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Intelect Advanced 2771
User Manual
56 pgs1.4 Mb0

Chattanooga Intelect Advanced 2771 User Manual

Therapy System
User Manual
Operation & Installation
Instructions for:
2771- sEMG and sEMG + Stim Module
DJO is an ISO 13485 Certified Company
TABLE OF CONTENTS
Intelect® Advanced sEMG and sEMG + Stim Module
PRODUCT DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
PRECAUTIONARY DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
CAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
WARNINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
DANGERS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
SEMG INDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
sEMG + STIM INDICATIONS, CONTRAINDICATIONS
AND ADVERSE EFFECTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Indications- sEMG + Stim using VMS™, Symmetrical Biphasic (TENS), . . . .
Asymmetrical Biphasic (TENS) or Russian waveforms . . . . . . . . . . . . . . . . . . . . 7
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Additional Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Adverse Eff ects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
sEMG and sEMG + STIM STANDARD ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . 8
SYMBOL DEFINITIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
System Hardware Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
SystemSoftware Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Operator Remote . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Battery Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Channel 3/4ElectrothrapyModule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
TERMINOLOGY DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
SEMG AND sEMG + STIM MODULE SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . 11
WAVEFORM SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
TENS- Asymmetrical Biphasic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
TENS- Symmetrical Biphasic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
VMSTM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
High Voltage Pulsed Current (HVPC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
GENERAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
sEMG Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Therapy System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
THERAPY SYSTEM PREPARATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Disconnect System Mains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Disconnect Leads and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Remove Therapy System from Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Remove Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Remove Breakout Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
INSTALLING SEMG MODULE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Position sEMG Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Secure sEMG Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Install and Reinstall Additional Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Install Rear Access Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Install Cables and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Apply Mains Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
REMOVING SEMG MODULE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Prepare System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Remove sEMG Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
sEMG Plug Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
SEMG AND SEMG+STIM PATIENT PREPARATION. . . . . . . . . . . . . . . . . . . . . . . . . 20
Electrode Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Dura-Stick™ II Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Install sEMG Lead Wires to System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Install Dura-Stick™ II Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Select Modality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Select Body Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
View Electrode Placement Graphic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
View Electrode Placement Text . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Prepare Treatment Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Electrode Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Intra-Vaginal Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
SEMG THERAPY SET UP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Optional Patient Data Management System (PDMS). . . . . . . . . . . . . . . . . . . . 25
sEMG Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
i
TABLE OF CONTENTS
Intelect® Advanced sEMG and sEMG + Stim Module
Prepare System and Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Select sEMG Modality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
View sEMG Description Text . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Select Edit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Select Channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Set Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Set Audio Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Select Target Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Setting Max Target. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Setting Avg Target . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Setting Manual Target . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Set Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Start sEMG Therapy Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Stopping sEMG Therapy Session. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
SEMG+STIM THERAPY SET UP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Prepare System and Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Select sEMG + Stim Modality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Select Edit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Select Channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Set Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Set Audio Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Select Stim Waveform. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Edit Stim. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Select Target Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Setting Max Target. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Setting Avg Target . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Setting Manual Target . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Set Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Set Auto Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Start sEMG Therapy Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Stopping Stim. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Stopping Therapy Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
SET UP OF NEW SEMG DATA CARD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Insert New sEMG Data Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Prepare System and Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Set Up sEMG Therapy Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Enter Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Begin Save . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
End Save. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
ERROR CODES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44-49
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Color Series Standard Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Color Series Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Mains Power Cords. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
CARING FOR THE THERAPY SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Cleaning the Therapy System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Cleaning the Lens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
FACTORY SERVICE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
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FOREWORD
This manual has been written for the owners of an Intelect Advanced Therapy System, sEMG and sEMG + Stim Module. It contains general information on the operation, precautionary practices, installation and maintenance for the Intelect Advanced sEMG and sEMG + Stim Module. In order to maximize use, efficiency, the life of the Therapy System, and the Intelect Advanced sEMG and sEMG + Stim Module, please read this manual thoroughly and become familiar with the Intelect Advanced sEMG and sEMG + Stim Module before operating the system.
