MAQUET

MAQUET Intra Aortic Balloon Pumps

CARDIOSAVE Battery Operation Quick Reference Guide-Transport Rev C

Quick Reference Guide

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File Size: 9.62 MB

File Name: MAQUET - MCV00020163 - CARDIOSAVE Battery Operation Quick Reference Guide-Transport Rev C.pdf

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Page 1

CARDIOSAVE IABP Operation – Transport ®

Quick Reference Guide

Note: This is an abbreviated guide. For complete instructions, refer to IAB Instructions for Use and CARDIOSAVE Operating Instructions.

| 2 | CARDIOSAVE Operation - Transport | Cardiac Assist |

IAB SIZING

INTRA-AORTIC Intra-aortic Balloon BALLOON NEWSizing SIZING GUIDE Reference Guide

6' 5'

< 5'0" (< 152cm)

30cc

5'0" to 5'4" (152cm - 162cm)

5'4" to 6'0" (162cm - 183cm)

5'4" & taller (≥ 162cm)

40cc

50cc

SENSATION PLUS® 7.5Fr.

SENSATION PLUS® 8Fr.

MEGA® 7.5Fr.

MEGA® 8Fr.

25cc

34cc

40cc

SENSATION® 7Fr.

LINEAR® 7.5Fr.

Note: This information is to be used as a guidance only. Clinical information and patient factors such as torso length should be considered when selecting the appropriate balloon size. SENSATION and SENSATION PLUS are fiber-optic IAB catheters.

CARDIOSAVE Rescue Initial Set-up 2 Connect ECG cable.

3 Connect fiber-optic sensor connector for Maquet/Datascope fiber-optic IAB.

Press POWER button to turn IABP ON.

Connect pressure cable for conventional IAB.

4 | 3 | CARDIOSAVE Operation - Transport | Cardiac Assist |

Connect IAB.

CARDIOSAVE SET-UP

| 4 | CARDIOSAVE Operation - Transport | Cardiac Assist |

CARDIOSAVE SET-UP

Initial Set-up using a Maquet/Datascope Fiber-optic IAB (continued) ECG

Lead: Auto - II

Rate

Source: Fiber-Optic

Pressure

bpm

0.5 mV

Trigger: ECG Arterial 130

30 Inflation

MEAN

Deflation

102 52

mmHg

0.0

Auto

Augmentation

Balloon Pressure

mmHg

106 1:1

Aug Alarm IAB Frequency

Deflated

Verify AUTO

(84)

116

Inflated

2 2

Verify Aug. Alarm is set 10mmHg below patient’s augmented diastolic pressure (approx. 3 minutes after initiation of assist).

Press START ECG

Lead: Auto - II

Rate

Source: Fiber-Optic

Pressure

Pressing the START key • Automatically purges and fills IAB • Automatically performs an in vivo calibration • Automatically selects most appropriate lead and trigger • Automatically sets inflation and deflation timing

bpm

0.5 mV

Arterial

Trigger: ECG

130

Inflation

Auto Balloon Pressure Inflated

Note: With a Maquet/Datascope fiber-optic IAB, there is no need to zero. Calibration occurs automatically after pressing START. Operator may invoke a calibration anytime by pressing and holding CALIBRATE pressure key for 2 seconds, while assisting. Deflated

MEAN

Deflation

102 52

mmHg

0.0

Augmentation

(84) mmHg

116 106 1:1

Aug Alarm IAB Frequency

2 2

Check fill status of the helium tank. A fully charged internal helium reservoir will provide approximately 36 fill cycles.

