Idiomas disponibles
Idiomas disponibles
61-4005 • H/S Elliptosphere™ Catheter Set for Hysterosonography and Hysterosalpingography
DEVICE DESCRIPTION
The H/S Elliptosphere™ Catheter Set consists of a latex free
balloon catheter, insertion sheath and a 1.5 cc (ml) syringe. The
catheter can be used with aqueous or oil-based contrast media.
(See Figure 1.) Not made with natural rubber latex.
1.5 cc Syringe
Stopcock
Luer Hub
Clamp
Figure 1
WARNINGS
• 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.
CAUTION: U.S. Federal law restricts this device to sale by or on the
order of a physician.
INTENDED USE/INDICATIONS
For administering contrast media during Hysterosalpingography or
Hysterosonography procedures to detect uterine pathology such as
polyps, fibroids, adhesions or endometrial thickening, and/or
patency of fallopian tubes.
CONTRAINDICATIONS
Suspected infection, suspected pregnancy, profuse bleeding or
sexually transmitted disease.
PRECAUTIONS
Do not exceed the recommended balloon inflation volume of 1.5 cc
(ml) or the balloon may burst.
ADVERSE EVENTS
Some patients may have a hypersensitivity to contrast media.
INSTRUCTIONS FOR USE
Catheter Preparation
1. Grasp the insertion sheath connected to the trapezoidal hub.
2. Remove and discard the crimped protective cover, exposing the
balloon catheter tip.
3. Test the balloon integrity by inflating with air or contrast media
using the syringe in the set. Deflate completely by pulling back on
the syringe plunger and closing the stopcock.
4. Attach a contrast media-filled syringe (not supplied) to the blue
luer hub and fill the catheter with contrast media to expel air.
Advance the insertion sheath so that the distal end of the
catheter protrudes slightly from the distal end of the sheat
(See Figure 2.)
Instructions for Use (English)
Insertion Sheath
Trapezoidal Hub
Figure 2
Catheter Placement
5. Visualize the external cervical os with the aid of a speculum and
advance the sheath and catheter so that the tip of the catheter
enters the cervical canal.
6. Hold the sheath stationary and advance the catheter into the
Balloon
cervical canal 0.4-0.8 in. (1-2 cm).
7. Open the stopcock and slowly inflate the balloon with up
to 1.5 cc (ml) of either air or saline to provide occlusion without
causing discomfort to the patient. Turn the stopcock off allow
ing the balloon to remain inflated.
Injection of Contrast Media
8. Inject the contrast media, close the clamp and complete the study
in a routine manner.
9. If uterine placement is desired, deflate the balloon by opening the
stopcock and pulling back on the syringe plunger. Advance the
catheter into the uterus, fully inflate the balloon using the
enclosed syringe, close the stopcock and withdraw the catheter
until the balloon occludes the internal os.
Catheter Removal
10.Open the stopcock and deflate the balloon by pulling back on the
syringe plunger. Withdraw the catheter.
11.Dispose of in accordance with all applicable Federal, State and
local Medical/Hazardous waste practices.
EXPLANATION OF SYMBOLS
REF
Reorder Number
STERILE EO
R
Only
x
2
!
2
STERILIZE
LATEX
EC REP
Marks bearing ™ are trademarks of CooperSurgical, Inc
© 2017 CooperSurgical, Inc.
Batch Code
LOT
Sterilized using ethylene oxide
U.S. Federal law restricts this device
to sale by or on the order of a physician.
Product conforms to the Medical Device
Directive 93/42/EEC
Do Not Re-use
Caution
Consult instructions for use
Do not use if package is damaged
Do not resterilize
Not made with natural rubber latex
Authorized Representative in the
European Community.
Manufacturer
Use By
