CIRCA Scientific Temperature Monitor User Manual

CIRCA Scientific Temperature Monitor User Manual
CIRCA Scientific Temperature Monitor User Manual
CIRCA Scientific Temperature Monitoring System
Model CS-1000
CIRCA Scientific, LLC
14 Inverness Drive East, Suite H240
Englewood, CO 80112
(303) 951-8767
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CIRCA Scientific Temperature Monitor User Manual
Table of contents:
1. General warnings and cautions … Page 3
2. Indications for use … Page 4
3. Description … Page 4
4. Alarm System Overview … Page 7
5. Setup instructions … Page 8
6. Check-out instructions … Page 9
7. Operating instructions … Page 10
8. Shut-Down … Page 12
9. Cleaning and Disinfection … Page 14
10. Maintenance … Page 14
11. Storage and Transportation … Page 15
12. Troubleshooting … Page 16
13. Accessories … Page 18
14. Technical Information … Page 19
15. Symbols Key … Page 21
16. Electromagnetic Compatibility … Page 22
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1. General warnings and cautions:
 Rx Only: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
 The monitor is designed for use with CIRCA Scientific interconnect cables and temperature
probes only. Incompatible components can result in degraded performance and could lead to
damage to the unit.
 No modification of this equipment is allowed.
 Never pour any liquid into an opening. This may cause fire or electrical shock.
 Do not cover the openings. Overheating may occur as the openings on the enclosure are for
air convection.
 If the equipment is not in use, disconnect it from the power source to avoid damage by
transient overvoltage.
 Do not remove cover. No user serviceable parts inside. There is a danger of shock if
incorrectly serviced. There is a danger of explosion if battery is incorrectly replaced. Refer
servicing to qualified personnel.
 To avoid the risk of electric shock, this equipment must only be connected to a supply mains
with protective earth.
 To avoid product damage, do not repair or replace power supply and USB Cable. Refer
servicing to qualified personnel.
 This equipment needs special precautions regarding EMC (Electromagnetic Compatibility)
and needs to be put into service according to the EMC information provided in section 16
“Electromagnetic Compatibility”.
 Do not connect additional accessory equipment to the analog and digital interfaces for signal
input or output. Personnel who connect additional equipment configure a medical system;
degraded performance and damage to the unit could occur.
 Part of defibrillation proof protection is provided by the S-Cath temperature probe. Do not
use with any other applied part.
Caution is a statement that alerts the user to the possibility of a problem with the device
associated with its use or misuse. Such problems include device malfunction, device failure,
damage to the device or damage to other property.
Warning is a statement that alerts the user to the possibility of injury, death, or other serious
adverse reactions associated with the use or misuse of the device.
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2. Indications for use:
Display continuous temperature measurement (C) from 12-sensor temperature probe.
3. Description:
The CIRCA Scientific Temperature Monitoring System consists of a touch-screen monitor,
bracket, and power supply. The monitor is to be used with CIRCA Scientific interconnect cable
and temperature probe only. The interconnect cable and temperature probe are sold separately.
Touch Screen Monitor
Power Button
Power Supply
Bracket
USB
Cable
Monitor (Front View)
Temperature Probe (Sold Separately)
Monitor (Back View)
Interconnect Cable
(Sold Separately)
[Figure 1: System Equipment]
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The monitor displays 12 temperature probe sensor readings (C), the maximum temperature of
all sensors, and contains an alarm system with user-selected levels. The monitor features the
following three screens:
Maximum
Temperature
Channel
Graphs
Set Up
[Figure 2: Display Screens]
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Note: numbered channels 1 through 12 correspond to each sensor located within the S-Curve of
the temperature probe. Channel number begins with sensor #1 located on distal end.
Sensor #1
#2
#3 …..
#12
[Figure 3: Temperature Probe Sensor Location]
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4. Alarm System Overview
The alarm system provides visual and audible feedback when a sensor temperature is equal to
and above the user-selected value.
The alarm system is intended to provide operator feedback regarding temperature compared to
user-selected levels only; it does not provide physiological alarm conditions.
The visual and audible signal is triggered when a sensor temperature is equal to and above the set
value. Alarm levels are set by the operator (see Operating Instructions section below for setting
instructions).
