EVOLUTION 3E Instruction Manual Rev K Oct 2020

E4

E5

F2

F3

F5

F6

F8

F1

G1

G2

F4

G3

G4

F7

H

G5

CONTENTS I. DISCLAIMER... 2 A. MAINTENANCE AND WARRANTY... 2 B. USE OF GENERIC PRODUCTS AND REUSE OF SINGLE-USE CONSUMABLES... 2 II.

GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC EMISSIONS AND IMMUNITY... 2

III. EQUIPMENT AND ACCESSORIES LIST... 2 A. EQUIPMENT LIST... 2 B. ACCESSORIES LIST... 3

XIII. DRAWINGS... 13 A. CONTROL UNIT (FRONT)... 13 B. CONTROL UNIT (BACK)... 13 C. FOOTPEDAL... 13 D. CONNECTING AND DISCONNECTING NITROGEN/AIR HOSE (#19120)... 13 E. HOW TO SELECT THE OPERATING VOLTAGE (115V OR 230V POSITION)... 13 F. CHANGING THE BATTERY... 13 G. CHANGING FUSES... 13 H. INSTALLING TUBING... 13

IV. TECHNICAL SPECIFICATIONS... 6 V.

REGULATORY INFORMATION... 6

VI. INTENDED USE... 6 VII. LABELING INFORMATION... 7 VIII. INSTALLATION AND CONNECTION... 7 A. INSTALLATION RECOMMENDATIONS... 7 B. ELECTRICAL SETTING... 7 C. BATTERY TEST... 8 D. CONNECTING THE ASPIRATION TUBING... 8 E. VACUUM TEST... 8 F. LOW VACUUM FUNCTION... 9 G. MANUAL MODE (CB, CBm, CBSU, ONE, ONE USE)... 9 1. PNEUMATIC TURBINE CONNECTIONS... 9 2. DISASSEMBLY OF THE NITROGEN/AIR SUPPLY... 10 H. AUTOMATED MODE (M2, M2SU, ONE USE-PLUS, EPI-K™)... 10 IX. USE OF FOOTPEDAL...11 A. COMPATIBILITY FOOTPEDAL-CONSOLE...11 B. COMPATIBILITY FOOTPEDAL-HANDPIECE...11 C. MANUAL MODE...11 D. AUTOMATED MODE...11 X. A. B. C. D.

TROUBLE SHOOTING...11 POWER SUPPLY...11 VACUUM LOSS... 12 RESIDUAL VACUUM... 12 TURBINE PRESSURE (MANUAL MODE)... 12

XI. CARE & MAINTENANCE... 12 A. HOW TO SELECT THE OPERATING VOLTAGE (115V OR 230V POSITION)... 12 B. INSTALLING A NEW BATTERY... 12 C. REPLACING FUSES... 13 XII. WARRANTY... 13 A. SCOPE OF WARRANTY... 13 B. NON-APPLICATION OF WARRANTY... 13 C. WARRANTY PERIOD... 13 D. LIABILITY... 13

#65060/INTL-K-10.2020

MORIA

1

This instruction manual is for EVOLUTION 3E with serial numbers 5000 and above. For the EVOLUTION 3E with serial numbers below this number, please refer to user manual (#65051). The most recent version of this user guide and additional information on your keratome are available on MORIA website: http://www.moria-surgical.com.

I.

DISCLAIMER A. MAINTENANCE AND WARRANTY

The EVOLUTION 3E system has been designed for optimal operation, provided that the recommendations listed in this user manual are followed carefully. The lifetime of the Evolution 3E system is 5 years. This lifetime can be extended to 15 years if the maintenance plan described above is strictly followed. The maintenance operations in the fifth and tenth years (M5 and M10) must be carried out by Moria. They guarantee the electrical safety and operating performance of the Evolution 3E Console and thus the user’s and the patient’s safety. The other annual, intermediate maintenance operations will be carried out by Moria or by its representative who will have been previously trained and authorized by Moria. This representative must have a valid training certificate and must use only spare parts supplied by Moria. MORIA shall not guarantee the performance of the Evolution 3e system and patient and user safety if the maintenance plan is not followed. Years

Ref.

