Order now.

I. INDICATIONS

The Phoresor Iontophoretic Drug Delivery System is indicated for the administration of soluble salts or 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 insertion and drug injection, when it is advisable to minimize the infiltration of carrier fluids, or to avoid the damage caused by needle insertion when tissue is traumatized. It is also indicated for production of local dermal

III. WA RNINGS AND PRECAUTIONS CAUTION: Federal law restricts this device to sale by or on the order of a physician.

A. The Phoresor II Auto 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. It is important to note the following:

1. Continuous direct current used in iontophoresis can cause anesthesia using IONTOCAINE (brand of lidocaine hydrochloridetransient (uniform or mottled) erythema under either 2% and epinephrine 1:100,000 Topical Solution)*.

II. CONTRAINDICATIONS

The Phoresor Iontophoretic Drug Delivery System is contraindicated for use on patients with electrically sensitive support 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.
electrode which will generally resolve within a few hours to a few days.
2. Advise patient to report any undue burning or pain during treatment at once. Pause the treatment, inspect the area under the electrodes and make any necessary corrective actions before resuming the treatment.
3. Patients should remove any jewelry that may come in contact with either electrode. Failure to do so may cause burns.

*Complete prescribing information available upon request.

4. DO NOT exceed maximum levels of current or dose (total delivered charge):
- Maximum current: 4.0 milliamps (mA).
- Maximum dose: Refer to directions for use supplied with electrodes.
5. Failure to observe the following precautions may result in excessive skin irritation or burns:
- DO NOT tape, bind or compress electrodes during treatment.
- DO NOT use electrodes which have been altered or appear damaged.
- DO NOT apply electrodes over damaged skin.
- DO NOT reuse electrodes.
6. DO NOT use the Phoresor II Auto and electrodes on patients with electrically sensitive support systems (e.g., pacemakers). Doing so may cause the support system to malfunction.
7. Exercise caution in handling the Phoresor II Auto. 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 II Auto 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 recom- mended for general use. If a treatment results in prolonged skin irritation or burns, do not give additional treatments and consult a physician.
10. Patients should be asked about their history of drug allergies or sensitivities. The Phoresor II Auto and electrodes should not be used on any patient who demonstrates a known allergy or sensitivity to the drug being administered. Consult the drug package insert for additional contraindications and warnings.
1 1 . T h e “REJECT” safety feature of the Phoresor II Auto terminates the delivery of electric current to the electrodes
whenever an interruption in the electrical circuit occurs. This is indicated by the flashing “REJ” light, beeps, and a flashing “ELECTRODE REJECT” on the display. 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 unnecessary movement during the treatment to insure that an inadvertent disconnection of an electrode or lead wire does not occur.
12. Refer to the directions for use supplied with IOMED
electrodes for important additional information.

IV. THEORY OF OPERATION

Iontophoresis can be used to transport 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 II AUTO SAFETY AND CONVENIENCE FEATURES

A. Description: The Phoresor II Auto is a solid state, microprocessor controlled device utilized to administer soluble salts or other drugs. The microprocessor performs several safety tests continually from the time of power on and other safety tests depending upon the mode of operation.

B. Display Help: During normal operation the display provides guidance. Various prompts help in performing the next step. In only a few seconds, the dose and current can be set and a treatment can be started.

C. Automatic Time Calculation: Only the desired dose and current need to be entered for a treatment. All time calculations are performed automatically, even if dose or current settings are changed.

D. Automatic Current Ramp Up: After selecting the desired dose and setting the current, treatment can be started. The unit automatically ramps up the current output at a rate comfortable for most patients. The current may be adjusted for patient comfort any time during a treatment, including during current ramp up.

E. Automatic or Manual Current Ramp Down: After the

preset dose 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 turned off manually any time, including during ramp up, to terminate treatment.

