Aircast VenaFlow Elite User manual

Operator’s Manual
Prophylaxis for Deep Vein Thrombosis for use in a clinical setting or in the home

1
Table of Contents
Design Philosophy................................................................. 2
Function .......................................................................... 2
Intended Use/Indications .......................................................... 3
Contraindications ................................................................. 3
Warnings and Precautions ......................................................... 3
Latex Information ................................................................. 3
General System Information and Application
Pump Features .................................................................... 4
Symbol Denitions ................................................................ 5
Pump Set-Up...................................................................... 6
Cu Application ................................................................... 7
Pump Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Single Leg Operation .............................................................. 8
Patient Compliance Counter Reset ................................................. 8
System Alarms
Alarm Reset ....................................................................... 8
S Mode Operation ................................................................. 8
Tube Alarm........................................................................ 9
Compliance Alarm................................................................10
Call For Service Alarm ............................................................10
Battery Information and Operation
Battery Operation ................................................................10
Battery Charging Instructions .....................................................10
Lithium-Ion Battery Maintenance Guidelines ......................................11
Low Battery Alarm................................................................13
Installing or Replacing the Battery ................................................13
Replacement Kit Instructions
Instructions for Installing/Removing/Replacing the Power Cord ....................14
Telescoping Bed Hanger Replacement ............................................14
Instructions for Replacing Fuses ..................................................14
Cleaning Instructions .............................................................15
Disposal..........................................................................15
Warranty .........................................................................15
Optional Tube Alarm Verication Test .............................................15
Ordering Information.............................................................16
Specications ....................................................................17
Customer Care Contact Information...............................................17

2 3
Design Philosophy
Pneumatic compression is a clinically proven modality for minimizing the risks
associated with deep vein thrombosis.¹ The Aircast VenaFlow Elite System leverages
the same clinically proven technology as the existing VenaFlow oering, but is
presented in a low prole, light-weight design. VenaFlow Elite combines two proven
technologies, rapid ination and graduated sequential compression, to accelerate
venous velocity and enhance brinolysis. This unique combination makes VenaFlow
the only technology platform on the market that mimics ambulation.² Additionally,
VenaFlow Elite incorporates asymmetric compression for the superior emptying
of veins.³ The breathable and comfortable VenaFlow Elite calf, foot and thigh cus
enhance the patient experience, assist in increasing compliance and are compatible
with one universal pump.
Function
Standard Operation (rapid ination): The VenaFlow Elite system defaults to a
rapid ination mode. Once powered on, the system begins the compression cycle
and inates the cus one leg at a time, alternating between the two legs every 30
seconds. First the distal aircell inates rapidly within less than 0.5 seconds, then the
proximal aircell follows. The distal pressure peaks at approximately 73 mmhg ±15%
and the proximal pressure peaks at approximately 63 mmhg ±15%. These pressures
then settle at 45mmhg ±10% and after 6 seconds, the cu deates. In 54 seconds, the
ination cycle begins again. An icon will appear on the graphical display signalling
when the ination cycle is in progress. (See‘Pump Features’section) Pressure and the
inate/deate cycle are automatic and an alarm will be activated if the system is not
functioning properly. (See‘System Alarms’ section).
S Mode Operation (slow ination): The user has an option to select the S mode
button to switch to a slower ination mode. After selection, both cus begin to inate
simultaneously once every 60 seconds. The ination cycle is approximately 10 seconds
long. The aircells inate to a peak pressure of 45mmhg ±10%. In 50 seconds, the
ination cycle begins again. In S mode, pressures are automatic and alarms function
normally.
Intended Use/Indications
The VenaFlow Elite System is an intermittent pneumatic compression device that
is intended as a prophylaxis for deep vein thrombosis (DVT) in a clinical setting or
in the home. The VenaFlow Elite System is designed to be used only with VenaFlow
Elite cus.
