Instruction Guide
Component of the IOMED Phoresor Iontophoretic Drug Delivery System.
Read and understand all instructions before using. Keep these instructions for future use.
I. INDICATIONS
The Phoresor Iontophoretic Drug Deliver y System is indicated for the administration of soluble salts and other drugs into the body for medical purposes as an alternative to hypodermic injection in situations when it is advisable to avoid the pain that may accompany needle inser tions and drug injection, when it is advisable to minimize the infiltration of carrier fluids, or to avoid the damage caused by needle inser tion when tissue is traumatized. It is also indicated for production of local dermal anesthesia using IONTOCAINE ® (brand of lidocaine hydrochloride 2% and epinephrine 1:100,000 Topical Solution).
II. CONTRAINDICATIONS
The Phoresor PM900 Iontophoretic Drug Deliver y System is contraindicated for use on patients with electrically sensitive suppor t systems (e.g. pacemakers) and patients with known allergy or sensitivity to the drugs to be administered. It is contraindicated for use over damaged or denuded skin or other recent scar tissue, across the right and left temporal regions and for treatment of the orbital region.
III. WARNINGS AND PRECAUTIONS
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
A. The Phoresor PM900 and IOMED electrodes are designed to operate safely when used together.
B. Never attempt to reuse disposable electrodes. Discard after use.
C. Iontophoresis can cause skin irritation and burns.
Patients should be advised of this potential prior to treatment. It is impor tant to note the following:
1. Continuous direct current used in iontophoresis can cause transient (uniform or mottled) er ythema under either electrode which will generally resolve within a few hours to a few days.
2. Advise patients to repor t any undue burning or pain during treatment at once.
3. Patients should remove any jewelr y that may come in contact with either electrode. Failure to do so may cause burns.
4. DO NOT exceed maximum levels of current or dose (total delivered charge). Refer to directions for use supplied with electrodes.
5. Failure to obser ve the following precautions may result in excessive skin irritation or burns:
- DO NOT tape, bind or compress electrodes during treatment.
- DO NOT use electrodes that have been altered or appear damaged.
- DO NOT apply electrodes over damaged skin.
6. DO NOT use the Phoresor PM900 and electrodes on patients with electrically sensi- tive suppor t systems (e.g. pacemakers). Doing so may cause the suppor t system to malfunction.
7. Exercise caution in handling the Phoresor PM900. Do not allow it to be dropped or immersed in fluids. DO NOT connect unit to external devices. Doing so may cause a malfunction or patient injury.
8. DO NOT apply electrodes over or across the right and left temporal regions, or use the Phoresor PM900 and electrodes for treatment of the orbital region. Doing so may cause transient visual disturbances.
9. Patients with known sensitivity to electrical current should be treated with lower current settings than those recommended for general use. If treatment results in prolonged skin irritation or bur n s, do not give additional treatments and consult a physician.
10. Patients should be asked about their histor y of drug allergies or sensitivities. The Phoresor PM900 and electrodes should not be used on any patient who demonstrates a known allergy or sensitivity to the drugs being administered. Consult the drugs package inser t for additional contraindica- tions and warnings.
11. The Phoresor PM900 has been tested and cer tified to operate correctly when subjected to strong electro- magnetic fields ranging from 27 to 1,000 megaHer tz. However, do not operate the Phoresor PM900 within 2m of transmitting cellular telephones or two-way radios or within 3m of equipment that generates high frequency or high-energy electro- magnetic radiation (e.g. radio transceivers, radio frequency diagnostic and therapeutic medical devices, welders or cutters, radio frequency
inductive heaters, etc.). Operation in close proximity to this type of equipment may produce changes in output or improper operation of the unit.
12. The "REJECT" safety feature of the Phoresor PM900 indicates an interruption in the electrical circuit has occurred. Tr eatment is temporarily suspended and the "REJECT" condition is indicated by the flashing "REJ" light and beeps. A mild shocking sensation may be experienced by the patient whenever an electrode reject occurs. Do not disconnect the lead wires from the electrodes, or the electrodes from the patient while the current is ON since this will cause the reject feature to function. The patient should avoid unnecessar y movement during the treatment to ensure that an inadver tent disconnection of an electrode or lead wire does not occur.
