Durr Dental VC 65 User manual

EN
VC 65
Operating Instructions
0297
0672100006L02
*0672100006L02*
2205V008

Contents
Important information
1About this document .. . . . . . . . . . . . . 3
1.1 Warnings and symbols .. . . . . . . 3
1.2 Copyright information .. . . . . . . . 4
2 Safety .. . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1 Intended purpose .. . . . . . . . . . . 4
2.2 Intended use .. . . . . . . . . . . . . . . 4
2.3 Improper use .. . . . . . . . . . . . . . . 4
2.4 General safety information .. . . . . 4
2.5 Information about infection pro-
tection .. . . . . . . . . . . . . . . . . . . . 5
2.6 Specialist personnel .. . . . . . . . . 5
2.7 Electrical safety .. . . . . . . . . . . . . 5
2.8 Only use original parts .. . . . . . . . 5
2.9 Essential performance charac-
teristics .. . . . . . . . . . . . . . . . . . . 6
2.10 Notification requirement of seri-
ous incidents .. . . . . . . . . . . . . . . 6
2.11 Transport .. . . . . . . . . . . . . . . . . . 6
2.12 Disposal .. . . . . . . . . . . . . . . . . . 6
Product description
3Overview .. . . . . . . . . . . . . . . . . . . . . . . 7
3.1 Scope of delivery .. . . . . . . . . . . . 8
3.2 Optional items .. . . . . . . . . . . . . . 8
4Technical data .. . . . . . . . . . . . . . . . . . . 9
4.1 Type plate .. . . . . . . . . . . . . . . . . 12
4.2 Evaluation of conformity .. . . . . . 12
5 Operation .. . . . . . . . . . . . . . . . . . . . . . 12
5.1 Foot switch .. . . . . . . . . . . . . . . . 13
5.2 Suction handpiece .. . . . . . . . . . 13
5.3 Suction cannula .. . . . . . . . . . . . . 13
5.4 Adapter .. . . . . . . . . . . . . . . . . . . 13
Assembly
6Requirements .. . . . . . . . . . . . . . . . . . . 14
6.1 Installation/setup room .. . . . . . . 14
7 Installation .. . . . . . . . . . . . . . . . . . . . . . 14
7.1 Remove the transport locks .. . . 14
7.2 Setting up the unit .. . . . . . . . . . . 14
7.3 VC 65 Cart .. . . . . . . . . . . . . . . . 15
7.4 Safety when making electrical
connections .. . . . . . . . . . . . . . . . 15
7.5 Connecting the unit to the mains
supply .. . . . . . . . . . . . . . . . . . . . 15
7.6 Preparation of the device .. . . . . . 16
8 Commissioning .. . . . . . . . . . . . . . . . . . 18
8.1 Electrical safety checks .. . . . . . . 18
Usage
9 Operation .. . . . . . . . . . . . . . . . . . . . . . 19
9.1 Setting up the unit .. . . . . . . . . . . 19
9.2 Suction .. . . . . . . . . . . . . . . . . . . 19
9.3 Replace the fuse .. . . . . . . . . . . . 19
10 Cleaning and disinfection .. . . . . . . . . . 20
10.1 Preparation at the operating
location .. . . . . . . . . . . . . . . . . . . 20
10.2 Device surface and hose mani-
fold .. . . . . . . . . . . . . . . . . . . . . . 20
11 Reprocessing .. . . . . . . . . . . . . . . . . . . 21
11.1 Risk analysis and categorisation .. 21
11.2 Preparation process in accord-
ance with ISO 17664 .. . . . . . . . . 21
11.3 Preparation at the operating
location .. . . . . . . . . . . . . . . . . . . 22
11.4 Manual cleaning, intermediate
rinsing, disinfection, final rinse,
drying .. . . . . . . . . . . . . . . . . . . . 23
11.5 Automatic cleaning, intermediate
rinsing, disinfection, final rinse,
drying .. . . . . . . . . . . . . . . . . . . . 23
11.6 Check for function .. . . . . . . . . . . 24
11.7 Steam sterilising .. . . . . . . . . . . . 24
11.8 Issue clearance for the parts for
sterilisation .. . . . . . . . . . . . . . . . 24
11.9 Storing parts for sterilisation .. . . 25
12 Maintenance .. . . . . . . . . . . . . . . . . . . . 26
Contents
0672100006L02 2205V008 1
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12.1 Lubricating the o-rings .. . . . . . . 27
Troubleshooting
13 Tips for operators and service techni-
cians .. . . . . . . . . . . . . . . . . . . . . . . . . . 28
Appendix
14 Handover record .. . . . . . . . . . . . . . . . . 29
Contents
2 0672100006L02 2205V008
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Important information
1 About this document
These installation and operating instructions rep-
resent part of the unit.
