Spencer STX 519 User Manual Download

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User’s Manual

STX 519 / STX 540 / STX 542

Lifting bridles systems

This appliance conforms with the Directive 93/42/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

page 2

Warning

page 3

Description of product

page 4

Operating instructions

page 6

Maintenance and cleaning

page 7

Accessories and spare parts

page 8

First edition: 07/02/02

Rev. 9 18/12/17

Spencer Italia s.r.l.

Tel. +39 0521.541111 / Fax +39 0521.541222 / e-mail: info@spencer.it

STX 519

STX 540

STX 542

Summary of Contents for STX 519

Page 1: ...rol of the products certified by the notifying body TÜV SÜD Product Service GmbH INDEX General information page 2 Warning page 3 Description of product page 4 Operating instructions page 6 Maintenance and cleaning page 7 Accessories and spare parts page 8 First edition 07 02 02 Rev 9 18 12 17 Spencer Italia s r l Tel 39 0521 541111 Fax 39 0521 541222 e mail info spencer it STX 519 STX 540 STX 542 ...

Page 2: ...and or on the box This label includes information about the manufacturer the product CE mark 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...

Page 3: ... 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 o any medi...

Page 4: ...ling the device on rough surfaces The device lifting device used must be approved by the actual norm The user is responsible to evaluate the application and the risks connected with the use of the device Always check the integrity of all the parts of the straps and buckles before every use Immediately replace straps and buckles if they are worn out or damaged Fix the straps and buckles into the de...

Page 5: ...1 Clinical Data MEDDEV 2 12 1 Medical Devices vigilance system UNI EN 14155 Clinical evaluation of the medical devices for human beings Part 2 Clinical evaluation plans 3 6 Environmental conditions Functioning temperature from 20 to 60 C Storage temperature from 20 to 60 C Relative humidity from 5 to 85 4 OPERATING INSTRUCTIONS 4 1 Transport and storage Before transporting the appliance make sure ...

Page 6: ...nism is broken Immediately remove the device from service and contact the service centre 5 MAINTENANCE AND CLEANING 5 1 Cleaning Failure to carry out the correct cleaning routine could increase the risk of cross infection The operator must always wear adequate personal protection such as gloves and mask etc during all checking and cleaning procedures The metal parts exposed to external agents unde...

Page 7: ...lity of the adjustment system Check the presence and legibility of the label containing warning data life span and loading capacity Depending on the intensity of use the device must undergo revision procedures to certify its suitability for use during the permitted life span of the product according to par 5 2 4 Such revisions shall be formalized and documented in a report with certain date which ...

Page 8: ...8 6 ACCESSORIES AND SPARE PARTS 6 1 Accessories There aren t any accessories for these items 6 1 Spare parts There aren t any spare parts for these items ...

Page 9: ... 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 ...

Page 10: ...ified 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 ther...

Page 11: ... the device under test The load shall be applied simulating the weight distribution of the human anatomy according to the following table 450 KG 9 HEAD AND NECK 39 CHEST AND ARMS 26 PELVIS 16 THIGHS 10 LEGS The simulation shall be carried out lifting the load slowly avoiding sudden application of the load Maintain the maximum load condition for 30 minutes It is therefore necessary to fill in the f...

Page 12: ...r testing pictures Basket strether pictures Bridles picture Picture of wights used for tests PICTURES AFTER MAXIMUM LOAD TEST CARABINERS FILL WITH PICTURES PROVING THE INTEGRITY OF CARABINERS BELTS FILL WITH PICTURES PROVING THE INTEGRITY OF BELTS SEAMS FILL WITH PICTURES PROVING THE INTEGRITY OF SEAMS ...

Page 13: ...true to their original form and are free of cracks deep scratches and gouges All belts and seams are in optimal condition and with no cuts or frayed edges Following the tests and visual inspection documented above the test s responsible declares that having not exceeded its life time the device is This certificate has a validity of 1 year Place Date Test s responsible Signature NOT SUITABLE FOR US...

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