I-Bresis 1361 Bresis System Instruction Manual

I-Bresis 1361 Bresis System

Specifications

• Device: Controller (1361)
• Compliance: UL 60601-1, CSA C22.2 No. 601-1-M90
• Treatment Options:
  • I-BresisTM Treatment: Current at 3 mA for 3 minutes for Skin Conductivity Enhancement (SCE), followed by wearing the Patch for 1-2 hours
  • Standard Treatment: Current at 2, 3, or 4 mA for 10-20 minutes
  • Patch Treatment: Low-level current over 2-4 hours
• Indications: Administration of soluble salts or drugs into the body as an alternative to hypodermic injection

Product Usage Instructions

Controller Operation
The I-BresisTM Controller is a solid-state, microprocessor-controlled device that delivers low-level electrical current. It is used in conjunction with the Patch for treatment.

WARNING: Do not use the Controller with any other charging station. Doing so may cause a malfunction or patient injury.

Button Functions
The Controller has three buttons:

• ON/OFF: Turns the power on and off. After power-on, the unit defaults to I-BresisTM mode. If power is turned off during treatment, the current is ramped to zero before the unit powers off, aborting the treatment and losing dose information.
• START/PAUSE: Starts or pauses the selected treatment. Pressing this button during treatment will ramp down the current and pause the treatment. Pressing it while paused will resume the treatment.
• STANDARD MODE: Select a standard treatment current of 2, 3, or 4 mA. The selection can be made during setup, pause, or treatment. If made during treatment, the current will ramp up or ramp down to the newly selected current setting.

GLOSSARY OF SYMBOLS

This device may contain one or all of the following symbols:

THEORY OF OPERATION
Iontophoresis transports charged water-soluble drugs and other ionic substances across intact skin. Iontophoresis technology is based on the principle that an electric potential causes charged water-soluble ions in solution to migrate according to their electrical charges. The distribution of a charged ionic drug delivered by iontophoresis is dependent upon the charge of the ion, the size of the ion (molecular weight), the strength and duration of the electrical current applied, the composition of the Patch, and numerous other factors.

DESCRIPTION

• The I-Bresis™ System delivers charged water-soluble drugs and other ionic substances across intact skin and consists of three components: a Charging Station, rechargeable Controller(s) and disposable Patch(es).
• The I-Bresis™ System is designed to provide the following three treatment options:

I-Bresis™ Treatment
The Controller delivers current at 3 mA to the Patch for three minutes for a Skin Conductivity Enhancement (SCE), followed by the patient wearing the Patch for approximately one to two hours, resulting in a 40-80 mA-min treatment respectively.

Standard Treatment
The Controller delivers current at 2, 3 or 4 mA to the Patch for 10-20 minutes, resulting in a 40 mA-min treatment. For an 80 mA-minute treatment, repeat the treatment.

Patch Treatment
The Patch delivers low-level current over 2-4 hours, resulting in an approximate 40-80 mA-min treatment respectively.

INDICATIONS
The I-Bresis™ System is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injection.

CONTRAINDICATIONS

• Cardiac pacemakers – Do not use on patients with pacemakers or other implanted devices.
• Drug sensitivity – Do not use on patients with known sensitivity to the drug to be administered.
• Pregnancy – Do not use it on pregnant women. The safety of the system used during pregnancy has not been established.
• Scarring – Do not use on damaged skin, denuded skin or other recent scar tissue.
• Skin sensitivity – Do not use on patients with known sensitivity to electrical current or to the solution being administered.
• Head treatment – Do not treat across either the temporal region or the orbital region.

