PROIMPLANT Instructions for Use Jan 2011

Set REF 1700389-001

CA 20:1

1 x REF 1600752-001

1 x REF 1600730-001

1 x REF 1600606-001

1 x REF 1600632-001

10 x

1 x REF 1600631-001

10 x

1 x REF 1303711-010

1 x REF 1500984-010

1 x REF 1303393-001

Set REF 1700395-001

10 x

1 x REF 1600730-001

1 x REF 1600752-001

1 x REF 1303711-010

1 x REF 1600606-001

10 x

1 x REF 1600631-001

1 x REF 1500984-010

1 x REF 1303393-001

Options

CA 20:1

REF 1600632-001

REF 1600752-001

10 x

REF 1600631-001

REF 1303711-010

REF 1600606-001

10 x

REF 1301560-010

10 x

REF 1500984-010

PROIMPLANT

Summary Starting display

PROIMPLANT

Available values IMPLANT PRG

Torque in Ncm

Irrigation in ml/min

100 - 40’000 rpm

0.48 - 4.8 Ncm

30 ml/min 20%

with a CA 1 : 1

with a CA 1 : 1

60 ml/min 40%

Depends on the CA

Depends on the CA

120 ml/min 80%

Steps

Ratio

Speed in rpm

Round bur 1

128:1

Round bur 2

64:1

Drill 1

30:1

Drill 2

27:1

Drill 3

20:1

Drill 4

16:1

Implantology

Implant PRG1 Implant PRG2 Implant PRG3 Implant PRG4 Implant PRG5 Implant PRG6 Implant PRG7 Implant PRG8

Tapping

10:1

Tap unscrewing

1:1

Implant screwing

1:2

Unscrewing

1:5

90 ml/min 60% 150 ml/min 100%

ENG

Table of contents Contenu

1 Symbols Meaning of symbols

Page 2

2 Description

3

Identification Intended use Environment Environmental protection and information for disposal of the instrument

3 3 3 3

Set supplied

4

4 Options

4

5 Technical description Technical data Electromagnetic compatibility

5 6-7

6 Installation

8-9

7 Description of keys and elements

10

8 Operation Description of functions Start-up Pre-settings (SETUP) Description of program - Implantology

9 List of errors / Toubleshooting

11 12 12-13 14

15

10 Default values Implantology

16+33

11 Maintenance Overhaul Information Cleaning-disinfection Important

16 16 16 16

12 Generalities and guarantee General information Terms of guarantee

16 16

1

ENG

1 Meaning of symbols

0120

Rx Only

CE Marking with number of the notified body.

Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner. Protective earth (ground). Main switch ON - The instrument is energized. OFF - The instrument is de-energized. Fuse Ø 5 x 20 mm. Alternating current. Device of type B.

CAUTION ! Dangerous voltage.

Element sensitive to electrostatic discharges.

CAUTION! Refer to the accompanying documents.

Danger of pinching. Do not put your fingers in rotating parts.

Variability in steps.

Symbol for «Water-cooling».

Symbol for «peristaltic pump».

Recyclable materials.

Recyclable electrical and electronic material.

Sterilisable in autoclave up to the specified temperature.

Operating mode intermittent.

Manufacturer.

2

ENG

2 Description

Identification

Electronically controlled tabletop device allowing operation of an MX CHIROPRO micromotor with variable speed control by a pedal. A peristaltic pump conveys the physiological liquid via a disposable irrigation line without being contaminated. The device's LCD display indicates the stage of implant fitting, the instrument's ratio, the bur speed, torque value and irrigation flow setting.

Intended use

Product intended for professional use only. Use in dentistry for implantology work. Any use other than that for which this product is intended is unauthorised and may be dangerous. The medical device meets all the current legal requirements. The device is not authorised for use in an explosive atmosphere (anaesthetic gas).

