Richmar ComboCare User manual

INSTRUCTION MANUAL
ComboCare™

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This manual is valid for the
ComboCare™
This user manual is published by Richmar.
Richmar does not guarantee its contents and reserves the
right to improve and amend it at any time without prior
notice. Amendments may however be published in new
editions of this manual.
All Right Reserved. Rev. V3 © 2019
United States Federal Law restricts this device to sale by or
on the order of a physician or licensed practitioner
Conformity to safety standards
Richmar declares that the device complies with following
normative documents:
IEC60601-1, IEC60601-1-2, IEC60601-2- 10, IEC60601-1-4,
ISO10993-5, ISO10993-10, ISO10993-1
Complies with MDD 93/42/EEC and Amended by directive
2007/47/EC requirements

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TABLE OF CONTENTS
1. GENERAL INFORMATION _______________________________4
1.1 General Description
1.2 Introduction to This Manual
1.3 Indication For Use
2. SAFETY INFORMATION _________________________________ 6
2.1 Warnings, Contraindications, Cautions, Adverse Reactions
3. PRESENTATION _______________________________________13
3.1 Panel for Front View
3.2 User Interface
4. INSTALLATION _______________________________________16
4.1 Connection of the Power Adapter
4.2 Switching On
4.3 Switching O and Disconnect Power Adapter
5. OPERATION __________________________________________18
5.1 Check Before Treatment
5.2 Quick Set-up for Electrical Stimulation
5.3 Quick Set-up for Combo Therapeutic (Ultrasound & Electrical)
5.4 The Default Parameters
5.5 Each Stimulation Set-up Procedure
6. CLEANING AND CARE _________________________________49
6.1 Tips for Skin Care
6.2 Cleaning the Device
6.3 Cleaning the Electrodes
6.4 Cleaning the Lead Wires and Cables
6.5 Maintenance
7. TROUBLESHOOTING ___________________________________51
8. SPECIFICATIONS ______________________________________53
8.1 General Specifications
8.2 Ultrasonic Generator Specifications
8.3 Waveform Specifications
9. STORAGE ____________________________________________56
10. DISPOSAL ___________________________________________56
11. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES ________57
12. GLOSSARY OF SYMBOLS ______________________________61
13. WARRANTY _________________________________________62

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1.1 General Description
Thank you for purchasing the ComboCare™. The microprocessor
controlled ComboCare™ provides interferential (4-pole), premodulated
(2-pole interferential), medium frequency (Russian), EMS and TENS
waveforms and Ultrasound.
You can choose between several dierent amplitude modulation
options. The interferential and premodulated modes oer frequency
modulation as well as a static frequency option.
The ComboCare™ can provide electrical stimulation, ultrasound
therapy or combination therapy.
1.2 Introduction to This Manual
This manual has been written for the users of the ComboCare™.
It contains general information on the operation, precautionary
practices, and maintenance information. In order to maximize
use, efficiency, and the life of the system, please read this manual
thoroughly and become familiar with the controls, as well as the
accessories before operating the system.
1. GENERAL INFORMATION

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1.3 Indications For Use
Therapeutic Ultrasound
Application of therapeutic deep heat for the treatment of selection
sub-chronic and chronic medical conditions such as:
1. Pain relief, muscle spasms and joint contractures.
2. Relief of pain, muscle spasms and joint contractures that may be
associated with
•Adhesive capsulitis
•Bursitis with slight calcification
•Myositis
•Soft tissue injuries
•Shortened tendons due to pas injuries and scar tissues
3. Relief of sub-chronic, chronic pain and joint contractures resulting
from Capsular tightness or Capsular scarring.
For TENS, Interferential and premodulated (IFC)
1. Symptomatic relief of chronic intractable pain
2. Reduction of inflammation
3. Post-traumatic acute pain and edema
4. Post-surgical acute pain and edema
For EMS and Russian:
1. Relaxation of Muscle spasms and edema reduction
2. Prevention 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

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2. IMPORTANT SAFETY INFORMATION
Read instruction manual before operating. Be sure to comply with all
“Contraindications”, Warnings”, “Cautions” and “Adverse reactions” in
the manual. Failure to follow instructions may cause harm to user or
device.
The precautionary instructions found in this section and throughout
this manual are indicated by specific symbols. Understand these
symbols and their definitions before operating this equipment. The
definition of these symbols are as follows.
Caution: Text with a “CAUTION” indicator will explain
possible safety infractions that could have the potential to
cause minor to moderate injury or damage to equipment.
Warning: Text with a “WARNING” indicator will explain
possible safety infractions that will potentially cause serious
injury and equipment damage.
Danger: Text with a “DANGER” indicator will explain possible
safety infractions that are imminently hazardous situations
that would result in death or serious injury.
2.1 Warnings, Cautions and Adverse Reactions
WARNINGS:
1. 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;
2. 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;
3. 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);
4. DO NOT apply stimulation over, or in proximity to, cancerous lesions;

