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XO FLEX – Instructions for use

Installation

10

XO FLEX unit must be installed by an XO authorized service provider.
Authorized service providers are listed under “Distributors” at xo-care.com.

WARNING: To avoid the risk of electric shock, this equipment must be connected to a
supply mains with protective earth.

When connecting an external PC (including monitor) to the XO FLEX unit, the
external equipment must be powered by a medical grade isolating transformer (e.g.
XO part number: XO-620).

The external equipment must also comply with the applicable standards, e.g.:

•

IEC 60950-1 (information technology equipment) or IEC 62368-1 (electronic
equipment within the field of audio, video, information and communication
technology), and

•

IEC 60601-1 (medical electrical equipment)

When external equipment is connected to the XO FLEX unit to create a medical
electrical system, the requirements of IEC 60601-1, 3

rd

edition, must be complied

with.

It is the responsibility of the person/organization installing and/or modifying the
equipment to ensure that the system conforms to applicable legislation, e.g.
Directive 93/42/EEC, or Regulation (EU) 2017/745, and the requirements of IEC
60601-1, 3

rd

edition.

Installation instructions for XO FLEX can be downloaded from xo-care.com.

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Содержание FLEX

Страница 1: ...XO FLEX INSTRUCTIONS FOR USE...

Страница 2: ...XO FLEX Instructions for use 2...

Страница 3: ...ents 17 Four handed or solo work 18 Working positions 18 3 8 Instrument control 21 Foot control of instruments 21 Instruments on the instrument bridge 21 Instrument bridge display 21 3 9 Syringe Luzza...

Страница 4: ...ection control 53 5 1 Cleaning disinfection and sterilization procedures 53 5 2 Detergents and disinfectants for cleaning and or disinfection of the unit 53 5 3 General cleaning of unit and patient ch...

Страница 5: ...rse filter 70 6 10 Flushing of cuspidor drain 70 6 11 Suction hoses 70 6 12 Air and Amalgam separator 71 D rr CS1 Combi Sepamatic Air separator 71 D rr CAS 1 Combi Separator Air and amalgam separator...

Страница 6: ...2 11 5 Product updates 82 11 6 Firmware version 82 11 7 Applicable standards 82 11 8 Electromagnetic emission 82 11 9 Interference Immunity 83 11 10 Classification 84 11 11 Applied parts 84 11 12 Mark...

Страница 7: ...n 9 you find a checklist containing all infection control and maintenance procedures that must be observed Section 10 contains a complete list of accessories detachable parts and consumables that you...

Страница 8: ...e 1 and in Table 2 the installation requirements are given Figure 1 Plan of installation XO FLEX Table 1 Operating and transport storage conditions Condition Operation Transport and storage Temperatur...

Страница 9: ...ith Repeater from D rr Dental part number 2106 155 60 USB extension cable 20 cm Suction air and water Requirement Height above floor surface Suction Suction machine power 600 l min Vacuum pressure at...

Страница 10: ...with the applicable standards e g IEC 60950 1 information technology equipment or IEC 62368 1 electronic equipment within the field of audio video information and communication technology and IEC 6060...

Страница 11: ...unit has a compact floor mounted stand fitted with a patient chair a cuspidor and single column pivoting articulated balanced arms for the instrument bridge operating light and display see Figure 2 Fi...

Страница 12: ...ble or explosive gases in its environment Use of other equipment adjacent to or stacked on this equipment should be avoided because it could result in improper operation Do not simultaneously touch th...

Страница 13: ...the patient does not see the instruments when getting in and out of the chair and the bridge will be easily accessible for cleaning and disinfection Figure 4 Position of instrument bridge for optimal...

Страница 14: ...can be moved north west south and east see Figure 6 Figure 6 Chair base joystick In this manual the above presented terminology e g move joystick to north will be used to explain the functions of XO...

Страница 15: ...ir in working position 2 with When you activate the chair moves to the entry position the position used to enter the chair and for rinsing Activating brings the chair to the previous position the last...

