Nouvag MD11 User manual

Motor System for Implantology
©NOUVAG AG • 31665 • V20220914 • All rights reserved.
MD 11
Instructions for use
EN

Instructions for use MD 11 • 31665 • V20220914

MD 11
MD 11, Operating Instructions, REF 31665, V07/21 1
EN
Table of contents
1Product description 2
1.1Intended use and operation 2
1.2Contraindications 2
1.3Technical data MD 11 2
1.4Ambient conditions 2
1.5Warranty coverage 2
2Explanation of symbols 3
3Safety information 4
3.1EMC Manufacturer's Declaration of Conformity 4
3.2Integrated peristaltic tube pump 4
3.3Modification and misuse 5
3.4Essential requirements 5
3.5 During use 5
4Scope of delivery 6
5Device overview 7
6Startup 8
6.1Device setup 8
6.2Connection to the power supply 8
6.3Device preparation 9
6.4Assembly of external irrigation system 10
6.5Assembly of internal and external irrigation system (optional) 11
7Operation 12
7.1Switching the device on and off 12
7.2Overview: control elements on the operating panel 12
7.3Overview: Standard display 13
7.4Adjusting the programs 14
7.4.1Step 1: Selecting the handpiece/contra angle to be used 14
7.4.2Step 2: Calibrating handpiece or contra angles 15
7.4.3Step 3: Setting the speed 16
7.4.4Step 4: Setting the torque 16
7.4.5Step 5: Setting the pump supply quantity 16
7.5Torque limit function, AL mode (Automatic Limiter) 17
7.6Torque limit function, AS mode (Automatic Stopper) 17
7.7Storing various programs 17
7.8Configuration Menu 18
7.9Operation using the VARIO pedal 21
7.10Functional check 22
7.10.1Electronic motor 22
7.10.2Pump 22
7.10.3Rotational direction of the electronic motor 22
8Cleaning, disinfection and sterilization 23
8.1Control unit and pedal 23
8.2 Tubing set, REF 1706 23
8.3 Handpiece cradle 23
8.4Electronic motor 21 23
9Maintenance 24
9.1Replacing the control unit fuse 24
9.2Safety inspections (STI) 24
10Malfunctions and troubleshooting 25
11Spare parts list with order numbers 28
12Information on disposal 28
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1 Product description
1.1 Intended use and operation
The MD 11 in combination with a motor and corresponding handpiece or contra angle (separate medical
device) is used primarily in dental Implantology. The device is designed for drilling, milling and sawing bone
as well as for screw insertion into bone. An integrated peristaltic pump is provided in order to cool the
rotating instruments so that damage to tissue can be prevented.
The MD 11 may only be operated by qualified and trained personnel.
It is used specifically in Implantology for:
• Milling and drilling the implant bed
• Cutting the thread for the implant
• Screwing in the implant
• Removing the fixture mount
• Placing the cover screw
1.2 Contraindications
Relative or absolute contraindications can arise from the general medical diagnose, or in special cases by a
significantly increased risk to the patient through the use of motor-driven systems.
Relevant cases in the literature must be taken into consideration.
1.3 Technical data MD 11
Voltage: -------------------------------------------------------------------------- variable: 100 V/ 115 V/ 230 V, 50/60 Hz
Fuse, power supply: ---------------------------------------------------------------------------------- 2 fuses T 3.15 AL 250 VAC
Power consumption: -------------------------------------------------------------------------------------------------------- 120 VA
Applied part: ---------------------------------------------------------------------------------------------------------------- Type BF*
Protection class: --------------------------------------------------------------------------------------------------------------- Class I
Dimensions (W x D x H): ------------------------------------------------------------------------------------ 260 x 250 x 110 mm
Net weight control unit: ------------------------------------------------------------------------------------------------------ 3.3 kg
Motor:
Motor coupling: ------------------------------------------------------------------------------------------ Intra coupling ISO3964
Motor speed: ---------------------------------------------------------------------------------------------------- 300 - 40,000 rpm
Max. Motor torque: ----------------------------------------------------------------------------------------------------------- 6 Ncm
Motor weight: ---------------------------------------------------------------------------------------------------------------- 0.280 kg
Motor cable length --------------------------------------------------------------------------------------------------------------- 2 m
Pedal:
IP code (pedal) -------------------------------------------------------------------------------------------------------------------- IPX8
Peristaltic pump:
Max. volumetric displacement of pump ---------------------------------------------------------------------------100 ml/min.