This manual contains general safety, operating, maintenance and care instructions as well as installation instruction for the Intelect Advanced sEMG and sEMG + Stim Module for the users of the Intelect Advanced Therapy Two Channel and Four Channel Electrotherapy and Combination Therapy Systems. Instructions for the Intelect Advanced Therapy System and its additional modules such as Battery, Laser, and Vacuum Electrode modules are found in their respective User Manuals that also contain installation and operation instructions.
Specifications put forth in this manual were in effect at the time of publication. However, owing to DJO, LLC's policy of continual improvement, changes to these specifications may be made at any time without obligation on the part of DJO, LLC.
Before administering any treatment to a patient, the users of this equipment should read, understand and follow the information contained in this and the Therapy System User Manual 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, ultrasound, sEMG (Surface Electromyography), sEMG + Stim (Surface Electromyography with Triggered Stimulation), and Laser therapy.
PRODUCT DESCRIPTION
The Intelect Advanced sEMG and sEMG + Stim Module is designed for use with the Intelect Advanced Therapy Two and Four Channel Electrotherapy and Combination Therapy Systems only. Additional options are available for separate purchase and can be installed by the end user.
Stay current with the latest clinical developments in the field of Electrotherapy, Ultrasound, sEMG (Surface Electromyography) , sEMG + Stim (Surface Electromyography with Triggered Stimulation), and Laser Therapy. Observe all applicable precautionary measures for treatment.
Keep informed of appropriate indications and contraindications for the use of Electrotherapy, Ultrasound, sEMG (Surface Electromyography), sEMG + Stim (Surface Electromyography with Triggered Stimulation), and Laser Therapy.
This equipment is to be used only under the prescription and supervision of a physician or licensed practitioner.
Intelect® Advanced sEMG and sEMG + Stim Module
© 2011 DJO, LLC. All rights reserved. Any use of editorial, pictorial, or layout composition of this publication without express written consent from DJO, LLC is strictly prohibited. This publication was written, illustrated, and prepared for distribution by DJO, LLC.
1
SAFETY PRECAUTIONS
DANGER
WARNING
PRECAUTIONARY DEFINITIONS
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;
Intelect® Advanced sEMG and sEMG + Stim Module
CAUTION
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.
Dangerous Voltage-
Text with a “Dangerous Voltage” indicator serves to inform the user of possible hazards resulting in the electrical charge delivered to the patient in certain treatment configurations of TENS waveforms.
Biohazardous Materials-
Text with a “BIOHAZARD” indicator serves to inform the user of possible hazards resulting in improper handling of components and accessories that have come in contact with bodily fluids.
NOTE:
Throughout this manual, “NOTE” may be found. These Notes are helpful information to aid in the particular area or function being described.
2
SAFETY PRECAUTIONS
CAUTIONS
Intelect® Advanced sEMG and sEMG + Stim Module
CAUTIONCAUTION
Read, understand and practice the precautionary and operating instructions. Know the limitations and hazards associated with using any electrical stimulation. Observe the precautionary and operational decals placed on the unit.
• DO NOT operate the Intelect Advanced Therapy System sEMG
Module when connected to any unit other than Chattanooga devices.
• DO NOT operate this unit in an environment where other devices
are being used that intentionally radiate electromagnetic energy in an unshielded manner.
• DO NOT use sharp objects such as a pencil point or ballpoint pen to
operate the buttons on the control panel as damage may result.
• This unit should be operated, transported and stored in
temperatures between 15° C and 40° C (59° F and 104° F), with Relative Humidity ranging from 30%-60%.
• Inspect Lead wires and associated connectors for signs of damage
before each use. Replace damaged lead wires immediately with new before any treatment is applied.
• The Intelect Advanced Therapy System is not designed to prevent
the ingress of water or liquids. Ingress of water or liquids could cause malfunction of internal components of the system and therefore create a risk of injury to the patient.
• This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. Harmful interference to other devices can be determined by turning this equipment on and off. Try to correct the interference using one or more of the following: Reorient or relocate the receiving device, increase the separation between the equipment, connect the equipment to an outlet on a different circuit from that to which the other device(s) are connected and/or consult the factory field service technician for help.
