ZOLL IVTM User manual

IVTMTM Intravascular Temperature
Management
OPERATION MANUAL
601285-001 Rev. 4
Caution: Federal law restricts this device to sale by or on the order of a physician.
EC REP
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands

©2019 ZOLL Circulation, Inc. All rights reserved. Thermogard XP, Cool Line, Icy, Quattro, Solex 7, and IVTM are
trademarks or registered trademarks of ZOLL Medical Corporation and/or ZOLL Circulation, Inc. All trademarks
are the property of their respective owners.
Patent: www.zoll.com/patents
ZOLL Circulation, Inc.
2000 Ringwood Avenue
San Jose CA 95131 USA
[phone] (main)
[phone] (fax)

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Table of Contents
1. Safety Information............................................................................................................................... 1
Overview ................................................................................................................................................ 1
Warnings, Cautions, and Notes ......................................................................................................... 1
Definitions of Symbols and Labels Used on the Product and in the Manual ............................................. 1
General Safety Precautions ..................................................................................................................... 2
Guidance and Manufacturer’s Declaration–
Electromagnetic Emissions ...................................................................................................................... 3
Electromagnetic Immunity Declaration (EID)............................................................................................ 3
Transportation, Shipping and Storage Conditions ................................................................................... 7
Ignition of Flammable Anesthetic Mixtures ............................................................................................. 8
Electrical Hazards.................................................................................................................................... 8
Primary Patient Temperature Probe (T1) Failure..................................................................................8
Configuration Changes .......................................................................................................................... 8
Priming the Saline Circuit........................................................................................................................ 9
Air Entry Into the Tubing Circuit ............................................................................................................. 9
Check the Integrity of the Catheter ................................................................................................... 9
Check the Integrity of the Start-Up Kit Tubing ................................................................................... 9
Interference.......................................................................................................................................... 10
Product Label ....................................................................................................................................... 10
2. Introduction........................................................................................................................................ 11
Use of the System................................................................................................................................. 11
Operating Life ................................................................................................................................. 11
Functional Description .......................................................................................................................... 11
Console Components ........................................................................................................................... 12
Controls and Display Screen ............................................................................................................ 12
Recirculating Chiller......................................................................................................................... 14
Temperature Controller ................................................................................................................... 14
Start-Up Kit ..................................................................................................................................... 16
Saline Circuit Diagram .......................................................................................................................... 18
Indications for Use - USA ...................................................................................................................... 19
Indications for Use – Cool Line Catheters.............................................................................................. 19
Indications for Use – All Other Catheters .............................................................................................. 19
3. Receiving, Inspection, and Assembly ............................................................................................... 21
Overview .............................................................................................................................................. 21
Inspection for Damage ......................................................................................................................... 21
Required Tools...................................................................................................................................... 21
Unpacking............................................................................................................................................ 21
Assembly.............................................................................................................................................. 22
4. Operation ........................................................................................................................................... 25
Overview .............................................................................................................................................. 25
Operating States................................................................................................................................... 25

ii
Setup .............................................................................................................................................. 25
Standby........................................................................................................................................... 27
Run - Treatment Modes .................................................................................................................. 27
User Interface ....................................................................................................................................... 28
Display Screen ................................................................................................................................. 28
Changing Target Temperature......................................................................................................... 30
Changing Treatment Mode ............................................................................................................. 30
Console Menus .................................................................................................................................... 33
Hi/Lo Patient Temperature Alarms ................................................................................................... 34
Bath Pre-set..................................................................................................................................... 35
Time and Date................................................................................................................................. 36
ºC/ºF (Temperature Notation) .......................................................................................................... 37
Language ........................................................................................................................................ 38
Standby Timer ................................................................................................................................. 38
T1/T2 Behavior ..................................................................................................................................... 39
First Use Warning – No T2 Probe ..................................................................................................... 40
T2 Probe Disconnection/Reconnection .............................................................................................40
Accidental Disconnection T1/T2 Probe ............................................................................................. 41
Alarms & Alerts .................................................................................................................................... 41
Alerts ................................................................................................................................................... 41
Alarms.................................................................................................................................................. 42
Your First Case ..................................................................................................................................... 43
What you need..................................................................................................................................... 43
Preparing the Console for Treatment .................................................................................................... 44
Installing the Start-Up Kit ................................................................................................................ 49
Setup - Variations ................................................................................................................................. 60
Setup Sequence.................................................................................................................................... 60
Time From Last Power Down ........................................................................................................... 60
Downloading Data After Improper Shutdown....................................................................................... 61
Ending Treatment................................................................................................................................. 65
End Procedure................................................................................................................................. 65
Data Download ............................................................................................................................... 65
New Patient – No Power Down............................................................................................................. 68
Change the Start-Up Kit .................................................................................................................. 68
Delete Previous Patient Data............................................................................................................ 68
Disposal of Used Components .............................................................................................................. 68
Temperature Trend Data....................................................................................................................... 69
Overview......................................................................................................................................... 69
Displaying the Temperature Trend Graph.............................................................................................. 69
Temperature Trend Graph .................................................................................................................... 70
Patient Temperature........................................................................................................................ 71
System Activity ................................................................................................................................ 71
Cursor............................................................................................................................................. 71
Status Bar........................................................................................................................................ 71
Setting the Time Scale .......................................................................................................................... 72
Mechanical Components ...................................................................................................................... 73