F. Pause: Any time during treatment, including during current ramp up, the current may be turned down to 0.0 mA manually to put the unit into “PAUSE” mode. The unit retains the total dose delivered prior to the pause. During a pause, dose and/or current may be adjusted if desired. On restarting treatment, the total dose delivered resumes accumulating from the level delivered prior to the pause.

G. 10 Minute Automatic Shut Off: The unit shuts off automatically after 10 minutes if a knob has not been turned. This feature is disabled under certain conditions: 1) treatment in progress; 2) unit is in any “REJECT” mode; 3) at the end of automatic ramp down.

H. Resistance Limit: Occasionally, when treating high resistance skin areas, such as the plantar surface of the foot, the unit may beep and flash “RESISTANCE LIMIT” on the display. However, the unit will continue treatment if possible. As resistance drops during treatment, the unit will automatically ramp up the current to the desired level, or as high as possible if the desired level cannot be reached.

I. Dose and Current Limit: The unit will beep and the dose display will flash “LIMIT” if an attempt is made to turn the dose knob beyond the upper limit of 80.0 mA-min. Also, the unit will beep and the current display will flash “LIMIT” if an attempt is made to turn the current knob beyond the maximum of 4.0 mA. Refer to directions for use supplied with electrodes for maximum recommended dose and current.

J. Electrode Reject: Circuit problems (e.g., loose electrodes, dry skin, improperly connected electrodes, inappropriate drugs, etc.)

can cause an “ELECTRODE REJECT.” The unit beeps, the “REJ” light flashes and the display shows “ELECTRODE REJECT.” The current output is turned off automatically. See Section IX, “Troubleshooting,” to correct the problem.

VI. SETTING UP THE PHORESOR II AUTO

A. Install 9V Batter y: NOTE: Duracell ® brand batteries are recommended for best performance (1604A/6LR61). Do not use rechargeable type batteries.
1. Prior to a treatment, if battery power is too weak for proper circuit operation, the current output of the unit will remain disabled and the “BAT” indicator will light. If a treatment is attempted, the alarm will sound and the display will flash “LOW BATTERY.”

2. The battery compartment is at the rear of the unit. To open, gently press the door inward and slide it open. (see Figure 1).

Polarity symbols (+) and (-) are marked on the inside of the compartment. If the battery is installed
incorrectly, with the polarity reversed, the unit will not operate. Be sure the door is fully closed after installing the battery.

FIG. 1

B. Twin Lead Connectors: Connect the appropriate twin lead connector to the Phoresor II Auto (see Figure 2). Different models of IOMED electrodes require the use of specific twin lead connectors. Refer to the directions for use supplied with the electrodes for information on the specific connector required.

FIG. 2

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, acne, 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.

Medications:

1. For local dermal anesthesia: use only IONTOCAINE (brand of lidocaine hydrochloride 2% and epinephrine 1:100,000 Topical Solution). Always refer to directions for use supplied with electrodes for correct fill volumes. Caution: DO NOT over- or under-fill electrodes.
2. For other medications: use water soluble formulations.

DO NOT use medications which are suspensions (i.e., not soluble in water).

C. Prepare the skin sites for both electrodes by briskly rubbing the areas with an alcohol wipe to remove dry skin, oils and other contaminants. Allow the skin to dry thoroughly. Remove any jewelry 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.

VIII. OPERATING THE PHORESOR II AUTO

Normally, a typical treatment requires only three steps:

l - Select dose

2 - Set current

3 - Start treatment

A. Selecting Dose: Turn the ON I DOSE I START knob clockwise to turn on the unit. The unit performs a "System Check." The unit is preset at 40.0 milliamp-minutes (rnA-min) dose. If desired , dose can be changed. Refer to directions for use supplied with electrodes for specific information concerning recommended dosages.

EXAMPLE: For a 40 rnA-minute dose the display shows:

NOTES:

l. Maximum possible dose is 80 rnA-min. The unit beeps

and the display flashes "LIMIT" if an attempt is made to exceed 80 rnA-min.

