Gentherm BLANKETROL CoolRepeat User manual

CoolRepeat®
BATTERYINDICATOR
THERMISTOR MONITOR CONSOLE
CAUTION: When using Accutrol Catheter please refer to IFU.
NOTE: UNPLUG ALL CONNECTIONS WHEN NOT IN USE.
REPLACE BATTERY WHEN LED IS FLASHING RED.
106724-001Rev 1
Blanketrol Console Patient Monitor Patient / Thermistor
English
1. Connect preattached cable from Blanketrol CoolRepeat
to stereo input on top right side of Blanketrol console.
2. Connect cable from Blanketrol CoolRepeat “monitor”
output to temperature input on patient monitor.
3. Connect extension cable from Blanketrol CoolRepeat
“thermistor” output to patient temperature probe.
4. After connecting all cables, attach Blanketrol CoolRepeat
below cable input on body of Blanketrol console; internal
magnets will ensure it remains in place.
NOTE:
• After connecting device, please wait 30 seconds
before initiating therapy as device will proceed with
automatic self-test at start up; device ‘turns on’ when
thermistor is connected.
CoolRepeat®
CoolRepeat is a connectivity solution that allows for
patient temperature information from an indwelling patient
temperature probe to be communicated to the Blanketrol
cooling/warming system and a patient monitor.
106726-001 Rev. 2

Instructions for Use
3
2
Blanketrol®CoolRepeat®
Graphic Symbols for Medical Device Labeling
Attention: See Instructions for Use
NDate of Manufacture
MManufacturer
Does not contain natural rubber latex
Separate Collection for Electrical and Electronic
Equipment
Do not use if box is damaged
Keep Away From Heat
Store in a Cool Dry Place
Type CF, Defibrillation Proof, Applied Part
Direct Current
Recyclable Paper Product
-20°Cl60°C
Temperature Limitation
Type B Equipment
U.S. Federal law restricts this device to sale by
or on the order of a physician
QTY Quantity
WARNINGS:
• Blanketrol
CoolRepeat must be used with a
Blanketrol system.
• Once thermistor and cables are connected, verify
that temperature consistently displays on console
and monitor.
• Discontinue use if LED on top of unit is not
illuminated when connected to thermistor.
• Inspect all components prior to use. Do not use any
component that appears damaged.
• For unit to function, please make sure battery is
installed and all cables are properly connected.
• Make sure to disconnect thermistor cable after use
to avoid depleting battery as device ‘turns on’ when
thermistor/patient temperature cable is connected.
• Only change battery when device is not connected
to patient.
• Remove battery from device if not likely to be used
for more than 6 months.
• Avoid movement of console when device is
connected to minimize loads on connecting cables.
• Avoid contact with ionic or corrosive fluids.
U.S. Federal law restricts this device to sale on or by
the order of a physician.
Copyright © 2021 ZOLL Medical Corporation. All
rights reserved. ZOLL®, CoolRepeat®are trademarks
or registered trademarks of ZOLL Medical Corpora-
tion and/or its subsidiaries in the United States and/or
other countries. All other trademarks are the property
of their respective owners.
LATEX
1

Instructions for Use
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4
Blanketrol®CoolRepeat®
Specifications
Power Requirements – DC Battery
9V .
Operating Limits
Temperature Range: 10°C to 40°C.
Humidity Range: 20% to 60% (non-condensing).
Atmospheric Pressure: 700 hPa to 1060 hPa.
Input PatientTemperature Range: 0°C-45°C.
Output Accuracy: 0.1 °C in the range of 32°C to 42°C;
0.2 °C outside this range.
Shipping/Storage Limits
Temperature Range: -20 °C to +60 °C.
Humidity Range: 20% to 95% (non-condensing).
Atmospheric Pressure: 500 hPa to 1060 hPa.
Physical Dimensions
Size: 3 H x 1 D x 5.5 W inch; 7.6 x 2.5 14cm.
Weight: 7 ounces (200 grams).
Classification of Equipment
Type B, Applied Part, Internally powered.
Mode of Operation: continuous.
Battery
Indicator
Indicator light on the top edge of the device emits light
patterns to indicate several conditions:
Flashing Green – Normal Operation when unit is ‘on’
(thermistor cable is plugged in).
Flashing Red – Low Battery; replace battery.
Solid Red – Fault State; attempt to re-set device by
disconnecting and re-attaching cables. If Solid Red light
pattern persists, discontinue use, there is a problem with
the device.
Replacement
To replace battery, unplug all cables from the device and
remove from console. Slide open battery compartment door,
carefully disconnect battery and attach new battery.
Suggested Battery: Ultralife 9 Volt Lithium; Part# U9VL-FP.
Disposal
Batteries need to be disposed of in accordance with local
ordinances.
Maintenance
Complete annual accuracy evaluation by connecting device
to thermistor simulator and verify repeated resistance on
outputs.
No user serviceable parts.
Surface of the device should be cleaned regularly with soft
cloth or paper towel dampened with warm water and a mild,
non-abrasive, non-staining hospital disinfectant or detergent.
NOTE:
Lithium-ion 9V battery recommended for maximum
hours of operation, but can also use standard 9V Alkaline
battery.

