Indications D'utilisation - 3M Ranger 24355 Bedienungsanleitung

Figure 1: Illustration of Disposable Set
A. Bag spikes
B. Luer connections (4)
C. Drip chamber with filter
D. Roller clamp
E. Blue inlet pinch clamp
F. Fluid warming cassette
G. Auto‑venting bubble trap
NOTE: Change the filter when it becomes clogged or according to institutional
protocol. Additional filters may be obtained from 3M Company.
Figure 2
Peel To Open
Figure 3
Instructions
Set‑up and Priming the warming set
1. Adjust warming unit height to patient level or lower.
2. Open warming set pouch where indicated by the arrows (Fig. 2)
3. Before priming, slide the fluid warming cassette (Fig. 1, F) into the slot in the
warming unit (Fig. 3, #1).
4. Place the auto‑venting bubble trap (Fig. 1, G) into the holder (Fig. 1, M) on
the warming unit.
5. Tighten luer connections (Fig. 1, B).
6. Close the clamp below the auto‑venting bubble trap (Fig. 1, H)
7. Close the 2 clamps below the spikes
8. Insert the Ranger set spikes (Fig. 1, A) into the I.V. bag ports. Open the clamp
(Fig. 3, #2).
9. Invert the drip chamber (Fig. 1, C) and fill 2/3 full. Turn upright.
10. Allow the auto‑venting bubble trap (Fig. 1, G) to fill. Flow will stop when the
chamber is properly filled. Gently tap the auto‑venting bubble trap against
the warming unit to expel any trapped air, if necessary.
11. Open the clamps below the auto‑venting bubble trap and continue to prime
the patient line.
12. Close any clamp to stop flow.
13. Turn the warming unit on (Fig. 3, #3).
The fluid warming set is now ready for use.
Removing Air from the Auto‑venting bubble Trap
1. The auto‑venting bubble trap is designed to continuously vent air from the
patient line. Monitor fluid lines to ensure that they are air‑free.
2. Gently tap the auto‑venting bubble trap against the warming unit to expel
any trapped air.
Removing the Disposable Set
1. Close the inlet clamp (Fig. 1, E) proximal to the fluid warming cassette and
open all clamps distal to the cassette.
2. Allow fluid to flow into the patient (this may take 2 to 3 seconds) and close
outlet clamp (Fig. 1, H).
3. Remove the fluid warming cassette from the warming unit and discard
according to institutional protocol.
Please report a serious incident occurring in relation to the device to 3M and
the local competent authority (EU) or local regulatory authority.
Symbol Glossary
Symbol Title Symbol
Manufacturer
Authorized
Representative
in European
Community
Date of
Manufacture
Use‑by date
Batch code
Catalogue
number
H. White outlet pinch clamp
I. Roller Clamp
J. Injection port
K. White outlet clamp
L. Patient connection
M. Bubble trap holder
Peel To Open
Description and Reference
Indicates the medical device
manufacturer as defined in
Medical Device Regulation (EU)
2017/745 formerly EU Directive
93/42/EEC. Source: ISO 15223, 5.1.1
Indicates the authorized
representative in the European
Community. Source: ISO 15223,
5.1.2, 2014/35/EU, and/or 2014/30/
EU
Indicates the date when the medical
device was manufactured. Source:
ISO 15223, 5.1.3
Indicates the date after which the
medical device is not to be used.
Source: ISO 15223, 5.1.4
Indicates the manufacturer's batch
code so that the batch or lot can be
identified. Source : ISO 15223, 5.1.5
Indicates the manufacturer's
catalogue number so that the
medical device can be identified.
Source : ISO 15223, 5.1.6
Sterilized using
ethylene oxide
Do not use
if package is
damaged or open
Sterile fluid path
Do not re‑use
Caution
Natural rubber
latex is not
present
Medical Device
Unique device
identifier
Importer
Single sterile
barrier system
CE Mark
Rx Only
For more information see, HCBGregulatory.3M.com
b Indications d'utilisation
Le réchauffeur pour sang/liquide Ranger est conçu pour réchauffer le sang, les
produits sanguins et les liquides.
Patients et établissements
Patients adultes et pédiatriques traités en salles d'opération, services
d'urgences et autres services où du sang ou des liquides sont perfusés.
Explication des conséquences correspondant aux mentions
d'avertissement
AVERTISSEMENT : indique une situation dangereuse qui, si elle n'est pas
évitée, peut provoquer la mort ou une grave blessure.
MISE EN GARDE : indique une situation dangereuse qui, si elle n'est pas
évitée, peut provoquer une blessure légère ou modérée.
AVERTISSEMENT : afin de réduire les risques d'embolie gazeuse :
• Ne jamais administrer de solutés en cas de présence de bulles d'air dans
la tubulure
• S'assurer que tous les raccords Luer sont serrés
• Ne pas installer le système de réchauffement de sang/soluté Ranger
au‑dessus du niveau du patient, car cette position pourrait provoquer une
embolie gazeuse
AVERTISSEMENT : afin de réduire les risques associés à une exposition aux
risques biologiques, à une contamination croisée ou à une infection :
• Ne pas réutiliser ce produit. Il est destiné à un usage unique / patient unique.
• Ne pas utiliser si les capuchons ne sont pas en place
• S'assurer que tous les raccords Luer sont bien serrés avant l'amorçage du set
• Ne pas soumettre à une pression supérieure à 300 mmHg. Veiller à ce que
les pompes de pression à main en ligne ou les autres pompes ne dépassent
pas 300 mm/Hg de pression.
AVERTISSEMENT : afin de réduire le risque de fuite et de perte de traitement :
• Ne pas réutiliser ce produit. Il est destiné à un usage unique / patient unique.
‑3‑
Indicates a medical device that has
been sterilized using ethylene oxide.
Source: ISO 15223, 5.2.3
Indicates a medical device that
should not be used if the package
has been damaged or opened.
Source: ISO 15223, 5.2.8
Indicates the presence of a sterile
fluid path within the medical
device in cases when other parts
of the medical device, including
the exterior, might not be supplied
sterile. Source: ISO 15223, 5.2.9
Indicates a medical device that
is intended for one use or for use
on a single patient during a single
procedure. Source: ISO 15223, 5.4.2
Indicates the need for the user to
consult the instructions for use for
important cautionary information
such as warnings and precautions
that cannot, for a variety of reasons,
be presented on the medical device
itself. Source: ISO 15223, 5.4.4
Indicates natural rubber or dry
natural rubber latex is not present
as a material of construction within
the medical device or the packaging
of a medical device. Source: ISO
15223, 5.4.5 and Annex B
Indicates the item is a medical
device.
Indicates bar code to scan product
information into patient electronic
health record
Indicates the entity importing the
medical device into the EU.
To identify a single layer that makes
up the sterile barrier system (SBS)
and differentiate it from layers of
protective packaging designed to
prevent damage to the sterile barrier
system and its contents
Indicates conformity to all
applicable European Union
Regulations and Directives with
notified body involvement.
Indicates that U.S. Federal Law
restricts this device to sale by
or on the order of a healthcare
professional. 21 Code of Federal
Regulations (CFR) sec. 801.109(b)(1)