ZOLL thermogard xp User manual

Operation Manual
600479-001 Rev 2 1/147

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

Contents
1. Safety Information
2. Introduction
3. Receiving, Inspection, and Assembly
4. Operation
Overview
Alarms & Alerts
Your First Case
Setup - Variations
Ending Treatment
Temperature Trend Data
Mechanical Components
Accessory: HMIA
5. TempTrend CSV Program User’s Guide
6. Alarms and Corrective Actions
7. Troubleshooting
8. Maintenance
9. Warranty and Service
10. Specification
600479-001 Rev 2 3/147

Safety Information
1
Safety Information
600479-001 Rev 2 4/147

Safety Information
2
Contents
Safety Information 3
Overview 3
Warnings, Cautions, and Notes 3
Definitions of Symbols and Labels Used on the Product and in the Manual 4
General Safety Precautions 5
Shipping and Storage Conditions 6
Ignition of Flammable Anesthetic Mixtures 6
Electrical Hazards 6
Primary Patient Temperature Probe (T1) Failure 7
Configuration Changes 7
Priming the Saline Circuit 7
Air Entry Into the Tubing Circuit 8
Check the Integrity of the Catheter 8
Check the Integrity of the Start-up Kit Tubing 8
Interference 9
Product Label 9
600479-001 Rev 2 5/147

Safety Information
3
Safety Information
Overview
Safety is of primary concern to ZOLL Circulation, Inc.. This chapter provides
information on safely using the System. You must read and understand the
information in this chapter before operating the System. Always follow the
warnings, cautions, and notes throughout this document.
If you have questions about the safe or effective use of the System, please
contact the manufacturer.
Warnings, Cautions, and Notes
This document uses the following conventions to indicate important information.
WARNING!
Warnings are accompanied by symbols surrounded by a triangle and are
printed in the text in bold italics. Warnings indicate events or conditions
that can result in serious injury or death or severe damage to the
equipment.
CAUTION!
Cautions are accompanied by symbols surrounded by a triangle and are
printed in the text in bold italics. Cautions indicate information for safe
operation, proper performance, or avoiding actions that may result in
damage to the equipment.
NOTE:
Notes are accompanied by a symbol of the letter “i” surrounded by a circle
and are printed in the text in italics. Notes clarify understanding, aid in the
proper operation of the product, and prevent problems or errors from
occurring.
600479-001 Rev 2 6/147

Safety Information
4
Definitions of Symbols and Labels Used on
the Product and in the Manual
Symbol Definition Symbol Definition
Attention. Consult
accompanying
documents.
This symbol designates
the connector for the data
acquisition cable.
Electrical warning or
electrical caution. Indicates notes intended
to clarify understanding.
Alternating current. Temperature and
pressure range.
Protective earth (ground). Do not allow liquids to spill
on the product or
package.
Type B applied part.
Defibrillator protected. Humidity range.
Type BF applied part.
Defibrillator protected. Fragile contents.
Fuse. Top facing up.
Ground equipment. Lo The low patient
temperature alarm limit.
On. Hi The high patient
temperature alarm limit.
Off.
600479-001 Rev 2 7/147

Safety Information
5
General Safety Precautions
WARNING! SYSTEMIC HYPOTHERMIA RISKS.
Systemic hypothermia may cause cardiac arrhythmia, patient shivering, or
other system or organ complications. Systemic hypothermia should only be
utilized under the supervision of a qualified physician.
When treating a patient with the System, appropriately qualified medical staff
must routinely and closely monitor the patient and must comply with the following
procedures:
Audible and visual alarms generated by the System require the
authorized individual to remain in close proximity to the patient
throughout the procedure.
Always verify the function of the System prior to insertion of an Alsius
catheter. In the event of a malfunction, have other means of cooling
available.
When combining the use of the System and other adjunctive means
of cooling, ensure that close observation of the patient is maintained.
Do not use the ZOLL System in conjunction with other temperature
maintenance devices that have an automatic temperature controller.
Temperature oscillations may occur that are dangerous to the
patient.
Performance of installation, operation, or maintenance procedures
other than those described in this manual may create hazards and
may cause the manufacturer’s warranty to become void.
Sterile components are designed for a single use only. If
unauthorized disposable components are used, proper operation
cannot be guaranteed and harm to the patient may result.
Proper aseptic technique must be used while making all sterile
connections to the System.
Never operate damaged or leaking equipment.
Never operate the equipment without coolant fluid in the coolant well.
Never use pure water, pure propylene glycol, or alcohol as a coolant
fluid.
Never operate the equipment while smoking or in the presence of
open flame.
600479-001 Rev 2 8/147