Warnings

• Keep out of the reach of children and pets.
• Do not apply electrodes such that the current pathway crosses the heart or brain, as safety has not been established.
• Advise the patient to remove electrodes if any undue sensation of pain or burning occurs during the treatment and to report discomfort to the clinic.
• To establish good contact between the electrodes and skin, excessive hair may be clipped, but DO NOT SHAVE. Shaving may cause skin breaks that are not readily seen and can increase the risk of adverse skin reactions.
• Do not apply over broken or compromised skin (e.g., sunburns, cuts, or acne) due to increased risk of skin reaction.
• Small pinhead size blisters may result in response to the drug. Contact the physician if the problem persists longer than 24 hours.
• On rare occasions, iontophoresis therapy can result in transient skin reactions such as rash, inflammation, irritation, or burns. These skin reactions may be the result of individual sensitivity to the ionic solution used, the condition of the skin at the onset of treatment, reaction to the materials in the electrodes, or a poor connection between the electrode and the patient’s skin. Advise the patient of this possibility before starting treatment. If a visible skin reaction does occur, instruct the patient to discontinue the treatment and consult the prescribing physician.
• Care must be taken when operating this equipment adjacent to or stacked with other equipment. Potential electromagnetic or other interference could occur to this or to the other equipment. Try to minimize this interference by not using other equipment in conjunction with it.
• The system is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
• Do not wear an electrode or controller during Magnetic Resonance Imaging (MRI) scans as this may result in metal overheating and causing skin burns in the area of the patch.
• Consult directions for the use of the drug before delivery. Some drugs require a specific polarization for use. Observe the indications, contraindications, warnings and precautions related to this issue.
• Do not use electrodes that have been previously used as these electrodes have been designed for single use only.
• Inspect the electrodes before use. Discard any electrode that shows signs of alteration or damage, as these electrodes may not be safe for use.
• The electrodes can be worn during normal activity. However, excessive motion where the electrodes have been placed can cause poor contact between the skin and the electrode or uneven distribution of current, resulting in greater risk of skin irritation.
• A transient erythematous reaction, characterized by a uniform red pattern, can sometimes occur directly under one or both electrodes. The redness usually disappears within 12 hours of treatment. Advise the patient of this possibility before starting treatment.
• Use only the saline ampule supplied for the return pad. For positive polarity (+), use only drugs with Chloride (Cl-) counter ions. Use of tap water or any other solution may cause tattooing or staining.
• Handle the system with care. Do not immerse the system in fluids or allow it to be connected with other electrical devices. Do not drop, abuse, or in any way exceed normal use. Do not sterilize.
• Do not operate this system in an environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner. Portable and mobile RF communications equipment can affect Medical Electrical Equipment.

CONTROLLER OPERATION
The I-Bresis™ Controller is a solid-state, microprocessor-controlled device that delivers low-level electrical current. When used in conjunction with the Patch, the Controller provides visual and audible indications of treatment status.

WARNING

• DO NOT allow it to be immersed or come in contact with fluids.
• DO NOT connect the unit to external devices except the I-Bresis™ Patch or the I-Bresis™ Charging Station. Doing so may cause a malfunction or patient injury.

Button Functions
There are three buttons on top of the Controller. The buttons have the following functions:

ON/OFF

• Turns the power on and off. After power-on, the unit defaults to I-Bresis™ mode. If power is turned off during treatment, the current is ramped to zero (to avoid excessive electrical sensation) before the unit powers off. This aborts the treatment and mA- minute dose information is lost.

START/PAUSE
Starts the selected treatment or pauses treatment. If pressed during treatment, the current will ramp down and the treatment will be paused. Pressing this button while paused will resume the treatment.

STANDARD MODE
Selects a standard treatment of 2, 3, or 4 mA. The selection can be made during setup, pause or treatment. If made during treatment, the current will ramp up or ramp-down to the newly selected current setting.

Lights
Five lights on the face of the Controller indicate the following:

I-Bresis™ Treatment – One Green Light
I-Bresis™ Treatment selected.

Standard Mode – One of Three Green Lights
Standard Treatment of 2, 3 or 4 mA selected.

Interpretation of Four Green Lights

• Flashing Slowly (1 Hz): Setup or Pause
• Flashing Rapidly (4 Hz): Ramp-up, Ramp-down or Current Interrupt
• Continuous: Steady State Current Alarm Light – One Multicolor Light
• Alarm Light – One Multicolor Light
• Red Flashing Rapidly: Current Interrupt Warning
• Yellow Continuous: Low Battery

Warnings or Cautions

Light Warning or Caution| ****

Cause

| ****

Corrective Action

---|---|---
Yellow light con- stant with beep sequence every 30 seconds| Low Battery: Controller not recently recharged.| Press OFF to terminate the treatment. Place the Controller in a Charging Station until fully charged.
Red light and selected green light flashing rapidly with a beep sequence every 30 seconds| Current Interrupt: This may be caused by a loose connection, insufficiently hydrated drug pads, or poor contact between the Patch and the skin.| Press PAUSE to pause the treatment. Check for loose connections, properly hy- drated drug pads, and good contact between the Patch and the skin. After correcting the problem, press START to continue the treatment.

Automatic Time Calculation
All time calculations are performed automatically, even if the current setting is changed.

Automatic Current Ramp-Up
When the start button is pushed, the Controller automatically ramps up the current output to the desired setting. While the current is ramping, the green light will flash rapidly. When the current reaches the setting selected, the green light will be on constantly.

