Thermogard Operation Manual

. Copyright © 2008 Alsius Corporation. All rights reserved. Printed in U.S.A.

Trademarks Alsius, CoolGard, CoolGard 3000, Thermogard XP, Cool Line, Fortius, and Icy are trademarks of Alsius Corporation. 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 Alsius Corporation 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

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Alsius Corporation 15770 Laguna Canyon Road Suite 150 Irvine, California 92618 U.S.A. Telephone: +1-949-453-0150 Facsimile: +1-949-453-0250 www.alsius.com

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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 7 Priming the Saline Circuit 7 Air Entry Into the Tubing Circuit 8 Check the Integrity of the Catheter 8 Check the Integrity of the Start-up Kit Tubing 8 Interference 9 Product Label 9

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Safety Information

Safety Information Overview Safety is of primary concern to Alsius Corporation. 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.

L

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.

L

Electrical warning or electrical caution.

Indicates notes intended to clarify understanding.

Alternating current.

Temperature and pressure range.

Protective earth (ground).

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

Type B applied part. Defibrillator protected.

Humidity range.

Type BF applied part. Defibrillator protected.

Fragile contents.

Fuse.

Top facing up.

Ground equipment.

Lo

The low patient temperature alarm limit.

On.

Hi

The high patient temperature alarm limit.

Off.

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Safety Information

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 Alsius System in conjunction with other temperature maintenance devices that have an automatic temperature controller. Temperature oscillations may occur that are dangerous to the patient.

•

Performance of installation, operation, or maintenance procedures other than those described in this manual may create hazards and may cause the manufacturer’s warranty to become void.

•

Sterile components are designed for a single use only. If unauthorized disposable components are used, proper operation cannot be guaranteed and harm to the patient may result.

•

Proper aseptic technique must be used while making all sterile connections to the System.

•

Never operate damaged or leaking equipment.

•

Never operate the equipment without coolant fluid in the coolant well.

•

Never use pure water, pure propylene glycol, or alcohol as a coolant fluid.

•

Never operate the equipment while smoking or in the presence of open flame.

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Safety Information

Shipping and Storage Conditions When shipping or storing the System, follow these recommendations: •

Temperature range: -20ºC (-4ºF) to 60ºC (140ºF).

•

Atmospheric pressure range: 50 kPa to 106 kPa.

•

Do not allow liquids to spill on the System or its packaging.

•

Humidity range: 10% to 90% noncondensing.

•

Fragile contents, handle with care.

•

Always handle and store with the top facing up.

Ignition of Flammable Anesthetic Mixtures The System is not category AP or APG equipment and must not be used in environments where flammable anesthetic gas mixtures are present.

Electrical Hazards This equipment has been tested and found to comply with the EMC limits of the international standard EN 60601-1-2. These limits are designed to provide reasonable protection against interference in a typical medical installation. The equipment can radiate radio frequency energy if not installed in accordance with the instructions, and may cause harmful interference to other devices in the vicinity. There is no guarantee that interference will not occur in a particular installation. Always comply with the following: •

To avoid the risk of electrical shock, do not remove any panels of the product.

•

Refer servicing to qualified personnel.

•

Never operate equipment with damaged power line cords.

•

Refer service and repairs to a qualified technician.

CAUTION! ELECTRIC SHOCK HAZARD. Electric shock hazard. Always turn off the System and disconnect the power line cord from the source before performing any service or maintenance procedures, or before moving the System.

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Safety Information

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 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 Alsius 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 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.

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Safety Information

Air Entry Into the Tubing Circuit Air entry may occur with the failure of any part of the start-up kit, between the saline bag and the outflow of the pump. In such cases, the integrity of the catheter prevents air entry into the patient. In the rare event of a second, simultaneous failure of the catheter, air entry into the patient is possible. Air entry into the tubing circuit will usually, but not always, be associated with an air trap alarm that will stop the System. Always investigate air trap alarms. The cooling circuit is a closed loop–usually air trap alarms indicate a breach somewhere in this closed loop (occasionally an air trap alarm can be caused by condensation forming on the air trap exterior). With any air trap alarm, check both the integrity of the catheter and the start-up kit (see below). Periodically check the start-up kit for significant air bubbles and replace the kit if necessary.

WARNING! NEVER CLINICALLY CIRCUMVENT THE AIR TRAP ALARM Alsius supplies air trap “dummies” for testing, training and demonstration purposes. These are fluid filled air trap assemblies that are separate from a standard Start-up Kit assembly. Never use this device, or other method, to circumvent the air trap alarm when the system is connected to the patient. Doing so exposes the patient to the hazards associated with air embolism should the catheter fail. Death or serious injury may result.

Check the Integrity of the Catheter To check the integrity of the catheter, perform these steps in the indicated order: 1.

Stop the System.

2.

Using aseptic technique, disconnect the tubing from the catheter and properly cap both the catheter and the tubing set.

3.

Fill a sterile 10 ml syringe with sterile saline.

4.

Connect the syringe to the INFLOW lumen of the catheter and disconnect the outflow cap.

5.

