ZOLL thermogard xp User manual

Operation Manual
600479-001 Rev 2 1/147

Copyright © 2009 ZOLL Circulation, Inc..
All rights reserved. Printed in U.S.A.
Trademarks
Alsius, CoolGard, CoolGard 3000,Thermogard XP, Cool Line, Fortius, and
Icy are trademarks of ZOLL Circulation, Inc.
Mallinckrodt is a registered trademark of Mallinckrodt Inc.
Windows is a registered trademark of Microsoft Corporation.
Other products and names listed in this document may be trademarked by their
owners and no representation is made by ZOLL Circulation, Inc. as to rights
thereto.
U.S. Patents Pending
This product is covered by or for use under one or more of the following U.S.
patents. Other U.S. and foreign patents pending:
4,290,428 4,648,384 4,689,041 4,850,969 4,865,581
4,917,667 4,927,412 5,011,468 5,033,998 5,059,167
5,908,407 6,019,783 6,126,684 6,149,670 6,165,207
6,287,326 6,290,717 6,299,599 6,338,727 6,368,304
6,393,320 6,405,080 6,409,747 6,416,533 6,419,643
6,432,124 6,436,130 6,447,474 6,450,990 6,451,045
6,454,792 6,454,793 6,458,150 6,460,544 6,494,903
6,516,224 6,520,933 6,529,775 6,530,945 6,530,946
6,554,797 6,572,640 6,581,403 6,582,398 6,585,692
6,589,271 6,602,243 6,620,131 6,641,602 6,641,603
6,645,233 6,645,234 6,652,565 6,682,551 6,699,268
6,706,060 6,709,448 6,716,188 6,716,236 6,719,724
6,726,653 6,726,710 6,733,517 6,749,585 6,749,625
6,755,851 6,786,916 6,796,995 6,872,222 6,878,156
6,893,419 6,893,454 6,942,644 7,001,418 7,014,651
7,070,612 7,090,792 7,097,657 7,101,388 7,144,407
ZOLL Circulation, Inc.
650 Almanor Avenue
Sunnyvale, California 94085
U.S.A.
Telephone: [phone]
Facsimile: [phone]
600479-001 Rev 2 2/147

Contents
1. Safety Information
2. Introduction
3. Receiving, Inspection, and Assembly
4. Operation
Overview
Alarms & Alerts
Your First Case
Setup - Variations
Ending Treatment
Temperature Trend Data
Mechanical Components
Accessory: HMIA
5. TempTrend CSV Program User’s Guide
6. Alarms and Corrective Actions
7. Troubleshooting
8. Maintenance
9. Warranty and Service
10. Specification
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Safety Information
1
Safety Information
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Safety Information
2
Contents
Safety Information 3
Overview 3
Warnings, Cautions, and Notes 3
Definitions of Symbols and Labels Used on the Product and in the Manual 4
General Safety Precautions 5
Shipping and Storage Conditions 6
Ignition of Flammable Anesthetic Mixtures 6
Electrical Hazards 6
Primary Patient Temperature Probe (T1) Failure 7
Configuration Changes 7
Priming the Saline Circuit 7
Air Entry Into the Tubing Circuit 8
Check the Integrity of the Catheter 8
Check the Integrity of the Start-up Kit Tubing 8
Interference 9
Product Label 9
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Safety Information
3
Safety Information
Overview
Safety is of primary concern to ZOLL Circulation, Inc.. This chapter provides
information on safely using the 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 are accompanied by symbols surrounded by a triangle and are
printed in the text in bold italics. Warnings indicate events or conditions
that can result in serious injury or death or severe damage to the
equipment.
CAUTION!
Cautions are accompanied by symbols surrounded by a triangle and are
printed in the text in bold italics. Cautions indicate information for safe
operation, proper performance, or avoiding actions that may result in
damage to the equipment.
NOTE:
Notes are accompanied by a symbol of the letter “i” surrounded by a circle
and are printed in the text in italics. Notes clarify understanding, aid in the
proper operation of the product, and prevent problems or errors from
occurring.
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Safety Information
4
Definitions of Symbols and Labels Used on
the Product and in the Manual
Symbol Definition Symbol Definition
Attention. Consult
accompanying
documents.
This symbol designates
the connector for the data
acquisition cable.
Electrical warning or
electrical caution. Indicates notes intended
to clarify understanding.
Alternating current. Temperature and
pressure range.
