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For US Physicians Only IVTM System Operation Manual

1. Figure 8 1 Location of Condensate Pan 3 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 7 600479 001 Rev2 137 147 Maintenance Remove the cap on the coolant well and set it aside on a clean surface 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 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 Place the open end of the drain hose into a suitable container or position it above a floor sink or drain Push the connector on the drain hose into the drain coupler on the MFA Tey ATA ENEA 4 ease i n a Perret ir
2. STANDBY Prepare data link 2006 03 05 18 26 Cancel 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 Turn power off 2006 03 05 18 26 Figure 4 66 Turn Power Off Message 10 At the rear of the console turn the power on off switch to OFF 53 600479 001 Rev2 84 147 Operation 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 power 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 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
3. 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 System Set Up Check the following Air Trap Roller Pump Lid Check Prime Switch Coolant 2006 03 05 18 26 Figure 4 1 System Setup Screen For the system to enter the next state STANDBY the following sensors must be checked and found normal 6 600479 001 Rev2 37 147 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 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 Pati
4. If particulate matter is Drain coolant clean the coolant well and observed in the refill with 1 1 mixture of distilled water and coolant 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 7 Inspection and cleaning are complete The System may be returned to service 5 600479 001 Rev2 135 147 Maintenance Temperature Accuracy Test Required Tools and Materials You will need a
5. ei a ect Piet g pi om Temi 2 econ a 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 32 600479 001 Rev2 63 147 Operation Figure 4 34 Covers Open 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 33 600479 001 Rev2 64 147 Operation 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 34 600479 001 Rev 2 65 147 Operation The Alsius Start up Kit 6 Open the System Start up Kit For convenience and sterility all items in the kit are preconnected Figure 4 38 System Start up Kit ie 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 h
6. 18 26 Figure 4 58 Patient Data Message f Choose Download Now 8 The screen displays the message Prepare data link System Set Up Prepare data link 2006 03 05 18 26 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 48 600479 001 Rev 2 79 147 Operation 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 System Set Up Download error Please check external computer Prepare data link Cancel 2006 03 05 18 26 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 s
7. 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 1 408 541 2140 Facsimile 1 408 541 1030 600479 001 Rev2 2 147 Contents 1 Safety Information 2 Introduction 3 Receiving Inspection and Assembly 4 Operation Overview Alarms amp Alerts Your First Case Setup Variations Ending Treatment Temperature Trend Data Mechanical Components Accessory HMIA 600479 001 Rev2 3 147 Safety Information Safety Information 1 600479 001 Rev2 4 147 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 2 600479 001 Rev2 5 147 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
8. Attached Brake Steering Brake Steering Yes current position Free swivel Will lock when Left Front Yes next straight ae Rear both Not Not Applicable o 1 Direction Locking Caster Note dome above caster axle Free Swivel Casters at rear of system 3 Kick Stop Caster Free swivel caster with brake Figure 4 73 Casters on the System 63 600479 001 Rev2 94 147 ZOLL Circulation Hospital Monitor Interface Accessory HMIA 1 600479 001 Rev2 95 147 Accesories HMIA Contents Overview 3 Operating the HMIA 3 Connecting to the Hospital Monitor 3 To begin operation 4 Controls and indicators on the HMIA 5 Operating States 6 START UP 6 RUN 6 Calibration 6 Installation 6 Installation Equipment 7 Installation Procedure 7 Removal of the HMIA 10 Connection Cable Part Numbers 10 Data Download 11 Troubleshooting 11 Errors 12 Green LED OFF 12 Flashing Red LED 12 No Temperature Reported On Hospital Monitor 12 Incorrect Temperature Reported On Hospital Monitor 12 Temperature jumps between 26 C and 49 C On Hospital Monitor 13 Hirose Connector does not fit 13 YSI 400 Temperature vs Resistance 14 2 600479 001 Rev2 96 147 Accesories HMIA Overview This chapter 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
9. 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 60 600479 001 Rev2 91 147 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 p 1 Kad N ad AT psi j 2 y E a 7 i Figure 4 71 Top cover fully open 61 600479 001 Rev 2 92 147 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 62 600479 001 Rev2 93 147 Operation Casters There are three different types of casters wheels on the System 1 The right front has a free swivel and brake feature 2 The left front has a free swivel and a directional lock feature 3 The rear casters do not lock and are free to rotate at all times The figure below shows the operation of the casters Table 4 6 Caster Operation
10. Run Button Rate Deg HR Button Press for Menu Enter Knob z ALSILS 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 31 C and 38 C 87 8 F and 100 4 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 10 C hr and 0 65 C hr 0 18 F hr and 1 17 F hr Standby Run 5
11. or control buttons fail to operate as expected e The System has been exposed to fire flood or hazardous substances e The System has suffered potential damage due to improper storage rough handling or being dropped 6 600479 001 Rev2 130 147 Maintenance Maintenance 1 600479 001 Rev2 131 147 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 2 600479 001 Rev2 132 147 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
12. 200818 002 MALINCKRODT MEDICAL FOLEY PROBE 12F 200818 003 MALINCKRODT MEDICAL FOLEY PROBE 14F 200818 004 MALINCKRODT MEDICAL FOLEY PROBE 16F 200818 005 MALINCKRODT MEDICAL FOLEY PROBE 18F 200818 006 MALINCKRODT MEDICAL GP RECTAL PROBE 9F 200820 001 SMITH MEDICAL FOLEY PROBE 10 FR 600224 001 SMITH MEDICAL FOLEY PROBE 12 FR 600224 002 SMITH MEDICAL FOLEY PROBE 14 FR 600224 003 _ Or SMr SMITH MEDICAL FOLEY PROBE 16 FR 600224 004 SMITH MEDICAL FOLEY PROBE 18 FR 600224 005 SMITH MEDICAL GP RECTAL PROBE 9 FR 600225 001 SMITH MEDICAL GP RECTAL PROBE 12 FR 600225 002 Rusch Sensor Temperature Foley Catheters CH 8 10 12 14 16 18 Rusch P N 179360 Rusch Temperature Supracath CH10 12 14 Rusch P N 179370 Model CG 500D 147 147
13. 68 147 Operation 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 38 600479 001 Rev2 69 147 Operation 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 amp 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 39 600479 001 Rev 2 70 147 Operation seconds to come up to operating speed Observe the movement of 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 are compl
14. 80 60 HZ 6A TSJA slow blow amp X 200M 230 220 240V 50 60 HZ 2 254 TEJA slow blow 5 X 20MM 230 220 240V S0 60 HZ 3A TJA slow blow 5 A 20MM wtp Tic K ZOLL Roc lb ZOLL ote ZOLL Circulation inc J ZOLL Circulation Inc 3040754 fe O50 Amano Awanu 3040754 650 Almanor Avenue CONFORMS TO ip lhe a CONFORMS TO llama UL STD 60601 1 408 841 4040 ULSTD 60601 1 406 844 4080 CERTIFIED TO CERTIFIED TO CANICSA STD EC REP aa d CANICSA STD 22 2 NO 601 1 2813BH Den Haag he 22 2 NO 601 1 iit AEW MAT 15 001 AEW 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 9 600479 001 Rev2 12 147 Introduction Introduction 1 600479 001 Rev2 13 147 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 2 600479 001 Rev2 14 147 Introduction Introduction Use of the System WARNING PATIENTS MUST BE CONTINUOUSLY MONITORED Patients being treated with the System must be checked
15. 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 2 Connection Cable Part Numbers Part Connects to Number 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 R sch 10 600479 001 Rev2 104 147 Accesories HMIA 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 disconn
16. Icy Quattro or Fortius model catheter is indicated for use e in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery intensive care and e to induce maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery intensive care 2 600479 001 Rev2 24 147 Receiving Inspection amp Assembly Receiving Inspection amp Assembly 1 600479 001 Rev2 25 147 Receiving Inspection amp 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 6 Power Cord 7 Condensate Pan 7 Saline Container Insulating Jacket 7 2 600479 001 Rev2 26 147 Receiving Inspection amp 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 an 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 s customer service department and file a damage claim with the carrier Required Tools To safely unpack inspect a
17. MAX WARMING i STANDBY A 30 Minutes iin STANDBY Click to clear Settings to reset MAX COOLING Figure 4 18 STANDBY Timer Alert 21 600479 001 Rev 2 52 147 Operation T1 T2 Behavior New 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 suddently 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 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
