Performance Health Performa Combin8 Quattro User manual

Performa Professional Series
Performa™ Professional Series
InTENSity Professional Series
USER MANUAL
Operation Instructions For:
Performa™Combin8 Quattro
Performa™Combin8 Duo
Performa™Stimul8
Performa™Gener8

Performa™Professional Series
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THIS USER MANUAL IS VALID FOR THE
PERFORMA™PROFESSIONAL SERIES DEVICES
This user manual is published by Performance Health®
Performance Health®reserves the right to improve and amend it at any time
without prior notice. Amendments will however be published in a new edition of this manual.
All Rights Reserved. 42-PH8000-MAN_00 © 2017
Conformity to safety standards
Performance Health®declares that the
Performa™Professional Series comply with following normative documents:
IEC60601-1, IEC60601-1-2, IEC60601-2-10, IEC60601-2-5, ISO7010
IEC61689, ISO14971, ISO10993-1, ISO10993-5, ISO10993-10
Complies with MDD 93/42/EEC and Amended by directive 2007/47/EC requirements

Performa™Professional Series
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TABLE OF CONTENTS
Forward ...............................................5
Safety Precautions And Warnings .....................5 –10
Do Not Use With These Medical Devices ..................6
Do Not Use This Device Under These Conditions ...........6
Electrode Warnings ...................................7
General Warnings ....................................8
Electrotherapy Warnings ...............................8
Ultrasound Warnings...............................8 – 9
Cautions & General Precautions .....................9 – 10
Intended Use..........................................11
Electrotherapy Indications & Contraindications ............11
Ultrasound Indications & Contraindications ...............12
Adverse Effects........................................13
Applicator Movement Of Ultrasound ....................13
Potential Adverse Effects Of Ultrasound..................13
Patient Susceptibility.................................13
Coupling ..........................................13
Parameter Definitions ..............................13 – 23
Waveform Specifications............................14 –23
IF-4P: IFC (Interferential) Traditional (4 Pole)...............14
IFC (Interferential) Premodulated (2 Pole) .................15
TENS: Biphasic — Asymmetrical & Symmetrical ...........16
RAAS: Biphasic .....................................17
Russian ...........................................18
High Volt ..........................................19
Microcurrent .......................................20
NMS .............................................21
Ultrasound Specications .........................22 – 23
Package Contents .................................24 –25
Operating Controls.................................26 –33
Stimul8 – Operating Controls ......................26 – 27
Combin8 Quattro – Operating Controls ..............28 – 29
Combin8 Duo – Operating Controls .................30 – 31
Gener8 – Operating Controls ......................32 – 33
Device Descriptions ................................34 –37
Home Screen Display ................................35
Main Therapy Display ................................35
Touchscreen Display .................................36
Electrotherapy Treatment Screen .......................36
Ultrasound Treatment Screen ..........................37
Combination Therapy Treatment Screen .................37
Navigation ........................................38 –50
Application Info (Electrotherapy) ......................38
Before Treatment ................................38
Self-Adhesive Electrodes..........................38
Connection and Disconnection Reactions.............38
Electrotherapy Set-Up — Clinical Protocols ...............39
Channel Selection ...............................40
Parameters.....................................40
Treatment Time Adjustment........................40
Start Therapy ...............................40 – 41
Storing Favorites ................................41
Performance Health®

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Navigation (Cont.)..................................38 –50
Electrotherapy Set-Up — Manual Operation ..............42
Waveform Selection ..............................42
Channel Selection ...............................42
Parameters.....................................42
Treatment Time Adjustment........................43
Start Therapy ...................................43
Storing Favorites ................................43
Ultrasound Therapy — Application . . . . . . . . . . . . . . . . . . . .44
Contact Control .................................44
Contact Medium ................................44
Before Treatment ................................44
During Treatment ................................44
After Treatment .................................44
Ultrasound Therapy Set-Up — Clinical Protocols...........45
Parameters.....................................46
Treatment Time Adjustment........................46
Start Therapy ...................................46
Storing Favorites ................................47
Ultrasound Therapy Set-Up — Manual Operation ..........47
Parameters.....................................48
Treatment Time Adjustment........................48
Start Therapy ...................................48
Combination Therapy Set-Up — Manual Operation.........49
Parameters — Electrotherapy ......................49
Treatment & Parameter Adjustment..................49
Parameters — Ultrasound .........................50
Treatment Time Adjustment........................50
Storing Favorites ................................50
Operating Details ......................................51
System Settings ....................................51
Setting Adjustment ..................................51
Adjusting Current Amplitude...........................51
CC/CV Mode.......................................51
Current Polarity .....................................51
Maintenance ......................................52 –53
Cleaning Device ....................................52
Cleaning Display Panel ...............................52
Cleaning Electrodes .................................52
Cleaning Lead Wires and Cables .......................53
Cleaning Ultrasound Applicator ........................53
Troubleshooting ...................................54 –56
Error Codes ........................................54
Technical Maintenance ...............................55
End Of Life ........................................56
Safety And Performance Standards .......................56
EMC Table ........................................57 –59
Warranty .............................................60
Performance Health®

