User GUide - De Vos Endo BV
Contents
1. DENTAL HI TEC SleeperOne Sleenerone User GUIDE IMPORTANT To BE READ BEFORE FIRST USE www dentalhitec com 17 10 11 09 40 N o a rel n S2 Dear User Thank you for purchasing SleeperOne It s characteristics and functions will meet up to all of your expectations concerning electronically controlled injections It is important that you perfectly handle the needle orientation angulation delicacy as described in this guide Only the handling of these two parameters will guarantee complete success in anaesthesia Contents Presentation 4 tilis SO V2 0 GB indd 2 17 10 11 09 40 Security rules TO BE READ IMPERATIVELY BEFORE FIRST USE SleeperOne is an electronic dental anaesthesia system designed for local injections before and or during treatment SleeperOne is a modern alternative to traditional dental syringes The dentist should take the usual precautions to ensure the success of every dental anaesthetic injection Keep out of direct light and sun Keep dry Utilis SO V2 0 GB indd 3 Description of the control pedal All of the commands have an all or nothing function The SleeperOne wireless pedal does not require an accumulator It is by pressing on the pedal that you create the energy necessary for the device to function 144 Plunger return Aspiration 4 Slow speed Fast speed injection constant b gt D constant2. gradual b b gt PII auto gradual Aspiration lt 4 144 Plunger return Fast speed injection Slow speed constant b gt gradual b b gt D constant D auto gradual Description of the control box Diagnostic LEDS k y g Power Handpiece Injection Only for Dental Hi Tec confirmed technical service A a a a f A 1 18V DHT electric Only for Dental Hi Tec power plug confirmed technical service ref MO144 DHT wire pedal plug option Activation Deactivation of pedal beeps 18V DHT Control box electric power plug fixing adhesives Ref MO144 Ref sa0226 A Utilis SO V2 0 GB indd 4 17 10 11 09 40 Description of the handpiece and accessories SleeperOne Handpiece Plastic container Ref SAOSO FR Needies DHT Needles have a patented bevel and a specific base indicator enabling an easy and painfree penetration Their specific bevels contrary to standard needles present identical cutting proprieties to a scalpel blade Therefore bringing forward 3 advantages DHT needles incise the tissues instead of tearing them allowing a painfree penetration of the mucosa For intraligamentaries and intraseptals they also have a higher penetration capacity compared to standard models The force of penetration is reduced by 29 Study by A Steele and coll Submitted Hub Infiltration free mucosa Infiltration attached mucosa Intrasep
3. Clean in a disinfectant bath after use with or without Ultrasonics Rinse thoroughly with water dry Autoclave cycle at 134 C 275 F according to ISO 17665 After disinfection thoroughly rinse the container with demineralised water to remove all traces of disinfectant product Failure to respect this rule can produce fast deteriorations whitening cracks which are not covered by the manufacturers warranty Utilis SO V2 0 GB indd 12 17 10 11 09 41 Spare parts You can order extra accessories from your local dealer or by contacting Dental Hi TEC directly Plastic containers Ref SAO50 or SAO51 2 5m Low voltage power supply Control box fixing adhesives Ref C2904 Ref SA0226 Needles 0 30 306 16 mm 0 30 30G 9 mm 0 40 276 13 mm Ref C3005 Ref C3002 Ref C3001 Utilis SO V2 0 GB indd 13 17 10 11 09 41 Technical characteristics Name SleeperOne Model S4 Dimensions Device classification IIA Do not use this device with Handpiece Diameter 26 mm Length 228 mm Weight 70 g Nominal voltage CA 100 240 V 50 60 Hz a power supply other than the Handpiece holder Height 75 mm Width 44 mm Length 44 mm Ambient temperature Tmra 10 40 C one supplied FW7660 Control box Length 109 mm Width 78 mm Height 24 mm Weight 106 g Altitude max 3000m Wireless pedal Length 250 mm Width 180 mm Height 63 mm Weight 603g Class Il powe
4. lightning fire water damage negligence or accident by improper use or non compliant installation the device is adapted to operating norms that are different from those indicated on the material safety data sheet located under the control unit the purchase documents are changed or altered the serial number of the device has been made unreadable In no case shall the application of this warranty constitute an entitlement to complete replacement of the device or give the right to claim damages SleeperOne cannot be subject to return outside of the warranty clauses Utilis SO V2 0 GB indd 15 17 10 11 09 41 Utilis SO V2 0 B indd 16 For any complementary information contact our advisors Clinical amp technical information 33 241 560 590 or sleeperone dentalhitec com LI K H ZI CID DENTAL HI TEC Innovation for dental anaesthesia BP 30051 ZI de l Appenti re 49280 Mazi res en Mauges FRANCE world dentalhitec com www dentalhitec com du N QUALITY Assunce raw NOSO 1011 GB 2 0 et Photos DHT St phane Rivi re Document et photos non contractuels QY philippe chauvire n ovau POO V 17 10 11 09 41
