Instruction Manual
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Evolution
INSTRUCTION MANUAL
Part 1/2 Ref.: 65038
MORIA S.A. – 15, rue Georges Besse - F-92160 Antony – France MORIA # 65038– version C – 08/2008
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CONTENTS I.
EQUIPMENT LIST............................................................................................... 3
II.
DESCRIPTION OF THE CONTROL UNIT .......................................................... 4 A.
Front panel ............................................................................................................. 4
B.
Rear panel............................................................................................................... 5
C.
Specifications......................................................................................................... 6 1. Power Supply ...................................................................................................... 6 2. Electrical characteristics ...................................................................................... 6 3. Pneumatic characteristics .................................................................................... 6
III.
INSTALLATION AND CONNECTION ................................................................. 7
A.
Electrical checking................................................................................................. 7
B.
How to change the main supply (230 V or 115V) ................................................. 8
C.
How to install a new battery. ................................................................................. 9
D.
How to replace the main fuses. ........................................................................... 10
E.
Footswitch connection ........................................................................................ 11
F.
Selecting Electric Mode and Turbine Mode........................................................ 12
G.
Manual Mode – Pneumatic turbine connections................................................ 13 1. Nitrogen supply set up ....................................................................................... 13 2. Disassembly of the Nitrogen supply................................................................... 16
H.
Automatic Mode – Electrical motor connection................................................. 17
I.
Vacuum system connection vacuum tubing to the console ............................. 18
J.
Test procedure ..................................................................................................... 20
K.
Vacuum level and atmospheric pressure ........................................................... 22
IV.
ALARMS & SAFETY......................................................................................... 24
A.
Loss of vacuum.................................................................................................... 24
B.
Loss of turbine pressure (if gas turbine selected)............................................. 24
C.
Loss of battery power .......................................................................................... 25
V.
CLEANING AND MAINTENANCE .................................................................... 26
VI.
WARRANTY...................................................................................................... 27
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For USA only: federal law restricts the use of this device to a physician or a licensed practitioner
The most recent version of this user guide and additional information are available on the Moria website: http://www.moria-surgical.com
I. EQUIPMENT LIST The equipment supplied with the standard system is the following: Designation EVOLUTION 3 Console EVOLUTION 3 Control footswitch EVOLUTION 3 Supply cords (CEE) EVOLUTION 3 Supply cords (USA) EVOLUTION 3 Supply cords (UK) Carrying case Instruction manual Nitrogen gas supply hose *
MORIA Reference 19360 19361 19362 19363 19364 19147 65038 19120
* This hose is supplied when the EVOLUTION 3 unit is ordered together with Moria manual microkeratomes.
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II. DESCRIPTION OF THE CONTROL UNIT
A. Front panel
“TEST” switch
Vacuum level Indicator
Mode display Automatic: “OP” Manual: turbine pressure
Low Vacuum Switch
Motor “2” display
Motor « 1(M2) » display Main Power Supply indicator
Battery Level indicators
Motor N°“2” Electric connector
Vacuum connector Keratome selector switch
Turbine hose connector
Speed 1 Speed 2 switch
Motor N°“1(M2)” Electric connector
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B. Rear panel
Quick connector for NITROGEN supply
Residual gas drain switch
Control knob to adjust gas pressure to the turbine
Footswitch connector
Main power supply connector
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Main OFF/ON switch
Fuse housing and 115V – 230V selector
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C. Specifications Dimensions Weight
430x240x190 mm 13.4 kg
1. Power Supply Before using Evolution 3 for the first time, check if power selected (115V or 230V) is appropriate for your country’s power supply (see also III.B) • 115 V / 50-60Hz • 230 V / 50-60 Hz 500 mA High Switching power
Supply Fuse
Note : Use only fuse provided by Moria To replace this fuse follow instructions described in III.D
2. Electrical characteristics NEVER OPERATE WITHOUT MAIN POWER SUPPLY NEVER USE THE CONTROL UNIT WITHOUT A BATTERY PLUGGED IN
Battery capacity and type
12 V - 7 Ah (Pb)
Fuse (inside the control unit)
Note : To replace a battery, follow instructions described in III.C 3.15 AT and 500 mAT Only Moria authorized dealer can replace this internal fuse. Never open the metallic cover of the unit
3. Pneumatic characteristics Inlet : Console supply
4-6 bars / 58-87 psi
Outlet : Turbine supply
Note : 1 bar = 14.5 psi. 3.2 bars / 46 psi (Authorized range: 2.5 to 3.5b) Note : 1 bar = 14.5 psi.
