System 97e with CardioSyne™ Software Service ManualINTRODUCTION CONTENTS Chapter 1. Operation Theory of Operation . Specifications |. Repair Information - Schematics 5. Parts Calibration Preventive Maintenance SIAM RwD FOREWORD This Service Manual is intended as a guide for technically qualified personnel during repair and calibration procedures. The information has been divided into the eight chapters listed above. A detailed table of contents is provided on the first page of each chapter, ‘This publication may have been updated to reflect product design changes and/or manual improvements. Any such changes to this manual would be accomplished by supplying replacement pages and instructions for inserting or affixing them into the manual. NOTE Unauthorized servicing may void the remainder of the warranty. Check with the factory or with a local authorized Datascope representative to determine the warranty status of a particular instrument. WARNING ‘The System 97e operates on line voltages. Therefore, an electric shock hazard may exist when the instrument covers are removed. Repair and calibration procedures should only be performed by qualified personnel who proceed with care and follow proper servicing techniques. Warnings are given in Chapters 4 and 7, as well as in other appropriate locations. System 97e Service Manval IntcoduetionCopyright © Darascope Corp., 1994. Printed in U.S.A. All rights reserved. Contents of this publication may nor be reproduced in any form without permission of Datascope Corp. ‘System 97e Service Manual IntroductionOPERATION CONTENTS OF THIS CHAPTER pee cn : Page 1.1 Introduction cece LL 1.2 Controls and Indicators. 6.6... eves 12 1.3 Operation 1-19 1.1 INTRODUCTION ‘This section of the Service Manual provides general information about the instrument. Sections 1.2 and 1.3 are included as review of instrument functions and ‘operation, although the reader is encouraged to refer to the Operating Instructions, PIN 0070-00-0362, for more complete details. System 97e Service Manual Chapter 1, Operation TT1.2 CONTROLS AND INDICATORS This section of the Service Manual identifies and describes each feature and control of the System 97e. For step-by-step operating instructions see Section 1.3 "Operation." Refer to the section and page numbers listed below for the location and description of a specific feature, control, or display. ODD ‘Section Number —_|Page Number Description \Control/Display | [Number 120 13 [IABP Controls nl 122 1s {Monitor Concrols |= 21 1.23 18 Display Sereen 22-36 124 110 ‘Recorder / Front Panel 137-43 125 1:12 ‘Pump Console Controls 144-51 1.26 115) Rear Pane! [52-70 ] IABP Controls, 19, Zero (Pressure) __-Recorder/Front Rear Panel Panel 1, Trigger Select TAB Frequency 1aB Fill ‘Assise Standby IAB Deflation IAB Inflation Monitor Controls 8, Help Screen 9. Aug. Alarm 10. Ref. Line 11, Alarm Volume 12, Up & Down Arrows 13, Alarm Mute 14. Speed (Displ 15, Freeze (Display) 16, Trend (Display) TAB Augmentation 20. Seale (Pressure) 21. Verify (Pressuse) Display Screen 22. Alarm Messages 23. Advisory 24. Lead 25. ECG Size 26, Pressure Seale 27. TAB Status 28, Trigger 29, Heart Rate 30. Sysrolic 31. Diastolic 32. Mean 33. Aug 34. Aug Alarm 35. Timing (Mode) 36. Fill Mode 37.1ABP ON/OFF 38. Balloon Waveform 39, Arcerial Pressure 40.8CG 4. Trend 42. 08 45, Barcery Charging. Pump Console 44, Slow Gas Loss Alarm 45.1AB Fill Mode 46.Timing 47.ECG Gain 48, Pressure Threshold 49. ternal Rate 50. Balloon Pressure ‘Waveform 51. Beep Volume 52. IAB Catheter Excender Input 53, Trainer Input 54,DC Input (CRM) 55. ECG Input 56. Pressure Input 57. Mains ON/OFF 58, External DC Inpuc 59, Diagnostic Ourpur 60. RS-232 61, Phone Line 62, System Timer 63. Equipocenial Lug 64, Pressure (Monitor Inpur) 65. ECG (Monitor Inpuc) 66. ECG) Pressure Ourput 67. Manual Fill Port 17. Lead (ECG) ae 18, Size (ECG) 69, Aue Fil Por 70. Helium Pressure Gauge 12 System 97e Service Manual Chapter 1, Operation1.2.1 LABP CONTROLS Aa Figure 1-1 1ABP CONTROLS i 3 1, TRIGGER SELECT KEYS Five individual keys which ace illuminated when activated. They are used to select the one signal by which balloon pumping is triggered. Each of the five keys are described below. ECG: The System is triggering on the patient's R-wave. The ECG signal source can be from either patient electrodes or an external ECG signal. When an external signal is plugged into the rear panel external ECG INPUT jack, the external signal has priority for triggering and display. PRESSURE: The System triggers from the patient's arcerial pressure ‘waveform. The signal source can be either the pressure transducer or an external pressure signal. When an external signal is plugged into the rear panel external PRESSURE INPUT jack, the external signal has priority for riggering and display. The pressure transducer must be zeroed to pump in the pressure crigger mode. Also, when in the pressure trigger mode, the key can be pressed to manually initiate an instantaneous resynchronization. INTERNAL: The System triggers from the built in timer whose frequency is adjustable from 40 to 120 bpm using the UP and DOWN arrow keys located on the Auxiliary keypad. In the presence of a valid QRS complex, che System automatically deflates the IAB on each R-wave. The ECG detected message and a double beep tone are generated. In the presence of electro- surgical unit (ESU) interference, the System continues to pump from the internal timer. System 97e Service Marval 13 Chapter 1, OperationPACER A: The System triggers on the patient’s R-wave without interference from atrial pacer artifact. This mode is recommended only if atrial pacer tails interfere with R-wave detection when using the ECG trigger mode. Fixed or demand atrial pacing can be used in this trigger mode. PACER V/PACER A-V: The System automatically identifies and displays which of the two pacer types is present. The System triggers on the ventricular pulse in either case. The ECG signal source can be either patient electrodes or an external ECG signal. When an external signal is plugged into the rear panel (external ECG INPUT jack), the external signal has priority for triggering and display. Electro-surgical noise interference automatically suspends pumping. The IABP remains deflated until ESU noise interference stops. The pacer interval must be consistent (j.e., no demand acing). The patient must be 100% paced and caprured. IAB FREQUENCY A single key used to select the ratio of augmented cardiac cycles to actual cardiac cycles. Selections available are every beat assisted (1:1), every other beat assisted (1:2), or every third beat assisted (1:3). The selected IAB frequency is indicated by an illuminated indicator. When either 1:2 oF 1:3 is selected, both the assisted and unassisted systolic and diastolic pressures are displayed and may be printed. They are labeled accordingly. IAB AUGMENTATION UP and DOWN arrow keys used to adjust the time interval, from OFF to MAX, during which drive pressure is applied to the safety disk. This incer- val determines the gas volume displaced from the safety disk into the patient balloon. IAB FILL Press and hold for 3 seconds to initiate the IAB gas purge and fill cycle. Also used to perform the Safety Disk Leak Test by holding ie pressed and curning the power on simultaneously. ASSIST/STANDBY Press to initiate or suspend balloon pumping. The key is continuously illuminated in the Standby Mode and flashes during the inflation period in the Assist Mode. IAB DEFLATION Slide control which adjusts how long the balloon will remain inflated before deflation occurs. Deflation will occur according to this time interval or a rigger event, whichever occurs first. IAB INFLATION Slide control which adjusts the time relationship between the trigger event and the beginning of the IAB inflation. 14 System 97e Service Manval Chapter 1, OperationFigure 1-2 MONITOR CONTROLS 1.2.2. MONITOR CONTROLS 10. HELP SCREEN Press co activate the Help Screen area on the display. The LED within the HELP SCREEN key is illuminated. Set-up procedures, abbreviated alarm descriptions, and alarm resecting instructions are available in the Help Screens. Once the Help Screen is displayed use the Up and Down Arrow keys (12) to page through the screens available. The Up arrow displays the previous page and the down arrow displays the next page. Press HELP SCREEN again co recurn to the normal display AUG. ALARM The augmentation alarm limit is automatically sec 10mmHg below diastolic augmentation after 1 minute of pumping. Once activated use the Up & Down arrow keys (12) co set the alarm limit. Pressing the arrow keys increments or decrements the Aug. Alarm in steps of 2mmHg. The limit is set when the key is released. The limic range is OFF, 60 - 200mmHg. If i is set to OFF, the next depression of either the UP or DOWN arrow will re-initialize the setting to 10mm/Hg below the current augmented pressure. Adjustments can be made from that point using the UP and Down arrows. REF. LINE Press to activate che REF LINE. The LED on the REF LINE key illuminates when activated. Once activated use the Up & Down Arrow keys to adjust the reference line position. System 97e Service Manval v5 Chapter 1, OperationM. 12. 13. 4. 15. 16. 18, ALARM VOLUME Press to activate the volume control for the audible alarm, The LED on the ALARM VOLUME key illuminates when activated. Once activated use the Up & Down Arrow keys (12) to increase or decrease the alarm volume in 8 steps. The audible alarm volume cannot be turned off completely. UP & DOWN ARROWS ‘These keys are used in association with the AUG. ALARM, REF. LINE, HELP SCREEN, and ALARM VOLUME keys. The arrow keys are only active when one of the associated keys’ LED is illuminated. ALARM MUTE Press to temporarily disable an active audible alarm for 30 seconds. This control does not override the alarm. If an alarm condition is not corrected within 30 seconds, the audible alarm is enabled again. Alarm messages will remain displayed while the associated audible tone is temporarily disabled. The LED illuminates when ALARM MUTE is activated, and extinguishes when ALARM MUTE is deactivated. The Alarm Mute will deactivate if the alarm condition is corrected within the 30 seconds. In the event that a new alarm condition occurs the audible alarm will reactivate. SPEED (Display) Press to set the sweep speed of the moving traces at either 25mmisec or 50mm/sec. This key is disabled when the recorder is activated. FREEZE (Display) Press to freeze all traces on the display. Press again to unfreeze the traces. This key is disabled when the recorder is activated. When the traces are frozen and the recorder is activated, the freeze is overridden. The ECG size, pressure scale, and lead keys are disabled when in the freeze mode. TREND (Display) Press to display up to 8 hours of trend graphics. Press once to display trend information for heart rate. Press again to display trend information for blood pressure. Press a third time to return the display to real time patient monitoring. . LEAD (ECG) Press to select the desired ECG lead configuration. A 5-lead patient cable is used and the key sequentially selects configuration J, 11, II], AVR, AVL, AVE, and V. This key is disabled if the display is frozen or if an external ECG is connected. When an external ECG signal is connected, "EXTERNAL" is displayed on the screen. SIZE (ECG) Press to select the desired size of the ECG display. Available sizes, when in the fixed gain mode, are 0.5cm/mV, 1.0cm/mV, 2.0cm/mV and 3.0cm/mV. This key is disabled if the display is frozen or if an external monitor is connected. 16 System 97e Service Manual Chapter 1, Operation21 19. 20. ZERO (Pressure) Press and hold for 3 seconds to zero the pressure transducer. The zeroing function will accommodate pressure transducers with offsets of up to +£120mmHHg. The zeroing attempt will not be successful on transducers with 4 greater offset and the message "NO ZERO" will display. This key is disabled when the System is in the Assist Mode and pressure trigger is, selected, when a transducer is not connected, or when external pressure is connected. SCALE (Pressure) Press to select the desired size of the displayed pressure waveforms. Available scales are 10mmHg/cm, 20mmfig/cm, and 40mmHg/em. Wich the balloon pressure waveform the scale sizes are 20mmH g/cm, 40mmHg/cm, and 80mmHg/cm. This key is disabled if the display is frozen. VERIFY (Pressure) While in the Assist Mode, press and hold co view the period of diastolic augmentation. The highlighted portion marks the balloon inflation period. Diastolic augmentation is highlighted from this point to the end of inflation. ‘When the key is quickly pressed and released, the physiological pressure delay at the pressure monitoring site is recalculated, with respect to balloon inflation. The recalculation occurs in synchrony with the pump cycle. 5 fem 97e Service Manual 17 jpter 1, Operation1.2.3 DISPLAY SCREEN Seascape System 7 Figure 13 DISPLAY SCREEN 22. ALARM MESSAGES ‘The section of the screen used co display alarm messages. 23. ADVISORY The section of the screen used to display alert, status, and prompr messages. 24. LEAD Indicates selected lead configuration. Selections are I, II, IH, AVL, AVR, AVE, V, or EXTERNAL (if an external ECG is being used). In the event of a lead fault, the lead configuration is alternately displayed wich the message "LEAD FAULT". 25. ECG SIZE Indicates scale factor of ECG signal in cm/mV. Scale factors are .5, 1, 2, or 3. With the balloon pressure waveform the scale factors are halved (e.g, .25, 5, 1, 1.5). When using variable ECG gain "VAR x _"is displayed. The ECG signal gain can be varied over a range of 0.15 x ‘Normal Gain to 3.0 x Normal Gain. 26. PRESSURE SCALE Indicates scale factor of internal or external pressure (EXTERNAL is displayed) signal in mmHigicm. Scale factors are 10, 20, or 40 mmHg, ‘With the balloon pressure waveform the scale factors are 20mmHg/cm, 40mmHg/em, and 80mmHgicm. 27. IAB STATUS A segmented bar graph chat depices movement of the diaphragm within the safery disk as sensed by the System’s internal pressure transducers. No quantitative measurement is intended v8 ‘System 976 Service Manual Chapter 1, Operation28. TRIGGER Displays the selected trigger source for both [ABP synchronization and Heart Rate determination. When pressure trigger is selected, the pressure trigger threshold and threshold adjustment mode (Auto or Manual) will be displayed along with the trigger source. 29. HEART RATE Indicates the current averaged heart rate. NOTE: When the System 97¢ decects a heart rate below 15 bpm, "0" is displayed. When the heart rate falls berween 15 and 30 bpm, the display indicates the detected heart rate alternating with *0". Above 30 bpm the display indicates the correct heart rate, 30. SYSTOLIC Indicates peak systolic pressure in mmHg. Displays NO ZERO if transducer requires zeroing. Display is blank if a pressure transducer is not connected, or if external monitor is not connected. When 1:2 or 1:3 is selected as the IAB Frequency, both the assisted and unassisted systolic pressures are displayed. They are labeled accordingly. 31. DIASTOLIC Indicates end diastolic pressure in mmHg. Display is blank if the zero 7 process has not been performed, if a pressure transducer is not connected, or if external monitor is not connected. When 1:2 or 1:3 is selected as the IAB Frequency, both the assisted and unassisted diastolic pressures are displayed. They are labeled accordingly. 32, MEAN Indicates mean pressure in mmHg. Display is blank if the zero process has not been performed, if a pressure transducer is not connected, or if an external monitor is not connected. 33. AUG (Diastolic Augmentation) Indicates peak augmented diastolic pressure in mmHg. The display is blank when IABP is in STANDBY, if the zero process for the transducer has not been performed, if pressure transducer is not connected, or if an external monitor is noc connected. 34. AUG. ALARM Indicates diastolic augmentation alarm limit in mmHg. If the alarm is not enabled, OFF is displayed. 35. TIMING (MODE) Indicates the selected timing mode, Auto or Manual. 36. FILL MODE Indicates the selected fill mode, Auto or Manual. System 97e Service Manvel 19 Chopter 1, Operation1.2.4 RECORDER / FRONT PANEL CONTROLS 39° «4041 a ee ee a a ify 5 / f/ =| lage OFF fe ! Figure 1-4 RECORDER / FRONT PANEL CONTROLS 37. IABP ON/OFF This recessed switch controls internal power to the pump console and monitor module. Operation of this switch does not affect the status of the internal battery charger. The recorder keypad consists of five keys (four standard keys and the balloon waveform key). All of the keys, except OFF, contain an LED which illuminates when the key’s function is enabled. Single or dual trace recording of ECG, Arterial Pressure, and Balloon Waveform is available. Press one of these keys for single trace recording. Press any 2 of these keys consecutively (within 1.5 seconds) for dual trace recording 38. BALLOON WAVEFORM Press this key to print a balloon waveform continuously until OFF or another recorder function is selected. 39. ARTERIAL PRESSURE Press this key co print a delayed invasive pressure waveform continuously until OFF or another recorder function is selected. 710 System 97e Service Manual Chopier 1, Operation40. ECG Press this key to print a delayed ECG waveform continuously until OFF or another recorder function is selected. 41, TREND Press this key co print the trend pages. Heart race trend is printed first followed by blood pressure trend. If no trend informacion is available, then a"NO TREND DATA AVAILABLE" message is printed. Trend will print until all accumulated trend pages are printed unless OFF or one of the other recorder keys is selected. 42. OFF Press this key to deactivate the current recorder function. 43. BATTERY CHARGING Iluminates continuously while the internal batteries are being charged at alow rate. The LED flashes when the internal batteries are charging at a high rate. PRECAUTION: The internal batteries are charging only when the AC Mains switch is ON and the AC Mains cord is plugged into an active AC power wilty System 97e Service Manual Chapter 1, Operation1.2.5 PUMP CONSOLE CONTROLS 1.2.5.1 Override Controls. 44, SLOW GAS LOSS ALARM When the OVERRIDE key is pressed, the advisory message "Slow Gas Override On" is displayed and the SYSTEM 97e continues to operate in the ASSIST mode even when a small gas loss is detected. A status message is displayed but no audible alarm is sounded. The gas loss alarm will flash as long as the slow gas loss condition exists. ‘When the ON key is pressed, and a slow gas loss is detected, pumping Taras _ a) foawe | (ome }[cmanval | J will be suspended, a continuous alarm tone will sound, and che message "Leak in IAB Circuit" is displayed. NOTE: When in the Manual Fill Mode, the slow gas loss alarm keys are disabled. The override key's LED is illuminated when these are disabled. WARNING: Extreme caution should be used if the user elects to continue to pump Pp mea 0 48 ou l o =a Figure 15 PUMP CONSOLE CONTROLS when a leak exists in the LAB. This may result in unwanted conditions such as an entrapped balloon, which may require the IAB tc be removed from sbe patient surgically. System 97e Service Marval Chapter 1, Operation45. IAB FILL MODE These keys are used to select the IAB gas fill and purge mode. ‘When the AUTO key is pressed, the System 97e automatically purges/fills at 2 hour intervals or by activation of the IAB FILL key. AUTO is displayed next to Fill Mode on the monitor module display ‘When the Manual key is pressed, the System 97e must be purged and filled manually. MANUAL is displayed next to Fill Mode on the monitor module display. 46. TIMING ‘These keys are used co change the IAB Inflation/Deflation Timing Mode. ‘When the AUTO key is pressed, the System 97¢ automatically tracks changes in patient heart rate or rhythm and adjusts the inflation and deflation points accordingly. AUTO is displayed next to Timing on the monitor module display. ‘When the MANUAL key is pressed, the IAB inflation/deflation points are fixed, determined by the position of the inflation/deflacion controls. MANUAL is displayed next to Timing on the monitor module display. 