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Table of Contents
Related Manuals for ThermoTek VascuTherm 5
Summary of Contents for ThermoTek VascuTherm 5
- Page 1 VascuTherm 5 Therapy System Patient User Manual...
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Page 2: Table Of Contents
Pausing Pre-Programmed DVT Compression Operation: ............. 21 Changing Therapy Profiles: ......................21 Quiet Mode Operation: ......................... 23 Things You Can Do To Keep Your VascuTherm 5 System Performing ..........25 Draining the Fluid from the Unit........................26 Storage and Re-Packing the Unit ........................27 Troubleshooting .............................. - Page 3 VascuTherm 5 System Technical Specification ................41 VascuTherm 5 Classification Information .................. 42 VascuTherm 5 Conformance Information ................. 42 VascuTherm 5 Guidance and Manufacture’s Declaration – Electromagnetic Emissions ..42 VascuTherm 5 Guidance and Manufacture’s Declaration – Electromagnetic Immunity ..42 EMC Notice ..........................43 MRI Notice ..........................
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Page 4: Introduction
If you have any questions about how to use the VascuTherm 5 or if the device is not functioning or displaying an alarm, please contact your local provider or prescribing clinic for assistance. You should have received the contact information when you were provided the VascuTherm 5 device. -
Page 5: Explanation Of Symbols
Explanation of Symbols IMPORTANT: Read Instructions before Use Before operating the device, please read the entire instruction guide. Keep the guide available for future reference. CAUTION. Consult user manual to determine potential hazards prior to operating the device. The use of this device shall be prescribed by a healthcare professional AC Power Type B Applied Part... -
Page 6: Glossary Of Terms
Device Serial Number Device Manufacturing location Device Manufacture Date Code Glossary of Terms: Arterial Dysregulation: A physiological impairment of the arteries. (Arterial/Venous) occlusive A condition where narrowed or blocked blood vessels block blood flow to the limbs. disease: Arteriosclerosis: A chronic disease in which thickening, hardening and loss of elasticity of the arterial walls result in impaired blood circulation. -
Page 7: Contraindications For Pneumatic Compression Therapy
Contraindications for Pneumatic Compression Therapy: The patient should not use the VascuTherm 5 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, •... -
Page 8: Cautions
Do not stick a finger or any other foreign objects into the reservoir. Do not place the VascuTherm 5 power cord near your neck. Strangulation risk. Do not place the VascuTherm 5 DVT compression tubes near your neck. These garments are to be worn on your calf or foot. Strangulation risk. -
Page 9: Indications For Use
Indications for Use: The VascuTherm 5 therapy system is designed to provide fluid heating, cooling and compression as specified in this manual. If the system is used in a manner other than as specified, its operation or the... -
Page 10: Unpacking Instructions
(swelling), reduce the need for anticoagulant (blood thinning) medications. Unpacking Instructions When the VascuTherm 5 system arrives, it is important that you carefully unpack the contents and ensure that you have all the equipment required for operation. Please retain the shipping carton for storage and future transportation of the device. - Page 11 treatment area depending on the type of treatment recommended by your physician. The wraps are labeled Non-Sterile. If the device shows shipping damage, do not use the device. 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.
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Page 12: Device Description
EVICE ESCRIPTION The VascuTherm 5 therapy system is an electronic heating, cooling and compression system that provides precisely controlled hot or cold fluid 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. -
Page 13: Device Illustration
Device Illustration Color Display w/touch control USB port Air intake Power switch Edema Compression port Power cord connection DVT Compression ports Fluid ports Coolant Reservoir opening Coolant Reservoir opening Handle Air exhaust Air exhaust... -
Page 14: Environmental Conditions You Should Be Aware Of Before Operating Your Vascutherm 5 Device
Do not operate the VascuTherm 5 system with therapy wraps in or near a wet environment. The VascuTherm 5 therapy system is not to be used in a confined space. Adequate air flow distance of minimum 1-foot from the unit sides must be maintained during operation. -
Page 15: Vascutherm 5 System Setup
Setting up the VascuTherm 5 System for Therapy Follow the steps outlined below: 1. Place the VascuTherm 5 control unit upright on a level surface and at least 1-foot from any wall or other obstruction on all sides that could restrict airflow through the unit. - Page 16 10. Unpack a prescribed therapy wrap and place the wrap flat on a surface lower than the VascuTherm 5 unit. 11. Connect the clear and grey hoses of the umbilical to the therapy wrap used for treatment. The fittings should make a “click”...
- Page 17 22. Refer to the Operation Instructions in the next chapter for details on your specific prescribed treatment. If you experience difficulty in setting up your VascuTherm 5 therapy system for use, please contact the clinic or hospital that prescribed the unit or the Durable Medical Equipment (DME) provider.
