UV Smart D25 User manual

UV Smart D25 |Instructions for use |Revision 9 EN 1
Instructions for use
EN English
UV Smart D25
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2UV Smart D25 |Instructions for use |Revision 9 EN
Use of the D25: Quickstart Guide
1
Remove visible debris from your
medical equipment according to
the corresponding instructions for
use provided by the manufacturer.
Insert your medical
equipment inside the D25.
3
Check for visible debris in the
disinfection chambers (walls
and glass plates). Clean with
an antiseptic wipe if dirty.
2
Keep your hands clear
from the inside of the
D25 and close the D25
manually until the clip
clicks in position.
4
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UV Smart D25 |Instructions for use |Revision 9 EN 3
Your medical equipment has been
successfully disinfected and is safe
to use. With disinfected hands, take
out your medical equipment.
6
51. Check if the lights are on.
If they are not, contact UV
Smart.
2. Wait for the D25 to
complete the disinfection
run.
3. Disinfect your hands in
the meantime.
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4UV Smart D25 |Instructions for use |Revision 9 EN
Table of contents
Use of the D25: Quickstart Guide........................................................................
Introduction .........................................................................................................
Intended Use ........................................................................................................
Intended Use
Intended Medical Indication
Indications for Use
Contra-indications for Use
Intended users
Intended use environment
Claimed performance
Non-medical D25 Use..........................................................................................
Warnings and precautions .................................................................................
Product overview ................................................................................................
Packaging contents
Features and dimensions
First time use .......................................................................................................
Use of the D25 .....................................................................................................
Interface ...............................................................................................................
Sounds
Lights
Display
Maintenance ........................................................................................................
Cleaning
Transport
Technical safety check
Disposal
Problem solving ..................................................................................................
Problem solving
Error codes
Broken glass or lamps
Overheating
Technical specications .....................................................................................
Symbols ...............................................................................................................
Warranty ...............................................................................................................
Contact details ....................................................................................................
2
5
6
9
10
14
16
19
21
28
32
35
36
37
37
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UV Smart D25 |Instructions for use |Revision 9 EN 5
Introduction
The UV Smart D25 is a software-controlled medical device which provides
disinfection of hard, non-porous outer surfaces of non-invasive medical devices1
using UV-C light.
The UV Smart D25 consists of a sealed disinfection chamber containing ultraviolet
germicidal lamps. When in use, the UV-C light that is used for disinfection cannot
escape the D25, guaranteeing safe use of the D25.
The germicidal effect of UV-C light will not penetrate dirt, debris and grime. To allow
the D25 to perform optimally, it is required that all medical equipment is cleaned
before use, according to the corresponding instructions for use provided by the
manufacturer.
The UV Smart D25 should be used by informed personnel. The Instructions for Use
should therefore be read prior to operation.
1Non-invasive medical device:
A device which, in whole or in part, does not penetrate inside the body, either through a body orice or
through the surface of the body.
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6UV Smart D25 |Instructions for use |Revision 9 EN
Intended use
Intended use
The UV Smart D25 is intended to reduce micro-organism count by at least log-4
on hard, non-porous outer surfaces (glass, plastic, metal) of non-invasive medical
devices within 30 seconds by using UV-C light.
The UV Smart D25 is intended for disinfection of the outer surfaces of the following
non-invasive medical devices:
▪Infusion pumps;
▪Thermometers;
▪Surveillance monitoring equipment;
▪Stethoscopes;
▪Communication systems;
▪Essential feeding pumps;
▪Blood pressure pumps;
▪ Reex hammers.
These devices should only have direct contact with intact patient skin, in cases
where direct contact applies.
To be disinfected surfaces cannot be shadowed or covered during the disinfection
process.
The device does not support or sustain life.
Intended medical indication
The UV Smart D25 is intended for disinfection of hard, non-porous outer surfaces
of non-invasive medical devices and physically able to t inside the disinfection
chamber’s designated volume.
Indications for Use
The UV Smart D25 can be used in case of the following needs:
▪Disinfection of common surfaces;
▪Disinfection within 30 seconds;
▪Automated disinfection;
▪Consistent disinfection;
▪Disinfection on location.
Previously administered, manual disinfection methods can be applied in case of
device failure.
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UV Smart D25 |Instructions for use |Revision 9 EN 7
Contra-indications for use
The UV Smart D25 cannot be used in case:
▪The Indications for Use are not met;
▪The D25 is damaged;
▪There is visible debris on (medical) equipment;
▪There is visible debris inside the disinfection chamber;
▪The medical equipment does not consist of hard, non-porous outer surfaces;
▪The surface is organic, wood or textile;
▪There is any doubt about how to use the D25.
