Thermogard XP Operation Manual Rev 10

©2023 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 +1-408-541-2140 (main) +1-408-541-1030 (fax)

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Table of Contents 1. Safety Information ...1 Overview ... 1 Definitions of Symbols and Labels Used on the Product and in the Manual ... 1 General Safety Precautions ... 3 Guidance and Manufacturer’s Declaration–Electromagnetic Emissions ... 4 Electromagnetic Immunity Declaration (EID)... 4 Transportation, Shipping and Storage Conditions ... 8 Ignition of Flammable Anesthetic Mixtures ... 9 Electrical Hazards... 9 Configuration Changes ... 9 Priming the Saline Circuit... 10 Air Entry Into the Tubing Circuit ... 10 Intraluminal or balloon leakage... 10 Interference... 11 Product Label ... 11 2. Introduction ...13 Use of the System... 13 Functional Description ... 13 Console Components ... 14 Saline Circuit Diagram ... 20 Intended Use ... 20 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 User Interface ... 28 Console Menus ... 33 T1/T2 Behavior ... 39 Alarms & Alerts ... 41 Alerts ... 41 Alarms... 42 Your First Case ... 43 What you need... 43 Preparing the Console for Treatment ... 44 Setup - Variations ... 60 Setup Sequence... 60

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Downloading Data After Improper Shutdown... 61 Ending Treatment... 65 New Patient – No Power Down... 68 Disposal of Used Components ... 68 Temperature Trend Data... 69 Displaying the Temperature Trend Graph... 69 Temperature Trend Graph ... 70 Setting the Time Scale ... 72 Mechanical Components ... 73 Top Cover ... 73 Display Head Tilt... 73 Casters ... 74 Hospital Monitor Interface Accessory (HMIA) ... 75 Overview ... 75 Operating the HMIA ... 75 Installation... 78 Data Download ... 81 Troubleshooting ... 81 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 8. Warranty and Service ...99 ZOLL Factory Warranty ... 99 Technical Support and Resources... 99 Obtaining Service from ZOLL ... 100 Packing and Shipping Instructions... 100 Disposal of the Console ... 100 9. Specification ...101 Specifications ... 101

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1. Safety Information Overview Safety is of primary concern to ZOLL Circulation, Inc. This chapter provides information on safely using the Thermogard XP or Coolgard 3000 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

LOT

Definition

Symbol

Definition

Alternating current

EC REP

Authorized Representative

Batch Code

Caution

C 0344

REF Rx ONLY

Catalog number Caution: Federal law restricts this device to sale by or on the order of a physician.

CE Mark

Connector for the data acquisition cable

Consult instructions for use

Danger: Keep hands and fingers away

Dangerous voltage warning

Date of manufacture

1

Symbol

2

STERILIZE

MR

Definition

Do not push or pull on the display head

Do not resterilize

Do not reuse

Do not stack

Do not use if package is damaged

Follow instructions for use

Fragile contents

Fuse

Hi

The high patient temperature alarm limit

Importer

Lo

The low patient temperature alarm limit

Manufacturer

MD

Medical device

MR Unsafe

Off

On

Potential Equalization Conductor. This is a safety measure to prevent earth current loops in equipment

QTY

Serial number

Sterilized using irradiation

Top facing up

2

Definition

Do not allow liquids to spill on the product or package.

Protective earth (ground)

SN

Symbol

Quantity

Sterile barrier

CH REP

Swiss authorized representative Type B applied part. Defibrillator protected

Symbol

Definition Type BF applied part. Defibrillator protected

Symbol

UDI

Use-by date

Definition Unique device identifier

Weight

General Safety Precautions WARNING. Systemic hypothermia risks. Systemic hypothermia may cause cardiac arrhythmia, patient shivering, or other system or organ complications. Systemic hypothermia should only be utilized under the supervision of a qualified physician. When treating a patient with the console, appropriately qualified medical staff must routinely and closely monitor 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 malfunction, have other means of cooling available.

•

When combining the use of the system and other adjunctive means of cooling, ensure that close observation 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 manual 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.

•

The ZOLL Coolgard and Thermogard consoles are MR Unsafe and, thus, these consoles are not allowed in the MR system room. Therefore, the catheter must be disconnected from the console prior to moving the patient into the MR system room.

MR

WARNING. Projectile hazard.

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 potential 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.

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Guidance and Manufacturer’s Declaration– Electromagnetic Emissions 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 RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage Fluctuations / Flicker Emissions IEC 61000-3-3

Compliance Group 1 Class A Class A

Complies

Electromagnetic Environment Guidance 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. The console is suitable for use in all establishments other than domestic establishments and those directly connected to a lowvoltage power supply network that supplies buildings used for domestic purposes. Note. The emissions characteristics of this equipment make it suitable 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.

Table 1.1. 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.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic environment -- guidance

Electrostatic discharge (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/output lines

Mains power quality should be that of a typical commercial or hospital environment.

