En - English - Instructions For Use; Indications For Use; Warnings And Precautions - sorin 3T AEROSOL COLLECTION SET Instrucciones De Uso

EN - ENGLISH
3T AEROSOL COLLECTION SET
REF: 050900100
This document supplements the current IFU for the Heater-
Cooler System 3T and should be used in conjunction with that
IFU.
INTRODUCTION
The 3T Aerosol Collection Set collects aerosol created by the Heater-Cooler 3T
water tanks during use. This 3T Aerosol Collection Set replaces the use of the
overflow bottle referenced in the Heater-Cooler System 3T Operating Instructions.
Please read all information carefully: Failure to properly follow these instructions
may allow for aerosol to be emitted from the Heater-Cooler 3T in its surrounding
environment.

INDICATIONS FOR USE

The Stöckert Heater-Cooler System 3T is used with a Stöckert S3 heart-lung
machine and/or any other heart-lung machine featuring a separate temperature
control for extracorporeal perfusion of durations up to 6 hours.
DEVICE
The 3T Aerosol Collection Set consists of a suction canister, a suction canister lid and
two pieces of tubing; the longer piece of tubing includes a connector (see Figure 1).
Figure 1) Overview of the 3T Aerosol Collection Set: 1 = suction canister, 2 = pre-
connected right angle connector, 3 = Heater-Cooler connection line, 4 = vacuum

WARNINGS AND PRECAUTIONS

● The use of a central hospital vacuum source is recommended for use with this
disposable. The vacuum source must be capable of 20 l/min flow or greater.
● If a central hospital vacuum source is not available the use of a portable vacuum
system capable of 20 l/min flow per ISO 10079-1 for Medical Suction Equipment is
required. The portable vacuum source must be specified for medical applications
and fulfill the requirements of IEC 60601-1 and IEC 60601-1-2.
● Do not place the portable vacuum system or any other object on top of the
Heater-Cooler 3T.
● Follow the portable vacuum system supplier's mounting and operating
instructions for the recommended use of the pump in an operating room
environment.
● To avoid disturbances in the laminar flow area of the operating room, make
sure that a portable vacuum system is placed in such a way that the exhaust
flow is not directed towards the operating field, but towards the exhaust vent
system.
● Power sources for the vacuum system selected must have connection to a
back-up power generator to avoid loss of power during use
● If the Patient #2 circuit is used and water tank level adjustment is required, only
add pre-mixed water/H O solution as per the separate Heater-Cooler 3T
2 2
operating instructions if the water level drops to the level where the red LED for
the patient tank is activated. In such a case, add water until the first green LED
is visible.
● The 3T Aerosol Collection Set is validated for 3 calendar days of use.
● Check the date of installation, which is written on the suction canister lid as per
point 13 of this "INSTRUCTIONS FOR USE", for use-by-date of the 3T Aerosol
Collection Set.
● The suction canister is not intended as a measuring device.
● The suction canister contents are potentially hazardous due to the possible
collection of aerosolized bacteria. Use appropriate personal protection
equipment (PPE) and handle accordingly.
● Store in dark place: long term exposure to light may compromise product
performance and result in breakage during use.

en - ENGLISH - INSTRUCTIONS FOR USE

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INSTRUCTIONS FOR USE
WARNING indicates serious adverse reactions and potential safety hazards for the
practitioner and/or the patient that may occur in the proper use or misuse of the
device as well as the limitations of use and the measures to be adopted in such
cases.
CAUTION indicates any special care to be exercised by a practitioner for the safe
and effective use of the device.
1. Before starting a procedure, with the heater-cooler and the vacuum source
switched off, verify that the tank vacuum gauge indicator located on the Heater-
Cooler is positioned at 0 (see Figure 2). If necessary, set the indicator needle to
0 using the adjustment screw near the bottom of the gauge.
Figure 2) Tank Vacuum gauge with zero point and adjustment screw in the
2. Ensure that a suction canister mounting bracket is attached to the right side or
rear panel of the Heater-Cooler 3T. The mounting bracket is attached by
inserting the two top tabs into the vent slots on the Heater-Cooler 3T and then
allowing the bracket to rest in a horizontal position. The mounting bracket
should be positioned so that the base of the suction canister is above the base
of the Heater-Cooler 3T to avoid displacement of the canister from the holder
during use. Please refer to the diagrams below.
Figure 4) Mounting bracket installed on right side panel.
EN - ENGLISH
bottom part of the gauge
Figure 3) Suction canister Mounting bracket
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