Operation Manual: Surgic Pro
Operation Manual: Surgic Pro
Surgic Pro
OPERATION MANUAL
Please read this Operation Manual carefully
before use, and file for future reference.
OM-E0560E
Original Operatrion Manual English
Thank you for purchasing the NSK Surgic Pro series surgical unit.
We recommend that prior to use, you carefully read this document regarding instructions for use, handling method, or
maintenance check so that you can carry on using the unit in the future. In addition, keep this operation manual in a place
where a user can refer to it at any given time.
◆ Intended to Use
Surgic Pro series is intended for use in dental oral surgery and surgical procedures by qualified personnel.
Contents
1. Safety precautions prior to use 2
2. Package Contents 4
3. Control Unit and Foot Control 5
4. Installation 7
5. Setting 10
6. Operation 12
7. Protection Circuit 16
8. Error Code & Troubleshooting 16
9. Fuse Replacement 18
10. Maintenance 18
11. Sterilization 19
12. Contra Angle Handpieces and Accessories 20
13. Specification 20
14. Disposing Product 20
15. Symbols 21
16. EMC Information 21
◆ Classification of equipment
• Type of protection against electric shock :
– Class l equipment
• Degree of protection against electric shock :
– Type BF applied part
• Method of sterilization or disinfection recommended by the manufacture :
– See 11. Sterilization
• Degree of protection against ingress of water as detailed in the current edition of IEC 60529 :
– Foot Control: IPX8 (Protected against the effects of continuous immersion in water)
• Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous
oxide :
– Foot Control: Category AP Equipment
• Mode of operation :
– Intermittent operation
1
Cautions for handling and operation
Read these safety cautions thoroughly before use and operate the product properly.
These indicators are to allow you to use the product safely, prevent danger and harm to you and others. These are
classified by degree of danger, damage and seriousness. All indicators concern safety, be sure to follow them.
CAUTION
• The accuracy of the Torque Monitor depends on the high precision performance of the handpiece attached to the
micromotor. Real torque value may not otherwise be correctly displayed. To guarantee handpiece torque accuracy,
that matches the monitor display system, USE ONLY the NSK contra angle handpieces listed on “12. Contra Angle
Handpieces and Accessories”. When other handpice had connected, it may not output accurate torque which
indicated on handpiece.
• Surgic Pro series needs special precautions regarding EMC and needs to be installed and put into service according
to the EMC information. (Refer to 16. EMC Information)
• Portable and mobile RF (Radio Frequency) communications equipment can affect Surgic Pro series. Do not use RF
equipment outskirts for the product.
• The use of accessories, Motors and cables other than those specified, with the exception of Motors and cables sold
by the manufacturer of Surgic Pro series as replacement parts for internal components, may result in increased
EMISSIONS or decreased IMMUNITY of the Control Unit.
• Surgic Pro series should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use
is necessary, the Control Unit should be observed to verify normal operation in the configuration in which it will be
used.
• When operating this system always consider the safety of the patient.
• Do not attempt to disassemble the Control Unit /Foot Control / Micromotor nor temper with the mechanism.
• Check for vibration, noise and overheating before use and if any abnormalities are found in use, stop using
immediately and contact dealer.
• Use an electrical outlet that is grounded.
• Do not drop, hit, or subject to excessive shock.
• Do not bend the Irrigation Tube while the water pomp is operating. It could cause tube breakage.
• Do not use bent, damaged or sub-standard burs or drill. The Shank could bend or brake.
• Do not exceed the recommended speed and torque.
2
• After each Operation, be sure to lubricate and sterilize the handpiece as soon as it’s cleaned. Blood coagulation can
cause corrosion and rusting. However, do not lubricate the Micromotor. Oil could generate excessive heat and cause damage.
• The Control Unit can be cleaned with a moist cloth. Disconnect the power supply before cleaning. The Control Unit
and the Foot Control cannot be sterilized by any method.
• When the system is very frequently used, consider the maintenance of a small stock of replaceable parts.
English
• Do not disconnect the Motor Cord from the motor.
• Do not wipe with or, clean or immerse in, high acid water or sterilizing solutions.