Infuse the 10 ml of saline – it should flow out the outflow lumen.

6.

Cap the OUTFLOW lumen and pull and hold 5 ml of vacuum for at least 10 seconds. Approximately 4 ml of saline, but not blood, should enter the syringe and you should be able to maintain the vacuum.

7.

Ease the vacuum, disconnect the syringe, and recap the INFLOW lumen.

Check the Integrity of the Start-up Kit Tubing To check the integrity of the start-up kit tubing, perform these steps in the indicated order: 1.

Stop the System.

2.

Look for obvious leakage.

3.

Remove the tubing from the pump and check it for damage. Replace it in the pump if it is undamaged.

4.

Inspect the tubing from the pump to the patient for sources of fluid loss:

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Safety Information •

Look for damage to the tubing and/or the presence of air inside the tubing.

•

Inspect, and tighten if necessary, each Luer fitting (do not use instruments to tighten the fittings).

5.

Inspect the tubing that returns to the pump from the patient.

6.

Examine the saline bag to ensure that it has not been accidentally compromised (for example, the spike may have damaged the bag wall).

7.

Inspect the tubing from the saline bag to the saline reservoir and the pump.

Interference If this equipment does cause interference with other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: •

Reorient or relocate the receiving device.

•

Increase the separation between the equipment.

•

Connect the equipment into an outlet on a circuit different from that to which the other device(s) is connected.

Product Label An identifying label is attached to the outside of the System console near the power cord inlet. The label is illustrated in Figure 1-1.

Figure 1-1. Product Label . The label provides safety information and identifies the manufacturer, model number, serial number, power requirements, fuse capacity, and manufacturing date for the System.

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Introduction

Introduction

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Introduction

Contents Introduction 3 Use of the System 3 Operating Life 3 Functional Description 3 System Components 4 Controls and Display 4 Display 4 Power Indicators 5 Alarm Indicators 5 Control Buttons 5 Control Knob 6 Serial Interface Connector 6 Recirculating Chiller 6 Temperature Controller 7 Temperature Probe Connectors 7 Pump 7 Prime Switch 8 Start-up Kit 9 Data Memory 10 Saline Circuit Diagram 10

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Introduction

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 Alsius Thermal Regulating System is comprised of an external heat exchange system (CoolGard 3000 or Thermogard) and an Alsius endovascular heat-exchange catheter connected via a sterile heat exchanger and tubing circuit (the Alsius Start-up Kit). These components together comprise a patient temperature-regulation apparatus employing feedback control. The catheter and the Start-up Kit (its heat exchange coil, air trap, and tubing) are single-use disposable devices. This manual provides operating instructions for the System and the start-up kit. Catheter components are referenced where it is necessary to assure proper use with the system components. Always refer to the catheter’s Instructions for Use for additional specific information.

Operating Life The operating life of the catheters may vary according to design as indicated by the model designation. Always refer to the catheter’s Instructions for Use for information about the catheter’s operating life. The disposable components of the Alsius System start-up kit are designed for continuous use for a period not to exceed seven (7) days. After seven days of use, all start-up kit components must be removed and replaced with components from a new start-up kit. CAUTION! START-UP KIT LIFETIME IS SEVEN (7) DAYS. The designed operating lifetime for start-up kit components is seven (7) days of continuous operation. If a patient must be treated for a longer period, a new start-up kit must be installed in the System. Failure to adhere to this time limit may cause injury to the patient.

Functional Description The System can be described in terms of three major components: a recirculating chiller, a sterile fluid roller pump, and a temperature control system. The System is connected to the temperature-controlled catheter by two 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.

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Introduction Patient temperature feedback is used to control the system. The patient’s temperature is measured by an indwelling YSI 400 thermistor temperature sensor. In response to the patient’s measured temperature, the System employs both cooling and heating. Cooling occurs when the patient’s temperature is above the set point target temperature. Heating occurs when the patient’s temperature is below the set point target temperature. The amount of heating or cooling power is proportional to the difference in temperature between the set point target temperature and the patient’s measured temperature. A basic diagram of the System is illustrated in the following figure. 1. Saline bag. 2. Peristaltic pump 3. Air trap 4. Heat exchange coil 5. Coldwell 6. Coolant pump 7. Chiller & Heater 8. Catheter 9. Patient 10. Pin wheel flow indicator Figure 2-1. Simplified Flow Diagram.

System Components Controls and Display The operator’s display panel contains four buttons and one knob used to access functions and adjust settings with the aid of the menus and messages displayed on the screen. The controls and display are illustrated in figure 2-2 and explained in the following text.

Display The display is a backlit color LCD panel that can be easily read in all ambient lighting conditions. It is used to display status, menus, messages, alarms, and patient temperature trend graphs. The display head is attached to the mast by an adjustable swivel/tilt mounting clamp. The user can adjust the tilt and rotation of the display head and lock it into position by using this clamp.

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Introduction

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. The pump flow rate can be selected by the user.

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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 next to the pump under the top cover. The switch is used to operate the pump to prime the tubing with sterile saline solution from the saline source. When the switch is held down, the pump runs; when the switch is released, the pump stops.

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