ 250 A reverses the direction of current flow for 10 seconds
every 10 minutes. This function has been factory programmed for use of the
device with SIS electrodes, for removing electro-chemical debris from the
active surfaces of the electrodes resulting from the reduction and oxidation
reactions from the applied electric voltages.
NOTE: For most DC applications where other non-SIS electrodes are used,
this function is not required and can be turned OFF in the POLARITY screen.
7.3. ELECTRODE STIMULATION EFFICIENCY (ESE)
MONITORING
The 250/ 250 A monitors the contact of the SIS or other electrode(s) with
the body, or with the stimulation target for in vitro applications, in real-time
and statistically via complex measurement, logging and assessment
algorithms with self-adaptive AI aspects. The highly summarized logged ESE
data are shown in the STATISTICS screen.
ESE monitoring can be turned OFF for various DC electrotherapy applications
in the ONITORING screen. When ESE is disabled, no data are shown in the
STI DATA and STATISTICS screens.
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
7.4. TYPES OF ELECTRODES
any types of cutaneous or inserted electrodes can be used with the
250/ 250 A, specific to the DC electrotherapy application. Refer to section
9. ELECTROTHERAPY ELECTRODE↔SKIN CONTACT for further
information.
7.5. DC electro-acupuncture
DC electro-acupuncture (E-AP) clinical applications utilizing the DC electrical
properties of the acupuncture meridians and their basic relationship with
neuroanatomy and neurophysiology.
It will usually be advantageous to turn OFF ESE monitoring for most E-AP
applications, especially when inserted AP needles are used. Refer to sections
7.3. and 9 for further information.
7.5. . ELECTRODES
Use the alligator clip adapters to modify the gold metal 'banana plugs' at the
ends of the electrode cable for connection to the metal parts of the shafts of
inserted AP needles, or to non-invasive AP point electrodes and probes.
Usually, nanoampere (nanoAmps) stimulation is the appropriate output
CURRENT range, and is highly therapeutically effective for DC E-AP. Higher
currents do not usually have any or have much less therapeutic effects.
Supporting and clinical guidance literature is available from:
https://siselectromed.com/research/#microcurrent
SIS anufacturing does not supply nor recommend individual E-AP protocols
nor treatments. DC E-AP is an advanced clinical AP application to be
performed by a specialist E-AP practitioner.
7.6. DC battlefield electro-acupuncture (BFA)
Battlefield Acupuncture (BFA) for clinic, home or emergency field use. Simple,
fast, needle or non-invasive ear BFA point treatment for pain relief.
Turn OFF ESE monitoring (see section 7.3). Refer to section 9. for further
information.
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
7.6. . ELECTRODES
Use inserted needle or non-invasive contact probe electrodes.
Supporting and clinical guidance literature is available from
https://siselectromed.com/research/#microcurrent
SIS anufacturing does not supply nor recommend individual BFA protocols
nor treatments. Refer to the published literature or consult your healthcare
professional.
7.7. Transcranial DC stimulation (tDCS)
Polarity-dependent cortical (brain) modulation of neural networks and
spontaneous neuronal activity. tDCS is a type of trans- cranial electrical
stimulation (CES).
It may be advantageous to turn OFF ESE monitoring for some applications
(see section 7.3). Refer to section 9 for further information.
7.7. . ELECTRODES
Use SIS silver-nylon cloth or standard self-adhesive hydrogel electrodes.
Refer to section 7 for further information.
SIS anufacturing does not supply nor recommend individual tDCS protocols
nor treatments. Refer to the published literature or consult your healthcare
professional.
7.8. Low intensity DC microcurrent electrical
neuromuscular stimulation (MENS)
Injured muscle regeneration enhancement treatment.
7.8. . ELECTRODES
Use SIS silver-nylon cloth or standard self-adhesive hydrogel electrodes.
Refer to section 7 for further information.
Supporting and clinical guidance literature is available from:
https://siselectromed.com/research/#microcurrent
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
SIS anufacturing does not supply nor recommend individual ENS
protocols nor treatments.