Check

Electrical safety

Remplacement of the primary circuit

Battery change

Turbine gasket change

Pump change

Tubing change

Engine board change

Vacuum solenoid valve change

1

M1

yes

no

no

no

yes

no

yes

no

no

2

M2

yes

no

no

no

yes

no

no

no

no

3

M3

yes

no

no

no

yes

no

yes

no

no

4

M4

yes

no

no

no

yes

no

no

no

no

5

M5

yes

yes

no

yes

yes

yes

yes

no

no

6

M6

yes

no

no

no

yes

no

no

no

no

7

M7

yes

no

no

no

yes

no

yes

no

no

8

M8

yes

no

no

no

yes

no

no

no

no

9

M9

yes

no

no

no

yes

no

yes

no

no

10

M10

yes

yes

yes

yes

yes

yes

yes

yes

yes

11

M11

yes

no

no

no

yes

no

no

no

no

12

M12

yes

no

no

no

yes

no

yes

no

no

13

M13

yes

no

no

no

yes

no

no

no

no

14

M14

yes

no

no

no

yes

no

yes

no

no

15

No maintenance

If, for any reasons, the system does not perform properly, have it checked immediately by MORIA. MORIA strongly recommends having the system thoroughly inspected by MORIA on a routine basis every year. The use of materials and/or components of a brand other than MORIA with the EVOLUTION 3E system will immediately nullify the MORIA warranty. MORIA may not be held responsible for any damage resulting from the use of materials and/or components of a brand other than MORIA. As only MORIA and its agents are fully expert in MORIA products, servicing and maintenance must be carried out by MORIA or its approved agents. MORIA shall not be held liable for any malfunction or damage to the apparatus, poor results, or surgical complications due to maintenance being having been carried out by an unqualified operator or third party.

B. USE OF GENERIC PRODUCTS AND REUSE OF SINGLE-USE CONSUMABLES Single-use devices should not be re-used. Doing so will negatively affect their clinical performance and increase the potential for adverse events. The reuse of single-use products, or the use of consumables other than those supplied by MORIA, may entail serious surgical consequences for the patient and dama ge the microkeratome. MORIA shall not be held liable in the event of a malfunction or damage to the microkeratome, poor results or surgical complications due to the reuse of a single-use product, or the use of consumables other than those supplied by MORIA. MORIA handpieces must only be connected to MORIA devices (console unit, heads, suction rings, etc.). All warranties become null and void if the microkeratome degrades or malfunctions due to such practices. The most recent version of this user guide and additional information on your keratome are available on MORIA website: http://www.moria-surgical.com.

II.

GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC EMISSIONS AND IMMUNITY

Refer to annexe document (#65073).

III.

EQUIPMENT AND ACCESSORIES LIST

A. EQUIPMENT LIST Designation

Regulatory designation

MORIA reference

EVOLUTION 3E Console (S/N above 5000)

EVOLUTION 3e CONTROL UNIT

19380

EVOLUTION 3-3E Control Footpedal

FOOT PEDAL FOR EVOLUTION

19361

EVOLUTION 3E Control Footpedal Epi-K™

EVOLUTION 3e FOOTSWITCH

19381

Evolution 3E Footswitch - China

EVOLUTION 3e FOOTSWITCH

19381C

Evolution 3E footswith - Japan

EVOLUTION 3e FOOTSWITCH

19381J

EVOLUTION 3 Supply Cords (CEE) (2.50m) / Cable (CEE)

EVOLUTION 3 SUPPLY CORD (EEC)

19362

EVOLUTION 3 Supply Cords (USA) (2.50m) / Cable (USA)

EVOLUTION SUPPLY CORD (USA)

19363

EVOLUTION 3 Supply Cords (UK) (2.50m) / Cable (UK)

EVOLUTION 3 SUPPLY CORD (UK)

19364

EVOLUTION 3 Supply Cords (China) (2.50m) / Cable (China)

EVOLUTION 3 SUPPLY CORD CHINA

19516

EVOLUTION 3 Supply Cords (Brazil) (2.50m) / Cable (Brazil)

EVOLUTION 3 SUPPLY CORD BRAZIL

19521

Supply cord USA

SUPPLY CORD (USA)

19451

Carrying Case

N/A

19511

User manual

N/A

65060/INTL

User manual - China

N/A

65060/ZH

User manual- Brazil

N/A

65060/BR

Annexe “Guidance and manufacturer’s declaration: electromagnetic emissions and immunity”

N/A

65073

Any such unauthorised intervention shall render the guarantee and any maintenance contract null and void.

