Indications for Use

The TrueRelief device is intended for use under the supervision of a Healthcare Professional.

TrueRelief is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Contraindications

You Must:

Never place electrodes in a manner that applies current to the carotid sinus (neck) region.
Never use TrueRelief on patients who have a demand-type cardiac pacemaker.
Never place the electrodes in a manner that causes the current to flow trans-cerebrally (through the head).
Never use the device when pain syndromes are undiagnosed until the etiology is established.

Warnings

The safety of TrueRelief for use during pregnancy or birth has not been established.
TrueRelief is not proven effective for pain of central origin. (This includes headache.)
TrueRelief should be used only under the continued direct supervision of a physician.
TrueRelief has no proven curative value.
TrueRelief has not been cleared as more than symptomatic treatment. A symptomatic treatment suppresses the sensation of pain which would otherwise serve as a protective mechanism.
Keep this device out of the reach of children.
Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when TrueRelief is in use.
Simultaneous connection of a patient to high frequency surgical equipment may produce instability in TrueRelief output.
Operation in close proximity (e.g. 1m) to a short wave or microwave therapy equipment may produce instability in the TrueRelief output.
TrueRelief uses dense electrodes and the user should use special attention in their placement and the patient’s response.
The equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with these 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. If this equipment does cause harmful interference with other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving device
- Increase the separation between the equipment
- Connect the equipment into an outlet on a circuit different from that to which the other device(s) is connected
- Consult the manufacturer or field service technician
Applications of electrodes (probes) near the thorax may increase the risk of cardiac fibrillation. Use of TrueRelief in such a manner should only be done after consultation with a qualified medical professional.
Current should not be applied directly on the eyes, covering the mouth, on the front of the neck, or across the heart with electrodes (probes) placed on either side of the heart or one electrode (probe) on the chest near the heart and the other electrode (probe) on the upper back (so that current flows through the heart) without consulting a qualified medical professional.
Exercise caution when handling the power supply as it could become hot to the touch.

Precautions

Isolated cases of skin irritation may occur at the site of electrode placement following long-term application.
Effectiveness is highly dependent upon patient selection by a person qualified in the management of pain patients.
The TrueRelief device has IP20 Ingress Protection: protected against solid foreign objects of 12.5 mm diameter and greater; not protected against water ingress.
TrueRelief is not suitable for use in an oxygen rich environment.

Adverse Reactions

Skin irritation is a potential adverse reaction to electrical stimulation. Skin reddening may also result from increased blood flow.