3M Ranger 24770 Bedienungsanleitung Seite 2

a 3M™ Ranger™ Fluid Warming Irrigation Set
Indications for Use
The 3M™ Ranger™ Irrigation Warming System is intended to warm
irrigation fluids.
Patient Population and Settings
Adult and pediatric patients being treated in operating rooms, emergency
trauma settings, or other areas where irrigation fluid warming is required.
Explanation of Signal Word Consequences
WARNING: Indicates a hazardous situation which, if not avoided, could
result in death or serious injury.
CAUTION: Indicates a hazardous situation which, if not avoided, could
result in minor or moderate injury.
WARNING: To reduce the risks of biohazard exposure,
cross-contamination or infection:
• Do not reuse. This product is designed for single patient use only.
• Do not use for IV infusion; use for irrigation only
• Do not exceed 245 mm/Hg pressure; ensure inline hand pressure
pumps or other pumps do not exceed 245 mm/Hg pressure.
WARNING: To reduce the risk of leaking and loss of therapy:
• Do not reuse. This product is designed for single patient use only.
• Do not use if end caps are not in place
• Ensure that all connections are securely tightened prior to priming set.
WARNING: To reduce the risk associated with patient exposure to leakage
current that exceeds Type BF equipment limits:
• Do not use in combination with other medical equipment without
verifying that the total leakage current from the combined equipment
does not exceed the safety limits for Type BF equipment.
CAUTION: to reduce the risk of leaking and loss of therapy
• Do not remove warming cassette from warming unit while in use
• Do not exceed 245 mm/Hg pressure; ensure inline hand pressure
pumps or other pumps do not exceed 245 mm/Hg pressure.
A
B3
B2
B1
E
C
Figure 1: Illustration of Disposable Irrigation Set
A. Spikes
B1-B3. White inlet pinch clamps
C. Drip chamber
D. Connectors
E. Blue inlet pinch clamp
F. Fluid warming cassette
G. White outlet pinch clamps
H. Connector
A
B2
B1
C
F
D
B3 F
D
E
Figure 2
Instructions for Use
Do not use if package has been previously opened or damaged. Refer to
the 3M™ Ranger™ irrigation fluid warming unit Model 247 Operator's
Manual for set up and use of the warming system.
Set‑up and Priming the irrigation disposable set
1. Open warming set pouch.
2. Ensure connectors are tight (Fig. 1, D)
3. Before priming, slide the fluid warming cassette (Fig. 1, F) into the
slot in the warming unit (Fig. 2)
4. Close white pinch clamps (B1-B3, G).
5. Obtain the patient line
irrigation set and patient line (Fig. 1, H).
6. Connect the patient line to the irrigation set (Fig. 1, H).
7. Insert the Ranger set spikes (Fig. 1, A) into the irrigation bag ports.
8. To begin priming open all clamps.
9. Invert the drip chamber (Fig. 1, C) until it fills at least 3/4 full, and
then turn upright.
Note: Remove residual air bubbles by pinching the tubing.
10. Close the white clamp (Fig. 1, G) when the line is free of air.
11. Connect the
similar device.
12. Raise I.V. pole or pressurize fluid if indicated and open clamps when
ready for use
13. Turn the warming unit on.
The irrigation fluid warming set is now ready for use.
Removing the Irrigation warming set
1. Turn the Ranger irrigation warming unit OFF.
H
2. Close the blue inlet clamp (Fig. 1, E) proximal to the fluid
warming cassette.
3. Open all clamps distal to the cassette.
4. Allow a small amount of fluid to drain from the end of the patient line
G
to reduce pressure in the cassette.
5. Remove the irrigation fluid warming cassette from the warming unit
and discard according to institutional protocol (Fig. 2).
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
Manufacturer
2
H
G
Insert
cassette
before
priming
24795 and twist off end caps from
24795 to the scope, Foley catheter, or
Symbol 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
Drain 2
mL or
more from
cassette to
remove