user manual - DHM
Contents
1. 6 connection hose EN 23964 user a permanent sight 145 mm Yirro plus Premium The system contains of a detachable mirror head 1 placed on a hollow handle 2 that is detachably connected to the central press air station by an flexible silicon air hose The detachable magnet coupler 3 at the end of this air hose is to be parked in a docking station The parking and lifting of the magnet coupler automatically switches on and off the air flow Beneath the docking the air regulator 5 is situated containing a turning knob for air regulation The system is to be installed independantly to the central press air and the eletricity net by a set of components consisting of a connection hose 6 and a Power Air supply box see p 6 7 8 9 The components of the system can be cleaned by the usual methods exclusion The Yirro plus system is NOT intended as a multi function syringe or general tool for your assistent The system is NOT meant to be connected to water or air suction Yirro plus handles are NOT meant to be used as an instrument without the mirror head The magnet coupler 3 is NOT to be cleaned in the autoclave it might lose its magnetism The connection hose 6 is NOT meant to be connected to other instruments 165 mm According to classification in annex IX from the European Rules for medical products variety of Yirro plus programme Premium The Premium basic set is an independant complete syst2. Yirro plus Premium bruikshandleiding user manual Benutzeranleitung mode d emploi ia nondspiec m self cleaning dental mirror system selbstreinigender Mundspiegelsystem syst me de miroir dentaire d auto nettoyage rsie December 3 version December 2013 Version Dezember 2013 version Decembre 2013 www Yirro plus com Deze gebruikshandleiding is met de grootst mogelijke zorg samengesteld Mocht u desondanks van mening zijn dat de inhoud van deze handleiding niet volledig of onjuist is stuur uw opmerkingen of verbetersuggesties naar service dhm dental com This manual has been compiled with care If you have any remarks please inform us at service dhm dental com Dieser Manual wurde mit Sorg zusammengestellt Sollten Sie Bemerkungen oder Tips haben so melden Sie diese bie uns ber service dhm dental com Ce mode d emploi a t r alis avec le plus grand soin Si pourtant vous avez des r marques veuillez les communiquer a service dhm dental com DHM dental B V ler Groot Vijverdal 27 wl 6822 MB Arnhem DENTAL Nederland inhoud contents Inhalt content UK user instructions declaration of conformity general description exclusion variants material specifications product safety standards amp regulation compatibility prescribed mounting quality policy and control safety measures installation components mounting docking parking amp switching regulation air flow start using cl
3. advance about the use of the system Extra handles and mirror heads are seperately available also a cleaning box for safely cleaning of 6 mirror heads in a thermodisinfector or autoclave cleaning instructions Cleaning handles is possible according to the hygiene directive for cleaning of hollow instruments The rear end of the handle fits to the oi mm pins and silicone instrument holders of your Miele thermodisinfector cleaning box A significant amount of regular damage of instruments is caused by the cleaning process The special Yirro plus cleaning box is a protection box to safely clean 6 mirror heads This will extend the life of the mirror heads significantly malfunctions There is interference in the system in the following situations 1 air flow does not function 2 parking Yirro plus does not switch off air flow 3 the air regulation does not function 4 the coupler does not click into the handle 5 the mirror head can not be mounted into the handle 6 silicone air hose is broken or punctured 7 the connection hose is broken or punctured Fault 1 airflow does not function Action Make sure your air pressure is functioning If the connection hose is blocked for air the Yirro plus system is not functioning There may be a pro blem with the power supply Both of these aspects are beyond the scope of this manual If the pressed air system is functioning and if there is no malfunctioning of the electricity th
4. be attaced at any place desired Please take into account in advance the required length of the connection hose and air hose Proceed as follows El Detemination of Mounting surface The Yirro plus system is preferrably positioned sideways most right on the assistance unit At your mirror hand If you are left handed then choose the opposite side most left A surface of 20 x 45 mm wil suffice Choose a position that minimizes conflicts with the work of your assistant Check the available length of the air coupler hose d WM ER 4 C Anthos For the purpose of better adhesion the mounting surface needs to be cleaned with alcohol KJ remove adhesive mount Remove the adhesive strip and attach the universal suspension Press firmly for 20 seconds CI place air coupler Carefully read the warning text before removing the label of the air coupler Place the air coupler in the docking CI mounting the connection hose Screw the connection hose to the air regulator After cleaning your system is ready for use mounting with adaptor docking ALTERNATIVE adaptor docking and adaptor ring Sometimes it is possible to place the Yirro plus system into a free slot of your assistance unit KaVo Planmeca Anthos A dec For this purpose in the basic set a adaptor docking and an adaptation ring are included Note This mounting option is not covered by our CE marking and might possibly conflict to the CE marking