Initial Set-up using a Conventional IAB (continued)

ECG ECG

Rate Rate

Lead: Lead:Auto Auto- II- II

bpm bpm

0.50.5 mVmV

Trigger: ECG ECG Trigger: Pressure Pressure

Source:Fiber-Optic Fiber-Optic Arterial Source: Arterial 130 130

8080

3030

Inflation Inflation

Balloon Pressure Balloon Pressure Inflated Inflated

ECG

Rate

Lead: Auto - II

Trigger: ECG Arterial

Pressure

Source: Fiber-Optic

130

30 Inflation

MEAN

Deflation

Auto Balloon Pressure Inflated

Deflated

102 52

mmHg

0.0

Augmentation

Augmentation Augmentation

Deflated Deflated

(84) mmHg mmHg

116 106 106 1:1 1:1

Aug Alarm Alarm Aug IABFrequency Frequency IAB

(84)

2222

He He

mmHg

116 106 1:1

Aug Alarm IAB Frequency

Verify AUTO

MEAN MEAN

102 52

mmHg mmHg

0.0 0.0

bpm

0.5 mV

Deflation Deflation

Auto Auto

2 2

Verify Aug. Alarm is set 10mmHg below patient’s augmented diastolic pressure (approx. 3 minutes after initiation of assist).

Press START

Pressing the START key • Automatically purges and fills IAB • Automatically selects most appropriate lead and trigger • Automatically sets inflation and deflation timing | 5 | CARDIOSAVE Operation - Transport | Cardiac Assist |

CARDIOSAVE SET-UP

| 6 | CARDIOSAVE Operation - Transport | Cardiac Assist |

Portable Operation Maquet/Datascope Corp. recommends: • Sufficient supply of fully charged batteries for use during transport. • Use of the Transport Power Supply for AC operation during transport. • Verifying internal helium reservoir is full when using the Transport System. • System must be properly secured in the transport vehicle.

TRANSPORT CONSIDERATIONS

Removing Pump Console from the Cart

Release latch located below pump console (ensure wheels are locked).

Grab handle and slowly slide console out.

Grab handles located on top and front of console, then remove from Hospital Cart.

4a Push button to release pop-up mount. 4b Pull UP pop-up mount to lock in place.

Squeeze latches located below Monitor and lift to remove from Hospital Cart.

Squeeze latches and attach to pop-up mount, then release latches. Ensure Monitor is securely attached.

Squeeze latch below handle and lift straight up until wheels extend outward and handle locks into extended position.

Tilt Transport System on wheels and begin transport.

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TRANSPORT CONSIDERATIONS

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eflation

MEAN

R-Wave

Inserting the Pump Console4.0 into the Hospital Cart Augmentation 2 min

Squeeze latch below handle. Push straight down until wheels retract and handle is fully collapsed.

Squeeze latches located below Monitor and lift to remove from Pump Console.

Off

(84)

TRANSPORT CONSIDERATIONS

mmHg

112

Squeeze latches and attach to display mount, then release the latches. Ensure monitor is securely attached.

Off

Aug Alarm

IAB Frequency:

1:1

4a Push and hold button on console to unlock monitor mount. 4b Push down to lock into place, then release button.

<5 min.

own 5 Grab handles located on top and front of console, then lift into Hospital Cart.

Grab handle and slowly slide console into Hospital Cart until it locks into place. Note: An audible click will be heard when console is locking into cart.

To ensure console was successfully installed into cart, plug Hospital Cart power cord into a compatible grounded AC receptacle. Confirm AC operation by presence of AC Plug Icon in the Battery Icon Display Area. If AC Plug Icon is not present: - Release latch on the Hospital Cart located below Pump Console - Grab the handle and slowly slide Console out approximately one quarter of the way - Repeat steps 6-7 to ensure Pump Console was successfully installed into Hospital Cart

Helium Supply Ensure the internal helium reservoir is full before using CARDIOSAVE for transport. If the helium icon is not showing full, the following actions should be taken:

CARDIOSAVE Hybrid: • Return the pump console to the hospital cart for a minimum of 30 seconds. • Ensure the helium icon indicates full.

He Helium tank icon displays a full tank.

• Remove pump console from cart and continue with transport (refer to page 6).

