thermogard_xp_operation_manual_rev_1.pdf
Page 1
IVTM
TM
Intravascular Temperature
Management
OPERATION MANUAL
EMERGO EUROPE
Molenstraat 15
EC
REP
2513 BH, T he Hague
T he Ne therlands
Caution: Federal law restricts this device to sale by or on the order of a physician.
601285-001 Rev. 1
Page 2
Copyright © 2015 ZOLL Circulation, Inc.
All rights reserved. Printed in U.S.A.
Trademarks
Thermogard XP, Cool Line, Icy, Quattro, Solex and IVTM are trademarks of ZOLL
Circulation, Inc.
Mallinckrodt is a registered trademark of Covidien, 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
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:
6,146,411
6,149,676
6,299,599
6,447,474
6,454,792
6,527,798
6,581,403
6,685,733
6,786,916
6,849,083
7,101,388
7,287,398
ZOLL Circulation, Inc.
2000 Ringwood Ave.
San Jose, CA 95131 U.S.A.
+1 (408) 541-2140 (main)
+1 (408) 541-1030 (fax)
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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
Safety Information
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Safety Information
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 8
Priming the Saline Circuit 8
Air Entry Into the Tubing Circuit 8
Check the Integrity of the Catheter 9
Check the Integrity of the Start-up Kit Tubing 9
Interference 9
Product Label 10
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Safety Information
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
Definitions of Symbols and Labels Used on
the Product and in the Manual
Symbol
Definition
Symbol
Attention. Consult
accompanying
documents.
Definition
This symbol designates
the connector for the
data acquisition cable.
Dangerous voltage
warning.
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.
Potential Equalization
Conductor. This is a
safety measure to
prevent earth current
loops in equipment.
Lo
The low patient
temperature alarm limit.
On.
Hi
The high patient
temperature alarm limit.
Danger: Keep hands and
fingers away.
Off.
Do not push or pull on
the Display Head
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Safety Information
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 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 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.
Avoid touching the patient simultaneously with metal parts in the
Thermogard XP system.
WARNING! ELECTRIC SHOCK RISK DURING CARDIAC
DEFIBRILLATOR DISCHARGE.
The System’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 system MUST be used in
conjunction with the approved patient temperature probes listed in
Specifications section of this manual.
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Safety Information
Transportation, 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.
When transporting the System around the hospital, follow these
recommendations:
Move the system 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
system 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 system may tilt in case of transport outside its crate and over a
threshold.
Ignition of Flammable Anesthetic Mixtures
The System 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 the
Service Manual.
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Safety Information
Portable and mobile RF communications equipment can affect the Thermogard
XP.
CAUTION! DANGEROUS VOLTAGE.
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.
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 System 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 System with
100% reliability. Failure of the T1 can result in either patient hypo- or hyperthermia. 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.
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Safety Information
Configuration Changes
WARNING!
No modification of this equipment is allowed.
CAUTION! CERTIFICATION REQUIREMENTS FOR
EXTERNAL EQUIPMENT CONNECTED TO THE SYSTEM
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 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.
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.
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Safety Information
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:
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:
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Safety Information
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 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
Introduction
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Introduction
Contents
Introduction 3
Use of the System 3
Operating Life 3
Functional Description 4
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
Indications for Use - USA 11
Indications for Use – Cool Line Catheters 11
Warning – Fever Reduction 11
Indications for Use – All Other Catheters 12
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Introduction
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 system (Thermogard XP®) 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 (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 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, 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 on a single patient. 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.
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 exchanged power
Device failures
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Introduction
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 smallbore 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.
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.
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Introduction
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.
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
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
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.
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Introduction
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 on the right side of the pump. 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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Introduction
Figure 2-6. Prime Switch .
Start-Up Kit
The ZOLLStart-Up Kit contains the sterile disposable components for this
system. Each kit contains a heat exchanger coil, air trap, saline coolant delivery
lines, saline container connectors, catheter connectors, and the roller pump
tubing. These components are described in detail in later chapters of this
document. The components in the Start-Up Kit are designed to operate
continuously for seven days, after which they must be replaced.
Figure 2-7. Start-Up Kit.
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Introduction
Data Memory
The System is capable of continuously recording patient temperature and system
activity for up to 21 days. This stored data can be downloaded to an attached
computer over a serial interface using optional software furnished by ZOLL.
Saline Circuit Diagram
A flow diagram is printed on the inside of the top cover. Use this diagram to
assure that the Start-Up Kit has been installed correctly.
Figure 2-8. Flow Diagram.
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Introduction
Indications for Use - USA
The Indications for Use listed below have clearance within the USA for the
following models of ZOLL IVTM® Thermal Regulation Systems:
The CoolGard 3000®
The Thermogard XP®
These systems can be used with any of the IVTM Catheters. The indications for
use are specific to the catheter. Please refer to the Indications for Use statement
in the catheter specific Instructions for Use.
Indications for Use – Cool Line Catheters
The ZOLL IVTM Thermal Regulation System using the Cool Line® Catheter is
indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in
patients with cerebral infarction and intracerebral hemorrhage who require
access to the central venous circulation and who are intubated and sedated.
Warning – Fever Reduction
The safety of this device has not been demonstrated for fever reduction in
patients presenting with subarachnoid hemorrhage or primary traumatic brain
injury. The safety and effectiveness of this device was examined in a randomized controlled trial of 296 patients. The mortality results reported in this trial,
for the four patient cohorts enrolled, are presented in the table below (CI –
cerebral infarction, ICH – intracerebral hemorrhage, PTBI – primary traumatic
brain injury, SAH – subarachnoid hemorrhage).
Table 1-1. Mortality by Diagnosis (ITT)
Cool Line
Control
n
N
%
n
N
%
p-value*
CI
3
16
18.8
3
14
21.4
0.74
ICH
8
33
24.2
7
27
25.9
1.00
PTBI
10
44
22.7
4
38
10.5
0.24
SAH
13
61
21.3
7
63
11.1
0.15
*Fischer’s exact test
For more details on the results of this study please refer to Physician’s Manual –
“Normothermia for the Neuro-critically Ill Stroke Patient” P/N 600248.
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Introduction
Indications for Use – All Other Catheters
The ZOLL IVTM Thermal Regulation System, using one of the Icy®, Quattro® or
Solex® model catheter, is indicated for use:
in cardiac surgery patients to achieve and or maintain normothermia
during surgery and recovery/intensive care, and
to induce, maintain and reverse mild hypothermia in neurosurgery
patients in surgery and recovery/intensive care.
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Receiving, Inspection & Assembly
Receiving, Inspection
& Assembly
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Receiving, Inspection & Assembly
Contents
Receiving, Inspection, and Assembly 3
Overview 3
Inspection for Damage 3
Required Tools 3
Unpacking 3
Assembly 4
Hook 4
Handle 5
Control Head 5
Control Cable 5
Power Cord 6
Condensate Pan 6
Saline Container Insulating Jacket 6
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Receiving, Inspection & Assembly
Receiving, Inspection, and Assembly
Overview
This chapter provides information on how to receive, unpack, and assemble the
System. If your System was delivered and set up by a ZOLL representative, you
may skip this chapter and turn to Chapter 4.
Inspection for Damage
Each System is carefully inspected before it is shipped. When the carrier delivers
your System, ensure that the shipping containers are not damaged. Visually
inspect the outside of the shipping container for any damage. If damage is
detected, please notify ZOLL Customer Service and file a damage claim with the
carrier.
Required Tools
To safely unpack, inspect, and assemble the System, you will need the following
tools:
Phillips screwdriver (included in shipping container).
3/16-inch Allen wrench (included in shipping container).
5/32-inch Allen wrench (included in shipping container).
7/64-inch Allen wrench (included in shipping container).
Scissors or box knife.
Unpacking
CAUTION! AVOID LIFTING INJURY.
The System weighs 107 lb (49 kg). Never attempt to lift the equipment without
assistance. Use safe lifting practice when handling the equipment.
To unpack the System, follow these steps in the indicated order.
1.
Remove the straps from the carton and pallet.
2.
Open the top flaps of the carton and remove the inner carton containing
the control head. This carton also contains the handle, attachment
hardware, spare fuses, the condensate pan, the saline container
insulating jacket, and other miscellaneous parts.
3.
Remove the protective inserts and lift the outer carton up and off.
4.
Use scissors or a box knife to carefully cut away the moisture barrier bag
surrounding the console. Use care to avoid scratching the console.
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Receiving, Inspection & Assembly
With the help of an assistant, grasp the base of the console just above
the casters, carefully lift the console off the platform, and set it on the
floor.
5.
Figure 3-1.
System Unpacked and Ready for Assembly.
Assembly
To assemble the unpacked System, follow these steps in the indicated order.
Hook
1.
Attach the gray hook to the front of the mast using the short bolt
provided. Use a 7/64-inch Allen wrench to tighten the bolt securely (see
figure 3-2).
Figure 3-2.
System With Hook Attached.
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Handle
2.
Attach the handle to the mast using the long bolt and the short screw
provided. Use a 3/16-inch Allen wrench to tighten the bolt securely. Use
a 5/32-inch Allen wrench to tighten the screw (see figure 3-3). Do not lift
the System by the handle.
Figure 3-3.
Use the Long Bolt and Center Screw to Attach the Handle.
Control Head
3.
Carefully remove the control head from its packaging.
4.
Attach the control head to the mast. Hold the pivot assembly perfectly
vertical and slide it into the mast opening by applying even, gradual
pressure. The pivot assembly fits into the mast only in one direction.
Figure 3-4.
5.
Attach the Control Head to the Mast.
Secure the control head to the mast by installing four screws in the holes
provided at the top of the mast. Use a Phillips screwdriver to tighten the
screws securely.
Control Cable
6.
Connect the control cable to the socket on the lower right rear corner of
the control head. Align the plug with the socket and gently push the plug
into the socket until it is seated. Turn the retaining collar approximately
two full turns clockwise to lock the plug in the socket.
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Receiving, Inspection & Assembly
Figure 3-5.
Plug the Control Cable Into the Socket.
Power Cord
7.
Plug the female end of the power cord into the recessed power inlet
connector. Wrap the power cord around the two cord hooks on the rear
of the console.
Condensate Pan
8.
Remove the condensate pan from its packaging and install it in the slot
under the front of the console (refer to figure 8-1).
Saline Container Insulating Jacket
9.
Remove the saline container insulating jacket from its packaging and
hang it on the saline container hook.
Assembly is complete.
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Operation
Operation
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Operation
Contents
Operation
1
Overview
5
Operating States in the System .......................................................................................... 5
SETUP ................................................................................................................... 5
STANDBY .............................................................................................................. 7
RUN - Treatment Modes ........................................................................................ 8
User Interface ...................................................................................................................... 8
System Controls ..................................................................................................... 9
The System Display Screen ................................................................................... 9
Changing Target Temperature............................................................................. 11
Changing Treatment Mode .................................................................................. 12
System Menu System ....................................................................................................... 14
Hi/Lo Patient Temperature Alarms....................................................................... 15
Bath Pre-set ......................................................................................................... 16
Time and Date...................................................................................................... 17
ºC/ºF (Temperature Notation) .............................................................................. 18
Language ............................................................................................................. 19
STANDBY Timer .................................................................................................. 20
T1/T2 Behavior .........................................................21
First Use Warning – No T2 Probe ........................................................................ 21
T2 Probe Disconnection/Reconnection ............................................................... 22
Accidental Disconnection T1/T2 Probe ................................................................ 22
Alarms & Alerts ........................................................24
Alerts ................................................................................................................................. 24
Alarms ............................................................................................................................... 25
Your First System Case ...........................................26
What you need .................................................................................................................. 26
Preparing the System for Treatment ................................................................................. 26
Installing the Start-Up Kit ..................................................................................... 32
Connecting the Patient to the System ................................................................. 41
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Setup - Variations .....................................................45
System Setup Sequence .................................................................................................. 45
Time From Last Power Down .............................................................................. 45
Downloading Data After Improper Shutdown ................................................................... 46
Ending Treatment .....................................................51
End Procedure .................................................................................................................. 51
Data Download .................................................................................................................. 51
New Patient – No Power Down ......................................................................................... 54
Change the Start-Up Kit ....................................................................................... 54
Delete Previous Patient Data ............................................................................... 54
Disposal of Used Components ......................................................................................... 54
Temperature Trend Data ..........................................57
Overview ........................................................................................................................... 57
Displaying the Temperature Trend Graph ........................................................................ 57
Temperature Trend Graph ................................................................................................ 58
Patient Temperature ............................................................................................ 58
System Activity ..................................................................................................... 58
Cursor .................................................................................................................. 59
Status Bar ............................................................................................................ 59
Setting the Time Scale ...................................................................................................... 59
Mechanical Components ..........................................61
Top Cover ......................................................................................................................... 61
Control Head Tilt ............................................................................................................... 62
Casters .............................................................................................................................. 63
Hospital Monitor Interface Accessory (HMIA) ...........64
Overview ........................................................................................................................... 64
Operating the HMIA .......................................................................................................... 64
Connecting to the Hospital Monitor ...................................................................... 64
To begin operation ............................................................................................... 65
Controls and indicators on the HMIA ................................................................... 66
Operating States .................................................................................................. 67
Calibration ............................................................................................................ 67
Installation ......................................................................................................................... 67
Installation Equipment .......................................................................................... 68
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Operation
Installation Procedure .......................................................................................... 68
Removal of the HMIA ........................................................................................... 71
Connection Cable Part Numbers ......................................................................... 71
Data Download .................................................................................................................. 71
Troubleshooting ................................................................................................................ 72
Errors ................................................................................................................... 72
YSI-400 Temperature vs. Resistance ............................................................................... 74
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Operation
Overview
This chapter explains how to start treatment and change target temperature and
rate settings during treatment. It provides instructions on the proper way to end
treatment, including how to download patient temperature trend data to a laptop
computer and how to remove used components and dispose of them safely.
Subsections at the end of this chapter provide detailed procedures for recovering
from improper shutdowns, including special procedures for downloading patient
temperature trend data.
In this Overview section, we will present the main features of system as they are
presented to the user on the display of the system. This section will help you be
familiar with the features of the System before starting to use it.
After the Overview, you will find sections that describe in detail the operation of
the System - see Operating the System. The sequence of events that you must
pass through in starting the System varies with the way it was last turned off.
Within this section we will review the different patterns of interaction you will
experience. Specifically we will review:
Your first case with the System.
Variations in the SETUP sequence of the System
Ending procedures.
Operating States in the System
The System has three operating states: SETUP, STANDBY and RUN.
