Mid America Motorworks CP Relief WandCP 1000 Operation Manual

Operation Manual

RoHS Compliant

CP Relief Wand®

Model CP 1000 (Rx Only)

Mid-America Medical Innovations, LLC

2704 Industrial Drive Jefferson City, MO 65109 USA

573-556-5569 844-226-1013

IFU-001 Rev D June 2014 FDA 510(k) Cleared

INDEX

I. Introduction

General
What is pain?
How long has electrical stimulation been used to alleviate pain?
How does your CP Relief Wand® work?

II. Important Prescription Information

Indications for Use
Contraindications
Precautions
Cautions
Warnings
Adverse Reactions

III. Operation

CP Relief Wand® Components
CP Relief Wand® Controls
CP Relief Wand® Battery Information
CP Relief Wand® Electrodes
Skin Preparation
Using the CP Relief Wand®

IV. Technical Specifications
V. Storage
VI. Routine Maintenance
VII. Inspection Requirements
VIII. Malfunctions
IX. Warranty Information
X. Information Regarding Electromagnetic Compatability (EMC)
XI. Glossary

IFU-001 Rev D June 2014 FDA 510(k) Cleared

I. INTRODUCTION

General

The CP Relief Wand® is a Neuro- Stimulator and is intended for use as an adjunctive therapy for pain
management for medical purposes such as symptomatic relief of chronic intractable pain and relief of
acute post surgical and post-traumatic pain. Please review this instruction manual before using. This
manual is intended to show you how to use and care for your CP Relief Wand®. Observe the indications,
cautions, warnings, contraindications, and precautions. The CP Relief Wand® is available by prescription
only and you should follow your physician’s advice when using your CP Relief Wand®.

What is pain?

Pain is a warning system and the body’s method of telling us that something is wrong. Pain is important
because without it, abnormal conditions may go undetected, causing damage or injury to vital parts of
our bodies. Pain is a necessary warning signal of trauma or malfunction in the body but aside from its
value in diagnosis, long-lasting persistent pain serves no useful purpose. Medical science has shown
that pain does not begin until a coded message travels to the brain where it is decoded, analyzed, and
then reacted to. The pain message is then interpreted and the pain is felt.

How long has electrical stimulation been used to alleviate pain?

Electro-therapy has a long history for the treatment of pain. Ancient documents indicate that it was used
in antiquity. During ancient times, almost everyone traveled long distances by foot and painful feet would
have been a common problem. Recovered ancient artifacts show that the Egyptians and Greeks knew of
the pain reducing effects of standing in a pool with electric fish. In 46 AD, Roman physician Scribonus
Largus recorded that he used the electrical discharge from Torpedo fish to relieve pain from gout. Today
we enjoy better living thanks to modern Neuro Therapy and the CP-1000 is one of the latest technology
advancements.

How does your CP Relief Wand® work?

The Model CP-1000 is a battery powered portable hand held Neuro Therapy device with self contained
electrodes that provide extra convenience to the patient or therapist. The pain messages normally
originate in the pain center within the nerve and muscle fibers. When the electrodes are positioned close
to one another to treat specific pain centers, the alignment of the electrodes relative to the pain becomes
increasingly important. The CP-1000 provides the extra convenience needed for the patient or therapist
to position the electrodes for best results. The therapy travels through and under the skin between the
electrodes to desensitize the nerves within its path. With the CP-1000, the patient or therapist can easily
control the electrode position relative to the location of the pain.

II. IMPORTANT PRESCRIPTION INFORMATION

NOTE: This product is to be used only as prescribed by your physician. Do not use on the face, head,
neck, or chest and observe prescription information below. Keep out of reach of children.

Federal Law restricts this device to sale by or on the order of a physician.

Indications for Use

IFU-001 Rev D June 2014 FDA 510(k) Cleared

1. Symptomatic relief of chronic intractable pain.

2. Post traumatic pain.

3. Post surgical pain.

Contraindications

1. Do not use this device on patients who have a cardiac pacemaker, implanted
Defibrillator or other implanted metallic or electronic device, because this may
cause electric shock, burns, electrical interference, or death.

2. Do not use this device on patients whose pain syndromes are undiagnosed.

Precautions

1. Transcutaneous electrical neuro stimulation is not effective for pain of central origin, including
headache.

2. Transcutaneous electrical neuro stimulation is not a substitute for pain medications and other pain
management therapies.

3. Transcutaneous electrical neuro stimulation devices have no curative value.

4. Transcutaneous electrical neuro stimulation is a symptomatic treatment and, as such, suppresses the
sensation of pain that would otherwise serve as a protective mechanism.

5. Effectiveness is highly dependent upon patient selection by a practitioner qualified in the management
of pain patients.

6. The long-term effects of electrical stimulation are unknown.

7. Since the effects of stimulation of the brain are unknown, the unit’s electrodes should not be applied

anywhere on the head.

8. The safety of electrical stimulation during pregnancy has not been established.
9, Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or
electrical conductive medium (gel).

10. Patients with suspected or diagnosed heart disease and epilepsy should follow precautions
recommended by their physicians.

11. Care should be taken so that when operating potentially dangerous machinery, the stimulator
controls are not changed abruptly.

Cautions

1. Use caution when the patient has a tendency to bleed internally, such as following an injury or
fracture.

2. Use caution following recent surgical procedures when stimulation may disrupt the patient’s healing
process.

3. Use caution if stimulation is applied over the menstruating or pregnant uterus.

4. Use caution if stimulation is applied over areas of skin that lack normal sensation.

5. Keep this device out of the reach of children.

6. Use this device in accordance with this instruction manual.

7. Use this device only under the continued supervision of a licensed practitioner.

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

IFU-001 Rev D June 2014 FDA 510(k) Cleared