WARNING is a lower priority than ALARM.
WARNING is identified by YELLOW.
ALARM is identified by RED.
AUDIO OFF inactivates the audible signal, only until another event occurs. Another event
includes maximum temperature increasing from warning to alarm level, or temperature drops
below warning or alarm value, then increases and is equal and above set value.
[Figure 4: Warning Signal]
[Figure 5: Alarm Signal]
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5. Setup instructions:
The operator is responsible for checking the compatibility of the monitor, interconnect cable, and
temperature probe before use. Ensure only CIRCA Scientific components and equipment is
connected.
S1) Mount monitor to standard IV pole or similar rigid structure. Secure by tightening knob
located at the bottom of the bracket.
S2) Adjust monitor to desired position (tilt position and angle) using lock levers located on
bracket. (Note: intended position of the Operator to observe the Alarm Signal is within an
approximate distance of 4.5 feet (1.4 meters).)
S3) Connect interconnect cable to monitor (connection located on back of monitor) by aligning
snap-fit connectors and pushing firmly.
S4) Connect temperature probe to interconnect cable by aligning snap-fit connectors and
pushing firmly.
S5) Plug power cord into power outlet. Warning: To avoid the risk of electric shock, this
equipment must only be connected to a supply mains with protective earth.
Cable to Monitor
connection
Lever Locks
Tightening Knob
Cable to Temperature Probe
connection
Power Supply
(100-240 AC)
[Figure 6: Setup Connections]
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6. Check-out Instructions
C1) Turn monitor on by momentarily pushing Power Button located on back of monitor.
C2) During start-up, monitor will deliver a test audible alarm signal (3 beeps). If no audible
signal is heard, sound system is defective. Refer service of monitor to qualified personnel.
C3) Verify temperatures are displayed on monitor. If no temperature displays, verify
connections are fully seated and resolve any error messages displayed on monitor.
The following messages will display if cables are not connected or unit does not initialize:
Message
Resolution
Touch “OK” button.
Ensure USB Cable (back of monitor) is firmly
seated in ports. Reconnect cable.
Proceed with Shut Down from Windows
screen.
Turn monitor back on by momentarily pushing
Power Button on back of monitor.
Ensure temperature probe is firmly seated to
interconnect cable and interconnect cable is
firmly seated to monitor.
When properly connected, message will
terminate and temperature readings display.
Touch “OK” button.
Ensure USB Cable (back of monitor) is firmly
seated in ports. Reconnect cable.
Proceed with Shut Down from Windows
screen.
Turn monitor back on by momentarily pushing
Power Button on back of monitor.
[Table 1: Message Overview]
C4) Proceed with operating instructions below.
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7. Operating instructions
Screen navigation and set-up is by touch screen. Different screens may be selected by touching
the tab near the top of the screen.
Maximum Temperature
Channel Graphs
Set Up
Touch Tab to Select
[Figure 7: Display Screens]
O1) Select “Set Up” tab to set desired alarm system levels and graph y-axis minimum and
maximum.
[Figure 8: Set Up Screen]
a. Settings – touch “+” button to increase value, touch “-“ to decrease value. (Note:
warning temperature cannot be set equal to or greater than alarm temperature.
Graph maximum and minimum cannot be set below alarm and warning levels.)
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b. Alarm and Warning Audible Levels – touch “ALARM” or “WARNING” button
to hear and update audible tone and volume settings. (Note: warning volume
cannot be set equal to or greater than alarm volume.) Touch bar graph level to
desired setting and then “UPDATE” button to save and exit.
[Figure 9: Tone and Volume Setting]
Note: all user selected values are retained; the last settings used before shut down will be those
recalled upon start-up.
O2) Once set up is complete, select desired screen, either “Maximum Temperature” or “Channel
Graphs” in which to view temperatures measured by the temperature probe.
O3) Disconnect probe from interconnect cable by grasping connectors. Do not pull on cable or
probe wire to disconnect. (Note: after disconnecting, the message “No valid temperature
data. Please check probe.” will display.)
O4) Prepare temperature probe for patient use per temperature probe‟s instructions for use.