If the instructions and information in these
installation and operating instructions are
not followed, Dürr Dental will not be able
to offer any warranty or assume any liabil-
ity for the safe operation and the safe
functioning of the unit.
The German version of the installation and oper-
ating instructions is the original manual. All other
languages are translation of the original manual.
These installation and operating instructions
apply to:
VC 65
Order number: 0672500000; 0672500900
1.1 Warnings and symbols
Warnings
The warnings in this document are intended to
draw your attention to possible injury to persons
or damage to machinery.
The following warning symbols are used:
General warning symbol
Warning – dangerous high voltage
Biohazard warning
The warnings are structured as follows:
SIGNAL WORD
Description of the type and source of
danger
Here you will find the possible conse-
quences of ignoring the warning
❯Follow these measures to avoid the
danger.
The signal word differentiates between four levels
of danger:
–DANGER
Immediate danger of severe injury or death
–WARNING
Possible danger of severe injury or death
–CAUTION
Risk of minor injuries
–NOTICE
Risk of extensive material/property damage
Other symbols
These symbols are used in the document and on
or in the unit:
Note, e.g. specific instructions regarding
efficient and cost-effective use of the unit.
Refer to Operating Instructions.
CE labelling with the number of the noti-
fied body
Manufacturer
Dispose of correctly in accordance with
EU Directive 2012/19/EU (WEEE).
Serial number
Order number
Medical device
Health Industry Bar Code (HIBC)
Do not sit on the unit
Do not climb onto the unit
Disconnect all power from the unit.
Application part type B
Wear protective goggles.
Important information
0672100006L02 2205V008 3
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Use a mask.
Use protective clothing.
Wear protective gloves.
1.2 Copyright information
All circuits, processes, names, software pro-
grams and units mentioned in this document are
protected by copyright.
The Installation and Operating Instructions must
not be copied or reprinted, neither in full nor in
part, without written authorisation from Dürr Den-
tal.
2 Safety
Dürr Dental has designed and constructed this
unit so that when used properly and for the inten-
ded purpose it does not pose any danger to
people or property.
Despite this, the following residual risks can
remain:
– Personal injury due to incorrect use/misuse
– Personal injury due to mechanical effects
– Personal injury due to electric shock
– Personal injury due to radiation
– Personal injury due to fire
– Personal injury due to thermal effects on skin
– Personal injury due to lack of hygiene, e.g.
infection
2.1 Intended purpose
The suction unit provides the user in dental sur-
gery, orthodontic practice, dental clinic and / or
oral and maxillofacial surgery with vacuum and
volume flow.
2.2 Intended use
Working in combination with the suction unit with
treatment unit, suction handpiece and cannula,
the media used in dental treatment are removed
by suction.
2.3 Improper use
Any other usage or usage beyond this scope is
deemed to be improper. The manufacturer
accepts no liability for damages resulting from
this.
In these cases, the user/operator will bear the
sole risk.
WARNING
Risk of explosion due to ignition of
combustible materials
❯Do not operate the unit in any rooms in
which inflammable mixtures may be
present, e.g. in operating theatres.
2.4 General safety information
❯Always comply with the specifications of all
guidelines, laws, and other rules and regula-
tions applicable at the site of operation for the
operation of this unit.
❯Check the function and condition of the unit
prior to every use.
Important information
4 0672100006L02 2205V008
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❯Do not convert or modify the unit.