13. Refer to the directions for use supplied with IOMED
electrodes for impor tant additional information.
IV. THEORY OF OPERATION
Iontophoresis can be used to transpor t soluble drug ions across intact skin. The technology is based on the principle
that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered by iontophoresis is dependent upon the charge of the ion, the size of the ion (molecular weight), the strength of the electrical current being applied, electrode composition, the duration of current flow and numerous other factors.
V. Phoresor PM900 SAFETY AND CONVENIENCE FEATURES
A. Description : The Phoresor PM900 is a solid state, microprocessor-controlled device utilized to administer soluble salts or other drugs. The microprocessor per forms several safety tests continually from the time of power on and other safety tests depending upon the mode of operation.
B. Automatic Dose Calculation: Only the desired current needs to be selected for a treatment. The total drug dose delivered calculation is per formed automatically by using a preset dose of 40 mA-minutes.
C. Automatic Time Calculation: Only the desired current needs to be selected for a treatment. All time calculations are performed automatically, even if the current selection is changed.
D. Automatic Current Ramp Up: After selecting the desired current the treatment will begin in approximately 2 seconds. The unit automatically ramps up the current output at a rate comfor table for most patients. The current may be adjusted for patient comfor t any time during a treatment, including during current ramp up.
E. Automatic or Manual Current Ramp Down: After the preset dose of 40 mA-minutes is reached, the current automatically ramps down to 0.0 mA and the unit beeps, terminating the treatment. Also, automatic current ramp down takes place if a "LOW BATTERY REJECT" occurs during treatment. Current may be tur ned of f manually by depressing and holding the OFF button any time, even during ramp up, to terminate treatment.
F. 10 Minute Automatic Shut Of f: The unit shuts of f automatically after 10 minutes if a "REJECT" occurs and no other action has been taken.
G. Resistance Limit: Occasionally, when treating high resistance skin areas, such as the plantar sur face of the foot, the unit will continue to beep and to flash on the selected current level display until the desired current level has been reached. As resistance drops during treatment, the unit will automatically ramp up the current to the desired level. If the desired level can not be reached within 30 addi- tional seconds, the unit will "REJECT."
H. Electrode Reject: Circuit problems (e.g., loose electrodes, dr y skin, improperly connected electrodes, inappropriate drugs, etc.) can cause an "ELECTRODE REJECT." The unit beeps and the "REJ" light flashes. The current output is turned of f automatically. See Section IX, "Troubleshooting," to correct the problem.
VI. SETTING UP THE Phoresor PM900
A. Install Batter y : NOTE: Use 9V alkaline batter y (1604A/6LR61). DO NOT use rechargeable type batteries. DO NOT simultaneously touch the battery terminals and the patient.
1. Prior to a treatment, if batter y power is too weak for proper circuit operation, the current output of the unit will remain disabled, the "BAT" indicator will light and the unit will beep ever y 10 seconds until the batter y is replaced or the unit is turned of f.
2. The batter y compar tment is on the back of the unit. To open, gently press the cover inward where indicated and slide it open. Press the batter y clip onto the batter y terminals. Place the batter y into the compar tment and ensure the cover is in place before beginning treatment.
B. Twin Lead Connectors: Attach the appropriate twin lead connector into the connector por t at the top of the Phoresor PM900. Dif f erent models of IOMED electrodes require the use of specific twin lead connectors. Refer to the back of this manual for information on the specific connector required for the IOMED electrode being used.
VII. PREPARING ELECTRODES AND PATIENT FOR TREATMENT
NOTE: Please refer to the directions for use supplied with electrodes for detailed instructions. DO NOT tape, bind or compress either electrode against the skin during treatment. Doing so may cause excessive skin irritation or burns.
A. Examine the skin sites for both electrodes. The skin must be free of damage, i.e., avoid broken skin, skin with ingrown hairs, pimples, razor nicks, wounds that have not healed,recent scar tissue, etc.
B. Prepare the drug electrode according to the directions for use supplied with the electrodes. 1. For local dermal anesthesia: use only IONTOCAINE (brand of lidocaine hydrochloride 2% and epineph- rine 1:100,000 Topical Solution). Always refer to directions for use supplied with electrodes for correct fill volumes. Caution: DO NOT over -fill or under -fill electrodes.
