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  9. Spencer CROSS UP 8409 User manual

Spencer CROSS UP 8409 User manual

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User’s Manual
Cross Up 8409
Self loading Trolley
This appliance conforms with the Directive 93/4 /CEE “Medical Devices”
Guarantee of Quality system for the production and the final control of the products certified by
the notifying body TÜV SÜD Product Service GmbH
INDEX
General information pag.
Warnings pag.
Description of product pag. 4
Operating instructions pag. 6
Maintenance and cleaning pag. 11
Accessories and spare parts pag. 1
First edition : 04/06/13
Rev. 3. 5/09/ 019
Spencer Italia s.r.l.
Tel. +39 0521.541111 / Fax +39 0521.541222 / e-mail: info spencer.it
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Thank you for choosing a Spencer product
. GENERAL INFORMATION
. Aim and contents
The aim of this manual is to supply all the information necessary so that the client will be able to use the appliance correctly
in the most autonomous and secure way possible. The manual includes information regarding technical aspects, functioning,
maintenance, spare parts and safety.
.2 Conservation of the instruction manual
The instruction and maintenance manual must be kept together with the product, for the whole life of the device, inside the
specially provided container and above all, away from any substances or liquids which could compromise perfect legibility.
.3 Symbols used
Symbol Meaning
General or specific warning
See instruction for use
Lot number
Serial number
Product code
The product is compliant with the specifications of the Directive 93/4 /CEE
.4 Servicing request
For any information regarding the use, maintenance and installation, please contact the Spencer Customer Care Service on
tel. 0039 05 1 541111, fax 0039 05 1 541 , e-mail ser[email protected] or write to Spencer Italia S.r.l. – Via Provinciale, 1 -
43038 Sala Baganza (Parma) - ITALY. In order to facilitate the assistance service, please always indicate or communicate the
serial number (SN) or lot number (LOT) shown on the label applied on the box or on the device.
.5 Demolition
When the device is no longer suitable for use and they haven’t been contaminated by any particular agents, they can
be disposed of as normal solid waste, otherwise the current regulations for demolition should be followed.
.6 Labelling
Each device has got an identifying label, positioned on the device itself and/or on the box. This label includes information
about the Manufacturer, the product, CE mark, lot number (LOT) or serial number (SN). It must never be removed or
covered.
2. WARNINGS
2. General warnings
•The product must be used only by personnel trained who have attended specific training for this device and not just for
similar products.
•At least every 6 months, is important to verify if updated User Manuals are available or there is any change involving your
product. This information is freely available on the website http://support.spencer.it in the section “User manuals” and
“Product Updates”.
•Training routines must be registered on a special register in which the names of those trained, of the trainers, date and
locations are indicated. This register which will certify the eligibility of the operators to use the Spencer device has to be
kept for a period of 10 years after the disposal of the device itself. This register will be made available to the Competent
Authorities and/or Manufacturer if requested.
•Spencer Italia S.r.l. is always at your disposal to plan product training.
•Before carrying out any kind of operation on the appliance (training, installation, use), the operator must carefully read
the enclosed instructions, paying particular attention to the correct safety precautions and to the procedures to be
followed for installation and for correct use.
•If the instructions belong to another device and not the device received, the Manufacturer must be informed immediately
and use of the device avoided.
•In the case of any doubts as to the correct interpretation of the instructions, please contact Spencer Italia S.r.l. for any
necessary clarifications.
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•Do not allow untrained persons to help during the use of the device, because they could cause damage to the patient or
to themselves.
•Regularly check the appliance, carry out the prescribed maintenance and respect the average life span, as indicated by
the Manufacturer in this User’s Manual.
•Before each use of device the perfect operating state of the device must be checked as specified in the Instruction
manual. If any damage or abnormalities which could in any way influence the correct functioning and the safety of the
device, of the patient and or of the user are detected, the device must be immediately removed from service and the
Manufacturer must be contacted.
•If any failure or incorrect functioning of the device is detected, it must be immediately substituted with a similar item so
that the rescue procedures are guaranteed without any interruption.
•Use of the device in anyway other than described in this manual is forbidden.
•Do not alter or modify in any way the appliance; any such interference could cause malfunctions and injury to the patient
and/or rescuer.
•The appliance must not in any way be tampered with (modification, adjustment, addition, replacement). In such cases all
responsibility will be denied for any malfunctions or injuries caused by the appliance itself; moreover CE certification and
product warranty will be considered void.
