Download Table 1: Guidance and Manufacturers Declarations

CP Relief Wand®
Model CP 1000
(Rx Only)
Operation
Manual
Mid-America Medical Innovations, LLC
2704 Industrial Drive
Jefferson City, MO 65109 USA
RoHS Compliant
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.
X.
Warranty Information
Information Regarding Electromagnetic Compatability (EMC)
XI. Glossary
I.
INTRODUCTION
General
The CP Relief Wand® is a TENS Device 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 TENS electro-therapy and the CP-1000 is one of the latest
advancements in TENS therapy.
How does your CP Relief Wand® work?
The Model CP-1000 is a battery powered portable hand held TENS device with self contained electrodes
that provide extra convenience to the patient or therapist. TENS therapy relieves pain by blocking the
pain messages to the brain. The pain messages normally originate in the pain center. When the TENS
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 TENS
pulses travel 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
Indications for Use
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 nerve stimulation is not effective for pain of central origin, including
headache.
2. Transcutaneous electrical nerve stimulation is not a substitute for pain medications and other pain
management therapies.
3. Transcutaneous electrical nerve stimulation devices have no curative value.
4. Transcutaneous electrical nerve 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.
Warnings
1. Do not apply stimulation over the front (throat area), sides, or the center (rear spinal cord area) of your
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.
13. Do not place this device on your head.
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
CP Relief Wand® Controls
The CP Relief Wand® controls are designed to be simple and easy to operate. Refer to the diagram
below for the location of the controls.
Intensity Control: The Intensity Control is a thumb dial located on the side for easy access during
treatment. This control provides continuous adjustment and control of the amplitude of the pulsating
electrical current during treatment. This dial is labeled 0-8 and corresponds to the output setting. Set the
Intensity to zero before placing electrodes against the skin and reduce the Intensity to zero after
removing the electrodes from the skin.
On-Off Switch: This is the main power switch.
Pulse Width Switch: The Pulse Width Switch selects either 150 microsecond pulse width (low) or 230
microsecond (uS) pulse width (high). Choose the 150 microsecond (uS) setting for lowest power and
maximum comfort during treatment.
Polarity Switch: The Polarity Switch allows you to choose the polarity of the electrodes for best results.
When using the CP Relief Wand® in certain locations of the body, uncomfortable muscle vibrations may
occur during treatment. By changing the polarity (or rotating the electrode axis) uncomfortable muscle
movements can often be minimized or eliminated.
CP Relief Wand® Battery Information
The battery in your CP Relief Wand® should last for up to 70 hours of operation and give you long
lasting service. We recommend that the battery be replaced with a fresh battery at regular intervals to
reduce the possibility of battery leakage. It is located in the CP-1000 handle and can be accessed by
removing the battery compartment door. Remove the battery during long term storage to prevent
damage caused by leakage from the battery. Always turn the CP-1000 off before removing the battery.
Replace with a fresh 9V alkaline battery and be careful to observe the polarity of the battery and
connector when installing a new battery.
CP Relief Wand® Electrodes
The CP Relief Wand® has built in stainless steel electrodes and is supplied with a pack of reusable stickon gel pads. The stick-on gel pads are intended to provide good electrical skin contact and to maintain
proper hygiene between patients. The skin should also be cleaned and moistened prior to using the CP
Relief Wand®. The gel pad should first be applied over the electrode end of the CP Relief Wand® before
using. While holding the CP-1000 between the knees, gently peel the gel pad from the backing material
and stick the gel pad completely over the electrode end of the CP Relief Wand®. Make sure that the
electrodes are fully exposed through the “windows” of the gel pad. Moisten the skin area and then firmly
press the CP Relief Wand® electrode end against the skin. After treatment, replace the outer tape over
the gel pad to preserve gel moisture for future use. The gel pad can be reused many times with
moistened skin. During long periods of non use, it is best to remove the gel pad from the end of the CP
Relief Wand® and stick it to the original plastic backing. Store in sealed bag. If your stick-on reusable gel
pads dry out, you can moisten them with water for continued use. After repeated usage, the gel pads
deliver less stimulation and should be replaced as needed. Always use CP Relief Wand® # 2088 Gel
Pads.
Skin Preparation
By properly caring for skin prior to using the CP Relief Wand®, you will allow more stimulation to reach
the targeted nerves and prolong the life of your gel pads. You will also reduce the chance that any skin
irritation will develop. However, if skin irritation develops, discontinue using your CP Relief Wand®, and
consult with your physician or health care provider.
To properly care for your skin:
1. Wash all electrode skin area sites with mild soap and water before using the CP Relief Wand®.
2. Moisten the skin prior to using the CP Relief Wand®.
3. Trim excess body hair from electrode site for comfort if needed.
4. Do not use on cut, broken or irritated skin
Using the CP Relief Wand®
Never place the CP Relief Wand® on the neck, throat, face, chest, or head. Review precautions,
cautions, warnings, and contraindications in Section II of this manual. Be sure that the gel pad is in full
contact with the skin when using. Do not use in areas of the body where full and complete contact of the
entire surface of the electrodes is not possible. Failure to position the Wand so that the entire surface of
the electrodes is in contact with the skin may result in reduced or insufficient effectiveness.