Safety Information
6
Shipping and Storage Conditions
When shipping or storing the System, follow these recommendations:
Temperature range: -20ºC (-4ºF) to 60ºC (140ºF).
Atmospheric pressure range: 50 kPa to 106 kPa.
Do not allow liquids to spill on the System or its packaging.
Humidity range: 10% to 90% noncondensing.
Fragile contents, handle with care.
Always handle and store with the top facing up.
Ignition of Flammable Anesthetic Mixtures
The System is not category AP or APG equipment and must not be used in
environments where flammable anesthetic gas mixtures are present.
Electrical Hazards
This equipment has been tested and found to comply with the EMC limits of the
international standard EN 60601-1-2. These limits are designed to provide
reasonable protection against interference in a typical medical installation. The
equipment can radiate radio frequency energy if not installed in accordance with
the instructions, and may cause harmful interference to other devices in the
vicinity. There is no guarantee that interference will not occur in a particular
installation. Always comply with the following:
To avoid the risk of electrical shock, do not remove any panels of the
product.
Refer servicing to qualified personnel.
Never operate equipment with damaged power line cords.
Refer service and repairs to a qualified technician.
CAUTION! ELECTRIC SHOCK HAZARD.
Electric shock hazard. Always turn off the System and disconnect the
power line cord from the source before performing any service or
maintenance procedures, or before moving the System.
600479-001 Rev 2 9/147

Safety Information
7
Primary Patient Temperature Probe (T1)
Failure
The System relies upon the patient temperature reading from a YSI-400 type
thermistor connected to the Primary Patient Temperature Probe (T1). There are
rare failures of this type of thermistor that cannot be detected by the System with
100% reliability. Failure of the T1 can result in either patient hypo- or hyper-
thermia. Death or serious injury to the patient may result. A secondary patient
temperature probe (T2) connection is therefore built into the system. For patient
safety, either use both the T1 and T2 connections or employ the T1 probe with
an independent frequent check of patient core temperature.
WARNING! NEVER CLINICALLY USE A RESISTOR IN PLACE
OF THE T1 TEMPERATURE PROBE
ZOLL supplies fixed value resistors and variable resistor test boxes (e.g the
TP-400 FOGG Box) for testing, training and demonstration purposes. These
can be plugged into the Primary Patient Temperature Probe T1 connection on
the front of the System to represent a patient. Never use this device, or other
method, to circumvent the normal patient temperature feedback control when
the system is connected to the patient. Doing so exposes the patient to the
hazards associated with hypo- or hyper- thermia. Death or serious injury may
result.
Configuration Changes
CAUTION! CONFIGURATION CHANGES MUST BE
CERTIFIED.
Equipment connected to the analog and digital interfaces must be certified to
the respective IEC standards (i.e., IEC 950 for data processing equipment
and IEC 60601-1 for medical equipment). Furthermore, all configurations shall
comply with the system standard IEC 60601-1. Any person who connects
additional equipment to the signal input part or the signal output part con-
figures a medical system and is therefore responsible that the system com-
plies with the requirements of the system standard IEC 60601-1.
Priming the Saline Circuit
WARNING! DO NOT PRIME THE SALINE CIRCUIT WHILE
CONNECTED TO A PATIENT
During the priming operation, the air-trap alarm will be disabled. Air present in
the saline line may be circulated through the indwelling catheter.
Before priming the circuit or during troubleshooting for possible leak,
disconnect the heat exchange catheter, then connect the inflow and outflow
luer fittings of the saline circuit together.
600479-001 Rev 2 10/147