The VenaOne DVT Compression System is a tubeless, portable, lightweight, and battery-operated device designed to aid in the prevention of Deep Vein Thrombosis (DVT) by stimulating blood flow in the legs. It applies pneumatic compression, a clinically proven modality, and is specifically designed for acute-care settings. The system consists of a main device and disposable wraps.
Function Description:
The VenaOne device inflates each leg cuff to a preset pressure of 55 mmHg in approximately 6 to 8 seconds, holds this pressure for about 2 seconds, then releases the pressure and rests for about 50 seconds before repeating the cycle. This cyclic compression helps enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, and aid in the treatment and healing of various conditions such as stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs. The device is operated with a single power button, controlling all functions.
Important Technical Specifications:
- Main Device Dimensions: 190 mm x 44 mm x 36.3 mm (7.5" x 1.7" x 2.5")
- Weight: Approximately 0.276.7 kg (0.61 lb)
- Mode of Operation: Cyclic
- Source of Power: 3.7V 3600mA Lithium-Ion Battery
- Power Supply (Charger): Class II, input: 100 - 240 Vac, 50-60 Hz, output: 12 Vdc @ 2 Amp. Only UL/60601-1 approved power supplies from VenaOne for use in hospital settings.
- System Operating Environment:
- Temperature: +5°C (41°F) to +40°C (104°F)
- Relative Humidity: 15%-93%
- Atmospheric Pressure: 525 mmHg to 795 mmHg
- Default Settings:
- Leg Pressure (not adjustable): 55 mmHg
- Cycle Time: 60 Seconds
- Tolerances: Pressure ±10%
- Battery: Internal Li-ion batteries.
- Battery Charge Time: Approximately 4 hours (from depleted state).
- Battery Life Expectancy: Approximately 24 hours of operation on a full charge. Lithium-Ion batteries have an estimated life of two to three years or 300 to 500 charge cycles, whichever comes first.
- Latex Information: All components, including VenaOne wraps, are latex-free.
- EMC Compliance: The device is Class II Medical Electrical Equipment and complies with CISPR 11 Group 1 Class B for RF emissions, and IEC 61000-3-2 Class A for harmonic emissions. It is suitable for use in commercial and domestic environments.
Usage Features:
- One-Touch Operation: Simple control of all functions via a single power button. To turn the device on or off, press the power button 3 times.
- Tubeless and Cordless Design: Enhances patient mobility and mitigates tripping hazards.
- Lightweight: Weighs less than one pound, making it fully ambulatory.
- Battery Operated: Provides approximately 24 hours of battery life for ease of use and patient compliance. The AC adapter can be connected while the device is in use.
- LED Display: Illuminates upon power-on and displays battery status, pressure, and alarm indicators.
- Application: The VenaOne device and bladder slide into the bottom of the disposable wrap. The wrap is then sealed using an adhesive strip. The wrap is applied around the calf and secured with fabric fasteners, ensuring a snug but not too tight fit.
- Alarm Indicators:
- High Pressure "HP": Displays if the device applies higher pressures than normal. Power off, restart; if it persists, remove from service.
- Low Pressure "LP": Displays if the device applies lower pressures than normal. Power off, restart; if it persists, remove from service.
- Battery Low "BL": Displays when the battery is running low (30 minutes or less remaining). Alarm ONE sounds 3 times every 2 minutes.
- One Bar Flashing RED: Displays when battery has 5 minutes or less remaining. Alarm ONE sounds 3 times every 10 seconds.
- System Failure "SF": Remove the device from service and replace.
- Alarm Silencing: Press and hold the POWER BUTTON for one second without turning off the device.
- Contraindications: MUST NOT be used for suspected, active, or untreated DVT, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis, active infection, or on legs with conditions like vein ligation, gangrene, dermatitis, open wounds, recent skin graft, massive edema, extreme deformity, neuropathy, or insensitivity to pain. Also contraindicated where increased venous or lymphatic return is undesirable.
Maintenance Features:
- Cleaning and Disinfecting:
- Device must be turned off and disconnected from the wall outlet prior to cleaning.
- Clean with a soft cloth dampened with soapy water or a mild detergent.
- Sanitize with a soft cloth moistened with 70% isopropyl alcohol.
- Avoid excessive spraying, especially near connection ports.
- DO NOT immerse the device in any liquid.
- DO NOT use abrasive or volatile cleaners.
- DO NOT remove the bladder from the device.
- The system cannot be sterilized by liquid immersion, autoclaving, or ETO sterilization.
- Allow 30 minutes for the device to dry completely after cleaning/disinfecting before use.
- User Maintenance: The device contains no serviceable parts. Contact customer service for issues. Inspect all components for damage prior to each use. Do not attempt to connect to a battery charger if damage is noticed. Avoid dropping the pumps.
- Battery Maintenance:
- Always follow charging instructions.
- Do not leave batteries unused for extended periods.
- Do not disassemble, crush, or puncture a battery.
- Do not short external contacts.
- Do not dispose of a battery in fire or water.
- Do not expose to temperatures above 60°C (140°F).
- Keep batteries away from children.
- Do not use a damaged battery.
- If a battery pack has leaking fluids, do not touch them. Dispose of properly. In case of eye contact, flush eyes thoroughly with water for at least 15 minutes and seek medical attention.
- Storage and Transportation:
- Store in a dry location between -25°C (-13°F) and +60°C (140°F).
- Relative Humidity: 15% to 93%.
- Atmospheric Pressure: 525 mmHg to 795 mmHg.
- Do not store in direct sunlight.
- Avoid folding or creasing the bladder during use and transportation.
- This device is not protected against water.
- Device Disposal: Dispose of contaminated products and accessories according to hospital policy and state law. The device itself, which includes printed circuit boards and rechargeable batteries, should not be discarded in landfills; consult local country requirements. The wraps are for single patient use and should be discarded after use.
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