Страница 16: ...ght of up to 150 kg Exceeding the maximum allowed weight will compromise the structural stability of the unit and the patient chair SUPINE PATIENT POSITION The unit is designed with over the patient d...

Страница 17: ...UMENT BRIDGE IN WORKING POSITION To obtain easy access to and optimal balancing of the instruments place the instrument bridge close to the center of the patient s chest with a distance from the tips...

Страница 18: ...ition and the hand instruments are positioned near the patient s temple XO FLEX is equally suited for four handed Figure 14 and two handed operation Figure 15 Figure 15 Two handed operation here the o...

Страница 19: ...is combined with the flexibility of working in positions between 9 and 12 o clock see Figure 16 provides you with the best possible view of each tooth surface without bending or straining your neck sp...

Страница 20: ...XO FLEX Instructions for use Operation 20 Figure 17 Six different patient positions...

Страница 21: ...of camera functions via the foot control is only possible when the video camera is the only instrument lifted forward INSTRUMENTS ON THE INSTRUMENT BRIDGE Up to 6 instruments may be fitted to the inst...

Страница 22: ...as the other instruments 3 10 MICROMOTOR BIEN AIR MC3 BIEN AIR MX2 The micromotor is used as described in the manual supplied by Bien Air or visit bienair com The micromotor is intended to be used wi...

Страница 23: ...Increase maximum speed with Decrease maximum speed with 3 11 XO OSSEO MOTOR XO OSSEO motor is intended for bone surgery in general and for dental implantology XO OSSEO motor is intended to be used wit...

Страница 24: ...n the motor is running Figure 22 Foot control of XO OSSEO motor Switch irrigation on off with X Choose between three levels of irrigation Increase amount of irrigation with Decrease amount of irrigati...

Страница 25: ...used as described by the supplier Air instruments with a type 3 coupling as specified in ISO 9168 shall be used Lift the air instrument forward and control it with the foot control Activate the air i...

Страница 26: ...se between three drive air levels Increase drive air with Decrease drive air with 3 13 ULTRASONIC SCALERS The ultrasonic scaler is used as described by the supplier For XO ODONTOSON scalers see below...

Страница 27: ...tain and calculus in all areas Particularly useful for removal of subgingival calculus in pockets as deep as 13 mm Use the tip as if using a periodontal probe Thin Line Straight instrument 209034 2 pi...

Страница 28: ...with the end of the tip probing the pocket when necessary Figure 25 Using XO ODONTOSON 360 When working with XO ODONTOSON 360 Always use the instrument parallel to the tooth surface with the sides of...

Страница 29: ...patient lips tongue or other soft tissue with the non cooled part of the instrument tip Handle the instruments carefully as the attached ferrite rod is fragile Always use as much irrigation water as p...

Страница 30: ...taltic pump as described in section 3 16 Insert the connector piece XO 069 between the hose and the handpiece as shown in Figure 27 Figure 27 Connector piece for external irrigation of XO ODONTOSON 36...

Страница 31: ...s light in the previously mentioned wavelengths CAUTION The high light intensity of XO ODONTOCURE is accompanied by heat generation on the exposed surface Uninterrupted exposure of more than 20 second...

Страница 32: ...n tube is part of a disposable irrigation kit that contains the different tube parts needed for connecting a reservoir or bag with the different supported instrument types The pump is detachable and c...

Страница 33: ...ble irrigation kits Additional kits can be ordered from your XO distributor Pre sterilized disposable irrigation kit 50 pcs XO 055 Pre sterilized disposable irrigation kit 10 pcs XO 056 ATTACHING THE...

Страница 34: ...e 1 clockwise see Figure 35 Figure 35 Locking the pump head Place the irrigation tube into the tube guide and attach it to the instrument bridge arm as shown in Figure 36 Figure 36 Placing the irrigat...

Страница 35: ...he knob at the bottom of the pump module see Figure 38 Figure 38 Irrigation bag IRRIGATION RESERVOIR Place the reservoir containing the irrigation liquid into the holder below the pump see Figure 39 F...

