DJO Global VenaPRo User manual

Enhancing Life Through Innovation
Vascular Therapy System
(Compressible Limb Sleeve Device)
Customer Service
Toll Free: 877-475-7050
Email: [e-mail]
Web: www.InnovaMedHealth.com
Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner
1299 West 75 North, Centerville, UT 85014
Document # IFU-VP3111-R1
Copyright 2013 InnovaMedHealth, LLC.
Manufactured For:

TECHNICAL DATA
Specications:
Main Unit:
Dimensions: 2.6”X 5.2”(66 mm X 131 mm)
Weight: Approx. 0.5 lb (0.227 kg)
Mode of Operation: Cyclic
Source of Power: 7.4 volt Li-ion battery pack (made up of 2 – 3.7 volt cells)
CAUTION: Charge batteries using only the power source provided by
InnovaMed health.
USER MAINTENANCE
Contains no serviceable parts. Contact InnovaMed Health Customer Service at
877-475-7050
Inspect the unit and all components for any damage that may have occurred during shipping or general
handling prior to each use (for example, frayed or cut charging cord, cracked plastic housings, torn cus,
etc). Refer to image ofVenaPro for description of all components.
Do not attempt to connect the wall supply if any damage is noticed.
Avoid subjecting the units to shocks, such as dropping the pumps.
Do not handle the leg cus with any sharp objects. If a bladder is punctured or you notice a leak, do not
attempt to repair the unit or cus. Replacement units are available through customer service.
Avoid folding or creasing the bladder during use and transportation of the units.
Battery is not replaceable, replacement units are available through customer service.
Contact InnovaMed Health to receive replacements instructions for any damaged items.
STORAGE
Store in a dry location between +10⁰C (50⁰F) and +40⁰C (104⁰F).
Do not expose to heat exceeding 65⁰C (149⁰F).
Do not store items in direct sunlight.
DISPOSAL
This unit is an electromechanical device that includes printed circuit boards and rechargeable batteries.
Do not discard in landll. Consult local county requirements for proper disposal instructions.
Pump control units contain rechargeable batteries. Do not discard the pump unit in regular waste. Bring
the unit to your local recycle center or contact InnovaMed Health.
The use of accessories, power supplies and cables other than those specied, with the
exception of components sold by the manufacturer of theVenaPro as replacement
parts, may result in increased emissions or decreased immunity of the VenaPro.
Class II medical electrical equipment
This unit is a electromechanical device that includes printed circuit boards and
rechargeable batteries. Do not discard in landll. Consult local county requirements
for proper disposal instructions.
This symbol designates the degree of protection against electrical shock from the wrap
as being a type B applied part.
Follow the instructions for use.
This device is not protected against water. Equipment is not suitable for use in the presence of ammable
anesthetic mixture with air, oxygen, or nitrous oxide. The rechargeable batteries supplied in this unit
are not eld replaceable. If you have any issues please contact 877-475-7050 for a replacement unit.
POWER SUPPLY:
Class II, input: 100 - 240 Vac, 50 - 60 Hz, output: 10 Vdc @ 1.1 Amp)
Use only UL/60601-1 approved power supplies from InnovaMed Health for use
in hospital settings.
Output:
Mode of Operation: Continuous
SYSTEM OPERATING ENVIRONMENT:
Temperature: +10 Degrees C (50 Degrees F) to +40 degrees C (104 degrees F)
Humidity: 30%-75%
DEFAULT SETTINGS:
Leg Pressure (not adjustable) 50mmhg
Cycle time: 60 Seconds
TOLERANCES:
Pressure 5%
BATTERY CHARGE:
Takes approximately 6 hours (from
depleted state).
PURPOSE OF THIS DEVICE
The purpose of theVenaPro is to aid in the prevention of Deep Vein
Thrombosis (DVT) by helping to stimulate blood ow in the legs. This
is accomplished by an electronically controlled pump delivering a set
amount of air to the leg cus that, in turn, compress the calf or calves
to aid blood ow out of the lower extremities.
The pump will inate each leg cu to a preset pressure of 50mmhg and
deate once the pressure is reached.The cycles are repeated on each
unit until the power is turned o. Internal rechargeable batteries allow
theVenaPro to be completely portable, thus preventing interruptions
in treatment.
Indications for Use:
TheVena Pro Vascular Therapy System, model VP-3111, 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 ow in the extremities (simulating muscle
contractions). 

