SINCTOK manuale EN
Contents
1. l the innovation company Via Don Corchia 8 e 43013 Langhirano PR Italia p iva 02663560346 phone fax 39 0521 358674 e mail info northwall it NoRTHwWALL INNOVATION Northwall srl Oct 2014 2 SINCTOK Contents 1 Safety information 1 1 Safety warnings 1 2 Load limits 1 3 Risks of infection 1 4 Compatibility with accessories 1 5 Labels and safety symbols 2 Training and operator skills 2 1 Training 2 2 Operator skills 3 Description 3 1 Technical specifications 4 Instructions for use 4 1 How to assemble Sinctok 4 2 How to disassemble Sinctok 4 2 Use for rescue operations by lifting 4 3 Lifting 5 Maintenance 5 1 Storing Sinctok 5 2 Maintenance 5 3 Cleaning 5 4 Disinfection 6 Technical assistance 6 1 Service and training 7 Warranty limitations 8 Conformity 9 Training registration O O O OAOWWWAAWAAONN DO UTAH HA HHA HA BW W _ 1 Safety information 1 1 Safety warnings This manual contains the following safety warnings Untrained users may cause injury or get hurt Only allow trained staff to operate Sinctok Improper use of Sinctok may cause injury Use Sinctok as described in this manual Modifying Sinctok may cause injury and unpredictable operational problems Do not modify or alter Sinctok in any way Any damage or injury to Sinctok s structure could affect its performance and related safety Frequently inspect Sinctok and do not use it in the event of excessive2. Conformity northwall s r l the innovation company m Via Don Corchia 8 e Langhirano 2 ottobre 2013 43013 Langhirano PR Italia p iva 02663560346 phone fax 39 0521 358674 e mail info northwall it NORTHwA INNOVATION Declaration of Conformity PRODUCT IDENTIFICATION MANUFACTURER Northwall s r l Commercial Name SINCTOK via Don Corchia 8 e Model Number 5P 43013 Langhirano PR Italia p iva 02663560346 CONFORMINTY ASSESMENT ROUTE TO COMPLIACE STANDARDS APPLIED Device classification CLASSI 93 42 EEC Council Directive UNI EN 1865 1 2010 Rule Long Spinal Board REGISTRATION INFORMATION Notify Body ID CE Certificate number Date CE Marking first applied not applicable for Class not applicable for Class 02 10 2013 medical devices medical devices Northwall s r l decalres that the above mentioned products meet the provision of the Council Directive 93 42 EEC for Medical Devices All supporting documentation is retained at the premises of manufacturer COMPANY REPRESENTATIVE Nicola Campani TITLE Vice President DATE 02 10 2013 SIGNATURE e northwall s r innovation company rchia 8 e O 43013 Langhirano PR Italia p iva 02663560346 A 6 m h K phone 39 0521 358674 A Q fax 39 0521 853629 Zz e mail info northwall it lt lt to Q Northwall srl Oct 2014 10 SINCTOK 9 Training registration type of training pan na
3. SINCTOK northwall s r l innovation company Via Don Corchia 8 e P 43013 Langhirano PR Use and maintenance manual ta piva 02663560346 phone 39 0521 358674 fax 39 0521 853629 e mail infoginorthwal it NoR THwALL MNNOV ATION SINCTOK disassemblable spine board Five pieces composite material modular long spine board Oct 2014 Eng rel 1a Northwall srl oct 2014 1 SINCTOK Attention This manual contains general information for the use operation and maintenance of this product The instructions do not cover all possible applications and operations The safety and use of this product are at the discretion of the user Safety related information is included for the user and ensures just the minimum level required to prevent accidents for operators and patients We recommend adequate training for the staff that will use this product before any actual application Keep this manual for future reference and in case the product is transferred to new users Additional copies may be requested from Northwall srl Rights The information included in this manual is the property of Northwall srl Via Don Corchia 8 e Langhirano PR Italy Northwall srl reserves all rights regarding images and drawings Any full or partial reproduction of this manual is prohibited unless expressly authorized by Northwall srl Copyright Northwall srl All rights reserved northwall s r
4. central label 2 fit together the pieces 3 check that all the pieces fit together 4 insert the belt buckles with the handles into the corresponding holes in symmetric pieces 5 fasten and check the symmetric position of the handles 6 continue for all the four handle belts Northwall srl Oct 2014 6 SINCTOK 4 2 How to disassemble Sinctok 1 start to remove the buckles from one side 2 do the same for all the handle belts 3 pack up the stretcher and place it in the appropriate bag to minimize the size 4 2 Use for rescue operations by lifting After loading the patient onto Sinctok while on the ground follow the local health authority instructions to apply the fixation belts on the patient as shown in fig 16 fig 16 Secure the head immobiliser system which is also able to secure a safety helmet for the patient if necessary An unattended patient may get injured Do not leave the patient unattended Assist him her during all operations Fixing the belts may vary depending on the size and conditions of the patient Before lifting or moving the patient using Sinctok check that the belts are fastened tightly and the patient is safe all operators are in the correct position and the loops bearing the load do not exceed the limits specified in this manual Northwall srl oct 2014 T SINCTOK 4 3 Lifting When lifting use only the appropriate loops thus distributing the pati