1.2.5.2 Auxiliary Controls ‘The Auxiliary Control keys allow adjustment of the ECG Gain, Pressure Threshold, or Internal Rate, depending on the selected trigger source (see table below), The LEDs next to the keys, when illuminated, indicate which one of the three controls is active for adjustment. ea er ECG ECG Gain Pacer V/A-V | Pacer A Pressure Pressure Threshold Invernal Incernal Rate 47. ECGGAIN The ECG GAIN LED is illuminated when ECG, PACER V/A-V or PACER A is selected as the trigger source. When ECG GAIN is illuminated and the NORMAL key is pressed (the indicator within the NORMAL key is ON), 2 fixed gain (x1000) ECG signal is used for triggering the System 97e and the ECG SIZE control on the monitor module is enabled. When either of the VARIABLE keys are pressed, the ECG signal gain can be varied over a range of 0.15 x Normal Gain to 3.0 x Normal Gain. The displayed ECG is nor calibrated in this mode as indicated by VAR displayed in place of ECG SIZE. System 97e Service Manvel 13 Chapter 1, Operation48. 49, 1.2. 50. PRESSURE THRESHOLD The PRESSURE THRESHOLD LED is illuminated when PRESSURE is selected as the trigger source. When PRESSURE THRESHOLD is illuminated and the NORMAL key is pressed (the indicator within the NORMAL key is ON), the System will automatically select the optimal threshold value and adapt to changes in systolic pulse height. When either VARIABLE key is pressed, the blood pressure trigger threshold can be manually adjusted in fixed steps of | mmHg within a 7.0 to 30 mmHg, range. The current threshold and threshold adjustment mode (Auto or Manual) are displayed with the trigger source. The arterial waveform will also be annotated to indicate when the system triggered and what point it triggered on. NOTE: When manually adjusting Pressure Threshold, reassess the proper timing of balloon inflation and deflation and correct as required. INTERNAL RATE ‘The INTERNAL RATE LED is illuminated when INTERNAL is selected as the crigger. When INTERNAL RATE is illuminated and the NORMAL key is pressed (the indicator within the NORMAL key is ON) the internal trigger rate is set to 80 bpm. When either VARIABLE key is pressed, the internal trigger rate can be adjusted between 40 - 120 bpm. The VARIABLE keys permit adjustment of 5 bpm with each key depression. 5.3 Additional Pump Controls BALLOON PRESSURE WAVEFORM - ON/OFF This key coggles between ON and OFF. When the key is illuminated (ON) the monitor displays three traces (ECG, Arterial Blood Pressure, and Balloon Pressure). When the key is not illuminated (OFF) the monitor displays two traces (ECG and Arterial Blood Pressure) 51. BEEP VOLUME Press these keys to increase or decrease the volume of the trigger capture beeper. There are 8 volume levels. 14 ‘System 97e Service Manual Chapter 1, Operation1.2.6 REAR PANEL All signal input and signal output parts (52-56, 58-61, 64-66) are intended only for connection to specified equipment, complying with TEC-601 standard requirements and other safety standard requirements relevant co the installation location. 52. IAB CATHETER EXTENDER Used for connection of the IAB catheter. 53. TRAINER INPUT ‘A mini-jack provides the appropriate timing signal required to synchronize the Series 90 Trainer. 54. DC INPUT (CONDENSATE REMOVAL MODULE CONNECTION) This is a single cable connection, from the rear panel to the condensate ii removal! safety disk assembly. This cable Figure 1-6 provides power to the condensate removal REAR PANEL apparatus. 58. ECG INPUT A six-pin connector used for attaching patient cable connections. This connection is electrically isolated for patient safery. 56. PRESSURE INPUT ‘A six-pin male connector used for attaching Datascope specified physiologic pressure cransducers (see precautions listed on page ix). This connection is electrically isolated for patient safety System 97e Service Manual Chapter 1, Operation57. 58. 59. 60. 61. 62. 63. 65. MAINS ON/OFF ‘A fase holder, switch, and line cord receptacle used to apply and remove AC power to the System 97e. PRECAUTION: The batteries are charging only when the AC Mains switch is ON, the AC Mains cord is connected 40 an active AC power utility, and the battery charging status LED is illuminated. EXTERNAL DC INPUT (optional) A connector that supplies external DC voltage to power the System. DIAGNOSTIC OUTPUT Reserved for Datascope use only. RS-232 A 9-pin D-type connector provided for RS-232 serial data communication lines. PHONE LINE A standard RJ11 modular telephone jack for connecting the internal modem to a standard analog phone line. NOTE: This phone line should be directly connected to an external phone system and not a company/ hospital switching system. SYSTEM TIMER Displays elapsed system operating time in hours (used to determine preventive maintenance intervals). The elapsed time cannot be reset. (See Section 8.4 for Preventive Maintenance Schedule.) EQUIPOTENTIAL LUG ‘A connector used to equalize the potential between the System 97e and other hospital equipment PRESSURE (Monitor Input) A.1/4" phone jack which permits connection of the System 97e to an external monitor (1V/100mmHg sensitivity). When plugged in, che monitor displays and can be triggered from the externally supplied signal. "EXTERNAL" is displayed along with the pressure scale numerical value. See Section 1.3.20, "External Monitor Interfacing" for additional information. ECG (Monitor Input) ‘A.1/4" phone jack which permits the System to display and/or trigger from a 1V/mV ECG signal acquired from an external monitor. When plugged in, the monitor displays the external ECG and can be triggered from the externally supplied signal. "EXTERNAL" replaces the Lead Select indication on the display. See Section 1.3.20, "External Monitor Interfacing" for addicional information. 116 System 97e Service Manual CChopter 1, Operation67. 70. 66. 68. 69. ECG/PRESSURE OUT This 1/4" phone jack, (with ECG connected on the tip and blood pressure signal connected on the ring) provides patient signal information for external equipment. The oucput sensitivities are LV/mV and 1V/100mmHg respectively. MANUAL FILL PORT This fitting provides a means through which fill gas (helium) may be extracted when syringe tip is attached and the helium cylinder is open. This pneumatic port can also be used to pre-load non-standard balloon volumes such as pediatric IAB sizes. Used only for manual filling. DRAIN PORT This port used to automatically drain excess water (condensate) from the System. AUTO FILL PORT ‘The AUTO FILL PORT is used for filling balloons. This port is located on the safety disk, and can be used co manually fill or purge the IAB in the MANUAL FILL mode. HELIUM PRESSURE GAUGE Indicates the amount of gas pressure in the cylinder. System 97e Service Manval V7 Chapter 1, Operation1.2.7 SPECIAL FUNCTION KEYS During the power-up sequence of the System 97e, certain functions ot modes can be enabled by pressing assigned keys. The following cable describes these functions and the key required to enable that function. Press and hold che key while activating the power switch until the function or mode is enabled [Power-up Special Function Keys | Function \Key to press and hold [How to Exit i | while powering up I \(call out number) } [To Enter the Safety Disk |IAB FILL (6) [When the test is [teak Tee Icompleted the System | |will automatically enter | | che normal operating mode, "To Enter the System [TIMING - [From che Main Menu jConfiguration Mode to [MANUAL (46) press the Assist/Standby |set the time and date. [Rey ewice tonic his | |(Gee section 1.3.22 for | mode and enter the details on using this normal operating mode. Lmode. | TWhile in the System ‘TIMING - AUTO (46) From the Main Menu) \Configuration Mode to (Once the System press the Assist/Standby jenter the Extended Configuration mode has key twice to exit this | System Configuration _been entered, press this mode and enter the | Mode which is used to key twice .) normal operating mode. select date format, select | modem, display event | logs, display internal |statistics, display software revision, language selection and ‘select balloon waveform, [To restore System default |SIZE (ECG) (18) The System powers up in settings (See section the normal operating 11.3.2.12 for details.) mode with all default | jo ! settings restored. | "To Princ Software |OFE (Recorder)(42) The System powers up in| Revisions the normal operating | mode with the software revisions printed from e recorder. To enter Service ‘SLOW GAS LOSS ower OFF 1 Diagnostics ‘ALARM - OVERRIDE | (44) and IAB FILL - MANUAL (45) 1 Te System 97e Service Manual Chopier 1, Operation1.3 OPERATION CONTENTS OF THIS CHAPTER .. .. 13.1 Introduction : 1.3.2 Sequence for Establishing IABP 1.3.2.1 Establish AC Operation 1.3.2.2 Safery Disk Leak Test 1.3.2.3 Normal Power Up Procedure 1.3.24 Establish Fill Gas Pressure 1.3.2.5 BCG Acquisition : 1.3.2.6 Arterial Pressure Acquisition : . 1.3.2.7 Initial Set-Up of Controls for Balloon Pumping . 1.3.2.8 Selection of Trigger 1.3.2.9 Selection of IAB Frequency 1.3.2.10 Timing of Intra-Aortic Balloon 1.3.2.11 Preloading IAB 13.212 Initiation of Assist a 1.3.2.13 System Power-Up Defaults . 1.3.3 System Alarms, Alerts, and Stacus/Promprs 1.3.4 Water Condensation 1.3.5 Clinical Considerations During Operation 1.3.6 Use in Electrosurgical Environment 1.3.7 Use During Cardiopulmonary Bypass. 1.3.8 Weaning a Patient from IABP Support 1.3.9 Portable Operation 1.3.9.1 Battery Operation 1.3.9.2 Battery Charging 1.3.9.3 Switching from AC to Portable Operation 1.3.9.4 Portable Operation from Vehicle Invercer . 1.3.9.5 Portable Operation (Oprional External DC Source) 1.3.96 Effects of Alricude Changes During Air Transport 1.3.9.7 Portable Operation Emergency Battery Back Up Recommendations 1.3.9.8 Removing Pump Console from the Cart 10 Using the Recorder 1.3.11 Using Trend 1.5.12 Installation and Replacement of Helium Cylinder : 1.3.13 Installation/Removal of Safety Disk/Condensate Removal Module 1.3.14 Doppler Information 1.3.15 Connecting the Modem 1.3.16 Connecting PCIABP 13.17 Data Communication . : : 1.3.18 Wheels and Cascers 1-62 1.3.19 Help Screens : . 2 168 1.3.20 External Monitor Interfacing 1-83 1.3.21 Pediatric Balloon Pumping 1-84 1.3.22 User Configuration 191 System 97e Service Manval Chapter 1, Operation1.3 OPERATION CONTENTS OF THIS CHAPTER .. eo cee ss Page 1.3.1 Introduction... : : 1-20 113.2 Sequence for Establishing IABP... <5 1-20 1.3.2.1 Establish AC Operation : : e120 1.3.2.2 Safety Disk Leak Test. 21-20 1.3.2.3 Normal Power Up Procedure. 1-21 1.3.2.4 Establish Fill Gas Pressure . oe 1-21 13.25 ECG Acquisition... 2... : 1-22 1.3.2.6 Arterial Pressure Acquisition... we 1-22 1.3.2.7 Initial Set-Up of Controls for Balloon Pumping - 123 1.3.2.8 Selection of Trigger... « 1.24 1.3.2.9 Selection of IAB Frequency ee 1-28 1.3.2.10 Timing of Intra-Aortic Balloon 1.28 1.3.2.1] Preloading IAB 1,3.2.12 Initiation of Assist occas 1.3.2.13 System Power-Up Defaults 0... 0. os 135 1.3.3 System Alarms, Alerts, and Status/Prompts =. 136 1.3.4 Water Condensation 1-42 1.3.5 Clinial Considerations Dating Operation . 143 1.3.6 Use in Electrosurgical Environment sees 144 1.3.7 Use During Cardiopulmonary Bypass : - 145 1.3.8 Weaning a Patient from IABP Support oe 146 1.3.9 Portable Operation... 60... 5s 1.47 1.3.9.1 Battery Operation . : 147 1.3.9.2 Batcery Charging : 147 1.3.9.3 Switching from AC to Portable Operation : 1-48 1.3.9.4 Portable Operation from Vehicle Inverter 1-48 1.3.9.5 Portable Operation (Optional External DC Source) 1-49 1.3.9.6 Effects of Alticude Changes During Air Transport 1.49 1.3.9.7 Portable Operation Emergency Battery Back Up Recommendations 1-49 1.3.9.8 Removing Pump Console from the Cart : 1-50 1.3.10 Using the Recorder 1-52 1.3.11 Using Trend : 1-56 1.3.12 Installation and Replacement of Helium Cylinder 1-57 1.3.13 Installation/Removal of Safety Disk/Condensate Removal Module 1.58 1.3.14 Doppler Information 1-59 1.3.19 Connecting the Modem 1-60 1.3.16 Connecting PC.IABP . : 1-60 1.3.17 Data Communication = 1460 1.3.18 Wheels and Casters 1-62 1.3.19 Help Screens : 1-63 1.3.20 Excernal Monitor Interfacing 2 83 1.3.21 Pediatric Balloon Pumping. 1-84 1.3.22 User Configuration LoL System 97e Service Manual Chapter 1, Operation1.3.1, INTRODUCTION This section of the manual provides step-by-step instructions for properly operating the System 97e. The Numbers in parentheses identify the controls and indicators described in Section 1.2. GENERAL SAFETY PRECAUTION: Prior 10 operating the equipment, the user must be familiar with she controls and functions af the System (refer to Section 1.2) and have a thorough knowledge of intra-aortic balloon pumping. 1.3.2. Sequence for Establishing IABP ‘NOTE: See Section 1.3.12 for Helium cylinder installation. See Section 1.3.13 for safety disk installation. 1.3.2.1 Establish AC Operation NOTE: Remove IAB or any plug ftom patient balloon connector. Visually inspect the safery disk fittings for operating soundness. 1. Attach the line cord securely into the MAINS power receptacle (57) on the pump console, 2. Plug the System line cord into a voltage- compatible grounded, 3-prong AC receptacle marked “Hospital Grade." Do not use an adapter to eliminate U-ground. NOTE: If auxiliary equipment is used with the System 97e, insure that the equipment is also properly grounded. 3. Set che MAINS ON/OFF switch (57) to the "ON" position. 4, Check that the BATTERY CHARGING indicator (43) is illuminated or flashing. NOTE: If a Safety Disk Test is desired continue with Step 1.3.2.2, otherwise proceed to Step 1.3.2.3. 1.3.2.2 Safety Disk Leak Test 1. Press and hold the IAB FILL key (4) while switching [ABP ON/OFF (37) to ON. Release the IAB FILL key when the message "SAFETY DISK LEAK TEST” appears adjacent to the ADVISORY (23) on the screen. NOTE: If the IAB Catheter Extender Input (52) is noc vented to air at the start of the Safety Disk Leak Test, a double beep alarm tone will sound and the message "UNPLUG OUTLET" will be displayed. After approximately 10 seconds a tone sounds and the message "PLUG OUTLET” is displayed in the ADVISORY section (23) on the screen, 2. Plug the IAB Catheter Extender Input (52) on the safety disk with a dead end Luer plug. 1-20 System 97e Service Manvel Chapter 1, Operation3. A-double beep will sound at the end of the safety disk test. If the System passes the test, the message "SYSTEM TEST OK" is displayed adjacent to ADVISORY (23) on the screen. NOTE: If the message on the display is "SAFETY DISK TEST FAILS," inspect all pneumatic connections and Luer locks. Switch the [ABP ON/OFF to the OFF position and repeat from Step °1". If in doubt about the integrity of the safety disk, replace ic. See Section 1.3.13, "Installation of the Safety Disk". If the safety disk has been replaced and no leak is evident, but the screen still flashes "SAFETY DISK TEST FAILS," the [AB AUTO FILL System may be malfunccioning and the manual fill procedure should be performed until a Service Representative can be contacted. WARNING: Use only the safety disk/CRM (PIN’s 0997-00-0344/0997-00-0380) thas is designed 10 be used with the System 97¢, Do not use a System 95 disk. WARNING: Do nor perform this procedure when the System 970 is connected 10 the patient. 1.3.2.3 Normal Power Up Procedure 1. If the System 97e is not already on, press the IABP ON/OFF switch (37) to ON. ‘The System performs an electrical and pneumatic self test. When the self- check is successful the ‘SYSTEM TEST 0.K." message appears. In the event that any electrical or pneumatic test fails, the message "ELECTRICAL TEST FAILS CODE #___" displays on the screen. The code number indicates which test has failed in the System. Power cycle the System (power down for a minimum of 10 seconds) and if message repeats, record code # and call Datascope Service Representative. See Section 4, Troubleshooting Procedure in the Operating Instructions for probable cause and recommended action, 1.3.2.4 Establish Fill Gas Pressure 1. Slowly open che Helium cylinder valve fully counter-clockwise. 2. Make sure thar the helium pressure gauge (70) shows chat the helium supply is in the operating range (within the white area). NOTE: When the System is not in use, close the cylinder valve fully clock- wise to prevent a potential leak and the depletion of the helium supply. 3. Check that the message "LOW HELIUM" is not displayed. If the "LOW HELIUM" message is displayed, check helium cylinder gauge for adequate ‘gas capacity and check helium cylinder attachment for leaks. Replace the cylinder if necessary. System 97e Service Manval Chapter 1, Operation raFigure 1-7 Blectrode Placement 1.3.2.5 ECG Acquisition The patient ECG signal is acquired with a patient cable and skin electrodes. ‘The type of skin electrode and technique of applying the electrodes are major factors in determining the quality of the signal chloride electrodes. These are designed co IN acquire an ECG with excellent baseline stability, recovery from @ | defibrillation, and minimum artifact from patient movement. obtained. Use high quality, silver-silver | 1. Attach electrodes to the patient as shown. 2. Plug patient cable into the rear panel ECG INPUT (55) connector. 3. Check that an ECG waveform is now present on the System screen and chat the heart rate read-out is now functional 4, Select desired lead setting by pressing the monitor module LEAD key (17). 5. Select desired ECG size by pressing the monitor module SIZE key (18). PRECAUTION: Conductive parts of electrodes and associated connectors for ‘applied parts, including the neutral electrode, should not contact other conductive parts including earth. 1.3.2.6 Arterial Pressure Acquisition 1. Plug the pressure transducer into the rear panel PRESSURE INPUT connector (56). 2. To establish a monitoring site, utilize che central lumen of the intra-aortic balloon or introduce an arterial pressure catheter into the patient's radial artery in accordance with standard hospital procedures. "Best practice," as determined by the medical community, should be observed. Connect catheter line with a flushing device co the pressure transducer. 4, Zero pressure transducer as follows: Initially, the message "NO ZERO" is displayed in place of the systolic reading, indicating the need to zero the transducer. a. Open transducer vent to atmosphere. 12 ‘System 97e Service Manual Chapler 1, Operationb, Press ZERO (19) and hold for a minimum of three seconds. Two audible clicks will sound and che aucomatic zero process is implemented All of the numerical pressure values ac the right side of the display will show 0 #2mmHg when zeroing is successful. NOTE: If the transducer offset exceeds #120mmHg, it will not be possible to automatically zero the transducer. A "NO ZERO" message indicates this is 2 fault condition. If this occurs, the transducer should be considered incompatible or defective and should not be used. 5. Close pressure transducer vent co atmosphere and check that the pressure waveform is displayed on the System screen and SYSTOLIC/DIASTOLIC and MEAN digital displays are functional ac this time. 6. Select desired pressure scale size by pressing SCALE (20). (A pressure scale of 20mmHg/cm is the default secting.) 7. To measure any point on the pressure waveform press REF. LINE (11) co activate the reference line. Once activated, use the Up & Down Arrow keys (10) to move the reference line. ‘The numerical value of che pressure corresponding co reference trace position is shown at extreme left side of the reference trace (when the monitor is initially turned on the reference trace is at OmmHg). (NOTE: If changing the SCALE causes the reference trace to go off scale, activate the REF. LINE (11) and press either the Up or Down Arrow key (10) to reset the reference trace to zero.) 8. Flush arcerial line ar regular intervals per standard hospital procedure. 1.3.2.7 Initial Set Up of Controls for Balloon Pumping 1. Verify che monitor module controls are set as follows: Contra} Setting IAB FREQUENCY @ Ll IAB AUGMENTATION (3) OFF IAB INFLATION ” Midpoine IAB DEFLATION © Midpoine 2. Verify che pump console controls are set as follows: Control Setting SLOW GAS LOSS ALARM (44) ON IAB FILL MODE 45) AUTO TIMING (46) AUTO ECG GAIN 4) NORMAL PRESSURE THRESHOLD (48) NORMAL 3. Actach IAB catheter, with the appropriate extender to the safety disk now. System 97e Service Manual Chapter 1, Operation 1231.3.2.8 Selection of Trigger Both the patient's ECG and arterial pressure waveform should be visible on the monitor. ECG triggering is always recommended as the primary trigger mode. Triggering is evidenced by a flashing diamond at each trigger event. * ECG 1. Press the ECG TRIGGER SELECT key (1). The System recognizes 2 120uV (minimum) QRS as a trigger event. This is indicated by a flashing diamond in the upper right corner of the screen. (The signal may be derived from either ECG electrodes or ftom a compatible external monitor whose gain is 1V/mV and bandwidch is 0.5-100 Hz of diagnostic quality.) Pacemaker pulses are rejected in this mode. NOTE: For the best pacer rejection performance, the use of the auto timing mode is recommended. In this mode the minimum QRS threshold of 120uV ‘will be increased automatically if a pacer spike is present to avoid detection of pacer artifact. If artifact is not problematic but greater sensitivity is needed to detect very small R-waves while pacing, the manual timing mode can be used or the ECG GAIN control can be adjusted to increase ECG signal.