Spencer Rock Скачать руководство пользователя страница 6 | Manualshive

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Spencer Rock Скачать руководство пользователя страница 6

6

3.4

Technical data

Characteristics

Spencer Rock

Rock Pin

Rock Pin Max

Length (mm)

1825

1840

1840

Width (mm)

445

445

445

Thickness (mm)

66

50

50

Handles

12

16

16

Fixing pins

/

14

14

Load capacity (kg)

192

200

350

Radiolucent

SI

SI

SI

Weight

7,8 ± 0,2 kg

Material

Polyethylene

3.5

Reference standards

Reference

Title of document

MDD 93/42/CEE

European Directive about Medical Devices

MDD 2007/47/CEE

Modifications to 90/385/CEE Directive about active
implants, Directive 93/42/CEE about medical devices
and Directive 98/8/CE about the introduction of biocides
onto the market

Legislative Decree 24/02/1997, n. 46

Application of the 93/42/CEE Directive about Medical
Devices

Legislative Decree 25/01/2010, n. 35

Modifications and additions to the 20/02/97 Decree n.
46

UNI EN ISO 14971

Application of risks managing to medical devices

UNI CEI EN 980

Graphic symbols used for medical devices labelling

UNI CEI EN 1041

Information

supplied

by

the

medical

devices

manufacturer

CEI EN 62366

Medical Devices - Application of the utilisation
characteristics of engineering 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

Functioning temperature Spencer Rock: from -35 to +55 °C
Functioning temperature Rock Pin/Pin Max: from -20 to +50 °C
Storage temperature: from -20 to +60 °C
Relative humidity: from 0 to 100 %

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.

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Содержание Rock

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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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