O5) Once temperature probe is set in patient and connected to interconnect cable, temperatures
will display.
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8. Shut-Down
Turn monitor off by following 3 steps:
Step 1:
Go to “Set Up” Screen and select “Stop” Button:
Select “Stop” Button
After Selecting “Stop”, Program will exit to Windows Screen.
Step 2: Select “Start” – “Shutdown”:
Select “Start” Button
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Select “Shut Down” Button
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Step 3: Select “OK” and unit will shut down:
Select “OK” Button
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9. Cleaning and Disinfection
Disconnect from power before cleaning.
Use a damp cloth. Do not use liquid or spray detergents for cleaning.
Wipe outer surfaces with damp cloth and let dry. Do not rinse, soak, wash or sterilize.
If disinfection is required, apply non-abrasive/non-corrosive disinfection fluid to disposable
cloth, wipe outer surfaces, and then let dry.
10. Maintenance
Routine Visual Inspection
Visually inspect the monitor and all accessories at least once before each use. Inspect the power
cord, cables, and monitor for damage, wear, and loose components. Particular attention should
be made to the power cord and interconnect cable for insulation damage such as cuts, brittleness,
cracking, and bare spots. Do not use if equipment appears damaged.
Annual Safety Inspection and Accuracy Test
The following safety inspection and accuracy test should be performed by hospital‟s equipment
service department at least every 12 months:
 Inspect the equipment and accessories for mechanical damage.
 Inspect all labels and markings for legibility.
 Check temperature accuracy with the following test:
Equipment: 10K Resistor Test Part (available from CIRCA Scientific)
1. Connect Test Part to Interconnect Cable.
2. Turn unit on.
3. Observe temperature readings (12) displayed on the monitor.
4. Calculate the measurement error for each individual Output Temperature measurement by
subtracting reading from 25.0C.
5. Ensure that the measurement error is not greater than 0.3C.
Do not use equipment if the inspections or test reveal a defect. The equipment has no
serviceable parts. Warning: to prevent shock, do not remove cover. Refer servicing to qualified
personnel.
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11. Storage & Transport
Do not leave this equipment in an environment where the storage temperature may go below
-20C (-4F) or above 60C (140F). This could damage the equipment.
If shipping equipment, pack in original carton and packing materials. If original packing
material is not available, cover monitor, pack with foam, and ship in sturdy box to prevent
damage during transport.
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12. Troubleshooting
Problem
Resolution
Message
Touch “OK” button.
Ensure USB Cable (back of monitor) is
firmly seated in ports. Reconnect cable.
Proceed with Shut Down from Windows
screen.
Turn monitor back on by momentarily
pushing Power Button on back of
monitor.
Message
Ensure temperature probe is firmly
seated to interconnect cable and
interconnect cable is firmly seated to
monitor.
Replace probe and/or interconnect cable
if no temperature data can be displayed
after verifying connections.
Message
Touch “OK” button.
Ensure USB Cable (back of monitor) is
firmly seated in ports. Reconnect cable.
Proceed with Shut Down from Windows
screen.
Turn monitor back on by momentarily
pushing Power Button on back of
monitor.
Monitor does not boot up and BIOS Configuration
reset to default.
The computer inside the monitor is
provided with a battery-powered realtime clock circuit. The battery has no
power.
Warning: There is a danger of explosion
if battery is incorrectly replaced. Refer
servicing to qualified personnel.
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Problem
Resolution
“----“ is displayed for an individual sensor
temperature reading and an individual sensor graph
(under “Channel Graphs” display) is orange.
No action required.
Frozen Screen: Monitoring indicator does not flash.
Shut down unit and re-start.
The four dashes („----„) and orangecolored graph indicate an individual
sensor wire has failed.
[Table 2: Troubleshooting Overview]
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13. Accessories
The monitor is designed for use with CIRCA Scientific interconnect cables and temperature
probe only. The interconnect cables and temperature probes are sold separately.
Contact CIRCA Scientific or Authorized Distributor for ordering information.
The “Recorder” Port located on the back of the monitor is intended to connect with the 0 to 5V
analog input of a recording device that is compliant with IEC 60601-1. Do not connect this port
to any other device.
