User Manual VARITHERM WAX BATH
Contents
1. xe ausum ES ae umcipsg 6 Vig gno OL Gn 8 psudee5 w pub qirszev v TETTE OVEM O EO 21 E B fel 1 er p ae DN ZZ raves ur RAM rind bunt poy HUM i Us va w2 p n imi 47451 1 21 Varitherm Wax Bath EMC Tables Guidance and manufacturers declaration electromagnetic emissions The Varitherm Wax Bath is intended for use in the electromagnetic 2 environment specified below The customer or the user of the Varitherm should assure that it is used in such an environment Electromagnetic environment 3 Emissions Test Compliance guidance The Varitherm generates negligible RF emissions switching of thermostat 4 RF emissions Group 1 Therefore its RF emissions are very CISPR 11 low and are not likely to cause any interference in nearby electronic equipment 6 RF emissions Class A CISPR 11 7 Harmonie The Varitherm is suitable for use in all emissions Class A IEC 6100 3 2 establishments other than domestic and those directly connecte2. it to be plugged into the tag on the new element assembly 6 Refer to the instructions on page 16 for the safety thermostat temperature setting Varitherm Wax Bath 17 LNC884 Part No 40 85 7 1 A17 23 OM884EN TIA 40 85 Part No 10 41 15 45 17 30B 17 49 19 3 2 24 2 73 24 50A 24 50B 24 51 24 52 24 53B 24 97 24 55B 24 57 24 59 24 83 31 66 33 18 33 25 33 30 33 31 33 37A 33 46A 33 48 Part No 33 50 18 VARITHERM WAX BATH Description WAX BATH HANDLE BLACK NYLON WAX BATH LID OPERATING MANUAL THERMOMETER WAX BATH Description PLUG TOP 13A RUBBER EXTRUSION SWITCH ROCKER GREEN TERMINAL BLOCK 4WAY CABLE TIE T18R SPIRAP 6mm CASTOR 2 RUBBER TYRE WAX BATH INNER TANK WOODEN SURROUND C T BACK NUT 2 1 4 BSP BACK NUT 1 2 GAS WATER FILLER MOULDED THERMOSTAT CAPILLARY ESCUTEON BEZEL POCKET THERMOSTAT BALL VALVE SEAT THERMAL CUT OUT CHROME SPACER SCREW M3 x 10 PAN HD SCREW M4 x 8 C SUNK SCREW M4 x 10mm SCREW M4 x 10mm SCREW M4 x 20mm SCREW 5 x 40 C SUNK SETSCREW M6 x 30 HEX Description SCREW M8 x 16 HEX HD Varitherm Wax Bath oo ce 34 1 34 22 34 23 34 24 34 34 34 42 34 43 34 45A 35 30 35 4 36 10 36 7 39 37 39 47 60 66 7 18 7 4 17 15 17 28 17 32 17 35 17 38 17 39 17 43 17 50 17 4 17 5 17 9 C126 C17 6 C184 C39 C41 C59 C82 G6 Part No G30 L106 L57A L78 WASHER M3 PLAIN WASHER M3 BERYLLIUM WAS
3. lamp to show when the mains switch is on It is marked with the recognised IEC Symbols for on and off Also on the front of the unit is a red warning lamp This lamp will illuminate if the safety thermostat has opened indicating that the unit is too hot This is usually because there is insufficient water in the unit The safety thermostat can only be reset by using the pull cord at the front of the unit figure 1 after the temperature has returned to a safe level Between the warning lamp and mains switch is located the control thermostat It is graduated in degrees Celsius Mains Switch IEC Symbol 878 01 01 Mains On O IEC Symbol 878 01 02 Mains Off Warning Light Control Thermostat ba VJ E Safety Thermostat Pull cord Reset Figure 1 Varitherm Wax Bath Front View Varitherm Wax Bath 11 Water filler cover Wax Container Mains Circuit Breakers Warning Light Mains Switch Temperature Mains Cable Control Figure 2 Varitherm Wax Bath Top View 12 Varitherm Wax Bath The water filler cover is located at the rear of the unit figure 2 A label reminds the user to check the water level daily On the rear of the unit is a label giving details of model serial number mains supply voltage and frequency figure 3 On the left side of the unit is a label showing symbols from Class B and Attention consult accompanying documents figure 4 EMS Physio
4. reflection from structures objects and people Essential Performance Power Input 200 240 VAC 50 60 Hz Temperature Control 20 60 C Accuracy 5 C Safety Cut out 75 5 Varitherm Wax Bath 25
5. EMS Physio Ltd Grove Technology Park Downsview Road Wantage Oxfordshire OX12 9FE England User Manual VARITHERM WAX BATH Model 17 0120 Varitherm Wax Bath General Information This manual provides the necessary information for the installation and operation of the Varitherm Wax Bath These instructions must be studied before putting the unit into operation The information contained in this manual is subject to change without notice No part of this manual may be photocopied reproduced or translated into another language without the prior written consent of EMS Physio Ltd It is intended that the Varitherm Wax Bath is only used by qualified health professionals such as trained physiotherapists Record of Amendments ISSUE COMMENTS DATE 4 CE Marking 25 06 1998 5 Revised 19 05 1999 6 Revised 25 04 2000 7 Revised 10 09 2001 8 Revised 05 07 2005 9 Revised Company Name 04 10 2006 10 Revised 01 10 2007 11 EMC Tables Added 05 02 2008 12 Revised 28 09 2010 13 Info for Thermal Switch added 27 09 2011 amp D of C amended 14 Operating instructions updated 22 06 2012 Varitherm Wax Bath 3 EC Declaration of Conformity EMS Physio Ltd Grove Technology Park Downsview Road Wantage Oxfordshire OX12 9FE United Kingdom Declares that the following medical device is in conformity with the essential requirements and provisions of Council Directive 93 42 EEC and is subject to the procedure set out in Annex 2 of Di