• Follow the table below for the motion time of motor and handpiece. Continuous
use over a long time with high torque may cause the overheating of the Operating Mode
handpiece, which in turn may result in an accident. Intermitternt Operation
• Applied parts for patient and/or operator is Handpiece.
ON OFF
• Do not fixate the eyes of LED light.
• If any abnormalities (dark, do not light on or flashing) are found for LED, stop 3 min. 10 min.
using the it immediately and contact dealer.
• Using the Micromotor with light ‘ON’ for more than 3 minutes continuously,
Power plug below is used in North America area.
motor will become hot. (The maximum surface temperature might reach 45˚
C by the situation used) In such cases, stop using the Micromotor till the light
part cools down, or use the Micromotor without turning on the light.
• Grounding reliability can only be achieved when the equipment is connected to
an equipment receptacle marked "Hospital Only" or "Hospital Grade". Plug Type NEMA 5-15P (Hospital Grade Type)
• For safety’s sake, install the Control Unit in a place where the AC POWER
Cord can be easily removed. (It is possible to disconnect the control unit from the power source by removing the AC
POWER Cord.)
NOTICE
• Turn off the Main Power Switch after each use.
• For service requirements and spare parts contact dealer.
• Use of NSK genuine pre-sterilized, disposable Irrigation Tube is recommended.
• Total recording time is about 100 minutes. (Surgic Pro+)
• Do not insert a USB flash drive during operation.
• Do not remove USB flash drive while LED lamp is on or blinking.
• Do not use data stored in USB flash drive for diagnostic purposes.
• Do not use a USB flash drive other than USB 2.0.
• This device is not guaranteed to work with all USB flash drive. It may not work with USB flash drive with security
functions or those requiring a great deal of electricity.
3
2. Package Contents
1 2 3 4 5
6 7 8
9 10
11 12 13 14 15 16 17 18 19
Item Item
No. Description Quantity No. Description Quantity
10 Tube Holder 7
4
3. Control Unit and Foot Control
Coolant Solution
Hanger Post Holder USB flash drive Socket
Calibration Load
English
Irrigation Pump
(1) Light Key
5
3-2 LCD display on the Control Unit Console
(A) Clock Display (E) USB flash drive (B) SPEED (G) TORQUE
( I ) Coolant Level (J) FWD/REV Direction (K) GEAR Ratio (L) PROGRAM Number
6
3-3 Foot Control Foot Control Cord and Plug
English
(b) PRG (Program) Button
4. Installation
CAUTION
Install the cord/plug only power is OFF.
Control Unit.
Push the Base of Motor Cord Plug into the socket until the
locking joint ‘clicks’ into place.
To disconnect the plug; pull back the Lock Joint, pull further
to disconnect the cord.
Lock Joint
[ ] mark
●
Fig.1
7
4-2 Connecting the Handpiece
CAUTION
When using the Optic Surgic Pro micromotor (SGL70M), USE ONLY Optic contra-angle handpieces. Non Optic
handpieces may not precisely connect to the micromotor and it may malfunction when the micromotor is under
load.
Fig.2
4-3 Connecting the Foot Control
Face the screw on the Foot Control Cord Plug downward
then insert the plug into the Foot Control Cord connector
socket on the Control Unit. Secure the plug by fastening Screw
the Lock Nut. Refer Fig.3.
Fig.3
4-5 Installing the Irrigation Tube
Ensure the Pump Cover Lever is in the ‘OPEN’ position, with the Irrigation tube ‘Needle’ towards the backside of the
Control Unit. Position the stoppers of the tube assembly in to the Tube Guide securely. (Fig.4)
Pump Cover
Fixed Position
Stopper
Fig.4
8
CAUTION
• Make sure that the tube is securely set on the
rollers when closing the Pump Cover. If the tube
is not correctly positioned on the Rollers and
English
the cover is closed, the tube could be cut or
sheared. (Fig.5)
• Do not mount the Irrigation Tube except the
person who specially educated.
