Yirro-plus Premium - DHM-dental
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Yirro-plus® Premium user manual / mode d’emploi / Benutzeranleitung / gebruikshandleiding self-cleaning dental mirror system / système de miroir dentaire auto-nettoyant / selbstreinigendes Mundspiegelsystem / zelfreinigend mondspiegelsysteem / version June 2020 / version Juin 2020 / Version Juni 2020 / versie juni 2020 / www.yirro-plus.com
This manual has been compiled with care.
If you have any remarks please inform us at info@dhm-dental.com
Ce mode d’emploi a été réalisé avec le plus grand soin. Si pourtant vous avez des
rémarques, veuillez-les communiquer à info@dhm-dental.com.
Diese Benutzeranleitung wurde mit Sorgfalt zusammengestellt. Sollten Sie
Bemerkungen oder Tips haben, so melden Sie diese bei info@dhm-dental.com.
Deze gebruikshandleiding is met zorg samengesteld. Mocht u desondanks opmerkingen
of verbetersuggesties hebben, informeer ons op info@dhm-dental.com.
MDR 2017/745 DHM-dental B.V.
Simon Stevinweg 48
6827 BT Arnhem
Nederlandcontents / content / Inhalt / inhoud EN user instructions F utilisation D Benutzerinstruktionen NL gebruiksinstructie declaration of conformity 4 déclaration de la conformité 16 Konformitätserklärung 28 conformiteitsverklaring 40 general description ... 5 description générale 17 allgemeine Beschreibung 29 algemene beschrijving 41 variations & exclusions 6 variantes & exclusions 18 Varianten/ Ausschließungen 30 varianten & uitsluitingen 42 material specifications 6 spécifications des matériaux 18 Spezifikation der Materialien 30 materiaal specificaties 42 product safety 7 sécurité des produits 19 Produktsicherheit 31 productveiligheid 43 safety measures 7 consignes de sécurité 19 Sicherheitshinweise 31 veiligheidsinstructies 43 compatibility 7 compatibilité 19 Kompatibilität 31 compatibiliteit 43 preferred mounting 7 montage préféré 19 die Bevorzugte Montage 31 beoogde montage 43 quality policy and reviews 8 qualité & les commentaires 20 Qualitätssystem & Reviews 32 kwaliteitsbeleid & reviews 44 standards and regulations 8 directives et normes 20 Richtlinien 32 richtlijnen & normen 44 mounting & installation 8 installation 20 Montage & Installation 32 installatie 44 location of docking station 8 le position du ‘docking’ 20 Position der Halterung 32 locatie van de docking 44 placing mirror with handle 9 le placement 21 Bereitstellen des Spiegels 33 klaarzetten van de spiegel 45 ‘on’ and ‘off’ switching 10 mise en marche 22 ‘an’ und ‘aus’ schalten 34 ‘aan’ en ‘uit’ schakelen 46 air flow regulation 10 régulation du flux d’air 23 Einstellen des Luftstroms 34 regelen van de luchtstroom 47 start using the system 11 utilisation du système 23 Betriebsbereit 35 in gebruikname 47 CDS (cleaning-desinfection-sterilization) 12 NDS (nettoyage-désinfection-stérilisation) 23 RDS (Reinigung-Desinfection-Sterilisation) 35 RDS (Reiniging-Desinfectie-Sterilisatie) 47 sterilization temperatures 12 températues de sterilisation 24 Sterilisationstemperaturen 36 sterilisatie temperaturen 48 verify & assembly 12 verifier & assembler 24 Überprufen und montieren 36 verifieer & monteer 48 disconnecting mirrors 13 démontage des miroirs 25 Spiegel abnehmen 37 uit elkaar nemen 49 storage temperatures 13 température de stockage 25 Lagertemperatur 37 opslagtemperatuur 49 malfunctions 13 pannes et réparations 25 Fehlfunktion & Reparatur 37 storing 49 maintenance 14 entretien 26 Wartung 38 onderhoud 50 stop using 14 mis hors service 26 Außer Betrieb stellen 38 buiten bedrijf stellen 50 dismantling & waste 14 démontage et déchets 26 Demontage & Abfall 38 demontage & afvalbeleid 50 warranty 15 garantie 27 Garantie 39 garantie 51 environmental aspects 15 aspects d’environnementaux 27 Umwelt Aspekte 39 milieu-aspecten 51 vigilance 15 vigilance 27 Aufsicht 39 toezicht 51 labelling of instructions 15 étiquettage des instructions 27 Anweisung der Beschriftung 39 labelling van instructies 51
declaration of conformity DHMD/CV01#8
This declaration of conformity contains the unique identification number DHMD/
CV01#8 and is published by DHM-dental BV, located on Simon Stevinweg 48, 6827
BT, Arnhem, NL. The subject of concern is a medical device, class 1, little risk, CE
marked, with registered trademark named Yirro-plus ® which is to be described as
a self cleaning dental mirror system, produced by DHM-Dental BV, Arnhem in the
Netherlands. DHM-dental BV has incorporated a Quality System according to EN/
ISO 13485 including GMP procedures. The Yirro-plus system is registrated at the
Dutch Government of Health [IGZ] with the registration number NL-CA002-29295.
