CARDIOSAVE Battery Operation Quick Reference Guide Rev C June 2019

2

CARDIOSAVE BATTERY OPERATION

Introduction This Quick Reference Guide is designed to highlight the location, functionality, alarms and maintenance of the lithium ion batteries that accompany the Cardiosave Intra-aortic Balloon Pump. The Cardiosave batteries are designed to be used during transport or portable operation and it is critical to keep these batteries charged at all times to avoid interruption in power during transport. Additionally, it is important to maintain the batteries in accordance with Cardiosave’s Operating Instructions.

Intro

Table of Contents Section

Page #

Battery Overview

4-5

Monitoring Battery Status

6-8

Battery Charging

9-15

Battery in Use

16-21

Battery Maintenance

22-25

Key Battery Warnings

26

3 CARDIOSAVE BATTERY OPERATION

Table of Contents

4

Battery Overview

CARDIOSAVE BATTERY OPERATION

Cardiosave Battery Location and In-Use Indicators It is extremely important to know the location of the batteries on the back panel of the Cardiosave unit and to pay attention to the “in-use” indicators.

Battery Bay In-Use Indicators There are two Battery Bay indicators, one over each Battery Bay, which indicate which bay is currently in use by the IABP. The indicator will illuminate green if the IABP is charging a battery or operating from power supplied by the corresponding Battery Bay.

Battery Bays The Battery Bays provide the IABP with the ability to operate from a portable power source. They have a common physical lock which prevents simultaneous removal of both power sources. Battery Bays Bay 1 Note: Depending on the current battery charge level, the system may take up to 30 seconds to detect battery status and begin charging the battery.

Battery Bay In-Use Indicators Bay 2

Installation and Removal of Batteries The IABP is capable of running from DC battery power supplied by lithium-ion rechargeable batteries which can be installed in the two (2) Battery Bays on the Pump Console. To avoid interruption of therapy, discharged batteries should be replaced with new charged batteries as necessary. For more information on battery maintenance, refer to the Battery Maintenance section of this document, beginning on page 22.

1

2

3

4

Turn knob to remove battery from Battery Bay.

Slide battery OUT.

Slide charged battery IN.

While holding battery in bay, turn knob to lock battery in place.

Use care to avoid dropping the battery.

WARNING: Removing both batteries or removing the energized battery, when AC power is not connected , will stop the therapy, (i.e.,power down the pump).

5 CARDIOSAVE BATTERY OPERATION

Battery Overview

6

Monitoring Battery Status

CARDIOSAVE BATTERY OPERATION

It is important to know the status of your batteries. There are two ways to determine this – on the batteries themselves, or on the monitoring display.

1

2

Viewing Battery Status on Battery Each battery has five {5) LEDs on the back which indicate the battery’s approximate state of charge. Each LED represents approximately 20% charge. For example, one (1) illuminated LED informs the user that the battery has approximately 0-20% charge remaining, while five {5) illuminated LEDs informs the user that the battery has approximately 80-100% charge remaining. LED Configurations

Approximate State of Charge

1 Flashing

0-10%

1 Illuminated

10%-20%

2 Illuminated

20%-40%

3 Illuminated

40%-60%

4 Illuminated

60% -80%

5 Illuminated

80% - 100%

Additionally, the battery status LEDs will be illuminated when the battery is charging. However, in this state, the LED representing the current state of charge will continuously flash informing the user that the battery is charging.

Press to Display LEDs

Battery Icon Display Area on Monitor Display The Cardiosave includes a Battery Icon Display Area in the lower right corner of the Monitor Display. The indicator numbers 1 and 2 beneath the icons in the Battery Icon Display Area correspond to the Battery Bay where each battery or the transport power supply is installed.

ECG

bpm

0.5 mV

Trigger: ECG Arterial

The Battery Icon Display Area displays different icons depending on the current power configuration of the IABP and inform the user when the IABP is using AC or battery power. Also, when a battery is installed in a Battery Bay, these icons inform the user of the current state of charge of each installed battery, and via the indicator numbers which battery, if running on battery power, is currently in use.

Rate

Lead: Auto - II

Pressure

Source: Fiber-Optic

130

80

30 Inflation

MEAN

Deflation

Auto Balloon Pressure Inflated

Deflated

80

102 52

mmHg

0.0

Augmentation

(84) mmHg

116 106 1:1

Aug Alarm IAB Frequency

1

2 2

He

Monitor Display Battery Icon Display Area

7 CARDIOSAVE BATTERY OPERATION

Monitoring Battery Status

(84)

8 CARDIOSAVE BATTERY OPERATION MEAN

eflation

Off MEAN

R-Wave

112 112 112 (84)

(84) Off

Off MEAN

R-Wave

Aug Alarm Aug Alarm Aug Alarm Off Off 4.0 4.0 Viewing Battery Status on Monitor Display (examples) IABmmHg Frequency: 1:1 IABmmHg Frequency: IAB Frequency: 1:1 Augmentation Augmentation mmHg 2ugmentation min 1

112 112 112 2

3

<5 min.