1. Verify that the power switch is turned off.
2. Before connecting the battery, be sure to check the polarity of the connector. Attach the connector to a
9V alkaline battery and insert the battery into the compartment and replace the cover.
3. Prepare the skin as shown above moisten the skin thoroughly with ordinary tap water.
4. Install the gel pad on the electrode end of the CP Relief Wand®. (You can hold the CP-1000 with your
knees while applying the gel pads to the electrodes.) Visibly inspect that the electrode end of the device
is free of any contamination such as dust, dirt, or debris prior to application of the gel pad. Be sure that
the electrodes are centered in the gel pad windows.
5. With the Polarity control in the normal position and the Intensity control at zero set the Pulse Width
control to 150 uS. After you are familiar with using the 150 uS setting, you may wish to become familiar
with using the 230 uS setting for higher power.
6. With the Intensity control set to zero, turn the CP Relief Wand® power switch on and place the unit in
the required location. Press the CP Relief Wand® firmly against the skin and increase the Intensity to the
highest tolerable setting.
NOTE: You should always follow your health professional’s instructions on proper use of the CP Relief
Wand®. The exact location of the pain is normally the best location to place the CP Relief Wand®. This
location can usually be found by pressing the finger in and around the area of the pain and locating the
most painful spot. The CP Relief Wand® is then pressed firmly over this spot. Gradually increase the
Intensity control to the maximum tolerable level. (If there is undesirable muscle vibration, the Intensity
can be reduced, the polarity can be reversed, the Wand can be rotated to a different angular position, or
the Wand can be moved to a different position.) Continue holding the CP Relief Wand® in this position
until some further reduction in pain is detected and again increase the intensity as high as is tolerable.
Treatment time may vary depending on the degree of pain, intensity setting, and the patient’s tolerance
to TENS therapy. When using the CP Relief Wand®, the pain center may be larger than the width of the
CP Relief Wand®. In such case, to assure the entire pain center is treated, repeat the treatment process
after moving the CP Relief Wand® in ¾ inch steps on both sides of the original position. After completion
of treatment with the CP Relief Wand® the patient should feel a tingling which will go away in a short
time. Once an acceptable placement has been achieved, you may wish to record the site location in a
notebook or in your operation manual for future reference.
8. After use, replace the tape over the gel pad to keep it dry for the next use. For longer term storage,
place the gel pad back onto its original plastic film and inside the original sealed plastic bag.
IV.
TECHNICAL SPECIFICATIONS
Peak Current
Peak Voltage
Pulse Rate
Pulse Width
Waveform
Maximum Charge per pulse
Power Supply
Electrodes
FDA Cleared
Safety Tests
RoHS Compliance
0-80 milliamps (500 ohms)
0-40 V (500 ohm)
40 Hz
150 or 230 microseconds (selectable)
Asymmetrical Bi-phase Square Pulse
20 Microcoulombs
9 Volt Alkaline Battery
Stainless Steel
FDA 510(k) #K133779
Complies with IEC60601-1, IEC60601-1-2, and IEC60601-2-10
Complies with RoHS Standards
V.
STORAGE
When your CP Relief Wand® is not in use, store it in the carrying case where it will be safe from
accidental damage. For long term storage, remove the battery and keep in dry storage area away from
sunlight at normal room temperature. Remove gel pads when not in regular use.
Remove battery before storing
VI.
ROUTINE MAINTENANCE
Wipe the electrodes with alcohol regularly. Clean the outside of the CP Relief Wand® case as needed
with a damp cloth and mild soap. Never immerse your CP-1000 in water, alcohol or other fluids, since
this could seriously damage the internal electronics. Avoid using cleaning fluids or solvents to remove
stains or dirt, because such liquids may damage the plastic. Keep your Wand stored in the carrying case
when not in use. Use only fresh batteries and replace as necessary. There are no replaceable parts
inside the CP Relief Wand®.
NOTE: Like any other stainless steel product, after extended periods of use, the stainless steel
electrodes may tarnish due to the salts in your skin. Stainless steel tarnish will not affect operation.
Should this occur and you wish to restore the finish, you can use a non-abrasive light duty cleaning pad
such as Norton BearTex® #59384 or 3M Scotch Bright® hand pad to polish the electrodes.
VII.
INSPECTION REQUIREMENTS
Your CP Relief Wand® should provide years of dependable service. Inspect your unit regularly for
damage. Verify that the switches and Intensity control work properly and that the indicator lamp is visible
when turned on. Replace battery as needed.
VIII.