DHM-dental BV hereby declares that the Yirro-plus® system meets all the
requirements that professional users may reasonably expect of a self cleaning
dental mirror system. During the development we have cooperated with expert
users. Prior to the launch both this product and its manual were tested by expert
users and service technicians for optimization of the usability, implentation and
reliability.
The Yirro-plus® system complies with the following directives and standards:
EN 980, Symbols for use in the labelling of medical devices
EN 1639, Dentistry — Medical devices for dentistry — Instruments
EN 1640, Dentistry — Medical devices for dentistry — Equipment
EN - english
EN-ISO 9873:2000, Dental hand instruments - reusable mirrors and handles
EN-ISO 14971, Medical devices — application of risk management to medical
devices EN 60601-1, Medical electrical equipment — Part 1: General requirements for
basic safety and essential performance 93/42/EEG (Medical devices, general rules)
This declaration of conformity is updated in Arnhem, Netherlands, on 05-04-2017 by
DGA DHM-dental BV.
signature:
This declaration of conformity was first issued on October 1, 2013 and is of unlimited
duration, will not be changed as long as the conditions described in the technical
documentation or the manufacturing conditions or the process of quality control
don’t change significantly.
4general description Yirro-plus® PREMIUM system
generic description
The Yirro-plus® system is a self-cleaning dental mirror system, in the Class 1
I of medical products. (Handles and mirrors are classified as Class Ir).
Product description
This dental mirror system is developed for professional dental experts. The 4b
self-cleaning function is based on controllable air flowing over the mirror 2
surface. The system consists of a detachable UHR mirror head [1], placed on
a hollow handle [2]; detachably connected to an air regulator [5] by a flexible 4c
silicon air-hose. A detachable magnet coupling [3] is to be docked in a station
[4]; docking and lifting of the coupling automatically switches on-and-off the 4a
3
air flow. Beneath the docking is an air regulator [5] containing a control knob
for regulation. The system is to be installed independantly to compressed air 5
(3-6 bar) and electricity net by a set of components: a connection hose [6];
a Power/Air supply box [7], T-part [8] and a medical power adapter [9]. The
components are to be disinfected and sterilized by usual methods (page 11).
[1] detachable mirror head (2 sizes) 9 6
[2] handle
[3] magnet coupling with ø4 mm silicone hose 7
[4a] universal docking
[4b] adaptor docking
[4c] mobile docking holder
[5] air regulator 8
[6] connection hose with strain relief
[7] Power/Air Supply box (CE) with FDA solenoid
valve 2W-NC connection to 24VDC 10
[8] T-part ø 6 mm T-part quick coupling for ø6 mm
compressed air tube
[9] Medical Power Adapter (100-240 VAC - 50/60 Hz)
out: 24 VDC according to EN 60601-1-11 with contra 11
part and interchangeable contacts (if applicable)
[10] Cleaning box
[11] noSPOT autoclave caps
[12] Allen key 12
5variations exclusions
Yirro-plus® Premium start set Yirro-plus® is NOT intended to be used as a multi-function syringe. The
Independant system, universal applicable, switching automatically. air hose is NOT meant to be connected to water or air-suction. Yirro-plus®
is not intended to treat a patient with a handle WITHOUT presence of a
Yirro-plus® Comfort start set mirror head or with a damaged mirror. Magnet coupling is NOT intende
Independant system, universal applicable, manually switched. to be sterilized; it might lose its magnetism. Do not use the system on
patients wearing medical devices vulnerable to magnetism.
