PFM Medical ASEPT 3000 ml Drainage Kit L User manual

ASEPT® 3000 ml Drainage Kit L
for peritoneal drainage
en Instructions for Use 3
de Gebrauchsanweisung 8
fr Mode d’emploi 13
es Instrucciones de uso 18
it Istruzioni per l‘uso 23
nl Gebruiksaanwijzing 28
0124
www.pfmmedical.com

2GA048/Rev02_2017-03-01
Explanation of the symbols on label and packaging // Erklärung der Symbole auf Etikett und Verpackung //
Explication des symbolessur l’étiquette et l’emballage//Explicación delossímbolos en laetiquetay elenvoltorio //
Illustrazione dei simboli riportati su etichetta e confezione // Verklaring van de symbolen op het etiket en de
verpakking
For single use only // Nur zum einmaligen Gebrauch bestimmt // À usage unique seulement //
Para un solo uso // Solo per impiego monouso // Uitsluitend voor eenmalig gebruik bedoeld
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Read Instructions for Use carefully // Gebrauchsanweisung beachten // Respecter les in-
structions du mode d’emploi // Lea atentamente las instrucciones de uso // Osservare le
istruzioni per l'uso // Neem de gebruiksaanwijzing in acht
Lot number // Chargennummer // N° de lot // Número de lote // Numero di lotto // Lotnummer
Referencenumber//Bestellnummer//N°decommande//Númerode referencia parapedidos //
Numero d'ordine // Bestelnummer
Do not re-sterilize // Nicht erneut sterilisieren // Ne pas restériliser // No volver a esterilizar //
Non risterilizzare // Niet opnieuw steriliseren
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STERILIZE
Expiry Date // Verfalldatum // Date de péremption // Fecha de caducidad // Data di scadenza //
Uiterste gebruiksdatum
Do not use if packaging is damaged // Bei beschädigter Verpackung nicht verwenden //
Ne pas utiliser si l’emballage est endommagé // No usarlo si el embalaje está dañado //
Non utilizzare se la confezione risulta danneggiata // Bij beschadigde verpakking niet ge-
bruiken
Manufacturer // Hersteller // Fabricant // Fabricante // Produttore // Producent
Sterilized by Ethylene Oxide // Sterilisiert mit Ethylenoxid // Stérilisé à l’oxyde d’éthylène //
Esterilizado con óxido de etileno // Sterilizzato con ossido di etilene // Gesteriliseerd met
ethyleenoxide
Protect from direct sunlight // Vor direkter Sonneneinstrahlung schützen // Protéger de
l’exposition directe au soleil // Proteger de la luz solar directa // Proteggere dall‘irradiazione
solare diretta // Tegen direct zonlicht beschermen
Store in a dry place // Trocken auewahren // A conserver au sec // Guardar en lugar seco //
Conservare in un luogo asciutto // Droog bewaren
Maximum storage temperature // Maximale Lagertemperatur // Limite supérieure de la
température de stockage // Límite superior de la temperatura de almacenaje // Limite supe-
riore della temperatura di conservazione // Maximale opslagtemperatuur