5. 67 If you are concerned by the European WEEE j j j j j directive please contact your distributor or the Dental Hi Tec For transmitters rated at a maximum output power not listed above the NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies iets i FA s company who will take all of the necessary measures towards the recommended separation distance d in metres m can be estimated using the NOTE 2 These guidelines may not apply in all situations Electromagnetic lect d ing of he dei equation applicable to the frequency of the transmitter where P is the maximum propagation is affected by absorption and reflection from structures objects collection and recycling o the device output power rating of the transmitter in watts W according to the transmitter and people DHT BP 30051 F 49308 Cholet cedex FRANCE 33 0 241 561 616 manufacturer Warranty conditions DENTAL Hi Tec offers a two year warranty for SleeperOne from the date of purchase This warranty does not apply to the sterilisable accessories The implementation of the warranty requires the submission of the original proof of purchase indicating the date of purchase This warranty only applies if the SleeperOne is used in compliance with the operating instructions and tolerances as indicated in this manual The warranty is invalid if a technical repair is made to the device by an unapproved person the device is damaged by an external source
6. T gt 95 dip in UT for 5 sec O V 5000 ms Power frequency 50 60 Hz magnetic field 3 A m Not Applicable Power frequency magnetic fields should be at levels characteristic of a typical location IEC 61000 4 8 in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level Immunity test IEC 60601 Test level required Compliance level Electromagnetic environment guidance Portable or mobile RF communications equipment should not be used closer to any part of the equipment including cables than the recommended Conducted RF 3 Vrms 3V separation distance calculated from the equation applicable to the frequency IEC 61000 4 6 150 kHz to 80 MHZ of the transmitter Recommended separation distance d 3 5 V1 vP Radiated RF 3 V m 3 V m d 3 5 E1 VP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 7 E1 VP 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies according to the manufacturer and d is the recommended separation distance NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and in metres m reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile Field strengths from fixed RF transmitters as d
7. chair The wireless pedal is the outcome of advanced research The wireless liaison is very reliable but like any radio system it can be disturbed by Utilis SO V2 0 GB indd 6 external elements metal furniture stainless steel immediate proximity of a strong radio transmitter no mobile phones within 1 5m of the control box a disturbing electronic device computer We therefore highly recommend that you carefully choose the position of the control box and pedal so they can communicate without being disturbed This pedal is wireless The movement of your foot on the pedal creates the energy necessary for the system to function It is therefore essential to perform fast and strong presses and releases A slow or incomplete movement may not create enough energy to transmit the information to the control box If a pedal release does not have any effect the injection remains active you simply have to press again on the same pedal to immobilize the device The handpiece remains under the dentist s constant supervision who must remove it from the work area in case of dysfunction A technical question Our team is ready to answer you on 33 241 560 590 or sleeperone dentalhitec com 17 10 11 09 40 Choosing the site The LEDS on the control box work only as a diagnostic in case of malfunction it can therefore be hidden below your instrument holder or on the side of a piece of furniture see fig 6 Th
8. e control box comes with non slip feet allowing it to be placed on a horizontal surface It is also possible to fix it on a vertical surface using the supplied adhesives see photos below It is recommended to wait 2h minimum before unfixing your control box with a forceps to avoid the adhesives from coming loose The fixation is optimal after 12h A To ensure good communication between the control box and wireless pedal avoid obstacles Install the control box especially metallic computers boxes between the 2 elements Do not fix place the box on an electronic device computer Do not place a mobile phone within 1 5 metres of the box pedal or power supply Install the handpiece support SleeperOne is going to be the device for all of your anaesthesias The handpiece must therefore always be immediately on hand just like your turbine or micro motor The handpiece support is designed to be placed either on the left or right of a vertical surface opening at the top Before sticking the handpiece support clean the surface with the pochette de nettoyage supplied with the device Remove the adhesive s protective film and position the support on the clean surface Wait 24h before placing the handpiece in the support to ensure optimal fixation The handpiece slides into the support with or without a container fig 6 The hole on the edge of the support is for recapping the needle It enables to recap wit
9. emove all of the glass debris especially in the plunger s throat and inside the handpiece Make sure that the plunger black o ring is not damaged Confirm the absence of pieces of glass in the body of the handpiece You can run the plunger under water but dry it after with the low pressure air jet Never run the handpiece under water To replace the plunger press on the Md pedal and present the plunger to the body aligning the 2 throats with the 2 metallic rods inside the body Press lightly on the plunger until it is quided inside the body and returns to its initial position Never grease or oil your SleeperOne s plunger it would cause future malfunctions Utilis SO V2 0 GB indd 11 17 10 11 09 41 The control box the pedal Unplug the device before cleaning Clean these parts with a clean cloth and an alcohol solution Never use powerful solvents or aggressive chemical products Never sterilise the control box or pedal Never immerse the control unit or pedal in liquid The handpiece and handpiece holder _ ici SIceperOne in Disinfect these 2 elements after each patient PR A Use disinfection products dedicated for this purpose Never sterilise the handpiece o Never immerse the handpiece into a liquid Warning try the product on a small surface beforehand to make sure that it will not deteriorate the surface of the handpiece or holder The plastic containers