* 2. If triggering from an excernal monitor is desired (see note), a supplied cable, P/N 0012-00-0323, may be wired for compatibility with the external monitor circuit and plugged into the ECG MONITOR INPUT (65) jack. An external monitor signal overrides the patient ECG if connected. NOTE: See section 1.3.20, External Monitor Interfacing, for additional information. "When an extremely low or bigh level ECG signal is encountered, the signal strength can be altered by wsing the ECG GAIN (47) key. When the NORMAL hey is deactinaced, the VARIABLE arrow heys can vary the ECG gain from 0.15 x Normal Gain to 3.0 x Normal Gain. The 3.0 x Normal Gain improves the rnstivity of the sriggr fom: ts normal value of 120xV 10 ~40,V.. ‘Make sure the ORS desesion operates propery by observing the flashing diamond and the HEART RATE display. © Pacemaker Triggers 1. PACER A: Press the "PACER A" trigger select key to trigger on the patient's QRS without interference from atrial pacer artifact. This mode is recommended only if atrial pacer tails interfere wich R-wave detection when using the "ECG" trigger mode. Fixed or demand atrial pacing can be used in this trigger mode. 2. PACER V/A-V: Press the "PACER V/A-V" trigger select key when ECG trigger is unobtainable in the presence of a ventricular or atrial-ventricular sequential pacemaker. In this mode, the System automatically identifies and displays the appropriate pacer type. The System triggers on che ventricular pulse for either type of pacer provided there is 100% paced thythm (i.e. no demand pacing). If the conditions for either pacer type are ‘ot met, @ trigger alarm occurs and the message "CHECK PACER TIMING’ is displayed. 1. PACER V: The System recognizes the presence of a ventricular pacer provided the ventricular pacing interval is fixed and the rate is less than 185 bpm. 1-24 System 97e Service Manual Chapter 1, Operation2. PACER A-V: The System recognizes the presence of an atrial-ventricular sequential pacer provided the A-V interval is between 80 - 224 msec. and che rate is less chan 125 bpm. NOTE 1: Ifa vencricular pacer is used, be sure an enhanced ventricular pacer tite te pulse is observed on each cardiac cycle. a ‘Two enhanced pacer pulses must be observed when using an atrial-vencricular sequential pacer. If this is noc the case, select a different ECG Lead until reliable detection is achieved. NOTE 2: Pacer V/A-V trigger will not function in che presence of ESU Interference. Pumping will be suspended | som soe temporarily and will resume automatically | “Sj /" 17 when interference disappears. The AIC "TRIGGER INTERFERENCE" status message is displayed when ESU interference 2 is detected in the pacer trigger modes, ALY Incerval © Pressure Trigger 1. Press the PRESSURE TRIGGER SELECT key (1). In the PRESSURE trigger mode the System 97¢ will use the arterial blood pressure waveform as its trigger source. This signal may be obtained either by direct connection to a physiological pressure transducer or indirectly from a compatible external physiological monitor that provides a 1V/100mmHg. ourput at a minimum bandwidth of D.C. to 15 Hz. If triggering from a compatible external monitor is desired, the supplied cable, PIN 0012-00-0323, may be wired for compatibility with the external monitor and plugged into the PRESSURE MONITOR INPUT (64) jack. NOTE: An external monitor signal overrides the patient pressure transducer if connected. See section 1.3.20, "External Monitor Interfacing” for additional information. In the PRESSURE trigger mode the System 97e will identify and trigger on the upstroke of the systolic pressure pulse. This upstroke is identified as a positive upturn in arterial pressure; exceeding the current amplitude threshold level and rising at a rate consistent with systolic ejection. The trigger level is indicated by a horizontal "tick" mark beside the arterial waveform. The System 97e automatically optimizes and adapts the threshold level ro changes, in the systolic pulse height. The threshold is also manually adjustable for greater triggering flexibility. A fixed threshold level from 7 to 30 mmHg can bbe manually selected in 1 mmHg steps (see Auxiliary Controls, section 1.2.5.2) ‘The chreshold level and mode, manual or automatic, are posted just below the "PRESSURE" trigger mode indication in the "TRIGGER" source display field in the upper right corner of the screen, WARNING: Readjust or re-evaluate inflation and deflation timing after each manual pressure trigger threshold change. Figure 1-8 Pacer V Figure 1-9 Pacer A-V System 970 Service Manual Chapter 1, Operation 1-25Figure 1-10 Suspended Pumping Waveform ‘The System 97e is designed to trigger on the upstroke of systole and ignore rises in arterial pressure attributed to the augmenting action of the IAB. This protective refractory mechanism is very useful in blocking erroneous diastolic trigger events bur consequently can mask very premature pulses associated with instantaneous rises in rate. The System 97e has the means of detecting and adapting to rises in rate, but extreme changes, such as rate doubling, can result in every other systole remaining "invisible" co detection. Alternate beat triggering is apparenc when the displayed heart rate is half the patients actual rate. This condition is rare, but if observed can be immediately corrected by pressing or tapping the PRESSURE trigger key. This will suspend pumping for a single beat and restore proper trigger detection. If no user action is taken, proper triggering will still be restored at che 6O second ausomatic synchronization check point. See details in the following paragraph. ‘An imporcant fail-safe feature of the System 97e is the pressure trigger 60 second periodic synchronization check. Every minute, when in 1:1 assist mode, pumping is suspended for a single bear. (See figure 1-10 below.) This permits the patient's natural systolic pulse and interval parameters, unaltered by the action of the IAB, to be checked. This check periodically ensures that the refractory and IAB timing intervals are being properly determined and if necessary, corrects these intervals. ‘This aucomatic synchronization check can also be user initiated at any time by momentarily pressing the PRESSURE trigger key (LED illuminated). This provides che capability to immediacely resynchronize triggering and timing in the rare event that a loss of synchronization is observed. When a synchronization check is initiated by pressing the PRESSURE trigger key, the clock on the 60 second periodic synchronization is reset to 60 seconds. Suspended pumeing is indicated by the — unintensie porton of the cisplayed wavetorm ‘The Syscem 97e will automatically adapt to sustained random dysthythmias, such as atrial fibrillation. Such rhythms lack a predictable pattern and will produce early systolic ejections that can unavoidably overlap with balloon deflation, impairing stable and consistent systolic pulse detection. The System 97e automatically detects such thythms and minimizes the probability of overlap by utilizing statistical heart rate data in its deflation timing determinations. Deflation is anticipated based on the fastest "global" rate recently observed rather than the current "local" instantaneous rate. ‘When this special timing mode is adopted, an "IRREGULAR TRIGGER" message is posted in the Advisory display field (upper left corner of the screen) and an alere cone is briefly activated. This message indicates to users that the System is compensating for an irregular rhythm by deflating somewhat earlier to avoid interfering with systolic ejection. Consequently, users should NOT attempt to adjust the deflation slider if the patient is dysthythmic and the "Irregular Trigger" advisory message is posted. Adjustments to deflation timing could compromise trigger performance when the patient finally resumes a regular thythm and che System automatically reverts back to standard timing mode. 1-26 System 97e Service Manual Chapier 1, OperationNOTE: When pressure trigger is being used, balloon deflation should always be adjusted ro occur and complete prior to the upstroke of systole. Late deflation timing causes a reduction in and delay in detection of systolic pulse pressure. The System relies on a prominent and timely systolic upstroke for consistent, reliable pressure triggering. Any overlap of balloon deflation and systolic ejection, while in he pressure tigger mode, could cause riggers tobe late or mised porentaly resulting in loss of synchronization. PRECAUTION: Prasure triggering is NOT recommended for use when sustained irregular cardiac rhythms or tachyarrhythmias are present. Remember to adjust deflation early enough 50 that deflation is completed prior to systole and be sure to provide continuous observation while triggering in this mode. © Internal Trigger 1. Press the INTERNAL key. For asynchronous balloon pumping, the IABP may be triggered from an internal signal generator. The rate can be adjusted from 40 to 120 bpm, in increments of 5 bpm, by pressing the variable keys of the INTERNAL RATE (49) auxiliary keys. The System will display "INTERNAL" in the upper right corner of the screen When Internal Trigger is selected, the System continues to monitor for R-wave activity via the ECG patient cable. If valid R-wave activity is detected, then the System sounds a double alarm beep for every R-wave detected and che trigger alarm indicator is illuminated with a message "ECG DETECTED." The System deflates the IAB immediately after an R-wave detection co prevent competitively pumping with che patient. If reliable R-wave activity has resumed then the System should be switched back to che ECG Trigger mode for proper timing. WARNING: Never leave she System set in the Internal Trigger Mode if the patient is generating a cardiac output. System 97e Service Manual Chapter 1, Operation 7Figue 1-110 Display Showing Assisted ‘ond Unassisted Pressure Figure 1-11b Detail of Waveform Showing Assisted ond Unassisted Pressure 1.3.2.9 Selection of IAB Frequency ‘The selection of IAB Frequency determines the amount of heart beats that are assisted by the LAB. The selections are: 1:1, every beat is assisted; 1:2, one out of ‘two beats are assisted; or 1:3, one out of three beats are assisted. Press the IAB Frequency Select key (2) to make selection. ‘When either 1:2 or 1:3 is selected, che System 97e will display the assisted and unassisted systolic and diastolic pressures. If the recorder is activated during 1:2 or 1:3 frequency, the assisted and unassisted systolic and diastolic pressure will be printed as trailing information on the strip. Below are samples of the display indicating the assisted and unassisted pressures. See section 1.3.10 for samples of the recorder printouts indicating the assisted and unassisted pressures. rat Soi Samo Pe ‘Augmented Unassistes Diastolic Pressure Systolic Pressure. Astistes / Systolic Pressure XN Assisted End Diastolic Pressure Unassisted End Diastolic Pressure 1.3.2.10 Timing of Intra-Aortic Balloon Automatic Timing Mode In this mode the System 97e is designed co examine cardiac interval patterns, on a beat by beat basis, and anticipate IAB timing. The System will auromatically adjust the inflation and deflation timing of the IAB to crack changes in rhychm and heart rate. The user must establish initial inflation and deflation timing points for each patient. Thereafter, che System will adjust timing automatically to accommodate changes in the patient's rate and rhythm. To use the Automatic Timing Mode: 1-28 System 97 Service Manval Chapter 1, Operation1, Ensure that "AUTO! is displayed on the screen, Establish initial timing as described in the "Initial Timing Adjustments” section below. Using unique ECG deflation timing logic, the System 97e provides consistent tracking under the demands of ectopics (isolated PVCs, couplers, bigeminy, trigeminy) and abrupt changes in heart rates. When either individual or paired ‘ectopic beats are identified, the System 97e invokes pattern specific timing rules to precisely track the compensatory pause to follow. Pattern specific timing rules are also applied when the onset of a substantial change in rate is detected Sustained random dysthythmias, such as attial fibrillation, lack a well defined pattern. When managing such cases in the ECG trigger mode, consistency of IAB deflacion can be maximized by moving the deflation slider to ies extreme right side stop, labeled "R-Wave Deflate’. This setting will hold the IAB inflated during the entire diastolic period. Since the start of IAB deflation is delayed until the next R-wave trigger is detected, this setting may not be appropriate in all patient conditions. Increases in systolic pressure should be monitored and avoided, Manval Timing Mode ‘A manual timing mode is provided to permit an expansion of the timing range available from the pump. In the manual mode, the operator sets fixed inflation and deflation points as 2 function of time relative to the trigger point. To use manual timing mode: 1. Press the MANUAL TIMING key (46) and check that "MANUAL" is displayed on the screen. Establish initial timing as described in the "Initial Timing Adjustments" section below. ‘The numbers under the INFLATE and DEFLATE controls ate used as guides ‘when secting the manual timing. On the inflace control scale "0" represents inflation at che trigger event with each increment representing a 125 msec delay. On the deflate control scale "0" represents deflation immediately after inflation with each increment representing a 125 msec delay. NOTE: If the inflation point is adjusted, the deflation point will also be adjusted proportionally WARNING: If the heart rate varies by more shan 10 bpm, readjustment of timing may be required. Initial Timing Adjustments - Use of the Intensified Inflation Marker ‘While in the Standby mode, an intensified inflation marker is provided to aide in initial timing adjustment. 1. Use the INFLATION (7) slide control to move the intensified segment of the arterial pressure trace so that it begins at the dictrocic notch. Adjust the DEFLATION (6) slide control so thar the intensified segment ends slightly before the up slope of the arterial pressure waveform, Dict Notch v Intensified Portion Figure 1-12 Intensified Inflation Marker Spm 97e Servos Manual Chapter 1, Operation 1-291.3.2.11 Preloading IAB A. Auto Filing Mode 1. Check that the IAB FILL MODE key (45) is set to the "AUTO" position. 2. Check that the helium tank valve has been opened. Check helium gauge (70) for supply level. Gauge should indicate normal supply level (within the white area). 3. Check that the message "LOW HELIUM" is nor flashing on the screen. If message displays, replace the helium rank. 4. Connect the IAB and extender to the safety disk. NOTE: Incorrect combination can result in an autofill failure. 5. Press and hold the "IAB FILL" key (4) for 1 second. The IAB will evacuate and then the safety disk will pre-load with the appropriate amount of helium. ‘The System will fill the safety disk twice upon an initial fill cycle. 6. Inthe AUTO mode the System will automatically purge and fill the IAB every ‘two hours or if local atmospheric pressure decreases or increases by 25 or 50 mmHg respectively, as occurs during air transport. These pressure changes will initiate auco fills approximately every 1,000 feet of rise or 2,000 feet of drop in altitude to keep the balloon pressure acclimated to local conditions. A fill cycle can be initiated at any time by pressing the LAB FILL key (4), which automatically resets the 2 hour timer. NOTE: The refill cycle time is typically 6 seconds. NOTE: If the auto filling procedure fails to pre-load the safety disk properly, the message "AUTO FILL FAILURE" will be displayed and an audible alarm activated. Repeat procedure, if fails again use manual fill procedure. Refer to Chapter 4, Troubleshooting Procedure in the Operating Instructions. NOTE: When in the Assist Mode the System 97 will auromatically purge and fill the IAB every two hours. If the System is placed in the Standby Mode and the 2 hour time out occurs, the message "AUTO FILL REQUIRED" will be displayed to notify the user co auto fill when pumping is resumed. System 97e Service Manual CChopter 1, OperationB. Manual Fill Mode WARNING: Gas loss and IAB catheter alarms are disabled while in the Manual Fill Mode, (The Slow Gas Loss override key is illuminated.) NOTE: When in the Manual Fill Mode, the condensate removal module system | will not operate | 1. Select the IAB FILL MODE by pressing the MANUAL key (45). 2. Remove the autofill cubing from the IAB Fill Port on the safety disk. 3. Atcach a three way stopcock o the IAB Fill Port (69) on the safety disk. 4. Arcach a plastic 60cc syringe to the stopcock. Figure 1-13 Press Manual Key Figure 1-14 Remove Autofil Tubing Figure 1-15, Aaoch3-way Stopcock Figure 1-16 ‘Attach Syringe Spm 970 Seviee Marvel ‘Chapter 1, Operation 131Fagute 1-17 Press IAB Fl Key Figure 1-18 Open and Close Stopcock Figure 1-19 Pull Back on the Plunger to Erauate the Syringe Figure 1-20 Attach Syringe to ‘Manual Fill Port 5. Press the IAB FILL key (4) for 1 second to relieve vacuum. Verify "MANUAL FILL" is displayed in the status area, NOTE: All Datascope adult size IAB catheters have 2 manual fill pre-load of 80cc. When using catheters from another manufacturer consult that manufacturer for guidelines. 6. Open the stopcock between the disk and syringe. Evacuate the disk by pulling back on the syringe plunger. 7. Close the stopcock to the disk. Evacuate the syringe. 8. Repeat steps 6 and 7 until a strong resistance is noted. A strong resistance should be noted within three attempts. If a strong resistance is (OPENED ‘CLOSED noted, proceed to step 10. 9. Ifa scrong resistance is not noted within three attempts, remove the Drain port tubing and attach the Drain port plug, located in the manual fill accessory kit, to the Drain port. Repeat steps 6 - 8. 10. Attach the syringe to the Manual Fill Port (53) located on the rear panel WARNING: Extreme care should be taken during this process. Never use a glass | syringe for this procedure. Hold hand over | the syringe plunger. 11. Fill che syringe and discard the | contents i 12, Fill che syringe with 40cc’s of helium. OH WU 732 ‘System 97e Service Manual Chapter 1, Operation13. 14 15. 16. 7. 18. 19. 20. Holding the syringe tip DOWN, attach the syringe to the stopcock on the safety disk, and open the stopcock to the disk. Press the IAB FILL key (4) for one second to allow the syringe contents to be drawn into the disk. Verify "LEAK ALARM DISABLED" is displayed in the status area. Close the stopcock to the disk. Refill the syringe with the remaining 40cc pre-load of helium from the Manual Fill Pore (53) Holding the syringe tip down, attach the syringe to the stopcock on the safecy disk. Open the stopcock to the safety disk. The remaining 40 ce’s of gas will be drawn into the disk Close the stopcock and remove the syringe PRECAUTION: If the consents of she syringe are not drawn into the safety disk DONOT resume balloon pumping. Return 10 step 6 in the Manual Fill Procedurepaying careful «attentionto syringe fll volume If second attempt fails, there most Tikely isa leak at one of she safety disk ports or stopcock and they should be checked, Press the ASSIST/STANDBY key (5) to begin pumping, Figure 1-21 ‘toch Syringe to Stopcock Figure 1-22 Press the IAB Fil Key Figure 1-23 Syringe Contents Drown into Disk Figure 1-24 Press ASSIST/STANDBY key qd System ‘97e Service Manual sapter 1, Operation 1-331.3.2.12 Initiation of Assist 1. Check chat the IAB AUGMENTATION (3) level is in the minimum setting prior to initiating assist. 2. To initiate assist, press the ASSIST/STANDBY (5) key. The indicator within the key begins to flash for each inflacion NOTE: A shore full inflation cycle is initiated to facilitate pressure delay measurements for the first initiation of assist only. 3. Use the up arrow key associated with IAB augmentation (3) to increase this level to its maximum setting. NOTE: Observe proper augmentation on the screen, 4, If necessary, adjust the IAB INFLATION (7) and IAB DEFLATION (6) control to achieve proper timing 5. Verify that the Aug. Alarm setting is approximately 1OmmHg below the patient's diastolic augmentation pressure. 