Each start set contains: 4 handles (durable plastic), 4 mirror heads (2x
‘no. 0’; 2x ‘no. 2’), 1 cleaning box, 4 noSPOT autoclave caps, 1 magnet
coupling, 1 universal docking, 1 adaptor docking, 1 air regulator, con- material specifications
nection supply and a user manual / instruction sheet.
durable, scratch-resistant and safe materials
mirrors and handles Yirro-plus® products are produced from high quality heat-resistant and
Mirror heads are available in 2 sizes [see p.5 no.1]: no. 0 (13.2 mm) durable medical plastic. The mirror head contains a glass mirror with an
and no. 2 (18.4 mm). Mirrors are packed in 6-packs with user / cleaning ultra-high-reflective surface. The handle contains a magnetic metal ring
instruction. Handles are also packed in 6-packs with user / cleaning of surgical steel. The weight of 1 assembled handle with mirror is 14
instruction. For cleaning, disinfection and sterilisation, see page 11. grammes. Yirro-plus® air-couplings are produced from durable scratch-
safe plastic; containing a magnet and a thin silicon air hose mounted
cleaning accessoires onto a metal nipple. The docking is produced from durable plastic, re-
- Cleaning box [article 0312] - For safe cleaning and desinfection of mirrors, sistant to manual cleaning procedures by disinfectant. The air regulator
a Cleaning box is available, offering space for 6 mirror heads. / regulation knob is assembled from preserved metal components.
- noSPOT autoclave caps [article 0514] - For safe sterilization of mirrors,
to be placed on pre-cleaned mirror heads during sterilization, heat-resistant, safe adhesive joints and coatings
thus minimizing spots on the UHR mirror surface. All adhesives and coatings that are used for the assembly of mirrors
- nozzle adaptor - [article 0395] For more efficient use of the thermal disin- and handles are heat-resistant and absolutely safe for this application.
fector pens, creating 4 positions from 1 position. [*] Preferred sterilization temperature to optimize durability: 121ºC - 125ºC
with max 15 minutes exposure.
other accessoires
- Optional foot pedal (on/off switching in between preparations (Premium only) reliable accessories
- Special integration adaptors for mounting are separately available [*] Connection supply is according to relevant medical safety guidelines.
packaging, brochures
[*] Consult our website for most recent information on integration adaptors and other accessoires Our brochures, packaging and cartons are printed on recyclable paper
and cardboard.
6product safety compatibility
safe in use compatible with any type of dental unit
The Yirro-plus® system is a safe system, provided it is handled with care Yirro-plus® PREMIUM system is a universal applicable system and can
and in the way it is intended to be used. Clinical evaluation tests have be connected to any compressor from the dental trade offering 4-6 bar.
not shown the use of this system to causes any nuisance for dentist or
patient nor any gasses or chemicals dangerous for the health of patient
or user. The dental mirror heads and handles do not contain any sharp preferred mounting
edges that might hurt patient or the user. On/off switching or regulation of
the air flow did not cause any dangerous situations during tests. universal mounting system
Yirro-plus® is preferrably mounted at the NON-DOMINANT side, near
aerosoles the suction system.
During any preparation, and also during the use of the Yirro-plus®
system, inevitably aerosoles are spread in the air. For this reason mirror hand
you should always wear safety glasses and use a proper functioning The system is used by the ‘mirror’ hand. In order to prevent the ø 4 mm
suction system. silicon air hose to conflict with hoses of assistance, preferrably place
the Yirro-plus® docking at the non-dominant hand side, near or on the
noise delivery or, when applicable, at the bracket-tube, near the delivery.
The sound of the use of Yirro-plus® is not louder than the sound of the
regular instruments [multi-function syringe, scaler; bur]. Please be
aware that the simultaneous use of instruments can generate a level of
sound capable to cause hearing damage to you or your staff in the long
term. The use of ear protection will prevent unnecessary damage.
safety measures
safety instructions a) installation on delivery /assistance b) installation on the bracket, near the
Only use the Yirro-plus® dental mirror to view the work area and clean suction [tube-docking necessary]
the system after every treatment by your regular hygiëne procedures.