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Page 18: Operating Instructions For Your Vascutherm 5 System
The patient must be familiar with all warnings and cautions listed in Chapter 2 before attempting to operate the unit. The wraps for the VascuTherm 5 system are designed to maximize the effectiveness of the therapies listed above. Only use wraps in combination with therapy modes as prescribed. -
Page 19: Pre-Programmed Therapy Operation
Pre-Programmed Therapy Operation: The equipment provider will have programmed the VascuTherm 5 controller with a specific prescribed therapy based on clinician instruction. To set up the unit for therapy, follow the instructions below: 1. Turn on the unit. The power switch is located on the right side panel of the unit. - Page 20 In this example, the edema compression is set to the Medium setting (30mmHg). Other available settings are LOW (15mmHg), HIGH (50mmHg) and OFF. In the OFF mode, edema compression therapy is not active. c. The window labeled COOLING shows the thermal therapy state and setting. In this example, the therapy mode is COOL with a setting of 49F.
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Page 21: Pausing Pre-Programmed Thermal Therapy Operation
Pausing Pre-Programmed Thermal Therapy Operation: 1. If this option is allowed by the clinician and if you want to temporarily pause COOL or HEAT therapy while compression therapy is active, PRESS and HOLD the COOLING or HEATING title on the screen for 2 seconds. 2. - Page 22 Figure 6-3: THERAPY CHANGE screen 3. Press the Profile Select key. 4. The PROFILE SELECT screen will be displayed as shown below. Figure 6-4: PROFILE SELECT screen 5. The controller can store up to three therapy profiles. The current active profile will be displayed in gold color with its settings below in white.
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Page 23: Quiet Mode Operation
Figure 6-5: THERAPY ACTIVE screen Quiet Mode Operation: 1. The VascuTherm 5 controller has a mode, if enabled by the equipment provider, to set the fans in QUIET mode. 2. To access this mode, from the THERAPY ACTIVE SCREEN, press the Next key twice. If the QUIET MODE has been enabled by the equipment provider, the option to set it will be visible on the screen as shown. - Page 24 Figure 6-7: QUIET MODE option 5. You will notice the fans operating in quiet mode. Please note, the controller will continue to monitor the thermal therapy temperature, and if required will enter the high fan speed mode to provide the prescribed treatment.
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Page 25: Things You Can Do To Keep Your Vascutherm 5 System Performing
Durable Medical Equipment (DME) provider for assistance. If microbial growth is present, the unit should not be used. If you are unable to contact the provider, please contact the ThermoTek service line at (214) 502-8800 for assistance. -
Page 26: Draining The Fluid From The Unit
RAINING THE LUID FROM THE Periodically between uses or if the unit is going to be stored for a long period of time, the system should be drained of fluid. 1. Turn the unit OFF and unplug from electrical source. 2. -
Page 27: Storage And Re-Packing The Unit
TORAGE AND ACKING THE When therapy is complete and it is time to return the VascuTherm 5 therapy system, you can use the transport box. 1. Turn the unit OFF and unplug from the electrical source. 2. Remove all therapy wraps. -
Page 28: Troubleshooting
ROUBLESHOOTING The VascuTherm 5 has many internal software safeguards to help protect the user and the device from unsafe operation. This section contains a list of possible system warnings and alarms presented to inform the user of the potential unsafe condition where therapy efficacy may be affected. -
Page 29: Alarm Message - Medium Priority
Below is a list of common notifications and alarms that may occur during therapy operation of the unit. Alarm Message – Medium Priority Problem Cause Suggested Actions My unit gives me an ALARM Reservoir is low on coolant. Press Accept Key to clear the alarm. Medium Priority This check is performed continuously Open the reservoir cap. - Page 30 Check the clear tubes on the wrap to see if fluid Is circulating. If fluid is circulating, reapply the wrap to the body, making sure there are no kinks when applied. Contact customer service if problem persists. Problem Cause Suggested Actions My unit gives me an ALARM Internal subsystem fault event.
- Page 31 Problem Cause Suggested Actions My unit gives me an ALARM Internal subsystem fault event. Press Accept Key to clear the alarm. Medium Priority This check is performed continuously Turn the unit off by turning the power I2C Bus Read Alarm when the system is powered and switch, located on the right side of the operational.
- Page 32 Problem Cause Suggested Actions My unit gives me an ALARM Heatsink temperature measurement Press Accept Key to clear the alarm. Medium Priority sensor within the cooling engine hardware fault. Turn the unit off by turning the power Heatsink Sensor Open switch, located on the right side of the Heatsink Sensor Short This check is performed continuously...
- Page 33 Problem Cause Suggested Actions My unit gives me an ALARM A temperature measurement Press Accept Key to clear the alarm. Medium Priority sensor(s) within the cooling engine is detecting a low temperature fault Make sure the air intake side (right Supply Sensor Low Limit limit.
