WR Medical Electronics Co
TB7 and TB6 Operators Manual Aug 2021
Operators Manual
12 Pages
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Therabath® Paraffin Bath Operator’s Manual
Model TB6 (100 to 125 volt) and Model TB7 (220 to 240 volt) Indications
For use by adults and adolescents in a medical, clinical or therapeutic setting. Useful in symptomatic relief of pain caused by medically diagnosed arthritis, bursitis, and chronic joint inflammation. Relaxes muscles, relieves stiffness and muscle spasms, and stimulates circulation. May be prescribed for postfracture or post-dislocation treatment, for sprains, strains, for restriction of motion due to scar tissue, and for other conditions for which heat is indicated. Commonly used prior to therapeutic exercise and massage. May be prescribed in certain peripheral vascular diseases. Consult your physician if you have any questions.
Contraindications Should not be used in the presence of open cuts or wounds, inflammatory skin conditions, neoplasm (growths), peripheral vascular disease where circulation is impaired, acute inflammation, or when sensation of the extremity is reduced or absent (such as in some cases of diabetes). If there is any question about peripheral vascular disease or decreased sensation of the extremities, consult a physician or physical therapist before using. Should not be used on areas subject to hemorrhaging or in cases involving abnormal sensitivity to heat. Discontinue use if dermatitis due to paraffin sensitivity occurs. Discontinue use if wax feels too hot or cool, which could indicate health problems with the user. Do not allow children or those with severe physical disabilities to use the device.
Warnings • • • • • • • • • •
Do not use while bathing or put unit where it can fall into a bathtub or sink. Do not pour water or other liquid into the unit. Do not reach for a unit that has fallen into water. Unplug immediately. Supervision is necessary when this product is used by, on, or near children. Use this product only for its intended use as described in this manual or as recommended by a health care professional. Never operate this product if it appears damaged, has been dropped in water, or is otherwise not working properly. To avoid improper operation, do not use other products or attachments not recommended by the manufacturer. Use paraffin wax that is formulated for use in a paraffin warmer. Paraffin that has a higher or lower melting point should not be used in this unit. Use an electrically grounded (3-pin) receptacle that conforms to the applicable local and national electrical codes. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. • 1 / 12 •
• • • • • • • •
Do not operate in the presence of flammable anesthetic mixtures, oxygen, or nitrous oxide. Do not operate the unit without the plastic grate on the bottom. Do not touch the bottom or sides of the metal tank, or a burn may result. Do not heat paraffin on a stove, hotplate, or in a microwave. Do use this appliance on a level, secure surface. Do not use any additives in the paraffin except as allowed by the manufacturer. Do not modify this equipment without authorization from the manufacturer. Care must be taken when operating this equipment around other equipment. Potential electromagnetic or other interference could occur to this or the other equipment. Minimize this interference by not using other equipment in conjunction with it.
Cautions • • • •
Do not remelt used paraffin, reintroduced particles or chemicals may damage the tank. Never use sharp objects to remove hardened paraffin from the unit. Do not leave an empty unit plugged in. Do not pour melted paraffin from the tank.
NOTE: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
Technical Information • • • • • • • • • • •
NOTE: “Hospital Grade” grounding
reliability can only be achieved when Power, Model TB6: 100–125V, 0.87–1.3A, 50–60Hz the equipment is connected to Power, Model TB7: 220–240V, 0.55–0.65A, 50–60Hz an equivalent receptacle marked Heater: TB6: 87–162 watts, TB7: 121-156 watts “Hospital Only” or “Hospital Grade” Operating temperature: 126º–134º F. (52.2º–56.7º C.) 14.3” L x 8.2” W x 7.5” H (36.32 cm L x 20.83 cm W x 19.1 cm H) NOTE: Current and wattage Capacity: 9 lbs. (4.08 kg.) must be measured at operating Melt time: 6-8 hours temperature. Duty cycle: continuous operation Degree of protection against moisture ingress: IPX0 220V unit must be used with a hospital grade cord of at least the maximum ratings: 10 A, 220 VAC. Meets IEC/EN 60601-1-2:2014 electromagnetic compatibility interference safety standard.
