ThermoTek VascuTherm 4 User Manual
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ThermoTek VascuTherm 4 User Manual

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Summary of Contents for ThermoTek VascuTherm 4

  • Page 1 VascuTherm ™ User Manual...

  • Page 3: Table Of Contents

    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 Cold Therapy ..................4 3.3 Precautions ............................
  • Page 4 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 ......................

  • Page 5: Chapter 1 Introduction

    Chapter 1 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.

  • Page 6: Chapter 2 Glossary Of Terms

    Chapter 2 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.
  • Page 7 Phlebothrombosis: Thrombosis of a vein without prior inflammation of the vein; associated with sluggish blood flow 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.

  • Page 8: General Warnings And Cautions

    Chapter 3 General Warnings and Cautions: 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, •...

  • Page 9: Precautions

    • Incapacitated patients, • Individuals with decreased skin sensitivity, • Individuals with poor circulation, • Patients with vein ligation or recent skin grafts. Precautions: When using the VascuTherm™ 4 system, basic safety precautions should always be followed to reduce the risk of fire, electric shock and personal injury. Please read the entire manual carefully before trying to operate the unit.

  • Page 10: Warnings

    Do not drink or ingest the coolant. 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.
  • Page 11 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.
  • Page 12 Observe all warning and caution labels. Never remove the caution/warning labels.

  • Page 13: Chapter 4 Indications For Use

    Chapter 4 Indications for Use: The VascuTherm™ 4 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 safety protection may be impaired. Indications for use: •...

  • Page 14: Vascutherm™ 4 Device Description

    Chapter 5 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 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.

  • Page 15: Options

    Options: • Non-Sterile Single Patient Use Therapy Wraps • Sterile Single Patient Use Therapy Wraps • Bed Hook • Carrying Case Device Description: Touch Screen User Interface Standard Compression DVT Connections Cooling Connections Device Information Label RIGHT SIDE LEFT SIDE Air Exhaust Vent...
  • Page 16 Coolant Reservoir Opening Air Intake Caution label Serial Number label Marking label USB Connection Power Connection BACK...

  • Page 17: Unpacking Your Vascutherm™ 4 Therapy System

    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 file a freight damage claim.
  • Page 18 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.

  • Page 19: Environmental Conditions You Should Be Aware Of Before Operating Your Vascutherm™ 4 Device

    Chapter 7 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.

  • Page 20: How To Set Up Your Vascutherm™ 4 System For Therapy

    Chapter 8 How to Set Up Your VascuTherm™ 4 System for Therapy: Now that you have fully unpacked your VascuTherm™ 4 Therapy System and verified that all of the necessary equipment is present and not damaged, you may begin to prepare the system for treatment.
  • Page 21 • Unpack and apply the prescribed therapy wraps to the indicated portions of your body as described on the wrap instructions contained in the wrap packaging. • Unscrew and remove the coolant reservoir cap from the top of the unit. Using the coolant bottle supplied with the therapy system, fill the reservoir to the bottom of the reservoir neck (see section 5.4 Coolant Reservoir Fill Location).
  • Page 22 Umbilical connections to VascuTherm 4 front panel • If DVT Compression wraps are provided, un-wrap them and connect to the front of the unit as shown in the picture below. • For bi-lateral operation, connect each of the wraps into the two available ports.