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III. INSTALLATION AND CONNECTION A. Electrical checking
Before using Evolution 3, check if power selected (115 or 230V) is appropriate for your country’s power supply (see also III.B) NEVER OPERATE WITHOUT MAIN POWER SUPPLY. NEVER OPERATE ONLY ON BATTERY. The EVOLUTION 3 runs on wall current (115 or 230V, 50-60Hz) and is equipped with a rechargeable battery as a back-up system. The battery is charged continuously by the main power supply and its charge level is displayed by two LEDs.
Battery level indicator • RED = Warning: low charge or discharged battery. Charge immediately. • GREEN = Battery charged.
Main Supply indicator : • Light On (Green) = Connected to the main power supply • Light Off = Running on battery
To charge the battery : • Switch the control unit on. • Connect the power supply cord to the main power supply. • When the battery is 90% charged, the same LED becomes Green. After unpacking, and before using for the first time, the EVOLUTION 3 must be charged for a minimum of 48 hours.
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B. How to change the main supply (230 V or 115V)
Switch off the control unit and remove the cord
Open gently the door with a screwdriver
A
Remove the selector (A) and Select the right voltage (here 115V)
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Replace the selector and close the door
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C. How to install a new battery. Electrical characteristics Battery capacity and type
12 V - 7 Ah (Pb)
USE ONLY BATTERY SUPPLIED BY MORIA If the battery cannot be charged, or does not hold a charge, a new battery must be installed in the console. BEFORE OPENING THE CONTROL UNIT, SWITCH OFF THE CONTROL UNIT AND REMOVE THE CORD BEFORE REMOVING THE BATTERY, UNPLUG THE BATTERY CONNECTORS. -2-
-1-
Unscrew completely the 2 screws located at the back of the control unit -3-
Slide the cover towards the front -4-
-5-
2
1
Lift the cover from back to front in 2 steps (1 – 2) -7-6-
Remove the metal sheet (while keeping screws in place)
Unplug the battery
Lift the battery with the plastic strap
Unscrew the 2 screws -8-
Replace the battery (Step 8 to 1)
PLEASE CONTACT MORIA FOR ANY OTHER SERVICING (Never open the metallic cover of the control unit) NEVER USE THE CONTROL UNIT WITHOUT A BATTERY PLUGGED IN
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D. How to replace the main fuses. Electrical characteristics Fuse
500 mA High Switching Power Use only fuse provided by Moria
Main fuses are located in the back panel of the unit.
Switch off the control unit and remove the cord
Open the door gently with a screwdriver
Remove the 2 fuses
Exchange the 2 fuses
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Replace the fuses according to the arrows engraved in the door
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E. Footswitch connection Using the screw connector, plug in the footswitch connector to the rear panel of the console (finger tight only)
VACUUM
BACKWARD
GAS DRIVEN MICROKERATOMES (CB, CBM, CBSU, ONE, ONE USE) “Backward” “Forward” footswitch footswitch MANUAL MODE Pneumatic turbine
AUTOMATIC MODE Electric motor
N.A.
Blade oscillation
FORWARD or TURBINE ON
“Vacuum” footswitch VACUUM (ON / OFF)
ELECTRICALLY DRIVEN MICROKERATOMES (M2, M2SU, ONE USE PLUS.) The microkeratome Blade Oscillation goes backward (even if Vacuum is Forward motion of VACUUM (ON / OFF) the off or Low vac is microkeratome On) Blade oscillation off
Note : 1. If Vacuum is not activated, the forward footswitch does not operate. 2. If Vacuum is Off or if Low Vac is On, the activation of the backward footswitch moves the microkeratome backward.
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F. Selecting Electric Mode and Turbine Mode
Switch Electric Motor “1(M2)” or “2” or “Turbine”
Motor N°“2” Electric connector Motor N°“1(M2)” Electric connector
Speed 1 Speed 2 switch
The console must be switched ON. Turn the keratome selector switch to either turbine, 1 or 2 depending on the keratome to be used.