SETUP
When the System is first powered up, it goes through a sequence of self tests. It
tests its own electronics and internal sensors. These tests are called the POST
(Power On Self Test). It is normal to hear two beeps during POST. Then the
System tests its thermometer functions and its cooling engine. The extent of the
testing during SETUP and the interactions required of you by the system both
vary depending upon the state of the system when it was last turned off.
You can pre-set the bath temperature so that the system is either cooling or
warming the bath in SETUP.
Patient temperature alarms are not active in SETUP.
System Self Tests
The System performs self tests both at initial power-on and then hourly during
operation. These tests allow the system to check its own performance.
Thermometer Functions Self Test
The Primary Patient Temperature monitoring circuit (T1) is checked during
SETUP and then hourly against the System internal high resolution calibration
resistor. This is a quick test.
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Operation
Cooling Engine Self Test
During SETUP and then every four hours, during run, the System will
dynamically test its cooling engine. This test will take a few minutes.
Cooling Engine Self Test - The Pump Will Stop
Each hour the System tests its cooling engine dynamically during RUN. These
tests are brief. The system will stop the pump during these tests to remove the
heat load from the patient during the test.
THE PUMP WILL STOP DURING THIS TEST - THIS IS NORMAL.
During these tests, the peristaltic pump is stopped (to remove the patient’s heat
load from the equation). The tests that are conducted depend upon the state of
the System at the time of the test. The test(s) done is (are) as follows:
Coolant Temperature
Heating Test
Cooling Test
<10 °C
10 °C - 38 °C
> 38 °C
= will be performed = will not be performed
You will not see any screen messages unless there is an abnormal result in
which case the appropriate alarm state will be called.
Sensor Checks
Figure 4-1. System Setup Screen
For the system to enter the next state, STANDBY, the following sensors must be
checked and found normal.
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Operation
Table 4-1.
Setup Sensor Checks
Air Trap
There is no Start-Up Kit installed or there is a large amount of air in the
Start-Up Kit chamber.
Roller Pump Lid
The clear plastic roller pump lid is not closed properly.
Check Prime Switch
The Prime Switch is being depressed (as when you use it to prime the
system) or has been jammed in the ‘on” position.
Coolant
The coolant level is low. Top up the coldwell with coolant.
If any of these sensor states are not correct you will see the “System Setup” and
the problem sensor state will be highlighted in red (see Figure 4-1 above). Once
you rectify the identified problems, the System will progress to STANDBY.
NOTE: Change in Design – Patient Temperature Probes
In earlier versions, the System would not enter STANDBY without at least a
Primary Patient Temperature Probe (T1) connected to the System. For XP
Systems, the System will enter STANDBY without a T1 probe being
connected; however, the System will NOT enter RUN without at least the
Primary Patient Temperature Probe (T1) connected to the System (see below:
T1/T2 Behavior).
STANDBY
Figure 4-2. System Operating Display - Standby
In STANDBY you can interact with the full user interface of the System. You can
select the target temperature, the rate and the treatment mode.
Patient temperature alarms are active in STANDBY if the primary patient
temperature probe (T1) is connected.
The coolant bath temperature graph is active in STANDBY (a new feature
compared to earlier versions of the System).
From STANDBY you may toggle into and out of RUN. You may only return to
SETUP by powering down the system.
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Operation
RUN - Treatment Modes
Once you are ready to begin treatment, you may move from STANDBY to RUN.
The System will become fully operational provided that all its sensors indicate
that it is ready. Alerts will trigger if it is not.
There are three treatment modes in RUN: “Max Power”, “Controlled Rate” and
“FEVER”.
Max Power (MAX)
In this treatment option, the System seeks to make the patient’s temperature the
same as the selected target temperature. It will keep the peristaltic pump
operating unless the patient’s temperature “inverts”. This occurs whenever:
A. Bath Temperature > Patient Temperature > Target Temperature,
OR
B. Bath Temperature < Patient Temperature < Target Temperature.
Controlled Rate
In this treatment option, the System will attempt to move the patient’s
temperature to the target temperature at the programmed rate of heat exchange
(°C /hr). When the patient reaches the target temperature, the System will revert
to the MAX treatment option i.e. it will attempt to make the patient’s temperature
the same as the selected target temperature.
NOTE: Controlled Rate
Controlled rate operates in both warming and cooling modes.
FEVER (FVR)
In this treatment option, the System will start cooling the patient once the patient
temperature is above the target temperature. It does this by keeping the bath at
its coldest permissible temperature and then operating the peristaltic pump
whenever the patient’s temperature moves above the target temperature.
WARNING! “Lo” patient temperature alarm limit with “FEVER”
The System will NOT heat the patient when the “FEVER” treatment option has
been selected. The “Lo” patient temperature alarm limit ensures that an alarm
occurs should the patient stop regulating his/her own body temperature. Such
patients will cool to room temperature. This can occur when the patient dies
or becomes comatose.
INVESTIGATE ALL PATIENT TEMPERATURE ALARMS.
User Interface
The primary controls for the System are mounted in the display head of the
system. The next sections describe:
The controls available to the user
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The System display screen
The System menu system available to the user.
System Controls
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 4-3. Controls and Display.
The use of each of the controls is described in the table below.
Table 4-2.
System Controls
Power Indicator
Glows green when the display has power.
System Alarm Indicator
Illuminates red during error conditions where the nature of
the failure prevents the System from displaying an alarm
message.
Standby/Run button
Toggles between RUN and STANDBY
Target Temperature button
Press this to change the target temperature
Rate Deg/Hr button
Press this to change the rate and/or treatment mode.
“Press & Rotate” knob
This knob operates the menus on the System display.
Rotate the knob to scroll between selections. Press and
release the knob to select.
The System Display Screen
The System features a color display screen. The figure below shows the screen
as it appears during RUN.
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Figure 4-4. Operating Screen.
The upper left hand of the screen displays:
The patient temperature
The “Lo” and “Hi” patient temperature alarm values.
The lower left hand of the screen displays:
The programmed Target Temperature for the System
The programmed treatment mode/controlled rate value
The right hand side of the screen is used either:
To display the temperature of the coolant in the System coldwell (as
depicted above), or,
To present menu selections. The main menu of the System is
presented in the figure below.
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Figure 4-5. System Main Menu
Changing Target Temperature
1.
Press the Target Temp button once. If you are in RUN, you will be taken
to STANDBY. The Target Temperature value may only be changed in
STANDBY.
Figure 4-6. Change Target Temperature in RUN
2.
To change the target temperature, turn the knob until the desired
temperature is displayed. You may choose a temperature from 31º C to
38º C (87.8º F to 100.4º F). When the correct selection is displayed,
press the knob once to enter the selection.
3.
The target temperature setting is updated on the Operating screen.
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Changing Treatment Mode
As explained above, there are three treatment modes: “MAX”, “Controlled
Rate” and “FEVER”. To select the Treatment Mode, including one particular
value of “Controlled Rate” you use the “Rate Deg/Hr” button.
1.
Press the “Rate Deg/Hr” button once. If you are in RUN, you will be
taken to STANDBY. The Treatment Mode value may only be changed in
STANDBY.
Figure 4-7. Change Rate/Mode Temperature in RUN
2.
Turn the knob until the desired Treatment Mode selection is displayed.
When the correct selection is displayed, press the knob once to enter the
selection.
Figure 4-8. Select Mode
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3.
If you select Controlled Rate, a second menu screen will be presented.
To change the controlled cooling/rewarming rate, turn the knob until the
desired selection is displayed. You may choose a rate from 0.10º C/hr to
0.65º C/hr. When the correct selection is displayed, press the knob once
to enter the selection.
Figure 4-9. Select Controlled Rate
4.
If you have selected FEVER Mode, you will be asked to confirm your
selection with the reminder that FEVER Mode only cools and does not
warm as per the figure below.
Figure 4-10. FEVER Mode Confirmation message
5.
The Operating screen will be updated to reflect your selection.
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NOTE: Target Temperature in FEVER Mode
The System keeps the bath cold and starts the peristaltic pump when the
patient temperature is greater than the target temperature
System Menu System
Main Menu
The main menu of the System is displayed in Figure 4-5 above. To call up the
main menu, press the knob from the operating screen. Some settings are
accessible only in Standby Mode.
The options available to you are as follows:
Table 4-3.
System Main Menu
View Graphs
Takes you to a display of the patient temperature data log. See:
Temperature Trend Data
New Patient
Indicates to the System that you are starting a new patient case.
Downloading or deleting the existing patient data log is required
End procedure
Settings
Exit menu
Indicates to the System that you are finishing a patient case. You will be
prompted to save the existing patient data log. See: Ending Treatment
Takes you to the Settings menu. See below
Returns you to the operating display. The bath temperature meter display
will replace the menu.
Settings Menu
The settings menu allows you to modify the information displayed on the
operating display. It appears as in Figure 4-11.
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Figure 4-11. System Settings Menu
The options offered by the settings menu are listed and described below.
Table 4-4.
Hi/Lo Alarms
Time and Date
System Settings Menu
Allows you to modify the low (Lo) and high (Hi) patient temperature alarms.
Allows you to modify the System time and date.
°C / °F
Allows you to toggle between displaying temperatures in degrees Celsius
or degrees Fahrenheit.
Bath Pre-Set
Allows you to set the system to either HEAT or COOL during STANDBY.
Language
Allows you to select the display language.
Standby Timer
Exit
Provides you with a warning alarm after the system has been in STANDBY
for either 15 or 60 minutes. This alarm can be deactivated.
Returns to the operating display.
NOTE:
There is no Pump Rate Selection in ZOLL Thermogard XP systems.
ZOLL has validated that the Cool Line catheter can be safely used at a
pump rate of 240 ml/min.
Hi/Lo Patient Temperature Alarms
The System features two patient temperature alarms: “Hi” and “Lo”. If the alarms
are set, the System will alarm whenever the patient’s temperature is higher than
the “Hi” Patient Temperature Alarm value and whenever the patient’s
temperature is lower than the “Lo” Patient Temperature Alarm value. The range
of values for both alarms is 28 ºC – 45 ºC (82.4 ºF – 113.0 ºF).
Setting the Alarms
The alarm values are set as follows in either STANDBY or RUN mode. Set the
“Lo” and “Hi” Patient Temperature Alarms to appropriate values.
1.
Press the knob and the Main Menu will appear.
2.
Select the “Settings” option and press the knob.
3.
Select the “Hi/Lo Alarms” option.
4.
The “Lo” Alarm value will be presented. Turn the knob until the desired
value is displayed and press the knob.
5.
The “Hi” Alarm value will be presented. Turn the knob until the desired
value is displayed and press the knob.
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Nature of the Alarm
Figure 4-12. “Hi” Patient Temperature Alarm
The alarms are both visual and audible. The alarms will not clear until the
patient’s temperature no longer triggers the alarm state.
The audible alarm may be temporarily muted for 2 minutes by pressing the Mute
button. The alarm will continue after that time unless it has cleared.
The visual alarm is affected by writing the patient temperature area on the screen
in RED flashing text. The visual alarm will not stop until the alarm has cleared.
WARNING! Change to Initial Specification of System.
In the initial release of the System there were no settable patient temperature
alarms. There were fixed high and low patient temperature alarms. These
fixed alarms have been made programmable.
The patient temperature alarms MAY NOT be deactivated. They may be
muted for a 2 minute period.
NOTE: Patient Temperature Alarms in STANDBY
If the System is in STANDBY and the T1 temperature probe is connected to
the System but NOT inserted into the patient you will experience “Lo” patient
temperature alarms if the ambient temperature of the exposed probe is below
the alarm limit. To avoid the annoyance of the alarm under these conditions,
simply unplug the T1 temperature probe from the System until you are ready to
connect to the patient. You may not enter RUN without the probe connected
to the System.
Bath Pre-set
The menu allows the user to select from either: Pre-Cool, Pre-Warm or None.
This selection operates only in STANDBY and is cancelled when the system
enters RUN.
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Figure 4-13. Bath Pre-Set Menu
Pre-Cool
The System bath is cooled to its lowest permitted temperature and maintained
at that temperature.
Pre-Warm
The System bath is heated to its highest possible temperature and maintained
at that temperature.
None
The Bath Pre-set is not activated or is cancelled. If cancelled, the bath is
maintained at the temperature that was measured at the time of cancellation.
Exit
Exits the menu without a change in System status or programming.
Time and Date
This menu displays the current time and date settings.
Figure 4-14. Time and Date Settings.
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The time is divided into two fields: hours (designated “HH”) and minutes (“MM”).
The System uses only 24-hour time notation (e.g., 3:00 p.m. is 15:00).
The date is divided into three fields: year (designated “YYYY”) - month
(designated “MM”) - day (designated “DD”). For example, the 24th February, 1959
would be shown as: 1959-02-24.
Time Setting
1.
The screen first displays the message “Select Hour. Press Enter to set.”
2.
The numbers displayed in the hour field will change as you turn the knob.
When the correct hour is displayed, press the knob once to enter your
selection.
3.
The screen next displays the message “Select Minute. Press Enter to
set.”
4.
Turn the knob until the correct minute is displayed. Press the knob once
to enter your selection.
Date Setting
1.
The screen displays the message “Select Day. Press Enter to set.”
2.
The numbers displayed in the day field will change as you turn the knob.
When the correct day is displayed in the field, press the knob once to
enter your selection.
3.
The screen next displays the message “Select Month. Press Enter to
set.”
4.
Turn the knob until the correct month is displayed. Press the knob once
to enter your selection.
5.
The screen next displays the message “Select Year. Press Enter to set.”
6.
Turn the knob until the correct year is displayed. Press the knob once to
enter your selection.
7.
The time and date settings will be updated and the screen will display the
settings menu.
ºC/ºF (Temperature Notation)
This menu displays the options setting for temperature notation. The currently
selected setting is highlighted.
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Figure 4-15. Temperature Notation Settings.
To keep the current selection, press the knob once. The current setting will not
be changed and the settings menu will be displayed.
To change the current setting, turn the knob to highlight the desired setting.
Press the knob once to enter the selection. The setting will be changed and the
settings menu will be displayed.
NOTE: Change in Design – Pump Rate
In earlier versions of the System, there was the option to set the pump rate to
either 200 or 240 ml/min. ALL ZOLL catheters have been validated to operate
safely at a pump rate of 240 ml/min. This control is no longer presented to the
operator.
NOTE: Change in Design - Alarm Volume & Key Press
Volume
In earlier versions of the System, there was the option to set the alarm volume
and the key press volume. In this version:
1. The Alarm Volume is always set to High
2. The Key Press Volume is always set to Medium
Language
This menu displays the current setting for the language used for displayed text.
The currently selected setting is highlighted.
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Figure 4-16. Language Settings.
To keep the current selection, press the knob once. The current setting will not
be changed and the settings menu will be displayed.
To change the current setting, turn the knob to highlight the desired setting.
