CP Relief Wand. Model CP 1000 (Rx Only) Operation Manual. Mid-America Medical Innovations, LLC Jefferson City, MO

Transcription

1 CP Relief Wand Model CP 1000 (Rx Only) Operation Manual Mid-America Medical Innovations, LLC Jefferson City, MO RoHS Compliant Attachment 13.6 Page

2 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 Attachment 13.6 Page

3 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 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. Attachment 13.6 Page

4 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. Attachment 13.6 Page

5 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 Carrying Case Attachment 13.6 Page

6 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. The 150 microsecond (us) pulse width setting normally requires longer treatment times than the 230 microsecond (us) setting. Use the 230 microsecond (us) setting for highest power and fastest treatment time. 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 Attachment 13.6 Page

7 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 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 numerous 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 electrodes and gel are in full contact with the skin when using. 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.) Be sure that the electrodes are centered in the gel pad windows. Attachment 13.6 Page

8 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 polarity can be reversed or the Wand can be rotated to a different angular 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 varies 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 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 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 Attachment 13.6 Page

9 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. 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 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. Attachment 13.6 Page

10 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 Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 RF Emissions CISPR 11 Group 1 Class B 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. 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 IEC test level Compliance level Electromagnetic Environment guidance Electrostatic Discharge (ESD) IEC ± 6 KV Contact ± 8 KV air ± 6 KV Contact ± 8 KV air Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30% Attachment 13.6 Page

11 Power Frequency (50/60 Hz) Magnetic Field IEC 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 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 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: Attachment 13.6 Page

12 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 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 Attachment 13.6 Page

13 XI. GLOSSARY us Microseconds Hz Rx Hertz Sold by Prescription Only Caution Type BF Applied Part Manufactured by: Mid-America Medical Innovations, LLC 2704 Industrial Dr. Jefferson City, MO Attachment 13.6 Page