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 environment.

Table 1.2. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

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Immunity Test

Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11

IEC 60601 Test Level

Compliance Level

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°

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 30 A/m IEC 61000-4-8

30 A/m

Electromagnetic environment -- guidance

Mains power quality should be that of a typical commercial or hospital environment. If you require continued operation during power mains interruptions, we recommend that the console be powered by an uninterruptable power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Table 1.2. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 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 3 Vrms 150 kHz to 80 MHz

Conducted RF immunity IEC 61000-4-6

6 Vrms in ISM bands within 150 kHz and 80 MHz

80% AM at 1 kHz

Compliance Level

Electromagnetic environment guidance

Portable and mobile RF communications 3 Vrms equipment should be used no closer to 150 kHz to 80 MHz any part of the console, including cables, than the recommended separation dis6 Vrms in ISM tance calculated from the equation applibands within cable to the frequency of the transmitter. 150 kHz and 80 MHz (see Note 3) 80% AM at 1 kHz

Recommended separation distance 150 kHz to 80 MHz d = 1.2

, 80 to 800 MHz

d = 2.3

, 800 MHz to 2.7 GHz

5

Immunity Test

Radiated RF IEC 61000-4-3

IEC 60601 Test Level

3V/m 80 Mhz to 2.7 GHz

Compliance Level

3V/m

Electromagnetic environment guidance 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,1 should be less than the compliance 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 absorption 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 measured field strength in the location in which the console is used exceeds the applicable RF compliance level above, the console 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.

Note. The following degradation associated with essential performance are not allowed during testing: component 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 interpretation of physiologically-produced signals.

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The Thermogard XP console is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the console as recommended below, according to the maximum output power of the communications equipment. 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

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

800 MHz to 2.7 GHz

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 absorption and reflection from structures, objects, and people. Table 1.3. Recommended separation distances between portable and mobile RF communications equipment and the console

Test Frequency (MHz)

Band1 (MHz)

Service

1

2

Modulation

Maximum Power (W)

Distance (m)

Immunity Test Level (V/ m)

0.3

27

2

0.3

28

2

0.3

28

Equipment: Valid test levels for professional healthcare facility 2 1.8 385 380 –390 TETRA 400 Pulse modulation 18 Hz GMRS 460, 450

430 – 470 FRS 460

710 745 780

704 – 787

LTE Band 13, 17

FM3 ± 5 kHz deviation 1 kHz sine Pulse modulation2 217 Hz

Table 1.4. Guidance and Manufacturer Declaration – Immunity to RF Wireless Communications

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Test Frequency (MHz)

Band1 (MHz)

Service

810 870

1

Modulation

Maximum Power (W)

Distance (m)

Immunity Test Level (V/ m)

2

0.3

28

2

0.3

28

2

0.3

28

0.2

0.3

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GSM 800/ 900, TETRA 800,

Pulse

iDEN 820,

modulation2

CDMA 850,

18 Hz

800 – 960 930

LTE Band 5 GSM 1800;

1720 1845

CDMA 1900; GSM 1900;

1 700 – 1970

2

DECT;

1 990

Pulse modulation2 217 Hz

LTE Band 1, 3, 4, 25; UMTS Bluetooth, WLAN, 2 400 – 2450

802.11 b/g/n, 2 570 RFID 2450,

5240 5500

5 100 –

5785

5 800

Pulse modulation2 217 Hz

LTE Band 7 WLAN 802.11

Pulse modulation2

a/n

217 Hz

Table 1.4. Guidance and Manufacturer Declaration – Immunity to RF Wireless Communications 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.

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.

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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.

Ignition of Flammable Anesthetic Mixtures The console is not category AP or APG equipment and must not be used in oxygen-rich environments or environments 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 instructions, and may cause harmful interference to other devices in the vicinity. There is no guarantee that interference 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 protective 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 primary 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 demonstration 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.

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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 configurations shall comply with the system standard IEC 60601-1. Any person who connects additional equipment 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 airtrap alarm will be disabled. Air present in the saline line may be circulated through the indwelling catheter. Before priming the circuit or during troubleshooting for possible leak, disconnect the heat exchange catheter, 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.

Intraluminal or balloon leakage WARNING. Intraluminal leakage (between the saline lumen and infusion lumens) or balloon leakage is a potential catheter failure mode. In the event of such a failure, sterile saline from the cooling circuit is introduced into the patient. Intraluminal leakage or balloon leakage is typically associated with a fluid loss alarm once the saline bag has been depleted and stops the system. ^äï~óë=áåîÉëíáÖ~íÉ=ÑäìáÇ=äÉîÉä=~ä~êãëK The cooling circuit is a closed loop system – usually fluid loss alarms indicate a breach somewhere in this closed loop. With any fluid loss alarm, check both the integrity of the catheter and the Start-Up Kit (see below). WARNING. If you notice a depleted saline bag or an air trap alarm, do not replace the saline bag prior to identifying the location of the leak and taking the appropriate mitigation. Check for system leaks according to the instructions in the Check for a Start-Up Kit leak and Check for a catheter leak sections below. (Note that a leak could be external or internal.) Replacing the saline bag repeatedly without investigating the leak or loss of saline may result in unintended infusion of saline into the patient. Saline infusion may lead to the following adverse effects: local swelling that can cause subsequent local tissue damage; systemic fluid overload that can lead to dependent edema and subsequent skin breakdown; internal organ fluid overload, with subsequent overloading of the brain, lungs or heart. In some cases, this fluid overload may lead to life threatening events.