10. etermined by an electromagnetic radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy site survey should be less than the compliance level in each frequency range To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the equipment is used exceeds the applicable RF Interference may occur in the vicinity of equipment marked with the following compliance level above the device should be observed to verify the normal operation If abnormal performance is symbol o observed additional measures may be necessary such as reorienting or relocating the device b Over the frequency range 150 kHz to 80 MHz the field strengths should be less than 3 V m TABLE 3 Recommended separation distances between portable amp mobile RF communications equipment and SleeperOne Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 kHz toa 800 MHz 800 kHz to 2 5 GHz Rated maximum output power This appliance must not be disposed of of transmitter W d 3 5 vP d 3 5 vP d 7 vP with household waste 0 01 0 12 0 12 012 It contains dangerous substances which 041 0 37 0 37 0 37 can have important consequences for the 1 117 17 117 A and rman health It ne be 10 369 3 69 3 69 e recycled in a specific treatment facility 100 11 67 11 67 11
11. hout risk of contamination ii To prevent accidental pricking never leave an unprotected needle on the handpiece when on the support Utilis SO V2 0 GB indd 7 17 10 11 09 41 Utilis SO V2 0 GB indd 8 Your SleeperOne functions START UP STOPPAGE WITH THE PEDAL SleeperOne starts up as soon as you press one of the pedals Each press is validated by one or two sound signals If necessary the beeps can be deactivated see following page SleeperOne does not contain an on off button it automatically goes into low power consumption mode as soon as the pedals are released SleeperOne can be plugged into your mains installation to be turned off at night THE PEDAL FUNCTIONS SleeperOne has different injection modes symbolised by the following pictograms on the pedals Anaesthesias recommended Sound signal validation Actions Number of beeps Type of press Complementary information a continuous press Slow auto gradual speed with a 2 second pause every 4 seconds Attached mucosa palatal infiltration into dense tissues Handpiece light continuously lit a double press Slow constant Intraligamentary or intraseptal Handpiece light continuously lit If there is no resistance to the injection the speed will increase automatically by 50 after 35 seconds to reduce the injection time a continuous press Fast gradual Infiltration nerve block spix infiltratio
12. ing a cartridge and needle TO INSTALL Make sure that the plunger is completely returned press the Md pedal Place a new cartridge in the container The use of a used cartridge can be the cause of injection malfunctions Screw the container onto Screw the DHT needle When you are ready to the handpiece onto the container start working remove the needle cap and place it in the dedicated hole on the handpiece holder TO REMOVE Press on the Md pedal to return the plunger to it s initial position Recap the needle with Unscrew the container Unscrew and incinerate the handpiece holder the used needle with a device for medical waste Inject in fast speed PP until the first drops come out of the needle You are ready to begin Remove the cartridge and place it in a dispositive for medical waste Clean and sterilise the container as indicated on the maintenance sheet Technical information Our team is ready to help on 33 241 560 590 or sleeperone dentalhitec com Utilis SO V2 0 GB indd 10 17 10 11 09 41 Procedure to be respected imperatively to prevent serious damage to the equipment which is not covered by the manufacturer s warranty 7 the handpiece holder Keep the handpiece faced Unscrew the plastic downwards at all times container Replace the needle cap with Inject in fast speed until the plunger is completely advanced and remove it from the handpiece R
13. n into easily extendable tissues for sensitive patients Handpiece light continuously lit a double press Fast constant Infiltration nerve block spix infiltration into easily extendable tissues Handpiece light continuously lit Plunger return a short press less than 1 sec The return stops automatically when the plunger has reached it s Starting position Aspiration for a nerve block or infiltration Infiltration nerve The aspiration is stopped by block spix releasing the pedal The aspiration can only be performed after injecting a sufficient quantity of product approx 1 8 to 1 4 of a cartridge a continuous press lt lt lt The double press is obtained in 2 ways You are starting the injection In this case press once quickly and then immediately press again on the same pedal A double beep confirms your selection You already injecting Release the pedal for less than 2 seconds then press continuously on the same pedal A double beep confirms your selection NOTE After the 2 seconds identified by a sound signal the pedal is no longer in double press mode A new continuous press will therefore trigger the slow auto gradual speed or fast gradual speed depending on the pedal In case of patient sensitivity when using the fast speeds use the constant slow or slow auto gradual speed 17 10 11 09 41 Quantity of anaesthetic injected The quantit