• Do this after Irrigation Tube power source has
been turned off. Fig.5
After the tubes are correctly positioned, close the Pump Cover by <CLOSE Position>
turning the Pump Cover Lever to the ‘CLOSE’ position. (180 degrees
counterclockwise) (Fig.6)
To remove, ‘OPEN’ the Pump Cover Lever then remove the tube.
Fig.6
4-6 Mounting the Coolant Solution Hanger Post
Mount the Coolant Solution Hanger Post onto the Holder on the
Control Unit. (Fig.7)
Align
Fig.7
4-7 Insertion of the Irrigation Tube
1) Close the Tube Clamp, between the Irrigation Tube Needle and the Irrigation Pump. (Fig.8)
2) Insert the Irrigation Tube Needle into the Bottle Cap. (Fig.9)
3) Open the Tube Cap to supply air into the bottle. (Fig.10)
4) Open the Tube Clamp.
Tube Clamp
Irrigation
Tube Needle
CAUTION
Do not operate the Irrigation Pump if the tube is bent or the Tube Clamp is in the closed position. This could cause
the tube to burst or slip out of the bottle.
9
4-8 Compatibility check of Internal Irrigation Nozzle/Drill
Internal irrigation nozzles accompanied with this product; is not necessarily fitted into all the drills on the market.
Follow the instructions given below for confirmation prior to use.
Failure to do so or to fit the Internal Irrigation Nozzle into drills may cause a leakage of saline solution, which will
result in problems such as rust or sudden stop of equipment during use.
* To mount the Drill, refer to attached Handpiece Operation Manual.
Instructions:
Irrigation Tube
1) Attach a bottle of saline solution to the Control Unit.
2) Connect the Internal Irrigation Nozzle into the tip of the irrigation tube.
3) Insert the Internal Irrigation Nozzle into the drill from the back. (Fig.11)
Drill
4) Purge at “Maximum” for 5 seconds.
Points to be checked: Fig.11
• Cleanliness of the saline solution coming out from the drill; if solution is colored there could be rust inside of the
drill. If so renew the drill.
• Water Flow; if the flow is low and/or the flow from the drill is asymmetric, renew the drill.
• No water leakage between Internal Irrigation Nozzle and drill before use, ensure no water is leaking from the
entry point of irrigation nozzle, a broken seal or no seal in the drill may be the cause. Replace the drill even if its
new, saline solution ingress into handpiece will cause malfunction.
CAUTION
If malfunction such as a leakage of saline solution from the back of Contra Head is detected during use, stop using
and perform some troubleshooting.
CAUTION
Do not apply strong impact to USB flash drive when it is connected.
When the USB flash drive is not connected, close the Insertion
Opening Cover. USB flash drive
Socket
Fig.13
5. Setting
5-1 Clock and Date
By setting the date and time, data on treatment will be recorded by day. (See 6-5 USB Function to learn how to
store data on a USB flash drive.)
10
NOTICE
• Set the Clock before you use this system.
• If the clock display does not appear or is shown as “- - : - -” the internal batteries may have run out. Contact the
retailer where device was purchased.
• The clock runs on a 24-hour display system.
English
• The years can be set from 2010 to 2099.
1) Push both the USB REC key and SPEED (-) for about 2 seconds.
2) The setting screen will appear on the LCD. Settings can be made for year, month, day, hour, and minute in that
order. Input the data, and press the USB REC key to move to the next item. (The item you have chosen will blink.)
3) Change numbers by pressing the SPEED (+ -) key. A long push will increase numbers in increments of 5.
4) When all items are set, press the USB REC key for 2 seconds to save settings.
CAUTION
• If the power goes off while settings are being made, the changes will not be saved. Start once more at the beginning.
• If data is already stored in the internal memory, it will not be possible to set the date.
NOTICE
• Repeat the above procedures when restoring operation.
• The lamp status will remain set even if the power is switched “OFF” and “ON”.
• This function is only applicable for an optic motor and handpiece.
NOTICE
Settings will be saved even if the power is turned off.
CAUTION
Even when the device reverts to factory settings, date and time data will not be initialized.
11
6. Operation
6-1 Programming the Micromotor Operation
The Control Unit can memorize 8 programs. Each program includes the following functions which will be
automatically performed when the appropriate program number is selected.
