Tecnomed Italia Skudo User manual

V.8.00
CODE DP2003S
Installation, operation and maintenance manual
Aerosol barrier

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CONTENTS
SECTION
1- SYMBOLS
1.1- WARNING LABELS
2- GENERAL WARNINGS
2.1 - GENERAL INSPECTION
2.2 - IN-TRANSIT DAMAGES FOR DELIVERIES IN ITALY
2.3 - IN-TRANSIT DAMAGES FOR DELIVERIES OUTSIDE ITALY
2.4 - TRANSPORT AND STORAGE CONDITIONS
3- SAFETY RULES FOR INSTALLATION
3.1 - WORK ENVIRONMENT
3.2 - MAXIMUM LOADS
4- SAFETY PROVISIONS
4.1 SAFETY REQUIREMENTS
5- PRODUCT DESCRIPTION
5.1 - INTENDED USE AND METHODS OF USE
5.2 - STANDARDS/CERTIFICATIONS
5.3 - TECHNICAL FEATURES
5.4 - DIMENSIONS
5.5 - PACKING LIST
5.6 - IDENTIFICATION PLATES
5.7 - PRODUCT PROFILE
6- INSTALLATION
6.1 - SUPPLY CONNECTION - STANDARD INSTALLATION
6.2 - SUPPLY CONNECTION - FIXED INSTALLATION
7- INSTRUCTIONS FOR USE
8- POSITIONING
9- OPERATION
10 - EXTERNAL CLEANING
10.1 - RECOMMENDED DISINFECTANT
11 - INTERNAL CLEANING
11.1 - RECOMMENDED DISINFECTANT
12 - MAINTENANCE
13 - TROUBLESHOOTING
14- RELATED ITEMS
15- DISPOSAL
16 - WARRANTY
17 - DECLARATION OF CONFORMITY
18- CERTIFICATE OF WARRANTY
19 - PNEUMATIC TEST
PAGE
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1- SYMBOLS
MANUFACTURER SYMBOL. This symbol is placed on the product next to the name and
address of the manufacturer.
SERIAL NUMBER SYMBOL. This symbol is placed on the product next to the serial
number of the device.
CE MARKING. This symbol indicates that the product has a CE marking
in conformity with the provisions of Directive CEE 93/42 and subsequent
amendments (Class I Devices).
INSTRUCTIONS FOR OPERATION. This symbol indicates that you need to consult the
user manual before using the device.
WARNING SYMBOL. It indicates a dangerous situation that might result in
moderate or mild injuries or damage to property unless avoided.
BILOGICAL HAZARD SYMBOL. This symbol indicates the possible presence of risks of
contamination due to contact with infected biological uids or materials.
GENERAL INFORMATION SYMBOL. This symbol indicates a piece of information
that allows you to use the device more efciently.
DISPOSAL SYMBOL. This symbol indicates that the product should not be
disposed of like normal waste, but it should be recycled as per Directive
2002/95/ EC, 2002/96/ EC and 2003/108/ EC.
STERILISABLE. This symbol indicates the possibility of sterilising the product in autoclave.
FRAGILE SYMBOL. This symbol indicates that the product inside the packaging is
fragile. Avoid shocks.
PROTECT FROM HUMIDITY SYMBOL. This symbol indicates that the product must
be kept away from water and humidity.
UP SYMBOL. Transport and store the product only in the direction indicated by the
arrows.
DO NOT STACK SYMBOL.
TEMPERATURE LIMIT SYMBOL. From -10° to 50° C.
HUMIDITY LIMIT SYMBOL. From 10 to 90%.
ATMOSPHERIC PRESSURE LIMIT SYMBOL. From 500 to 1060 hPa.