  • Page 23: Chapter 9

    Priming your Unit: 1. Follow the instructions in Chapter 9 for turning on Cool Therapy. NOTE: Remove the reservoir cap from the unit. 2. After turning on Cool Therapy, lower the wrap about 1.5 ft. [0.5 m] below the unit and tilt the unit to the right for no more than 10 seconds at initial start up as to release the air bubbles trapped in the system.
  • Page 24 Tilt unit to the right to release air bubbles trapped in the system. 3. Stop therapy. Check the reservoir fluid level after stopping the fluid pump and fill the reservoir as necessary. NOTE: you may get a Check Flow/Fluid Alarm or Low Temp Alarm if the unit remains with the therapy running and with the fluid pump ON without having a good flow of fluid through the system and the wraps.
  • Page 25 • Disconnect the umbilical hose from the unit and connect the therapy wrap directly to the unit. Disconnect umbilical from unit. Connect therapy wrap directly to unit. • From the front of the unit, remove the (right) wrap connector from the unit. Press the connector end to purge 4 ounces of fluid from the wrap into a cup.
  • Page 26 Re-connect the wrap to the unit. Check the fluid flow and verify all air bubbles have been purged. • Disconnect the therapy wrap from the unit completely. Re-connect the umbilical to the unit and re-connect the wrap to the umbilical. Visually check fluid flow. Let the system run for 1 minute or so to cool the wrap which determines fluid flow.
  • Page 27 Re-connect the wrap to the umbilical. • Replace the reservoir cap. Screw onto the reservoir tightly. • The VascuTherm™ 4 needs to be primed only when it is first set-up or when a new unfilled wrap is connected. Once correctly primed, the system should operate for 2-3 weeks until you may need to add fluid and possibly prime the system again.

  • Page 28: Operating Instructions For Your Vascutherm™ 4 System

    AC power outlet. • When first powered up, the unit will beep briefly and the VascuTherm™ 4 and ThermoTek logos will briefly appear while the unit is starting up. The selections are “SETUP GUIDE” (a guide on how to setup the unit and the wraps before •...

  • Page 29: Automatic Pre-Programmed Therapy

    Automatic Pre-Programmed Therapy If the device has been pre-programmed, then by selecting “START THERAPY” on the Start • Screen, the pre-programmed therapy is initiated and the Main Therapy Screen will appear. To stop therapy, select “STOP THERAPY” on the Main Therapy Screen. •...
  • Page 30 MAIN THERAPY SCREEN MAIN THERAPY SCREEN THERAPY SETUP SCREEN THERAPY SETUP SCREEN • The temperature can be set to the desired setting by selecting “COOL” then selecting “SET”. The Temperature Set Screen will appear. On the left, the current set temperature is displayed.
  • Page 31 • Once the desired temperature setting is achieved, select “APPLY”. The Therapy Setup Screen will re-appear. Select “SAVE” to save the new set temperature selected or select “CANCEL” to cancel the set temperature changes and cancel Therapy Setup Screen and go back to the Main Therapy Screen.

  • Page 32: Heat Therapy

    MAIN THERAPY SCREEN For the current therapy duration, the “ON TIMER” will display the minutes remaining • for therapy and appear “Bold” and the “REST TIMER” will appear “Faded Out”. When the therapy has stopped, the “REST TIMER” will display the minutes remaining before the therapy can start again and it will appear “Bold”...
  • Page 33 “APPLY” and then select “SAVE”. The Main Therapy Screen will re-appear. • If the Heat Mode is OFF, select “HEAT” and select “ON” on the Therapy Setup Screen and select “SAVE” to initiate Heat Therapy. • If set to 105°F, the label will change to “HEAT”. In degree Celsius scale, the temp will scroll from 6°C to 10°C, and then it will jump to 40.5°C.

  • Page 34: Pneumatic Compression Therapy For Edema And Lymphedema

    MAIN THERAPY SCREEN For the current therapy duration; the “ON TIMER” will display the minutes remaining • for therapy and appear “Bold” and the “REST TIMER” will appear “Faded Out”. When the therapy has stopped, the “REST TIMER” will display the minutes remaining before the therapy can start again and it will appear “Bold”...
  • Page 35 To help ease discomfort during compression treatments, pneumatic compression therapy can be used in combination with Cool or Heat. See the instructions in Chapters 9.2 and 9.3 for additional details on Cool or Heat therapies. Make sure the therapy wrap is applied properly before initiating any compression therapy.
  • Page 36 • If you want to show the current therapy setting for compression, select “INFO” under the “COMP” menu. The system will show the following information; therapy setting and therapy pressure.