14. ns CISPR 11 Class B IEC 61000 3 2 Harmonics transmission Class A The use of SleeperOne is suitable for use in all types of establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes IEC 61000 3 3 Voltage fluctuations Complies Flicker emissions TABLE 2 Electromagnetic immunity Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are covered with synthetic ESD IEC 61000 4 2 8 kV air 8 kV air material the relative humidity should be at least 30 Electrical fast transient burst 2 kV for power supply lines 2 kV ied H Laas 1 KV for input output lines 1 kV Mains power quality should be that of a typical commercial or hospital environment Surge 1 kV differential mode 1 kV IEC 61000 4 5 2 kV common mode 2 kV Voltage dips short interruptions and voltage lt 5 UT gt 95 dip in UT for 0 5 cycles 03710 ms Mains power quality should be that of a typical commercial or hospital environment variations on power supply input lines 40 UT 60 dip in UT for 5 cycles 92 V 100 ms If the user requires continued operation during power mains interruptions it is recommended to use an uninterruptible power supply 70 UT 30 dip in UT for 25 cycles 161 V 500 ms lt 5 U
15. r supply enclosed 18V 560 mA Wire pedal option Length 180 mm Width 145 mm Height 33 mm Weight 320g Characteristics of the radio transmitter Cartridge to be used 1 8 ml cartridge ISO 11499 Frequency Transmission power 868 3MHz max 10mW EIRP Auto off After 10 minutes without use Data rate Channel bandwidth Modulation type 120 kbps 280 kHz ASK Compliance We declare on our own liability that this product complies with the EC and CSA regulatory provisions In the interest of product improvement Dental Hi Tec reserves the right to make modifications to its products without prior notice SleeperOne is intended for use in an electromagnetic environment where the as described and can help to prevent interferences by respecting minimal distance electromagnetic interferences are controlled and defined in tables 1 amp 2 on the between RF communication devices portable or mobile transmitters and following pages SleeperOne as recommended in table 3 depending on the transmission power of The customer or user of the device must make sure that it is used in an environment the communication device TABLE 1 Electromagnetic emissions Emission tests Compliance Electromagnetic environment Directives RF emissions CISPR 11 Group 1 SleeperOne uses RF energy only for its internal function Furthermore its RF emissions are very low and not likely to cause any interference in nearby electronic equipment RF emissio
16. tal adult Intraseptal child PDL Intraligamentary Palatal Utilis SO V2 0 GB indd 5 SICCHCIONG Type of needle Da 044444 Injection resistance information window Integrated needle recapping system N Handpiece support Ref C3140 Respect the model of needle corresponding to the type of anaesthesia performed to obtain maximal results and prevent needle breakages or post operative side effects Consult the instructions in the boxes before use 30G 16 mm White 17 10 11 09 40 Prepare your SleeperOne Connection Assemble the plug adaptor corresponding to your country photos 1 amp 2 Connect the handpiece power supply and wire pedal option as indicated below then plug in the power supply to your mains installation Your SleeperOne is ready to work 110 220V Assembling the wireless foot pedal Put in place the pedal hoop Present the hoop to the back of the pedal squeeze it to allow the arms to enter the oval slots situated at the back of the pedal photo 1 Push in the hoop and release the extremities should appear in the 2 windows situated beneath the pedal photo 2 Your wireless pedal is ready to work It does not require an accumulator It is by pressing on the pedals that you create the energy necessary for it to function A Never place the pedal under the chair during lowering to prevent squashing the pedal s hoop and damaging the
17. y injected is visible through the transparent container It is also indicated by a different number of beeps for each quarter of The beeps are only cartridge injected see table below an indication only the view of the cartridge Transparent container through the container can determine the exact Sleeperdie quantity injected 1 4 cartridge lt 2 mn 20 s uc emae Gm Joc 1 cartridge PDA Resistance during injection Sleener ns The light on the handpiece flashes when there is resistance during injection Type of light Level of resistance Information Continuously lit bow Continue injecting Slow flashing Medium Continue injecting Fast flashing High Continue injecting Off Critical lt Injection stops to prevent the cartridge from breaking Plunger return before stoppage The needle is Long blocked or the anaesthetic can not diffuse Change Beep needle or injection site Activate Deactivate the pedals beep sounds Press for approx 3 seconds on the button with a paper clip The deactivation is confirmed by a sound signal NOTE This function does not deactivate the quantity beeps To reactivate this function press again for 3 seconds on the button until you hear the beep Technical information Our team is ready to help on 33 241 560 590 or sleeperone dentalhitec com Utilis SO V2 0 GB indd 9 17 10 11 09 41 Installing remov
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