•Those who modify or have modified, prepare or have prepared medical appliances in such a way that they no longer
serve the purpose for which they were intended, or no longer supply the intended service, must satisfy the valid
conditions for the introduction onto the market.
•Handle with care.
•Ensure that all the necessary precautions are taken in order to avoid the hazards that can arise as the result of contact
with blood or body fluids.
•Register and store with these instructions: lot number, place and date of purchase, first date of use, date of checks, name
of users, any comments.
•When the device is being used, the assistance of qualified staff must be guaranteed.
•Do not store the device underneath any heavy objects which could cause structural damage.
•Store in a cool, dry, dark place and do not expose to direct sun.
•Store and transport device in its original packaging.
•The device not be exposed to or come into contact with any source of combustion or inflammable agents.
•Position and adjust the device taking care not to cause any obstruction to rescuers and or any other rescue equipment.
•Attention: laboratory testing, post production tests, instruction manuals cannot always consider every possible scenario
for use. This means that in some cases the performance of the product could be notable different from results to date
obtained. Instructions are continually being updated and are under tight surveillance of fully qualified staffs with
adequate technical formation.
•With reference to the D. Lgs. 4
th
February 1997, n. 46 emended by D. Lgs. 5/01/ 010, n. 37 – Acknowledgement of
Directive 93/4 /CEE and 007/47/CE, we remind both public and private operators that they are obliged to report any
accident that involves any medical device to the Ministry of Health and to the Manufacture as specified and within time
given by the European regulations.
In addition, both public and private operators are obliged to inform the Manufacturer of any measures that should be
adopted to make the steps necessary to guarantee the safety and the health of the patients and the users of any medical
device.
•As a Distributor or End Users of products manufactured and/or marketed by Spencer Italia S.r.l., you are strictly required
to have a basic knowledge of any legal requirements applying to the devices supplied in the goods final destination
Country (including laws and norms regarding technical specifications and / or safety requirements) and therefore you are
also strictly required to have the necessary knowledge to guarantee all aspects regarding the total conformity of the
products to the regulations in the relevant territory.
•Promptly notify Spencer Italia S.r.l. regarding any revisions to be made by Manufacturer in order to guarantee the
conformity of the product to the territory’s legal specifications (including those resulting from rules and/or norms of
other nature).
•Act, with all due care and diligence, and contribute to ensure conformity to general safety requirements of all devices
marketed in the territory, by providing final users with all necessary information for carrying out periodical checks on
their devices, as specified in the relevant User Manual.
•Actively contribute to product safety checks on products sold, by communicating any relevant risk analysis information
both to the Manufacturer and to any competent authorities so that the necessary action can be promptly taken.
•You are aware that in the event of any failure to conform to the above mentioned requirements you will be deemed fully
responsible for all damages that might occur. Therefore we expressly disclaim any responsibility and/or liability for your
non-compliance with the present “Regulatory provisions”.
Special warnings
•Establish a maintenance program and periodic testing and identify the reference person. The person to whom the
ordinary maintenance of the device is entrusted must ensure the basic requirements foreseen by the Manufacturer in the
user’s manual.
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•Training routines must be registered on a special register in which the names of those trained, of the trainers, date and
place are indicated. This register which will certify the eligibility of the operators to use the Spencer device has to be kept
for a period of 10 years after the disposal of the device itself. This register will be made available to the Competent
Authorities and/or Manufacturer if requested.
•Use only accessories/spare parts that are original or approved by Spencer Italia S.r.l., in order to carry out any operation
without causing any alteration or modification to the device, otherwise we assume no responsibility for the proper
functioning or damage resulting from device to the patient or the operator and warranty and will be considered void
according to the compliance to the Medical Device Directive 93/4 /CEE.
•Always respect the maximum capacity of the device, as indicated in this user's manual. Maximum load capacity means
the total weight distributed according to the human anatomy. In determining the load of the total weight on the
product, the operator must consider the weight of the patient, the equipment and the accessories. Moreover, the
operator must consider that the overall dimensions of the patient do not reduce the functionality of the device.
•Never leave the patient unassisted on the device, because he may be injured.
•The device and all its components, after washing, should be allowed to dry completely before storing.
•Lubrication must be carried out after cleaning and complete drying.
•Avoid contact with sharp objects.
•Do not use the device if it is pierced, torn or frayed.
•Make sure, before lifting, that the operators have a firm grip on the device.