  • Page 37: Dvt Calf Compression Therapy

    • Select “RETURN” to return to the Therapy Setup screen. Select “SAVE” to return to the Main Therapy screen. When the prescribed therapy duration is complete: If the display is in the Main Therapy screen, select “STOP THERAPY” from the Main Therapy •...
  • Page 38 The preset inflation and deflation cycle of the VascuTherm 4™ therapy system simulates natural walking action. This increases blood flow return to the heart through the veins of the lower extremities to reduce the risk of clot formation.
  • Page 39 • If your prescribed therapy is for left calf or right calf only, keep on tapping “CALF”, the display will continue to change and now read “C-LEFT” or “C-RIGHT”. Select “SAVE” to save the settings. The next screen will be the Main Therapy screen. •...

  • Page 40: Dvt Foot Compression Therapy

    When the prescribed therapy duration is complete: • If the display is in the Main Therapy screen, select “STOP THERAPY” from the Main Therapy screen. The compression therapy will stop and the display will return to the Start screen. • To disable DVT Compression therapy and prevent it from running on the next start up, go to the “DVT”...
  • Page 41 The preset inflation and deflation cycle of the VascuTherm 4™ therapy system simualtes natural walking action. This increases blood flow to the heart through the veins of the lower extremities to reduce the risk of clot formation.
  • Page 42 • If your prescribed therapy is for left foot or right foot only, keep on tapping “FOOT”; the display will continue to change and now read “F-LEFT” or “F-RIGHT”. Select “SAVE” to save the settings. The next screen will be the Main Therapy screen. •...
  • Page 43 • Select “RETURN” from the Info screen to return to the Primary Therapy screen. Select “SAVE” or “CANCEL” to return to the Main Therapy screen. When the prescribed therapy duration is complete: If the display is in the Main Therapy screen, select “STOP THERAPY” from the Main Therapy •...

  • Page 44: Pneumatic Compression Therapy And Dvt Calf Therapy

    The preset inflation and deflation cycle of the VascuTherm 4™ therapy system simulates natural walking action. This increases blood flow to the heart through the veins of the lower extremities to reduce the risk of clot formation.

  • Page 45: Pneumatic Compression Therapy And Dvt Foot Therapy

    When the prescribed therapy duration is complete: Select “STOP THERAPY” from the Main Therapy screen. The STD Compression and DVT • Calf therapy will stop and the display will return to the Start screen. • To disable STD Compression and DVT Compression therapy and prevent it from running on the next start up, from the Main Therapy screen select “DVT”...
  • Page 46 The preset inflation and deflation cycle of the VascuTherm 4™ therapy system simulates natural walking action. This increases blood flow to the heart through the veins of the lower extremities to reduce the risk of clot formation.

  • Page 47: Chapter 10 System Screen

    • Select “HELP” to access the unit’s information about who to contact if there are any questions or concerns regarding the VascuTherm 4. Select “RETURN” to return to the previous screen. Select “BACK” to return to the Main Therapy screen.
  • Page 48 SYSTEM SCREEN SYSTEM INFO SCREEN • Select “MONITOR” to access the unit’s information about its performance regarding temperature and pressure. Select “RETURN” to return to the previous screen. Select “BACK” to return to the Main Therapy screen. SYSTEM SCREEN MONITOR INFO SCREEN •...
  • Page 49 If you experience difficulty in setting up your VascuTherm 4 therapy system for use, please contact the clinic or hospital that prescribed the unit or the Durable Medical Equipment (DME) provider.

  • Page 50: Things You Can Do To Keep Your Vascutherm™ 4 System Performing

    Durable Medical Equipment (DME) provider for assistance. If microbial growth is present, the unit should not be used. If assistance is not available or is ineffective, please contact ThermoTek technical assistance toll-free at 1-877-242-3232 during the hours of 8am-5pm Central Time. If technical assistance is needed after these hours, you may contact the 24-hour line at 214-502-8800.

  • Page 51: Draining The Fluid From The Unit

    Chapter 12 Draining the Fluid from the Unit: 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 52: Storage And Re-Packing The Unit

    Chapter 13 Storage and Re-Packing the Unit: When therapy is complete and it is time to return or store the VascuTherm™ 4 therapy system, you can use the shipping box. 1. Turn the unit OFF and unplug from the electrical source. 2.
  • Page 53 Failure to properly store the unit, wraps, power supply and umbilical may result in the following: Damage to the unit, hoses and/or wraps. Catastrophic system damage if the unit is not properly drained. Microbial growth inside the unit if not properly drained.