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1.1- WARNING LABELS
It indicates a dangerous situation that might result in moderate or severe/fatal injuries
unless avoided.
It indicates a dangerous situation that might result in moderate or mild injuries or
damage to property unless avoided.
This symbol indicates the possible presence of risks of contamination due to contact
with infected biological uids or materials.
This icon provides information that allows you to use the device more efciently.
2- GENERAL WARNINGS
•Read this manual carefully before carrying out any operation on the product, follow the
warnings contained in it and keep it for future reference.
•This manual is intended to provide the user with instructions for correct installation and
use of the product.
•The product must be used in accordance with the procedures contained in the manual
and never for purposes other than those provided for therein.
•The user is responsible for the installation, operation and maintenance of the device.
•The manual describes all product versions and optionals, therefore not all instructions are
applicable to your product.
•The product may be equipped with additional components, which are described in this
manual.
•The information, technical specications, drawings contained in this publication are not
binding.
•Tecnomed Italia s.r.l. pursues a policy of continuous product improvement and reserves
the right to make changes to the product or to this manual without prior notice, as long
as said changes do not affect the safe use of the device.
•Keep the manual within reach.
•It is also strictly forbidden any kind of reproduction or appropriation of the text and/or
images in the manual; therefore, some of the instructions, specications and images
contained in this manual may differ slightly from the product purchased by you.
•All the materials contained in this manual are the property of Tecnomed Italia and/
or of the companies represented by it. The images are not binding and are given for
explanatory purposes only.
•This manual must be delivered together with the machine in case of resale.
•The original text of this manual is in Italian.
DANGER! It is strictly forbidden to make changes to the device.
Tecnomed Italia s.r.l. assumes NO responsibility for personal injury and/or direct or indirect
property damage resulting from non-compliance with this requirement.
DANGER! Tecnomed Italia s.r.l. declines any liability, expressed or implied, and cannot
be held liable for personal injury and/or direct or indirect property damage deriving from
failure to comply with the instructions in this manual and/or from incorrect installation and/
or use of the device and its accessories and/or from improper and/or lack of cleaning and/
or maintenance.

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2.1 - GENERAL INSPECTION
ATTENTION! Check the package upon delivery and make sure it is intact and does
not present signs of impact. Otherwise, follow the indications in paragraph 2.2 or 2.3.
2.2 - IN-TRANSIT DAMAGES FOR DELIVERIES IN ITALY
Upon delivery, if the package/parcel shows visible signs of damage, the recipient must
or may sign the delivery note conditionally, reserving the right to claim for any damages.
The Italian law stipulates that “the receipt of goods by paying the amount due without
reserving the right to claim for any damages, renders the rights of the recipient deriving
from the contract void, except in cases of willful misconduct or negligence of the carrier”
(art. 1698 CC). To reserve the right to claim for any damages, ll in the dedicated elds on
the delivery note handed to you by the carrier before signing it. Each carrier has his own
procedure for conditional delivery, therefore you need to ask him how to proceed.
If the package presents clear signs of damage upon delivery, proceed as follows:
1. Check the appearance and the condition of the packages. Make sure they are intact
and complete: if the document mentions several packages, make sure you received
them all. The recipient and the carrier must sign the delivery note subject to verication
after clearly writing down the reason:
- “delivery refused/accepted subject to verication”
- “package with packing tape pulled off, delivery refused/accepted subject to
verication”
- “package with visible signs of damage, cardboard bent, delivery refused/accepted
subject to verication”
- “package extremely damaged and/or partially open, delivery refused/accepted
subject to verication”
2. Leave the product and the packaging as they are. Take a photo and/or a video of the
damaged package/parcel.
3. Do not use the product.
4. Report the damages to the transport company.
5. Report the damages to Tecnomed Italy srl ([email protected]).
6. Do not return the product to Tecnomed Italy srl before receiving an answer and an
authorisation to do so.
7. Send the signed delivery note to Tecnomed Italia srl.
8. Leave the product and the packaging as they are.
9. Do not use the product.
Note: if you suspect that the product might present hidden damages, not visible
from the outside, sign the delivery note conditionally.
If the product is damaged but the packaging presents no visible signs of damage,
proceed as follows:
1. Inform the transport company no later than 7 days after delivery.
2. Report the damages to Tecnomed Italy srl ([email protected]).
3. Leave the product and the packaging as they are.
4. Do not use the faulty product.
ATTENTION! If the recipient fails to comply with any of the aforementioned provisions,
the damage shall be considered as if arising after delivery.