• The Nylatex® Wraps shipped with this unit contain dry natural
rubber and may cause allergic reactions in patients with allergies to latex.
3
WARNING
WARNING
SAFETY PRECAUTIONS
WARNINGS
Intelect® Advanced sEMG and sEMG + Stim Module
These devices are restricted 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.
• 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 sEMG + Electrical Stimulation.
• To prevent electrical shock, disconnect the unit from the power
source before attempting any maintenance procedures.
• Keep stim electrodes separated during treatment. Electrodes in
contact with each other could result in improper stimulation or skin burns.
• Long term effects of chronic electrical stimulation are unknown.
• Stimulation should not be applied over the anterior neck or mouth.
Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing.
• Stimulation should not be applied transthoracically in that the
introduction of electrical current into the heart may cause cardiac arrhythmia.
• Stimulation should not be applied over swollen, infected, inflamed
areas or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
• Stimulation should not be applied over, or in proximity to, cancerous
lesions.
• The safety of TENS devices for use during pregnancy or birth has
not been established.
• TENS is not effective for pain of central origin. (This includes
headache.)
• TENS devices should be used only under the continued supervision
of a physician or licensed practitioner.
• TENS devices have no curative value.
• TENS is a symptomatic treatment and as such suppresses the
sensation of pain which would otherwise serve as a protective mechanism.
• The user must keep the device out of the reach of children.
• Electronic monitoring equipment (such as ECG monitors and ECG
alarms) may not operate properly when TENS stimulation is in use.
• Before each therapy session begins, make certain the patient has
the appropriate patient switch for the channels being used.
4
SAFETY PRECAUTIONS
DANGER
DANGERS
• Stimulus delivered by the TENS waveforms of this
device, in certain configurations, will deliver a charge of 25 microcoulombs (µC) or greater per pulse and may be sufficient to cause electrocution. Electrical current of this magnitude must not flow through the thorax because it may cause a cardiac arrhythmia.
• Patients with an implanted neurostimulation device
must not be treated with or be in close proximity to any shortwave diathermy, microwave diathermy, therapeutic ultrasound diathermy or laser diathermy anywhere on their body. Energy from diathermy (shortwave, microwave, ultrasound and laser) can be transferred through the implanted neurostimulation system, can cause tissue damage and can result in severe injury or death. Injury, damage or death can occur during diathermy therapy even if the implanted neurostimulation system is turned “off.”
• Handle, clean, and dispose of components and accessories
that have come in contact with bodily fluids according to National, Local and Facility rules, regulations and procedures.
Intelect® Advanced sEMG and sEMG + Stim Module
5
SAFETY PRECAUTIONS
SEMG INDICATIONS
Indications- Surface EMG
To determine the activation timing of muscles for:
• Retraining of muscle activation
• Coordination of muscle activation
• An indication of the force produced by muscle for control and
maintenance of muscle contractions.
• Relaxation muscle training
• Muscle re-education
Intelect® Advanced sEMG and sEMG + Stim Module
6
SAFETY PRECAUTIONS
sEMG + STIM INDICATIONS, CONTRAINDICATIONS AND ADVERSE EFFECTS
Indications- sEMG + Stim using VMS™, Symmetrical Biphasic (TENS), Asymmetrical Biphasic (TENS) or Russian waveforms
• Stroke rehab by muscle re-education
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
Contraindications
• This device should not be used for symptomatic local pain relief unless
etiology is established or unless a pain syndrome has been diagnosed.
• This device should not be used when cancerous lesions are present in the
treatment area.
• Stimulation should not be applied over swollen, infected, inflamed areas,
or skin erruptions, e.g. phlebitis, thrombophlebitis, varicose veins, etc.
• Other contraindications are patients suspected of carrying serious
infectious disease and or disease where it is advisable, for general medical purposes, to suppress heat or fevers.
• Electrode placements must be avoided that apply current to the carotid
sinus region (anterior neck) or transcereberally (through the head).