  • Page 54: Chapter 14 Troubleshooting Guide

    Durable Medical Equipment (DME) provider. If assistance is not available or ineffective, please contact ThermoTek technical assistance toll-free at 1-877-242-3232 during the hours of 8am - 5pm Central Time.
  • Page 55 Turn the unit off by disconnecting the power supply. Wait 10 minutes and re-connect the power supply. Try an alternate AC outlet. Contact ThermoTek customer service if problem persists. Problem/Alarm Screen Cause Suggested Actions The unit is leaking. The coolant ports...
  • Page 56 “Monitor Screen”. Compression levels should never exceed 50mmHg for Standard Compression and 100mmHg for DVT Compression. If the unit is displaying a pressure that exceeds these values for the therapies listed, stop compression immediately and contact ThermoTek customer support.
  • Page 57 Turn the unit off by disconnecting the power supply. Wait 10 minutes and reconnect the power supply. Try an alternate AC outlet. Contact ThermoTek customer service if problem persists. Problem/Alarm Screen Cause Suggested Actions The unit is noisy.
  • Page 58 Turn the unit off by disconnecting the power supply. Wait 10 minutes and re- connect the power supply. Try an alternate AC outlet. Contact ThermoTek customer service if problem persists. Problem/Alarm Screen Cause Suggested Actions My unit gives me a TIMER NOT...
  • Page 59 Problem/Alarm Screen Cause Suggested Actions My unit gives me a CHECK Reservoir is low on Make sure the therapy mode is set to FLOW/FLUID alarm. coolant. COOL mode. Open the reservoir cap. Check the fluid level and if necessary, add fluid to the bottom of the neck.
  • Page 60 Turn the unit off by disconnecting the power supply. Wait 10 minutes and reconnect the power supply. Try an alternate AC outlet. Contact ThermoTek customer service if problem persists. Problem/Alarm Screen Cause Suggested Actions My unit gives me a HIGH HEAT Fan failure.
  • Page 61 Internal fault within the Check if the power supply LED is green. therapy unit. Turn the unit off by disconnecting the power supply. Wait 10 minutes and reconnect the power supply. Try an alternate AC outlet. Contact ThermoTek customer service if problem persists.
  • Page 62 Turn the unit off by disconnecting the power supply. Wait 10 minutes and reconnect the power supply. Try an alternate AC outlet. Contact ThermoTek customer service if problem persists. Problem/Alarm Screen Cause Suggested Actions My unit gives me a STD WRAP Wrap is loose on the If the wrap is “ballooned”...
  • Page 63 Turn the unit off by disconnecting the power supply. Wait 10 minutes and reconnect the power supply. Try an alternate AC outlet. Contact ThermoTek customer service if problem persists. Problem/Alarm Screen Cause Suggested Actions My unit gives me a STD WRAP...

  • Page 64: Chapter 15

    Turn the unit off by disconnecting the power supply. Wait 10 minutes and reconnect the power supply. Try an alternate AC outlet. Contact ThermoTek customer service if problem persists. “TYPE” defined as: TSH SHORT TSH OPEN TSS SHORT...

  • Page 65: Chapter 15 Device Summary

    Chapter 15 Device Summary: The VascuTherm™ 4 Therapy System is capable of performing therapies for the following: • Cool Therapy: the unit passes cool (*43°F - 50°F) fluid through the wrap for the management of pain, discomfort and swelling. If prescribed, Cool therapy can be used in combination with Pneumatic Compression Therapy.
  • Page 66 5. If Pneumatic Compression was utilized, make sure to stop the compression therapy before removing the therapy wrap. If you experience difficulty in setting up your VascuTherm 4 therapy system for use, please contact the clinic or hospital that prescribed the unit or the Durable Medical Equipment (DME) provider.

  • Page 67: Service And Customer Support

    Chapter 16 Service and Customer Support: ThermoTek, Inc. is committed to servicing our VascuTherm™ 4 unit both during and after sale to the cutomer. If you have any questions concerning the operation of your VascuTherm™ 4 unit, please refer to the following to contact us at our Flower Mound, Texas facility: •...