CARDIOSAVE Rescue: • Attach the Helium Refilling Station for a minimum of 30 seconds. • Ensure the helium icon indicates full. • Disconnect Helium Refilling Station and continue with transport. Caution: The Helium Refilling Station is not intended for use in transport. It is intended to be used in office buildings, aircraft hangars, or similar environments, and should not be within the vicinity of a patient.

Helium Refilling Station | 9 | CARDIOSAVE Operation - Transport | Cardiac Assist |

TRANSPORT CONSIDERATIONS

| 10 | CARDIOSAVE Operation - Transport | Cardiac Assist |

Helium use from Internal Reservoir The internal helium reservoir contains sufficient helium to provide approximately 36 fill cycles at full capacity. With every Autofill, helium will be depleted in the following approximate amounts: Autofill Condition

Helium Used

Pump is powered off, powered on, and IAB fill performed to restart therapy

6 Autofill cycles

IAB disconnected and reconnected and IAB fill performed to restart therapy

6 Autofill cycles

Autofill performed due to a Gas Gain in IAB Circuit alarm, IAB Disconnected alarm, or an Autofill Failure alarm

6 Autofill cycles

Autofill every 2 hours

1 Autofill cycle

Autofill every 1000 feet (305 meters) of altitude increase during ascent

1 Autofill cycle

Autofill every 2000 feet (610 meters) of altitude decrease during descent

1 Autofill cycle

Note: The supply of helium in the internal helium reservoir will deplete more rapidly when an autofill is performed when the system is powered on, when the catheter is disconnected and reconnected or when an autofill is performed due to a gas loss, catheter disconnect, or autofill failure alarm.

Effects of altitude changes during air transportation For proper operation during air transport, IABP balloon pressure must adapt to local atmospheric pressure. The system will automatically purge and fill the IAB when local atmospheric pressure decreases by 25mmHg or increases by 50mmHg. These pressure changes occur approximately every 1,000 feet (305 meters) of increase in altitude or 2000 feet (610 meters) of decrease in altitude.

112 76 112 112 76 112

MEAN

ug Alarm

(84)

MEAN

R-Wave

Off

(84)

Aug Alarm Off

Viewing Status on Monitor Display (examples) 4.0Battery IAB Frequency: IAB Frequency: 1:1 B Frequency: 1:1

ugmentation

Augmentation mmHg

Off

112 112

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

Off

Lit green circle indicates battery 1 is in use. Battery 2 is fully charged and available for use when battery 1 is depleted.

Aug Alarm ug Alarm Off r IAB Frequency: B Frequency: 1:1 r y <5 <30 min. y 1 2 He Timing 11

Off

1:1 IAB Frequency:

<5 min.

Off Aug Alarm

1:1

mmHg

<5 min.

1to Shutdown 2 He own Seconds 1 2

only shows temporarily

Off

Battery 1 is depleted, thus battery 2 is currently being used.

1:1

<5 min.

Battery 2 has less than 5 minutes of charge remaining.

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

| 11 | CARDIOSAVE Operation - Transport | Cardiac Assist |

<30 min.

<30

Battery 2 has less than 30 minutes of charge remaining (Low Battery message is displayed).

Red Text and Waveforms (was Yellow)

AP markers - only option A - stay with show green in Pressure Trigger mode

Transport Power Supply installed in Battery Bay #2 is plugged into AC receptacle and is in use. The battery in Battery Bay #1 is not being charged.

Red Text and Wave (was Yello

AP markers option A - stay -w in Pressure T

Transport helium icons show full gray version when “T” is pressed

Tr sh wh Standa icons -

TRANSPORT CONSIDERATIONS

| 12 | CARDIOSAVE Operation - Transport | Cardiac Assist |

Viewing Battery Status on Battery 1

Note: Each LED represents a charge of approximately 20%. Battery run time: approximately 90 minutes each.

attery is approximately B 100% charged.

attery installed in B Battery Bay 1.

Transport Power Supply installed in Battery Bay 2.

Changing the Battery

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.

