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Compliance
M editelle
Equipment complies with recommendations
and guidelines provided by British
Standards and CE marking:
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CE Marked
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All
Meditelle products comply The Medical
Devices Directive’s essential
requirements in Annex 1 of EC Directive
93/42/EEC and the technical
documentation is detailed within the
‘technical file’.
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British Safety
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Meditelle
products meet relevant British safety
regulations within British Safety
Standards BS3379 / BS5852 and BS EN
60601-1:1190 ; BS EN60601-2-38 ; BS EN
1021 /2 ; Furniture & Fire Safety
Regulations S.I 1324:1988. |
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Mechanical Safety & Load Testing
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Meditelle couches, chairs, seating
and trolleys have been load tested in
accordance with CE requirements. For
Safe Working Loads (SWL) – see
individual product pages.
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Warranty
Meditelle guarantees couches and
larger equipment products against mechanical
defect for 1 year and framework for 5
years. Seating (i.e. chairs
and stools) Trolleys and Ancillary
equipment are guaranteed against defect
for 1 year.
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Manufacturers Annual Maintenance Service
Meditelle offers comprehensive out of
warranty maintenance & servicing which
includes an onsite visit by a Meditelle
Technician with full equipment safety
check & routine maintenance.
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Equipment Technical Information
Meditelle products meet relevant
British safety regulations
within
British Safety
Standards BS3379
;
BS5852 and
BS EN 60601-1:1190 ; BS
EN60601-2-38 and BS EN 1021
/2 ;
Furniture & Fire Safety
Regulations S.I 1324:1988.
All Meditelle medical products
including Plinths; Couches;
Chairs; Practice Furniture;
Trolleys; Screening and Seating
are CE marked as a medical
device and comply with The
Medical Devices Directive’s
essential requirements in Annex
1 of EC Directive 93/42/EEC and
the technical documentation is
detailed within the ‘technical
file’.
Meditelle couches have
been load tested in accordance
with CE requirements. Electronic
and hydraulic couch and chair
models have a Lifting Capacity
and Safe Working Load (SWL) of
225kgs; static couches and
plinths have a SWL of 225kgs;
portable couches have a SWL of
160kgs.
All Electronic Couches feature a
CE approved 24v DC (6000n,
3.5amp) electric motor which has
been tested for mechanical
safety and load bearing and
complies with: EMC Directive
89/336/EØF to standard
EN50082-1:97,EN50081-1:92,
EN61000-3-2:95, A1:98, A2:98,
A14:00,EN 61000 3 3:95; Low
Voltage Directive 73/23/EØF to
standard EN60335-1:94, EN 60742.
Electronic height couches are
designed to descend low enough
for ease of patient transfer.
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Materials Technical Information &
Infection Control
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Vinyl
Meditelle vinyl's
are suitable for use in high
risk Infection Control areas and
contain Biocide antimicrobial
ingredients to provide
long-lasting effectiveness
against the spread of surface
bacteria including MRSA, VRE, E
coli and NDM-1; micro-organisms
such as Clostridia and will
prevent the growth of viruses
including COVID-19, even after
regular cleaning. Independent
laboratory tested.
Stain Resistance
All Meditelle Vinyl coated
fabrics are hydrophobic and do
not absorb water or retain
dampness and can be completely
dried after washing. Resistant
to urine, mild acids/alkalis,
drinks and beverages which can
be easily wiped off.
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Vinyl Technical Information
Quality
Colour
tested for: Colour fastness to light
to BS EN ISO 105-B02: 2014;
Resistance to staining GSR: 4-5 Pass
Strength
tested according to BS EN 14465:
2003 / BS 2543: 2004 and meets
requirements of Tensile strength BS
EN ISO 13934-1: 2013; Tear strength
BS EN ISO 13937-3: 2000; Bursting
strength BS EN ISO 13938-2: 1999;
Adhesion of finish BS EN ISO
2411:2000; Abrasion BS EN ISO
12947-2: 1998.
Martindale
abrasion tested in excess of
1,000,000+ rubs to BS EN ISO
12947-2: 1998 / BS EN 14465: 2003
Annex A and rated as Performance
Level A.
Antimicrobial and Antibacterial
resistance tested for E. Coli, MRSA
and Staphylococcus to ISO 22196:2011
standards.
Antiviral
resistance and growth prevention
tested for Coronavirus to ISO
18184:2019.
Resistance
of fabric to deterioration tested to
meet ISO 1419: 1995 Method C
“Tropical Test” against moisture and
elevated temperatures to withstand
extreme conditions over a period of
5 years.
Flame Retardancy
Inherently
flame retardant. Ignitability tested
and passes the flammability
requirements according to BS 5852 :
2006 Clause 11, Methods of Test for
the Assessment of the ignitability
of upholstered seating by
smouldering and flaming Ignition
Sources, Ignition Source 5
Tested and
passes the requirements according to
Assessment of the ignitability of
upholstered furniture BS EN 1021-1 :
2006, Part 1 Smouldering Cigarette &
BS EN 1021-2 : 2006, Part 2 Match
Flame Equivalent
Tested and
meets requirements in accordance to
DIN4102-1 B2 (1198-05); IMO FTP Code
2010 Part 8 (Upholstered Furniture).
Meets
requirements and complies with
BS7176 : 2007+A1:2011 Direct test
for medium hazard. (Specification
for Resistance to Ignition for
Upholstered Furniture for
Non-domestic Seating by Testing
Composites).
Tested to
BS5852 : Part 1 : 1979. Meets
requirements of Schedule 4 & 5, Part
1, of The Furniture & Furnishings
(Fire Safety) Regulations 1988 S.I.
1324
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Framework
Meditelle’s framework is finished using
powder coating technology that aids
cleaning and ensures long term
performance.
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