C. Prepare the skin sites for both electrodes by briskly rubbing the areas with an alcohol wipe to remove dr y skin, oils and other contaminants. Allow the skin to dr y thoroughly. Remove any jewelr y that may come in contact with either electrode.
D. Apply the drug electrode over the treatment site according to the directions for use supplied with the electrodes.
E. Apply the dispersive pad over a major muscle at least 4-6 inches away from the drug electrode according to the electrode’s directions for use. Avoid placing the dispersive pad over a bony prominence with minimal tissue thickness; excessive skin irritation or burns may result.
F. Attach the twin lead connector clips to the electrodes. Refer to the directions for use supplied with the electrodes for specific guidelines concerning polarity.
IMPORTANT:
Current lower than 4.0 mA is recommended for:
- Patients known to be sensitive to direct current.
- Sensitive anatomic sites (e.g., palms, fingers, face, carpal tunnel area, feet).
- Patients with thin or fragile skin.
VIII. OPERATING THE Phoresor PM900
A. Star ting a treatment:
1. Turn the unit on by depressing the ON/SELECT button. The lowest current level, 2.0 mA, is automatically selected.
2. After a 2 second delay the Phoresor PM900 will automatically ramp the current up to begin the treatment. NOTE: The preset dose is 40 mA-minutes.
B. Setting Current: Push the ON/SELECT button until the desired current level LED is lit. The maximum possible current is 4.0 mA.
NOTE: The LED for the selected current level will blink continuously until desired current level is achieved. The LED
will then be illuminated constantly.
NOTES:
1. If the current level needs readjustment, push the
ON/SELECT button until the desired current level LED is lit.
2. After a 2 second delay, the current will automatically ramp to the new level.
IMPORTANT:
1. If a patient experiences significant discomfor t at a current setting of 4.0 mA, the current may be decreased anytime by pushing the ON/SELECT button until the lower desired current level LED is lit.
2. Tr eatment time is automatically adjusted to achieve the preset dose of 40 mA-minutes. For example, if the current is reduced from 4.0 mA to 2.0 mA, the treatment time will automatically adjust to deliver
the preset dose.
NOTES:
1. The Phoresor PM900 continuously keeps track of the total dose (mA-minutes) delivered until the treatment is completed at 40 mA-minutes or the unit is tur ned of f.
2. If the unit "REJECTS" during a treatment the unit will retain the dose delivered information. The treatment can be resumed by pushing the ON/SELECT button.
C. Stopping Treatment Manually: In case of emergency, the treatment can be stopped manually by depressing and holding the red OFF button until the unit beeps. The current level LED will flash as the unit ramps down, the unit will beep and the current level LED will turn of f. DO NOT disconnect the lead wires or remove the electrodes until all LEDs are turned of f.
NOTE: When the Phoresor PM900 is tur ned of f all infor m ation regarding the total dose (mA-minutes) delivered will be erased from memor y.
D. Stopping Treatment Automatically: After the preset dose of 40 mA-minutes is delivered, the current automatically
ramps down to 0.0 mA.
NOTES:
1. The LED for the selected current level will blink continuously until 0.0 mA is reached.
2. After 0.0 mA is reached the unit will beep and automatically turn of f.
E. After Treatment: Disconnect the lead wire clips and remove the electrodes from the patient. Discard both the drug electrode and the dispersive pad. The electrodes cannot be reused.
IX. TROUBLESHOOTING
"REJ" indicator lit
NOTE: Unit will sound 3 consecutive beeps twice and the "REJ" light will flash continuously for 10 minutes. Identify problem and correct from the following list:
• Loose electrical connection at one or both electrodes
• One or both electrodes have pulled away from the skin
• Drug electrode not properly hydrated
• Medication inappropriate for iontophoresis
• Skin resistance at an electrode site is too high for selected current level, for example, on the plantar sur face of the foot Press ON/SELECT button to restar t treatment at current level previously selected
• The unit automatically ramps current up to selected level and adjusts the time to deliver the preset dose of 40 mA-minutes
"BAT" indicator lights when unit is turned on
• Batter y voltage is low
• If batter y voltage is ver y low, unit will not allow treatment to begin
• Replace batter y (Refer to Section VI.)
