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6 • User Guide

1.3.1

Quality Standards

Fimet Oy is a responsible dental device manufacturer. The company’s quality manage-

ment system is certified by a notified body according to the following standards:



ISO 9001:2008 Quality management system - Requirements



ISO 13485:2003 Medical devices - Quality management system - System require-

ments for regulatory purposes

1.4

Terms and Abbreviations

System:

Dental Treatment System, consisting of Dental Unit, Dental Chair,

Operating Light, Foot Control, and Hand Control.

Dental Unit:

Part of the System consisting of Cuspidor, Instrument Bridge, Dis-

play, Suction Head, Connection Box, and Tray(s).

Dental Chair:

Part of the

System

consisting of the patient chair, including a seat,

a backrest, a headrest, armrests, a footrest,

display

and

joysticks

Connection Box:

An enclosure consisting of the power supply and connections to

drainage, pressurised air, mains power, suction, and water.

Operating Light:

Light source with swivel arms and an optional power supply.

Display:

Flat panel display with a swivel arm.

Cuspidor:

Main part of the unit consisting of a pneumatic centre, a spittoon

bowl, a clean water bottle, a water heater, filter(s), an amalgam

separator, and water taps for glass filling and bowl flushing.

Instrument Bridge:

Device consisting of instrument holders, hoses with whip arms or

hanging hoses, swivel arms, control buttons, and a display. Nor-

mally used by the dentist.

Suction Head:

Device consisting of hanging hoses with holders, swivel arms, con-

trol buttons, and a display. Normally used by the assistant.

Tray:

Metallic or plastic tray with a supporting arm.

Foot Control:

Radio operated control device with batteries or pneumatic remote

control.

Hand Control:

Radio operated control device with batteries.

Joystick:

Four-way control device for controlling the chair.

1.5

Symbols and Markings

Follow the instructions for use

The information provided is important and must be read.

Note!

The information provided is important and should be read before use.

Содержание F1

Страница 1: ...Fimet F1 User Guide Version 1 1 1 6 2016 ...

Страница 2: ...itch optional 19 2 6 Suction Head 19 2 6 1 Suction Head User Interface 20 2 6 2 Positioning the Suction Head 20 2 7 Trays 21 2 8 Dental Unit 21 2 8 1 Cuspidor 22 2 8 2 Filling the Cup and Rinsing the Bowl 23 2 8 3 Water Heater optional 23 2 8 4 Clean Water Bottle 23 2 8 5 Disinfecting the Water System 24 2 8 6 Daily Use of Mild Disinfecting Solutions 24 2 9 Connection Box 24 2 9 1 Switching the De...

Страница 3: ...ntrol Lever 41 3 4 4 Replacing the Batteries 41 3 5 Amalgam Separators Instruments Suction Motors Compressors and other 3 rd Party Devices 42 3 6 Replacing the Lithium Battery of the Clock Control Card 42 3 7 Clean Water Bottle 42 3 8 Tightening the Headrest Lock Mechanism 42 3 9 Annual Service Operations 42 4 Product Information and Safety 43 4 1 Device Label 43 4 2 Intended Use 43 4 2 1 Expected...

Страница 4: ...4 User Guide 1 Appendix A Dimensions and space requirements 53 1 1 Dimensions F1 53 1 2 Dimensions F1 Cab 54 1 3 Dimensions F1 Cart 55 1 4 Dimensions F1 Prime 56 1 5 Dimensions F1 Side 58 ...

Страница 5: ...eatment System F1 PRIMEPLUS Dental Treatment System F1 CITY Dental Treatment System F1 MONDO Dental Treatment System F1 EUROPA Dental Treatment System F1 CEILING Dental Treatment System F1 SIDE Dental Treatment System F1 is also sold under trade names F1 CONTINENTAL F1 TRADITIONAL F1 MODULARM Podiatry unit F1 PODOCART Podiatry unit F1 HANDYARM Podiatry unit 1 3 Directives and Standards This produc...

