Class I medical devices

03 December 2021
class-i-medical-devices-Lineevita

Among the various tools available to each company with personnel trained in first aid and recovery(vd. Courses available) as part of work in confined spaces and/ or at high altitude can not miss a stretcher.

Exact!  It is the tool that in case of emergency must have certain characteristics with respect to the type of recovery and transport of the injured person.

The legislation to refer to is therefore, first of all, Directive 93/42 EC  transposed in Italy with  LegislativeDecree 46/97,concerning the safety of medical devices.

The obligation to ensure the safety of the device therefore falls primarily on the manufacturer. However, there are also obligations for the buyer/user, since the objective of the directive is to ensure the safety of the product not only at the time of its placing on the market but also subsequently. In particular, Article 2 of Regulation 93/42 (Article 3 of Legislative Decree 46/97) provides  that the device is subject to adequate maintenance in order not to compromise the safety and health of patients, users and possibly third parties.

We reiterate that before moving on to this phase it is necessary to respect theprogress and    learned with the certified courses then the application of the same in the field of first aid.

Here is a list of stretchers with different applications:

  1. Rollable stretchers;
  2. Spoon rescue stretchers;
  3. Estricatori;
  4. Spinal Tables;
  5. Basket type stretchers;
  6. Special mountain stretchers;
  7. Special snow stretchers.

 

Rollable stretchersSpoon rescue stretchersEstricatoriSpinal Tables
Rollable medical device designed for rescue in confined environments; it is particularly suitable for the evacuation of injured people from narrow places and with narrow or complicated passages.
It is an extremely flexible device, very useful in the evacuation of injured people in complex environmental conditions.
It is mostly used for a first transport and then transfer the patient to a spinal table. Applied especially when you want to avoid dangerous movements of the spine or traumatized partsFirst aid device that is mainly used for the extraction of a traumatized from a vehicle.It is a garrison for the immobilization, collection and short movements of trauma victims. Designed to maintain the alignment of the injured person’s head, neck and trunk.

 

 

Basket type stretchersSpecial mountain stretchersSpecial snow stretchers
Ideal for very difficult rescue operations. Ideal for rescue in the mine, at high altitude, in the water. The spacious basket stretcher provides space to accommodate blankets and life support equipment.Product congenial for hostile environments and used above all for alpine rescue, they facilitate transport because they allow transport on the shoulder keeping the injured in the heat.They are able to slide on the snow and can be led by rescuers with skis to take the injured to the valley.

 

Which one to choose? As we said before there are different situations and therefore the choice of the type of medical device is not easy if you do not know the environment in which it will be used.

In fact, in the d.lgs. Articles 28-30 of Amendment No 81/2000 explain the definitions, methods  of carrying out the risk assessment  and  the models of organization and management of the same.

It is advisable to verifythe effectiveness and ease of use of medical devices by means of practical tests.

If you need advice send us an email progettazione@lineevita.it

 

 


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