Integra LifeSciences Codman HOLTER A Manual Del Usuario página 4

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ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
HOLTER
Type "A" Atrial Catheter
®
READ ALL WARNINGS, PRECAUTIONS,
AND INSTRUCTIONS CAREFULLY PRIOR
TO USE.
Description
The Type "A" Atrial Catheter, catalog no. 82-1670, is made
of barium-impregnated silicone rubber with dimensions as
noted in Figure 1. Two stainless steel Type "A" Connectors,
catalog no. 82-1694, are included; however, one is a spare,
to be used if contamination of the first connector occurs.
Indications
The Type "A" Atrial Catheter is indicated for use to shunt
cerebrospinal fluid, when shunting of cerebrospinal fluid
to the atrium is the procedure of choice in the treatment of
hydrocephalus.
1
Contraindications
This device is not designed, sold, or intended for use
except as indicated.
Ventriculoatrial shunting is contraindicated in patients with
infection (e.g., meningitis, septicemia), risk of infection,
pulmonary emboli, or a high right atrial pressure associated
with congenital heart disease.
WARNINGS
Use this product only with components compatible with the
dimensions shown in Figure 1.
In patients who have congenital heart disease without
manifestation of high right atrial pressure, the decision to
place a ventriculo-atrial shunt must be evaluated on an
individual case basis.
Obstruction requiring revision,
infection,
disconnection
2,3
2,3
of the atrial catheter from the valve,
pulmonary
2,3
embolism,
throm bosis,
cardiac perforation,
and
3,4
1,3,4
4
cardiac tamponade
are complications reported in the use
2–5
of ventriculoatrial shunts. These, therefore, are potential
complications of the use of this atrial catheter.
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