Environmental Ratings Temperature: Relative Humidity: Atmospheric Pressure:
Operating
Transport and Storage
65° to 85° F (18.3° to 29.4° C) 10% to 95% 70 to 160 kPa
-40° to 130° F (-40° to 54.4° C) 10% to 95% 70 to 160 kPa
No.
Test/Standard
Port (enclosure, AC, DC, I/O)
Emissions Class and Group / Immunity Test Level
1
CISPR 11, Radiated Emissions
Enclosure
Class A; Group 1
2
IEC 61000-4-2
Enclosure
±8kV contact, ±2kV, ±4kV, ±8kV, ±15kV air
3
IEC 61000-4-3 Radiated RF Immunity
Enclosure
3V/m, 80-2700MHz, 80% 1kHz AM
4
IEC 61000-4-3 Proximity fields from RF wireless equipment
Enclosure
Section 8.10 of the IEC 60601-1-2 standard
5
IEC 61000-4-4
AC
2kV, 100kHz repetition rate
6
IEC 61000-4-5
AC
Line-to-Line: ±0.5 kV, ±1 kV Line-to-Ground: ±0.5 kV, ±1 kV, ±2 kV
7
IEC 61000-4-6
AC
3V, 0.15-80MHz, 80% 1kHz AM, 6V in ISM Band within 0.15-80MHz, 80% 1kHz AM
8
IEC 61000-4-8
Enclosure
30A/m, 50Hz and 60Hz
9
IEC 61000-4-11 Voltage Dips
AC
0% (100% reduction), 0.5 cycle; 0% (100% reduction), 1 cycle; 70% (30% reduction) UT, 0.5 sec
10
IEC 61000-4-11 Voltage Interruptions
AC
0% (100% reduction), 5 sec
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Heating System and Pilot Light Operation
• The Therabath is equipped with 2 thermostats. The Control Thermostat automatically heats and maintains the paraffin at 130 degrees F (54.4 C) with ± 4 degrees F variation. If the Control Thermostat fails, the High Limit Thermostat automatically shuts off the unit completely. Return to manufacturer for servicing. • The pilot light (on end of unit) indicates the unit is heating, and is lit only during the heating cycle. During normal operation, the pilot light goes on and off at regular intervals. Most of the time it is off. • If the unit is not completely melted after being plugged in for 12 hours, follow troubleshooting steps at therabath.com/service.
Operating Instructions 1. Unpack the unit and place it on a flat, secure surface. 2. Open the included bags of paraffin and place the contents inside the tank. 3. Place the plastic grille on TOP of the un-melted paraffin. 4. Rest the lid on top of the paraffin and grille. The paraffin will compact as it melts. 5. Plug the unit in. 6. The paraffin will melt in about 6 to 8 hours. 7. Keep the unit plugged in continuously so that it is always ready for use.
Adding Refill Paraffin 1. Keep the paraffin level to the desired level: 6lb standard usage, 8lb - max. deep immersion foot level, 9lb - max. deep immersion hand level. Do not overfill the unit. 2. For optimal performance use only Therabath brand refill paraffin.
Treatment Guidelines • • • • •
Refer to contraindications before use. Cleanse and dry the skin before applying paraffin. Keep clothing and jewelry away from the treatment area. Do not remelt used paraffin, discard. Keep the lid on when unit is not in use.
1. Apply Pre-Treatment Cleansing Spray.†† (Do not use spray near the eyes, nose, or mouth.) 2. Apply Hydrating Cream.†† 3. Slowly dip hand, foot, or elbow into the bath. Use paraffin application strips for other treatment areas. 4. Remove and wait a few seconds until the shine goes away. Repeat 3 to 10 times. 5. Cover hand or foot with a plastic liner.†† 6. Slip on an insulated mitt or boot to retain heat.†† 7. Keep paraffin in place for 10 to 15 minutes. 8. Remove. Discard used paraffin and plastic liner (if used). ††
OPTIONAL: Pre-Treatment Cleansing Spray, Hydrating Cream, paraffin application strips, plastic liners, mitts, boots, and more are sold separately. Call your dealer or visit www. therabath.com.