❯Comply with the specifications of the Installa-
tion and Operating Instructions.
❯The Installation and Operating Instructions
must be accessible to all operators of the unit
at all times.
2.5 Information about infection
protection
The national accident prevention regulations, as
well as the biological agent regulations that apply
for dental practices and dental hospitals, must be
observed during work with the VC 65 and during
disposal.
2.6 Specialist personnel
Operation
Unit operating personnel must ensure safe and
correct handling based on their training and
knowledge.
❯Instruct or have every user instructed in han-
dling the unit.
The following groups are not permitted to
operate or use a commercially operated unit:
– People without the necessary experience and
knowledge
– People with reduced physical, sensory or men-
tal capabilities
– Children
Installation and repairs
❯Installation, readjustments, alterations,
upgrades and repairs must be carried out by
Dürr Dental or by qualified personnel specifi-
cally approved and authorized by Dürr Dental.
2.7 Electrical safety
❯Comply with all the relevant electrical safety
regulations when working on the unit.
❯Never touch the patient and unshielded plug
connections on the device at the same time.
❯Replace any damaged cables or plugs immedi-
ately.
Observe the EMC rules concerning medical
devices
❯The unit is intended for use in professional
healthcare facilities (in accordance with IEC
60601-1-2). If the appliance is operated in
another environment, potential effects on elec-
tromagnetic compatibility must be taken into
account.
❯Do not operate the unit in the vicinity of HF sur-
gical instruments or MRT equipment.
❯Maintain a minimum distance of at least 30 cm
between the unit and other electronic devices.
❯Keep a minimum distance of 30 cm between
the unit and mobile radio devices.
❯Note that cable lengths and cable extensions
have effects on electromagnetic compatibility.
❯No maintenance measures are required to
maintain the EMV basic safety.
NOTICE
Negative effects on the EMC due to
non-authorised accessories
❯Use only Dürr Dental parts or accesso-
ries specifically approved by Dürr Den-
tal.
❯Using any other accessories may result
in increased electromagnetic interfer-
ence emissions or the unit having
reduced electromagnetic immunity,
leading to an erroneous operation
mode.
NOTICE
Erroneous operation mode due to use
immediately adjacent to other devices
or with other stacked devices
❯Do not stack the unit together with
other devices.
❯If this is unavoidable, the unit and other
devices should be monitored in order
to ensure that they are working cor-
rectly.
2.8 Only use original parts
❯Only use accessories and optional items that
have been recommended or specifically
approved by Dürr Dental.
❯Only use only original wear parts and replace-
ment parts.
Important information
0672100006L02 2205V008 5
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Dürr Dental accepts no liability for dam-
ages or injury resulting from the use of
non-approved accessories or optional
accessories, or from the use of non-origi-
nal wear parts or replacement parts.
The use of non-approved accessories,
optional accessories or non-genuine wear
parts / replacement parts (e.g. mains
cables) can have a negative effect in
terms of electrical safety and EMC.
2.9 Essential performance char-
acteristics
The VC 65 unit does not have any essential per-
formance characteristics as set out in
IEC 60601-1 (EN 60601-1) section 4.3.
The unit complies with the requirements accord-
ing to IEC 60601-1-2:2014.
2.10 Notification requirement of
serious incidents
The operator/patient is required to report any
serious incident that occurs in connection with
the device to the manufacturer and to the com-
petent authority of the Member State in which
the operator and/or patient is established/resi-
dent.
2.11 Transport
The original packaging provides optimum protec-
tion for the unit during transport.
If required, original packaging for the unit can be
ordered from Dürr Dental.
Dürr Dental will not accept any responsi-
bility or liability for damage occurring dur-
ing transport due to the use of incorrect
packaging, even where the unit is still
under guarantee.
❯Only transport the unit in its original packaging.
❯Keep the packing materials out of the reach of
children.
2.12 Disposal
Unit
The unit must be disposed of properly.
Within the European Union, the unit must
be disposed of in accordance with EU
Directive 2012/19/EU (WEEE).