Automatic Current Ramp Down
After reaching the preset dose, the current automatically decreases, returning to 0 mA, indicating the treatment is complete. Also, automatic current ramp down takes place if the ON/OFF button is pressed (i.e. Treatment Abort) or if the PAUSE button is pressed.

Automatic Fast Current shut-off
If there is a Low Battery Alarm or Current Interruption Alarm, the current will be immediately set to 0 mA.

PATCH DESCRIPTION

The I-Bresis™ Patch is a disposable, single-use Patch with an internal battery and current-limiting circuitry. It can deliver both negatively and positively charged water-soluble drugs. The Patch-Only Treatment can be used with and without the Controller. The Controller is used with the Patch to deliver an I-Bresis™ or Standard Treatment. A Patch Treatment does not require the use of the Controller.

Drug Polarity Labeling
The polarity of the drug pads is labeled on the Patch.

Patch Drug Pads

• The Patch has two drug pads. Each drug pad has a ~1.5 mL fill volume. Use negatively charged water-soluble drugs on the negative (-) drug pad and positively charged water-soluble drugs on the positive (+) drug pad.
• Battery Pack and Controller Connector.
• The Battery Pack that contains two 3-volt batteries is also the connecting location for the Controller.

PREPARING THE PATIENT
Advise the patient that iontophoresis has the potential to result in skin irritation and/or burns.

• Direct current may result in transient erythema under the pads. The erythema generally resolves itself within a few hours to a few days.
• Use caution when treating patients with sensitive skin or those who may have difficulty healing.

1. Advise the patient that iontophoresis causes mild tingling, prickling, and/or a warm sensation. This is normal and should be anticipated by the patient.
2. Advise the patient to report immediately any pain during treatment. If the patient complains of pain, pause the treatment, inspect the area under the Patch, and make any necessary adjustments (e.g. reposition the Patch to ensure full skin contact, decrease current, etc.) before resuming the treatment, or discontinuing the treatment.
3. Advise the patient to remove any jewelry that may come in contact with the Patch.

PREPARING THE PATCH

1. Tear open the sealed treatment kit and remove the Patch.

2. Place the Patch on a flat surface with the absorbent pads facing up.

3. Clean the treatment site thoroughly with alcohol prep by rubbing for six to eight seconds to remove dry skin, oils, and other contaminants. Allow the treatment site to dry completely.
   CAUTION: Failure to clean skin thoroughly may cause excessive skin irritation or burns.
   NOTE: The Patch will not adhere sufficiently to skin with lotion, oil, or dirt.
   NOTE : Clip hair if necessary to improve skin contact. DO NOT shave.

4. Place ~1.5 mL of a charged water-soluble drug on an appropriate polarity pad (active pad). On the other pad (return pad), apply
   ~1.5 mL of supplied saline ampule. Use negatively charged water-soluble drugs on the negative (-) drug pad and positively charged water-soluble drugs on the positive (+) drug pad to actively deliver the drug. For (+) polarity, use only drugs with Chloride (Cl-) counter ions. NOTE: Fill volume is approximately ~1.5mL. Drug pads should be saturated but not overfilled. If the drug pads are overfilled beyond the saturation point, the pads will leak and directly affect the adhesion of the patch to the treatment site.
   CAUTION: Failure to evenly distribute drug or saline onto active or return pads can cause excessive skin irritation or burns. DO NOT fill the Patch while it is on the patient.

   • DO NOT over or underfill drug pads.
   • DO NOT use drugs that are not water-soluble.
   • DO NOT use drug suspensions.
   • DO NOT use a Patch that appears altered or damaged.
   • DO NOT apply the Patch to dirty, oily, or lotioned skin.
   • Use of tap water or non-chloride drug solution on positive polarity may cause tattooing or staining.

5. Make sure that the treatment site has intact skin.
   CAUTION: Failure to follow these guidelines may result in skin irritation or burns.
   WARNING: DO NOT apply the Patch over damaged or denuded skin or other recent scar tissue, skin with ingrown hair, pimples, sunburned skin, razor nicks or skin with wounds that have not healed.

6. Remove the adhesive release liner from the hydrated Patch.

7. Apply the hydrated Patch so that the drug pad is over the treatment site and secure it by pressing the adhesive border. Avoid pressing directly over the pads. Pressing directly on the pads can cause leakage that will compromise adhesion to the patient.

NOTE: DO NOT tape or bind the Patch during treatment. Do not apply hot or cold therapy over Patch during treatment.

