ZOLL IVTM Operation Manual Download

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IVTM

Intravascular Temperature

Management

O P E R A T I O N M A N U A L

601285-001 Rev. 4

Caution: Federal law restricts this device to sale by or on the order of a physician.

EC REP

EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands

Summary of Contents for IVTM

Page 1: ...perature Management O P E R A T I O N M A N U A L 601285 001 Rev 4 Caution Federal law restricts this device to sale by or on the order of a physician EC REP EMERGO EUROPE Prinsessegracht 20 2514 AP T...

Page 2: ......

Page 3: ...d IVTM are trademarks or registered trademarks of ZOLL Medical Corporation and or ZOLL Circulation Inc All trademarks are the property of their respective owners Patent www zoll com patents ZOLL Circu...

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Page 5: ...ng the Saline Circuit 9 Air Entry Into the Tubing Circuit 9 Check the Integrity of the Catheter 9 Check the Integrity of the Start Up Kit Tubing 9 Interference 10 Product Label 10 2 Introduction 11 Us...

Page 6: ...erts 41 Alarms 42 Your First Case 43 What you need 43 Preparing the Console for Treatment 44 Installing the Start Up Kit 49 Setup Variations 60 Setup Sequence 60 Time From Last Power Down 60 Downloadi...

Page 7: ...82 YSI 400 Temperature vs Resistance 83 5 Alarms and Corrective Actions 85 Overview 85 Alarms and Corrective Actions 85 6 Troubleshooting 89 Overview 89 Symptoms and Remedies 89 Events Requiring Techn...

Page 8: ...iv Specifications 101...

Page 9: ...t in serious injury or death or severe damage to the equipment Caution Cautions indicate information for safe operation proper performance or avoiding actions that may result in damage to the equipmen...

Page 10: ...ic temperature controller Temperature oscillations may occur that are dangerous to the patient Performance of installation operation or maintenance procedures other than those described in this man ua...

Page 11: ...and those directly connected to a low voltage power supply network that supplies buildings used for domestic purposes Note The emissions characteristics of this equipment make it suit able for use in...

Page 12: ...typical commercial or hospital environment The Thermogard XP console is intended for use in the electromagnetic environment specified below The customer or user of the console should ensure that it is...

Page 13: ...scientific and medical bands between 150 kHz and 80 MHz tested are 6 765 MHz to 6 975 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz Note 5 Tested for immunity to RF...

Page 14: ...paration distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorp tion and reflection from structures o...

Page 15: ...ing hazard The console may tilt in case of transport outside its crate and over a threshold 1720 1 700 1 990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation2 217 Hz 2 0 3 28 1...

Page 16: ...hen available Refer to the requirements in the IEC 60601 1 standard Primary Patient Temperature Probe T1 Failure The console relies upon the patient temperature reading from an YSI 400 type thermistor...

Page 17: ...r 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...

Page 18: ...e with other devices which can be determined by turning the console off and on try to correct the interference by one or more of the following measures Reorient or relocate the receiving device Increa...

Page 19: ...of use remove and replace the Start Up Kit with a new Start Up Kit Caution Start Up Kit lifetime is seven days The designed operating lifetime for Start Up Kit components is seven 7 days of continuous...

Page 20: ...ed Flow Diagram Console Components Controls and Display Screen The display head contains four buttons and one knob used to access functions and adjust settings with the aid of the menus and messages d...

Page 21: ...tion 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 temperatur...

Page 22: ...the console Figure 2 3 Serial Interface Connector Recirculating Chiller The chiller consists of an air cooled refrigeration system reservoir heater circulation pump stainless steel res ervoir reservo...

Page 23: ...the tubing installed in the pump head The pump rota tion speed is accurately controlled by an electronic speed control system If a tubing leak or failure occurs in the pump raceway the saline solutio...

Page 24: ...ed the pump stops Figure 2 6 Prime Switch Start Up Kit The Start Up Kit contains the sterile disposable components for this system Each kit contains a heat exchange coil air trap saline delivery lines...

Page 25: ...ory The console 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...

Page 26: ...18 Saline Circuit Diagram A flow diagram is printed on the inside of the top cover Use this diagram to ensure that the Start Up Kit has been installed correctly Figure 2 8 Flow Diagram...

Page 27: ...use in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery intensive care and to induce maintain and reverse mild hypothermia in neurosurgery patients in surg...

