InterX 5002 Manuel utilisateur
5002 Professional Device
OPERATIONS
MANUAL
®
Patent Pending
2797
US Patent No. 9,630,003 B2 and Patents Pending
Introduction
The InterX 5002 is designed specifically for medical professionals,
combining interactive technology with a new user interface that provides
access to stimulation patterns to treat a range of conditions from traumatic
injury to post-surgical rehabilitation to chronic degenerative conditions.
InterX Therapy is effective in the treatment of both acute and chronic pain
caused by inflammatory or degenerative processes; it is also proven in
cases of neuropathic pain. InterX treatment provides very effective, non-
invasive, non-drug pain relief and has proven to be an excellent addition to
any rehabilitation program.
The therapeutic effect of the InterX 5002 is based on Interactive
Neurostimulation. Unlike conventional neuro-stimulation products, the
InterX 5002 provides an interactive response to impedance changes in the
tissue. When applied to the skin, its electrical impulses adjust dynamically
as the device encounters changes in the tissue contacting its electrodes.
The InterX 5002 responds to the condition of the tissue it is touching, and
continues to adjust as the body responds and reflects its changes through
the skin. This interactive capability not only provides results, but also resists
the body’s natural tendency to develop a tolerance to static therapies.
Please read this manual completely prior to using the InterX 5002.
Table of Contents
Indications for Use ............................................................................3
Contraindications .............................................................................4
Warnings & Cautions ........................................................................4
Definitions & Symbols ......................................................................7
Controls and Functions......................................................................8
Instructions for Use............................................................................9
Condition Specific Preset List.............................................................10
Navigation Screen Options................................................................11
Electrode Contact ..............................................................................12
How to Set Stimulation Intensity........................................................13
Full Preset List ...................................................................................14
Preset Stimulation Patterns (illustrations) ............................................15
Accessory Electrodes .........................................................................19
Activity Reading ................................................................................20
Point-stim ..........................................................................................21
Multi-stim..........................................................................................22
InterX Set-up Options ........................................................................24
Sport Mode........................................................................................25
Injury Stage .......................................................................................26
Battery Operation..............................................................................27
General Care.....................................................................................29
Glossary of Terms ..............................................................................30
InterX 5002 Screen Symbols..............................................................31
Service and Warranty ........................................................................33
Product Specifications .......................................................................34
InterX 5002 Operations Manual
This manual provides information regarding the controls and functions of
the InterX 5002. The InterX 5002 must be used strictly in accordance with
these instructions. Further training is required to fully use the device and
obtain optimal patient treatment outcomes.
Indications for use
The InterX 5002 is indicated for:
• symptomatic relief and management of chronic intractable pain
• adjunctive treatment in the management of post-surgical and
post-traumatic pain
The InterX 5002 carries the European CE mark for pain relief.
InterX Technologies is an ISO 13485 Registered company.
Contact InterX Technologies for country specific information or additional
regulatory approvals.
Definition –Warning: A WARNING message contains special
safety emphasis and must be observed at all times. Failure to observe a
WARNING message could result in serious personal injury.
Definition –Caution: : Failure to observe a CAUTION associated with
use could result in minor injury or product damage. Such problems
include device malfunction, device failure, damage to the device or damage
to other property.
3
Any serious incident that occurs in relation to the device should be reported
immediately to the manufacturer and the competent authority of the Member
State in which the user and/or patient is established.
Contra-indications
• Electrode placement over malignant tumors
• Transcerebral and/or carotid sinus electrode placement
• Use over mucous membranes
• Undiagnosed pain (until etiology is established)
• Patients who are prone to seizures (e.g. patients with epilepsy)
• Use over pharyngeal or laryngeal muscles. The electrical impulses
generated may cause muscle spasm resulting in difficulty in breathing
• Patients that have a demand-type cardiac pacemaker
Warnings
Federal (U.S.A.) law restricts this device to sale by, or on the order of a
practitioner licensed by the law of the State in which he/she practices to use,
or order the use of the device.
