Advertisement
Quick Links
Advertisement
Related Manuals for Zenith Therm-X series
Summary of Contents for Zenith Therm-X series
-
Page 1: User Manual
Manufactured by: Zenith Technical Innovations, LLC User Manual... - Page 2 1 About these Instructions for Use 1.1 Glossary of Terms and Abbreviations Abbreviation / Term Definition Deep Vein Thrombosis Electrostatic discharge Instructions for Use Radio Frequency Universal Serial Bus; USB interface Certified User User with the ability to create or modify treatment cycles 2 Symbols and Abbreviations on the Product and Packaging 2.1 Product 2.1.1 Device...
- Page 3 Symbol/Term Significance 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) Class II ME equipment Caution: Federal law restricts this device to sale by or on the order of a physician 2.1.2 Garments Symbol/Term...
-
Page 4: Indications For Use
Symbol/Term Significance Caution: Federal law restricts this device to sale by or on the order of a physician 2.2 Packaging 2.2.1 Device Symbol/Term Significance Temperature Limitation Humidity Limitation Pressure Limitation Indications for Use Therm-X (Therm-X Pro and Therm-X AT) combines cold, heat, contrast, and compression therapy. - Page 5 Deep acute venal thrombosis (Phlebothrombosis) Inflammatory phlebitis process Episodes of pulmonary embolism Pulmonary edema Acute inflammation of the veins (Thrombophlebitis) Decompensated cardiac insufficiency Arterial dysregulation Erysipelas Carcinoma and carcinoma metastasis in the affected extremity ...
-
Page 6: General Warnings And Cautions
The following patients must use Therm-X for temperature therapy under the supervision of a physician if they are: o Patients with extremities not sensitive to pain o Patients with Extremely low blood pressure o Patients with Raynaud’s disease o Hypersensitivity to cold o Children under 12 o Diabetics o Incapacitated patients... - Page 7 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. Non-sterile therapy garments should never be directly applied to an open wound or breached skin.
- Page 8 All therapies using compression must be turned OFF when the wrap is removed from the patient. Do not drink or ingest the coolant. Do not stick foreign objects into the coolant reservoir. Do not smoke while using therapy garments or use garments by an open flame. Slots and openings in the console are provided for ventilation to protect the unit from overheating.
- Page 9 compliance to a chosen cycle. The device also provides functionality to allow the health care provider to assign a date at which the user will be able to access a second stored cycle instead of the first. The Therm-X is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device.
- Page 10 5.4 Therm-X System Components 5.4.1 Device Schematics Front View Side View IFU-001, Rev. 1 Page 10 of 47...
- Page 11 Back View 5.4.2 Garment Schematics Hose View Garment Side 3-in-1 connector Quick Release Button Hose Side 3-in-1 connector IFU-001, Rev. 1 Page 11 of 47...
- Page 12 Back-of-Garment View 5.5 Control Panel 5.5.1 Display Configuration Icon Name Color Significance Round Action Buttons Power Off Grey Enables the user to Power Off the device Enables the user to return to the previously Back Grey viewed screen Shows the currently programmed treatment Current Settings Grey cycle...
- Page 13 Icon Name Significance Other Buttons Enables the user to scroll Scroll through screens displaying information Allows the user to increase the Increase value of a unit when setting the Value date or second cycle start Allows the user to decrease the Decrease value of a unit when setting Value...
- Page 14 Icon Name Significance Other Buttons Allows the user to select a Custom custom temperature for a given Temperature cycle Allows the user to add a DVT Add DVT prophylaxis cycle to a thermal cycle Allows the user to select a DVT only cycle that does only DVT Prophylaxis...
- Page 15 The Therm-X must be operated with a 90% water, 10% isopropyl alcohol mixture for maximum performance and microbial resistance; it is recommended to use the Therm-X coolant sold by Zenith Technical Innovations, LLC. Once you have obtained this mixture, you should open the tank located at the back of the Therm-X and fill the tank to the lower lip.