iii
Top Cover ............................................................................................................................................ 73
Display Head Tilt................................................................................................................................... 73
Casters ................................................................................................................................................. 74
Hospital Monitor Interface Accessory (HMIA) ........................................................................................ 75
Overview .............................................................................................................................................. 75
Operating the HMIA ............................................................................................................................. 75
Connecting to the Hospital Monitor ................................................................................................ 75
To begin operation.......................................................................................................................... 76
Controls and indicators on the HMIA............................................................................................... 76
Operating States ............................................................................................................................. 77
Calibration ...................................................................................................................................... 77
Installation............................................................................................................................................ 78
Installation Equipment..................................................................................................................... 78
Installation Procedure ...................................................................................................................... 78
Removal of the HMIA ...................................................................................................................... 80
Connection Cable Part Numbers...................................................................................................... 81
Data Download .................................................................................................................................... 81
Troubleshooting ................................................................................................................................... 81
Errors .............................................................................................................................................. 82
YSI-400 Temperature vs. Resistance...................................................................................................... 83
5. Alarms and Corrective Actions.......................................................................................................... 85
Overview .............................................................................................................................................. 85
Alarms and Corrective Actions.............................................................................................................. 85
6. Troubleshooting................................................................................................................................. 89
Overview .............................................................................................................................................. 89
Symptoms and Remedies...................................................................................................................... 89
Events Requiring Technical Assistance................................................................................................... 91
7. Maintenance....................................................................................................................................... 93
Overview .............................................................................................................................................. 93
Safety Precautions ................................................................................................................................ 93
Scheduled Maintenance ....................................................................................................................... 93
Unscheduled Maintenance ................................................................................................................... 94
Inspect/Replace Condenser Filter ..................................................................................................... 94
Temperature Accuracy Test ............................................................................................................. 95
Clean Console and Condensate Pan ................................................................................................95
Drain Coolant.................................................................................................................................. 96
8. Warranty and Service ........................................................................................................................ 99
Warranty .............................................................................................................................................. 99
Technical Support and Resources.......................................................................................................... 99
Obtaining Service from ZOLL ................................................................................................................ 99
Packing and Shipping Instructions......................................................................................................... 99
Disposal of the Console ...................................................................................................................... 100
9. Specification ..................................................................................................................................... 101

iv
Specifications ..................................................................................................................................... 101

1
1. Safety Information
Overview
Safety is of primary concern to ZOLL Circulation, Inc. This chapter provides information on safely using the
Thermogard XP system. You must read and understand the information in this chapter before operating the
system. Always follow the warnings, cautions, and notes throughout this document.
If you have questions about the safe or effective use of the system, please contact the manufacturer.
Warnings, Cautions, and Notes
This document uses the following conventions to indicate important information:
WARNING. Warnings indicate events or conditions that can result in serious injury or death or severe damage
to the equipment.
Caution. Cautions indicate information for safe operation, proper performance, or avoiding actions that may
result in damage to the equipment.
Note. Notes clarify understanding, aid in the proper operation of the product, and prevent problems or errors
from occurring.
Definitions of Symbols and Labels Used on the Product
and in the Manual
Symbol Definition Symbol Definition
Attention. Consult accompa-
nying documents
This symbol designates the
connector for the data acqui-
sition cable
Dangerous voltage warning Fragile contents
Alternating current Do not allow liquids to spill
on the product or package.
Protective earth (ground) Do not stack
Type B applied part. Defibril-
lator protected
Type BF applied part.
Defibrillator protected