6. If needed, adjust by pressing AUG. ALARM (9) and using the UP & DOWN arrow keys (10) to change the value displayed on the screen. NOTE: The AUG. Alarm limit is automatically set 10 mmHg below the augmented diastolic pressure, one minute after the start of assist. During this time the AUG. alarm limit can increase to a maximum of 200mmHg, However, the limit will not decrease more than SmmHg below the initial setting. Manual changes can be made to the automatic setting. NOTE: The Low Augmentation Alarm, when used properly, serves as an important backup to internal monitoring alarms. Due to the dynamic nature of the shuttle gas system, Gas Loss and IAB Catheter alarms do not operate under all patient conditions (see Section 1.3.3 for more details). By setting the Low Augmentation Alarm, the system monitors the level of assist and alerts the user in the event of a decrease in augmentation pressure. ‘When MANUAL pre-loading is employed, the use of the Low Augmentation Alarm is essential in intra-aortic balloon patient care. WARNING: Do not leave the patient unattended during LABP procedure. 34 ‘System_97e Service Manual Chapter 1, Operation1.3.2.13 System Power-Up Defaults ‘The power-up settings depend on the amount of time the System has been pow- ered down, The System recognizes when it has been powered down for less than 15 minutes. ‘When the power is restored within the 15 minute period, the System restores the user sectings (with exceptions as noted in the table below) and trend. A double auro fill is required before pumping. ‘When the System is powered down for longer than 15 minutes the factory default setting are restored. At this point when the System is powered on, the user settings and the trend are cleared. To change the settings to their defaults prior to che 15 minutes, press the ECG SIZE key (18) while powering on the System. The following table lists all of the controls and their defaule settings. Default settings are programmed at Darascope and cannot be changed, [conrrois [perautrs Trigger Selece ECG. IAB Frequency aa ‘AsssStandby Mode Standby (oe filled)™ | [1aB Fill Secus [Nor Filled (a doubie auto ili required)® | [IAB Augmencaion OFF | [TAB Iaflaion| Manually Sec Ne Defaule [IAB Deflation [Manually Set = No Defaule [ECG Lead i 1 [ECG Size Lea i | Pressure Seale OmmHgiem (2 eaves) dOmmFigiem (3 aces) | Presuve Ze ot Zeoed i [Aerial Pressure Delay [APD Firs: Pump* | Trend [Cleared (noe displayed) Freese [Not Frozen™ Speed 25 mmisee Help Srcen [Orr ‘Refine (@ 0 mmbige Alarm Mace ot Mured® [Alarm Volume Mid-Level aug Alarm lore RECORDER CONTROLS [DEFAULTS Recorder Mode Ltnacciver | AUXIUARY CONTROLS ierauuTs ECG Gain {Nocmal [Pressure Tareshold {Normal Toeroal Trigaee [Normal (Fixed 60 BPM) __] OVERRIDE CONTROLS |perauirs eee |Slow Gat Lose Alarm on Timing [Avro ftas Eat ‘AUTO, J * These stems always return to ther default setting System 97e Service Manval Chapler 1, Operation 1-35MISCELLANEOUS CONTROLS | [Beep Volume [As Lase See (italy Se to Mid-level ac Daascope) Balloon Pressure Waveform [As Las Se (Initially Sec ro ON at Darascope) 736 System 97e Service Manval Chapter 1, Operation1.3.3 SYSTEM ALARMS, ALERTS, and STATUS/ PROMPTS There are various types of condition-specific messages. They are: ALARMS, ALERTS, STATUS/PROMPTS and AUX (auxiliary). These messages are displayed based on the priority of the condition that prompted them. ‘When an ALARM message is displayed, IAB pumping is suspended and a steady tone is sounded. When ALERT messages are displayed, IAB pumping is not suspended, bue corrective action is required. ALERT conditions which require immediate action cause a continuous double beep tone to sound. All ocher ALERT conditions sound a double beep cone that repeat for 30 seconds, STATUS/PROMPT messages do not sound any tones (except for "Unplug Outlet and Plug Outlet") and are advisory in nacure. AUX messages display when Secup or Help screens are available. ALARM messages are displayed in the ALARM MESSAGES (22) section of the display. There is one alarm message line. If more than one alarm condition occurs simultaneously, the highest priority alarm is displayed. When the first alarm condition has been corrected, then the next highest priority alarm is displayed. See Message Summary Table for priority listing. The cable is in priority order. ALERT and STATUS/PROMPT messages are displayed in the ADVISORY (23) section of the display. There are two lines in this display. If more than two messages need to be displayed simultaneously, the two highest priority messages are displayed. When one alere or starus/prompt condition is corrected or elimi- nated, then the next highest priority message is displayed. See Message Summary Table for priority listing. The table is in priority order. Gas Loss Alarms provide surveillance for leaks which can result in gas leaving or entering the IAB circuit. IAB Catheter Alarms detect an occlusion of the IAB catheter or extender. Gas can be trapped in the IAB and/or the safety disk depending on the time of such an occlusion. Gas Loss including IAB Disconnect and LAB Catheter alarm operation is ‘maintained ac heart rates up co 140 BPM*. However one component of the catheter alarms, detection of gas trapped in the safery disk, is suspended at 112 BPM* to minimize nuisance alarms. WARNING: The Augmentation Alarm, which is automatically set at power-up, provides back-up to these alarms at higher rates. Therefore, it is important that once set this alarm NOT be manually disabled. WARNING: When the System is operated in the Manual Fill mode, [AB gas loss and catheter alarms are disabled. "Timing slides at nominal mid-position (Auto Timing) stem 97e Service Manual spter 1, Operation 1371.3.3.1 Alarm and Advisory Table ‘The following pages pfovide a table of all ALARM, ALERT, STATUS, and PROMPT messages. The table provides detailed information for each message, but does not contain corrective action. See the Help Screens for correction action. [Message [Messoge [Probable System The [Alarm (Type Displayed Cause Response {Alarm {Reset [Alarm |"Eleccical [Failure ofone or more Sytem is eld [Steady on Accemp vo clea by cycling power | “Tesefais, — [elecracal subsysem [ia VENT mode [immediately |OFF & ON. Code t+ [eet during sytem | IAB deflated. | owerip dagooric | TSyxem [Solenoid driver Syren diabled (Sredy, on [Anempe deat by ocing power ce cigs 2EiRedive omelncty [ORSON Noccermuatle | [acum snd pressure [vacuum i | lsolenoid energized for restored to | | |spprox 2sscoodsor afer dink | | | HABP processor failure. IIAB deflated. | | "Safe Disk jLeakdercted in Safey (SID. Diagnostic [Scady, on [Hold FILL key down for one second | | TesePaile”|Disk/Aueo Fill |Mode/IAB in immediacy | | | ‘Asembly during SD. NOT connected. | Aiggnore restr tee | | prompa nes ected | | . properly “EeakinTAB Gain ofS ccs ofshucde |Vene/IAB [Steady. on Mesage ad ron cleared when Fill Circuit pur veaive ola auto |deiared Immediately [boron preed for one tcond fil volume. | / Seandby condition cleared with | i ‘anual depression of ASSIST | | | FEANDBY key APTER succes | or | fl Icumulacive sure ges [Standby TAB. |Seady.on Message and cone cleared when Fil | lows exceeds te 3 ech. [dened ttsmedinely buon presiedforone second. | |dynamic limit or total | {Standby condition cleared with | loweceeds Dec | (Imanaal depression of ASSIST | i else colt aad | | [BANDE Ee APTER aceon | olume i 7 j “Auvohil [Balloon could nor be [Venu IAB |Sready, on | Manly, muse hold FILL Key for } Falue-No [AUTOMATICALLY |delaed —jimmetiariy lone scond tithe ety acai or | Helium? [fled bees of fo manualy fil, {adequate Helium gas | |supply. “Bicod |Patienelak in BY |Veqc/IAB [Sealy on |Manvally ave Bold FILL key for] Dececed’ —femherecteulting in [aeflaed——_[immeiarly lone secondo retry manval fl blood migration back | ; oscil rab | “Aucohil [Balloon could nor be Venv TAB [Sready, 00 | Manvally, muse bold FILL key for Failure’ |AUTOMATICALLY —delted rmmediaely lone second eo esther etry auf or filled at defined in i to manally fll performance section Bu, Helium supply i } ory adequate Large insancancous__|Vent/IAB Steady, on | Message and cone cleared when FILL | \eat-to-beae) loss of deflated immediately | key is pressed for one second. approx. 25 cc's of | Standby condicion cleared wich | shucele gas. Possible | manual depression of ASSIST! tear break in balloon or | STANDBY key AFTER successful catheter. | (Disconnection ac JAB | Vent /IAB [Steady on | Message and cone cleared when FILL | [Diconneced” jorexcenion cathecer (defied limmediately | key is pressed for one second, |ewhile inthe ASSIST | Standby condition cleared with =| | mode. ‘manual depression of ASSIST/ | STANDBY key AFTER scent | L Ll il. J 1-38 System 97e Service Manual ‘Chapter 1, Operationfor4-6 seconds while |deflated on each Tsystem TAwéile Alarm 1 Respense Alor Reset { [Alarm |"High Drive {Regulaced presure Standby /TAB Steady, on | Manually. by presng ASSIST? | Pressure" fom compres deflated immediately | STANDBY key H exceeds acteprable | lopersting rage | "Aucofll | Prompes the wer so |Sandby /IAB | Srady,on (Manually, when an aaroil } Required" aurfll the IAB. This [defaced inated |prompc only cccur in | |fhe Assist node when: | 1) The curent TAB fil |was "Manual" and the | |e switched to the | itAnto® mode | | |2) The current IAB Fill ! | Vis Auto" andthe : | | fsucomatic ils over- [due beease ce Sytem | tru: 2) switched co the | "Manual IAB Al | | ‘mode, or B) in che "Sandy" mode | "Check TAB [Occlusion of AB’ [Standby /IAB | Seeady, on |Manual, by presing ASSIST Cater” exertion eatherer or [deflated immediately [STANDBY key |cowrapped balloon ! No Pressure | Displayed when ‘Saandby [IAB |Seeady, on |Mestage and vone cleared when | Trigger Zero lioternal source BP. [deflated immediarely |ansdbce is mancally essed Transducer” | transducer is connected |Standby condition cleared with land pressure gger = ‘panual depression of ASSIST | ed but the STANDBY key AFTER successful | j ranaducer bat NOT | jeeoing | [ben sree | | i [Plow Vacuam® [Insuficient rao [Waiting co [Steady on Automatially, when coum is | i |compressor vacuum. pump (Pseudo immediately restored. | |standby) / [AB } | defaced "Check Pacer |W/A-V pacer trigger | Waiting to |Onsteady | Automatically, f pacer ming. | i |Timing’ [interval vaies >25% or [pump Pseudo [afer 15sec [conditions ate mee Macualiy be { | A ALY pacerratets [iandoy) IAB. |silenee \develecng pace rigger mode £125 bpm |sefaced | No Trigge®™ Valid wigger,se Waiting vo [On seedy J Awromarialy, when rigger ares. defined in pefrmance pump Pieudo afer 15sec fection, docs NOT cust |standby)/ IAB silence | i ris loxewhilein ECO. (defaced | NOTE: The | |ecPacercngger mode. | jaudblealarn | | |e Suppressed, if valid heart, meme cera was ot dereced | i nce the | | pump was i | _ 1 turned on. 4 IVaid wiggeeas [Waiting co On stesdy | Atomaticaly, when wigger evar | ned ecarmuce |pup Pads {ee 1 e aa| | Section, does NOT ext |standby) IAB. |ilence | oris lose while in |defared | |Pretareeigger mode Trigger [Electrosurgical noise | Waiting wo {Steady,on | awomnatialy, when ESU Inererence’ [detected while inthe pump (Pseudo after Ib see |ntedference sop Pacer tigger mode |feandby)/ IAB delay, cme | defaced oucafer 15 sec |alen [Eco ECG sciviey e [Assisxing /IAB [Continuous [Aucomascally, when ECG activiny | [Deceeesr —[deecred persistently [isimmediacely [double beep [ceases Manually, desleceing inthe internal Rewave (non-synch.) mode. Internal crigger mode. System 97e Operating Insiruclions Chapter 3, Operation’ 139Message [hese [Probable {System Audible |Alorm | fe Displayed __|Couse Response | Alarm [Reset | TAlere ["lrregular [While in Pressure [System ‘After 60 |Aucomatially, when erigger interval | t Tegger’ —|iggermode, eric [automatically | second delay, is regular } rigger from: 1) bases deflzion double beep ~ fchychmic patience —onsborter [times cut ater | | yh |cardiac intervals. |2-3 seconds| | | 2) late deflation: and repens | | anibing reine | |every 3 min | pulse deection. "Augmentation Diastolic augmentation |Unaffeced [Continuous |Automatically, when augmentation | Below Limit. has dropped below user |Gouble beep rises above alarm limit. 4 | Sec’ selecced limit, ) "Low Bavany” [Batcery eserve fils [Unaffecred Double besp- | Automatically removes message and | [below 30 minutes of Iimes out ater |ruras off tone when AC i estored loperaing time SOseconds. | i | | Repeats every \ 10 mminvtes. | | [row Barcery |The external source | Unaffected [Double beep - |Automatically removes message, | exty falls Below 30 minutes |eimes out aker |eurns off tone, eranser co internal | of operating time. Boseconds, — [bateery occurs. | Repeats every | | 10 minutes. | ‘Malneenance [System maintenance [Unafecced [Double beep [Actempe co clear by cycling power | | Required may be required | limes out ater |OFF and ON. | \Code#— | [50 seconds| i “Low Helium [Helium supply below |Unaflcied [Double beep - |Aucomatically with new He nk 1 24sfil reserve as | imes out afer | | decermined by eank 50 seconds | | [No Paden llncernal deczonics Assisting /IAB (Continucus Attempt vo clear By cyling power | seus |fallure {lating & (double beep [OFF and ON. ! ‘Available’ | [defacing | | Prompe "Unplug Dik [Prompis weracsare |SD. Diagnostic [Sready,on [Manual pres FILL key for one Outer lof Safety Disk Leak [Mode /IAB is |immediacely [second to resume vesting, i Diagnostics ro open the deflated safety disks cathecer [eemerac ce | Scmospherie pressure | Iimay be sampled. The Giagnostic will eemain | | paused until che | prompt is cleared. | L [Prompts wer ar stare | SD, Diagnostic (Steady, on ‘of Safety Disk Leak | Mode /IAB is |immediately (Diagnostics, co cap the NOT connected | safety disks catheter | connector, The user is fiven 10 seconds to plug the connector before the prompt is [leared and the diagnostic resumes Notifies the operator chat request to assist fas been made but the IAB circuit has NOT. been filled wich shurcle Leas. “Manual Fill |Notifies che operator AB |when to manually fill | |ehe TAB cathecer wich shuctle gas. Displayed in MANUAL FILL. | mode when the FILL rey is activated, venting the safecy disk. "Plog Disk Ourl [AB Noe Filled TVene Mode? [Nene HAB is deflated | Fill Mode GD. Drive Vented) / |TAB deflaced j Ne ‘Aatomatie, after ten second delay | interval i | | Manual, press FILL key for one second fo initiate fll “Manual, press FILL key for one second | 1-40 Sysiem 97 Service Manual Chapter 1, Operation[Messoge [Message Probable System Thvdible [Alarm Type {Displayed _| Cavs {Response ‘Alarm {Reset Stacus "Leak Testing |Duplayed during the |S. Diagnostic [None N/A |Safery Disk” |safery Disk Leake Mode IAB is | | i [Diagnostic co indicare_|not connected | ha testing is sill | pronres. Aacofilling” | Indieates tac che Fill Mode /IAB [None ina |Syscem is in the process |deflaced | (ofsucomatically | | [puging and refilling | | | fhe IAB with Helium. | Heart Rate |H.R. < 40 BPM [Unaffected [None Aucomatieally, when HLR. increases, | Low" | ! "Gas Less and |Allleak and catherer —[Unaffecced None NA \Cathecer [alarms are disablea | ‘Ales ‘when mana fil mode [Disabled [is selected AB | ‘catheer i manually | filled) | | Slow Gas Sow gas low alarm [Unaffcced _jNone NA j Loss Override disable is selected by | | Os" ser. (Noe: Rapid loss | i |fanccion sil active) | | i [FSjpem Tose Indicates cha all [Venu IAB [None Poronati, meape a dpaped | lok subsystems checked [deflated | approx. 10 seconds folowing the (aang power | epitome | pused diagnosis | *Syacem | Displayed when the | Unaffeced [None NA Taine” | Series 90 Trainer is | | being used as ECG and | | Prsnure souee | | “huniliary | Inernal electronic [Unaffexed None \Goncinue pumping iFnecesary, i Conetols” malfunction | Jonless aucliary conerl settings) i Unavsible’ | | |rmust be changed) | | “Barceryin Indicates Sytem is | Unaffeed None [Power Syscem from external battery [Use | operating from an Jrource of AC power source Lincernal bates ! “Bawary in (Indicates Sycem is |Unalfecred | None Power System from an AC power | [UselEXT operating fom an souree. | fxcemal DG source, | hae Relp Dilayed when che [Unalfeced None Na 1 \awalable for wer selects MANUAL | \ |Manual Ful” Bil, Thereien0 | | IAB" scvisny metage | | Aisplayed: Only a saras | ressage on the bottom okcbe screen I Pelp Displayed a power-up |Unaifeceed [None ina { ‘Available for until the ise pump | i | Iwai Serup*_eyele, 1 Tal System 97e Operating Instructions Copter 3, Operation1.3.4 Water Condensation During the balloon pumping procedure, a fine mist or small droplers of wacer may occasionally be observed within the IAB extension catheter andior fill and drain tubing. This mist is condensed water vapor. The System 97e has a condensate removal module which automatically collects and removes condensate without operator intervention. If desired, the following procedure may be used to ‘manually check and purge any condensate which may have collected in the IAB extension catheter. 1. Set JAB FILL MODE key (45) co "MANUAL" and the ASSIST/STANDBY key (5) to "STANDBY." 2. Disconnect patient balloon catheter extender from patient IAB and tip downward. . Set pump co "ASSIST." 3. 4, Pump for approximately 20 to 30 seconds. Water will be expelled. 5. Set pump to "STANDBY" and reconnect extender to patient IAB. 6 . Rerurn the IAB fill switch to the original fill mode, preload patient balloon/safety disk and resume balloon pumping. NOTE: If large water droplets remain in 6 foot extender (P/N 0684-00-0182), i may be attached to suction to remove them. Be sure extension is disconnected from IAB and safety disk. (Gee User Maintenance, Chapter 4 of System 97e Operating Instructions) NOTE: When in the Manual Fill Mode or when the battery is low, che condensate removal module will not operate. NOTE: When transferring a patient from another IABP System without a condensate removal feacure, ensure that all droplets of condensate are removed from the extension catheter tubing before connecting to the System 97e. To remove condensate the procedures above may be used or follow the IABP manufaccurer's recommendations. PRECAUTION: Proper operation of she axtomatic condensate removal module requires | proper connection of the safety disk assembly to the console. Excessive condensate may indicate the need 10 service the condensate removal module PRECAUTION: The Condensate Removal Module (CRM) is designed to function most ficiently when the unit is in a normal upright (vertical) position. Transient operation of the CRM in a horizontal position should be limited if condensate reroval functionality 1s required. Technical Service should be consulted for IABP's which are permanently configured for borizontal use. System 97e Service Manual Chapter 1, Operation1.3.5 CLINICAL CONSIDERATIONS DURING OPERATION 1, ECG: There are several methods to correct conditions which alter or hamper the acquisition of a reliable ECG. Repositioning or replacement of the ECG electrodes, choosing an alternate lead selection or ECG GAIN settings and checking that the pacienc cable is properly connected are the most common solutions. 2. Pressure: Adequate flushing to maintain pressure line patency and alignment of stopcock in the proper position will prevent the majority of possible pressure trace problems. Certain disposable transducers should be properly dampened to avoid excessive ringing noise 3. Atrial Fibrillation: Use the AUTO timing mode. With the pump in "STANDBY", adjust the IAB INFLATION (7) and IAB DEFLATION (6) controls to position the intensified portion of the arterial waveform to correspond to diastole. In the ECG Trigger mode, the deflate slide control may be moved all the way to the right (to the R-wave deflate label) allowing che R-wave to deflate the LAB. 4, Ectopics: In the Auto mode, the System 97¢ automatically deflates on and assists the eccopic beat if the ectopic R-wave is sensed. If ectopic is of small amplitude reliable triggering can be assured if an ECG Lead is selected which minimizes the amplitude difference between the normal QRS complex and chat of the ectopic beat. No special adjustments are necessary. 5. Cardiac Atrest-Ventricular Fibrillation: When defibrillating the patient, the System 97e has protection and is completely isolated from the patient and the unic. However, the operator should stand clear of the System during. defibrillation 6. Ventricular Standstill or Prolonged Cardiac Arrest: If possible, use ECG or arterial pressure trigger during CPR. The System will synchronize trigger to the rate and rhythm of chest compressions. If ECG or arterial pressure trigger does nor produce adequate trigger to allow for balloon movement, the LAB may be placed in the internal trigger mode. The normal internal rate is 80 BPM but can be varied between 40 and 120 BPM using the Auxiliary Controls. ‘Adjust the augmentation keys to produce a slight movement of the disk diaphragm. Observe IAB status indicator (27) and the patient's arterial pressure to make the proper adjustments. Minimal movement of the IAB and reduce potential chrombus formation. Note that, IAB FREQUENCY key does not affect pump rate in INTERNAL trigger mode. WARNING: The patient balloon should not remain inactive (i.e. no inflating and deflating) for more than 30 minutes; due to the potential for thrombus formation. 