7.9. Scar pain treatment
Drug free, non-invasive deactivation and treatment of persistent pain in scars.
Turn OFF ESE monitoring if using a contact probe type electrode (refer to
section 7.3.).
7.9. . ELECTRODES
Use non-invasive contact probe, SIS silver-nylon cloth, or standard self-
adhesive hydrogel electrodes.
Supporting and clinical guidance literature is available from:
https://siselectromed.com/research/#microcurrent
SIS anufacturing does not supply nor recommend individual scar pain
treatment protocols nor treatments.
7. 0. Ionic solution medication iontophoresis
250 A drug iontophoresis, also termed transcutaneous drug delivery.
aximum stimulation current is 1.8 – 2.0 mA. Refer to section 15. DEVICE
SPECIFICATIONS for more information.
Adjust and PROGRA the required milliampere (milliAmps) output
CURRENT.
The maximum Output Current achievable at any time during medication
solution iontophoresis is dependent on the actual total circuit resistance.
Refer to 9.1. AXI U OUTPUT CURRENT and monitor on-screen alerts.
7. 0. . ELECTRODES
Use a standard silver-silver chloride or other pH buffered iontophoresis
electrode as the medication delivery (+)electrode.
Use a 4.7cm (1.87 inch) diamete⌀r circular SIS electrode for the (-)return
electrode, in order to achieve a maximal Output Current upper limit. Apply the
SIS electrode over wet standard surgical gauze to reduce the overall circuit
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
resistance if necessary.
Refer to 7.1. OUTPUT CURRENT POLARITY for correct electrode cable
connections.
Clinical practice information is available from:
http://www.electrotherapy.org/modality/iontophoresis
SIS anufacturing does not supply nor recommend individual drug
iontophoresis treatment protocols nor treatments.
7. . Cellular apoptosis stimulation
7. . . ELECTRODES AND TREATMENT
Use SIS silver-nylon cloth electrodes for this application due to their lower
contributing electrical resistances.
Silver iontophoresis is not required for this application; this is a DC
electrotherapy stimulation application only. High quality conductive
electrotherapy gel can be applied to the silver-nylon surfaces (electrically
active side) of the SIS electrodes before placing them on the skin, instead of
the usual method of wetting these surfaces. In some instances, the
conductive gel advantageously decreases the contributing electrical
resistances of the electrode↔skin contact areas below the values achieved
with wet SIS electrodes. Refer to the section 7 for further explanation.
The positioning and application of the SIS electrodes in relation to the target
tissue is the same as for infection treatment. Read the following sections for
instructions:
➔4.1. Electrode size
➔4.2. Securing SIS electrodes
➔4.3. Connection of electrode cable to electrodes
➔5.1.1. Internal infection or 5.1.2. Surface infection
Adjust and PROGRA the required milliampere (milliAmps) output
CURRENT.
Supporting and clinical guidance literature is available from:
https://siselectromed.com/research/#lidc
SIS anufacturing does not supply nor recommend cell apoptosis treatment
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
protocols nor treatments.
7. 2. Laboratory and research use
The 250/ 250 A can be used as a low intensity (amperage) direct
constant current generator.
Applications include any nanoampere to microampere (low milliampere for
250 A model) constant current generation.
Refer to section 15. DEVICE SPECIFICATIONS for further information.
It may be advantageous to turn OFF ESE monitoring for some in vitro and in
vivo applications. Refer to sections 7.3. and 9 for further information.
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
8. AUDIO AND VISUAL ALERTS
Alert essage eaning / Notes Action
STANDBY CALIBRATING Device is calibrating to
programmed Output Current.
Wait.
STATUS: OK Device is operating within
normal limits. Electrode contact
is established.
None.
STATUS: ALERT Problem detected with
electrode contact.
Follow alert
message
instructions.
Output Current value flashing Total circuit resistance exceeds
operating limits for programmed
Output Current.
Refer to section 9.1.