❯If you have any questions about the correct
disposal of parts, please contact your dental
trade supplier.
The unit may be contaminated. Instruct
the company disposing of the waste to
take the relevant safety precautions.
❯Decontaminate potentially contaminated parts
before disposing of them.
❯Uncontaminated parts (e.g. electronics, plastic
and metal parts etc.) should be disposed of in
accordance with the local waste disposal regu-
lations.
❯If you have any questions about the correct
disposal of parts, please contact your dental
trade supplier.
An overview of the waste keys for Dürr
Dental products can be found in the
download area at:
www.duerrdental.com
Document no.: P007100155
Disposable bag
In Europe, dispose of disposable bags in accord-
ance with waste code 18 01 03* "Waste prod-
ucts, the collection and disposal of which
involves special requirements in order to prevent
risk of infection".
* If the waste code is marked with an aster-
isk (*), this indicates that the waste is haz-
ardous in the sense of the List of Waste.
Important information
6 0672100006L02 2205V008
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Product description
3 Overview
4
5
3
2
1
1 VC 65 cart
2 Foot switch
3 Hose manifold
4 Mains cable
5 surgical suction unit
Product description
0672100006L02 2205V008 7
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3.1 Scope of delivery
The following items are included in the scope of
delivery (possible variations due to country-spe-
cific requirements and/or import regulations):
VC 65 .. . . . . . . . . . . . . . . . . . . . . . 0672500000
VC 65 China .. . . . . . . . . . . . . . . . . 0672500900
– Mains cable 5 m
– Hose manifold
– Foot switch
3.2 Optional items
The following optional items can be used with the
device:
VC 65 Cart .. . . . . . . . . . . . . . . . . . 0672300000
Disposable container kit VC 65 .. . . 0670-987-00
Disposable hose L=2.10 m (50x)
with integrated cannula, internal
diameter d=2.5 mm .. . . . . . . . . . 0670-981-04E
Disposable hose l=2.10 m (50x) .. 0670-981-05E
Disposable bags, 2 l (22x) .. . . . . . 0670-980-09E
Surgical suction cannula, sterile Ø
2.5mm, 20 pieces .. . . . . . . . . . . . 0700-007-50
Surgical suction cannula, sterile
Ø 2.5 mm, 100 pieces .. . . . . . . . . 0700-007-51
Cannula attachments, straight,
gray (3 pieces) .. . . . . . . . . . . . . 7600A020-05E
Suction handpiece, straight .. . . . . 7600A025-00
Adapter .. . . . . . . . . . . . . . . . . . . . 7600A020-12
Product description
8 0672100006L02 2205V008
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4 Technical data
Electrical data
Rated voltage V
Hz
230
50
220-240
60
Nominal current A 0.8
Type of protection IP 22
Protection class II
Mains frequency Hz 50 / 60
Fuse T 2.5 AH/250 V IEC 60127-2/V
Classification
Medical Device Class (MDR) IIa
General technical data
Dimensions (W x H x D) mm 325 x 349 x 372
Dimensions with cart (W x H x D) mm 454 x 1050 x 571
Weight kg 16
Weight with cart and foot switch kg 27
Duty cycle % 100
Noise level* dB(A) 44
Air flow rate l/min
Hz
65**
50
75**
60
Pressure mbar (hPa) -910
* Noise level in accordance with ISO 3746 at 50 Hz
** Measurement in accordance with EN EN 10079-1 (with a silicone hose with a diameter of
10 mm and a length of 1.3 m).