Avoid placing the magnet-coupling in the heart region of the patiënt, Several optoins of possible locations of the docking station are given at
for potential influence of pacemakers. Be sure to always wear ear page 9 and the separate ‘installation & mounting instructions’ sheet.
protection, hand gloves and safety glasses and follow the instructions
of the cleaning protocol, see page 11. [*] Consult our website for most recent information on integration adaptors and other accessoires
7quality policy & reviews installation by service technician
The Yirro-plus® PREMIUM system is to be installed independantly to
high quality standards compressed air and electricity. Instruct your technician for the instal-
Yirro-plus® is manufactured according to EN / ISO 13485 standard. lation of an independant system by use of included components, to be
Delivery of high quality is of greatest importance. In case this product connected with the main electricity and compressed-air system.
should not meet your expectations, contact the customer service
department; info@dhm-dental.com. More detailed installation instructions are shown on the separate
installation & mounting instruction sheet.
product development
The development of this product has been concluded in cooperation
with expert users. Important aspects such as ease of use, comfort, location of docking station [ 3 options]
functionality, safety and hygiene were assessed in an interactive process
contributing to the design, weight, user aspects, choice of materials and For the docking station the following 3 options are applicable:
production of the system.
A B C
reviews - postmarket surveys
It is our wish that Yirro-plus® is regularly reviewed by expert users. Check
our social media accounts on Twitter and Facebook. We invite you to give
your opinion about our product and post your pictures of installation to help
us to complete the online database of installation examples.
standards & regulations
The applicable standards for this product are indicated on the Declara-
tion of Conformity, see page 4.
A. universal docking B. ‘in free slot’ C. on tube ø 22mm
mounting and installation Ad A: Universal docking
On deliveries with vertical flat sides, the universal docking is always
choose the right spot for your docking station applicable.
For mounting, please consider the 3 options visualised at the right.
Check length of connection hose and (thin) silicon air hose. When Ad B: ‘In free slot’
mounting the docking, follow instructions of the separate installation & In case you have a spare slot available in your delivery, the included
mounting sheet. When mounting a special adaptor, follow the included docking adaptor might fit into the slot. For slots with different shapes,
mounting instructions.for the specific adaptor. alternative integration adaptors are available. (See website)
8Ad C: On tube ø13-ø22 mm
In case of a dental unit with a bracket arm and suction on the tube, the
Tube-docking is applicable. This docking has a ø13 adaptor that fits also placing dental mirrors (WITH sleeve)
on Cart tubes. Wear gloves and take the disinfected magnetic air coupling from the
parking docking. [Air flow starts blowing]. Mount a sleeve; punch the
Mounting options are described on a seperate installation & mounting air coupling through. Click the coupling at the handle and place the
instruction sheet. Most recent info is found on www.yirro-plus.com. assembly back into the docking station. [Air flow will stop].
placing mirror with handle
Disinfect handles and mirror heads according to standard procedures
as described on p. 11. Clean parking docking and air coupling accor-
ding to standard procedures. (Alcohol / disinfectant)
parking - (WITH sleeve)
wear gloves
place mirror into docking
parking (WITHOUT sleeve)
Wear gloves and take a disinfected and sterilized dental mirror. wear gloves
Place it in the docking station with the mirror head upright. mounting the sleeved coupling docking sleeved coupling
The magnetic air coupling will snap into the rear end of the handle, and at the handle at docking station
the mirror is ready for use.
9‘on’ and ‘off’ switching air flow regulation
docking and lifting in 1 movement Set the air flow as desired, by turning the control knob.
‘Docking’ and ‘lifting’ Yirro-plus® handles in and from the docking This setting can always be changed, even during treatment.
will switch ‘on’ or ‘off’ the air flow. It requires a swift movement, that
needs a little practice, but without any further extra attention. The
sensor in the system responds to the presence of the magnetic
coupling.
Conclusively, placing and lifting only the magnet coupling [without
handle] will also switch the air flow. clockwise: air flow will blow softer
counter-clockwise: air flow will blow more
firmly
lifting handle: ‘ON’ docking: ‘OFF’
Remove/lift the docked handle Placing back the dental mirror
vertically from the docking. into the docking automatically
The air flow starts immediately. switches-OFF the air flow.