2
General Safety Precautions
WARNING. Systemic hypothermia risks. Systemic hypothermia may cause cardiac arrhythmia, patient shiv-
ering, or other system or organ complications. Systemic hypothermia should only be utilized under the super-
vision of a qualified physician.
When treating a patient with the console, appropriately qualified medical staff must routinely and closely mon-
itor the patient and must comply with the following procedures:
• Audible and visual alarms generated by the console require the authorized individual to remain in close
proximity to the patient throughout the procedure.
• Always verify the function of the console prior to insertion of an IVTM catheter. In the event of a malfunc-
tion, have other means of cooling available.
• When combining the use of the system and other adjunctive means of cooling, ensure that close observa-
tion of the patient is maintained.
• Do not use the system in conjunction with other temperature maintenance devices that have an automatic
temperature controller. Temperature oscillations may occur that are dangerous to the patient.
• Performance of installation, operation, or maintenance procedures other than those described in this man-
ual may create hazards and may cause the manufacturer’s warranty to become void.
• Sterile components are designed for a single use only. If unauthorized disposable components are used,
proper operation cannot be guaranteed and harm to the patient may result.
• Proper aseptic technique must be used while making all sterile connections to the system.
• Never operate damaged or leaking equipment.
• Never operate the equipment without coolant fluid in the coolant well.
• Never use pure water, pure propylene glycol, or alcohol as a coolant fluid.
• Never operate the equipment while smoking or in the presence of open flame.
• Avoid touching the patient simultaneously with metal parts in the console.
Do not push or pull on the
display head Top facing up
Fuse Lo The low patient temperature
alarm limit
Potential Equalization Con-
ductor. This is a safety mea-
sure to prevent earth current
loops in equipment
Hi The high patient tempera-
ture alarm limit
On Danger: Keep hands and fin-
gers away
Off Weight

3
WARNING. Electric shock risk during cardiac defibrillator discharge. The console’s protection against the
effect of the discharge of a cardiac defibrillator is partially in the patient temperature probe. To prevent poten-
tial hazards to the patient or operator, the console must be used in conjunction with the approved patient
temperature probes listed in Specifications section of this manual.
Guidance and Manufacturer’s Declaration–
Electromagnetic Emissions
Electromagnetic Immunity Declaration (EID)
The Thermogard XP console is intended for use in the electromagnetic environment specified below. The
customer or user of the console should ensure that it is used in such an environment.
The Thermogard XP console is intended for use in the electromagnetic environment specified below. The
customer or user of the console should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic Environment Guidance
RF Emissions
CISPR 11 Group 1
The Thermogard XP console uses RF energy for its internal function
only. Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby equipment.
RF Emissions CISPR 11 Class A The console is suitable for use in all establishments other than
domestic establishments and those directly connected to a low-
voltage power supply network that supplies buildings used for
domestic purposes.
Note. The emissions characteristics of this equipment make it suit-
able for use in industrial areas and hospitals (CISPR 11 Class A). If it
is used in a residential environment (for which CISPR B is normally
required), this equipment might not offer adequate protection to
radiofrequency communication services. You may need to relocate
or re-orient the equipment.
Harmonic Emissions
IEC 61000-3-2 Class A
Voltage Fluctuations /
Flicker Emissions
IEC 61000-3-3
Complies
Table 1.1. Guidance and Manufacturer’s Declaration–Electromagnetic Emissions
Immunity Test IEC 60601 Test
Level Compliance Level Electromagnetic environment -- guidance
Electrostatic dis-
charge (ESD)
IEC 61000-4-2
± 8kV contact
± 15 kV air
± 8kV contact
± 15 kV air
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be 30% or higher.
Electrical fast transit/
burst
IEC 61000-4-4
±2 kV for power
supply lines
±1kV for input/
output lines
±2 kV for power
supply lines
±1kV for input/out-
put lines
Mains power quality should be that of a
typical commercial or hospital environ-
ment.
Surge
IEC 61000-4-5
±1kV differential
mode
±2kV common
mode
±1kV differential
mode
±2kV common
mode
Mains power quality should be that of a
typical commercial or hospital environ-
ment.
Table 1.2. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