2. After a two-second delay, current can be set.

B. Setting Current: Turn the CURRENT knob clockwise to set the current. Maximum possible current is 4.0 rnA.

EXAMPLE: To deliver 4.0 rnA of current the display shows:

DOSE DME CURRENT

40.0

mAx min min: sec mA

IMPORTANT:

Current lower than 4.0 rnA 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.

NOTES:

l. If the dose needs readjustment, set the current at 0.0 rnA,

reset the dose, then set the current.

2. Af ter a two-second delay, treatment can be started. C. Starting Treatment:

EXAMPLE: After selecting dose and setting current, the display shows:

DOSE nME CURRENT

40.0

mAx min min :se< mA

Turn the ON I DOSE I START knob clockwise one "click" to start t reatment. Current automatically ramps up gradually to desired set point and display shows:

DOSE nME CURRENT

36.0

mAx min min:se< mA

NOTES:

l. "DOSE" shows dose delivered as rnA-minu tes accumulate.

2. "TIME" shows time remaining in minutes and seconds until treatme nt is co mplete. Time calcu la tio n

is automatic.

3. "CURRE NT" shows actual current being delivered in rnA-minutes.

4. Au t omatic current ramp up includes built in

"comfort pauses." IMPORTANT:

If a patient experiences significant discomf ort at a current

setting of 4.0 rnA, the current may be decreased anytime during the treatment by turning the CURRENT k nob counterclockwise. Treatment time is automatically increased to achieve the preset dose. For example, if the current is reduced from 4.0 rnA to 2.0 rnA, the treatment time willautomatically double to deliver the preset dose.

TIP:

For manual ramp up: Set dose, then set current below the maximum desired. Example: Set current at 0.1 rnA. Start treatment. Gradually increase current to desired level, according to patient comfort, by turning CURRENT knob clockwise. Each "click" increases current 0.1 rnA.

D. Pausing or Stopping Treatment Manually: During treatment or current ramp up turn the CURRENT knob counterclockwise to reduce current output to 0.0 rnA. The display flashes "PAUSE" and the dose delivered prior to the pause is retained in memory

EXAMPLE: After decreasing current to 0.0 rnA display shows:

DOSE nME CURRENT

20.0 I PAUSEI o.o I

NOTES:

l. During a pause, electrodes may be disconnected, replaced or removed. Dose and/or current may also be adjusted.

2. Turn CURRENT knob clockwise to reset current after pause.

3. After restarting treatment, dose accumulates from the level delivered prior to the pause.

E. Stopping Treatment Automatically: After the preset dose is reached, the current automatically ramps down to 0.0 rnA.

EXAMPLE: During automatic current ramp down the display shows:

DOSE nME CURRENT

40.0

mAx min min:sec mA

mAx min

min z sec mA

After a 40 rnA-minute treatment is complete the unit beeps and the display shows:

DOSE liME CURRENT

40.0 o.oo 1 o.o 1

mAxmln min • sec mA

NOTES:

l. After automatic current ramp down, turn the current knob to silence the beep. Then turn the ON I DOSE I START knob counterclockwise to turn the unit off, or after 10 minutes the unit will turn off automatically.

2. Turn CU RRENT knob counterclockwise to 0.0 rnA anytime

to stop treatment. E After Treatment:

1. Remove elect rodes: Disconnect the lead wire clips and

remove the electrodes f ro m the patient. Disca rd both t he drug electrode and the dispersive pad. They cannot be reused.

NOTES:

1. W he n administe ring local a nesthesia prior to a medical procedure, begin the procedure promptly as the duration of local anesthesia will vary wit h treat ment time and the dose (total cha rge) delivered.

2. If n o further me dica l proce dure is co nt e mplated involving the skin a rea under the drug e lectrod e, immediately apply a non-irritat ing, unscented , neutral pH skin lotion to both electrode sites.