Note:
Always keep in mind
that a constant air
flow set very strong
might be uncomforta-
ble to your patient.
Optional foot pedal
With the foot pedal [article 0268] option the air flow can be switched on/
off in between the preparation.
Alternatively, in order to work without air flow, detach the handle from
the coupling and place the coupling back in the docking [OUT]; or turn
the turnknob to the right [OUT].
lifting; air flow immediately docking; air flow
starts working immediately stops
10start using the system cleaning, disinfection & sterilization (CDS)
start using the system cleaning, disinfection & sterilization
For each treatment you (and if applicable your assistent) follow Yirro-plus® dental mirror system consists of a mounted docking station
this routine: with magnet coupling, accessoires and reusable instruments. The
Yirro-plus® CDS protocol consists of diverse stages. Depending on the
1 disinfect the handles and mirror heads separately [see p.11] intended use (not-critical, semi-critical or critical) and dependent on the
2 disinfect the docking and the magnetic coupling with disinfectant, regulation of your region, you will need to perform 1 or more stages.
place back the coupling into the docking Inform yourself which CDS protocols in your region are prescribed.
3 if preferred, use a sleeve for the air coupling [see p. 10] For Netherlands, this is the WIP regulation. ((*) Relevant actions are
4 check the disinfected mirror head / handle for post-cleaning residu / detailed specified in action tables, see downloads at our website for full
damage and assemble the handle and mirror; put it on a dental tray or details. Below the main summary is provided).
5 attach the disinfected dental mirror to the magnet coupling and place it
back into the docking (=switch OFF) non-critical use
6 start the treatment - use the dental mirror at your convenience - Mounted docking station, magnet coupling and mounting accessoires
regulate the air by turning the control knob, if applicable (adaptors) and SOLO clips are used in a non-critical way. These items
7 after the treatment, place back the dental mirror in the docking station. are to be cleaned by manual disinfection protocol. (Action table A(*)).
8 after the treatment: detach mirror and handle for separate disinfection
9 repeat steps 1 upto 8 semi-critical use / critical use
Yirro-plus® mirrors / handles are reusable components and may
repeated use of cleaned handles and mirror heads be used in semi-critical / critical way. For cleaning, disinfection and
The Yirro-plus® system is developed for repeated use of disin- sterilization of these components, you need to follow the applicable
fected instruments according to hygienic rules. Please instruct cleaning prototocols for semi-critical / critical instruments. (Action
your assistant in advance about the use and cleaning methods tables B-C-D-E (*)):
of the system. The start set includes 4 handles and 4 mirror
heads, enough to conduct several treatments. - Manual (pre)cleaning (action table B).
- Machinal cleaning by use of ultrasonic cleaner (action table C)
Extra handles and mirror heads are separately available: - Machine thermal disinfection (action table D)
- Machine sterilisatie by use of autoclave (action table E).
article 0009 6-pack of no. 0 mirrors
article 0002 6-pack of no. 2 mirrors (**) Sterilization by Eto / plasma are also possible. Sterilization by Gamma radiation /
article 0728 6-pack of handles E-beam is not recommended due to negative influence on durability of plastics.
(***) Chemical disinfection is excluded from this CDS: WIP guideline (Netherlands)
prescribes chemical disinfection is an exclusive option, only to be applied for instru-
ments that are NOT resistant to thermal disinfection.
11Depending on the situation if you DO or DO NOT make use of machine Sterilization temperatures
thermal disinfection, you need follow applicable CDS method tables:
Yirro-plus® handles are produced from medical plastic that is resistant
CDS methods for cleaning WITH use of machine thermal disinfection to sterilisation at 134ºC, however, that shows a longer durability when
applying plastic programm (121ºC-125ºC, max. 15 min. - see table E.)
component use CDS method action table
non-critical manual disinfection A General CDS instructions
docking, air-regulator,
magnet coupling use • Follow the applicable regulation for CDS of semi-critical and critical
use of reusable instruments that apply to your region
mirrors and handles semi-critical manual (pre) cleaning B • Comply to the rules for personal protection and clean workspace
use (optional) ultrasonic cleaning C • Follow the directions of this CDS protocol and ensure your staff is
machinal thermal D aware of it and can perform the instructions.
