SPENCER RD-02030 Spider Straps System for Spine Board User Manual

Use and Maintenance Manual FULL BODY RESTRAINT BELT
SPENCER ITALIA SRL
43038 Sala Baganza (PR) – Italy

MODELS

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

• T-Straps
• Pin Straps
• Reflex Straps
• ECS Straps
• Rock Straps
• RSP Straps

INTENDED USE

2.1 INTENDED USE AND CLINICAL BENEFITS
Full body restraint belts are aids used to immobilise patients on Spencer spine boards.
2.2 TARGET PATIENTS
There are no particular indications related to the patient group.
The design of the product allows it to be used with any person within the dimensions of the device. If paediatric subjects must be transported, it will be in the role of the rescuer to determine whether the belt systems are suitable for immobilization or if it will be necessary to use another device.
2.3 PATIENT SELECTION CRITERIA
The expected patient selection criteria are those applicable to the device with which the belt is used.
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 and experts in patient handling, immobilisation and transport.
These devices are not intended for lay people.
Full body restraint belts are devices intended for professional use only. Do not allow untrained persons to help while using the product, as they may cause injury to themselves or others.
Despite all efforts, laboratory tests, trials, and instructions for use, standards do not always reproduce practice, so the results obtained under actual conditions of product use in the natural environment may sometimes differ significantly.
The best instructions are the continuous practice of use under the supervision of competent and trained personnel.
Operators using the device should be physically able to use the device and have good muscle coordination. Operators’ ability must be assessed before the definition of roles in use of the stretcher.
Operators must be able to provide the necessary patient care.
2.5.1 USER TRAINING

• Regardless of your level of experience with similar devices in the past, you should carefully read and understand the contents of this manual before installing, operating, or servicing this product. In case of any questions, please contact Spencer Italia S.r.l. for the necessary clarifications.
• The product must be used only by personnel trained in the use of this product and not on other similar products.
• The suitability of the users for use of this product can be attested by the training registration, in which trained persons, trainers, date and place are specified. This documentation must be kept for at least 10 years after the end of the  product’s life and must be made available to the competent authorities  and/or the Manufacturer when requested. In the absence of such documentation, the relevant bodies will apply any foreseen sanctions.
• Do not allow untrained persons to help while using the product, as they may cause injury to themselves or others.
  Note: Spencer Italia S.r.l. is always available for training courses.

2.5.2 INSTALLER TRAINING
Installation is not required.

REFERENCE STANDARDS

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.

INTRODUCTION

4.1 USING THE MANUAL
The purpose of this manual is to provide healthcare professionals with the information necessary for safe and appropriate use and maintenance of the device.
Note: The Manual is an integral part of the device and therefore it 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 products User Manuals can be downloaded from the site http://support.spencer.it or by contacting the Manufacturer. Exceptions are those items whose essentiality 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 carefully read and understand the contents of this manual 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, serial number (SN) or lot number (LOT). This 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.
If the assigned Lot/SN cannot be traced, the device must be reconditioned, provided only under the responsibility of the manufacturer.
EU Regulation 2017/754 requires manufacturers and distributors of medical devices to keep track of their location. If the device is in a location other than the address to which it was shipped or sold, or if it was donated, lost, stolen, exported or destroyed, permanently removed from use, or if the device was not delivered directly from Spencer Italia S.r.l., please register the device at http://service.spencer.it, or inform Customer Service (see § 4.4).

4.3 SYMBOLS

directly related to serious injury or death.
**| See
` LOT| Lot number REF**`| Product code
| Caution: Federal law restricts the sale of this device by or on the order of a licensed professional (US market only)

Production identification
Alphanumeric code that identifies the production units of the device, composed of:

| (01)805771123| company
---|---|---
0| progressive GS1
6| control number
(11)200626| date
(10)1234567890| lot

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 information regarding correct interpretation of the instructions for use, maintenance, installation or return, please contact Spencer Customer Service tel. +39 0521 541154, fax +39 0521 541222, e-mail [email protected].
To facilitate service, always indicate the lot number (LOT) or serial number (SN) on the label attached to the package or device itself.
Warranty and service conditions are available at http://support.spencer.it.
Note: Record and keep with these instructions: lot (LOT) or serial number (SN), if present, place and date of purchase, date of first use, date of checks, user name and comments.

