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ENGLISH

 

 

I Class Medical Device

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 5 April 2017 concerning medical devices

1. CODES

MI481 

 

1 step stool 150 Kg

 

MI482   

2 steps stool 150 Kg

2. INTRODUCTION

Thank you for choosing a step stool from the SKEMAFORM by MORETTI S.p.A. Their design and 
quality are a guarantee of comfort, safety and reliability. The step stools from the SKEMAFORM 
by MORETTI S.p.A. are designed and built to meet all your demands for a practical, correct use. 
This  user  manual  provides  for  some  suggestions  as  to  how  correctly  use  the  item  you  have 
chosen and offers a lots of valuable advice for your safety. Please read carefully through the 
manual before using the step stools. Should you have any queries, please contact your retailer 
for advice and assistance.

3. INTENDED USE

The step stool by SKEMAFORM is a device designed to help people to easily get on and off onto medical 
examination bed. 
 

WARNING!
•  Do not use the product for a purpose not indicated in this manual
•  Moretti S.P.A. declines all responsibilities for any consequences  resulting from 
  an incorrect use of this product and from unauthorized alteration to the frame of  
  the product
•  The manufacturer reserves the right to change the information contained in this 
  document without previous notice

If you should have any doubts please contact your dealer who will help and advice you correctly.

4. DECLARATION OF CONFORMITY

Moretti S.p.A. declares under its sole responsibility that the product made and traded by  
Moretti S.p.A.and belonging to the group of STEP STOOL complies with the provisions of the 
regulation 2017/745 on MEDICAL DEVICES of 5 April 2017.
For this purpose, Moretti S.p.A. guarantees and declares under its sole responsibility what 
follows:
1.  The devices satisfy the requirements of general safety and performance requested by   
     the Annex I of regulation 2017/745 as laid down by the Annex IV of the above mentioned 
     regulation.
2. The devices ARE NOT MEASURING INSTRUMENTS.
3. The devices ARE NOT MADE FOR CLINICAL TESTS.
4. The devices are packed in NON-STERILE BOX.
5. The devices belong to class I in accordance with the provisions of Annex VIII of the above 
     mentioned regulation
6. Moretti S.p.A. provides to the Competent Authorities the technical documentation to 
    prove the conformity to the 2017/745 regulation, for at least 10 years from the last lot 
    production.

Note:

 

Complete product codes, the manufacturer registration code (SRN), the UDI-DI code 

and any references to used regulations are included in the EU declaration of conformity that 
Moretti S.p.A. releases and makes available through its channels.

Summary of Contents for SKEMA FORM

Page 1: ...PREDELLINI MANUALE DI ISTRUZIONI MA MI481_MI482 03 A _ITA_11 2020 ITALIANO...

Page 2: ...Istruzioni di montaggio MI481 predellino ad 1 gradino pag 5 8 2 Istruzioni di montaggio MI482 predellino a 2 gradini pag 6 9 MODALIT D USO PAG 7 10 MANUTENZIONE PAG 7 11 PULIZIA E DISINFEZIONE PAG 7...

Page 3: ...ortare modifiche al dispositivo e al seguente manuale senza preavviso allo scopo di migliorarne le caratteristiche In caso di dubbi contatta il tuo rivenditore che ti aiuter e ti consiglier correttame...

Page 4: ...te grave verificatosi in relazione al dispositivo al fabbricante e all autorit competente dello Stato membro in cui l utilizzatore e o il paziente stabilito 6 SIMBOLOGIA UTILIZZATA Codice prodotto Ide...

Page 5: ...dino 1 Disporre le due gambe esterne rif A con la svasatura del foro centrale rivolta verso l esterno rif 1 immagine 1 2 2 Assemblare da prima le gambe e il traversino centrale rif B attraverso i racc...

Page 6: ...lino a 2 gradini 1 Disporre le due gambe esterne rif A con le svasature dei fori rivolte verso l esterno immagine 5 2 Assemblare da prima le gambe e i traversini centrali rif B attraverso i raccordi s...

Page 7: ...lizzare la stessa procedura PRECAUZIONI Non superare la portata massima di 150 kg Prima dell uso assicurarsi sempre che il predellino SKEMA sia ben montato e che non presenti danni tali da compromette...

Page 8: ...ura non scrupolosamente conforme alle istruzioni riportate nei manuali per l installazione il montaggio e l uso Moretti non garantisce i prodotti Moretti contro danni o difetti nelle seguenti condizio...

Page 9: ...ti sono garantiti per 6 sei mesi a decorrere dal giorno in cui si riceve il ricambio 17 CLAUSOLE ESONERATIVE Salvo quanto specificato espressamente in questa garanzia ed entro i limiti di legge Morett...