disinfection • Use approved cleaning agent and approved equipment
• Separate clean and dirty instruments according to the guidelines
critical use manual (pre)cleaning B
mirrors and handles
ultrasonic cleaning
Specific instructions for CDS of Yirro-plus®
(optional) C
machinal thermal D
Cleaning, disinfection and sterilization: general instructions
disinfection • Disassemble mirrors/handles prior to cleaning,disinfecting/sterilization.
sterilization (packed or E • When rubbing dry Yirro-plus® mirror heads, it is best to use soft
unpacked) microfibre cloth, sterile cloth / gauze. Rub gently to avoid scratches.
• Use the included Yirro-plus® cleaning accessories: Yirro-plus® Cle-
aning box, Yirro-plus® noSPOT Autoclave Cap.
CDS methods for cleaning WITHOUT use of machine thermal disinfection • During cleaning / disinfection, place mirror heads in the Yirro-plus®
cleaning box.
component use CDS method action table • When sterilizing mirrors in a steam autoclave, preferably use noSPOT
Autoclave Caps, also in the pouch. (In order to minimize solid spots on
docking, air-regulator, non-critical manual disinfection A
mirror surface due to dirt in water system).
magnet coupling use
mirrors and handles semi-critical manual (pre) cleaning B
use (optional) ultrasonic cleaning C Verify & assemble
AND manual cleaning/disinfection B
critical use sterilization (packed or E Verify & assemble
unpacked) Check with each mirror and handle for contamination residues or other da-
mage. Worn or damaged mirrors are not safe to use and must be replaced.
12mounting malfunctions
Press the mirror head in the handle - DO NOT TOUCH the mirror
surface with your fingers. malfunctions
The Yirro-plus® system has been manufactured from high quality compo-
DO NOT TOUCH glass
nents and allows a use without worries for a long time. If, however, you
notice a malfunction, following list will help you to make a first diagnosis:
Press tightly and verify assembly ‘click’.
1 no air flow
2 automatic switch does not function
3 the air regulation does not function
“click” 4 the magnet coupling does not function
5 the mirror head can not be mounted into the handle
6 silicone air hose ø 4 mm is broken or punched
7 the connection hose is broken or punched
fault 1 - no air flow
Action: Check if the air is completely “ turned off ” [control knob in most right
disconnecting mirrors position? Turn it leftward and check if air starts]. Check if the air pressure is
functioning. If this is the case and the system does not function, there might be a
disconnecting problem with the power supply. Action: Check if the contacts of the Power adapter
Pull the mirror head from the
are connected properly to power and Power/Airbox. In case of a functioning
handle by a lineair movement.
compressed air system and no malfunctioning of electricity, the air might be
blocked for another reason. Contact your service technician.
lineair movement fault 2 - automatic switch does not function
Action: Make sure to place the handle deep enough in the parking docking;
then the sensor detects the magnet. If this does not help, check if magnetism
of the magnet coupling is functioning. If the magnet is OK there might be a
storage temperature malfunction with the reed sensor. Contact your service technician.
storage temperature fault 3 - air regulation does not function
The storage temperature of mirrors and handles is 0 oC - 50 oC. Check if turning the control knob influences the air flow. If turning does not
change the flow from hard to soft or vice versa, then the regulation system is
malfunctioning. Contact your service technician.
13fault 4 - air coupling does not click into handle REMARK 1: The docking station contains a sensor that should NOT be
Action: Make sure the magnet is still functioning by holding it near to a cleaned in thermo-disinfector or the ultrasonic cleaner, nor sterilized in the
metal object. If the magnet is defect, order a new coupling or contact autoclave. Clean the docking by whiping-off with desinfectant.
your service technician.