Contraindications
The VenaFlow Elite System should not be used by persons with known or
suspected deep vein thrombosis, severe congestive heart failure, pulmonary
edema, thrombophlebitis, severe arteriosclerosis, or active infection. Do not
use on extremities which are not sensitive to pain, where cu will interfere
with gangrene, on patients with vein ligation or recent skin grafts, or extreme
deformity of the leg. Do not use the VenaFlow Elite System where increased
venous or lymphatic return is undesirable.
Warning and Precautions
• TheVenaFlowElitecusaredesignedforsinglepatientuseonly.
• Riskofexplosionifusedinthepresenceofammableanaesthetics.
• Theequipmentorsystemshouldnotbeusedadjacenttoorstackedwithother
equipmentand,ifadjacentorstackeduseisnecessary,theequipmentorsystem
should be observed to verify normal operation in the conguration in which it will
be used.
• 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.
Regularly check for patient comfort, compliance and skin irritation.
• Specialattentionshouldbegiventothosepatientswithneuropathiesortissue
viability problems (i.e. diabetes, arterial or venous insuciencies).
• 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 compression cus.
• Ifyouexperiencepain,swelling,sensationchangesoranyunusualreactionswhile
using this device, consult your medical professional immediately.
• Footcusareonlyforuseinstandardrapidinationmode.
• Ingressofwaterorliquidscouldresultinunpredictablefailures.
• Inspectequipmentforobviousdamagepriortouse.
• Donotwalkwithtubingconnectedtocus.
• Thedeviceshouldneverbeopenedbyanyoneotherthanatrainedtechnician.
• Useofdeviceoutsideofallrecommendedspecicationscouldresultinunpredictable
failures.
Latex Information
All components of the VenaFlow Elite System are latex-free. All VenaFlow Elite
cus are latex free and may be placed directly against the skin or over a light
compression dressing.
1. Labropoulos N, OH D.S, Golts, E, et al: Improved Venous Return By Elliptical, Sequential and Seamless
Air-cell Compression. Loyola University Medical Center, January 2003.
2. Whitelaw G, Oladipo O, Shah BP, et al: Evaluation of Pneumatic Compression Devices. Boston Orthopedics,
March 2001.
3. Kamm R: Unsteady Venous Blood Flow Resulting From Different Modes of External Compression Cambridge,
MIT, 1996

4 5
Bed hanger release
Graphical display
Pump indicator lights
Telescoping bed hanger
Pump Features Symbol Denitions
Battery indicator
* Note: not all VenaFlow Elite
Systems will contain a battery
S mode operation button
Ination cycle
indicator
First 3 minutes (ramp
up) indicator
Patient compliance
counter
Patient compliance
counter reset push
button
Power on/o button and alarm reset
Compliance monitor reset
Tube alarm
Call for service
Ination cycle indication (Bars indicate cus are inating)
See VenaFlow Elite System operator’s manual
Safety classication: Class 1 BF
250V 2A IEC FA 5X20MM
Battery
Separate collection for electrical and electronic equipment. Remove and dispose of
batteries in accordance with local or national requirements.
S Mode operation
Lock mode
Dual calf/thigh
Single calf/thigh
Dual foot
Single foot
Visual only compliance alarm enabled
Visual and audio compliance alarm enabled
ON/OFF/RESET push
button
S Mode operation indicator
Single/dual leg
operation indicator
C
C

6 7
Pump Set-Up
1) Hang pump from bed frame (foot of
bed), bed rail, or rest on oor or table.
To use the telescoping bed hanger,
press release button on the back of the
device and gently pull out bed hook to
the desired width.
2) Connect tube assembly to the pump.
Make sure tubing connectors lock
securely into pump connectors.
3) Plug in the power cord to electrical
outlet.
Cu Application
The VenaFlow Elite System will automatically detect the cu that is attached to the
device and apply appropriate pressures. You must attach the cus prior to powering
on the device.
1) Calf cu – Apply cu with the tube pointed toward the foot. The aircell may be
placed either on the back, side or front of the leg.
It doesn’t matter where the aircell sits on the leg, it
will perform the same.