Environment

Working

Temperature: Relative humidity: Atmospheric pressure:

Transport and storage

Environmental conditions for a period of max. 15 weeks Temperature: -25°C (-13°F) to +70°C (158°F) Relative humidity: 10% to 100%, including condensation Atmospheric pressure: 500 hPa to 1060 hPa

Environmental protection and information for disposal of the instrument

+10°C (50°F) to +25°C (77°F) 30% to 80%, including condensation 700 hPa to 1060 hPa

The disposal and/or recycling of materials must be performed in accordance with the legislation in force.

This device and its accessories must be recycled. Electrical and electronic equipment may contain dangerous substances which constitute health and environmental hazards. The user must return the device to its dealer or establish direct contact with an approved body for treatment and recovery of this type of equipment (European Directive 2002/96/EC).

3

ENG

3 Set supplied Set REF 1700389-001

1x 1x 1x 1x 1x 1x 1x 1x 1x 1x

PROIMPLANT control REF 1600730-001 Micromotor MX CHIROPRO REF 1600752-001 Cable for MX CHIROPRO micromotor REF 1600606-001 Contra-angle handpiece CA 20:1 (without light) REF 1600632-001 Pack of 10 disposable sterile lines REF 1500984-010 10 attachments collars for fastening the sterile irrigation line to a cable REF 1303711-010 Bracket for fluid bottle REF 1303393-001 Pedal 3 buttons REF 1600631-001 Cable system 3P, US / Asia, length 2,00 m REF 1300067-001 Instruction REF 2100227

Set REF 1700395-001

1x 1x 1x 1x 1x 1x 1x 1x 1x

PROIMPLANT control REF 1600730-001 Micromotor MX CHIROPRO REF 1600752-001 Cable for MX CHIROPRO micromotor REF 1600606-001 Pack of 10 disposable sterile lines REF 1500984-010 10 attachments collars for fastening the sterile irrigation line to a cable REF 1303711-010 Bracket for fluid bottle REF 1303393-001 Pedal 3 buttons REF 1600631-001 Cable system 3P, US / Asia, length 2,00 m REF 1300067-001 Instruction REF 2100227

4 Options Contra-angle handpiece CA 20:1 (without light) Micromotor MX CHIROPRO Cable for MX CHIROPRO micromotor Pack of 10 disposable sterile lines 10 attachments collars for fastening the sterile irrigation line to a cable Pedal 3 buttons Cable system 3P, Switzerland, length 2,00 m Cable system 3P, Europe, length 2,50 m Cable system 3P, US / Asia, length 2,00 m 10 fuse T4.0A L 250 VAC

4

REF 1600632-001 REF 1600752-001 REF 1600606-001 REF 1500984-010 REF 1303711-010 REF 1600631-001 REF 1300065-001 REF 1300066-001 REF 1300067-001 REF 1301560-010

Pedal REF 1600631-001 Dimensions (LxWxH) 250 x 205 x 54 mm with handle: 250 x 205 x 144 mm The pedal is waterproof (IP X8 in accordance with CEI 529).

Manufacturer Bien-Air Dental SA. Voltage 100 – 240 VAC 50 / 60 Hz Fuses 2 fuses T4.0A L 250 VAC, breaking capacity 40A Power demand 300 VA Classification Class IIa in accordance with European Directive 93/42/EEC concerning medical devices. Electric insulation class I type BF. Type BF apparatus, according to EN 60601-1 (apparatus protected against electric shocks). Degree of protection IP 40 (protection against insertion of objects larger than 1 mm). Dimensions L x W x H 309 x 220 x 123 mm. Height with bracket 506 mm Weight Housing 2.7 kg Cable 105 g

ENG

5 Technical Description: Technical data

Pedal Bracket

830 g 115 g

Memory Implantology mode: Storage in memory of 8 implant fitting sequences of 10 steps each.