REMARK 2: The air coupling contains a magnet, which magnetic force
fault 5 - the mirror head can not be mounted into the handle might vanish when sterilized in the autoclave. Therefore, DO NOT place
Action: Check the front of the handle. If it is bent, the handle cannot be the air coupling in the autoclave or thermal-disinfector; instead disinfect by
used anymore. Use a replacement handle or order new ones. Check if wiping-off with disinfectant.
the mirror head is thoroughly cleaned; material residu [composite] may block
the clicking and can damage a mirror when mounted into the handle. Check
mirror head clickers. If they are defect, replace mirror head. stop using
fault 6 - silicone air-hose is broken or leaks stop using
After a period of time, the silicon hose might show some relaxation, For de-activation of the system, disconnect the connection hose from the
causing the nipple-connection to leak some air. In this case pull off the air supply. Make sure to reconnect the air hose to the compressor correctly.
air-hose and cut-off a piece (1 cm) and put it back in place. It will fit If necessary, ask your service technician to dismantle the system.
more tightly. In other cases: if the air-hose is damaged, order a spare
part. You can also contact your service technician.
dismantling & waste
fault 7 - the connection-hose is broken or punctured
Action: Contact your service technician for a repair. dismantling and waste
The Yirro-plus® system can be dismantled into separate components
for separate collection: All used and unused technical components,
maintenance accessoires and non-consumables are taken back for disassembly and
maximal re-use of components. If you deliver the goods back at your
maintenance dealer, the dealer will periodically return the goods to the producer.
Apart from regular cleaning, the Yirro-plus® system needs no maintenence. Used consumables [like mirror heads] will NOT be taken back by the
Disinfect mirrors and handles after every treatment by proceeding the manufacturor.
regular hygiene procedures [p.11]. Whipe-off / clean docking station
and air coupling after every treatment by use of disinfectant. The
regular wearance of mirrors and occasional wearance of the silicon air
hose is normal and their replacement will be necessary after a certain
time of use. This replacement is not to be considered as a repair and it
is excluded from warranty.
14warranty labelling of instructions
warranty The packaging and disclaimers of the Yirro-plus® system contain the
The Yirro-plus® system has a limited 2-year warranty, which only relevant product information and instruction labels / safety ratings
applies to installation / system components: air control system, sup- according to EN 980:2008.
plied connection materials, magnetic coupling, the foot pedal and the
dockings. DHM-dental is not liable for any consequential damage as Consult instructions for use
a result of the system not functioning. Consumables such as handles, The synonym for ‘consult instructions for use’ is ‘consult operating instructions’.This
symbol corresponds to the one in ISO 7000-1641 and symbol 5.3 in ISO 15223-1:2007
mirror heads and autoclave caps are not covered by the warranty.
Symbol for CE Mark. This symbol certifies that this product has met European
Union consumer safety, health or environmental requirements.
! Symbol for caution. This safety symbol is used at Yirro-plus® within the context:
environmental aspects “attention, see Instructions for Use.”
Symbol for temperature limitation/temperature range. Both upper and lower
limits are indicated adjacent to horizontal lines.
environmental aspects
The raw materials, production and transport processes required for NON
Symbol for nonsterile. This symbol should be used only to distinguish between
identical or similar devices sold in both sterile and nonsterile conditions.
production of the Yirro-plus® system, inevitably pollute the environment. STERILE
By choosing sustainable materials with a long life and low energy pro- SS Symbol for Surgical steel
duction the environmental load of the Yirro-plus ® system is minimized. o
124 C
The energy required for the supply of compressed air and for cleaning Autoclavable at temperature indicated
of the system, is a factor of importance for the environment. By using
alternative energy sources such as wind or solar power, you can help Resistant to chemicals of thermo-disinfection
minimizing the environmental aspects when using this system.
Do not place magnet coupling on chest of people with pacemakers or motorised insulin
pumps.
vigilance LOT Symbol for batch code/lot number.
The symbol is accompanied by the manufacturer’s batch code.
vigilance Symbol for manufacturer. This symbol is accompanied by address and name of
manufacturer.
DHM-dental bv is convinced to have done everything possible to
safely and reliably market this product. To this end, all the guidelines Symbol for manufacturing date. This symbol is accompanied by a date, to
indicate the manufacturing date.
have been followed, discussions with experts have been held and an
ISO 13485 quality management system including a GMP have been 2 Symbol for quantity per box. Any number can be represented in the box.
implemented. If despite all this you believe this system does not meet
the qualities and standards reasonable to expect, you can report this to Symbol for angle of view of mirrors. The number indicates the angle in degrees.
the appropriate authorities.
15MDR 2017/745 DHM-dental B.V.
Simon Stevinweg 48
6827 BT Arnhem
NederlandYou can also read
