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Details about electromagnetic compatibility according to

EN60601-1-2

9.1

Electromagnetic Transmissions

The Status 1080 TM treatment unit is for use in an environment like the one cited

below. The customer or user of the Status 1080 TM should ensure that it is used in

the correct environment.

Measurements of noise transmis‐

sions

Conformance

Electromagnetic environment -

Guidelines

HF transmission according to

CISPR 11

Group 1

The Status 1080 TM uses HF ener‐

gy only for its internal operation. Its

HF transmission is therefore very

low, and it is improbable that neigh‐

bouring electronic devices will be

disturbed.

HF transmission according to

CISPR 11

Class B

The Status 1080 TM is for use in all

facilities including residential ones,

and facilities that are directly con‐

nected to a public power supply that

also supplies residential buildings.

Transmissions of harmonics ac‐

cording to IEC 61000-3-2

Class A

The Status 1080 TM is for use in all

facilities including residential ones,

and facilities that are directly con‐

nected to a public power supply that

also supplies residential buildings.

Transmission of voltage fluctuations

or flicker according to IEC

61000-3-3

Conforms

The Status 1080 TM is for use in all

facilities including residential ones,

and facilities that are directly con‐

nected to a public power supply that

also supplies residential buildings.

9.2

Resistance to electromagnetic interference

The Status 1080 TM treatment unit is for use in an environment like the one cited

below. The customer or user of the Status 1080 TM should ensure that it is used in

the correct environment.

Immunity tests

IEC 60601 test level

Conformance level

Electromagnetic environ‐

ment - guidelines

Electrostatic discharge

(ESD) according to IEC

61000-4-2

± 6 kV contact discharge

± 8 kV atmospheric dis‐

charge

± 2/4/6 kV contact dis‐

charge

± 2/4/8 kV atmospheric

discharge

Floors should be made of

wood or concrete or have

ceramic tiles. When the

floor is made of synthetic

material, the relative hu‐

midity must be at least

30%.

Fast transient electrical

disturbances/ Bursts ac‐

cording to IEC 61000-4-4

± 2 kV for power lines

± 1 kV for input and output

lines

± 2 kV for power lines

The quality of the supply

voltage should correspond

to that of a typical business

or hospital environment.

Instructions for use Status 1080 TM
9 Details about electromagnetic compatibility according to EN60601-1-2 | 9.1 Electromagnetic Transmissions

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Содержание Status 1080 TM

Страница 1: ...Instructions for use Status 1080 TM Always be on the safe side...

Страница 2: ...Distributed by KaVo Dental GmbH Bismarckring 39 D 88400 Biberach Tel 49 7351 56 0 Fax 49 7351 56 1488 Manufacturer Kaltenbach Voigt GmbH Bismarckring 39 D 88400 Biberach www kavo com...

Страница 3: ...uct specific 11 3 Product description 14 3 1 Treatment unit 14 3 2 Unit base 15 3 3 Unit body with patient s part 16 3 4 Dentist s unit 17 3 5 Assistant unit 18 3 6 Keypads 19 3 7 Footswitch 20 3 8 Te...

Страница 4: ...hree function and multi function handpiece 58 4 8 7 Setting the spray mist suction device and saliva ejector 60 5 Preparation methods DIN EN ISO 17664 61 6 Adaptable accessories and kits 62 6 1 Unit b...

Страница 5: ...unaut Europ enne A product with this mark meets the requirements of the applicable EU directive Action required 1 1 3 Target group This document is for dentists and office personnel 1 2 Service Servic...

Страница 6: ...rranty Claims from this warranty can only be asserted when the transfer form copy be longing to the product has been sent to KaVo and the original can be presented by the operator or user 1 4 Transpor...

Страница 7: ...delivery receipt Without this evidence the recipient will not be able to assert a claim for damages against the shipping company 2 Leave the product and packaging in the condition in which you receive...

Страница 8: ...ws pointing upwards Fragile protect against impact Protect from moisture Permissible stacking load Temperature range Humidity Air pressure Instructions for use Status 1080 TM 1 User instructions 1 4 T...

Страница 9: ...s a hazardous situation that can di rectly cause death or serious injury 2 1 3 Structure DANGER The introduction describes the type and source of the danger This section illustrates the potential cons...

Страница 10: ...s of VDE 0751 1 Repeated tests and test before startup of electronic medical devices and systems general guidelines Users have a duty to Only use equipment that is operating correctly to protect himse...