Cables Length of cables: Pedal cable 2,90 m Motor cable 2,00 m WARNING To prevent any risk of electric shock, this device should be connected only to a power supply network provided with protective earth. The apparatus is not adapted to the presence of an inflammable gas. Do not attempt to open the apparatus when it’s connected to the electric mains. Beware of electrical shocks. Parts applied Micromotor MX CHIROPRO CA 20:1 Irrigation lines

REF 1600752-001 REF 1600632-001 REF 1500984-010

Accuracy of displayed values Speed ± 5% Torque ± 5% Operating mode: Intermittent ON: 5 min. OFF: 40 min.

Interface Languages French, German, English, Italian, Spanish, Portuguese, Japanese and Russian. List of errors & Toubleshooting Page 15 Bracket Stainless steel Important Micromotor MX CHIROPRO Cable for MX CHIROPRO micromotor Contra-angle CA 20:1, without light

Peristaltic pump Pump delivery: Hose for pump:

see instruction REF 2100161 REF 2100163 REF 2100209

From 30 to 150 ml/min. (5 levels). External Ø 5.60 mm, internal Ø 2.40 mm Wall thickness 1.60 mm.

5

ENG

5 Technical Description: Electromagnetic compatibility Precautions regarding Electromagnetic Compatibility (EMC)

Electro-medical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the present document.

Frequency surgical and similar equipment so that the HF cables are not routed on or near the device. If in doubt, please contact a qualified technician or Bien-Air Dental.

PROIMPLANT complies with the EMC requirements according to IEC 60601-1-2. Radio transmitting equipment, cellular phones, etc. shall not be used in the close proximity of the device since they could influence the performance of the device. Particular precaution is required when using strong emission sources such as High

PROIMPLANT should not be used adjacent or stacked with other equipment. If adjacent or stacked use is necessary, PROIMPLANT should be monitored to verify normal operation in the configuration in which it will be used.

WARNING!

The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by Bien-Air Dental as replacements parts for

internal components, may result in increased emissions or decreased immunity of PROIMPLANT.

Guidance and manufacturer’s declaration - electromagnetic emissions

PROIMPLANT is intended for use in the electromagnetic environment specified below. The customer or the user of PROIMPLANT should ensure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

PROIMPLANT uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Not applicable

Voltage fluctuations/flicker emissions IEC 61000-3-3

PROIMPLANT is suitable for use in all Establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Conform

Guidance and manufacturer’s declaration - electromagnetic immunity PROIMPLANT is intended for use in the electromagnetic environment specified below. The customer or the user of PROIMPLANT should ensure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic tile. If floors discharge (ESD) are covered with synthetic material, the relative humidity ±8 kV air ±8 kV air should be at least 30%. IEC 61000-4-2 Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that of a typical commertransient/burst supply lines supply lines cial or hospital environment. IEC 61000-4-4 No input/output lines No input/output lines Surge IEC 61000-4-5

Voltage dips, short interruptions and variations de tension voltage variations on power supply input lines 1 IEC 61000-4-11

±0.5 kV line to line ±1 kV line to line

±0.5 kV line to line ±1 kV line to line

±0.5 kV line to earth ±1 kV line to earth ±2 kV line to earth <5% UT (>95% dip in UT) for 0,5 cycle

±0.5 kV line to earth ±1 kV line to earth ±2 kV line to earth <5% UT (>95% dip in UT) for 0,5 cycle

40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles

40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles

3 A/m

3 A/m

<5% UT (>95% dip in UT) for 5 sec

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

Mains power quality should be that of a typical commercial or hospital environment. If the user of PROIMPLANT requires continued operation during power mains interruptions, it is recommended that PROIMPLANT be powered from an uninterruptible power supply or a battery.

<5% UT (>95% dip in UT) for 5 sec

NOTE UT is the a.c. mains voltage prior to application of the test level.

6

Mains power quality should be that of a typical commercial or hospital environment.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercialor hospital environment.