Ambient conditions during operation*
Temperature °C +5 to +40
Relative humidity % ≤ 70
Air pressure hPa 800 - 1030
* 2000 m above MSL
Ambient conditions during storage and transport
Temperature °C -20 to +60
Relative humidity % ≤ 95
Air pressure hPa 750 - 1060
Electromagnetic compatibility (EMC)
Interference emission measurements
High-frequency emissions in accordance with CISPR 11 Group 1
Class B
Product description
0672100006L02 2205V008 9
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Electromagnetic compatibility (EMC)
Interference emission measurements
Interference voltage at the power supply connection
CISPR 11:2009+A1:2010
Compliant
Electromagnetic interference radiation
CISPR 11:2009+A1:2010
Compliant
Electromagnetic compatibility (EMC)
Interference immunity measurements on the cover
Immunity to electrostatic discharge
IEC 61000-4-2:2008
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Compliant
Immunity to high-frequency electromagnetic fields
IEC 61000-4-3:2006+A1:2007+A2:2010
3 V/m
80 MHz–2.7 GHz
80% AM at 1 kHz
Compliant
Immunity to near fields of wireless HF communication
devices
IEC 61000-4-3:2006+A1:2007+A2:2010
Refer to the table with immunity to interference levels for
near fields of wireless HF communication devices.
Compliant
Electromagnetic compatibility (EMC)
Interference immunity measurements on the supply input
Immunity to fast electrical transients/bursts – AC mains
voltage
IEC 61000-4-4:2012
± 2 kV
100 kHz repetition rate
Compliant
Immunity to surges, line-to-line
IEC 61000-4-5:2005
± 0.5 kV, ± 1 kV
Compliant
Immunity to surges, line-earth
IEC 61000-4-5:2005
± 0.5 kV, ± 1 kV, ± 2 kV
Compliant
Immunity to conducted disturbances, induced by radio-
frequency fields – AC mains voltage
IEC 61000-4-6:2013
3 V
0.15–80 MHz
6 V
ISM frequency bands
0.15–80 MHz
80% AM at 1 kHz
Compliant
Immunity to voltage dips, short interruptions and voltage
variations
IEC 61000-4-11:2004
Compliant
Product description
10 0672100006L02 2205V008
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Immunity to interference levels, near fields of wireless HF communication devices
Radio service Frequency band
MHz
Test level
V/m
TETRA 400 380 - 390 27
GMRS 460
FRS 460 430 - 470 28
LTE band 13, 17 704 - 787 9
GSM 800/900
TETRA 800
iDEN 820
CDMA 850
LTE band 5
800 - 960 28
GSM 1800
CDMA 1900
GSM 1900
DECT
LTE band 1, 3, 4, 25
UMTS
1700 - 1990 28
Bluetooth
WLAN 802.11 b/g/n
RFID 2450
LTE band 7
2400 - 2570 28
WLAN 802.11 a/n 5100 - 5800 9
Product description
0672100006L02 2205V008 11
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4.1 Type plate
1
1 Type plate
4.2 Evaluation of conformity
This device has been subjected to conformity
acceptance testing in accordance with the cur-
rent relevant European Union guidelines. This
equipment conforms to all relevant requirements.
5 Operation
2
4
4
3
1
1 Pressure gauge
2 Pressure regulator
3 On/off switch
4 Disposable container
The unit is used to suck secretions, blood, tissue
and bone fragments, as well as fluids accumulat-
ing during drilling, from the patient´s oral cavity.
The unit is used particularly in oral, orthodontic
and maxillofacial surgery, e.g. in implantology,
where a lot of bleeding occurs.
To adjust the pressure, close the suction hand-
piece and adjust the pressure on the control
knob. After insertion of a surgical suction cannula
into the suction handpiece the VC 65 is ready for
operation. The aspirated material passes directly
to the collecting container. Inside the collecting
container, the air is separated from the aspirated
fluids and other particles. After finishing work,
switch off the device. Before the collecting con-
tainer can be removed for emptying, wait a short
time until the pressure indicator shows normal
pressure.
Product description
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5.1 Foot switch
To switch on the unit, briefly press the foot switch
once. Pressing the foot switch again will switch
off the unit. The foot switch operates pneumati-
cally.
5.2 Suction handpiece
A suction cannula and a disposable hose can be
plugged onto the curved suction handpiece.
5.3 Suction cannula
The suction cannula is used during dental treat-
ments to aspirate media (e. g. water, saliva, pol-
ishing powder, solid materials like fillers, etc.)
from the patient's mouth. The suction cannula is
connected to the suction hose via a suction
handpiece.