*Applied part of Type BF is the instrument used with the MD 11.
1.4 Ambient conditions
Transport and storage: Operation:
Relative humidity: 10 % – 90 % Max. 80 %
Temperature: 0 – 60°C (32 – 140°F) 10 – 30°C (50 – 86°F)
Atmospheric pressure: 700 – 1060 hPa 800 – 1060 hPa
1.5 Warranty coverage
Purchasing the MD 11 entitles you to a 1-year warranty. If you return the warranty card for registration
within four weeks of the date of purchase, warranty coverage will be extended for a further 6 months.
Consumable parts are not covered by the warranty. Improper use or repair, or failure to observe these
instructions, relieve us from any obligation arising from warranty provisions or other claims.
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2 Explanation of symbols
Important information Suitable for thermal disinfection
Do not use if the packaging is damaged Autoclavable at 134°C
Warning Sterilized using ethylene oxide
Manufacturer Observe the instructions for use
The device is designed for intermittent
duty operation at “1 min ON/3 min OFF”
at 4 cycles, after 15 min. brake.
Electrical and electronic devices that have
reached the end of their service life comprise
hazardous waste and may not be disposed of
together with household waste. Valid local
disposal regulations apply.
Type BF applied part
Applied parts is the instrument
Symbol indicating the serial number with the
date of manufacture (year/month).
Do not reuse Symbol indicating the order number.
Biohazard Symbol indicating the lot number.
Motor Date of expiry
Pedal Protective ground
Protection against contact and continual
submerging.
Certified by the Canadian Standards
Association (CSA)
Date of manufacturing Indication of the pump flow direction
Dangerous goods Aerosol spray:
Environmentally hazardous
NouvaClean/NouvaOil
Dangerous goods Aerosol spray:
Extremely flammable
NouvaClean/NouvaOil
Dangerous goods Aerosol spray:
Warning
NouvaClean/NouvaOil
European authorized representative
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3 Safety information
Your safety, the safety of your team, and of course that of your patients is very important to us. It is
therefore essential to bear the following information in mind:
Every use of the MD 11 different to the product description defined in chapter “Intended use and operation”,
causes risks for patients and trained personnel. If physical examinations and therapies are carried out
without use of the devices then the devices must be removed from the place of treatment. Avoid any
connection or close adjacency to other devices.
3.1 EMC Manufacturer's Declaration of Conformity
The use of (RF) Radio Frequency emitting devices and equipment as well as the occurrence of negative
environmental factors in the close area of the MD 11 may cause unexpected or adverse operation. The
connection or the placing of other devices in close vicinity is not allowed.
The Product is suitable for use in establishments of the industrial sector and hospitals. When used in the
domestic establishments, this unit may not provide adequate protection for radio services. The user must
take remedial measures such as implementation or reorientation of the product.
Use only accessories and cables as specified in the product description. Further observe the EMC
manufacturer declaration of conformity.
3.2 Integrated peristaltic tube pump
The integrated peristaltic pump is used to cool tissue in order to prevent damage to the tissue. It may only
be operated with watery solutions, such as 0.9 % Sodium Chloride irrigation solution or “Ringer” solution.
Supplying medication using the integrated pump is expressly prohibited.
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3.3 Modification and misuse
3.4 Essential requirements
The use of third-party products is the
responsibility of the operator.
Functionality and patient safety cannot be
guaranteed with third-party accessories.
Improper use or repair of the device and failure to
observe these instructions relieve us from any
obligation arising from warranty provisions or other
claims!