#65060/INTL-K-10.2020

MORIA

2

B. ACCESSORIES LIST Designation

Regulatory designation

MORIA reference

Dry medical grade nitrogen gaz / Dry and filtered medical grade air Gas Supply Hose* *This hose is supplied when the EVOLUTION 3E unit is ordered together with MORIA manual microkeratomes"

GAS SUPPLY TUBING

19120

Tonometer

BARRAQUER autoclavable tonometer

19042

Aspiration tubing

Evolution 2-3-3E tubing x10

19138

Turbine hose (for ONE or CBm-ALTK turbine)

SHORT CONNECTOR TURB FLEX HOSE

19353

Turbine handpiece for ONE microkeratome

GAS TURBINE FOR LSK ONE

19155

Turbine handpiece for CB microkeratome

LSK C & B TURBINE MOTOR

19303

M2 handpiece

M2 ELECTRIC MOTOR

19326

Epi-K™ handpiece (green color)

EPI-K HANDPIECE

19342

One Use-Plus handpiece (blue color)

ONE USE PLUS MOTOR

19345

One Use-Plus One-Handed handpiece (blue color)

ONE HAND ONE USE PLUS HANDPIECE

19345OH

One Use-Plus hanpiece for artificial chamber (black color)

OUP HANDPIECE F/ ARTIFCIAL CHAMBER

19175

EPI-K REUSABLE SUCTION RING -1

19389/-1

EPI-K REUSABLE SUCTION RING 0

19389/0

EPI-K REUSABLE SUCTION RING +1

19389/1

Reusable Epi-K™ metal ring size Large Diameter (LD) -1 with stops at 8.0 - 8.5 - 9.0 - 9.5 (green color)

EPI-K LD REUSABLE SUCTION RING -1

19399/-1

Box of 10 sterile Epi-K™ heads

EPI-K HEAD

19390

Box of 10 Epi-K™ ring -1 and 10 Epi-K™ heads

EPI-K SET (-1 RING)

19384

ONE USE PLUS SBK SET (90/-1)

19336/90

ONE USE PLUS SET (130/-1)

19336/130

ONE USE PLUS SBK SET (90/0)

19337/90

ONE USE PLUS SET (130/0)

19337/130

ONE USE PLUS 110 LARGE CUT SET

19354/110

ONE USE PLUS 130 LARGE CUT SET

19354/130

OUP LC -1 REUSABLE SUCTION RING

19519/-1

OUP REUSABLE SUCTION RING -1

19391/-1

OUP REUSABLE SUCTION RING 0

19391/0

OUP REUSABLE SUCTION RING 1

19391/1

OUP REUSABLE SUCTION RING 2

19391/2

OUP REUSABLE SUCTION RING 3

19391/3

OVAL FLAP OUP METAL SUCTION RING +1

19391/1/OV

OVAL FLAP OUP METAL SUCTION RING +2

19391/2/OV

OVAL FLAP OUP METAL SUCTION RING +3

19391/3/OV

ONE USE PLUS SBK HEAD

19393/90

ONE USE PLUS 130 HEAD

19393/130

M2 SUCTION RING -1

19325/-1

M2 SUCTION RING 0

19325/0

M2 SUCTION RING +1

19325/1

M2 SUCTION RING +2

19325/2

M2 SUCTION RING +3

19325/3

M2 SUCTION LARGE CUT RING -1

19379/-1

M2 HEAD 110

19327/110

M2 HEAD 130

19327/130

M2 BLADE

19329

Reusable Epi-K™ metal ring size -1, 0, +1 with stops at 7.5 - 8.0 - 8.5 - 9.0 (green color)