4
Voltage dips, short
interruptions, and
voltage variations on
power supply input
lines
IEC 61000-4-11
Voltage Dips >
95% reduction,
0.5 period At 0°,
45°, 90°, 135°,
180°, 225°, 270°
and 315°
Voltage Dips >
95% reduction,
0.5 period At 0°,
45°, 90°, 135°,
180°, 225°, 270°
and 315°
Mains power quality should be that of a
typical commercial or hospital environ-
ment. If you require continued operation
during power mains interruptions, we
recommend that the console be powered
by an uninterruptable power supply or a
battery.
Voltage Dips >
95% reduction, 1
period At 0°
Voltage Dips >
95% reduction, 1
period At 0°
Voltage
Interruptions >
95% reduction,
250/300 periods
Voltage
Interruptions >
95% reduction,
250/300 periods
Power frequency (50/
60 Hz) magnetic field
IEC 61000-4-8
30 A/m 30 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical loca-
tion in a typical commercial or hospital
environment.
The Thermogard XP console is intended for use in the electromagnetic environment specified below. The
customer or user of the console should ensure that it is used in such an environment.
Immunity Test IEC 60601 Test
Level Compliance Level Electromagnetic environment guidance
Conducted RF
immunity
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
150 kHz to 80 MHz
Portable and mobile RF communications
equipment should be used no closer to
any part of the console, including cables,
than the recommended separation dis-
tance calculated from the equation appli-
cable to the frequency of the transmitter.
Recommended separation distance
150 kHz to 80 MHz
d = 1.2 , 80 to 800 MHz
d = 2.3 , 800 MHz to 2.7 GHz
6 Vrms in ISM
bands within
150 kHz and
80 MHz
6 Vrms in ISM
bands within
150 kHz and
80 MHz (see Note
3)
80% AM at 1 kHz 80% AM at 1 kHz
Immunity Test IEC 60601 Test
Level Compliance Level Electromagnetic environment -- guidance
Table 1.2. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

5
Note. The following degradation associated with essential performance are not allowed during testing: com-
ponent failure, changes in programmable parameters, resets to factory defaults, changes in operating modes,
false alarms, cessation or interruption of any intended operation, even if accompanied by an alarm, initiation
of any unintended operation, including unintended or uncontrolled motion, even if accompanied by an alarm,
error of a displayed numerical value sufficiently large to affect diagnosis or treatment, noise on a signal in
which the noise is indistinguishable from physiologically-produced signals or the noise interferes with interpre-
tation of physiologically-produced signals.
Radiated RF
IEC 61000-4-3
3V/m
80 Mhz to
2.7 GHz
3V/m
Where P is the maximum 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 determined by electromagnetic site
survey,1should be less than the compli-
ance level in each frequency range.2
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Note 1. At 80 Mhz and at 800 MHz, the higher frequency range applies.
Note 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorp-
tion and reflection from structures, objects, and people.
Note 3. The frequency range between 100-150 kHz is associated with interference from low frequency RFID
equipment.
Note 4. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz tested are
6.765 MHz to 6.975 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to
40.70 MHz.
Note 5. Tested for immunity to RF interference from transmitters operating at 125 kHz, 134.2 kHz and in
the frequency ranges between 3.155 MHz to 3.4 MHz and between 7.4 MHz to 8.8 MHz.
1. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcasts 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 mea-
sured field strength in the location in which the console is used exceeds the applicable RF compliance level above, the con-
sole should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the console.
2. Unless otherwise noted, over the frequency ranges 150 kHz to 80 Mhz, field strength should be less than 10 V/m.
The Thermogard XP console is intended for use in an electromagnetic environment in which radiated RF dis-
turbances are controlled. You can help prevent electromagnetic interference by maintaining a minimum dis-
tance between portable and mobile RF communications equipment (transmitters) and the console as
recommended below, according to the maximum output power of the communications equipment.
Table 1.3. Recommended separation distances between portable and mobile RF communications
equipment and the console.
Immunity Test IEC 60601 Test
Level Compliance Level Electromagnetic environment guidance