18. Prepare the hospital monitor such that it will monitor patient temperature 9 600479 001 Rev 2 103 147 Accesories HMIA 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 35 C 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 1 C Note There may be a delay as long as 2 minutes before the temperature displayed by the hospital monitor agrees within 0 1 C with the temperature displayed by the System 19 Set the TP 400 to 38 C 20 Verify that the patient temperature displayed on the System screen is also displayed on the hospital monitor 0 1 C 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 23 Verify that the patient temperature displayed on the System screen is also displayed on the hospital monitor 0 1 C 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
19. See image below Secondary Temp Probe T2 Not Connected If you do not use the T2 probe you must use another secondary means of monitoring the patient temperature Otherwise failure of the primary temp probe 11 may result in patient injury Do you wish to continue 2006 03 05 18 26 Figure 4 19 No T2 Probe Connected The System remembers the User s preference 22 600479 001 Rev2 53 147 Operation 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 MAX WARMING PATIENT TEM P 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 4 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 Primary temp probe T1 disconnected Press Enter to proceed MAX WARMING PATIENT TEMP Absence or disconnection of the T1 probe during STA
20. The default directory is C TempTrendCSV Data SE Save in E TempTrendCS Data do ft ee EE TestS cs File name JF csv Save as ppe esv Cancel fe Figure 5 5 Select File Dialog Box 2 You can either select an existing file name or create a new one e To select an existing file name double click on it All existing data within the file will be over written with the new download e To enter anew file name replace the csv with the file name of your choosing Type it in place of the csv in the file name box ry Temp TrendCS P N103710 Rev A om Fort CA Teamplrendcs Datasdemo cew Patient Log File Name Select File Download Figure 5 6 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 7 600479 001 Rev2 115 147 TempTrend CSV 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 Ole Click on this icon to exit from TempTrend CSV Using the Alsius Add in The Alsius Add in contains Microsoft macro codes that allow the viewing of the patient data file These are accessed via the Alsius menu item in the EXCEL menu bar EJ Micro
21. The low patient temperature alarm limit 4 600479 001 Rev2 7 147 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 e Audible and visual alarms generated by the System require the authorized individual to remain in close proximity to the patient throughout the procedure e 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 e When combining the use of the System and other adjunctive means of cooling ensure that close observation of the patient is maintained e 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 e 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 e Sterile components are designed for a single use only If unauthorized disp
22. 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 SETTINGS PATIENT TEMP Sath Pre set Pre Cool Pre Warm None Exit 2006 03 05 18 26 Figure 4 13 Bath Pre Set Menu 17 600479 001 Rev 2 48 147 Operation The System bath is cooled to its lowest permitted temperature and maintained Pre Cool at that temperature The System bath is heated to its highest possible temperature and maintained Pre Warm at that temperature 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 Exits the menu without a change in System status or programming Time and Date This menu displays the current time and date settings PATIENT TEMP SETTINGS Time and Date Select Hour Press enter to set STANDBY TARGET TEMP RATE 18 26 2006 03 05 2006 03 05 18 26 Figure 4 14 Time and Date Settings The time is div
23. cloth moistened with water Clean rollers and apply light lubri cating oil if rollers have been in contact with saline solution 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 Tes 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 4 600479 001 Rev2 134 147 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 When deterioration is Inspect mechanical and electrical evident 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
24. in the System coldwell as depicted above or e To present menu selections The main menu of the System is presented in the figure below 10 600479 001 Rev2 41 147 Operation PATIENT TEM P View Graphs A New Patient End Procedure Settings Exit 2006 03 05 18 26 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 TARGET TEMP PATIENT TEMP To change Target Temperature or Rate system must be in Standby Would you like to go to Standby mode 2006 03 05 18 26 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 31 C to 38 C 87 8 F to 100 4 F When the correct selection is displayed press the knob once to enter the selection 11 600479 001 Rev 2 42 147 Operation 3 The target temperature setting is updated on the Operating screen 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 r button once If you are in RUN you will be taken to STANDBY The Treatment Mode value may on
25. iv 0021 001 CAN CSA STD rPo97 9 Me ens C22 2 NO 601 1 HMIA 601033 RS232 T1 out SYSTEM Figure 3 Front Panel of the HMIA The meaning of the symbols on the front panel are as described in the table below Table 1 HMIA Control Indicators Symbol RST 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 C receiving power from the System RS 232 Serial port connector This short extension cable is connected to the cable RS 232 data port connector on the back of the display head of the System T1 out Patient temperature output This connector accepts the custom Alsius connector interface cable SYSTEM System umbilical cord One connector is attached to the round multi connections pin 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 5 600479 001 Rev2 99 147 Accesories HMIA 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 monit
26. 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 IMPORTANT System troubleshooting must be performed only by qualified personnel Observe all safety warnings and use the required safety equipment when performing troubleshooting and repairs Safety Precautions Required personal protective equipment PPE e Safety glasses e Latex or neoprene gloves Required tools and materials e Phillips screwdriver e Screwdriver e Inspection lamp or flashlight e Vacuum cleaner with crevice tool 3 600479 001 Rev2 133 147 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 Scheduled Maintenance 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 Every 6 months Inspect the filter and replace if necessary filter refer to the nspect Replace Condenser Filter section of this chapter Roller pump Monthly Clean rollers and tubing path with
27. patient without powering off the system follow these steps in the indicated order 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 Alsius 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 54 600479 001 Rev 2 85 147 Operation 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
28. 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 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 zox Fie Action a lig Computer Es Disk drives H a Display adapters Fl DWD CO ROM drives H a Human Interface Devices HE IDE ATA ATAPI controllers Keyboards Ty Mice and other pointing devices fae Modems i Monitors Ee Network adapters ly Ports COM amp LPT be Sitecom USE to Serial Adapter CN 1o4v2 Com2 COM H Processors pe Sound video and game controllers fl yf System devices na Universal Serial Bus controllers ee ee Figure 5 4 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 6 600479 001 Rev2 114 147 TempTrend CSV 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 simple receive a warning message as per Figure 5 3 Select File Click on this icon to 1 Select the directory into which you want to save the data logs
29. to support catheter insertion CAUTION REFER TO THE CATHETER IFU Alsius 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 an Alsius 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 patients 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 9 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 26 600479 001 Rev 2 57 147 Operation 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 ALSIUS Self Tests in Progress Software Version 2 00 1B 36 1 57 2006 03 05 18 26 Figure 4 23 Self Test Screen Whe
30. will be updated and the screen will display the settings menu C F Temperature Notation This menu displays the options setting for temperature notation The currently selected setting is highlighted PATIENT TEM P SETTINGS CIF Please select Celsius or Fahrenheit STANDBY Calsius Fahrenheit 2006 03 05 18 26 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 19 600479 001 Rev2 50 147 Operation 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 Alsius catheters have been validated to operate safely at a pump rate of 240 ml min This control is not longer presented to the operator NOTE Change in Design Alarm Volume amp 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 highligh
