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Empi Hybresis 199587 Instructions For Use Manual

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Controller - Instructions For Use
READ THE HYBRESIS PATCH AND CHARGING STATION
INSTRUCTIONS FOR USE FOR ADDITIONAL IMPORTANT
INFORMATION.
REF: 199587

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Summary of Contents for Empi Hybresis 199587

  • Page 1 Controller - Instructions For Use READ THE HYBRESIS PATCH AND CHARGING STATION INSTRUCTIONS FOR USE FOR ADDITIONAL IMPORTANT INFORMATION. REF: 199587...

  • Page 2: Glossary Of Symbols

    GLOSSARY OF SYMBOLS This device may contain one or all of the following symbols: Refer to Instruction Underwriters Laboratories Manual/Booklet Inc., indicates product 11N1 meets US and Canadian product safety standards. Council Directive 2002/96/ This device complies with EC concerning Waste UL 60601-1 and CSA Electrical and Electronic C22.2 No.

  • Page 3: Theory Of Operation

    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,...
  • Page 4 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 Hybresis System is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injection.
  • Page 5 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 clinic.
  • Page 6 Warnings • 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.

  • Page 7: Controller Operation

    CONTROLLER OPERATION The Hybresis 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. •...

  • Page 8: Standard Mode

    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.

  • Page 9: Corrective Action

    Warnings or Cautions Light Warning Cause Corrective Action or Caution Yellow light con- Low Battery: Controller Press OFF to terminate the stant with beep not recently recharged. treatment. Place the Control- sequence every ler in a Charging Station until 30 seconds fully charged.
  • Page 10 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.

  • Page 11: Preparing The Patient

    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. •...
  • Page 12 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.
  • Page 13 DO NOT use drug suspensions. DO NOT use a Patch that appears altered or damaged. DO NOT apply 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.
  • Page 14 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 The Patch delivers low level current over 2-4 hours, resulting in an approximate 40-80 mA-minute treatment respectively.
  • Page 15 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.
  • Page 16 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.

  • Page 17: Controller Specifications

    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 Relative Humidity: 10-75%; Operating: 15° - 30° C (59° - 86° F); Ingress of Not protected against ingress of water, IPX0 Water...
  • Page 18 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: Hybresis, 2, 3 or 4 mA ramping-up or ramping-down Green Continuous: Hybresis, 2, 3 or 4 mA steady state Battery Light Yellow Continuous: Low Battery Warning...

  • Page 19: Electromagnetic Environment - Guidance

    Guidance and manufacturer’s declaration – electromagnetic emissions The Hybresis Controller is intended for use in the electromagnetic environ- ment specified below. The customer or the user of the Hybresis Controller should assure that it is used in such an environment. Electromagnetic Emission tests Compliance...
  • Page 20 Guidance and manufacturer’s declaration – electromagnetic immunity The Hybresis Controller is intended for use in the electromagnetic environment specified below. The customer or the user of the Hybresis Controller should assure that it is used in such an environment. IEC 60601 Electromagnetic Immunity test Compliance level...
  • Page 21 Guidance and manufacturer’s declaration – electromagnetic immunity The Hybresis Controller is intended for use in the electromagnetic environment specified below. The customer or the user of the Hybresis Controller should assure that it is used in such an environment. IEC 60601 Electromagnetic Immunity test Compliance level...
  • Page 22 Recommended separation distances between portable and mobile RF communications equipment and the Hybresis Controller The Hybresis Controller is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Hybresis Controller can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF com- munications equipment (transmitters) and the Hybresis Controller as recommended below, according to the maximum output power of the communications equipment.
  • Page 23 Controller case to access the battery or for any other reason. Service For clinical questions, contact the Professional Services Department at 1-800-328-2536 ext. 8506. If any component of the Hybresis System is not functioning properly or requires servicing, contact the Empi Repair Department at 1-800-862-2343.

  • Page 24: Repair And Maintenance

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

  • Page 25: Limited Warranty

    Limited Warranty I. Warning While, in the opinion of Empi (“Empi”), the use of the Hybresis System (the “Product”) has met with some success, Empi makes no warranties to the purchaser as to the effectiveness of the product. II. Warranty A.
  • Page 26 Notice and return shipment shall be sent to Empi at 47492 SD Hwy. 22, Clear Lake, South Dakota 57226, USA, or to an Empi Authorized Service Center. To locate the appropriate service center outside of North America, or to request shipment approval, contact Empi directly. Empi will not be responsible for damage due to improper packaging or shipment.
  • Page 27 Purchaser.) D. EMPI 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,...
  • Page 28 Empi, Inc. 205 Hwy 22 East Clear Lake, SD 57226 USA 651.415.9000 800.328.2536 company 360353 Rev. E © 2007, 2015 Empi, Inc. DJOglobal.com...

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