Indications For Use; Contraindications; Directions For Use - CooperSurgical RUMI UMY514 Gebrauchsanleitung

To accommodate different uterine sizes, the tips are available in the following shaft
diameters and shaft lengths:
Part Number
UMY514
UML516
UMW676
UMB678
UMG670
UMO672
For further Information on how to use The RUMI
Handle Directions for Use.
WARNINGS
• NEVER use a tip that is longer than the sounded depth of the uterus.
• NEVER attempt to use the device in utero without first performing the balloon test
inflation procedure. Inflate the balloon with sterile saline only. DO NOT use air for
inflation of the intrauterine balloon.
• NEVER use the device with the intrauterine balloon deflated.
• Contents supplied sterile. Do not use if sterile barrier is damaged.
• For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the device and/or lead to device
failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or
resterilization may also create a risk of contamination of the device and/or cause patient
infection or cross-infection, including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the device may lead to injury,
illness or death of the patient. Dispose of in accordance with all applicable Federal, State,
and local Medical/Hazardous waste practices.
CAUTIONS
• U.S. Federal law restricts this device to sale by or on the order of a physician.
• THE TIP IS SINGLE-USE ONLY. NEVER REUSE A RUMI TIP.

INDICATIONS FOR USE

The Tip is intended to be used only with the RUMI, RUMI II, RUMI Arch
Handles. Please refer to the appropriate Handle Directions for Use for further indications.

CONTRAINDICATIONS

DO NOT use if the balloon will not inflate during test inflation, or if sterility has been
compromised. For further contraindications, please refer to the appropriate Handle Directions
for Use.
PRECAUTIONS
Dilate the cervix using standard technique, as required, to accommodate the tip diameter
selected.
Lubricate the tip with sterile solution to ease patient insertion if necessary.

DIRECTIONS FOR USE

Tip Selection
1. Sound the uterus for depth and direction.
2. Select the Tip which is less than or equal to the sounded depth of the uterus.
Color Diameter
Yellow 5.1 mm
Lavender
5.1 mm
White 6.7 mm
Blue 6.7 mm
Green 6.7 mm
Orange 6.7 mm
Length
3.75 cm
6 cm
6 cm
8 cm
10 cm
12 cm
®
System, please refer to the appropriate
®
and Advincula Arch
™