Press the knob once to enter the selection. The setting will be changed and the
settings menu will be displayed.
STANDBY Timer
The STANDBY Timer provides the User with an alarm as a reminder when the
System has been left in STANDBY for 15 or 60 minutes. The STANDBY Timer
presents the User with the opportunity to select from the following values: No
Alarm, 15 minutes, 60 minutes.
Figure 4-17. STANDBY Timer Menu
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If the system has been left in STANDBY for more than the specified time, an
alarm will sound to remind the User that the System remains in STANDBY.
Pressing the knob will reset the timer. The Standby Timer function will continue
until either:
The System is placed into RUN.
The STANDBY Timer Menu is used to deactivate the STANDBY
Timer.
The STANDBY Timer alert may be silenced for two (2) minutes by pressing the
mute button.
Figure 4-18. STANDBY Timer Alert
T1/T2 Behavior
Thermogard XP Systems differ from earlier ZOLL Heat Exchange Systems in
their T1/T2 behavior i.e. in how the Primary and Secondary Temperature probes
are monitored and alarmed.
WARNING! Dislodged Foley Catheter Temperature Probe
The System can detect when a patient temperature probe is dislodged
suddenly from the patient.
However it is possible for the Foley catheter patient temperature probe (T1) to
become dislodged from the bladder to rest on the perineum or within the fold of
the thighs. In such a position the System may not detect the dislodgement
from the patient and will underestimate the patient’s core temperature. As a
result the System may inappropriately heat the patient.
Failure to use a second temperature probe may result in patient injury.
First Use Warning – No T2 Probe
For each time the System is powered on:
1. The System will check to see if the Primary (T1) and Secondary (T2)
Temperature Probes are present. The System will enter STANDBY
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without probes being present. The System will not enter RUN unless the
T1 probe is present.
2. When the System is first put into RUN, it will check to see which probes
are present.
3. If there is no T2 present, the System will ask the User to verify that this is
intentional. See image below.
Figure 4-19. No T2 Probe Connected
The System remembers the User’s preference.
T2 Probe Disconnection/Reconnection
If the User connects a T2 probe at any time during the operation of the System
(in STANDBY or RUN), the System will assume that the use of the T2 probe is
desired. If the T2 probe is then disconnected the System will alarm – see below.
If the User disconnects a T2 Probe in STANDBY, the System will NOT assume
that this is intentional. When the System is placed into RUN WITHOUT a T2
Probe present, the User will again see the Warning as described above.
Accidental Disconnection T1/T2 Probe
Disconnection of the T1 probe during RUN results in
an Alarm. Press the knob to silence the alarm. The
System moves to STANDBY. Treatment cannot
continue until the T1 probe has been replaced.
Note that the patient temperature is displayed as
“---“ and the yellow warning banner covers the bath
temperature display.
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Absence or disconnection of the T1 probe during
STANDBY results in a warning display WITHOUT a
persistent audible alarm. The system CANNOT
enter RUN until a T1 probe has been connected.
Note that the patient temperature is displayed as
“---“ and the yellow warning banner DOES NOT
cover the bath temperature display.
Disconnection of the T2 probe during RUN results in
an Alarm. Press the knob to silence the alarm. The
System moves to STANDBY. If you attempt to return
to RUN without reconnecting the T2 probe, you will be
asked to verify your intention.
Note that the patient temperature will be displayed
correctly if the T1 probe remains connected. The
yellow warning banner covers the bath temperature
display.
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Alarms & Alerts
A detailed description of the alarms of the System is provided in later sections of
this manual. See:
Section 6.
Alarms and Corrective Actions
Section 7.
Troubleshooting
Alerts
Alerts can be cleared by correcting the problem that caused them to occur. For
example, a low coolant alert can be cleared by adding coolant to the coldwell of
the System. In most cases, the System will identify and notify you to rectify alert
states at power up.
In STANDBY, Alerts are displayed across the lower half of the display screen,
with the bath temperature display not obscured, against a yellow background
(See Figure 4-20 – Right). Alerts in STANDBY are generally NOT accompanied
by an audible alarm tone.
Figure 4-20. T1 Disconnect alerts in RUN (left) and STANDBY (right)
In RUN, Alerts are displayed across the full lower half of the display screen
against a yellow background with the bath temperature display is partially
obscured (See Figure 4-20 – Left). If an alert occurs in RUN, the System will
generally revert to STANDBY and an audible alarm tone will sound. The
exception to this is that if you depress the prime switch during run – no audible
alarm will sound and the bath temperature display will not be obscured.
In both STANDBY and RUN, a message on the screen will indicate the action
required to clear the alert.
During an alert, the patient temperature display is still visible and the patient
temperature alarms are still active if the T1 Temperature probe is functional.
NOTE: In the Event of an Alert
Investigate and rectify the cause - refer to:
Section 6. Alarms and Corrective Actions
Section 7. Troubleshooting
If the alert persists, call ZOLL for service.
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Alarms
An alarm is more serious in nature than an alert and relates to issues that will
typically require a service call. In most cases a text message, specific to the
alarm, identifies the system code for the alarm. For example, the screen might
announce “TCM ID 01” or “MID 23” in addition to the text in the figure below.
Figure 4-21. Alarm Screen
In some cases, however, the alarm may be cleared by power cycling the system.
For example, such an alarm would occur if the pump tubing were to become
jammed in the peristaltic pump causing the pump to slow down.
If the reason for the alarm is not cleared by power cycling, the alarm will repeat
each time the System is turned back on.
During an alarm, the patient temperature display and the patient temperature
alarms are NOT active.
NOTE: In the Event of an Alarm
Investigate and troubleshoot the cause - refer to:
Section 6. Alarms and Corrective Actions
Section 7. Troubleshooting
Power cycle the System.
If the alarm persists, call ZOLL for service.
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Your First System Case
What you need
You will need the following for each System case:
A new Start-Up Kit
A new 500ml bag of normal saline.
A YSI-400 compatible temperature probe e.g. a Foley catheter, rectal
or esophageal temperature probe
The blue patient connection cable to connect the temperature probe
to the System
A ZOLL heat exchange catheter
An aseptic work area to support catheter insertion.
WARNING! REFER TO THE CATHETER IFU
ZOLL heat exchange catheters are inserted via a Seldinger technique as a
central venous line. There are specific instructions for use included with each
catheter. Refer to these to understand the specific unique insertion
requirements of a ZOLL heat exchange catheter.
Preparing the System for Treatment
To prepare the System for treatment, follow these steps in the indicated order.
1.
Roll the System to a convenient position near the patient’s bedside. Plug
the power cord into a hospital-grade receptacle.
2.
Lock the right front caster by stepping down on the tab above the wheel.
3.
At the rear of the console, near the upper left corner is the power on/off
switch. Turn the switch ON.
Figure 4-22. Power Switch and Power Indicator Lamp.
4.
The green power indicator lamp will be illuminated and the alarm will
beep one long beep followed by a shorter softer beep.
5.
The System performs a self-test. During this interval, the self-test screen
appears on the display. If the self-test detects a problem, an error
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message will be displayed. If this occurs, refer to Chapter 6–Alarms and
Corrective Actions for assistance. At the end of the self-test there will be
two short beeps.
NOTE: The Software Version shown in the figure 4-23 is shown for
reference only; the current product may use a different Software Version.
Figure 4-23. Self-Test Screen.
6.
When the self-test is finished, the System Set Up screen displays the
message “Bath Pre-Set?”
Figure 4-24. System Pre-Cool?
7.
To start cooling or heating the coolant reservoir immediately, choose the
desired option and press the “Press for Menu/Enter” knob (the “knob”)
once to enter the selection. If you do not wish to begin cooling or
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warming the coolant reservoir now, choose “None” and press the knob
once to enter the selection.
8.
You may be asked questions relating to the downloading of patient data.
This is a new patient. Delete any old data left from the inservice you
received.
Figure 4-25. New Patient? Message.
9.
Choose “Yes.”
10.
The screen displays the message “Previous patient data must be
downloaded or deleted to proceed.”
Figure 4-26. Patient Data Message.
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11.
Choose “Delete”. You will be asked to confirm your choice to delete the
data file. Choose “Yes”. A brief confirmation message will appear and
then automatically close. See below.
Figure 4-27. Delete Previous Patient Data
12.
The System Set Up screen then displays the message “Select Target
Temp.”
Figure 4-28. Select Target Temp Message.
13.
Turn the knob until the target patient temperature is displayed. When the
desired value is displayed, press the knob once to enter the selection.
14.
The System Set Up screen displays the message “Select Treatment
Mode”. Note that you have three choices: “Max Power”, “Controlled
Rate” or “Fever”.
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Figure 4-29. Select Treatment Mode Message.
15.
Turn the knob to highlight the desired mode. Press the knob once to
enter the selection. Controlled rate should not be selected when using
the Cool Line catheter.
16.
If you select “Controlled Rate” for the Treatment Mode, you will be
prompted to “Select Rate. Press Enter to Set”. Use the knob to scroll
through to the desired rate and then press the knob to select it.
Figure 4-30. Select Rate Screen
17.
If the System has not yet finished its self tests, the Self-Test screen is
displayed.
NOTE: The Software Version shown in the figure 4-31 is for reference
only; the current product may use a different Software Version.
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Figure 4-31. Self-Test Screen.
18.
Install the Start-Up Kit now. If the system finishes its self test before you
complete installing the Start-Up Kit, you will see the following Check
Screen. An item in RED requires your attention.
Figure 4-32. Check the Following Screen.
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Setup Sensor Checks
Air Trap
There is no Start-Up Kit installed or there is a large amount of air in the
Start-Up Kit chamber.
Roller Pump Lid
The clear plastic roller pump lid is not closed properly.
Check Prime Switch
The Prime Switch is being depressed (as when you use it to prime the
system) or has been jammed in the ‘on” position.
Coolant
The coolant level is low. Top up the coldwell with coolant.
Installing the Start-Up Kit
Hang the Saline Bag
To install the System Start-Up Kit, follow these steps in the indicated order.
1.
Obtain an IV bag or bottle of sterile normal saline solution. The bag or
bottle must contain no more than 0.5 liter (500 ml) of solution. Hang the
saline container on the hook mounted on the rear of the display post.
The container hangs inside the circumference of the handle.
Figure 4-33. 500ml Saline Bag on Hook.
The Top Cover
2.
Open the top cover of the System. Open the transparent top cover of the
roller pump.
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Figure 4-34. Covers Open.
3.
A tubing circuit diagram is printed on the inside of the System top cover.
Refer to this diagram when installing the Start-Up Kit.
Figure 4-35. Tubing Circuit Diagram.
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The Coldwell
4.
Remove the cap from the coolant well and set it aside in a clean location.
Figure 4-36. Coolant Well Cap.
5.
Check the level of the coolant. The liquid level should be between the
two indicator lines on the wall of the coolant well. If the level is below the
bottom indicator line, add distilled water until the liquid is at the top
indicator line. If the coolant level is unusually low because of spillage,
add premixed propylene glycol and water until the liquid is at the top
indicator line.
Figure 4-37. Coolant Well Liquid Level Indicator Lines.
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The Start-Up Kit
6.
Open the System Start-Up Kit. For convenience and sterility, all items in
the kit are pre-connected.
Figure 4-38. System Start-Up Kit.
7.
Insert the heat exchanger coil into the coolant well.
Figure 4-39. Installing the Heat Exchanger Coil.
8.
Temporarily slide the air trap into the holder.
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Figure 4-40. Air Trap Placed In Holder.
The Peristaltic Pump
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.
9.
Locate the pump tubing and route it to the right side of the roller pump.
Do not stretch or pull on the tubing. The tubing lengths and flanged
connector allow the tubing to fit into the pump in only one direction.
10.
Lift the handle on the pump rollers.
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Figure 4-41. Lift the Pump Rollers Handle.
11.
Place the flanged connector of the pump tubing into the slot on the right
side of the pump head.
1. Place flanged connector
into socket on right hand
side of pump raceway.
Figure 4-42. Flanged Connector Fits Into Recess.
12.
Load the pump tubing around the rollers and into the channel of the
pump head. You must turn the handle counterclockwise as you feed the
tubing into the channel. Press down firmly on the tubing until it settles
into the bottom of the channel. Once the tubing is installed, press the
handle down onto the rollers until it presses into its detent.
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Figure 4-43. Pump Tubing Installation.
13.
Close the top cover on the pump. It will snap shut.
Cover the Coldwell
14.
Replace the cap on the coolant well. Position the cap so that the heat
exchanger coil and tubing fits into the notch. Press down on the cap to
create a tight seal.
Figure 4-44. Replace the Cap on the Coolant Well.
Spike the Saline Bag
15.
Using aseptic technique, connect the priming line to the sterile saline
container. The priming line is equipped with a “spike” connector. Hang
the saline container on the hook provided.
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Figure 4-45. Making a Sterile Connection to the Saline Container.
CAUTION! START-UP KIT SPIKE
The spike on the Start-Up Kit is relatively long. Be careful not to puncture the
side wall of the saline bag when connecting to the Start-Up Kit.
Prime & Fill the Air Trap
16.
Remove the air trap from its holder and hold it upside down (with the
tubing connections pointing downward).
Figure 4-46. Hold the Air Trap Upside Down.
17.
Prime the air trap and the tubing circuit by pressing and holding the
PRIME switch. The roller pump will slowly start and take about 20
seconds to come up to operating speed. Observe the movement of
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saline until it fills the air trap and the entire length of the tubing. The
PRIME switch will only function after the system self-tests is
completed.
Figure 4-47. Use the Prime Switch to Prime the Tubing Circuit.
18.
Continue to hold the PRIME switch. When the air trap is completely filled
with saline, tap it to dislodge any remaining air bubbles. Observe the 500
ml saline bag. When bubbles are no longer seen in the saline bag,
priming is complete. Release the PRIME switch.
NOTE: Air Trap
The air trap must be completely filled for proper system operation.
19.
Turn the air trap right side up and insert it in the holder.
20.
Place the tubing to the catheter in the two notches at the front of the
console. Place the priming line and the saline return line in the channels
leading to the rear of the console. Close the top cover of the System.
CAUTION! Damage to Top Cover
Do not sit on the top cover or place heavy objects on the top cover.
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Figure 4-48. Route the Tubing Out of the System.
21.
Lift the saline container off the hook and slip the insulating jacket around
the container. Carefully close the hook-and-loop fasteners at the top and
bottom of the jacket. Rehang the container on the hook.
22.
When the self tests are completed and the Start-Up Kit is loaded and
primed, the System will enter STANDBY. The System is ready to be
connected to the patient.
Figure 4-49. STANDBY Screen – T1 Probe Not Connected.