Performa™Professional Series
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INTENDED USER/OPERATOR
This manual has been written for the users of the Performa™
Professional Series medical devices. It contains general
information on the operation, precautionary practices, and
maintenance information. In order to maximize its use, efciency,
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.
These devices are designed to only be used by or under the
supervision of persons using the medical device in the course of
their work and in the framework of a professional healthcare activity,
who understand the benets and limitations of electrotherapy and
ultrasound therapy.
WARNING (USA ONLY):
U.S.A. Federal Law restricts these devices to sale by, 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.
These devices have been thoroughly tested and inspected to assure
proper Performance and operation.
Specications put forth in this manual were in effect at the time of
publication. However, to ensure continual improvement measures,
changes to these specications may be made at any time without
obligation on the part of manufacturer.
IMPORTANT SAFETY PRECAUTIONS
AND WARNINGS
It is important that you read all the warnings and
precautions included in this manual because they
are intended to keep the patient safe, prevent injury
and avoid a situation that could result in damage to
the device.
SAFETY SYMBOLS USED IN THIS MANUAL
DANGER Indicates a potentially hazardous situation which,
if not avoided, could result in death or serious injury.
WARNING
Indicates a potentially hazardous situation which,
if not avoided, could result in serious injury and
equipment damage.
CAUTION
Indicates a potentially hazardous situation which,
if not avoided, may result in minor or moderate injury
to the user or patient or damage to the device or
other property.
Forward

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DANGER
THIS STIMULATOR MUST NOT BE USED IN COMBINATION
WITH THE FOLLOWING MEDICAL DEVICES:
1. Internally transplanted electronic medical devices,
such as a pacemaker.
2. Electronic life support equipment, such as respirators.
3. Electronic medical devices attached to the body,
such as electrocardiographs.
Using this stimulator with other electronic medical devices may cause
erroneous operation of those devices.
Do not use other RF equipment near the Performa™Professional
Series.
Do not use RFID systems near the Performa™Professional Series.
Do not use electrical stimulation in conjunction with high frequency
surgical equipment or microwave or shortwave therapy systems.
This device needs special precautions regarding EMC and
needs to be installed and put into service according to the
EMC information provided on pages 57 – 59.
These devices are contraindicated for use in an MRI
environment and should be removed prior to an MRI exam
or MRI exposure. Keep the device away from strong magnetic elds.
These devices are MR unsafe.
WARNING
DO NOT USE THIS DEVICE UNDER THESE CONDITIONS:
• If a patient has a cardiac pacemaker, implanted debrillator, or other
implanted metallic or electronic device. Such use could cause electric
shock, burns, electrical interference, or death.
• Together with a life-supporting medical electronic device such as an
articial heart or lung or respirator.
• 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.
• On open wounds or rashes, or over swollen, red, infected, or inamed
areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins);
or on top of, or in proximity to, cancerous lesions.
• Over areas of skin that lack normal sensation.
• Do not use while patient is in bath or shower.
• Do not use while patient is sleeping.
• 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.
• Fresh fractures should not be stimulated in order to avoid unwanted
motion.
• Stimulation should not be applied immediately following trauma or
to tissues susceptible to hemorrhage.
Safety Precautions