•Avoid pulling the device on rough surfaces.
•The device is a trolley for patients transport and cannot be used as a stationing device.
•First practice with an empty trolley in order to get used to the way in which the trolley manoeuvres.
•For the use of the device, at least two operators in suitable physical conditions are needed; they must therefore
have strength, balance, coordination, and common sense and must be trained on the correct functioning of the
device Spencer trolley.
•For techniques for loading particularly heavy patients, for rescue operations on steep ground or in unusual circumstances,
it is recommended the presence of more operators (not just two as required under standard conditions).
•The maximum weight sustained by each rescuer must comply with requirements prescribed by the law of the
Country, concerning Health and Safety at Work.
•Before each use, check the integrity of the belts and their hooks, as specified in the User’s Manual. In case of malfunction
or damage that may compromise the function and safety of the device, patient or operator, it is necessary to replace the
belts.
•Make sure the belts are properly fastened to the frame of the stretcher.
•In order to meet the requirements of the standard UNI EN 1789, use only belts that have as anchor point the frame of the
stretcher.
•To optimize patient’s immobilization, is necessary to use a thorax belt secured to the frame of the stretcher in addition to
the supplied ones.
•Make sure the mattress is properly secured/anchored to the frame /patient board of a trolley.
•Make sure the sheet does not interfere with the footrest and do not prevent the operator from handling of the sidebars.
•Do not operate in case the weight has not been distributed correctly.
•The sidebars may be damaged due to improper use. Keep the sidebars always raised during patient transport.
•Always grasp the structure to lift and carry the trolley and not the sidebars or polyethylene boards.
•Avoid extreme force during the loading procedure of the trolley on the ambulance. Too much force may have negative
effects on the functioning of the trolley.
•Keep the trolley firmly if the patient is sitting.
•Use the trolley only as described in this user's manual.
•Do not alter or modify the trolley arbitrarily to make it fit into the ambulance: the modification may cause unforeseeable
functioning and damages to the patient and operators. In any case the warranty will be lost.
•Pay a lot of attention to possible obstacles (water, ice, debris, etc.) on the route of the trolley, because they could
cause loss of balance for the operator and compromise the proper functioning of the device. If you can not set the path
free from obstacles, choose an alternative path.
•For gradients greater than 10 mm, the device must be raised, taking care to grasp the structure and not from the
banks/platforms.
•Condensation, water, ice and accumulations of dust can affect the correct operation of the device, making
it unpredictable and causing a sudden alteration of the weight that operators have to carry.
•The self-loading trolleys are certified for use with dedicated Spencer fastening systems, it is therefore forbidden the
use of fasteners not approved by the Manufacturer. Fastening systems that have not been approved may alter
the structural and functional characteristics of the trolleys.
•Once positioned the wheels of the loading trolley on the support surface of the ambulance, the wheels of the front
leg must have a distance from the ground of at least 6 cm. Check regularly the loading height of the ambulance; if it is
altered, the trolley must be immediately set up by the Manufacturer or by an authorized centre. Otherwise we assume
no responsibility for the proper functioning or damage caused by the device itself.
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•Improper installation of the loading platform may cause structural damage and consequent injury to the welding of
the front legs.
•Improper installation of the loading platform may cause undesired operation of the device and cause harm to the
patient and to the operator.
•Replace the wheels with original parts, in case of failure to stop the device.
2.3 Contraindications and side effects
The use of this device, if used as described in this manual, does not present any contraindications or collateral effects.
. ZIONE DEL PR
2.4 Physical requirements of the operators
The Cross Up 8409 trolley is designed exclusively for professional use. The rescue operators must have the following
minimum requirements:
•physical capacity for operating the device
•be able to grasp the device firmly with both hands
•have a strong back, arms and legs for lifting, pushing and pulling the trolley
•have good muscular coordination
The operators must be trained in efficient, effective and safe patient transport.
This trolley requires the employment of at least two operators equipped with strength, balance, coordination and common
sense.
Patient loading procedures for extremely heavy patients, operations in rough terrain and in particular situations more
operators may be needed (not only two as in normal conditions).
The capacity of the various operators must be considered before determining his role in the employment of the trolley.
3. DESCRIPTION OF PRODUCT
3. Intended use
Spencer Cross Up 8409 is a self-loading stretcher for the transport of patients which can be used in combination with the
Cross Up 8409 stretcher on road operations and in the emergency vehicle. The legs fold independently during the loading
process when the lever is actioned and they automatically open on unloading using the lever.