AXI U OUTPUT
CURRENT
POOR CONTACT Electrode contact is insufficient
for therapeutic effect, due to
mechanical (physical) and/or
electro-chemical factors.
Follow alert
message
instructions.
Replace or apply
additional dressing
tape to electrodes
(pads) if necessary.
UNSTABLE CONTACT Electrode contact is varying too
rapidly for therapeutic effect.
CIRCUIT BREAK No electrical stimulation circuit. Follow alert
message
instructions.
HIGH RESISTANCE Cautionary alert only. Device is
operating within normal limits.
Alert will automatically de-
activate after 30 seconds.
Follow alert
message
instructions.
Check skin for
redness or other
signs of irritation.
BATTERY CHARGE LOW Remaining charge in the
replaceable batteries is below
the minimum operating level.
Replace batteries.
CANNOT CALIBRATE Device cannot calibrate due to
alerted, uncorrected electrode
contact problem.
Wait for device to
power off.
Re-check
appropriate
application
instructions.
Power on device
again if necessary.
POWERING OFF Device is powering off due to
uncorrected alert status,
discontinued user input in menu
screen, low battery charge, or
user powering off device.
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
9. ELECTROTHERAPY ELECTRODE↔SKIN
CONTACT
Electrical resistance (R), which is part of total electrical impedance (Z) to the
flow of electric current, is measured in units of Ohms (Ω):
1 megaOhm (MΩ) = 1000 kiloOhm (kΩ) = 1,000,000Ω
The total circuit resistance during non-invasive electrotherapy stimulation via
any pair of any type of electrode is the sum of the electrical resistances at
both the electrode↔skin/body contact areas, and the internal body electrical
resistance(s) in the pathway(s) of electric current between the two
electrodes. Large variations in total circuit resistance (R) into the Ω range
can occur depending on many device related and bioelectric factors.
A major factor that affects electrode↔skin contact area electrical resistances
is moisture; the wetter these areas the lower their contributing electrical
resistances to total circuit resistance.
The top layer of skin, called the stratum corneum, consists mainly of dead
skin cells, and usually contributes most to the total circuit resistance (R).
Gently washing intact skin with a clean, wet sponge or cloth can reduce the
contributing electrical resistance of this outermost skin layer.
Different electrotherapy electrodes contribute varying electrical resistances,
due to their material composition, size, shape, and conformity to the body
surface during cutaneous application. Especially common are self-adhesive
‘hydrogel’ types.
The following table compares standard hydrogel electrodes and SIS silver-
plated nylon or carbon cloth electrodes, for practical electrotherapy:
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
ELECTRODE TYPE TYPICAL TOTAL CIRCUIT
RESISTANCE PER PAIR NOTES
Self-adhesive hydrogel ~500 kiloOhm – 2-4
egaOhms.
Check that the hydrogel
layer remains sticky at all
times; re-wet/replace as
frequently as needed. Only
use high quality electrodes.
Typical use time is 1-2 hours
only before resistance
increases significantly.
SIS silver-nylon cloth ≤ 50 kiloOhm.
< 10 kiloOhm achievable (eg
over wet gauze).
Contributes far lower circuit
resistance (R) than standard
electrotherapy electrodes.
Follow INSTRUCTIONS
FOR USE (IFU) on the IFU
card inside each SIS
electrode pack.
Electrodes must be kept wet
during use.
M250/M250MA FUNCTIONS
Total circuit resistance is shown in the STI DATA screen as RES and
updates every 30 seconds with an average value of multiple real-time
measurements. The Output Voltage that produces the programmed output
CURRENT with the given RES is shown as VOLTS.
The 250/ 250 A operates more power efficiently with lower VOLTS the
lower the RES value, and vice versa; there is no operational RES lower limit.
The 250/250 A continuously and rapidly self-adapts to the electrical
resistance dynamics of the electrode↔skin contact areas.
