IFU-001 Rev D June 2014
FDA 510(k) Cleared
Warnings
1. Do not apply stimulation over the patient’s neck because this could cause severe muscle spasms
resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood
pressure.
2. Do not apply stimulation across the patient’s chest or place both hands, arms, or fingers on electrodes
at the same time, because the introduction of electrical current into the chest may cause rhythm
disturbances to the patient’s heart, which could be lethal. This device can affect the operation of demand
type cardiac pacemakers and is not recommended for patients with known heart disease without physical
evaluation of risk.
3. Do not apply stimulation over open wounds or open rashes, or over swollen, red,
infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins).
4. Do not apply stimulation over, or in proximity to, cancerous lesions.
5. Do not apply stimulation 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.
6. Do not apply stimulation when the patient is in the bath or shower.
7. Do not apply stimulation while the patient is sleeping; or while the patient is driving, operating
machinery, or during any activity in which electrical stimulation can put the patient at risk of injury.
8. Consult with your physician before using this device, because the device may cause lethal rhythm
disturbances to the heart in susceptible individuals; and
9. Apply stimulation only to normal, intact, clean, healthy skin.
10. Federal law restricts this device to sale by or on the order of a physician
11. Do not place electrodes on the front of the throat as spasm of the
Laryngeal and Pharyngeal muscle may occur
12. Electrodes should not be placed over the eyes, in the mouth, or internally.
Adverse Reactions
1. Patients may experience skin irritation or burns beneath the stimulation electrodes.
2. Patients should stop using the device and should consult with their physicians if they experience any
adverse reactions from the device.
3. Patients may experience headache and other painful sensations during or following the application of
electrical stimulation near the eyes and to the head and face.
III. OPERATION
CP Relief Wand® Components
The CP Relief Wand® is provided with:
1 CP Relief Wand®
1 Package of reusable gel pads
1 9V Alkaline battery
1 Instruction Manual
1 Quick Start Guide
1 Carrying Case