- Page 16 6.3 Making the Therm-X coolant – If you have no coolant available, the easiest way to make it is by purchasing the 91% isopropyl alcohol solution available at most drug stores. Mix 1 gallon (128 ounces) of distilled water with 1 pint (16 ounces) of 91% isopropyl alcohol to create the Therm-X coolant.
- Page 17 7.1.2 When the unit is powered up it will beep briefly and the Therm-X logo will appear. Underneath the Therm-X logo an icon for the Therm-X model type (Pro or AT for Athletic Trainer) will appear. 7.1.3 The selections on the Home screen will be “Start Treatment”, “Settings”, “Quick Start Guide”, “Current Settings”, and “Power”.
- Page 18 Program Treatment and Access Tools Screen will appear immediately for the Therm-X Pro and Therm-X AT models if the password is disabled. 7.2.2 The selections on the Program Treatment and Access Tools screen are “Program Treatment”, “Access Tools”, “Help”, and “Back”. To continue to the tools, select the “Access Tools”...
- Page 19 7.2.4 The Cycle Use Information History screen can be reached by selecting the “Cycle Usage” button. It will display the past cycles run on the unit which may be scrolled through using the arrows on the right of the screen. Additionally, there will be a “Back”...
- Page 20 7.2.5 The Enter New Date & Time screen can be reached by selecting the “Date/Time” button. On this screen you may select the correct date and time by using the “+” or “-” buttons to change the displayed values to the correct values. There will also be a “Back”...
- Page 21 7.2.7 The Alert Information screen can be reached by selecting the “Alert Data” button. This screen will display the alerts that have occurred for this unit. You may navigate through these past alerts using the “Up” and “Down” arrow buttons on the right of the screen. There will also be a “Back” button to return to the Select Tool screen.
-
Page 22: Automatic Pre-Programmed Therapy
7.2.8 The password may be toggled on and off by selecting the “Toggle Password” button. Each time the button is selected the password state will change. By enabling the password, you will be able to ensure that unauthorized users are unable to change the stored cycle. - Page 23 8.1.2 Once the cycle has been initiated you should expect to begin feeling garment inflation and fluid flow. The Run screen will appear and will show the current cycle settings, a progress bar, and a “Stop” button. The unit will run through the end of the prescribed cycle automatically.
- Page 24 you received with your machine. You will have a maximum of 5 attempts to input the correct password. If too many incorrect attempts are made, the machine will display an error and you will need to restart it before resuming use of the machine.
- Page 25 9.1.4 When one of the Quick Picks is selected the temperature, compression level, and time of the cycle will be preloaded. On this screen, you will be able to select buttons for “Add 2nd Cycle”, “Add DVT”, “Confirm”, or “Back” to return to the Select Treatment Cycle screen.
- Page 26 9.1.6 When the “Add DVT” button is selected, the unit will present the Set DVT Location screen. This screen will have options available for “Foot” and “Calf” DVT locations, as well as a “Back” button that will return you to the “Cycle Selection”...
- Page 27 9.1.8 On the Finish 1st Cycle screen (Section 9.1.13) buttons are available for “Back” and “Confirm”. “Confirm” will store the cycle and return you to the Home screen, and “Back” will return you to the Set DVT Cycle screen. 9.1.9 If a cycle other than the Quick Picks is desired, you will be able to customize a cycle from the “Custom”...
- Page 28 9.1.11 After the temperature cycle is chosen, the Therm-X will prompt you to select a pressure value on the Select Compression Level screen. There will be 3 levels of compression available to select. There will also be a “Back” button to return to the Select Temperature screen.
- Page 29 9.1.13 After the cycle length cycle is made, a complete cycle will have been created. Programmed Cycle you will then have options to “Add 2nd On the Finish 1 Cycle”, “Add DVT”, “Confirm” to return to the Home screen and store the cycle, and “Back”...
- Page 30 10.1.2 Garments Garments should never be used by multiple patients. Between uses, a garment may be wiped down with an alcohol cleaning pad or equivalent soft cloth with a mild cleaning product. DO NOT MACHINE WASH. Do not use solvent based cleaners or abrasive materials to clean the garment. 10.1.3 Umbilical Hose Between uses, an umbilical hose may be wiped down with an alcohol cleaning pad or equivalent soft cloth with a mild cleaning product.