One Use-Plus: ring –1 and Head SBK (90) or 130 One Use-Plus: ring 0 and Head SBK (90) or 130 One Use-Plus: ring –1 Large Cut and Head Large Cut 110L and 130L One Use-Plus Large cut reusable metal ring size -1, 0 with stops at 7.5 - 8.0 - 8.5 - 9.0 (mauve color) One Use-Plus reusable metal ring size -1, 0 with stops at 7.5 - 8.0 - 8.5 - 9.0 (blue color)

One Use-Plus reusable metal ring size +1, +2, +3 with stops at 7.0 - 7.5 - 8.0 - 8.5 (yellow color)

One Use-Plus reusable metal oval rings size +1, +2, +3, with stops at 7.0 - 7.5 – 8.0 - 8.5 (grey color)

Box of 10 sterile heads One Use-Plus SBK (90) or 130

M2-M2SU suction ring (size -1, 0, +1, +2, +3)

M2-M2SU suction ring size -1 Large-Cut M2 metallic head

Box of 10 sterile disposable M2 blades

M2 BLADE

X100 (CHINA)

19329C4

M2 BLADE

X50

19329L3

M2SU 90 HEAD

User manual

65043

65044

65039

65040

65013

19334/90

Box of 10 sterile disposable M2SU heads

19334/130 M2SU 90 HEAD

X80 (CHINA)

19334/90C5 #65060/INTL-K-10.2020

MORIA

3

Designation Microkeratome CB manual suction rings (size -1, 0, +1, +2)

Box of 10 sterile CBm blades

Regulatory designation

MORIA reference

LSK C & B MANUAL FIXATION RING -1

19309/-1

LSK C & B MANUAL FIXATION RING 0

19309/0

LSK C & B MANUAL FIXATION RING 1

19309/1

LSK C & B MANUAL FIXATION RING 2

19309/2

CBM BLADE

19333

CBM BLADE

X50

19312/110

CBSU 130 HEAD

19312/130

ONE MICROKERATOME BLADE

19137

CBM / ALTK HEAD 110

19170/110

CBM / ALTK HEAD 130

19170/130

CBM / ALTK HEAD 150

19170/150

CBM / ALTK HEAD 200

19170/200

CBM / ALTK HEAD 250

19170/250

CBM / ALTK HEAD 300

19170/300

CBM / ALTK HEAD 350

19170/350

CBM / ALTK HEAD 400

19170/400

CBSU 50 HEAD - ART. CHAMBER

19178/50

CBSU 90 HEAD - ART. CHAMBER

19178/90

CBSU 110 HEAD - ART. CHAMBER

19178/110

CBSU 130 HEAD - ART. CHAMBER

19178/130

CBSU 200 HEAD - ART. CHAMBER

19178/200

CBSU 250 HEAD - ART. CHAMBER

19178/250

CBSU 300 HEAD - ART. CHAMBER

19178/300

CBSU 350 HEAD - ART. CHAMBER

19178/350

CBSU GUIDE RING FOR ARTIFICIAL CHAMBER

19180

OU LC 110 HEAD ARTIFICIAL CHAMBER

19184/110

OU LC 130 HEAD ARTIFICIAL CHAMBER

19184/130

OU LC 150 HEAD ARTIFICIAL CHAMBER

19184/150

OU LC 200 HEAD ARTIFICIAL CHAMBER

19184/200

OU LC 250 HEAD ARTIFICIAL CHAMBER

19184/250

OU LC 300 HEAD ARTIFICIAL CHAMBER

19184/300

OU LC 350 HEAD ARTIFICIAL CHAMBER

19184/350

OU LC 400 HEAD ARTIFICIAL CHAMBER

19184/400

OU LC 450 HEAD ARTIFICIAL CHAMBER

19184/450

OU LC 500 HEAD ARTIFICIAL CHAMBER

19184/500

OU LC 550 HEAD ARTIFICIAL CHAMBER

19184/550

One Use Large-Cut guide ring for ALTK artificial chamber (19161-19162)

OU LC RING FOR ALTK ARTIFICIAL CHAMBER

19168

One Use-Plus Large-Cut guide ring for ALTK artificial chamber (19161-19162)

