The medi® pcs brio is a basic pneumatic compression device that allows patients to continue their lymphedema treatment at home with patient-specific programs for easy, safe and effective treatment.
• Self-learning Fill-to-Fit technology automatically adjusts to limb size during each therapy session
• Create individualized treatment programs to meet patient needs
• Overlapping chambers apply consistent, gradient compression to reduce the potential for window edema
• Full-color touchscreen can be programed in four languages (English, Spanish, French and Portuguese)
• Patient safety lock prevents mis-programming
The medi® pcs brio assists in the management and treatment of lymphedema, venous stasis ulcers, venous insufficiency and peripheral edema.
Absolute contraindications: Use while ambulatory; use while sleeping; the presence of lymphangiosarcoma; suspected or known acute deep vein thrombosis; existing pulmonary edema; existing pulmonary embolism; inflammatory phlebitis; severe congestive cardiac failure; severe atherosclerosis or other ischemic vascular diseases; any circumstance where increased venous and lymphatic return is undesirable; extreme musculoskeletal deformity of limb intended for treatment; any local skin or tissue condition which the device would interfere such as gangrene, untreated or infected wounds, recent skin graft, and dermatitis; known presence of malignancy in the limb intended for treatment; limb infections, including cellulitis, that have not received antibiotic coverage.
Relative Contraindications: unsupervised children use under the age of 18; allergy or intolerance to garment material (100% Nylon).
Caution should be used when treating patients with heart disease or peripheral occlusion disease as the increased movement of fluids may pose additional health risks.
Warning: Explosion Hazard
Do not use in the presence of flammable gases, including flammable anesthetics.
Warning: Electrical Shock Hazard
Do not allow liquid to enter any part of the system.
Warning: Electric Shock Hazard
Never attempt to perform maintenance or service the device while in use. To completely eliminate power, disconnect the power supply from the Pressure Control Unit or from the wall outlet.
Warning: Electric Shock Hazard
Unplug power supply from source and do not use medi® pcs during electrical storms.
Warning: Electric Shock Hazard
To prevent electric shock, do not open the Pressure Control Unit. Do not attempt to service the pressure control unit yourself. All maintenance tasks should be performed only by the manufacturer or by authorized service personnel. Service by unauthorized personnel shall void the warranty.
Warning: Ventilation Hazards
Always place the pump on a solid surface free of objects that may block ventilation openings. Never lock the ventilation openings. Keep the ventilation opening free of debris such as lint and hair. Never operate the pump on a soft surface, such as a bed, couch, or pillow, where the ventilation opening may be blocked. Never drop or insert any object into any opening of the pump.
Warning: Environmental Hazards
Keep the pump, garments, and power supply cord and plug away from sharp objects, flames, and heated surfaces.
Warning: Proper Inspection Required
Prior to using always inspect pressure control unit, power supply, garments, and connectors for damage.
Never operate the controller where the cord or tubing harness shall present a tripping hazard.
The power supply and hoses of this product may pose a strangulation hazard. Keep power supply and hoses out of the reach of children at all times.
Warning: Contact Injuries
Pressure Control Unit should be placed at same height or below patient to prevent possible injury from device falling on patient.
Warning: Treatment Should Never Hurt
The garment compression should never hurt. If you experience pain or notice your condition worsening, contact your physician. Do not change your treatment settings without consulting your physician.
Warning: Parental Supervision
Children under the age of 18 should only use the system under adult supervision and direction of a physician.
Caution: Single Patient Use
Garments are intended for single patient non-ambulatory use only.
Use only the medi® pcs power supply (GSM60B24), garments, and accessories with the medi® pcs system.
After treatment is complete and the Pressure Control Unit (PCU) is turned off, unplug the power supply cord from the power outlet and from the PCU. Disconnect the garments from the PCU. Store the garments by first loosely coiling the hoses and garment connectors. Avoid kinking or crushing the hoses. Lay the garments flat in a cool, dry place for storage. Store the PCU in a cool, dry place, avoiding direct sunlight. Keep it away from excessive heat or cold, and keep away from children and pets.
Loosely form the garment to your leg's shape and fasten the hook tabs. With the foot piece of the garment furthest from you, slide your leg into the garment until it reaches your knee or upper thigh. Note: do not stand or walk while wearing leg garments. Readjust the hook and loop material of the garment if necessary so that it fits securely but comfortably on your leg. As the garment inflates it will intelligently apply compression based on your limb size so it is not necessary that the garment have a snug fit or apply compression from donning.
Loosely form the garment to your arm's shape and fasten the hook tabs. Use the outermost hook panel for larger circumference arms. Fold the panel under itself and use the inner hook panel for smaller circumference arms. With the curved end of the garment closest to you, slide your arm into the garment until it reaches your armpit. Ensure that the curved top edge of the garment is positioned on the outer side of your shoulder. The straight end of the garment should be positioned over the hand. Readjust the hook and loop material of the garment, if necessary, so that it fits securely but comfortably on your arm. As the garment inflates it will intelligently apply compression based on your limb size so it is not necessary that the garment have a snug fit or apply compression from donning. Your fingers may or may not extend from the end of the garment depending on the length of your arm. When applied, the garment should not be so tight that it applies compression and it should never hurt. The garment connector should extend from the end of the garment closest to the wrist.
Disconnect the garment from the Pressure Control Unit (PCU) and deflate as necessary. To remove the garment, either slide your limb out of the garment or undo the hook and loop material and remove your limb. It is recommended to keep the hook and loop material fastened even when the compression garment is not in use to avoid it snagging on clothes, linens, or other materials.
Sleeves are 100% nylon.
The Manufacturer's Warranty states that products are warranted to be free from defects in material and workmanship for a defined period. The Manufacturer's sole obligation in the event of a breach of this warranty is expressly limited to the replacement of defective parts that, in the sole discretion of the Manufacturer, cannot be repaired. Replacement parts may be new or refurbished parts as solely determined by the Manufacturer. This warranty is available only to the original user and is not transferable. Repairs or alterations to the product not conducted by the Manufacturer shall void these warranties. These warranties do not cover failures due to improper or negligent use of the product. The Pressure Control Unit (PCU) is covered by warranty for 3 years. The garments are covered by warranty for 1 year.
IEC PROTECTION CLASSIFICATION: Class II
DIMENSION: 8.75" (W) x 13" (D) x 4.5" (H)
PRESSURE RANGE: 20-80mmHg
ELECTRICAL: 100-240vac, 50/60Hz, 1.4-0.7 amps
POWER: 60 Watts
IP2X: Protected against ingress of solid objects over 12.5mm e.g. accidental touch by a person's hand.
No protection against ingress of liquids.
APPLIED PART: Type BF
APPLIED STANDARDS: ANSI/AAMI ES60601-1, AAMI HA60601-1-11, CSA C22.2 No. 60601-1, CSA C22.2 No. 60601-1-11, ISO 13485, ISO 14971, IEC 62304 IEC/EN 60601-1-2, IEC/EN61000-3-2, IEC/EN 61000-3-3, FCC CFR 47; Part15; Subpart B, ICES 001; ISSUE 4, AS/NZS CISPR 11, JIS T 0601-1-2, ABNT NBR IEC 60601- 1-2
LEGAL MANUFACTURER: medi USA, LP, 6481 Franz Warner Parkway, Whitsett, NC 27377
Made in USA
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