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INSTRUCTION MANUAL
WARNING: READ ALL INFORMATION CONTAINED IN THE TWO INSTRUCTIONS: GENERAL
AND SPECIFIC.
SPECIFIC INSTRUCTIONS
Before using the rescue stretchers, you must read carefully and understand the safety
information described on general instructions and the specific equipment instructions. The User
Manual is 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. ATTENTION!!! If you have any doubt
about the product, if you need other language version of the instructions for use, declarations of
conformity or any question about the product, please contact us: www.fallsafe-online.com.
WARNING: The manufacturer and the seller decline any responsibility in case of incorrect use,
improper application or modifications/ reparations by persons not authorized by FALL SAFE®,
invalidating the warranty and invalidating compliance with EU Regulation 2017/745. MODELS:
FS34108 – FLADDERMUS | RESCUE STRETCHER and FS34109 – BO | IMMOBILIZER VEST
WITH INTEGRATED RESCUE HARNESS (these models may be subject to implementation or
change without notice). INTENDED USE AND CLINICAL BENEFITS: Rescue stretches are
devices intended to be used when the morphological characteristics of the intervention area
require particularly compact equipment and adherence to the patient. FLADDERMUS and BO
can also be lifted with the aid of hoisting systems fixed to the ground, using the integrated
harness with the immobilizer vest. Patient intervention in the devices is not planned. PATIENTS:
There are no particular indications related to the patient group. The product configuration is able
to accommodate any subject as long as she/he is within the maximum capacity and within the
limits of the size of the device. Expected patients are those who have injuries that prevent them
from walking or are in an unconscious state, in a given rescue situation. CONTRAINDICATIONS,
RISKS AND UNWANTED SIDE EFFECTS: No particular contraindications, residual risks or side
effects are known with relation to the use of the device, as long as it is used in accordance with
the users manual. USERS ANS INSTALLERS: Please read section 1 – PHYSICAL CONDITIO-
NING AND TRAINING from GENERAL INSTRUCTIONS. The intended users are rescue teams,
carrying out operations related to the use of harnessing systems: 1 - Personnel trained for use of
the device must also have training in managing lifting and handling suspended loads with people.
2 - Personnel who carry out interventions in situations classified as high risk or which are purely
technical must be suitably trained and experienced in rescue. These devices are not intended for
lay people. Do not allow untrained persons to help while using the product, as they may cause
injury to themselves or others. 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. FALL
SAFE® is always available for training. INSTALLATION: Installation is not required.
STANDARDS: UE Regulation 2017/745 (UE Regulation on medical devices) As Distributor or
End-User of the products manufactured and/or marketed by FALL SAFE®, 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. 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 competent
authority of the Member State, within the terms and in the manner established by one or more
ministerial decrees, and notify the Manufacturer. MARKING AND TRACEABILITY: Each device
is provided with a label, placed on the device itself, which contains the Manufacturer's identifica-
tion data, product information, CE marking and serial number (SN). This must never be removed
or covered, or else the warranty will be void as the device can no longer be traced. If the assigned
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 FALL SAFE® please contact
us or use FALL SAFE INSPECTOR®. WARNINGS: Use of the product for any purpose other
than that described in the User Manual is prohibited. When using the devices, avoid contact with
sharp or abrasive objects. The application of the device should not last longer than the time
required for first aid operations and subsequent transport to the nearest rescue point. 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. Always comply with the
maximum capacity indicated in the User Manual. When determining the total weight load on the
product, the operator should consider the weight of the patient, equipment and accessories. In
addition, the operator should assess whether the overall size of the patient reduces the
functionality of the product. Use only original or FALL SAFE® approved components/replace-
ment parts and/or accessories to carry out any operation without causing alterations or modifica-
tions to the device. Before lifting, make sure that operators have a secure grip on the device. The
device is a patient transport stretcher and cannot be used as a stationing device. For patient
loading techniques for particularly heavy patients, for operations on steep terrain or in special
and unusual circumstances, the presence of more operators is recommended in addition to the
minimum foreseen operators. Always immobilize the patient. A failure to do so can cause serious
damage to the patient. Do not move the stretcher if the weight is not properly distributed. Pay the
utmost attention to any obstacles (water, ice, debris, etc.) present on the route, as they may
cause the operator to lose balance and compromise proper functioning of the device. Dragging
the stretcher on any type of surface leads to premature deterioration of the stretcher, which
reduces its useful life and initial safety conditions. To preserve the life of the device, protect it as