5. of your dental unit For dental units of the type KaVo A dec and Anthos the docking adapter 1 can be used At the Plan meca units the additional adapter ring nr 2 is required Proceed as follows I cheching the doching adaptor and adaptor ring Planmeca mounting first mount the extra adaptor ring 2 into the slot and afterwards click the docking adapter 1 into it EN r emove universal doching Loosen the screw and remove the universal docking of the control unit Place the universal docking aside and keep the screw at hand i 2 at ENS mounting on air regulator with screws Place adaptor docking with or without the extra adaptator ring in the free slot with its opening to the front Slide the air regulator into the slots of the adaptor docking Screw both parts together by means of the detached 1 screw F e O Se e Carefully read the text before removing the label information of the air coupling Place the air coupler in the docking S En mounting the connection hose gi Mount the connection hose to the air regulator After cleaning the system is ready for use Spd a mene yinrot parking and switching Clean handle and mirror head according to standard procedures parking WITHOUT sleeve Put on your sterile gloves and take a clean dental mirror Park it in the parking docking with its head upright The magnetic air coupler will snap perfectly into the rear end of t
6. an also deconnect the connection hose dismantling and waste dismantling and waste The Yirro plus system can be dismantled into separate components for separate collection environmental aspects environmental aspects The raw materials production and transport processes required for pro duction of the Yirro plus system inevitably pollute the environment By choosing sustainable materials with a long life and low energy production the environmental load at Yirro plus is minimized The energy required for the supply of compressed air and for cleaning of the system are factors that are important for the environment By using alternative energy sources such as wind or solar power you help minimizing the environmental aspects when using this system vigilance vigilance DHM dental bv is convinced to have done everything possible to this safely and reliably to market this product To this end we have followed all the gui delines discussed with experts and have implemented a quality management system If you still believe that this product does not meet the qualities and standards that are reasonable to expect you can report this to the appropri ate authorities product information product information In all packageing and disclaimers of the Yirro plus system you will find the relevant product information and instruction labels safety ratings according to EN 980 2008 We use the following labels Con
7. e air hose might be blocked Contact your service technician Fault 2 parking Yirro plus does not switch OFF air flow Premium You may not place the the handles far enough into the parking doc king in which case the switch sensor does not detect the magnet Action push the handle a little further into the parking docking If this does not help check the magnetism of the magnet See also at nr 4 Fault 3 air regulation does not function Premium The air flow is controlled by the rotary knob on the air regulator If turning the knob does not change the flow from hard into soft or vice versa then the regula tion system is malfunctioning Action Make sure that the control knob can be turned If so and still no change of air flow occurs than contact your service technician If this is not the case then the control knob is defect If you can turn the knob but there is no effect in air force than the air regulator is defect inside In both situations you need to contact your service technician Fault 4 coupler does not click onto the handle The magnetic force of your magnet coupler might have gone lost Action Make sure the magnet in the coupler is functioning by holding it near to a metal object If the magnet is defect you can order a new coupler or you can contact your service technician Fault 5 the mirror head can not be mounted into the handle Action Check the end of the handle Is this bent then the handle cannot be used an
8. eaning malfunctions maintainance stop using Premium dismantling amp waste environmental aspects vigilance labelling o cS a Sn Wen Li LL NL nederlands declaration of conformity This declaration of conformity contains the unique identification number DHMD CV01 2 and is published by DHM dental BV located on Grand Vijverdal 27 6822 MB Arnhem NL The subject of concern is a medical device in class 1 with registered trademark named Yirro plus to be described as a self cleaning dental mirror system produced by DHM Dental BV Arnhem in the Netherlands 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 to optimize 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 1041 Information supplied by the manufacturer with medical devices EN 1639 Dentistry Medical devices for dentistry Instruments EN 1640 Dentistry Medical devices for dentistry Equipment EN ISO 9873 2000 Dental hand instruments reusable mirrors and handles EN ISO 9687 Dental equipment Graphica