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5. 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;
6. DO NOT apply stimulation when the patient is in the bath or shower;
7. DO NOT apply stimulation while the patient is sleeping; and
8. 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 of injury.
9. Consult with the patient’s physician before using this device,
because the device may cause lethal rhythm disturbances to the
heart in susceptible individuals; and
10. Apply stimulation only to normal, intact, clean, healthy skin.
11. This device should not be used for symptomatic local pain
relief unless etiology is established or unless a pain syndrome
has been diagnosed. 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 aected area should not be
stimulated .
12. Fresh fractures should not be stimulated in order to avoid
unwanted motion.
13. Stimulation should not be applied immediately following trauma or
to tissues susceptible to hemorrhage.
14. DO NOT apply electrodes directly over the eyes or inside body
cavities .
15. DO NOT use electrical stimulation in conjunction with high
frequency surgical equipment or microwave or shortwave therapy
systems.
16. Keep electrodes separated during treatment. Electrodes in contact
with each other could result in improper stimulation or skin burn s .
17. Since the eects 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.

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Contraindications
1. Therapeutic ultrasound should not be applied over the pregnant
or potentially pregnant uterus. Therefore, therapeutic ultrasound
should not be applied over the uterus unless specific assurance can
be attained from the patient that she is not pregnant.
2. Patients who have cardiac pacemakers should be protected from
direct ultrasound exposure over the thorax to protect the lead
wires and pacer from such exposure.
3. Therapeutic ultrasound should not be applied to the eye.
4. Applications of therapeutic intensities of ultrasound should be
avoided over the heart.
5. Neoplastic tissues or space occupying lesions should not be
exposed to ultrasound.
6. Ultrasound should not be applied to the testes to avoid increases
in temperature.
7. Areas of thrombophlebitis should not be treated with therapeutic
ultrasound due to the increased possibility of clotting or dislodging
a thrombus. Conditions where this might occur are deep vein
thrombosis, emboli and severe atherosclerosis.
8. Tissues previously treated by deep x-ray or other radiation should
not be exposed to therapeutic ultrasound.
9. Ultrasonic treatment over the stellate ganglion, the spinal cord
after laminectomy, subcutaneous major nerves and the cranium
should be avoided.
10. DO NOT treat ischemic tissues in individuals with vascular disease
where the blood supply would be unable to follow the increase in
metabolic demand and tissue necrosis might result.
11. DO NOT apply therapeutic ultrasound over a healing fracture.
12. Ultrasound should not be applied over the epiphyseal areas (bone
growth centers) of the bones of growing children.
13. 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.
14. DO NOT use this device on patients whose pain syndromes are
undiagnosed.

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CAUTIONS:
For Therapeutic Ultrasound
1 Ultrasound should not be applied in areas of reduced sensation or
circulation. Patients having reduced sensation will not be able to
notify the practitioner of discomfort if ultrasound intensities
are too high. Patients with compromised circulation may have an
excessive heat buildup in the treatment area.
2. If a patient complains of periosteal pain (deep, achy pain) during
ultrasonic treatment, intensity should be reduced to a comfortable level.
3. Any bleeding tendency is increased by heating because of the
increase in blood flow and vascularity of the heated tissues.
Care, therefore, should be used in treating patients with
therapeutic ultrasound who have hemorrhagic diathesis or
bleeding disorders.
4. Moving technique of the applicator should be used when applying
therapeutic ultrasound at intensities greater than 0.5 W/ cm 2 to
assure even exposure of tissues to ultrasound.
5. Heating of the joint capsule in a cute or subacute arthritis should
be avoided.
6. This device should not be used for symptomatic local pain relief unless
etiology is established or unless a pain syndrome has been diagnosed.
7 This device should not be used when cancerous lesions are present
in the treatment area.
8. Additional precautions should be used when ultrasound is used on
patients with the following conditions:
• Over an area of the spinal cord following:
• Laminectomy, i.e., when major covering tissues have been removed
• Over anesthetic areas
• On patients with hemorrhagic diathesis
9. Ultrasound should be routinely checked before each use to
determine that all controls function normally, especially that the
intensity control does properly adjust the intensity of the ultrasonic
power output in stable manner. Also, determine that the treatment
time control does terminate ultrasonic power output when the
timer reaches zero.
10. The Ultrasound Applicator with care. Inappropriate handling of the
Ultrasound applicator may adversely aect its characteristics.

