24-Hour Emergency Hotline: N. America 1-800-422-8666
September 2006 DRAFT
Document No. x Rev. 2
IMPORTANT NOTICE: Read this entire manual before using the RECOVER BP
IABP/VAD System. The RECOVER BP IABP/VAD System is to be used only in
accordance with this manual and in conjunction with the RECOVER BP Intra-Aortic Balloon Catheter Instructions for Use ****[document number].
Information contained in this document is subject to change without notice.
NOTE: A warning indicates a situation that could result in injury or
death.
•The RECOVER BP System is not suitable for use in the presence
of a flammable anesthetic mixture with air or with oxygen or
nitrous oxide. It is also not suitable for use in an oxygen-enriched
atmosphere.
•The RECOVER BP Console does not contain any
user-serviceable parts. To reduce the risk of electric shock, do
NOT attempt to remove the Console housing or to replace the
Console Battery.
•Do NOT connect items to the RECOVER BP System that are not
specified as part of the System. All equipment intended for
connection to signal input, signal output, or other connectors
must comply with the relevant IEC standard (IEC 60950 for IT
equipment and IEC 60601 series for medical electrical
equipment).
In addition, all such combinations (systems) must comply with
IEC 60601-1-1, Safety requirements for medical electrical systems. Equipment not complying with IEC 60601-1 must be
kept at least 1.5 m outside the patient environment, which is
defined in the standard and in the System Specifications section
of this manual.
•Do NOT simultaneously touch the patient and any part of the
RECOVER BP System exposed by removal, without the use of a
tool, of a connector or cover. In addition, do NOT simultaneously
touch the patient and any other equipment.
•Power the Console using its internal battery if the integrity of the
protective earth conductor is questionable.
•Per IEC 60601-1-1: Enclosure leakage current measured from or
between parts of the RECOVER BP System within the patient
environment must NOT exceed 0.1 mA. Enclosure leakage
current in the event of interruption of any non-permanently
installed protective earth conductor must NOT exceed 0.5 mA.
1.2 RECOVER BP IABP/VAD System – Operator’s Manual
Warnings and Cautions 1
Warnings
•Per IEC 60601-1-1: Patient leakage current must NOT exceed
0.01 mA.
•Medical Electrical Equipment needs special precautions
regarding EMC and needs to be installed and put into service
according to the Electromagnetic Compatibility (EMC)
information provided in the accompanying documents.
•Portable and Mobile RF Communications Equipment can affect
Medical Electrical Equipment.
•The Equipment or System should not be used adjacent to or
stacked with other equipment. If adjacent or stacked use is
necessary, the Equipment or System should be observed to verify
normal operation in the configuration in which it will be used.
•A patient monitor must be provided and used to continuously
monitor patient physiological parameters. Do NOT rely solely on
the System alarms to notify you of life-threatening conditions.
•Be sure to follow the warnings and cautions on the high-pressure
gas (helium) cylinder. Observe all DOT and IATA regulations for
Dangerous Goods/Hazardous Materials when transporting a
Console containing a helium cylinder. Only personnel trained in
the handling of high-pressure gas cylinders should install or
replace the helium cylinder.
•Use only original accessories and replacement parts supplied by
ABIOMED. Use of any other accessories or parts can endanger
the patient.
• Do NOT reuse single-use devices.
• The RECOVER BP System is intended for use only by personnel
®
trained in accordance with the ABIOMED
Training Program.
•Do NOT operate the RECOVER BP System near a Magnetic
Resonance Imaging (MRI) machine.
•If the pressure trigger threshold is changed, evaluate inflation and
deflation timing and make adjustments if necessary.
•Do NOT use Internal trigger source while the patient is producing
cardiac output.
RECOVER BP IABP/VAD System – Operator’s Manual 1.3
1 Warnings and Cautions
Warnings
•If the heart rate varies by more than 10 beats per minute (bpm)
within X seconds, evaluate inflation and deflation timing and
make adjustments if necessary.
•Pumping an IAB that has a leak can result in: (1) a blood clot in
the IAB that may require surgical removal of the IAB, and (2) air
embolism.
•Due to the potential for thrombus formation, an IAB must NOT
remain dormant.
• Do NOT place an IAB patient in a hyperbaric chamber.
• Do NOT use Auto timing when the patient's heart rate is greater
than 200 bpm.
•Be extremely careful when a defibrillator is used on a patient.
Dangerous high voltage is present during defibrillation. Do NOT
touch the Console, patient, table, accessories, cables, or any
connected equipment.