6
Radiated maximum
output power of
the equipment (in
Watts)
Separation distance according to frequency of transmitter (in meters)
150 kHz to 80 MHz
inside ISM bands
150 kHz to 80 MHz
inside ISM bands
80 MHz to
800 MHz
800 MHz to
2.7 GHz
0.01 0.12 0.12 0.12 0.23
0.1 0.38 0.38 0.38 0.73
1 1.2 1.2 1.2 2.3
10 3.8 3.8 3.8 7.3
100 12 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters can be determined using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in Watts according to the transmitter manufacturer.
Note 1. At 80 MHz and at 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 absorp-
tion and reflection from structures, objects, and people.
Test
Frequency
(MHz)
Band1
(MHz) Service1Modulation2
Maximum
Power
(W)
Distance
(m)
Immunity
Test Lev el
(V/m)
Equipment: Valid test levels for professional healthcare facility
385 380 –390 TETRA 400 Pulse modulation2
18 Hz 1.8 0.3 27
450 430 – 470
GMRS 460,
FRS 460
FM3
± 5 kHz deviation
1kHzsine
20.328
710
704 – 787 LTE Band 13,
17
Pulse modulation2
217 Hz
20.328745
780
810
800 – 960
GSM 800/
900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation2
18 Hz
20.328
870
930
Table 1.4. Guidance and Manufacturer Declaration - Immunity to RF Wireless Communications
Table 1.3. Recommended separation distances between portable and mobile RF communications
equipment and the console.

7
Transportation, Shipping and Storage Conditions
When shipping or storing the console, follow these recommendations:
• Do not allow liquids to spill on the console or its packaging.
• Keep in a cool, dry place.
• Fragile contents, handle with care.
• Always handle and store with the top facing up.
When transporting the console around the hospital, follow these recommendations:
• Move the console by the handle only; do not push or pull on the display head.
• Request assistance from another person to lift the front wheels of the console when moving it over a
threshold. Use handle to gently pull unit over the obstacle while your assistant stabilizes the front of the
unit.
WARNING. Tipping hazard. The console may tilt in case of transport outside its crate and over a threshold.
1720
1 700 –
1 990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3,
4, 25; UMTS
Pulse modulation2
217 Hz
20.328
1845
1970
2450
2 400 –
2 570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse modulation2
217 Hz
20.328
5240 5 100 –
5 800
WLAN
802.11
a/n
Pulse modulation2
217 Hz
0.2 0.3 9
5500
5785
1. For some services, only the uplink frequencies are included.
2. The carrier shall be modulated using a 50% duty cycle square wave signal.
3. As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent
actual modulation, it would be worst case.
Test
Frequency
(MHz)
Band1
(MHz) Service1Modulation2
Maximum
Power
(W)
Distance
(m)
Immunity
Test Lev el
(V/m)
Table 1.4. Guidance and Manufacturer Declaration - Immunity to RF Wireless Communications

8
Ignition of Flammable Anesthetic Mixtures
The console is not category AP or APG equipment and must not be used in oxygen-rich environments or envi-
ronments where flammable anesthetic gas mixtures are present.
Electrical Hazards
This equipment has been tested and found to comply with the EMC limits of the international standard IEC
60601-1-2. These limits are designed to provide reasonable protection against interference in a typical medical
installation. The equipment can radiate radio frequency energy if not installed in accordance with the instruc-
tions, and may cause harmful interference to other devices in the vicinity. There is no guarantee that interfer-
ence will not occur in a particular installation. Always comply with the following:
• To avoid the risk of electrical shock, do not remove any panels of the product.
• Refer servicing to qualified personnel.
• Never operate equipment with damaged power line cords.
The Thermogard XP requires special precautions regarding EMC and needs to be installed and put into service
according to EMC information provided in this manual.
Portable and mobile RF communications equipment can affect the Thermogard XP.
Caution. Dangerous Voltage. Electric shock hazard. Always turn off the console and disconnect the power
line cord from the source before performing any service or maintenance procedures, or before moving the
console.To avoid the risk of electric shock, this equipment must be connected to a supply mains with protec-
tive earth.
WARNING. The potential equalization conductor should be connected to the potential equalization bus bar of
the electrical installation when available. Refer to the requirements in the IEC 60601-1 standard.
Primary Patient Temperature Probe (T1) Failure
The console relies upon the patient temperature reading from an YSI-400 type thermistor connected to the pri-
mary patient temperature probe (T1). There are rare failures of this type of thermistor that cannot be detected
by the console with 100% reliability. Failure of the T1 can result in either patient hypo- or hyper- thermia.
Death or serious injury to the patient may result. A secondary patient temperature probe (T2) connection is
therefore built into the console. For patient safety, either use both the T1 and T2 connections or employ the T1
probe with an independent frequent check of patient core temperature.
WARNING. Never clinically use a resistor in place of the T1 temperature probe. ZOLL supplies fixed
value resistors and variable resistor test boxes (e.g the TP-400 FOGG Box) for testing, training and demonstra-
tion purposes. These can be plugged into the primary patient temperature probe T1 connection on the front of
the console to represent a patient. Never use this device, or other method, to circumvent the normal patient
temperature feedback control when the console is connected to the patient. Doing so exposes the patient to
the hazards associated with hypo- or hyper- thermia. Death or serious injury may result.
Configuration Changes
WARNING. No modification of this equipment is allowed.
Caution. Certification requirements for external equipment connected to the console interfaces.
Equipment connected to the analog and digital interfaces must be certified to the respective IEC standards
(i.e., IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all con-
figurations shall comply with the console standard IEC 60601-1. Any person who connects additional equip-