ADMINISTERING TREATMENT
The I-Bresis™ System is designed to provide the following three treatment options:

I-Bresis™ Treatment
The Controller delivers current at 3 mA to the Patch for three minutes for a Skin Conductivity Enhancement (SCE), followed by the patient wearing the Patch for approximately one to two hours, resulting in a 40-80 mA-minute treatment respectively.

Standard Treatment
The Controller delivers current at 2, 3 or 4 mA to the Patch for 10-20 minutes, resulting in a 40 mA-minute treatment. For an 80 mA-minute treatment, repeat the treatment.

Patch-Only Treatment (For use without Controller)
The Patch delivers low-level current over 2-4 hours, resulting in an approximate 40-80 mA-minute treatment respectively.

I-Bresis™ MODE TREATMENT

NOTE: While using the Controller, should an in-process iontophoresis treatment need to be stopped or paused, DO NOT suddenly remove the Controller from the Patch without first switching off the Controller. To stop treatment while the Controller is administering iontophoresis, press the ON/OFF button and wait a few moments for the Controller to turn off.

1. Examine the Controller before use to ensure that the two prongs inserted into the Patch are free of grime and debris. Dirty contact could cause erratic behavior during treatment. If needed, the prongs may be cleaned with an alcohol wipe.

2. Push the ON button on the Controller. The Green I-Bresis™ Light will blink slowly.

3. Attach the Controller to the Patch. The Patch connector (located at the center of the Patch) plugs into the slot on the back of the Controller. Ensure that the Patch connector is fully and securely
   engaged into the Controller- a click will be heard upon full engagement.

4. Position the patient so that there is no pressure on the Patch during treatment.

5. Press the START button to begin treatment. The Green I-Bresis™ Light will blink more rapidly, and then glow steadily.

6. After three minutes, the Controller will sound a beep and the lights will turn off automatically. This indicates that the Skin Conductivity Enhancement (SCE) is completed.

7. Remove the Controller from the Patch. The Patch will now continue to deliver the remainder of the iontophoresis treatment to the patient.

8. The average time to complete the dose is indicated in the following table. To prevent excessive dosing, the Patch automatically switches off iontophoresis after the maximum dose has been administered.
   I-Bresis™ Mod| 40 mA-minutes| 60 mA-minutes| 80 mA-minutes
   ---|---|---|---
   Wear Time| 1 hour| 1.5 hours| 2 hours

9. Instruct the patient to remove and discard the Patch after a minimum of one to two hours for a 40 to 80 mA-minute dose respectively.

10. Discard the Patch after treatment has been completed. The Patch cannot be reused.

STANDARD MODE TREATMENT
NOTE: While using the Controller, should an in-process iontophoresis treatment need to be stopped or paused, DO NOT suddenly remove the Controller from the Patch without first switching off the Controller. To stop or pause a treatment while the Controller is administering iontophoresis, press the ON/OFF button and wait a few moments for the Controller to turn off.

1. Press the ON/OFF button on the Controller. The Green I-Bresis™ Light will blink slowly.
2. Push the Standard Mode button on the Controller. The 2 mA indicator light will blink slowly. Each additional depression of the button will scroll to the next setting- 3 mA or 4 mA.
3. Attach the Controller to the Patch. The Patch connector (located at the center of the Patch) plugs into the slot on the back of the Controller. Ensure that the Patch connector is fully and securely engaged into the Controller- a click will be heard upon full engagement.
4. Position the patient so that there is no pressure on the Patch during treatment.
5. Press the START button to begin treatment. The Green mA Light will blink more rapidly, then glow steadily.
6. To change the iontophoresis current setting while the Controller is administering a treatment, press the Standard Mode button to re-select the desired setting. Within a few moments, the Controller will automatically adjust to the new setting.
7. In 10-20 minutes (see following table) the Controller will sound a beep and the lights will turn off, indicating the 40 mA-minute treatment has been completed.
   Standard Mode| 40 mA-min| 80 mA-min
   ---|---|---
   2mA| 20 minutes| Repeat steps 1-2 and 5-7
   3mA| 13 minutes| Repeat steps 1-2 and 5-7
   4mA| 10 minutes| Repeat steps 1-2 and 5-7
8. Remove the Controller from the Patch.
9. Remove and discard the Patch after the treatment has been completed. The Patch cannot be reused.