• Safety has not been established for the use of therapeutic electrical
stimulation during pregnancy.
• Powered muscle stimulators should not be used on patients with cardiac
demand pacemakers.
• There should not be any use of TENS waveforms on patients with cardiac
demand pacemakers.
Additional Precautions
• Caution should be used for patients with suspected or diagnosed heart
problems.
• Caution should be used for patients with suspected or diagnosed epilepsy.
• Caution should be used in the presence of the following:
• When there is a tendency to hemorrhage following acute trauma or
fracture.
• Following recent surgical procedures when muscle contraction may disrupt
the healing process.
• Over a menstruating or pregnant uterus; over areas of the skin which lack
normal sensation.
• Some patients may experience skin irritation or hypersensitivity due to
the electrical stimulation or electrical conductive medium. The irritation can usually be reduced by using an alternative conductive medium or an alternative electrode placement.
• Electrode placement and stimulation settings should be based on the
guidance of the prescribing practitioner.
• Powered muscle stimulators should be used only with the lead wires and
electrodes recommended for use by the manufacturer.
• With TENS waveforms, isolated cases of skin irritation may occur at the site of
electrode placement following long term application.
• The effectiveness of TENS waveforms is highly dependent upon patient
selection by a person qualified in the management of pain patients.
Adverse Effects
• Skin irritation and burns beneath the electrodes have been reported with the
use of powered muscle stimulators.
• Potential adverse effects with TENS are skin irritation and electrode burns.
Intelect® Advanced sEMG and sEMG + Stim Module
7
DANGER
NOMENCLATURE
sEMG & sEMG + STIM STANDARD ACCESSORIES
5
3
2
Intelect® Advanced sEMG and sEMG + Stim Module
1. Surface EMG (sEMG) Module
2. sEMG + Electrical Stimulation Lead Wires for Channel 1
4
1
3. sEMG + Electrical Stimulation Lead Wires for Channel 2
4. Dura-Stick II 3.2 cm (1.25”) Self Adhesive disposable
Electrodes (3 packs of 4)
5. User Manual (CD-ROM)
6. Intra-Vaginal Probe (not illustrated)
Handle, clean, and dispose of components and accessories that have come in contact with bodily fluids according to National, Local and Facility rules, regulations and procedures..
8
NOMENCLATURE
Intelect® Advanced sEMG and sEMG + Stim Module
SYMBOL DEFINITIONS
Below are the definitions for all of the symbols used in the Intelect Advanced hardware and software. Study and learn these symbols before any operation of the system.
System Hardware Symbols
CONTRAST CONTROL (NOT FUNCTIONAL ON COLOR SYSTEMS)
ON/OFF SWITCH
DATA PORT
MULTI-MEDIA
AND
PATIENT CARD
STOP TREATMENT
PAUSE TREATMENT
START TREATMENT
THERAPY INTENSITY CONTROL
HOME
CLINICAL RESOURCES LIBRARY
BACK
CHANNEL 1/2 OPERATOR REMOTE CONTROL (OPTIONAL)
PATIENT INTERRUPT SWITCH
CHANNEL 1 LEAD WIRES
CHANNEL 2 LEAD WIRES
MICROCURRENT PROBE
ULTRASOUND APPLICATOR
System
Software Symbols
MOVE UP
MOVE DOWN
MOVE RIGHT
MOVE LEFT
ACCEPT AND RETURN
DO NOT ACCEPT AND RETURN
PAD CONTACT QUALITY
(SINGLE CHANNEL GRAPH)
PAD CONTACT QUALITY
(DUAL CHANNEL GRAPH)
Optional Module and Accessory Symbols
Operator Remote
Channel 3/4
Electrothrapy
INCREASE INTENSITY
DECREASE INTENSITY
PAUSE TREATMENT
MANUAL
M
STIMULATION
Battery Module
CHARGE LEVEL
BATTERY CHARGING
Module
PATIENT INTERRUPT SWITCH
CHANNEL 3 LEAD WIRES
CHANNEL 4 LEAD WIRES
MICROCURRENT PROBE
CHANNEL 3/4 OPERATOR REMOTE CONTROL (OPTIONAL)
9
NOMENCLATURE
TERMINOLOGY DEFINITIONS
Below are the definitions for all of the unique terminology used throughout this manual. Study these and become familiar with these terms for ease of system operation, component and control functionality of the Intelect Adavnced Therapy System. Some of these terms and definitions refer to a specific button, control, or module on the system. Refer to page 9 for symbol definitions.