Caution: Use of accessories or replacement parts not supplied by CIRCA Scientific can result in
degraded performance and could lead to damage to the unit.
Warning: Use of cables and accessories other than those supplied by CIRCA Scientific may
result in increased emissions or decreased immunity of the equipment.
Power Supply (use only
Sinpro model MPU50-105
power supply)
Recorder
Port
Monitor (Front View)
Temperature Probe (Sold Separately)
USB
Cable
Monitor (Back View)
Interconnect Cable
(Sold Separately)
[Figure 10: Equipment Illustration]
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14. Technical Information
Classification
Class I
Defibrillation-Proof Type BF Applied Part
Continuous Operation
Software
Revision level 1.1
Electrical (Mains)
Mains Supply Voltage: 100-240V AC
Mains Supply Frequency: 47-63 Hz
Mains Rated Input: 1.35A
Electrical (Power
Supply)
Output Voltage: 12V DC
Max
Current: 3.75A Max
Use only Sinpro model MPU50-105 power supply.
Electrical (Monitor
Power Input)
Input Voltage: 12-19 V DC
Electrical (Safety and
Electromagnetic
Compatibility)
Meets IEC 60601-1:1988 +A1:1991 + A2:1995
User Settings
Alarm and Warning Temperature Levels in 0.1C increments
Current: 3.75-2.63A
Meets IEC 60601-1-2:2007
Alarm and Warning Tone and Volume 1 – 10 in single digit increments
Graph y-axis Minimum and Maximum in 1C increments
Setting range = 0C to 90C
Measurement Display
Update rate = 50 milliseconds
Graph time span = 60 seconds
Accuracy = ± 0.3C
Precision = 0.1C
Alarm System
Intended position of the Operator to observe the Alarm Signal is within
an approximate distance of 4.5 feet (1.4 meters).
Alarm Signal Sound Pressure Range = 45 to 85 dB
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Physical
Dimensions (monitor): 10.2” W x 7.8” H x 3.25” D
258 W x 199 H x 83 D (mm)
Weight: 5.5 lbs. (2.6 kg)
Disposal
No special precautions are required. Dispose of equipment per hospital
policy.
EU Only: Products affected by the directive Waste of Electrical and
Electronic Equipment (WEEE). These products are not to be discarded
together with non-electrical or non-electronic products.
[Table 3: Technical Information]
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15. Symbols Key (Equipment Markings)
Alternating current
Dangerous voltage
Direct current
Caution
“ON” / “OFF” (push-push)
NOTE Each position,
"ON" or "OFF", is a stable
position.
EU Only: Products affected by
the directive Waste of
Electrical and Electronic
Equipment (WEEE). These
products are not to be discarded
together with non-electrical or
non-electronic products.
Centre Positive.
Indicates that the center
(tip) of the output plug is
Positive (+) and the barrel
of the output plug is
Negative (-).
Rx Only
For indoor use only
Defibrillation-Proof
Type BF Applied Part
Manufacturer
Consult Instructions for
Use
Date of Manufacture
Caution: Federal (U.S.A.)
law restricts this device to
sale by or on the order of a
physician
Serial Number
Caution: part of
defibrillation proof
protection is provided by
the S-Cath temperature
probe. Do not use with
any other applied part.
Catalogue Number
[Table 4: Symbols Key]
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16. Electromagnetic Compatibility
 Warning: Use of cables and accessories other than those supplied and sold by CIRCA
Scientific may result in increased emissions or decreased immunity of the equipment.
 Warning: The equipment should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the monitor should be observed to verify normal
operation. Normal operation is considered as absence of unusual, erratic variations in
temperature readings.
 The equipment may be affected by portable and mobile RF (Radio Frequency)
communications equipment.
Table 5 – Guidance and manufacturer’s declaration – Electromagnetic Emissions
The CIRCA Scientific CS-1000 Temperature Monitoring System is intended for use in the
electromagnetic environment specified below.
The customer or the user of the CIRCA Scientific CS-1000 Temperature Monitoring System
should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
Group 1
The CIRCA Scientific CS-1000 Temperature
Monitoring System 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.
