6
The cleaning schedule for reusable products must be performed in accordance with the directions provided by the manufacturer in
the user manual, in order to avoid the risk of cross-infection due to the presence of secretions and/or residuals.
The device and all its components, after washing, should be allowed to dry completely before storing.
If required, lubrication must be carried out after cleaning and complete drying.
Regulatory requirements
As a distributor or end user of products manufactured and/or marketed by Spencer Italia S.r.l., you are strictly required to have a
basic knowledge of any legal requirements applying to the devices contained in this supply that are in power in the final
destination Country (including laws and norms regarding technical specifications and/or safety requirements) of the goods and
therefore you are also strictly required to have the necessary knowledge to guarantee all aspects regarding the total conformity of
the products to the regulations in the relevant territory.
Promptly notify Spencer Italia S.r.l. (already during the first product enquiry) when requesting in details regarding any revisions to be
made by manufacturer in order to guarantee the conformity of the products to the territory’s legal specifications (including those
resulting from rules and/or norms of other kind).
Act, with all due care and diligence, and contribute to ensure conformity to general safety requirements of all devices marketed in
the territory, by providing final users with all necessary information for carrying out periodical checks on their devices, exactly as
specified in the relevant user’s manual.
Actively contribute to safety checks on product
sold, by communicating any relevant risk analysis information both to the
manufacturer and to any competent authorities so that the necessary action can be promptly taken.
The distributor or final user is aware that in the event of any failure to conform to the above mentioned requirements you will be
deemed fully responsible for all damages that might occur. Therefore Spencer Italia S.r.l. expressly disclaims any responsibility and/or
liability for your non-compliance with the present regulatory provisions.
General warnings for medical devices
When in possession of a medical device, the user must carefully read not only these general warnings, but also those listed below.
It is not foreseen that the use of the device is prolonged beyond the time necessary for recovery of patient and his transfer to the
main stretcher.
When the device is being used, the assistance of qualified staff must be guaranteed and at least one operator must be present.
Follow the procedures and protocols approved by the internal organization.
The activities of disinfection and sterilization should be carried out in accordance with the parameters given in the validated cycle as
specified in the technical standards.
With reference to the D. Lgs. 24th February 1997, n. 46 emended by D. Lgs. 25/01/2010, n. 37 – Acknowledgement of Directive
93/42/CEE and 2007/47/CE concerning Medical Devices, we remind both public and private operators, , That in the exercise of their
activity detect an accident involving a medical product are required to notify the Ministry of Health, under the terms and in the
manner established by the relative ministerial decrees and also to the manufacturer. Health care providers whether public or private
are required to communicate to the manufacturer, any other inconvenience that may allow for the adoption of measures to ensure
the protection and health of patients and users
6.
SPECIFIC WARNINGS
Follow the procedures approved by the Emergency Medical Service for the immobilization and transport of patients.
Follow the procedures approved by the Emergency Medical Service for the positioning and transport of patients.
Do not use if the device or its parts are pierced, torn, frayed or excessively worn out.
Make sure, before lifting, that the operators have a firm grip on the device.
When lifting the device in stretcher mode, grab the telescopic handles at the head side and the ones at foot side which are placed on
the main frame.
Don’t use the handles placed on the seat frame to lift the device.
Avoid pulling the device on rough surfaces.
Do not lift by crane or other mechanical lifters.
Do not use drying machines.
The device is intended for recovery and transfer of patients and cannot be used as a parking device.
Have practice with an empty stretcher/chair, in order to make sure you become familiar with the manoeuvres.
For loading techniques of the patient, for particularly heavy patients, for working on uneven ground or in special and unusual
circumstances, the presence of more operators is recommended (not only 2 as expected under standard conditions).
Before each use, check the integrity of the belts and their hooks, as specified in the user’s manual. In case of malfunction
or damage that may compromise the functioning and safety of the device, patient or operator, it is necessary to replace the belts.
Make sure the belts are properly fastened to the frame of the stretcher.
Always immobilize the patient, using the straps supplied by the manufacturer; lack of immobilization may cause serious damage.
To optimize the immobilization of the patient, it is required the use a thorax belt, in addition to the belts provided.
Make sure the sheet is properly secured to the frame the stretcher.
Make sure that any sheet does not interfere with the folding system, with the handles movement and with any other operation on
the device.
Do not operate in case the weight has not been distributed correctly.
Always grasp the handles to carry the stretcher/chair and not other parts of the device.
Avoid extreme force when changing the configuration of the device. Excessive force can compromise the integrity of the product.