Connecting the Patient to the System
CAUTION! Verify System Function First
Ensure proper functioning of the System and initiate pre-cool or pre-warm (if
applicable) prior to placing the catheter in the patient.
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When the System has been prepared as directed in the preceding sections, it
may be moved to the patient’s bedside and connected to the patient. Follow
these steps in the indicated order.
1.
Position the System near the patient’s bed. It must be close enough so
that the temperature probe cables and the tubing can conveniently reach
the patient. Route the cables and tubing safely.
2.
If the primary and secondary patient temperature probes have not been
placed in the patient, this should be done now. Refer to the Instructions
for Use that accompany the temperature probes for information about the
probes.
3.
Connect the blue patient temperature cable to the YSI-400 primary
temperature probe (e.g. Foley catheter, rectal or esophageal). Connect
the plug at the end of the blue patient temperature cable into the
connector labeled “T1” on the front of the System console.
Figure 4-50. Temperature Probe Connections.
4.
If you are using a secondary patient temperature probe, connect the blue
patient temperature cable to the YSI-400 secondary temperature probe.
Connect the plug at the end of the blue patient temperature cable into
the connector labeled “T2” on the front of the System console. If you are
not using a secondary temperature probe, the patient MUST be
monitored by a separate hospital patient temperature monitor.
5.
Place the ZOLL catheter in the patient now. Refer to the Instructions for
Use for information about the catheter.
6.
The tubing to the catheter is supplied with the supply and return
connectors connected to each other. Using aseptic technique,
disconnect the two connectors.
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Figure 4-51. Disconnect the Connectors Using Aseptic Technique.
7.
Connect the female tubing connector to the male connector on the
catheter. The gender of the tubing connectors and the catheter
connectors assures that they cannot be connected backwards.
Figure 4-52. Connect the Tubing to the Catheter.
8.
Connect the male tubing connector to the female connector on the
catheter. Note that the return line is equipped with an inline flowindicator.
9.
Safely route the tubing so that it is not kinked or obstructed and cannot
be easily dislodged by a patient’s movement.
The System is now ready to begin treatment.
Once treatment has begun, confirm that saline is flowing through the tubing and
catheter circuit by observing the rotation of the inline flow indicator (see figure). If
the flow indicator does not rotate freely during patient treatment, inspect the
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entire tubing circuit for kinks or other restrictions to flow. Tapping on the flow
indicator will liberate any trapped air bubbles and return them to the saline bag.
Figure 4-53. Inline Flow Indicator.
WARNING! INVESTIGATE AIR TRAP ALARMS.
If an “Air Trap Fault” alarm occurs, it is likely that there is a leak in the tubing
circuit or the catheter has failed. Refer to Chapter 6 – Alarms and Corrective
Actions for assistance. Do not keep replenishing saline that is being rapidly
depleted–a problem exists that must be immediately remedied.
WARNING! START-UP KIT LIFETIME IS SEVEN (7) 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 System. 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 exchanged power
Device failures
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Setup - Variations
System Setup Sequence
The System Setup sequence varies depending upon the following factors:
1.
The time from the last power down.
2.
Whether or not you used the “End Procedure” menu option when you
terminated the previous case.
Time From Last Power Down
If the System detects that it is less than 3 minutes since the last time it was
powered down it will dispense with some of its self tests depending upon the
state of the cooling engine at the time of power down. The idea being that, with
such a short time, it is more likely than not that the power down was either
unintentional (you tripped over the power cord) or an intentioned brief adjustment
that required the system to be powered off (you moved the System to a new
position).
The System will give you the option to use the last programmed settings. If you
elect to do this you may still use the menu system to change system settings in
STANDBY.
Figure 4-54. Operate at Current Settings
At power on of the system, if it has been less than 3 minutes since the last power
down, then you will be presented with the screen above.
1.
If you select “Yes” and press the knob, you will proceed directly to
STANDBY once the system self tests have completed.
2.
If you select “No” and press the knob, you will continue to be presented
with screens that allow you to select operating parameters for the
System prior to entering Standby starting at Figure 4-57 – see below.
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If the System detects that it is more than 3 minutes since the last time it was
powered down it will conduct all its self tests. You will not be offered the option
of operating the system at the current settings.
Downloading Data After Improper Shutdown
To help prevent the accidental loss of patient trend data, the System is designed
to store patient trend data if power to the system is interrupted or lost. If the
System has not been properly shut-down, all patient trend data will be preserved.
The next time the System is switched on, the self-test program detects the saved
patient data and offers the user the option to download the data to a laptop
computer. If the user does not wish to download the saved data, the System will
delete the data before permitting set up for a new patient.
To download patient trend data after an improper shutdown, follow these steps in
the indicated order.
1.
Plug in and switch on the System. The self-test screen appears on the
display.
NOTE: The Software Version shown in the figure 4-55 is for reference only; the
current product may use a different Software Version.
Figure 4-55. Self-Test Screen.
2.
When the self-test is finished, the System Set Up screen displays the
message “Bath Pre-Set?”
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Figure 4-56. Bath Pre-Set?
3.
Choose “Pre-Warm”, “Pre-Cool” or “None” as desired.
4.
When the System detects the presence of saved patient trend data, the
System Set Up screen displays the message “New Patient?”
Figure 4-57. New Patient? Message.
5.
Choose “Yes.”
6.
The screen displays the message “Previous patient data must be
downloaded or deleted to proceed.”
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Figure 4-58. Patient Data Message.
7.
Choose “Download Now.”
8.
The screen displays the message “Prepare data link.”
Figure 4-59. Prepare Data Link Message.
9.
Connect one end of a serial interface cable to the laptop computer’s
serial interface connector.
10.
Attach the other end of the cable to the serial interface connector on the
System. The male 9-pin subminiature “D” connector is located on the
rear of the control head.
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Figure 4-60. Location of the Serial Interface Connector.
11.
Start the TempTrend CSV program on the laptop computer. Refer to
Chapter 5 - TempTrend CSV.
12.
If a problem occurs during downloading, the System screen will display
the message “Download error. Please check external computer.” Check
the serial cable connections and the operation of the laptop computer
and choose “Try again.” If repeated failures occur, choose “Cancel.”
Repeated failures indicate a problem with the TempTrend program or the
System; contact your ZOLL representative for assistance.
Figure 4-61. Download Error Message.
13.
When the data download is complete, the System screen briefly displays
the message “Download Complete.” At this time, the patient trend data
saved from the improper shutdown is deleted.
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14.
After about two seconds, System Set Up screen displays the message
“Set up system now. Press Enter to proceed.”
15.
Disconnect the serial interface cable from the System and the laptop
computer.
Downloading of patient trend data is now complete. To set up the System for a
new patient, return to the section in this chapter titled Preparing the System for
Treatment.
CAUTION! There is no “Undelete”
If you choose “Delete,” the patient’s trend data will be permanently deleted
and cannot be recovered later.
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Ending Treatment
End Procedure
Use of the “End Procedure” menu option ensures that the patient data log is
closed and cleared so that the System is ready to receive the next patient. If the
“End Procedure” menu option is not used to terminate a case, then the System is
programmed to ensure that you make active decisions as to what is to happen to
the patient data log when you next power on the system. See: Downloading
Data After Improper Shutdown.
We refer to the use of the END PROCEDURE menu option as “PROPER
SHUTDOWN” in this manual.
Data Download
Data may be downloaded at the end of a case. To download patient trend data
from the System to a laptop computer, follow these steps in the indicated order.
1.
When you choose to end the procedure, the screen displays the
message “Patient data must be downloaded or deleted to proceed.”
Figure 4-62. Patient Data Message.
2.
Choose “Download Now.”
3.
The screen displays the message “Prepare data link.”
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Figure 4-63. Prepare Data Link Message.
4.
Connect one end of a serial interface cable to the laptop computer’s
serial interface connector.
5.
Attach the other end of the cable to the serial interface connector on the
System. The female 9-pin subminiature “D” connector is located on the
rear of the display head.
Figure 4-64. Location of the Serial Interface Connector.
6.
Start the TempTrend program on the laptop computer. Refer to Chapter
5 – TempTrend CSV.
7.
If a problem occurs during downloading, the System screen will display
the message “Download error. Please check external computer.”
Check the serial cable connections and the operation of the laptop
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computer and choose “Try again.” If repeated failures occur, choose
“Cancel” and contact your ZOLL representative for assistance.
Figure 4-65. Download Error Message.
8.
When the data download is complete, the System screen briefly displays
the message “Download Complete.”
9.
If you are downloading data after treatment has ended, the patient trend
data in the System will be deleted. After about two seconds, the
message is automatically cleared and the screen displays the message
“Turn power off”.
Figure 4-66. Turn Power Off Message.
10.
At the rear of the console, turn the power on/off switch to OFF.
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11.
Disconnect the serial interface cable from the System and the laptop
computer. Patient trend data downloading is now complete.
New Patient – No Power Down
Change the Start-Up Kit
The system does not have to be powered down to start a new case. A new
catheter, patient temperature probe and Start-Up Kit are required for each patient
– see Disposal of Used Components. To immediately start a new case without
powering down.
1.
Place the System is Standby.
2.
Delete the previous Patient Data – see below.
3.
Verify the System Settings.
4.
You may select to Pre-Cool or Pre-Warm the coolant using the settings
menus.
5.
Connect the New Patient.
6.
Place the System in RUN when desired.
Delete Previous Patient Data
To delete a previous patient’s data and prepare the System for immediate use
with a new patient, without powering off the system, follow these steps in the
indicated order:
1.
Press the “Press for Enter/Menu” knob once. The menu is displayed.
2.
Turn the knob until the “New Patient” selection is highlighted. Press the
knob once to enter the selection.
3.
The New Patient menu will appear. The screen displays the message
“Select Yes to Delete Previous Patient Data.” Press the knob once to
enter “Yes.”
4.
The screen displays the message “Are you sure you want to delete the
previous patient data?” Press the knob once to enter “Yes.”
5.
The screen briefly displays the message “Previous patient data deleted”
and then displays the standby screen.
Disposal of Used Components
WARNING! SINGLE USE DEVICE–DO NOT REUSE.
ZOLL intravascular heat exchange catheters and System Start-Up Kit
components are single-use devices and may not be reprocessed or reused.
The cyclical stresses of the peristaltic pump on the catheter and Start-Up Kit
cause fatigue failures.
DO NOT Use Catheters or Start-Up Kits Beyond the Labeled Usage Time.
Failure of the product will result.
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CAUTION! AVOID CONTACT WITH USED COMPONENTS.
Handle used components as medical waste.
To remove used components from the System and dispose of them properly,
follow these steps in the indicated order.
1.
Assure that the patient has been disconnected from the System and that
the power switch has been turned off.
2.
Cross connect the loose ends of the Start-Up Kit when you disconnect it
from the catheter. This will reduce the amount of fluid that has to be
cleaned up later.
3.
Position a large empty medical waste container or collection bag near
the System.
CAUTION! DO NOT DISASSEMBLE START-UP KIT.
Do not disconnect the tubing connecting the components. They are removed
and disposed of as a complete unit. To avoid injury, do not disconnect the
saline solution container.
4.
Open the top cover of the System. Open the transparent top cover of the
roller pump.
5.
Remove the cap from the coolant well and set it aside in a clean location.
6.
Remove the insulating jacket from the saline container and set it aside.
7.
Lift the handle on the pump rollers.
8.
Grasp the pump tubing and gently pull it up and out of the channel while
rotating the pump head.
9.
Pull the tubing out of the pump head. Press the handle down onto the
rollers until it press into the detent and close the top cover of the roller
pump.
10.
Loosely coil the disconnected ends of the catheter tubing.
11.
Lift the heat exchanger coil out of the coolant well. Hold the coil above
the coolant well to allow coolant to drip back into the well.
12.
Pull the air trap up and out of the holder.
13.
Unhook the saline solution container from the hook.
14.
Bundle up the collection of components, still connected together, and
gently deposit them in the medical waste container. Take care to avoid
contact with the IV container “spike.”
15.
Use a disposable tissue to wipe up any spilled coolant from the top of the
coolant well. Place the tissue in the medical waste container.
16.
Replace the insulated cap on the coolant well. Replace the insulating
jacket on the hook.
Removal and disposal of the used components is complete. The System may
now be stored or moved to its next treatment location.
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NOTE: Disposal of System
When the System itself has reached the end of its useful life, it must be
disposed of in accordance with local governing ordinances and recycling plans
for refrigerated appliances.
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Operation
Temperature Trend Data
Overview
During operation, the System continuously collects and stores temperature trend
data, storing a record each minute. This data is stored in memory and can be
downloaded to an attached laptop computer for later analysis or plotting.
The memory will hold up to 21 days of data. Data can be collected for 21 days
before the memory is filled and a download of data is necessary to preserve all of
the stored data. If data is not downloaded when memory is full, the newest data
will overwrite the oldest data and only data from the past 21 days will be stored.
At any time during operation, the complete record of temperature trend data can
be displayed as a graph on the screen. This chapter explains how to display
temperature trend data and provides details about the format and structure of the
downloaded data.
Displaying the Temperature Trend Graph
To display the temperature trend graph, follow these steps:
1. Press the Press for Enter/Menu knob once. The screen displays the
menu. The selection “View Graphs” will be highlighted.
Figure 4-67. Menu.
2. Press the knob once. The screen will display the temperature trend graph.
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Temperature Trend Graph
Temperature trend data can be displayed as an interactive graph on the screen.
The display is a time-series of patient temperature (from the primary temperature
probe) and System activity, plotted in two graphs. The patient temperature graph
plots temperature vertically and time horizontally. The System activity graph plots
cooling/warming activity vertically and uses the same time scale horizontally. An
example of the patient temperature trend display is shown below.
Figure 4-68. Temperature Trend Display.
Patient Temperature
The patient temperature graph (labeled “Patient Temp”) is scaled for any
temperature between 31º C and 41º C (87.8º– 105.8º F). The time scale can be
set to any of four intervals (refer to Setting the Time Scale, later in this chapter,
for details). Figure 4-68 shows the vertical temperature displayed in degrees
Celsius, and the horizontal time scale displayed for a 4-hour interval.
System Activity
The System activity graph (labeled “System”) is scaled for any System activity,
from maximum cooling to maximum warming. The horizontal time scale is the
same as that set for the Patient Temperature graph. The vertical scale uses a
colored activity indicator:
The red zone indicates coolant temperatures between 36º C and 42º C.
The neutral point (between red and blue) indicates coolant temperature of
36º C and also indicates when the pump is not operating.
The blue zone indicates coolant temperatures between 0º C and 36º C.
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Operation
Cursor
The cursor is a fixed vertical line that runs through the center of both graphs.
When the temperature trend graph is displayed, you may turn the Press for
Enter/Menu knob to scroll the display to the left or right. As data scrolls under
the cursor, the top of the screen shows the time and date of the data under the
cursor.