Страница 11: ...e recycled or disposed of in a manner which is safe both for people and for the environment This must be done in strict com pliance with all applicable national regulations Questions on proper disposa...

Страница 12: ...deadline The owner or user of the device will bear the costs for disassembly transporta tion and packaging International EU For country specific information on disposal contact your dental supplier 2...

Страница 13: ...The product meets the applicable requirements regarding electromagnetic fields Given the complex interactions between equipment and cell phones the product may be influenced by a cell phone that is in...

Страница 14: ...H2O2 since the water is steri lised with OXYGENAL 6 at a concentration up to 0 02 CAUTION Damage to the instrument hoses from stickers Instrument hoses can explode Do not affix stickers or adhesive t...

Страница 15: ...a load above its limit 135 kg CAUTION Hair may become caught in the patient s chair when the headrest is moved Injuries When moving the patient chair and headrest be aware of the patient s hair and t...

Страница 16: ...tment unit Standard headrest Armrest supplementary equipment SOMATIC headrest Basic chair 2 joint headrest Comfort Backrest Bench Progress Backrest Instructions for use Status 1080 TM 3 Product descri...

Страница 17: ...e patient unit device body and assis tant unit Main fuse Supply unit customer connection of power water compressed air wastewater and suction air Main switch Rating plate Instructions for use Status 1...

Страница 18: ...part Unit body The central control is housed in the unit body Tumbler filler Pressurized water bottle additional equipment Spittoon Foot control Instructions for use Status 1080 TM 3 Product descript...

Страница 19: ...emodent PIEZOlux Locking brake Either INTRA Lux K 200 motor or IN TRA Lux KL 701 motor Small x ray film viewer Instrumentation such as Tray holder Turbine The arrangement of the instruments can be cha...

Страница 20: ...nit Three function handpiece or multi functional handpiece Saliva ejector Spray mist suction Satelec Mini LED Key and display field Instructions for use Status 1080 TM 3 Product description 3 5 Assist...

Страница 21: ...ED Seat up AP 0 automatic position 0 green Seat down rinsing position green Backrest down AP 1 automatic position 1 green Backrest up AP 2 automatic position 2 green Last position automatic position g...

Страница 22: ...the patient chair into automatic position Sets the preset spray Stirrup switch Turns on the safety shutoff Switches the foot but tons to the Chair move ment function Blown air AP foot switch Moves th...

Страница 23: ...V 97 to 2 106 kJ h Heat emission at 220 to 240 V 97 to 3 240 kJ h Mark of approval CE DVGW VDE Footswitch IPX1 moisture protection Water supply Note If the water is very hard above 12 dH a water soft...

Страница 24: ...essure 5 2 to 7 bar Air consumption max 80 Nl min Customer air filtration 50 m Air connection R 1 2 Air connection above the floor min 40 mm max 75 mm Diameter of the suction connection 40 mm Suction...

Страница 25: ...C Relative humidity 5 to 95 non condensing Air pressure 700 to 1 060 hPa Weight Treatment unit 282 kg gross 242 kg net 3 9 Rating and name plates Rating plate F1 F2 Name plate Instructions for use Sta...

Страница 26: ...atient chair 300 seconds The permissible operating times correspond to dental practice Fuse rating 100 V to 130 V T10H 220 V to 240 V T6 3H For disposal information see also Purpose proper use CE mark...

Страница 27: ...ssed air and water supplies are connected and discon nected using the solenoid valves installed in the device Switch the device on at the main switch When the device is ready for use the LEDs in and a...

Страница 28: ...TION Collision and damage to the unit Ensure sufficient space for swinging Turn off the device before conversion Right handed model Left handed model Instructions for use Status 1080 TM 4 Operation 4...

Страница 29: ...ve the seat Carefully place the foot control in the spittoon bowl Use protective base Remove the cover Instructions for use Status 1080 TM 4 Operation 4 2 Converting from right handed to left handed 2...

Страница 30: ...ON Let the instrument hose hang on the patient chair or another object When swinging the dentist s unit and the articulation make sure that the in strument hoses do not get caught Instructions for use...

Страница 31: ...Remove the lock and simultaneously rotate the device body toward the backrest Instructions for use Status 1080 TM 4 Operation 4 2 Converting from right handed to left handed 29 74...

