SPENCER CONTOUR HP Head Restraints and Ankle Restraints User Manual

Use and Maintenance Manual
HEAD RESTRAINTS AND ANKLE RESTRAINTS
SPENCER ITALIA SRL
SPENCER ITALIA SRL – Via Provinciale n° 12
43038 Sala Baganza (PR) – Italy

MODELS

The following basic models may be subject to implementation or change without notice.

INTENDED USE

2.1 INTENDED USE AND CLINICAL BENEFITS
Head and ankle restraints are accessories for spine boards or pick-up stretchers, to be used to increase the degree of patient immobilisation.
2.2 TARGET PATIENTS
There are no particular indications related to the patient group.
The target patients are those for whom use of a spine board or pick-up stretcher is foreseen.
2.3 PATIENT SELECTION CRITERIA
The patients expected are those for whom use of a spine board or pick-up stretcher is foreseen.
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 rescue workers with in-depth knowledge related to the immobilisation and handling of individuals with suspected spinal trauma or who require immobilisation. The user must be able to evaluate the most suitable type of device for use on the specific patient.
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.

REFERENCE STANDARDS

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).
4.2 SYMBOLS

directly related to serious injury or death.
| See the user manual
| Lot number
| Product code
| Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner (only for USA Market)

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. +39 0521 541154, fax +39 0521 541222, e-mail service@spencer.it
Warranty and service conditions are available on the website http://support.spencer.it

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 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.

SPECIFIC WARNINGS

To use the head and ankle restraints, you must also have read, understood and carefully follow all the instructions in the user manual.

• Perform immobilisation simulations with dummies before putting the device into service.

• Improper use may result in injury or permanent disability. Always follow the procedures and protocols approved by the relevant Emergency Medical Service.

• These instructions provide information on the functionality and application of the device and do not address patient positioning procedures, for which it is advisable to always follow the guidelines of the relevant emergency medical service.

• 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 The device must only be used by trained personnel.

• Qualified personnel must be present during use of the device.

• At least two rescuers must be present for correct application of the device.

• Operators must be able to assess the patient’s injuries and decide whether the use of the device is appropriate.

• Before using the head or ankle restraints, assess the need for their application according to the clinical condition of the patient and make sure that the most suitable type of device is used.

• Operators must be able to assess the most suitable type of head restraint for use, taking into account the type of patient and the characteristics of the injuries.

• The device must not be exposed, much less come into contact with thermal sources of combustion or flammable agents.

• Always check the conditions of all parts before use.

7. RESIDUAL RISK

No residual risks, or rather risks that could arise despite compliance with all warnings in this user manual, have been identified.

TECHNICAL DATA AND COMPONENTS

Cushions: Made of polyurethane foam, they immobilise the patient’s head from lateral movement.
Base: Made of padded PVC, or rigid polyethylene for the HP versions, it is used for anchoring to the primary immobilisation device (e.g. spine board or pick-up stretcher). It is equipped with strap inserts for the application of cushions.
Ankle restraints: Made of rigid polyethylene, it is equipped with straps for application to the spine board as well as for fixing the ankles.

PROPER USE

Operators performing immobilisation must be able to select the most suitable type of head restraint.
Regardless of the type of head restraint used, make sure that there are no conditions that are not compatible with use of this device (i.e. penetrating bodies).
9.1 APPLYING THE HEAD RESTRAINT BASE TO THE SPINE BOARD

The cushions can be applied after making sure that the base is properly secured, placing them on the base and having the straps adhere..
Pedi Go is not equipped with a base and therefore cushions must be applied directly on the Baby Go spine board at the strap areas.
Once the patient is positioned according to the protocols approved by your emergency medical service, attach the cushions with the chin and forehead straps provided with the headband.
If the device is to be used with paediatric patients on the Tango Fix, the paediatric cushions can be removed from the adult cushions, then applied as described above.

9.2 APPLYING THE SUPER SX HEAD RESTRAINT

• Carefully clean the surface of the pick-up stretcher so that no dust or oily residues are present.
• Apply the strap adhesive elements in the head rest area where the head restraint is to be applied.
• Cushions can be applied during patient positioning manoeuvres by placing them in the dedicated strap areas and attaching them to the patient by means of the chin and forehead straps.

9.3 APPLYING THE ANKLE RESTRAINTS

• After positioning the patient on the board, insert the device below the ankles so that the logo representing the feet is visible to the operator.
• Wrap the ankles with the straps, pass them through the eyelets on either side of the device and, after wrapping them around the handles, close them on themselves by adhering the strap inserts.

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.
Clean the exposed parts with water and delicate soap. Never use solvents or stain removers.
Rinse thoroughly with lukewarm water, making sure you have removed all traces of detergent, which may deteriorate or compromise conditions and durability. The use of high-pressure water should be avoided.
Allow to dry thoroughly before storing. Drying after washing or after use in a wet environment must be natural and not forced. Do not use flames or other direct heat sources. If blood is visible, oxidise it before washing with water.
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 5 years from the date of purchase.

TROUBLESHOOTING TABLE

from the straps.
Excessive device mobility| The base is excessively mobile with respect to the
spinal board to which it is attached| Tighten the fixing straps around the spine board
The device has tears or other damaged parts| Misuse or normal wear and tear| Put the device out of service immediately and replace
it with a similar one

ACCESSORIES

There are no accessories present.

SPARE PARTS

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.
© 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.

Prima emissione: 28/04/2021
Rev. 1 28/04/2021
Codice CCI5155
spencer.it | support.spencer.it – e-mail: info@spencer.it | service: service@spencer.it
Ph./Tel. +39.0521.541111
Quality System EN ISO 9001 – EN ISO 13485

References

• Attrezzature per emergenza e primo soccorso | Barelle | Spencer
• Spencer. 360° Emergency Solutions

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