ENG

5 Technical Description: Electromagnetic compatibility Guidance and manufacturer’s declaration - electromagnetic immunity PROIMPLANT is intended for use in the electromagnetic environment specified below. The customer or the user of PROIMPLANT should ensure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of PROIMPLANT, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3V 80 MHz to 800 MHz 800 MHz to 2,5 GHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3 V/m

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. 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 PROIMPLANT is used exceeds the applicable RF compliance level above, the PROIMPLANT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the PROIMPLANT. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the PROIMPLANT The PROIMPLANT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PROIMPLANT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PROIMPLANT as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

0.01 0.1 1 10 100

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz

0.12 0.38 1.2 3.8 12

0.12 0.38 1.2 3.8 12

0.23 0.73 2.3 7.3 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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 NOTE 2

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

7

ENG

6 Installation

Fuse

= >

16 ON/OFF

Installation A. PROIMPLANT may be positioned on a table, on a trolley or another surface, but in no case on the floor. Power plug 14 is the device for disconnection in case of problems, and it must be easily accessible at all times. B. The fuse box may be opened with a screwdriver . 100 - 240 Vac = fuse T-4.0 A L 250 VAC REF 1301560-010

Plug

C. The apparatus is powered by your line voltage (100/115/230 Vac). Connect the power cable to the plug fig. 1.

fig. 1

D. Connect the pedal cable to the output provided on the rear panel, guiding the connector and plug by means of the index pin on the connector fig. 2.

Do not raise the pedal using the connection cable.

fig. 2

E. Connect the MX CHIROPRO micromotor cable to the motor output, guiding the connector and plug by means of the index pin and red dot on the connector fig. 3.

7 fig. 3

F. Align and attach the bracket to the housing provided on the console’s rear and suspend the flask or bottle fig. 4.

fig. 4

G. Check the packaging integrity, as well as the expiration date of the irrigation line. Only lines supplied by Bien-Air Dental ensure trouble-free operation. These lines are sterile and for single use. Re-use may result in microbiological contamination of the patient.

fig. 5

8

ENG

6 Installation H. Remove the single-use sterile irrigation line from its pouch.

fig. 6

Fitting on the spray tube I. Connect the flexible hose of the irrigation line to the spray tube of the handpiece or contra-angle fig. 7.

fig. 7

Installation on the peristaltic pump J. Install the plastic cassette in the peristaltic pump. Check that the cassette is clipped correctly. Close the pump lid, fig. 8. If there is resistance to closing, open the lid again and check the correct positioning of the cassette.

Warning! Do not run the pump while the lid is open. Danger of pinching! fig. 8

K. Perforate the cap of the physiological liquid flask with the pointed end of the irrigation line after removing the protective cap. REF 1303711-010

L. Attach the irrigation line on the motor cable using the attachment collars REF 1303711-010 fig. 9.

fig. 9

Stopping procedure

The device can be safely stopped using the main switch 16 .

9

ENG

7 Description of keys and elements 0

DEVICE SCREEN

Name of program Instrument transmission ratio Torque setting

Only in SETUP mode Activation/deactivation of the stage

ROUND BUR

Reversal of motor rotation symbol

20:1 28.0 Ncm

Selection cursor

1’000

RPM

Irrigation stopped

Adjusting irrigation

1

COMMAND TO REVERSE THE ROTATION OF THE MX CHIROPRO MICROMOTOR

2

“SETUP” MENU CALL-UP KEY

Motor overheating Speed adjustment

9

“PROGRAM” BUTTON ON PEDAL In implantology mode: - Short press: next stage - Long press: previous stage

:

BUTTON TO REVERSE THE ROTATION OF THE MX CHIROPRO MICROMOTOR ON PEDAL

3

PARAMETERS BACKUP KEY

4

RETURN KEY

;

VARIABLE SPEED DRIVE ON PEDAL

u

COMMANDS DEVICE Down key cursor Up key Left key (–) adjusting Right key (+) Confirmation/selection key OK In implantology mode: next stage

<

PEDAL CONNECTOR

=

MAINS CONNECTOR (100/115/230 VAC)

>

FUSE HOLDER

6

PERISTALTIC PUMP LID

?

