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
- 2 -
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
- 3 -
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®

Performa™Professional Series
- 4 -
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
- 5 -
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