1

own Seconds to 1Shutdown Off Off

2

1

He

Empty battery bay. No backup battery or Transport Power Supply detected in battery bay.

 lugged into AC power P outlet and batteries are fully charged.

5

6

Aug Alarm Off

Aug Alarm Off

AB Frequency:

IAB Frequency: 1:1

IAB Frequency: 1:1

own

2

IABP has been plugged into AC power outlet, battery 1 is depleted and battery 2 is being charged.

ug Alarm

<5 min.

1:1

4

<30 min.

<5 min.

1

He

Off 1:1

7

<30

Off

<5 min.

Off

2

He

Note: The Low Battery alarm is displayed when 30 minutes or Lit green circle indicates less of internal battery battery 1 is in use. Battery 2 is fully charged and available operating time remains. When Red Text Red Text for use when battery 1 is this message is displayed, the and Wavef and Waveforms depleted. battery symbol is displayed as

(was Yellow (wasempty. Yellow) There is also an audible

8

tone every 30 seconds. See the User Maintenance chapter in the Operating Instructions AP markers - only show for AP markers additional information. in Pressure T in Pressure Trigger mode

<5 min.

<30

Monitoring Battery Status

option A - stay with green

1

2

imingBattery 1 is depleted,

thus battery 2 is currently being used.

He

1

22

Battery 1 is depleted and battery 2 has less than 30 minutes of charge remaining (Low Battery message is displayed). Caution: Prompt attention is needed to either insert fully charged batteries or plug into AC source.

He

11

2

Battery 1 is depleted and battery 2 has less than 5 minutes of charge remaining. Caution: Prompt attention is needed to either insert fully charged batteries or plug into AC source.

He

1

2

Transport helium icons show full gray version when ÒTÓ is pressed

IABP detects an unusable battery in a Battery Bay, the attention icon will be superimposed over the battery icon, with a corresponding message displayed in the Message Display Area.

Tra sh wh Standa icons -

112

Off Note: There are various ways to charge the Cardiosave batteries. The following pages provide these instructions.

Charging Batteries While in CartAug Alarm

Off 1:1

IAB Frequency: 1

2

3

<5 min.

1

own 1. Grab the handles located on top and front of the console and lift the console into the Hospital Cart.

2. Grab the handle and slowly slide the Pump Console into the Hospital Cart until it locks into place. Note: An audible click will be heard when console is locking into cart and 3 audio tones will sound.

2

He

3. To ensure the Pump Console was successfully installed into the Hospital Cart, plug the Hospital Cart power cord into a compatible grounded AC receptacle, and confirm AC operation by checking that the AC Plug Icon is present in the Battery Icon Display Area.

If AC Plug icon is not present after installing console into the cart: • Release latch on Hospital Cart located below Pump Console • Grab handle and slowly slide Console out approximately one quarter of the way • Repeat steps 1-3 to ensure Pump Console was successfully installed into Hospital Cart Note: The batteries will only charge if the Pump Console is properly seated in the Hospital Cart.

9 CARDIOSAVE BATTERY OPERATION

Battery Charging

10

Battery Charging

CARDIOSAVE BATTERY OPERATION

Hybrid and Rescue Modes on Touch Screen The Cardiosave Configuration Icon shows the current mode of configuration for the IABP, Hybrid Mode or Rescue Mode. The Cardiosave must be in Hybrid Mode to properly charge the batteries.

Configuration Icon

OPERATION MODE

Semi Auto

Auto

Zero Pressure

Trigger

Sources

IAB IAB Frequency Frequency

ECG

1:1

II

ECG

Direct

Hybrid

Rescue

IABP is in Hybrid Mode

IABP is in Rescue Mode

Thresholds

Pacer V/AV

Pressure Threshold

Inflation

Deflation

1:3

Off

Messages Posted Autofill Failure - No Helium

20

Pacer A

Auto Pacer Detection

Internal

If the IABP is set up in the Hybrid Mode and the Rescue Mode icon is displayed, ensure that the Rescue unit is securely docked into the Hospital Cart. Upon transitions from Rescue to Hybrid the IABP will sound three audio tones of increasing volume, upon transitions from Hybrid to Rescue the IABP will sound three audio tones of decreasing volume. Upon all transitions between Hybrid and Rescue the IABP will blink the icon for approximately 6 seconds.