"1" MODE M2, M2SU Microkeratome “1” Electrical motor display: “OP” & “1” Electric Motor LED is ON
“2”. MODE One Use Plus Microkeratome “2” Electrical motor display: “OP” & “2” Electric Motor LED is ON
TURBINE MODE CBM, CBSU, ONE, One Use Microkeratomes gas turbine display: the turbine pressure is indicated in bars and Gas turbine LED is ON. MORIA # 65038– version C – 08/2008
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G. Manual Mode – Pneumatic turbine connections 1. Nitrogen supply set up MORIA provides 2 different types of pneumatic turbines (CB turbine Ref. 19303 and ONE turbine Ref. 19155). MORIA strongly recommends use of dry medical grade nitrogen gas for operation of pneumatic turbines, available from your medical gas supplier; Moria does not supply the gas. MORIA recommends using a high-pressure dual stage regulator. Nitrogen hose (Ref. 19120): Moria supplies a 9/16 black hose (black is the international code for nitrogen), internal diameter 9mm, external diameter 16 mm. The hose is delivered with a copper quick connection on one end (see picture below), and free on the other end. The free end has to be connected to your own gas supply system (nitrogen bottle with its dual stage gas regulator and male nozzle). Copper quick connection
Free end Φint = 9mm Φext = 16mm
Step 1 – Switch ON the console. Step 2 – Connect the non-copper end of the hose to the gas supply. Ensure that there is no pressure into the hose before connecting it to the console.
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Step 3 – Attach the copper quick connection to the console (see pictures A & B below).
Picture A
Picture B
To pressurize the system, the pressure to the generator should be between 4 and 6 bars (58 and 87 psi). If the pressure going IN the console exceeds 8 bars (116 psi), the console detects overpressure and opens the high pressure valve. The Nitrogen gas is ejected from the turbine connector (front panel) in order to protect the internal components. In case pressure exceeds 10 bars, MORIA strongly recommends sending back the console for a complete check-up. The pressure sensor board and other components may have been damaged and may alter the performance of the turbines and/or alter the information on the display panel. Step 4 – Set the pressure going out of the console by turning the knob on the rear panel. The pressure to the turbine should be at 3.2 bar +/- 0.2 bar (46 +/- 3 psi). To operate the knurled blue knob, pull it out towards the back.
Knurled blue knob
• • •
To increase pressure, turn clockwise. To decrease pressure, turn counterclockwise. Once the correct pressure has been selected, lock the knob by pushing it in.
Note: always set pressure first by increasing it to the appropriate amount (3.2 bar). Nominal pressure = 3.2 bars / 46 psi. Pressure higher than 10 bars may damage the unit. Pressure lower than 2.5 bars will not ensure the proper cutting speed and may result in a poor quality of corneal resection.
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N2 Pressure > 3.5b
OK
2.5b < N2 Pressure < 3.5b
INCORRECT
N2 Pressure < 2.5b
3
iNCORRECT
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Step 5 – Check that the hose and the connector are not damaged and that the orange gasket is present and undamaged on the front panel of the console and on the rear of the turbine. Attach the turbine hose to the turbine connector of the console. Screw on the connector firmly and completely (finger tight only). Step 6 – Connect the hose to the turbine.
All questions regarding gas, gas bottles, or regulators should be addressed to the gas supplier.
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2. Disassembly of the Nitrogen supply After each surgical session, the console must be disconnected from the nitrogen gas supply (internal circuit or tank). For safety reasons no Nitrogen Pressure must remain in the console after a working day. Strictly follow the disassembly procedure. The console must not have been switched OFF and must be ON and ready to work. 1 2 3 4 5 6
7
Nitrogen pressure must be removed from the console. Close the Nitrogen Pressure supply system (internal circuit or tank). Press the vacuum footswitch. Operate the turbine by pressing the Forward/Turbine control footswitch for a few seconds until the turbine runs out of gas and comes to a stop. Stop the vacuum. Stop the console by setting the required switch on “O”. Disconnect the gas supply hose: first push the blue ring toward the unit (step 1), then pull the hose toward the back (step 2).
Disconnect the turbine flexible hose, the suction tubing, and the footswitch from the console. Be sure to set the battery on charge (see part III.A.).
