Spencer STX 518 User manual

STX 518 STX 537
PT
ES
FR
DE
EN
IT
SPENCER ITALIA SRLSPENCER ITALIA SRL – Via Provinciale n° 12
43038 Sala Baganza (PR) – Italy
Manuale d’uso e Manutenzione
GALLEGGIANTI BARELLE BASKET E TAVOLE SPINALI
Use and Maintenance Manual
BASKET STRETCHER AND SPINE BOARD
FLOATATION SYSTEMS
Betriebs- und Wartungshandbuch
SCHWIMMKÖRPER KORBTRAGEN UND SPINEBOARDS
Manuel d’utilisation et d’entretien
FLOTTEUR CIVIÈRE DE TRANSPORT
ET TABLES SPINALES
Manual de uso y mantenimiento
FLOTADORES PARA CAMILLAS TIPO CESTA
Y TABLEROS ESPINALES
Manual de Uso e Manutenção
FLUTUADORES, MACAS TIPO CESTO (“BASKET”) E
PRANCHAS DORSAIS

2
PT
ES
FR
DE
EN
IT
1. MODELS
The following basic models may be subject to implementation or change without notice.
• STX 518 – 2-PIECE FLOATATION DEVICE
• STX 537 - 1-PIECE FLOATATION DEVICE
2. INTENDED USE
2.1 INTENDED USE AND CLINICAL BENEFITS
The floating devices are accessories for basket stretchers or spine boards, to be used to increase the degree of buoyancy in water of the device with which they are used. The
device is not suitable for use with the Dakar, Dakota and Dakota Light basket stretchers because they cannot be used in water.
2.2 TARGET PATIENTS
The target patients are those for whom use of the basket stretcher of spring board in an aquatic environment.
2.3 PATIENT SELECTION CRITERIA
The selection criteria are those foreseen for use of the basket stretcher or spine board.
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 user manual.
2.5 USERS AND INSTALLERS
The intended users are water rescue workers.
• Personnel trained for use of the device must also have training in managing lifting and handling suspended loads with people.
• Personnel who carry out interventions in situations classified as high risk or which are purely technical must be suitably trained and experienced in rescue.
• Personnel should be specifically trained in water rescue procedures.
These devices are not intended for lay people.
Operators must be able to provide the necessary patient care.
Operators must know how to swim.
• 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 DOCUMENT TITLE
EU Regulation 2017/745 EU Regulation on Medical Devices
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.
If the assigned Lot/SN cannot be traced, the device must be reconditioned, provided only under the responsibility of the manufacturer.
4.2 SYMBOLS
Symbol Meaning Symbol Meaning
Device in compliance with EU Regulation 2017/745 Danger – Indicates a hazardous situation that may result in a situation directly
related to serious injury or death.
Medical device See the user manual.
Manufacturer Lot number
Date of manufacture Product code
Unique Device Identifier Caution: Federal Law restricts this device to sale by or on the order of a licensed
practitioner (only for USA Market)
(01)08057711230006 (11) 200626 (10) 1234567890
Production identification
Alphanumeric code that identifies the production units of the device,
composed of:
(01)0805771123 company prefix
000 progressive GS1
6 control number
(11)200626 date of production (YYMMDD)
(10) 1234567890 lot/SN
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.
Spencer Customer Service tel. [phone], fax [phone], e-mail [email protected].
Warranty and service conditions are available at http://support.spencer.it.

STX 537
STX 518
3
5. WARNINGS/DANGERS
Product features
Use of the product for any purpose other than that described in the User Manual 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.
6. SPECIFIC WARNINGS
To use the floatation devices, you must also have read, understood and carefully follow all the instructions in the user manual.
• Never apply more weight than the buoyancy thrust offered by the product. Incorrect evaluations could cause the stretcher and patient to sink. When determining
the applicable weight and thus the appropriate float, the operator should consider the weight of the patient, device, equipment, accessories and any other object attached
to the stretcher.
• Perform water rescue simulations with a stretcher and a patient simulating load and accessories before putting the device into service.
• This device is a buoyancy aid and cannot be used to float the stretcher without the assistance and supervision of the operator.
• Make sure that the belts are properly fastened to the stretcher frame.
• Rescue operations must be carried out solely by personnel adequately trained and experienced in water rescue.
• To preserve the life of the device, protect it as much as possible from UV rays and adverse weather conditions.
• If the product is found to be malfunctioning, immediately use a similar device to ensure continuity of ongoing operations. Non-compliant devices must be taken out of
service.
7. RESIDUAL RISK
No residual risks, or rather risks that could arise despite compliance with all warnings in this user manual, have been identified.
8. TECHNICAL DATA AND COMPONENTS
Component ID Description
1 Casing zipper
2 Anchorage straps
3 Casing
4 Quick-release buckles
STX 518 STX 537
Floatation device dimensions Ø150x1020 ± 10mm (per piece) ø150x3330 ± 10 mm
Total buoyancy thrust
With floatation device fully immersed 300 N 550 N
Materials PE, PVC, Nylon PE, PVC, Nylon
Weight 2,2 ± 0,1 kg 3,1 ± 0,1 kg
9. PROPER USE
Before applying the floatation device, carefully evaluate that the buoyancy thrust of the supplied floata-
tion device is sufficient to support the total weight connected to the floatation device itself.
9.1 STX 518 FLOATATION DEVICE APPLICATION
This type of floatation device is made up of two pieces, to be applied specularly to the right and left side
of the basket stretcher or spine board.
• Application must be made on the straight section of the device, applying it as close as possible to
the head side of the patient.
• Pass the belts through the handles or through the spaces between the frame tubes. Each belt must
also wrap the floatation device itself.
• Finish the application by attaching the quick-release buckles, making sure they are properly locked.
9.2 STX 537 FLOATATION DEVICE APPLICATION
This type of floating device consists of a single piece to be applied to the head side of the basket
stretcher or spine board, taking care to position the right and left parts symmetrically.
• Pass the belts through the handles or through the spaces between the frame tubes. Each belt must
also wrap the floatation device itself.
• Finish the application by attaching the quick-release buckles, making sure they are properly locked.