No interaction on behalf of the patient is required for the device to function correctly.
3.2 Main components
n° Description of component
1 Rear legs folding lever
Front legs folding lever
3 Rear locking system
4 Wheel 00 mm
5 Brake
6 Opening/closing piston for rear legs
7 Rear legs
8 Opening/closing piston for front legs
9 Front wheels
10 Front legs
11 Handle for adjustable heights selection
1 Loading wheels
14 Fasteners for stretcher Cross Up 8409
15 Release lever front wheels (only Twist version)
16 Release lever stretcher Cross Up 8409
Fig. A
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3.3 Models
This model could be modified, with reference to codes and/or descriptions without any previous notification.
CR00007E TROLLEY CROSS UP 8409
CR00008E TROLLEY CROSS UP 8409 TWIST
CR60003E TROLLEY CROSS UP 8409 CERTIFIED 10G
CR60004E TROLLEY CROSS UP 8409 TWIST CERTIFIED 10G
3.4 Technical data
Characteristics CROSS UP 8409 CROSS UP 8409 TWIST
Width (mm) 570 570
Length (mm) 1970 1970
Weight (kg) 6 8
Load capacity (kg) 50 50
3.5 Reference standards
Reference Title of document
MDD 93/4 /CEE European Directive for Medical Devices
MDD 007/47/CEE
Modifications to 90/385/CEE Directive about active implants, Directive 93/4 /CEE
about medical devices and Directive 98/8/CE about the introduction of biocides
onto the market
Decreto Legislativo 4/0 /1997, n. 46 Application of the 93/4 /CEE Directive regarding Medical Devices
Decreto Legislativo 5/01/ 010, n. 35 Modifications and additions to the 0/0 /97 Decree n. 46
UNI EN 1865-1 Directives for stretchers and other patient transport equipment on ambulances
UNI EN ISO 14971 Application of risks managing to medical devices
UNI CEI EN ISO 15 3-1 Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements
UNI CEI EN 1041 Information supplied by the medical devices manufacturer
CEI EN 6 366 Medical Devices - Application of the utilisation characteristics of engineering to
medical devices
MEDDEV .4/1a-b Guideline for the classification of medical devices
NB-MED .5.1 /Rec 5 Technical Documentation
MEDDEV .7.1 Clinical Data
UNI EN 14155 Clinical evaluation of the medical devices for human beings - Part : Clinical
evaluation plans
UNI EN 1789 Medical vehicles and their equipment
3.6 Environmental conditions
Functioning temperature: from -10 to +50 °C
Storage temperature: from - 0 to +60 °C
4. OPERATING INSTRUCTIONS
4. Transport and storage
Before transporting the appliance, make sure that it is correctly packaged ensuring also that there are no risks of shocks,
bumps or falls during the transport itself.
Keep the original packaging for use in case of any further transport and for storage. Damage to the appliance caused during
transport and handling is not covered by the guarantee. Repairs or replacement of the damaged parts are the responsibility
of the client. The device must be stored in a dry, cool area away from direct sunlight. It must not be placed in contact with
any substances or chemical agents which could cause damage and reduce safety characteristics.
4.2 Preparation
On receipt of the product:
•Remove the packaging and display the material so that all components are visible.
•Check that all the components/pieces on the accompanying list are present.
The appliance must be checked before every use so as to reveal any working abnormalities and/or damage caused by
transport and/or storage. In particular, check:
•General functionality of the device
•Cleanliness of the device (remember that the failure of cleaning may cause the risk of cross infections)
•Absence of cuts, holes, tears on the structure, including the straps
•Correct fixation of all nuts, bolts and screws
•Correct fixation of straps
•Correct fastening of straps
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•State of use (moving parts, wheels, belts)
•Integrity of components
•Lubrication of moving parts
•When taking out for the first time the stretcher from its box, the its legs should bend and lock properly
•Backrest and Trendelenburg work the same way and lock properly
•Sidebars are raised and lowered properly
•State of use of wheels and breaking system
•Functioning of springs
•The stretcher can easily get in the ambulance
•The emergency vehicle is equipped with a fastening system dedicated to the Spencer stretcher
•There are seat belts for the immobilization of the patient and they are intact and functioning
•Welding is intact, no cracks or breaks
•No piping or metal sheet present bends or cracks
•The backrest has no structural damages or fissures
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.