MALFUNCTIONS
Should any malfunctions occur while using the CP Relief Wand®, check the switches and controls for
correct settings.
If stimulation output is diminished, insert a new battery. Should there be any other problem, please return
the unit to your dealer or factory. Do not try to repair a defective device. There are no serviceable parts in
the CP-1000. The factory warranty will be voided if there is evidence of disassembly.
IX.
WARRANTY INFORMATION
The CP Relief Wand® carries a one year manufacturers warranty from the date of purchase. The
warranty covers both parts and labor for any problems that arise from defects or faults in manufacturing.
The warranty does not apply to damage resulting from failure to follow the operating instructions,
accidents, abuse, alteration or disassembly by unauthorized personnel.
When returning to the factory, a Return Authorization Number must be obtained prior to returning the
unit. Make sure to keep your purchase receipt since you will need this to receive a Return Authorization
Number.
A potential hazard exists if this device is used near high frequency surgical equipment.
Also, do not use near microwave equipment.
X.
INFORMATION REGARDING ELECTROMAGNETIC COMPATABILITY (EMC)
Table 1: Guidance and Manufacturers Declarations
- Electromagnetic Emissions
The CP Relief Wand® is designed to produce very low levels of radio frequency
(RF) emissions (interference), to be immune to the effects of interference
produced by other equipment operating in the vicinity, and to be immune to
damage due from electrostatic discharge, all when operating in a domestic or
clinical environment. For more information, please refer to the tables below.
Emissions
Test
RF
Emissions
CISPR 11
RF
Emissions
CISPR 11
Compliance
Electromagnetic Environment Guidance
Group 1
The CP Relief Wand® uses RF energy only for
its internal function. Therefore its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
Class B
The CP Relief Wand® is suitable for use in all
establishments including domestic
establishments and those directly connected to
the public low voltage power supply network
that supplies buildings used for domestic
purposes.
Table 2: Guidance and manufacturer’s declaration
- electromagnetic immunity
The CP Relief Wand® is intended for use in the electromagnetic
environment specified below. The customer or the user
should assure that it is used in such environment
Immunity
test
Electrostatic
Discharge
(ESD) IEC
61000-4-2
IEC 60601
test level
Compliance
level
± 6 KV
Contact
± 6 KV
Contact
± 8 KV
air
± 8 KV
air
Electromagnetic
Environment
guidance
Floors should be wood,
concrete, or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%
Power
Frequency
(50/60 Hz)
Magnetic
Field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment
Table 3: Guidance and manufacturer’s declaration
- electromagnetic immunity
The CP Relief Wand® is intended for use in the electromagnetic
environment specified below. The customer or user
should assure that it is used in such an environment.
Immunity
test
IEC 60501
Test level
Compliance
level
Electromagnetic environment
guidance
Portable and mobile RF
Communications equipment
should be used no closer to any
part of the device, including
cables, than the recommended
distance calculated from the
equation applicable to the
frequency of the transmitter’s
recommended separation distance
Radiated
RF IEC
61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
80 MHz to 800 MHz
d = 1.2 √P
800 MHz to 2.5 GHz
d = 2.3 √P
Where “P” is the maximum output
power rating of the transmitter in
Watts (W) according to the
transmitter manufacturer and “d” is
the recommended separation distance
in meters “m”. Field strength from
fixed RF transmitters as determined
by the electromagnetic site survey, a.
should be less than the compliance
level in each frequency range. b.
interference may occur in the vicinity
of equipment marked with the
following symbol:
NOTE 1: At 80 MHz to 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as based stations for radio (cellular and
cordless) and land mobile radios, amateur radio, AM and FM radio broadcast, and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the CP Relief Wand® is
used exceeds the applicable RF compliance level above, the CP Relief Wand® should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the device.
b. Over the frequency range of 150 KHz to 80 MHz, field strengths should be less
than 3 V/m.
Table 4: Recommended separation distances between portable and
mobile RF communication equipment and the CP Relief Wand®.
The CP Relief Wand® is intended to be used in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or user of the
device can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) as recommended below, according to the maximum output power
of the communications equipment.
Rated maximum
output power of
transmitter (W)
Separation distance (m) according to frequency of transmitter
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1.2 √P
d = 2.3 √P
0.01
0.12
0.23
0.1
0.38
0.73
1
1.2
2.3
10
3.8
7.3
100
12
23
For transmitters not listed above, the recommended separation distance (d) in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter,
where P is the maximum output power of the transmitter in Watts (W) according to the
manufacturer.
NOTE 1: At 80 MHz to 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
XI.
GLOSSARY
uS
Microseconds
Hz
Hertz
Rx
Sold by Prescription Only
Caution
Type BF Applied Part
Manufactured by:
Mid-America Medical Innovations, LLC
2704 Industrial Dr.
Jefferson City, MO 65109 USA
IFU-001 Rev D June 2014