Protective earth (ground). Do not allow liquids to spill
on the product or
package.
Type B applied part.
Defibrillator protected. Humidity range.
Type BF applied part.
Defibrillator protected. Fragile contents.
Fuse. Top facing up.
Ground equipment. Lo The low patient
temperature alarm limit.
On. Hi The high patient
temperature alarm limit.
Off.
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Safety Information
5
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 System, 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 System require the
authorized individual to remain in close proximity to the patient
throughout the procedure.
Always verify the function of the System prior to insertion of an Alsius
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 ZOLL 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.
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Safety Information
6
Shipping and Storage Conditions
When shipping or storing the System, follow these recommendations:
Temperature range: -20ºC (-4ºF) to 60ºC (140ºF).
Atmospheric pressure range: 50 kPa to 106 kPa.
Do not allow liquids to spill on the System or its packaging.
Humidity range: 10% to 90% noncondensing.
Fragile contents, handle with care.
Always handle and store with the top facing up.
Ignition of Flammable Anesthetic Mixtures
The System is not category AP or APG equipment and must not be used in
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 EN 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.
Refer service and repairs to a qualified technician.
CAUTION! ELECTRIC SHOCK HAZARD.
Electric shock hazard. Always turn off the System and disconnect the
power line cord from the source before performing any service or
maintenance procedures, or before moving the System.
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Safety Information
7
Primary Patient Temperature Probe (T1)
Failure
The System relies upon the patient temperature reading from a 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 System 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 system. 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 System to represent a patient. Never use this device, or other
method, to circumvent the normal patient temperature feedback control when
the system 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
CAUTION! CONFIGURATION CHANGES MUST BE
CERTIFIED.
Equipment connected to the analog and digital interfaces must be certified to
the respective IEC standards (i.e., IEC 950 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 con-
figures a medical system and is therefore responsible that the system com-
plies 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 catheter.
Before priming the circuit or during troubleshooting for possible leak,
disconnect the heat exchange catheter, then connect the inflow and outflow
luer fittings of the saline circuit together.
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Safety Information
8
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 System. 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
standard Start-up Kit assembly. Never use this device, or other method, to
circumvent the air trap alarm when the system 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 System.
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 INFLOW lumen of the catheter and
disconnect the outflow cap.
5. Infuse the 10 ml of saline – it should flow out the outflow lumen.
6. Cap the OUTFLOW 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 INFLOW 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 System.
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:
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Safety Information
9
Look for damage to the tubing and/or the presence of air inside the
tubing.
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 this equipment does cause interference with other devices, which can be
determined by turning the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:
Reorient or relocate the receiving device.
Increase the separation between the equipment.
Connect the equipment 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 System console near the
power cord inlet. The label is illustrated in Figure 1-1.
Figure 1-1. Product Label .
The label provides safety information and identifies the manufacturer, model
number, serial number, power requirements, fuse capacity, and manufacturing
date for the System.
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Introduction
1
Introduction
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Introduction
2
Contents
Introduction 3
Use of the System 3
Operating Life 3
Functional Description 3
System Components 4
Controls and Display 4
Display 4
Power Indicators 5
Alarm Indicators 5
Control Buttons 5
Control Knob 6
Serial Interface Connector 6
Recirculating Chiller 6
Temperature Controller 7
Temperature Probe Connectors 7
Pump 7
Prime Switch 8
Start-up Kit 9
Data Memory 10
Saline Circuit Diagram 10
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Introduction
3
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 Thermal Regulating System is comprised of an external heat
exchange system (CoolGard 3000 or Thermogard) and an Alsius endovascular
heat-exchange catheter connected via a sterile heat exchanger and tubing circuit
(the Alsius Start-up Kit). These components together comprise a patient
temperature-regulation apparatus employing feedback control. The catheter and
the Start-up Kit (its heat exchange coil, air trap, and tubing) are single-use
disposable devices.
This manual provides operating instructions for the System and the start-up kit.
Catheter components are referenced where it is necessary to assure 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 Alsius start-up kit are designed for continuous
use for a period not to exceed seven (7) days. After seven days of use, all start-
up kit components must be removed and replaced with components from a new
start-up kit.
CAUTION! START-UP KIT LIFETIME IS SEVEN (7) DAYS.
The designed operating lifetime for start-up kit components is seven (7) days
of continuous operation. If a patient must be treated for a longer period, a new
start-up kit must be installed in the System. Failure to adhere to this time limit
may cause injury to the patient.