To check whether pressure remains in the console, if the control unit has been switched off, press the “Gas drain switch” localized at rear of the console. Check that the gas tank has been closed.
Drain or indicator switch
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H. Automatic Mode – Electrical motor connection Step 1 – Switch ON the console. Step 2 – Select the “Electric Motor” position (“1” or “2”.) “OP” must appear on the display panel (right side – see picture “A”).
"1" MODE M2, M2SU Microkeratome “1” Electrical motor display: “OP” & “1” Electric Motor LED is ON
“2”. MODE One Use Plus Microkeratome “2” Electrical motor display: “OP” & “2” Electric Motor LED is ON
Step 3 – Plug the Motor system to the control unit (connector “ELECTRIC MOTOR”) Step 4 – Select the appropriate speed (Speed 1 or Speed 2) Note: “speed 1” is on average 10% slower than “speed 2”. Speed 1 is recommended for steep corneas or when a slower forward speed is required (a lower forward speed increase flap thickness) The oscillation speed rate is not modified.
Keratome selector switch
Speed 1 Speed 2 switch
Motor N°“2” Electric connector
Motor N°“1(M2)” Electric connector
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3
Vacuum system connection vacuum tubing to the console
The vacuum tubing is made of a tubing and a drip chamber designed to protect the vacuum circuit inside the console from leakage of liquid.
Drip chamber “A”
Luer lock “B”
Tubing end “C”
Step 1 – Hold the chamber at the top (Pict.1). Step 2 – Slide it down as shown in Pict.2.
Pict.5
• Never place the chamber bottom up (as shown in Pict.3). • If liquid appears in the chamber, replace the tubing immediately (Pict.4). • Check for kinks and obstruction (as shown in Pict.5). • Use only original parts supplied by the manufacturer.
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Step 3 – Connect the tubing end “C” to the vacuum connector of the console,
Drip chamber holder “A”
Tubing end “C”
Step 4 – Connect the luer lock “B” to the appropriate suction ring.
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J. Test procedure The unit has a self checking function operated by pressing the “TEST” key on the front panel. This will check the efficiency of the pumps and the pressure (if gas turbine is selected). The unit can only be operated if the test is passed. Blinking and audible tones will indicate a test that has not been passed. The test should be made :
Test function steps
• daily and prior to surgery. • whenever tubing is changed. • whenever a red indicator light is illuminated
A
B
1 - Clamp the aspiration tubing, 2 - Press the “TEST” key, The unit will check each pump: “P1”, then “P2”. The display indicates the pressure obtained by each pump during the test.
The test is passed if the green LED “A” turns ON. The display indicates the atmospheric pressure of the day (approximative 760mmHg at sea level).
If LED A is green and LED B is red, one of the two pumps has not passed the test. Check that the tubing has been clamped and make another test. If both LEDs are red, neither the two pumps have passed the test. Check that the tubing has been clamped and make another test. If the problem still occurs, do not use the console and contact your local distributor for a complete evaluation of the unit.
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Testing of the tubing This test must be done whenever new sterile tubing is connected to the console. 1. Connect the sterile, single use aspiration tubing to the unit. 2. Select and inspect the appropriate suction ring. 3. Connect the suction ring handle to the aspiration tubing. 4. Start the pump test with the tubing clamped just after its connection to the console; the test is passed when the green LED is displayed on the console. 5. Unclamp the tubing, press the vacuum pedal, and read the displayed vacuum level. It must be slightly below the value displayed when vacuum is not activated (approximately 690 mmHg on display panel). 6. Clamp the tubing just before the connection with the ring; the new displayed value must be below 250 (mmHg). 7. If the test is not passed, proceed as follows : •
Visually check that the tubing is free of folds both before and after set up. Partial or total obstruction of the tubing may occur as a result of inappropriate folding, crushing in the packaging, or torsion during set up. Aspiration through a partially blocked tube may increase the degree of obstruction and may result in a loss of vacuum during surgery
•
Poorly connected tubing, either on the console or on the ring, may also cause insufficient aspiration. It is very important to check the integrity of all connections.
