ThermoTek VascuTherm 4 User manual

VascuTherm™ 4
User Manual

TABLE OF CONTENTS
Chapter 1
Introduction.............................................................................................................................. 1
Chapter 2
Glossary of Terms....................................................................................................................... 2
Chapter 3
General Warnings and Cautions .................................................................................................. 4
3.1 Contraindications for Pneumatic Compression Therapy......................................................................... 4
3.2 Contraindications for Heat and ColdTherapy.........................................................................................4
3.3 Precautions ...........................................................................................................................................5
3.4 Cautions................................................................................................................................................5
3.5 Warnings............................................................................................................................................... 6
Chapter 4
Indications for Use ..................................................................................................................... 9
Chapter 5
VascuTherm™ 4 Device Description............................................................................................ 10
5.1 Features .............................................................................................................................................. 10
5.2 General Specications......................................................................................................................... 10
5.3 Options ............................................................................................................................................... 11
5.4 Device Description............................................................................................................................... 11
Chapter 6
Unpacking Your VascuTherm™ 4 Therapy System ........................................................................ 13
Chapter 7
Environmental Conditions You Should be Aware of Before Operating Your VascuTherm™ 4 Device.. 15
Chapter 8
How to Set Up Your VascuTherm™ 4 System for Therapy............................................................... 16
Chapter 9
Operating Instructions for Your VascuTherm™ 4 System .............................................................. 24
9.1 Turning the Unit ON for the FirstTime: ................................................................................................ 24
Automatic Pre-Programmed Therapy.................................................................................................. 25
Manually Controlled Therapy............................................................................................................... 25
9.2 Cool Therapy........................................................................................................................................ 25
9.3 Heat Therapy....................................................................................................................................... 28
9.4 Pneumatic CompressionTherapy for Edema and Lymphedema.......................................................... 30
9.5 DVT Calf CompressionTherapy ............................................................................................................ 33
9.6 DVT Foot Compression Therapy ........................................................................................................... 36
9.7 Pneumatic CompressionTherapy and DVT CalfTherapy....................................................................... 40
9.8 Pneumatic CompressionTherapy and DVT Foot Therapy...................................................................... 41

Chapter 10
System Screen ......................................................................................................................... 43
Chapter 11
Things You Can Do To Keep Your VascuTherm™ 4 System Performing............................................ 46
Chapter 12
Draining the Fluid from the Unit............................................................................................... 47
Chapter 13
Storage and Re-Packing the Unit .............................................................................................. 48
Chapter 14
Troubleshooting Guide............................................................................................................. 50
Chapter 15
Device Summary...................................................................................................................... 61
Chapter 16
Service and Customer Support.................................................................................................. 63
Chapter 17
Wraps, Accessories and Replacement Parts................................................................................ 64
Chapter 18
Specications.......................................................................................................................... 67
18.1 Calibration......................................................................................................................................... 67
18.2 Product Listing.................................................................................................................................. 67
Chapter 19
Index...................................................................................................................................... 69
Chapter 20
Warranty and Disclaimer Information....................................................................................... 70

Introduction:
Please read the entire manual carefully before trying to operate the VascuTherm 4™ system.
It is unsafe to start using the VascuTherm™ 4 system before reading the entire user manual.
Please keep this user manual for future reference.
At ThermoTek, we pledge to provide the highest quality product with excellent support and
service. If we can do anything to make your VascuTherm™ 4 experience better, please do not
hesitate to contact us.
User Assistance Information:
The VascuTherm™ 4 Therapy System is manufactured by:
ThermoTek, Inc.
1200 Lakeside Parkway #200, Flower Mound, Texas 75028
Hours of Operation: Monday-Friday 8 a.m. to 5 p.m. CT
Phone/Fax Numbers:
Telephone: [phone] Toll-free Telephone: [phone] (U.S. only)
Fax: [phone]-hour service line: [phone]
ThermoTek Website: www.thermotekusa.com
Icons Used for Warnings and Cautions:
Dangerous Voltage
General Caution
Do not drink or ingest the coolant mixture.
In the event of a Medical Emergency, call:
9-1-1
1
Chapter 1