much as possible from UV rays and adverse weather conditions. Rescue stretchers are not
approved for use with aircraft. BEFORE USE: Before each use, always check the conditions of
the product, as specified in section 2 – BEFORE USE from "GENERAL INSTRUCTIONS". For
first use, please check: if the packaging is intact and has protected the device during transporta-
tion; if all parts included in the packing list are present; general functionality of the device; product
cleanliness; if there are no cuts, holes, lacerations or abrasions on the entire structure of the
device and its parts (including detachable parts); correct fixing and holding of strap and ropes
and the conditions of wear of the device and its standard parts. If the above conditions are met,
the device may be considered ready for use. Non-compliant devices must be taken out of
service. OPERATION: Before moving the patient, a medical evaluation of the patient's condition
must be performed to stabilize the patient's clinical condition, verify possible surrounding
hazardous situations, assess how to move the patient and whether it may be necessary to use
alternative devices. Remove the device from the bag. Unlock all the straps and unroll the
stretcher completely, while holding one end of it firmly on the ground with one foot. Then roll up
the upper half of the stretcher in the opposite direction to that in which it was taken out of the bag,
in order to eliminate the "memory" effect of the material. Carry out the same operation on the
opposite side in order to make the stretcher perfectly flat. Place the stretcher on the ground. You
can load the patient in two ways. Place the device next to the patient. Make sure that the side of
the device on which the patient's head is to be placed is adjacent to the head itself. Position the
transverse straps under the stretcher. Roll the patient to one side and slide the device as far as
possible under the patient. Gently lay the patient on the device. Or fold the foot end of the
stretcher to form a kind of ramp and place the belts under or to the side of the stretcher. Using
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SPECIFIC INSTRUCTIONS
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forearms to stabilize the head, grasp the patient in the underarm area, and then pull the patient
onto the stretcher until the stretcher is in the proper position for anchoring. Make sure that you
have correctly centred the patient in relation to the stretcher. Adjust all the harness straps around
the patient's body and wrap her/him around the immobilizer vest. Raise the sides of the stretcher
and fasten the straps, wrapping the stretcher around the patient. Do not cross the straps. Adjust
the feet straps (highlighted in green) around the patient foot to prevent she/he from sliding. If only
using BO, lift the patient by the D-ring with the A marking located at the chest (A). If only using
FLADDERMUS, use the O-rings located at the sides of the stretcher; we recommend attaching
FS806 to each side upper O-rings (O1) and to the anchor plate and attaching two anchor slings
(FS800) to each side lower O-rings (O2), connecting FS910 to the slings and to the anchor plate,
to facilitate changing the angle of the rescue stretcher; you can use the middle O-rings for extra
anchor points. If using both, BO must be fixed to FLADDERMUS by the fix locks and by the rope
loops (P2), then lift the patient by the rescue stretchers anchor points. The loops marked as P1
serve as a backup in the event of any anchor point becoming badly connected or failing.
Transport by hand can only be performed if the patient is correctly positioned and all
requirements specified in this user manual are met. Transporting the stretcher requires a
minimum of 4 operators. A greater number of operators is necessary in the case of transport for
long and/or difficult journeys. The handles are located on the sides of the rescue stretcher,
attached to the straps (highlighted in orange). If it is not possible to transport the stretcher by
hand, but ropes, winches, ladders, lifting straps or other suitable means are used, this is
considered high risk rescue and must be carried out only by personnel adequately trained in this
area and with the necessary experience on the field. MAINTENANCE, CLEANING AND
INSPECTION: Please read "GENERAL INSTRUCTIONS. Checks must be made before and
after use and regularly to verify: general functionality of the device, cleanliness of the device,
holding and conditions of all straps and buckles, conditions of grommets, conditions of the rope
knots and fulfilment of the requirements of 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. 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. Be sure to take all
precautions to ensure that there is no risk of cross-infection or contamination of patients and
operators. STORAGE: After carrying out cleaning and maintenance, lay out the rescue stretcher
and place the straps facing inward; starting at the head end, roll up the stretcher as tightly as
possible; continue rolling up the device, using your knees to prevent it from rolling out; fasten the
straps to the metal buckles and place the device in its bag. For the immobilizer vest, fold down
the sides and insert the device into its bag. Check section 8 – STORAGE/TRANSPORT from
"GENERAL INSTRUCTIONS". WARRANTY AND DISPOSAL: Please read "GENERAL
INSTRUCTIONS. ACCESSORIES AND SPARE PARTS: The accessories of these products
consist of FS800 - ANCHOR SLING, FS806 - RESCUE Y-PAD and FS910 - EVACUATION KIT.