Страница 36: ...fore the pump can be used a designated instrument must be selected With all instruments at rest press the button 1 once see Figure 41 The unit enters configuration mode and a menu will be shown on the...

Страница 37: ...link If you want to use the designated instrument without peristaltic pump select NONE in the PUMP menu ADJUSTING THE FLOW LEVEL Choose between three levels of irrigation Increase irrigation with Decr...

Страница 38: ...the foot control to the imaging program This is in addition to the USB cable carrying the video signal Please consult your XO authorized service provider for further details To ensure a stable connect...

Страница 39: ...in activation distance for less than one second and the lamp switches on off Change the light intensity 3 levels by activating the sensor for more than one second Figure 47 No touch sensor Optionally...

Страница 40: ...e connected to an external PC The best image quality is obtained using the native resolution of 1920 1080 pixels The display contains 6 sensor buttons at the bottom right see Figure 49 The meanings of...

Страница 41: ...button Used for selecting functions in the OSD AUTO Auto button Use this button to automatically adjust the display settings when using an analog input ON OFF button Switches the display on and off No...

Страница 42: ...n arm to fail altogether exposing the patient to a risk 3 21 SUCTION Activate each suction hose individually by lifting it from the holder When working solo move the suction hose holder forward to fac...

Страница 43: ...nd water lls the cup while the button is activated The cup filler may alternatively be activated deactivated using X while all unit instruments rest Figure 55 Foot control of cup filler AUTOMATIC FUNC...

Страница 44: ...display See details in section 7 3 26 XO SEAT AND XO STOOL We recommend you sit in an upright balanced position with an angle between thighs and upper body of about 120o see Figure 57 To maintain a he...

Страница 45: ...e Operation 45 Figure 57 Upright balanced position XO SEAT Adjust the seat height using the left handle as shown in Figure 58 Figure 58 Adjustment of seat height Adjust the seat angle with the right h...

Страница 46: ...59 Adjusting the seat angle XO STOOL Adjust the seat height as shown in Figure 60 and the seat angle as shown in Figure 61 Figure 60 Adjusting the seat height Figure 61 Adjusting the seat angle Adjust...

Страница 47: ...XO FLEX Instructions for use Operation 47 Figure 62 Adjusting the backrest angle Figure 63 Adjusting the backrest height...

Страница 48: ...orking position 1 Working position 2 Rinse position twice within one second Entry position 5 Subsequently an OK sound is heard 6 The display will show the configured position shortly afterwards Figure...

Страница 49: ...n cup filler stops FLUSH CF Enabled Disabled enabled Light on when patient chair reaches a working position or previous position Light off when chair moves towards entry 0 position or working position...

Страница 50: ...th contra angle approximately 70 ml min Without contra angle 10 100 ml min Amount of spray water Level 2 W LEVEL 2 Without contra angle what you see on the display 50 ml min With contra angle approxim...

Страница 51: ...ml min With turbine hand piece approximately 70 ml min Without turbine hand piece 10 100 20 ml min Amount of spray water Level 2 W LEVEL 2 Without turbine hand piece what you see on the display 50 ml...

Страница 52: ...XO ODONTOCURE curing light Curing time 3 TIME 3 20 s 1 300 s Curing time 2 TIME 2 10 s 1 300 s Curing time 1 TIME 1 5 s 1 300 s Soft start SOFT T Disabled Enabled disabled Soft start SOFT T 5 s 1 300...

Страница 53: ...minutes Please note that some instruments and accessories are not designed for thermo disinfectors or autoclaves Please note that autoclaving and thermo disinfection processes wear down the materials...

Страница 54: ...never directly to the fabric 5 5 GENERAL DISINFECTION OF UNIT SURFACES Disinfect the surfaces of the unit using a lint free cloth with D rr FD 333 or D rr 366 please see details in section 10 3 Look...

Страница 55: ...INFECTION OF INSTRUMENT HOSES AND SUSPENSIONS Remove the instrument hose by turning the release handle 1 counter clockwise and pulling out the plug as shown in Figure 69 Figure 69 Removing instrument...