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English
GA048/Rev02_2017-03-01
Instructions for Use
ASEPT® 3000 ml Drainage Kit L (Reference No.P09080009)
The pfm medical ASEPT® 3000 ml Drainage Kit L is intended to be used for connection to the ASEPT® Peritoneal
Drainage Catheter to drain uid from the abdomen. Before using this product make sure that you have been fully
trained on the correct use of the items in this kit. If you have any questions or problems in regards to draining
uid, please contact your doctor or nurse.
The ASEPT® 3000 ml Drainage Kit L is a complete kit with all the items generally required for drainage.
Below is outlined what is included in the kit:
①Bottles with scaling in
10 ml steps
②A green clamping piece with
ventilation lter and a white
sliding clamp
(on each of the bottles)
③A green clamping piece with a
green sliding clamp, connected
to a drainage tube
(on each of the bottles)
④Handle
⑤Transparent drainage tube
with a white tube clamp
⑥Connector with protective cap
at the end of the drainage tube
One procedure pack includes:
• 2 Pairs of Gloves
• 3 Alcohol Pads
• Foam Catheter Pad
• Gauze Pads
• Self Adhesive Dressing
• Blue Emergency Slide Clamp
Sterility
The vacuum bottle with drainage tube and procedure pack have been sterilized.These products are for single use
only and are not to be reused. As long as the packaging remains sealed and undamaged, the contents within each
package are sterile.
pfm medical will not be responsible for any product that is resterilized, nor accept for exchange or credit any
product that has been opened by the patient or purchaser but not used.
These user instructions and the information on the packaging should be read carefully before each use.
Product description
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English
GA048/Rev02_2017-03-01
The pfm medical ASEPT® 3000 ml Drainage Kit L is intended to be used to connect to the ASEPT® Peritoneal Drai-
nage Catheter to drain uid from the abdomen.
• This product contains natural rubber latex, which may cause allergic reactions.
• Potential complications of access and drainage of the abdomen include, but may not be limited to, the following:
Laceration of liver or bowel, hypotension/circulatory collapse, electrolyte imbalance, protein depletion, ascites
leakage, peritonitis, wound infection, tumor growth in the catheter tunnel, and loculation of the peritoneal
space.
WARNINGS
Do not reuse. Intended for single patient use. The reuse of this single-use device can affect
safety, performance and effectiveness, exposing patients and staff to unnecessary risk.
Do not use scissors or other sharp objects near the ASEPT® Drainage Catheter.
Clamp the catheter with the blue emergency sliding clamp should you have accidentally cut it.
Keep the valve on your ASEPT® Drainage Catheter clean and the end connector of the drainage
tube sterile.
The ASEPT® 3000 ml Drainage Kit L is not to be used for pleural drainage as there is a risk that
air can access the system through the ventilation filter, it ultimately reaching the pleural gap.
If the catheter gets punctured or cut follow the following instructions:
❶ Pinch the catheter closed between your ngers.
❷Push the blue emergency slide clamp that is included in the procedure pack over the catheter between the
patient’s body and the cut or leak and push the catheter completely into the small end of the clamp.The clamp
will close the catheter.
❸Contact your doctor or nurse immediately.
General Information and Warnings
Precautions
Indication
Using the ASEPT® 3000 ml Drainage Kit L
Use of the ASEPT® 3000 ml Drainage Kit L should be easy since you have been fully trained.Follow these step-by-
step directions.
Your doctor decides how often the drainage is to take place.
Before beginning with the drainage procedure
❶Locate a clean and uncluttered workspace.
❷Wash your hands with soap and water for at least 1 minute.
❸ Remove the adhesive dressing, gauze pads and foam catheter pad from over your catheter. Check for any red-
ness, tenderness, swelling or uid around the catheter.
Caution: If you see any signs of infection, do not continue with the drainage procedure and contact your doctor
or nurse.
❹Pick up the bag that contains the ASEPT® Drainage Kit L.
❺Peel open the Drainage Kit pouch all the way and remove the procedure pack. Leave the drainage bottles on
top of the pouch. Open the procedure pack by peeling the front and back of the pouch apart, starting at the top.
❻Place the procedure pack on your workspace. Remove the tape and unfold the blue wrapping. Leave the enc-
losed items on the wrapping.
Caution: The items and the inside of the wrapping are sterile, do not touch them with your ungloved hands or
other non-sterile items.
Application

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❼Pick up one glove by the wrist and put it on. Pick up the other glove by the wrist and put it on the other hand.
Both gloves t either hand. Be careful not to let the outside of the gloves come in contact with anything nons-
terile for example clothing or skin.The outside of the gloves needs to remain sterile.
❽Tear open the three alcohol pads but do not remove the pads from the pouches. Place the pads on the blue
wrapping.
❾Remove the twist tie that holds together the drainage tube. Put the bottle back on the open pouch. Do not
remove the protective cap on the end of the drainage tube yet.
Connecting the Drainage Bottle to the catheter
❿Squeeze the tube clamp on the drainage line completely closed.
Hold the catheter valve end in one hand and vigorously clean the valve surface and around the valve with one
of the alcohol pads.
Remove the protective cap from the connector on the drainage tube and align it in the center of the silicone
valve surface.
Push the connector into the silicone valve and twist clockwise to close.The connection must be tight to open
the valve and allow the ow of uid.
WARNINGS
Make sure the connection is tight.
Draining uid into the bottle
Drainage is possible using two procedures.The drainage can be carried out by using a low vacuum and gravity or
by exclusively using gravity.
1.Use of low vacuum and gravity:
Loosen the green sliding clamps on each of the bottles until green clamping piece is no longer closed.
Slowly loosen the tube clamp on the drainage tube so that the uid can start to ow.
The uid ows into the vacuum bottle. The ow and the suction can be regulated by partially closing the clamp.
Note: Should no uid or only a very small amount of uid ow out at the beginning, check the tightness of the
connection between the connector and the valve.
The vacuum in the bottle has been used after a few minutes and no more uid drains o.
The drainage can now be continued with using gravity by opening both of the white sliding clamps on both of
the ventilation lters.
Note: The uid ow can become slower if the uid has almost been fully drained o. When no more uid is drained
o or the prescribed drainage volume has been reached, fully close the tube clamp on the drainage clamp.
Dispose of the gloves.
2.Gravitation drainage:
Loosen the white sliding clamps on each of the bottles until the green clamping pieces with the ventilation
lter is no longer closed.
The bottles no longer contain a vacuum.Drainage is now immediately possible by gravitation.
Loosen the green sliding clamp until the green clamping piece is no longer clamped.
Loosen the tube clamp on the drainage tube so that the uid can start to ow.
The uid ows into the bottle.
Note: Should no uid or only a very small amount of uid ow out at the beginning, check the tightness of the
connection between the connector and the valve.
The uid ow can become slower if the uid has almost been fully drained o. When no more uid is drained
o or the prescribed drainage volume has been reached, fully close the tube clamp on the drainage clamp.
Dispose of the gloves.
The drainage process normally lasts 10-30 minutes.The drainage duration depends on the volume that is to be
drained and the selected drainage procedure.