9. em universal ap plicability The set contains 2 boxes of handles with in total 8 plastic handles 2 boxes of mirrors with in total 12 mirror heads 6x type Triade 0 6x type Triade no 2 1 magnet air coupling 1 parking docking 1 air regulator 1 Power Air supply box with solenoid valve and connection hose 1 user manual and 1 disclaimer mirror box Triade no 2 size big 1 box with 6 mirror heads no 2 18 4 mm user instruction disclaimer mirror box Triade no 0 size small 1 box wit 6 mirror heads no 1 13 2 mm user instruction disclaimer handle box 1 box with 4 handles durable plastic user instruction disclaimer cleaning box from spring 2014 cleaning box for protected cleaning of 6 mirror heads 20 N B None of our products are sterile please clean before use material specifications durable scratch safe and secure materials The Yirro plus handles and mirror heads are produced from high quality heat resistant and durable plastic The mirror head contains a glass mirror with ultra reflection surface The base contains a metal ring of stainless steel and its weight is only 11 5 grammes The housing of the Yirro plus air coupler is produced from durable and scratch safe plastic with attached to it an silicon air hose The air hose is mounted on both sides into a metal nipple The parking docking is fabricated of a durable plastic resistant to the usual cleaning procedures by alcohol or desin
10. f the Yirro plus system quality policy amp reviews quality Yirro plus Yirro plus is manufactured according to EN ISO 13485 standard and the quality is of the greatest importance from product development to implemen tation and expedition Should nevertheless occur the case that this product does not meet your expectations you may contact the customer service department service dhm dental com product development The development of this product has been concluded in close consultation with expert users whereby every step and solution has been tested and verified Important aspects such as ease of use comfort functionality safety and hygiene were assessed and this interactive process has contributed to the de sign weight aspects choice of materials and production of the whole system reviews postmarket surveys It is our wish that the Yirro plus system is regularly reviewed by expert users Take a look at our social media accounts on Twitter and Facebook see links on http www dhm dental com socialmediaNL html We kindly invite you to give your personal opinion about our product safety measures safety instructions Use the Yirro plus dental mirror only for the view of your workspace and put it back in place after every patient treatment The system is to be cleaned af ter every treatment by using the regular hygi ne procedures as described Do not place the magnet coupling near by the heart of the pat
11. fectants The air regulator and regula tion knob are composed of preserved metal components heat resistant safe adhesive joints and coatings All adhesives and coatings used in assembly are heat resistant and absolu tely safe for this application reliable accessories The parking docking is mounted with a standard connection hose produced by the EN 23964 directive All components meet medical safety guidelines packaging brochures Our brochures packaging and cartons are printed on recyclable paper and cardboard product safety safe in use The Yirro plus system is a safe system provided it is used with care and in the way it is meant to be used no danger or nuisance This dental mirror does not contain any sharp parts or edges that might hurt patient or the user The on off switching or the regulation of air does not enable any dangerous situations By use of this product no hinder or nuisance for dentist or patient is caused nor do any gasses or stoffen occur that are dangerous for the health of patient or user This product has been tested thoroughly by expert users in this respect standards and regulations For this product the following directions have been applied EN 980 Symbols for use in the labelling of medical devices EN 1041 Information supplied by the manufacturer with medical devices EN 1639 Dentistry Medical devices for dentistry Instruments EN 1640 Dentistry Medical devices for de