31. will reset when the patient s temperature falls below the programmed Hi patient temperature alarm value The System alarm will reset when the patient s temperature rises above the programmed Lo patient temperature alarm value 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 Ti Replace probe in patient The pump cover is open Close the cover PUMP FAILURE 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 600479 001 Rev 2 123 147 Alarms amp Corrective Actions Alarm Message Cause Corrective Action SECONDARY TEMPERATURE PROBE DISCONNECTED SECONDARY TEMPERATURE PROBE DISLODGED TEMPERATURE PROBES DO NOT AGREE SYSTEM MALFUNCTION The secondary temperature probe is disconnected Temperature output from the secondary patient temperature probe changed by 0 2 C or more within 10 seconds Temperature outputs from the primary and secondary patient temperature probes differ by more than 2 C May be caused by a variety of failures 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
32. 600479 001 Rev 2 17 147 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 U a 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 6 600479 001 Rev2 18 147 Introduction Tempera
33. A 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 2 600479 001 Rev2 146 147 SALINE COOLANT CIRCUIT Priming volume Heat exchanger Priming source Patient connection Pump tubing Sterility Saline alarm Coolant circuit operating life EQUIPMENT CLASSIFICATIONS Type of protection against moisture Type of protection against electric shock Protection class Mode of operation APPROVED PATIENT TEMPERATURE PROBES Temperature Probe Standard YSI 400 Temperature probes verified by ZOLL to work with the System YSI 400 Temperature probes verified by ZOLL to work with the System and Rusch patient interconnection cable Rusch P N 179516 ALSIUS START UP KIT Tubing set including heat exchange coil airtrap and roller pump tubing 3 600479 001 Rev 2 Specifications 200 ml Disposable stainless steel coil 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 amp alarm system Replace disposable components after seven 7 days of continuous use Ordinary Type BF for temperature inputs Type B for catheter connections i Continuous YSI 400 MALINCKRODT MEDICAL FOLEY PROBE 8F 200818 001 MALINCKRODT MEDICAL FOLEY PROBE 10F
34. A to ZOLL for service Incorrect Temperature Reported On Hospital Monitor 1 2 3 Disconnect the hospital monitor from the HMIA interface cable Using a DMM measure the resistance between the two pins Using the chart YSI 400 Temperature vs Resistance determine if the resistance value measured corresponds to the temperature dispalyed on the System display If the resistance value is correct then the HMIA is functioning to specifications lf the resistance value is wrong then test Alsius interface cable for shorts or opens 12 600479 001 Rev2 106 147 Accesories HMIA If it passes the test then press the reset button RST Wait for 20 seconds and then repeat step 3 above 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 26 C and 49 C On Hospital Monitor There has been an internal component failue 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
35. Circulation Inc at its sole discretion shall repair or replace the defective parts without charge to the purchaser ZOLL Circulation Inc 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 Circulation Inc 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 Circulation Inc to perform repairs The express warranty above is the sole warranty obligation of ZOLL Circulation Inc 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 Circulation Inc shall have no liability whatsoever for any improper use or improper repair of the System Technical Support and Resources ZOLL Circulation Inc provides field and factory based technical support for its products Our service hotline can answe
36. 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 STARTUP 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 Remove the cap from the coolant well and set it aside in a clean location Remove the insulating jacket from the saline container and set it aside Lift the handle on the pump rollers ONO 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 con
37. D 5 TEMPERATURE PROBES DO NOT AGREE 5 SYSTEM MALFUNCTION 5 Stops operation of the System 2 600479 001 Rev2 121 147 Alarms amp 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 Alarms and Corrective Actions Alarm messages are listed in alphabetical order Stops operation of the System Table 6 1 Alarm Messages Causes and Corrective Actions Alarm Message Cause Corrective Action R Air has been detected in the Verify that the air trap is AIR TRAP FAULT air trap 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 Completely dry the outside of but the saline level detector the air trap with a towel to indicates a fault remove any condensation Verify that the air trap is seated firmly at the bottom of the air trap holder If the problem persists di
38. HMIA Figure 5 The Hirose Connector Rear of the Display Head Verify that the connector type on the end of the Umbilical Cable is identical to the connector on the HMIA 601033 001 for the 8 pin circular connector and 601033 002 for the 6 pin circular connector If the connectors are incompatible then contact ZOLL to arrange for a replacement Remove the paper protecting the Velcro strips found on the mounting surface of the HMIA 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 Press on the lower half the HMIA until the snaps engage Connect the Umbilical Cable to the mating connector on the HMIA labelled SYSTEM Connect the cable with the circular connector to the mating connector on the rear of the Display Housing 8 600479 001 Rev2 102 147 9 Accesories HMIA Figure 6 RS 232 Connector Rear Display Head Connect the HMIA RS232 connector labelled RS232 to the mating connector on the Rear of the Display Housing See Figure 6 E Figure7 Installed HMIA Rear Display Head Select the appropriate custom Alsius interface cable that mates with the patient cable of the hospital temperature monitor Insert the phone jack of the selected cable into the HMIA connector labelled T1 out Connect the other end of the Alsius interface cable to the patient cable of the hospital monitor
39. NDBY 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 MAX COOLING f MAX WARMING Disconnection of the T2 probe during RUN results in PATIENT TEMP an Alarm Press the knob to silence the alarm The N 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 secondarytemp probe 12 Gaconnected display Press Enter to proceed 23 600479 001 Rev 2 54 147 Operation Alarms amp 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 reverting the state 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 Figur
40. 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 3 HMIA Part Numbers 601033 001 8 pin circular Hirose connector 601033 002 6 pin circular Hirose connector 13 600479 001 Rev2 107 147 Accesories HMIA YSI 400 Temperature vs Resistance F ohms omo 5 252 zs 26 as sea B 197 a2 3 ia o 3 i5 o eas a 733 s6 32 1667 o ota 3 159 932 a 383 so a o oun o8 3 ma 98 6 37 1355 1301 o3 tag 40 1200 1152 1107 1064 1023 983 8 946 2 910 2 8795 8 842 8 811 3 14 600479 001 Rev2 108 147 TempTrend CSV TempTrend CSV 1 600479 001 Rev2 109 147 TempTrend CSV Table of Contents TempTrend CSV Overview 3 Installation 3 TempTrend CSV Installation 3 Automated Installation Autorun 3 Manual Installation 3 Alsius Add In Installation 3 Automated Installation Standard Windows Setup 4 Manual Installation 4 Using TempTrend CSV 4 What TempTrend CSV Does 5 Starting TempTrend CSV 5 Com Port 5 Select File 7 Download 8 Ol Using the Alsius Add in 8 Open CSV 8 Graph CSV 8 Activate Scroll Control 9 The Scroll Control 10 Location 10 Zoom 10 Scroll 10 Limits of Scroll Control 11 Uninstalling TempTrend CSV 11 2 600479 001 Rev2 110 147 TempTrend CSV TempTrend CSV Overview Temp
41. T be monitored by a separate hospital patient temperature monitor 5 Place the Alsius 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 42 600479 001 Rev 2 73 147 Operation 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 ze h fst tm Lia T 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 flow indicator 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 43 600479 001 Rev 2 74 147 Operation the flow indicator does not rotate freely during patient treatment inspect the entire tubing circuit for kinks or other restrictions to flow Tapping on the flow indicator will liberate any trapped air bu
42. 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 ALSIUS Self Tests in Progress Software Version 2 00 1B 36 1 57 2006 03 05 18 26 Figure 4 55 Self Test Screen 2 When the self test is finished the System Set Up screen displays the message Bath Pre Set 46 600479 001 Rev2 77 147 Operation System Set Up Bath Pre Set Pre Warm None 2006 03 05 18 26 Figure 4 56 Bath Pre Set Choose Pre Warm Pre Cool or None as desired When the System detects the presence of saved patient trend data the System Set Up screen displays the message New Patient System Set Up New Patient 2006 03 05 18 26 Figure 4 57 New Patient Message Choose Yes The screen displays the message Previous patient data must be downloaded or deleted to proceed 47 600479 001 Rev 2 78 147 Operation System Set Up Previous patient data must be downloaded or deleted to proceed Download Now Delete Exit 2006 03 05
43. Trend 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 Alsius 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 Copy the file to a director