9
ment to the signal input part or the signal output part configures a medical system and is therefore responsible
that the system complies with the requirements of the system standard IEC 60601-1.
Priming the Saline Circuit
WARNING. Do not prime the saline circuit while connected to a patient. During the priming operation,
the air-trap alarm will be disabled. Air present in the saline line may be circulated through the indwelling cath-
eter. Before priming the circuit or during troubleshooting for possible leak, disconnect the heat exchange cath-
eter, then connect the IN and OUT Luers of the saline circuit together.
Air Entry Into the Tubing Circuit
Air entry may occur with the failure of any part of the Start-Up Kit, between the saline bag and the outflow of
the pump. In such cases, the integrity of the catheter prevents air entry into the patient. In the rare event of a
second, simultaneous failure of the catheter, air entry into the patient is possible.
Air entry into the tubing circuit will usually, but not always, be associated with an air trap alarm that will stop
the console. Always investigate air trap alarms. The cooling circuit is a closed loop–usually air trap alarms
indicate a breach somewhere in this closed loop (occasionally an air trap alarm can be caused by condensation
forming on the air trap exterior). With any air trap alarm, check both the integrity of the catheter and the
Start-Up Kit (see below).
Periodically check the Start-Up Kit for significant air bubbles and replace the kit if necessary.
WARNING. Never clinically circumvent the air trap alarm. ZOLL supplies air trap “dummies” for testing,
training and demonstration purposes. These are fluid filled air trap assemblies that are separate from a stan-
dard Start-Up Kit assembly. Never use this device, or other method, to circumvent the air trap alarm when the
console is connected to the patient. Doing so exposes the patient to the hazards associated with air embolism
should the catheter fail. Death or serious injury may result.
Check the Integrity of the Catheter
To check the integrity of the catheter, perform these steps in the indicated order:
1. Stop the console.
2. Using aseptic technique, disconnect the tubing from the catheter and properly cap both the catheter and
the tubing set.
3. Fill a sterile 10 ml syringe with sterile saline.
4. Connect the syringe to the IN lumen of the catheter and disconnect the OUT cap.
5. Infuse the 10 ml of saline – it should flow out the OUT lumen.
6. Cap the OUT lumen and pull and hold 5 ml of vacuum for at least 10 seconds. Approximately 4 ml of
saline, but not blood, should enter the syringe and you should be able to maintain the vacuum.
7. Ease the vacuum, disconnect the syringe, and recap the IN lumen.
Check the Integrity of the Start-Up Kit Tubing
To check the integrity of the Start-Up Kit tubing, perform these steps in the indicated order:
1. Stop the console.
2. Look for obvious leakage.
3. Remove the tubing from the pump and check it for damage. Replace it in the pump if it is undamaged.
4. Inspect the tubing from the pump to the patient for sources of fluid loss:
• Look for damage to the tubing and/or the presence of air inside the tubing.

