Z 5000 and Z 5002 Scoop Stretcher Users Manual Rev 0 April 2014

Thank you for choosing a Spencer product 1. GENERAL INFORMATION 1.1 Aim and contents The aim of this manual is to supply all the information necessary so that the client, will not only attain adequate use of the appliance, he will also be capable of using the instrument in the most autonomous and secure way possible. This includes information regarding technical aspects, functioning, maintenance, spare parts and safety. 1.2 Conservation of the instruction and maintenance manual The instruction and maintenance manual must be kept together with the product, for the whole life of the device, inside a dedicated container and above all, away from any substances or liquids which could compromise perfect legibility. 1.3 Symbols used Symbol Meaning General or specific warnings See instructions for use Lot number Product code 1.4 Servicing request For any information regarding the correct interpretation of the instruction manual, the use, maintenance, installation and restore of the product, please contact the Spencer Customer Care Service tel. 0039 0521 541111, fax 0039 0521 541222, email [email protected] or write to Spencer Italia S.r.l. - Strada Cavi, 7 - 43044 Collecchio (Parma) - ITALY. In order to facilitate the assistance service, please always indicate the lot number (LOT) shown on the label applied on the box or on the device. 1.5 Demolition When the devices are no more suitable for being used, if they haven’t been contaminated by any particular agents, they can be disposed of as normal solid waste, otherwise follow the current regulations about demolition. The disposal of the accessories and the device shall be performed according to the current regulations in each country. 1.6 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, the lot number (LOT). It must never be removed or covered. 2. WARNINGS 2.1 General warnings • The product must be used by trained personnel only, having attended specific training for this device and not for similar products. • 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. • Spencer Italia S.r.l. is always at your disposal to plan trainings on products. • 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 to the device received, inform the manufacturer immediately and avoid use of the device. • In case of any doubts about the correct interpretation of the instructions, please contact Spencer Italia S.r.l. for any necessary clarifications. • Do not allow untrained persons to help during the use of the device, because they could cause damage 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 and of the user are detected, the device must be immediately removed from service and the manufacturer must be contacted. 2

• 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 operators. • 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 product warranty will be considered void. • 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 presence 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 must not be exposed to or come into contact with any source of combustion or inflammable agents. • 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. • 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 users of any medical device. • As a distributor or end user 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 contained in this supply that are in power 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’s 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. • The distributor or final user is 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 Spencer Italia S.r.l. expressly disclaims any responsibility and/or liability for your non-compliance with the present regulatory provisions. 2.2 Specific warnings • Establish a maintenance program and periodic testing, identifying a reference employee. 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. • All maintenance and periodic check activities must be registered and collected together with their intervention reports (see Maintenance Register) these documents have 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 components/spare parts and/or accessories 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 operator and warranty and will be considered void. • Always respect the maximum load 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 corpse, the equipment and the accessories. Moreover, the operator must consider that the overall dimensions of the corpse do not reduce the functionality of the device. • 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. • Make sure, before lifting, that the operators have a firm grip on the device. • Avoid pulling the device on rough surfaces. • Do not lift by crane or other mechanical lifters. 3

• Have practice with an empty stretcher, in order to make sure you become familiar with the manoeuvres. • The use of the device requires at least two operators in suitable physical conditions, they must therefore be endowed with strength, balance, coordination, and common sense and they must be trained on the proper operation of the device Spencer stretcher. • For loading techniques of the corpse, for particularly heavy corpses, for working on uneven ground or in special and unusual circumstances, the presence of more operators is recommended (not only 2 as expected under standard conditions). • The maximum weight supported by each rescuer must comply with the requirements prescribed by the law of the land, in the field of 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 functioning and safety of the device or operator, it is necessary to replace the belts. • Make sure the belts are properly fastened to the frame of the stretcher. • Always immobilize the corpse, using the straps supplied by the Manufacturer. • Do not operate in case the weight has not been distributed correctly. • Use the stretcher only as described in this user's manual. • Do not alter or modify the stretcher arbitrarily to make it fit into the ambulance: the modification may cause unforeseeable functioning and damage to the operators. In any case the warranty will be void. • Pay a lot of attention to possible obstacles (water, ice, debris, etc.) on the route of the stretche, because they could cause loss of balance of the operator and compromise the proper functioning of the device. If the path free cannot be made free of obstacles, choose an alternative path. 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. 2.4 Physical requirements of the operators Z 5000 and Z 5200 scoop stretchers are devices destined to professional use only. The rescue operators must have the following minimum requirements: • physical capacity for operating the device • be able to seize the device firmly with both hands • have strong back, arms and legs for lifting, pushing and pulling the stretcher • have a good muscular coordination The operators must be trained in efficient, effective and safe transport of the corpse. Corpse loading procedures, for extremely heavy corpses, operations in rough terrain and in particular situations more operators may be needed (not only two as in normal conditions). The capacities of the various operators must be considered before determining their role in the employment of the stretcher. 3. DESCRIPTION OF PRODUCT 3.1 Intended use Z 5000 and Z 5200 scoop stretchers are devices which allow the lifting and loading of a corpse onto devices such as transport stretchers. 3.2 N° 1 2 3 4 5

