Argon 660005040 Kurzanleitung

ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road
Athens, Texas 75751 USA
Tel: +1 (903) 675 9321
Tel: +1 (800) 927 4669
www.argonmedical.com
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
+31 70 345 8570
Argon Medical Devices UK Ltd
Eastgate Business Centre
Eastern Avenue
Burton-on-Trent
Staffordshire
DE13 0AT
https://www.argonmedical.com/resources/product-information
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IFU6600-0221/0221A
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EN - ENGLISH
HSG Catheter
Intended Use /Purpose
The Hystero-Salpingography Catheter
hysterosonography or hysterosalpingography procedures.
Device Description
The HSG Catheter balloon provides secure placement in the uterus or cervical
canal and effectively seals to prevent retrograde leakage of saline or contrast
media. The malleable introduction sheath retains curvature to facilitate easy
placement into the cervical canal and it also include a fixed volume syringe to
prevent from over-inflation of the balloon.
It has color-coded stopcocks on both catheter lumens with the following
functions:
Blue Stopcock – is for balloon inflation.
White Stopcock – is for saline/contrast media infusion.
The HSG catheters are available in the following sizes with corresponding
balloon diameters with air and saline.
Accepts
Catalog No.
GW
660005040 0.035"
(5.5Fr) (0.89mm)
660007040 0.038"
(7Fr) (0.96mm)
Indication for Use
HSG Catheters are intended for use in the injection of contrast material in the
examination of the uterus and fallopian tubes.
Contraindications for Use
Physician judgment should be used in determining in which patients Hystero-
Salpingography or Hystero-Sonography procedures are contraindicated. These
procedures are not recommended for patients with active pelvic infections.
Side Effects
• It is not uncommon for patients to experience mild pain during or after the
procedure, bleeding, exposure
inflammation of the endometrium or the fallopian tubes.
Duration
Transient, less than 60 minutes.
Warnings
•
Do not use this device with a power injector for the delivery of the contrast
media.
•
This device was designed, tested and manufactured for single use only.
Reuse or reprocessing has not been evaluated and may lead to its failure and
subsequent patient illness, infection or other injury. Do not reuse, reprocess
or re-sterilize this device.
•
Inspect the package integrity before use.
•
Do not use if package is open or damaged and if the expiry date has been
exceeded.
•
Do not continue to use if any of the components are damaged during the
procedure.
•
Do not use Lipiodol or other oil-based contrast media.
•
Do not apply excessive force or deflection, this could result in damage and/or
breakage of the device.
Risks
• Associated risks include perforation, fallopian tube infection or an allergic
reaction due to contrast injection.
Precautions
• These devices should be used only by a physician familiar with the possible
side effects, typical findings, limitations, indications and contraindications of
Hystero-Salpingography and Hystero-Sonography.
• A contrast and saline will be delivered by injection through the catheter as
part of the procedure and the delivery rate is controlled by physician.
Pre-Procedure Preparation
Preparation
•
Fill the catheter with contrast liquid and close the stopcock. Remove the
contrast syringe to facilitate handling of the catheter.
•
Check that the blue stopcock on the balloon port is open and mount the
syringe with the required quantity of air (X- ray) or sterile saline
(ultrasound).
•
If sterile saline is used in the balloon the air is deflated from the system
by filling and emptying the balloon with sterile saline before use
•
Inflate and deflate the balloon (extend and retract the plunger on the
syringe) to insure its functionality and integrity.
Procedure
•
Insert the introduction tube (IT) into the vagina and guide the balloon
catheter through the (IT) into uterus (max 6 cm).
•
Inflate the balloon and close the stopcock. Pull back the catheter to secure
the balloon thus preventing outflow of contrast liquid into the vagina.
•
Fix the introducer tube onto the reinforced part of the catheter shaft at
the bifurcation.
(HSG) is designed for
Balloon Dia.
Balloon Dia. W/ air
W/ saline
10mm with
11mm with 2.0ml air
0.8ml saline
12mm with
13mm with 3.0ml air
1.2ml saline
to radiation, pelvic infection,
use in
and