44. ZOLL Circulation 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 9 033 998 9 059 167 9 908 407 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 6 916 224 6 520 933 6 929 775 6 930 945 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 86 916 6 796 995 6 872 222 6 878 156 6 893 419 6 893 454 6 942 644 7 001 418 7 014 651
45. a log file are both visible and active on your desk top i e both visible and both the focus for a mouse click Uninstalling TempTrend CSV The automated installation program installs an Uninstall option with TempTrend CSV To uninstall TempTrend CSV e Open the TempTrend CSV folder within your Program menu e Select Uninstall e 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 2006 TempTrend GraphTrend CoolGard 3000 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 11 600479 001 Rev2 119 147 Alarms amp Corrective Actions Alarms amp Corrective Actions 1 600479 001 Rev2 120 147 Alarms amp Corrective Actions Contents Alarms and Corrective Actions 3 Overview 3 Alarms and Corrective Actions 3 AIR TRAP FAULT 3 COOLANT EMPTY 3 COOLANT LOW 3 DOWNLOAD ERROR PLEASE CHECK EXTERNAL COMPUTER 4 PATIENT DATA LOG FULL PLEASE DOWNLOAD NOW 4 Hi PATIENT TEMPERATURE ALARM 4 Lo PATIENT TEMPERATURE ALARM 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 DISLODGE
46. allation CD and locate the file Alsius xls Double Click on Alsius xls Alsius xls should open in Microsoft EXCEL Follow the instructions in this file 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 e An RS 232 serial cable if your computer has an RS 232 port or e AUSB 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 specify the Com Port in use See below Com Port There are MANY non standard USB Serial Adaptor cables in the personal computer marketplace Please ensure that e You have loaded all the recommended drivers for your USB Serial Adaptor cable and that it uses a communication port between Com1 and Com s e You do not have another device attempting to use the same communications port as TempTrend CSV 4 600479 001 Rev2 112 147 TempTrend CSV 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 fi
47. ata 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 PATIENT TEM P View Graphs New Patient End Procedure Settings Exit Figure 4 67 Menu 2 Press the knob once The screen will display the temperature trend graph 57 600479 001 Rev 2 88 147 Operation 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 TempTrend v Figure 4 68 Temperature Trend Display Patient Temperature The patient temperature graph labeled Patient Temp is scaled for any temperature between 31 C and 41 C 87 8 105 8 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 t
48. aved from the improper shutdown is deleted 49 600479 001 Rev2 80 147 Operation 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 50 600479 001 Rev2 81 147 Operation 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 Error Reference source not found 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 acase 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 proc
49. 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 System Status Bar Messages Status Message ist Mt aie Color Explanation sTBY _ The System was in standby mode pump off wep sd The System wes warning tow Red o Black The System was neither warming nor cooling LOW Blue MED The System was cooling E nE E 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 pop up menu with the choice Set Time Scale highlighted 59 600479 001 Rev 2 90 147 Operation TempTrend v Set Time Scale Exit 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 TempTrend v Time Scale Select interval 12 Hours 24 Hours 72 Hours
50. bbles 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 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 44 600479 001 Rev2 75 147 Operation 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 lf 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 intention
51. calibrated temperature source e g Fogg System Co model TP 400 or equivalent Procedure To perform a temperature accuracy test follow these steps in the indicated order 1 Set the calibrated temperature source to exactly 37 C and plug it into connecior 11 Start the System and proceed to the Standby screen Observe the patient temperature displayed on the screen It should indicate 37 C 0 2 C lf the displayed temperature is above or below the indicated range contact your ZOLL service representative lf 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 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 Wipe down the outside surfaces with a water dampened cloth to remove remaining spots or residue Slide out and remove the condensate collection pan from under the front of the console see the following figure 6 600479 001 Rev2 136 147 Maintenance
52. ciated 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 if Stop the System 2 Using aseptic technique disconnect the tubing from the catheter and properly cap both the catheter and the tubing set 2 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 9 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 re 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 Stop the System 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 8 600479 001 Rev2 11 147 Safety Information e Look for damage to the tubing and or the presence of air inside the tubing e Inspect and tighten if necessary each Luer fitting do not use instruments to tighten the fittings 5 Ins
53. ck the plug in the socket Figure 3 5 Plug the Control Cable Into the Socket 6 600479 001 Rev2 30 147 Receiving Inspection amp Assembly Power Cord T 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 7 600479 001 Rev2 31 147 Operation Operation 1 600479 001 Rev2 32 147 Operation Contents Overview 5 Operating States in the System 5 SETUP 5 System Self Tests 5 Thermometer Functions Self Test 5 Cooling Engine Self Test 6 Sensor Checks 6 STANDBY 7 RUN Treatment Modes 8 Max Power MAX 8 Controlled Rate 8 FEVER FVR 8 User Interface 9 System Controls 9 The System Display Screen 10 Changing Target Temperature 11 Changing Treatment Mode 12 System Menu System 14 Main Menu 14 Settings Menu 15 Hi Lo Patient Temperature Alarms 16 Setting the Alarms 16 Nature of the Alarm 16 Bath Pre set 17 Pre Cool 18 Pre Warm 18 None 18 Exit 18 Time and Date 18 Time Setting 18 Date Setting 19 C F Temperature Notation 19 Language 20 STANDBY Timer 20 T1 T2 Behavior New 22 2 600479 001 R
54. ck to the patient Clear all restrictions indicator Check the flow indicator to confirm flow The saline flow rate is Set the pump flow rate as specified by the incorrect catheter s nstructions for Use The catheter is impro Place and position the catheter as directed perly positioned or is not by the nstructions for Use connected Connect the saline circuit tubing to the catheter and prime the saline circuit 4 600479 001 Rev2 128 147 Troubleshooting Symptom Probable Cause Corrective Action The patient does not cool The activity monitor indicates MAX COOLING and the patient s temper ature is increasing 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 patient s temper ature is more than 0 5 C below the setpoint The patient does not stop cooling The ac tivity monitor indi cates MAX COOLING when the target tem perature has been reached The patient is warming when set for cooling The heat exchanger coil is not in the coolant reservoir The System is not operating within specifi cations The System is not operating within specifications The patient s resistance to hypothermia has dimin ished resulting ina temperature controller undershoot Machine malfunction A cooling or temperature controller fault has occurred A c
55. der 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 4 600479 001 Rev2 28 147 Receiving Inspection amp Assembly 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 5 600479 001 Rev 2 29 147 Receiving Inspection amp Assembly Figure 3 4 Attach the Control Head to the Mast 5 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 lo
56. e 4 20 Right Alerts in STANDBY are generally NOT accompanied by an audible alarm tone PATIENT TEMP MAX WARMING PATIENT TEM P MAX WARMING STANDBY P STANDBY Primary probe 11 disconnected MAX COOLING Figure 4 20 T1 Disconnect alerts in RUN left and STANDBY right Primary temp probe T1 disconnected Press Enter to proceed 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 e Section 6 Alarms and Corrective Actions e Section 7 Troubleshooting If the alert persists call ZOLL for service 24 600479 001 Rev2 55 147 Operation Alarms An alarm is more serious in nature than an alert and relates to an issues that will typically require a service call In most cases a text
57. e weit ES A T aS n Ee A ies Figure 8 3 Push Hose Into Drain Coupler As soon the connector is firmly seated in the coupler coolant will automatically begin to flow through the line 8 600479 001 Rev 2 138 147 Spillage 10 11 12 13 14 Maintenance 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 Dispose of the used coolant Clean the coolant well using distilled water Do not use alcohol or any harsh or abrasive cleansers Reconnect the drain hose as described in steps 4 7 and drain the liquid used for cleaning Dispose of the liquid Repeat this process while flushing the coolant well with distilled water 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 Preparation for First Use in Chapter 3 for details Replace the cap on the coolant well Replace the drain hose in the clamp Replace the front panel on the console 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 ISO 60601 it is important to clean up spillage quickly 1 2 To ensure a safe work environment Spillage especially of coolant can result in a very slippery floor To