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11. Before each use, inspect the Ultrasound Applicator for cracks,
which may allow the ingress of conductive fluid.
12. The ultrasound therapy controls unit is not designed to prevent
the ingress of water or liquids. Ingress of water of liquids could
cause malfunction of internal components or system and therefore
create risk of injury to the patient.
For Electrical Stimulation
1. Federal law (USA) restricts this device to sale by or on the order of
a physician.
2. The long-term eects 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. Eectiveness is highly dependent upon patient selection by a
practitioner qualified in the management of pain patients;
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. Patients with suspected or diagnosed heart disease should follow
precautions recommended by their physicians;
9. Patients with suspected or diagnosed epilepsy should follow
precautions recommended by their physicians.
10. Use caution when the patient tends to bleed internally, such as
following an injury or fracture;
11. Use caution following recent surgical procedures when 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 lack
normal sensation.
14. Use this device only under the continued supervision of a licensed
practitioner.
15. Electrical stimulation is ineective for pain of central origin.
16. Use extreme caution when treating desensitized areas or 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;

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ADVERSE REACTIONS:
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.
Note: Always use devices that are legally marketed and sold in the
United States under 510K guidelines.
4. If the stimulation levels are uncomfortable, reduce the stimulation
intensity to a comfortable level and contact your physician if any
problems persist.

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Applicator Movement
If movement of the applicator is too slow, the patient may feel
periosteal pain characterized by a deep ache or pain. If motion is too
fast, or if the applicator does not maintain good contact with the skin,
the therapeutic eect of the sound waves will be reduced and the
applicator may overheat.
Patient Susceptibility
Some patients are more sensitive to ultrasound output and may
experience a reaction similar to a heat rash. Be sure to inspect the
treatment area during and following treatment, and discontinue if an
adverse reaction does occur.
Coupling
Coupling is described as contact between the applicator and the
treatment site and may be accomplished through the use of a
coupling agent, such as gel, lotion. Anything used as a coupling agent
must be highly conductive. Air is a very poor conductor of ultrasonic
waves.
WARNING
1. The device complies completely with all parts of 21 CFR 1050.
10 of the performance standard for sonic, infrasonic and
ultrasonic radiation-emitting product.
2. Cautions- use of controls or adjustments or performance of
procedures other than those specified herein may result in
hazardous exposure to ultrasonic energy.

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3. PRESENTATION
3.1 Panel for Front View
1. Select Channel 1 or adjust the output intensity of channel 1.
2. Select Channel 2 or adjust the output intensity of channel 2.
3. Central Controller Dial and Pause button.
4. Stop treatment button.
5. Power indicator.
6. LCD display: Shows the current information of the device.
7. Ultrasound output intensity control knob
8. Adapter receptacle
9. ON / OFF switch
10. Output connector: connect with ultrasound applicator
11. Output connector: connect with electrical stimulation cable
12. Eight parameters selection buttons, see next page for details:
Waveform
Mode
F.M.
Vector
Burst
Duty
Beat H.
A.M.
Time
Treat.
Cycle
Ramp
Program
CC/CV
Freq.
C.F.
Beat L.
P. Dur.
Freq.
Duty
ComboCare™
STOP
ULTRASOUND

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Button Remark
Waveform
Mode
Choose between therapeutic modes:
Electrical stimulation, Ultrasound thera-
peutic or Combo therapeutic
Program
CC—Constant Current output mode
CV—Constant voltage output mode
Choose the therapeutic program, select
the [CC/CV] or switch program types
(Common or professional)
F.M.—Frequency Modulation Vector
Burst—Burst Frequency
Choose the parameter F.M/Vector/Burst
Freq.—Frequency
C.F.—Carrier Frequency
Press to adjust Freq. and Carrier Freq.
Duty—Duty Cycle for Russian Waveform
Beat H. Sweep High Beat Frequency
A.M.—Amplitude Modulation
Press to adjust Duty/Beat H./A.M.
Beat L.—Sweep Low Beat Frequency
P. Dur—Pulse Duration
Press to adjust Beat L./P. Dur
Time Treat.—Treatment Time
Cycle—Cycle time
Ramp—Ramp Time
Press to adjust Treat./Cycle/Ramp
Freq.—Frequency for Ultrasound
Duty—Duty Cycle for Ultrasound
Choose the parameter Freq./Duty for
ultrasound
Beat H.
A.M.
Duty
Waveform
Mode
Program
CC/CV
F.M.
Vector
Burst
C.F.
Freq.
Beat L.
P. Dur
Time
Treat.
Cycle
Ramp
Freq.
Duty