Foot cu – Apply cu with the aircell centered on bottom of foot and with the
tube pointed to the left. Foot cus are only for use in standard rapid
ination mode.
Thigh cu – Apply cu with the distal and proximal aircells centered on either the
back, side or front of the calf and thigh with the tube pointed toward the foot. It
doesn’t matter where the aircell sits on the leg, it will perform the same.
2) Connect cus to the tubing that is attached to the pump.
For varied patient sizes, trim calf and thigh cus as needed for proper t.
Be sure to secure cu straps snug but not tight. Once again, when using the calf cu
and thigh cu, rotation of the aircell on the leg does not aect performance of the system.

8 9
Pump Operation
1) To turn the device on, press . The graphical display, green pump indicator lights
and green light above button will turn on.
2) Once device is powered on, system will immediately enter cu detection mode
which means the system will be detecting whether or not there are cus attached.
Display will read“Detecting Cus”and will display percentage of detection
complete. Once it reaches 100%, the display will then transition to the standard
display screen.
3) Any changes to cu conguration requires that the device be powered o and
restarted in order to detect the new conguration.
4) To turn the device o, press . The graphical display, green pump indicator lights
and green light above button will turn o.
5) To shut down the power completely, disconnect the power plug by removing it
from the AC socket.
Single Leg Operation
1) Cus should be attached prior to powering on the device. Once powered on, the
device will automatically detect if one or two cus are attached.
2) Any changes to cu conguration requires that the device be powered o and
restarted in order to detect the new conguration.
3) Either port may be used for single leg operation. The system will automatically
detect which one is in use.
4) Single and dual leg operation are available in both standard rapid mode and S
mode operation.
Patient Compliance Counter Reset
To reset the patient compliance counter, press for 1 second and release. The hours,
minutes and seconds will reset.
Alarm Reset
To reset any alarm, press the button and take steps to correct the alarm if
necessary. Pressing the button does not x the alarm but silences it until the problem
is xed. If you wish to turn the device completely o, you must press the power button
once to silence alarm and a second time to power down the device.
S Mode Operation
When powered on, the VenaFlow Elite System will default to standard rapid ination
mode. If a slower ination is desired, select the S mode operation button. Once
selected, both cus will inate simultaneously once per minute. Both cus will inate
and compress for a total of 10 seconds. While in S mode the icon will appear in
the top center of the graphical display. The device will remain in S mode until user
presses the S mode operation button again. This button allows user to toggle between
standard rapid ination mode and S mode.
Locking the System in Standard Rapid or S Mode
You have the ability to lock the system in either standard rapid mode or S mode. Once
a mode is locked, it will stay in that mode regardless of powering the device on or o.
Once locked, it is not possible to toggle modes until the system is unlocked.
To lock the system in standard rapid ination mode: First
make sure the device is in standard rapid ination mode. The S
mode icon should NOT appear on the display. Next, press and
hold the S mode button for no less than 5 seconds. After 5
seconds, a lock will appear at the top center of the display.
This lock icon indicates that the system is locked in standard
rapid mode.
To lock in S mode: First select S mode and make sure the
S mode icon appears at the top center of the display.
Press and hold the S mode button again for no less than
5 seconds. After 5 seconds, a lock will appear next to the S
mode icon at the top center of the display. This lock icon
next to the S mode icon indicates that the system is locked in S
mode.
To unlock either mode: Press and hold the S mode button for no less than 5
seconds. After 5 seconds, the lock icon will disappear.
Tube Alarm
1) If one or both tubes has a kink or leak, after 4-6 minutes this
symbol and the text “CHECK TUBES”will alternate on the
graphical display, an audible alarm will sound and the pump
indicator lights on the side of the system will ash red.
2) If a tube alarm occurs, reset alarm and then ensure that the
tube connections are secure and that the tubing is kink-free.
Check pump connectors and tubing/cu connectors for
cracks or damage. Check cus for damage as well.
3) If alarm occurs again, replace cus and tubing altogether.
Enabling Compliance Alarm
A compliance alarm can be enabled on the device as an option. To enable compliance
feature, complete the following steps:
1) Start with the system powered o.