GENERAL TERMINOLOGY
Back Button
The dedicated button on the System, below the display, that each time pressed takes the user back one screen at a time.
Previous Page Button
The button used in some modalities and functions that will take the user back one page when reading multiple pages of text.
UP and DOWN Arrows
Controls used in various modality parameter screens to navigate or change a value up or down within the parameter.
Electrotherapy
Refers to the electrical muscle or nerve stimulation modalities of the system.
System
The primary system with all controls and functions.
sEMG Module
The Module installed into the bottom cavity of the System and utilized by the System to cause the sEMG and sEMG + Stim modalities to function.
sEMG
Abbreviation for the Surface Electromyography modality.
sEMG + Stim
Abbreviation for Surface Electromyography with Triggered Electrical Stimulation modality.
Intelect® Advanced sEMG and sEMG + Stim Module
10
SPECIFICATIONS
sEMG AND sEMG + STIM MODULE SPECIFICATIONS
DEPTH
WIDTH
HEIGHT
Intelect® Advanced sEMG and sEMG + Stim Module
DIMENSIONS
Width . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.3 cm (3.25”)
Depth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9.2 cm (3.625”)
Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 cm (1.187”)
Input Impedance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .> 1,000,000 ohm
Input Sensitivity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . < 1.0 µV RMS
Frequency Range . 15 Hz-300 Hz with CMMR of > 120 dB CMMR
at 50/60 Hz > 180 dB
Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 g (3.8 oz)
Product Type
Internally Powered . . . . . . . . . .Intelect Advanced Therapy System
Electrical Class . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Class I
Electrical Type. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Type BF
For Continuous Operation
Regulatory Compliance
UL/IEC/EN 60601-1
IEC/EN 60601-1-2 IEC 60601-2-10
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SPECIFICATIONS
DANGER
WAVEFORM SPECIFICATIONS
Intelect® Advanced sEMG and sEMG + Stim Module
TENS- Asymmetrical Biphasic
The Asymmetrical Biphasic waveform has a short pulse duration. It is capable of strong stimulation of the nerve fibers in the skin as well as of muscle tissue. This waveform is often used in TENS devices. Because of its short pulse, the patient typically tolerates the current well, even at relatively high intensities.
Output Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrodes
Output Intensity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-110 mA
Phase Duration . . . . . . . . . . . . . . . . . . . . . . . . . Adjustable 20-1,000 µsec
Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-250 Hz
Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CC or CV*
Burst Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-10 bps
Frequency Modulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-250 Hz
Amplitude Modulation . . . . . . . . . . . . Off, 40%, 60%, 80% and 100%
Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 minutes
Stimulus delivered by the TENS waveforms of this device, in certain configurations, will deliver a charge of 25 microcoulombs (µC) or greater per pulse and may be sufficient to cause electrocution. Electrical current of this magnitude must not flow through the thorax because it may cause a cardiac arrhythmia.
TENS- Symmetrical Biphasic
The Symmetrical Biphasic waveform has a short pulse duration and is capable of strong stimulation of nerve fibers in the skin and in muscle. This waveform is often used in portable muscle stimulation units, and some TENS devices. Because of its short pulse duration, the patient typically tolerates the current well, even at relatively high intensities.
