Table of Contents
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Table of Contents
Related Manuals for Zenith Therm-X Series
Summary of Contents for Zenith Therm-X Series
- Page 1 IFU-001 Rev. 8...
- Page 2 IFU-001 Rev. 8...
- Page 3 Welcome to the Team. We're glad you're with us. IFU-001 Rev. 8...
- Page 4 UICK TART IFU-001 Rev. 8...
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Page 5: Table Of Contents
ONTENTS Indications for Use ............... 5 2 Therm-X Features ..............5 3 System Components ............6 4 Garments................7 5 Icons ..................7 6 Preparing your Therm-X System for use ......8 7 Operating Instructions For Patients ........9 8 Operating Instructions For Healthcare Providers ....11 9 System Tools ............... -
Page 6: Indications For Use
NDICATIONS FOR Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated. -
Page 7: System Components
YSTEM OMPONENTS What’s in the Box? Main Unit Main Unit Power Supply Instruction Manual Instruction Manual Power Cord Coolant Dispenser Umbilical Hose Coolant Dispenser Touchscreen USB Charging Port DVT Port Umbilical Hose connector Tank Cap Power Supply Connector IFU-001 Rev. 8... -
Page 8: Garments
ARMENTS Instructions for use are provided with each garment. CONS Power Off Exit Back Help Stop Treatment Select Tool Confirm Pause Treatment Scroll Increase Value Decrease Value Compression Resume Temperature IFU-001 Rev. 8... -
Page 9: Preparing Your Therm-X System For Use
(128 ounces) of distilled water with 1 pint (16 ounces) of 91% isopropyl alcohol to create the Therm-X coolant; it is recommended to use the Therm-X coolant sold by Zenith Technical Innovations, LLC. Once you have prepared the coolant mixture, open the tank located at the back of the Therm-X and fill the tank to the red line inside the tank filler neck. -
Page 10: Operating Instructions For Patients
PERATING NSTRUCTIONS ATIENTS Before use, please read Section 16, “Contraindications” and Section 17, “General Precautions and Warnings” Connect the power supply to the Therm-X main unit and an AC outlet. When the unit initiates, it will beep briefly and the Therm-X logo will briefly appear followed by the Home Screen. The Therm-X will come pre-programmed by your healthcare provider with a custom cycle for use. - Page 11 To change the temperature of a treatment, select the 'Temperature' symbol, then select one of the available temperatures. You may adjust the temperature as many times as needed during a cycle. Note: Temperatures may only be changed to a temperature equal to or closer to room temperature than the programmed treatment.
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Page 12: Operating Instructions For Healthcare Providers
PERATING NSTRUCTIONS EALTHCARE ROVIDERS Before use, please read Section 17, “Contraindications”, and Section 18, “Precautions and Warnings” If you are a certified healthcare provider, you may program the device for therapy using the following instructions: Connect the power supply to the Therm-X main unit and an AC outlet. When the unit initiates it will beep briefly and the Therm-X logo will briefly appear followed by the Home Screen. - Page 13 When the “Add 2nd Cycle” button is selected, the unit will present the ‘Select Temperature’ screen. The purpose of this button is to program a second cycle that will initiate at a future date. Compression level and type (constant or intermittent) will mirror that of the 1 cycle.
- Page 14 Customizing a Cycle If a cycle other than a Quick Pick or Favorite is desired, you will be able to customize a cycle from the “Custom” button on the Select Treatment Program screen. (Please note: Custom cycles are single-use only. If you would like to retain your custom cycle for future use, please see the “Quick Picks and Favorites”...
- Page 15 Quick Picks and Favorites Your Therm-X will come preloaded with 3 commonly-prescribed therapies. • Quick Pick 1, 30 minute treatment, 30 minute rest, 40°F, lite intermittent compression, continuous treatment. • Quick Pick 2, 30 minute treatment, 30 minute rest, 40°F, intermittent compression, continuous treatment.
- Page 16 Thermal Garment Compression For thermal garment compression, either constant or intermittent pressure may be selected. If constant pressure is selected, the thermal garment will fill to the selected pressure, and remain at that pressure for the duration of the treatment cycle. If intermittent pressure is selected, the thermal garment will fill to the selected pressure, will hold and then release the selected pressure in cyclic fashion for the duration of the treatment.
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Page 17: System Tools
YSTEM OOLS To navigate to the System Tools screen from the Home screen you must first select the “Settings” button in the lower left corner of your Therm-X touchscreen. A password screen will appear if the password is enabled. Use the password that you received with your machine. - Page 18 correct values. There will also be a “Back” button to return to the ‘Select Tool ‘screen and a “Confirm” button to store the date and time you have chosen. The Device Information screen can be reached by selecting the “Device Info”...
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Page 19: Caring For Your Therm-X System
10 C -X S ARING FOR YOUR HERM YSTEM Cleaning Therm-X Device The interior of the Therm-X does not need to be cleaned; there is no need to empty and replace the coolant in the tank. To clean the exterior of the device, wipe down the exterior with an alcohol cleaning pad or equivalent soft cloth with a mild cleaning product. -
Page 20: Alerts
11 A LERTS The table below can guide you through possible alerts you may observe while using your Therm-X Home device. IFU-001 Rev. 8... - Page 21 IFU-001 Rev. 8...
