What Is an Intra-aortic Balloon Pump?

Intra-aortic balloon pump is composed of host, display, ECG lead, and power cord. The registration number is the National Food and Drug Administration 2008 No. 3213096. The frequency response is 1 25Hz (+ 0.4dB, -0.3dB ).

Intra-aortic balloon pump

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Chinese name: Intra-aortic balloon pump
Foreign name: Intra-Aortic Balloon Pump System

Make up: Host, display, ECG lead, power cord
Registration Number: State Food and Drug Administration 2008 No. 3213096
Frequency response characteristics: 1 25Hz (+ 0.4dB, 0.3dB)

Product name (Chinese) Intra-aortic balloon pump ^[1]

Product Name (English)

Product performance structure and the product are composed of (see attachment). : Heart rate measurement range: 40 200bpm; Heart rate measurement accuracy: +/- 1 times or +/- 2%, whichever is greater; Arterial pressure test range: 0 250mmHg (can be divided into 7 levels); Artery Pressure measurement accuracy: +/- 1mmHg or +/- 2%, whichever is greater; Arterial pressure alarm range: Diastolic blood pressure 50 250mmHg, average pressure 30 120mmHg; the internal pressure of the balloon is between 0 250mmHg ; Auxiliary rate adjustment range: 1: 1, 1: 2, 1: 4, 1: 8; Auxiliary rate accuracy: +/- 1 times or +/- 2%, whichever is greater; the trigger mode of the device is divided into For: standard type, peak type, atrial fibrillation type, ventricular pacing type, atrial pacing type, arterial pressure type. <Scope of application> = Indications for internal medicine: Cardiogenic shock; The range of pre-shock syndrome continues to increase; Unstable angina; Intractable ventricular arrhythmia; Septic shock syndrome; Contusion and laceration of the heart Preventive support during diagnostic interventions and non-surgical procedures; mechanical defects of the heart; heart valve stenosis; valvuloplasty of the mitral valve; valvular dysfunction of the mitral valve; ventricular septal defect (VSD); Surgical indications; preventive preparations for cardiac surgery; myocardial insufficiency after surgery; cardiac functional support after calibrating defects in the anatomy of the heart; maintenance of open grafts after coronary artery bypass surgery; provided Pulsating blood flow during cardiopulmonary bypass; a bridge to assist left ventricular function. Absolute contraindications: aortic valve insufficiency with significant changes in hemodynamics; aortic aneurysm or aortic vascular wall disease. Relative contraindications: coronary atherosclerosis; advanced disease. Potential complications: Obstruction of the vessel due to catheter placement, or improper placement of the catheter, causing ischemia of the limb. Due to the exfoliation of the endothelial surface, improper insertion of the catheter or accidental aortic wall disease may cause damage to the aortic wall. If the catheter is left in the aorta for a long period of time, thrombosis may occur on the intima of the aorta or on the catheter near the insertion site of the catheter. Emboli may form from the time the catheter is first inserted until the device is removed. Embolism that is known to occur in emboli include thromboembolism, sclerotic plaque, gas, and air. When a weak patient is exposed to a hospital environment with a variety of monitoring equipment, microbial infections can occur. The presence of a balloon, especially if the balloon is completely blocked when the balloon is inflated, can cause thrombocytopenia. Rupture and / or invasion of a balloon in the aorta.

Registered as Beijing Shimao Medical Equipment Trading Co., Ltd.

Beijing Shimao Medical Equipment Trading Co., Ltd.

Approval date 2008.11.01

Validity deadline 2012.10.31

Manufacturer Name (English) Arrow International, Inc.

Factory Address (Chinese) 2400 Bernville Road, Reading, Pennsylvania, 19605

Production site 9 Plymouth Street, Everret, Massachusetts, 02149 USA

Country of manufacture (Chinese)

Specification model ACAT 1 Plus (order number: IAP-0100)

Product Standard Imported Products

Registration standard YZB / USA 4585-2008 "Intra-aortic balloon pump" ^[1]