Specific Warnings; Residual Risk; Technical Data And Components - Spencer CARRERA INCUBATOR Instructions D'utilisation

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General warnings for medical devices

The user must carefully read the following in addition to the general warnings.

• The application of the device should not last longer than the time required for first aid operations and subsequent transport to the nearest rescue point.

• Qualified personnel and at least two operators must be present during use of the device.

• Follow the internal procedures and protocols approved by your organisation.

• Disinfection operations must be carried out in accordance with the validated cycle parameters, as stated in the specific technical standards. .

SPECIFIC WARNINGS

To use the product, you must also have read, understood and carefully follow all the instructions in the Instructions for use.

• Follow approved Emergency Medical Service procedures for patient positioning and transportation.

• Do not use if the device or parts of it are punctured, torn, frayed, or excessively worn.

• Before any type of handling, make sure that operators have a secure grip on the device.

• Do not drag the device on uneven surfaces.

• Do not lift with a crane or other mechanical lift.

• Do not use drying machines.

• The device is a transport device and cannot be used as a stationing device.

• Do not use with devices other than those expressly approved by the manufacturer.

• Practice with a device without a patient to make sure you are familiar with the manoeuvres.

• For loading techniques, for operations on steep terrain or in special and unusual circumstances, the presence of multiple operators is recommended (not just 2 as expected

in standard conditions).

• Make sure that the patient is adequately immobilized before loading the incubator on the trolley. A failure to immobilize can cause serious damage to the patient.

• Make sure that nothing interferes with any stretcher handling or control mechanisms.

• Do not move the device if the weight is not properly distributed.

• Use only the perimeter frame to move the stretcher and not other points not intended for this purpose.

• Avoid excessive force when loading the stretcher into the ambulance: unnecessary force can cause damage and can adversely affect the fastening system and the functioning

of the stretcher itself.

• Hold the device firmly if there is a patient in the incubator.

• Parking brakes are aids for the operator but they do not in any way replace his or her supervision.

• Pay the utmost attention to any obstacles (water, ice, debris, etc.) present on the route, as they may cause the operator to lose balance and compromise proper functioning

of the device. If you cannot clear the way, choose an alternative route.

• Condensation, water, ice and accumulations of dust can affect correct operation of the device, making it unpredictable and causing a sudden change in the weight the

operators have to support.

• For height differences greater than 10mm, the device must be lifted, taking care to grasp it from the structure and not from the sidebars/beds or other points not intended

for this purpose.

• Once the wheels of the loading trolley have been placed on the ambulance floor, the wheels of the front leg must have a ground clearance of at least 5/6 cm, which allows

the front leg to be opened and locked safely. Check the height of the ambulance bed after each use; if it is altered, the trolley must be adjusted immediately by the ma-

nufacturer or by a specialised technician authorised by the manufacturer. If not, the manufacturer cannot be held responsible for correct functioning of the device or any

damage caused by it.

• If the vehicle is equipped with pneumatic or hydraulic suspensions, the loading height must be adjusted taking into account the worst-case conditions and/or the working

conditions foreseen by the outfitter.

• Any problems regarding the use and/or safety risks associated with this system are not the responsibility of the manufacturer.

• Inadequate installation of the loading floor can lead to buckling and subsequent damage to the welds of the front legs.

• Improper installation of the loading floor can lead to abnormal operation of the device and cause harm to the patient and user.

• Do not alter or modify the stretcher to adapt it to the emergency vehicle: doing so could result in unpredictable operation and damage to the patient or rescuers and shall

void the manufacturer's warranty and release the Manufacturer from all liability.

• The product can only comply with regulation EN 1789 if used with the dedicated fixing system. The use of fasteners not approved by the Manufacturer is therefore prohi-

bited. Non-approved fixing systems may alter the structural and functional characteristics of the device. Compliance with EN 1789, and if necessary EN 60601-1, is limited

to the interaction between the trolley and its fixing system. The assessment and verification of conformity of the entire Incubator system, i.e. the trolley complete with

incubator and its accessories, is the responsibility of the installer of such systems.

• Do not place limbs and/or objects between the legs and the frame, in the vicinity of the leg lifting pistons or in general between moving parts as this may result in crushing

injuries.

RESIDUAL RISK

The residual risks listed below have been identified solely with reference to the intended use of the device.

Incorrect assessment of compliance to EN 1789 of the fixing interfaces between the trolley and the incubator by the installer can lead to serious damage to the patient

•

in the event of an ambulance accident.

• Incorrect positioning of the masses on the trolley which is not in accordance with the requirements described in these operating instructions can impair the hold of the

trolley attachment system, resulting in serious injury to the patient and occupants of the vehicle. .