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d) Decompensated heart failure
e) Florid endocarditis
f)
Known allergic tendency towards the material of the biopsy forceps
4.
Complications
The following possible complications are associated with the endomyocardial biopsy:
a) Perforation (ventricular, vascular, septum)
b) Coronary fistula
c) Pericardial tamponade
d) Arterial puncture
e) Pain
f)
Cardiac arrhythmia
g) Pericardial effusion
h) Vasovagal reaction (hypotonia)
i)
Haemorrhaging/haematoma
j)
Pneumothorax
k) Injury to the tricuspid valve
l)
Infection/sepsis
m) Embolism (thromboembolism/air embolism)
n) Haemothorax
o) Stroke
p) Death
q) Neurological events
r)
Allergic reaction
s) Shifting of a pacemaker electrode
t)
Cardiac infarction
u) Pericardial fibrosis
5.
Patient group
The Biopsy Forceps Knipsa are intended for use on HTX patients as follow-up monitoring after heart transplants, for the diagnosis of suspec-
ted heart muscle inflammation (myocarditis), suspected cardiac storage disease (e.g. amyloidosis), or if there is existing cardiomyopathy. The
patient group contains adults. Gender and weight are unimportant for the selection of patients.
6.
User profile
The Biopsy Forceps Knipsa for the myocardial biopsy are only intended to be used by experienced doctors who are trained in interventional
techniques and in dealing with possible complications.
7.
Environment for use
The Biopsy Forceps Knipsa are usually used for the endomyocardial biopsy in a sterile environment, such as an operating theatre. Other
requirements for carrying out the procedure include monitoring the patient's vital signs and using suitable diagnostic imaging, e.g. a C-arm
for diagnostic radiography. The procedure is carried out under sterile conditions.
8.
Warnings and precautions
8.1
See the 'Explanation of symbols' to understand the symbols used on the packaging.
8.2
The medical techniques and procedures described here make NO claim to completeness. They do not illustrate all the medically
possible procedures and, most of all, do not replace the doctor's own experience regarding the use and the treatment of certain
patients.
8.3
Sterilised using ethylene oxide. Do NOT resterilise the device.
8.4
FOR SINGLE USE ONLY! This device is designed for single use in one patient. It must not be reused, resterilised or reconditioned.
Reuse, resterilisation or reconditioning can result in impairment of the structural integrity of the device or in device failure, which
could lead to injury, illness or the death of the patient. Reuse, resterilisation or reconditioning can also lead to a higher risk of device
contamination and/or infection in the patient, including but not limited to the transmission of infectious diseases from one patient to
another.
8.5
The device must be used before the expiry date stated on the packaging ('Use-by' date). The device must not be used after the expiry
date has passed and must be disposed of.
8.6
This device is only sterile and pyrogen-free if the sterile packaging is unopened and undamaged. Do not use the device if the pa-
ckaging has already been opened or is damaged. If you identify damage of any sort, then the device must not be used.
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