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Quality & Safety Standards |
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Quick reference guide to this page
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Compliance
M editelle
Equipment complies with recommendations and guidelines provided by British
Standards and CE marking:
CE Marked
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’.
British Safety
 Meditelle
products meet relevant British safety
regulations within British Safety
Standards BS3379/BS5852 and BS EN
60601-1:1190 and BS EN60601-2-38 and The
Furniture & Fire Safety Regulations
S11324:1989.
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Mechanical Safety & Load Testing
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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Electrical Safety
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 the relevant EMC Directive
/Low Voltage Directives – see blue panel for full
details.
Electronic height couches are designed to
descend low enough for ease of patient transfer. |
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Warranty
Meditelle guarantees couches and
equipment products against mechanical
defect for 1 year and framework for 5
years.
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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 and BS EN60601-2-38 and The Furniture &
Fire Safety Regulations S11324:1989.
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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Meditelle anti-microbial vinyl’s
and framework incorporate
an infection proof additive which is
effective at reducing the spread of bacteria
such as E coli and MRSA.
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Vinyl
All Meditelle vinyl is suitable for use in high risk
Infection Control areas. It contains an antimicrobial
additive to provide long-lasting effectiveness even
after regular cleaning. Independent laboratory tests
show that it is effective against the spread of MRSA, E
coli and other bacteria on its surface. Clostridium
Difficile can not multiply on the vinyl surface under
normal aerobic conditions.
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
Conforms to BS5790 part 1 : Type 2: Grade X
: 1996 and ISO7617-1 : 1994E
Flame Retardancy
Inherently flame retardant. Conform to DOE
FTS No 3 Source 5 BS5852 : 2006 Section 4 :
Ignition Sources 0 and 1 ; Clause 11:
Ignition Source 5 BS7176 : 2007 Medium
Hazard BS. EN1021-1 Part 1;EN1021-2 Part 2 :
2006 (ISO8191-1 : 1987 and ISO 8191-2: 1988)
BS5852 1990 : Section 4 IMO Res A 652 (16)
EASA.CS925.853(a) App F, Part 1 (A) (i and
ii ) – as C.A.A.8
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Framework
Meditelle’s
framework is finished using a powder coating
that incorporates an ingredient to prevent the
growth of bacteria, mould and fungi. This powder
coating effectively inhibits growth of bacteria
such as MRSA and E coli. Microbial efficiency is
ensured as the ingredient is uniformly
distributed throughout the coated film to ensure
long term performance for the life of the powder
coating. |
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Framework Technical Information
Powder
coatings have undergone microbiological laboratory
testing for antibacterial performance using the JIS Z
2801:2000 Industrial Standard method against the two
most widely encountered and problematic organisms:-
Staphylococcus Aureus (MRSA strain) and Escherichia (E)
coli. With both Micro-organisms, at least a 3-log (i.e.
99.9%) reduction in population was seen compared to an
unmodified control. |
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