58. ect 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 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 incumbant 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 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 Alsius interface cable of the HMIA e The other end of the Alsius interface cable is connected to the HMIA 11 600479 001 Rev2 105 147 Errors Accesories HMIA Green LED OFF The Green LED indicates that power is present on
59. ed 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 System Set Up TARGET TEMP 37 0 MAX _ Operate at current settings Yes No 2006 03 05 18 26 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 i If you select Yes and press the knob you will proceed directly to STANDBY once the system self checks 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 45 600479 001 Rev2 76 147 Operation 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
60. edure the screen displays the message Patient data must be downloaded or deleted to proceed PATIENT TEMP MENU End Procedure Patient data must be downloaded or deleted to Aalia proceed TARGET TEMP Download Now Download Later Delete Sa Figure 4 62 Patient Data Message Choose Download Now The screen displays the message Prepare data link 51 600479 001 Rev 2 82 147 Operation PATIENT TEMP MENU End Procedure Prepare data link 2006 03 05 18 26 Cancel Figure 4 63 Prepare Data Link Message Connect one end of a serial interface cable to the laptop computer s serial interface connector 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 Start the TempTrend program on the laptop computer Refer to Chapter 5 TempTrend CSV 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 52 600479 001 Rev 2 83 147 Operation computer and choose Try again If repeated failures occur choose Cancel and contact your ZOLL representative for assistance PATIENT TEMP MENU End Procedure Download error please check external computer
61. ending 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 coolingor 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 5 600479 001 Rev2 36 147 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 v will be performed x will not be performed
62. ent Temperature Probe T1 connected to the System see below T1 T2 Behavior New STANDBY PATIENT TEM P MAX WARMING STANDBY TARGET TEMP 2006 03 05 18 26 MAX COOLING 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 7 600479 001 Rev2 38 147 Operation From STANDBY you may toggle into and out of RUN You may only return to SETUP by powering down the system 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 gt Patient Temperature gt Target Temperature OR B Bath Temperature lt Patient Temperature lt Ta
63. er then connect the inflow and outflow luer fittings of the saline circuit together 7 600479 001 Rev2 10 147 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 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 asso
64. eted 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 40 600479 001 Rev 2 71 147 Operation 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 PATIENT TEMP MAX WARMING E Figure 4 49 STANDBY Screen T1 Probe Not Connected 41 600479 001 Rev 2 72 147 Operation Connecting the Patient to the Sys
65. ev 2 33 147 Operation First Use Warning No T2 Probe 22 T2 Probe Disconnection Reconnection 23 Accidental Disconnection T1 T2 Probe 23 Alarms amp 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 Hang the Saline Bag 32 The Top Cover 32 The Coldwell 34 The Alsius Start up Kit 35 The Persitaltic Pump 36 Cover the Coldwell 38 Spike the Saline Bag 38 Prime amp Fill the Air Trap 39 Connecting the Patient to the System 42 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 5 7 Overview 57 Displaying the Temperature Trend Graph 57 3 600479 001 Rev2 34 147 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 Operation 600479 001 Rev 2 35 147 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 lapto
66. frequently hourly when the System is operating It is possible for malfunctions or misuse of the System to result in patient injury or death The ZOLL Thermal Regulating System is comprised of an external heat exchange system CoolGard 3000 or Thermogard and an Alsius endovascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit the Alsius Start up Kit These components together comprise a patient temperature regulation apparatus employing feedback control The catheter and the Start up Kit its heat exchange coil air trap and tubing are single use disposable devices This manual provides operating instructions for the System and the start up kit Catheter components are referenced where it is necessary to assure proper use with the system components Always refer to the catheter s Instructions for Use for additional specific information Operating Life The operating life of the catheters may vary according to design as indicated by the model designation Always refer to the catheter s nstructions for Use for information about the catheter s operating life The disposable components of the Alsius start up kit are designed for continuous use for a period not to exceed seven 7 days After seven days of use all start up kit components must be removed and replaced with components from a new start up kit CAUTION START UP KIT LIFETIME IS SEVEN 7 DAYS The designed operating lifetime for s
67. he 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 deleteing the existing patient data log is required End procedure 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 14 600479 001 Rev 2 45 147 Operation Settings Menu The settings menu allows you to modify the information displayed on the operating display It appears as in Figure 4 11 MENU PATIENT TEM P Settings Hi Lo Alarms Time and Date aS i Bath Pre Set Language Standby Timer Exit 2006 03 05 18 26 Figure 4 11 System Settings Menu The options offered by the settings menu are listed and described below Table 4 4 System Settings Menu Hi Lo Alarms Allows you
68. ided 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 24 February 1959 would be shown as 1959 02 24 Time Setting 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 18 600479 001 Rev2 49 147 Operation Date Setting 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
69. ime 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 e The red zone indicates coolant temperatures between 36 C and 42 C e The neutral point between red and blue indicates coolant temperature of 36 C and also indicates when the pump is not operating e The blue zone indicates coolant temperatures between 0 C and 36 C 58 600479 001 Rev2 89 147 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
70. into the cable and the cable is plugged into T2 Verify position of secondary temperature probe Determine the cause of the discrepancy and correct it One or both temperature probes may need to be replaced Discontinue use and contact your ZOLL service representative see Chapter 9 600479 001 Rev2 124 147 Troubleshooting Troubleshooting 1 600479 001 Rev2 125 147 Contents Troubleshooting 3 Overview 3 Symptoms and Remedies 4 Events Requiring Technical Assistance 6 Troubleshooting 600479 001 Rev 2 126 147 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 an ZOLL representative 3 600479 001 Rev2 127 147 Troubleshooting Symptoms and Remedies Consult the following table for help with tr
71. istors 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 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 TOA 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 cathet
72. lant 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 9 600479 001 Rev2 21 147 Introduction 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 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 10 600479 001 Rev2 22 147 Introduction Indications for Use USA The Indications for Use listed below have clearance within the USA for the following models of ZOLL Thermal Regulation System e The CoolGard 3000 e The Thermogard XP These systems can be used with any of the Alsius Catheters The indications f
73. 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 gt gt X lt lt 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 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 10 600479 001 Rev2 118 147 TempTrend CSV Limits of Scroll Control Scroll Control was designed to work only when it and the graphed dat
74. le name for the patient data log This is called the root file name lt rootfilename gt TempTrend CSV creates three files based upon this root file name lt rootfilename gt It varies the suffix on the lt rootfilename gt depending upon the purpose of the file Table 5 1 Installation File Paths The main patient data log lt roottiliename gt _Event csv The events data log lt roottilename gt _Info csv The system information If you are asked to download the datalogs as part of a service call please send all three files Starting TempTrend CSV To start TempTrend CSV click one of the Alsius A shortcuts that have 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 Ea Temp TrendCs P N103710 Rey A zj Lom Port Patient Log File Mame Select File Download E mit Figure 5 2 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 5 600479 001 Rev2 113 147 TempTrend CSV fa Temp Trend CSY P N103710 Res i Y Com Pork TempTrendCs x Patient Log File Name C Temp Unable to open CammPart1 Select File Figure 5 3 Com Port Error This error is typically due to one of two