The applied parts in accordance with IEC
60601-1 are:
– Suction cannulas
5.4 Adapter
Connecting piece, which, when plugged on, con-
nects the suction cannula d = 6.5 mm to the dis-
posable hose.
Product description
0672100006L02 2205V008 13
EN

Assembly
6 Requirements
6.1 Installation/setup room
The room chosen for installation must satisfy the
following requirements:
– Closed, dry room.
– Should not be a room made for another pur-
pose (e.g. boiler room or wet cell).
– The required environmental conditions are sat-
isfied (refer to the "Technical Data" in the oper-
ating instructions).
7 Installation
7.1 Remove the transport locks
❯Remove the transport protection on the under-
side of the device.
7.2 Setting up the unit
❯Place the unit on a horizontal table. The load-
bearing capacity of the table must be suitable
for the weight of the unit including its filling.
16
kg
Assembly
14 0672100006L02 2205V008
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7.3 VC 65 Cart
❯Place the unit on the VC cart and secure it.
7.4 Safety when making electrical
connections
❯The device must only be connected to a cor-
rectly installed power outlet.
❯Do not place non-fixed multi-socket units on
the floor. Follow the requirements in section 16
of IEC 60601-1 (EN 60601-1).
❯Do not operate any other systems using the
same multiple socket.
❯Make sure that none of the electrical cables
leading to the unit are under any mechanical
tension.
❯Before initial start-up check that the mains sup-
ply voltage and the voltage stated on the type
plate match (see also "4. Technical data").
7.5 Connecting the unit to the
mains supply
Requirements:
üProperly installed power outlet close to the unit
(max. mains cable length 5 m)
üEasily accessible power outlet
üMains voltage must match the information
shown on the type plate of the power supply
unit
WARNING
Electric shock
❯The device may only be connected to
a supply system with a earthed power
outlet.
❯Plug the connecting plug into the socket con-
nection of the device.
❯Plug the mains plug into the power outlet.
Assembly
0672100006L02 2205V008 15
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7.6 Preparation of the device
Attach the hose manifold
❯Attach the hose manifold to the housing until it
snaps into place.
Disposable container
❯Hook in the disposable container.
WARNING
Risk of cross contamination when
reusing the disposable bag
❯Do not use the disposable bag more
than once (disposable item).
❯Insert the disposable bag in the disposable
container.
❯Push the connecting hose and the connecting
sleeve on the standard rail mount adapter and
on the container. Insert the connecting sleeve
in the disposable bag.
❯Switch on the unit.
Assembly
16 0672100006L02 2205V008
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❯Close the connecting sleeve on the disposable
bag and press the cover slightly down in the
middle until the disposable bag has completely
unfolded.
WARNING
Danger of cross-contamination when
reusing the disposable bag and the
suction cannula for single use
❯Do not reuse the suction hose and the
suction cannula (disposable items).
❯Connect the suction hose to the suction hand-
piece and the connecting sleeve to the con-
tainer.
Connecting the foot switch
❯Connect the hose coming from the foot switch
to the connecting sleeve on the unit.
1
2
1 Knurled nut
2 Foot switch
❯Use the knurled nut to secure hose coming
from the foot switch.
Assembly
0672100006L02 2205V008 17
EN

8 Commissioning
NOTICE
Short circuit due to the build up of
condensation
❯Do not switch on the unit until it has
warmed up to room temperature and it
is dry.
If reusable items are used, comply with
the reprocessing instructions of the man-
ufacturers.
Regarding reusable components, the
components that contact the patient
directly, e. g. suction cannulas, need to
be reprocessed before each use. For
reprocessing instructions, see the operat-
ing instructions of the manufacturer.
❯Check the hose connections for leak-tightness.
❯Check the integrity of the collecting container.
8.1 Electrical safety checks
In many countries technical medical prod-
ucts and electrical devices are subject to
regular checks at set intervals. The owner
must be instructed accordingly.
❯Perform the electrical safety check according
to national law.
❯Document the results.
The applied parts in accordance with IEC
60601-1 are the suction cannulas (see
"5.3 Suction cannula").
Assembly
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