Roscoe Medical Quattro 2.5 User manual

TENSPros
CAUTION: United States Federal Law restricts this
device to sale by or on the order of a physician
INSTRUCTION MANUAL
www.roscoemedical.com

TENSPros
TM
This manual is valid for the Quattro 2.5
Declaration of conformity:
Roscoe Medical, Inc. declares that the Quattro™ 2.5 complies with the
following normative documents:
IEC60601-1, IEC60601-1-2, IEC60601-2-10, ISO 7010, ISO14971,
ISO10993-1, ISO10993-5, ISO10993-10
Complies with MDD 93/42/EEC and Amended by directive 2007/47/EC requirements
This user manual is published by Roscoe Medical, Inc. Roscoe Medical, Inc.
and reserves the right to improve and amend it at any time without prior notice.
Amendments will be published in a new edition of this manual.
All Rights Reserved.Rev. V1.0 © 2013, 20131216

TENSPros
3
1. FOREWORD....................................................................4
2. SAFETY INFORMATION.....................................................4
3. INDICATIONS FOR USE.....................................................7
4. PRESENTATION................................................................8
5. INSTALLATION...............................................................11
6. OPERATION..................................................................12
7. MAINTENANCE..............................................................36
8. TROUBLESHOOTING......................................................37
9 SPECIFICATIONS.............................................................39
10. STORAGE....................................................................41
11. DISPOSAL....................................................................42
12. EMC TABLES................................................................42
13. WARRANTY..................................................................46
14. NORMALIZEDSYMBOLS.................................................47
Contents
Quattro™ 2.5 DQ8450

TENSPros
1.
FOREWORD
1.1
General
information
The microprocessor controlled Quattro™2.5 provides Interferential (4-
pole interferential), Premodulated (2-pole interferential), medium
frequency Russian (S and A), EMS （S and A）and TENS waveforms.
You can choose between several different amplitude modulation options.
The Interferential and Premodulated waveforms offer frequency
modulation as well as a static frequency option. There are four output
channels available with the Quattro™ 2.5. Channel 1 and 2 are grouped
together and are independent of the grouped channels 3 and 4. This
design feature enables the Quattro™ 2.5 to be used on two patients with
different waveforms, programs and output intensities simultaneously.
1.2
Introduction
to This
Manual
This manual has been written for the users of the Quattro™ 2.5. It contains
general information on operation, precautionary practices, and
maintenance. In order to maximize its use, efficiency, and the life of the
stimulator, please read this manual thoroughly and become familiar with
the controls, as well as the accessories before operating the stimulator.
2.
SAFETY
INFORMATION
2.1
CAUTION
4
1) Keep yourself informed of the contraindications.
2) Read, understand, and practice the warnings, cautions and operating
instructions. Know the limitations and hazards associated with using
any device. Observe the precautionary and operational decals placed
on the unit.
3) DO NOT operate this unit in an environment where other devices used
intentionally radiate electromagnetic energy in an unshielded manner.
4) DO NOT use sharp objects such as a pencil point or ballpoint pen to
operate the buttons on the control panel.
5) Inspect applicator cables and associated connectors before each use.
6) This device should not be used adjacent to or stacked with other
equipment. If adjacent to or stacked equipment use is necessary, this
device should be observed to verify that it is operating within the
normal configuration in which it is to be used.
7) This device needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information
provided in the manual.
8) Portable and mobile RF communications equipment can affect this
device. Do not use a mobile phone or other device that emits
electromagnetic fields, near the unit. This may result in incorrect
operation of the device.
9) This device has been thoroughly tested and inspected to assure proper
performance and operation!
Quattro™ 2.5 DQ8450