Intended users
The UV Smart D25 is suitable for use by any medical professional or laymen
working under the supervision of a medical professional. A medical professional
is an individual qualied by education, training, licensure or facility privileging
who performs a professional service within his/her scope of practice. Medical
professionals include doctors, nurses, hospice workers, (emergency) medical
technicians and other trained caregivers.
Intended use environment
The intended use environment of the UV Smart D25 is medical related, meaning;
hospitals, medical clinics, nursing home, doctor’s ofce, etc.
The UV Smart D25 shall be used in the following environmental conditions:
Temperature: -20oC – + 50oC
Relative Humidity: 20% – 90% (without condensation)
Atmospheric pressure: 700hPa – 1060hPa
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8UV Smart D25 |Instructions for use |Revision 9 EN
Claim Micro-organism Sort and type Log reduction
Bactericidal
Staphylococcus aureus Gram-positive bacteria, vegetative ≥ 5,0
Pseudomonas aeruginosa Gram-positive bacteria, vegetative ≥ 5,0
Enterococcus hirae Gram-positive bacteria ≥ 5,0
Escherichia coli Gram-negative bacteria, Enterobacteriaceae ≥ 4,0
Fungicidal
Candida albicans Fungus, vegetative yeast ≥ 4,0
Aspergillus brasiliensis Fungus, spore ≥ 4,0
Yeasticidal
Candida albicans Fungus, vegetative yeast ≥ 4,0
Candida auris Fungus, yeast ≥ 4,0
Sporicidal Bacillus subtilis Gram-positive bacteria, endospore ≥ 4,0
Mycobactericidal
Mycobacterium avium Gram-positive mycobacteria, vegetative ≥ 4,0
Mycobacterium terrae Gram-positive mycobacteria, vegetative ≥ 4,0
Tuberculocidal Mycobacterium terrae Gram-positive mycobacteria, vegetative ≥ 4,0
Virucidal
Adenovirus type 5, strain Adenoid 75 Adenoviridae ≥ 4,0
Bovine coronavirus type 1 Coronaviridae ≥ 4,0
Poliovirus type 1; LSc-2ab (picornavirus) Enterovirus ≥ 4,0
Murine norovirus, strain s99 Berlin Caliciviridae ≥ 4,0
Polyomavirus SV40, strain 777 Incertae sedis ≥ 4,0
Claimed performance
The required reduction of micro-organisms is based on the EN 14885:2018 to
compare it to the state of the art of chemical disinfectants and antiseptics. The
following reductions are determined and claimed:
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UV Smart D25 |Instructions for use |Revision 9 EN 9
Non-medical D25 Use
UV-C light can be applied on hard, non-porous surfaces. This also includes surfaces
of non-medical devices.
The UV Smart D25 can be used for disinfection of the hard, non-porous outer
surfaces (glass, plastics, metal) of the following non-medical devices:
▪Telephones;
▪Smartphones;
▪Tablets;
▪Badges;
To be disinfected surfaces cannot be shadowed or covered during the disinfection
process.
After using the D25 for disinfection of non-medical devices, all visible debris
should be removed from the disinfection chambers to make sure disinfection is not
impaired. The D25 can be applied for medical use again only if all visible debris is
removed from the disinfection chambers.
All information provided on the following pages of this Instruction for Use is also
applicable for non-medical use of D25.
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10UV Smart D25 |Instructions for use |Revision 9 EN
Warnings
Upon delivery, check that all items are present, without debris and undamaged.
Do not use a damaged D25. If you think the D25 is damaged, dirty or items are
missing, please contact UV Smart or your local distributor.
Do not place the D25 in a position where a patient or user could come to harm
should it fall.
Do not transport the device on a cart if not properly positioned and/or xed.
Transportation with or afxing to a trolley is at the customer’s own risk.
Do not use the USB-port on the back of the device. The port is for UV Smart
equipment and maintenance personnel only.
Do not use the D25 in an oxygen enriched environment or in the vicinity of
combustible gases (e.g. anesthetics).
The D25 must only be connected to a supply mains with protective earth, to avoid
the risk of electric shock.
Visible debris should be removed from the medical equipment surface according to
the corresponding instructions for use provided by the manufacturer before placing
it inside the D25 for disinfection.
Protect the D25 and the power supply against liquids and moisture.
Follow the instructions as indicated on the device display.
Do not insert medical equipment with working channels.
Do not insert invasive medical equipment.
Do not insert medical equipment made of organic materials.
Only insert medical equipment consisting of hard, non-porous outer surfaces.
Warnings and precautions
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UV Smart D25 |Instructions for use |Revision 9 EN 11
Do not insert medical equipment made of elastic materials.
Do not insert medical equipment made of textile materials.