• Do NOT use pressure triggering while arrhythmia is present.
• When pressure triggering is used, adjust deflation to be complete
at the upstroke of systole.
•Do NOT leave an IABP patient unattended.
1.4 RECOVER BP IABP/VAD System – Operator’s Manual
Warnings and Cautions 1
Cautions
Cautions
NOTE: A caution indicates a situation in which equipment may
malfunction, be damaged, or cease to operate.
•The RECOVER BP Console must be plugged into AC power to
maintain a charged battery.
•To remove all AC power from the Console, unplug the power
cord from the AC outlet.
•Be sure to route the power cord and all cables, including the
keypad/display extension cable, in a manner which prevents
tripping hazards and equipment damage.
•Do NOT lean or place any objects on the Console keypad or on
the screen.
•Do NOT pour liquid, including cleaning solution, directly on any
part of the Console. Doing so can cause electrical malfunction.
If liquid is accidentally spilled on the Console, be sure to
thoroughly dry the affected area. Wait at least 15 minutes, after
drying, before turning the Console ON. Verify that the Self-Test
runs and indicates that the unit is operating properly.
•Minimize exposure of RECOVER BP
System components to
sources of electromagnetic interference (EMI). Exposure to
sources of EMI, such as cell phones and two-way radios, may
cause operational interference. To clear interference, either
increase the distance between RECOVER BP System
components and the EMI source or turn off the EMI source.
•Operation of RECOVER BP System components may interfere
with the operation of other devices. If interference occurs,
increase the distance between the device and RECOVER BP
System components.
•Avoid activities that may build up static charges on the Console
or on personnel contacting the Console. Avoid brushing bed
sheets across the Console or touching the Console immediately
after performing activities likely to build static charge. If
electrostatic discharge interrupts operation of the Console, cycle
the Power ON/OFF switch.
RECOVER BP IABP/VAD System – Operator’s Manual 1.5
1 Warnings and Cautions
Cautions
•Do NOT power the RECOVER BP System using Multiple
Portable Socket Outlets (MPSO) or an extension cord.
•Do NOT allow the conductive parts of electrodes and associated
connectors to contact any conductive parts and/or earth ground.
•Do NOT use a RECOVER BP System if any part of the System
is damaged.
• Do NOT use damaged or contaminated connector cables.
• To prevent overheating and improper operation, do NOTblock
the RECOVER BP Console cooling vents while the Console is
operating.
•The Console and cables should be disposed of according to all
local, state, federal, and country regulations. The Console battery
is a sealed lead-acid unit and should be reclaimed.
•Close the helium cylinder supply valve when the Console is not
in use.
1.6 RECOVER BP IABP/VAD System – Operator’s Manual
VAD ................................................................................................................2.4
2.1
2 Indications, Contraindications, and Potential Adverse Events
Indications
Indications
IABP
• Cardiogenic shock
• Unstable angina
• Acute myocardial infarction (AMI)
• Complications following MI
• Adjunct to **** (PTCA)
• Adjunct to cardiac catheterization
• Bridge to transplant
• Hemodynamic support pre-, intra-, and post-operatively
• Bridge to other therapies
• Intractable arrhythmias
VAD
ABIOMED® RECOVER BP Circulatory Support System (CSS)
therapy is intended to treat patients suffering from reversible
ventricular dysfunction. Typical patients have undergone successful
cardiac surgery and subsequently developed low cardiac output, or
have suffered from acute cardiac disorders leading to hemodynamic
instability.
The intent of the RECOVER BP System therapy is to provide
circulatory support, restore normal hemodynamics, reduce ventricular
work, and allow the heart time to recover adequate mechanical
function.
2.2 RECOVER BP IABP/VAD System – Operator’s Manual
Indications, Contraindications, and Potential Adverse Events 2
Indications
Appropriate patient groups include those that are likely to recover
cardiac function after the myocardium is permitted to rest on
ventricular support. Examples include, but are not limited to:
• Patients who fail to wean from cardiopulmonary bypass (CPB)
following heart surgery.
• Failed transplant patients who require ventricular assist following
heart transplantation.
• Patients who require right ventricular assist device (RVAD)
support while on implantable left ventricular assist device
(LVAD) support.
• Patients suffering from acute cardiac disorders such as viral
myocarditis.
A patient is a candidate for mechanical assistance with the
RECOVER BP System if she/he meets all of the following criteria:
• Patient has a body surface area > 1.3 m² and is ≤ 75 years of age.
• Patient is in relatively good health other than the cardiovascular
problem for which surgery was undertaken.