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2.3 - IN-TRANSIT DAMAGES FOR DELIVERIES OUTSIDE ITALY
ATTENTION! Tecnomed Italy srl shall not be liable for damages occurred during transit.
Check the goods as soon as you receive them!
If the package presents clear signs of damage upon delivery, proceed as follows:
1. The recipient must note down the missing parts or the damage on the delivery note.
The recipient and the carrier must sign the delivery note. The recipient may claim the
replacement of the product due to in-transit damages only based on such evidence.
2. Leave the product and the packaging as they are.
3. Do not use the product.
If the product is damaged but the packaging presents no visible signs of damage, proceed
as follows:
1. Inform the transport company no later than 30 days after delivery.
2. Leave the product and the packaging as they are.
3. Do not use the faulty product.
ATTENTION! If the recipient fails to comply with any of the aforementioned provisions,
the damage shall be considered as if arising after delivery.
2.4 - TRANSPORT AND STORAGE CONDITIONS
The product inside the packaging is fragile. Avoid shocks.
Keep the package away from water and humidity.
Transport and store the product only in the direction indicated by the arrows.
Do not stack.
Temperature limit: from -10° to 50° C.
Humidity limit: from 10 to 90%.
Atmospheric pressure limit: from 500 to 1060 hPa.

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3- SAFETY RULES FOR INSTALLATION
DANGER! Tecnomed Italia s.r.l. declines any liability, expressed or implied, and cannot be
held liable for personal injury and/or direct or indirect property damage deriving from failure to
comply with the instructions in this manual and/or from incorrect installation and/or use of the
device and its accessories and/or from improper and/or lack of cleaning and/or maintenance.
ATTENTION! For safety reasons, Tecnomed Italia s.r.l., manufacturer of the SKUDO™,
recommends that the installation, maintenance and repair operations are carried out only
by authorised technical staff of Tecnomed Italia s.r.l.
DANGER! In case of faults, the components are to be replaced using only original spare parts.
DANGER! Any technician not authorised by Tecnomed Italia s.r.l., who makes changes to
the product replacing parts or components with spare parts different from those recommended
by the manufacturer, assumes a responsibility similar to that of the manufacturer.
DANGER! Comply with the conditions of use provided in the “Technical Specications”
chapter and do not exceed the recommended values.
DANGER! Do not use the product with accessories not approved by Tecnomed Italia
s.r.l. and without CE marking or tted with standardised interfaces. The patient and the dentist
might get injured or the device might get damaged. Install only accessories authorised by
Tecnomed Italia s.r.l. The company assumes NO responsibility for personal injury and/or direct
or indirect property damage resulting from non-compliance with this requirement.
3.1 - WORK ENVIRONMENT
ENVIRONMENTAL REQUIREMENTS:
• Environmental temperature: from +10°C to + 40°C.
• Optimum environmental temperature: from 15°C to 30°C.
• Relative air humidity: from 30 to 75%.
3.2 - MAXIMUM LOADS
• MAXIMUM PERMITTED LOAD ON THE SKUDO™HEAD:0.2 kg
DANGER! Tecnomed Italia srl declines any responsibility, expressed or implied, and
cannot be held responsible for injuries to people and/or damage to direct or indirect prop-
erties, which have occurred from the failure to comply with the above.