This device can be used 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 insuciency and reduction of
edema in the lower limbs
As prophylaxis for DeepVein Thrombosis (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, thrombphlebitis, or an active infection.
On the legs where cus 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.

INSTRUCTIONAL
POWER OFF:
Unit is in“sleep”mode. No visible LED illumination.
POWER ON:
Unit powers up with GREEN LED illuminated (YELLOW can be illuminated if battery voltage
is LOW). After a 5 second delay, the pumps will allow ination of the attached wrap to a
pre-determined pressure of 50 mmHg. Once the pressure reaches the proper level, the pump
will turn OFF for a 50 second“rest”period, and the cu deates through the vent port to cool
the leg or legs. After the“rest”period, the wrap is again inated, and so on every 50 seconds.
By Prescribing Physician Only:
Unit use time (amount of time the unit is powered ON) is monitored and stored by the MPU
(Microprocessor Unit) and can be downloaded into Excel via the USB interconnecting to an
interface module.
BATTERY INDICATOR:
In order to properly indicate the state of the battery and charger, there are THREE stages of
the BATTERY INDICATOR as follows:
STAGE 1 – GREEN:When unit power is ON and fully operational.
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 connect-
ed immediately to avoid any interruption in the treatment sessions.
FLASHING YELLOW: If the battery voltage drops below a critical level at any time,
while unit is ON, ashing yellow and audible alarm beeps for 30 seconds. Unless unit is
turned o OR connected to charger within that 30 seconds, unitWILL AUTOMATICALLY power
OFF.
STAGE 3 – RED: When the unit is turned OFF and the battery is charging, the RED LED
FLASHES. Once the battery reaches full charge, the RED LED REMAINS SOLID.
SYSTEM
COMPONENTS QUICK START
Low Pressure Indicator
USB Port
Power Button &
Battery Indicator
Charging Port
CALF CUFF APPLICATION
Wrap the cu around the calf and secure theVelcro to hold it in place.
Make sure the wrap is snug, but not too tight.
When both wraps are secured on
your legs, they should look like
the picture above.
Left Leg Pictured
1
2
USING THE DEVICE
Don’t be startled.The device will make a“humming”sound when
inating and squeezing your leg. THIS IS NORMAL.The wraps will
inate once a minute. IF you FEEL air releasing around the legs, this
is normal. This is a function of the device to keep your legs cool.
TURNING THE DEVICE ON
When the wraps are secured on your
legs PRESS and HOLD theWHITE power
button for about a second until the
light is illuminated on each unit.
3
4