Use NouvaClean spray (REF 2127) for the
cleaning of handpieces and contra angles.
Using other cleaning products can result
in malfunctions, the warranty to be
revoked.
Only use the NouvaOil spray (REF 2128) to lubricate
electronic motors, handpieces and contra-angles.
The use of other care products can lead to
malfunctions. The guarantee expires!
Repairs may only be performed by
authorized NOUVAG service technicians.
The MD 11 may only be operated by qualified and
trained personnel.
Prior to using the device, before startup, and before any operation, the user must always ensure that the
device and accessories are in good working order and are clean, sterile and operational.
3.5 During use
The device is not sterile on delivery. All
sterilizable parts must be sterilized before
use (see Chapter 8.0 Cleaning,
disinfection and sterilization).
Never operate the clamping mechanism of the
handpieces or contra angles while they are running
or coasting! Instruments can be damaged.
Handpieces and contra angles may only
be attached to the electronic motor when
it is in a stand still.
To prevent injuries, never touch drill bits or burrs
while they are still running or coasting.
When selecting the instrument, the user
must ensure that it is biocompatible in
accordance with EN ISO 10993.
Do not use the device, pedal and motor in the
vicinity of flammable mixtures!
When used on patients, utmost care must be taken that as little frictional heat as possible occurs.
Excessive thermal influence causes necrosis of the tissue. The heat development is directly related to the
speed and the contact pressure of the instrument.
 Modification or manipulation of the MD 11 and its accessories is prohibited. The manufacturer is not
liable for any damages resulting from unauthorized modifications or manipulations. The warranty will
be canceled.
 Use of the MD 11 outside the indications described in Section 1.1 is prohibited. The user or operator is
solely responsible for any such use.
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4 Scope of delivery
REF Description Quantity
3335 MD 11 control unit ---------------------------------------------------------------------------------------------------- 1
1866nou VARIO pedal; IPX8; electronic ------------------------------------------------------------------------------------- 1
2097nou Electronic motor 21 incl. 2 m motor cable, max. speed 40’000 rpm ------------------------------------- 1
1706 Tubing set, sterile, 2 m, single-use -------------------------------------------------------------------------------- 1
1873 Clip set (10 pieces) for the tube set attachment to the motor cable -------------------------------------- 1
1881 Clip set (3 pieces) for the tube set attachment at handpieces and contra angles --------------------- 1
1770 Stand for irrigation fluid --------------------------------------------------------------------------------------------- 1
1170 Handpiece cradle ----------------------------------------------------------------------------------------------------- 1
19584 Spray adapter for NouvaOil-Spray for the care of electronic motors, handpieces and contra-
angles -------------------------------------------------------------------------------------------------------------------- 1
31665 Information for use, MD 11 on CD-ROM ------------------------------------------------------------------------- 1
In line with regulations pertaining to hazardous materials, the following items are not
delivered with the control unit and must be ordered separately:
2127 NouvaClean spray for the cleaning of handpieces and contra angles ------------------------------------ 6
2128 NouvaOil spray for the lubrication of handpieces, contra angles and electronic motors ----------- 6
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1
18 19 20 21
6
1
3
9
10
12
13
14
15
16
2
11
57 8
17
4
22
5 Device overview
Front view
1. Pedal socket, device rear
2. VARIO pedal
3. Contra angle (optional)
4. Clip for tubing set attachment at handpieces
and contra angles
5. Handpiece cradle
6. Electronic motor
7. Clip for tubing set attachment at motor cable
8. Motor socket
9. Operating panel
10. Release key for tubing set bracket
11. Display
12. Peristaltic pump
13. Tubing set
14. Stand for irrigation fluid bottle
15. Drip chamber
16. Bleed valve
17. Bottle with irrigation fluid
18. Type plate with type designation, reference number, serial
number, information on power supply and device fuse.
19. Power plug socket
20. Main switch
21. Fuse compartment
22. Spray adapter for the lubrication of the electronic motor
Rear view
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6 Startup
6.1 Device setup
• Installation layout
• Place the MD 11 and all required accessories and instruments on an even, non-slip surface and make sure
you have good access to all controls.