IAB Transport Fixation with the Mounting Plate

Center CARDIOSAVE on open end of Transport Mounting Plate. Ensure pump’s wheels are fully retracted before rolling into position on the plate.

Roll CARDIOSAVE into Transport Mounting Plate between guide tracks until seated on guide pins and firmly braced against rear track.

Lift swing bolt into upright position.

| 13 | CARDIOSAVE Operation - Transport | Cardiac Assist |

Turn bolt clockwise until tight. Ensure CARDIOSAVE is firmly locked in place.

TRANSPORT CONSIDERATIONS

| 14 | CARDIOSAVE Operation - Transport | Cardiac Assist |

Technical Specifications Operating Ambient

Weight* kg

lbs

Operating Temperature

10° C to 40° C (50° F to 104° F)

Monitor

3.6

Operating Humidity

15% to 85% Relative Humidity (non-condensing)

Battery Pack (0146-00-0097)

1.4

Operating Altitude

-1250 feet to 12,000 feet (795 mmHg to 483 mmHg) (1060 hPa to 644 hPa)

Pump Console

17.7

Transport Configuration (including monitor and pump console with 2 batteries)

24.1

* All weights ± 5%

Dimensions Transport and Display Display Closed

57.2cm H x 40.6cm D x 33.0cm W 22.5" H x 16" D x 13" W

Display Open 90°

78.0cm H 30.7" H

CARDIOSAVE operation Modes Auto Operation Mode • Automatic lead and trigger selection • Automatic and continuous inflation and deflation timing management - User has ability to fine-tune deflation timing • Automatic management of irregular rhythms • Automatic in vivo calibration (when using a Maquet/Datascope fiber-optic IAB)

Semi-Auto Operation Mode • Operator selects most appropriate lead and trigger source • Operator establishes timing, then CARDIOSAVE automatically adjusts timing with heart rate and rhythm changes • Automatic management of irregular rhythms • Automatic in vivo calibration (when using a Maquet/Datascope fiber-optic IAB)

| 15 | CARDIOSAVE Operation - Transport | Cardiac Assist |

CARDIOSAVE OPERATION

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Cardiosave Monitor Display and Touchscreen ECG

Rate

Lead: Auto - II

Trigger: ECG Arterial

Pressure

Source: Fiber-Optic

130

30 Inflation

MEAN

Deflation

Auto Balloon Pressure Inflated

Deflated

102 52

mmHg

0.0

Augmentation

(84)

Semi Auto

Auto

116

Trigger

Sources Sources

IAB IABFrequency Frequency

ECG

1:1

ECG

Standby

Start Start

Augmentation

Timing

Max

Inflation

1:2

Pressure

Direct

Pressure

Deflation

1:3

Off

Thresholds

Pacer V/AV

Pressure Threshold

Pacer A

Auto Pacer Detection

Internal

106 1:1

2 2

Calibrate Pressure Hold 2 Sec.

mmHg

Aug Alarm IAB Frequency

Monitor Display

OPERATION MODE

bpm

0.5 mV

Default Lock Screen

Open Close Menus

Hold 2 Sec.

Touchscreen

Preferences

106 Ref Line

IAB Fill Hold 2 Sec.

Freeze Display

Aug Alarm Alarm

Print Strip Hold For Continuous

Cardiosave Lock Screen Feature OPERATION MODE

OPERATION MODE

Semi Auto

Auto

Calibrate Pressure

Standby

Start Start

Semi Semi Auto

Auto

Calibrate Pressure

Hold 2 Sec.

Trigger

Sources Sources

IAB IABFrequency Frequency

ECG

Timing

Max

Inflation

1:2

Direct

Sources

Pressure

Pressure Threshold

Pacer A

Pacer Detection

Preferences

Hold 2 Sec.