6. HER M4 BERYLLIUM WASHER M6 M8 INTERNAL 5 NUT M3 HEX NUT M4 NUT M8 WASHER 2BA HEAVY SCREW 2BA x 3 8 HEX HD GRUB SCREW 4BA x SCREW 4BA 1 4 C SUNK WASHER 5 16 HEAVY FIBRE WASHER 38mm OD ELEMENT MODIFIED NEON INDICATOR HANDLE HAF 525 FRONT PANEL KNOB ASSEMBLY THERMOSTAT COPPER WASHER SPACER THERMOSTAT RET BRK T THERMOSTAT RESET PT INSULATOR LABEL SET FRONT CASTOR PLATE REAR CASTOR PLATE COPPER WATER TANK CABLE BLACK MAINS OUTER CASE P CLIP RICHCO NE6 CABLE BLACK 63 0 2 CABLE RED 63 0 2 NYLON BRAIDED CORD CABLE GRN YEL 63 0 2 GROMMET 3028 3 8 Description CABLE STRAIN RELIEF LEN LABEL LABEL PER No BATCH LABEL EARTH SYMBOL Varitherm Wax Bath COrRNNNABRWAKNNWOA Ww Ur j ee ee paa ai e 2 190cm 162cm 30cm 54cm eee L94 P2 PLASKLIP 5 16 R10 POP RIVET TSP D 435 R18 RIVET BUTT HD NO 16 144 HEAT TRANSFER COMPOUND 535 SLEEVING YELLOW 3mm T100 TAG RING YELLOW TERMINAL 42095 1 28 TERM BOOT 154509 2 T40A 2BA BLUE RING TAG 50 TERMINAL 41729 2 67 BRASS TAB Spare Parts Only B17 37 WATER FILLER ASSEMBLY C17 42 COMPLETE CABLE ASSEMBLY 20 Varitherm Wax Bath LABEL POWER Noe 5 ircuit Diagram Varitherm Wax Bath Model 17 on 8 1 caben 7 PHI SWJ
7. In normal treatment several layers of wax are applied and further heat is released from the wax into the skin Another consequence of the solid layer of wax is that moisture is prevented from being lost from the surface being treated At the end of treatment when the wax is peeled off the skin is left moist and soft The Varitherm Wax Bath comprises a resin tank which holds the paraffin wax surrounded by an electrically heated thermostatically controlled water jacket The temperature control may be set to maximum in order to provide rapid melting of the solid wax when the unit is first switched on After almost all of the wax is melted the temperature control is normally set to approximately 50 C so that the paraffin is just in its molten state It is advisable to check the actual wax temperature with a suitable thermometer prior to treatment Varitherm Wax Bath 7 Contraindications Areas with open wounds must not be treated Patients with skin infections as heat may increase inflammation Patients with reduced thermal sensation Precautions Paraffin wax is inflammable Its flash point is in excess of 200 C As the Varitherm Wax Bath heats the wax via a water jacket heating of the wax to dangerous temperatures is prevented Should a fire occur involving paraffin wax dry powder or foam extinguishers should be used DO NOT USE WATER Wax spilt on floors can be extremely slippery Spillages must be dealt with promptl
8. Ltd Oxfordshire England www emsphysio co uk WAX BATH MODEL 17 MAINS SUPPLY 230V 50 60 Hz RATING CONTINUOUS POWER INPUT 3kW CLASS 1 TYPE B Made in England 2 es Figure 3 Label Rear of Unit VARITHERM WAX BATH mk Ill CAUTION DO NOT TILT 5 BEYOND HORIZONTAL IEC Symbol 878 02 02 Figure 4 Label Side of Unit Type B Equipment IEC Symbol 348 Attention consult accompanying documents Varitherm Wax Bath 13 Operating Instructions 1 Having filled the Varitherm Wax Bath with water and paraffin wax and connected it to a suitable supply as described in the installation section of this manual switch on the unit using the mains switch which will then be illuminated 2 Turn the Control Thermostat to 60 65 C and leave until all the wax has melted 3 When no solid wax remains set the Control Thermostat to 50 55 C 4 Wait for the temperature of the wax to stabilise just above its melting point approximately 50 C The temperature of the wax should be checked using the thermometer Please note the wax temperature will usually be 2 3 C lower than the water temp 5 Inspect the area to be treated for contraindications Wash and dry the area to be treated 6 Immerse the part of the body to be treated in the wax for 2 or 3 seconds and then withdraw it A thin layer of solid wax will be formed Repeat this procedure 5 to 10 times to produce a layer of wax about 3