• The installation of the device in close proximity to other devices is prohibited due to EMC – please see
section 3.1 and the manufacturer’s EMC declaration in the appendix of this manual.
• Do not allow the operating range of the device (including the cable and contra angle) to be compromised
by limiting factors.
• The system display must be fully visible at all times.
• The pedal must be placed within stepping distance between the patient and the surgeon.
• It must be explicitly ensured that no objects can fall onto the pedal.
• The power plug at the rear of the device must be accessible at all times.
• The motor ventilation slots must be kept clear in order to prevent the motor temperature from
becoming excessive.
6.2 Connection to the power supply
If the voltage shown does not correspond to the local mains voltage, the grey fuse holder must be set to the
correct voltage:
A) Switch the device off and unplug the power cable.
B) Use a screwdriver to unlock the fuse holder.
C) Pull out the fuse holder.
D) Remove the grey fuse holder and reinsert it so that the local mains voltage setting is shown in the
small window.
E) Slide the fuse holder back in and lock it with a click.
F) Double check the mains voltage shown on the fuse slot window.
G) Plug the power cable back into the device.
In order to prevent the risk of an electric shock, the device may only be connected to a power network
with a PE protective ground conductor.
Before plugging the power cable into the power socket for the first time, you must check the supply
voltage setting next to the power switch!
Only a certified power cord may be used to connect the device to the power supply.
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6.3 Device preparation
1. Sterilize the motor (the motor is not sterile on delivery). If the motor has already been sterilized: when
removing the motor from the sterile packaging, ensure that the sterile packaging is not damaged and
that the sterility indicator confirms sterility (if no sterility indicator is provided, the sterile packaging
must at least show the date on which the shelf life of the sterile item is due to expire).
2. Insert the stand for the irrigation fluid into the stand holder.
3. Plug the motor plug of the electronic motor into the motor socket.
4. Plug the pedal plug into the pedal socket at the rear of the control unit.
5. Attach the sterilized handpiece or contra angle to the electronic motor. Press the handpiece or contra
angle firmly onto the electronic motor until it clicks into position. Check seating with a slight
countermovement.
6. Assemble the tubing set: Attach tubing set REF 1706, for the cooling of the contra angle, like described
in the following article.
Use only Nouvag tube set REF 1706, otherwise the proper functioning cannot be guaranteed.
Check the expiry date of the tubing set and ensure that the packaging is not damaged. Using
non-sterile tubing sets can result in serious infection and, in extreme cases, can be fatal.
When inserting the tubing set, watch the arrow on the cover of the pump compartment.
It indicates the flow direction of the cooling liquid.
Do not regulate the amount of irrigation fluid using the roller clamp on the tubing set; with the MD 11, this
is regulated instead using the integrated pump. For this reason, make sure to open the roller clamp as far
as it will go (please refer to 7.4.5 Setting the pump supply quantity).
A) Press release key for tubing set bracket (on top of the control unit) to open the pump.
B) The compartment with the integrated tubing bracket opens.
C) Place the tubing set into the tubing bracket provided in such a way that the part of the tubing set
with the spike exits the pump towards the rear of the device. Make sure the tubing is secure.
D) With the tubing set inserted, press the compartment downwards until it clicks into place.
The integrated peristaltic pump is used to cool tissue in order to prevent damage to the tissue. It may only
be operated with watery solutions, such as 0.9 % Sodium Chloride irrigation solution or “Ringer” solution.
Supplying medication using the integrated pump is expressly prohibited.
A B C D
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7. Pierce the spike of the tubing set into the rubber membrane of the cap of the coolant bottle and hang
the bottle on the stand.
8. Open the roller clamp on the tubing set as far as it will go.
9. Open the bleed valve beneath the drip chamber.
10. Connect the control unit to the power socket.
6.4 Assembly of the external cooling system
A) Connect the open end of the irrigation tubing set (REF 1706) with the cooling pipe of the contra angle.