Timing

Max

Disable Pulsatile Test

Hybrid Mode – The Rescue unit is docked into the Hospital Cart. Rescue Mode – The IABP is in Rescue configuration and is not docked into the Hospital Cart.

Startt Star

Augmentation

1:2

Pressure

Pressure

Standby

Hold 2 Sec.

Hybrid

1 of 2

Unable to Update Timing

No Backup Battery Detected

Default Lock Screen Hold 2 Sec.

Open Close Menus

Preferences

105 Ref Line

Help Exit Available Pause Audio

108 IAB Fill Hold 2 Sec.

Freeze Display

Aug Alarm

Print Strip Hold For Continuous

Cardiosave Battery Charging Indicators It is extremely important to be aware of the charge status of the Cardiosave batteries. These indicators are located on the top panel of the unit.

Battery Charging LED This indicator has three states: • It illuminates continuously when the internal batteries are fully charged • The LED indicator flashes when the internal batteries are charging

Battery Charging LED

• It is not illuminated when the system is using the battery as a power source, or when AC power is not available to the system, or when the battery or batteries are faulty. CAUTION A battery can only charge when the AC plug is connected to a live AC receptacle and the battery charging status LED is flashing. This charging condition must be maintained even when the system is not in use. The battery charging status LED will stop flashing and remain illuminated when the batteries are fully charged. If the system is to be stored for extensive periods of time, or in ambient temperatures above the operating range, refer to the Battery Section of the User Maintenance Chapter in the Operating Instructions.

Note: Depending on current battery charge level, the system may take up to 30 seconds to detect battery status and begin charging the battery.

CAUTION When AC power operation is intended, insure that the system is plugged into a live AC receptacle and that the “Battery in Use” informational message is NOT displayed. 11 CARDIOSAVE BATTERY OPERATION

Battery Charging

12

CARDIOSAVE BATTERY OPERATION

Charging Batteries Using the Battery Charging Station The Battery Charging Station is used to charge the IABP‘s exchangeable rechargeable lithium ion batteries when they are not being used to operate the IABP. Batteries should be maintained at full charge when being used to operate the IABP. Battery charge time is 5 hours per pack to 90% or greater capacity. For more information on battery maintenance, refer to the Battery Maintenance section of this document, beginning on page 22. WARNING: Internal Shock Hazard – This instrument does not contain any user-serviceable parts. DO NOT remove the instrument covers. Refer servicing to Getinge Factory Trained and Certified Service Personnel. WARNING: Route Battery Charging Station AC power cord safely. Keep walkways clear to reduce risk of injury WARNING: Do not stack the Battery Charging Station with or on other equipment. WARNING: Use only Datascope Corp. batteries REF 0146-00-00 97. CAUTION: Do not use a damaged or broken unit or accessory. CAUTION: The Battery Charging Station is not intended for use in transport. The Battery Charging Station is intended to be used in office buildings, aircraft hangars, or similar environments, and should not be within the vicinity of a patient.

Battery Charging

Charging a Single Battery 1

2

3

4

5

1. Attach the power cord, appropriate for the country of use securely into the back of the Battery Charging Station and plug the power cord into a compatible grounded AC receptacle. Do not use an adapter to eliminate the plug’s connection to ground.

2. Ensure the green power LED is illuminated.

3. Insert a battery into the battery slot, ensuring that the battery connector is facing the battery slot. Press gently on the battery to ensure it is fully seated in the charging slot. Note: Both slots can be used for single battery charging.

4. The status LED over the battery slot will begin to flash green indicating that the battery is currently being assessed, and if necessary will begin to charge. Battery charging is indicated by the sequential flashing of the 5 battery status LEDs on the rear of the battery pack. Once the battery is charged, the status LED will be illuminated solid green. The battery is now fully charged and ready for use.

5. If the status LED over the battery slot is flashing red, an error has been detected with the battery and as a result, will not charge. Note: Detecting a bad battery will take approximately 3 minutes.

13 CARDIOSAVE BATTERY OPERATION

Battery Charging

14

Battery Charging

CARDIOSAVE BATTERY OPERATION

Charging Multiple Batteries See page 13 “Charging a Single Battery” before reading this section. If a battery is already charging in the Battery Charging Station, a second battery can also be inserted. When the first inserted battery is fully charged, the second battery will automatically begin charging. 1

2

3

4

1. Insert a battery into the second battery slot, ensuring that the battery connector is facing the battery slot. Press gently on the battery to ensure it is fully seated in the charging slot.