Federal (U.S.A.) law requires the InterX 5002 be used only by a trained
healthcare practitioner or under the continued supervision of a licensed
healthcare practitioner. The InterX 5002 must be used only by the person for
whom it is prescribed. Electrode placement and stimulation settings should
be based on the guidance of the prescribing practitioner.
Safe use of the InterX 5002 is the primary responsibility of the user. The user
is responsible for the monitoring of the product. Contact clinical/technical
support if the InterX 5002 appears to be operating incorrectly.
The user must keep this device out of reach of children.
The InterX 5002 is not effective for pain of central origin including
headaches.
The InterX 5002 is a symptomatic treatment and as such could suppress the
sensation of pain which would otherwise serve as a protective mechanism.
The safety of the use of the InterX 5002 has not been established during
pregnancy or childbirth.
Do not operate the InterX 5002 before verifying that other medical devices
will not be adversely affected by the electrical impulses generated. (eg.
electrical implants)
4
Warnings (cont.)
Stimulus delivered by this device may cause electrocution. Electrical current
of this magnitude must not flow through the thorax or carotid sinus nerves
because it may cause cardiac arrhythmia or interfere with cardiac function.
Use caution in applying the InterX 5002 over areas which are swollen,
infected, or inflamed as this may result in a worsening of symptoms. In
particular, caution should be taken when electrodes are placed over areas
associated with phlebitis, thrombophlebitis and varicose veins as these
conditions present an increased risk of forming blood clots which could
become dislodged during stimulation.
Use caution in applying the InterX 5002 to patients suspected of having
heart disease.
If the display becomes blank or inoperative discontinue use.
Do not make contact with the InterX 5002 electrodes on wet skin. Natural
bodily fluids, including sweat, are acceptable.
Extreme heat or cold may effect the operation of the InterX 5002.
Electronic monitoring equipment (such as ECG monitors and ECG alarms)
may not operate properly when stimulation is in use.
Do not use on patients that are undergoing dialysis or are being treated in an
MRI, X-ray, or with other diagnostic equipment that may be impacted by the
electrical impulses. Remove all jewelry before treatment.
The InterX 5002 is not to be used in the presence of anesthetic or other
flammable gases.
The InterX 5002 has no curative value.
Avoid placing the device on the skin when turning on or returning from
pause to avoid electrical signal.
Treatments with the InterX 5002 should not exceed 1 hour in any specific area
of the body and there should be a minimum of 2 hours between treatment
sessions, to avoid isolated cases of skin irritation.
Skin irritation, bruising, electrode burns, dizziness, nausea, and headaches
are potential adverse reactions.
5
Cautions
The InterX 5002 should be used only with manufacturer approved electrodes
and accessories. Built-in device electrodes and external electrodes should
not be used in combination transcerebrally.
Avoid spilling fluids on the device. If the InterX 5002 is immersed in any
liquid it must be replaced with a new device.
Do not sterilize the InterX 5002.
Do not expose any part of the InterX 5002 to chemical solvents or harsh
cleaning fluids. Follow cleaning instructions in this manual.
Effectiveness of the InterX 5002 is highly dependent upon patient selection
by a person qualified in the management of pain.
The InterX 5002 should not be used while driving, operating machinery, or
during any activity which may put the user at undue risk of injury.
Do not open the InterX 5002 case. Opening or removing the device housing
may expose you to dangerous voltage or other hazards and can damage
operating circuits. Opening the case will void the manufacturer’s warranty. If
the device should need repair or service contact InterX Technologies, your
InterX 5002 distributor or an authorized InterX service representative.
Turn device OFF before replacing batteries to avoid unexpected electrical
signal. Only the battery cover may be removed when changing batteries. Do
not attempt to connect the InterX 5002 to any other power source.
6
Table des matières
Autres manuels InterX Équipement médical