THE MEASUREMENT OF THE LOADING PLATFORM MUST BE TAKEN WITH THE AMBULANCE POSITIONED ON A UNIFORM
AND PERFECTLY HORIZONTAL SURFACE AND WITH TWO OPERATORS SEATED IN THE PATIENT COMPARTMENT
(SIMULATING A LOAD OF APPROXIMATELY 250 KG).
If the vehicle is equipped with pneumatic or hydraulic suspensions, the loading height adjustment must be carried out
taking into account the worsening condition of use and/or the operating one provided by the vehicle builder.
Problems during use and/or safety risks associated with such system, cannot be attributed to the manufacturer.
4.2. Requirements of the emergency vehicle
Spencer trolley Cross Up 8409 has been designed for entering and exiting the patient compartment of an ambulance. The
requirements of the vehicle are:
•levelled loading platform
•sufficiently wide and long platform with no obstacles for the stretcher
The front leg wheels (n° 9 paragraph 3. ), during loading/unloading, when the loading trolley is still on the emergency
vehicle, must be at least 5/6 cm higher than the ground to allow correct and safe opening of the legs of the stretcher.
A lack of the point above may cause unsafe use of the device, with the risk of damage for the patient, the operators or for
the device.
In order to make the loading procedure easier, it is recommended to take away any edges from the border of the loading
platform. The stretcher must be fixed using Spencer fixing systems so any movement of the stretcher is avoided, also in
difficult driving situations. The loading and unloading procedures should be performed with an empty stretcher before
putting the stretcher into regular service.
4.3 Functioning
4.3. Lowering the stretcher
Make sure the side bars are positioned upwards; otherwise
the stretcher may be damaged.
Before lowering the stretcher, reach the place where to make
all the following operations on/with the stretcher.
Lower the stretcher without patient, as follows:
•grab command handles of the Cross Up 8409 trolley at
the rear end “feet”
•lift the rear part “feet” of the stretcher, until the loading
trolley wheels (n° 1 paragraph 3. ) touch the ground
•keeping a firm grasp on the stretcher and ready to
sustain its weight, pull both command handles in order to
close the legs (n° 1 e paragraph 3. )
•lower the stretcher, carrying its weight, until it touches
the ground
Before loading the patient, while the stretcher is on the
ground, make sure the underground is stable and horizontal;
unstable and non-horizontal surfaces may affect the static balance of the stretcher.
4.3.2 Lowering trolley to intermediate height
The Spencer Cross Up 8409 trolley has been conceived in order to be able
to assume different heights, making easier the transfer of a patient from
the stretcher to a bed and back, optimizing the loading procedures with
Fig. B
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elder or handicapped people. This stretcher is able to assume an
intermediate height, apart from the maximum height (completely open)
and the minimum height (completely closed), as described below.
Passage from the standard to the intermediate height
In order to reach the intermediate position, at least two operators and the
complete respect for the following indications are needed:
a) Bring the stretcher as close as possible to the place of operations and
make sure the ground is stable and safe.
b) Lift the stretcher 1 cm in the posterior part (“feet” side) and lift the
green lever (left) upwards. Lower 10 cm the stretcher and then release the
lever until intermediate locking of the posterior leg. Make sure the
stretcher is in a stable position.
c) Pull the blocking lever turning the edge of the lever towards the loading
wheels (n° 11 paragraph 3. ), using the other hand to support the frame
until the stretcher reaches a lower, stable position.
Change from the standard to the intermediate height when the stretcher
is empty (without patient on the patient board)
a) repeat the operations described on steps a) and b).
b) insert the brake (n°5 paragraph 3. ) present on the rear pivoting wheels
in order to stabilize the stretcher.
c) repeat the operation described above on step c) but push in the
intermediate position. Always make sure the stretcher reaches a stable
position.
Change from the intermediate to the standard height
In order to return to the original position of the stretcher:
a) Grab the frame tube at the rear end of the stretcher and pull it upwards
until the first automatic safety block inserts. Always make sure the
stretcher has reached a stable position.
b) Grab with both hands the frame tube on the front end of the stretcher
(loading trolley) and pull upwards until the stretcher reaches a stable
position.
4.3.3 Front wheel rotation lock (Only TWIST models)
The TWIST version is equipped with a mechanism that will block the pivoting of the front wheels which will improve
manoeuvrability of the trolley in difficult conditions.
