Introduction:
The Cirona® 6400 system is intended for patients at risk for deep vein thrombosis and pulmonary embolism due to the associated risk factors for thrombus formation during and following various surgical situations. The application of this device can effectively increase venous flow velocity so as to reduce unexpected stasis, and upregulate the fibrinolytic activities in order to prevent early blood clotting.

Intended patient population: 

• Age: 18 or above
• Nationality: Irrelevant
• Body weight: Not concern
• Patient state: Normal or anaesthetized
• Health: Check contraindications

Intended user profile:

• Education/Knowledge: 7th grade+
• Experience Requirement: None
• Language understand: N/A (one button operation)
• Permissible impairments: Except for contraindications 

Indication for use:
The Cirona® 6400 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used in the home or clinical settings to:

• Aid in the prevention of DVT
• Enhance blood circulation
• Diminish post-operative pain and swelling
• Reduce wound healing time
• Aid in the treatment of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs
• As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

Contraindications:
The Cirona® 6400 series system should NOT be used in the following conditions.

• Severe arteriosclerosis or other ischemic vascular diseases
• Acute or active deep vein thrombosis
• Existing pulmonary edema, pulmonary embolisms, and/or congestive cardiac failure
• On patients with neuropathy, active infections, and/or thrombophlebitis 
• On extremities that are extremely deformed, insensitive to pain, or where increased venous or lymphatic return is undesirable
• Any local skin or tissue condition in which the garments would interfere including but not limited to-vein ligation, recent skin graft, gangrene, dermatitis, open wounds, massive edema.

Caution: Federal law restricts this device to sale by or on the order of physician

Operating instructions:

• Press the power button. The power button should be solid green when powered on.
• Wrap the sleeve snug around the calf, with the inflatable chamber positioned behind it, and press and hold the power button on each unit until the light turns green.
• After a 5-second delay, the pump will inflate the attached wrap to a pre-determined pressure of 40 mmHg.
• Once the pressure reaches that level, the pump will turn OFF, deflate until a 60 second cycle time is reached.
• To manually shut off the device, press the power button directly above the USB port. If the unit is off, no LED light will be illuminated.

Note: When the chamber is inflating, it is completely normal to hear a humming noise and feel a squeezing sensation around your leg.

Charging:

• Insert the supplied power supply plug into the USB port at the bottom of the unit and plug the power supply adapter provided into the wall. The green light on the unit will flash and become solid green once fully charged.