Do not insert sharp objects.
Do not insert humans or animals.
Do not insert ammable substances in the D25 to prevent damage and risk of re/
explosion.
Do not insert medical equipment larger than the dimensions dened on page 15.
This could damage the medical equipment/D25 and/or jeopardize the disinfection
performance.
When inserting multiple pieces of medical equipment, they should not overlay and/
or cast shadows on each other.
Medical equipment should not touch the side walls of the disinfection chamber.
Do not close the lid with excessive force.
Do not open the D25 during a disinfection run, unless it is instructed by the display
or when strictly necessary because of external factors.
Use of the D25 could inuence the color of the outer surface of the disinfected
equipment.
Precautions
With initial use, the user is required to read the Instructions for Use.
Do not carry the D25 when the lid is in an open position.
Make sure the D25 is properly positioned on a steady surface.
The display is not a touch screen. The display is solely meant to visually instruct
the user.
Avoid applying external force in the ‘opening’ direction when the lid is in open
position.
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12UV Smart D25 |Instructions for use |Revision 9 EN
Gently place equipment inside the disinfection chamber of the D25 to prevent
damage to the D25 and medical equipment.
Always verify if the UV-C lamps switch on when a disinfection run is ongoing.
Do not place any medical equipment on top of the D25 when it is in operation.
After a disinfection run the lid opens automatically and might cause damage to the
medical equipment or to the D25 itself.
Only clean the D25 following the cleaning instructions on page 28.
Placement of medical equipment
The medical equipment
should not be higher than
the indicated edge.
The medical equipment
should not touch the
side walls.
The medical equipment
should not be placed
outside of the middle
plane.
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UV Smart D25 |Instructions for use |Revision 9 EN 13
Indications for Use
The UV Smart D25 can be used in
case of the following needs:
Disinfection of common surfaces;
Disinfection within 30 seconds;
Automated disinfection;
Consistent disinfection;
Disinfection on location.
Indications and contra-indications for use
Contra-indications for use
The UV Smart D25 cannot
be used in case:

The Indications for Use are not met;
The D25 is damaged;
There is visible debris on medical
equipment;
There is visible debris inside the
disinfection chambers;
The medical equipment does not
consist of hard, non-porous outer
surfaces;
The surface is organic, wood or textile;
There is any doubt about how to use
the D25.
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14UV Smart D25 |Instructions for use |Revision 9 EN
Product overview
Packaging content
Items
1. Power cable
2. Instructions for Use
3. D25 Medical Device
1
2
3
1
2
3
5
4b
4a
6
a
b
Features and dimensions
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UV Smart D25 |Instructions for use |Revision 9 EN 15
9 9
Features
1. Handle
2. Clip
3. Lid
4a. Disinfection chamber - top
4b. Disinfection chamber - bottom
Dimensions
a. Disinfection chamber height (150mm)
b. Disinfection chamber area (225x380mm)
c. Maximum medical equipment depth (225mm)
d. Maximum medical equipment height (150mm)
e. Maximum medical equipment width (380mm)
5. Top surface
6. Display
7. On/Off-switch
8. Power cable input
9. Carrying features
7
8
c
d
e
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16UV Smart D25 |Instructions for use |Revision 9 EN
First time use
1Check if all items are
included in the box,
unpack all items from the
box. If items are missing
or damaged contact
UV Smart or your local
distributor.
Read these Instructions
for Use.
2
Ensure that the D25 is
situated on a steady
surface.
3
Items
1. Power cable
2. Instructions for Use
3. D25 Medical Device
1
2
3
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UV Smart D25 |Instructions for use |Revision 9 EN 17
Plug the power cable
into the back of the
D25.
4
Plug the other end of the power
cable into a mains power supply
with protected earth.
5
Switch on the D25.
(press the “1” on the switch)
6
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18UV Smart D25 |Instructions for use |Revision 9 EN
The D25 is ready for use.7
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UV Smart D25 |Instructions for use |Revision 9 EN 19
Use of the D25
Insert your medical
equipment inside the
D25.
3
Check for visible debris in the
disinfection chambers (walls
and glass plates). Clean with
an antiseptic wipe if dirty.
2
Keep your hands clear
from the inside of the
D25 and close the D25
manually until the clip
clicks in position.
4
1
Remove visible debris from your
medical equipment according to
the corresponding instructions for
use provided by the manufacturer.
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20UV Smart D25 |Instructions for use |Revision 9 EN
Your medical equipment has been
successfully disinfected and is safe
to use. With disinfected hands, take
out your medical equipment.
6
51. Check if the lights are on.
If they are not, contact UV
Smart.
2. Wait for the D25 to
complete the disinfection
run.
3. Disinfect your hands in
the meantime.
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