Integra Miltex 30-3000 Instrucciones De Uso

Integra Miltex
® ®
Reusable Cervical Dilator Set
Directions for Use / English
REF LOT
REF 30-3000 Reusable Cervical Dilator Set
Description
Cervical dilators are smooth and flexible, light in weight and can be easily
inserted and removed for their intended applications. They are made of
medical-grade PTFE and are latex-free.
The OS Locator
One molded band above the tactile handle and opposite the distal end of the
device identifies the disposable OS locator. The OS locator may be used to
find and gently dilate the external OS. The OS locator offers gradual dilation,
tip flexibility, and a smooth surface. The OS locator is tapered 23 mm to an
intermediate diameter of 3.8 mm.
The Canal Dilator
Two molded bands above the tactile handle identify the canal dilator from the
OS locator and the fundus sound. Its longer tapered tip is 45 mm and extends
to an intermediate diameter of 3.8 mm. The canal dilator may be used to slowly
dilate the length of the cervical canal.
The Fundus Sound
Three molded bands opposite the distal tip identify the fundus sound from the
others as described above. The tapered length from the distal tip is 85 mm. The
smooth and flexible fundus sound is designed to pass through the entire length
of the cervix, dilate the internal OS and sound the fundus to determine
uterine depth.
Indications
Cervical dilators are useful in locating and dilating the external OS, cervical
canal and internal OS of the uterus. Cervical dilators may be used on post-
menopausal patients with cervical stenosis.
Contraindications
Cervical dilators should not be used under the following conditions:
• Acute genital track or pelvic infections.
• A pregnancy or the suspicion of a pregnancy.
• Any invasive cancer that is visible upon examination.
• Any non-compliant patient.
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Warnings
This procedure should only be performed by a trained medical professional.
The use of excessive force should be avoided.
Cervical dilators should not be used for prolonged periods of time.
Precautions
• Reusable cervical dilator set is provided non-sterile.
Dilators must be sterilized prior to use.
• Visually inspect the dilators for any surface damage prior to use.
• Dilators that are damaged must not be used.
Instructions
Dilation of the cervix may be required for many diagnostic and treatment
procedures. This procedure should always be performed by a medical professional
who is trained in the procedure and aware of all possible complications and risks
that may be present.
1. A pelvic examination of the patient should be performed prior to dilation to
determine conditions present and risks of dilation.
2. The insertion of a weighted speculum may assist with visualization of the cervix.
3. Uterine tenaculum forceps should be used to grasp the cervix. Stabilization of the
tenaculum should be maintained during the dilation procedure to absorb
resistance and avoid trauma to surrounding anatomical structures.
4. The OS locator is used to gently dilate the external OS to allow access to the
cervical canal. Holding the dilator like a pen, gently insert the dilator into the
external OS. Slight, slow movements can be used to break up connective tissues
that may exist. Proceeding slowly allows the OS to gently stretch to
accommodate the dilator.
5. The canal dilator is often needed next to continue the dilation of the cervical
canal to gain access to the internal OS. The canal may become atrophic and rigid
in post menopausal patients. Proceeding slowly using the technique referenced
above, allows the canal to gently stretch over the dilator.
6. The fundus sound is utilized to complete the dilation of the internal OS and
palpate the depth of the uterus. Dilation of the internal OS should also proceed
slowly to allow the tissues to gently stretch over the dilator. Continuing to hold
the dilator like a pen, care should be exercised to minimize the risk of perforation
of the uterus or tearing of the internal OS.
7. If additional dilation is required, the use of progressively larger diameter dilators
can be utilized following the same process allowing for slow dilation of the
cervix to accommodate instrumentation needed for the procedure.
8. If resistance is met to any size dilator it is advisable to leave it in the internal
OS for several seconds to allow the tissues to expand around it.
Cleaning Instructions/Sterilization Instructions
1. Cleaning: submerge in enzymatic cleaner for 20 minutes. Cleaning was validated
using 3M Rapid Multi-Enzyme. Other enzymatic cleaners may be effective but
have not been validated.
Remove from enzymatic cleaner and rinse thoroughly with water. Demineralized
water is recommended for rinsing.
Allow to dry completely prior to sterilization.
2. Disinfecting: use Cidex® disinfecting solution for 12 minutes. Follow the
disinfecting solution's instructions for use. Other disinfecting solutions may
be effective but have not been validated.
Remove from disinfecting solution and rinse thoroughly with demineralized water.
Allow to dry completely prior to sterilization.
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