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PURPOSE OF THIS DEVICE

The purpose of the VenaPro is to aid in the prevention of Deep Vein Thrombosis (DVT) by helping to stimulate blood flow in the legs. This is accomplished by an electronically controlled pump 
delivering a set amount of air to the leg cuffs that, in turn, compress the calf or calves to aid blood flow out of the lower extremities.
The pump will inflate each leg cuff to a preset pressure of 50 mmHg and deflate once the pressure is reached. The cycles are repeated on each unit until the power is turned off.  Internal 
rechargeable batteries allow the VenaPro to be completely portable, thus preventing interruptions in treatment.

User Profile:

The intended users are the patient, caretaker or a family member providing assistance. The user should be able to:

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read and understand the operator’s manual, warnings and cautions

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manually place the compression cuff on the body part to be treated

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sense auditory and visual signals

 

Indications for Use:

The VenaPro Vascular Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in 
patients by stimulating blood flow in the extremities (simulating muscle contractions).  

 

This device can be used to:

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Aid in the prevention of DVT

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Enhance blood circulation

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Diminish post-operative pain and swelling

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Reduce wound healing time

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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

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As prophylaxis for Deep Vein Thrombosis (DVT) by persons expecting to be stationary for long periods of time

CONTRAINDICATIONS 

The VenaPro MUST NOT be used to treat the following conditions:
Persons with suspected, active or untreated: deep vein thrombosis, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis, or an 
active infection.
On the legs where cuffs would interfere with the following conditions: vein ligation, gangrene, dermatitis, open wounds, a recent skin graft, massive edema or extreme deformity of the leg.
On any neuropathy.
On extremities that are insensitive to pain.
Where increased venous or lymphatic return is undesirable.

 WARNINGS 

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The VenaPro cuffs are designed for single patient use only.

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Device is to be used only by the patient prescribed, and only for its intended use.

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Operation of this device can be done by the patient.

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To avoid tripping or falling, do not walk with cuffs on your legs while the device is charging.

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Keep this device out of the reach of children and away from household pets and pests.

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The VenaPro is a standalone device that uses a DJO AC Adapter and Battery Charger only (see Using the AC Adapter and Battery Charger section) and is not to be used or 

interconnected to any other device.

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Do not open or remove covers. No user serviceable parts inside. Direct all unit issues to your local Customer Service representative.

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If you experience pain, swelling, sensation changes or any unusual reactions (including allergic reactions to the materials used in this device) while using this device, stop 

using this device and consult your medical professional immediately. 

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If pulsations or throbbing occur, the cuff may be wrapped too tightly. Loosen Immediately.

Summary of Contents for VenaPRo

Page 1: ...Vascular Therapy System Compressible Limb Sleeve Device 30MI Enhancing Life Through Innovation Instructions for Use ...

Page 2: ...STORAGE 8 DISPOSAL 8 COMPLIANCE STATEMENTS 9 ELECTROMAGNETIC COMPATIBILITY EMC 9 ELECTROMAGNETIC COMPATIBILITY EMC TABLES RF EMISSIONS CLASS B 9 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS 9 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY 10 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY 11 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE A...

Page 3: ... limbs As prophylaxis for DeepVeinThrombosis DVT by persons expecting to be stationary for long periods of time CONTRAINDICATIONS TheVenaPro MUST NOT be used to treat the following conditions Persons with suspected active or untreated deep vein thrombosis ischemic vascular disease severe arteriosclerosis pulmonary edema severe congestive heart failure thrombophlebitis or an active infection On the...

Page 4: ...es If you believe interference is occurring please consult Electromagnetic Compatibility EMC section To prevent extremity compartment syndrome special attention should be given to patients who are positioned in the supine lithotomy position for extended lengths of time This includes patients with or without cuffs Cuffs used in combination with warming devices may cause skin irritation Regularly ch...

Page 5: ... Easy one touch operation No restricting air hoses Air releases to cool the patients leg Soft breathable cuffs Battery Operated Single Patient Use Low Pressure Alarm Downloadable Compliance Monitor Lightweight Compact Design Downloadable Compliance Monitor Air Releases to Keep Leg Cool Easy OneTouch Operation Low Pressure Indicator USB Port for physician use Power Button Battery Indicator Charging...

Page 6: ...harging the GREEN LED flashes A steady GREEN LED indicates battery is fully charged if connected to charger or has adequate power for portable operation if not connected to charger STAGE 2 YELLOW The yellow LOW BATTERY INDICATOR will REMAIN ILLUMINATED during the pumping time and rest period At this stage the battery charger MUST be connected immediately to avoid any interruption in the treatment ...

Page 7: ...ngandsqueezingyourleg THIS IS NORMAL Thewrapswill inflateonceaminute IFyouFEELairreleasingaroundthelegs this isnormal Thisisafunctionof thedevicetokeepyourlegscool 4 PUMP ALARMS What to do if the Pump Alarms Don t worry the alarms are there to ensure the units are operating correctly BATTERY CRITICAL Ifbatteryvoltagedropsbelowacriticallevel cyclingstops audiblealarmwillsound andUNITWILLFLASHYELLOW...

Page 8: ...any damage is noticed Avoid subjecting the units to shocks such as dropping the pumps Do not handle the leg cuffs with any sharp objects If a bladder is punctured or you notice a leak do not attempt to repair the unit or cuffs Replacement units are available through customer service Avoid folding or creasing the bladder during use and transportation of the units Battery is not replaceable replacem...

Page 9: ... control such as paging systems Label devices susceptible to EMI Educate clinical staff to recognize potential EMI related problems Eliminate or reduce EMI with technical solutions such as shielding Restrict use of personal communicators cell phones computers in areas with devices susceptible to EMI Share relevant EMI information with others particularly when evaluating new equipment purchases whi...

Page 10: ...e 2kV common mode 1kV differential mode 2kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cycle 40 UT...

Page 11: ...y To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which theVenaPro is used exceeds the applicable RF compliance level above theVenaPro should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting o...

Page 12: ...PUT Mode of Operation Continuous SYSTEM OPERATING ENVIRONMENT Temperature 5 C 41 F and 40 C 104 F Relative Humidity 15 93 Atmospheric Pressure 525mmHg to 795mmHg Altitude below 3000 m DEFAULT SETTINGS Leg Pressure not adjustable 50 mmHg Cycle time 60 Seconds TOLERANCES Pressure 5 BATTERY This device is powered by internal Li ion batteries BATTERY CHARGE Takes approximately 4 hours from depleted st...

Page 13: ...d Perungudi Chennai 600 096 India Tel 91 44 66915127 Email customercare india DJOglobal com ITALY DJO Italia Srl Via Leonardo DaVinci 97 Trezzano Sul Naviglio 20090 Milano Italy Tel 39 02 484 63386 Fax 39 02 484 09217 Email vendite djoglobal com SOUTH AFRICA DJO South Africa Pty Ltd Unit 1 Brackengate Business Park 5 on London Brackenfell 7560 CapeTown South Africa Tel 27 21 706 16 88 Email info s...

Page 14: ...MDSS GmbH Schiffgraben 41 30175 Hannover Germany DJO LLC 1430 Decision Street Vista CA 92081 8533 USA DJOglobal com 30M100_A Raising the Standard of DVT Prevention ...

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