WARNINGS/DANGERS

** Warnings, dangers, notes, and other important safety information are provided in this section and are clearly visible throughout the manual.
At least every 6 months, it is important to check for updated instructions and any changes involving your product. This information is freely available on the website www.spencer.it on the specific product page.
Product features
Use of the product for any purpose other than that described in the User Manual is prohibited.
Before each use, always check the conditions of the product, as specified in the User Manual. In the event of faults/damage that could compromise its functionality/safety, immediately remove it from service and contact the Manufacturer.
** The product must not be tampered with or modified without the manufacturer’s authorisation (modification, tweaking, additions, repair), as they may constitute imminent danger of injury to persons and material damage. Should these operations be performed, we decline any responsibility for incorrect operation or any damage caused by the product itself; moreover, the CE marking and the product warranty shall be null and void Be sure to take every precaution to avoid hazards from contact with blood or body secretions, if applicable.

• 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.
• When using the devices, position and adjust them in such a way that they do not hinder operator works or the use of any other equipment.
• Avoid contact with sharp or abrasive objects.
• Operating temperature: from -5°C to + 50°C.

Storage

• The product must not be exposed or come into contact with thermal sources of combustion or flammable agents, but must instead be stored in a dry, cool place, away from light and sun.
• Do not store the product under other more or less heavy materials that may damage the device.
• Store and transport the product with its original packaging, otherwise the warranty shall be invalidated.
• Storage temperature: -10°C to +60°C.

Regulatory requirements
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.

• Promptly and in detail notify Spencer Italia S.r.l. (already in the quotation request phase) about possible fulfilments by the Manufacturer necessary for the compliance of products with specific legal requirements of the territory (including those deriving from regulations and/or regulatory provisions of another nature).
• Act with due care and diligence to help ensure compliance with the general safety requirements of the devices placed on the market, providing end-users with all the information necessary to carry out periodic revisions on the supplied devices, exactly as indicated in the User Manual.
• 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.
• Without prejudice to the above, the Distributor or End-User shall assume wider liability related to non-compliance with non-fulfilment of the above-mentioned obligations, with consequent obligation to indemnify and/or hold Spencer Italia S.r.l. harmless from any possible injurious effect.
• 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.

General warnings for medical devices
The user must carefully read the following in addition to the general warnings.

• It is not foreseen that application of the device lasts longer than the time required for first aid operations and subsequent transport to the nearest rescue point.
  **** 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

• Qualified personnel and at least two operators must be present during use of the device.

• Follow the internal procedures and protocols approved by your organisation.

• Disinfection operations must be carried out in accordance with the validated cycle parameters, as stated in the specific technical standards.

• Do not use drying machines to dry the device.

• In case of exposed and/or injured skin, cover the surfaces in contact with the patient with a surgical sheet that respects bio-compatibility regulations to protect the patient’s health.

SPECIFIC WARNINGS

To use the full body restraint belts, you must also have read, understood and carefully follow all the instructions in the user manual.

• Always comply with the positioning specifications defined by the device with which the belts are used. In addition, the operator should assess whether the overall size of the patient reduces the functionality of the product.

• Always apply the number of belts provided by the transport equipment in use.

• Establish a maintenance program and periodic checks, identifying a designated reference person. The person entrusted with routine maintenance of the device must ensure the basic requirements envisaged by the manufacturer within these operating instructions.

• All maintenance activities must be recorded and documented with the relevant technical operation reports. This documentation must be kept for at least 10 years after the end of the device’s life and must be made available to the competent authorities and/or the manufacturer when requested.
  **** Perform rescue simulations with the belts applied to the product with which it is intended to be used and a patient simulating load and accessories before putting the device into service.
  Before each use, always check the conditions of the device and its components, as specified in the user manual. In case of faults or damage that may compromise the functionality and safety of the device, and therefore the patient and the operator, remove the device from service.
  Follow approved Emergency Medical Service procedures for patient positioning and transportation.

