Models; Intended Use; Target Patients; Patient Selection Criteria - Spencer ST00002C Instrucciones De Uso

1.

MODELS

The following basic models may be subject to implementation or change without notice.
• SHERPA • SHERPA PLUS
2.

INTENDED USE

2.1 INTENDED USE
Sherpa and Sherpa Plus are support trolleys for field stretchers which can also be used for short trips within the equipped area. The Plus version is equipped with a system to
keep the device in an inclined position. Compatible with series 100/200/300/Slim/Stock stretchers. Unsupervised parking is not permitted.

2.2 TARGET PATIENTS

The target patients are those for whom use of the field stretcher is foreseen.

2.3 PATIENT SELECTION CRITERIA

The selection criteria are those foreseen for use of the field stretcher.

2.4 CONTRAINDICATIONS AND UNWANTED SIDE EFFECTS

No particular contraindications or side effects are known with relation to use of the device, as long as it is used in accordance with the instructions for use.

2.5 USERS AND INSTALLERS

The intended users are those foreseen for use of field stretchers.
These devices are not intended for lay people.
Operators must be able to provide the necessary patient care.
The product must be used only by personnel trained in the use of this product and not on other similar products.
3.

REFERENCE STANDARDS

REFERENCE
EU Regulation 2017/745
4.

INTRODUCTION

4.1 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, serial
number (SN) or lot number (LOT). This must never be removed or covered.
EU Regulation 2017/745 requires manufacturers and distributors of medical devices to keep track of their location.

4.2 SYMBOLS

Symbol Meaning
IT
Device in compliance with EU Regulation 2017/745
Medical device
EN
Manufacturer
Date of manufacture
Unique Device Identifier
DE
FR
(01)8057711230006 (11) 200626 (10) 1234567890

4.3 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.
ES
Spencer Customer Service tel. +39 0521 541154, fax +39 0521 541222, e-mail service@spencer.it.
Warranty and service conditions are available at
5.

WARNINGS/DANGERS

PT
Product features
Use of the product for any purpose other than that described in the instructions for use is prohibited.
• The product must not be tampered with or modified without the manufacturer's authorisation.
• Avoid contact with sharp or abrasive objects.
• Operating temperature: from -5°C to + 50°C.
• Storage temperature: -10°C to +60°C .
General warnings for medical devices
• Do not use if the device or parts of it are punctured, torn, frayed, or excessively worn.
• 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 manufacturer's
warranty and release the manufacturer from all liability.
• Participate in safety checks on products placed on the market, transmitting information regarding product risks to the Manufacturer as well as to the Competent Authorities
for their respective actions.
• 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.
8
Symbol
Production identification
Alphanumeric code that identifies the production units of the device, composed of:
(01)805771123
000
6
(11)200626
(10)1234567890
http://support.spencer.it
DOCUMENT TITLE
EU Regulation on Medical Devices
Meaning
Danger – Indicates a hazardous situation that may result in a situation
directly related to serious injury or death.
See the instructions for use
Lot number
Product code
Caution: Federal law restricts the sale of this device by or on the order of a
licensed professional (US market only)
company prefix
progressive GS1
control number
date of production (YYMMDD)
lot number