Glossary of Terms:
Arterial Dysregulation: A physiological impairment of the arteries.
Arteriosclerosis: A chronic disease in which thickening, hardening and
loss of elasticity of the arterial walls result in impaired
blood circulation.
Constant Compression: Continuous, regulated and compressive force
applied to the skin surface for the manipulation of
subcutaneous compartment pressures.
Carcinoma Metastasis: A malignant new growth having potential to spread.
Contraindication: A reason that makes it inadvisable to prescribe a
particular drug or employ a particular procedure or
treatment to a patient.
Contrast: A pain management therapy consisting of repeatedly
heating and cooling of the subcutaneous muscle
tissue.
Deep Venous Thrombosis (DVT): A type of phlebothrombosis; the formation of a clot
in the deep veins of the extremities typically due to
slowing or halting of blood return to the heart.
Edema: A accumulation of an excessive amount of watery
uid or blood in cells, tissues or serous cavities of the
body.
Erysipelas: An acute supercial form of cellulitis; a spreading
inammation of subcutaneous or connective tissue.
Hypertonia: Extreme tension of the muscles or arteries.
Non-Ambulatory: To be in a resting or immobile state; not moving.
2
Chapter 2

Phlebothrombosis: Thrombosis of a vein without prior inammation of
the vein; associated with sluggish blood ow or with
rapid coagulation of the blood. Usually caused by
prolonged bed-rest, pregnancy or surgery.
Pulsating Compression: Also called intermittent or undulating compression,
is the manipulation of subcutaneous compartment
pressures in a high-to-low repeating cycle.
Stasis Dermatitis: A common inammatory skin disease that occurs on
the lower extremities in patients with chronic venous
insuciency with venous hypertension.
Thrombophlebitis: An acute inammatory reaction of a vein due to
thrombus presence.
Thrombus: A clot formed in a blood vessel or in a chamber of the
heart.
Vein Ligation: The presence of veins that have been surgically
rejoined.
Venous Stasis: Slowing of blood ow typically caused by venous
valve failure or the existence of clots in the vein.
3

General Warnings and Cautions:
3.1 Contraindications for Pneumatic Compression Therapy:
The patient should not use the VascuTherm™ 4 therapy system if the patient is suspected of
or observed to have any of the following:
• Presumptive evidence of Congestive Heart Failure,
• Pre-existing DVT condition,
• Deep Acute Venal Thrombosis (Phlebothrombosis),
• Inammatory Phlebitis Process,
• Episodes of Pulmonary Embolism,
• Pulmonary Edema,
• Acute Inammations of the veins (Thrombophlebitis),
• Decompensated Cardiac Insuciency,
• Arterial Dysregulation,
• Erysipelas,
• Carcinoma and Carcinoma Metastasis in the aected extremity,
• Decompensated Hypertonia,
• Acute inammatory skin diseases or infection,
• Venous or Arterial Occlusive Disease,
• Venous or Lymphatic Return is undesirable,
• Poor peripheral circulation,
• Severe Arteriosclerosis, or active infection.
3.2 Contraindications for Heat and Cold Therapy:
The following patients must use the VascuTherm™ 4 therapy system for temperature
contact therapy under the supervision of a physician if they are:
• Individuals with extremities not sensitive to pain,
• Individuals with extremely low blood pressure,
• Individuals with Raynaud’s Disease,
• Hypersensitive to cold,
• Children,
• Diabetics
4
Chapter 3

• Incapacitated patients,
• Individuals with decreased skin sensitivity,
• Individuals with poor circulation,
• Patients with vein ligation or recent skin grafts.
3.3 Precautions:
When using the VascuTherm™ 4 system, basic safety precautions should always be followed
to reduce the risk of re, electric shock and personal injury. Please read the entire manual
carefully before trying to operate the unit.
3.4 Cautions:
Never push objects of any kind into the therapy unit through the exterior case.
Never spill liquid of any kind into the therapy unit.
Do not overll the reservoir of the unit.
If the unit gets wet, unplug the unit from the wall and allow the unit to dry before
use.
The unit must be operated with the supplied power cord and power supply; Autec
Power Systems model DT-M250-48-BE2, and plugged into a 3-prong grounded outlet.
Do not operate the unit if it has any noticeable or physical damage or is leaking uid.
Do not operate the unit with a damaged or frayed power cord.
The therapy unit is not intended to be used in a wet environment or when relative
humidity is greater than 60%.
Do not spray the unit with any water solvents or cleaners.
Do not drop the therapy unit or cause impact to the unit.
Do not pull or otherwise put undue stress on the hoses.
Do not use near equipment that generates electromagnetic or other interferences as
this may be harmful to the therapy unit.
5

