Halyard Mini-BAL Gebrauchsanweisung Seite 3

HALYARD* Mini-BAL
e
Sampling Catheter
Instructions for Use
Rx Only: Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
Contents
• Mini-BAL Catheter
• Suction Adapter (1a)
• Access Port Elbow (1b)
• Seal Cassette (1c)
• Mini-BAL Adapter (1d)
Description
Mini-BAL is a catheter within a catheter. The 8 Fr inner catheter
(Fig. 2a) is contained within a 13 Fr outer sheath (Fig. 2b). The inner
catheter has a rounded mushroom shaped tip (Fig. 2c) that seals
and covers the end of the outer catheter. This design permits the
advancement of the inner catheter into the distal bronchial segments
reducing exposure to upper airway microorganisms. The mushroom
tip is radiopaque for radiographic confirmation of catheter location.
A large diameter stopcock allows connection to suction source and
specimen trap (Fig. 2e).
Designed to be compatible with HALYARD* Multi-Access Port (MAP)
Closed Suction System (CSS).
Indication
Mini-BAL is used in the diagnosis of diffuse lung disease by allowing
collection of bronchoalveolar lavage (BAL) specimens from deep within
the lung (Fig. 5). The use of a bronchoscope is not necessary. This
catheter is used in intubated adult patients.
Contraindication
There are no absolute contraindications for BAL (Bronchoalveolar
Lavage). Relative contraindications to this procedure include:
• Lack of patient cooperation
• FVC (forced vital capacity) of less than one liter
• Asthma with moderate airway obstruction
• Hypercapnia
• Hypoxemia that cannot be corrected to a saturation
greater than 90%
• Serious cardiac arrhythmia
• Myocardial infarction within the previous 6 weeks
• Uncorrected bleeding susceptibility
• Hemodynamic instability
• Hemoptysis of unknown origin
Warning
Non-bronchoscopic bronchial alveolar lavage (BAL) may
be expected to have complications similar to those seen
in bronchoscopic BAL procedures, which may include:
pneumothorax, pneumonitis, post procedure fever,
bronchospasm and bleeding.
Do not reuse, reprocess, or resterilize this medical device.
Reuse, reprocessing, or resterilization may 1) adversely affect
the known biocompatibility characteristics of the device,
2) compromise the structural integrity of the device, 3) lead
to the device not performing as intended, or 4) create a risk
of contamination and cause the transmission of infectious
diseases resulting in patient injury, illness, or death.
Caution
This medical device contains DEHP (Di(2-ethylhexyl) phthalate) that
is presently classified in the European Union as a presumed human
reproductive toxicant based on data from animal studies. There is
no conclusive scientific evidence that exposure to DEHP contained
in medical devices has caused harmful effects in humans. A risk
assessment, which took into account DEHP exposure of all indicated
patient populations, including those who are potentially at increased
risk, was performed for this device and the conclusion is that the device
is safe when used as directed.
For intubated patients, HALYARD* Mini-BAL compatibility should be
based on the evaluation of the inner diameter of the artificial airway
and Hospital Protocol.
For use on intubated adult patients only.
Preparation
Prepare patient for procedure based on hospital protocol.
Suggested Equipment
• Mini-BAL (Ref 143)
• Sterile gloves
• Dressing pack
• Sterile saline
• 20/50 ml syringes
• Sputum trap
• Suction tubing
Adult Intubated Patients
1. Remove Mini-BAL from package.
2. Remove protective clip from tip of Mini-BAL catheter.
3A. Set-Up Protocol (For use directly with artificial airway)
a. Insert the Mini-BAL catheter into and through the access port
elbow. (Fig. 2f)
b. Disconnect the ventilator circuit from the endotracheal or
tracheostomy tube.
c. Attach access port elbow (Fig 1b) to the ventilator circuit.
(Fig. 3)
d. Attach access port elbow to the endotracheal or tracheostomy
tube while guiding the Mini-BAL catheter into the lumen.
(Fig. 4)
e. Position the curve of directional tip catheter for right or left lung
(oxygen port (Fig. 2d) on same side).
f. Attach suction adapter (Fig. 1a) and 20/50 ml syringe with
saline to 3-way stopcock. (Fig. 2e)
g. Attach sputum trap and suction apparatus to Mini-BAL and
proceed with flushing and sampling protocols.
3B. Set-Up Protocol (For Use with HALYARD* MAP CSS)
a. Depress plunger button and rotate HALYARD* MAP Closed Suction
Catheter (CSC) so the "Alternate Therapy Port" is in-line with the
airway. (Fig. A)
Caution: Do not rotate with instrument inserted through the
"Alternate Therapy Port".
b. Open cap of Seal Cassette (Fig. Aa) on HALYARD* MAP CSC.
c. Remove Mini-BAL adapter (Fig. 1d) from package and attach
onto Seal Cassette. (Fig. Aa)
3