TENSPros
2.2
WARNING
5
1) United States Federal Law restricts this device to sale to, or on the order of,
a physician or licensed practitioner. This device should be used only under
the continued supervision of a physician or licensed practitioner.
2) Make certain the unit is electrically grounded by connecting only to a
grounded electrical service receptacle conforming to the applicable
national and local electrical codes.
3) Care must be taken when operating this equipment around other equipment.
Potential electromagnetic or other interference could occur to this device or
to the other equipment. Try to minimize this interference by not using the
other equipment in conjunction with it.
4) Before administering any treatment to a patient you should become
acquainted with the operating procedures for each mode of treatment
available, as well as the indications, contraindications, warnings and
precautions. Consult other resources for additional information regarding
the application of electrotherapy.
5) To prevent electrical shock, disconnect the unit from the power source before
attempting any maintenance procedures.
6) The use of accessories, transducers and cables other than those specified,
with the exception of transducers and cables sold by the manufacturer as
replacement parts for internal components, may result in increased emissions
or decreased immunity of the device.
7) This device is not designed to be use in an MRI environment and should be
removed prior to MRI exposure.
8) Do not apply stimulation over the patient's neck because this could cause
severe muscle spasms resulting in closure of the airway, difficulty in breathing,
or adverse effects on heart rhythm or blood pressure.
9) Do not apply stimulation across the patient's chest, because the introduction
of electrical current into the chest may cause rhythm disturbances to the
patient's heart, which could be lethal.
10) Do not apply stimulation over open wounds or rashes, or over swollen, red,
infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis,
varicose veins).
11) Do not apply stimulation over, or in proximity to, cancerous lesions.
12) 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.
13) Do not apply stimulation when the patient is in the bath or shower.
14) Do not apply stimulation while the patient is sleeping.
15) Do not apply stimulation while the patient is driving, operating machinery, or
during any activity in which electrical stimulation can put the patient at risk for
injury.
16) Consult with the patient's physician before using this device, because the
device may cause lethal rhythm disturbances to the heart insusceptible
individuals.
17) Apply stimulation only to normal, intact, clean, dry, healthy skin.
18) This device should not be used for symptomatic local pain relief unless
etiology is established or unless a pain syndrome has been diagnosed.
Quattro™ 2.5 DQ8450

TENSPros
6
2.3
CONTRA-
INDICATIONS
1) Do not use this device on patients who have a cardiac pacemaker, implanted
defibrillator, or other implanted metallic or electronic device, because this
may cause electric shock, burns, electrical interference, or death.
2) Do not use this device on patients whose pain syndromes are undiagnosed.
2.4
PRECAUTIONS
1) Federal law (USA) restricts this device to sale to or on the order of a physician.
2) The long-term effects of chronic electrical stimulation are unknown.
3) Electrical stimulation devices have no curative value.
4) Electrical stimulation is not a substitute for pain medications and other pain
management therapies.
5) Effectiveness is highly dependent upon the patient and the selection of a
practitioner qualified in the management of pain.
6) The safety of electrical stimulation during pregnancy has not been established.
7) Some patients may experience skin irritation or hypersensitivity due to the
electrical stimulation or electrical conductive medium (gel).
8) Physician recommended precautions should be followed when treating
patients with suspected or diagnosed heart disease.
9) Physician recommended precautions should be followed when treating
patients with suspected or diagnosed epilepsy.
10) Physician recommended precautions should be followed when treating
patients who have a tendency to bleed internally, such as following an injury
or fracture.
11) Physician recommended precautions should be followed when treating
patients who recently had any surgical procedures; stimulation may disrupt
the patient's healing process.
12) Use caution if stimulation is applied over the menstruating or pregnant uterus.
13) Use caution if stimulation is applied over areas of skin that lacks normal
sensation.
14) Use of this device on a patient should only be used under the continued
supervision of a licensed practitioner.
15) Electrical stimulation is ineffective for pain of central origin.
Quattro™ 2.5 DQ8450
19) Patients with arterial or venous thrombosis or thrombophlebitis are at risk of
developing embolisms when electrical stimulation is applied over or adjacent
to the vessels containing the thrombus. If a patient has a history of deep vein
thrombosis, even many years past, the affected area should not be stimulated.
20) Fresh fractures should not be stimulated in order to avoid unwanted motion.
21) Stimulation should not be applied immediately following trauma orto tissues
susceptible to hemorrhage.
22) Do not apply electrodes directly over the eyes or inside body cavities.
23) Do not use electrical stimulation in conjunction with high frequency surgical
equipment or microwave or shortwave therapy systems.
24) Keep electrodes separated during treatment. Electrodes in contact with each
other could result in improper stimulation or skin burns.
25) Since the effects of stimulation of the brain are unknown, stimulation should
not be applied across the head, and electrodes should not be placed on
opposite sides of the head.