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4- SAFETY PROVISIONS
DANGER! Tecnomed Italia s.r.l. declines any liability, expressed or implied, and cannot
be held liable for personal injury and/or direct or indirect property damage deriving from
failure to comply with the instructions in this manual and/or from incorrect installation and/
or use of the device and its accessories and/or from improper and/or lack of cleaning and/
or maintenance.
DANGER! The device must be used exclusively by specialised and suitably trained
personnel. Use the device only for the intended use that is foreseen for it. Failure to observe
this prescription may cause serious injuries to the patient, the operator, and damages to
the device.
DANGER! Do not use the product with accessories not approved by Tecnomed Italia
s.r.l. and without CE marking or tted with standardised interfaces. The patient and the dentist
might get injured or the device might get damaged. Use only accessories authorised by
Tecnomed Italia s.r.l. The company assumes NO responsibility for personal injury and/or direct
or indirect property damage resulting from non-compliance with this requirement.
DANGER! The device and its accessories are supplied non-sterile. At the rst use and after
each treatment, the device and its accessories must be cleaned and/or sterilised following
the instructions in paragraphes “External CLEANING” and “INTERNAL CLEANING” page 22-23.
ATTENTION! After sterilising the components in the autoclave, wait for them to cool
down before using them.
CAUTION! Use only care and cleaning products authorised by Tecnomed Italia
s.r.l. Inappropriate products might damage the surface of the device, affect its operation,
lead to contamination or cause injuries to the patient and/or the operator. Tecnomed
Italia s.r.l. assumes NO responsibility for personal injury and/or direct or indirect property
damage resulting from non-compliance with this requirement. For more information, see
paragraphes “External CLEANING” and “INTERNAL CLEANING” page 22-23.
ATTENTION! Do not expose the device to direct sunlight or to sources of UV light.
ATTENTION! Disconnect the pneumatic, hydraulic and electrical power supply at
the end of the day (if present). Tecnomed Italia s.r.l. shall not cover damages caused by
failure to comply with the indications above.
DANGER! Before every treatment, always check that the device works perfectly
and that the accessories are efcient. Always check that there is no water underneath
the device. Do not perform the treatment if you notice any malfunctions. In case of
anomalies, contact a service centre authorised by Tecnomed Italia s.r.l.
DANGER! It is strictly forbidden to make changes to the device. Tecnomed Italia s.r.l.
assumes NO responsibility for personal injury and/or direct or indirect property damage
resulting from non-compliance with this requirement.
ATTENTION! In order to ensure the functionality and safety of the product and to avoid
any wear-related damages, the product requires routine and extraordinary maintenance
interventions at specied intervals (contact a service centre authorised by Tecnomed
Italia s.r.l.). For more information, see the paragraph “Maintenance” on page 24.
DANGER! Do not disassemble the device. In case of malfunction, please contact an
authorised Tecnomed Italia s.r.l. centre.

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BIOLOGICAL RISK - SKUDO™ blocks and sucks only the aerosols that follow the path
from the patient's oral cavity to the operator's face.SKUDO™ cannot be classied as a
personal protective equipment as it is not wearable and is not held in the hand by the op-
erator.For this reason it is necessary to always wear PPE as per current regulations.
WARNING! To ensure the functionality of the air curtain, check periodically the ef-
ciency of the compressed air system of the surgery and the supply pressure.
4.1 SAFETY REQUIREMENTS
Tecnomed Italia s.r.l. declines any liability, expressed or implied, and cannot be held
liable for personal injury and/or direct or indirect property damage deriving from failure
to comply with the instructions in this manual and/or from incorrect installation and/or use
of the device and its accessories and/or from improper and/or lack of cleaning and/or
maintenance.
Tecnomed Italia srl cannot be held responsible, expressly or implicitly, for any type of
injuries to persons and/or damages to property inicted by the user of the product and its
accessories, and which have taken place in the following cases:
• If the device is used for other purposes than those for which it is intended;
• If the device is not used in compliance with the instructions and requirements provided
in this manual;
• Lack of stock materials to be used in the event of device stop due to fault or
inconveniences;
• Use of accessories not authorised by Tecnomed Italia srl;
• If the electrical system available at the installation site does not comply with the
application standard and the appropriate requirements;
• Assembly and/or repairs carried out by staff not authorised by Tecnomed Italia srl;
• If the storage conditions do not comply with the requirements specied in chapter
“Transport and storage conditions”.
5- PRODUCT DESCRIPTION
5.1 - INTENDED USE AND METHODS OF USE
SKUDO™ is an aerosol protection system designed for the following sectors:Dentistry, max-
illofacial surgery, cosmetic microsurgery, otolaryngology or in any other sector where it is
necessary to protect yourself from aerosol ows.
It is the responsibility of the user to:
1- Use only EC certied devices in perfect state.
2- Protect himself, the patients and any third parties from any hazards.
3- Avoid any contamination of the product.
When using the device, follow the applicable regulations in force in the country of use, especially:
1- The provisions in force regarding safety at work.
2- The accident prevention measures in force.
DANGER! he device must be used exclusively by specialised and suitably trained personnel.
Use the device only for the intended use that is foreseen for it. Failure to observe this prescription
may cause serious injuries to the patient, the operator, and damages to the device.
DANGER! Tecnomed Italia s.r.l. declines any liability, expressed or implied, and cannot
be held liable for personal injury and/or direct or indirect property damage deriving from
failure to comply with the instructions in this manual and/or from incorrect installation and/