MAIN SWITCH ON THE DEVICE

7

MX CHIROPRO MICROMOTOR CONNECTOR

@

LABEL

A

BRACKET SUPPORT

8

IRRIGATION ON/OFF CONTROL BUTTON ON PEDAL B

MX CHIROPRO MICROMOTOR

10

｝ ｝

ENG

8 Operation Description of functions

1 2 PROIMPLANT

3

ENG

4

1 REV

The "reverse" function can be chosen directly in all the programs. Upon selection, a beep and the "reversal of motor rotation" icon

indicate reverse rotation.

2 SETUP See next page. 3 SAVE Stores the settings of a program: press the key until a beep is emitted, and the values that are flashing will be stored in memory directly. 4

ESC

Return function. With "ESC", you can leave the current screen. In “Implantology” mode, can also be used to return to the previous stage. If the name of the program flashes when exiting, the changes will not be taken into consideration. The changes must always be confirmed with "SAVE", otherwise they will be lost.

ORANGE Program key: - Short press - Long press

next stage previous stage

BLUE Activation/Deactivation of the peristaltic pump.

GREY Activation/Deactivation of reversal of motor rotation.

Motor speed control pedal.

11

ENG

8 Operation Start-up 1. System loading...

3. IMPLANT. PRG

OK

Implant PRG2

OK

LANGUAGE

Implant PRG3

English

Implant PRG4

Français

Implant PRG5

Deutsch

Implant PRG6

Italiano

Implant PRG7

Espanol

Implant PRG8

Português

Select with Confirmation with OK

Russian

6. MAIN MENU

Please check the pre-programmed values before inserting implant.

Implant PRG1 2.

OK 4. <Name of selected program>

OK

Implantology Select with Confirmation with OK

OK: continue ESC: back 5. INFORMATION

with OK: go directly to pre-setting with no possibility of deactivating the stages

OK

Key functions: move cursor UP

Japanese

move cursor DOWN

Select with Confirmation with OK

decrem./disable

or with SETUP, possibility of deactivating the stages with

increm./enable OK: continue

The 8 implantology programs contain default values that represent common settings used during implant procedures. This storing in memory takes place only at the first connection of the device and is subsequently maintained. These parameters can then be modified in SETUP.

Pre-settings OK

OK

SETUP

English

Language

128:1

Implant. PRG

Français Deutsch

Implant. PRG Ratio

64:1

Ratio

Language

30:1

Light

Italiano

Light

27:1

Footpedal

Español

Footpedal

20:1

Torque units

Português

Torque units

16:1

Contrast

Russian

Contrast

10:1

Editor

Japanese

System info Select the language wanted and confirm with OK.

Restore defaults

OK

OK

Language

Implant PRG1

Implant. PRG Ratio

Implant PRG2

Light

Implant PRG4

Footpedal

Implant PRG5

Torque units

Implant PRG6

Contrast

Implant PRG7

Editor

Implant PRG8

Implant PRG3

System info Restore defaults

12

OK

OK

Select the system wanted and confirm with OK. ESC: change

Editor

1:1

System info

1:2

Restore defaults

1:5

Select the ratio to be changed OK, then change of value with and with then save with SAVE. Continue with OK. ESC: back

ENG

8 Operation Pre-settings OK

OK

Language

Language Implant. PRG Ratio

Implant. PRG Ratio

OK

Light OFF

Light

Light

Light ON

Footpedal

Footpedal

ON or OFF with then OK. Display under light ON: Level: adjustment with Time delay: setting with , save with SAVE, continue with OK. ESC: back

Torque units Contrast Editor System info Restore defaults

OK

Implantology (Ncm)

Torque units Contrast Editor

Adjustable with , save with SAVE, continue with OK. ESC: back

System info Restore defaults

OK

Language

OK

Implant. PRG Ratio

Language Implant. PRG Ratio

Contrast adjustment with , save with SAVE, continue with OK.