TENSPros
7
2.5
Adverse
reaction
16) Use extreme caution when treating desensitized areas on patients who may
not be able to report discomfort or pain.
17) Patients should not be left unattended during any treatment.
18) Keep this device out of the reach of children.
3.
INDICATIONS
FOR USE
For TENS, Interferential and Premodulated(IFC):
1) Symptomatic relief of chronic intractable pain
2) Post-traumatic acute pain
3) Post-surgical acute pain
Additionally for EMS and Russian:
1) Relaxation of Muscle spasms
2) Prevention or retardation of disuse atrophy
3) Increasing local blood circulation
4) Muscle re-education
5) Maintaining or increasing range of motion
6) Immediate postsurgical stimulation of calf muscles to prevent venous
thrombosis
1) Skin irritation, inflammation, and electrode burns beneath the
electrodes are potential adverse reactions.
2) Patients may experience headache and other painful sensations
during, or following the application of, electrical stimulation near
the eyes and to the head and face.
3) The clinician should stop using this device and should consult with the
patient’s attending physician should the patient experience any
adverse reactions from treatment used with this device.
Quattro™ 2.5 DQ8450

TENSPros
1234
Beat H.
A.M.
Duty
Vector
F.M.
Burst
Beat L.
P. Dur.
Freq.
C.F.
Freq.
Save
Time
Cycle
Ramp
8
4.
PRESENTATION
4.1
Panel For
front view
1) Channel Button:
•Press to enter treatment parameters for channel 1 and 2.
•During treatment, press to display treatment parameters for channel
1and 2.
•Rotate to adjust the output intensity for channel 1.
2) Channel Button:
•Press to enter treatment parameters for channel 1 and 2.
•During treatment, press to display treatment parameters for channel
1 and 2.
•Rotate to adjust the output intensity for channel 2.
3) Parameters Control Knob and Pause button.
4) Stop Treatment Button Press to stop current channels’ treatment.
5) Power Indicator Light
6) LCD display: Shows the current information of the device.
7) Channel Button:
•Press to enter treatment parameters for channel 3 and 4.
•During treatment, press to display treatment parameters for channel
3 and 4.
•Rotate to adjust the output intensity for channel 3.
:
5
9
61 2
4
B1
B2
B3
B4
B5
B6
B7
B8
10
7 8
11
12
1
2
3
4
DC15V/1.2A
Quattro™ 2.5 DQ8450
3

TENSPros
9
8) Channel Button:
•Press to enter treatment parameters for channel 3 and 4.
•During treatment, press to display treatment parameters for channel
3 and 4.
•Rotate to adjust the output intensity for channel 4.
9) For the eight parameters selection buttons, see below for details:
B1: In standby mode, press the B1 button a second time to select the
therapeutic waveform;
In setting mode, press the B1 button to select CC/CV output mode.
B2: In standby mode, press the B2 button a second time and hold it about
5 seconds to switch to professional therapy or normal therapy;
In professional therapy standby mode, press the B2 button to switch
treatment step.
B3: Press the B3 button to select the parameter Time/Cycle./Ramp.
B4: Press the B4 button to select the therapeutic program.
Press and hold the B4 button again to save settings.
B5: Press the B5 button to select the parameter Vector/F.M/Burst.
B6: Press the B6 button to select the parameter C.F./Freq.
B7: Press the B7 button to select the parameter Beat H./A.M./Duty.
B8: Press the B8 button to select the parameter Beat L./P.Dur/Freq.
Quattro™ 2.5 DQ8450
Remark:
CC—Constant Current output mode
CV — Constant Voltage output mode
F.M. — Frequency Modulation
Burst— Burst Frequency
Freq. — Frequency
C.F. — Carrier Frequency
Duty — Duty Cycle for Russian Waveform
Beat H. — Sweep High Beat Frequency
A.M. — Amplitude Modulation
Beat L. — Sweep Low Beat Frequency
P.Dur. — Pulse Duration
Time. — Treatment time
Cycle— Cycle time(Con/Rel)
Ramp— Ramp time
10 Adapter Receptacle.
11) ON/OFF Switch.
12) Output Connector: connect with connector of cable.