5. een tested to be used for operations requiring accessories for immobilization such as Northwall head immobilizer system Northwall belt system and other accessories specified by Northwall srl as compatible Apply immobilization systems to the patient that are in compliance with the technical specifications prescribed by current regulations 1 5 Labels and safety symbols The labels include important information that must be known to the user and is described below SINCTOK Main label C E 0000 NoRTHWALL It shows the name of the product Sinctok and production related information concerning the serial number The main label is CE marked 2 Training and operator skills The operators authorized to use Sinctok must know the procedures and precautions required when handling and moving patients have the necessary skills for assisting patients have understood the procedures described in this manual have the necessary authorization and have carried out specific training with Sinctok 2 1 Training In order to complete adequate training the following is required carefully read this manual contact your distributor Northwall srl for additional copies train and practice with Sinctok and its accessories before using it in actual operations record training sessions performed with Sinctok in this manual Untrained staff may cause or suffer serious injury Only allow appropriately trained staff to use Sinctok 2 2 O
6. ent s weight on at least 6 loops Systems are to be applied to the loops which ensure a secure grip in a specific operating environment Operators must be able to assess the number of helpers required to lift and move the patient according to his her weight thus limiting any danger for themselves and the patient in compliance with current regulations Always use technical rescue gloves Untrained staff may cause or suffer serious injury Only allow appropriately trained staff to use Sinctok Sinctok must only be used by adequately trained staff Contact Northwall srl to arrange specific training All the maneuvers described must be performed by experienced rescuers and after adequate and specific training The professionals who are authorized to use Sinctok in a specific environment must comply with the laws in force in each individual country Northwall srl shall not be held liable for any damage caused to rescuers or the patient due to improper use of Sinctok or if it is used by untrained or unauthorized staff Improper operation may cause serious accidents Only use Sinctok as shown in this manual 5 Maintenance 5 1 Storing Sinctok We recommend storing Sinctok or the rescue kit containing it e g Tyromont HS SACK ready for use In order to store Sinctok we recommend deflating it using the low pressure valve and keeping it open during storage 5 2 Maintenance IMPORTANT The polyamide materials belts and head immobiliser and t
7. h disinfection cleaning ooo e o inspection O O O a a 6 Technical assistance If you should require technical assistance for this product as well as repairs and information please contact Northwall srl 6 1 Service and training For any further information regarding its use and to arrange any necessary training please contact Northwall srl northwall s r l ANOVaNon company Via Don Corchia Be 43013 Langhirano PR ltalla piva 02663560346 NoRTHWwALL phone 39 0521 358674 fax 39 0521 853629 e mail infodinorthwal it hwiyYYyv amp Thee 7 Warranty limitations Northwall srl guarantees this product against any manufacturing defects in its materials for a period of two years This warranty applies when the product is used and maintained in compliance with the instructions provided in this manual Any misuse or improper maintenance shall make the warranty conditions null and void The warranty period takes effect from the day and the time the product is shipped by Northwall srl Shipping costs are not covered by this warranty Northwall shall not be held liable for any damage during shipping or any damage incurred while using this product If the product is partly or fully damaged Northwall srl shall repair or replace the product or if deemed necessary shall refund its purchase price The customer shall implicitly accept these warranty terms Northwall srl oct 2014 9 SINCTOK 8