Performa™Professional Series
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WARNING (cont.)
• The electrodes are already pre-gelled and will adhere to clean skin.
• To avoid damage to the adhesive surface of the electrodes, put them
only on the skin or on the plastic lm provided.
• Make sure the components are connected well and the electrodes are
xed on the part of the body you wish to treat or the therapy may not be
effective.
DO NOT USE ELECTRODES THIS WAY:
• Self-adhesive electrodes are for single-patient use only.
Do not use electrodes on several different patients to avoid
transferring any contamination.
• Electrodes should not touch each other when placed onto patient’s
skin. Keep them at least 1½" apart (and no more than 6" apart) during
treatment. Electrodes too close together or touching could result in
improper stimulation or skin burns.
• Do not place on patient’s spine or backbone.
• Electrodes should not touch any metal object, such as a belt buckle
or necklace.
• Electrodes should not be placed simultaneously on the soles
of both feet.
• Electrodes should not be placed simultaneously on the calves
of both legs.
• Do not place or relocate the electrodes while the device is on.
• Always turn the power off before removing or changing the
electrode location.
• Do not leave electrodes attached to the skin after treatment.
• Do not lean against or lay on electrodes while administering
electrotherapy as this could cause an increase in stimulation.
WARNING (cont.)
DO NOT USE ON THESE INDIVIDUALS:
• Pregnant women, because the safety of electrical stimulation during
pregnancy has not been established.
• Children or infants, because the device has not been evaluated for
pediatric use.
• Persons incapable of expressing their thoughts or intentions.
NEVER APPLY THE ELECTRODES TO:
• The head or any area of the face. The effects of stimulation
of the brain are unknown.
• Any area of the throat because this could cause severe
muscle spasms resulting in closure of the airway, difculty
in breathing, or adverse effects on heart rhythm or
blood pressure.
• Both sides of the thorax simultaneously (lateral or front and
back), or across the patient’s chest because the introduction
of electrical current may cause rhythm disturbances which
could be lethal.
WARNINGS AND PRECAUTIONS REGARDING
THE ELECTRODES:
• Apply electrodes to normal, healthy, dry, clean skin (of adult patients)
because it may otherwise disrupt the healing process.
• If the patient experiences any skin irritation or redness after a session,
do not continue stimulation in that area of the skin. Do not bend or
fold the electrode because it may not function properly. Place the
self-adhesive electrodes onto the plastic lm and then store into the
sealed package when not in use.
• Do not apply ointment or any solvent to the electrodes or to the patient’s
skin because it will disrupt the electrodes from functioning properly.
Safety Precautions

Performa™Professional Series
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WARNING (cont.)
ELECTROTHERAPY WARNINGS
• TENS therapy has not been established for pain of central origin.
• This device is to be used as a symptomatic treatment for pain and
has no curative value. Patients should be cautioned and their activities
regulated if pain that would otherwise serve as a protective mechanism
is suppressed.
• The long-term effects of chronic electrical stimulation are unknown.
• Safety has not been established for the use of therapeutic electrical
stimulation during pregnancy.
• Stimulation should not be applied over swollen, infected, or inamed
areas of skin eruptions (e.g., phlebitis, thrombophlebitis, varicose
veins, etc.).
ULTRASOUND WARNINGS
• Precaution should be taken when using therapeutic ultrasound on
patients with hemorrhagic diathesis.
• Ultrasound treatment presents a potential safety hazard in patients
whose pain response has been decreased because of disease, previous
surgery, ionizing radiation therapy, chemotherapy, general or regional
anesthesia. It may cause burns. Do not use on insensitive areas or in
the presence of poor circulation.
• Large thermal doses may result in regions of thermal aseptic necrosis
which may not be apparent on inspection of the skin.
• Patients who have cardiac pacemakers should be protected from
direct ultrasound exposure over the thorax to protect the lead wires
and pacemaker from such exposure.
• If a patient complains of periosteal pain (deep, achy pain) during
ultrasonic treatment, intensity should be reduced to a comfortable level.
WARNING (cont.)
GENERAL WARNINGS:
• 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.
• To avoid the risk of electric shock, this equipment must only be
connected to a grounded outlet.
• The Performa™Professional Series devices are not suitable for use
in the presence of ammable anesthetics mixture with air, oxygen,
or nitrous oxide.
• These devices should be kept out of the reach of children.
• Care must be taken when operating this equipment around other
equipment. Potential electromagnetic or other interference could
occur to this or to the other equipment. Try to minimize this
interference by not using other equipment in conjunction with it.
• 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 and ultrasound.
• To prevent electrical shock, disconnect the unit from the power source
before attempting any maintenance procedures.
• The use of accessories, transducers and cables than those specied,
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.
• Make certain there are no cracks or damage to any wires attached
to the device.
Safety Precautions