TENSPros
10
Quattro™ 2.5 DQ8450
4.2
User interface
1) Displays output intensity of channel 1;
Displays total treatment steps of channels 1 and 2.
2) Displays output intensity of channel 2;
Displays treatment steps of channels 1 and 2.
3) Displays output intensity of channel 3;
Displays total treatment steps of channels 3 and 4.
4) Displays output intensity of channel 4;
Displays treatment steps of channels 3 and 4.
5) Displays therapeutic programs (including professional mode) of
channels 1 and 2.
6) Displays treatment time, cycle time or ramp time of channels 1 and 2.
7) Displays 7 therapeutic waveform: IF-4P (IFC-Interferential, Traditional
4 Poles), IF-2P (Premodulated, Traditional 2 Poles IFC), TENS, EMS S
(Synchronous), EMS A (Asynchronous), or Russian S (Synchronous),
and Russian A (Asynchronous).
8) Displays parameters of B7 button: Beat H./A.M./Duty.
9) Displays parameters of B5 button: Vector/F.M./Burst.
10) Displays parameters of B8 button: Beat L./P.Dur./Freq.
11) Displays parameters of B6 button: C.F./Freq.
12) Displays treatment time, cycle time or ramp time of channels 3 and 4.
13) Displays therapeutic programs (including professional mode) of
channels 3 and 4.

TENSPros
CAUT ION: Un ited St ates Fe deral L aw rest ricts t his
devi ce to sal e by or on th e order o f a physi cian
INS TRUCT ION MAN UAL
www.roscoemedical.com
11
Quattro™ 2.5 DQ8450
User Manual
5.
INSTALLATION
5.1
Before Use
Remove the equipment and all accessories from shipping carton and
box. Visually check if there is any damage or missing parts or accessories.
If yes, please report to local dealer or retailer where you purchase this unit.
Your equipment contains the following accessories.Quattro™ 2.5 – DQ8450
12
5 6 7
8
9
11
34
Part
Rubber Electrodes,2.5” X 3.5”
Rubber Electrodes, 2.75” x 4.3”
Electrode Sponges, 2.75” x 4”
Electrode Sponges,3.0” x 4.75”
Self-adhesive Electrodes, 2” x 2”
Self-adhesive Electrodes,2” x 3.5”
Elastic Wrap, 3” x 23.5”
Elastic Wrap , 3” x 47”
Lead wires
Adapter 100-240V/50-60Hz
Connector of cable
Quantity
1
2
3
4
5
6
7
8
9
10
11
12
4pcs
4pcs
4pcs
4pcs
8pcs
8pcs
2pcs
2pcs
4pcs
1pc
2pcs
1pc
10 12
No. Replenishment
Part #
ER2535B2
ER2743B2
ES2740Y2
ES3047Y2
EW2023BW2
EW3047BW2
WQ6005PLUG
DQ2001MGC
DQ8432CPLUG

