CARDIOSAVE User Service Manual Rev B

Copyright All rights reserved. No part of this publication may be duplicated, adapted or translated without prior written permission, except within the framework of the copyright laws. © Copyright 2013 Datascope Corp. ® U.S. Registered Trademark of Datascope Trademark Corp. Manufactured by: Datascope Corp. 1300 MacArthur Blvd. Mahwah, NJ 07430, USA Phone: 1 800 777 4222 or 1 201 995 8700 Fax: 1 201 995 8910 http://ca.maquet.com http://www.maquet.com

CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright Datascope Corp.

TABLE OF CONTENTS Foreword Warnings, Cautions and Notes Warnings Cautions

1

ALARMS AND HELP SCREENS

1.1 1.2 1.2.1 1.2.2 1.2.3 1.2.4 1.2.5 1.2.6 1.2.7

Help Screens Alarm and Informational Messages Technical Alarms High Priority Alarms Medium Priority Alarms Low Priority Alarms Informational Messages Sudden Shutdown Alarm Power-up Failure Codes

2

ALTERNATE POWER UP MODE

2.1 2.2 2.3 2.4 2.5 2.5.1 2.5.2

Pneumatic Module Leak Test Display/Print SW Revisions Display System Statistics Touch Screen Calibration Helium Reservoir Purge Helium Reservoir Purge (Using System Diagnostics) Manual Release of Pressure From Helium Reservoir

3

PREVENTIVE AND USER MAINTENANCE

3.1 3.2 3.3 3.3.1 3.3.2 3.4 3.4.1 3.4.2 3.5 3.6 3.7 3.8 3.9

System Log Book Orientation Nomenclature: Preventive Maintenance Schedules Schedule A Schedule B Cleaning Cleaning the System Cleaning the Monitor Display and Touchscreen Pneumatic Module Leak Test Touchscreen Calibration Battery Maintenance Low Helium Helium Tank Refilling Information

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1-1 1-2 1-3 1-5 1 - 11 1 - 14 1 - 15 1 - 24 1 - 25

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2-3 2-4 2-5 2-6 2-8 2-8 2-8

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3-1 3-2 3-3 3-3 3-4 3-5 3-5 3-5 3-5 3-5 3-6 3-7 3-8

CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright MAQUET Cardiovascular LLC

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CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright Datascope Corp.

| CARDIOSAVE | Foreword | i |

FOREWORD This manual is intended to provide the user with information required to properly perform basic user maintenance on the CARDIOSAVE Intra-Aortic Balloon Pump (IABP).

WARNINGS, CAUTIONS AND NOTES Please read and adhere to the following list of warnings, cautions and notes; some of which are repeated in the appropriate areas throughout this manual. A WARNING is provided if there is reasonable evidence of an association of a serious hazard with the misuse of this device or when special attention is required for the safety of the patient. A CAUTION is provided when any special care is to be exercised by the practitioner to avoid causing damage to this device or other property. They may also include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury, but about which the user should be aware. A NOTE is provided when extra general information is applicable. Notes appear in the appropriate areas throughout the manual.

WARNINGS WARNING: The Augmentation Alarm, which is automatically set at power-up, provides back-up to IAB alarms (gas loss and IAB catheter alarms) at higher heart rates. Therefore, this alarm should not be manually disabled. WARNING: If more than one pump is being used in close proximity, ensure that the source of the alarm sound is correctly identified by confirming the corresponding visual indication.

WARNING: Pneumatic Module Leak Test MUST NOT be performed with the pump connected to a patient's IAB.

WARNING: Calibration should not be done while the system is connected to a patient.

WARNING: Preventive Maintenance should never be performed when the IABP is attached to a patient.

WARNING: Batteries have the risk of fire, explosion or severe burn hazards. Do not disassemble, crush, heat above 60° C (140° F), or incinerate. Replace only with Datascope Corp. REF 0146-00-0097. CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright Datascope Corp.

| ii | Cautions | CARDIOSAVE |

WARNING: Compressed gasses (helium tanks) and Lithium ion batteries are considered Dangerous Goods/ Hazardous Materials per I.A.T.A. and D.O.T. regulations. It is a violation of U.S. federal and international law to offer any package or over pack of dangerous goods for transportation without the package being appropriately identified, packed, marked, classified, labeled and documented according to D.O.T. and I.A.T.A. regulations. Please refer to the applicable I.A.T.A. Dangerous Goods Regulations and /or the Code of Federal Regulations 49 (Transportation, Parts 171-180) for further information.

CAUTIONS CAUTION: Do not set the alarm volume to such a low level that it cannot be readily heard over the ambient noise level of the venue in which the IABP is used.