Main components Description of component Locks Support for the lower limbs Side blocks Support for the body Extensions

Material Aluminium Aluminium Aluminium Aluminium Aluminium

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Fig. A

3.3 Models These models could be modified, with reference to codes and/or descriptions without any previous notification. ZS00400A Z 5000 – Adjustable scoop stretcher, grey ZS00412A Z 5000 – Adjustable scoop stretcher, black ZS00410A Z 5200 – Fixed scoop stretcher, grey 3.4 Technical data Characteristics Height (mm) Width (mm) Minimum lenght (mm) 1 Intermediate lenght (mm) 1 Intermediate lenght (mm) Maximum lenght (mm) Folded lenght (mm) Weight (kg) Load capacity (kg)

Z 5000 70 430 1660 1780 1900 2020 1190 9,5 170

Z 5200 70 440 1660 1780 1900 2050 1190 8 150

3.5 Environmental conditions Functioning temperature: from -10 to +40 °C Storage temperature: from -20 to +60 °C 4. OPERATING INSTRUCTIONS 4.1 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 • State of use (moving parts,belts) • Integrity of components 5

• • • • •

Lubrication of moving parts There are seat belts for the immobilization of the corpse and they are intact and functioning No piping or metal sheet present bends or cracks Test the hooks closing them and opening them in succession Check cleanliness of the hooks and the absence of extraneous parts to the mechanisms

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. 4.3 Functioning 4.3.1 Loading the corpse Before loading the corpse, the stretcher must be positioned as close as possible. Before proceeding with transport, it is essential that the corpse is fastened to the scoop stretcher using the belts supplied, which will offer stability and safety. The scoop stretcher is not indicated for transporting corpses for long periods or distances. • Position the scoop stretcher in the closed position as close as possible to the corpse. The lengthening of the top support profile should be reduced to a minimum and it should correspond to the head of the corpse (fig. B). • To lengthen the profile - turn the side blocks. • Lengthen the supporting profile for the l lower limbs so that it corresponds with the corpse heels and turn the side locks until you hear the locks close (fig. C). • After checking that the locks are correctly closed and the length is correctly adjusted, open the scoop stretcher longitudinally and position the two halves on the sides of the corpse (fig D). • The operators should position themselves on the sides of the corpse in the trunk area. Move each half of the device and position them under the corpse. A minimum movement of a few centimetres in the shoulder and the hip area can be made in order to assist this operation (fig E). • In order to lock - proceed first with the head lock and then the area of the feet making sure that the red lock is pushed in so that the two halves lock together correctly (fig. F). Before moving the device with the corpse loaded, check that the two halves of the stretcher are correctly attached to each other, both at the foot end and at the head end. Also check that the length adjusting mechanisms are correctly blocked. The insertion of the two halves of the device under the corpse could be impeded or hampered by the characteristics of the ground underneath the corpse or by its clothes.

Fig. B

Fig. C

Fig. D

Fig. E 6

Fig. G Fig. F During the closure of the two halves of the device, check that no parts of the corpse or of his clothes are caught up. • The corpse should be fixed to the device bearing in mind that the support is only for temporary use previous to transfer to the correct type of transport device. Lifting and transport of the device with the corpse loaded must be carried out by at least two rescuers bearing in mind the maximum load that they are permitted to lift according to the their physical structure and condition. If the scoop stretcher is lifted from the head/foot area, the resistance to flexion of the stretcher decreases; for this reason we advise to lift the scoop stretcher from the sides (fig. H).