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or use of the device and its accessories and/or from improper and/or lack of cleaning and/
or maintenance.
5.2 - STANDARDS/CERTIFICATIONS
Medical device
The SKUDO™ device bears the CE mark.
The SKUDO™ device is classi ed as a class I medical device according to rule 1 of annex
IX of Directive 93/42/EEC.
The device also complies with the following standards:
Number Title
EN ISO 14971:2012 Medical devices – Application of risk management
Dir.93/42/EEC European directive concerning medical devices
Legislative Decree46/97 Implementing directive 93/42
Dir.2007/47/EC Updating directive 93/42
Legislative Decree37/10 Implementing directive 2007/47
EN 1041:2010 Information supplied by the manufacturer with the Medical
Devices
ISO 15223-1:2012
Medical devices -Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1:General
requirements
EN ISO 13485:2012 Medical devices. Quality management systems
EN 62366:2007 Application of Usability engineering to Medical Devices
5.3 - TECHNICAL FEATURES
Product code: DP2003S
Head diameter:300 mm
Flexible arm length:900 mm
Swivel angle:180°
Min/Max Operating air pressure:4-4.5 bar
Air consumption at 4 bar:16 l/min
Minimum suction depression:180 mbar
Additional noise at suction:12 db
Air blade size:H 210 x L 150 mm
Collar buttonhole size:90 x 10.5 mm
Weight:2 kg
Head material:White Plexiglas / anodised aluminium
Suction tube connection:Universal connector for large or small cannula
Power supply: pneumatic (with tube and quick coupling supplied)
93/42 EEC certi cation, Class I
WARNING! If there is no 4 bar, it is essential to insert a pressure regulator upstream of
the unit.The regulator must be connected to the pneumatic system of the dental unit and
calibrated at 4 bar.
Packing dimensions:
•BOX 1
Dimensions 400x400x100 mm
(width x depth x height).Weight 2 kg (approx).

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5.4 - DIMENSIONS
5.5 - PACKING LIST

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PHOTO DESCRIPTION
Collar for the head support arm
SKUDO™ with arm
Suction conveyor
Suction adapters 17/11 mm
Quick male  tting - 4 mm tube
Quick female  tting - 1/8F
Instruction manual
M6 knob
2 M5 knobs with washers
2 M5x14 stainless steel
4 M5x5 stainless steel
2 M5x10 stainless steel
2 M5x25 stainless steel

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5.6 - IDENTIFICATION PLATES
The plate is located on the headrest collar.
Data on the plate
• Name of the manufacturer.
• Name of the device.
• Product code.
• Serial number.
• Air pressure
• Suction depression
Guide to reading the serial number
1308001
Week of production
Progressive number
Year of manufacture

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5.7 - PRODUCT PROFILE
Headrest collar
Micro suction input
Compressed air outlet
Toggle
valve
Pneumatic
unit
Flexible arm
Pneumatic tube
4 x 0.75 mm
Adaptor
Suction
output
Suction unit