1:2 1:3

Deflation Off

to unlock press Unlock Screen button

Pacer Detection

Internal

Default Open Close Menus

Inflation

Auto

Lock Screen

Timing

Max

Thresholds

Pacer V/AV

Internal

Startt Star

Augmentation

Screen is locked

Direct

Pressure Threshold

Pacer A

1:1

Pressure

Off

IAB IAB Frequency Frequency

ECG

Deflation

1:3

Thresholds

Pacer V/AV

Trigger

ECG

Pressure

Augmentation

1:1

E CG

Standby

Hold 2 Sec.

Default

106 Ref Line

IAB Fill

Freeze Display

Hold 2 Sec.

Aug Alarm Alarm

Print Strip

Unlock Lock Screen Screen

Hold For Continuous

Hold 2 Sec.

Open Close Menus

Preferences

106 Ref Line

IAB Fill

Freeze Display

Hold 2 Sec.

Touchscreen Unlocked

Touchscreen Locked

ouchscreen will Lock: T • Automatically after 2 minutes of inactivity • When operator presses LOCK SCREEN key for 2 seconds

ouchscreen will Unlock: T • Automatically with any Technical, High, Medium, or Low Priority Alarm • When operator presses UNLOCK SCREEN key

| 17 | CARDIOSAVE Operation - Transport | Cardiac Assist |

Aug Alarm

Print Strip Hold For Continuous

CARDIOSAVE OPERATION

| 18 | CARDIOSAVE Operation - Transport | Cardiac Assist |

Cardiosave Triggers Triggering

CARDIOSAVE Triggers

• A Trigger is the signal that CARDIOSAVE uses to identify the beginning of the next cardiac cycle • When CARDIOSAVE recognizes the trigger event, it will deflate the balloon if not already deflated • Trigger Source keys are only active while in Semi-Auto operation mode

ECG Trigger event is the R-Wave • Trigger of choice when an adequate R-Wave is present • Pacer spikes are automatically rejected Pressure Trigger event is the systolic upstroke • Trigger of choice (with a regular rhythm) when an adequate R-Wave is not present • A fixed pressure threshold can be manually set while in Semi-Auto operation mode Pacer V/AV Trigger event is the Ventricular pacer spike • Typically used when ECG triggering is unsuccessful and a V or AV pacer is being used • Must be 100% paced • Only available in Semi-Auto operation mode Pacer A Trigger event is the R-Wave • Recommended only if atrial pacer tails are interfering with R-Wave detection while in ECG trigger • Only available in Semi-Auto operation mode Internal Trigger event is asynchronous at a fixed rate of 80 BPM • Only used when there is no mechanical cardiac cycle (i.e.: cardiopulmonary bypass or asystole) • Rate can be adjusted from 40 to 120 BPM • Only available in Semi-Auto operation mode

Theory of Counterpulsation Therapy

Inflation: increases supply of oxygen to the myocardium.

Deflation: decreases demand for oxygen by the left ventricle.

How it works • B alloon inflates at onset of diastole (when aortic valve closes)

How it works alloon deflates just prior to systolic • B ejection (before aortic valve opens)

• D isplaces blood, causing an increase in aortic pressure

• R esults in a rapid decrease in aortic pressure

Benefits • Increases coronary artery perfusion

Benefits • D ecreases afterload

• Increases mean arterial pressure

• D ecreases cardiac workload • Increases cardiac output

| 19 | CARDIOSAVE Operation - Transport | Cardiac Assist |

CARDIOSAVE OPERATION

| 20 | CARDIOSAVE Operation - Transport | Cardiac Assist |

Timing Timing refers to the positioning of inflate and deflate points on the arterial pressure waveform.

Diastolic Augmentation

Proper IABP Timing

Unassisted Systole

Inflation ccurs at the dicrotic notch • O

Assisted Systole

• Appears as a sharp “V” • Ideally diastolic augmentation rises above systole Deflation • O ccurs just prior to systolic ejection • Results in a reduction in assisted end diastolic pressure • Results in a reduction in assisted systolic pressure

One Cardiac Cycle

Unassisted End Diastolic Pressure

Assisted End Diastolic Pressure

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