Turn the knob clockwise to scroll to the right. As you scroll to the right, the time
and date display will indicate later data. By scrolling right to the end, you can
display the most current data.
Turn the knob counterclockwise to scroll to the left. As you scroll to the left, the
time and date display will indicate earlier data. By scrolling left to the end, you
can display the data collected when treatment began.
Status Bar
Across the bottom of the display is a status bar which displays the patient’s
temperature, the status of the System, and the target temperature for the data
point under the cursor.
The patient’s temperature and target temperature are displayed using the current
temperature notation setting (Celsius or Fahrenheit).
The System status field uses colors to display one of nine status messages that
are described in the following table.
Table 4-5.
Status
Message
Message
Color
STBY
Black
MAX
Red
MED
Red
LOW
Red
0
Black
LOW
Blue
MED
Blue
MAX
Blue
OFF
Black
System Status Bar Messages.
Explanation
The System was in standby mode (pump off).
The System was warming.
The System was neither warming nor cooling.
The System was cooling.
The System was turned off.
Setting the Time Scale
The time scale displayed by the temperature trend graph can be set to any of
four intervals: 4 hours, 12 hours, 24 hours, or 72 hours. To set the time scale,
follow these steps:
1. Display the temperature trend graph.
2. Press the Press for Enter/Menu knob once. The screen displays a popup menu with the choice “Set Time Scale” highlighted.
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Figure 4-69. Set Time Scale.
3. Press the knob once. The screen displays the message “Select interval”
followed by four interval choices. The most recent choice will be
highlighted.
Figure 4-70. Select Interval.
4. Turn the knob to highlight your desired selection. When it is highlighted,
press the knob once.
5. The screen displays the pop-up menu again. Turn the knob to highlight
the “Cancel/Exit” selection.
6. Press the knob once. The menu will disappear and the temperature trend
graph will be displayed using the interval you selected.
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Operation
Mechanical Components
Top Cover
When access to the tubing or Coldwell of the System is required, lift the top cover
to a fully upright position.
Figure 4-71. Top cover fully open.
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Operation
Control Head Tilt
To modify the tilt of the Control Head, or to lock the Control Head in place use
the lever located at the swivel point. Turn the lever clockwise to tighten or
counterclockwise to loosen. The position of the lever may be changed, without
adjusting the tightness, by pulling the lever towards you.
Figure 4-72. Control Head Tilt Lever.
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Operation
Casters
There are two different types of casters (wheels) on the System.
1.
The front casters have a brake feature.
2.
The rear casters do not lock and are free to rotate at all times.
The figure below shows the operation of the casters.
1.
Locking Casters
2.
Non-locking Casters
Figure 4-73.
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Operation
Hospital Monitor Interface Accessory
(HMIA)
Overview
This explains the installation, operation, and maintenance of the Hospital Monitor
Interface Accessory (HMIA).
The sole function of the HMIA module is to simulate the patient temperature
probe connected to the T1 port on the front of the System. Connection of the
HMIA to a hospital temperature monitor using one of the ZOLL custom cables will
permit the display of an identical patient temperature on both the System and the
hospital temperature monitor, while using only a single patient temperature
probe.
WARNING:
The HMIA is not a replacement for the T2 Temperature probe on the System.
It simply simulates the T1 Temperature probe. Use of the HMIA does not
obviate the need for a second patient temperature monitoring method. Failure
to use a second patient temperature monitoring method can result in injury to
the patient in the event of a T1 Temperature Probe failure.
Operating the HMIA
Connecting to the Hospital Monitor
The HMIA simulates a standard YSI 400 temperature sensor, such as in a patient
temperature sensing Foley catheter or rectal probe.
The HMIA is connected to a hospital monitor via a ZOLL custom interface cable
included with the HMIA. These cables have connectors that are identical to the
connectors of Foley and rectal patient temperature probes.
One end of the ZOLL interface cable plugs directly into the standard patient cable
of the hospital monitor. In this way, the hospital monitor connects to the HMIA
interface cable in the same fashion as it would connect to a Foley or rectal
temperature probe. (See Figure 4-74).
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Figure 4-74. Cables and Connections
The other end of the ZOLL interface cable plugs into the HMIA connector labelled
T1 out. (See Figure 4-75).
Figure 4-75. HMIA with T1 out connection
To begin operation
The operation of the HMIA is very simple. There is no independent on/off switch.
As soon as the System is switched on, the HMIA automatically begins
functioning.
Connect the custom ZOLL interface cable to the patient cable of the hospital
monitor. (See Figure 4-74). Plug the other end of the ZOLL interface cable into
the HMIA connector labelled “T1 out”.
The set-up is now complete.
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Controls and indicators on the HMIA
The HMIA has the following control/indicators: a reset switch, a green power
indicator and a red warning light.
The front panel of the HMIA is illustrated in the figure below.
Figure 4-76. Front Panel of the HMIA
The meaning of the symbols on the front panel is as described in the table below
Table 4-6.
Symbol
RST
HMIA Control/Indicators
Description
Function
Reset Button
This is a reset button. Lightly push the tip of a
paperclip, or similar sized device, into the hole
until you feel a “click” and then withdraw the
paper clip.
Caution LED
This red light indicates that there is a
malfunction in the HMIA.
Power LED
This green light indicates that the HMIA is
receiving power from the System.
RS232
RS-232 Serial port connector
cable
This short extension cable is connected to the
RS-232 data port connector on the back of the
display head of the System.
T1 out
Patient temperature output
connector
This connector accepts the custom ZOLL
interface cable.
System umbilical cord
connections
One connector is attached to the round, multipin connector on the back of the display head
of the System via a short cable. The other
connector mates with the umbilical cord of the
System.
SYSTEM
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Operating States
The HMIA has the following operating states: START-UP and RUN.
START-UP
When the System is powered on, illumination of the Green LED is indication that
power has been supplied to the HMIA. If there is no power to the HMIA the
Green LED is not lit and the hospital monitoring system, if attached to the HMIA,
should detect this as a probe disconnection or temperature probe error.
Once powered, the HMIA immediately establishes its link with the System and
performs a series of self tests including self-calibration – see below.
RUN
The HMIA is designed to provide a variable resistance value that is interpreted by
YSI-400 compliant hospital monitors as patient temperature. The patient
temperature is obtained via the T1 connection of the System.
Calibration
HMIA performs a self-calibration at START-UP. It will also perform a selfcalibration upon reconnection of the RS-232 port (for example, you might
temporarily disconnect the HMIA to allow access for data download). Selfcalibration takes less than half a second. During self-calibration, it may be
detected by the hospital monitor as a disconnected probe. At the end of selfcalibration the HMIA will automatically return to RUN.
Installation
The HMIA is quickly and easily installed.
Prior to installation of the HMIA, verify that the System has the correct software
to support the HMIA. The software version is displayed during initial start-up of
the System as per the figure below. The first number in the Software Version
must be equal to or greater than 1.04 (See Figure 4-77).
Figure 4-77. System Software Version
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If your System does not have the compatible software version, then the correct
software will need to be installed for the HMIA to function. Failure to install the
correct software prevents the HMIA from functioning but it has no adverse affects
on the System.
Installation Equipment
The following items are necessary to install a HMIA.
1. System with correct software.
2. There are two different configurations of umbilical cables in the field. One
has a 6-pin connector and the other has an 8-pin connector. The
configuration of the HMIA corresponds to the type of connector on the
Umbilical Cable of the System being modified. HMIA part number 87000652-40 is for the 8-pin circular connector and HMIA part number 87000653-40 is for the 6-pin circular connector
3. TP-400 test fixture with adapter cable (ZOLL Part number 8700-0677-40)
that mates to the T1 connector of the System
4. Air trap assembly filled with water (ZOLL Part number 500395-001).
5. The standard Hospital Monitor patient temperature cable that is used to
connect the Hospital Monitor to a Foley or rectal patient temperature
sensor.
6. Hospital Monitor that conforms to the YSI-400 requirements.
7. Optionally a Digital Multimeter may be used if a hospital monitor is not
available.
Installation Procedure
1. Disconnect power to the System
2. Disconnect the Umbilical Cable from the rear of the Display Housing
(See Figure 4-78)
Figure 4-78. The Hirose Connector – Rear of the Display Head
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3. Verify that the connector type on the end of the Umbilical Cable is
identical to the connector on the HMIA. 8700-0652-40 for the 8-pin
circular connector and 8700-0653-40 for the 6-pin circular connector. If
the connectors are incompatible then contact ZOLL to arrange for a
replacement.
4. Remove the paper protecting the Velcro® strips found on the mounting
surface of the HMIA.
5. Hang the HMIA on the stainless steel bracket located on the back of the
Display Housing. The connectors on the HMIA should be facing
downward.
6. Press on the lower half the HMIA until the snaps engage.
7. Connect the Umbilical Cable to the mating connector on the HMIA
labelled SYSTEM.
8. Connect the cable with the circular connector to the mating connector on
the rear of the Display Housing.
Figure 4-79. RS-232 Connector – Rear Display Head
9. Connect the HMIA RS232 connector, labelled RS232, to the mating
connector on the Rear of the Display Housing. (See Figure 4-79)
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Figure 4-80. Installed HMIA – Rear Display Head
10. Select the appropriate custom ZOLL interface cable that mates with the
patient cable of the hospital temperature monitor.
11. Insert the phone jack of the selected cable into the HMIA connector
labelled T1 out.
12. Connect the other end of the ZOLL interface cable to the patient cable of
the hospital monitor.
13. Prepare the hospital monitor such that it will monitor patient temperature.
14. Power ON the System.
15. Verify that the Green LED of the HMIA is ON.
16. Connect a TP-400 temperature simulator to the T1 connection on the
front of the System. Set to 35OC.
17. Using an air trap test fixture to complete the set-up procedure, place the
System in STAND-BY.
18. Verify that the patient temperature displayed by the System is also
displayed on the hospital monitor +/- 0.1OC.
Note:
There may be a delay, as long as 2 minutes, before the temperature displayed
by the hospital monitor agrees, within +/- 0.1OC, with the temperature
displayed by the System.
19. Set the TP-400 to 38OC.
20. Verify that the patient temperature displayed on the System screen is
also displayed on the hospital monitor +/- 0.1OC.
21. Remove the TP-400 and verify that the hospital monitor recognizes the
loss of patient temperature. Typically the hospital monitor will indicate
that the probe is DISCONNECTED.
22. Reconnect the TP-400
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23. Verify that the patient temperature displayed on the System screen is
also displayed on the hospital monitor +/- 0.1OC.
24. Power OFF the System.
25. Verify that the hospital monitor recognizes the lack of input. Typically the
hospital monitor will indicate that the probe is DISLODGED.
26. The System with the HMIA module is now available for clinical use.
Removal of the HMIA
To remove the HMIA, simply apply the installation instructions in reverse
beginning with step 12.
Connection Cable Part Numbers
The following connection cables are available to allow the connection of the
HMIA to your hospital monitor. If you have another type of connector or do not
know which connector to use, please contact ZOLL Customer Service.
Table 4-7.
Connection Cable Part Numbers
Part
Number
Connects to
500628-001
Monitors using a 3.5mm phone jack (Bard®)
500629-001
Monitors using a 2.5mm phone jack (Terumo®)
500630-001
Monitors using a 2-pin Molex type connector with socket contacts (Mallinckrodt® or
Smiths Medical®)
500631-001
Monitors using a 2-pin Molex type connector with pin contacts (Rüsch®)
500632-001
Monitors using an RCA type Phono plug (GE®, WelchAllyn® or Mallinckrodt®)
Data Download
You may download data from the System at any time. Simply disconnect the
HMIA RS-232 connector from the RS-232 port on the back of the display head of
the System. Then download data as per the instructions in the TempTrend
section of the System manual.
This procedure will not delete the data from the System. The data is simply
copied from the system to the laptop.
Reconnect the HMIA RS-232 connector when you have finished.
You cannot damage the HMIA by mistakenly “downloading data” into it.
The HMIA does not store data.
Note:
When you disconnect the HMIA RS-232 connector from the display head of
the System, the HMIA will stop sending data to your hospital monitor. The
hospital monitor will detect this as a patient disconnection or a very low patient
temperature. Depending upon the set-up of your hospital monitor, this may or
may not result in a patient temperature alarm on the hospital monitor.
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Troubleshooting
The HMIA has a very limited user interface. The only function of the HMIA is to
simulate the patient temperature probe connected to the T1 input port of the
System.
This troubleshooting guide deals only with the HMIA. It is incumbent on the
technician doing troubleshooting to verify Items 1 through 4 below prior to
troubleshooting of the HMIA:
1. The System is powered ON, operational, and reporting a valid
temperature on the Display Screen.
2. The hospital monitor is ON and operational.
3. The hospital monitor conforms to the YSI-400 specifications.
4. All cables are connected.
a. RS232 from the HMIA to the Display Head.
b. The circular connector on Umbilical Cable of the System is
plugged into the HMIA.
c.
The HMIA is attached to the circular connector on the display
head.
d. The hospital monitor is connected to one end of the ZOLL
interface cable of the HMIA.
e. The other end of the ZOLL interface cable is connected to the
HMIA.
Errors
Green LED OFF
The Green LED indicates that power is present on the HMIA circuit board.
If the Green LED is not on then the LED has either burned out or the internal
power connector is dislodged. Return the HMIA to ZOLL for service.
Flashing Red LED
The Red LED flashes only when there is a problem with the CPU or the internal
self-calibration fails. Using a small solid wire (paperclip), press the reset button
(RST). If the Red LED continues to flash return the HMIA to ZOLL for service.
No Temperature Reported On Hospital Monitor
1. Observe Red LED.
2. If it is flashing then follow instructions for
Flashing Red LED above.
3. If the Red LED is not flashing then disconnect the hospital monitor from
the HMIA interface cable.
4. Using a DMM measure the resistance between the two pins.
5. Using the chart YSI-400 Temperature vs. Resistance determines if the
resistance value measured corresponds to the temperature displayed on
the System display.
6. If the resistance value is correct then the HMIA is functioning to
specifications.
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7. If the resistance value is wrong, then test ZOLL interface cable for shorts
or opens.
8. If it passes the test, then press the reset button (
RST ).
9. Repeat step 5 above.
10. If the resistance value is still wrong, then disconnect the RS232 cable
from the rear of the display housing, wait for 15 seconds and then
reconnect.
11. Wait for an additional 20 seconds for the HMIA to re-establish
communication with the System
12. If the resistance value is wrong then return the HMIA to ZOLL for service.
Incorrect Temperature Reported On Hospital Monitor
1. Disconnect the hospital monitor from the HMIA interface cable.
2. Using a DMM measure the resistance between the two pins.
3. Using the chart YSI-400 Temperature vs. Resistance determines if the
resistance value measured corresponds to the temperature displayed on
the System display.