• Avoid contact with sharp objects.

• Follow approved Emergency Medical Service procedures for patient immobilization and transportation.

• To preserve the life of the device, protect it as much as possible from UV rays and adverse weather conditions.

• Make sure that the buckles are properly anchored to the strap and that they are intact and functional.

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

Note: Spencer Italia S.r.l. reserves the right to make changes to specifications without notice.

DESCRIPTION

1. Spring catches for Pins (if present)
2. Transversal belts with strap
3. Longitudinal belt
4. V-belts

| ROCK STRAPS| T-STRAPS| REFLEX STRAPS| PIN STRAPS| ECS STRAPS| RSP STRAPS
---|---|---|---|---|---|---
No. Belts| 10| 10| 10| 10| 12| 10
Fastening type| Strap| Strap| Strap| Straw-metal spring
catches| Strap| Strap
Material| Polypropylene/Nylon| Polypropylene/Nylon| Polypropylene/Nylon| Polypropylene/Nylon/
Metal alloy| Polypropylene/Nylon| Polypropylene/Nylon
Weight| 600g| 8008| 60%| 15008| 800g| 350g

COMMISSIONING

For first use, check that:

• Packaging is intact and has protected the device during transportation
• Check that all parts included in the packing list are present
• General functionality of the device
• Product cleanliness
• Absence of cuts, holes, tears or abrasions on the entire structure
• Conditions of wear of the device.
• Check that the belts slide correctly,
• Check that the spring catches are working correctly, if present on the model.
• Check the correct adhesion of the strap inserts.
  See paragraph 11 for how to carry out the above-mentioned checks.

Do not modify the device or its parts for any reason as this could cause damage to the patient and/or rescuers.
**** Failure to take the above measures will preclude safe use of the device, resulting in risk of damage to the patient, operators and the device itself.
For subsequent use, perform the operations specified in paragraph 12.
If the above conditions are met, the device may be considered ready for use; otherwise, you must immediately remove the device from service and contact the Manufacturer.

OPERATING CHARACTERISTICS

See paragraph 11 – Proper use for operating characteristics.

PROPER USE

Primary medical evaluations must be carried out before intervening on the patient. Before using any type of belt described in this manual, carefully read the operating instructions of the device with which it is intended to be used.
11.1 APPLYING THE BELTS
Follow approved Emergency Medical Service reference procedures for patient immobilization, positioning and transport.
The following procedures are based on general usage information.

1. The patient is placed on a spine board with a cervical collar.

2. While maintaining adequate immobilization, place the belt on the patient, arranging the V-belts about 2/3 cm below the cervical collar.

3. Position the other transversal belts as follows:
   • The thorax strap at chest height just below the shoulders
   • The pelvic strap at the height of the iliac crests
   • The first leg strap on the femur, close to the knee
   • The second leg strap on the tibiae, close to the ankles (if the patient is short, roll up the straps)
   Always be extremely careful with any areas that may have suffered trauma and/or fractures.

4. Apply head restraints and/or ankle restraints if necessary.

5. Starting from the shoulders towards the feet, insert the straps into the corresponding holes on both sides of the spine at the same time, if necessary using the spring catches, which must be hooked onto the pins of the spine board.

6. Fasten the straps by applying equal traction on both sides, from the shoulders towards the feet, paying attention to any respiratory and abdominal problems;

7. Make sure that the patient is adequately immobilized, then continue the manoeuvres according to the guidelines of the relevant Emergency medical service.
   The RSP paediatric belt, intended for use with the Baby Go spine board, is equipped with a tape measure with coloured areas which allow quicker identification of which side is most likely to be appropriate for the patient in relation to their height. The rescuer is however solely responsible for the choice of device and its correct application.

CLEANING AND MAINTENANCE

Spencer Italia S.r.l. declines all responsibility for any direct or indirect damage which is the consequence of improper use of the product and spare parts and/or in any case of any repair carried out by a person other than the Manufacturer, who uses internal and external technicians authorised to do so; moreover, doing so will invalidate the warranty.