A VOLTS level and spike monitoring algorithm assesses 10 minute
stimulation periods at a time, and is calibrated in relation to a relatively low ≤
50-100 kΩ RES value, in order to assess early possibility of skin irritation
during extended device application.
9. . MAXIMUM OUTPUT CURRENT
The maximum total circuit resistance RES operating limit of the
250/ 250 A for any programmed output CURRENT can be computed via
the Ohm’s Law equation, using the maximum Output Voltage in Current
Stimulation ode value for the 250/ 250 A given in section 15. DEVICE
SPECIFICATIONS.
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
0. CONTRAINDICATIONS AND SAFETY
DO NOT POSITION ELECTRODES OVER THE BRAIN. CONSULT WITH A
SPECIALIST HEALTHCARE PROFESSIONAL BEFORE APPLICATION.
DO NOT POSITION ELECTRODES OVER THE HEART (CENTRAL AND
LEFT SIDE OF CHEST). CONSULT WITH A SPECIALIST HEALTHCARE
PROFESSIONAL BEFORE APPLICATION.
DO NOT POSITION ELECTRODES ON THE ABDO EN IF THE SUBJECT
IS PREGNANT OR IGHT BE PREGNANT.
DO NOT POSITION ELECTRODES NEAR A PACE AKER OR OTHER
I PLANTED ELECTRO-STI ULATOR. CONSULT WITH A SPECIALIST
HEALTHCARE PROFESSIONAL BEFORE APPLICATION.
DO NOT POSITION ELECTRODES ACROSS THE EYES. CONSULT WITH
A SPECIALIST HEALTHCARE PROFESSIONAL BEFORE APPLICATION.
DO NOT POSITION ELECTRODES ACROSS THE ANTERIOR NECK
(CAROTID SINUS). CONSULT WITH A SPECIALIST HEALTHCARE
PROFESSIONAL BEFORE APPLICATION.
DO NOT USE THE ELECTRO-STI ULATOR IF THERE IS A HISTORY OF
SEIZURES. CONSULT WITH A SPECIALIST HEALTHCARE
PROFESSIONAL BEFORE APPLICATION.
DO NOT EXPOSE THE ELECTRO-STI ULATOR TO WATER.
DISCONNECT ELECTRODES FRO HARNESS (CABLE) OR RE OVE
FRO BODY WHEN ENTERING WATER.
DISCONTINUE USE IF SKIN IRRITATION OCCURS.
KEEP AWAY FROM CHILDREN.
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SIS MACHINE M250/M250MA MODEL OPERATING MANUAL
. MEDICAL DISCLAIMER
NO ADVICE
Information provided for education and research information only. This
manual contains general information about medical conditions and
treatments. The information is not advice, and should not be treated as such.
The information in this manual is made available on the basis that no
professional advice on a particular medical matter is being provided. No
liability is accepted for any injury, loss or damage incurred by use of or
reliance on the information provided in this manual.
PROFESSIONAL ASSISTANCE
You must not rely on the information in this manual as an alternative to, or
substitute for, medical advice from your professional healthcare provider. If
you have any specific questions about any medical matter you should consult
your professional healthcare provider. If you think you may be suffering from
any medical condition you should seek immediate medical attention. You
should never delay seeking medical advice, disregard medical advice, or
discontinue medical treatment because of information in this manual.
LI ITATION OF WARRANTIES
The medical information in this manual is provided “as is” without any
representations or warranties, express or implied. SIS anufacturing Ltd NZ
makes no representations or warranties in relation to the medical information
in this manual. Without prejudice to the generality of the foregoing paragraph,
SIS anufacturing Ltd NZ does not warrant that: the medical information in
this manual will be constantly available, or available at all; or the medical
information in this manual is complete, true, accurate, up-to-date, or non-
misleading. Nothing in this medical disclaimer will limit any of the liabilities of
SIS anufacturing Ltd NZ in any way that is not permitted under applicable
law, or exclude any of its liabilities that may not be excluded under applicable
law.
Page 20. SIS ANUFACTURING LTD NZ. JULY 2020.