Aircast VenaFlow Elite User manual

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

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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

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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

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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

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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.