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Page 22: Accessories And Replacement Parts
12 A CCESSORIES AND EPLACEMENT ARTS Replacement parts may be ordered by contacting Zenith Technical Innovations at: customerservice@thermxtherapy.com 847.672.7481 Device Replacement Parts and Accessories Model Number Description TX0206 Therm-X Coolant (1 quart) – The coolant that is recommended for use in the Therm-... -
Page 23: Acronyms And Definitions
Model Number Description TX0304 Ankle SPU Thermal Garment – The single-patient use thermal garment designed for your elbow TX305 Back SPU Thermal Garment - The single-patient use thermal garment designed for your back TX0308 Hip SPU Thermal Garment – The single-patient use thermal garment designed for your hip 13 A CRONYMS AND... - Page 24 Symbol/Term Significance Direct current Identification label Product number Serial number Manufacturer Caution! There are specific warnings and precautions associated with this device. Consult the instructions for use USB connection On/Off button Temperature Limitation (Temperature must be between 60°F - 80°F) Humidity Limitation (Humidity must be below 60%) Atmospheric pressure Limitation (Atmospheric pressure must be between 700 hPa and 1060 hPa)
- Page 25 Garments Symbol/Term Significance Identification label Product number Serial number Manufacturer Caution! There are specific warnings and precautions associated with this device. Follow instructions for use Type BF applied part Caution: Federal law restricts this device to sale by or on the order of a physician Packaging Symbol/Term...
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Page 26: Product Specifications And Technical Data
15 P RODUCT PECIFICATIONS AND ECHNICAL Device Functional Specifications Parameter Value Cold Therapy Temperature Range Default 34°F, 45°F or 55°F Custom 34°F - 55°F Continuous Cycle Length 40°F - 55°F Heat Therapy Temperature Range Default 105°F, 107°F or 110 °F Custom 105°F - 110°F Continuous Cycle Length... - Page 27 Device Physical Specifications Parameter Value Dimensions of Device Dimensions (L x W x H) 10” W x 9” H x 15” L Weight 14lbs. maximum when empty and 15 lbs. maximum with fluid. Umbilical Hose (with Therm-X AT) 5 ft +/- 0.5 ft Length 3-in-1 connector for multi-patient use garments Type...
- Page 28 Parameter Value IEC 60601-1-2 Interference suppression EN 55011: Class B Interference immunity IEC 61000-3, Part 2, Part 3 IEC 61000-4, Parts 2-6, Part 8, Part 11 Garment Specifications Parameter Value Applied part type Patient contacting material Multi-Patient Use Thermal Garment: 30 Denier Nylon Ripstop coated in urethane Single-Patient Use Thermal Garment: 200 Denier Nylon Oxford coated in urethane...
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Page 29: Contraindications
ONTRAINDICATIONS Pneumatic Compression Therapy Do not use the device without a licensed healthcare practitioner prescription. NOTE: The prescription must show the time, temperature range, pressure, duration, and frequency of use of the device. Make sure you fully understand the use of the device before starting. The patient should NOT use the therapy system if the patient is suspected of or observed to have any of the following pre-existing conditions. -
Page 30: General Precautions And Warnings
Therapy garments are to be initially selected by a healthcare professional familiar with their purpose. Do not apply the therapy garment so tightly as to restrict blood or fluid flow. Use only Zenith Technical Innovations approved therapy garments. Therapy garments are non-sterile unless specifically labeled as sterile. - Page 31 A healthcare professional is responsible for providing warning 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 therapy garment with Therm-X at home, the healthcare provider must provide adequate and appropriate instructions for use to the patient.
- Page 32 Electromagnetic Compatibility (EMC) Table 1. Electromagnetic Emissions Declaration Declaration – Electromagnetic Emissions Therm-X is intended for use in the electromagnetic environment specified below. The customer or the user of Therm-X should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment –...
- Page 33 Table 2. Electromagnetic Immunity Declaration I Declaration – Electromagnetic Immunity Therm-X is intended for use in the electromagnetic environment specified below. The customer or the user of Therm-X should assure that it is used in such an environment. IEC 60601 Immunity Test Compliance Level Electromagnetic Environment –Guidance Test Level...
- Page 34 Table 3. Electromagnetic Immunity Declaration II Declaration – Electromagnetic Immunity Therm-X is intended for use in the electromagnetic environment specified below. The customer or the user of Therm-X should assure that it is used in such an environment. IEC 60601 Compliance Immunity Test Electromagnetic Environment –...
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Page 35: Service And Customer Support
When reporting problems, provide the Unique Device Identification number (e.g. S/N) of the device (as identified on the device label) and the affected garment, in addition to the corresponding alert information, if any. Contact Information: Zenith Technical Innovations 1396 St. Paul Ave. Gurnee, IL 60031 customerservice@thermxtherapy.com 847.672.7481... -
Page 36: Master Product Warranty
(a “Therm-X Unit”), if properly used, will operate in accordance with its specifications as described by Zenith, and will be free from defects in material and workmanship for a period of one (1) year following its date of purchase. Zenith warrants that the Therm-X garments (the “Therm-X Attachments”), if properly used, will... - Page 37 Replace the Product with another equivalent product. Repair or replacement is Customer’s sole and exclusive remedy. Zenith may elect to replace or repair the Product with either a new or reconditioned equivalent Product. Any repaired or replaced Product is warranted only for the remainder of the original Warranty Period that covered the original Product and is subject to the same limitations and exclusions.
- Page 38 Customer or patients or clients of Customer, or injury to other users of a Product or bystanders to any use, even if Zenith is advised of the possibility of such damages.