Cleaning Instructions • • • •
Clean paraffin bath when noticeable sediment accumulates on the tank bottom. Do not scratch or damage the inside tank coating. Do not immerse the unit in water. Do not use abrasive scouring powders of any kind when cleaning the tank.
1. Unplug the unit. Remove the grille. Allow the paraffin to solidify. 2. After the paraffin is solid, plug in unit and tip upside down on a wax-safe surface for approximately 15-20 min. until the paraffin loosens from the tank and falls out. Unplug the unit. 3. Remove remaining paraffin in the tank with soft paper towels. 4. Refill with Therabath® brand paraffin. • 3 / 12 •
Maintenance and Service
US and Canadian Customers
• Device is not user serviceable. • Contact the manufacturer to obtain service assistance, return authorization instructions and prior approval before shipping the product for warranty service. Proof of purchase, name, address, contact information and a detailed description of the defect are required. The purchaser is responsible for shipping and handling expense for all warranty service.
International Customers
• Contact WR Medical Electronics Co. or your dealer for service instructions. WR Medical Electronics Co. 1700 Gervais Avenue, Maplewood, MN 55109 USA Phone: 651-604-8400 | Toll-free phone: 800-321-6387 (U.S) | FAX: 651-604-8499 E-mail: [email protected] | Web: www.therabath.com Medical Device Safety Service (MDSS) GmbH Schiffgraben 41, 30175 Hannover, Germany
Limited Warranty THIS WARRANTY IS LIMITED TO THE STANDARD LIFE OF THE PRODUCT, WHICH IS 5 YEARS. WR Medical Electronics Co. warrants the Therabath Professional Paraffin Bath solely to the original consumer owner to be free from manufacturer defects under normal use and service for the natural life of the product (5 years). For a valid warranty claim, WR Medical Electronics Co. will, at its option, either (i) repair the product or replace it with a comparable product, free of charge, or (ii) refund the purchase price for that product. This warranty does not apply to any defects in the aesthetic appearance of the product, nor to any damage or defects resulting from normal wear and tear, accidents, improper use, misuse, shipping damage, or alterations. This warranty terminates immediately and does not apply to any product or part which is repaired, replaced, altered, or modified other than by a trained, service technician authorized by WR Medical Electronics Co. to provide such service. This warranty is not valid on a product that requires modifications / adaptation to enable operation in a country or for electrical specifications other than those for which it was designed. This warranty does not apply to the purchase of opened, used, repaired, or unauthorized repackaged or resealed products. We neither assume, nor authorize any other person, including our sales representatives, dealers or distributors to extend or assume for us, any other warranty or liability in connection with the sale of our products. Purchaser must contact WR Medical Electronics Co. to obtain service assistance, return authorization instructions and prior approval before shipping the product prepaid for warranty service. Proof of purchase, name, address, contact information and a detailed description of the defect are also required. The purchaser is responsible for shipping and handling expense for all warranty service. WR Medical Electronics Co. makes no other warranty, express or implied, and expressly disclaims the implied warranties of merchantability and fitness for a particular purpose. WR Medical Electronics Co.’s total liability with respect to any product shall in no event exceed the price paid by purchaser for such product. In no event shall WR Medical Electronics Co. be liable to purchaser for indirect, special, incidental, exemplary, punitive or consequential damages. This warranty gives you specific legal rights and you may have other rights, which vary from state to state. Some states may not allow the exclusion or limitation of consequential or incidental damages so the above limitations or exclusions may not apply to you.
Explanation of Symbols
• • • •
Attention: Consult accompanying documents. Safety approvals. Class 1, type B protection against electric shock. Protective earth.
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