7. Change in Pressure Monitoring Site: If patient's pressure monitoring site is changed while pumping, the VERIFY (21) key can be quickly pressed and released to recalculate arterial pressure transmission delay. This will assure accurate digital pressure displays and arcerial pressure trace. 8. Simultaneous connection of several medical devices to the patient may cause summation of LEAKAGE CURRENTS which can exceed the values allowed by the Safecy Agency Standards (see section 3.16 - Agency Compliance). System 97e Service Manval Chapter 1, Operation 1-431.3.6 USE IN ELECTROSURGICAL ENVIRONMENT ‘The System 97e IABP has buile in Electrosurgical Interference Suppression (ESIS) which minimizes electrosurgical unit (ESU) noise from disturbing System perform- ance. While the ESIS will suppress ESU noise, it cannot eliminace it altogether. Sparking to tissue occurs when an ESU is operated. This generates noise that extends into the ECG frequency range. Since the ESIS must pass these frequencies, some ESU noise may interfere with the ECG signal, particularly with high ESU power settings. Limiting the power of this noise energy is desirable. The magnitude of interference is directly related to the power setting of the ESU, which should be as low as possible for che intended effect. Successful ECG triggering in the presence of ESU noise depends, co a large extent, on proper patient preparation and ESU use Following the guidelines listed will minimize the amount of energy coupled from the ESU to the ECG input of the System 97e, generally resulting in stable ECG criggeting. However, if noise cannot be reduced to an acceptable level, the arterial pressure trigger mode can be selected. When ECG signal acquisition improves, recur to the original trigger mode selection. ‘When che System 97¢ is to be used in an electrosurgical environment, the following cechniques are recommended to minimize interference from electrosurgical devices. © Place the electrosurgical return plate directly under the surgical site. # Locate the ECG electrodes as far away from the surgical site as possible. # Locate the ECG electrodes approximately equidistant from the surgical site to minimize any difference in potential between electrodes. «Place all ECG electrodes on the same plane (either anteriot ot posterior) to minimize any difference in potential between electrodes. « Always use the shielded patient cables. «Keep the ECG cables at right angles to the electrosurgical cables to the greatest extent possible. «Use the minimum required electrosurgical setting WARNING: External bedside monitors used with she System 97e in the operating room, ust be equipped with electrosurgical interference suppression. System 976 Service Manual Chapter 1, Operation1.3.7 USE DURING CARDIOPULMONARY BYPASS During cardiopulmonary bypass the System 97e can be used to inflate and deflate an IAB already in position by setting trigger to INTERNAL. The internal rate is determined by the INTERNAL TRIGGER (49). ‘When weaning a patient from cardiopulmonary bypass an IABP can be used to assist cardiac function. If an ECG is established ic can be used to crigger the System. Check to see if ECG is reliable by noting a flashing diamond in the upper Fight corner of the screen. The diamond should flash one time for each R-wave. If the patient is on full bypass, "AUTO TIMING" mode can be used and the INFLATION (7) and DEFLATION (6) controls set co mid position. As flow rate is decreased and the heart begins to generate a cardiac output, check that timing is correct. Frequent reassessment may be necessary as changes in patient condition may alter the relationship of electromechanical events. If the ECG amplitude is insufficient to cause triggering, the ECG GAIN key (47) may be adjusted to increase amplicude. If a pacer is present, the appropriate pacer ‘trigger mode can also be used (see TRIGGER section 1.3.2.8). Pressure triggering is also available. WARNING: Do not remain in the internal trigger mode wen the patient is generating a cardiac output. System 97e Service Manual Chapter 1, Operation 451.3.8 WEANING A PATIENT FROM IABP SUPPORT ‘Weaning may be accomplished by a reduction in IAB frequency, a reduction in augmentation of a combination of both. ‘When weaning, ic is recommended that frequent assessment of hemodynamic parameters and patient condition be done. WARNING: When weaning by reduced IAB augmentation, do not reduce augmentation below the point at which no movement of the IAB indicator is observed. 1-46 ‘System 97 Service Manual Chapter 1, Operation1.3.9 PORTABLE OPERATION Datascope recommends that certain conditions should be met during portable operation. They are: «Battery fully charged. Back up battery available. # Altitude changes are compensated for automatically in the Auto Fill mode or manually in the Manual Fill mode. The System is secure and stable when used on an ambulance, helicopter or fixed wing aircraft The System 97e is available in two versions. A console version with a hospital cart or the System 97e Universal Transport System (UTS). Both may be used in transport, however, for more intensive transport requirements, the UTS version mechanically accaches to a docking station for high load strength mounting. See section 6.11.1 for details. PRECAUTION: The wser should continually rely on visual alarm messages during high noise transport situations. PRECAUTION: Prior to transport, ensure that the belin cylinder yoke handle is tight cand the cylinder is a least 25% full. Approximately every 30 minutes during transpon, verify that the yoke handle has remained tight and that a novceable pressure drop bat not occurred. PRECAUTION: Prior t0 using the System in any other position except vertical, consult with Technical Service 1.3.9.1 Battery Operation During portable operation, the System 97e is powered by a rechargeable battery Prior to portable operation the battery should be fully charged. A fully charged battery is indicated by a continuously illuminated BATTERY CHARGING indicator (43). NOTE: It is important to perform preventive maintenance procedures on the battery. Refer to Chapter 8 in this manual and Chapter 4 in the Operating Instructions for guidelines. The "BATTERY IN USE" status message displays whenever the System 97¢ is operated from the internal rechargeable battery. When the battery has approximately 30 minutes of operating time remaining the following occurs: © An audible double beep alarm is activated for 30 seconds. The "LOW BATTERY" or "LOW BATTERY (EXT)" alert message is displayed on the screen continuously. The condensate removal module will not operate The "BATTERY IN USE (EXT)" status message is displayed when the spare battery pack or external DC supply is connected and AC power is not present. System 97¢ Service Manual Chapter 1, Operation 1-471.3.9.2 Battery Charging To charge the internal battery: 1. Leave the System power cord plugged in and set the MAINS ON/OFF (57) to"ON." 2. Check that the BATTERY CHARGING indicator (43) is illuminated. 3. Allow a minimum of 18 hours to fully charge a low battery 4. A fally-charged new internal battery will provide at least 120 minutes of portable operation. NOTE: A reduction in run time will occur over a baccery's life for various reasons such as, age, storage temperature, and discharge depth. Batteries which are continually subjected to complete discharge cycles without the recommended immediate recharging, can incur permanent damage. For further information refer to the Preventive Maincenance Schedule B, page 4-8. 1.3.9.3 Switching from AC to Portable Operation 1. The System automatically switches to portable operation if AC power is removed (intentionally or due to power loss) 2. If necessary, charge battery as described in accordance with previous instructions 3. Verify thae the "BATTERY IN USE" advisory message is displayed. NOTE: Battery charging is nor active in this state. 4, When AC power is restored the System automatically reverts from internal battery operation to AC Mains usage. The internal battery pack will resume its charging, while che System operates from AC Mains power. Always verify chat the BATTERY CHARGING indicator (43) is continuously illuminaced or flashing, 1.3.9.4 Portable Operation from Vehicle Inverter The System 97e can be powered from a portable AC source, such as an emergency vehicle inverter. (An inverter converts the low voltage, DC power from the vehicle's electrical system to AC power at 115V compatible with the System 97e.) The inverter should be checked for proper operation by qualified maintenance personnel prior to emergency use. The message "Battery in Use" will not be displayed during proper AC inverter operation. The inverter must meet the following specifications: ‘SPECIFICATIONS OF VEHICLE INVERTER FOR USE WITH DATASCOPE SYSTEM 97¢ Voleage Ourpur: 100-120 / 220-240 VAC 410% Frequency: 50 He #2 Hz, 60 He #2 He ‘Overshoors: Shall not continuously generate overthoots greater chan. 375 voles peak with sridehs greater chan 10 micro seconds ‘when powering the System. Waveform: Sine wave, modified sine wave or square wave NOTE: Square wave level must be 110 VRMS or greater. ‘Ousput Capabilicy: ‘Minimum of 1000 wares continuous power; 10A surge current Safety Compliance: ‘Muse meet or exceed safety standards per IEC 601-1 ‘The operating sequence is the same as described in Section 1.3.2.1, except that AC power is obtained from the inverter receptacle. Interruption of the vehicle inverter AC power will resulc in portable internal bartery operation, as described in Section 1.3.9.1. 1-48 ‘System 97e Service Manvel Chapter 1, OperationIn this case, the System is to be powered from an external DC source such as, on an ambulance, helicopter, or external battery pack. 1. Connect a voltage-compatible* external source to 24VDC Input Connector (58). Incernal battery will noc be charged in this mode. ‘The IABP ON/OFF switch (37) will activate the System 97e. Interruption of the external DC source power will result in portable internal battery operation, as described in Section 1.3.9.1. +See Safety Designations page xi in the Operating Instructions, for connection compatibility, 1.3.9.6 Effects of Altitude Changes During Air Transportation NOTE: Before using the System in air transportation, check for sufficient supply of helium since the balloon will be filled several times. For proper operation during air transport, the System 97¢ balloon pressure must adapr co local atmospheric pressure. In the Auto Fill Mode the System will automatically purge and fill che IAB when local atmospheric pressure decreases of increases by 25 or 50 mmHg respectively. These pressure changes occur approximately every 1,000 feet of rise or 2,000 feet of drop in altitude. NOTE: The Auto Fill Mode should be used during air eranspore. If the Auto Fill ‘Mode cannot be used and the Manual Fill Mode is required, ensure that a manual fill is performed at the same intervals that an auto fill would occur. NOTE: For information on outfitting an aircraft for ABP transpore contact your local Datascope sales representative. Also, see Section 6 for part numbers and inseructions for use for the Docking Station and Mobilizer. 1.3.9.7 Portable Operation Emergency Battery Back Up Recommendations Datascope recommends that a back-up co the internal battery always be available. In the event that the internal battery pack does not power the System, the operator should first atcempt to restore power via AC Mains sources (including those listed in Section 1.3.9.4). The second attempt is to restore power via external DC sources as listed in Section 1.3.9.5. System 97e Service Menval Chapter 1, Operation 149Figure 1-25, Push Down to Release Handle Figure 1-26 Pull Console Release Handle Figure 1-27 Lift Levers to Unlock Botery 1.3.9.8 Removing Pump Console from the Cart The console can be removed from the cart with or without the battery pack attached. Removing the console without the battery pack attached reduces the lift weight by approximately 35 Ibs. NOTE: When either removing the pump console from the cart or returning the pump console to the cart, ensure that the wheels of the cart are in the locked position. 1. Pivor the cart handle out of the way. The cart handle swivel release is located on the inside surface of the vertical support column near the top. To release, push knob down and pivor the handle counter-clockwise approximately 180°. Follow the same procedure when returning the handle to its normal "locked" position. To remove console with battery pack at- tached, continue with step 2. To remove console by detaching battery pack, skip to step 3, 2. To remove with the battery pack attached: Lock the wheels on the cart. Keep the release levers, on the battery pack, in the locked position. Pull the console release handle (on cart base) by pressing the tab to the right of the handle and pulling straight out. Lift pump console (to lift, grab the pump console along the top edge of the front and rear panel) straight up, off the cart and place down near the cart. Skip to step 5. 3. To remove by detaching battery pack: While the console is attached to the cart, lift both battery release levers up to the unlocked position. Lift the console (to lift, grab the pump console along the cop edge of the front and rear panel, as shown in the figure with step 4) straight up, off the cart and place down near the cart. The battery pack remains on the cart 150 System 97e Service Manvel Chopter 1, Operation4, To release the bactery pack from the cart, pull the console release handle located just below the battery pack (as. shown figure 1-25): Use both hands to pick up the battery pack. Place the battery pack on a dry, flat surface. Lift the release levers up to the unlocked position. Lift che pump console (to lift, ‘grab the pump console along the top edge of the front and rear panels) and carefully lower it straight down onto the baccery pack. When firmly seated, push the release levers into the locked position. Test the electrical integrity by ‘urning the [ABP ON/OFF switch ON. If System does not turn on, lift the release levers, life up pump console and lower again. Repeat until proper connection is made. 5. Push the button on the rear of the monitor to detach it from the cart handle, 6. Atcach monitor on top of the pump console. Make sure that the monitor is securely attached before transporting the System, 7. Pull up the console handle and tilt the System to pull for transport, PRECAUTION: Be sure 0 only pull she System by this handle, DO NOT PUSH. NOTE: For information on outfitting an aircraft for ABP transport contact your local Datascope sales representative. Also, see Section 6 for part numbers and instructions for use for the Docking Station and Mobilizer. Figure 1-28 Placement of System ‘Over the Battery Figure 1-29 Push Button to Detach Monitor Figure 1-30 Pull Up Handle and Tit System System 97e Service Manual Chapter 1, Operation Ti1.3.10 USING THE RECORDER ‘The dual trace chart recorder selectively provides a hard copy record of patient ECG, arverial pressure, and optional balloon pressure waveforms, as well as trend data, NOTE: The recorder does not activate automatically upon System alarm. ‘The recorder keypad consists of five keys. They are OFF (42), ECG (40), Arcerial Pressure (39), Balloon Waveform (38) (optional), and Trend (41). The recorder prints waveforms which are delayed 6 seconds (delayed from real time) at a speed of 25mm/sec or delayed 3 seconds at a speed of 50mmisec. When the display is in the FREEZE mode, activation of the recorder overrides the FREEZE mode. When the recorder is activated in the FREEZE mode the ‘waveforms that are frozen on the display are printed followed by the delayed recording, © OFF: Completes the selected recorder function. At the completion of the recording a status of patient and System information is priated. Depending on which IAB Frequency is selected, determines how the systolic and diastolic pressures are presented. When 1:2 or 1:3 is selected as the IAB Frequency, the recorder will print the assisted and unassisted systolic and diastolic pressure information. Below are samples of the various printouts. The date and time of the recording is automatically printed by the System 97e, The Patient I.D. is left blank and can be filled in manually. Pace 1. Pair 1D Pie. Dav 200697 ue 200697 ae 20065) Fon 1133 Tie 1134 e133 Amand Advi Menges | | Aamiad adi Menges | | alr aad Advi Monge TIMING: Awe TIMING. Ase TIMING. Awe ThuGcER- #0 TRIGGER. Ee suGcER- #00 HEARTRATE 69 HEARTRATE 10 HEART RATE. 99 ASSISTFREQ, Sandy AsSsT FREQ: 14 sSSST FREQ. 13 SYSTDIAS 1752 SYSTDIAS: 11546 ‘sisTED MEANo5 1063125 Sys 10847 veanon sg 126 UNASSISTED SidDas 11782 Meas79 Figure 1-31 Print Outfor Figure 1-32 Print Out for [AB Figure 1-33 Print Out for IAB Standby Mode Frequency 1:1. Frequency 1:3 (NOTE: 1:2 ‘uses the same layout) 97e Service Monvol ‘Chapter 1, OperationECG: A delayed ECG waveform is recorded continuously until OFF or another recorder function is selected. Numeric information for Lead selection and Size is printed ac che beginning of the trace. If either are changed the numeric information is reprinted. Figure 1-34 - ECG Somple © Arterial Pressure: A delayed invasive arterial pressure waveform is recorded continuously until OFF or another recorder function is selected. Scale informa- tion is annotated at the beginning of the trace. If the pressure scale is changed che annoration is automatically repeated 40 Fatacee : = a Treas of Decay Freze Figure 1-35 - Arterial Pressure Sample * Balloon Waveform: A delayed balloon pressure waveform is recorded continuously until OFF or another recorder function is selected. NOTE: There is no scale information printed for balloon pressure waveform. Figure 1-36 - Balloon Waveform Somple System 97e Service Manual Chapter 1, Operation 153‘© Trend: All of the accumulated trend pages are printed unless OFF is selected. Heart rate trend is printed first followed by the blood pressure trend (includes systolic, diastolic, mean, and augmented pressure). When both assisted and unassisted beats are present, systolic, diastolic and pressure indices consist of the pressures combined and averaged. NOTE: If no trend data is available the message "NO TREND DATA AVAILABLE" is printed. int Hart fate Trend i Figure 1-37 - Trend Sample ‘Dual trace recording is possible by pressing one of the tracing controls (ECG, Arterial Pressure, or Balloon Waveform) and within 1.5 seconds pressing another one of the tracing controls. © ECG and Arterial Pressure: Delayed ECG and arterial pressure are printed continuously until OFF or another recorder function is selected. The ECG size is recorded at .Scm/mV and positioned above the blood pressure trace at 80mm He/cm scale. The ECG lead, ECG size and pressure scale are annotated at the beginning and repeated automatically if any are changed. Figure 1-38 - ECG and Arterial Pressure Sample 5a System 970 Service Manvel ‘Chapter 1, Operation‘* ECG and Balloon Waveform: Delayed ECG and balloon pressure waveform are printed continuously until OFF or another recorder function is selected. The ECG is on the top half of the recording and the balloon waveform is on the bottom half. The ECG lead and ECG size are printed at the beginning and repeated if either are changed. NOTE: There is no annotation printed for balloon pressure waveform. att tet tt — Figure 1-39 - ECG ond Balloon Waveform Sample * Arcerial Pressure and Balloon Waveform: Delayed blood pressure and balloon waveform are printed continuously until OFF or another recorder function is selected. The blood pressure is on the top half of the recording and the balloon waveform is on the bottom half. The blood pressure scale is annotated at the beginning and automatically repeated if changed. NOTE: There is no annotation printed for balloon pressure waveform. Figure 1-40 - Arterial Pressure ond Balloon Waveform Som- Spier ‘97e Service Manual wapler 1, Operation 1-551.3.11 USING TREND The monitor trend function and the chart recorder can be used as effective tools for patient data collection and record keeping. Two different display screens can be viewed by pressing the TREND key (16). The first press of the TREND key (16) displays the Heart Rate Trend. The second press displays the Blood Pressure Trend. Pressing the key again returns the display to the normal format. See Section 1.3.10 "Using the Recorder" for information on printing the trend daca, Eight hours of patient parameter data is collected. Trend is cleared when che IABP ON/OFF switch (37) is placed in the OFF position for more than 15 minutes or by pressing the ECG SIZE key (18) while powering on the System, Both the heart rate trend and the blood pressure trend displays consist of two segments. On the right side is a smaller segment that represents the latest 30 minutes of data. The left side is a larger segment that represents 7.5 hours of data, The displays are labeled Heart Rate and Blood Pressure, accordingly. NOTE: The display only holds 8 hours of data, with the most recent data points replacing the oldest, therefore, it is recommended to print the trend data every eight hours or earlier, and at the end of balloon pumping, = = aS MEART RATE TREND | | Figure 1-41 - Heart Rate Trend Screen 156 ‘System 97e Service Manval Chapter 1, Operation1.3.12 INSTALLATION AND REPLACEMENT OF HELIUM CYLINDER PRECAUTION: Only personnel familiar with the handling of high pressure gas cylinders should perform this procedure. PRECAUTION: Use medical grade helium only. The helium cylinder should be replaced whenever pressure drops below a preset level. This is indicated when the "LOW HELIUM’ message is displayed during operation and/or when the helium pressure gauge (70) shows that the helium supply is not in the operating range (within the red area). There is no need to interrupt IABP. However, the cylinder should be replaced as soon as possible to avoid a potential "AUTOFILL" which can delay pumping. To replace cylinder: 1. Close helium cylinder valve fully | clockwise. 