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Temperature Modulation Therapy

Philips InnerCool RTx Endovascular System


Enhancing patient care. That’s at the core of the InnerCool RTx Endovascular System.

Modulating patient temperature has been clinically used in The catheter is made of a flexible metallic material with an
limited settings since the 1950s, however in recent years, innovative design of helices and bellows to maximize heat
momentum for Temperature Modulation Therapy is exchange. A balanced electrolyte solution circulates in a
building for more wide-reaching clinical practice uses. As closed-loop manner from the console throughout the
these cases expand and research continues, Philips catheter.
Healthcare is there to meet the needs of patients and
clinicians with the high performance of the InnerCool RTx. The System can be used with either the InnerCool
Accutrol Catheter or Standard Catheter. Both catheters
The InnerCool RTx Endovascular System for cooling and maintain their small profiles in situ unlike catheters with
warming provides rapid cooling power. The System can inflatable balloons. The catheters have a covalently-bonded
induce, maintain and reverse mild hypothermia as well as Heparin coating to minimize blood clotting and they can
maintain normal body temperature (normothermia). It is remain in situ during certain “head-only” MRI procedures.
backed by over 10 years of research in multiple clinical
settings. The Accutrol Catheter also contains an integrated sensor
for temperature feedback. This eliminates the need for an
In creating the InnerCool RTx, our engineers and scientists independently placed temperature probe, avoiding the lag
have developed several unique advances in temperature in core temperature measurement inherent in rectal and
modulation therapy including: bladder sensors.
• The fastest cooling and warming rates in the industry.
• Dynamic temperature modulation (a change in Using an intuitive touch screen, clinicians can select from
temperature of ≥4 °C/hr) for rapid cooling. multiple modes of operation. You can set the InnerCool
• The ability to cool non-paralyzed patients who are RTx to provide active warming and/or cooling. Auto
either awake or unconscious. Rewarm rewarms the patient according to a
• Precise temperature control using the only catheter predetermined set of criteria and Transport Mode allows
that contains an integrated temperature monitoring you to stop treatment, shut the device off, move to
sensor. another location and restart treatment without losing the
• Rapid cooling of patients previously considered current treatment parameters.
“difficult to cool” – those with a Body Mass Index
greater than 30Kg/m2. Whether it is warming, cooling or maintaining normal body
temperature, the InnerCool RTx is ready to provide what
The InnerCool RTx System consists of an endovascular patients need and clinicians require.
catheter, the console, and a heat-transfer circulating
cassette with color-coded tubing. The circulating cassette
is easily inserted into the console making for rapid set-up.

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Features / Supplies

Console Features
Product Ordering Information
• Compact, easily transportable endovascular system
861470 InnerCool RTx Endovascular System (120V)
• Whole body Dynamic Temperature Modulation
861472 InnerCool RTx Endovascular System (240V)
• Controlled cooling and/or warming
• Cools awake, non-paralyzed patients
• Cools patients with high body mass indexes Catheters
• Integrated circulating cassette for easy set-up Standard Catheters
• Color coded tubing for easy set-up 989803172281 10.7F Catheter
• Closed-loop system - no fluid exchange with the 989803172291 14F Catheter
patient
Accutrol Catheters
• Intuitive user interface
• Choice of operating modes 989803172301 10.7F Catheter
• Temperature profile graph 989803172311 14F Catheter
• Auto Rewarm function
• Transport Mode Miscellaneous Supplies
• 10-inch color LCD touch screen on pivoting post Introducer Kits
989803171481 For 10.7F Catheters
Catheter Features 989803171491 For 14F Catheters
• Flexible metallic temperature control element
Circulating Cassette
• Innovative design of helices and bellows for maximum
989803171591 Circulating Cassette
heat exchange
• Integrated temperature sensor (Accutrol only) Temperature Extension Cable
• Easy insertion similar to a central venous line 989803171501 RTx extension cable
• Covalently-bonded Heparin coating Galden® Fluid
• Small profile maintained in situ
989803171511 Galden Fluid
• Can remain in situ during “head-only” MRIs
• Incidence of catheter-related infection no greater than
placement of central venous lines
• Latex-free design

Circulating Cassette Features


• Easy setup for rapid deployment
• Color-coded tubing
• Closed-loop system means no patient fluid exchange
• Latex-free design

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Specifications

Console Environmental
Physical Dimensions Classification: Class 1
Size: inches: 48H x 28.5D x 19.5W Solids/Water IPXO
cm: 121.9H x 72.4 x 49.5W Resistance
Weight: 250 Lbs (114 kg) Patient Type CF Defibrillation Proof
Power Supply Isolation:

AC Input 110-120V, 60Hz, 12A (U.S. Domestic) Mode of Continuous


Voltage: 220-240V, 50/60Hz 8A (International) Operation:
Sterilization: System is not sterilized.
Operating Limits
Atmosphere: Not suitable for use in the presence of
Temp. Range: 12°C to 27°C (54°F to 80°F)
flammable anesthetic mixture with air or
Humidity 30% to 75% (non-condensing)
oxygen or nitrous oxide.
Range:
Interference This equipment has been tested and
Atmospheric 700hPa to 1060hPa
Precaution: found to comply with the limits for
Pressure:
medical devices to IEC 60601-1-2:2001.
Shipping/Storage Limits These limits are designed to provide
Temp. Range: -20°C to 60°C (-4°F to 140°F) reasonable protection against harmful
Humidity 20% to 95% (non-condensing) interference in a typical medical
Range: installation.
Atmospheric 500hPa to 1060hPa Radio This equipment generates, uses and can
Pressure: frequency radiate radio frequency energy and, if
Display energy: not installed and used in accordance with
the instructions, may cause harmful
Type: LCD, 10-inch diagonal, color, VGA;
interference to other devices in the
minimum 45-degree tilt; 75-degree left/
vicinity.
right rotation
Accessory Accessory equipment connected to the
Target Temp. 31.5°C to 37.5°C (88.7°F to 99.5°F)
equipment: analog (T1 and T2) interfaces must be in
Range:
compliance with the respective
Accuracy: +0.1°C (+0.2°C system accuracy when
nationally harmonized IEC standards
including Accutrol Catheter at
(IEC 60601-1 for medical equipment).
temperature readings between 32°C to
42°C)
Battery
Resolution: 0.1°
Type: Panasonic LC-R127R2P; 12V,
Alarms rechargeable, sealed lead acid
Type: Audible tones and displayed messages. Duration: In Transport Mode, the InnerCool RTx
Temperature Probes can store data for one hour on a fully-
Connector YSI400 charged battery
Type: Life 3 years
Refrigerant expectancy:
Primary Loop: R-404a (not an ozone depleting
substance)
Secondary Galden HT135 Perfluoropolyether fluid
Loop:

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Catheter Circulating Cassette
Physical Dimensions Shipping Limits
Size: 10.7F < .018 in. guidewire compatible; Temperature 10°C to 50°C (50°F to 122°F)
14F < .038 in.guidewire compatible Range:
Usable Length: 55 cm Relative 20% to 95% (non-condensing)
Length of 23 cm Humidity:
Temperature Operating Limits
Control Temperature 12°C to 27°C (54°F to 80°F)
Element: Range:
Shaft Markers: Four in total, every 5 cm Relative 30% to 75% (non-condensing)
Temperature Measurement Accuracy Humidity:
Accutrol +0.1°C for readings 32°C to 42°C; Storage Limits
Catheter: +0.2°C for other readings between 0°C Temperature 10°C to 40°C (50°F to 104°F)
to 50°C Range:
Operating Limits Relative 20% to 95% (non-condensing)
Temperature 12°C to 27°C (54°F to 80°F) Humidity:
Range:
Relative 30% to 75% (non-condensing)
Humidity:
Shipping Limits
Temperature 10°C to 50°C (50°F to 122°F)
Range:
Relative 20% to 95% (non-condensing)
Humidity:
Storage Limits
Temperature 10°C to 40°C (50°F to 104°F)
Range:
Relative 20% to 95% (non-condensing)
Humidity:

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Philips Healthcare is part of
Royal Philips Electronics

How to reach us
www.philips.com/healthcare
healthcare@philips.com
fax: +31 40 27 64 887

Asia
+852 2821 5888

Europe, Middle East, and Africa


+49 7031 463 2254

Latin America
+55 11 2125 0744
Galden® is a registered trademark of Solvay Solexis S.p.A., Heparin™ is a
North America trademark of Baxter International Inc. Panasonic® is a registered trademark of
+1 425 487 7000 Panasonic Corporation of North America. Other trademarks and trade names are
800 285 5585 (toll free, US only) those of their respective owners.

Please visit www.philips.com/innercool

© 2010 Koninklijke Philips Electronics N.V.


All rights are reserved.
Philips Healthcare reserves the right to make changes in specifications or to discontinue any product at any time without notice or
obligation and will not be liable for any consequences resulting from the use of this publication.
Printed in The Netherlands.
4522 962 60951 * MAY 2010 InnerCool: 12253