4. If the resistance value is correct then the HMIA is functioning to
specifications.
5. If the resistance value is wrong, then test ZOLL interface cable for shorts
or opens.
6. If it passes the test, then press the reset button ( RST ).
7. Wait for 20 seconds and then repeat step 3 above.
8. If the resistance value is still wrong, then disconnect the RS232 cable
from the rear of the display housing, wait for 15 seconds and then
reconnect.
9. Wait for an additional 20 seconds for the HMIA to re-establish
communication with the System
10. If the resistance value is wrong then return the HMIA to ZOLL for service.
Temperature jumps between 26OC and 49OC On Hospital
Monitor
There has been an internal component failure. Return the HMIA to ZOLL for
service.
Hirose Connector does not fit
There are two versions of System Hirose connectors in clinical use: a 6-pin and
an 8-pin. If the Hirose connector does not fit, count the number of pins in the
HMIA cable. If this is not the same as the number of pins in the umbilical cable
of the System you have the wrong version of HMIA. If you have the wrong
version of the HMIA, then contact ZOLL to arrange for a replacement.
Table 4-8. HMIA Part Numbers
8700-0652-40
8-pin circular Hirose connector
8700-0653-40
6-pin circular Hirose connector
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Operation
YSI-400 Temperature vs. Resistance
Temperature
Resistance
°F
°C
(ohms)
77.0
25
2252
78.8
26
2156
80.6
27
2064
82.4
28
1977
84.2
29
1894
86.0
30
1815
87.8
31
1739
89.6
32
1667
91.4
33
1599
93.2
34
1533
95.0
35
1471
96.8
36
1412
98.6
37
1355
100.4
38
1301
102.2
39
1249
104.0
40
1200
105.8
41
1152
107.6
42
1107
109.4
43
1064
111.2
44
1023
113.0
45
983.8
114.8
46
946.2
116.6
47
910.2
118.4
48
875.8
120.2
49
842.8
122.0
50
811.3
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TempTrend CSV
TempTrend™ CSV
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TempTrend CSV
Table of Contents
TempTrend™ CSV Overview 3
Installation 3
TempTrend CSV Installation 3
Automated Installation - Autorun 3
Manual Installation 3
IVTM Add-In Installation 3
Automated Installation 4
Using TempTrend CSV 8
USB-Serial Adaptor Driver Installation 8
What TempTrend CSV Does 8
Starting TempTrend CSV 9
Com Port 9
Select File 10
Download 11
Exit 11
Using the IVTM Add-in 12
Open CSV 12
Graph CSV 12
Activate Scroll Control 13
The Scroll Control 14
Location 14
Zoom 14
Scroll 15
Limits of Scroll Control 15
Convert Old Format 15
Uninstalling TempTrend CSV 15
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TempTrend CSV
TempTrend™ CSV Overview
TempTrend CSV is used to download patient data logs from the System.
The use of the CSV format is intended to allow the System user the greatest flexibility in
analyzing data downloaded from the System.
The Graph CSV Add-In converts the data log file from a “.csv” format to an EXCEL “.xls”
format file. In this way, it facilitates graphing of the patient data that was downloaded
using TempTrend CSV.
Installation
The TempTrend CSV installation CD is designed to work with any version of Microsoft
Windows. Your system may have a configuration or security features that prevent the
installation from working. If you experience trouble with this installation, please send us
a description of the trouble you are having via email to:
complaints@zollcirculation.com
We will respond quickly to your email.
TempTrend CSV Installation
Automated Installation - Autorun
TempTrend CSV is supplied on a CD with an autorun feature. Simply put the CD into a
CD drive on your computer. A series of dialog boxes should guide you through
installation. If the install program has worked correctly, you should have TempTrend
CSV installed on your computer. See: Using TempTrend CSV.
Manual Installation
If your Microsoft Windows is a non-standard setup, the IVTM Add-In will have to be
loaded manually.
1.
Using Microsoft Windows Explorer, open the TempTrend CSV installation CD
and locate the file: TempTrendCSV.exe
2.
Copy the file to a directory on your computer.
3.
Right Click the copied file and select: Create Shortcut
4.
Move the shortcut to your desktop or other desired location.
5.
Double click on the shortcut to start TempTrend CSV.
IVTM Add-In Installation
TempTrend CSV is designed to use the features provided within Microsoft EXCEL. To
view the data in the patient data log you will use an Add-In loaded into EXCEL. This
Add-In is called: IVTM.xla. Once it is installed, it will appear as a new item, called IVTM,
in the menu bar of EXCEL.
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TempTrend CSV
Figure 5-1.
Figure 5-2.
The IVTM Menu with CSV Functions
The IVTM Menu with CSV Functions (Excel 2007/2010)
Automated Installation
Excel 2003 Installation
1.
2.
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TempTrend CSV
Excel 2007 Installation
1.
2.
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TempTrend CSV
3. (Excel 2007 Installation)
Excel 2010 Installation
1.
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2. (Excel 2010 Installation)
3.
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TempTrend CSV
Using TempTrend CSV
You must connect the System to your computer and power it on before you can use
TempTrend CSV to download data logs. Make this connection as described in the
System Operations Manual. To do this you will need either:
An RS-232 serial cable if your computer has an RS-232 port, or
A USB-Serial Adaptor cable if your computer does not have an RS-232 port
but does have a USB port.
Your computer will assign a communications port to this connection (a “Com Port”).
TempTrend CSV will attempt to determine which Com Port is in use by System with each
download. However, if you have a non-standard Microsoft installation, you may have to
set up the TempTrend Com Port assignment to match the Microsoft assignment for the
USB-Serial Adaptor cable. See Figure 5-5.
Com Port
There are MANY non-standard USB-Serial Adaptor cables in the personal computer
marketplace. Please ensure that you use the cable supplied with TempTrend CSV,
part number UT232R-200 (ZOLL part number 8700-0729-01). Also, please ensure
that:
You have loaded all the recommended drivers for your USB-Serial Adaptor cable
and that it uses a communication port between Com1 and Com16.
You do not have another device attempting to use the same communications
port as TempTrend CSV.
USB-Serial Adaptor Driver Installation
The first time the USB-Serial Adapter cable (FTDI cable assembly) is plugged into your
system, the operating system will detect new hardware. Follow the Microsoft prompts to
install the hardware. If asked whether to search Windows Update for the driver, select
Yes for this option and follow the prompts to automatically install the software. Be sure
you are connected to the Internet before starting the driver search.
Upon completion of the USB-Serial Adapter installation, you may also be prompted to
install the USB serial port. Follow the prompts to automatically install the USB serial port.
What TempTrend CSV Does
TempTrend CSV downloads the data logs from the System. It creates three files in
comma separated values format (CSV). You are asked to supply a file name for the
patient data log. This is called the root file name (“<rootfilename>”). TempTrend CSV
creates three files based upon this root file name (<rootfilename>). It varies the suffix on
the <rootfilename> depending upon the purpose of the file.
Table 4-1.
Installation File Paths
<rootfilename>.csv
The main patient data log
<rootfilename>_Event.csv
The events data log
<rootfilename>_Info.csv
The system information
If you are asked to download the data logs as part of a service call, please send all three
files.
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Starting TempTrend CSV
To start TempTrend™ CSV click the IVTM shortcut that has been created on your
computer.
The TempTrend CSV control box will open on your screen. TempTrend CSV has only
four controls and is very simple to use.
Figure 5-3.
TempTrend Program Screen
Com Port
TempTrend CSV will attempt to determine which Com Port is in use by your computer to
connect to the System with each download. If it cannot find the connection you will
receive an error message:
Figure 5-4.
Error Message
This error is typically due to one of two reasons, either:
1. The System is not connected and powered on. In which case simply connect the
System, power it on and try again.
or
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TempTrend CSV
2. You have a non-standard Microsoft installation. In which case you must specify the
Com Port to use.
To find out which port is being used, look inside “Device Manager”. You will select the
Com Port that matches your USB-Serial Adaptor.
Figure 5-5.
Device Manager Display
Select the communications port for your System cable connection. Click on the button
“Com Port” and select the appropriate one of the ports listed.
HINT: It is safe to just try each port setting offered within TempTrend CSV until you
find the one that works. TempTrend CSV will not allow you to select a port that is not
connected to the System. You will simply receive a warning message as per Figure
5-4.
Select File
Click on this icon to:
1.
Select the directory into which you want to save the data logs. The default
directory is: C:\TempTrendCSV Data
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TempTrend CSV
Figure 5-6.
2.
Select File Dialog Box
You can either select an existing file name or create a new one.
To select an existing file name, double click on it. All existing data within the
file will be over written with the new download.
To enter a new file name, replace the *.csv with the file name of your
choosing. Type it in place of the *.csv in the file name box.
Figure 5-7.
Fully Qualified File Name Displayed
The full path name of the patient data log file that you selected is displayed above the
Select File icon.
Download
Click on this icon to download data from the System. Both the Select File and
Download icons will grey out during the download. TempTrend CSV will display a %
complete message during download. After the download is complete, both the Select
File and Download icons will appear normal again.
Exit
Click on this icon to exit from TempTrend CSV.
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Using the IVTM Add-in
The IVTM Add-in contains Microsoft macro codes that allow the viewing of the patient
data file. These are accessed via the IVTM menu item in the EXCEL menu bar.
Figure 5-8.
Figure 5-9.
The IVTM Menu with CSV Functions
The IVTM Menu with CSV Functions (Excel 2007/2010)
Open CSV
This menu item allows you to open a CSV file. It will open ANY CSV file.
Graph CSV
The Graph CSV Add-In converts the data log file from a “.csv” format to an EXCEL “.xls”
format file. It also saves the new format with the words “Copy of“ appended as a prefix to
the original file name. In this way the original downloaded data logs are unchanged. You
are free to modify and experiment with your data analyses.
This menu item will create a graph from a patient data log file. The graph will display the
following data series as an XY Cartesian graph with the X axis set as minutes of elapsed
time from the start of the data log and the Y axis as temperature in oC:
1.
Patient Temperature
2.
Target Temperature
3.
Coolant Temperature
4.
System RUN/STANDBY
A graph value equivalent to 8oC indicates that the system was in RUN.
A graph value equivalent to 0oC indicates that the system was either in
STANDBY or powered off.
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Figure 5-10.
Graph CSV Display with Scroll Control
Activate Scroll Control
The Scroll Control is automatically activated after you have graphed a patient data log.
The Scroll Control allows you to:
1.
Select a location in the record that is of interest and display the data on either
side of that point in time.
2.
Change the degree of expansion on the X axis (the time base).
3.
Scroll forward or backward in time.
The Scroll Control will be deactivated by EXCEL depending upon what you do within
EXCEL and you may close it yourself by clicking the Close Button. If it is deactivated,
select this menu item to reactivate.
Within the Chart Menu Bar, the IVTM menu selection has only one option: Activate
Scroll Control.
Figure 5-11.
IVTM Menu in the Chart window
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Figure 5-12.
The IVTM Menu in the Chart window (Excel 2007/2010)
The Scroll Control
Figure 5-13.
The Scroll Control Dialog Box
The Scroll Control is divided into four layers:
1.
The location layer
2.
The zoom layer
3.
The scroll layer
4.
The Close Button
To close the Scroll Control click the Close Button.
Location
There are two boxes in the upper layer of the Scroll Control. On the left is a text box.
Enter the offset in minutes of the section of the patient data log that is of interest to you.
Then click the right hand box with the X in the center of the scroll symbols (>>X<<). The
Scroll Control will center the graph, at your existing zoom, with the entered value in the
center of the graph.
If you are already at MAX zoom, there will be no change in the display.
Zoom
The X axis of the graph will be scaled depending upon which of the buttons in the middle
layer of the Scroll Control that you click.
If you are at MAX zoom, clicking on one of the three other buttons will result in the graph
remaining centered where it is and the span of the graph being modified to either 4 hours,
12 hours or 24 hours. The graph will not move beyond the ends of the graph by more
than half the width of the displayed window.
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Scroll
There are two buttons in the scroll layer of the Scroll Control. Clicking on the left hand
facing triangle will scroll the graph half a zoom distance to the left (i.e. to earlier in the
record). Clicking on the right hand facing triangle will scroll the graph half a zoom
distance to the right (i.e. to later in the record). The graph will not move beyond the ends
of the graph by more than half the width of the displayed window.
Limits of Scroll Control
Scroll Control was designed to work only when it and the graphed data log file are both
visible and “active” on your desk top (i.e. both visible and both the focus for a mouse
click).
Convert Old Format
Convert Old Format provides compatibility with a previous format of the TempTrend CSV
file by converting the previous CSV file format to its current format for use by the
TempTrend graphing module. This function is not used by new installations of
TempTrend CSV that generate the current CSV file format.
Uninstalling TempTrend CSV
The automated installation program installs an “Uninstall” option with TempTrend CSV.
To uninstall TempTrend CSV:
Open the TempTrend CSV folder within your Program menu
Select Uninstall
You will be asked to confirm that you want to uninstall and given a progress
report at the end of the uninstall process
© ZOLL Circulation, Inc. 2013 TempTrend, GraphTrend, and Thermogard XP are
registered trademarks of ZOLL Circulation, Inc. No part of this document or software
may be reproduced or reused without prior written authorization of ZOLL Circulation, Inc.
Microsoft, Windows, EXCEL are registered trademarks of Microsoft Corporation.
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Alarms & Corrective Actions
Alarms & Corrective
Actions
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Alarms & Corrective Actions
Contents
Alarms and Corrective Actions 3
Overview 3
Alarms and Corrective Actions 3
Hi PATIENT TEMPERATURE ALARM 3
Lo PATIENT TEMPERATURE ALARM 3
Alarm Message 4
AIR TRAP FAULT* 4
COOLANT EMPTY* 4
COOLANT LOW 4
PRIMARY TEMPERATURE PROBE DISCONNECTED* 4
PRIMARY TEMPERATURE PROBE DISLODGED* 4
PUMP DOOR OPEN* 4
PUMP FAILURE* 4
SECONDARY TEMPERATURE PROBE DISCONNECTED* 5
SECONDARY TEMPERATURE PROBE DISLODGED* 5
TEMPERATURE PROBES DO NOT AGREE* 5
SYSTEM MALFUNCTION * 5
DOWNLOAD ERROR. PLEASE CHECK EXTERNAL COMPUTER 5
PATIENT DATA LOG FULL. PLEASE DOWNLOAD NOW 5
* Stops operation of the System.
