INSTRUCTIONS FOR USE
ECC/93/ 42
Lot no.
AB123
ONE PATIENT Device:
YES
CLASS of Medical Device
IIb
Supplied STERILE:
NO
CUSTOM- MADE Device
NO
PESSARY
For.me.sa S.r.l.
Ed. 2 Rev. 04 del 05.12.2019
Do not use in contact with injured parts (wounds).
Do not reuse the Device for another Patient.
Do not use for a longer tim e than indicated by medical staff.
Do not use in combination with or as a part of other med ical Devices.
Do not modify or change its components and/or characteristics.
Do not use of drugs or substances considered as or comparable to drugs, in combination / together with the Device.
Don’t abuse.
Via Canvelli 6, 43015 Noceto (PR) – Italia
USE ALLOWED TO TRAINED ME DICAL
STAFF ONLY
Tel. +39 0521 628482
Fax +39 0521 620382
EN
1 INTRODUCTION
Thank you for choosing a For.me.sa Srl product.
The Medical Device y ou have purcha sed has been manufactured in compliance with all current EEC Directives/regulations on safety of Medical Device for only medical use.
This document has been prepared to supply you with a general description of the Device and its Instructions for use, maintenance, storage and all those information we
deemed necessary.
For.me.sa Srl is entitled to make any changes and/or improvements to the production of their Medical De vices.
For.me.sa Srl is not obliged to ensure that these instructions for use and the corresponding symbols on the packaging will be closely followed by the buyer (see also C hapter 3).
Please keep these instructions for us e in a safe place for further consultation.
2 DUTIES OF THE MEDICAL S TAFF
This Me dical Device must be only handled by a qualified medical staff properly trained to use it.
The medic al staff MUST AL WAYS give thes e instructi ons for use t o their Pati ent in case t he Patient does not have them already.
Before, during and after the insertion of pessary, all criteria and behaviors regarding professional procedures and appropriate environment must be respected. Explain clearly to
the Patient all the procedures to be followed to keep the medical Device correctly into position, including check-ups you think will be necessary.
Use the medi cal device acc ording with current regulations and according to its intended us e.
3 DEVICE IDENTIF ICATION
For.me.sa Srl identifies the Device through a label applied on the item itself or on the package containing it.
Keep these re ferences where they can be easily found.
As a further safety precaution, prior to use, the medical st aff (or the Patient) must copy in the space report ed below the batch number indicated on the produ ct label.
Below the symbols description you may find on the p roduct label (instructions to be followed if the SYMBOL is present:
It indicates the BATCH number to which the specific Device refers to.
It indicates that the user/Patient must
READ and BE AWARE of the INSTRUCTION
FOR US E prior t o use.
4 INTENDED USE
This Device is meant t o be used for uterine prolapse.
Continuous use on the Patient must be fi xed by traine d medical staff.
Respect all the PROHIBITIONS as indicated in USE NOT ALLOWED (Chapter 5). The Device is not intended for use other than expressly indic ated.
Any other different use must be considered as improper and therefore unauthorized. This Device is for SINGLE PATIENT.
4.1 SIDE EFFECTS
The trained medical staff who performs the insertion of the Medical Device must explain possible side effects deriving from its use.
5 USES NOT ALLOWED
Here are a few uses of the Device which are not allowed and therefore should be considered as UNAUTHORIZED:
6 WARNINGS AND PRECAUTIONS FOR MEDICAL STAFF AND PATIENT
o Any infringements and/or improper use will be prosecuted as prescribed by law.
o Strictly stick to the intended use of the Device (see Chapter 4).
o The use of the Device can be , at the discreti on of the medi cal sta ff in cha rge, subj ect to perio dic check up. Stick meticolously to the indications you will receive f rom the
medical staff.
o The Device mu st be cleansed prior to use (see Chapter 14).
o Use the Device w ith care.
It indicates t he Device expiry date. If the Device ha s past its
YYYY - MM
expiration date, it must be replaced by a new one or a Device
with a dat e which has not expi red.
0476
7 STORAGE
The Device is supplied inside FOR.ME.SA. standard packaging. FOR.ME.SA. guarantees its correct storage prior to use.
For a correct storage of the Device, keep the origi nal packagin g in a dry pl ace with a temperature ranging from +1°C to +40°C, not in direct contact with heat sources, sheltered
from powders and harmful materials. Keep out of reach of children. Do not pile up heavy object on the Device. Do not expose the Device to mechanical stress.
8 PACKAGE CONTENTS
The medic al paper contains the Medical Device in a non-sterile packaging and these instructions for use.
9 PRECAUTIONARY VERIFICATIONS PRIOR TO USE
Before unpacki ng, make sure that the Device is intact and sealed inside its PE bag which has been specially sealed.
If you t hink there are damaged parts, DO NOT USE it but refer to the person who sold you the Device.
For any explanations, please address to your Chemist/Medical professional.
Prior to use, make sure that the Device:
• is intact and undamaged ( e.g. verify pr esence of cra cks, dent s, teari ng),
• has not changed colour or take on uneven colourings, does not show surface moulds, etc.
In any of these events, DISCARD the Device and REPLACE IT IMMEDIATELY.
IMPORTANT !!! A surface whitish colouring does not correspond to a wrong preservation (or a damaged product); it is due to talc, or another equivalent product, on the
protective film which has been used during its production.
10 CHARACTERIST ICS
Shelf life of the Device if used correctly: see label.
Material
RUBBER 50 55 60 63 65 70 75 80 83 85 89 90 95 100
SILICONE 50 55 60 65 70 75 80 85 90 95 100
11 PREPARA TORY PROCEDURES PRI OR TO USE
Perform a cleaning before use as defined in Chapter 14 and insert it in the following way:
1. Exceed the ent rance osteo-vagin al;
2. Bend the ring ellipse to facilitate their entry;
3. Circle the neck of the uterus.
12 MEDICAL STAFF PROC EDURES
o Operat e in a safe e nvironment a nd condition s avoiding a ny potential dangerous situations for operators, the Patient or others.
o Identify the right si ze to be used relying on the expertise devel oped on the filed. wrong and/or inappropri ate sizes do not lead to expected results.
o Prior to use, do not lea ve the Device unattended and do not put it on hot surfaces or surfaces with edges o r sharp pa rts. Leave it only on a flat surface which has been duly
sanitized.
o Do not try to rep air a damaged Device. In this event, discaed the Device as per Chapter 15.
13 INSTRUCTIONS FOR USE FOR THE PATIENT
o Use the Device observing every precaution (obligations, prohibitions, recommendations, etc.) carried out by the medical staff in charge duri ng its inse rtion.
o The Patient mus t never int ervene on t he Device on her own initiative.
o In case of abnormal discomfort not prognosticated or explained by the medical staff, refer immediately to your medical professional.
14 CLEANING (CL EANSING) PRIOR TO USE
o Prior to use, cleanse the Device with tepid water and mild soap, then rinse with a physiologic solution. Do not use brushes during cleansi ng but only s oft spon ges so n ot to
scratch the surfa ce of the Device.
o Do not use alcohol, solvents, acids or any other liquids that could damage the surfaces of the Device.
o After cleansi ng, do not leave the Device unatten ded but place it immediately i nto the vagina. This Devic e, for the first use , is autoclavable u p to two consecutive cycles set
at 121 ° C for 15 minutes.
15 DISPOSAL
In case of replacement or breaks, dispose of the Device according to local regulations on wastes disposal. Toxic substances are not present.
Diameter (centimeters)
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