Страница 6: ...r suction and water Operating Light Light source with swivel arms and an optional power supply Display Flat panel display with a swivel arm Cuspidor Main part of the unit consisting of a pneumatic centre a spittoon bowl a clean water bottle a water heater filter s an amalgam separator and water taps for glass filling and bowl flushing Instrument Bridge Device consisting of instrument holders hoses...

Страница 7: ...s better electrical protection than a type B applied part BF applied parts are electrically isolated from earth floating 2014 Manufacturing year RF transmitter a symbol for non ionising radiation The system contains low power close range RF transmitters one in the remote foot control and one inside the patient chair Alternating current AC symbol Protective earth PE IPX1 Ingress Protection Rating C...

Страница 8: ...ed to 135 kg If the F1 Dental Chair is used as stand alone with no unit the maxi mum allowed weight of the patient is 160 kg The F1 Dental Chair can be positioned with the help of electric motors to pre set working entry exit and spitting positions The height of the seat and the tilt of the back rest can al so be set separately to the wanted position The dental chair can be rotated around its cent...

Страница 9: ...es and the patient simultaneously There is a risk of electric shock Illustration of the Complete System Sewage system Water main Electrical network External air compressor External suction motor system Operating light Video camera Computer Patient area ...

Страница 10: ...reat ment System F1 CITY Electric Air Hanging hose Whip arm Floor Chair No No Dental Treat ment System F1 SIDE Electric Air Hanging hose Floor Chair No Yes Dental Treat ment System F1 MONDO Air Hanging hose Whip arm Floor Chair No Yes Dental Treat ment System F1 EUROPA Electric Hanging hose Whip arm Floor Chair No Yes Dental Treat ment System F1 CEILING Electric Hanging hose Whip arm Floor Ceiling...

Страница 11: ...User Guide 11 F1 F1 Europa F1 Mondo F1 City F1 Prime F1 Ceiling F1 Cart F1 Cab ...

Страница 12: ...12 User Guide 2 2 System Overview Container of the flushing liquid ...

Страница 13: ...telec NSK Mectron EMS Ag Neovo 17 TFT display X 17 Cattani Mini Separator Faro Edi Micromotors Bien Air Kavo NSK max 3 pcs Ag Neovo 22 TFT display X 22 Dürr CAS 1 G Comm Vision Syringe s Luzzani DCI Forest G Comm Polaris Curing light Satelec Lysta Mectron Air driven instruments turbine air motor pneumatic scaler NSK Kavo Bien Air MTI DentalEZ Container of the flushing liquid ...

Страница 14: ...ple devices for instance electrical door lock external suction motor etc Relay Max 25 V AC 60 V DC 5 A 2 4 Instrument Bridge Warning Beware of damaging the instrument bridge arms when lifting the backrest of the chair The Instrument bridge is used to hold the instruments so that they are conveniently avail able for use when needed Instrument Bridge Swivel arms guide the instrument hoses so that th...

Страница 15: ...s Memory slot Function Press briefly action Press and hold Bowl rinse Rinse bowl for pre set duration Doorbell Open door activate relay Cup fill Fill cup for pre set duration AUX Activate relay Backrest up 1 Chair to exit position Raise backrest Backrest down 2 Chair to working position Lower backrest Chair down 3 Chair to spitting position Return to previous position Lower chair Chair up 4 Chair ...

Страница 16: ...e foot control The colours represent the functions blue for water green for air and orange for speed range The colour coding makes it easy to recognize the active functions 7 segment display an option The 7 segment display normally shows the time When using an instrument with rotation control e g micro motor the display shows the rotations per minute of that instrument The display shows when air a...

Страница 17: ...r electric or pneumatic Turbine Syringe Curing light Special instruments e g sandblasters There are three places for instruments and suctions on the suction head The suction head usually has two suction hoses with suction tips The instruments are ready for use when picked up from their resting place The display of the instrument bridge shows information specific to the selected instrument for exam...