B) Attach white clip (REF 1881) to the tubing set.
C) Attach the white clip, connected with the tubing set, to the contra angle.
D) Connect the electronic motor with the Contra Angle.
E) Attach the grey clip (optional, REF 1873) to the tubing set.
F) Attach grey clip, connected with the tubing set, to the cable of the electronic motor.
G) Ready to use drill unit with attached external cooling system.
If required, secure additional clips to the motor cable.
Ensure that the operating voltage setting corresponds to the local mains voltage.
"When selecting the instrument / tubing set, the user must ensure that it is biocompatible in
accordance with EN ISO 10993."
7 8 9
REF 1873
REF 1881
A B C D
E F G
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6.5 Assembly of internal and external cooling system (optional)
A) Attach open end of the tubing set (REF 1706) to the single out branch of the Y-connector (optional, REF 1777).
B) Connect a 16 cm piece of tube (optional, REF 1773) to each of the branching tubes of the Y-connector.
C) Connect one of the 16 cm pieces of tube, that branch out of the Y-connector, with the internal cooling tube of
the contra angle (delivered together with the contra angle, REF 39116).
D) Connect the second piece of tube that branches out of the Y-connector with the external cooling pipe of the
contra angle (welded on laterally to the contra angles head).
E) Both 16 cm pieces of tube are now connected to the cooling system of the contra angle.
F) Secure white tube clips (included with the contra angle, REF 1881) to each of the short tube pieces.
G) Secure tube clips to the contra angle.
H) Contra angle with attached tube clips.
I) Fix a gray clip (optional, REF 1873) to the tubing set, leading to the Y-connector.
J) Fix tubing set with the gray clip to the motor cable.
K) Motor cable with ready attached tubing set to the motor cable. Secure further gray clips to the motor cable if
needed.
L) Tubing set routing with Y-connector for internal and external cooling of the instrument.
Essential accessories for internal cooling:
REF 1881 F G E H
REF 1873
J
K
I L
REF 1777
A B C D
REF 1777
Y-connector
REF 1773
16 cm connection tubes
REF 1873
Motor cable clips
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7 Operation
7.1 Switching the device on and off
The power switch “I/O” (at the rear) is used to switch the control unit on and off.
The device can be switched off at any time irrespective of any procedure for switching off the device.
7.2 Overview: control elements on the operation panel
A) Display: Shows the operating values (See chapter “7.3 Overview: Standard display”).
B) “Handpiece” key: Selection of the required handpiece/contra angle
 The factory default settings contain the handpiece/contra angles 1:1, 16:1, 20:1 and 32:1. If you want to use
your 70:1 contra angle it has to be activated in the configuration menu (refer to “7.8 Configuration menu/
handpiece existing”).
C) “Program” key: Selection of program 1 to 6. The factory setting is adjusted to 4 usable programs.
 The number of usable programs can be altered from 2 to 6 available programs (refer to „7.8 Configuration
menu/handpiece existing”).
 By pressing both „HP + PR“ keys at the same time the programs can be reset to the factory default setting.
D) “Speed” keys:
 Restrict the maximum speed that can be selected using the pedal.
“▲”: increases the maximum speed “▼”: reduces the maximum speed
 By pressing both “Speed” keys at the same time “Speed ▲ + ▼” the handpiece calibration will be started
(refer to “7.4.2 Calibrating handpieces”).
E) “Torque” keys:
 Restricts the maximum torque.
“▲”: increases the maximum torque “▼”: reduces the maximum torque
 By pressing both “Torque” keys at the same time “Torque ▲ + ▼” the torque modes AL or AS are selected
(see chapter “7.5 Torque limit function, AL mode (Automatic Limiter)” and chapter
“7.6 Torque limit function, AS mode (Automatic Stopper)”).
 If a speed of 20 rpm is set, irrespective of the selected handpiece/contra angle, the pressing of both torque
keys, “Torque ▲ + ▼” causes the activation of the thread cutting function.
