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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 Additional Warnings
Page 8 General Information
Page 8 Parts List
Page 9 Operational Principle
Page 9 Technical Parameters
Page 10 Product Diagrams
Page 11 Instructions
Page 12-14 Thermostat Operation Instructions
Page 15 Cleaning Instructions
Page 15 Maintenance
Page 15 Storage
Page 16 How to Remove Lid
Page 17 Thermostatic Water Tank Schematic Diagram
Page 18 Thermostatic Water Tank Exploded View
Page 19-20 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 Class A
Harmonic emissions
IEC 61000-3-2 Not Applicable
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
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 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
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
Not Applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines IEC
61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
Mains power quality should be
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
battery.
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
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 Vrms
3 V/m
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
Pd 2.1
Pd 2.1 80 MHz to 800 MHz
Pd 3.2 800 MHz to 2,5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
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,
ashould 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 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
b 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.
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
Rated maximum output power of
transmitter
W Pd 2.1 Pd 2.1 Pd 3.2
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 14o F – 104 o F (-10 o C – 40 o C)
Transport & Storage -22o 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
13
14
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
16
17
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
20
Patterson Medical
1000 Remington Blvd.
Suite 210
Bolingbrook, IL 60440
Phone: 800-323-5547
Direct Phone: 630-378-6000
Fax: 800-547-4333