Gear ratio of contra angle handpieces
Speed
Direction of rotation Power Switch
٤
Torque upper limit Symbol Mark
Coolant Solution Flow Function OFF ON
Light Level
1) Turn on the power by pushing the Main Power Switch toward [-]; on
power up IMPLANT SYSTEM Number 1 program number 1 is displayed by default.
2) Select a program number by using either step (a) or step (b):
(a) Press the PROGRAM (+ -) Key on the Control Panel until the desired program number is displayed.
(b) Press the PRG(Program) Button on the Foot Control until the desired program number is displayed.
3) Selecting the Rotate direction of the handpiece. Select it by using either step (a) or (b):
(a) Press FWD/REV Key on the Control Panel until the desired direction is displayed.
(b) Press the Forward/Reverse Button on the Foot Control until the desired direction is displayed.
NOTICE
• There will be a beeping sound while “R” is pressed.
• Beeping sounds heard during rotations and when the device is stopped are not the same. Different sounds do not
indicate a malfunction.
4) Selecting the Gear ratio of contra angle handpieces relevant to the program; Press the GEAR Key to select the
gear ratio of the handpiece (Gear Ratio will display on the LCD).
5) Set the required max operating speed by pressing the SPEED (+ -) Key. Each time this Key is pressed display
changes to the next speed level. By pressing this Key for more than 1 second brings the speed quickly to the
next level until the speed display reaches its upper or lower limit.
- When the speed setting reaches the upper or the lower limit, an audible beep is heard and the speed setting
cannot be changed any further.
6) Set the torque upper limit by pressing the TORQUE Key on the Control Panel. Each time this Key is pressed
display changes to the next torque level. By pressing this Key for more than 1 second brings the torque quickly
to the next level until the torque display reaches its upper or lower limit.
- When the torque setting reaches the upper or the lower limit, an audible beep is heard and the torque setting
cannot be changed any further.
7) The level of Coolant Solution Flow volume has 6 Flow level (0-5) (0 = no coolant Flow). Select a Coolant Solution
Flow Volume using either step (a) or step (b):
(a) Press the COOLANT Key on the Control Panel until the desired flow level is displayed.
(b) Press the Coolant Solution Flow Volume Button on the Foot Control until the desired flow level is displayed.
8) After completing steps 2) - 7). press and hold MEMORY Key until beep is heard. The beep confirms that the
programming is completed. If you hear a short beep when the MEMORY Key is first pressed ignore this sound
and keep the MEMORY Key depressed until a long beep is heard.
* Repeat the above steps 2) - 8) to program any one of the 8 available programs.
English
Surgic Pro Series can memorize 8 different IMPLANT SYSTEMs. Also, you can program 8 steps in one SYSTEM
number which you use. When you set the program, refer to values which Implant manufacture recommends.
When programming each IMPLANT SYSTEM, the SYSTEM number may be changed by pressing the PROGRAM (+)
and (-) Key simultaneously.
NOTICE
• This equipment is optimized to obtain the highest calibration accuracy at a gear ratio of 20:1. For calibration USE
ONLY the 20:1 reduction handpiece listed on “12. Contra Angle Handpieces and Accessories”.
• Micro saw handpiece should not be calibrated.
• Calibration should be performed only on NSK handpiece.
CAUTION
Do not apply load during no-load calibration. If load is applied, “FAIL” will appear on the LCD, and calibration will
stop.
13
CAUTION
During a process, it is important to hold the Calibration Bur vertically without applying any forcible power. Making
the Calibration Bur tilt or pressing it may cause a loss in accuracy.
CAUTION
• Using the Micromotor with light ‘ON’ for more than 3 minutes continuously, motor will become hot (The maximum
surface temperature might reach 45˚C by the situation used). In such cases, stop using the Micromotor till the
light part cools down, or use the Micromotor without turning on the light.
• Activation of the torque limiter: During use, when the drilling load reaches the preset torque upper limit, the integrated
torque limiter automatically activates to prevent over torque. When the torque limiter activates, the motor stops after
beeping for 1 second. To reactivate the Micromotor, release the speed control pedal and depress it again.