6
Do not smoke while using therapy wraps or use therapy wraps by an open ame.
Do not stick a nger or any other foreign objects into the reservoir.
Do not drink or ingest the coolant.
3.5 Warnings:
If unusual swelling, skin discoloration or discomfort occurs, immediately discontinue
use of the VascuTherm 4 unit and consult a healthcare professional.
Follow the prescribed instructions of your physician for area, frequency and duration
of treatment.
A licensed healthcare practitioner must select the correct temperature setting for hot
or cold therapy use.
Patients vary in sensitivity to cold. Make a regular check of the patient’s temperature
once established.
Therapy wraps are to be tted initially by a healthcare professional that is familiar
with the purpose for which the wraps are used.
Do not apply the therapy wrap so tightly as to restrict blood or uid ow.
Use only ThermoTek approved therapy wraps.
Therapy wraps are non-sterile unless specically labeled as sterile.
Non-sterile therapy wraps should never be directly applied to an open wound or
breached skin.
Use only sterile wraps over wounds or breaks in the skin.
A healthcare professional is responsible for providing wearing instructions and
precautions to other healthcare professionals, care providers involved in the patient’s
care, and the patient.

If it is appropriate for the patient to use the wrap with therapy unit at home, the
healthcare provider must provide adequate and appropriate instructions for use to
the patient.
The healthcare provider must monitor the patient’s use of the therapy unit, assuring
appropriate use and application of all therapies.
Disposable therapy wraps are designed for single patient use only and may only be
used on the same patient for the length of the treatment.
The therapy wrap should be periodically cleaned if it is used on the same patient for
an extended period of time.
Do not attempt to sterilize this device by any means.
Clean exposed surfaces of the therapy wrap with either a mild anti-bacterial soap
and water solution or an isopropyl alcohol and water solution. Do not use bleach on
therapy wraps.
Dressings used under the therapy wrap should be applied lightly.
Do not use pins to secure the therapy wraps or hoses.
Do not allow the therapy wrap or hoses to contact sharp objects that could puncture
it.
All therapies using compression must be turned OFF when the unit is not in use or
the wrap is removed from the patient for prolonged periods or for repositioning of
the wrap.
Immediately stop compression therapy if you experience any sense of discomfort,
numbness or tingling of the limb.
Use only the approved coolant in the VascuTherm 4 unit.
Slots and openings in the cabinet are provided for ventilation to protect the unit
from overheating. These openings must not be blocked or covered at any time
except by the supplied air lter.
The power cord could be a potential tripping hazard. Use caution while walking over
the power cord.
7

Observe all warning and caution labels. Never remove the caution/warning labels.
8

Indications for Use:
The VascuTherm™ 4 therapy system is designed to provide uid heating, cooling and
compression as specied in this manual. If the system is used in a manner other than as
specied, its operation or the safety protection may be impaired.
Indications for use:
• Treatment of disorders associated with vascular or lymphatic insuciency such as Chronic
Venous Insuciency (CVI), venous stasis ulcers, post-mastectomy edema and chronic
lymphedema,
• Reduction of edema associated with soft tissue injuries such as burns, postoperative
edema and ligament sprains,
• Localized thermal therapy (hot or cold) for post traumatic and post-surgical medical and/
or surgical conditions,
• Decrease the risk of deep venous thrombosis (DVT),
• Aids the blood ow back to the heart,
• Treat and assist healing of cutaneous ulceration (wounds), reduce healing time, enhance
arterial circulation (blood ow), reduce compartmental pressures, reduce edema
(swelling), reduce the need for anticoagulant (blood thinning) medications.
9
Chapter 4

10 11
VascuTherm™ 4 Device Description:
The VascuTherm™ 4 therapy system is an electronic heating, cooling and compression system.
The VascuTherm™ 4 therapy system provides precisely controlled hot or cold uid that never
has to directly contact the skin during therapy. The system is also capable of providing
calibrated compressed air all in one convenient unit. This lightweight, portable system
utilizes solid-state thermoelectric heat pumps that heat and cool with electricity in a safe and
environmentally friendly manner.
5.1 Features:
• Fluid Therapy Temperature Range between *43°F - 50°F [6.0°C - 10.0°C] and 105°F [40.5°C]
• Compression Modality to reduce the risk of DVT formation on the Calf (45mmHg
compression) and Foot (100 mmHg compression)
• Treatment for Edema and Lymphedema in the Upper and Lower Extremities with
alternating compressions of Low (15 mmHg), Med (30 mmHg) and High (50 mmHg)
• Pain Management
• Programmable Therapies
• Lightweight and Portable Package
• User-Friendly Interface
• 100-240 VAC, 50/60 Hz Operation
• Easy to use and read Touch Screen Display
• Quiet Operation
* The ability to achieve 43°F will depend on the wrap size and ambient temperature and may not be
possible in every situation.
5.2 General Specications:
• Weight: 9.5 lbs.
• Hose Length: 5 ft.
• Hospital Grade Power Cord
• Dimensions: 9.81”W x 9.88”H x 8.75”D
• Operating Fluid: 90% Distilled Water/10% Isopropyl Alcohol
• Safety: IEC 60601-1 and IEC 60601-1-2
Chapter 5