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Alarms & Corrective Actions
Alarms and Corrective Actions
Overview
This chapter lists alarm messages that may appear on the System display during
operation. If an alarm occurs, refer to the following table for information about the
cause and corrective actions you can take to remedy the problem.
Please note that in many cases the System will automatically restart when
the condition that generated the alarm has been cleared. In other cases,
you must take corrective action and then restart the System.
WARNING!
When treating a patient with the System, appropriately qualified medical staff
must routinely and closely monitor the patient. Audible and visual alarm
signals generated by the System require the authorized individual to remain in
close proximity to the patient throughout the procedure.
NOTE: Alarm Priorities
In accordance with the IEC 60601-1-8:2006 safety standard, the System
Alarms have been categorized as HIGH, MEDIUM and LOW priority. HIGH
priority alarms are indicated by red flashing text on the display and require
prompt attention from the operator to prevent irreversible injury or death.
MEDIUM priority alarms are indicated by a yellow banner and require attention
from the operator to prevent reversible injury or discomfort to the patient. LOW
priority alarms are displayed with a yellow banner and delay the treatment of
the patient until they are addressed by the operator.
Alarms and Corrective Actions
Alarm messages are grouped according to their priority and listed in alphabetical
order.
* Stops operation of the System.
Table 6-1.
HIGH priority Alarm Messages, Causes, and Corrective Actions.
Alarm Message
Cause
Corrective Action
Hi PATIENT
TEMPERATURE
ALARM
The patient’s temperature is
above the programmed Hi
patient temperature alarm
value.
The System alarm will reset
when the patient’s
temperature falls below the
programmed Hi patient
temperature alarm value.
Lo PATIENT
TEMPERATURE
ALARM
The patient’s temperature is
below the programmed Lo
patient temperature alarm
value.
The System alarm will reset
when the patient’s
temperature rises above the
programmed Lo patient
temperature alarm value.
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Alarms & Corrective Actions
Table 6-2.
MEDIUM priority Alarm Messages, Causes, and Corrective Actions.
Alarm Message
AIR TRAP FAULT*
COOLANT EMPTY*
COOLANT LOW
PRIMARY
TEMPERATURE
PROBE
DISCONNECTED*
PRIMARY
TEMPERATURE
PROBE DISLODGED*
PUMP DOOR OPEN*
PUMP FAILURE*
Cause
Corrective Action
Air has been detected in the
air trap.
Verify that the air trap is
completely filled with saline.
Inspect tubing circuit for
leaking saline. Refer to “Air
entry into the tubing circuit” in
the Preface.
If the problem persists,
discontinue use and contact
your ZOLL service
representative (see Chapter
9).
The air trap is full of saline
but the saline level detector
indicates a fault.
Completely dry the outside of
the air trap with a towel to
remove any condensation.
Verify that the air trap is
seated firmly at the bottom of
the air trap holder.
If the problem persists,
discontinue use and contact
your ZOLL service
representative (see Chapter
9).
The coolant well is empty.
Fill with mixture of propylene
glycol and distilled water.
The coolant level is low.
Add distilled water until liquid
level reaches top fill line in
coolant well.
The primary patient
temperature probe is
disconnected.
Verify position of primary
temperature probe. Assure
that primary probe is plugged
into socket T1, or if an
interconnect cable is used, the
probe is plugged into the cable
and the cable is plugged into
T1.
Temperature output from the
primary patient temperature
probe changed by –0.2° C or
more within 10 seconds.
Replace probe in patient.
The pump cover is open.
Close the cover.
The pump has failed.
Inspect the pump. Clear any
obvious faults and restart. If
the problem persists,
discontinue use and contact
your ZOLL service
representative (see Chapter
9).
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Alarms & Corrective Actions
Alarm Message
Cause
Corrective Action
The secondary temperature
probe is disconnected.
Verify position of secondary
temperature probe. Assure
that primary probe is plugged
into socket T2, or if an
interconnect cable is used, the
probe is plugged into the cable
and the cable is plugged into
T2.
SECONDARY
TEMPERATURE
PROBE DISLODGED*
Temperature output from the
secondary patient temperature
probe changed by –0.2° C or
more within 10 seconds.
Verify position of secondary
temperature probe.
TEMPERATURE
PROBES DO NOT
AGREE*
Temperature outputs from the
primary and secondary patient
temperature probes differ by
more than 2° C.
Determine the cause of the
discrepancy and correct it.
One or both temperature
probes may need to be
replaced.
May be caused by a variety of
failures.
Discontinue use and contact
your ZOLL service
representative (see Chapter
9).
SECONDARY
TEMPERATURE
PROBE
DISCONNECTED*
SYSTEM
MALFUNCTION *
Table 6-3. LOW priority Alarm Messages, Causes, and Corrective Actions.
Alarm Message
DOWNLOAD ERROR.
PLEASE CHECK
EXTERNAL
COMPUTER
PATIENT DATA LOG
FULL. PLEASE
DOWNLOAD NOW
Cause
Corrective Action
Patient trend data download
has failed or there is no
computer connected to the
System.
Check the connection
between the computer and the
System and select “Try again.”
If problem persists, select
“Cancel” and contact ZOLL
technical support.
Patient trend data log is full.
Only two hours of space
remain.
Download patient trend data.
If data is not downloaded, it
will be overwritten.
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Troubleshooting
Troubleshooting
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Troubleshooting
Contents
Troubleshooting 3
Overview 3
Symptoms and Remedies 4
Events Requiring Technical Assistance 6
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Troubleshooting
Troubleshooting
Overview
IMPORTANT:
Qualified medical personnel must read and understand these instructions
before performing troubleshooting on the System.
This chapter provides information about performing troubleshooting and service
for the System. A table of symptoms, probable causes, and recommended
corrective actions has been provided to assist troubleshooting by qualified users.
Some test and repair tasks must be performed only by ZOLL-trained service
personnel. If you encounter a problem that is not listed in this chapter, do not
attempt to make repairs or adjustments–contact your ZOLL service
representative for assistance.
Chapter 9, Warranty and Service, provides information about how to obtain
assistance or service from a ZOLL representative.
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Troubleshooting
Symptoms and Remedies
Consult the following table for help with troubleshooting the System. If the
problem you are experiencing is not listed in the table, contact your ZOLL service
representative for assistance.
Table 7-1. Symptoms, Probable Causes, and Corrective Actions.
Symptom
Probable Cause
Corrective Action
Red LED on control
panel is illuminated
and audible alarm
sounds.
System or control failure.
Discontinue use and contact ZOLL.
Red LED on control
panel is blinking and
audible alarm beeps
repeatedly.
Electrical power was
momentarily interrupted.
Turn off power and wait 30 seconds. Turn
on the System and restart. If problem
persists, discontinue use and contact ZOLL.
System will not start.
No electrical power.
Verify that the System is plugged into a
working circuit of correct capacity.
Assure that the power cord is securely
plugged into the power inlet connection of
the System.
The patient does not
cool. The activity
monitor indicates “MAX
COOLING” and the
patient’s temperature
is increasing.
The patient may be
febrile.
The fever has overcome the cooling capability of the catheter. Use additional patient
cooling methods as needed until the
patient’s temperature is stabilized.
The temperature controller setting is incorrect.
Verify that the target temperature and that
the cooling rate option is not used.
The saline flow is
obstructed–indicated by
no rotation of the flow
indicator.
Inspect the entire length of tubing, from the
patient’s catheter connection to the System
and back to the patient. Clear all restrictions.
Check the flow indicator to confirm flow.
The saline flow rate is
incorrect.
Set the pump flow rate as specified by the
catheter’s Instructions for Use.
The catheter is improperly positioned or is not
connected.
Place and position the catheter as directed
by the Instructions for Use.
Connect the saline circuit tubing to the
catheter and prime the saline circuit.
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Troubleshooting
Symptom
Probable Cause
Corrective Action
The patient does not
cool. The activity
monitor indicates
“MAX COOLING” and
the patient’s temperature is increasing.
The heat exchanger coil is
not in the coolant
reservoir.
Place the heat exchange coil in the
reservoir.
The System is not
operating within specifications.
Verify operation by performing the cooling
engine power test described in the System
Service Manual.
The patient does not
cool. The activity
monitor does not
indicate “MAX
COOLING” and the
patient’s temperature
is increasing after 45
minutes of sustained
activity.
The System is not
operating within
specifications.
Download the TempTrend data file. If the
coolant temperature is above 42 °C perform
the cooling engine power test described in
the System Service Manual.
The patient’s temperature is more than
0.5º C below the set
point.
The patient’s resistance to
hypothermia has diminished, resulting in a
temperature controller
undershoot.
Monitor the patient’s temperature. If the
patient’s temperature drops more than one
degree below the target temperature,
ensure that the System is operating normally. If the coolant temperature is at or below
the patient’s temperature, the activity monitor should indicate warming and the pump
should be off. Use warming blankets to
stabilize the patient’s temperature.
Machine malfunction.
See above for correct machine function. Use
conventional methods to rewarm the patient
and discontinue use of the System.
The patient does not
stop cooling. The activity monitor indicates “MAX COOLING”
when the target temperature has been
reached.
A cooling or temperature
controller fault has
occurred.
If the activity monitor indicates “MAX COOLand the patient’s temperature is one
degree below the target temperature, discontinue treatment and contact ZOLL.
The patient is
warming (when set
for cooling).
A cooling or temperature
controller fault has
occurred.
If the target temperature is below the
patient’s temperature, and the activity
monitor does not indicate cooling activity,
discontinue treatment and contact ZOLL.
ING”
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Troubleshooting
Symptom
Probable Cause
Corrective Action
The patient does not
warm. The activity
monitor indicates
“MAX WARMING” and
the patient’s temperature continues to
decline.
The warming capacity of
the catheter has reached
its upper limit.
Use warming blankets to supplement
catheter performance until the patient’s
temperature has been stabilized.
The patient is
warming too fast
(when set for
warming).
The warming rate is
incorrect.
Reset the target temperature to hold or cool
the patient’s temperature. Verify the warming rate setting.
Events Requiring Technical Assistance
CAUTION!
The System has multiple internal alarm states - see Alarms & Corrective
Actions.
As described in this manual, some are remedied by the user action e.g. Filling
the coldwell with coolant will rectify the coolant level alarm.
There are others that may be alleviated, in some cases, by power cycling the
System (i.e. turning it off and then back on).
If neither user action nor power cycling the system clears the alarm – DO NOT
USE THE SYSTEM. Call a ZOLL Service Representative for service of any
alarm that does not clear.
Immediately discontinue using the System and seek advice from your ZOLL
service representative if any of the following events occur:
•
The System repeatedly trips an outlet equipped with a ground fault
circuit interrupter (GFCI).
•
The protective fuse repeatedly blows.
•
Fluid is observed leaking from the console.
•
The System emits an unusual odor when operating.
•
The System produces loud or unusual noises when operating.
•
The display screen, control knob, or control buttons fail to operate as
expected.
•
The System has been exposed to fire, flood, or hazardous
substances.
•
The System has suffered potential damage due to improper storage,
rough handling, or being dropped.
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Maintenance
Maintenance
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Maintenance
Contents
Maintenance 3
Overview 3
Safety Precautions 3
Required personal protective equipment (PPE) 3
Required tools and materials 3
Scheduled Maintenance 4
Unscheduled Maintenance 5
Inspect/Replace Condenser Filter 5
Required Tools and Materials 5
Procedure 5
Temperature Accuracy Test 6
Required Tools and Materials 6
Procedure 6
Clean Console and Condensate Pan 6
Required Tools and Materials 6
Procedure 6
Drain Coolant 7
Required Tools and Materials 7
Procedure 7
Spillage 9
Verify Pump Roller Gap 9
Required Tools and Materials 9
Procedure 9
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Maintenance
Maintenance
Overview
To assure safe operation and a long service life, the System must be periodically
maintained. This chapter describes the scheduled and unscheduled maintenance
tasks that must be performed by the user.
Scheduled maintenance tasks must be performed at least as frequently as
recommended in this chapter. If your System is subject to very long periods of
continuous use, you may be required to perform these tasks more frequently
than the schedule recommends.
The frequency of performing unscheduled maintenance tasks depends upon the
manner in which you use the System. Most of these tasks are performed when
an inspection indicates that they are necessary, or after a problem is discovered.
Failure to perform the maintenance tasks listed in this chapter may cause
degraded performance of the System or may reduce the operating life of its
parts.
WARNING!
No user-serviceable parts inside the system. All system troubleshooting and
repairs to be performed by qualified service personnel. Contact a ZOLL
representative for assistance.
Safety Precautions
Required personal protective equipment (PPE)
•
Safety glasses
•
Latex or neoprene gloves
Required tools and materials
•
Phillips screwdriver
•
Screwdriver
•
Inspection lamp or flashlight
•
Vacuum cleaner with crevice tool
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Maintenance
Scheduled Maintenance
The following table lists scheduled maintenance tasks for the System. Detailed
procedures for some of these tasks are listed later in this chapter.
Table 8-1.
Item
Scheduled Maintenance.
Frequency
Maintenance Task
Coolant reservoir
Before each use
Inspect and refill with distilled water to
indicated line if necessary.
Condensate pan
After each use
Inspect. Empty condensate if necessary (refer
to the “Clean Console and Condensate Pan”
section of this chapter).
Refrigeration condenser
filter
Every 6 months
Inspect the filter and replace if necessary
(refer to the “Inspect/Replace Condenser
Filter” section of this chapter).
Roller pump
Monthly
Clean rollers and tubing path with cloth
moistened with water.
Clean rollers and apply light lubri-cating oil if
rollers have been in contact with saline
solution.
Annually
Verify the pump roller gap.
Coolant
Annually
Drain and refill with new coolant mixture.
Power cord
Annually
Inspect for wear or damage.
Temperature accuracy
Annually
Perform a temperature accuracy test (refer to
the “Temperature Accuracy Test” section of
this chapter).
NOTE TO INFECTION CONTROL:
50% propylene glycol coolant has been evaluated for antimicrobial
effectiveness and determined not to promote growth of gram negative rods,
gram positive cocci, or yeast microbes. 50% propylene glycol was found to
be comparable to 70% isopropyl alcohol.
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Maintenance
Unscheduled Maintenance
The following table lists unscheduled maintenance tasks for the System. These
tasks should be performed when indicated. Detailed procedures for some tasks
are listed later in this chapter.
Table 8-2. Unscheduled Maintenance.
Item
Criteria
Maintenance Task
System
When deterioration is
evident
Inspect mechanical and electrical
components for wear and loose or
deteriorated parts. Verify continuity of the
electrical ground connection.
System console
When soiled
Clean the exterior of the console (refer to
the “Clean Console and Condensate Pan”
section of this chapter).
Coolant
If contaminated
Drain coolant, clean the coolant well, and
refill with 1:1 mixture of distilled water and
propylene glycol (refer to the “Drain
Coolant” section of this chapter).
