Aircast VenaFlow Elite User manual

30B101_C
Rx Only
DJO, LLC
1430 Decision Street • Vista, CA 92081-8553 • USA
t 800.336.6569 • f 800.936.6569
DJOglobal.com
Operator’s Manual
Prophylaxis for Deep Vein Thrombosis

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
Tube Alarm........................................................................ 9
Single/Dual Leg Operation Alarm .................................................. 9
Compliance Alarm................................................................. 9
Call For Service Alarm.............................................................10
Battery Information and Operation
Battery Operation ................................................................10
Battery Charging Instructions .....................................................10
Low Battery Alarm................................................................10
Installing or Replacing Battery ....................................................11
Replacement Kit Instructions
Instructions for installing/removing/replacing the power cord .....................12
Bed Hanger Replacement.........................................................12
Instructions for replacing fuses....................................................12
Cleaning Instructions .............................................................13
Warranty .........................................................................13
Optional Alarm Verication Test ...................................................13
Ordering Information.............................................................14
Specications ....................................................................15
Customer Care Contact Information...............................................15

2
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, via our new
single tube Integrated Graduated Sequential Flow System (IGSF), to accelerate venous
velocity and enhance brinolysis. This unique combination makes VenaFlow the
only technology platform on the market that produces blood ows that mimic those
achieved through 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
Once activated, the VenaFlow Elite 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 .5 seconds, then the proximal aircell
follows. The distal pressure peaks at approximately 78 mmhg ± 15% and the proximal
pressure peaks at approximately 68 mmhg ±15%. These pressures then settle at
45mmhg ±15% 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)
Pressure [mmHg]
Time [sec]
distal
VenaFlow Elite Calf Cu Pressure Curve
90
80
70
60
50
40
30
20
10
0
01 2 3 4 5 6 7
proximal
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
15
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 ext 5568
Technical support: 800-336-6569 ext 5566

3
Intended Use/Indications
The VenaFlow Elite System is intended as a prophylaxis for deep vein thrombosis
(DVT). The VenaFlow Elite System is designed to be used only with Aircast
VenaFlow Elite Compression Cus. Battery operation use only with DJO, LLC
battery packs.
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.
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.
14
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
Systems:
Part # Description
30B VenaFlow Elite System
30B-B VenaFlow Elite System with Battery
30BI VenaFlow Elite System, International
30BI-B VenaFlow Elite System, International with 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