- Page 31 11 Alerts The table below guide you through addressing the alerts you may potentially receive during use of the Therm-X device. Alert Type Alert Explanation This alert occurs when the Therm-X senses that the fluid level in the device is low. Refill the device’s tank to address the problem.
- Page 32 Alert Type Alert Explanation This alert occurs when too many attempts are taken to surpass the password screen. Power down the device and restart it to unlock the device. Do not attempt to access the password loop if you are not a certified user.
- Page 33 Alert Type Alert Explanation This alert occurs when the air temperature in the device is higher than expected. This error usually occurs when the vents on the side of the device are blocked, ensure that airflow through the device is not obstructed.
- Page 34 Alert Type Alert Explanation This alert occurs when the power supply is out of the expected range. Try restarting the device. If the alert persists, contact the distributor. This alert occurs when the temperature sensor is reading an unexpected temperature. Try restarting the device.
- Page 35 Alert Type Alert Explanation This alert occurs when the device is unexpectedly retaining air pressure. Immediately remove all garments. Try restarting the device and reattaching the garments. If the alert persists, contact the distributor. This alert occurs when either the garment is wrapped too loosely to apply pressure or the air pump is not functioning correctly.
-
Page 36: Accessories And Replacement Parts
12 Accessories and Replacement Parts 12.1 Ordering Address - Replacement Parts – ZTI Phone: (847) 672-7481 1396 St Paul Ave Gurnee, IL 60031 Email: customerservice@thermxtherapy.com 12.2 Device Replacement Parts and Accessories Catalog number Description Therm-X Model 1 – Pro – The Therm-X Pro Device TX0001 Therm-X Model 2 –... -
Page 37: Product Specifications And Technical Data
13 Product Specifications and Technical Data 13.1 Device Functional Specifications Parameter Value Cold Therapy Temperature Range Default 34°F, 45°F or 55°F Custom 34°F - 55°F Heat Therapy Temperature Range Default 105°F, 107°F or 110 °F Custom 105°F - 110°F Cycle Length Default: 20, 30 or 40 minutes Contrast Therapy Temperature Range... - Page 38 Parameter Value Umbilical Hose 5 ft +/- 0.5 ft Length 3 in 1 connector Type Classifications Information about IEC 60601-1 classification Class of protection against electric shock Protection against accidental IP21 contact and ingress of solid Degree of protection against: foreign bodies Touch by fingers and objects with Ø...
- Page 39 13.4 Environmental Conditions for Operating Your Device Parameter Value Temperature range In operation +60°F to +80°F During storage/transport +33°F and +122°F Humidity In operation Below 60% non-condensing During storage/transport Below 60% non-condensing Atmospheric pressure 700 hPa – 1060 hPa In operation 700 hPa –...
- Page 40 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. Electromagnetic Environment – Immunity Test IEC 60601 Compliance...
- Page 41 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. Electromagnetic Environment – Immunity Test IEC 60601 Compliance...
- Page 42 Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
-
Page 43: Service And Customer Support
When reporting problems, provide the UDI numbers of the device (as identified on the nameplate on the back of each device) 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 Email: customerservice@thermxtherapy.com... -
Page 44: Warranty
“Therm-X Unit”), if properly used, will operate in accordance with its specifications as described by Zenith, and will be free from defect in material and workmanship for the Warranty Period applicable to the Therm-X Unit. The “Warranty Period” for a Therm-X Unit is the period of one (1) year after its date of purchase. - Page 45 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 46 PRODUCT IS EXPRESSLY DISCLAIMED. LIMITATION OF LIABILITY Zenith will not be liable to Customer with respect to this Warranty or otherwise, whether in an action based on a contract, tort (including negligence and strict liability) or any other legal theory, however...
- Page 47 UPDATES AND ADVANCEMENTS Zenith reserves the right to modify and improve the design of any Product without assuming any obligation to modify any previous model of a Product previously manufactured, distributed or sold by Zenith and without assuming any obligation to modify this Warranty.