Display Shows Possible Cause Corrective Action

“PAUSE” • Treatment has been paused by • During a pause electrodes may be decreasing current to 0.0 mA. disconnected, moved or replaced.

• Correct situation that caused treatment to be paused.
• Turn CURRENT knob to reset current. Restart treatment.

“LOW BATTERY” and	• Battery voltage is too low for proper	• Replace battery. Duracell 9V (1604A/6LR61)
BAT indicator lights when	operation.	is recommended for best results.
unit is turned on	• If battery voltage is very low only	Refer to Section VI.A. above.

BAT indicator lights.
• Unit will not allow treatment to begin.

BAT indicator lights during treatment	• Battery voltage is decreasing during treatment but treatment may continue.	• After treatment is finished, replace battery. Duracell 9V (1604A/6LR61) is recommended for best results. Refer to Section VI.A. above.
“LOW BATT REJECT” and during treatment BAT indicator lights	• Battery voltage is too low for treatment to continue. • Unit will not allow treatment to be restarted. • Unit ramps down current before preset	• Replace battery. Duracell 9V (1604A/6LR61) is recommended for best results. Refer to Section VI.A. above.

dose is delivered.

“HARDWARE CHECK” • Unit is malfunctioning • Have unit serviced (see section XI below).

X. SPECIFICATIONS

Electromagnetic The Unit has passed all EMC required testing for radiated emissions per test standard EN 606010102: 1993.

Electrical Shock Internally powered

Type BF Equipment.

Environmental Transport and store in a cool dry place

Conditions 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.

Flammability Do not use around flammable gasses, liquids or materials.

Mode of Operation Continuous.

Dimensions 5.5cm H X 7.8cm W X 15.8cm L

Weight 272g without battery

Cleaning Clean the case and lead clip wires

as needed with an alcohol moistened
cloth. Do not immerse in fluids.

Disposal Dispose of according to local, state and federal regulations. Remove battery before disposal.

Controls 2 (dose and current) Dose Range 0 to 80 mA-minutes Maximum Voltage 80V DC

Maximum Current 4.0 mA

Current Ramp Up Automatic (0 to 4.0 mA; built in option for manual override)

Current Ramp Down Automatic at end of treatment

(built in option for manual override)

Battery Use only 9V DC alkaline (for best results, use Duracell 1604A/6LR61). Ensure battery door is in place before starting treatment. Remove battery from unit when not in use.

Display Dose, Time Remaining, and Current (displayed simultaneously with interactive set-up)

Pause Feature Yes

Visual Indicators Yes (low battery and open circuit)

Audible Alerts Yes (low battery, open circuit, and end-of-treatment)

XI. SERVICE

After following the troubleshooting procedures in section IX, if a problem still exists.  If you must return your Phoresor II Auto for inspec- tion or repair, place the unit, along with the twin lead connector(s), in its original carrying case. Be sure to include a copy of the Return Goods Authorization (RGA) you received after contacting customer

service. No repairs or refunds are performed without an RGA. Return the unit with postage and insurance prepaid to:

A U T O

Order No. Model Description

5060004 . . . . . . .PM850 . . . . . . . . . . Phoresor II Auto Iontophoretic Drug Delivery System with TL7 twin lead

5060005 . . . . . . .PM850 . . . . . . . . . . Phoresor II Auto Iontophoretic Drug Delivery System with TL6 twin lead

5060006 . . . . . . .PM850 . . . . . . . . . . Phoresor II Auto Iontophoretic Drug Delivery System with AN-3 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

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, TransQ, IOGEL, IONTOCAINE, and Numby Stuff are registered trademarks of IOMED, Inc. Duracell is a registered trademark of Duracell Corp.

©IOMED, Inc. 1999. All rights reserved. Printed in USA. 04/01.

P/N 1920022 A/W 1927037 Rev 0D

IOMED, Inc.