12. he handle sterile gloves parking at Premium docking parking WITH sleeve Clean parking docking and air coupling according to standard procedures Alcohol disinfectant parking dental mirrors WITH sleeve on and off switching through parking Put on your sterile gloves and take the clean magnetic air coupler from the parking docking Prick the air coupler into a sleeve and then click the magnetic coupler on the rear end of the handle Place it back in the docking station parking and lifting Through the parking and lifting of your Yirro plus handle into and from the parking docking you are able to switch on or off the air flow It requires a swift movement that needs a little practice but without any further extra attention The system responds to the presence of the magnetic coupler Re placing the magnet coupler without the handle will also switch off the air flow lifting air flow ON parking air flow OFF lifting handle ON parking OFF Removellift the parked handle Park the mouth mirror back into the vertically from the docking The docking The system detects the air flow shall start immediately magnet and the airflow will automatically be switched OFF sterile gloves parking the sleeved mouth mirror mounting the sleeve to docking station click coupler at rear end of handle lifting air flow immediately parking air flow starts worki
13. he installation instruction instruction split air by making use of T part R 3 8 8 create an electrical connection for Power Adapter 9 Connect Power adapter togehter with contra plug into the electricity and put the end plug in Power Air Supply box 7 Connect the end of the Air Tube fitting to the Power Air Supply box The CE marking for this product prescribes that installation of the system is to be carried out by an authorized service technician mounting parts for installation 3 connection hose EN 23964 7 Power Air Supply box 8 T part R 3 8 9 Power adapter medical Povver Air Supply box CE with FDA solenoid valve 2W NC 24 VDC 2 metres of connection hose according to EN 23964 with strain relief T part R 3 8 CE T part to be connected directly to compressed air system Power adapter CE 100 240 VAC 50 60 Hz out 24 V DC according to EN 60601 1 accompanied by contra plug and wires CT Despite the fact that it is technically possible to connect this system directly to 24V DC this is not recommended Direct connection may conflict with the warranty and CE requirements of your unit Consequently direct connection is not covered by the CE marking of the Yirro plus system Cl cleaning the mounting surface Brp a mnir ynrot mounting of parking docking use the universal mounting system By use of the included universal mounting system the system can
14. i nt for potential influence of pacemakers Do NOT clean the detachable magnet coupler in the autoclave since its magnetic force might be lost Clean the detachable couplers properly with alcohol or disinfectant installation by a qualified technician installation Your Yirro plus system is to be installed by a qualified technician You can instruct your technician to install an independant system by use of included components to be connected with the main electricity and compressed air system For connection instructions see aside right spot Decide in advance whether you will use the universal mounting system CE Maybe you prefer the use of the adapter rings See for this the 2 options visualised at page 21 Check the length of the connection hose and the thin silicon air hose After installation the Yirro plus parking docking can be mounted For this see the steps described at pages 23 25 instructions for independant connection Your service technician enables an independant connection to the electri city net and a connection to your compressed air system For this purpose in the Premium set of Yirro plus all necessary components are included They concern a Medical transformator 100 240 VAC 50 60 Hz with output 24Volt DC and a connection box with in it an integrated 24Volt regulation system and standard connection supplies Beneath you will find the over view of the connection components and underneath t
15. l symbols ISO 13402 1995 Surgical and dental hand instruments determination of resistance against autoclaving cor rosion and thermal exposure EN ISO 14971 Medical devices application of risk management to medical devices EN 21942 1 3 4 Dental vocabulary Part 1 General and clinical terms Part 3 Dental instruments Part 4 Dental equipment EN 23964 Dentistry Dental handpieces Coupling dimensions EN 60601 1 Medical electrical equipment Part 1 General requirements for basic safety and essential perfor mance 93 42 EEG Medical devices general rules This declaration of conformity is drawn up in Arnhem Netherlands on December 14th 2013 by DGA DHM dental BV signature This declaration of conformity was first issued on October 1 2013 and is of unlimited duration but not siginificant change as long as the conditions that are described in the technical documentation or the manufacturing conditions in the factory or the process of quality control epee a miren Ynrot general description Premium generic description The Yirro plus system is a selfcleaning dental mirror system in the Classe A a a of medical products 2 handle 3 magnet coupler Product description il parking dockiny This product is developed for professional dental experts Its self cleaning 5 air regulator function is based on an air flow constantly cleaning the mirror thus offering its
