GIMA Balloon-type Resuscitator User Manual
- June 6, 2024
- GIMA
Table of Contents
GIMA Balloon-type Resuscitator User Manual
ATTENTION: The operators must carefully read and completely understand the present manual before using the product.
GIMA Spa – Via Marconi, 1 – 20060 Gessate (MI) – Italia
ITALIA : Tel. 199 400 401 (8 linee r.a.) – Fax 199 400 403
E-mail: gima@gimaitaly.com –
www.gimaitaly.com
INTERNATIONAL : Tel. ++39 02 953854209 – Fax ++39 02 95380056
E-mail: export@gimaitaly.com –
www.gimaitaly.com
FEATURES
The balloon-type resuscitator is a medical device that is ideal for first aid purposes, as it enables fast, effective intervention in cases where the patient is struck by breathing problems. It can be used with every model of resuscitation mask.
The balloon-type resuscitator consists of a sack, a mask connection unit (containing a membrane outlet), and an inlet valve. The membrane outlet opens during insufflation, exercising slight pressure, and closes when the patient exhales, thereby preventing the patient from breathing into the sack. All balloon parts, except the disposable models, can be easily sterilized in a steam autoclave at 121ºC and then reused.
The bag has been designed to be used in hospital or private facilities with the aim of permitting the storing and/or the shifting of air or air/oxygen mixture for the resuscitation of patients with respiratory failure using proper reanimation masks.
In any case the manufacturer does not assume any responsability for improper uses of the product under the conditions listed below:
Connecting the bag to improper devices which could interfere with the
working of the bag;
Using the bag for inhalation therapies;
Introducing changes or tampering not authorized by GIMA;
Violating the rules specified on the information report.
PRESCRIPTIONS
The product is to be used solely by qualified medical personnel with specific experience in medical treatment, so as to ensure patients the highest level of safety.
Since the product is made of corrosion-proof materials suitable for the environmental conditions foreseen for its normal use, does not require special care, however it is necessary to store it in a closed place making sure that is protected from dust and dirt to assure its hygenic conditions. Moreover, it is recommended to store the product in a place which can be reached easily by the personnel in case of necessity.
Check the product periodically, especially their hygienic conditions of the storage place in order to assure the maximum efficiency and safety when used.
UNPACKING
Always remember that packing elements (paper, cellophane, stitches, adhesive
tape, etc.) can cut and/or hurt if they are not carefully handled.
They shall be removed with adequate means and shall not be left at the mercy
of irresponsible persons; the same is valid for tools used to remove packages
(scissors, knives, etc.).
After opening the packages, first of all it is necessary to check all pieces and parts composing the product. Check that they are all present and in perfect conditions.
We should also remind you that, as the product is packed in non-sterile packaging, before using it for the first time, it must be washed under running water, using neutral, sterilized soap.
To clean and reassemble the product, use sterile latex gloves.
FUNCTIONING
For a correct use the bag must be connected to the mask using the proper tube fitting on the linkage group, fig. 1.
Then start the reanimation pressing the insufflator alternatively to transfer air or air/oxygen mixtures to the patient, according to the medical indications, making sure that the mask adheres to the patient’s face, fig. 2.
During use do not turn the air influx zone of the bag to areas contaminated by gas, dust or smoke. If the patient starts vomiting or bleeding from the nose, remove the mask and follow the prescribed medical emergency procedures.
MAINTENANCE
The following maintenance procedures refer solely to reusable balloon parts; disposable models must be disposed of after being used and may not, under any circumstances , be reused.
After every use, the product must be fully disassembled and carefully washed using water and neutral soap; then, after it has dried thoroughly, the product must be sterilized. It may be either cold-sterilized or sterilized in a steam autoclave at 121ºC (with non-enveloped cycle).
Once sterile, the product must be kept in a closed space, so as to avoid any contact with dust or dirt, and to ensure the necessary hygienic conditions.
Should the product come into contact with non-sterile agents, it will no longer ensure the necessary hygienic conditions: as a result, cleaning and sterilizing procedures must be carried out once again.
GUARANTEE
Thank you for having acquired our product.
This product meets the most stringent requirements regarding the selection of quality manufacturing materials and also the final control. The product has a 12-month warranty, valid from the date it is delivered by GIMA.
During the guarantee period free repair and/or replacement of any defective parts due to faulty manufacture will be given, labour, postal, transport and packaging charges etc. are not included. The guarantee therefore excludes components subject to wear and tear such as parts in rubber or PVC, doppler probes, SpO2 sensors, lamps, batteries, electrodes, handpieces, washers and packings, resistances, etc. No compensation will be given for loss of use of the product.
Furthermore replacement or repairs effected during the guarantee period do not lengthen the duration of the guarantee.
This guarantee is void in the event of: repairs effected by unauthorised persons or with spare parts not approved by GIMA, damage or defects caused by negligence, blows, abnormal use of the appliance or faulty installation.
The guarantee will be invalidated if the registration number has been removed, cancelled or altered. Faulty appliances must be returned only to the retailer where the item was bought. Any item dispatched directly to us will be refused.
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