"BAT" indicator lights during treatment
• Battery voltage is decreasing during treatment but treatment may continue
• After treatment is finished, replace battery (Refer to Section VI.A)
"BAT" and "REJ" indicator lights during treatment
• Batter y voltage is too low for treatment to continue
• Unit will not allow treatment to be restar ted
• Unit ramps down current before preset dose of40 mA-minutes is delivered
• Replace batter y (Refer to Section VI.A)
All LEDs are lit
• Batter y voltage is too low for proper operation
• Unit is malfunctioning
• Replace batter y (Refer to Section VI.A)
• Have unit ser viced (see Section XI)
X. SPECIFICATIONS
Electromagnetic The unit has passed all EMC required testing for radiated emissions per test standard EN 606010102: 1993.
Electrical Shock I n t e r n a l l y p o w e r e d t y p e
BF Equipment.
Environmental Conditions Transport and store in a cool dry place between -20?C to +50?C, less than 90% humidity and operational up to 10,000m above sea level.
Ingress of Water Not protected against ingress of water. IPX0
Flammability Do not use around flammable gasses, liquids or materials.
Mode of Operation Continuous.
Controls ON/SELECT and OFF Dose 40 mA-minutes
Maximum Voltage 80V DC Maximum Current 4.0 mA
Current Ramp Up Automatic (0 to 4.0 mA)
Current Ramp Down Automatic at end of treatment
Batter y Use only 9V alkaline (1604A/6LR61). Ensure batter y compar tment cover is in place before star ting treatment. Remove batter y from unit when not in use for an extended period of time.
Visual Indicators Yes (low batter y and open circuit)
Audible Aler ts Yes (low batter y, open circuit, and end-of-treatment)
Dimensions 2.3cm H X 6.4cm W X 11.2cm L Weight 75g without batter y
Cleaning Clean the case and lead clip wires as needed with an isopropyl alcohol moistened cloth. Do not immerse in fluids. Disinfection and sterilization not required.
Disposal Dispose of according to local, state and federal regulations. Remove batter y before disposal.
XI. SERVICE
After following the troubleshooting procedures above, if a problem still exists, call IOMED Customer Ser vice toll free at 1-800-621-3347. If your Phoresor PM900 requires ser v icing contact Customer Ser vice for a Return Goods Authorization (RGA). No repairs or refunds are per formed without an RGA.
Return the unit with twin lead connector. Please include your name, address, phone number, a description of the problem and a copy of the IOMED Customer Product Repor t issued to you by Customer Ser vice.
Return the unit with postage and insurance prepaid to:
IOMED, Inc.
Repair Depar tment
5070001 . . . . . . . . PM900 . . . . . . . . . Phoresor PM900 Iontophoretic Drug Delivery System with AN-3 twin lead
5020004 . . . . . . . . PM900 . . . . . . . . . Phoresor PM900 Iontophoretic Drug Delivery System with TL6 twin lead
5020005 . . . . . . . . PM900 . . . . . . . . . Phoresor PM900 Iontophoretic Drug Delivery System with TL7 twin lead
5020012 . . . . . . . . AN-3 . . . . . . . . . . Twin Lead - Use only with Numby Stuff ® anesthesia electrodes
5020013 . . . . . . . . TL6 . . . . . . . . . . . Twin Lead - Use only with tab connector style electrodes
5020014 . . . . . . . . TL7 . . . . . . . . . . . Twin Lead - Use only with snap connector style electrodes
IOMED, Inc. 2441 South 3850 West, Suite A • Salt Lake City, Utah • 84120 USA
1.800.621.3347 • FAX 1.801.975.7366 US Pat. Nos. 4,744,787; 5,135,477; 5,374,241; 5,415,628; 5,558,632; 5,846,217. Other patents pending. IOMED, Phoresor, We Deliver Solutions, IONTOCAINE, and Numby Stuff are registered trademarks of IOMED, Inc.
©IOMED, Inc. 1998. All rights reserved. Printed in USA 04/01. P/N 1920025 A/W 1927048 Rev 0D