CAUTION: The internal helium tank may contain up to 250 PSI of helium. This tank must be emptied prior to shipping the system via commercial ground and air carriers. Use the procedure below to purge the tank prior to shipment. If this cannot be accomplished, or the system is non-functional, then the internal helium reservoir must be manually vented.

CAUTION: The troubleshooting charts are not intended as a rapid course on how to repair devices of this type. Rather, they are intended as a guide for MAQUET factory trained and certified technical personnel only. The instrument covers should only be removed by MAQUET factory trained and certified personnel who have received supplementary instructions regarding maintenance of medical electronic equipment or have had equivalent experience in this area.

CAUTION: The accidental shorting of component leads can easily over stress components, resulting in a second unnecessary failure (aside from creating a possible safety risk).

CAUTION: Preventive Maintenance is to be performed by a MAQUET factory trained and certified technician.

CAUTION: Do not remove circuit boards without first removing AC power AND all battery packs. Permanent damage to the unit may occur if this is not done.

CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright Datascope Corp.

| CARDIOSAVE | Alarms and Help Screens | 1 - 1 |

1

ALARMS AND HELP SCREENS

1.1

HELP SCREENS Help screens are provided for consultation regarding alarm or informational message descriptions and alarm configuration. Help Screens are context sensitive and available based on the information displayed on the Monitor. For example: The Help Screens for alarm messages are only available while an alarm condition or informational message exists. When one or more alarm/informational message is present, the Help Available key will appear on the Touch Screen indicating that help is available for the current alarm/informational message(s). Navigating the Help Screens: 1. Press the Help Available key on the Touchscreen. The Help Screen will open and display all of the current alarms/informational messages in their predetermined priority order within each classification, higher priorities being displayed above lower priorities. The priority order is as follows: Technical Alarms, High Priority Alarms, Medium Priority Alarms, Low Priority Alarms, and Informational Messages. 2. If only a single alarm or informational message exists, the corresponding Help Screen will be immediately displayed. If multiple alarm or informational messages exist, a Multiple Alarm Display will be provided in the Help Screen Area. Each listed alarm or informational message is actually a key that, when selected, displays the associated Help Screen. 3.

In the Help Screen, use the Page Up and Page Down keys to navigate through the available help information.

4. If the Help Screen is only displaying a single alarm or informational message, pressing the Exit Key will close the Help Screen. However, if a single alarm or informational message is being displayed, and there are multiple alarm or informational messages present, pressing the Back Key will close the current Help Screen, and display the Help Screen for multiple alarm or informational messages. If the Help Screen is displaying multiple alarm or informational messages, pressing the Exit key will close the Help Screen.

Figure 1-1: Example single alarm Help Screen

Figure 1-2: Example multiple alarm Help Screen CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright Datascope Corp.

| 1 - 2 | Alarms and Help Screens | CARDIOSAVE |

1.2

ALARM AND INFORMATIONAL MESSAGES The IABP utilizes both auditory and visual alarm signals to communicate the need for immediate Operator response, prompt Operator response, or Operator awareness. Auditory alarm signals (tone sequences) are primarily intended to attract the attention of the operator. They were carefully developed to communicate the urgency of the response, as well as the pump's location. Auditory signals are effective over a relatively broad range of operator positions. CAUTION: Do not set the alarm volume to such a low level that it cannot be readily heard over the ambient noise level of the venue in which the IABP is used. Visual alarm signals consist of both symbols and text. The displayed information further reinforces the urgency of the alarm (color, flashing property and symbol shape) and also identifies the alarm via a specific text message. Textual information is legible at the operator's position, up to 1 meter from the front of the Monitor. Additionally, alarms are further complimented by an option to display context sensitive help information to aid in the understanding and guide in the resolution of the alarm condition. Alarm and informational messages are grouped into the following categories in order to facilitate operator awareness and understanding: Technical Alarms, High, Medium and Low Priority Alarms, and Informational Messages. These messages are displayed based upon the priority of the condition(s) that prompted them. Technical Alarms and High Priority Alarm messages are displayed first at the top of the Message Display Area on the Monitor Display. These alarms require the Operator's immediate response. Technical Alarms initiate a continuous alarm tone and suspend pumping. High Priority Alarms initiate the High Priority Alarm Tone, and, in a majority of cases, suspend pumping. If multiple alarm conditions are present, all of the current alarms/informational messages are displayed in their predetermined priority order within each classification, higher priorities being displayed above lower priorities. The associated Help Screens Area is organized to reflect the order of priority. When Medium Priority Alarms are displayed, depending on IABP conditions, IAB assist will not be suspended and the Medium Priority Alarm tone is sounded. Medium Priority Alarms require the Operator’s prompt response. When Low Priority Alarms are displayed, IAB assist is not suspended and the Low Priority Alarm tone is sounded. Low Priority Alarms require the Operator’s awareness. Informational messages typically provide awareness of conditions that do not require immediate action and may persist for longer periods. These messages may also be accompanied by an infrequently repeated audio reminder tone. Gas Loss and IAB Catheter alarm operation is maintained at heart rates up to 140 BPM*. However, one component of the IAB Catheter Alarms, detection of gas trapped in the safety disk, is suspended at 112 BPM to minimize nuisance alarms. * The cited heart rates assume that the timing controls are at nominal mid-position.

CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright Datascope Corp.

| CARDIOSAVE | Alarms and Help Screens | 1 - 3 |

WARNING: The Augmentation Alarm, which is automatically set at power-up, provides back-up to IAB alarms (gas loss and IAB catheter alarms) at higher heart rates. Therefore, this alarm should not be manually disabled.

WARNING: If more than one pump is being used in close proximity, ensure that the source of the alarm sound is correctly identified by confirming the corresponding visual indication. Note: The CARDIOSAVE maintains a non-volatile event log which is accessible in Service Diagnostics Mode. For more information, see the Service Manual.

1.2.1

TECHNICAL ALARMS Technical Alarms are indications that an IABP electrical hardware failure has occurred. Technical Alarms are the highest priority alarms and sound a continuous tone. In all cases of Technical Alarms, pumping is suspended.

Figure 1-3: Technical Alarm Icon

Power-Up Test Fails Code #___ There is a start-up failure in a major subsystem of the IABP. 1 Note the code number displayed. 2 Turn the IABP OFF by pressing and holding the green IABP Power Button, located on the back panel, for 2 seconds. 3 Wait 10 seconds. 4 Turn the IABP ON by pressing and releasing the green IABP Power Button. 5 If the alarm message persists, switch to another MAQUET IABP if available and contact MAQUET Service. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: Failure of one or more electrical sub-system tests during system power-up diagnostics. System Response: System is held in VENT Mode / IAB deflated. Reset: Attempt to clear by cycling power OFF and ON.

CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright Datascope Corp.

| 1 - 4 | Alarms and Help Screens | CARDIOSAVE |

System Failure There is a malfunction of the microprocessor. 1 Turn the IABP OFF by pressing and holding the green IABP Power Button, located on the back panel, for 2 seconds. 2 Wait 10 seconds. 3 Turn the IABP ON by pressing and releasing the green IABP Power Button. 4 If the alarm message persists, switch to another MAQUET IABP if available and contact MAQUET Service. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: Solenoid driver watchdog detected vacuum and / or pressure solenoid energized for approximately 2 seconds or vacuum valve is not activated within 2 seconds of pressure valve or IABP processor failure. System Response: System is disabled and Pneumatic Module is vented to atmosphere / IAB deflated. Reset: Attempt to clear by cycling power OFF and ON.

Internal Communication Failure There was an internal communications failure. 1 Turn the IABP OFF by pressing and holding the green IABP Power Button, located on the back panel, for 2 seconds. 2 Wait 10 seconds. 3 Turn the IABP ON by pressing and releasing the green IABP Power Button. 4 If the alarm message persists, switch to another MAQUET IABP if available and contact MAQUET Service. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: Internal electronics communications failure. System Response: System is disabled/IAB deflated. Reset: Attempt to clear by cycling power OFF and ON.

System Over Temperature The system has detected an over temperature condition. 1 Turn the IABP OFF by pressing and holding the green IABP Power Button, located on the back panel, for 2 seconds. 2 Wait 10 seconds. 3 Turn the IABP ON by pressing and releasing the green IABP Power Button. 4 If the alarm message persists, switch to another MAQUET IABP if available and contact MAQUET Service. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: An over temperature condition has been detected in the compressor assembly. System Response: System is disabled and Pneumatic Module is vented to atmosphere / IAB deflated. Reset: Attempt to clear by cycling power OFF and ON.

CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright Datascope Corp.

| CARDIOSAVE | Alarms and Help Screens | 1 - 5 |

1.2.2

HIGH PRIORITY ALARMS High Priority Alarms indicate situations that require immediate Operator response. Pumping is suspended for the majority of High Priority Alarms. A red flashing alarm icon with three (3) exclamation points denotes the High Priority Alarm Icon. All High Priority Alarms have a uniform audio tone. The combination of five notes for High Priority Alarms is played in the following sequence: five notes a short pause, five notes a long pause and then this cycle repeats.

!!! FIGURE 1-4

!!!

