infondere il sangue contaminato.
-
Qualora si utilizzasse un agente anti-coagulante, questo può
essere inserito nell'apposito punto d'iniezione (2).
STERILE - Sterilizzato ad ossido di etilene
Il prodotto è sterile se la confezione è integra. Smaltire dopo ogni
singolo impiego, non riutilizzare. Evitare l'esposizione a temperature
elevate e ai raggi ultravioletti durante lo stoccaggio. Per l'eliminazione
e lo smaltimento del dispositivo è necessario adottare le adeguate
precauzioni e rispettare le disposizioni di legge, vigenti, in materia di
rifiuti biologicamente pericolosi.
MATERIALI UTILIZZATI
SILICONE, PP, PEHD, ABS, PVC, ACCIAIO.
DISPOSITIVO MEDICO PRIVO DI LATTICE.
Data emissione ultima versione :
vedere ultima pagina : (REV.: XX-XXXX)
LEGENDA
01 Tubo di drenaggio paziente
02 Punto di iniezione
03 Clamp rossa
04 Valvola unidirezionale
05 Valvole di non ritorno
06 Bulbo di silicone 400 cc
07 Attacco per Unità per Autotrasfusione
08 Filtro macro-aggregati
09 Raccordo con membrana perforabile
10 Filtro microemboli da 40 µm
11 Unità per Autotrasfusione (sacca)
12 Molla inox per media pressione negativa
13 Morsetto di uscita
14 Morsetto Unità per Autotrasfusione
15 Capsula
16 Tappo perforabile per diagnostica
EN
INSTRUCTIONS FOR USE
DESCRIPTION
The ATS Bulb Set is a complete single-use postoperative surgical
drainage system for collection and recovery of autologous blood for
immediate autotransfusion. The system is available in two versions
with different levels of negative suction pressure.
-
The ATS Bulb Set has a 50 mmHg (6,6 KPa) initial pressure and an
average operating pressure of about 30 mmHg (4,0 KPa);
-
The ATS Bulb Set with inox inner spring has a 90 mmHg (12,0 KPa)
initial pressure and an average operating pressure of about 65
mmHg (8,6 KPa).
Moreover, an Autotransfusion Unit (bag) is available separately; for its
use see the section "Autotransfusion Unit replacement" in these
directions for use.
The system is composed of the following parts (see Figure 1):
-
A silicone bulb with a 400 ml capacity that is highly biocompatible
and transparent to have a clear vision of drained blood;
-
A 200 µm filter situated inside the silicone bulb to filter the
macroaggregates;
-
Double no return valve: one situated at the bulb entrance and the
other at the Autotransfusion Unit entrance;
-
A unidirectional valve, which is normally closed, to drain the air from
the bulb in order to keep the latter pressed, maintaining the vacuum
activated;
-
Autotransfusion Unit with a 40 µm filter inside that allows
eliminating microaggragates before the reinfusion;
-
Optional components for the completion of the system: one or
more drainage tubes, with or without trocar, an extension
connecting the bulb to the bag.
Note: This device, and its components, can only be used in safety
conditions in the field of applications and using the procedures
indicated on this operating instruction sheet for the specific type of
product. The manufacturer declines all liability relating to improper use
or use different to that indicated.
This instruction leaflet must
accompany the device during its entire lifetime and must always be at
hand for consultation.
GENERAL WARNINGS
Do not use if the package has been opened or damaged. Carefully
read this instruction leaflet before using the product.
product. Reuse may lead to alteration of performance and risks of
cross-contamination.
CONTRAINDICATIONS
Blood recovery and reinfusion are contraindicated in the following
cases: anomalous hepatic and/or renal functionality; malignant
wounds; contamination and/or sepsis; use of fluids unsuitable for
reinfusion (ex. Betadine, etc.); Presence of amniotic fluid or bile;
presence of haemostatic agents, coagulation problems.
unadvisable the reinfusion of the recovered blood beyond 6 hours from
the onset of the recovery (ref.Guidelines AABB). The infusion of the
recovered blood is also contraindicated in all those medical situations
considered inadequate by the physician in charge.
mentioned contraindications refer to the immediate autotransfusion of
autologous blood and are independent of the Ats Bulb Set device.
PREPARING THE SYSTEM
The ATS Bulb Set system and its components are packed in a double
sterile wrapping. Open the package using aseptic procedures.