2. If the battery in the first battery slot is still charging, the status LED over the second battery slot will be illuminated solid amber indicating that the battery in that slot is currently waiting to charge and will begin charging once the first battery has completed.

3. Once the battery is ready to charge, the status LED over the battery slot will begin to flash green indicating that the battery is currently being assessed, and if necessary will begin to charge. Battery charging is indicated by the sequential flashing of the 5 battery status LEDs on the rear of the battery pack. Once the battery is charged, the status LED will be illuminated solid green. The battery is now fully charged and ready for use.

4. If the status LED over the battery slot is flashing red, an error has been detected with the battery and as a result, will not charge.

Note: Detecting a bad battery will take approximately 3 minutes.

Transport Power Supply The Transport Power Supply provides the IABP with the ability to use AC power when it is not connected to the Hospital Cart. Installed batteries will only be charged from a Transport Power Supply when the Transport Power Supply is plugged into an AC receptacle, and the IABP is powered off. When a Transport Power Supply is installed and in a Battery Bay and plugged into an AC receptacle, the Transport Power Supply icon with AC plug is displayed in the Battery Icon Display Area informing the user that the Transport Power Supply is installed, and the IABP is currently running on AC power. When the Transport Power Supply is not plugged into an AC power receptacle, the AC plug icon is not displayed on the Transport Power Supply icon. CAUTION: When AC power operation is intended, insure that the system is plugged into a live AC receptacle and that the “Battery in Use” informational message is NOT displayed. NOTE: Installed batteries can only be charged from a Transport Power Supply when the Transport Power Supply is plugged into an AC receptacle, and the IABP is powered off.

15 CARDIOSAVE BATTERY OPERATION

Battery Charging

16

Battery in Use

CARDIOSAVE BATTERY OPERATION

Battery In Use – Check Messages and Icons

ECG

Lead: Auto - II

Rate

Source: Fiber-Optic

Pressure

bpm

0.5 mV

The Battery in Use Informational Message is displayed in the Message Display Area on the Touchscreen and the Battery Icon in the Battery Icon Display Area on the Monitor Display. Verify that the Battery Icons display at the charge level for each of the installed batteries.

Trigger: ECG Arterial

80

Inflation

0.0

Auto

As the charge level of the battery decreases, the battery icon will reflect this by incrementally decreasing the colored level inside the battery icon. Similarly, as the charge level of the battery decreases, the battery icon’s colored level will transition from green to yellow to red. When a battery is depleted, and no longer available for use, the battery icon will appear grayed out. When the battery has approximately 30 minutes of operating time remaining, the following occurs:

Augmentation

Balloon Pressure

(84) mmHg

116

Inflated

106 1:1

Aug Alarm IAB Frequency

Deflated

1

Monitor Display

• The Low Battery Medium Priority Alarm message is displayed continuously in the Message Display Area.

2 2

He

Battery Icon Display Area

OPERATION MODE

Semi Auto

Auto

• The Battery Icon Display Area will display the approximate time remaining in 5-minute intervals starting at <30 min.

Zero Pressure

Trigger

Sources

IAB IAB Frequency Frequency 1:1

II

ECG

Direct

Startt Star

Augmentation

Timing

Max

Inflation

1:2

Pressure

Pressure

Standby

Hold 2 Sec.

Hybrid

ECG

A reduction in run time will occur over a battery’s life due to age, storage temperature and discharge cycles. Batteries which are continually subjected to complete discharge cycles without the recommended immediate recharging, can incur permanent damage. For more information on battery maintenance, refer to the Battery Maintenance section of this document, beginning on page 22.

MEAN

Deflation

102 52

mmHg

130

30

80

Deflation

1:3

Off

Disable Pulsatile Test

Thresholds

Pacer V/AV

Pressure Threshold

Message Area

Messages Posted Autofill Failure - No Helium

20

Pacer A

Auto Pacer Detection

Internal

1 of 2

Unable to Update Timing

No Backup Battery Detected

Default Lock Screen Hold 2 Sec.

Open Close Menus

Preferences

105 Ref Line

Help Exit Available Pause Audio

108 IAB Fill Hold 2 Sec.

Freeze Display

Aug Alarm

Print Strip Hold For Continuous

Viewing Cardiosave Alarms on Monitor Display ECG

Rate

Lead: Auto - II - V, RL Disconnected

1

The Cardiosave has four types of alarms that indicate operating issues or failures that require attention by the Operator. These Alarm Icons are displayed in the lower left corner of the Monitor Display.