2) Press and hold the S mode operation button and while holding, press the
power button. The graphical display screen will go blank with no backlight.
3) Press the S mode operation button .
4) Select button underneath ‘Change’.
5) Select button underneath ‘Other’.
6) Select button under ‘No alarm’.
Continued on next page

10 11
Compliance Alarm
1) If the cus are removed from the patient while the device
is still functioning and the cus are not reapplied after 15
minutes, a visual alarm or visual and audio alarm (depending
on your selection) will ash and the graphical display
will read“COMPLIANCE ALARM”. Additionally, the pump
indicator lights on the side of the system will ash red.
2) Reset alarm rst, and then reapply cus. You must reapply
the cus within 9-15 minutes after resetting the alarm in order to prevent another
compliance alarm from occurring.
3) If cus are reapplied without resetting the alarm, the compliance alarm will
automatically reset after 9-15 minutes
Call For Service Alarm
1) If one of the system’s critical components is not working
properly, the Call For Service alarm symbol will appear on
the graphical display and it will alternate with the text “CALL
FOR SERVICE”. Additionally, the pump indicator lights on the
side of the system will ash red.
2) If Call For Service alarm occurs, unplug the device and call
DJO Technical support at 800-336-6569 option 1, option 3 for further instructions.
Battery Operation
The VenaFlow Elite System is available in a battery conguration for an additional
charge. When the battery-installed system is powered on, a battery icon will appear on
the right side of the graphical display beneath the leg icons and a sticker appears on
the case. If the system does not have a battery installed, then there will be no battery
icon on the graphical display at all. When the system with battery is unplugged and
powered on, the system will automatically switch to battery power.
The battery must be charged before use. Once a system has been congured to run
with a battery, it must always have a battery installed. Otherwise a 'LOW BATTERY'
alarm will continuously occur. See 'Specications' section for battery pack information.
Battery Charging Instructions
1) To charge the battery, simply plug in the system to an electrical outlet either while
the system is on and functioning, or when it is powered o. The system will begin
charging immediately after being plugged in.
2) The VenaFlow Elite System with a fully charged battery will last for approximately
2 hours. It takes an estimated 2 hours to fully charge the battery when the unit is
o. When the unit is on, it takes an estimated 4 hours to charge the battery.
COMPLIANCE
ALARM
Lithium-Ion Battery Maintenance Guidelines
Overview
Do not leave batteries unused for extended periods of time because Lithium-Ion
batteries continue to slowly discharge (self-discharge) when not in use or while in
storage. Routinely check the battery’s charge status. The product Operator’s manual
includes information on how to check battery status as well as battery charging
instructions. When a battery has been unused for 6 months, check the charge status
and charge or send the system back to DJO for battery replacement.
The typical estimated life of a Lithium-Ion battery is about two to three years or
300 to 500 charge cycles, whichever occurs rst. One charge cycle is a period of use
from fully charged, to fully discharged, and fully recharged again. For batteries that do
not run through complete charge cycles, there is a two to three year life expectancy.
The intended operating temperature of the device is between 0 and 50 °C.
Rechargeable Lithium-Ion batteries have a limited life and will gradually lose their
capacity to hold a charge. This loss of capacity (aging) is irreversible. As the battery
loses capacity, the length of time it will power the product (run time) decreases.
Battery Maintenance
You should routinely check the battery’s charge status. Carefully monitor batteries that
are approaching the end of their estimated life. Consider shipping the device back to
DJO to replace the battery if you note either of the following conditions:
1. The battery run time drops below about 80% of the original run time.
2. The battery charge time increases signicantly.
If a battery is stored or otherwise unused for an extended period, be sure to follow the
storage instructions in this document. If you do not follow the instructions, and the
battery has no charge remaining when you check it, consider it to be damaged. Do not
attempt to recharge it or to use it. Send the system back to DJO for replacement.
Charging
Always follow the charging instructions provided in your Operator’s manual.