1. Position the drainage tubes in the wound following an aseptic
procedure, proceeding from inside to outside. Fix the drainage
tubes by means of suture or plaster.
2. Connect the connecting tube (1) to the patient drainage through the
Y connector provided and all possible available connectors. Cut
the multi-size connectors in correspondence with the drainage
measurement (the measurement is indicated on the connector
section); insert the drainage on the connector (see Figure 2).
Note: A multi-size connector is supplied already open, with a CH 6
measure, and it is identified by the relevant "OPEN" label.
3. To put the suction into operation, close the blood recovery clamp
(13) and press the silicone bulb (see Figure 3). The air comes out
from the unidirectional valve (4) while the no return valve (5)
prevents that the former moves to the patient. Insert the cap on the
unidirectional valve (4).
4. Apply the Autotransfusion Unit on the way out of the silicone bulb
(7). Indicate patient identity on the Autotransfusion Unit and the
time of the start of blood collection. As recovered blood is kept at
room temperature, the time between the starting of the collection
and the starting of the reinfusion must be within and not later than 6
hours.
5. Open the output clamp (13).
Once the maximum of 400 ml
recovery capacity has been obtained, the direct communication
between the silicone bulb and the Autotransfusion Unit allows
passing automatically to a mechanic suction phase and to operate
by gravity. The drainage continuity is a safety guarantee that
reduces the possibility of huge haematoma and the risk for
infections. To obtain this operational continuity, the Ats Bulb Set
must be positioned below the patient level.
RECOVERY OF AUTOLOGOUS COLLECTED BLOOD
The silicone bulb transparency (6) visualizes the quantity and quality of
blood passed in the system through the macroaggregate filter. To drain
the collected blood in the bulb, press slowly with both hands until the
whole content has been transferred to the Autotransfusion Unit (see
Figure 3). Once this operation is over, the bulb maintains a suction
condition ready to continue the drainage.
AUTOTRANSFUSION UNIT REPLACEMENT (BAG)
1. Close the clamp (13).
2. Close the clamp (14) of the Autotransfusion Unit.
3. Remove, detaching the Autotransfusion Unit, and close with the
cap (15).
4. The ATS Bulb Set uses an Autotransfusion Unit of 1,000 ml
capacity that is normally sufficient for the autotransfusion. If it is
necessary to collect more blood, use a new Autotransfusion Unit.
5. Connect a replacement bag for the wound drainage, after 6 hours
from the beginning of the surgery.
IMMEDIATE INFUSION OF RECOVERED BLOOD
1. Extract the transfusion set by observing all aseptic procedures and
proceed as indicated in the directions for use of the set.
2. The 40 µm filter (10), which is directly inserted in the
Autotransfusion Unit, allows eliminating all microaggregates
before patient reinfusion.
WARNINGS
-
The ATS Bulb Set and its components can be used only if the
physician and the assistant staff are aware of the possible
implications associated with drainage procedure and autologous
blood transfusion.
-
It is warmly recommended to observe the "Universal precautions
relating to blood and body fluids for treatment of any blood or similar
products".
-
The staff must always wear gloves.
-
Do not handle drainage tubes nor make additional drainage
openings.
-
If the tube is fixed with suture, it is warmly recommended to avoid
possible damages.
Do not perform any fixing suture passing
Single-use
through the tube.
-
During the drainage tube removal, do not use any forceps or other
It is
The above
CH 6 8 10 12 14-16
2
Identificazione paziente - Patient identification - Patientenidentifikation - Identification patient - Identificación del paziente - Identificatie
patiënt - Identificação do paciente – Pasientidentifikasjon – Patientidentifiering – Potilastiedot - Patient-id - Áíáãíþñéóç áóèåíïýò -
Identifikaèní údaje pacienta - Äàííûå ïàöèåíòà
Ora inizio recupero - Recovery start time - Anfangszeit der Erholung - Temps de récupération - Tiempo inicio recuperación - Herstel
start tijd - Início da recuperação - Klokkeslett for start av oppsamling - Tidpunkt för start av uppsamling - Talteenoton aloitusaika -
00:00
Tidspunkt for start af prøvetagning - Ùñá áñ÷Þò áíÜêôçóçò - Godzina rozpoczêcia odzyskiwania - èas zahájení sbìru krve –
Âðåìÿ íà÷àëà âîññòàíîâëåíèÿ
1
04
08
06
13
09
15
10
18
01
03
02
05
12
16
07
14
05
3
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