If it is necessary that the wheels pivot, the lever (n°15 par.3. ) must be turned about 90° towards the outer part. (fig.A). To
return to the locked mode, the lever must be returned to its original position while at the same time the trolley should be
pushed forwards until the wheels return to the neutral position as illustrated in fig. F.
During the unlocking of the wheels and following operations an additional operator is necessary at the front part (head
side), in order to move the device safely.
Fig. C
Fig. D
Fig. E
Fig. F
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4.3.4 Lifting the stretcher with patient
Fix the patient on the stretcher with the dedicated belts.
The capacities of the various operators must be considered when his role in the employment of the stretcher is
determined.
Two operators must be positioned at the sides of the stretcher, but how many operators are needed depends on the weight
each operator can lift and his or her state of fitness. Using an adequate lifting technique, make sure to grab the stretcher
firmly at both ends. Lift the stretcher until the legs, front and rear, are open and completely blocked. Make sure also that the
ground below where the stretcher will unload is safe and stable.
4.3.5 Loading the stretcher onto the ambulance
Make sure the ambulance's doors are blocked correctly in open position, in order to avoid any hindrances. Make sure the
sidebars are blocked in upward position, otherwise the stretcher may be damaged. During the loading operation:
•push the stretcher towards the rear door opening of the ambulance;
•push the stretcher onto the loading platform of the ambulance until the front legs touch the edge of the ambulance
(bumpers and/or platform);
•the operator must make sure both wheels of the loading trolley are placed on the loading platform (safety position) and
contemporarily evacuate the distance between the wheels on the front legs and the terrain (at least 5/6 cm);
•once the front legs touch the ambulance's bumpers, the operator must pull the red handle for unlocking the front legs
(n° paragraph 3. ), without pushing the stretcher;
•once pulled the handle, push the stretcher inside the ambulance, allowing the front legs to fold and close; avoid
extreme bumping of the front legs against the ambulance's bumpers and/or loading platform; legs and related
mechanisms could be damaged;
•insert the stretcher into the ambulance until the rear legs touch the bumpers and/or platform, then lift the stretcher
slightly and pull the green handle (left) unlocking the rear legs (n° 1 paragraph 3. ) and complete the loading procedure
of the stretcher;
•make sure the wheels of the loading trolley move into the dedicated anterior and posterior Spencer fastening systems;
•make sure the stretcher is securely fixed to the Spencer fixing system.
The use of the original Spencer fixation systems is recommended in order to guarantee optimal stability in all directions.
Whenever other fixation systems are used, the safety and correct functionality of the device are not granted.
In case the front and/or rear legs bump violently against the bumpers/loading platform of the ambulance, an automatic
security system will be inserted in order to avoid the folding of the legs, even when the handles are pulled.
4.3.6 Unloading the stretcher from the ambulance
Unlock the stretcher from its fixation system.
Grab the stretcher at the posterior tube of the frame (“feet” end) and gently pull the stretcher out of the ambulance. Make
sure the stretcher remains horizontal until the safety position (the rear legs block automatically in the open position): the
legs will open and block automatically.
The operator must make sure the rear and front legs open up and block correctly.
Make sure also that the ground below where the stretcher will unload is safe and stable.
When unloading the stretched do not grasp the footrest of the Trendelenburg board, this could cause injury to the
operator, the patient or the device.
4.3.7 Positioning stretcher Cross Up 8409 on trolley Cross Up 8409
•Stop trolley and apply the brakes.
•Place stretcher on trolley as indicated fig G;
•Slide until the locks automatically engage. (fig. H);
•Check that the stretcher is well attached to the trolley;
•This operation requires the presence of at least two people.
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4.3.8 Unlocking Cross Up 8409 stretcher from trolley Cross Up 8409
•Stop trolley and apply the brakes.
•Using the correct command lever, extract the stretcher and slide it out for about 10 cm.
•Terminate the operation by lifting the stretcher off the trolley.
•This operation requires the presence of at least two people. One person should be at the foot of the stretcher to action
the commands and one at the top end ready to lift it. In the case of particularly heavy patients or in particularly difficult
conditions, another operator must be present to assist.
4.3.9 Brakes
The brakes can be inserted by pushing down the lever on the rear pivoting wheels (n° 5 paragraph 3. ). The brake system not
only blocks the rotation of the wheel, but also of the complete wheel unit, offering complete immobilization of the stretcher.
To unblock the brakes, push the lever on the wheels.