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Page 29: ...included in shipping container 7 64 inch Allen wrench included in shipping container Scissors or box knife Unpacking Caution Avoid lifting injury The console weighs 107 lb 49 kg Never attempt to lift...

Page 30: ...o assemble the unpacked console follow these steps in the indicated order Hook 1 Attach the gray hook to the front of the mast using the short bolt provided Use a 7 64 inch Allen wrench to tighten the...

Page 31: ...fectly vertical and slide it into the mast opening by applying even gradual pressure The pivot assembly fits into the mast only in one direction Figure 3 4 Attach the Display Head to the Mast 5 Secure...

Page 32: ...ord 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 7 1 Sal...

Page 33: ...ough 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 console tests its...

Page 34: ...m sensor state will be highlighted in red see Figure 4 1 above Once you rectify the identified problems the console will progress to Standby Note Presence of patient temperature probes The console can...

Page 35: ...r Controlled Rate and Fever Max Power MAX In this treatment option the console aims to make the patient s temperature the same as the selected target temperature The peristaltic pump may stop temporar...

Page 36: ...face The primary controls are mounted in the display head of the console The next sections describe Controls and display screen Menu system Console Controls The controls and display screen are illustr...

Page 37: ...m values The lower left hand of the screen displays The programmed target temperature The programmed treatment mode Controlled Rate value The right hand side of the screen is used either To display th...

Page 38: ...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 4 The target temperature setting is updated on the display screen Changing Treat...

Page 39: ...played press the knob once to enter the selection Figure 4 7 Select Mode 3 If you select Controlled Rate a second menu screen will be presented To change the rate turn the knob until the desired selec...

Page 40: ...that Fever mode only cools and does not warm per Figure 4 9 Figure 4 9 Fever Mode Confirmation message 5 The display screen is updated to reflect your selection Note Target temperature in Fever mode...

Page 41: ...the settings menu are listed and described below View Graphs Takes you to a display of the patient temperature data log See Temperature Trend Data on page 69 New Patient Indicates that you are startin...

Page 42: ...the knob 3 Select the Hi Lo Alarms option 4 The Lo alarm value will be presented Turn the knob until the desired value is displayed and press the knob 5 The Hi alarm value will be presented Turn the...

Page 43: ...are programmable They cannot be deactivated Press the Mute button to mute the alarm for 2 minutes Note Patient temperature alarms in Standby If the console is in Standby and the T1 temperature probe...

Page 44: ...rmitted temperature and maintained at that temperature Pre Warm The console bath is heated to its highest possible temperature and maintained at that temperature None The Bath Pre set is not activated...

Page 45: ...nge 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 kn...

Page 46: ...ill 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 c...

Page 47: ...mer The Standby Timer alert may be silenced for two 2 minutes by pressing the mute button Figure 4 17 Standby Timer Alert T1 T2 Behavior WARNING Dislodged Foley Catheter Temperature Probe The console...

Page 48: ...it will check to see which probes are present 3 If there is no T2 present the console will ask you to verify that this is intentional See image below Figure 4 18 No T2 Probe Connected The console rem...

Page 49: ...the T1 probe has been replaced Note that the patient temperature is displayed as and the yellow warning banner covers the bath temperature display Absence or disconnection of the T1 probe during Stand...

Page 50: ...me 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 al...

Page 51: ...e 85 and Troubleshooting on page 89 If the alarm persists call ZOLL for service Your First Case What you need You will need the following for each case A new Start Up Kit A new 500ml bag of normal sal...

Page 52: ...power indicator lamp will be illuminated and the alarm will beep one long beep followed by a shorter softer beep 5 The console performs a self test During this interval the self test screen appears on...

Page 53: ...wish to begin cooling or warming the coldwell now choose None and press the knob once to enter the selection 8 You may be asked questions relating to the downloading of patient data This is a new pati...

Page 54: ...be asked to confirm your choice to delete the data file Choose Yes A brief confirmation message will appear and then automatically close See below Figure 4 26 Delete Previous Patient Data 12 The Syst...

Page 55: ...hat you have three choices Max Power Controlled Rate or Fever Figure 4 28 Select Treatment Mode Message 15 Turn the knob to highlight the desired mode Press the knob once to enter the selection Contro...