4) Release the Foot Control Pedal, and the Micromotor will automatically stop.
The internal clock is used along with the different operations of this device (date used, starting time, length of time,
Gear Ratio,level of Coolant Solution Flow, Rotation Speed, FWD/REV, Torque, Program Number), making it possible
to store data in chronological order on USB flash drive (CSV files, BMP files).
Stored data can be viewed on a personal computer.
*Files and graphs saved
14
NOTICE
A BMP file can only be created only when Gear Ratio is 20:1 and the number of rotations is 50min-1 or less.
English
Torque
Time
CAUTION
• Total recording time is about 100 minutes.
• Do not insert a USB flash drive during operation. Only insert after operations are completed in order to store data.
• Do not use data stored in USB flash drive for diagnostic purposes.
• Do not use a USB flash drive other than USB 2.0. (To 32GB verification being complated)
• Do not remove USB flash drive while the LED lamp is on or blinking. (During the blinking, USB flash drive is
communication with the system)
• This device is not guaranteed to work with all USB flash drive. It may not work with USB flash drive with security
functions or those which use a great deal of electricity.
• Do not turn the device on or off with the USB flash drive inserted.
• Be careful to insert the USB flash drive in the correct direction.
• When a USB flash drive is not connected, close the cover of the connector.
• The LED displays and their meanings are given below:
lamp on = internal memory is copying data, blinking = USB flash drive is storing data.
• If power is turned off, the internal memory will be erased. Turn off power after storing data on USB flash drive.
6-5-3 Resetting
Press the USB REC key for at least 2 seconds. The amount of remaining recording time will be reset after the
beep goes off (Initialized time: 100 min).
15
7. Protection Circuit
An electronic circuit breaker automatically functions to protect the motor and the Control Unit if the motor is ever
overloaded. Power supply to the motor will automatically be terminated an Error code will be displayed on the Control
Unit.
When torque exceeds the set figures, “SAFE” will appear on the LCD, and the device will stop.
*Resetting the Protection Circuit
To reset the Protection Circuit, release and then depress the Speed Control Pedal.
16
E7 Pump excess voltage. The Irrigation tube is incorrectly Check the Irrigation tube.
fitted and loading the pump roller. If an Error Code is displayed even when the
E8 Pump excess current. The pump fails. Irrigation tube is normal, request repair.
Check the connection state of the connector.
Connection failure of the connector.
English
Foot Control The Error Code is displayed even when the
E9 Failure of the inside of the Foot
abnormality. connector is normally connected, request
Control.
repair.
LED excess voltage
E10 Failure of LED circuit. Request repair.
(Optic Motor).
Check if the saline solution hasn’t
LED excess current Remove the saline solution completely.
E11 penetrated the motor lamp.
(Optic Motor).
Failure of LED circuit. Request repair.
17
9. Fuse Replacement
If the Control Unit does not function, check the fuses (Fuse Box lock
located on the rear of the Control Unit). To access the Fuse, use
a pointed tool push on the fuse locking latch and the drawer will
spring open. (Fig.16)
Fuse Ratings
120V T3.15AL 250V
230V T1.6AL 250V Fuse
Fig.16
10. Maintenance
10-1 Maintenance of the Control Unit and Foot Control
If blood or saline solution has stained the Control Unit or Foot Control, remove the AC Electrical Cord; wipe Control
Unit or Foot Control with a damp cloth, then with an alcohol-absorbed cloth.
CAUTION
• Always use the Protection Plug during Thermo-Disinfector.
• Do not use Protection Plug without the mounting O-Ring. It may cause a malfunction. If O-Ring had damaged,
replace it immediately.
NOTICE
Protection Plug O-ring is consumable supply. If it damaged, replace it new one.
Optional Protection Plug: Order Code 10001595
Protection Plug O-Ring: Order Code 0312457102
18
11. Sterilization
This handpiece and motor can be autoclavable up to Max.135°C.
English
• Autoclave sterilization is required for the first time use and after each patient as noted below.