4.4 Troubleshooting
PROBLEM CAUSE REMEDY
Pushing the stretcher against the vehicle's
bumper, the legs do not fold away
The lever has not been actioned or
the metal cable under the
stretcher does not transmit the
commands
Immediately remove the stretcher from
service and contact the service centre
During patient transport the stretcher is
difficult to move The brakes are still blocked Unblock the brakes and check the
condition of the wheels
Structural damage Improper use or operators are not
adequately trained
Put immediately the stretcher out of
service and contact the service centre
The intermediate height does not unlock
after actioning the lever Unlocking lever is damaged Put immediately the stretcher out of
service and contact the service centre
Stretcher fails to unlock after actioning the
lever Unlocking lever is damaged Put immediately the stretcher out of
service and contact the service centre
Fig. G Fig. H
Fig. I
Fig. L
Fig.
G
Fig.
H
11
5. MAINTENANCE AND CLEANING
5. Cleaning
Failure to carry out the correct cleaning routine could increase the risk of cross infection, due to presence of body fluids
and/or residuals.
The operator must always wear adequate personal protection such as gloves and mask etc. during any checking and/or
cleaning procedures.
The exposed metal parts are usually treated and/or painted in order to increase their resistance.
The board has been made out of in contaminable material, in order to increase hygiene and easy cleaning.
Clean the exposed parts with water and delicate soap then dry with a soft cloth. To obtain a polished effect, it is possible to
use car wax and cream. Do not clean with high pressure water which will damage the joints and the lubricated parts.
If the stretcher is not cleaned regularly, this may cause cross-contamination risks.
We recommend the use of the polishing detergent Spencer STX 99.
Rinse thoroughly with warm water making sure that all traces of detergent are removed. Failure to do so could
degrade or compromise the integrity and durability of the device. The use of high pressure water should be
avoided. Water penetrates the joints and removes the oil, creating the risk of corrosion of components.
Allow to dry thoroughly before storing. Drying after washing or after use in wet environments must be natural and not
forced. Do not use flames or other sources of direct heat.
5.2 Maintenance
5.2. Precautionary maintenance
The person who carries out the precautionary maintenance of the appliance (user in person, Manufacturer/supplier or a
third party) has to guarantee the following basic requirements:
•Technical knowledge of the appliance and of the periodic maintenance procedures as described in these instructions.
•Specific qualifications and training in the maintenance operations of the appliance in question.
•The use of components/replacement parts/accessories that are either original or approved by the supplier, in such a way
that each operation causes no alteration or modification to the appliance.
•Possession of the checklist of operations carried out on the appliance.
•Guarantee complete adherence to the instructions of the Directive 93/4 /CEE which includes also the obligation towards
the Manufacturer to maintain post sales records and traceability of the appliance if requested.
During all checking, maintenance and cleaning procedures, the operator must wear adequate personal protection such as
gloves, mask, glasses etc.
Checks to be carried out before and after each use, and at least every 3 months, are as follows:
•General functionality of the device
•Cleanliness of the device (remember that the failure of cleaning may be the cause of cross infections)
•Absence of cuts, holes, tears on the structure, including the straps
•Correct fixation of all nuts, bolts and screws
•State of use (moving parts, wheels, belts)
•Integrity of components
•Lubrication of moving parts
•When taking out for the first time the stretcher from its box, the its legs should bend and lock properly
•State of use of wheels and breaking system
•Functioning of springs
•That the stretcher is easily loaded on the ambulance
•The emergency vehicle is equipped with a fastening system dedicated to the Spencer stretcher
•Welding is intact and presents no cracks or breaks
•None of tubes or metal sheet present dents or cracks
The inspection frequency is determined by factors such as legal requirements, the type of use, frequency of use,
environmental conditions during use and storage. Please note that you must do the cleaning as described in paragraph 5.1
and verify functionality before and after each use. Spencer Italia S.r.l. declines any responsibility for the proper functioning or
damages caused to the patient or user by the use of devices not subject to routine maintenance warranty and will void the
compliance to the Medical Device Directive 93/4 /CEE.
The person responsible for routine maintenance can identify damaged/worn parts, but the replacement or renovation of
them can only be done by the manufacturer or by an authorized service centre.
Use only accessories/original spare parts approved by Spencer Italia S.r.l., otherwise we will accept no responsibility for the
incorrect functioning and/or damage caused by the use of any device which has not been repaired, or certified on expiry date
by the Manufacturer or by one of the Manufacturer's Authorised Service centres. Warranty will be considered void in
compliance with the Medical Device Directive 93/4 /EEC.