10
• Inspect, and tighten if necessary, each Luer fitting (do not use instruments to tighten the fittings).
5. Inspect the tubing that returns to the pump from the patient.
6. Examine the saline bag to ensure that it has not been accidentally compromised (for example, the spike
may have damaged the bag wall).
7. Inspect the tubing from the saline bag to the saline reservoir and the pump.
Interference
If the console does cause interference with other devices, which can be determined by turning the console off
and on, try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving device.
• Increase the separation between the console and device.
• Connect the console into an outlet on a circuit different from that to which the other device(s) is con-
nected.
Product Label
An identifying label is attached to the outside of the console near the power cord inlet.
The label provides safety information and identifies the manufacturer, model, serial number, power require-
ments, fuse capacity, and manufacturing date for the console.

11
2. Introduction
Use of the System
WARNING. Patients must be continuously monitored. Patients being treated with the system must be
checked frequently (hourly) when the system is operating. It is possible for malfunctions or misuse of the sys-
tem to result in patient injury or death.
The ZOLL Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange
console (Thermogard XP® console) and an IVTM™ endovascular heat-exchange catheter connected via a ster-
ile heat exchanger and tubing circuit (Start-Up Kit). These components together comprise a patient tempera-
ture-regulation apparatus employing feedback control. The catheter and the Start-Up Kit are single-use
disposable devices.
This manual provides operating instructions for the console and the Start-Up Kit. Catheter components are ref-
erenced where it is necessary to ensure proper use with the system components. Always refer to the catheter’s
Instructions for Use for additional specific information.
Operating Life
The operating life of the catheters may vary according to design as indicated by the model designation. Always
refer to the catheter’s Instructions for Use for information about the catheter’s operating life.
The disposable components of the Start-Up Kit are designed for continuous use for a period not to exceed
seven (7) days on a single patient. After seven days of use, remove and replace the Start-Up Kit with a new
Start-Up Kit.
Caution. Start-Up Kit lifetime is seven days. The designed operating lifetime for Start-Up Kit components
is seven (7) days of continuous operation on a single patient. If a patient must be treated for a longer period, a
new Start-Up Kit must be installed in the console. Failure to adhere to this time limit may cause injury to the
patient.
Product designed for single use only. Do not resterilize or reuse. Do not alter the Start-Up Kit in any way.
Potential risks with re-use of a single use device include but are not limited to:
• Potentially life threatening infection
• Toxic shock due to degradation of materials
• Increased risk of thrombosis
• Reduced heat exchange power
• Device failures
Functional Description
The console can be described in terms of three major components: a recirculating chiller, a roller pump, and a
temperature control system. The system is connected to the temperature-controlled catheter by two small-
bore plastic tubes. One tube supplies temperature-controlled sterile saline solution to the catheter, and the
other tube returns the saline solution to the console. The sterile saline is pumped through a continuous recircu-
lating loop by a peristaltic pump inside the console. The saline solution acts as an intermediate heat-transfer
medium between the patient and the console. Sterile saline is used because it is biologically compatible with
the patient and in the unlikely event of a leak in the catheter, the possibility of harming the patient is reduced
to a practical minimum.

12
Patient temperature feedback is used to control the console. The patient’s temperature is measured by an
indwelling YSI 400 thermistor temperature sensor. In response to the patient’s measured temperature, the con-
sole employs both cooling and heating. Cooling occurs when the patient’s temperature is above the set point
target temperature. Heating occurs when the patient’s temperature is below the set point target temperature.
The amount of heating or cooling power is proportional to the difference in temperature between the set
point target temperature and the patient’s measured temperature.
A basic diagram of the System is illustrated in Figure 2.1.
Figure 2.1. Simplified Flow Diagram
Console Components
Controls and Display Screen
The display head contains four buttons and one knob used to access functions and adjust settings with the aid
of the menus and messages displayed on the screen. The controls and display screen are illustrated in
Figure 2.2 and explained in the following text.
Display Screen
The display screen is a backlit color LCD panel that can be easily read in all ambient lighting conditions. It is
used to display status, menus, messages, alarms, and patient temperature trend graphs.
The display head is attached to the mast by an adjustable swivel/tilt mounting clamp. You can adjust the tilt
and rotation of the display head and lock it into position by using this clamp.
1. Saline bag
2. Peristaltic pump
3. Air trap
4. Heat exchange coil
5. Coldwell
6. Coolant pump
7. Chiller & Heater
8. Catheter
9. Patient
10.Pin wheel flow indicator