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Caution. The console emits an alarm when the saline bag is empty. The bag must be completely empty and additional saline must have drained between the saline spike and the air trap for the saline level in the air trap to drop sufficiently to trigger the alarm.

Check for a Start-Up Kit leak 1. Check the air trap for condensation. If the air trap shows signs of condensation, wipe the air trap and reinstall it in the console. In the case of an air trap alarm, verify that the air trap alarm is cleared after this step. 2. Carefully check the saline path from the saline bag to the console for any leaks. Check if there is saline on the floor, console, or the patient’s bed. 3. If there is any saline on the floor, console, or the patient’s bed, check that the Luers on the catheter and Start-Up Kit are not cracked or damaged and that the connections are tight enough to prevent leaks. 4. If you find a leak in the Start-Up Kit, replace the Start-Up Kit and see if there is also a leak in the catheter. 5. If you do not find a leak in the Start-Up Kit, there is likely a leak in the catheter. Investigate further.

Check for a catheter leak 1. Disconnect the Start-Up Kit from the catheter. Properly cap both the catheter and Start-Up Kit using an aseptic technique. 2. Fill a sterile 10 mL slip tip syringe with sterile saline. 3. Connect the syringe to the IN Luer of the catheter and disconnect the OUT cap. Infuse 10 mL of saline – the saline should flow out the OUT Luer. If the saline does not flow out of the OUT Luer, a catheter leak is indicated. 4. Cap the OUT Luer and pull 5 cc of vacuum. Sustain for at least 10 seconds. Up to 4 mL of saline (not blood) should enter the syringe and you should be able to maintain the vacuum. If traces of blood are seen in the syringe or vacuum cannot be maintained, it indicates a catheter leak. 5. If you find a leak in the catheter, replace the catheter. 6. Replace the saline bag and re-prime the Start-Up Kit. 7. Ensure leak-tight Luer connections to the Start-Up Kit and continue the therapy. WARNING. Never clinically circumvent the air trap alarm. ZOLL may use an air trap simulator fixture for testing, training and demonstration purposes. These are fluid filled air trap assemblies that are separate from a standard 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.

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 connected.

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 requirements, fuse capacity, and manufacturing date for the console.

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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 system 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 sterile heat exchanger and tubing circuit (Start-Up Kit). These components together comprise a patient temperature-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 referenced 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 smallbore 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 recirculating loop by a roller 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.

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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 console 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.

1. Saline bag 2. Roller pump 3. Air trap 4. Heat exchange coil 5. Coolant well 6. Coolant pump 7. Chiller & Heater 8. Catheter 9. Patient 10.Pin wheel flow indicator

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.

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1. Display Screen 2. Alarm Indicator LED 3. Mute Button 4. Power On Indicator LED 5. Target Temp Button 6. Standby / Run Button 7. Rate Deg / Hr Button 8. Press for Menu / Enter Knob

Figure 2.2. Controls and Display Screen

Power Indicators An indicator lamp on the control panel is illuminated when power is switched on. A second power-on indicator is mounted directly above the power switch on the rear of the console.

Alarm Indicators The console typically notifies users of alarm conditions in two ways. When an alarm occurs, the screen displays an alarm message, and an alarm annunciator produces an audible alarm tone (beep). You can temporarily mute the alarm tone, but cannot turn it off. If the nature of the failure prevents the console from displaying an alarm message, the alarm indicator on the control panel will be illuminated.

Control Buttons The display head features four pushbuttons that are used to control console functions. To provide confirmation, each time a button is pressed, a “key click” sound is produced by the annunciator. Target Temp Press the “Target Temp” button to display a screen that allows you to set the patient’s target temperature. You may set a target temperature between 31º C and 38º C (87.8º F and 100.4º F). Rate Deg/Hr Press the “Rate Deg/Hr” button to display a screen that allows you to set the cooling/warming rate (expressed in degrees per hour). You may set a cooling/ warming rate between 0.10º C/hr and 0.65º C/hr (0.18ºF/hr and 1.17ºF/hr). Standby/Run Press the “Standby/Run” button to toggle the operation of the console between Standby mode (the pump is stopped) or Run mode. An alarm or fault can place the console into Standby mode automatically. After remedying the condition that caused the alarm, press this button to return to Run mode.

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