2. Slowly loosen the cylinder yoke. 3, Remove the cylinder. Cylinder 4, Check that the washer is present Valve and in good condition on che cylinder yoke. 5. Install « fresh helium cylinder Cylinder 6. Tighten the cylinder yoke. Yoke 7. Slowly open the helium cylinder valve Cylinder gauge needle. (For helium cylinder specifications see section 3.9.) |_ © 8. Verify deflection of the helium =| [FH 2 NOTE: Disposal of used helium cylinders should be in accordance | with prevailing local statues and in | conformance with recycling | requirements NOTE: For installation instructions Figure 1-42 of the helium cylinder strap, see | section 6, aT Helium Cylinder System 97e Service Manual 157 Chapter 1, Operation1.3.13 INSTALLATION/ REMOVAL OF SAFETY DISK/CONDENSATE REMOVAL MODULE PRECAUTION: When installing or removing the safety disk a moderate amount of and sightening is all hat is neaded to accomplish a good connection since the O-ring provides a pneumatic seal. WARNING: Datascope recommends the use of surgical gloves while doing these procedures 40 avoid contact with residual condensate or other body fluids. Disposal of used safety disk should be in accordance with prevailing bespisal practices for medical refuse. The safery disk and condensate removal module are combined into one assembly. ‘The assembly is located on the rear of the System 97e. Installation/removal of the assembly: 1. Disconnect assembly's pneumatic connections: a. Luer fitting, labeled AUTO FILL (69) b. condensate drain line, located on the rear panel, labeled DRAIN PORT (68). 2. Disconnect assembly's electrical Figure 143 connector labeled DC INPUT (54). Tuinth Sty Dik | 3° Tus the safety disk approximacely 30° counter-clock-wise. 4, Pull straight our. 5. Remove the condensate removal module from the disk by removing the two screws and peeling back che label. Assemble the CRM to the new safety disk, replace and tighten screws and replace label Figure 144 | 6. To inseall the assembly, reverse ‘ the above procedure aligning the Aino up the Sofety Disk curved narrow slot with the pin. Figure 1-45 Softy Disk/CRM Assembly 158 ‘System 97e Service Manual Chapter 1, Operation1.3.14 DOPPLER INFORMATION ‘The doppler used with the System 97e is the Huntleigh Mini Dopplex®. This doppler uses ultrasound techniques to detect vascular blood flow To use the doppler: eT 7] 1. Open the top storage bin. The doppler is located inside che door panel. Wavetorm eagprone | ‘Seener 2. Remove the doppler from the probe Holder storage bin, Press the burton on the tether reel to retract the j—Prove doppler 3. If baccery replacement is necessary, remove the cover of the battery | cbs cable Pe compartment, and lift out the Connector old battery. Install a new 6LR61, GLF22, or equivalent 9V alkaline battery. Replace cover. 4, Place a liberal amount of coupling gel on the transducer or the patient's skin. 5. Turn on che unit and position the probe over the artery to be considered Volume Control 6. Hold the probe at a 45° angle to the surface of the skin. Adjust the position and angle of the probe to obrain the optimum audio signal. Cal Button Battery Compartment | Refer to the Huntleigh Operators Manual for more detailed inseructions. Figure 1-46 Doppler, Front View Figure 1-47 Doppler, Reo View Seem 97e Service Manvel Chapter 1, Operation 59Figure 1-48 Connecting the Modem 1.3.15 Connecting the Modem The System 97¢ has an internal modem. The modem is used for connection to phone lines which can link the System 97¢ to a remote PC, having either PCSIABP remote clinical support software or Remote Service Diagnostics software, The connection is made through a standard analog telephone line. NOTE: The telephone line should directly connect to the external phone system and not go through a company/hospital switching system. 1. Connect a standard analog phone line into the PHONE LINE connector (61). 2. Ensure that the telephone line is connected to the telephone jack 1.3.16 Connecting PC+lABP PCsIABP is a personal computer (PC) software application program that is designed for clinicians to assist in monitoring an Incra-Aortic Balloon Pump (IABP) supporced patient from a remote location. PCelABP will not affect ‘operator settings on the IABP, or have the capability of altering patient parameters. PC+lABP displays all user available information from the System 97e onto a remore PC screen. 1. Connect the modem as shown in section 1.3.15. 2. All other work is performed through the PC. See the PCsIABP Operating Inscruction, P/N 0070-00-0291, for complete details. 1.3.17 Data Communication The System 97e can transmit data, that is requested by a host (i.e., PC*IABP), through the RS-232 port (60) and the Phone Line (61). The following table list the data thar can be transmitted. eeoeroro En ee | Description System System [Sym (System I 96 97—*97e “Trigger source (ECG, Paces A, Pacer V, Pacer AIV, 5 5 5 | Pressure, Ineernal | | Frequency (il, 1:2 13) TABP Operating Stavus (Assit or Standby) ele ele no) |} le | ew |e ECG Lead Selection i, 1, I, AVR, AVL, AVF, V) ° | 1-60 System 97e Service Manual Chapter 1, Operation[Sect Presare . . “ [Diastolic Pressure : . . * [ Mean Blood Pressure : : . . | Augmenced Pressure * . : . Augmentation Alarm Limit Sewing . . : . ‘Augmentation LED position Representing 0.9Bar | 9 |» ° . Ponsion /Avementation Time (0.-168ms) rial 5 - | Timing Mode (Aveo or Manual) ial 5 a Fill Mode (Auto or Manual) . . . . | ECG Se (03,1,2.5) . . . BP Scale 40/80, 20740, 10720 mmHg) oan rs 5 al [Blood Pressure & ECG Status (Lend Fouls BP 5 : : | Zeroed, Transducer Present, ECG Variable Gain, | i ECG Excemal, BP Excernal) | ‘Asiliary Message (ceserved, noe displayed) ranean |r te | ‘Last Alarm Code |e fone are raul Tse Alarm Time [exarate aero ear : [Alarms Currently Muced Le e le * [alae Mewages ! . . . [Advisory Messages (@) . . . {General Status Menages (Recorder Running, Tainer —g e . . Present, On Bare [Last Autofill Time Elapsed Time ia Minutes of Lse | HABP Run Time | Variable Trigger T Tflace Timing Sexcing . : . Deflace Timing Serer . : . 3ld [ : Acofil | I cry Sac eA EEE | EET Fake History (last 20) T ‘Alarm History (ast 20) tT Tigger His (a 20) 1 | I Graphical: Pressure Waveform (ealed) Es . . . | [Graphical ECG Waveform [ome | Graphical Balloon Pressure Walon ——~=~*~s‘“< | ed {Graphical nflare Incnsry (low Worm) ated ars ees eno | \ Graphical: Tagger Marker rains Baa eo | Graphical: Pacer Masker 5 5 | Graphical: Pressure Threshold Marker jae 5 | Graphical: Reference Value L The System 97¢ transmits both Assisted and Unasssted Systolic and Diastolic Pressures, System 97e Service Manvel Chopter 1, Operation 161Figure 1-49 Dual Function Castors 1.3.18 Wheels and Casters ‘The System 97¢ features two dual function casters. They are located on the handle side of the cart. Pressing the appropriate pedals on the casters enables the uuser to have greater control when moving the System and can also lock the wheels and casters in place. Press the caster pedals with the white arrow on a blue background to prevent the caster from swiveling (direction lock). This provides greater control when making turns and berter tracking on long straight-2-ways. Return the pedal to the up position to have greater maneuverability when positioning che System inco tight spaces. Press the caster pedals with the white octagon on a red background to apply the ‘wheel brake, which locks the whee! from rotating and che caster from swiveling. This should be used once the System has been positioned or when left unattended. NOTE: it is recommended that all four caster brakes be applied at these time. weet AND DIRECTION CASTER Lock LOCK 1-62 System 97e Service Manual Chapter 1, Operation1.3.19 HELP SCREENS Help screens are provided to guide the user through set-up procedures and for consultation regarding alarm message descriptions and alarm resetting instructions, Help Screens are context sensitive and thus are only available when the situations arise. For example: The help screens for initial set-up are only available at power-on and a help screen for an alarm message is only available when thar alarm occurs. To display the Help Screens: 1. Press the front panel HELP SCREEN key (8). The key’s LED illuminates. A help screen box displays at the bottom of the screen. NOTE: When a help screen is present on the screen, the ECG and Pressure waveforms are condensed in the upper portion of the screen. Ifthe 3 trace mode is in operation, the third trace is replaced by the help screen. All alarms remain active and no data is lost when help screens are activated. 2. Use the UP and DOWN Arrow keys (12) to page through the screens available. Pressing the DOWN arrow displays the next available page of hhelp screen information. Pressing the UP arrow displays the previous page of information, If there are no previous pages or next pages available and the UP or DOWN arrow is pressed, then the same page is displayed again. 3. Press the HELP SCREEN key (8) again to return the screen to the normal waveform or trend graphics display. The following pages show the available alarm and set-up help screens. | me PAGENO. TOTAL PAGES INITIAL SETUP NofN 2. Establish ECG and Pressure. 3. Zoro the wansducer: nthe transducer to air. japress the ZERO key for 3 seconds. Cioae the tansducer | | Figure 150 tPREVioUs PAGE | {NEXT PAGE | (HELP) to end HELP Example of Help Screen System 97e Service Manual 63 Chapter 1, OperationNo Trigger [CONDITION [CORRECTIVE ACTION An electrode is detached or |. Reattach or reposition the electrode. } malpositioned. i | © An incorrect crigger source has _|1.Selece a different trigger source | been selected. using the TRIGGER SELECT keys. | Resume pumping by pressing the |_ASSIST/STANDBY key. © There is inadequate signal |1. Try alternate lead selections. acquisition. 2. Adjust the ECG gain setting by using the ECG GAIN keys, located on the Auxiliary Controls Keypad. No Pressure Trigge |CONDMION | CORRECTIVE ACTION }* The patient’s pulse pressure is 1. Ifappropriate, select a different inadequate to generate a pressure | trigger source. Resume pumping by trigger. pressing the ASSIST/STANDBY key. . If pressure trigger is required, adjust the pressure trigger threshold located on the auxiliary control keypad until a reliable trigger is | obtained. 3. The selected pressure trigget | threshold will be displayed on the |__monitor screen. No Pressure Trigger - Zero Transducer CONDITION (CORRECTIVE ACTION | I 1 © Atcempcing to use pressure trigger |1. Zero the transducer by opening the | wichouc having the transducer transducer to air and pressing the zeroed, | ZERO key for three seconds. 2. Resume pumping by pressing the ASSIST/STANDBY key. 1-4 ‘System 97e Service Manual Chapter 1, OperationHeart Rate Low |* The patient heart rate is less than | 1. Assess the patient. 40 bpm. | 12. Verify proper timing. | © There is inadequate signal 1. Check electrode contact and | acquisition from the patient placement. Verify the integrity of electrodes. | the lead wires and che patient cable. |2. Adjust the ECG gain by using the | ECG GAIN keys, located on the | Auxiliary Controls Keypad Check Pacer Timing CONDITION. CORRECTIVE ACTION '* The patient is not 100% Paced. _|1. Select ECG trigger source, using the TRIGGER SELECT keys, when demand pacing a patient. Press the ASSIST/STANDBY key ro | resume pumping. |e The patient’s AV paced rate is 1. Reduce the pacer rate. above 125 BPM. | j© The patient's V paced rate is above | 185 BPM, ‘© The system is unable co identify (1. Adjust the A-V time interval | |_the A-V interval. between 80 to 225 msec. | |ECG Detected CONDITION. CORRECTIVE ACTION Je A valid ECG is now detected with |1. Select ECG as the trigger source | the INTERNAL trigger selected as | using the TRIGGER SELECT keys. | the trigger source. 2. Verify proper timing. Resume pumping by pressing the ASSIST/STANDBY key. System 97e Service Manual Chopier 1, Operation 1-5ular Trigger je The patient's rhythm is too variable to accurately predict the next systolic trigger event. Je The patient's chychm is regular, however IAB deflation timing is set too lace, interfering with systolic detection. —_—<—<—<———————————— Trigger Interference CONDITION, ‘© The system is detecting electro- surgical interference while in a pacer trigger mode |1. The System has automatically compensated by deflating earlier to avoid interfering with systolic ejection. Consequently, do NOT attempt to adjust the DEFLATION control. 2. Confirm that the patient's ECG also indicates irregularity. If rhythm disturbance persists, consider using ECG trigger mode for more reliable triggering 1. Confirm that the patient's ECG rhythm is regular. If so, then adjust the DEFLATION control earlier to improve consistency of pressure trigger, |CORRECTIVE ACTION 1, Pumping automatically resumes | when interference clears 2. If condition persists however, and interferes with patient support, | select PRESSURE crigger using the TRIGGER SELECT keys. 3. Verify timing and press the ASSIST/STANDBY key to resume | i | pumping a SL System 97e Service Manual CChapler 1, OperationRapid Gas Loss CONDITION. Je A large leak has been detected in |1. Check for blood in the tubing. If | the LAB circuit. found, stop pumping and notify physician. Refer to IAB ‘manufacturer's instructions for [AB removal. 2. If blood is not found in the tubing, verify the connections are leak free. Refill the IAB and closely observe the tubing to verify no blood is present. Press the ASSIST/ | L STANDBY key to resume pumping. —_—— Leak in IAB Circuit (Loss) | |CONDMON. | CORRECTIVE ACTION ‘© There is a small leak in the IAB —_|1. Check for blood in the tubing. If circuit, a loose connection, or a found, stop pumping and notify high rate of Helium diffusion, physician. Refer to IAB | possibly due to the patient being | manufacturer's instructions for IAB | febrile or tachycardiac. | removal. | 2. IF blood is not found in che tubing, verify che connections are leak free. Refill che IAB and closely observe | the eubing to verify no blood is | present. Press the ASSIST/STANDBY key to resume pumping. |3. If the alarm persists and there is no evidence of a leak in the [AB catheter, consider setting the SLOW | GAS LOSS ALARM keys, located on the Override Control Keypad, to the OVERRIDE position System 976 Service Manvel Chopler 1, Operation Ter‘© A gas gain has been detected in che |1. Verify all connections are leak free. TAB circuit. 2. Refill the LAB. Press the | ASSIST/STANDBY key to resume pumping. 3. If alarm persists, contact Datascope Service. Ld —_—— IAB Disconnected | CONDITION. | CORRECTIVE ACTION. }@ The LAB catheter or extension |1, Reattach the IAB catheter and tubing is disconnected, extension tubing. }2. Refill che IAB catheter. Press the ASSIST/STANDBY key to resume pumping. Gas Loss and Catheter Alarms Disabled i 1. If appropriate, set IAB FILL located | on the Override Control Keypad, ro | | AUTO. The system must now be | | | autofilled to activate the alarms. j | | NOTE: The autofill system cannot | _be used with pediatric size catheters, ‘System 97e Service Manvel ‘Chapter 1, OperationBlood Detected CONDITION. [CORRECTIVE ACTION © Blood is detected in the LAB |1. Verify the presence of blood in the catheter. | IAB catheter and/or autofill cubing. 12. Ifblood is present, notify the Physician. Disconnect the [AB catheter from the console as soon as this can be done without endangering the patient. 3. Refer to the IAB catheter manufacturer's instructions for [AB removal. |4. Contact Datascope Service. 5. If no blood is present, then turn the IABP off by setting the SYSTEM POWER switch, located on the front panel, to the OFF position. |6. Wait 10 seconds. 7. Turn the IABP on by setting the ‘SYSTEM POWER switch, located ‘on the front panel, co the ON position. 8, Depress the IAB FILL key for 2 seconds to initiate an autofill. When the autofill completes, depress the | ASSIST/ STANDBY key ro resume | pumping. |9. If "BLOOD DETECTED" message | repeats, then the [AB must be | manually filled before pumping can | continue: Set "IAB FILL" switch, | located on the Override Control Panel to "MANUAL" 10. See the Help Screen, "MANUAL FILL IAB" for instructions on how to perform the manual fill procedure. 11. Contact Datascope Servic System 97e Service Manual Chapter 1, Operation 169Check IAB Catheter CONDITION |CORRECTIVE ACTION 1. Check the markings on the [AB The IAB remains in the sheath immediately after insertion. The IAB membrane is not completely unfolded. catheter co assure the balloon has exited the sheath. If not pull sheath back to appropriate position. |2. Press ASSISTISTANDBY key to resume pumping. 1. Manually inflate and deflate the IAB with 60 cc of gas through the male Tuer of the IAB, |2. Refill the LAB. Press the ASSIST/STANDBY key to resume { pumping. J There is a kink in the IAB catheter |1. Check the catheter tubing and or tubing relieve kink if possible. ae High Drive Pressure |2. Press the ASSIST/STANDBY key to resume pumping. [CONDITION \CORRECTIVE ACTION. ‘There is a component failure in the pneumatic system. | Datascope Service. 1. Artempr to resume pumping by | pressing che ASSIST/STANDBY key. 2. Ifthe message persists, contact | ‘The patient is tachycardiac, ‘There is insufficient vacuum in the drive system. [CORRECTIVE ACTION. | |1. Change the IAB frequency to 1:2 by | using the IAB FREQUENCY key. 2. If the message persists, contact | Datascope Service L_dtive syseerm OS System 97e Service Manual Chapter 1, Operationsee | Augmentation Below Limit Set | |CONDITION | CORRECTIVE ACTION '@ There is a change in the patient's _|1. Assess the patient. | hemodynamic status. | i ‘© The augmentation alarm limit is |1. Reset the AUG ALARM limit to 8 - | set t00 high. 10 mmfig below the patient's augmented diastolic pressure. j@ The IAB AUGMENTATION is |1. If appropriate, increase | set too low. | augmentation by pressing the IAB | AUGMENTATION key toward the | ‘maximum setting. '@ The Helium concentration is low. |1. Refill the IAB catheter. Press ASSIST/STANDBY to resume pumping. J Low Helium | CONDITION | CORRECTIVE ACTION I J* The Helium tank is closed. 