F) “Pump” keys:
 Adjusting the maximal pump flow rate, recalled by the pedal.
“▲”: increases the maximum supply quantity “▼”: reduces the maximum supply quantity
 By pressing both “Pump” keys at the same time “Pump ▲ + ▼” the pump will be put on call, pressing again
will switch it off.
B
C
D
E
F
A
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7.3 Overview: Standard display
A) Information line
Information and error messages are displayed here. Display is illuminated red at error messages.
At standby the display shows “Nouvag AG – MD 11 V2.0” with the note of the device history.
B) Program
Shows the selected program number 1 to 6. The factory setting is adjusted to 4 usable programs.
In the configuration menu the number of available programs can be set from 2 to 6 (refer to “7.8
configuration menu/number of programs”).
C) Pump
The numerical value shows the pump flow rate in percent and the drop symbol together with the
On/Off indication shows if the pump is in stand-by mode or switched off.
D) Rotational direction of the motor
The arrow indicates the rotational direction set for the motor. Change the rotation direction by
pressing the button “FOR/REV” on the pedal.
E) Current speed
At stand still of the device the set maximum speed is displayed. If the pedal is activated and the
motor begins to run, the current speed is displayed in real time.
F) Transmission ratio of contra angle
Shows transmission ratio of used contra angle, e.g. 1:1, 16:1, 20:1, 32:1 or 70:1.
G) Speed range
Shows speed range of the handpiece used.
H) Maximum torque
Shows maximum torque setting.
I) Bar graph (current torque)
The bar graph is providing a graphical representation of the current torque. All bars active means
max. torque reached.
J) AS/AL
Indication of the Auto Stopper (AS) mode or the Automatic Limiter (AL) mode, (see chapter “7.5
Torque limit function, AL mode” and chapter “7.6 Torque limit function, AS mode”).
The pump does not begin to operate until the motor has been activated by pressing the pedal.
A
B
C
D
E
E
G
H
I
F
G
H
I
J
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7.4 Adjusting the programs
The values for operation settings depend on the connected handpiece/contra angle as well as the task to be
performed.
7.4.1 Step 1: Selecting the handpiece/contra angle to be used
The selected handpiece/contra angle must comply with the factual used handpiece/contra angle.
Press the “HP” key to select the handpiece/contra angle
Press the “PR” key to choose between programs 1 to 6. The factory setting is adjusted to 4 usable programs.
In the configuration menu the number of available programs can be set from 2 to 6 (refer to “7.8
configuration menu/number of programs”).
* The limitation of the AS-range (Automatic Stopper) can be adjusted in the configuration menu.
Handpieces or contra angles that don’t belong to one’s own assortment can be deactivated in the Configuration
Menu (refer to “7.8 configuration menu/handpiece existing”). As a result by pressing the button «Handpiece» not
all handpieces will be recalled, but only those that belong to the assortment.
Table of possible handpieces/contra angles
Name of the
handpieces/contra angles
with transmission ratio Display
Speed
min. rpm
Speed
max. rpm
Torque
min. Ncm
Torque
max. Ncm
AS-range
(Factory def.)
rpm
Limit
AS-range
rpm (*)
Drill handpiece, 1:1 1 : 1 300 40,000 1 6 - –
Drill contra angle, 16:1 16 : 1 20 2400 5 27 up to 20 20 – 45 *
Drill contra angle, 20:1 20 : 1 15 1700 10 70 up to 20 15 – 45 *
Drill contra angle, 32:1 32 : 1 10 1000 10 55 up to 20 10 – 45 *
Drill contra angle, 70:1 70 : 1 5 600 10 55 up to 20 5 – 45 *
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7.4.2 Step 2: Calibrating handpiece or contra angles
To make sure the displayed parameters correspond with the actual, measurable parameters of the
handpiece or contra angle, it is recommended to calibrate each handpiece or contra angle on a regular basis.
It’s a procedure as simple as it is important to guarantee safety and precision of each handpiece or contra
angle being used.