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6- INSTALLATION
DANGER! Tecnomed Italia s.r.l. declines any liability, expressed or implied, and cannot
be held liable for personal injury and/or direct or indirect property damage deriving from
failure to comply with the instructions in this manual and/or from incorrect installation and/
or use of the device and its accessories and/or from improper and/or lack of cleaning and/
or maintenance.
1
Insert the collar into the headrest rod and secure it using four M5 nuts, with different
lengths, of the 8 supplied.
2
R L
After listening to the doctor's need, screw the arm to the collar with the 2 M5x14
countersunk screws to the right or left.If the surgery/practice has continuous needs
for position inversion,  t the two M5 knobs with washers instead of the two counter-
sunk screws.
3
Screw in the locking knob
M6.
Secure the pneumatic tube to the arm by inserting it
into the o-rings.

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6.1 - SUPPLY CONNECTION - STANDARD INSTALLATION
AIR:
• Install the supplied female quick coupling on the water unit or on the back of the
chair.
• Connect it to a 4 bar pneumatic supply (NB: if necessary, install a pressure reducer -
Cod.PV1803MR)
• Insert the male quick coupling on the 4 mm pneumatic supply tube
SUCTION:
• Insert the cannula into use

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6.2 SUPPLY CONNECTION - FIXED INSTALLATION
WARNING! Procedure reserved for technical assistance.
Recommended when double suction is always used in the oral cavity.
WARNING! If all the dental units of the surgery/practice work simultaneously using
SKUDO™ and double suction cannula, it is necessary to check the ow rate of the suction
system as it could be under sized.
2,5X4 mm
4X6 mm
TUBO 17.5 mm
Cod. AS17TB10R
TUBO 25 mm
Cod. 040T990
1
2
3B
A
ARIA
AB
ARIA
AB

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7- INSTRUCTIONS FOR USE
ATTENTION! At the end of the day, disconnect the equipment by disconnecting the
quick air connection or turning off the dental unit.
ATTENTION! For any malfunctions not described herein, put the device out of service
and contact an authorised Tecnomed Italia s.r.l. technician.
DANGER! Before using the equipment, read the previous sections of this manual carefully,
paying particular attention to paragraph “Safety provisions” on page 9.
DANGER! Tecnomed Italia s.r.l. declines any liability, expressed or implied, and cannot
be held liable for personal injury and/or direct or indirect property damage deriving from
failure to comply with the instructions in this manual and/or from incorrect installation and/
or use of the device and its accessories and/or from improper and/or lack of cleaning
and/or maintenance.
DANGER! The device and its accessories are supplied non-sterile. At the  rst use and
after each treatment, the device and its accessories must be cleaned and/or sterilised
following the instructions in paragraphes “External CLEANING” and “INTERNAL CLEANING”
page 22-23.
8- POSITIONING
The SKUDO™ head is keyed onto an arm with a  exible end, which in turn is mounted on
an arm that rotates 160°, thanks to the presence of 2 stops, quickly
assuming the rest or working position.
160°

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70°
If necessary, it is possible
to block the SKUDO™ arm in intermedi-
ate positions by acting
on the central knob.
Once in the working position,
engage in the lower opening
the suction conveyor
duly disinfected.
WARNING!
Hold the SKUDO™ head in the centre
and bring it close to the patient's face
DANGER!
Never handle SKUDO™ from the ends of
the arch.Breakage hazard.
Damages attributable to this default are
not covered by the warranty.
SKUDO™ head should be
positioned at a distance of
about 20 cm from the face
so that the practitioner
can work easily in the oral
cavity.SKUDO™ creates an
invisible barrier that blocks
and sucks the aerosols that
pass through it or are in the
vicinity.
To facilitate the work at 9
hours, it is advisable to tilt
the SKUDO™ head by 45°.
In 12 hours, position
SKUDO™ about 10
centimetres from the face
with an angle that allows
agility of action.