Rolyan Splint Pan OPERATION MANUAL Item #081544816 - Small Item #081544808 Large
PLEASE READ THIS ENTIRE MANUAL BEFORE OPERATING YOUR NEW SPLINT PAN. Failure to follow these instructions could result in damage to the device, warranty avoidance, or/and cause bodily injury When first using this product, check whether the external power supply meets the power requirements of the product, the power: 1400W (min), 1440W (max). The power supply must be utilized in accordance with power requirements. The power socket is consistent with single three-wire electrical outlets, and to withstand greater than or equal to the current requirements of the safe heating loop current socket, the power socket must be connected to a grounded line of protection. Do not leave machine unattended for extended time periods during use. If it becomes necessary to leave the machine unattended, turn off the power switch. Also turn off the power switch if there is a power failure. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual. Portable and mobile RF communications equipment can affect Medical Electrical Equipment. The use of Accessories, transducers, and cables other than those specified by the manufacturer, may result in increased Emissions or decreased Immunity of the Splint Pan. The Splint Pan should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Splint Pan should be observed to verify normal operation in the configuration in which it will be used. To avoid injury, do not touch the tank cover while in operation. 2
TABLE OF CONTENTS Page 4 Guidance and manufacturer s declaration electromagnetic emissions Page 5-6 Guidance and manufacturer s declaration electromagnetic immunity Page 7 Recommended separation distances between portable and mobile RF communications equipment and the Splint Pan Page 7 Page 8 Page 8 Page 9 Page 9 Page 10 Page 11 Page 12-14 Page 15 Page 15 Page 15 Page 16 Page 17 Page 18 Page 19-20 Additional Warnings General Information Parts List Operational Principle Technical Parameters Product Diagrams Instructions Thermostat Operation Instructions Cleaning Instructions Maintenance Storage How to Remove Lid Thermostatic Water Tank Schematic Diagram Thermostatic Water Tank Exploded View Parts List 3
Guidance and manufacturer s declaration electromagnetic emissions The Splint Pan is intended for use in the electromagnetic environment specified below. The customer or the user of the Splint Pan should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Splint Pan uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations / flicker emissions IEC 61000-3-3 Class A Not Applicable Not Applicable The Splint Pan is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 4
Guidance and manufacturer s declaration electromagnetic immunity The Splint Pan is intended for use in the electromagnetic environment specified below. The customer or the user of the Splint Pan should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic guidance environment Electrostatic discharge (ESD) ±6 kv contact ±6 kv contact Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, IEC 61000-4-2 ±8 kv air ±8 kv air 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 typical commercial or IEC 61000-4-4 ±1 kv for input/output lines Not Applicable hospital environment. Surge ±1 kv line(s) to line(s) ±1 kv line(s) to line(s) Mains power quality should be that of a typical commercial or IEC 61000-4-5 ±2 kv line(s) to earth ±2 kv line(s) to earth hospital environment. <5 % UT <5 % UT (>95 % dip in UT) (>95 % dip in UT) for 0,5 cycle for 0,5 cycle Mains power quality should be Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles that of a typical commercial or hospital environment. If the user of the Splint Pan requires continued operation during power mains interruptions, it is recommended that the Splint Pan be powered from an uninterruptible power supply or a <5 % UT <5 % UT battery. (>95 % dip in UT) (>95 % dip in UT) for 5 sec for 5 sec Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A / m 3 A / m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level. 5
Guidance and manufacturer s declaration electromagnetic immunity The Splint Pan is intended for use in the electromagnetic environment specified below. The customer or the user of the Splint Pan should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Splint Pan, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d 1. 2 P d 1. 2 P 80 MHz to 800 MHz Conducted RF IEC 61000-4-6 3 Vrms 150 khz to 80 MHz 3 Vrms d 2. 3 P 800 MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2,5 GHz 3 V/m manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as deter-mined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: 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. a b 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 Splint Pan is used exceeds the applicable RF compliance level above, the Splint Pan should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Splint Pan Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. 6
Recommended separation distances between portable and mobile RF communications equipment and the Splint Pan The Splint Pan is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Splint Pan can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Splint Pan as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d 1. 2 P d 1. 2 P d 2. 3 P 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 metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, 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 reflection from structures, objects and people. Additional Warnings Operate the machine on a table or counter in a dry, clean ventilated area. Do not move machine during operation. Do not use machine close to other items. Keep children away from machine at all times. Do not replace fuses until power is off. Do not use in direct sunlight. Do not put hands in tank to retrieve splinting material. Use tongs or other grasping tool to remove the material. Do not use this item while in close proximity to gases or flammable liquids, as fire or explosion may occur. Keep chlorine away from machine at all times as it may destroy the stainless steel surface. Before draining or moving the unit, let the machine cool down completely to avoid injury. 7
