Spencer 4BELL + MAX Instrucciones De Uso página 11

1. MODELS
The following basic models may be subject to implementation or change without notice.
• 4BELL + MAX – 10G FASTENING SYSTEM
• 4BELL STAIR+ MAX – 10G FASTENING SYSTEM
2. INTENDED USE
Intended use
Chair fastening systems allow chairs to be anchored in a closed position inside ambulances.
Intended users
The intended users are those envisaged to use folding transport chairs.
Patients
It is not intended for use with a patient.
3. REFERENCE STANDARD
As Distributor or End-User of the products manufactured and/or marketed by Spencer Italia S.r.l., users are strictly required to be familiar with the legal provisions in force in
the country of destination of the goods, applicable to the devices to be supplied (including regulations relating to technical specifications and/or safety requirements) and,
therefore, to understand the requirements necessary to ensure compliance of the products themselves with all legal requirements of the territory.
REFERENCE
UNI EN 1789 § 4.5.9 - § 5.4.2 - § 5.4.5
4. INTRODUCTION
4.1 USING THEINSTRUCTIONS
The purpose of these instructions is to provide healthcare professionals with the information necessary for safe and appropriate use and maintenance of the device.
Note: The instructions for use are an integral part of the device and therefore must be kept for the entire life of the device and must accompany it in any changes of use or
ownership. If any instructions for use for products other than the one received are present, please contact the Manufacturer immediately before use.
Spencer product instructions for use can be downloaded from the site
lity and reasonable and predictable use are such that it is not necessary to draw up instructions, in addition to the following warnings and indications on the label.
Regardless of your level of experience with similar devices in the past, it is advisable to read with care and understand the contents of these instructions for use before
installing, operating, or servicing this product.
4.2 DEVICE LABELLING AND TRACEABILITY
Each device is provided with a label, placed on the device itself and/or on the packaging, which contains the Manufacturer's identification data, product, CE marking or serial
number (SN). It must never be removed or covered.
In the event of damage or removal, request a duplicate from the Manufacturer, or else the warranty will be void as the device can no longer be traced.
The Regulation UE 2017/745 requires manufacturers and distributors of medical devices to keep track of the device location. If the device was in a different 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
4.3 SYMBOLS
Symbol Meaning
Class I Medical Device, compliant with the Regulation UE 2017/745
Medical Device
Manufacturer
Date of manufacture
UDI
(01)08057711230006(11)200626(10)1234567890
4.4 WARRANTY AND SERVICE
Spencer Italia S.r.l. guarantees that products are free from defects for a period of one year from the date of purchase.
For any information regarding the correct interpretation of the instruction manual, the use, maintenance, installation and restore of the product, contact the Spencer customer
care service ph. +39.0521.541111, fax +39.0521.541222, e-mail service@spencer.it.
To facilitate service, always indicate the serial number (SN) on the label attached to the package or device itself.
Warranty and service conditions are available at
Note: Record and keep with these instructions: serial number (SN), place and date of purchase, date of first use, date of checks, user name and comments.
To ensure the traceability of the products and protect maintenance and service procedures on your devices, Spencer has made the SPENCER SERVICE portal
spencer.it/) available to you. From this site, you can view the data of the products in your possession or placed on the market, monitor and update schedules for periodic
checks and view and manage special maintenance.
DOCUMENT TITLE
Medical vehicles and their equipment - Road ambulances
http://support.spencer.it
http://service.spencer.it or inform the customer (see § 4.4).
Symbol
Unique Device Identification
Alphanumeric code that identifies the production units of the device, composed of:
(01)0805771123
000
6
(11)200626
(10) 1234567890
http://support.spencer.it
or by contacting the Manufacturer. Exceptions are those items whose essentia-
Meaning
Caution: Federal Law restricts this device to sale by or on the order of a
licensed practitioner (USA market only)
General and/or specific warnings
See the instructions for use
Product identification code
Serial Number
company prefix
progressive GS1
control number
date of production (YYMMDD)
lot/SN
IT
EN
DE
FR
ES
PT
PL
BG
RO
(http://service.
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