9. an extra thermal switch limits any higher settings so that the wax temperature never exceeds 65 C Varitherm Wax Bath 15 Disassembly and Assembly Replacing the Wax Tank 24 50A Remove the two grub screws securing the wooden surround Remove the wooden surround 24 50B Remove the wax tank 24 50A Inspect the rubber seal 15 45 around the edge of the copper tank and replace if damaged or perished 5 Insert the new tank replace the wooden surround and secure with the two screws d os Replacing the Safety Thermostat 24 57 1 Remove the four screws which secure the front cover and remove the cover itself 2 Remove the two M3 screws which secure the fibreglass plate to the metal bracket attached to the element 3 Remove the red and black wires from the screw terminals on the thermostat 4 Withdraw the safety thermostat from its tube 5 Fit the new thermostat connect the red and black wire to the screw terminals on the thermostat 6 Check the water level is correct and set the control thermostat to 60 C Set the safety thermostat to its maximum position 7 Connect the mains supply and wait for the water to reach the set temperature 8 Reduce the setting of the safety thermostat until it opens and the red warning light comes on 9 Increase the setting of the safety thermostat to about 75 C and pull the reset cord The warning light should go out 10 Switch off the unit and replace the fr
10. carrier and the Company or its agent from whom the unit was purchased If not already fitted connect a suitable plug to the mains cable The plug must have provision for an EARTH GROUND connection The mains cable has the following colour code BROWN is LIVE LINE BLUE is NEUTRAL and GREEN YELLOW is EARTH The Wax Bath lid is supplied for ease of packaging with the handle on the reverse side Remove the two screws holding the handle and attach it to the correct side of the lid using the same screws The Varitherm Wax Bath must be positioned on a flat horizontal surface or on the optional stand Lift the water filler cover and fill with tap water until the water level is seen to be just above the inlet hole The water capacity is approximately 17 litres Fill the wax container with approximately 18 kg of paraffin wax The wax should be broken into small lumps to aid melting Wax supplied by EMS Physio Ltd is strongly recommended as melting point and correct operating temperature are highly dependent on the composition of the paraffin wax Connect the Varitherm Wax Bath to a suitable mains oulet capable of supplying at least 13A The Varitherm Wax Bath is now ready for use 10 Varitherm Wax Bath Controls and Markings Varitherm Wax Bath Front View The mains on off switch is located on the front of the Varitherm wax Bath figure 1 and is a two position rocker switch up for on down for off It has a built in green indicator
11. d to the public Voltage low voltage power supply network that supplies buildings used for domestic 8 Flicker emissions Complies 61000 3 3 22 Varitherm Wax Bath Guidance and manufacturers declaration electromagnetic immunity The Varitherm Wax Bath is intended for use in the electromagnetic environment specified below The customer or the user of the Varitherm should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic Environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a 53 1 kV for 1 kV for input output typical commercial or input output lines hospital environment lines ZIK Mains power qualit differential i i wer qua ity Surge UA NUM differential should be that of a typical commercial or IEC61000 4 5 2 kV common 2 kV common mode hospital environment mode lt 5 UT gt 95 dip in UT lt 5 UT Mains power quality For 0 5 cycle gt 95 dip in UT should be that of a Voltage dips 4095 UT For 0 5 cycle typical commercial or Shor
12. ended separation distance Conducted RF 3Vrms 3V d 3 5VP V 61000 4 6 150kHz to 80MHz paste 3v m 3V m d 3 5 P E 80MHz to 800MHz 61000 4 3 80MHz to d 7NP E 800MHz to 2 5GHz 2 5GHz where P is the maximum output power rating of the transmitter according to the manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80MHz and 800MHz 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 To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Varitherm Wax Bath is used exceeds the applicable RF compliance level above the Varitherm Wax Bath should be observed to verify normal operation If abnormal performance is observed additional measu
13. he mains cable entry at the front right of the unit Should the mains switch not be illuminated when in the on position check to see if either of the circuit breakers has tripped To reset the circuit breakers push them in firmly If resetting the circuit breakers does not correct the fault examine the fuse in the mains plug if fitted If neither replacing the fuse in the mains plug nor resetting the mains circuit breakers rectifies the fault then qualified service personnel should be contacted Circuit Description Refer to the Wax Bath Model 17 Circuit Diagram on Page 21 The mains supply is applied to the unit through 15A circuit breakers in both live and neutral connections The mains on off switch has an integral green lamp to show when the power is on The heating element is rated at 3 kW and carries a safety cut out thermostat in a tube close to the element The safety thermostat is set to open at 75 C The red warning lamp is wired across the safety thermostat so that it will be illuminated should it open The safety thermostat has a manual reset which can only be activated when the temperature has fallen below 60 C and is accessed by the pull cord at the front of the unit The control thermostat is a capillary type with its sensor located in a tube away from the heating element This thermostat controls the temperature of the water and therefore the wax in normal use It is normally set to a maximum of 60 C to melt the wax