Output Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrodes
Output Intensity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0-80 mA
Phase Duration . . . . . . . . . . . . . . . . . . . . . . . . . Adjustable 20-1,000 µsec
Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-250 Hz
Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CC or CV*
Burst Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0-4 bps
Frequency Modulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-250 Hz
Amplitude Modulation . . . . . . . . . . . . Off, 40%, 60%, 80% and 100%
Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 minutes
*CC= Constant Current CV= Constant Voltage
12
SPECIFICATIONS
WAVEFORM SPECIFICATIONS (continued)
TM
VMS
Intelect® Advanced sEMG and sEMG + Stim Module
High Voltage Pulsed Current (HVPC)
VMS is a symmetrical biphasic waveform with a 100 µsec interphase interval. Because the pulse is relatively short, the waveform has a low skin load, making it suitable for applications requiring high intensities, such as in muscle strengthening protocols.
Output Mode: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Electrodes
Output Intensity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-255 mA
Channel Mode . . . . . . . . . . . . . . . . . . . . . . . . . Single, Reciprocal, Co-Contract
Phase Duration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20-1000µsec
Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CC or CV*
Anti-Fatigue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Off or On
Set Intensity . . . . . . . . . . . . . . . . . . . . Individual Channel Intensity Setting in
Reciprocal and Co-Contract modes
Cycle Time . . . . . . . . . . .Continuous, 5/5, 4/12, 10/10, 10/20, 10/30, 10/50
Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-200 pps
Ramp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0.5 sec, 1 sec, 2 sec, 5 sec
Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 minutes
Available on Channels . . . . . . . . . . . . . . . . . . . . . . . . 1 & 2, 3 & 4 Option
The High Voltage Pulsed Current (HVPC) has a very brief pulse duration characterized by 2 distinct peaks delivered at high voltage. The waveform is monophasic (current flows in one direction only). The high voltage causes a decreased skin resistance making the current comfortable and easy to tolerate.
Output Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrodes or Probe
Output Intensity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-500 V
Polarity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Positive or Negative
Ramp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0.5 sec, 1 sec, 2 sec, 5 sec
Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Peak Current or Volts
Sweep . . . . . . . . . . . . . .Continuous, 80/120 pps, 1/120 pps, 1/10 pps
Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-120 pps
Cycle Time . . . . . .5/5, 4/12, 10/10, 10/20, 10/30, 10/50, Continuous
Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 Minutes
Available on Channels . . . . . . . . . . . . . . . . . . . . . . . . 1 & 2, 3 & 4 Option
*CC= Constant Current CV= Constant Voltage
13
INSTALLATION & REMOVAL
WARNING
GENERAL INFORMATION
sEMG Module
The Intelect Advanced (Color Series) Electrotherapy and Combination Therapy Systems have, as standard equipment, an sEMG Module factory installed.
A second sEMG Module may be installed onto the Optional Channel 3/4 Electrotherapy Module only. The sEMG Module will not install to any other optional modules such as the Battery or Laser Modules.
The sEMG Module is available as an option for the Intelect Advanced (Monochromatic) Therapy System.
These instructions assume that there is no sEMG Module installed on the Therapy System in order to provide the proper installation instructions for future use should it become necessary.
Disconnect the system from the power source (outlet or remove battery module if installed) before attempting any maintenance, installation, removal, or replacement procedures to prevent electrical shock and possible damage to system.
Intelect® Advanced sEMG and sEMG + Stim Module
Therapy System
If installing the sEMG Module on a Therapy System equipped with a Battery, Laser, or the Channel 3/4 Electrotherapy Module and it is desired to install the sEMG Module onto the Therapy System, it will be necessary to remove the Battery, Laser, or Channel 3/4 Electrotherapy Module. Refer to the respective Module User Manual for Instructions.
Installing the sEMG Module on the System will make the sEMG and sEMG + Stim modalities available for Channels 1/2. If installed on the Optional Channel 3/4 Electrotherapy Module, sEMG and sEMG + Stim modalities will be available on Channels 3/4.
If two sEMG Modules are installed, one on the Therapy System and one on the Channel 3/4 Electrotherapy Module, sEMG and sEMG + Stim modalities will be available to all four Channels. However, only two channels at a time may be used; either Channels 1/2 or Channels 3/4.
This section provides general instructions to prepare the Therapy System and the optional Channel 3/4 Electrotherapy Module for installation of the sEMG and sEMG + Stim Module(s).
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