75. ly be changed in STANDBY PATIENT TEM P To change Target Temperature or Rate system must be in Standby Would you like to go to Standby 2006 03 05 18 26 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 12 600479 001 Rev2 43 147 Operation PATIENT TEM P Select Mode STAN D BY Controlled 2006 03 05 18 26 Figure 4 8 Select Mode 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 10 C hr to 0 65 C hr When the correct selection is displayed press the knob once to enter the selection PATIENT TEM P Select Rate eee TARGET TEMP 2006 03 05 18 26 Figure 4 9 Select Controlled Rate 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 13 600479 001 Rev2 44 147 Operation Fever Mode Fever Mode provides cooling ONLY There is no warming with Fever Mode Do you wish to continue 2006 03 05 18 26 Figure 4 10 FEVER Mode Confirmation message 5 The Operating screen will be updated to reflect your selection NOTE Target Temperature in FEVER Mode T
76. 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 System error Please power off and restart Contact your Alsius service representative if problem persists TCM Id 01 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 e Section 7 Troubleshooting Power cycle the System If the alarm persists call ZOLL for service 25 600479 001 Rev2 56 147 Operation Your First System Case What you need You will need the following for each System case e Anew ALSIUS Startup Kit e Anew 500ml bag of normal saline e A YSI 400 compatable temperature probe e g a Foley catheter rectal or esophageal temperature probe e The blue patient connection cable to connect the temperature probe to the System e An Alsius heat exchange catheter e An aseptic work area
77. minimize the risk of corrosion or damage to the System Spillage is most likely under the following conditions ih 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 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 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 9 600479 001 Rev2 139 147 Warranty amp Service Warranty amp Service 1 600479 001 Rev2 140 147 Warranty amp Service Contents Warranty and Service 3 Warranty 3 Technical Support and Resources 3 Obtaining Service from ZOLL 3 Packing and Shipping Instructions 4 Disposal of the System 5 2 600479 001 Rev2 141 147 Warranty amp Service Warranty and Service Warranty ZOLL Circulation Inc 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 lf during the warranty period a System requires repair ZOLL
78. n the self test is finished the System Set Up screen displays the message Bath Pre Set System Set Up Bath Pre Set Pre Warm 2006 03 05 18 26 Figure 4 24 System Pre Cool 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 warming the coolant reservoir now choose None and press the knob once to enter the selection 2 600479 001 Rev2 58 147 Operation 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 System Set Up New Patient 2006 03 05 18 26 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 System Set Up Previous patient data must be downloaded or deleted to proceed Download Now Exit 2006 03 05 18 26 Figure 4 26 Patient Data Message 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 28 600479 001 Rev 2 59 147 Operation System Set Up System Set Up Are you sure you want to delete previous i patient data Previous patient da
79. nd assemble the System you will need the following tools e Phillips screwdriver included in shipping container e 3 16 inch Allen wrench included in shipping container e 5 82 inch Allen wrench included in shipping container e 7 64 inch Allen wrench included in shipping container e Scissors or box knife Unpacking CAUTION AVOID LIFTING INJURY The System weighs 115 Ib 52 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 5 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 3 600479 001 Rev2 27 147 Receiving Inspection amp Assembly Figure 3 1 System Unpacked and Ready for Assembly Assembly To assemble the unpacked System follow these steps in the indicated or
80. 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 3 600479 001 Rev2 6 147 Safety Information Definitions of Symbols and Labels Used on the Product and in the Manual Attention Consult This symbol designates accompanying the connector for the data documents acquisition cable Electrical warning or Indicates notes intended electrical caution to clarify understanding Temperature and pressure range Do not allow liquids to spill on the product or package Type BF applied part Defibrillator protected
81. older 35 600479 001 Rev2 66 147 Operation Figure 4 40 Air Trap Placed In Holder The Persitaltic 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 36 600479 001 Rev 2 67 147 Operation 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 37 600479 001 Rev 2
82. ooling or temperature controller fault has occurred Place the heat exchange coil in the reservoir Verify operation by performing the cooling engine power test described in the System Service Manual Download the TempTrend data file If the coolant temperature is above the limits below perform the cooling engine power test described in the System Service Manual Catheter Coolant Temperature Used ICY 11 C 26C 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 normal ly If the coolant temperature is at or below the patient s temperature the activity moni tor should indicate warming and the pump should be off Use warming blankets to stabilize the patient s temperature See above for correct machine function Use conventional methods to rewarm the patient and discontinue use of the System If the activity monitor indicates MAX COOL ING and the patient s temperature is one degree below the target temperature dis continue treatment and contact ZOLL If the target temperature is below the patient s temperature and the activity monitor does not indicate cooling activity discontinue treatment and contact ZOLL 600479 001 Rev2 129 147 Troubleshooting Symptom Probable Cause Corrective Action The patient does not The warming capacity of Use warming blankets to supplement warm The activity
83. or 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 Thermal Regulation System using the Alsius 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 random ized controlled trial of 296 patients The mortality results reported in this trial for the four patient cohorts enrolled are presented in the table below Cl cerebral infarction ICH intracerebral hemorrhage PTBI primary traumatic brain injury SAH subarachnoid hemorrhage Table 1 1 Mortality by Diagnosis ITT Cool Line Control Fischer s exact test n e fw ae 7 ase 10 For more details on the results of this study please refer to Physician s Manual Normothermia for the Neuro critically Ill Stroke Patient 101416 001 1 600479 001 Rev2 23 147 Introduction Indications for Use All Other Catheters The ZOLL Thermal Regulation System using one of the
84. oring 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 self calibration upon reconnection of the RS 232 port for example you might temporarily disconnect the HMIA to allow access for data download Self calibration 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 self calibration 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 6 600479 001 Rev2 100 147 Accesories HMIA ALSIUS Self Tests in Progress Software Version 1 04 XX XX X XX 2006 03 05 18 26 Figure 4 System Software Ve
85. osable components are used proper operation cannot be guaranteed and harm to the patient may result e Proper aseptic technique must be used while making all sterile connections to the System e Never operate damaged or leaking equipment e Never operate the equipment without coolant fluid in the coolant well e Never use pure water pure propylene glycol or alcohol as a coolant fluid e Never operate the equipment while smoking or in the presence of open flame 5 600479 001 Rev2 8 147 Safety Information Shipping and Storage Conditions When shipping or storing the System follow these recommendations e Temperature range 20 C 4 F to 60 C 140 F e Atmospheric pressure range 50 kPa to 106 kPa e Do not allow liquids to spill on the System or its packaging e Humidity range 10 to 90 noncondensing e Fragile contents handle with care e 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 ma
86. oubleshooting 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 System or control failure Discontinue use and contact ZOLL panel is illuminated and audible alarm sounds Red LED on control Electrical power was Turn off power and wait 30 seconds Turn panel is blinking and momentarily interrupted on the System and restart If problem audible alarm beeps persists discontinue use and contact ZOLL repeatedly 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 The patient may be The fever has overcome the cooling cap cool The activity febrile ability of the catheter Use additional patient monitor indicates MAX cooling methods as needed until the COOLING and the patient s temperature is stabilized patient s temperature The temperature control Verify that the target temperature and that ler setting is incorrect the cooling rate option is not used is increasing The saline flow is Inspect the entire length of tubing from the obstructed indicated by patient s catheter connection to the System no rotation of the flow and ba