8. he materials Sinctok is made of will deteriorate if exposed to prolonged direct sunlight and must not be directly exposed to sources of heat Sinctok must be stored in a cool dry place protected from direct sunlight Sinctok must be inspected and decontaminated every time after use If it is not used it must be inspected at least once a month Sinctok should be inspected by persons authorised by Northwall srl at least every two years Sinctok and all its accessories can be used in climatic conditions with temperatures normally tolerated by humans 5 3 Cleaning Wash Sinctok with warm water and a mild detergent then leave it to dry away from direct sunlight Make sure water or liquids do not enter Sinctok Before each wash make sure that the low pressure valve is closed and the safety lid is inserted and secured 5 4 Disinfection Use surface disinfectants approved by the local health authority Avoid ammonium based disinfectants In the event of possible contamination due to immersion of the internal part of the device please contact Northwall srl Northwall srl Oct 2014 8 SINCTOK Improper maintenance may cause serious accidents Store Sinctok as described in this manual IMPORTANT Disinfectants containing bleaches phenols and iodine may cause damage to Sinctok s accessories Disinfect and clean using only products that do not contain these substances Maintenance table __ every use when necessary every mont
9. me of the operator 11 Northwall srl oct 2014
10. perator skills In order to use Sinctok in a specific environment skills and knowledge are required which are not described but taken for granted in this manual Operators need to know how to act in a specific environment and ensure safety for themselves and the patient during all operations They must also be able to use any other accessory provided The use of collaborators or occasional helpers for moving or lifting the patient should be limited to actual needs and in compliance with the general safety conditions Northwall srl Oct 2014 4 SINCTOK 3 Description Sinctok is a device for the immobilisation long spinal board and rescue of an injured patient with the aid of lifting accessories Sinctok is intended to protect an immobilised patient from a specific environment and transport him her by lifting using special handles or auxiliary systems which are compatible as specified or by making Sinctok slide on even surfaces Sinctok is designed for the rescue of patients from confined industrial areas while ensuring all the handling precautions that are usually applied to injured patients Sinctok must only be used by adequately trained staff Contact Northwall srl to arrange specific training Northwall srl shall not be held liable for any damage caused to users or third parties due to improper use of the device Features 5 pieces carbon fiber and polyethylene board 12 lateral handles 28 rings for utility or immobiliza
11. tion belts 4 secure assembling belts with 2 immobilization loops each Modifying Sinctok s features may cause unpredictable reactions and serious injury to operators and the patient Do not modify or alter Sinctok s features in any way 3 1 Technical specifications Sizes and features maximum length ccceee eee eee eeeeee ees 1830 mm 72 in MAXIMUM width cceceeeeee eee eeeeeeeseeeeess 420 MM 16 7 in WOIGIM esos esc ceccccnncemesemcssancesteencanGnccdscetes 6 4 kg 14 1 Ib MAXIMUM lOAd 0 cece cece eee eeeeeeeeeeeeeaes 200 kg 441 Ib maximum load per handle 00ceseeeee 50 kg 110 Ib Materials used external structure ccccceeeeeeeeeeeeaes carbon fiber polyethylene GING a ne taca teu cuca naccanaeseis seduces polypropylene aluminum alloy Tested accessories belt Sy SIS rants tania taernane ae intamns nun nene Northwall quick belts head immobilizer system 0ceeee eae Northwall NQH2I rescue SYSTEM ccc ccc cece eeeeeeeeeeneeeees Tyromont HS SACK Check the load limits of the aids for the Sinctok system that are used for rescue operations Do not exceed the lowest load limit detected for the aids used for lifting A 22 z a 4 a tal fig 1 Northwall srl oct 2014 5 SINCTOK 4 Instructions for use 4 1 How to assemble Sinctok 1 0n a flat surface dispose the parts in right position following the colored triangles on main
12. wear or damage Do not leave the patient unattended for any reason while positioned on Sinctok An operator must assist the patient during all rescue stages If the safety fasteners for the patient are not secured this may cause serious damage or injury Applying Sinctok belts in a different way to the one specified in this manual may result in serious accidents Any occasional helpers may damage Sinctok s structure Control all operations when occasional helpers are present Do not let occasional helpers carry out preparation manoeuvres on Sinctok or operations without the supervision of trained operators Applying equipment on Sinctok incorrectly or combining it with tools that are not indicated in this manual may result in serious accidents Unauthorized repairs performed by technicians or laboratories that are not authorized by Northwall srl shall make all warranties null and void and might endanger all operations when using Sinctok Northwall srl oct 2014 3 SINCTOK 1 2 Load limits Comply with the maximum loads specified for each component of the system See the data sheet attached to this manual to check the loads and safety features 1 3 Risks of infection In order to reduce the risk of exposure to infectious diseases transmitted by blood such as HIV 1 or hepatitis while using Sinctok carefully follow the disinfection and cleaning instructions specified in this manual 1 4 Compatibility with accessories Sinctok has b
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