Страница 32: ...ce body are fixed when they audibly lock in place Swing the dentist s unit into position and rotate the patient s unit 360 Instructions for use Status 1080 TM 4 Operation 4 2 Converting from right han...

Страница 33: ...body Change over the safety lever Change over the safety lever ItemA The ability of the armrest to swing is blocked ItemB Swingable armrest Attach the seat in reverse order 1 2 Instructions for use S...

Страница 34: ...arm rest back until it locks in place WARNING The armrest is not fixed on the device body side The armrest unintentionally swings out and collides with the device body Make sure that the safety lever...

Страница 35: ...eed to raise their head slightly during adjustment Adjust the brake for the lengthwise headrest shift Remove the cover Adjust the braking force with hexagon socket screw WAF 3 mm Remount the cover Adj...

Страница 36: ...slight pressure arrowA SOMATIC headrest CAUTION Adjusting the headrest Injury of neck muscles Make sure that the patient is aware of the headrest setting Patients need to raise their head slightly du...

Страница 37: ...Remount the cover Adjust the height Push in or pull out the headrest depending on the patient s size Swing the headrest Turn the knob to the left or right and swing the headrest into position To lock...

Страница 38: ...their head slightly during adjustment Adjust the brake for the lengthwise headrest shift Remove the cover Adjust the braking force using hexagon socket screw WAF 3 mm Remount the cover Adjust the hei...

Страница 39: ...is nothing in area B 4 3 4 Turning the head cushion The head rest cushion is a rotating cushion It can be turned to offer better neck support for example when treating children Evenly pull the cushio...

Страница 40: ...t Cross switch on the foot control Dentist unit key Cross switch Counter clockwise motor rotation function T M The seat moves upward T M The seat moves down T M The backrest moves up ward T M The back...

Страница 41: ...down and getting up position using the AP 0 key and the rinsing position with the SP key Move the chair into the position that is to be saved Briefly press the LP AP button The LEDs of the buttons AP...

Страница 42: ...ed with the press of a button Four automatic positions can be retrieved with the controls on the dentist s unit and assistant s unit and two automatic positions can be re trieved with the foot control...

Страница 43: ...ic position last position Blown air footswitch SP automatic position rinsing position Move the chair when the instrument is mounted T M Press the Preselected spray or Blown air foot switch The chair m...

Страница 44: ...hair can occur when the assistant s unit is in certain positions Damage to the assistant element and patient chair Keep the assistant unit out of the range of movement of the patient chair Always moni...

Страница 45: ...patient chair and foot control safety shutoffs Backrest Armrest Cover on the curved segment of the backrest Bracket on foot control Seat Safety shut off on the assistant unit Assistant unit Swinging...

Страница 46: ...g display flashing on the dentist s or assistant s unit Display LED Safety shut off Assistant unit Backrest Cover on the curved segment of the backrest Seat Armrest Footswitch Patient unit Note The ch...

Страница 47: ...ating temperature of 140 C The cooling phase lasts approx 15 minutes After the cooling phase is over the lift and backrest motors are operable Such temper atures are not reached in normal practice The...

Страница 48: ...il the lock releases and then lower the assistant unit 4 6 Swing the patient unit by hand The swinging range is about 360 C 360 CAUTION The left armrest can collide with the manually adjusted patient...

Страница 49: ...the spittoon The operation of the tumbler filler and bowl rising is the same for the dentist s unit and assistant s unit Adjust at the time for bowl rinsing and tumbler filling Beeps sound when adjus...

Страница 50: ...mode group 9 and when a DCA relay is installed Set down all the instruments Press the Cold light button to turn the treatment light on or off 4 7 6 Set the time and use the timer only with Memospeed...

Страница 51: ...se the function keys only with the Memospeed From the 14 functions you can select two that can be retrieved using the function keys Select and save the function F1 Press F1 or F2 until you hear a tone...

Страница 52: ...do not work the drill bits or PIEZOlux tips of these instruments can be changed 4 8 1 Save instrument specific settings The following settings can be individually saved for the instruments Instrument...

Страница 53: ...s for use and assembly in the instrument packaging The following settings can be changed Speed cold light intensity Setting turbine with Memospeed Take turbine out of rack Setting the speed Note The s...

Страница 54: ...to the left or right Setting cold light intensity The cold light intensity can be set in 10 levels E123 Press the Level selection button T M Set the desired intensity from 1 to 10 by pressing the Red...