  • Page 68: Wraps, Accessories And Replacement Parts

    Chapter 17 Wraps, Accessories and Replacement Parts: Replacement Parts: Part Number Description 0P2DCAPBTL Reservoir Cap 0P3WHG13PC Power Cord, PW 10A/125 VAC, Hospital Grade, 12 ft. 0P5WEXT36V Power Supply, Ext, Med, 250W 0P2DNANTFB Mixing Bottle, Thermoflow Available Therapy Wraps: Part Number Description Thermal Compression Wraps: 0P9BANKLMR3...
  • Page 69 0P9BFARMMR3-U Wrap, Full Arm, SPU, Unfilled 0P9BFTAKMR3 Wrap, Foot/Ankle, SPU 0P9BFTAKMR3-U Wrap, Foot/Ankle, SPU, Unfilled 0P9BHEADMR3 Wrap, Head, SPU 0P9BHPSBMR3 Wrap, Hip, Standard, SPU 0P9BHPSBMR3-U Wrap, Hip, Standard, SPU, Unfilled 0P9BJWWSMR3-U Wrap, Jaw w/Strap, SPU, Unfilled 0P9BKNEEMR3 Wrap, Large Knee, Half Leg, SPU 0P9BKNEEMR3-U Wrap, Large Knee, Half Leg, SPU, Unfilled 0P9BLARMMR3...
  • Page 70 0P9BSSWHMR3 Wrap, Shoulder, Half Arm w/Harness, SPU 0P9BSSWHMR3-U Wrap, Shoulder, Half Arm w/Harness, SPU, Unfilled 0P9BTCRVMR3 Wrap, Total Cervical, SPU 0P9BTCRVMR3-U Wrap, Total Cervical, SPU, Unfilled 0P9BUCRVMR3 Wrap, Upper Cervical, SPU 0P9BUCRVMR3-U Wrap, Upper Cervical, SPU, Unfilled 0P9BUKNEMR3 Wrap, Universal U, SPU 0P9BUKNEMR3-U Wrap, Universal U, SPU, Unfilled 0P9BWTHDMR3...

  • Page 71: Chapter 18 Specifications

    The VascuTherm™ 4 therapy unit 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, Inc. for testing or repair to original manufacturing specifications.

  • Page 72: Mri Notice

    Electromagnetic interference could disrupt the operation of the VascuTherm 4 system. Internal Battery The VascuTherm 4 uses a 3V, 48 mAH, Lithium coin cell battery for maintaining its real time clock. The battery is not user replaceable.

  • Page 73: Index

    Chapter 19 Index: Precautions for Use, 5 Alarms: Priming, 19 Automatic Therapy, 25 Programmed Therapy, 25, 45 Beeping, Re-Packaging, 48 Alarms and Warning, 50 Setup, 16 Calf Therapy, 33, 40 Startup, 24 Cautions for Use, 5-6 Storage, 48 Contraindications, 4-5 Support, 1, 66 System Error, 51 Deep Venous Thrombosis (DVT), 2, 9...

  • Page 74: Warranty And Disclaimer Information

    Warranty and Disclaimer Information: Limited Warranty Terms: ThermoTek, Inc. (“ThermoTek”) warrants to the immediate purchaser from ThermoTek or an immediate purchaser of an unused unit from an authorized distributor of ThermoTek products, that any VascuTherm™ 4 will be free from defects in workmanship and material under normal use for two years after the date of purchase.
  • Page 75 Any mention of non- ThermoTek products or services is for informational purposes only and is not an endorsement, recommendation or representation. If any provision of this Limited Warranty is held to be invalid or unenforceable, such provision shall be fully severable and the remaining portions of the Limited Warranty shall remain in full force and effect.
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  • Page 80 1200 Lakeside Parkway #200 Flower Mound, TX 75028 Ph: 972-874-4949, Fax: 972-874-4945 Website: www.thermotekusa.com For customer service information, please see Section 16 of this manual. 0P1DVT4MNL Rev: A 3/15 CAPA A01501...

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