Controller Specifications

• Electrical Shock Internally Powered Type BF
• Battery Rechargeable Lithium-ion, 3.7 VDC Nominal, 230 mA- Hr
• Environmental Storage : 10° – 35° C (50° – 95° F)
• Conditions Operating : 15° – 30° C (59° – 86° F)
• Ingress of Water Not protected against ingress of water, IPX0
• Flammability Do not use around flammable gasses, liquids, or materials
• Treatment I-Bresis™ and Standard
• Dimensions 5.5 cm H x 4.5 cm W x 1.5 cm L
• Weight 23 g
• Disposal Dispose according to local, state, and federal regulations.
• Dose Range 0 to 40 mA-minute (I-Bresis™ Patch has an 80 mA-minute dose capacity)
• Controller Capacity Approximately 200 mA-minutes when fully charged.
• Maximum Voltage 70V DC
• Maximum Current 4 mA
• Current Ramp Up 0.1 mA/sec (start of treatment, restart after a pause)
• Current Ramp Down 0.5 mA/sec (end of treatment, pause, power-off)
• Fast Current Instantaneous (Low Battery Warning, Current
• Ramp Down Interrupt Alarm)
• Buttons ON/OFF , START/PAUSE and STANDARD
• Treatment Lights Green Flashing: I-Bresis™, 2, 3 or 4 mA ramping-up or ramping-down Green Continuous: I-Bresis™, 2, 3 or 4 mA steady state
• Battery Light Yellow Continuous: Low Battery Warning
• Interrupt Light Red Flashing: Current Interruption Alarm

Charging
The single internal 3.7 VDC rechargeable lithium-ion battery cell is connected to a Protection Circuit Module (PCM) that provides additional protection for over-charging and over-discharging. However, the battery will enter an over- discharge state via self-discharge if it has not been used for a long time. This results in battery degradation (e.g. the mA-Hr capacity of the battery will decrease). To prevent over-discharging, return the Controller to the Charging Station after each use. If the Controller cannot be stored in the Charging Station for a considerable period (e.g. 6 months), fully charge the Controller before long-term storage.

Lithium-ion batteries, unlike Ni-Cad batteries, do not suffer from the “Memory Effect” (the lithium-ion battery does not require a periodic full discharge and recharge to “refresh” the battery). The Controller can be stored and recharged in the Charging Station after each use. Elevated temperature will result in degraded battery performance and reduced battery service life. Therefore, never place the Controller near heating sources or in direct sunlight for long periods. DO NOT open the Controller case to access the battery or for any other reason.

When returning any products, please include your name, address, phone number, and a description of the problem.
Return to:

DJO Global
1430 Decision Street
Vista, CA 92081

Repair and Maintenance

• There are no user-serviceable parts inside the Controller. If the Controller appears to be non-functional, contact your Authorized DJO, LLC Distributor, or contact DJO, LLC directly.
• Clean the case as needed with a damp cloth. Do not immerse in fluids.

Ordering

Limited Warranty

Warning: While, in the opinion of DJO, LLC (“DJO, LLC”), the use of the I-Bresis™ System (the “Product”) has met with some success, DJO, LLC makes no warranties to the purchaser as to the effectiveness of the product.
Warranty

• A. DJO, LLC warrants to the initial Purchaser (“Purchaser”) (and to no other person) that the Product (with the exclusion of accessories) and the parts thereof, distributed or manufactured by DJO, LLC, shall be free from defects in the workmanship and materials for three years from the initial date of purchase from DJO, LLC (the “Warranty Period”).
• B. The patches are excluded from the Warranty and sold “AS IS” because their structure is such that they may be easily damaged before or during use.

Limitation of Liabilities and Disclaimer of Warranties

• A. DJO, LLC’s sole obligation in the case of any breach of its warranties outlined in Paragraph IIA above, shall be, at DJO, LLC’s option, to repair or replace the Product without charge to Purchaser or to refund the purchase price of the Product. To recover under this Warranty, Purchaser must send DJO, LLC written notice of the defect (setting forth the problem in reasonable detail) before the expiration of the Warranty Period, and within 30 days of discovery of the defect. Upon DJO, LLC’s written request and authorization, Purchaser shall return the Product to DJO, LLC, freight and insurance prepaid, for inspection.
  Notice and return shipment shall be sent to DJO LLC at 1430 Decision
  St. Vista, CA 92081, USA, or to a DJO, LLC Authorized Service Center. To locate the appropriate service center outside of North America, or to request shipment approval, contact DJO, LLC directly. DJO, LLC will not be responsible for damage due to improper packaging or shipment. If DJO, LLC determines in its sole reasonable discretion that the Product contains defective workmanship or materials, DJO, LLC will refund to the Purchaser, the purchase price for the defective product, or return the repaired Product or a replacement thereof to the Purchaser, the purchase price for the defective product, or return the repaired Product or a replacement thereof to Purchaser, freight and insurance prepaid, as soon as reasonably possible following receipt of the Product by DJO, LLC. If DJO, LLC determines in its sole reasonable discretion that the Product does not contain defective workmanship or materials, DJO, LLC will return the Product to the Purchaser, freight, and insurance billed to the Purchaser.