16. ng immediately stops air regulation Premium Set the air strength as desired by turning the rule knob This setting can always be changed even during treatment clockwise air flow blows softer counter clockwise air flow blows harder The Premium system is now ready for use Clean the parking docking and the magnetic air coupler carefully with alcohol or disinfectant before each treatment and bsure to always use cleaned handles and mirror heads Rep a miren yinrot start using the Premium version start using the Premium version At every treatment you or your assistent follow the hygiene routine 1 clean in advance the handles and mirror heads through regular methods thermo disinfector and or autoclave 2 clean the parking docking and the magnetic coupling with alcohol place the coupling back in the docking 3 if you prefer you can use a sleeve 4 attach the cleaned dental mirror to the magnet coupling and place it back into the docking switched OFF 5 start with the treatment use the dental mirror any moment you like 6 after every treatment you park the dental mirror into the docking station repeat steps 1 upto 6 repeated use of clean handles and mirror heads The Yirro plus system is developed for repeated use of cleaned instru ments according to hygienic rules The start set provides you with sufficient handles and mirror heads to work for several hours 4 You should instruct your assistant in
17. ntistry Equipment EN ISO 9873 2000 Dental hand instruments reusable mirrors and handles EN ISO 9687 Dental equipment Graphical symbols ISO 13402 1995 Surgical and dental hand instruments determination of resistance against autoclaving corrosion and thermal exposure EN ISO 14971 Medical devices application of risk management to medical devices EN 21942 1 3 4 Dental vocabulary Part 1 General and clinical terms Part 3 Dental instruments Part 4 Dental equipment EN 23964 Dentistry Dental handpieces Coupling dimensions EN 60601 1 Medical electrical equipment Part 1 General requirements for basic safety and essential performance 93 42 EEG Medical devices general rules Rep a aber yinrot compatibility compatible with every type of dental unit The Yirro plus system is universal and can be installed independantly of the type of dental unit prescribed mounting universal mounting system Yirro plus is preferrably mounted by use of the universal mounting system placed sideways of the dental assistance unit on the side of the mirror hand mounting by use of the docking adaptor When a free slot is available it is possible to mount the Yirro plus system directly into the assistance unit by use of the included docking adaptor vum prescribed mounting CE mounting in docking adaptor Note that installation in docking adaptor is NOT covered by the CE marking o
18. sult instructions for use 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 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 attention see Instructions for Use Symbol for temperature limitation temperature range Both upper and lower limits are indicated adjacent to horizontal lines Symbol for nonsterile This symbol should be used only to distinguish between identical or similar devices sold in both sterile and nonsterile conditions Symbol for Surgical steel Symbol forTitanium OOP PA E S cf Autoclavable at temperature indicated Symbol for professional use only Keep magnet coupler away from people with pacemakers or motorised insulin pumps ip AR aaa oF Symbol for serial number The manufacturer s serial number is found after or below Symbol for batch code lot number The symbol is accompanied by the manufacturer s batch code Symbol for authorized representative in the European Community This symbol is ac companied by the name and address of the authorized representative in the European Community Symbol for manufacturer This symbol is accompanied by address and name of manufacturer Symbol for quantit
19. y per box Any number can be represented in the box A LA No Symbol for angle of view of mirrors The number indicates the angle in degrees Arria a manie yinrot DHM dental B V Groot Vijverdal 27 6822 MB Arnhem Nederland
20. ymore Use a replacement handle or order a set of new ones Check if the mirror head clickers are defect If this is the case use a replacement mirror head or order a set of new ones Fault 6 silicone air hose is broken or leaks Action Pull off the air hose and order a new air coupler with hose You can also contact your service technician Fault 7 the connection hose is broken or punctured Action Contact your service technician for a repair maintainance maintainance free Besides the regular cleaning your Yirro plus system does not require any maintainence Please clean mirror heads and handles after every treatment by using the regular cleaning procedures Thermodesinfector or autoclave Clean your Premium docking and the air coupling of the Basic coupling after every treatment with alcohol REMARK 1 The parking docking contains a sensor and it should NOT be cleaned in the autoclave or thermodesinfector for this reason Clean your docking with alcohol or other desinfection Rep a mir yinrot REMARK 2 The air coupler includes a magnet and the magnetic force might vanish when used in the autoclave Therefore DO NOT clean the air coupler in the autoclave or thermodesinfector but clean it by wiping off with alcohol or other disinfectants stop using For de activating of the system close the air flow through the control knob by turning it OFF You can ask your service technician to disconnected the system You c
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