Страница 18: ...ring light or laser beam Please read the operation instructions in the manufacturer s manual 2 5 3 Ultrasonic Scaler Warning Check that the scaler gets water for cooling the tip The scaler may be damaged if not cooled properly The ultrasonic scaler power is controlled with a rotating knob on the back of the instru ment bridge Power setting 1 is the smallest 10 is the maximum For more information s...

Страница 19: ...oses 2 6 Suction Head Normally the suction head holds the suction hose s evacuator tips and syringe or other instruments The instruments are easily reachable and in correct position ready for work ing An instrument can be activated simply by picking it up from its holder Suction head The suction head is connected either to the chair with swivel arms or to the cuspidor with an extendable arm depend...

Страница 20: ...ation AUX Activate external relay 2 6 2 Positioning the Suction Head Warning To prevent damage to the system check that there is nothing obstructing the movement of the chair Positioning the suction head The suction head can be adjusted as shown in the above image The height adjustment an option has a locking mechanism which can be tightened by turning the locking screw Locking screw ...

Страница 21: ...nstruments and utensils Do not place more than 1 kg on the tray 2 8 Dental Unit The Dental Unit consists of a Cuspidor an Instrument Bridge a Display a Suction Head a Connection Box and Tray s The maximum total weight of the Dental Unit without the Connection Box is 50 kg Max 1 kg ...

Страница 22: ...wl with flushing system cup holder with cup filling system and suction filters Separation systems are located inside the cuspidor Clean wa ter bottle and waste management are also located in the cuspidor The spittoon bowl is easily detachable The maintenance door is optional If there is no maintenance door maintenance operations are made by lifting the top of the cuspidor out of way ...

Страница 23: ...versible thermal cut out de vice If the injected water is cold please check the position of the button of the thermal cut out device The release button is located on the right side of the water heater in the bottom of the cuspidor 2 8 4 Clean Water Bottle Warning Use only bottles provided by Fimet Oy Do not use bottles past their expiry dates Otherwise there is a possibility that the bottle breaks...

Страница 24: ...ontamination coming from main water line and build up of microfilm These liquids may be added to the clean water bottle in the right proportion Please read the manufacturer s instructions for correct usage 2 9 Connection Box Warning The maximum connection voltage to the relays for the external devices is 24 V The Connection Box consists of a power supply and connections to drainage air mains power...

Страница 25: ...t into the light Looking straight at operating light beam may cause damage to eyes The display can be used with an intra oral video camera and an external computer The display must be either Connected to the F1 power source or Approved according to the medical device standard IEC 60601 1 The operating light contains its own power switch which controls the light Please see the operating light s use...

Страница 26: ...ration of lift and tilt motors is limited The limiting system is load sensing With full load the chair lift and tilt motors operate a shorter time F1 Chair Chair control panel and remote foot control Chair control panel Removable hand rest Double articulat ed head rest Adjustable foot rest ...

Страница 27: ...orque of the unit attachment is 250 Nm Maximum allowed mass of the unit is 60 kg The max mass specified is for chair with no unit attached 2 11 1 Motors and Electronics The lift and tilt motors and the electric circuits of the F1 Dental Chair are of low voltage type which reduces the risk of electric shock A combination of steel and plastic materials is used in the gears of the lift and tilt mecha...

Страница 28: ...ir seat and backrest are designed to be adequate but not fast enough to cause danger to operator or patient Manual Positioning Func tion Remote Foot Con trol Remote Hand Con trol Joystick Left push and hold Joystick Right push and hold Instrument Bridge Suction Head but tons Raise Backrest 1 1 1 1 1 Lower Backrest 2 2 2 2 2 Chair Down 3 3 3 3 3 Chair Up 4 4 4 4 4 Rotating the Chair and Locking the...