4
10. CLEANING AND MAINTENANCE
10.1 CLEANING
Failure to carry out the correct cleaning operations could increase the risk of cross-infection due to presence of body fluids and/or residues.
The operator must wear suitable personal protective equipment, such as gloves, goggles, etc. during all checking and cleaning operations.
Open the casing zipper, take out the inner element and rinse it with warm water and neutral soap. Never use solvents or stain removers.
In the same way, clean the floatation device casing and the respective belts.
Rinse thoroughly with lukewarm water, making sure you have removed all traces of soap, which may deteriorate or compromise conditions and durability. Avoid using high
pressure water, as this may damage the device.
Let the parts dry separately completely before storing. Drying after washing must be natural and not forced. Do not use flames or other direct heat sources.
After drying, reposition the floatation element inside the casing, carefully closing the zipper.
If disinfecting, use products that do not have a solvent or corrosive action on materials constituting the device, in addition to being classified as medical-surgical devices. Be
sure to take all precautions to ensure that there is no risk of cross-infection or contamination of patients and operators.
10.2 MAINTENANCE
The device does not require a routine maintenance program, but checks must be made to verify:
• General functionality of the device
• Cleanliness of the device (remember that the failure of cleaning may cause the risk of cross infections)
• Fulfilment of the requirements of the user manual in section Warnings and Specific Warnings.
• Fulfilment of the requirements of the manual in section on Proper use.
No periodic overhaul is foreseen for the device.
10.3 LIFE SPAN
The device, if used as described in the following instructions, has a life span of 10 years from the date of purchase.
11. TROUBLESHOOTING TABLE
PROBLEM CAUSE REMEDY
You cannot lock the belts in the
buckles
Incorrect passage of the belt
around the buckle
If you find that this is the problem, pull the belt out of the buckle, reverse the direction in which
the belt passes through the buckle and check that it is working properly
Fabric or belts are torn Normal wear or improper
use. Immediately remove the device from service and contact the manufacturer
It is not possible to attach one or
more buckles
Possible incorrect buckle
orientation or buckle failure
Check the correct orientation of the buckle and its conditions.
If damaged, immediately remove the device from service and contact the manufacturer.
If a problem or fault is detected that does not correspond to the above, please contact Spencer Italia srl customer care service.
12. ACCESSORIES
There are no accessories for these devices.
13. SPARE PARTS
There are no spare parts available for these devices.
14. DISPOSAL
When devices and their accessories are no longer suitable for use, they can be disposed of as normal municipal solid waste if they have not been contaminated by special
agents. Otherwise, follow the regulations in force regarding disposal.
Warning
The information contained in this document is subject to change without notice and is to be intended as a commitment by Spencer Italia S.r.l. subject to change. Spencer
products are exported to many countries where the same rules do not always apply. For this reason, there may be differences between what is described herein and the
products delivered. Images are included as examples and may vary slightly from the actual device.
Spencer is constantly working on improving all types and models of the products sold. We therefore rely on your understanding if we should reserve the right to make
changes to the scope of delivery at any time in terms of form, equipment, set-up and technology. Spencer Italia S.r.l. assumes no responsibility for any errors contained herein
or for any damages, accidents or consequential damages related to the supply, performance or use of this manual.
© Copyright Spencer Italia S.r.l.
All rights reserved. No part of the document may be photocopied, reproduced or translated into another language without prior written consent from Spencer Italia S.r.l.

spencer.it | support.spencer.it - e-mail: [e-mail] | service: [e-mail]
Ph./Tel. [phone]
Quality System EN ISO 9001 – EN ISO 13485
Prima emissione: 22/03/2021
Rev. 1 22/03/2021
Codice CCI5286
First issue: 22/03/2021
Rev. 1 22/03/2021
Code CCI5286
Erstausgabe: 22/03/2021
Überarb. 1: 22/03/2021
Code CCI5286
Première émission: 22/03/2021
Rév. 1 22/03/2021
Code CCI5286
Primera emisión: 22/03/2021
Rev. 1 22/03/2021
Código CCI5286
Primeira emissão: 22/03/2021
Rev. 1 22/03/2021
Código CCI5286