1. Open the Helium tank © There are fewer than 24 fills of |_—_—1. Replace the Helium tank. Helium remaining in the tank. ——_— eee Low Battery (EXT) [CONDITION [CORRECTIVE ACTION © There is less than 30 minutes of _|1. The system will switch to internal | baceery operating time remaining | batteries when the external arteries |___on the external battery. | _are depleted. | Low Battery [CONDITION CORRECTIVE ACTION fe There is less than 30 minutes of 1. Verify chat the MAINS power key, | battery operating time remaining. | located on the back panel below the | | |_ safer disk, si ehe ON positon. | | 2. Connect system to an AC power outlet, System 97e Service Manval Chapler 1, Operation 171a | system Failure CONDITION | CORRECTIVE ACTION 'e There is a malfunction of the 1. Turn the IABP off by setting the microprocessor. SYSTEM POWER switch, located | ‘on the front panel to the OFF | position, | 2. Wait 10 seconds. | 3. Turn the IABP on by setting the SYSTEM POWER switch, located ‘on the front panel to the ON position. '4. Ifthe condition repeats, contact} | Datascope Service. i ——_—_——_———— Electrical Test Fails Code #. CONDTION | CORRECTIVE ACTION j¢ There is a start-up failure in a 1. Turn the IABP off by setting the ‘major subsystem of the IABP. SYSTEM POWER switch, located con the front panel to the OFF | | position. | { [2 Waie 10 seconds. } 3. Turn the IABP on by setting the | SYSTEM POWER switch, located | on the front panel to the ON position. |4, If che condition persists, note the code number displayed and contact Datascope Service a Slow Gas Loss Override On CONDITION [CORRECTIVE ACTION © The SLOW GAS LOSS ALARM is 1. Set the SLOW GAS LOSS ALARM set to OVERRIDE. | “located on the Override Controls | Keypad, co the ON position, if appropriate System 97e Service Manual ‘Chapler 1, Operation= Maintenance Required Code #__ CONDTON | CORRECTIVE ACTION | j© The internal microprocessor has 1. Note the code number displayed and determined that System contact Datascope Service. maintenance may be required. | ———S$ Autofill Failure CONDITION. [CORRECTIVE ACTION. © The IABP cannot fill the IAB 1. Verify that the correct size IAB | cathecer system automatically. catheter and extender are attached. |2. Verify that the aurofill tubing is connected to the IAB Fill Port and the drain tubing is connected to the Drain Port, on the Safety Disk. 3. Refill the LAB catheter. Press ASSIST/STANDBY to resume | pumping. If the autofill fails | again, set IAB FILL located on | the Override Control Keypad to | MANUAL. Manual fill the LAB catheter. Contact Datascope Service. | Autofill Failure - No Helium | CONDITION. {CORRECTIVE ACTION |e The Helium tank is closed. [1 Open the Helium tank. © The Helium tank is empry. |L. Replace the Helium tank. | Safety Disk Test Fails | CONDITION, |CORRECTIVE ACTION |e There is a leak in the drive system | 1. Check that the fittings are leak tight | ois fittings and that the Safety Disk is properly inscalled. | 2. Repeat the leak test. Ifthe test fails | again, replace the Safety Disk. 3, Repeat the leak test. | jem 97e Service Manual ‘pier 1, Operation 173No Patient Status Available <_< _ << CONDITION © There was an internal communications failure — ‘CORRECTIVE ACTION 1. Monitor patient paramecers closely on the external monitor. 2. Contact Datascope Service. |Autofill Required [CONDITION [CORRECTIVE ACTION [©The IAB FILL key bas been Ti. ifappropriate return the LAB FILL changed from MANUAL co key, located on the Override AUTO without an Controls Keypad, co MANUAL. auofill. Press the ASSIST/STANDBY key to | resume pumping. 2. If the autofill mode is desired, refill | the IAB catheter. Press the ASSIST/STANDBY key to resume pumping. ©The Syscem was in standby when the aucofill was due. Auxiliary Controls Unavailable |1. Refill che IAB. Press the ASSIST/STANDBY key to resume pumping. CONDITION CORRECTIVE ACTION je The Auxiliary controls and | Recorder controls are not | functioning properly 1. Contact Datascope Service. Note: All auxiliary controls can not be changed and are set to their last setting. See the display to verify settings, ‘System 97e Service Manval Chapter 1, Operation{Battery in Use (EXT) CONDITION /* The IABP is being powered from ‘an external (Battery or DC) power source. Battery in Use | CORRECTIVE ACTION 1. Verify that it is necessary to operate from an external power source. If appropriate, switch to the AC power source. 2. Verify MAINS power switch located ‘on the back panel below the safety disk is on. CONDITION [CORRECTIVE ACTION [* The ABP is being powered from the internal batteries. 1. Verify that it is necessary to operate from the internal battery. If appropriate, switch to the AC power source. |2. Verify MAINS power switch located on the back panel below the safety disk is on. ‘System 97e Service Manual Chapter 1, Operation 1-75——_————— [Manvel Fill JAB (Follow these steps i AB Fill Key hos olready been pressed) ‘Adult Size IAB Catheters 1. Remove the autofill rubing from the IAB Fill Port on the Safety Disk. | 2. Attach a three way stopcock to the LAB Fill Port on the Safecy Disk. 3. Attach a 60 cc syringe to the stopcock. '4. Open the stopcock between the disk and syringe. Evacuate the disk by pulling back on the syringe plunger. 5. Close the stopcock to the disk. Evacuate the syringe. 6. Repeat steps 4 and 5 until strong resistance is noted. A strong resistance should be noted within three attempts. Ifa strong resistance is noted, proceed to step 8. 7. Ifa strong resistance is not noted within three attempts, remove the Drain port tubing and attach the Drain port plug, located in the manual fill accessory kit, to the Drain port. Repeat steps 4 through 7. | ee [Manual Fill LAB, Adult Size IAB Catheters NOTE: All Datascope adult size IAB Catheters have a manual fill pre-load of 80 cc, When using catheters from another manufacturer consult manufacturer for guidelines. 8. Attach the syringe to the manual fill port located below the Safety Disk. (9. Fill the syringe and discard the contents. | 10. Fill the syringe with 40 cc's of Helium. | 11. Holding the syringe tip DOWN, attach the syringe to the stopcock on the Safety Disk, and open the stopcock to the disk. Se |Manual Fill 1AB Adult Size IAB Catheters 12. Press the IAB FILL key for one second to allow the syringe contents to be | drawn into the disk. | 13. Close the stopcock to the disk. 14, Refill the syringe with the remaining 40 cc pre-load of Helium from the manual fill port. 15. Holding the syringe tip down, attach the syringe to the stopcock on the Safety Disk. |16. Open the stopcock to the Safety Disk. The remaining 40 ccs of gas is drawn | | into the disk. 117. Close the stopcock and remove the syringe. | 18, Press the ASSIST/STANDBY key co begin pumping. 176 System 97e Service Manvel ‘Chapter 1, Operation|Manual Fill LAB (Follow these Pediatric IAB Catherers 1. The IABP Override keys, TIMING and IAB FILL, located in the Auxiliary Controls Compartment, must be set to MANUAL. if 1AB Fill Key has already been pressed) 2. Refer to the pediatric balloon catheter instructions for the correct Safecy Chamber size, pre-load volume and extender. 3. Detach the autofill cubing line from the IAB Fill Port on the Safety Disk. | 4, Remove the Adult Safery Disk from the IABP. Install the pediatric adapter, | drive hose and the appropriate size Safety Chamber as directed in the Operator manual, /Manval Fill {AB Catheter Pediatric LAB Catheters 5. Attach a three way stopcock to the LAB Fill Port on the Safety Chamber. \ (6. Attach the patient balloon and extender to the Safety Chamber. 7. Attach 20 ce syringe to the stopcock. '8. Open the stopcock between the chamber and syringe. Evacuate the chamber by palling back on the syringe plunger. '9. Close the stopcock to the disk. Evacuate the syringe. 10. Repeat steps 8 and 9 until strong resistance is noted. Pediatric IAB Catheters 11, Attach a 20 ce syringe to the manual fill pore below the Safety Disk. 12. Fill the syringe and discard the contents. 13, Fill the syringe with che correct pre-load volume of Helium as outlined in the catheter instructions. If the pre-load volume exceeds 20 cc, fill the syringe with half of the appropriate pre-load volume. 14, Holding the syringe tip DOWN, attach the syringe to the stopcock on the |__ Safety Chamber, and open the stopcock to the chamber. stem 97e Service Manual Chapier 1, Operation|Manual Fill [AB Catheter Pediatric IAB Catheters j 15. Press the AB FILL key for one second to allow the syringe contents to be drawn into the chamber. Close the stopcock and remove the syringe. 16, If the pre-load volume exceeded 20 cc's, add the remaining pre-load volume by repeating steps 13 through 15. 17. Close the stopcock and remove the syringe. 18, Press the ASSIST/STANDBY key to begin pumping. en /Manvol Fill [AB (Follow these steps if JAB Fill Key has not been ) Adult Size IAB Catheters 1. Remove the autofill cubing from the LAB Fill Port on the Safety Disk. 12. Attach a three way stopcock to the IAB Fill Port on the Safety Disk. 3, Artach a 60 cc syringe to the stopcock. 4, Press the LAB FILL key for 1 second to relieve vacuum. 5. Open the stopcock between the disk and syringe. Evacuate the disk by pull- ing back on the syringe plunger. | 6. Close the stopcock to the disk. Evacuate the syringe. 7, Repeat steps 5 and 6 until strong resistance is noted. A strong resistance should be noted within three attempts. If a strong resistance is noted, proceed to step 9. 8. If a scrong resistance is not noted within three attempts, remove the Drain port tubing and attach the Drain port plug, located in the manual fill acces- sory ki, to the Drain port. Repeat steps 5 through 7. |Manual Fill LAB [Manwal Fill AB Adult Size IAB Catheters NOTE: All Datascope adult size IAB Catheters have a manual fill pre-load of | 80 cc. When using catheters from another manufacturer consult manufacturer for guidelines. 9. Artach the syringe to the manual fill port located below the Safety Disk. | 10, Fill che syringe and discard the contents. 11. Bill the syringe with 40 cc's of Helium. | 12. Holding the syringe tip DOWN, attach the syringe to the stopcock on the | | Safety Disk, and open the stopcock to the disk. 178 ‘System 97e Service Manual ‘Chapter 1, Operation ee oe ee ee ee ee ee ee ee ee ee‘Manval Fill WAB Adult Size IAB Catheters ||13. Press che IAB FILL key for one second to allow the syringe contents to be drawn into the disk. 14, Close the stopcock to the disk. 15, Refill the syringe with che remaining 40 cc pre-load of Helium from the ‘manual fill port. 16. Holding the syringe tip down, artach the syringe to the stopcock on the Safery Disk. 17. Open the stopcock to the Safety Disk. The remaining 40 cc's of gas is drawn into the disk. 18. Close the stopcock and remove the syringe. 19. Press the ASSIST/STANDBY key to begin pumping. |Manval Fil JAB (Follow these steps if 1AB Fill Key has not been pressed) Pediatric IAB Catheters } j 1. The IABP Override keys, TIMING and IAB FILL, located in the Auxiliary ‘Controls Compartment, must be set to MANUAL. 12. Refer to the pediatric balloon catheter instructions for the correct Safety Chamber size, pre-load volume and excender. 3. Detach the autofill tubing line from the IAB Fill Pore on the Safety Disk. ||4. Remove the Adult Safety Disk from the IABP. Install che pediatric adapter, drive hose and the appropriate size Safety Chamber as directed in the Opera- tor manual (EES ‘Manvel Fill AB Catheter | Manvel Fill AB Catheter Pediatric IAB Catheter 5. Attach a three way stopcock to the IAB Fill Pore on the Safety Chamber. |6. Accach the patient balloon and extender to the Safety Chamber. |7. Actach a 20 cc syringe to the stopcock. 8, Press the IAB FILL key for 1 second to relieve vacuum, }9. Open the stopcock between the chamber and syringe. Evacuate the chamber by pulling back on the syringe plunger. 10. Close the stopcock to the disk. Evacuate the syringe. | 11. Repeat steps 9 and 10 until strong resistance is noted. | LiL Repeat steps 9 and 10 uncil strong resistance nore ‘System 97e Service Manual Chapier 1, Operation 1-79Pediatric LAB Catheters 12, Attach a 20 cc syringe to the manual fill port located below the Safety Disk. 13. Fill the syringe and discard the contents, 14, Fill che syringe with the correct pre-load volume of Helium as outlined in the catheter instructions. If the pre-load volume exceeds 20 cc, fill the syringe with half of the appropriate pre-load volume. 15. Holding the syringe tip DOWN, attach the syringe to the stopcock on the | Safecy Chamber, and open the stopcock to the chamber. |Manual Fill LAB Catheter Pediatric LAB Catheters 16. Press the IAB FILL key for one second to allow the syringe contents to be drawn into the chamber. Close the stopcock and remove the syringe. 17. If the pre-load volume exceeded 20 cc’s, add the remaining pre-load volume by repeating steps 14 through 16. 18. Close the stopcock and remove the syringe. 19. Press the ASSIST/STANDBY key to begin pumping. 1-80 System 97 Service Manual Chapter 1, OperationInitial Set Up 1. Open the Helium Tank. 2. Establish ECG and Pressure. 3. Zero the transducer: © Open the transducer to air. ‘* Press the ZERO key for 3 seconds. 1 Close the transducer. Initial Set Up 4. Confirm the initial pump settings: Control Panel: ‘TRIGGER SELECT: ECG IAB FREQUENCY: 1:1 | IAB AUGMENTATION: Off IAB INFLATION: Midpoint IAB DEFLATION: Midpoint Override Controls: TIMING: Auto TAB FILL: Auro SLOW GAS LOSS ALARM: On Auxiliary Controls: ECG GAIN: Normal Verify MAINS power switch is ON |5. Set the Initial Timing: | * Adjust the IAB INFLATION and DEFLATION controls to position the | intensified portion of the arterial waveform to begin at the dicrotic notch and | end before the systolic upstroke I 6. Fill the IAB catheter: ‘© Attach the IAB catheter and the appropriate extender to the Safety Disk. * Press and hold the IAB FILL key until che message "Autofilling" appears in the upper left corner of the display. System 97e Service Manual Chapter 1, Operation 7-817. tnitiace Pumping: | # Once the "Autofilling" message clears, Press che ASSIST/STANDBY key. | ‘¢ Increase the IAB AUGMENTATION until optimal augmentation is, observed in diastole. ‘* Fine rune the timing by adjusting the IAB INFLATION and DEFLATION controls if needed. 8. Verify AUG. ALARM: «© Verify that the AUG. ALARM setting is approximately 10 mmHg less than the patient's diastolic augmentation pressure. Adjust, if needed, by pressing AUG. ALARM and using the arrow keys to change the value displayed on the screen. 9. Initial secup is now complete. 7-82 System 97e Service Manval Chapter 1, Operation1.3.20 EXTERNAL MONITOR INTERFACING ‘The System 97¢ can display and be triggered from analog signals provided by external monitors. The signal level should be 1V/mV for ECG and 1V/100mmHg for blood pressure. ECG with Standard Accessory External Signal Cable (0012-00-0323)* 1. The cable is supplied wih a stereo phone plug to be connected to the ‘System 97e rear panel ECG Monitor Input jack (65). The other end should be terminated wich the appropriate connector for the external monitor. ‘The external monitor's signal output should be 1V/ImV. Pacer trigger selections can be used with this cable. See section 3.11 for external monitor specifications. These specifications must be met for proper System ECG triggering, 2. The following connections should be made to the external monitor connector: Brown To. Volt / 1 mV ECG signel output —__ Ch Black RAG, To signal ground Figure 1-51 - External Signal Coble Pressure with Standard Accessory External Interface Cable (0012-00-0323) 1. The cable is supplied with a stereo phone plug to be connected to the System 97e rear panel Pressure Monitor Input jack (64). The other end should be terminated with the appropriate connector for the external monitor. The external monitor's signal output must be 1V/100mmHg. See section 3.11 for external monitor specifications. These specifications must be met for proper System ECG triggering. 2. The following connection should be made to the external monitor connector. Brown 72 1 Volt / 100mmHg PRESSURE ——— signal output of external monitor Black White To signal ground Figure 1-52 - External Interface Cable WARNING: External bedside monitors used with the System 97¢ in the operating room must be equipped with elecro-surgical interference suppression "*Daatatcope daes not recommend the use of the 0012-00-0467 cable with the System 97e | | System 97e Service Manual Chapter 1, Operation 183Figure 1-53 Disconnect Connections Figure 1-54 Remove Safety Disk Figure 1-55, Install Pedctric Adapter Assembly 1.3.21 Pediatric Balloon Pumping The following is an abbreviated version of refer to Sections 1.3.1 through 1.3.16 for d che normal set up instructions. Please leailed procedures. ‘The drive system of the System 97¢ is modified for pediatric use by replacing the safety disk with the pediatric adapter assembly P/N 0998-00-0110-01. This adapter extends the drive pressure line allowing remote placement of the safecy chamber isolator by the patient's side. This is required to keep pediatric IAB catheter length short. Note that the 4 and 6 fe. extension catheters are used only ‘with adult balloons. 1.3.21.1 Pediatric Adapter Installation 1. Disconnect all pneumatic and electrical connections {Auto Fill Port (69), Drain Port (68), IAB Catheter Extender (52), and DC Input (54)} 2. Turn the adult safety disk approximately 30° counter-clock-wise and pull straight out. 3. Install pediatric adapter assembly. 84 System 976 Service Manual Chapter 1, Operation4, Hand-tighten the appropriate size pediatric safety chamber onto the other | end of the adapter hose. (See table below for the correct safety chamber selection.) | | Datasco rite Safety Chamber Pedi ABs aero 25.5.6 [Pediaeric (15 cc) Safety Chamber 12,20 Adult (72 cc) Safecy Chamber 1.3.21.2 Safety Chamber Leak Test (Pedicstric) Perform a safety chamber leak test using the following procedure: 1. Unplug the safecy chamber fill pore and install a plastic 3-way stopcock. 2. Move the safecy chamber close ro the System 97e and attach the aurofill tube ro the stopcock, Open stopcock to the safety chamber. 4, Press and hold the IAB FILL key (4) while pressing the System Power On/Off key to ON. Release the IAB FILL key when the message "SAFETY DISK LEAK TEST" appears adjacent to the ADVISORY (23) on the display. See section 1.3.2.2 for a detailed description of the leak test. ‘At the completion of the leak test, remove the autofill cube. The 3-way stopcock can remain in order to facilitate manual pre-loading. 1.3.21.3 Establish Trigger (Pediatric) Establish Power (AC Operation) 1. Remove IAB or any plug, or syringe, from the patient balloon connector on the safety disk. 2. Check thar che detachable line cord is securely seated in MAINS power receptacle (57) on the pump console. Plug System line cord into a grounded, 3-prong AC receptacle marked "Hospital Grade." Do not use an adapter to eliminate U-ground. 3. Check thar che IABP ON/OFF key (37) is in the "ON" position. Figure 1-56 Attach Pe Sofety Char ric amber Spe 978 Seviee Manvel Chapter 1, Operation 1-854. Check thar the BATTERY CHARGING indicator (43) is illuminated or flashing. Normal Power Up Procedure L. Select ECG as the trigger. 2. The System performs an electrical and pneumatic self test. ‘When self-check is successful, "SYSTEM TEST 0.K." message will appear. In the event that any electrical or pneumatic test fails, the message "ELECTRICAL TEST FAILS CODE #___" displays on the screen. The code number indicates ‘which test has failed in the System. Power cycle the System (power down for a minimum of 10 seconds) and if message repeats, record code # and call Datascope Service Representative. See Section 4, Troubleshooting Procedure for probable cause and recommended action. Establish Fill Gas Procedure 1. Slowly open helium cylinder valve fully counter-clockwise. NOTE: Close cylinder valve fully clockwise when System is not in use to prevent potential leak and depletion of helium supply. 2, Make sure that the helium pressure gauge (70) shows supply is in the operating range (within the white area). 3. Check that the message "LOW HELIUM " is not displayed. If ic is displayed, check the helium cylinder gauge for adequate gas capacity and check helium cylinder attachment for leaks. Replace the cylinder if necessary. Initial Set-up for Pediatric Balloon Pumping 1. Set the monitor module controls as follows: Control Setting IAB FREQUENCY @ Ll IAB AUGMENTATION — 3) off IAB INFLATION ” Midpoint IAB DEFLATION 6 Midpoint 2. Set pump console controls as follows: Control Sexting SLOW GAS LOSS ALARM (44) ON IAB FILL MODE 45) MANUAL TIMING 46) MANUAL ECG GAIN 7) NORM PRESSURE THRESHOLD (48) NORM 3. Atcach Pediatric LAB catheter to safety disk now or after acquisition of ECG and pressure signals. See sections 1.3.2.5, 1.3.2.6, and 1.3.2.8 for ECG Acquisition, Arcerial Pressure Acquisition, and Selection of Trigger. 