Page 56: ...tware Version shown in Figure 4 31 is for reference only the current product may use a different Software Version Figure 4 30 Self Test Screen 18 Install the Start Up Kit now If the console finishes i...

Page 57: ...ner on the hook mounted on the rear of the display head The container hangs inside the circumference of the handle Air Trap There is no Start Up Kit installed or there is a large amount of air in the...

Page 58: ...arent top cover of the roller pump Figure 4 33 Covers Open 3 A tubing circuit diagram is printed on the inside of the console top cover Refer to this diagram when installing the Start Up Kit See Figur...

Page 59: ...d propylene glycol until the liquid is at the top indicator line If the coolant level is unusually low because of spillage add 1 1 mixture of propylene glycol and water until the liquid is at the top...

Page 60: ...52 Figure 4 36 Start Up Kit 7 Insert the heat exchange coil into the coolant well Figure 4 37 Installing the Heat Exchange Coil 8 Temporarily slide the air trap into the holder...

Page 61: ...n the pump rollers Figure 4 39 Lift the Pump Rollers Handle WARNING Finger injuries Be careful when inserting the pump tubing that you do not catch your fingers with the roller When the console is ope...

Page 62: ...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 Figure 4 41 Pump Tubing I...

Page 63: ...g the saline container on the hook provided Figure 4 43 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 t...

Page 64: ...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 compl...

Page 65: ...47 Standby Screen T1 Probe Not Connected Connecting the Patient to the Console WARNING Verify console function first Ensure proper functioning of the console and initiate pre cool or pre warm if appl...

Page 66: ...o 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 console If you are not using a secondary t...

Page 67: ...ng through the tubing and catheter circuit by observing the rotation of the inline flow indicator see Figure 4 51 If the flow indicator does not rotate freely during patient treatment inspect the enti...

Page 68: ...a short time it is more likely than not that the power down was either unintentional you tripped over the power cord or an intentioned brief adjustment that required the console to be powered off you...

Page 69: ...t time the console is switched on the self test program detects the saved patient data and offers you the option to download the data to a laptop computer If you do not wish to download the saved data...

Page 70: ...ed 4 When the console detects the presence of saved patient trend data the System Set Up screen displays the message New Patient Figure 4 55 New Patient Message 5 Choose Yes 6 The screen displays the...

Page 71: ...link Figure 4 57 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 interfac...

Page 72: ...TempTrend program or the console contact your ZOLL representative for assistance Figure 4 59 Download Error Message 13 When the data download is complete the screen briefly displays the message Downlo...

Page 73: ...ve decisions as to what is to happen to the patient data log when you next power on the console See Downloading Data After Improper Shutdown on page 61 We refer to the use of the End Procedure menu op...

Page 74: ...he Serial Interface Connector 6 Start the TempTrend CSV program on the laptop computer See the TempTrend CSV Instructions for Use IFU 7 If a problem occurs during downloading the display screen will s...

Page 75: ...the patient trend data in the console will be deleted After about two seconds the message is automatically cleared and the screen displays the message Turn power off Figure 4 64 Turn Power Off Messag...

Page 76: ...message Previous patient data deleted and then displays the Standby screen Disposal of Used Components WARNING Single use device do not reuse ZOLL intravascular heat exchange catheters and Start Up K...

Page 77: ...or refrigerated appliances Temperature Trend Data Overview During operation the console continuously collects and stores temperature trend data storing a record each minute This data is stored in memo...

Page 78: ...time series of patient temperature from the primary temperature probe and console activity plotted in two graphs The patient temperature graph plots temperature vertically and time horizontally The c...

Page 79: ...ay screen to the left or right As data scrolls under the cursor the top of the display screen shows the time and date of the data under the cursor Turn the knob clockwise to scroll to the right As you...

Page 80: ...nce The screen displays a pop up menu with the choice Set Time Scale highlighted Figure 4 67 Set Time Scale 3 Press the knob once The screen displays the message Select interval followed by four inter...

Page 81: ...console is required lift the top cover to a fully upright position Figure 4 69 Top cover fully open Display Head Tilt To modify the tilt of the display head or to lock the display head in place use th...

Page 82: ...types of casters wheels on the console 1 The front casters have a longer latch to engage the lock 2 The rear casters have a shorter latch to engage the lock Figure 4 71 shows the location of the cast...

Page 83: ...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...