TENSPros
12
Caution
Quattro™ 2.5 DQ8450
5.2
Connection
of the power
adapter
Connect the power adapter to the device connector.
Connect the power adapter to a wall socket.
Prior to connecting this device to the power supply, check that the
voltage and frequency stated on the rating label match with the
available power supply.
The power adapter is a part of the supply circuit on which the device's
safety partly depends upon. The approvals for Quattro™ 2.5 are only
valid if used in combination with this type of adapter.
5.3
Switching on
Switch on the device, using ON/OFF switch [ ].The device executes a
self-test, checking all important functions and enters standby mode about
6~8 seconds later.
5.4
Switching off
and
disconnecting
power adapter
Switch off the device by switching the ON/OFF switch from the [ ] to
the [ ] position.
Remove the power adapter from the wall socket.
Remove the power adapter from the device.
6.1.2
Electrode
Placement
6.
OPERATION
6.1
Measures
with regards
to treatments
6.1.1
Electrotherapy
Before
the
treatment
Ensure there are no contraindications to treatment.
Inspect the skin treatment area for any abrasions, inflammation,
surface veins etc.
Clean the skin treatment area with soap or alcohol (70%).
Shaving or clipping excessive hair on the skin treatment area can
provide optimal treatment.
Test the heat sensitivity of the treatment area.
Examine the skin for any wounds and clean the skin.
When using self-adhesive electrodes, remove the electrode from plastic
backing.
Apply the electrodes to the treatment area.
Ensure that the electrodes are applied securely to the skin.
Ensure good contact between each electrode and the skin.
Check the electrode contact regularly during the treatment.
Examine the skin again after the treatment.
Choose electrodes to properly fit the anatomy.
Follow electrode manufacturer’s instructions for use.

TENSPros
13
Quattro™ 2.5 DQ8450
To avoid skin irritation due to high current density, do not use electrodes
smaller in surface area than 25cm2 self-adhesive electrodes.
Caution
Keep electrodes separated during treatment. Electrodes in contact with
each other could result in improper stimulation or skin burns.
Output current density is related to electrode size. Improper application
may result in patient injury. If any question arises as to the proper
electrode size, consult a licensed practitioner prior to the therapy session.
Powered muscle stimulators should be used only with the leads and
electrodes recommended by the manufacturer.
This device is supplied with 8 pieces 2”×2” and 8 pieces 2”×3.5” adhesive
electrodes. You can select the appropriate sized electrodes according to the
treatment area and output current density.
It is recommended that manufacturer's electrodes be used whenever possible
to ensure the highest level of performance and contact with the treatment
area and to give the most uniform delivery of the prescribed electrotherapy
treatment.
Properly dispose of used electrodes upon completion of the therapy session.
If you are unsure of your electrode’s adhesive properties, it is suggested that
you order new replacement electrodes. Replacement electrodes should be
re-ordered through or on the advice of your physician to ensure proper
quality.
Before applying electrodes, be sure the skin surface over which electrodes
are placed is thoroughly cleaned and dried. Make sure the electrodes are
placed firmly to the skin and make good contact between the skin and the
electrodes. Place the electrodes over the skin; attach them properly, firmly,
and evenly.
1) Before applying the self-adhesive electrodes, it is recommended to wash
and degrease the skin, and then dry it.
2) Do not turn on the device when the electrodes are not positioned on the
body.
3) Never remove the self-adhesive electrodes from the skin while the device
is still turned on.
4) It is recommended that, at minimum, 2”x 2” self-adhering based, square
electrodes are used at the treatment area.
6.1.3
Self-
Adhesive
electrodes
Caution

TENSPros
Quattro™ 2.5 DQ8450
14
Connecting
Lead Wires
6.1.4.
Rubber
Electrodes
If used for delivery of electrotherapy, there are two conductive mediums
for you to select from, the first one is to use electrode sponges as
conductive mediums, and the other is to use a conductive medium such
as an FDA approved Transmission Gel(Note: transmission gel is sold
separately).
The rubber electrodes should be secured to the treatment area using the
nylon wraps that are included with the Quattro™ 2.5 device.
Insert the lead with the red (+) electrode connector
into one adhesive electrode. Insert the lead with the
black (-) electrode connector into the other electrode.
Make certain the lead wires are seated completely
into the electrodes, and there are no bare metal
parts of the pins exposed.
Securing
Electrodes Remove the adhesive electrodes from the protective
backing and apply to the treatment area as
prescribed. Ensure that the entire electrode surface
is in contact with the patient’s skin by pressing the
electrode firmly into place.
Rubber
Electrodes
Instructions
Insert the lead with the red (+) electrode connector
into one rubber electrode. Insert the lead with the
black (-) electrode connector into the other rubber
electrode. Make certain the lead wires are seated
completely into the electrodes, and there are no
bare metal parts of the pins exposed.
Conductive
Medium 1 Insert the rubber electrodes into the electrode
sponges that have been moistened with distilled
water.
Conductive
Medium 2 Liberally apply transmission gel to electrode prior to
placement on the patient.
Please note: purchase the transmission gel with CE
mark or that has been cleared by the FDA.
Connecting
Lead Wires