High Priority Alarm Icon

Gas Gain in IAB Circuit A gas gain has been detected in the IAB circuit. 1 Verify all connections are leak free. 2 Press the START key to Autofill and resume pumping. 3 If alarm persists, contact MAQUET Service. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: Cumulative shuttle gas gain exceeds 5 cc, relative to the last autofill volume. Active when IAB inflation period >= 80 mSec and deflation period >= 250 mSec. System Response: Vent / IAB deflated. Reset: Message and Audio Tone cleared when: the START key is pressed and the Autofill is automatically initiated, or the IAB FILL key is pressed and held for 2 seconds.

Autofill Failure - No Helium The Helium tank is closed. 1 Open the Helium tank. The Helium tank is empty. 1 Replace the Helium tank. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: While using the IABP in its Hospital configuration, the IAB could not be automatically filled because of inadequate Helium gas supply. System Response: Vent / IAB deflated. Reset: Replace the Helium Tank then retry the autofill by pressing the START key, or by pressing the IAB FILL key for 2 seconds.

Autofill Failure - No Helium There is insufficient Helium supply to perform an Autofill. 1 Connect the Helium Filling Station to the Transport Console to replenish the internal Helium gas supply. 2 If Helium Filling Station is unavailable, reinsert the Transport Console into the Hospital Cart to replenish the internal Helium gas supply. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: While using the IABP in its Transport configuration, the IAB could not be automatically filled because of inadequate Helium gas supply. System Response: Vent / IAB deflated. Reset: Replenish the Helium gas supply then retry the autofill by pressing the START key, or by pressing the IAB FILL key for 2 seconds. CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright Datascope Corp.

| 1 - 6 | Alarms and Help Screens | CARDIOSAVE |

Autofill Failure - Blood Suspected A leak is suspected in the IAB Catheter. 1 Check for evidence of blood in the tubing. If found, stop pumping and notify physician. Refer to IAB manufacturer's instructions for IAB removal. 2 If blood is not present, turn the IABP OFF by pressing and holding the green IABP Power Button for 2 seconds, wait 10 seconds, turn the IABP ON by pressing and releasing the green IABP Power Button. 3 Press the START key to refill the IAB and resume pumping. 4 If “AUTOFILL FAILURE - BLOOD SUSPECTED” message repeats and there is still no evidence of blood in the tubing, switch to another MAQUET IABP, if available. 5 Contact MAQUET Service. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: While the system was Autofilling, a leak in the IAB resulted in blood migration back to the system. System Response: Vent / IAB deflated. Reset: Attempt to clear by cycling power OFF and ON.

Autofill Failure The IABP cannot fill the IAB catheter system. 1 Ensure that one correctly sized IAB extender tubing is tightly connected to the IAB and the IABP, and there are no restrictions in the tubing. 2 Check for evidence of blood in the IAB tubing. If found, stop pumping and notify physician. Refer to IAB manufacturer's instructions for IAB removal. 3 If blood is not present, press the START key to refill the IAB and resume pumping. 4 If the alarm message persists, switch to another MAQUET IABP if available. 5 Contact MAQUET Service. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: The Helium supply is adequate however the IAB could not be automatically filled. System Response: Vent / IAB deflated. Reset: Retry the autofill by pressing the START key, or by pressing the IAB FILL key for 2 seconds.

IAB Disconnected The IAB catheter or extension tubing is disconnected. 1 Reattach the IAB catheter and extension tubing. 2 Press the START key to refill the IAB and resume pumping. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: Disconnection at IAB or extension catheter while in assist mode. System Response: Vent / IAB deflated. Reset: When the IAB is reconnected and an Autofill is initiated by pressing the START key, or the IAB FILL key is pressed and held for 2 seconds High Drive Pressure There may be a component failure in the pneumatic system. 1 Attempt to resume pumping by pressing the START key. 2 If the alarm message persists, switch to another MAQUET IABP if available. 3 Contact MAQUET Service. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: Regulated pressure from the compressor exceeds the acceptable operating range. System Response: Standby / IAB deflated. Reset: Resume assist by pressing the START key.

CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright Datascope Corp.

| CARDIOSAVE | Alarms and Help Screens | 1 - 7 |

IAB Catheter Restriction There is a restriction in the IAB catheter or tubing. 1 Check the catheter tubing, extracorporeal tubing, and extender tubing for restriction, and relieve restriction if possible. 2 Press the START key to resume pumping. The IAB membrane is not completely unfolded. 1 Aspirate to assure blood is not returned through the extracorporeal tubing. 2 Using a syringe, manually inflate and deflate the IAB with 30 cc of air through the male Luer of the IAB. 3 Press the START key to Autofill and resume pumping. The IAB remains in the sheath immediately after insertion. 1 Check the markings on the IAB catheter to confirm that the balloon has fully exited the sheath. If the balloon has not fully exited the sheath, refer to the IAB catheter manufacturer's instructions for use to reposition the sheath relative to the IAB catheter. 2 Press the START key to resume pumping. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: See Probable Causes above. System Response: Standby / IAB deflated. Reset: Reset when assist is resumed by pressing the START key

Gas Loss in IAB Circuit A Helium loss has been detected due to a leak or high rate of diffusion in the IAB Circuit. 1 Check for evidence of blood in the tubing. If found, stop pumping and notify physician. Refer to IAB manufacturer's instructions for IAB removal. 2 If blood is not detected, ensure that the IAB extender tubing is tightly connected to the IAB and the IABP. If appropriate, perform an Autofill by pressing and holding the IAB FILL key for 2 seconds, then press the START key to resume pumping. 3 If the patient is febrile or tachycardic, consider increasing the frequency of Autofills by initiating an Autofill prior to the regularly scheduled 2-hour Autofill. 4 If the alarm persists and there is no evidence of blood in the IAB tubing, consider setting the GAS LOSS ALARM to the OFF position via the PUMP OPTIONS menu from within the PREFERENCES MENU. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: Cumulative shuttle gas loss exceeds a nominal 5 cc/hr. dynamic limit. Active only when IAB inflation period >=80 mSec and deflation period >=250 mSec. System Response: Vent / IAB deflated. Reset: Message and Tone cleared when: the IAB FILL key is pressed and held for 2 seconds. Low Vacuum There may be a component failure in the pneumatic system. 1 If the alarm message persists, switch to another MAQUET IABP if available. 2 Contact MAQUET Service. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: Insufficient or no compressor vacuum. System Response: Waiting to pump / IAB deflated. Reset: Automatically when vacuum is restored.

CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright Datascope Corp.

| 1 - 8 | Alarms and Help Screens | CARDIOSAVE |

Trigger Interference The system is detecting electro-surgical interference while in Pacer V/AV trigger mode. 1 Pumping automatically resumes when interference clears. 2 If the condition persists, select PRESSURE Trigger via the TRIGGER menu if appropriate. 3 Verify timing and press the START key to resume pumping. Alarm Attributes: Operation Mode: Semi Auto Trigger Source: Pacer V/AV Detailed Cause: Electro-Surgical Noise (ESU) detected while the Pacer trigger source is selected. System Response: Waiting to pump / IAB deflated. A nominal 10 second alarm delay is incorporated to reduce false-positive nuisance alarms due to transient violations. Reset: Automatically, when ESU interference stops. Or manually, by deselecting the Pacer trigger source.

Check Pacer Timing The patient is not 100% paced. 1 Use ECG Trigger whenever the pacemaker is operating in a demand pacing mode. 2 Select ECG Trigger via the TRIGGER menu. 3 Press the START key to resume pumping. The system is unable to distinguish between the intervals of an A-V Pacemaker. 1 A typical A-V interval (approximately 170 mSec) may have to be shortened when pacing rates exceed 130 to 135 BPM. The rate on the V or A-V Pacemaker is set too high. 1 Verify that the pacing rate does not exceed 180 BPM. Alarm Attributes: Operation Mode: Semi Auto Trigger Source: Pacer V/AV Detailed Cause: Beat-to-beat pacing intervals vary by more than 6.25% or the V or A-V pacer rate is >180 bpm. System Response: Waiting to pump / IAB deflated. A nominal 10 second alarm delay is incorporated to reduce false-positive nuisance alarms due to transient violations. Reset: Automatically, when acceptable Pacer timing conditions are met. Or manually, by deselecting the Pacer Trigger.

No Trigger Both the ECG and Arterial Pressure (A.P.) signals are absent or inadequate for triggering. 1 Attach or reposition the ECG electrode(s) and check the integrity of all ECG cable/lead connections. 2 Check integrity of all A.P. cable connections, optical or electrical. If transducer is in use, verify that the transducer was not left vented. 3 If an over damped A.P. signal is present, attempt to improve signal quality by aspirating and flushing the arterial pressure line. Alarm Attributes: Operation Mode: Auto Trigger Source: ECG or Pressure Detailed Cause: ECG and Arterial Pressure trigger are unavailable or are lost while in Auto OPERATION MODE. System Response: Waiting to pump / IAB deflated. A nominal 10 second alarm delay is incorporated to reduce false-positive nuisance alarms due to transient violations. Reset: Automatically, when trigger returns.

CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright Datascope Corp.

| CARDIOSAVE | Alarms and Help Screens | 1 - 9 |

No Trigger An electrode is detached or malpositioned. 1 Reattach or reposition the ECG electrode(s). There is inadequate signal acquisition. 1 Select an alternate ECG lead or an External ECG signal via the SOURCES Menu. An inappropriate trigger source has been selected. 1 Select an alternate trigger source via the TRIGGER Menu. Resume pumping by pressing the START key. Pacer pulses are not being detected while in Pacer V/AV Trigger mode. 1 Enhance pacer pulse recognition by increasing the Pacer Detection level. First open the SOURCES Menu, then press the Pacer Detection UP ARROW key in the THRESHOLDS Menu until pacer pulses are enhanced on the ECG Waveform. Alarm Attributes: Operation Mode: Semi Auto Trigger Source: R-Wave derived triggers (ECG & Pacer A) or Pacer Pulse derived (Pacer V/AV). Detailed Cause: Trigger is unavailable or lost when either the ECG or Pacer Trigger modes are selected while assisting. System Response: Waiting to pump / IAB deflated. A nominal 10 second alarm delay is incorporated to reduce false-positive nuisance alarms due to transient violations. Reset: Automatically, when trigger returns.

Poor Signals Persist ECG triggering is too unreliable for Auto Operation due to poor ECG signal quality. 1 Attempt to improve ECG signal by ensuring electrode contact and optimal placement. If necessary, change electrodes. 2 Check integrity of all cable/lead connections. The Arterial Pressure (A.P.) waveform is absent, flat, or over damped. 1 Check integrity of all cable connections, optical or electrical. 2 If a transducer is in use, verify the transducer was not left vented. If the waveform is still flat, attempt to clear the inner lumen by aspirating and flushing the arterial pressure line. 3 If unable to clear the inner lumen, cap the lumen. Provide an alternate A.P. source (i.e.: radial) by connecting and zeroing a standard transducer or by connecting an interface cable from the A.P. high level output of an external monitor to the IABP. 4 If signal problems persist, resume pumping by switching the OPERATION MODE to SEMI AUTO. Verify trigger and proper timing, and press the START key. Alarm Attributes: Operation Mode: Auto Trigger Source: ECG Detailed Cause: Both ECG and Arterial Pressure signal quality have been poor for a sustained period of time. System Response: Waiting to pump / IAB deflated Reset: Automatically upon detection of a good ECG or A.P. signal, or manually by switching to Semi Auto OPERATION MODE. ECG Detected While Using Internal Trigger A valid ECG is being detected while in the INTERNAL trigger mode. 1 Using the TRIGGER Menu, select a patient derived trigger source (such as ECG or PRESSURE). 2 Verify proper timing. Resume pumping by pressing the START key. Alarm Attributes: Operation Mode: Semi Auto Trigger Source: Internal Detailed Cause: ECG activity is detected persistently for 4-6 seconds while in the Internal Trigger mode. System Response: Assisting however IAB is immediately deflated on each R-Wave detection. Reset: Automatically, when ECG activity ceases. Manually, by deselecting Internal Trigger mode.

CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright Datascope Corp.

| 1 - 10 | Alarms and Help Screens | CARDIOSAVE |

No Pressure Trigger The Arterial Pressure (A.P.) signal is absent or flat. 1 Verify that the desired Pressure Source has been selected, either Direct or External. Use the PRESSURE arrow keys via the SOURCES menu to select an appropriate Pressure Source. 2 Check integrity of all A.P. cable connections, optical or electrical. If transducer is in use, verify that the transducer was not left vented. 3 If a transducer is in use, attempt to clear inner lumen by aspirating and flushing the arterial pressure line. If not successful, cap the inner lumen. Provide an alternate A.P. source (i.e.: radial) by connecting and zeroing a standard transducer or by connecting an interface cable from the A.P. high level output of an external monitor to the IABP. The patient's pulse pressure is inadequate for pressure triggering. 1 If a transducer is in use, aspirate and flush the arterial pressure line in an attempt to improve an over damped A.P. signal. 2 If appropriate, select a different trigger source via the TRIGGER Menu. Resume pumping by pressing the START key. 3 If Pressure trigger is required, reduce the Trigger Threshold Level by activating the THRESHOLDS Menu within the SOURCES Menu and using the PRESSURE THRESHOLD down ARROW key to decrease the Trigger Threshold Level. Alarm Attributes: Operation Mode: Semi Auto Trigger Source: Pressure Detailed Cause: Valid trigger is unavailable or lost when the Pressure trigger mode is selected (Not applicable to Auto OPERATION MODE). System Response: Waiting to pump / IAB deflated. A nominal 10 second alarm delay is incorporated to reduce false-positive nuisance alarms due to transient violations. Reset: Automatically, when a valid Pressure trigger is detected or an alternate trigger source is selected.