- Page 34 Problem Cause Suggested Actions My unit gives me an ALARM Hardware safety temperature Press Accept Key to clear the alarm. Medium Priority detection activated when supply temperature sensor readings are Turn the unit off by turning the power HW Temp Lockout Failure within range as reported by the switch, located on the right side of the software.
- Page 35 Problem Cause Suggested Actions My unit gives me an ALARM Internal pressure monitoring system Press Accept Key to clear the alarm. Medium Priority has detected that the thermal compression wrap is not able to Check the connection ports on the Standard Wrap Not Holding maintain its high-pressure state.
- Page 36 Problem Cause Suggested Actions My unit gives me an ALARM Internal pressure monitoring system Press Accept Key to clear the alarm. Medium Priority has detected that the DVT wrap is not inflating to its high-pressure Check the connection ports on the DVT Wrap Not Inflating state.
- Page 37 Problem Cause Suggested Actions My unit gives me an ALARM Internal pressure monitoring system Press Accept Key to clear the alarm. Medium Priority has detected that the DVT compression wrap’s pressure is rising Check for any kinks in the thermal DVT Comp Over Pressure –...
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Page 38: Alarm Message - Low Priority
Alarm Message – Low Priority Problem Cause Suggested Actions My unit gives me an ALARM The coolant in the reservoir is getting Press Accept Key to clear the alert. Low Priority low when heat / cool therapy is active. The run therapy information screen will be displayed. - Page 39 the right side of the device, to the OFF position. This disconnects AC power to the unit. Wait 10 minutes and re-connect. Try an alternate AC outlet. Contact customer service if problem persists. Problem Cause Suggested Actions My unit gives me an ALARM Internal ambient temperature Press Accept Key to clear the alert.
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Page 40: General Questions
General Questions Problem Cause Suggested Actions Nothing happens when I turn the No power to the device. Make sure the device is plugged in to unit on a 120 VAC AC power outlet in your Potential internal subsystem fault home. event. -
Page 41: Technical Information
The wraps for the VascuTherm 5 system are designed to maximize the effectiveness of the therapies listed above. Only use wraps in combination with therapy modes as prescribed. -
Page 42: Vascutherm 5 Classification Information
EN 55011 equipment. Harmonics Emission Complies EN 61000-3-2 The VascuTherm 5 System is suitable for use in all hospitals, health service clinics and homes Voltage fluctuations / connected to the public low voltage power flicker emissions Complied... -
Page 43: Emc Notice
Conducted RF 3Vrms 3Vrms be used no closer to any part of the EN 61000-4-6 0.15MHz to 80 MHz 0.15MHz to 80 MHz VascuTherm 5 system, including cables, than the recommended Radiated RF 3V/m 3V/m separation distance calculated from EN 6100-4-3 80 MHz –... -
Page 44: Calibration
Calibration VascuTherm 5 is comprised of components that are of high accuracy and low drift. Under normal operation, the therapy unit does not require calibration. The end user has the option to send the unit back to ThermoTek for testing and calibration. -
Page 45: Service And Customer Support
USTOMER UPPORT ThermoTek, Inc. is committed to servicing our VascuTherm 5 unit both during and after sale to the customer. If you have any questions concerning the operation of your VascuTherm 5 unit, please refer to the following to contact us at our Flower Mound, Texas facility: •... -
Page 46: Packaging
ACKAGING Boxes/Foam: Part Number Description 0P2H257DFM Packing Foam 0P2H257DBX Shipping Box 0P9KVT5TCS Traveling Case, Single... -
Page 47: Warranty
ThermoTek will, at its option, repair or replace within a reasonable time any product that is found to have a defect in material or workmanship under normal use during the applicable warranty period. This is the immediate purchaser’s sole remedy. - Page 48 ABOVE, IS MADE OR AUTHORIZED BY THERMOTEK (whether in the past or future). Thermotek has not made any affirmation of fact or promise relating to the product being sold that has been relied upon or become the basis of a bargain. This limited warranty is not transferable or made to any person other than the original purchaser of the product from ThermoTek OR THE ORIGINAL PURCHASER OF THE PRODUCT FROM AN AUTHORIZED DISTRIBUTOR OF THERMOTEK.
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- Page 52 PN: 0P1DVT5MEN Rev: C [5/2020] 1200 Lakeside Parkway, #200 Flower Mound, TX 75028 Website: www.thermotekusa.com Tel: (001) 972-874-4949...
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Questions and answers
Leaks through cap on reservoir
To fix a leak through the cap on the ThermoTek reservoir part number 5:
1. Turn off the unit and disconnect it from AC power.
2. Inspect the cap and surrounding area for damage or debris.
3. Wipe off any condensate to confirm it's not mistaken for a leak.
4. Ensure the cap is seated and tightened properly.
5. If the leak continues, discontinue use and inspect for physical damage.
6. If damaged, do not use the reservoir and contact customer service to obtain a replacement.
This answer is automatically generated