Spencer Rock User Manual Download Page 4

 

 

 

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 patient or the operator and warranty and will be considered void according to 
the compliance to the Medical Device Directive 93/42/CEE. 

 

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  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. 

 

Follow the procedures approved by the Emergency Medical Services for the immobilization of the 
patient. 

 

Follow  the  procedures  approved  by  the  Emergency  Medical  Services  for  the  positioning  and 
transport of the patient. 

 

Do not wash the device in the washing machine. 

 

Do not use drying machines. 

 

Avoid contact with sharp objects. 

 

Do not use the device if it is pierced, torn,frayed or eccessively worn out. 

 

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 lifts. 

 

The device is a spine board for patients transport and cannot be used as a stationing device 

 

First practice with an empty spine board in order to get used to the way in which the spine board 
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 Spencer device. 

 

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 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. 

 

Always  immobilize  the  patient,  using  the  straps  supplied  by  the  manufacturer;  lack  of 
immobilization may cause serious damage. 

 

Do not operate in case the weight has not been distributed correctly. 

 

Use the backboard only as described in this Manual 

 

Do  not  alter  or  modify  the  spine  borad  arbitrarily,  the  modification  may  cause  unforeseeable 
functioning and damages to the patient and operators. In any case the warranty will be lost. The 
manufacturer will no more considered responsible. 

 

Pay  a  lot  of  attention  to  possible  obstacles  (water,  ice,  debris,  etc.)  on  the  route  of  the  chair, 
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. 

 

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. 

 

Should it be necessary to secure the device within the ambulance, we recommend the use of the 
dedicated fastening system by Spencer. The use of fasteners not approved by the manufacturer is 
forbidden, as they may alter the structural and functional characteristics of the spine board. 

Summary of Contents for Rock

Page 1: ...on and the final control of the products certified by the notifying body TÜV SÜD Product Service GmbH INDEX General information pag 2 Warnings pag 2 Product description pag 5 Operating instructions pag 6 Maintenance and cleaning pag 10 Accessories and spare parts pag 12 First edition 2001 Rev 2 23 08 18 Spencer Italia s r l Tel 39 0521 541111 Fax 39 0521 541222 e mail info spencer it ...

Page 2: ...ble 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 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 CE mark the lot number LOT...

Page 3: ...ce 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...

Page 4: ...transport of the patient Do not wash the device in the washing machine Do not use drying machines Avoid contact with sharp objects Do not use the device if it is pierced torn frayed or eccessively worn out 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 lifts The device is a spine board f...

Page 5: ...atility Using the four skids of high density polyethylene Spencer Rock can slip on the steps of the stairs It ensures in all situations a proper safe and secure total immobilization of the spine and of the patient The material and the construction technique confer the Spencer Rock exclusive characteristics rigidity water resistance buoyancy resistance to impact and corrosion X ray homogeneity and ...

Page 6: ...g to medical devices MEDDEV 2 4 1a b Guideline for the classification of medical devices NB MED 2 5 1 Rec 5 Technical Documentation MEDDEV 2 7 1 Clinical Data UNI EN 14155 Clinical evaluation of the medical devices for human beings Part 2 Clinical evaluation plans UNI EN 1865 1 2010 Directives for stretchers and other patient transport equipment on ambulances 3 6 Environmental conditions Functioni...

Page 7: ...on behind the patient s head in misaligned position so that at the end of the pronation supination he will be aligned as much as possible to the patient s head Res 2 manually immobilizes the cervical spine with his hands in such a position that they do not become crossed during rotation he slips his hand under the patient s head to get a good grip making sure to move the head as little as possible...

Page 8: ...e to the pelvis Res 1 places his hands at shoulder and pelvis including the patient s wrist Res 3 places his hands at the side and the femur fig F Res 2 at the head controls the rotation of the patient on the side saying On three One two three At three Res 1 and 3 rotates the patient 90 degrees keeping the entire column immobilized in line they stop at the stop of Res 2 fig G While Res 1 maintains...

Page 9: ...N Res 1 and 3 one on each side insert the arm in the armpit of the patient grasping the handle of the spine board just above the armpit fig O Res 4 or a bystander puts a foot on the end of the table so that it can not slip Res 1 and 3 are challenging the spine board with the other free hand and the lower to the ground stopping approximately half way to allow the Res 2 officer heads to reposition t...

Page 10: ...event of a possible disinfection use products that have not solvent or corrosive action on the materials constituting the device 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 Allow to dry thoroughly before storing Drying after wa...

Page 11: ...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 42 CEE The replacement or restoration can only be done by the manufacturer or by an authorized service center Use only accessories ori...

Page 12: ...Set with 3 belts with quick release buckle ST00494B Board Straps STX 494 Set with 3 belts with carabiner SH00111C Super Blue Compact universal head immobilizer SH00201A Spencer Contour Anatomic universal head immobilizer SH00300A Fix Head Advanced universal head immobilizer SH00240A Tango Fix Integrated adult paediatric head immobilizer SH00150A FXA Universal ankle immobilizer SH00151A FXA Pro Ana...

Page 13: ...y 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 14: ... 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 ...

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