Light

Light

Footpedal

OK

Torque units

Implantology

Footpedal

Contrast

Torque units Contrast

Editor

ON/OFF or progressive with , save with SAVE, continue with OK. ESC: back

Editor System info

System Info: software version, serial number and electronics of the device.

System info Restore defaults

Restore system: Can be used to reinitialise factory settings.

Restore defaults

OK OK

Language Implant. system Ratio Light

Used to rename or customise the name of the system, tool or treatment. Select with then OK,choose the letters on the keypad by moving the cursor using then OK, save the new name with SAVE, ESC: back

Implant PRG1 Implant PRG2 Implant PRG3 Implant PRG4 Implant PRG5

Footpedal

Implant PRG6

Torque units OK

Contrast Editor System info Restore defaults

OK

Implantology (Ncm)

System names Tool names

Implant PRG7 Implant PRG8 OK

OK

Implant PRG1

ROUND BUR 1

Implant PRG2

ROUND BUR 2

Implant PRG3

DRILL 1

Implant PRG4

DRILL 2

Implant PRG5

DRILL 3

Implant PRG6

DRILL 4

Implant PRG7

TAPPING

Implant PRG8

TAP UNSCREWING IMPLANT SCREWING UNSCREWING 13

ENG

8 Operation Description of functions

Name of program Instrument transmission ratio Torque setting

Only in SETUP mode Activation/deactivation of the stage

ROUND BUR

Reversal of motor rotation symbol

20:1 28.0 Ncm

1’000

Selection cursor

RPM

Irrigation stopped

Adjusting irrigation

MAIN MENU

Steps

Selection wanted and confirm with OK

Each of these stages can be activated or deactivated from the SETUP menu. See also info on the last page. OK: next step ESC: previous step

Implantology

Motor overheating Speed adjustment

Transmission ratio

Speed in rpm

Torque in Ncm

Irrigation in ml/min

Select with the cursor

Ajustable:

Ajustable:

Ajustable:

Ajustable:

then SAVE

then SAVE

then SAVE

then SAVE

ROUND BUR 1 ROUND BUR 2 DRILL 1 DRILL 2 DRILL 3 DRILL 4 TAPPING TAP UNSCREWING

128:1

100 - 40’000 rpm

0.48 - 4.8 Ncm

30 ml/min 20%

IMPLANT SCREWING

64:1

with a CA 1 : 1

with a CA 1 : 1

60 ml/min 40%

UNSCREWING

30:1 Depends on the CA selected

120 ml/min 80%

27:1 20:1

90 ml/min 60% Depends on the CA selected

150 ml/min 100%

16:1 10:1 1:1 1:2 1:5

Pre-programmed values, see pages 33 14

Message

Release the pedal

ENG

9 List of errors & Toubleshooting Cause of error The pedal is pressed when starting the device. Safety The motor is blocked for more than 2 sec. The motor control card limits the power supplied to the motor to prevent motor overheating.

Safety

Action Release the pedal and press again.

Avoid extended use.

Equipment initialisation error The following error may occur at start-up of PROIMPLANT 1. Check on the integrity of the PROIMPLANT memory INIT ERROR 1

The memory is corrupt! The memory data check failed. Please contact Bien-Air Dental SA. ESC: restore

Press the ESC key to try to restore the memory. Contact Bien-Air Dental SA.

Device operating error The following errors may occur during operation of the device 1. Loss of pedal connection ERROR 1

The pedal is not connected! Please check the connection. ESC: exit

The pedal is not connected correctly.

Check pedal connection. Contact Bien-Air Dental SA.

Peristaltic pump motor overheating

Wait until the system cools. Contact Bien-Air Dental SA.

2. Peristaltic pump overheating ERROR 2

Irrigation pump overheating! Please wait for it to cool. ESC: exit

3. Peristaltic pump general error ERROR 3

Irrigation pump fault! Peristaltic pump electrical fault. Please contact Bien-Air Dental SA. ESC: exit

Contact Bien-Air Dental SA.