Страница 55: ...on of motor rotation and the speed are set using the keys on the control element or the foot control Note The minimum and maximum speed depends on the motor and the attached hand piece or contra angle...

Страница 56: ...toring values Press the LP AP button until you hear a beep Adjust the speed and cold light intensity Setting the speed K 200 motor KL 701 motor Minimum 400 rpm 2 000 rpm Maximum 2900 rpm 2900 rpm E123...

Страница 57: ...ntensity Page 52 The values are saved in same manner as with the turbine See also Storing values Page 53 4 8 5 Operating the PIEZOlux CAUTION Danger of injury when the torque wrench is laid down The s...

Страница 58: ...imum torque is reached Adjust the water emission Turn the ring on the handpiece Adjust the PIEZOlux without Memospeed The cold light is set and saved as with the turbine The intensity is adjusted in t...

Страница 59: ...the lamp cool down after long use Turn off the device Screw the hose sleeve off the handpiece and pull the handpiece off the hose coupling Pull the high pressure lamp out of the socket Insert the new...

Страница 60: ...minutes with a resting time of 3 minutes Remove the turbine from the holder Check the passage of the media through the cannula before using it on the pa tient Press the Air button the exiting air flo...

Страница 61: ...rom contact Switch main device switch off Let the lamp cool down after long use Pull off the grip sleeve together with the cannula from the valve body Push the holder forward and pull the defective hi...

Страница 62: ...To set the suction or block it move the slides that are integrated in the conical pieces of the saliva ejector and spray fog suction Start stop the suction with the vacuum stop extra Remove the saliva...

Страница 63: ...5 Preparation methods DIN EN ISO 17664 Note The preparation methods can be found in the care instructions Instructions for use Status 1080 TM 5 Preparation methods DIN EN ISO 17664 61 74...

Страница 64: ...nit with device body and assistant unit Designation Description External equipment con nections To connect and supply third party devices such as an airflow through the quick couplings D rr CAS amalga...

Страница 65: ...th a removable and sterilisable sleeve X ray viewer The 5 x 5 cm x ray viewer is optionally adaptable to the left or right side of the dentist s unit Speed timer LCD display for the time speed and tim...

Страница 66: ...pray preselected Preselect spray Close the ring for controlling the spray on the instruments Open the ring for controlling the spray on the instruments The main water valve in the office is closed Ope...

Страница 67: ...t chair does not move The safety shutoff is activated The LED on the control panel flash es Check the safety shutoff and eliminate the reason for the shutoff The patient chair does not move or only mo...

Страница 68: ...e book Check the ratings of fuses that are accessible from outside Visually inspect the medical device and accessories Protective conductor tests according to VDE 0751 1 Leakage current measurements a...

Страница 69: ...nufacturer treatment lamps multimedia system etc Raise the patient chair Scan the following positions with the test tip Measuring points Backrest spindle motor Base plate Lift spindle motor Main switc...

Страница 70: ...leakage current EUL can be measured using an EPA meas uring line Mat no 1 001 9904 or at the falling measuring points on the patient chair Fuses F4 F7 and F10 and X Instructions for use Status 1080 TM...

Страница 71: ...411 8811 to X 2 Check the EUL at the measuring points or with an EPA measuring line Mat no 1 001 9904 8 3 Measuring dummy patient leakage current Threshold 5 mA The equivalent unit leakage current EUL...

Страница 72: ...l equipment such as connection to equipment by a different manufacturer treatment lamps multimedia system etc Disconnect L N device side from the mains Instructions for use Status 1080 TM 8 Carrying o...

Страница 73: ...Check the EPA at the measuring points or with an EPA measuring line Mat no 1 001 9904 Instructions for use Status 1080 TM 8 Carrying out safety checks 8 3 Measuring dummy patient leakage current 71 74...

Страница 74: ...of voltage fluctuations or flicker according to IEC 61000 3 3 Conforms The Status 1080 TM is for use in all facilities including residential ones and facilities that are directly con nected to a publ...

Страница 75: ...tal environment NOTE V T is the alternating mains voltage before the test level is used 9 3 Recommended safe distance between portable and mobile HF telecommunications equipment and the treatment unit...

Страница 76: ...waves is absorbed and reflected by buildings objects and people Instructions for use Status 1080 TM 9 Details about electromagnetic compatibility according to EN60601 1 2 9 3 Recommended safe distance...

Страница 77: ......

Страница 78: ...1 000 6141 Fk 20100309 04 en...

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