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Symbol Definitions
IFC-Interferential
(Traditional 4 Pole)
Ultrasound output
indicator
IFC-Interferential
(Traditional 2 Pole)
Constant current
control
Electrical output
channel indicator
Parameter
Electrical
Stimulation/
Ultrasound
therapeutic/
Combination therapy
Time indicator
Therapeutic program Constant Voltage
control
3.2 User Interface

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4. Installation
Remove the equipment and all accessories from shipping carton and gift-
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 ComboCare™ equipment contains the following accessories.
No. Part # Part Quantity
1 ER2535B2 Rubber electrodes 2.5”x3.5” 2
2 ER2743B2 Rubber electrodes 2.75”x4.3” 2
3 ES2740Y2 Electrode Sponges 2.75”x4” 2
4 ES3047Y2 Electrode Sponges 3.0”x4.75” 2
5 E1P2020WC2 Self-adhesive Electrodes 2”x2” 4
6 E1P2035WC2 Self-adhesive Electrodes 2”x3.5” 4
7 EW2023BW2 Elastic Wrap 3”x23.5” 1
8 EW3047BW2 Elastic Wrap 3”x47” 1
9 WQ6005PLUG Electrode wires (black/red) 2
10 DQ2001MGC Adapter 100-240V~47-63Hz 1
11 Power Cord 1
12 DQ8432CPLUG Electrical Stimulation Cable 1
13 WW1001PLUG Electrode Wire for Ultrasound Combination 1
14 DQ9275W5 5cm AER ultrasound applicator 1
15 LC5288 Transmission gel 1
16 DQ9275W1 1cm ultrasound applicator (optional) 1
17 Operating manual 1

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4.1 Connection of the Power Adapter
• Connect the power cord to the power adapter
• Connect the power adapter to the device connector
• Connect the power adapter to a wall socket
CAUTION:
• Prior to connecting this apparatus to the power supply, check
that the voltage and frequency states 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. The approvals for ComboCare™ are
only valid if used in combination with this type of adapter.
4.2 Switching On
Switch on the device, using ON/OFF switch []
4.3 Switching O and Disconnect Power Adapter
• Switch o the device by switching the ON/OFF switch from []
to []position.
• Pull out the power adapter from the wall socket.
• Pull out the power adapter from device.

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5. OPERATION
5.1 Check Before Treatment
• Ensure there are no contraindications to treatment.
• Inspect the treatment area skin seriously for any abrasions,
inflammation, surface veins etc.
• Clean the skin of the treatment area with soap or alcohol (70%).
• If the skin is hairy, shaving can get optimal treatment.
• Test the heat sensibility of the treatment area.
5.1.1 Electrode Placement
• Examine the skin for any wound and clean the skin.
• Apply the electrodes to the treatment area or around the
treatment area. At least 2” but no more than 6” apart, per channel
• 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 that fit the anatomy.
• Follow electrode manufacturer;s instructions.
• To avoid skin irritation due to high current density, DO NOT use
electrodes smaller in surface area than 25cmself-adhesive electrode.
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 therapy session.
• Powered muscle stimulator should be used only with the leads and
electrodes recommended by the manufacturer.
5.1.2 Adhesive Electrodes
This device is supplied with 4 pieces 2”x2” and 4 pieces 2”x3.5” adhesive
electrodes. You can select the right adhesive electrodes according to
treatment area and output current density. It is recommended that
manufacturer’s electrodes be used whenever possible to ensure the
highest level of contact with the treatment area and most uniform
delivery of the prescribed electro-therapy treatment. Properly dispose
of used Electrodes upon completion of the therapy session.

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After the electrodes no longer stick to the treatment site completely,
dispose of electrodes and start with new electrodes. Replacement
electrodes should be re-ordered through or on the advice of your
physician to ensure proper quality.
CAUTION:
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 turns on.
4. It is recommended that, at minimum, 2”x2” self-adhering based,
square electrodes are used at the treatment area.
5.1.3 Electrode Instructions
Connecting Lead Wires
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, there
are no bare metal 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 elec-
trode surface is in contact with patient skin by
pressing into place.

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5.1.4 Rubber Electrodes
If used for delivery of electro-therapy, there are two conductive mediums
for you to select, the first one is use electrode sponges as conductive
mediums, another is use other conductive medium such as Transmission
Gel. If using sponges, make sure the sponges are damp before putting
electrodes into the sponges. These rubber Electrodes should be
secured to the treatment area using the Nylon Wraps shipped with the
Therapy System.
Rubber Electrodes
- Connecting Lead
Wires
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.
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.
Elastic Straps to
secure rubber
electrodes in place
Use Nylon Wrap to secure each rubber
electrode into position on the patient.