CAUTION
Only Items Specified below can be autoclaved.
The following items can be autoclaved.
• Handpiece • Micromotor with Motor Cord • Handpiece Stand
• Internal Irrigation Nozzle • Tube Holder • Nozzle Holder
• Protection Plug • Calibration Bur
*Autoclaving
1) Remove blood and debris from the handpiece and motor.
2) Clean inside the handpiece; by using the spray lubricant
3) Place those in autoclave pouch (not included in the package) and seal it.
4) Autoclavable up to max. 135˚C.
ex.) Autoclave for 20 min. at 121°C, or 3 min. at 134°C.
5) Keep the handpiece in the autoclave pouch to keep it clean until you use it.
* EN13060/EN ISO17665-1 recommends autoclaving for 3 minutes (minimum holding time) at 134°C or 15
minutes(minimum holding time) at 121°C.minutes(minimum holding time) at 121°C.
NSK recommends Class B sterilization.
CAUTION
• Clean and lubricate the handpiece before autoclaving. Autoclaving a handpiece stained with blood or debris could
cause damage to the handpiece.
• Do not lubricate the micromotor.
• Do not disconnect the motor cord from the micromotor.
• The Irrigation tube is a single use and cannot be autoclaved.
• We do not recommend you to sterilize on plasma sterilization or EOG sterilization.
19
12. Contra Angle Handpieces and Accessories
Listed below are the contra angle handpieces which should be used with the Surgic Pro micromotor to guarantee torque
accuracy.
Order Code Description Remarks
C1003 X-SG20L Optic surgial handpiece.
C1010 SG20 Non-optic surgial handpiece.
C1068 X-DSG20L Optic dismantling surgial handpiece.
C1067 X-DSG20 Non-optic dismantling surgial handpiece.
C1076 X-DSG20Lh Optic dismantling surgial handpiece with hexagon.
C1075 X-DSG20h Non-optic dismantling surgial handpiece with hexagon.
13. Specification
(Control Unit) (Micromotor)
Model Surgic Pro+ Model SGL70M SG70M
(with USB) Type E1023 E1025
Surgic Pro Rotation Speed Range 200 – 40,000 min-1
(Without USB) Input Voltage DC24V
Type NE250 (with USB) Dimensions Ø23.5xL103.3mm (without cord)
NE294(without USB) Cord Length 2m
Power Supply Voltage AC120/230V OPTIC White LED −
Frequency 50/60Hz
Power Consumption 40VA (Foot Control)
Max. Pump Output 75ml/min Model FC-78
Dimensions W265xD220xH100mm Cord Length 2m
20
15. Symbols
TUV Rhineland of North America is a Nationally Recognized Testing Laboratory (NRTL) in the United States and is accredited by the
Standards Council of Canada to certify electro-medical products with Canadian National Standards.
This product is designed not to become the ignition source in air and flammable anesthetic gas.
English
The EU directive 93/42/EEC was applied in the design and production of this medical device.
Dispose of this device and its accessories via methods approved for electronic device and in compliance with the Directive 2002/96/EC
Marking on the outside of Equipment or Equipment parts that include RF transmitters or that apply RF electromagnetic energy for
diagnosis or treatment.
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Guidance and manufacturer's declaration - electromagnetic immunity
Surgic Pro series is intended for use in the electromagnetic environment specified below.
The customer or the user of the Surgic Pro series should assure that it is used in such an environment.
Immunity test IEC/EN60601 test level Compliance level Electromagnetic environment - guidance
Conducted 3V rms 3V rms Portable and mobile RF communications equipment should be
RF IEC61000-4-6/EN61000-4-6 150 kHz to 80MHz used no closer to any part of the Surgic Pro series, including
cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Recommended separation distances between portable and mobile RF communications equipment and the Surgic Pro series.
The Surgic Pro series is intended for use in an electromagnetic environment in which radiated RF disturbances are control LCD. The customer or the user of the
Surgic Pro series can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Surgic Pro series as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum output power of m
transmitter
W 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
d =1.2 P d =1.2 P d =2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance ‘d’ in meters (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.
NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
22
’11.09.03 S