USING THE AC ADAPTER /
BATTERY CHARGER
UNIT POWERED OFF
Insert the supplied power supply plug by into the port at the bottom end of the unit and
connect the power supply adapter to the wall socket. The RED“Charging”indicator on the unit
will illuminate or ash, depending on the state of charge.
A full charge of a depleted battery should take about 6 hours.When the unit is turned o and
plugged in the battery is charging, the power button will ash red. Once the battery reaches
full charge the power button will be red and remain solid.
UNIT POWERED ON
For extended operation periods, or to charge the battery during treatment sessions, the AC
adapter CAN be connected while the device is in use.The UNIT LED will illuminate GREEN
and they will be charging simultaneously. Whenever the unit is powered ON and charger
connected, LED indicator will always show GREEN.
CHARGING THE BATTERY: USE ONLY THE CHARGER PROVIDED BY
INNOVAMED HEATLH. Use of the wrong charger can cause excessive heat, damage to
the charging circuit and shorten the life of the battery.
ALARMS:
“Battery Critical” – If battery voltage drops below critical level, cycling stops, audible
alarm will sound, and UNITWILL FLASHYELLOW. Alarm will continue for 30 seconds (unless
unit is powered OFF) and automatically turn the unit OFF. Plug in power supply immediately.
“Low Pressure or Leak” –When activated, if pressure limit is NOT reached within 30
seconds after pump is energized, cycling stops, ALARM sounds and BLUE“low pressure”LED
ashes. Alarm will continue for 30 seconds (unless unit is powered OFF) and automatically
turn the unit power OFF. Make sure wrap is attached snugly leg.Turn the unit OFF, and then
turn the unit back ON. If the unit continues to alarm after this step, DO NOT try to x the
device. Call customer service for a replacement unit at 877-475-7050.
ALARM RESET:
To reset an alarm condition after the“operation inhibit”stage is reached, the unit must
be turned OFF. If not manually turned OFF within 30 seconds of such an alarm condition
occurring, unit automatically turns itself OFF. Once the unit is turned back on the alarm is
RESET.
OPTIONS:
By Prescribing Physician Only:
At the top edge of the pump/controller unit is access to a mini USB port. This is NOT to be directly
connected to a computer. In order to download use data, a data expander interface must be purchased
from InnovaMed Health.
An additional function available thru the USB port is to add a remote control module for ON/OFF
operation from a handheld transmitter. These modules aid in controlling the system for patients
unable to access the device operations.
CLEANING AND DISINFECTING
NOTE: Inspect the VenaPro unit and follow the cleaning and disinfecting procedures prior to each use.
WARNING: Device must be turned o and disconnected from the wall outlet prior to and during
cleaning or disinfecting.
DO NOT IMMERSE UNIT IN ANY LIQUID FOR ANY REASON
• Clean the outer surface of the pump unit using a soft cloth, moistened with soapy water or 70%
isopropyl alcohol.
• Do not use abrasive or volatile cleaners.
WARNINGS AND
PRECAUTIONS
• TheVenaPro cus are designed for single patient use only.
• Medical Electrical Equipment needs special precautions
regarding EMC. Portable and mobile RF Communications
Equipment can be aected by other Medical Electrical Devices.
• Cus used in combination with warming devices may
cause skin irritation. Regulary check for patent discomfort,
compliance, and skin irritation.
• 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 cus.
• Do not open or remove covers. No user serviceable parts inside.
Direct all unit issues to InnovaMed Health.
• If pulsations or throbbing occur, the cu may be wrapped too
tightly. Loosen Immediately.
• Stop using device if swelling occurs; consult a Physician.
• Device is to be used only by the patient prescribed, and only for
its intended use.
• Ensure the pump control unit is turned o and unplugged from
the wall outlet prior to and while cleaning or disinfecting.
• Equipment should not be used in the presence of any
ammable anesthetic mixture with air, oxygen, or nitrous
oxide.
• Do not immerse in any liquid for any reason.
• Do not operate device in a wet environment.
• Allow cus to warm to room temperature if exposed to
temperatures below 5⁰C or (41⁰F).
• Do not subject the unit to extreme shocks, such as dropping
the pump.
• Contains no user serviceable parts. Contact InnovaMed health
Customer Service.
• Do not place any items in an autoclave.
• Operation of this device can be done by the patient.
• No Service is to be attempted while the device is in use.
• This device is NOT to be altered or modied.
• Do not place cus in dryer.
• NEVER remove the unit from the cu.
• Hand wash the exterior of the cus using a soft cloth, moistened with soapy
water or 70% isopropyl alcohol and let air dry.
• To ensure the unit IS completely dry prior to use, leave unit in the OFF
condition and disconnected from the wall outlet for 30 minutes after cleaning
or disinfecting.