Spencer S-MAX PRO Gebrauchsanweisung Seite 12

1. MODELS
The following standard models can undergo change, revision and implementation without any notice.
• S-MAX PRO 10G FASTENER FOR STRETCHER
2. INTENDED USE
The fixing systems are devices to be installed permanently in the ambulance, with the aim of safely holding the stretcher during patient transport.
S-Max Pro is intended for use with Spencer stretchers with an interaxis in correspondence to the loading trolley crossbar of 235mm.
The patient should not intervene on the device.
TARGET PATIENTS
The expected patients are those for whom the transport on a stretcher is foreseen.
PATIENT SELECTION CRITERIA
The expected patients are those who need to be transported by ambulance on a stretcher.
CONTRAINDICATIONS AND UNDESIRABLE SIDE EFFECTS
There are no known contraindications or side effects resulting from the use of the device, provided it is used in accordance with the user manual
USERS AND INSTALLERS
The intended users are people trained in first aid procedures and the use of medical equipment in the EMS (Emergency medical service) environment.
Among the possible users are also contemplated the fitters of emergency vehicles who can use the product before putting it into service or during any maintenance of the
vehicle on which the stretcher is used.
2.1 REFERENCE STANDARD
As a distributor or end user of products manufactured and/or marketed by Spencer Italia S.r.l. you are strictly required to have basic knowledge of any legal requirements
applying to the devices contained in this supply that are in power in the goods final destination Country (including laws and norms regarding technical specifications and/
or safety requirements) and therefore you are 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.
REFERENCE
EU Regulation 2017/745
UNI EN 1789 § 4.5.9 - § 5.4.2 - § 5.4.5
IT
3. INTRODUCTION
3.1 USE OF THE MANUAL
This manual is intended to provide the health care operator with the all the necessary information for its safe and appropriate use as well as adequate maintenance of the
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device.
Note: The manual is an integral part of the device. It must be kept for the duration of the device and must accompany the device in case of change of ownership or destination.
If the operating instructions received relate to products not received, you must immediately contact the manufacturer before use.
The Use Manuals of Spencer products can be viewed and downloaded from the web page
Spencer site or it is possible to contact the Manufacturer. Exceptions are articles whose essentiality and reasonable and foreseeable use are such that it is not necessary to draw
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up instructions in addition to the following warnings and indications on the label.
Regardless of the level of experience gained in the past with similar devices, it is recommended that you carefully read this manual before installing, operating or using
the product or any maintenance.
3.2 LABELLING AND TRACKING CONTROL OF THE DEVICE
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Each device has got an identification label positioned on the device itself and/or on its box, which includes identification data about the manufacturer, the product, the CE mark,
the serial number (SN) or lot number (LOT). It must never be removed or covered.
In case of damage or loss, request a duplicate from the manufacturer. Failure to do so will interrupt the validity of the guarantee as the device can no longer be traced.
The Directive Regulation 2017/745/UE requires manufacturers and distributors of medical devices to keep track of the device location. If the device was in a different
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location to the address where it was sent or to where it had been sold, donated, lost, stolen, exported, or destroyed, permanently removed from use, or if the device had
not been delivered directly from Spencer Italia S.r.l., register your device at service.spencer.it, or inform the customer service department (see § 3.4).
3.3 SYMBOLS
Symbols Meaning
PT
The product is compliant with the Regulation 2017/745/UE
Medical Device
Manufacturer
Date of manufacture
Unique Device Identifier
(01)8057711230006 (11) 200626 (21) 1234567890
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DOCUMENT TITLE
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices
Medical vehicles and their equipment - Road ambulances
www.spencer.it/en/emergency-medical-solutions/user-manuals
Symbols Meaning
General or specific warnings
See instructions for use
Product code
Serial Number
Production identification
Alphanumeric code that identifies the production units of the device, composed of:
(01)805771123 company prefix
000 progressive GS1
6 control number
(11)200626 date of production (YYMMDD)
(21)1234567890 SN
present on the