Storage
Charge or discharge the battery to approximately 50% of capacity before storage.
Charge the battery to approximately 50% of capacity at least once every six months.
The battery is best stored at 20±5 °C. For periods of less than 1 month, the battery can
be stored between -20~45 °C.
NOTE: The battery self-discharges during storage. Higher temperatures (above 20 °C
or 68 °F) reduce the battery storage life.
7) Select the button under ‘Done’ to set the new conguration. The change is
complete and the system is ready to operate. A“C”will appear on the display
indicating that the compliance alarm is enabled.

12 13
Low Battery Alarm
1) When there is approximately 15 minutes of charge left in the
battery, an audible alarm will beep 3 times every minute.
When there is less than approximately 5 minutes of charge
left, a consistent beep will sound and a larger version of the
battery icon will appear on the graphical display and it will
alternate with the text“LOW BATTERY”.
2) When either battery alarm occurs, immediately plug device in to electrical outlet
to begin replenishing the charge.
3) If the device is not plugged in during the alarm period, the device will shut down
and will fail to power on again until the device is plugged in again.
Installing or Replacing the Battery
1) Remove power cord. Refer to the ‘Instructions for
installing/removing/replacing the power cord’ section.
2) Remove back cover of device by removing 4 screws
using TORX (star) T20 driver.
3)
Remove power supply connector from board connector J4.
4) Install battery into the device below the reservoir.
5) Attach power supply connector to battery connector #1.
6) Attach battery connector #2 to J4 connector on board.
7) Attach battery connector #3 to J2 connector on board.
8) Close back cover of device and fasten
screws.
9) Reinstall the power cord and power
cord cover per previous instructions.
10) Plug in the system.
11) Hold down single/dual leg operation
button and then press the power
button to turn on the system. LCD
back light will turn on, with blank
LCD.
12) Release the single/dual leg operation
button.
13) Press and release counter reset
button.
14) Turn o the system by pressing the
power button. Battery will be congured at this point.
15) Turn on the system. After the cu detection cycle, the system should display a
battery icon on the right hand side of the LCD.
16) Leave the device plugged in for at least 4 hours to allow battery to charge. The
battery will charge whether the system is turned on or o.
1
2
3
J4
J2
Handling Precautions
• Donotdisassemble,crush,orpunctureabattery.
• Donotshorttheexternalcontactsonabattery.
• Donotdisposeofabatteryinreorwater.
• Donotexposeabatterytotemperaturesabove60°C(140°F).
• Keepthebatteryawayfromchildren.
• Avoidexposingthebatterytoexcessiveshockorvibration.
• Donotuseadamagedbattery.
• Ifabatterypackhasleakinguids,donottouchanyuids.
• Properlydisposeofaleakingbatterypack.
• Incaseofeyecontactwithuid,donotrubeyes.Immediatelyusheyesthoroughly
with water for at least 15 minutes, lifting upper and lower lids, until no evidence of
the uid remains. Seek medical attention.

14 15
Replacement Kit Instructions
Replacement kits may be ordered through customer care.
Instructions for Installing/Removing/
Replacing the Power Cord
1) Make sure system is powered o and unplugged.
2) Remove the screw retaining the power cord cover
using a 1/16”hex driver.
3) Remove the power cord cover.
4) Remove the power cord.
5) Install new power cord and reassemble power cord
cover.
Telescoping Bed Hanger Replacement
1) The telescoping bed hanger piece can be
removed and replaced if necessary.
2) To replace the bed hanger, hold down release
button on the back of the system and rmly pull
bed hanger out of the body of the system.
3) Discard the broken or ineective hanger. To
install the new bed hanger, slide the new hanger
back into the body of the device and set at
desired length.
Instructions for Replacing Fuses
1) Remove the power cord. Refer to the ‘Instructions for
installing/removing/replacing the power cord’ section.
2) Remove fuse holder from power entry module.
3) Remove fuses from fuse holder.
4) Replace any blown fuses with 250V, 2A, IEC fast acting
5X20mm fuses.