87. p 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 e Your first case with the System e Variations in the SETUP sequence of the System e Ending procedures Operating States in the System SETUP The System has three operating states SETUP STANDBY and RUN 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 dep
88. pect 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 e Reorient or relocate the receiving device e Increase the separation between the equipment e 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 To avoid electric shock disconnect all JN To avoid electric shock disconnect all A WARNING cords before removing access panels WARNING cords before removing access panels AN WARNING Nouser serviceable pare inside Refer AN WARNING Nouser serviceable pare inside Refer all servicing to qualified personnel all servicing to qualified personnel mod COOlGard 3000 sa Thermogard XP 3000 XXXXX XAXXXKK m TGXP KXXXX MRMRRE Power Regts Fuse Regts Power Regts Fuse Regts 175 100 1207 S0 60 HZ 5A TAJA slow blow amp X 200M 115 100 1207
89. peration ALSIUS Self Tests in Progress Software Version 2 00 1B 36 1 57 2006 03 05 18 26 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 System Set Up Check the following Air Trap Roller Pump Lid Check Prime Switch Coolant l 2006 03 05 18 26 Figure 4 32 Check the Following Screen 31 600479 001 Rev 2 62 147 Operation 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 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 p WE cauite Au i ws on p gi A 2 E A bes ake see
90. r questions provide guidance and schedule service for your System Upon request ZOLL Circulation Inc can provide circuit diagrams parts lists and service documentation to authorized users Obtaining Service from ZOLL To obtain service from ZOLL Circulation Inc contact their service hotline at 877 225 7487 Ext 3 You may send inquiries to us by FAX at 408 541 1030 3 600479 001 Rev2 142 147 Warranty amp Service 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 ltems to be returned to ZOLL Circulation Inc must be packed carefully to avoid damage during shipment ltems may be shipped to us at ZOLL Circulation Inc 650 Almanor Avenue Sunnyvale California 94085 U S A 4 600479 001 Rev2 143 147 Warranty amp 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 Circulation Inc 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 your
91. rget 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 8 600479 001 Rev2 39 147 Operation User Interface The primary controls for the System are mounted in the display head of the system The next sections describe e The controls available to the
92. rsion 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 2 System with correct software 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 601033 001 is for the 8 pin circular connector and HMIA part number 601033 002 is for the 6 pin circular connector TP 400 test fixture with adapter cable Alsius Part number 500341 001 that mates to the T1 connector of the System Air trap assembly filled with water Alsius Part number 500395 001 The standard Hospital Monitor patient temperature cable that is used to connect the Hospital Monitor to a Foley or rectal patient temperature sensor Hospital Monitor that conforms to the YSI 400 requirements Optionally a Digital Multimeter may be used if a hospital monitor is not available Installation Procedure 1 2 Disconnect power to the System Disconnect the Umbilical Cable from the rear of the Display Housing See Figure 5 7 600479 001 Rev2 101 147 Accesories
93. scontinue use and contact your ZOLL service representative see Chapter 9 The coolant well is empty Fill with mixture of propylene COOLANT EMPTY The coolant welis empty glycol and distilled water The coolant level is low Add distilled water until liquid COOLANT LOW level reaches top fill line in coolant well 3 600479 001 Rev2 122 147 Alarms amp Corrective Actions Alarm Message Cause Corrective Action DOWNLOAD ERROR PLEASE CHECK EXTERNAL COMPUTER PATIENT DATA LOG FULL PLEASE DOWNLOAD NOW Hi PATIENT TEMPERATURE ALARM Lo PATIENT TEMPERATURE ALARM PRIMARY TEMPERATURE PROBE DISCONNECTED PRIMARY TEMPERATURE PROBE DISLODGED Patient trend data download has failed or there is no computer connected to the System Patient trend data log is full Only two hours of space remain The patient s temperature is above the programmed Hi patient temperature alarm value The patient s temperature is below the programmed Lo patient temperature alarm value The primary patient temperature probe is disconnected Temperature output from the primary patient temperature probe changed by 0 2 C or more within 10 seconds Check the connection between the computer and the System and select Try again If problem persists select Cancel and contact ZOLL technical support Download patient trend data If data is not downloaded it will be overwritten The System alarm
94. selected by the user 7 600479 001 Rev2 19 147 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 Remove the pump rotor refer to Pump Rotor removal instructions in System Service Manual 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 8 600479 001 Rev2 20 147 Introduction Figure 2 6 Prime Switch Start up Kit The Alsius start up kit contains the sterile disposable components for this system Each kit contains a heat exchanger coil air trap saline coo
95. self as this may release R134a refrigerant into the atmosphere The System contains e Solder that contains Lead e Adischarge vapor bulb e Refrigerant R134a e 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 5 600479 001 Rev2 144 147 Specifications Specifications 1 600479 001 Rev2 145 147 PHYSICAL Dimensions Weight ELECTRICAL Configuration 100 120 VAC 50 60 Hz 5 A 220 240 VAC 50 60 Hz 2 25 A ENVIRONMENTAL Operating temperatures Operating humidity Atmospheric pressure CHILLER and HEATER Reservoir volume Pump capacity Temperature range Coolant Refrigerant CONTROLLER AND DISPLAY Screen display Controls Temperature input Articulation Data interface Alarms Displayed temperature range Displayed temperature accuracy Specifications Height 45 in 114 cm Width 17 in 43 cm Depth 30 in 76 cm 115 Ib 52 kg Voltage Fuse protection 115 V T6 3A slow blow 5 x 20 mm 230 V T6 3A slow blow 5 x 20 mm 10 C 27 C 50 F 81 F 30 to 75 noncondensing 70 kPa to 106 kPa 2 0 liters 0 5 gal 7 lpm at O m head 0 ft 0 C 42 C 1 1 mixture of propylene glycol and distilled water HFC 134a 6 4 in 16 25 cm LCD color VG
96. soft Excel Book1 4lsius Adobe PDF Open CS File Edit View Insert Format Tools Data Window Help DSH SIiSGRAlIFHa sae FI9 Arial 10 B Z7 U 8 amp ZE gE I Graph cs Activate Scroll Control Figure 5 7 The Alsius Menu with CSV Functions 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 C 1 2 d 4 Patient Temperature Target Temperature Coolant Temperature System RUN STANDBY e A graph value equivalent to 8 C indicates that the system was in RUN e A graph value equivalent to 0 C indicates that the system was either in STANDBY or powered off 8 600479 001 Rev 2 116 147 TempTrend CSV CoolGard 3000 Patient Data e T i ares o a on OT 9260 9400 9520 9640 9760 9880 10000 10120 10240 10360 1048 Minutes Figure 5 8 Graph CSV Di
97. splay 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 Alsius menu selection has only one option Activate Scroll Control EJ Microsoft Excel Copy of demo xls EH File Edit wiew Insert Format Tools Chart Window Help Alsius Adobe POF LJ eS m fa fe ed ol tt EF A WJ 5 Activate Scroll Control Ep g5 s E 0 B z u SE SE mm Ss gt co fe Value CY Axi CoolGard 3000 Patient Data Figure 5 9 Alsius Menu in the Chart window MT ola a 9 600479 001 Rev 2 117 147 TempTrend CSV The Scroll Control lt lt lt SCROLL gt gt gt Figure 5 10 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
98. t 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 oF The Hi Alarm value will be presented Turn the knob until the desired value is displayed and press the knob Nature of the Alarm MENU PATIENT TEM P z Settings Hi Lo Alarms Time and Date CIF Bath Pre Set Language Standby Timer Exit 2006 03 05 18 26 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 effected by writing the patient temperature area on the screen in RED text and flashing the text The visual alarm will not stop until the alarm has cleared 16 600479 001 Rev2 47 147 Operation 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 deactived 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
99. ta deleted 2006 03 05 18 26 2006 03 05 18 26 Figure 4 27 Delete Previous Patient Data 12 The System Set Up screen then displays the message Select Target Temp System Set Up Select Target Temp Press Enter to set TARGET TEMP 2006 03 05 18 26 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 29 600479 001 Rev2 60 147 Operation System Set Up Select Treatment Mode Max Power Controlled Rate Fever 2006 03 05 18 26 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 System Set Up Select Rate Press Enter to set 2006 03 05 18 26 Figure 4 30 Select Rate Screen 17 If the System has not yet finished its self tests the Self Test screen is displayed 30 600479 001 Rev2 61 147 O
100. tact 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 55 600479 001 Rev2 86 147 Operation 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 56 600479 001 Rev2 87 147 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 d