• All appropriate measures have been attempted to correct low
arterial pH, arterial blood gas abnormalities, electrolytes,
hypovolemia, hypervolemia, inadequate cardiac rate,
dysrhythmias, and residual hypothermia.
• Cardiac resuscitation employing pharmacologic agents has been
attempted. While the use of an Intra-Aortic Balloon Pump (IABP)
is recommended prior to RECOVER BP System assistance, its use
may not always be appropriate (e.g., fibrillating heart, peripheral
atherosclerosis).
• Patient is unable to be weaned from CPB or is unable to maintain
acceptable hemodynamics in the immediate postoperative period
(< 6 hours after the first attempt to wean from CPB), or patient is
unable to maintain acceptable hemodynamics following a
significant cardiac event despite the measures cited above.
RECOVER BP IABP/VAD System – Operator’s Manual 2.3
2 Indications, Contraindications, and Potential Adverse Events
Contraindications
Contraindications
IABP
• Significant aortic valve insufficiency
• Thoracic or abdominal aortic aneurysm
• Severe **** (PVD)
• Occluded aorta
VAD
• Major cardiac or extracardiac catastrophes occurring during
operation or in the postoperative period that preclude survival
such as uncontrolled hemorrhage, massive air embolization,
interstitial pulmonary hemorrhage with inability to maintain
adequate ventilation, pump oxygenator or perfusion difficulties, or
massive transfusion reaction, hemolysis during bypass, or
inadequate cannulation.
• Central nervous system damage resulting in fixed and dilated
pupils.
Potential Adverse Events
IABP
VAD
****[clinical]
2.4 RECOVER BP IABP/VAD System – Operator’s Manual
VAD ................................................................................................................3.4
3.1
3 The RECOVER BP IABP/VAD System
Overview
Overview
The RECOVER BP IABP/VAD System (RECOVER BP System) is a
versatile cardiac assist device that combines IABP and VAD support
capability within one Console (described in Section 4). This mobile
System uses a laptop-style interface.
Laptop-style
Interface
Console
Cart
Figure 1 RECOVER BP Console
3.2 RECOVER BP IABP/VAD System – Operator’s Manual
The RECOVER BP IABP/VAD System 3
Disposables and Accessories
Disposables and Accessories
WARNING: Do NOT reuse single-use devices.
IABP
For IABP support (described in Section 6), the following items are
used with the RECOVER BP System:
•8F 40 cc IAB Catheter Kit (see Figure 2)
Figure 2 IAB Catheter Kit
RECOVER BP IABP/VAD System – Operator’s Manual 3.3
3 The RECOVER BP IABP/VAD System
Disposables and Accessories
• IAB Insertion Kit (see Figure 3)
Figure 3 IAB Insertion Kit
• Patient Cable Set
• Helium Cylinder
• Chart Recorder Paper
• Adapter for Datascope
®
8F (40 cc) IAB Catheter
VAD
For VAD support (described in Section 7), the following items are
used with the RECOVER BP System:
•AB5000
™
Ventricle (Ventricle) – a pneumatically driven device
that provides pulsatile, hemodynamic support (see Figure 4). The
single-chamber Ventricle provides circulatory support in the
presence of left-, right-, or both-sided heart failure. It uses
vacuum assist technology to operate either horizontally or
vertically.
3.4 RECOVER BP IABP/VAD System – Operator’s Manual
The RECOVER BP IABP/VAD System 3
Disposables and Accessories
Figure 4 AB5000™ Ventricle
•BVS
®
Blood Pump (BVS Pump) – a pneumatically driven device
that provides pulsatile, hemodynamic support (see Figure 5). The
dual-chamber BVS Pump provides circulatory support in the
presence of left-, right-, or both-sided heart failure. It can operate
either vertically or horizontally and its atrial chamber fills
passively.
Figure 5 BVS® Blood Pump
• BVS
• BVS
• BVS
®
5000 Atrial Cannula (32F, 36F, and 42F)
®
5000 Arterial Cannula (42F)
®
Pump Mount Set (includes BVS® IV Pole Mount and
BVS® Bed Mount)
•Aircraft Mounting Plate
RECOVER BP IABP/VAD System – Operator’s Manual 3.5
The following pages present a general overview of Console features,
electrical connections, and interface layout.
For operating instructions, refer to IABP Support (Section 6) and
VAD Support (Section 7). These sections contain detailed instructions
and task-specific information.
4.2 RECOVER BP IABP/VAD System – Operator’s Manual
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