Augmentation Below Limit Set There is a change in the patient's hemodynamic status. 1 Assess the patient’s hemodynamic status and attempt to optimize. 2 If necessary, decrease the augmentation alarm limit to 8-10 mmHg below the patient’s diastolic augmentation pressure by pressing the AUG ALARM key and using the DOWN arrow key. The augmentation alarm limit is set too high. 1 Decrease the AUG ALARM limit to 8-10 mmHg below the patient's augmented diastolic pressure by pressing the AUG ALARM button and using the DOWN arrow key. The AUGMENTATION level has been set too low 1 Increase the IAB augmentation by pressing the UP arrow key via the AUGMENTATION Menu until the level reaches Max. The IAB is positioned incorrectly. 1 Verify placement and reposition if necessary. There is a timing error. 1 Assess for late inflation and early deflation timing and correct, if necessary. There is a balloon leak. 1 Check for blood in the tubing. If found, stop pumping and notify physician. Refer to the IAB manufacturer's instructions for IAB removal. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: Diastolic augmentation has dropped below the Augmentation Alarm limit. System Response: Unaffected. A nominal 10 second alarm delay is incorporated to reduce false-positive nuisance alarms due to transient violations. Reset: Automatically, when the augmentation rises above alarm limit.

CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright Datascope Corp.

| CARDIOSAVE | Alarms and Help Screens | 1 - 11 |

1.2.3

MEDIUM PRIORITY ALARMS Medium Priority Alarms indicate situations in which a prompt Operator response is required. This class of alarm does not suspend pumping, but may indicate a need for corrective action. A yellow flashing alarm icon with two (2) exclamation points denotes the Medium Priority Alarm Icon. All Medium Priority Alarms have a uniform audio tone. The combination of three (3) notes for Medium Priority Alarms is played in the following sequence: three notes a pause and then this cycle repeats.

!! FIGURE 1-5

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Medium Priority Alarm Icon

Fiber-Optic Sensor Failure There is a failure in the communication of the Fiber-Optic Sensor signal with the IABP. 1 Firmly grasp the Fiber-Optic Sensor Connector using the raised grips. Remove it from the Fiber-Optic Sensor Input and reinsert until it clicks. 2 Check for visible kinks in the orange Fiber-Optic cable, if found relieve the kink. 3 If problem persists, disconnect the Fiber-Optic Sensor Connector. 4 Provide an alternate A.P. source (i.e.: radial) by connecting and zeroing a standard transducer or by connecting an interface cable from the A.P. high level output of an external monitor to the IABP. 5 If an external high level A.P. input is provided and the IABP is in SEMI AUTO operation mode, manually switch the IABP's pressure input to EXTERNAL using the PRESSURE ARROW keys via the SOURCES Menu. Confirm that the trigger and timing settings are set appropriately. 6 In the event that an alternate A.P. source cannot be provided, consider replacing the balloon. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: There is a failure in the communication of the Fiber-Optic Sensor signal with the IABP. System Response: Pumping will continue while in ECG trigger, the Fiber-Optic pressure waveform and indices will not be available. Reset: Upon removing the Fiber-Optic Sensor Connector.

Poor Signal Quality ECG triggering is too unreliable for Auto Operation due to poor ECG signal quality. 1 Attempt to improve ECG signal by ensuring electrode contact and optimal placement. If necessary, change electrodes. 2 Check integrity of all cable/lead connections. The Arterial Pressure (A.P.) waveform is absent, flat, or over damped. 1 Check integrity of all cable connections, optical or electrical. 2 If a transducer is in use, verify the transducer was not left vented. If the waveform is still flat, attempt to clear the inner lumen by aspirating and flushing the arterial pressure line. 3 If unable to clear the inner lumen, cap the lumen. Provide an alternate A.P. source (i.e.: radial) by connecting and zeroing a standard transducer or by connecting an interface cable from the A.P. high level output of an external monitor to the IABP. Alarm Attributes: Operation Mode: Auto Trigger Source: ECG Detailed Cause: Both ECG and Arterial Pressure signal quality is poor while in ECG trigger. System Response: System continues to pump but may time conservatively. Reset: Automatically upon detection of a good ECG or A.P. signal.