Instructions for Use
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Blanketrol®CoolRepeat®
Device Inputs
One (1) input forYSI-400 compatible temperature cable.
One (1) output from YSI-400 compatible temperature cable.
Blanketrol Part #8700-000833-01 can be used for both con-
nectors.
Has been designed to be compatible with YSI 400 series
thermistor input monitors with less than 330 microamperes
DC only (non pulsing) thermistor drive current at 7500 ohms.
Only connect to patient monitors that comply with IEC60601-1.
Catalog Number
Blanketrol CoolRepeat catalog number is 8700-001026-01.
For pricing information or to place an order, please
contact the Gentherm Customer Service department at
[phone].
Guidance and Manufacturer’s Declaration
Electromagnetic Emissions
The Blanketrol CoolRepeat Console is intended for use
in the electromagnetic environment specified below. The
customer or the user of the Blanketrol CoolRepeat device
should assure that it is used in such an environment.
Emissions Tests Compliance Electromagnetic Environment Guidance
RF emissions
CISPR 11
Group 1 The Blanketrol CoolRepeat device, Model 25-01 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 The Blanketrol CoolRepeat device, Model 25-01 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.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Complies

Instructions for Use
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Blanketrol®CoolRepeat®
Electromagnetic Immunity
The Blanketrol CoolRepeat device, Model 25-01 is intended
for use in the electromagnetic environment specified below.
The customer or the user of the Blanketrol CoolRepeat
device, Model 25-01 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
±1 kV for input/
output lines
Mains power quality to Blanketrol console should be that of a
typical hospital environment. The Blanketrol CoolRepeat does
not possess a CD power port and the interface cables do not
exceed 3 meters in length.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
±1 kV differential
mode
±2 kV common
mode
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 cycles
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 Blanketrol
CoolRepeat device requires continued operation during
power mains interruptions, it is recommended that the
Blanketrol console be powered from an uninterruptible
power supply.
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: UTis the AC mains voltage prior to application of
the test level.

Instructions for Use
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Blanketrol®CoolRepeat®
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
Blanketrol CoolRepeat device, Model 25-01, including
cables, than the recommended separation distance
calculated from the equation applicable to the frequency
of the transmitter.
Recommended separation distance:
where Pis the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and dis the recommended separation
distance in meters (m). Field strengths from fixed RF
transmitters, as determined by an electromagnetic
site survey,ashould be less than the compliance level
in each frequency range.bInterference may occur in
the vicinity of equipment marked with the following
symbol:
aField 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 predicated theoretically with accuracy.
To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be
considered. If the measure field strength in the location in
which the Blanketrol CoolRepeat device is used exceeds
the applicable RF compliance level above, the Blanketrol
CoolRepeat device should be observed to verify normal
operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating
the Blanketrol CoolRepeat device.
bOver the frequency range 150 kHz to 80 MHz, field strengths
should be less than 3 V/m.
NOTE:
1. At 80 MHz and 800 MHz, the higher frequency range applies.
2. These guidelines may not apply in all situations.Electromagnetic
propagation is affected by absorption and reflection from
structures, objects and people.
Electromagnetic Immunity (continued)

Instructions for Use
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Blanketrol®CoolRepeat®
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
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
NOTE:
1. At 80 MHz and 800 MHz, the higher frequency range applies.
2. These guidelines may not apply in all situations.Electromagnetic
propagation is affected by absorption and reflection from
structures, objects and people.
For transmitters rated at a maximum output power not listed
above, the recommended separation distance din meters
(m) can be estimated using the equation applicable to the
frequency of the transmitter, where Pis the maximum output
power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
Recommended Separation Distances
Recommended Separation Distances Between Portable and
Mobile RF Communications Equipment and the Blanketrol
CoolRepeat Device.
The Blanketrol CoolRepeat device, Model 25-01, is intended
for use in an electromagnetic environment in which radiated
RF disturbances are controlled.The customer or the user of the
Blanketrol CoolRepeat device, Model 25-01 can help prevent
electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment
(transmitters) and the Blanketrol CoolRepeat device, Model 25-
01, as recommended below, according to the maximum output
power of the communications equipment.

Instructions for Use
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Blanketrol®CoolRepeat®
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ZOLL Circulation Inc.
2000 Ringwood Avenue
San Jose, CA 95131 U.S.A.
t: [phone]
Distributed by:
Gentherm Medical
12011 Mosteller Road
Cincinnati, OH 45241
1-513-772-8810
www.gentherm.com
M
ZOLL International Holdings B.V.
Newtonweg 18
6662 PV ELST
The Netherlands
Tel: [phone]