Страница 56: ...ted to a wrong position Make sure that the instrument hose plugs and sockets in the instrument bridge are completely dry before the hoses are re mounted on the instrument bridge 5 9 INFECTION CONTROL...

Страница 57: ...ts can be cleaned and sterilized using all clinically acceptable methods The handpiece can be cleaned and disinfected with D rr FD 333 or autoclaved max 121 C 5 13 INFECTION CONTROL XO ODONTOCURE CURI...

Страница 58: ...the surfaces of the pump unit using a lint free piece of soft cloth with D rr FD 333 Tubing clips and spear can be autoclaved Tube guide can be thermo disinfected Risk of contamination The pre sterili...

Страница 59: ...ents directly onto the display FRONT PANEL Take care not to scratch the front surface with any hard or abrasive material Dust finger marks grease etc can be removed with a lint free piece of soft clot...

Страница 60: ...tion holder 2 Remove the covers from both suction nozzles see Figure 75 3 Activate the suction disinfection button 2 see Figure 76 to deactivate the suction 4 Place the two suction nozzles on the suct...

Страница 61: ...f the unit is equipped with an amalgam separator or if the above described procedure is not sufficient Please see the instructions provided by D rr Dental Please note that XO Water Clean and XO Suctio...

Страница 62: ...DISINFECTION CARTRIDGE When the cartridge is almost empty a warning sound is heard and the message CHECK YELLOW BOTTLE appears in the unit display The XO Suction Disinfection cartridge is replaced as...

Страница 63: ...ter treatment procedure should be used Step 1 evening 1 Fit the water disinfection instrument holder on the cuspidor bowl 2 Place all water bearing unit instruments in the disinfection instrument hold...

Страница 64: ...own in Figure 80 3 Activate the button 2 in Figure 80 and the instrument water lines are flushed 4 Watch the display for the remaining time of the disinfection process When FLUSH OK appears in the dis...

Страница 65: ...lean the surface with a damp cloth To avoid accidentally exposing the patient to suction disinfection additive be careful not to interchange XO Water Clean cartridges white and XO Suction Disinfection...

Страница 66: ...on the floor when activated If necessary clean the rubber feet and floor with petroleum benzine to avoid the foot control from sliding when activated Figure 82 Cleaning of foot control rubber feet 6 2...

Страница 67: ...uld be measured once a month to ensure that the effectiveness of the lamp is consistent A substantial change in effectiveness is indicative of a fault which may affect the curing result adversely XO C...

Страница 68: ...the depth of the test plug At an interval of approximately 1 month perform the following steps 7 Please refer to points 1 5 on page 67 8 Compare the result of this test with the reference made upon re...

Страница 69: ...key Figure 87 Adjustment of the hand instrument table 6 7 CONTROL OF THE WATER DISINFECTION SYSTEM If the unit is fitted with a water disinfection system we recommend that you control the function ev...

Страница 70: ...y activating the manual valve button 1 in Figure 89 for 5 seconds 3 Remove the filter 2 4 Clean the filter 5 Replace the filter Figure 89 Manual activation of cuspidor valve 1 and cuspidor valve filte...

Страница 71: ...t and should therefore be disposed of safely and in accordance with regulatory requirements Remember to use safety gloves 6 12 AIR AND AMALGAM SEPARATOR D RR CS1 COMBI SEPAMATIC AIR SEPARATOR Service...

Страница 72: ...after start up of unit if no communication with Stand Controller is detected Call your XO authorized service provider SUCTION CLEAN FAIL CALL SERVICE Displayed when unit detects that it takes more th...

Страница 73: ...tion Call your XO authorized service provider and require a preventive service and safety inspection SERVICE OVERDUE YYYY MM DD Date for preventive service and safety inspection is overdue Call your X...

Страница 74: ...or time for service A is 1 5 hours PREVENTIVE SERVICE AND SAFETY INSPECTION B 24 48 ETC MONTHS AFTER INSTALLATION Service B includes a general checkup and exchange of parts contained in XO FLEX Servic...