General Information Splint Pan is constructed of heavy duty stainless steel with double wall insulation. This item has guaranteed long life of trouble-free energy efficient operations. The device shall be used as a reservoir in hospitals, clinics and other medical facilities to heat and soften thermoplastic used in the splinting process. Indoor use ONLY. Classification: Continuous Duty, Class I Water Enclosure Protection: IPX0 Environmental Requirements: Temperature: Operating 14 o F 104 o F (-10 o C 40 o C) Transport & Storage -22 o F 140 o F (-30 o C 60 o C) Humidity: Operating Up to 80% Transport & Storage Up to 90%, non-condensing Atmospheric Pressure: 700 hpa to 1060 hpa Additional Note: No Applied Parts Not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE Parts List (see detailed machine parts list on page 19-20) Rolyan Splint Pan Heating device Insert Rack Power Cord Drain Hose Operation & Maintenance Manual The Rolyan Splint Pan is made up of a thermostatic tank inner box which is made of high quality stainless steel and precision machining technology, with high temperature resistance and corrosion-resistant characteristics. The main structure of the machine includes the cabinet, liner, cover shelves, long row hinge, electric control, and a digital temperature controller. The shell is made of high quality steel with electrostatic spray, temperature control adopt high stability operational amplifier and high-precision double integral A/D conversion technology. The Rolyan Splint Pan has two tuning methods; self-tuning and manually tuning, and both have the BBS compensation feature setting function. 8
Operational Principle Through the intelligent digital temperature control, when the temperature of the water reaches the set value, the control circuit automatically shuts off, stops heating ducts; when the temperature of the water is below the temperature setting value, the control circuit automatically powers up to start electric heating, and the water pipe once again reaches the temperature setting value. In such an automatic cycle, the water temperature is always in a constant state, so as to achieve the temperature requirements. Technical Parameters Packaging size: Small 29 x 17 x 10 (in) Large 33 x 25 x 10 (in) Inside Tank Dimensions: Small 19 ½ x 11 ¾ x 5 ½, Large 24 ¼ x 18 ¼ x 6 Outside Tank Dimensions: Small 25 ½ x 14 ¾ x 7 ¼, Large 30 x 21 x 8 Power: 120V 60HZ Warming power: 1400W Temperature range: Room temperature 210 F 9
PRODUCT DIAGRAM EXTERNAL VIEW PRODUCT DIAGRAM INTERNAL VIEW 10
Instructions Check the drain valve and make sure it is in the off position. Open the tank cover, and make sure the internal tank is clean. Fill machine 2/3 full of clean water, put the testing container into the tank, and then close the tank cover. During use of the machine, regularly check the water level, making sure it is always 2/3 full. Always make sure that the lid is closed while in use. This will enable the machine to properly hold its temperature at the desired setting. Attach the external power source to the back of the machine and plug into your external power source. Turn on the power. The power button will light up, as well as the digital thermometer display. Please note it is recommended that no other plug be used by the same power receptacle that is being used for the Rolyan Splint Pan. The Temperature Controller has a two row digital display; above row is workroom actual temperature (PV), below row is setup temperature (SP). See the diagrams on the next page for direction on setting the temperature of the machine. The Temperature Controller is set to 149 F before the machine leaves the factory. If you do not need to change the temperature, turn on power button. Please allow for a +/-3 F variance. In order to avoid burning of splinting material, use the rack that is included with the splint pan. To drain water, make sure power of the machine is OFF. Allow the machine to cool down before draining the water. Turn valve to drain water. Use included hose if needed. 11
Thermostat Operation Instructions 12
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Cleaning Instructions Before cleaning the machine, turn off the power switch and unplug the unit from the electrical outlet. Open the cover above the tank. Use a clean, soft and absorbent cloth to clean the water tank cover. Do not use this cloth to clean the lid to prevent scratches and rust. Make sure all water has been drained before cleaning the machine. After the machine has cooled, clean the heating pipe lining with a clean, soft, absorbent cloth. Do not leave water droplets or dirt residue to prevent scratches and rust. With a clean soft absorbent cloth, clean the inner tank, including heat pipes and sensors. Do not leave water droplets or dirt residue on machine to prevent rusting (when scrubbing, do so gently to avoid scratching). When cleaning the heating pipe, do not touch the sensor. Clean downward, left and right of the vane heat pipe to prevent the sensor from becoming loose or broken. After cleaning the machine, place in a clean and ventilated area. Maintenance Do not let water spray on the surface while the machine is working. If using frequently or prolonged on high temperatures, the circuit connection should be checked by an electrician every three months, in case the connection needs to be replaced. To perform maintenance or repair, you must disconnect the power plug. Storage Do not keep water in tank long term. After each use, drain water and wipe clean. Store at ambient temperature of -22 to 140 F (-30 to 60 Celsius); store in no more than 90% relative humidity, and without non-corrosive gases indoors. 15
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1. Gemel 2. Tank cover 3. Handle 4. Stainless steel screw 5. Hole 6. Shelf/Tray 7. Heating tube 8. Water-out hole 9. Stainless steel screw 10. Stainless steel inner flask 11. Sensor 12. Fixed hole 13. Sensor fixing hole 14./15. Heating tube fixing hole 16. Drain valve 17. Water-out hole 18. Shell 19. Instrument fixing hole 20. Switch fixing hole 21. Power cord/mains plug 22. Insurance base 23. Temperature controller 24. Power switch 25. Base board 26. Fixed hole 27. Stand hole 28. Solid-state relay 29. Stand 30. Screw 18
Parts List 19
Patterson Medical 1000 Remington Blvd. Suite 210 Bolingbrook, IL 60440 Phone: 800-323-5547 Direct Phone: 630-378-6000 Fax: 800-547-4333 20