1-86 ‘System 97e Service Manual Chapter 1, OperationTiming of Pediatric Balloon Pumping MANUAL TIMING NOTE: The System 97e is designed to recognize heart rates up to 200 bpm. At rates in excess of 200 bpm #4 bpm, the trigger refractory period causes the System 97e to automatically switch to a frequency of 1:2, The System will automatically revert to 1:1 frequency when the heart rate falls below 200 +4 bpm. Check that the TIMING key (46) is in the MANUAL position and the "MANUAL" indicator is illuminated. Use the INFLATION (7) slide control to move the intensified segment of the arterial pressure trace so that it begins at the dicrotic notch. Adjust the DEFLATION (6) slide control so that the intensified portion ends slightly before the up slope of the arterial pressure waveform, (On the inflate control scale "0" represents inflation at the trigger evenc wich each increment representing a 125 msec delay. On the deflate control scale "0" represents deflation immediately after inflation with each increment representing 2 125 msec delay. If inflation is adjusted, deflation will also require adjustment. If a trigger event is detected prior to the IAB deflation point, a safeguard will automatically deflate the IAB at the trigger event. AUTO TIMING WARNING: Use ONLY MANUAL TIMING when pumping with pediatric catheters, Efficacy of auto timing logic is unproved in she pediatric population and is not recommended. Use of Auto Timing Logic is NOT recommended with pediatric catheters. IMPORTANT: Ac rates in excess of 200 +4 bpm, it is possible that auto timing logic could cause patient harm, as inflation could extend into the next cardiac cycle. Under NO circumstances should auto timing be used when the patient's heart rate approaches this range. 1.3.21.4 Preloading Pediatric Catheters NOTE: Autofill cannot be used with pediatric catheters. Follow this procedure and use the exact preload specified on the balloon package. NOTE: Complete the installation of the pediatric adapter assembly, as derailed in section 1,3.17.1, before proceeding. 1. Set the TIMING (46) and IAB FILL (45) keys to manual, 2. Attach a 3-way stopcock to the side port luer fitting on the chamber. 3. Press IAB FILL key (4) for one second. Screen will display "MANUAL FILL IAB" message. System 97e Service Manual Chapter 1, Operation 1-87Figure 1-57 Attach Syringe ‘to Stopcock Figure 158 Open and Cose Figure 1-59 Attach Syringe to Manual Fill Port Figure 1-60 Attach filed ‘Syringe to Stopcock Check that the helium gauge indicates sufficient gas pressure. ‘Attach an empty 20 cc syringe to the 3-way stopcock. Open the stopcock between the syringe and the safety chamber. Use only the plastic syringe supplied. Evacuate the safecy chamber by pulling up on the plunger of the syringe. Close the stopcock to the safety chamber and press the plunger down to empry the syringe. Repeat this | until a strong resiscance is felt. Safety chamber balloon should be tightly collapsed after this procedure. Close the stopcock to the safety chamber to the "OFF" position. Remove syringe. Artach a 20cc syringe to the Manual Fill Pore (67). Fill the syringe and discard the contents. Fill the syringe second time with the amount of preload specified on the balloon package. WARNING: Extreme care should be taken during this process. Never use a glass syringe for this procedure. Hold your hand over the syringe plunger. Fill rhe syringe and discard the contents. Hold che syringe tip down and/or cover ‘with your finger. Attach the filled syringe to the stopcock on the safery ‘chamber and open the stopcock becween the safery chamber and the sytinge. iL | OPENED ‘cLoseD 1-88 ‘System 97e Service Manvel Chapter 1, Operation9. Press the IAB FILL key (4) for 3 seconds. Contents of the syringe will be pulled into the safety chamber. PRECAUTION: If the content of the syringe are not drawing into the safety chamber, DO NOT resume balloon ‘pumping. Return to sep 5 and repeat the ‘procedure paying careful attention to the syringe fill volume. Ifthe second attempt fails, there most likely isa leak at one of ‘the safety chamber ports or stopcock and they should be checked. Close the stopcock and remove the syringe. Manual fill is complete. NOTE: Due to diffusion of gas, the manual fill procedure should be repeated as needed or every 45 minutes. 1.3.21.5 Initiation of Assist (Pediatric) 1. Check that IAB AUGMENTATION (3) is OFF. 2. To initiace assist, press the ASSIST/STANDBY (5) key. The indicator within the key begins co flash for each inflation. NOTE: Only for the first initiation of assist, a short full inflation cycle is initiated to facilicate pressure delay measurements. 3. Use the IAB AUGMENTATION arrow key (5) to slowly increase the level uncil IAB augmentation is optimal. 4, If necessary, adjust the IAB INFLATION (7) and LAB DEFLATION (6) controls to achieve proper timing. 5. Press and hold the VERIFY key (21) to confirm that the intensified segment of the arterial pressure trace begins approximately at the dicrotic notch. If not, the intensification delay can be automatically recalculated by quickly pressing and releasing the VERIFY key (21). Confirm proper intensification position. If still incorrect, it can be manually adjusted by holding down the VERIFY key (21) and pressing the Pressure SCALE key (20). Each subsequent depression of the pressure SCALE key moves the intensification by four msec. The intensification delay will also be indicated at the bottom left of the display as APD _ __ (Arterial Pressure Delay). This delay can be adjusted from 0 to 140 msec NOTE: If the patient's pressure monitoring site is changed while pumping, the VERIFY key (21) can be quickly pressed and released to recalculate Figure I-61 Press IAB Fill Key System 97e Service Manual Chopter 1, Operation 7-89arcerial pressure transmission delay. Reconfirm proper intensification position. This will assure accurate digital pressure displays. 6. Confirm thar the AUG ALARM is ON and the limit is set approximately 10 mmHg below diastolic augmentation. PRECAUTION: Wen in the Manual Fill Mode, the IAB Catheter and Gas Loss ‘Alarms are disabled. Therefore, use of the Low Augmentation Alarm is essential in pediatric IAB patient care. By setting the Low Augmentation Alarm, the System ‘monitors the level of assist and alerts the user in the evens that readjustment of camerals andjorre-selection of modes of eperasion is required. 7-90 System 97e Service Manual ‘Chapter 1, Operation1.3.22. System Configuration 1.3.22.1 To Set the Time/Date The Time/Date is set in the System Configuration. 1. To enter the System Configuration mode press and hold the Manual Timing key (46) while curning the [ABP ON/OFF switch (37) to ON. NOTE: the Manual Timing key must be held pressed until the System Configuration screen displays.) The Set Time/Date menu displays. | | Set Time/Date Soket(SEIEC) ar STANDBY, STANDBY) Figure 1-62 - Time/Date Menu 2. Press che IAB FREQUENCY SELECT key (2) to set the time and date. HRM DO/NMY/YY <> (AUG) Select (SELECT) Exit (STANDBY) Figure 1-63 - Time/Date Screen 3. The hours (HHH) field is highlighted. (The field chat is highlighted, is the field hac can be changed.) Press the IAB AUGMENTATION Up & Down Arrow keys (3) to change the number in this field 4, Press the IAB FREQUENCY SELECT key (2) to move the highlighting to the minutes (MM) field, Press the IAB AUGMENTATION Up & Down Arrow keys (3) to change the number is this field, 5. Continue using the SELECT key and the Arrow keys to set the month, day and year. 6. When the desired time and date have been set, press the ASSIST/STANDBY key (5) to exit this screen. The Ser Time/Dare menu displays. Press the ASSIST/STANDBY key (5) twice to exit this mode. The System restarts and recurns (0 the normal monitoring mode. Sper 97e Service Manvel Chapter 1, Operation 1911.3.22.2. Extended System Configuration 1. Toenter the extended system configuration, while in the System Configuration Mode press the TIMING-AUTO key (46) rwice. The Extended System Configuration menu displays. Date Format Selection Modem Selection Display Event Logs Display Interna! Stotistics Display Software Revision Language Selection Balloon Waveform Selection { Select (SELECT) Enit (STANDBY, STANDBY), {Sect (SELECT) STANDBY, STANDBY) Figure 1-64 - Extended System Configuration Menu 1.3.22.3 Date Format Selection The System 97e allows the date to be set as DD/MM/YY or MM/DD/YY. 1. Toenter che dace format menu item, press the IAB AUGMENTATION Up & Down Arrow keys (3) to select Date Format Selection. 2. Press the IAB FREQUENCY SELECT key (2) to select che desired format, 3. When che desired format is selected, press the ASSIST/STANDBY key (5) ro exit this screen, The Extended User Configuration menu displays. Press the ASSISTISTANDBY key (5) twice to exit this mode, The System restarts and returns to the normal monitoring mode Date Format Selection Curent Format-> —DD/MNY/YY (20/10/97) AM\/OD WY (10/20/97) Select (SELECT) Exit (STANDBY) Figure 1-65 - Date Format Selection Screen 1-92 System 97e Service Manvel Chapter 1, Operation1.3.22.4 Modem Selection 1. To enter the modem selection menu icem, press the IAB AUGMENTATION Up & Down Arrow keys (3) to highlight Modem Selection. 2. Press the IAB FREQUENCY SELECT key (2) to open the Modem Selection screen. 3. Press the AUG Up & Down Arrow keys (3) to highlight the desired modem. 4, When the desired modem is highlighted, press the SELECT key (2). ‘Modem Selection TDK - Germany Current Modem -> TDK - Japan Internal TDK -UK. TDK - France TDK - Spanish Cermerek CH1793 Cermerek CH1794 Generic 2400 User Define/Country < > (AUG) Select (SELECT) Exit (STANDBY) Figure 1-66 - Modem Selection Screen For all selections, except "User Define/Country", a second sub-menu will display In this sub-menu the modem location needs co be specified as Internal or External. Use the AUG Up & Down Arrow keys to highlight the location and then press the SELECT key to enter. ‘Modem Selection Current Modem -> Generic 2400 Internal External | < > (AUG) Select (SELECT) Exit (STANDBY) Figure 1-67 - Modem Internal/External Selection Screen 5. Press the ASSIST/STANDBY key (5) to exit this screen, The Extended User Configuration menu displays. Press the ASSIST/STANDBY key (5) twice to exit this mode. The System restarts and returns to the normal monitoring mode. System 97e Service Manual Chapter 1, OperationUser Define/Country Modem Selection When the User Define/Country modem is selected, the following screen is displayed NOTE: Contact Datascope Service Personnel for assistance in setting up 2 User Define/Country modem. User Define/Country | Modem ID String USER DEFINED MODEM Initialization String AT&F1 Reset String AT&CL Default DTE Baud Rate 9600 Override DTE Default (Y/N)? NO ‘Modem Location EXTERNAL < > (AUG) Select (SELECT) Exit (STANDBY) Figure 1-68 - User Define/Country Modem Selection To set the Modem ID String, Initialization String, and Reset String or modify the current secting of these strings, highlight one of them and press the SELECT key (2). A "Key Inpuc’ displays at the bottom of the screen along with the string co be modified in square brackets *[ ]* User Define/Country } Modem ID String USER DEFINED MODEM Initialization Sering AT&L Reser String AT&C1 | Default DTE Baud Rate 9600 i Override DTE Defaule (Y/N)? NO Modem Location EXTERNAL | | ' | Key Inpue: | | | &/96\$*-+=ABCDEFGHIJK =LMNOPQRSTUVWXYZ | | 0123456789 SPACE <- -> DONE [ USER DEFINED MODEM J | | foe ee |< > (AUG) Select (SELECT) Exit (STANDBY) | tL Figure 1-69 - User Define/Country Modem Selection with Key Input 194 System 97e Service Manual Chapter 1, Operation2. Ahighlighted cursor is placed on the first character within the square brackers. To change that character, use the AUG Up & Down Acrow keys (3) 10 highlight a character in the "Key Input" section and press the SELECT key (2). The cursor has now moved over to the next character within the square brackets. To skip a character or to go back to a character, highlight either the <-, or => in the "Key Input" and press the SELECT key (2). Each time this is done the cursor will move one space to the left or right accordingly. 3. To change the ‘Default DTE Baud Rate", highlight that line and press the SELECT key (2) ‘The available choices display within that line. Highlight the desired choice and press the SELECT key (2). ee | User Define/Country ‘Modem ID String USER DEFINED MODEM Initialization String AT&EL | Reser String AT&C1 Default DTE Baud Rate 1200 2400 4800 9600 19200 38400 | Override DTE Default (Y/N)? NO ‘Modem Location EXTERNAL < > (AUG) Select (SELECT) vit (STANDBY) Fiore 170- User Deine/ Country Modem Selection, Changing the Def OTE Bovd Rate 4. To change the "Override DTE Default (Y/N)?", highlight that line and press the SELECT key (2), The choices of "Yes: and "No" display on that line. Highlight the desired choice and press the SELECT key (2). To change the "Modem Location’, highlight that line and press the SELECT key (2) ‘A sub-menu displays the choices of "Internal" and "External". Highlight the desired choice and press the SELECT key (2). System 97e Service Manual Chapter 1, Operation 1-95‘Modem Setup Instructions i Press and hold the MANUAL Timing Key in the override controls section of the Auxiliary keypad and then power on the system while keeping the key pressed. The first SYSTEM CONFIGURATION screen will be displayed. Double press the AUTO Timing key in the override controls section of the Auxiliary keypad. The full configuration menu, with modem selection as a choice, should be displayed. Use the Up/Down Arrow keys in the IAB Augmentation section of the Main keypad to highlight the modem selection. Press the SELECT key. If the system is equipped with a configurable modem, the USER DEFINED selection will be highlighted and pointed to. Press SELECT to continue. NOTE: If the USER DEFINED section is not highlighted, the modem is noc configurable. 5. Using the AUG Arrow keys, highlight Initialization string. Press SELECT. Use the AUG Arrow keys to highlight characters, and press the SELECT key to choose. Enter the following: ATAE-I (country code) Z For example, in the United Kingdom the string will be: AT&F-12Z and in Germany the string will be AT&E-117Z “The following are the country codes. If the country in which the system is to be used is not on the list contact your Datascope Representative. (Country, {Country Code ‘Australia [20 [auseria 22 | Belgium 23 Czech Republic __|18 (Denmark 10 Egypt 3 Finland 9 France i25 [Germany 7, [Ireland 24 | Israel Las. Teal | Japan 13 Netherlands 5 New Zealand {11 Norway | Poland is ‘South Africa 116 Spain ia Sweden Zz i 7-96 System 97e Service Manual Chapter 1, Operation(Country [Country Code Switzerland 14 Turkey [3 [United Kingdom [2 UAE 2 All Other {1 | {Countries Select DONE when all initialization information has been encered. 7. Verify che Reset Scring is sec to AT&F. 8. Set Defaule DTE Baud Rate to 9600. 9. Verify Override DTE Default (Yes/No) is NO. 10. Verify modem Location is INTERNAL. 11. Press ASSIST/STANDBY key to exit. 12, At Modem Selection Screen, press ASSIST/STANDBY key. 13. At System Configuration Screen, press the ASSISTISTANDBY key twice. System should now return to regular operation, configured and ready for use. 1.3.2.5 Display Event Logs 1. Toenter the Display Event Logs menu item, press the IAB AUGMENTATION Up & Down Arrow keys G3) to highlight Display Event Logs. 2. Press the IAB FREQUENCY SELECT key (2) to open the Current Faults! Occurences log. Current Faults/Occurrences This displays the fault log containing the fault number and the count of that fault. This fault log can be cleared by pressing the REF LINE key twice. Current Fault/Occurrence | 173 | 331 | 372 | 573 | Cheor (REF LINE - REF LINE) Next Log (SELECT) Exit (STANDBY) Figure 1-71 - Cument Faul/Ocurrence Log Siptem 970 Serce Marval Chapter 1, Operation 17(Clear (REF LINE - REF LINE) ‘Next Log (SELECT) Exit (STANDBY) Last Faults Press the SELECT key (2) again to display the time and date of the last 20 faults. This fault log can be cleared by pressing the REF LINE key cwice Last Faults 37 22/04/97 10:01:58 Autofill Fail FILL.C 1938 50 57 21/04/97 10:01:58 Autofill Fail FILL-C 1938 50 57 20/04/97 10:01:30 Autofill Fail FILL.C 1938 50 | 00 00/00/00 00:00:00 000 00 00/00/00 00:00:00 000 00 00/00/00 00:00:00 000 00 00/00/00 00:00:00 000 00 00/00/00 00:00:00 000 00 00/00/00 00:00:00 000 00 00/00/00 00:00:00 000 00 00/00/00 00:00:00 000 00 00/00/00 00:00:00 000 00 00/00/00 00:00:00 000 00 00/00/00 00:00:00 000 00 00/00/00 00:00:00 000 00 00/00/00 00:00:00 000 00 00/00/00 00:00:00 000 00 00/00/00 00:00:00 000 00 00/00/00 00:00:00, 000 00 00/00/00 00:00:00 000 ‘Clear (REF LINE - REF LINE) ‘Next Log (SELECT) Exit (STANDBY) Figure 1-72 - Lost Faults Lo Last Alarms ™ § Press the SELECT key (2) again to display the time and date of the last 20 alarms. This fault log can be cleared by pressing the REF LINE key twice. Last Alarms 22/04/97 10:01:58 Autofill Failure-No Helium 21/04/97 10:01:58 ‘Autofill Failure-No Helium 20/04/97 10:01:30 ‘Autofill Failure-No Helium 17/03/97 14:15:20 No Trigger 00/00/00 00:00:00 00/00/00 00:00:00 | 00/00/00 00:00:00 (00/00/00 00:00:00 00/00/00 00:00:00 | 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 (00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 Figure 1-73 Lost Alarms Log 198 System 97e Service Manual Chapter 1, OperationLast Electrical Failures Press the SELECT key (2) again to display the time and date of the last 20 power up faults. This fault log can be cleared by pressing the REF LINE key twice. Last Electrical Failures 22/02/97 10:01:58 Electrical Test Fails Code #119 00/00/00 00:00:00 00/00/00 00:00:00 | 00/00/00 00:00:00 | | | 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 000 (Gleor (REF LINE - REF LINE) Next Log (SELECT) Exit (STANDBY) | [hee Reetoe EE ece cee ne | Figure 1-74 Last Becca Failures Log System 97e Service Monval Chapter 1, Operation 1-99Last Triggers Press the SELECT key (2) again to display the time and date of the last 20 trigger selections. This fault log can be cleared by pressing the REF LINE key cwice. 22/02/97 10:01:58 21/04/97 12:00:10 20/04/97 13:00:20 19/04/97 14:00:30 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00: 00/00/00 00:00: 00/00/00 00:00: 00/00/00 00:00: 888888 00/00/00 00:00: 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 00/00/00 00:00:00 lear (REF LINE - REF LINE) Last Triggers ECG PRESSURE ECG INTERNAL Next Log (SELECT Exit (STANDBY) Figure 1-75 Last Triggers 1-100 ‘System 97e Service Manual Chapter 1, Operation1.3.2.6 Display Internal Statistics 1. To enter the Display Internal Statistics menu item, press the IAB AUGMENTATION Up & Down Arrow keys (3) to highlight Display Internal Statistics, 2. Press the [AB FREQUENCY SELECT key (2) to open the Display Internal Statistic information. Incernal Statistics [Pump Cycle Count - 9031 |Accumulated Assist Time (hh:mm) - 237:54 i | |BATTERY STATISTICS (2) el) (0) \Scart of Discharge: 00-00 00:00:00 07-15 06:43:58 07-22 10:06:46 End Of Discharge: 00-00 00:00:00 7-19 11:32:43 07-22 10:15:42 \Full Charge: 00-00 00:00:00 07-20 09:15:40 00-00 00:00:00 (leor (REF LINE - REF LINE) Next Log (SELECT) Exit (STANDBY) Figure 1-76 - Internal Statistics Explanation of Battery Statistics The first column where data is entered is the "x(0)" column. The "Start of Discharge" date and time is entered when the pump is first run on battery power. The "End of Discharge" date and time is entered when battery power is removed. ‘When the battery is fully charged, the time is entered into the "Full Charge" line. ‘When the System is run on battery power again, the whole "x(0)" column is moved ‘over to the "t(-1)" column and new data is entered into the “t(0)" column. When the battery is charged again, the whole "t(-1)" column is moved ro the "-2)" column and the "(0)" column is moved to "x-1)". If che battery has not been fully charged before the System is run on battery again, the date and time in the "End of Discharge’ row will update. Information remains in the "t(0)" column until the battery has been fully charged. Sysem 97e Service Manual ;opter 1, Operation 1-1011.3.2.7 Display Software Revision 1. To center the Display Software Revision menu item, press the IAB AUGMENTATION Up & Down Arrow keys (3) to highlight Display Sofeware Revision. 2. Press the JAB FREQUENCY SELECT key (2) to open the Display Software Revision information. Display Sofeware Revision FRONT END: AOOF | COMM PROC: Cooc | MONITOR KEYPAD: A00K | | BASE KEYPAD: A00K DSS: coop | TABP: cou | | tan sw0en) Figure 1-77 - Sofware Revision 1.3.2.8 Language Selection 1. To enter the Language Selection menu item, press the LAB AUGMENTATION Up & Down Arrow keys (3) to highlight Language Selection. 2. Press the IAB FREQUENCY SELECT key (2) to open the Language Selection menu item. Language Selection ‘Current Language -> English German French Spanish Japanese Tealian | = >i Sd SEC ‘a ACE | Figure 1-78 - Language Selection NOTE: The text used in the System Configuration menus will always remain in English, 1-102 ‘System_97e Service Manval Chopter 1, Operation