Страница 75: ...ervice provider in accordance with the load on the norm tray fitted under the instrument bridge Adjustments of arm systems must be done by qualified personnel only Maladjustment may result in a mechan...

Страница 76: ...ment pad bridge protection pad handles covers for suction nozzles cuspidor bowl protection disk and gold trap cup holder See sections 10 2 and 10 3 Unit instrument pad Bridge protection pad See sectio...

Страница 77: ...10 3 When the unit has not been used for several days after a long weekend holidays etc Start the intensive water line disinfection procedure See section 5 20 2 XO Water Clean cartridges See section...

Страница 78: ...thanded use Please shorten hose to 1710 mm when used by right handed operator None None AP 711 Cover for high volume suction nozzle 250 250 AP 714 Cover for saliva suction nozzle 250 250 AP 715 Suctio...

Страница 79: ...d skai fabric See details at duerrdental com XO Water Clean Disinfection of unit water and water lines Disinfection additive Significantly reduces but does not eliminate pathogens in unit water 6 0 6...

Страница 80: ...e regularly depending on how much the unit is used Contains 2 suction hoses complete with nozzles 2 complete suction filters with filter cartridges 1 gold trap 1 tip for syringe Please shorten hose to...

Страница 81: ...CARE s instructions on handling cleaning disinfection sterilization or service have not been adhered to XO CARE and the XO distributor undertake no responsibility for warranties safety reliability an...

Страница 82: ...ended for operation in the electromagnetic environment specified below Please make sure that the unit is used in such an environment Table 15 EMC information Emission measurement Conformity Electromag...

Страница 83: ...ower supply lines 1 kV for input and output lines 2 kV for power supply lines The quality of the line power supply should be that of a typical residential or hospital environment Surge voltages accord...

Страница 84: ...field strength of stationary radio transmitters should be less than the conformance level at all frequencies in an on site check Disturbances are possible close to devices that have the following sym...

Страница 85: ...ty to dispose of your waste equipment by handing it over to a designated collection point for the recycling of waste electrical and electronic equipment The separate collection and recycling of your w...

Страница 86: ...g dangerous voltage Follow instructions for use Mandatory action Information Other important messages not related to safety Do not reuse For single use only Serial Number This information is found on...

Страница 87: ...al Type B applied part Foot control pedal right Foot control pedal left Foot control pedal down X X button on foot control O O button on foot control Foot control joystick north Foot control joystick...

Страница 88: ...XO FLEX Instructions for use Symbols 88 Chair base joystick south Chair base joystick east...

Страница 89: ...XO FLEX Instructions for use Dimensions and technical data 89 13 DIMENSIONS AND TECHNICAL DATA 13 1 DIMENSIONS AND RANGE OF MOVEMENT Figure 91 XO FLEX dimensions and range of motion...

Страница 90: ...rque contra angle gear ratio 1 1 2 5 Ncm Spray water without contra angle 20 70 ml min 20 Spray air without contra angle 10 100 Cooling air 10 l min Contra angles according to ISO 3964 type 2 or type...

Страница 91: ...cted to a suction machine with High flow rate Type of suction Wet or dry Inner diameter of high volume suction nozzle 16 mm Inner diameter of saliva suction nozzle 7 mm Head loss between the suction i...

Страница 92: ...ble 19 Boxes dimensions and weight Box Dimensions cm L x W x H Gross weight kg Unit stand 120 x 72 1 x 140 150 170 Arm and instrument bridge 134 4 x 72 4 x 44 35 Operating light 118 x 53 x 40 15 Patie...

Страница 93: ...rest inclination X Call chairside assistant O Start stop cup filler Short Operating light on off Long Change operating light intensity Increase maximum speed power time Decrease maximum speed power ti...

Страница 94: ......

Страница 95: ...Product XO FLEX 2018 09 06 Ref YB 660 Ver 2 02 Subject to change Manufacturer XO CARE A S Usser d M lle H ndv rkersvinget 6 DK 2970 H rsholm Denmark 45 70 20 55 11 info xo care com xo care com...

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