After you take care of all prior preparations such as sterilization, care of handpieces and motor, device
preparation and the selection of the handpiece according to the chapter 7.4.1, the calibration procedure can
be performed.
The calibration of handpieces or contra angles guarantees accurate torque. Due to wear as well as varying
lubrication of the handpieces or contra angles, and lack of maintenance and care, the distribution of
torque can vary widely.
1. Select the handpiece, attached to the motor, by pressing the “handpiece” key. Make sure that this
handpiece attached to the motor is also on the display.
2. Hold motor with mounted handpiece or contra angle in your hand at safe distance from your body.
3. Press both “Speed” keys at the same time (Speed ▲ + Speed ▼). Display indicates “Calibrating
handpiece XX”.
4. Motor and handpiece start running and pass several speed cycles up to maximum speed.
5. After a tone is emitted and a message is displayed the calibration is finished. The display returns to
normal mode.
If a handpiece is not working within the range of the calibration algorithms, even when it was cleaned and
lubricated before, the display shows an error with a red backlit display, „Handpiece XX is faulty“.
This indicates soiling, wear or a technical defect of the handpiece. These handpieces have to undergo a
maintenance and care cycle or have to be repaired or replaced.
At the calibration procedure, the handpieces are tested on their torque delivery behavior. With the 1:1
handpiece the control unit is additionally adjusted to altered conditions of the handpiece to keep it
delivering the appropriate torque.
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7.4.3 Step 3: Setting the speed
The possible speed range depends on the contra angle to be used. The maximum speed within this speed
range can be restricted to the required value.
Using the pedal, the speed can be varied from the minimum speed up to the maximum speed as set.
Setting the speed:
Press the “Speed” keys “▲” to increase or “▼” to decrease the maximum speed. When key is pressed
constantly the speeds will be shown in fast forward mode.
7.4.4 Step 4: Setting the torque
Once the speed has been selected, the torque can be limited from the torque range of the corresponding
handpiece or contra angle.
Depending on the speed, the torque mode AL or AS is applied.
For information on AL and AS mode, see Chapter “7.5 Speed reduction AL (Automatic Limiter)” and
Chapter “7.6 Torque limit function: AS (Automatic Stopper)”
Press the “Torque” keys “▲” to increase or “▼” to decrease the maximum torque. By pressing the key
continuously the torques are changed in fast forward mode.
7.4.5 Step 5: Setting the pump supply quantity
Press the “Pump” keys “▲” to increase or “▼” to decrease the pump supply quantity. By pressing the key
continuously the values are fast forwarded.
Minimum and maximum of pump supply quantity as well as incremental steps can be adjusted in the
Configuration Menu (refer to «7.8 Configuration Menu, Parameter level 2, Pump»).
To activate or deactivate the pump, press both “Pump” keys at the same time,
“Pump ▲ + ▼”, or push the foot switch “PUMP” shortly.
The build up of torque is displayed
as a bar graph. When maximum
torque is reached all elements of
the bar graph are full displayed.
Instructions for use MD 11 • 31665 • V20220914

MD 11
MD 11, Operating Instructions, REF 31665, V07/21 17
EN
7.5 Torque limit function, AL mode (Automatic Limiter)
The AL function limits the torque applied to the instrument, for example to prevent crack initiation and
bone fracture.
The speed at the instrument remains constant until the preset torque is reached. If the applied force gets
over this limit the speed will be reduced, if necessary down to a stop, but the torque remains constant. If
the applied force is reduced the speed picks up again.
On the display this procedure is shown as a bar graph. The bars in the graph fill up to their full range as the
torque increases to its preset value. When the bar graph shows full capacity the speed will be reduced. As
soon as the force on the instrument is reduced the torque decreases and the speed starts to pick up again
as shown on the display.
The AL mode is active at all speeds, except where the AS mode is active.