Страница 29: ...ad panel joysticks remote foot control and remote hand control Using Pre set Positions Remote Foot Hand Control Press 5 key PROG key briefly and after that the desired key within three seconds Joysticks Push either one of the chair s joysticks in the desired direction Instrument Bridge and Suction Head Press briefly one of buttons 1 2 3 or 4 1 Chair to entry and exit position 2 Chair to working po...

Страница 30: ...rol The upper segment of the 7 segment display flashes during the setting time The memory positions are user specific Both users A and B can be programmed sepa rately Please note that position 1 is reserved for entry and exit position and is pre set at the fac tory It cannot be reprogrammed the normal way Please contact service personnel to change the default behaviour 2 11 5 Selecting the User Ch...

Страница 31: ...Position Mechanical chair controls Unlocking the chair tilting lock allows the seat backrest and legrest to be tilted for setting the legs to a higher position than the head 2 11 8 Headrest The headrest is double articulated and extendable The locking mechanism locks the headrest to the desired position Warning Check the tightness of the locking mechanism after adjusting the position of the headre...

Страница 32: ...lever locks the double articulated movements Headrest adjustments The movements of the headrest are double articulated The headrest can be adjusted around the two axels when the locking lever is in open position Double articulated headrest movements 2 11 9 Legrest The legrest can be extended and the knee break angle can be adjusted The legrest moves synchronically with the backrest Optional ...

Страница 33: ...break The legrest is positioned synchronically with the backrest 2 11 10 Joysticks Joysticks are used to control the movements of the seat and backrest of the chair The joystick can be moved to four different directions Joysticks can also be used to position the chair to pre set positions Joysticks on the base of the chair 2 11 11 Armrests You can turn the armrests and also detach them if needed T...

Страница 34: ...urned When the armrest has been turned 90 it can be removed completely by lifting it from its holder Turning and detaching the armrest 2 12 Remote Foot Control Foot Control is used to control the movement of the seat and backrest of the chair and al so to control the instruments Lever Foot control buttons Lift handle 90 ...

Страница 35: ... control The connector in the chair is located in the front side of the chair s bottom part The connector in the foot control is located on the bottom Recharging time is about 24 hours and charging must be done periodically in normal use after every 1 3 months depending on the operating time When letter A is displayed in the back panel of the chair the charge of the batteries in the foot control i...

Страница 36: ...ll devices inside the patient area within 1 5 m of patient must be IEC 60601 1 ap proved All devices to be connected must be CE marked All electrically connected devices must be compliant with IEC 60601 1 or and other applicable IEC standards The computer must be compliant with either IEC 60950 or IEC 60601 1 Compliance with IEC 60601 1 has to be re evaluated after each modification made to the sy...

Страница 37: ...s for External Devices Relays are used for controlling the external devices These devices may be for example an electric door lock an external suction motor a compressor or doctor reserved light etc Maximum connection voltage is 24 V ...

Страница 38: ... patient or operator Follow the instrument manufacturer s instructions on disinfection and sterilisation All dental instruments that are heat resistant should be sterilised after each use by steam under pressure autoclaving dry heat or chemical vapour Before sterilisation or disinfec tion instruments must be cleaned of any debris 3 1 2 Prior to Treatment Warning Before treatment make sure there is...

Страница 39: ...At the start of work week let water flow through the instruments for at least 10 minutes before starting treatment 3 1 5 Display Use cleaning solutions designed for cleaning the displays To disinfect the display alcohol based solutions can be used See the display s user guide for detailed instructions on how to clean and disinfect the display 3 1 6 Operating Light See the operating light s user gu...

Страница 40: ...holder located on top of the cuspidor bowl Water goes through the water tubing and instruments and flows into to the drain It is also possible to use a disinfection solution in the bottle Flush all instruments switch To start the flushing of all instruments move the switch to the ON position Flushing will stop automatically after three minutes or when the switch is returned to the OFF position 3 2...

Страница 41: ... connector on the foot control Receiver in the instrument bridge starts to beep Release the button 5 Before the beeping ends in 30 seconds detach the charging cable from the foot con trol and attach it to the charging connector of the chair If pairing is successful the beeping will end immediately Note If the beeping stops before successful pairing perform sections 1 5 again 3 4 3 Calibration of t...