• The operator must wear suitable personal protective equipment, such as gloves, goggles, etc. during all checking, maintenance and cleaning operations.
• Establish a maintenance schedule, periodic inspections and extend the average life span, if foreseen by the Manufacturer in the User Manual, identifying a reference person who meets the basic requirements set forth in the User Manual.
• The frequency of inspections is determined by factors such as legal requirements, type of use, frequency of use, and environmental conditions during use and storage.
• Repairs of products manufactured by Spencer Italia S.r.l. must be carried out by the Manufacturer, who shall make use of specialised internal or external technicians who, using original spare parts, shall provide quality repair service   in strict compliance with the technical specifications indicated by the Manufacturer. Spencer Italia S.r.l. declines any responsibility for any direct or indirect damage which is a consequence of improper use of spare parts and/or any repair work carried out by unauthorised parties.
• Reconditioning, a process performed on the device to restore the technical and functional safety of the device used, for example re-registration, must be performed by the Manufacturer.
• All maintenance and overhaul activities must be recorded and documented with the relevant technical operation reports. This documentation must be kept for at least 10 years after the end of the product’s life and must be made available to the competent authorities and/or the Manufacturer when requested.
• Cleaning, provided for reusable products, must be carried out in accordance with the Manufacturer’s instructions in the User Manual in order to avoid the risk of cross-infection due to the presence of body fluids and/or residues.

12.1 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.
Any metal parts exposed to external agents undergo surface treatments and/or coating in order to obtain better resistance. 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 soap, which may deteriorate or compromise conditions and durability. Avoid using high pressure water. Let dry completely 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 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.
In the case of disposable products, no cleaning is required except that the product be properly stored and packaged according to the manufacturer’s specifications.
12.2 ROUTINE MAINTENANCE
You must establish a program for periodic checks, identifying a designated reference person. The person entrusted with device maintenance must ensure the basic requirements envisaged within this user manual.
All maintenance activities must be recorded and documented with the relevant technical intervention reports. This documentation must be kept for at least 10 years after the end of the device’s life and must be made available to the competent authorities and/or the Manufacturer when requested.
The operator must wear suitable personal protective equipment, such as gloves, goggles, etc. during all checking, maintenance and cleaning operations.
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 5 Warnings and 6 Specific Warnings.
• Fulfilment of the requirements of the manual in section 11 Proper use

Use only original or Spencer Italia S.r.l. approved components/replacement parts and/or accessories to carry out any operation without causing alterations or modifications to the device. Otherwise, we decline all responsibility regarding incorrect operation or any damage caused by the device to the patient or the operator, invalidating the warranty and invalidating compliance with EU Regulation 2017/745.
12.3 PERIODIC OVERHAUL
No periodic overhaul is foreseen for the device.
12.4 SPECIAL MAINTENANCE
Special maintenance can only be carried out by the Manufacturer, who uses internal and external technicians specialised and authorised by the Manufacturer itself.
Only maintenance activities carried out by specialised technicians authorised by the Manufacturer are considered valid by Spencer Italia S.r.l.
12.5 LIFE SPAN
The device, if used as described in the following instructions, has a life span of 5 years from the date of purchase.
Spencer Italia S.r.l. will accept no responsibility for incorrect operation or damage caused by the use of devices that have exceeded the maximum allowable life span.

TROUBLESHOOTING TABLE

nothing is interfering with the opening. If everything is clean and theproblem has not been solved, immediately remove the device from service andcontact the manufacturer.
The belt does not close.| Strap areas dirty or detached.| Clean the strap areas and check for proper adhesion.
If the problem persists, 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.

ACCESSORIES

There are no accessories for these devices.

SPARE PARTS

There are no spare parts available for these devices.

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.
The images are included as examples and may vary slightly from the actual device.
© 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: [email protected]
service: [email protected]
Ph./Tel. +39.0521.541111
Quality System EN ISO 9001 – EN ISO 13485

References

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

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