Page 10: ...10 ITALIANO NOTE...

Page 11: ...___________________________ Acquistato in data____________________________________________________________ Rivenditore __________________________________________________________________ Via __________...

Page 12: ......

Page 13: ...STEP STOOL INSTRUCTIONS MANUAL MA MI481_MI482 03 A _ENG_11 2020 ENGLISH...

Page 14: ...MI481 1 step stool pag 5 8 2 Installation instructions MI482 2 steps stool pag 6 9 HOW TO USE PAG 7 10 MAINTEINANCE PAG 7 11 CLEANING AND DISINFECTION PAG 7 11 1 Cleaning pag 7 11 2 Disinfection pag...

Page 15: ...es the right to change the information contained in this document without previous notice If you should have any doubts please contact your dealer who will help and advice you correctly 4 DECLARATION...

Page 16: ...any serious accident that have occurred related the device to the manufacturer and appropriate authority of the State which the user and or patient belongs to 6 SYMBOLS Product code Unique Device Ide...

Page 17: ...481 1 step stool 1 Place the two outer legs ref A with the flaring of the central hole facing outwards ref 1 pictures 1 2 2 First assemble the legs and the crossbar ref B by the flared fittings and M8...

Page 18: ...on instructions MI482 2 steps stool 1 Place the two outer legs ref A with the flaring of the central hole facing outwards ref 1 pictures 1 2 2 First Assemble the legs and the crossbars ref B by the fl...

Page 19: ...aximum load of 150 kg Before use always make sure that the step stool SKEMAFORM is securely assembled and hasn t any damage that could compromise the stability of the product 10 MAINTEINANCE The MOPED...

Page 20: ...s or components not provided by Moretti failure in accomplishing the guidelines and instructions for use non authorized alterations damages due to the transport different from Moretti original deliver...

Page 21: ...essed or implicit including any declaration warranty or condition of merchantability of non violation or non interference of suitability for a specific aim Moretti S p A does not guarantee that the us...

Page 22: ...10 ENGLISH NOTES...

Page 23: ...______________________________________________ Address _______________________ Town city_______________________________________ Sold to_________________________________________________________________...

Page 24: ......

Page 25: ...ESTRIBOS MANUAL DE INSTRUCCIONES MA MI481_MI482 03 A _ESP_11 2020 ESPA OL...

Page 26: ...e montaje de MI481 estribo de 1 pelda o pag 5 8 2 Instrucciones de montaje de MI482 estribo de 2 pelda os pag 6 9 MODO DE USO PAG 7 10 MANTENIMIENTO PAG 7 11 LIMPIEZA Y DESINFECCI N PAG 7 11 1 Limpiez...

Page 27: ...aportar modificaciones al producto y a este manual sin aviso previo con prop sitos de mejora En caso de dudas contacta con tu revendedor que podr ayudarte y darte consejos tiles 4 DECLARACI N UE DE CO...

Page 28: ...e grave ocurrido en relaci n con el producto al fabricante y a la autoridad competente del pa s miembro donde se encuentre 6 S MBOLOS C digo producto Identificaci n un voca de productos Marcado CE EC...

Page 29: ...ciones de montaje de MI481 estribo de 1 pelda o 1 Disponer las dos patas externas ref A con el abocinado del orificio central hacia el exterior ref 1 imagen 1 2 2 Ensamblar primero las patas y el trav...

Page 30: ...MI482 estribo de 2 pelda os 1 Disponer las dos patas externas ref A con los abocinados de los orificios hacia el exterior imagen 5 2 Ensamblar primero las patas y los travesa os centrales ref B utiliz...

Page 31: ...cidad m xima de 150 kg Antes del uso asegurarse siempre de que el estribo SKEMA est bien montado y no presente da os que puedan comprometer la estabilidad del producto 10 MANTENIMIENTO Los productos M...

Page 32: ...itivo no conforme con las instrucciones que se encuentran en el manual de instalaci n montaje y uso Moretti no garantiza los productos Moretti por da os o defectos en la condiciones siguientes calamid...

Page 33: ...garant a de 6 seis meses desde la fecha de entrega del repuesto 17 CL USULAS EXONERATIVAS M s all de las especificaciones de esta garant a y dentro de los l mites de ley Moretti no ofrece ninguna otra...

Page 34: ...10 ESPA OL NOTAS...

Page 35: ...__________________________ Fecha de compra______________________________________________________________ Distribuidor _ _________________________________________________________________ Calle ________...

Page 36: ...MORETTI S P A Via Bruxelles 3 Meleto 52022 Cavriglia Arezzo Tel 39 055 96 21 11 Fax 39 055 96 21 200 www morettispa com info morettispa com...

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