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No Pressure Source Available No DIRECT or EXTERNAL arterial pressure (A.P.) source was detected. 1 If using a Fiber-Optic IAB, ensure that the Fiber-Optic Sensor Cable is connected. Once connected, a calibration will occur automatically in 20 seconds. 2 If a transducer is in use, ensure that the pressure cable is connected to the transducer and the IABP. If alarm persists, consider replacing the pressure cable. 3 If an A.P. source is still unavailable, consider providing an interface cable from the A.P. high level output of an external monitor to the IABP. Alarm Attributes: Operation Mode: Auto Trigger Source: ECG or Pressure Detailed Cause: Neither a direct or external pressure source was detected. System Response: System continues to pump but may time conservatively. Reset: Automatically, upon connection of a viable pressure source.

Low Battery There is less than 30 minutes of battery operating time remaining. 1 Connect system to an AC power source. 2 If an AC power source is unavailable, insert a charged battery into the battery bay not currently in use. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: Cumulative reserve of both batteries falls below 30 minutes of operating time. System Response: Unaffected. Reset: Automatically removes message and turns off tone when an AC power source is restored or when a charged battery is inserted. Catheter Alarms Paused - Enable AUG. ALARM The Augmentation Alarm has been set to OFF while Catheter Alarms are Paused. 1 Set the AUG. ALARM to 10 mmHg below the patient's augmented diastolic pressure. 2 Adjust the Augmentation Alarm by pressing the AUG. ALARM key and using the ARROW keys. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: Catheter Alarms are Paused while the Augmentation Alarm is set to OFF. System Response: Unaffected. Reset: Once the user reactivates the Augmentation Alarm. Over Temperature Condition Detected An over temperature condition has been detected in the pneumatic system. 1 Switch the IAB FREQUENCY to 1:2 or 1:3 in an attempt to reduce the load on the pneumatic system, then switch to another MAQUET IABP if available. 2 Contact MAQUET Service. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: An over temperature condition has been detected in the pneumatic compressor. System Response: Unaffected. Reset: Automatically once the compressor temperature falls below the established over temperature threshold.

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Transport Power Supply Over Temperature An over temperature condition has been detected in the Transport Power Supply. 1 If available connect the IABP to an alternate AC power source and discontinue use of the Transport Power Supply. 2 Insert a charged battery into the available battery bay. 3 Contact MAQUET Service. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: An over temperature condition has been detected in the Transport Power Supply. System Response: Unaffected. Reset: Automatically once the Transport Power Supply temperature falls below the established over temperature threshold.

Multiple AC Power Sources Detected The IABP is connected to multiple AC power sources. 1 Disconnect the IABP from the unused AC power source(s). Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: The system has detected that multiple AC power sources are connected to the IABP. System Response: Unaffected. Reset: Automatically, once the unused AC power source is disconnected.

Disconnect Trainer - Patient Cable(s) Connected The System Trainer remains connected to the IABP and patient ECG / Pressure waveforms are detected. 1 Disconnect the System Trainer. Alarm Attributes: Operation Mode: All Trigger Source: All Detailed Cause: A combination of Patient and Trainer cable(s) are connected to the IABP. System Response: Triggering and timing response may be altered due to the inappropriate combination of trainer and patient signals. Reset: Automatically, when the mix of trainer and patient cables is eliminated.

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1.2.4

LOW PRIORITY ALARMS Low Priority Alarms are indications that Operator awareness is required. A cyan alarm icon with one exclamation point denotes the Low Priority Alarm Icon. All Low Priority Alarms have a uniform audio tone. The combination of two (2) notes for Low Priority Alarms is played in the following sequence: two notes a pause and then this cycle repeats.

! FIGURE 1-6

Low Priority Alarm Icon

Unable to Update Timing Poor waveform quality. 1 Check integrity of all A.P. cable connections, optical or electrical. If transducer is in use, verify that the transducer was not left vented. 2 If a transducer is in use, aspirate and flush the arterial pressure line in an attempt to improve an over damped A.P. signal. 3 Attach or reposition the ECG electrode(s) and check the integrity of all ECG cable/lead connections. 4 If not properly triggering or signal problems persist, switch OPERATION MODE to SEMI AUTO. Verify trigger and proper timing, resume pumping by pressing the START key. The sustained heart rate is less than 30 BPM or greater than 150 BPM. 1 Switch the OPERATION MODE to SEMI AUTO. Verify trigger and proper timing, resume pumping by pressing the START key. Poor diastolic augmentation. 1 If diastolic augmentation cannot be observed when AUGMENTATION level is set to MAX, attempt to improve the patient's hemodynamic status. Alarm Attributes: Operation Mode: Auto Trigger Source: ECG or Pressure Detailed Cause: See Probable Causes above. System Response: Pumping is unaffected, conservative timing rules are applied. System increases frequency of attempts to update timing. Reset: Automatic upon completion of a successful update, or entry into Standby.

CARDIOSAVE | User Service Manual | English | 0070-00-0640 Copyright Datascope Corp.