14. mm in thickness over the part of the body being treated 7 The coating of wax is normally left in place for 15 to 20 minutes The wax may then be peeled off and returned to the wax bath for re use 8 For areas of the body which cannot be immersed in the wax tank molten wax may be carefully and slowly poured or ladled on to the area to be treated making sure that wax that runs off the area can be collected in a suitable container 9 After several treatments dirt and other undesirable impurities may collect at the bottom of the wax tank When this reaches an unacceptable level the wax should be removed and purified using an EMS wax purifier which allows the lower layers of impure wax to be removed 10 Daily check the water level in the wax bath 11 Always check the wax temperature before use In more recent units an additional thermal switch ensures that the water temperature can never exceed 65 C Maintenance Each day check the water level is correct The water level should be just above the inlet hole when viewed through the water filler cover If the water level becomes too low the safety thermostat will operate and cut off the mains supply to the heating element The red warning lamp will light Refill with water to the correct level and pull the reset cord at the bottom of the unit figure 1 This will reset the safety thermostat and the red warning light will go out The mains circuit breakers are located adjacent to t
15. ont cover with its four fixing screws 16 Varitherm Wax Bath Element Thermostat Assembly The original heating element and cut out thermostat for Wax Baths prior to serial number 70074 are no longer available For these earlier Wax Baths the complete Element Thermostat assembly part number C17 41 must be used whenever either the heating element or cut out thermostat are required to be replaced Fitting of replacement element Thermostat Assembly For wax baths serial number 70074 onwards the element assembly part number 60 66 and cut out thermostat part number 24 83 are direct replacements for the original components For wax baths prior to serial number 70074 follow the procedure below for installation of the combined replacement element assembly part number C17 41 this assembly includes the cut out thermostat 1 Remove the wires linking the old assembly to the wiring loom and unscrew the assembly from the tank 2 Fit the new element assembly C17 41 to the wax bath tank 3 Undo the two M3 screws holding the reset plate and swing it to the right exposing the screw for the left hand terminal in the thermostat housing 4 Refit the black wire to the left hand terminal and refit the reset plate into position the red wire from the 3 way terminal to the cut out thermostat has been fitted at the factory 5 The previously removed red wire step 1 must now be extended by unwrapping part of its length from the wiring loom to enable
16. rective 93 42 EEC under the supervision of Notified Body Number 0120 SGS United Kingdom Ltd Class IIb according to Annex IX of 93 42 EEC Product Name Varitherm Wax Bath Model Number 17 Signature Position Quality Assurance Manager Date 8 October 2011 Date first issued 6 May 1998 4 Varitherm Wax Bath Contents page Title 1 General Information 3 Record of Amendments 3 Declaration of Conformity to 93 42 EEC 4 Contents 5 Warranty 6 Introduction 7 Contraindications 8 Precautions 8 Technical Specification 9 Installation 10 Controls and Markings 11 Operating Instructions 14 Maintenance 15 Circuit Description 15 Disassembly and Assembly 16 Parts List 18 Circuit Diagram 21 EMC Tables 22 Varitherm Wax Bath Warranty This EMS Physio Ltd hereinafter called the company product is warranted against defects in materials and workmanship for a period of two years from the date of shipment The Company will at its option repair or replace components which prove to be defective during the warranty period provided that the repairs or replacements are carried out by the Company or its approved agents The Company will consider itself responsible for the effects on safety reliability and performance of the product only if assembly operations re adjustments modifications or repairs are carried out by persons authorised by it only if the product is used in accordance with the instructions for use onl