We recommend the use of FS806 to avoid squeezing the victim when lifting her/him. FS910 is
recommended for a faster and more versatile use of the rescue stretcher. This device has an
adjustment mechanism that allows the rescue stretcher to be tilted to any desired angle. The
connectors to be used can be selected considering the customer's needs and field of application.
Spare parts can be supplied by the manufacturer.
ATTENTION: ALSO READ THE MANUAL USER FOR FS236.01 and FS910.
ADDITIONAL INFORMATION
AI1 - Acceptable Temperature; AI2 - Storage; AI3 - Annual Inspection; AI4 - Cleaning; AI5 -
Drying; AI6 - Hazards; AI7 - Risk of death; AI8 - Attention; AI9 - Right; AI10 - Wrong; AI11 -
Check.
MARKING/ LABLES
ML(A) - Serial Number; ML(B) - Reference number; ML(C) - Standard; ML(D) - Manufacture date;
ML(E) - Brand name; ML(F) - Notified boby which carries out product quality management; ML(G)
- Instruction; ML(H) - QR code; ML(I) - CE Marking - complies with regulation (EU); ML(J) - Size;
ML(K) - Maximum load; ML(L) - Fit icons.
EQUIPMENT RECORD
1-Product; 2-Reference Number; 3-Serial Number; 4-Manufacturing Date; 5-Purchase Date;
6-Date of first use; 7-Other relevant information; 8-Date; 9-Reason for entry; 10-Defects,Repair-
s,Etc; 11-Name & Signature; 12-Next periodic examination
NOMENCLATURE/FIELD OF APPLICATION
NFA1- Polyester Webbing - 45mm with Velcro straps®; NFA2- Polyester + Polyvinyl chloride -
Textile; NFA3- EN1497 - Aluminium D-ring; NFA4- Polyester Webbing - 45mm; NFA5- IZY buckle
- Aluminium; NFA6- EN361 - Aluminium D-ring; NFA7- Steel alloy "O" ring for webbing
adjustment; NFA8- Plastic webbing keppers; NFA9- Polyester heavy duty seams; NFA10-
Stainless Steel eyelet; NFA11- Static rope - Ø 9mm | Core: polyamide/ Cover: polyester; NFA12-
Aluminium "O" ring for lift points; NFA13- Handle points - polyester webbing 45mm; NFA14-
Stretcher body - High-density polyethylene; NFA15- Victim feet positioning - polyester webbing
45mm; NFA16- Polyester Webbing - 30mm; NFA17- Botton rope loop - Static rope (11); NFA18-
Steel alloy buckle - 3 bars; NFA19- Elastic webbing keppers; NFA20- Upper rope loop - Static
rope (11).
P1/ P2 - See "SPECIFIC INSTRUCTIONS"
DONNING AND SETUP
FS34108
DS(1) - Buckle locations; DS(O) - Anchor points;
FS34109
DS(1) - Buckle locations; DS(A) - Anchor points; DS(P1) - Backup points; DS(P2) - FS34109
backup points and connection between FS34108 and FS34109
(CS)
NÁVOD K POUŽITÍ
VAROVÁNÍ: PŘEČTĚTE SI VŠECHNY INFORMACE OBSAŽENÉ VE DVOU POKYNECH:
OBECNÉ A SPECIFICKÉ.
KONKRÉTNÍ POKYNY
Před použitím záchranných nosítek si musíte pozorně přečíst a porozumět bezpečnostním
informacím popsaným ve všeobecných pokynech a specifických pokynech k vybavení.
Uživatelská příručka je nedílnou součástí zařízení, a proto musí být uchovávána po celou dobu
životnosti zařízení a musí být doprovázena při jakýchkoli změnách použití nebo vlastnictví.
POZORNOST!!! Máte-li jakékoli pochybnosti o produktu, potřebujete-li jinou jazykovou verzi
návodu k použití, prohlášení o shodě nebo jakékoli dotazy k produktu, kontaktujte nás: www.fall-
safe-online.com. VAROVÁNÍ: Výrobce a prodejce odmítají jakoukoli odpovědnost v případě
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