CISPR 11
RF emissions
Class A
CISPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
Complies
The CIRCA Scientific CS-1000 Temperature
Monitoring System is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.
IEC 61000-3-3
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Table 6 – Guidance and manufacturer’s declaration – Electromagnetic Immunity
The CIRCA Scientific CS-1000 Temperature Monitoring System is intended for use in the
electromagnetic environment specified below.
The customer or the user of the CIRCA Scientific CS-1000 Temperature Monitoring System
should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
± 6 kV contact
± 6 kV contact
± 8 kV air
± 8 kV air
Electrical fast
transient / burst
± 2 kV for power
supply lines
± 2 kV for power
supply lines
IEC 61000-4-4
± 1 kV for input /
output lines
± 1 kV for input /
output lines
Surge
± 1 kV line(s) to
line(s)
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
± 2 kV line(s) to
earth
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
<5 % UT
(>95 % dip in UT)
for 5 s
IEC 61000-4-2
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
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Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Mains power quality
should be that of a typical
commercial or hospital
environment.
Mains power quality
should be that of a typical
commercial or hospital
environment.
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user of
the CIRCA Scientific CS1000 Temperature
Monitoring System
requires continued
operation during power
mains interruptions, it is
recommended that the
CIRCA Scientific CS1000 Temperature
Monitoring System be
powered from an
uninterruptible power
supply or a battery.
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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.
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Table 7 – Guidance and manufacturer’s declaration – Electromagnetic Immunity
The CIRCA Scientific CS-1000 Temperature Monitoring System is intended for use in the
electromagnetic environment specified below.
The customer or the user of the CIRCA Scientific CS-1000 Temperature Monitoring System
should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance Electromagnetic environment
level
- guidance
Portable and mobile RF
communications equipment
should be used no closer to any
part of the CIRCA Scientific
CS-1000 Temperature
Monitoring System, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance:
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2,5 GHz
3 Vrms
d = 1.2 √
3 V/m
d = 1.2 √
80 to 800 MHz
d = 2.3 √
800 MHz to 2.5 GHz
Where 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
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transmitters, as determined by
an electromagnetic site
(a)
survey should be less than the
compliance level in each
(b)
frequency range .
Interference may occur in the
vicinity of equipment that
include RF transmitters or that
apply RF electromagnetic
energy for diagnosis, i.e.
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 CIRCA Scientific CS-1000 Temperature Monitoring
System is used exceeds the applicable RF compliance level above, the CIRCA Scientific CS1000 Temperature Monitoring System should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating the CIRCA Scientific CS-1000 Temperature Monitoring System.
(b)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Note: If high frequency surgical equipment is used at the same time and interferes with the
operation of the CIRCA Scientific CS-1000 Temperature Monitoring System, additional
measures may be necessary, such as re-orientation of cables, relocation, and/or connecting the
hospital grade power cable into a different grounded receptacle or separate grounded power
source.
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Table 8 – Recommended separation distances between portable and mobile RF
communications equipment and the CIRCA Scientific CS-1000 Temperature Monitoring
System
The CIRCA Scientific CS-1000 Temperature Monitoring System is intended for use in an
electromagnetic environment in which radiated RF disturbances are controlled. The customer or
the user of the CIRCA Scientific CS-1000 Temperature Monitoring System can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the CIRCA Scientific CS-1000 Temperature
Monitoring System as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum
output power of
transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
W
d = 1.2 √
d = 1.2 √
d = 2.3 √
0.01
0.12 meters
0.12 meters
0.23 meters
(4.7 inches)
(4.7 inches)
(9.1 inches)
0.38 meters
0.38 meters
0.73 meters
(15.0 inches)
(15.0 inches)
(28.7 inches)
1.2 meters
1.2 meters
2.3 meters
(3.9 feet)
(3.9 feet)
(7.6 feet)
3.8 meters
3.8 meters
7.3 meters
(12.5 feet)
(12.5 feet)
(24.0 feet)
12 meters
12 meters
23 meters
(39.4 feet)
(39.4 feet)
(75.5 feet)
0.1
1
10
100
Separation distance according to frequency of transmitter
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 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.
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