Spencer 4BELL + MAX Instrucciones De Uso página 13

General warnings for medical devices
The user must carefully read the following in addition to the general warnings.
• Qualified personnel 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.
• With reference to EU Regulation 2017/745, please note that public or private operators who, when exercising their activity, detect an incident involving a medical product
are required to notify the Ministry of Health, within the terms and in the manner established by one or more ministerial decrees, and notify the Manufacturer. Public or
private health care professionals are required to notify the Manufacturer of any other incident that may allow the adoption of measures to ensure the protection and health
of patients and users.
6. SPECIFIC WARNINGS
To use the device, you must also have read, understood and carefully follow all the instructions in the instructions for use.
• Do not use if the device or parts of it are damaged or excessively worn.
• Read the instructions for use of the 4BELL+ and 4BELL STAIR + chair. You must be familiar with the procedures for opening and closing the chair.
• Do not use drying machines.
• Do not use the fastening system with devices not approved by the manufacturer.
• Before each use, always check the conditions of the device, as specified in the instructions for use. In case of faults or damage that may compromise the functionality and
safety of the device, discontinue service and contact the manufacturer.
• Do not alter or modify the device arbitrarily, as doing so could result in unpredictable operation and damage to the patient or rescuers and shall void the warranty and
release the Manufacturer from all liability.
• When closing the device belt, ensure that nothing interferes with the buckle. Carelessness during these steps could lead to injury caused by the buckle becoming unfastened.
• The fastening systems described in these instructions only comply with standard EN 1789 when used with the 4BELL+ and 4BELL STAIR + chairs and are installed on surfaces
capable of withstanding the stresses specified in this standard.
• Make sure that the requirements for the emergency vehicle are met before installing.
• Do not remove the chair from the hook while the vehicle is running.
• Make sure that the buckle is always correctly and fully engaged and that the chair is correctly positioned on the hook.
• There must be no foreign bodies between the chair and the fastening system.
• To limit the risk of injury, make sure that the footrests and telescopic handles of the chair are in the closed position when it is placed on the fastening system
• Make sure that the screws are tightened in accordance with these instructions for use.
• When positioning the chair on the fastening system, pay attention to the positioning of your hands. Incorrect positioning could result in injury.
6.1 PHYSICAL REQUIREMENTS FOR OPERATORS
The device is intended for professional use only. All operators must be trained in safe and efficient use. Do not allow untrained persons to help while using the product, as
they may cause injury to themselves or others.
Operators using the device should be physically able to use the device and have good muscle coordination, as well as strong back, arms, and legs for lifting and holding and be
able to grasp the chair firmly with both hands. Users must be able to lift and handle the chair safely to ensure a secure fit with the Fastening system.
Installers must be able to carry out the installation as prescribed by the manufacturer, ensuring the suitability of the supporting surfaces.
The ability of each operator must be assessed before the definition of rescuer roles in use of the stretcher.
7. RESIDUAL RISK
The residual risks listed below have been identified solely with reference to the intended use of the device.
• Use by untrained personnel may result in injury to the rescuer or third parties.
• Failure to check that the buckle fits correctly and place the chair on the hook can result in injury to vehicle occupants.
• Failure to read and understand the instructions for use may result in injury to the patient and operators.
8. TECHNICAL DATA AND COMPONENTS
Note: Spencer Italia S.r.l. reserves the right to make changes to specifications without notice.
N° DESCRIPTION
1 Lower stop elements
2 Spacers (only on 4Bell+ Max)
3 Main body
4 Quick-release buckle
TECHNICAL DATA
Dimensions (HxLxD)
Weight
IT
EN
DE
FR
ES
MATERIAL
Steel
Nylon
PT
Steel
Steel/Nylon
PL
778x490x143 ± 3 mm
BG
3.5 ± 0.1 kg
RO
13