• B. This Warranty is voided immediately as to any Product which has been repaired or modified by any person other than authorized employees
  or agents of DJO, LLC or which has been subjected to misuse, abuse, neglect, damage in transit, accident, or negligence.

• C. EXCEPT AS PROVIDED IN PARAGRAPH IIA, THE PRODUCT IS BEING SOLD ON AN “AS IS” BASIS, ALL ACCESSORIES ARE SOLD “AS IS”, AND THE ENTIRE RISK AS TO THE QUALITY AND PERFORMANCE OF THE PRODUCT IS WITH PURCHASER. THE WARRANTY PROVIDED IN PARAGRAPH IIA IS INTENDED SOLELY FOR THE BENEFIT OF THE INITIAL PURCHASER AND DJO, LLC DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED.
  WARRANTIES OF MERCHANTABILITY AND FITNESS FOR
  A PARTICULAR PURPOSE; PROVIDED, HOWEVER, THAT NOTWITHSTANDING THE FOREGOING SENTENCE, IN THE EVENT
  AN IMPLIED WARRANTY IS DETERMINED TO EXIST, THE PERIOD
  FOR PERFORMANCE BY DJO, LLC THEREUNDER SHALL BE LIMITED TO THE LIFETIME OF THE INITIAL PURCHASER. NO EMPLOYEE, REPRESENTATIVE, OR AGENT OF DJO, LLC HAS ANY AUTHORITY
  TO BIND DJO, LLC TO ANY AFFIRMATION, REPRESENTATION, OR WARRANTY EXCEPT AS STATED IN THIS WRITTEN WARRANTY POLICY.
  (This Warranty gives Purchaser specific legal rights and Purchaser may also have other rights which vary from state to state. Some states do
  not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to the Purchaser.)

• D. DJO, LLC SHALL NOT BE LIABLE TO ANY PERSON FOR ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, LOST PROFITS, OR MEDICAL EXPENSES CAUSED BY ANY DEFECT, FAILURE, MALFUNCTION OR OTHERWISE OF THE PRODUCT, REGARDLESS OF THE FORM IN WHICH ANY LEGAL OR EQUITABLE ACTION MAY BE BROUGHT AGAINST DJO, LLC (E.G. CONTRACT, NEGLIGENCE OR OTHERWISE) THE REMEDY PROVIDED IN PARAGRAPH IA ABOVE SHALL CONSTITUTE PURCHASER’S SOLE REMEDY. IN NO EVENT SHALL DJO, LLC’S LIABILITY UNDER ANY CAUSE OF ACTION RELATING TO THE PRODUCT EXCEED THE PURCHASE PRICE OF THE PRODUCT.

(This Warranty gives Purchaser specific legal rights and Purchaser may also have other rights which vary from state to state. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to the Purchaser.)

FAQ

• Q: What is the purpose of the I-BresisTM System?
  • A: The I-BresisTM System is designed to deliver charged water-soluble drugs and other ionic substances across intact skin as an alternative to hypodermic injection.
• Q: How long should I wear the Patch for I-BresisTM Treatment?
  • A: For I-BresisTM Treatment, you should wear the Patch for approximately one to two hours after the Skin Conductivity Enhancement (SCE) using a current of 3 mA for three minutes.
• Q: How long does a Standard Treatment last?
  • A: A Standard Treatment lasts for 10-20 minutes using a current of 2, 3, or 4 mA. For an 80 mA-minute treatment, the treatment can be repeated.
• Q: How long does a Patch Treatment last?
  • A: A Patch Treatment lasts over 2-4 hours, delivering low-level current.

DJO Global, LLC

• 1430 Decision St.
• Vista, CA 92081 USA
• 800.336.6569
• 760.727.1280
• 14-72008 Rev. B © 2017 DJO, LLC, Inc.

DJOglobal.com

References

• Manual-Hub.com – Free PDF manuals!

Read User Manual Online (PDF format)

Read User Manual Online (PDF format)  >>

Download This Manual (PDF format)

Download this manual  >>