Functional Description
The System can be described in terms of three major components: a
recirculating chiller, a sterile fluid 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
System. The sterile saline is pumped through a continuous recirculating loop by a
peristaltic pump inside the console. The saline solution acts as an intermediate
heat-transfer medium between the patient and the System. 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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Introduction
4
Patient temperature feedback is used to control the system. The patient’s
temperature is measured by an indwelling YSI 400 thermistor temperature
sensor. In response to the patient’s measured temperature, the System 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 the following figure.
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
Figure 2-1. Simplified Flow Diagram.
System Components
Controls and Display
The operator’s display panel 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 are illustrated in figure 2-2 and explained
in the following text.
Display
The display 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. The user can adjust the tilt and rotation of the display head and lock it into
position by using this clamp.
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Introduction
5
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.
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 System 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). The alarm tone can be temporarily
muted by the user, but it cannot be turned off.
If the nature of the failure prevents the System 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 System
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 (0.18º F/hr and 1.17º F/hr).
Standby/Run
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Introduction
6
Press the “Standby/Run” button to toggle the operation of the System between
standby mode (the pump is stopped) or run mode.
An alarm or fault can place the System into standby mode automatically. After
remedying the condition that caused the alarm, press this button to return to run
mode.
Silence Alarm
Press the silence alarm button to silence the audible alarm tone for two minutes
(120 seconds). If the alarm condition has not been cleared during this two-minute
period, the audible alarm will sound again.
Control Knob
The “Press for Menu/Enter” control is a dual-function control knob and
pushbutton.
Press the knob to display a menu screen or to indicate the completion of a
selection.
Turn the knob to scroll between selections or to scroll temperature trend graphs.
Serial Interface Connector
A female 9-pin subminiature D connector is mounted on the lower left corner of
the rear of the display head. Use this connector to attach a serial interface cable
between the System and a laptop computer. Once connected, the computer can
download patient temperature trend data stored by the System.
Figure 2-3. Serial Interface Connector.
Recirculating Chiller
The chiller consists of an air-cooled refrigeration system, reservoir heater,
circulation pump, stainless steel reservoir, reservoir cover, and a temperature
controller.
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Introduction
7
Temperature Controller
The temperature controller uses input from the patient’s temperature probe and
the operator-selected patient temperature setpoint to regulate the coolant
temperature of the recirculating chiller. The temperature controller constantly
adjusts the coolant temperature by means of a closed-loop control system. The
operator enters a setpoint that represents the patient’s target temperature. The
controller cools or heats the coolant, in a range between 0º and 42º C (32º and
107.6º F) to optimally achieve and maintain the target temperature. The controller
constantly displays the measured patient temperature and the target
temperature.
An optional mode can command the controller to approach the target
temperature at a user-selected rate.
Temperature Probe Connectors
The front of the System console features two connectors, labeled “T1” and “T2”
which are used for connection to patient temperature probes. The primary patient
temperature probe is plugged into connector T1. The secondary probe is plugged
into connector T2.
Figure 2-4. Temperature Probe Connectors.
Pump
Sterile saline solution is circulated through the heat exchanger coil and the
catheter by a high-performance, compact roller pump. It pumps by peristaltic
action on the tubing installed in the pump head. The pump rotation speed is
accurately controlled by an electronic speed control system. The pump flow rate
can be selected by the user.
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Introduction
8
WARNING! FINGER INJURIES
Be careful when inserting the pump tubing that you do not catch your fingers
with the roller.
When the System is operating DO NOT attempt to circumvent the safety
interlocks on the peristaltic pump lid. DO NOT place fingers or foreign objects
into the pump raceway when the pump is turning. The peristaltic pump has
sufficient torque to severely damage a finger.
If a tubing leak or failure occurs in the pump raceway, the saline solution will
cause corrosion in the moving parts of the rotor.
1. Remove the pump rotor (refer to Pump Rotor removal instructions in
System Service Manual).
2. Rinse the rotor in clean water and thoroughly dry the rotor.
3. Apply a few drops of light machine oil to the moving parts of the rotor.
4. Reinstall the rotor (refer to pump rotor installation instructions in System
Service Manual).
Figure 2-5. Pump.
Prime Switch
The prime switch is located next to the pump under the top cover. The switch is
used to operate the pump to prime the tubing with sterile saline solution from the
saline source. When the switch is held down, the pump runs; when the switch is
released, the pump stops.
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