If particulate matter is
observed in the
coolant
Drain coolant, clean the coolant well, and
refill with 1:1 mixture of distilled water and
propylene glycol (refer to the “Drain
Coolant” section of this chapter).
Inspect/Replace Condenser Filter
Required Tools and Materials
You will need a Phillips screwdriver, an inspection lamp, and a vacuum cleaner
with a crevice tool to perform these tasks.
Procedure
To inspect and replace the condenser filter, perform these steps in the indicated
order:
1.
Assure that the System has been switched off and the power cord has
been disconnected.
2.
Use a screwdriver to release the screws securing the access door.
Remove the access door from the panel.
3.
Remove and inspect the filter. Replace it if it is clogged with dust.
4.
Use the inspection lamp to inspect the area in and around the
condenser. Look for accumulations of dust and debris.
5.
If necessary, use the vacuum cleaner’s crevice tool to remove dust from
the condenser. Gently pass the crevice tool over all exposed surfaces of
the condenser only. Take care not to bend any of the cooling fins of the
condenser. Never use cleaning fluids or water on the condenser.
6.
When finished, replace the access door and secure the screws.
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Maintenance
7.
Inspection and cleaning are complete. The System may be returned to
service.
Temperature Accuracy Test
Required Tools and Materials
You will need a calibrated temperature source (e.g., Fogg System Co. model TP400 or equivalent).
Procedure
To perform a temperature accuracy test, follow these steps in the indicated order:
1.
Set the calibrated temperature source to exactly 37º C and plug it into
connector T1.
2.
Start the System and proceed to the Standby screen.
3.
Observe the patient temperature displayed on the screen. It should
indicate 37º C ± 0.2º C.
4.
If the displayed temperature is above or below the indicated range,
contact your ZOLL service representative.
5.
If the displayed temperature was within the indicated range, the test is
complete.
Clean Console and Condensate Pan
Required Tools and Materials
You will need a soft, lint-free cloth and a solution of mild detergent and water to
perform these tasks.
Procedure
To clean the System console, follow these steps in the indicated order:
1.
Assure that the System has been switched off and the power cord has
been unplugged.
2.
Clean the exterior of the console using a soft cloth dampened with a mild
detergent and water mixture. Never use solvents or abrasive cleaners on
the console. Avoid vigorous scrubbing, especially on the front surface of
the display.
3.
NOTE: System Disinfection
If disinfection is desired of the Thermogard XP System, ZOLL recommends
PDI® Super SANI-CLOTH® germicidal disposable wipes (EPA Reg. No:
9480-4). Other similar disinfectants may also be adequate, but ZOLL highly
recommends testing the disinfectant on a small area on the outer surface of
the console prior to wiping all surfaces of the console. Follow directions
provided by the manufacturer of the disinfectant. The determination of the
effectiveness of the disinfectant should be considered by the hospital.”
Wipe down the outside surfaces with a water-dampened cloth to remove
remaining spots or residue.
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Maintenance
4.
Slide out and remove the condensate collection pan from under the front
of the console (see the following figure).
Figure 8-1.
5.
Location of Condensate Pan (see arrow).
The pan may be washed in hot soapy water. Never use solvents or
abrasive cleaners on the pan. Dry the pan when finished and reinstall it
in the System.
IMPORTANT:
Do not operate the System without a condensate collection pan properly
installed. Failure to do so may allow water to accumulate on the floor under
the System.
Drain Coolant
It may become necessary to drain and clean the coolant well because the
coolant has become contaminated, or to prepare the System for shipment.
Required Tools and Materials
You will need the drain line and connector assembly (supplied with the System),
and a 2-liter waste container to perform this task.
Procedure
To drain the coolant well, follow these steps in the indicated order.
1.
Unplug the System.
2.
Remove the cap on the coolant well and set it aside on a clean surface.
3.
Remove the front panel of the console by pulling the panel straight away
from the front of the machine (no tools are required to remove the panel).
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Maintenance
Near the bottom left corner of the console is a drain hose held by a
clamp and the drain coupler.
Figure 8-2. Drain Hose and Drain Coupler.
4.
Place the open end of the drain hose into a suitable container or position
it above a floor sink or drain.
5.
Push the connector on the drain hose into the drain coupler on the
coolant well (refer to the following figure).
Figure 8-3. Push Hose Into Drain Coupler.
6.
As soon the connector is firmly seated in the coupler, coolant will
automatically begin to flow through the line.
7.
Wait until the coolant flow has stopped. Disconnect the drain line by
pressing down on the metal tab on the coupler. Gently pull out the drain
hose.
8.
Dispose of the used coolant.
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Maintenance
9.
Clean the coolant well using distilled water. Do not use alcohol or any
harsh or abrasive cleansers.
10.
Reconnect the drain hose as described in steps 4-7 and drain the liquid
used for cleaning. Dispose of the liquid.
11.
Repeat this process while flushing the coolant well with distilled water.
12.
When cleaning is complete, you may leave the coolant well empty (to
prepare it for shipment), or refill it with a 1:1 mixture of distilled water and
propylene glycol. Refer to Preparing the System for Treatment in
Chapter 4 for details.
13.
Replace the cap on the coolant well.
14.
Replace the drain hose in the clamp. Replace the front panel on the
console.
Spillage
Both saline and coolant are corrosive and electrically conductive. Although the
System is designed and tested to be in compliance with the spillage protection
requirements of IEC 60601-1, it is important to clean up spillage quickly:
1.
To ensure a safe work environment. Spillage, especially of coolant, can
result in a very slippery floor.
2.
To minimize the risk of corrosion or damage to the System.
Spillage is most likely under the following conditions:
1.
During set-up of the Start-Up Kit. Spillage of saline in this case should
be cleaned up as with the handling of any infusion fluid.
2.
During filling or emptying of the coldwell. The coolant may be safely
wiped with paper towel and the towel disposed of in the standard trash.
Propylene-glycol: Water mix is slippery on sealed floors.
3.
In the event of an air trap alarm. With any air-trap alarm, investigate to
see if there is spillage into the raceway. Remove the rotor and blot dry
the raceway and motor shaft.
Verify Pump Roller Gap
Required Tools and Materials
You will need a 0.125” pin gauge to verify the pump roller gap adjustment.
Procedure
Position the rotor in the pump raceway as shown in Fig. 8-4 and check the rotor
gap, by ensuring that the 0.125” pin gauge fits between the roller and the inside
surface of the pump raceway, at the narrowest point between the roller and
raceway.
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Maintenance
PINNED SIDE OF
HANDLE
ROLLER #1
ROLLER #2
INLET SIDE
OUTLET
SIDE
Check gap between rotor roller and
pump raceway
Figure 8-4. Push Hose Into Drain Coupler.
Position the pin gauge to a depth of approximately 4 mm below the top surface of
the rotor roller, checking both inlet and outlet sides. Rotate the rotor 180o
counter-clockwise and check the gap again at both rollers.
The pin gauge should fit with light physical contact between the ping gauge and
roller/raceway surfaces all 4 checks
If the pin gauge check fails any of the 4 checks (does not fit in gap), refer to the
Service Manual for instructions on replacing the combined Pump Rotor and
Pump Raceway assembly.
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Warranty & Service
Warranty & Service
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Warranty & Service
Contents
Warranty and Service 3
Warranty 3
Technical Support and Resources 3
Obtaining Service from ZOLL 3
Packing and Shipping Instructions 3
Disposal of the System 5
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Warranty & Service
Warranty and Service
Warranty
ZOLL warrants that the System shall be free from defects in materials and
workmanship for a period of one year after the purchase date or the date first
installed, whichever date occurs later, when the System has been properly
installed, maintained, and used for its intended purpose.
This warranty applies only to the original purchaser of the System.
If, during the warranty period, a System requires repair, ZOLL at its sole
discretion, shall repair or replace the defective parts without charge to the
purchaser.
ZOLL reserves the right to make any necessary repair at its factory, at any
authorized repair station, or at the facilities of the purchaser.
Replacement parts may be new parts or remanufactured parts. Parts replaced
under warranty become the property of ZOLL.This warranty does not apply to
repairs or replacements to correct damage resulting from mishandling or abuse,
failure to perform the required maintenance described in the operator’s manual,
voltage surges, or casualty losses caused by man or by nature.
This warranty shall be void if repairs or attempted repairs have been performed
on the System by any person not authorized by ZOLL to perform repairs.
The express warranty above is the sole warranty obligation of ZOLL and
the remedies provided above are in lieu of any and all other remedies.
There are no other agreements, guarantees, or warranties, oral or written,
expressed or implied, including without limitation any warranty of fitness
for a particular purpose or merchantability. ZOLL shall have no liability
whatsoever for any improper use or improper repair of the System.
Technical Support and Resources
ZOLL provides field- and factory-based technical support for its products. Our
service hotline can answer questions, provide guidance, and schedule service for
your System.
Upon request, ZOLL can provide circuit diagrams, parts lists, and service
documentation to authorized users.
Obtaining Service from ZOLL
To obtain service from ZOLL Circulation, Inc., call +1-949-453-0150 ext. 3 or
contact your local sales representative.
Packing and Shipping Instructions
Please call the service hotline to obtain a Return Goods Authorization (RGA)
number before returning items to ZOLL. The RGA number must be marked on
the outside of shipping containers.
Items to be returned to ZOLL must be packed carefully to avoid damage during
shipment.
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Warranty & Service
Items may be shipped to:
ZOLL Circulation, Inc.
2000 Ringwood Ave.
San Jose, CA 95131 U.S.A.
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Warranty & Service
Disposal of the System
Do not dispose of the
System
as
unsorted
municipal waste.
When you wish to dispose of the System, call ZOLL. At no expense to you, we
will arrange for the crating, removal and disposal of the System. You will have to
arrange a date for the pick-up and allow us access to crate and pick-up the
system.
The functional life of the System will be best extended if you properly maintain
the system. Please refer to your service manual. Do not attempt to service the
cooling engine yourself as this may release R134a refrigerant into the
atmosphere.
The System contains:
Solder that contains lead
A discharge vapor bulb
Refrigerant R134a
Mercury in some of its switches.
Mercury and lead are long lasting organic metal pollutants that can cause direct
toxic effects in humans. R134a is a green house gas.
The symbol above is fixed to the System to remind you – DO NOT dispose of the
System as unsorted municipal waste.
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Specifications
Specifications
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Specifications
PHYSICAL
Dimensions:
Weight:
Height:
Width:
Depth:
45 in. (114 cm)
17 in. (43 cm)
30 in. (76 cm)
107 lb. (49 kg)
ELECTRICAL
Configuration
100-120 VAC, 50/60 Hz, 6 A
220-240 VAC, 50/60 Hz, 2.25 A
Voltage
Fuse protection
115 V
230 V
T6.3A (slow blow) 5 x 20 mm
T6.3A (slow blow) 5 x 20 mm
ENVIRONMENTAL
Operating temperatures:
Operating humidity:
Atmospheric pressure:
10° C – 27° C (50° F – 81° F)
30% to 75% noncondensing
70 kPa to 106 kPa
CHILLER and HEATER
Reservoir volume:
Pump capacity:
Temperature range:
Coolant:
Refrigerant:
2.0 liters (0.5 gal.)
7 lpm at 0 m head (0 ft.)
0° C – 42° C
1:1 mixture of propylene glycol and distilled water
HFC 134a
CONTROLLER AND DISPLAY
Screen display:
Controls:
Temperature input:
Articulation:
Data interface:
Alarms:
Displayed temperature range:
Displayed temperature accuracy:
6.4 in. (16.25 cm) LCD color VGA
Pushbuttons and knob
Thermistor, YSI 400 series
180° swivel, 45° tilt
Serial RS-232C, 9-pin sub-D connector
Audible tones and displayed text messages
26° C – 42° C
± 0.2° C
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Specifications
SALINE COOLANT CIRCUIT
Priming volume:
200 ml
Heat exchanger:
Disposable stainless steel coil
Priming source:
Patient connection:
Pump tubing:
Sterility:
Saline alarm:
Coolant circuit operating life:
Sterile saline solution (hospital-provided)
Directional Luer connections on
72 in. (183 cm) lines
Roller pump compatible with directional fittings
Gamma sterilized
Reservoir level detection & alarm system
Replace disposable components after seven (7)
days of continuous use
EQUIPMENT CLASSIFICATIONS
Type of protection against moisture:
Type of protection against
electric shock:
Protection class:
Mode of operation:
Ordinary
Type BF for temperature inputs
Type B for catheter connections
1
Continuous
APPROVED PATIENT TEMPERATURE
PROBES
Temperature Probe Standard
YSI-400 Temperature probes verified by
ZOLL to work with the System
Use with temperature probe cable ZOLL P/N
500581
YSI-400 Temperature probes verified by
ZOLL to work with the System and HP patient
interconnection cable P/N 81-1010HP.
YSI-400
MALINCKRODT MEDICAL FOLEY PROBE 8F
MALINCKRODT MEDICAL FOLEY PROBE 10F
MALINCKRODT MEDICAL FOLEY PROBE 12F
(8700-0669-12 )
MALINCKRODT MEDICAL FOLEY PROBE 14F
(8700-0669-14)
MALINCKRODT MEDICAL FOLEY PROBE 16F
(8700-0669-16)
MALINCKRODT MEDICAL FOLEY PROBE 18F
MALINCKRODT MEDICAL GP/RECTAL PROBE 9F
(8700-0670-09)
SMITH MEDICAL FOLEY PROBE 10F
(8700-0669-10)
SMITH MEDICAL FOLEY PROBE 12F
(8700-0669-12)
SMITH MEDICAL FOLEY PROBE 14F
(8700-0669-14)
SMITH MEDICAL FOLEY PROBE 16F
(8700-0669-16)
SMITH MEDICAL FOLEY PROBE 18F
(8700-0669-18)
SMITH MEDICAL GP/RECTAL PROBE 9F
(8700-0670-09)
SMITH MEDICAL GP/RECTAL PROBE 12F
(8700-0670-12)
Rüsch Sensor Temperature Foley Catheters (CH
8, 10, 12, 14, 16, 18) – Rüsch P/N 179360.
Rüsch Temperature Supracath (CH 10, 12, 14) –
Rüsch P/N 1016.
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Specifications
APPROVED POWER CORDSETS
(for EU Countries only)
Europe Main
United Kingdom, Ireland
Switzerland
Italy
ZOLL P/N 8700-0668-12
ZOLL P/N 8700-0668-05
ZOLL P/N 8700-0668-09
ZOLL P/N 8700-0668-11
START-UP KIT
Tubing set including heat exchange coil,
airtrap and roller pump tubing:
Model CG-500D, CG-500D EX
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