•
Moria strongly advises against the re-use of aspiration tubing. Re-use of tubing may : - Damage connector, resulting in vacuum loss - Damage the vacuum pumps
•
Only use Moria tubing
•
Check that internal air ducts of the ring are not obstructed by surgical residue. This obstruction, resulting from insufficient or inappropriate cleaning, would create pseudo-aspiration and risk the loss of vacuum.
•
The vacuum is generated by electric pumps, which are protected against external liquid by a collecting chamber placed on the tubing. Penetration of liquid may damage the pumps and reduce aspiration. In such cases, the pumps must be changed by the manufacturer, and the tubing should be discarded.
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K. Vacuum level and atmospheric pressure The system displays the actual vacuum value in mmHg. The higher the vacuum power, the smaller the value displayed. When the ring is fixated on the eye, the vacuum value displayed must be less than 250mmHg. If the value displayed is above 250, the unit must be immediately turned off and sent back to MORIA for an evaluation.
WARNING The vacuum level provided by the console depends on the local atmospheric pressure, and thus, on the elevation. The higher the elevation, the less efficient the suction will be. The atmospheric pressure decreases with elevation (approx: 8 mmHg/100 m) The suction capacity of the ring is proportional to the difference in pressure between the limit level of vacuum of the pump and the local atmospheric pressure. The surgery has to be performed according to the IOP achieved.
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a) Low Vacuum Function
The low vacuum function is activated by pressing the Low Vacuum key on the front panel (left bottom side). When it is activated, the LED “A” turns ON.
LED A
For safety reasons, when the low vacuum function is activated, the electrical motor can only be activated for a backward pass. The “Low Vacuum” allows for low level of vacuum of the suction ring on the eye. This option can be useful to maintain suction on the eye while the patient undergoes laser ablation (nervous patient, eye tracker shut down, etc.).
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IV. ALARMS & SAFETY A. Loss of vacuum In case of a loss of vacuum during surgery:
1. If a loss of vacuum has been detected on the main pump (over 250 mmHg): An audible tone informs the surgeon, The 2nd pump automatically and instantaneously takes over to provide vacuum power. The display is as shown.
2. If a loss of vacuum has been detected during surgery on the safety pump: An audible tone informs the surgeon, As the system had previously detected that the first pump was probably defective, the 2nd pump still runs and the red LED is on.
It is recommended to run a test once the surgery is done in order to check pumps. B. Loss of turbine pressure (if gas turbine selected)
In case of a loss of turbine pressure during surgery: An audible tone informs the surgeon, The turbine red LED turns ON (as soon as the pressure is below 2.5 bars), The display is as shown, At the end of the surgery during which the alarm has occurred, check the system and proceed to the test mode.
2.0 2
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C. Loss of battery power If power is not coming from the main supply, the system will run automatically on the backup battery An audible tone informs the surgeon The Main power Supply LED turns Off.
Main power Supply LED
If battery is not adequately charged: An audible tone informs the surgeon The battery red LED turns ON, At the end of the surgery during which the alarm has occurred and after the turbine is stopped, connect the main power supply and recharge the battery immediately.
,
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V. CLEANING AND MAINTENANCE
• • •
No specific maintenance is required for the control unit. To clean the control unit, use isopropyl alcohol on a cloth. Do not use solvents or abrasives. WARNING : Do not pour liquids or solutions on the control unit.
•
The battery is designed for long use, but it must be replaced if : o The battery charge indicator is still RED after a normal time of charging (48h if battery is totally discharged). o The charge decreases rapidly during the use of the unit. o A “clicking” noise can be heard during the charge.
WARNING : Use only the original manufacturer’s parts. The use of a different battery may result in severe damage to the unit, or in malfunction. WARNING : If the unit has not been operated for four weeks or more, the battery should be checked and recharged prior to further use. WARNING : In case of unusual vibrations or noises, do not use the unit and contact your distributor
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VI. WARRANTY The EVOLUTION 3 system will function optimally provided that the recommendations for cleaning and maintenance are followed carefully. If however you experience a decrease in performance (irregular movement or slowing down for instance…), it is strongly recommended to have your system thoroughly checked by MORIA.