TENSPros
Quattro™ 2.5 DQ8450
15
Securing
Electrodes Use Nylon Wrap to secure each rubber electrode
into position on the patient.
6.2
Quick Set-up
for Electrical
Stimulation
1. In order to turn on the device, press ON/OFF
switch to [ ] icon which is located on the side
of the device
2. When you turn the Quattro™ 2.5 on, the device
will perform a self-check for about 6~8 seconds,
and then the default parameters will display the
last treatment mode.
3. Connect the electrode wires to the cable; note
the color of the wires and the color marks on
the cable, they should correspond.
Caution: If you want to use 4 channels, connect
all electrode lead wires to two cables.
5. Connect the electrodes to electrode lead wires.
6. Place the electrodes on the patient according
to section 6.1.
4. Plug the cable(s) to the device connector(s), the
left connector corresponds to output channel 1
and channel 2; the right connector corresponds to
output channel 3 and channel 4.
7. Press channel button ( or ) to enter
channel 1and channel 2 parameter setting mode.

TENSPros
16
Quattro™ 2.5 DQ8450
9. There are 50 programs for all waveforms. For
detailed preset programmable parameters for
each program refer to section 6.3 in this manual.
To change parameters refer to each waveforms
“Set-up Procedure”.
Press the “Program” button to choose the
therapeutic program. Then rotate the Parameters
Control Knob ( ) to select the therapeutic
programs in the corresponding waveform.
11. Adjust the output intensity and start treatment by
rotating the output intensity adjustment knobs on
the control panel. 0.5mA/step or 0.5V/step. The
"STIM” symbol in the LCD indicates there is
intensity output.
12. For safety purposes, the load detection function
was designed so when the output intensity
surpasses10.0mA/10.0V, and there are no
electrodes placed on the patient’s skin or the
device is not connected to the electrodes, an
alarm buzzer will sound and the intensity value
will flash and reset to zero.
Caution: In TENS or EMS mode when the pulse
duration is less than 80µs, the load detection
function will activate when the output intensity
surpasses 40.0mA/40.0V.
10. Press the“Waveform/CC/CV” button twice to
select “CC” or “CV” control mode.
8. There are 7 therapeutic waveforms for you to
select. Press the “Waveform” button to choose the
therapeutic waveform. Then rotate the Parameters
Control Knob ( ) to select one of the following
waveform:IF-4P, IF-2P, EMS S, EMS A,TENS,
Russian S and Russian A.
Save
13. Press the channel button ( or ) to
enter channel 3 and 4 parameter setting mode
if necessary. Then set the parameters following
steps 8 thru 12 above.

TENSPros
17
Quattro™ 2.5 DQ8450
15. Press the ( ) button to stop treatment of the
current channel(s).
If you want to stop the other channel(s)treatment,
press corresponding channel button first, and
then press the ( ) button. This will only stop the
selected flashing channels, not all 4 channels.
14. To pause current channels’ treatment, press the
output intensity knob until desired channels’
(either 1 and 2 or 3 and 4) flash. Then press
below button.
6.3
Using Preset
Programs
Each therapeutic waveform has 10 programs with default parameters, but
you can also set and save the parameters according to the patient’s need.
The default parameters for each program are referenced below:

TENSPros
18
Quattro™ 2.5 DQ8450
Symptoms Program Vector C.F. Beat L. Beat H. Time Step 1 Step 2 CC/
CV
IFC-4P
Premodulated
IFC-2P
Symptoms Program Vector C.F. Beat L. Beat H. Time Step 1 Step 2 CC/
CV

TENSPros
19
Quattro™ 2.5 DQ8450
Symptoms Program Freq. Pulse Dur. CC/
CV
A.M. Time
F.M/
Burst

TENSPros
20
Russian S/ A
Quattro™ 2.5 DQ8450