7.6 Torque limit function, AS mode (Automatic Stopper)
The AS function limits the torque applied to the instrument. As soon as the preconfigured torque is
reached, the electronic motor stops immediately. The electronic motor no longer generates any force. In
order to restart the electronic motor, the treadplate must be released and pressed again.
On the display, the bar graph completes up to its full range, until the maximum torque is reached, then
drops to zero.
The function “AS” is just active for certain contra angles
and only in a certain speed range.
From the minimal speed up to the speeds shown at the
right the AS-mode is activated automatically.
(refer to “7.8 Configuration Menu, Parameter level 2, AS-Zone”)
The upper limit of the AS range can be adjusted in the configuration menu.
In the following speed ranges the AS-/AL-mode can also
be switched manually by pressing both torque keys
“Torque ▲+▼” at the same time.
7.7 Storing various programs
With the MD 11, up to 6 different settings can be set as fixed program (program 1 to program 6). Which
program is currently active is shown on the display.
At switch-off, the settings made by user are automatically saved. This includes the following parameters:
• Handpiece/Transmission ratio
• Maximal speed
• Maximal torque
• Pump On/Off
• Pump performance
• AS/AL mode
To change a program go to the specific parameter and change it. When the device is switched off all
parameters are saved in that program.
The number of storable programs can be limited in the configuration menu from 2 to 6 programs.
When the MD 11 is switched on, the display shows the prior used program and motor.
Handpiece 16:1 20:1 32:1 70:1
Speed rpm: 20 20 20 20
Handpiece 16:1 20:1 32:1 70:1
From rpm:
To rpm:
20
45
15
45
10
45
5
45
Instructions for use MD 11 • 31665 • V20220914

MD 11
18 MD 11, Operating Instructions, REF 31665, V07/21
7.8 Configuration Menu
In the Configuration Menu the user can customize the device after his favor. The parameters are organized
in two levels. The following information and parameters are stored in there.
• Software version
• Mainboard serial number
• Language selection, DE/EN
• Display illumination
• Number of programs
• Power on, at last program
• Operating hours MD 11
• Operating hours Motor
• Operating hours of irrigation pump
• Error log
• Activation of available handpiece
• Speed limitation for each handpiece
• Range of action of AS mode
• Pump behavior
• Motor behavior
• Behavior of torque at reverse mode
• Pedal behavior
• Reset to factory default
Be cautious when changing parameters. Unusual behavior of instruments while operating may provoke
false reactions and jeopardize the patient.
Every setting and the new behavior of the instrument has to be verified and tested.
1. Access to Configuration Menu:
• Press “HP” and “Speed ▼” key for about 3 sec. until you hear a tone.
On the display the first position of the configuration menu shows up.
2. Selection of parameters:
• Press “HP” or “PR” to choose the desired parameter.
• Press “Speed ▼” to select the parameter.
• Change the value by pressing “HP” for up or “PR” for down.
• To confirm the changes made, press “Speed ▼” for about one sec., until you hear a short tone.
• To abort the settings made, press “Speed ▼” briefly. The setting returns to its previous value.
3. Exit from Configuration Menu:
• To leave the Configuration Menu press “HP” and “PR” for 3 sec. until you hear a tone.
Parameter Level 1
Group/Parameter Rights Factory Definition
Software/Version read VX.XXXX Shows current software version
Hardware/Serial number MB read XXXXXXXXXXX Shows serial number of the main board
Language, 0 = DE, 1 = EN read/write 1 Select language between German and English
Backlight/brightness (0. .10) read/write 9 Display brightness, changeable: 0, … , 10
Number of programs read/write 4 Select between 2 and 6 available programs
Power on at last program read/write Yes Display of the last program after switching device on.
Operating hours/Control Unit read 0 Shows operating hours of Control Unit
Operating hours/Motor read 0 Shows operating hours of motor 1
Operating hours/Pump read 0 Shows operating hours of pump
Error memory/ 1 – 8 read 0 8 Error messages in chronological order.
+
The arrows at the beginning of the lines indicate
the operation in the Configuration Menu.
Instructions for use MD 11 • 31665 • V20220914