4. Loss of motor connection ERROR 4

The motor is not connected! Please check the connection. ESC: exit

Loss of motor phase fault. The motor is not connected correctly.

Check motor connection. Contact Bien-Air Dental SA.

Motor power fault. The motor cable may be defective.

Check motor cable. Contact Bien-Air Dental SA.

Overheating of motor control card (electrical control of motor).

Wait until the system cools. Contact Bien-Air Dental SA.

System electrical fault! Communication fault with motor Please contact Bien-Air Dental SA. control card: [EC100] ESC: exit Motor control card power supply undervoltage: [EC101]

Contact Bien-Air Dental SA.

5. Motor cable fault ERROR 5

Motor cable fault! Please change cable. ESC: exit

6. Motor control overheating ERROR 6

System overheating! Please wait for it to cool. ESC: exit

7. System electrical fault GEN ERROR [Error code]

Motor control card power supply overvoltage: [EC102] Other motor control card faults: [EC120] 15

ENG

10 Default values Implantology: Default values page 33 The table shows the default operating values for 8 different implantology sequences.

11 Maintenance Only use original Bien-Air Dental maintenance products and parts or those recommended by Bien-Air Dental. Using other products or parts may cause operational failure and/or void the guarantee. Overhaul Never disassemble the device. For any modification and repair, we recommend that you contact your regular supplier or BienAir Dental directly. Bien-Air Dental asks the user to have its dynamic instruments checked or inspected at least once a year. Information The technical specifications, illustrations and dimensions contained in these instructions are given only as a guide. They may not be the subject of any claim. The manufacturer reserves the right to make technical improvements to its equipment, without amending these instructions. For all additional information, please contact Bien-Air Dental SA at the address indicated on the back cover.

Cleaning-disinfection • Disinfect the surfaces of the console and pedal with a clean cloth soaked in a suitable product. • Do not exert any pressure on the screen. • Do not immerse in disinfectant solution • Not designed for an ultrasonic bath. • Use a new sterile irrigation line for each patient. • AAMI TIR 12:2004 - Disinfection level: intermediate. Important For maintenance: - MX CHIROPRO micromotor - Cable for micromotor MX CHIROPRO - Contra-angle CA 20:1

see instruction REF 2100161 REF 2100163 REF 2100209

12 Generalities and guarantee General information The device must be used by a qualified person in compliance with the current legal provisions concerning industrial safety, health and accident prevention measures, and these working instructions. In accordance with such requirements, the operators: • must only use devices that are in perfect working order; in the event of irregular functioning, excessive vibration, abnormal heating or other signs that may indicate malfunction of the device, the work must be stopped immediately; in this case, contact a repair centre that is approved by Bien-Air Dental; • must ensure that the device is used only for the purpose for which it is intended, must protect themselves, their patients and third parties from any danger, and must avoid contamination through the use of the product. Terms of guarantee Bien-Air Dental grants the user a guarantee covering all functional defects, material or production faults. The device is covered by this guarantee for 12 months from the date of invoicing. In case of justified claim, Bien-Air Dental or its authorised representative will fulfil the company’s obligations under this guarantee by repairing or replacing the product free of charge.

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Any other claims, of whatever nature, in particular in the form of a claim for damages and interest, are excluded. Bien-Air Dental shall not be held responsible for damage or injury and the consequences thereof, resulting from: • excessive wear and tear • improper use • non-observance of the instructions for installation, operation and maintenance • unusual chemical, electrical or electrolytic influences • poor connections, whether of the air, water or electricity supply. The guarantee does not cover flexible “fibre optic” type light conductors, or any parts made of synthetic materials. The guarantee shall become null and void if the damage and its consequences are due to improper manipulation of the product, or modifications to the product carried out by persons not authorised by Bien-Air Dental.Claims under the terms of the guarantee will be considered only on presentation, together with the product, of the invoice or the consignment note, on which the date of purchase, the product reference and the Serial No. should be clearly indicated.