1. Moria warrants the following items exclusively
DESCRIPTION EVOLUTION 3 console (except battery) EVOLUTION 3 footswitch
REFERENCE 19360 19361
1. If the above items are found to be defective within the period specified in paragraph 3, MORIA will repair, or at its option, replace the defective parts at no charge. The units must be returned in their original packaging. 2. An authorized representative of MORIA must do servicing and replacement of parts. 3. In case of malfunction of the equipment, an authorized MORIA technician will do the repairs at the purchaser’s request. 4. The purchaser of the equipment will appoint one person specifically dedicated to it. MORIA will provide this person with appropriate training. 5. The servicing of the unit will take place during MORIA’s normal working hours. 6. Any defective part exchanged during the period of warranty will become the property of MORIA. 7. Batteries and disposable items, such as blades, single-use heads & rings, and tubing, are not covered by the warranty.
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2. The warranty does not apply in the following cases: • • • • • •
When defects or malfunctions occur after the period specified in paragraph 3 When the equipment is not properly installed, properly maintained, or used for the intended purposes. When the unit is connected to an inappropriate power source. When the user attempts to service the equipment. If the service is performed by non-authorized MORIA personnel. The use of non-Moria tubing will void the warranty.
3. Warranty Period 1. The equipment is under warranty from the date of the shipment from MORIA and for a period of twelve months starting from the date of the shipment. 2. Servicing: the period of warranty for repairs out of the 1 year warranty is three months starting from the date of the shipment of the repaired equipment. 4. Warranty and Liabilities 1. The use of non-Moria tubing will immediately void the warranty. 2. MORIA’s liability is limited to the service above mentioned in paragraph 1. In no case will MORIA be held liable for loss of revenue resulting from the equipment not being in operation. 3. This contract is constructed according to the French Law. Only a French court will be competent.
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Please complete and fax back this questionnaire to become a Member of the MORIA USERS’ CLUB and have access to our USERS’ CLUB Heading (MORIA web-site: http://www.moriasurgical.com) and to many other advantages.
Please send or continue sending me MORIA News YES NO Without cost or obligation on my part
Type of equipment : Number
Microkeratome
One One Use CB, CBSU M2, M2SU One Use Plus
……... ……... ……... ……... ……...
Control Unit
Classic Classic II Evolution Evolution II Evolution 3
Are you using other microkeratomes ?
_____________________________________ Signature MD Dr. Mr.
PhD
Date Pr.
Associate Pr.
Ms.
Last name : ……………………………………………………
……... ……... ……... ……... ……...
First name : …………………………………………………… Second name : ………………………………………………...
Yes
Date of birth : ………………………………………………… Function : ……………………………………………………..
Hospital / Institution : …………………………………………
Address : ………………………………………………………
Hospital Administrator / Director Medical Department Head Medical Practitioner Central Services Staff Non Hospital Function (E.G. Distributor, Turnkey
Contractor)
50 to 100 200 and +
No
If so, please indicate their names and professional data :
Name : .................................................................................. ............................................................................................... Address : ...............................................................................
Your Function:
20 to 50 150 to 200
Do you know other refractive surgeons who would be interested in joining MORIA’s USERS Club ? Yes
Fax : (…………….)(……………………………….…………)
From time to time, MORIA may use your name and address to send information on related products and services which may be of interest to you. If you do not wish to receive this information, please tick this box
How many LASIK procedures do you perform monthly ? 0 to 20 100 to 150
Phone : (…….…..….)(……………………..…………..……)
E-mail Nr : …………………………………………………….
When did you start performing LASIK with MORIA ? ………………………………………………………………..
State: ………………………………………………………… Country : ………………………………………………………
When did you start performing LASIK ? ………………………………………………………………..
P.O. Box Nr Postal Code: …………………………………… City: …………………………………………………………...
If yes, which ones ? ………………………………………………………………...
Department : ………………………………………………….
Street Name: ………………………………………………….
No
............................................................................................... Phone / Fax : ........................................................................ E-Mail : ..................................................................................
Name : ..................................................................................
Other (please specify) :
…………………………………………………………………
............................................................................................... Address : ...............................................................................
Type of institution:
...............................................................................................
Hospital / University Hospital Clinic Outpatient clinic / Medical Centre Nursing Home / Extended Care Government Authority / Health Agency Refractive Centre
............................................................................................... Phone / Fax : ........................................................................ E-mail : ..................................................................................
Please, fax this form back to +33.1.46.74.46.70
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