Performa™Professional Series
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WARNING (cont.)
ULTRASOUND WARNINGS (CONT.)
• Moving technique of the applicator should be used when applying
therapeutic ultrasound at intensities greater than 0.5 W/cm² to assure
even exposure of tissues to ultrasound.
• Heating of the joint capsule in acute or subacute arthritis should be
avoided.
• Additional precautions should be used when ultrasound is used on
patients with the following conditions:
1. Laminectomy, i.e., when major covering tissues have been removed
2. Over anesthetic areas
3. On patients with hemorrhagic diathesis
• Ultrasound should be routinely checked before each use to determine
that all controls function normally. Especially if the intensity control
does properly adjust the ultrasonic power output in a stable manner.
Also, determine that the treatment time control does actually terminate
ultrasonic power output when the timer reaches zero.
• Use the ultrasound applicator with care. Inappropriate handling of the
ultrasound applicator may adversely affect its characteristics.
• Before each use, inspect the ultrasound applicator for cracks, which
may allow conductive uid to seep through.
• Ultrasound therapy is not designed to be water tight. Entrance of water
or liquid could cause malfunction of internal components and therefore
create risk of severe injury to the patient.
• Any bleeding tendency is increased by heating because of the increase
in blood ow and vascularity of the heated tissues. Care, therefore,
should be used in treating patients with therapeutic ultrasound who have
hemorrhagic diathesis or bleeding disorders.
• Do not use a conductive medium with an alcohol based content.
CAUTION
CAUTION WHILE USING THE STIMULATOR:
• If the stimulator is not functioning properly or the patient feels
discomfort, immediately stop using the device.
• Do not use for any other purpose except for what it is intended for.
• Do not pull on the electrodes or lead wires during treatment.
• Patients should remove all metal accessories (i.e. necklace, watch,
ring(s), etc.) prior to administering therapy as these items may cause
damage to the device.
• Do not use near a cell phone as this may cause the stimulator
to malfunction.
• Do not bend or pull the end of the cord.
• When pulling out the cord from the device, hold the plug and pull.
• Replace the lead wires when broken or damaged.
• Dispose of the device, batteries, and components according to
applicable legal regulations. Unlawful disposal may cause
environmental pollution.
• The size, shape and type of electrodes may affect the safety and
effectiveness of electrical stimulation. Please read instructions for
which electrodes should be used (specically for combination therapy
and High Volt).
• The electrical Performance characteristics of electrodes may affect the
safety and effectiveness of electrical stimulation.
• Using electrodes that are too small or incorrectly applied, could result
in discomfort or skin burns.
• Keep yourself informed of the contraindications.
• DO NOT operate this unit in an environment where other devices are
being used that intentionally radiates electromagnetic energy in an
unshielded manner.
Safety Precautions

Performa™Professional Series
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GENERAL PRECAUTIONS
• The long-term effects of electrical stimulation are unknown.
• Apply stimulation to only normal, intact, clean, dry, and healthy skin.
• Electrotherapy is not effective in treating the original source or cause of
the pain, including headache.
• Electrotherapy is not a substitute for pain medications and other
pain management therapies.
• Electrotherapy devices do not cure disease or injuries.
• Effectiveness is highly dependent upon patient selection by a practitioner
qualied in the management of pain.
• Patients may experience skin irritation or hypersensitivity due to the
electrical stimulation or electrical conductive medium (gel).
• If patients have suspected or diagnosed epilepsy, proceed with caution.
• Use caution if patient has a tendency to bleed internally, such as
following an injury or fracture.
• Using the device after a recent surgical procedure may disrupt the
healing process.
• Use caution if stimulation is applied over areas of skin that lack
normal sensation.
GENERAL PRECAUTIONS
• Keep unit out of the reach of young children. The unit contains
small pieces that may be swallowed. The electrode cord can cause
strangulation. Immediately DIAL 911 should any of these things occur.
• It is highly recommended that only clinical grade electrodes be used
with these devices. Economic electrodes used with other portable
electrotherapy devices could cause uneven dispersion and/or cause
shocking sensation or possible burns to the area being treated.
• If a patient is injured during treatment, discontinue use immediately
and contact your dealer about the injury.
CAUTION
CAUTION WHILE USING THE STIMULATOR (CONT.)
• Inspect applicator cables and associated connectors before each use.
• This device should not be used adjacent to or stacked with other
equipment and if adjacent or stacked use is necessary, the equipment
should be observed to verify normal operation in the conguration in
which it will be used.
Safety Precautions