Page 84: ...able of the hospital monitor See Figure 4 72 Plug the other end of the ZOLL interface cable into the HMIA connector labeled T1 out The set up is now complete Controls and indicators on the HMIA The HM...

Page 85: ...nnect 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...

Page 86: ...A from functioning but it has no adverse affects on the console Installation Equipment The following items are necessary to install a HMIA 1 Console with correct software 2 Hospital Monitor Interface...

Page 87: ...the stainless steel bracket located on the back of the display head The connectors on the HMIA should be facing downward 6 Press on the lower half the HMIA until the snaps engage 7 Connect the Umbilic...

Page 88: ...nitor 0 1 C Note There may be a delay as long as 2 minutes before the temperature displayed by the hospital mon itor agrees within 0 1 C with the temperature displayed by the console 19 Set the TP 400...

Page 89: ...tor Troubleshooting The HMIA has a very limited user interface The only function of the HMIA is to simulate the patient tempera ture probe connected to the T1 input port of the console This troublesho...

Page 90: ...button RST 9 Repeat step 5 above 10 If the resistance value is still wrong then disconnect the RS232 cable from the rear of the display head wait for 15 seconds and then reconnect 11 Wait for an addi...

Page 91: ...28 1977 84 2 29 1894 86 0 30 1815 87 8 31 1739 89 6 32 1667 91 4 33 1599 93 2 34 1533 95 0 35 1471 96 8 36 1412 98 6 37 1355 100 4 38 1301 102 2 39 1249 104 0 40 1200 105 8 41 1152 107 6 42 1107 109 4...

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Page 93: ...riority High priority alarms are indicated by red flashing text on the display and require prompt attention from the operator to prevent irreversible injury or death Medium pri ority alarms are indica...

Page 94: ...probe is disconnected Verify position of primary temperature probe Ensure that primary probe is plugged into socket T1 or if an inter connect cable is used the probe is plugged into the cable and the...

Page 95: ...tive Action DOWNLOAD ERROR PLEASE CHECK EXTERNAL COMPUTER Patient trend data download has failed or there is no com puter connected to the con sole Check the connection between the computer and the co...

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Page 97: ...s blinking and audible alarm beeps repeatedly Electrical power was momentarily interrupted Turn off power and wait 30 seconds Turn on the console and restart If problem persists discontinue use and co...

Page 98: ...s temperature Machine malfunction See above for correct machine function Use conven tional methods to rewarm the patient and discon tinue use of the console The patient does not stop cooling The acti...

Page 99: ...presentative for service of any alarm that does not clear Immediately discontinue using the console and seek advice from your ZOLL service representative if any of the following events occur The conso...

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Page 101: ...he operating life of its parts WARNING No user serviceable parts inside the console All console troubleshooting and repairs to be per formed by qualified service personnel Contact a ZOLL representativ...

Page 102: ...ct the area in and around the condenser Look for accumulations of dust and debris Roller pump Monthly Clean rollers and tubing path with cloth moistened with water Clean rollers and apply light lubric...

Page 103: ...e 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 console follow these steps in the indic...

Page 104: ...ent Required Tools and Materials You will need the drain line and connector assembly supplied with the console and a 2 liter waste container to perform this task Drain the coolant in an area where spi...

Page 105: ...r coolant will automatically begin to flow through the line 8 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 dra...

Page 106: ...and tested to be in compliance with the spillage protection requirements of IEC 60601 1 it is important to clean up spill age quickly 1 To ensure a safe work environment Spillage especially of coolant...

Page 107: ...casualty losses caused by man or by nature This warranty shall be void if repairs or attempted repairs have been performed on the console by any person not authorized by ZOLL to perform repairs The e...

Page 108: ...pital or medical practice The functional life of the console will be best extended if you properly maintain the console See Mainte nance on page 93 Do not attempt to service the cooling engine yoursel...

Page 109: ...iller and Heater Reservoir volume 2 0 liters 0 5 gal Pump capacity 7 lpm at pump head Temperature range 0 C 42 C Coolant 1 1 mixture of propylene glycol and distilled water Refrigerant RFC 134a Contro...

Page 110: ...standard YSI 400 Compatible YSI 400 Temperature probes Use with ZOLL temperature probe cables Compatible YSI 400 temperature probes C R Bard Foley Catheter BARDEX 8F C R Bard Foley Catheter BARDEX 12...

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