11
DVT Connections Cooling Connections
Standard Compression
Touch Screen User Interface
RIGHT SIDE LEFT SIDE
Device Information Label
Air Exhaust Vent
5.3 Options:
• Non-Sterile Single Patient Use Therapy Wraps
• Sterile Single Patient Use Therapy Wraps
• Bed Hook
• Carrying Case
5.4 Device Description:

12
TOP
Coolant Reservoir Opening
BACK
Air Intake
Marking label
Power Connection
Caution label
Serial Number label
USB Connection

Unpacking Your VascuTherm™ 4 Therapy System:
When you rst unpack the carrying case you should have the following items:
All of these items are needed for safe system operation. If any of these items are missing
from the shipping container, please contact the clinic or hospital that prescribed the unit, the
Durable Medical Equipment (DME) provider or ThermoTek Customer Service at 877-242-3232.
Immediately upon unpacking your VascuTherm™ 4 Therapy System, inspect your unit. If the
unit shows shipping damage, contact the transportation company and le a freight damage
claim. Be sure to retain all packing material and the original box or case.
Along with the VascuTherm™ 4 Therapy System, you should have received all therapy wraps
necessary for your prescribed treatment in individually sealed, unopened bags. These wraps
may be marked “Sterile” or “Non-Sterile”depending on the type of treatment recommended
by your physician.
13
VascuTherm 4 Unit
Thermoow Bottle
VascuTherm 4
User Manual
External Power Supply
Umbilical Hose Power Cord
Chapter 6

Disposable therapy wraps are designed for single patient use only. If you received
a therapy wrap in a non-sealed bag or container, the wrap should not be used.
Please contact the clinic or hospital that prescribed the unit or the Durable Medical
Equipment (DME) provider immediately to obtain a new, sealed therapy wrap.
Non-sterile therapy wraps should never be directly applied to an open wound or
breached skin.
Use only sterile wraps over wounds or breaks in the skin.
Disposable therapy wraps are designed for single patient use only and may only be
used on the same patient for the length of treatment.
14

Environmental Conditions You Should Be Aware Of
Before Operating Your VascuTherm™ 4 Device:
The VascuTherm™ 4 therapy system is intended for indoor use only.
Do not operate the VascuTherm™ 4 system with therapy wraps in or near a wet
environment.
The VascuTherm™ 4 therapy system is not to be used in a conned space. Adequate
air ow distance from the unit sides must be maintained during operation.
Inadequate air ow can result in overheating of internal electrical components and
undesirable or excessive noise.
Only use the VascuTherm™ 4 system in a ambient environment between 60-80°F (degrees
Fahrenheit) and a relative humidity below 60%.
Failure to meet these operating environment conditions may result in:
Condensate buildup inside the unit.
Overheating or freezing of the unit.
Internal electronics malfunction.
• A reduction in the heating or cooling capabilities of the unit.
• The inability of the unit to properly regulate and administer uid temperature during heat
or cold therapies.
• The inability of the unit to properly regulate and administer pneumatic compression as
specied in the indications for use.
15
Chapter 7

How to Set Up Your VascuTherm™ 4 System for Therapy:
Now that you have fully unpacked your VascuTherm™ 4 Therapy System and veried that all of
the necessary equipment is present and not damaged, you may begin to prepare the system
for treatment.
• Place the VascuTherm™ 4 unit upright on a level surface and at least 1-foot from any wall
or other obstruction on all sides that could restrict airow through the unit.
• Connect the output connector and the power supply to the back of the unit.
Follow steps 3-12 on the touch screen display for a complete setup guide prior to
beginning any treatment.
• Connect the power cord to the power supply input connector and connect the opposite
end of the power cord to a grounded wall outlet.
• The unit will power-up and the Start Screen will be presented.
16
Chapter 8