17. res may be necessary such as re orienting or relocating the Varitherm Wax Bath 5 Over the frequency range 10kHz to 80Mhz field strengths should be less than 3 V m 24 Varitherm Wax Bath Recommended separation distances between portable and mobile RF communications equipment and the Varitherm Wax Bath The Varitherm Wax Bath is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the Varitherm can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Varitherm Wax Bath as recommended below according to the maximum output power of the communications equipment 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2 5GHz d 3 5 P V d 3 5VP E d 7 P E 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating in watts W according to the transmitter manufacturer NOTE 1 At 80MHz and 800MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and
18. t 60 dip in 40 UT hospital environment If interruptions and yr 60 dip in UT the user of the voltage For 5 cycles For 5 cycles Varitherm requires variations on o continued operation power supply 70 T UT during power mains input lines 30 dip in 30 dip in UT interruptions it is UT For 25 cycles recommended that the IEC 61000 4 11 For25cycles lt 5 UT Varitherm be powered lt 5 UT gt 95 dip in UT from an uninterruptible gt 95 dip in For 5 sec power supply UT For 5 sec Power frequency Power frequency magnetic field should be 50 60 Hz at levels characteristic Magnetic field SAM TAM of a typical location in a IEC 61000 4 8 typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level Varitherm Wax Bath 23 Guidance and manufacturers declaration Electromagnetic immunity The varitherm Wax Bath is intended for use in the electromagnetic environment specified below The customer or user of the Varitherm Wax Bath should assure that it is used in such an environment Immunity IEC 60601 Compliance Electromagnetic Environment Test Test level level Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Varitherm Wax Bath including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recomm
19. y and completely Paraffin wax is a petroleum hydrocarbon and its molten state will produce some fumes Always use the Varitherm Wax Bath in a well ventilated area When not in use always cover the tank with the lid provided 8 Varitherm Wax Bath Technical Specification Power Input Power Consumption Protection Devices Alarm Indicator Size H x W x D Water Capacity Wax Capacity Weight empty Weight fully loaded Classification EN60601 1 200 240 VAC 50 60 Hz 100 120 VAC 50 60 Hz available to special order 3 kW 15A circuit breakers in each supply line Red Neon Lamp 410 x 440 x 760 mm 17 litres 18 kg 23 kg 58 kg Class 1 Type B All information on model serial number and month year of manufacture is located on the rear panel The Varitherm Wax Bath is supplied with a lid a thermometer to check the wax temperature and this manual Wax must be purchased separately The Varitherm Wax Bath has been designed to meet the requirements of BS EN60601 1 2001 Medical Electrical Equipment Part 1 General Requirements for Safety Optional Accessories Catalogue Description Number LNC885 Tubular steel stand for Varitherm Wax Bath TIA Thermometer Pll Paraffin Wax Varitherm Wax Bath 9 Installation Upon receipt check for any visible damage which may have occurred in transit If any signs of damage are found then retain all packaging material and inform the
20. y if the electrical installation of the relevant room complies with the appropriate national requirements Should the product be returned to the Company for repair it must be sent carriage paid Consumable items for example electrodes electrode covers and batteries are excluded from the above warranty 6 Varitherm Wax Bath Introduction Hot Wax therapy is one of several methods available to the therapist of applying heat directly to the surface of the body Paraffin Wax supplied by EMS Physio Ltd melts at between 45 and 47 C The wax is held at a temperature just above its melting point and the part of the body being treated is either immersed in the molten wax or the wax is poured onto it Heat is transferred from the wax to the treatment area by thermal conduction Although temperatures above 45 may lead to skin damage under normal circumstances immersing a hand or foot in paraffin wax at 50 C is quite comfortable Water or oil at the same temperature would be uncomfortable and possibly damaging However when the skin comes into contact with the molten wax the wax immediately next to the skin solidifies forming a thin insulating layer This insulating layer which is of low thermal conductivity lowers the rate at which heat energy is applied to the skin to a level which is safe The latent heat of fusion of the wax is released as the wax solidifies therefore applying heat to the treatment area at constant temperature
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