5.2.2 Periodical maintenance
The device must be subjected to a ual revisio s to verify the proper operatio a d complia ce with the safety requireme ts
guara teed by the Ma ufacturer whe the device is placed o the market.
12
The revisio s must be made by the Ma ufacturer, who uses specialized i ter al a d exter al tech icia s a d is authorized by
the Ma ufacturer himself. I the abse ce of such a ual revisio s, the device must be SECRETED UNTIL REPAIRING,
otherwise it must be DISPOSED OF AND IT MUST BE GIVEN COMMUNICATION TO THE MANUFACTURER.
Legs moveme t drive pisto s , are compo e ts subjected to periodic replaceme t depe di g o i te sity of use.
The followi g table shows some replaceme t i tervals related to the umber of average uses. The evaluatio of eeded
mai te a ce, must be carried out by people respo sible for mai te a ce of the device, accordi g to this table.
The replacement is mandatory in order to ensure the safety of the product.
Intensity of use Heavy usage
(over 30 times/month)
Medium usage
(less than 30 times/month)
Pistons replacement frequency Every 3 years Every 5 years
Belts and front legs movement spring shall be replaced every year.
For a y operatio s that are ot carried out directly by the Ma ufacturer but by a authorised ce tre, we have to u derli e
that a report regardi g all operatio s carried out must be requested. This will permit both Spe cer Italia S.r.l. a d the e d
user to keep a log book regardi g the operatio s carried out o the device.
5.2.3 Special servicing
Only the Manufacturer or centres with written authorisation are authorised to complete any special servicing
operations.
For a y operatio s that are ot carried out directly by the Ma ufacturer but by a authorised ce tre, we have to u derli e
that a report regardi g all operatio s carried out must be requested. This will permit both Spe cer Italia S.r.l. a d the e d
user to keep a log book regardi g the operatio s carried out o the device.
6. ACCESSORIES AND SPARE PARTS
6. Accessories
ST4 0 A 00 mm Ø high density wheel with bearings
ST4 100A Posterior fastener (FP)**
ST4 00A Anterior fastener (FA)**
ST4 70 C R-MAX B fixation system certified 10G
** Warning: Doesn’t meet the requirements of EN 1789 – Not suitable for use with 10G Certified Stretchers
6.2 Spare parts
ST41603A Support with brake for 00 mm Ø wheel
ST4 0 1A 00 mm Ø black wheel with bearings
ST70606A 00 mm Ø black wheel with bearings for loading trolley
ST4 110A 100 mm Ø wheel with wheel axis pin
ST70605B Loading trolley block
ST70646B Red handle 15x4x5x6 for Trendelenburg movement
ST70706A Kit pair of antivibration springs for stretcher supports
ST70697B Antivibration kit for posterior leg support
13
ATTACHMENT A – TRAINING REGISTER
The product must be used by trained personnel only, having attended specific training for this device and not for similar
products. Keep this document at least 10 years from the end of life of the device.
Operator’s name
Training date Training method (user’s
manual, during service, former
class, etc.)
Trainer
Basic training Advanced training
14
ATTACHMENT B – MAINTENANCE REGISTER
Keep this document at least 10 years from the end of life of the device.
Perform the required maintenance and to respect the life span of the device, as indicated by the Manufacturer in the User’s
Manual.
Code and description of the device
Purchase date
Lot (LOT) or serial number (SN)
Bought by
SERVICE DATE
KIND OF SERVICE
(Maintenance/
check/
extension of life span)
OPERATIONS MADE ON THE DEVICE RESULT
PERSON IN CHARGE OF
SERVICE (Operator/
Authorized centre/
Manufacturer)
Warning
The information contained in this document could be modified without any warning and is not to be intended as a commitment on behalf of Spencer Italia
S.r.l. Spencer products are exported to many countries and the same identical regulations are not always valid. For this reason there could be differences
between the description here described and the product actually delivered. Spencer continually strives to reach the perfection of all items sold. We
therefore hope you will understand if we reserve the right, at any time, to modify the shape, equipment, lay-out or technical aspects that are herein
described.
© Copyright Spencer Italia S.r.l.
All rights reserved.
No part of this document can be photocopied, reproduced or translated into another language without the written approval of Spencer Italia S.r.l.

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