Contraindications - Cooper Surgical wallace Mode D'emploi

English
These instructions are for use with the following Wallace
Catalog No. 700/300/050 - 700/300/110 Ring Pessary PVC
These instructions contain important information for safe use of the product. Read the entire contents of these
Instructions for Use, including Warnings and Cautions, before using this product. Failure to properly follow
warnings, cautions and instructions could result in death or serious injury to the patient and/or clinician.
DESCRIPTION
• A range of Ring Pessaries manufactured in PVC for the palliative treatment of uterine displacement and stress
incontinence.
• The PVC Ring Pessary is flexible with a large cross section.
Ring Pessaries are available on the UK National Health Prescription.
• Wallace ®
WARNINGS
• Insertion and removal of Ring Pessaries should only be performed by competent trained personnel.
• After removal of the Ring Pessary an inspection of the vagina should be performed to check for ulceration,
bleeding, infection.
• This product contains DEHP – data derived from animal and epidemiological studies outline the following
risks, but are not limited to: Adverse effects on fetal development, kidney and liver toxicity, negative impact
on fertility. Special attention on the application of phthalate products should be given for the following patient
populations: pediatrics, pregnant and nursing women.
INDICATIONS FOR USE
• Wallace Ring Pessaries provide vaginal support to prevent the uterus from descending.
• Designed to ease uterine prolapse.
• Ring Pessaries are also used to correct other uterine displacements and to alleviate stress incontinence by pressure
through the anterior vaginal wall onto the urethra.

CONTRAINDICATIONS

• Ring Pessaries are not suitable for patients with active infections of the pelvis or vagina.
• Ring Pessaries should not be prescribed for patients who are noncompliant, or unlikely to follow-up.
PRECAUTIONS
• Inspection of the vagina using a speculum is recommended prior to insertion or replacement of a Ring Pessary.
Ring Pessaries are supplied non-sterile and are reusable for single patient use only. Products must be
• The Wallace ®
disposed of after 6 months.
INSTRUCTIONS FOR USE
1 Determine the size of Ring Pessary required by currently accepted medical techniques.
2 The Ring Pessary may be immersed in hot water to warm it and increase its flexibility if required.
3 Wearing sterile gloves, hook the middle finger around the outer rim of the Ring Pessary in the center until the edges
make contact.
4 To ease insertion, a water-soluble lubricating jelly may be applied to the front edge of the Ring Pessary. Holding the
Ring Pessary vertically, insert into the vagina angling it down towards the floor of the pelvic basin.
5 Remove fingers and thumb and push the Ring Pessary into place ensuring it is on the bony ledge behind the symphysis
pubis.
6 Check the position of the Ring Pessary, the cervix should be felt protruding through it. The Ring Pessary should be
across the vagina with the back edge in the posterior fornix and the front edge behind the symphysis pubis.
INSTRUCT/ADVISE PATIENT
1 Instruct the patient that the Ring Pessary should only be inserted and removed as directed by the attending physician.
2 Instruct the patient that, after removal, she should wash the Ring Pessary with soap and water and rinse before
re-insertion.
3 Instruct the patient that it is important for her to attend follow-up appointments.
4 Advise the patient that there is a possibility that she may experience discomfort or more vaginal discharge than usual
and instruct her to report any such side effects to her physician immediately.
5 Advise the patient how long she should be expected to use the Ring Pessary.
6 Advise the patient that the Ring Pessary may interfere with sexual intercourse. If any discomfort is experienced, her
physician should be consulted.
2
Ring Pessary PVC
INSTRUCTIONS FOR USE
NOTE: DISTRIBUTE THIS INSERT SHEET TO ALL PRODUCT LOCATIONS.
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