Страница 42: ...nually to prevent bursting of the bottle due to ageing of material 3 8 Tightening the Headrest Lock Mechanism The movements of the headrest are double articulated The headrest can be adjusted around the two axels when the locking lever is in open position The tightness of the lock ing system is adjusted with a plastic tool delivered with the system Headrest lock mechanism tightening tool Remove th...

Страница 43: ...iced according to the manufacturer s instructions In normal conditions the system is suitable for opera tion for a longer period of time than this The manufacturer ensures that spare parts are available at least for this time period 4 2 2 Limitations of Use Warning To avoid the risk of fire this equipment must not be used with flammable anaesthetics The maximum allowed weight of the patient on the...

Страница 44: ... the installation work The guarantee time of the replaced parts is limited to the guarantee period of the product Manufacturer s guarantee does not cover defects caused by the following normal wear and tear improper installation maintenance repair care use or service of the device or part of it using non compliant parts for example instruments without CE mark mains power surges shortages or outage...

Страница 45: ...z 600 VA PS2150C1 240 PS2150C2 240 4 7 Information about Electromagnetic Compatibility The information in this chapter has to be considered when installing and using the F1 product family Portable and mobile RF communications equipment for example mobile phones can affect the functionality of F1 products Guidance and manufacturer s declaration electromagnetic emissions The F1 products are intended...

Страница 46: ...low The customer or the user of the F1 products should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 V 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the F1 pro...

Страница 47: ...ers m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absor...

Страница 48: ...ifting motor potentiometer wire or the potentiometer is defective 51 2 A lifting motor potentiometer wire or the potentiometer is defective 52 2 A back rest motor potentiometer wire or the potentiometer is defective 53 2 A back rest motor potentiometer wire or the potentiometer is defective 54 Lift movement limits are too close to each other or too close to the mechanical lim it 55 Back rest movem...

Страница 49: ...play in the following manner 1X2Y where X and Y are replaced with error codes listed above 1 is for lift motor and 2 is for back rest motor For example error code 1520 means that lift motor has been stopped because the current was too high 1 for lift motor 5 for software current limit reached The back rest motor was ok 2 for backrest motor 0 for OK The actual reason for the stoppage could be a mec...

Страница 50: ...ature Limiters The transformer is equipped with a temperature limiter It prevents the temperature from rising above predefined levels This can happen if the chair is operated excessively with out adequate pauses The lift motor is equipped with software which measures active versus idle time If the limit ratio is exceeded operation is stopped for a certain period of time 4 15 Programmed Safety Limi...

Страница 51: ...rective 2002 96 EC WEEE Waste Electrical and Electronic Equipment regulates the disposal of this product in Europe Do not dispose of the device or any part of it with normal household waste Prior to disassembly disposal of the product it must be fully prepared cleaned disinfected sterilized The device may also be disposed of by the manufacturer if no other adequate way is possible transportation p...

Страница 52: ...e empty Charge the batteries by con necting the charging cable Rechargeable batteries have leaked Ask the maintenance person to replace the batteries Device pairing is lost Pair the devices according to instructions in 3 4 1 or 3 4 2 Remote Foot Control does not function at all without the charging cable Rechargeable batteries are loose Ask the maintenance person to return the batteries in their p...

Страница 53: ...1 Appendix A Dimensions and space requirements 1 1 Dimensions F1 ...

Страница 54: ...54 User Guide 1 2 Dimensions F1 Cab ...

Страница 55: ...User Guide 55 1 3 Dimensions F1 Cart ...

Страница 56: ...56 User Guide 1 4 Dimensions F1 Prime ...

Страница 57: ...User Guide 57 ...

Страница 58: ...58 User Guide 1 5 Dimensions F1 Side ...

Страница 59: ...User Guide 59 ...

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