Fig. H 4.3.2 End of use Once the transport of the corpse has terminated, carry out the procedures described in the paragraph regarding maintenance and cleaning before putting the device into storage. The scoop stretcher should be reduced to its minimal size before storage by folding the upper half on top of the lower half. • Open both of the side locks and pull out the two halves until the joints are exposed (fig. I) and the scoop stretcher reaches its maximum extension before folding the stretcher (fig. L). If the joints are not completely extracted the stretchers could be irreparably damaged. • Place the scoop stretcher into its transport bag. If the scoop stretcher is stored with its forks (vertical and horizontal) it must be shortened to its minimal length before being fixed to the fork.

Fig. I 7

Fig. L

4.4

Troubleshooting PROBLEM

One or all the locks do not open/close (without corpse loaded)

CAUSE The spring in the block is damaged

REMEDY Put the device out of service and contact the Assistance Center Accurately clean blocks Accurately clean blocks Put the device out of service and contact the Assistance Center

Blocks are dirty The extension for the lower limbs does Blocks are dirty not lengthen/shorten after unlocking Deformed profiles the lock The extension for the lower limbs does The joint has not been completely Lengthen the stretcher more until the not exposed joints are completely exposed. bend up to close for storage Lengthen the stretcher more until it The extension for the lower limbs does There are no holes to block the hinge blocks not Put the device out of service and block at the desired length Blocking system is broken contact the Assistance Center The supporting profiles turn around the Put the device out of service and Fixing rivets are broken borders. contact the Assistance Center Put the device out of service and Damage to the structure Improper use contact the Assistance Center 5. MAINTENANCEAND CLEANING 5.1 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 all checking and 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 incontaminable material, in order to increase hygiene and easy cleaning. Clean the exposed parts with water and delicate soap, then dry with a soft cloth. In order to obtain a shine effect, it is possible to use car waxes and creams. Do not clean with high pressure water; this will damage the joints and the lubricated parts. If the stretcher is not cleaned regularly, this may cause risks in terms of cross-contamination. We recommend the use of the polishing detergent Spencer STX 99. Rinse thoroughly with warm water making sure that you have removed all traces of detergent, which 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. In the presence of blood, oxidize it before to washing the device with water. 5.2 Maintenance 5.2.1 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. The operator must always wear adequate personal protection such as gloves and mask etc. during all checking and cleaning procedures. Checks to be carried out before and after each use, and at least every month, are as follows:

• • • • • • •

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 State of use (moving parts,belts) 8

• • • • • •

Integrity of components Lubrication of moving parts There are seat belts for the immobilization of the patient and they are intact and functioning No piping or metal sheet present bends or cracks Test the hooks closing them and opening them in succession Check cleanliness of the hooks and the absence of extraneous parts to the mechanisms

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. The person responsible for routine maintenance must identify damaged/worn parts, but the replacement or restoration of them can only be carried out by the manufacturer or or by an authorized service centre. For other replacement/repair activities contact the Manufacturer or an authorized 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 93/42/EEC. 5.2.2 Periodic maintenance Planned interventions by the Manufacturer or authorized center are not required, but it is prescribed to make cleaning and checking indicated in the specific sections "Cleaning" and "Precautionary Maintenance". 5.2.3 Special servicing Only the Manufacturer or centres with written authorisation are authorised to complete any special servicing operations. For any operations that are not carried out directly by the Manufacturer but by an authorised centre, we have to underline that a report regarding all operations carried out must be requested. This will permit both Spencer Italia S.r.l. and the end user to keep a log book regarding the operations carried out on the device. The device, if used as indicated in the following instruction manual, has an average life span of 5 years. Spencer Italia S.r.l. 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, making void both the guarantee. 6. ACCESSORIES AND SPARE PARTS 6.1 Accessories ST05009A SX Bag - Carrying case for scoop stretchers, orange ST05010A SX Bag - Carrying case for scoop stretchers, blue ST05016A SXO - Horizontal fixing system in aluminium for scoop stretcher ST05017A SXV - Vertical fixing system in aluminium for scoop stretcher ST05018B SXV – Vertical fixing system in aluminium for scoop stretcher 20G ST05019B SXO – Horizontal fixing system in aluminium for scoop stretcher 20G ST05050B Ranger SX – Foldable trolley for scoop stretchers’ transport ST00598A STX 598 – Two pieces belt with plastic hook and orange belt ST00592A STX 592 - Two pieces belt with metal hook and orange belt 6.2 Spare parts ST05048A Z 5000 - Plastic joint for replacement

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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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