0.5 mV

bpm

80

20mm Auto Threshold

Trigger: Pressure Arterial

96 76

Pressure

Source: Transducer - Zeroing Complete

mmHg

130 112

80

1. 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.

30 Inflation

Deflation

Inflated

R-Wave

MEAN

4.0

Auto Balloon Pressure

Time in Standby:

22 min

Augmentation

!!!

!!!

112

Deflated

!!! Check IAB Catheter !!! No Trigger !! Poor Signal Quality

2. 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.

17 CARDIOSAVE BATTERY OPERATION

3

!!

!!

3. M  edium 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.

mmHg

Aug Alarm IAB Frequency

1

No Backup Battery Detected

2

(84)

4

Off 1:1

2

He

!

4. 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.

Battery in Use

18

Battery in Use

CARDIOSAVE BATTERY OPERATION

Cardiosave Alarm Messages on Touch Screen

OPERATION MODE

Semi Auto

Auto

Zero Pressure

Cardiosave Alarms are accompanied by a message on the unit’s Touchscreen and require appropriate Operator action.

Trigger

Sources

IAB IAB Frequency Frequency

ECG

1:1

II

ECG

Startt Star

Augmentation

Timing

Max

Inflation

1:2

Pressure

Direct

Pressure

Standby

Hold 2 Sec.

Hybrid

Deflation

1:3

Off

Disable Pulsatile Test

Thresholds

Pacer V/AV

Pressure Threshold

Message Area

Messages Posted Autofill Failure - No Helium

20

Pacer A

Auto Pacer Detection

Internal

1 of 2

Unable to Update Timing

No Backup Battery Detected

Default Lock Screen

Open Close Menus

Preferences

105 Ref Line

Hold 2 Sec.

No Backup Battery Detected

IAB Fill

Freeze Display

Pause Audio

Aug Alarm

Hold 2 Sec.

Print Strip Hold For Continuous

Messages Posted

AC is the only power source available to the IABP 1.

Help Exit Available

108

Autofill Failure - No Helium

Restore a backup source of power by inserting a functional battery into an available battery bay.

1 of 2

Unable to Update Timing

Exit

Single Alarm If only a single alarm or informational message exists that has a corresponding Help Screen, the corresponding Help Screen will be immediately displayed when the Help Available key is pressed.

Battery Overtemperature Detected in Battery Bay #___

Exit

Multiple Alarms If multiple alarms or informational messages exist, a multiple alarm display will be provided in the Help Screen area to allow the user to select specific Help Screens for the list of active messages. Each listed alarm or informational message is actually a key that, when selected, displays the associated single alarm Help Screen.

Cardiosave Medium Priority Alarm Messages – Battery/AC Power Low Battery

Multiple AC Power Sources Detected

There is less than 30 minutes of battery operating time remaining.

The IABP is connected to multiple AC power sources. 1. Disconnect the IABP from the unused AC power source (s).

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 :

Alarm Attributes:

Operation Mode: All

Operation Mode: All

Trigger Source: All

Trigger Source: All

Detailed Cause: Cumulative reserve of both batteries falls below 30 minutes of operating time.

Detailed Cause: The system has detected that multiple AC power sources are connected to the IABP.

System Response: Unaffected.

System Response: Unaffected.

Reset: A  utomatically removes message and turns off tone when an AC power source is restored or when a charged battery is inserted.

Reset: A  utomatically, once the unused AC power source is disconnected.

19 CARDIOSAVE BATTERY OPERATION

Battery in Use

20

Battery in Use

CARDIOSAVE BATTERY OPERATION

Cardiosave Low Priority Alarm Messages – Battery/AC Power Battery in Use

Unable to Charge Batteries

The IABP is on battery power.

A component over temperature condition has suspended the IABP’s ability to charge the batteries.

1. If available, switch to an AC power source.

1. Switch to another Getinge IABP if available. 2. If another Getinge IABP is not available, ensure at least one charged battery is present in the battery bays. 3. If charged batteries are unavailable, ensure that the IABP is connected to an uninterruptible AC power source. 4. Contact Getinge Service. Message Attributes:

Message Attributes:

Operation Mode: All

Operation Mode: All

Trigger Source: All

Trigger Source: All

Detailed Cause: The IABP is being powered by battery.

Detailed Cause: An over temperature condition of the power management board has suspended the IABP’s ability to charge batteries.

System Response: Unaffected. Reset: A  utomatic once AC power source is connected.If an AC power source is unavailable, insert a charged battery into the battery bay not currently in use.

System Response: Patient therapy uninterrupted, ability to charge batteries is suspended. Reset: A  utomatically once the power management temperature falls below the established over temperature threshold.