5) Reassemble fuse holder and replace power cord per
previous instructions.
Cleaning Instructions
Both the pump case and the tube assembly can be cleaned with a mild soap solution,
antiseptic or disinfectant wipes. DJO tested numerous disinfectants on the device and
found no adverse eects using isopropyl alcohol and hydrogen peroxide (Oxivir Tb).
According to the results, it is advised to avoid using Dimethyl benzyl ammonium
chloride or Dimethyl ethylbenzyl ammonium chloride (Tec-Surf II), or solutions
containing chlorine. Apply using a dampened cloth or wipes. Do not submerge the
device in any liquid.
Disposal
All contaminated product or accessories should be disposed of properly according to
hospital policy and/or state law.
Warranty
For consigned systems: DJO, LLC will repair or replace all or part of the 30B-S and
30B-SB systems for material or workmanship defects for the life of the customer
contract. Warranty and maintenance terms are specied for each consignment contract.
For purchased systems: DJO, LLC will repair or replace all or part of the 30B-S or 30B-SB
systems for material or workmanship defects for 3 years from the date of sale. For
disposable cus, tubing and battery pack purchases: DJO, LLC will repair or replace all
or part of the cus, tube units and battery packs for material or workmanship defects,
not including normal depreciation of battery life or charge capacity, for a period of six
months from the date of sale.
Optional Tube Alarm Verication Test
The Tube Alarm Verication Test is provided for facility verication purposes only and is
not required prior to use.
Attach tube assembly to pump and connect power cord to electrical outlet. Simulate
a kinked tube situation by folding the tube over onto itself once and holding it for 4-6
minutes. The second cycle after the simulated kink should activate an audible alarm
and this symbol will appear with“CHECK TUBES”on the graphical display and the
pump indicator lights on the side of the system will ash red.

16 17
System Replacement Parts
Part # Description
3070 Power Cord (U.S.), Hospital Grade
3071 Bed Hanger
3072 Tube Attachment Tag
3073 Fuse
3074 Battery Pack
Ordering Information (Reference separate IFU for each accessory)
Systems:
Part # Description
30B-S VenaFlow Elite System with S Mode
30B-SB VenaFlow Elite System with S Mode & Battery
30BI-S VenaFlow Elite System, International with S Mode
30BI-SB VenaFlow Elite System, International with S Mode & Battery
Accessories:
Part # Description Qty Maximum Calf
Circumference
3040 VenaFlow Elite Calf Cu Pair 19”
3042 VenaFlow Elite XL Calf Cu Pair 22”
3043 VenaFlow Elite Bariatric Calf Cu Pair 30”
3045 VenaFlow Elite Thigh Cu Pair One size ts all
3046 VenaFlow Elite Foot Cu Pair One size ts all
3050 VenaFlow Elite Foam Calf Cu Pair 19”
3008 Tube Assembly, 5.5' Each
3008XL Tube Assembly, 8.5' Each
3008XXL Tube Assembly, 10.5' Each
3008XXXL Tube Assembly, 12.5' Each
Specications
Size: 7.6”x 8.5”x 4.6”
Weight: no battery: 4 lbs. with battery: 4.75 lbs.
Power input: 100-240~, 50-60 Hz, 200 – 500 mA
Cord: Hospital grade, 15 ft
Standards: IEC 60601-1, IEC 60601-1-2
TUV Device Classication: Class 1 BF
Ination mode: rapid ination and graduated, sequential compression
Bed hanger: accommodates up to 3.5”
Battery: Li-ion polymer 11.1V, 4250 mAh
Fuse: 250V 2A IEC FA 5X20MM
Storage
Storage/Transportation Temperature: 0º C (32º F) to 50º C (122º F).
Operating Conditions
Operating Temperatures: 0º C (32º F) to 50º C (122º F)
Relative Humidity: 30% to 70%
Atmospheric Pressure: 650 mmhg to 790 mmhg
Customer Care Contact Information
Service: 800-336-6569 press option 1, then option 3
Technical support: 800-336-6569 ext 5566