101. tart up kit components is seven 7 days of continuous operation If a patient must be treated for a longer period a new start up kit must be installed in the System Failure to adhere to this time limit may cause injury to the patient Functional Description The System can be described in terms of three major components a recirculating chiller a sterile fluid roller pump and a temperature control system The System is connected to the temperature controlled catheter by two small bore plastic tubes One tube supplies temperature controlled sterile saline solution to the catheter and the other tube returns the saline solution to the System The sterile saline is pumped through a continuous recirculating loop by a peristaltic pump inside the console The saline solution acts as an intermediate heat transfer medium between the patient and the System Sterile saline is used because it is biologically compatible with the patient and in the unlikely event of a leak in the catheter the possibility of harming the patient is reduced to a practical minimum 3 600479 001 Rev2 15 147 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 occ
102. ted PATIENT TEM P SETTINGS Language Set system language eens Cli TARGET TEMP Francais Espafiol Italiano 2006 03 05 18 26 Portugu s 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 20 600479 001 Rev2 51 147 Operation presents the User with the opportunity to select from the following values No Alarm 15 minutes 60 minutes SETTINGS PATIENT TEM P Standby Timer A Select Delay Press enter to set 15 Minutes in standby until warning 2006 03 05 18 26 Figure 4 17 STANDBY Timer Menu 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 e The System is placed into RUN e 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 PATIENT TEM P
103. tem 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 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 nstructions 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 MUS
104. 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 11 12 Observe Red LED If it is flashing then follow instructions for Flashing Red LED above If the Red LED is not flashing then disconnect the hospital monitor from the HMIA interface cable Using a DMM measure the resistance between the two pins Using the chart YSI 400 Temperature vs Resistance determine if the resistance value measured corresponds to the temperature displayed on the System display If the resistance value is correct then the HMIA is functioning to specifications lf the resistance value is wrong then test Alsius interface cable for shorts or opens If it passes the test then press the reset button RST Repeat step 5 above 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 Wait for an additional 20 seconds for the HMIA to re establish communication with the System lf the resistance value is wrong then return the HMI
105. the catheter has reached catheter performance until the patients monitor indicates its upper limit temperature has been stabilized MAX WARMING and the patient s temper ature continues to decline The patient is The warming rate is Reset the target temperature to hold or cool warming too fast incorrect the patient s temperature Verify the warm when set for ing rate setting warming Events Requiring Technical Assistance CAUTION The System has multiple internal alarm states see Alarms amp 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 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 e The System repeatedly trips an outlet equipped with a ground fault circuit interrupter GFCI e The protective fuse repeatedly blows e Fluid is observed leaking from the console e The System emits an unusual odor when operating e The System produces loud or unusual noises when operating e The display screen control knob
106. the front of the System Connection of the HMIA to a hospital temperature monitor using one of the Alsius 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 an Alsius 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 Alsius 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 1 3 600479 001 Rev2 97 147 Accesories HMIA Figure 1 Cables and Connections The other end of the Alsi
107. to modify the low Lo and high Hi patient temperature alarms Time and Date Allows you to modify the System time and date C F Allows you to toggle between displaying temperatures in degrees Celsius or degrees Farhenheit 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 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 XP systems ZOLL has validated that the Cool Line catheter can be safely used at a pump rate of 240 ml min 15 600479 001 Rev 2 46 147 Operation 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 C 45 C 82 4 F 113 0 F 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 Selec
108. ture Controller Pump 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 0 and 42 C 32 and 107 6 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 a e9 Al es Figure 2 4 Temperature Probe Connectors 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
109. urs when the patients 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 Saline bag Peristaltic pump Air trap F Heat exchange coil le Coldwell Coolant pump ai LAN Chiller amp Heater ilo o Catheter LJe UZ Patient 1J G ii ee ee E R P A O 0 Pin wheel flow indicator D 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 4 600479 001 Rev2 16 147 ot ee Se ee I Introduction Display Screen Alarm Indicator LED Mute Button Power On Indicator LED Target Temp Button Standby
110. us interface cable plugs into the HMIA connector labelled T1 out See Figure 2 a SUITE 150 CUDAN By RIVAL CA T7511 ee TEL 49 453 060 CONFORMS TO lt DA r UA STD 60801 1 p51 6H Den Haag FAX 340 483 0220 34 CERTHED TO CANTSA STD 7 2 NO AY lt c 1 l E RS232 T1 out CG3000 Figure 2 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 Alsius interface cable to the patient cable of the hospital monitor See Figure 1 Plug the other end of the Alsius interface cable into the HMIA connector labelled T1 out 4 600479 001 Rev2 98 147 Accesories HMIA The set up is now complete 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 RST HOSPITAL MONITOR l INTERFACE F a C ZOLL Circulation ee l c us 7 ly ee dy hee U344 ZOLL Circulation line Lat fa 650 Almanor Avenue 404 OSA E MERI af EUR IPE bt view i i a kin ae I aT J es r E L TE Sunnyvale CA 940845 PaT N Tm ea oh Mslanetraal 15 j CONFI IRMS TO eeii aa IS t 408 541 2140 UL STD 60601 1 25 1J68H Den Haag ane had aan CERTIFIED TO The Netherlands 408 541 1030 a m i f ir
111. user e The System display screen e The System menu system available to the user System Controls Display Screen Alarm Indicator LED Mute Button Power On Indicator LED Target Temp Button Standby Run Button Rate Deg HR Button Press for Menu Enter Target Temp Knob oO Oe e SY Rate Deg Hr Press for Menu Enter Standby Run ALSIUS 00 Figure 4 3 Controls and Display The use of each of the controls is described in the table below Table 4 2 System Controls Flashes red during alarm states Rate Deg Hr button Press this to change the rate and or treatment mode Press amp 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 9 600479 001 Rev 2 40 147 Operation The System Display Screen The System features a color display screen The figure below shows the screen as It appears during RUN MAX WARMING PATIENT TEM P 2006 03 05 18 26 MAX COOLING Figure 4 4 Operating Screen The upper left hand of the screen displays e The patient temperature e The Lo and Hi patient temperature alarm values The lower left hand of the screen displays e The programmed Target Temperature for the System e The programmed treatment mode controlled rate value The right hand side of the screen is used either e To display the temperature of the coolant
112. y 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 e To avoid the risk of electrical shock do not remove any panels of the product e Refer servicing to qualified personnel e Never operate equipment with damaged power line cords e 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 6 600479 001 Rev2 9 147 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 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 res
113. y on your computer Right Click the copied file and select Create Shortcut Move the shortcut to your desktop or other desired location Double click on the shortcut to start TempTrend CSV Alsius 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 Alsius xla Once it is installed it will appear as a new item called Alsius in the menu bar of EXCEL M S amp 3 600479 001 Rev 2 111 147 TempTrend CSV E Microsoft Excel Booki Es File Edit View Insert Format Tools Data Window Help Je WdsighisaivGls ae J7 i9 Arial 10 B Z7 UJ EBZSSZEBAL I Adobe PDF Open CS Alsiiis Graph cs Activate Scroll Control Figure 5 1 The Alsius Menu with CSV Functions Automated Installation Standard Windows Setup If your Microsoft Windows is a standard setup the Alsius Add In has already been placed in the appropriate directory To complete installation you should Open Microsoft EXCEL From the main menu bar select Tools Add Ins Click the box next to the word Alsius Click OK In the main menu bar you should see the new item Alsius aia NY a Manual Installation If your Microsoft Windows is a non standard setup the Alsius Add In will have to be loaded manually 1 Using Microsoft Windows Explorer open the TempTrend CSV inst

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