OUP LC RING F/ ALTK ARTIFICIAL CHAMBER

19173

Disposable One Use Large-Cut guide ring for disposable artificial chamber (19182)

OU LC GUIDE RING FOR ARTIFICIAL CHAMBER

19186

Disposable One Use-Plus Large-Cut guide ring for disposable artificial chamber (19182)

OUP LC GUIDE RING F/ ART. CHAMBER X5

19187

Box of 10 ONE Microkeratome blades

CBm-ALTK Head

Box of 5 sterile CBSU heads for artificial chamber

Disposable CBSU guide ring for disposable artificial chamber (19182)

Box of 5 sterile One Use Large-Cut heads for artificial chamber

65005

19333L3

CBSU 110 HEAD

Box of 10 sterile CBSU heads

User manual

65006 - 65007

65078

N/A

65009

N/A

#65060/INTL-K-10.2020

MORIA

4

Designation

Regulatory designation

MORIA reference

Base of the ALTK artificial chamber

Donor artificial chamber base

19161

User manual

ALTK/CBm cover with guide ring

ALTK/CBm cover with guide ring

19172

Universal chamber cover for ALTK artificial chamber

Artificial chamber cover for ALTK

19162

Infusion tubing set for artificial chamber

INFUSION TUBING SET FOR ARTIFICIAL CHAMBER

19181

Disposable artificial chamber

ONE - SU ART. CHAMBER x1

19182

OUP Ring sterilization box

OUP ring sterilization box

22519513

65040

Polymer box for OUP handpiece

Polymere box for OUP handpiece

22519514

65039-65040

Sterilization box for M2

Sterilization box for M2

22519330

65013-65062

ALTK sterilization box

ALTK sterilization box

22519167

ALTK lenses storage box

ALTK lenses storage box

22519169

Storage box for M2

Storage box for M2

22519331

Storage box F/art. Chamber OUP handpiece

STORAGE BOX F/ART. CHAMBER OUP HANDPIECE

22519174

Sterilization box for LSK

Sterilization box for LSK

22519139

LSK CB sterilization tray

LSK CB sterilization tray

22519343

OUP motor loosening key

OUP MOTOR LOOSENING KEY

19345C

Applanator lense 8-10 F/LSK C&B

Applanator lense 8-10 F/LSK C&B

19311

ALTK applanator lense 6-8-10

ALTK applanator lense 6-8-10

19166

ALTK applanator lense 7-9-11

ALTK applanator lense 7-9-11

19165

Artificial Chamber cover for ALTK/CBm

Artificial Chamber cover for ALTK/CBm

19171

Artificial chamber guide ring for ALTK

Artificial chamber guide ring for ALTK

19164

65009

ONE head blade push

ONE head blade push

19135

N/A

65009

N/A

N/A

65005-65078 65009-65078

#65060/INTL-K-10.2020

MORIA

5

IV

TECHNICAL SPECIFICATIONS

V.

The control unit is mainly composed of the following elements: • 1 x 12V-7Ah battery (back-up) • 1 x transformer • 2 x vacuum pumps: vacuum circuit (main pump + « back-up » pump) • valves for the vacuum & gas circuit • 1 x gas regulator used for the set up of the nitrogen pressure going to the turbine (manual microkeratomes) • Electronic boards.

Reference

mm

kg

Pressure

Elect. Supply

19380

430 x 240 x 190

13.6

IN : 4-6 bars / 58-87 psi OUT : 2.5-3.5 bars / 36-50 psi Precision of displayed values: +/-0,2bar = 2,9 psi. Vacuum display: +/- 30 mmHg

100-120V / 220-240V 50/60Hz Fuse : 500 mA high switching power Battery :12 V - 7 Ah (Pb)1 Power input: 50 VA

19381

Double footswitches: 220 x 200 x 60 Single footswitch : 100 x 70 x 30

2.55

19361

Double footswitches: 160 x 130 x 70 Single footswitch : 100 x 70 x 30

1.05

19381C

Double footswitches: 160X130X70 Simple pédale: 100X70X30

1.05

19381J

Double pédale: 220X200X30 Single footswitch: 100X70X30

2.55

REGULATORY INFORMATION MORIA S.A. 15, rue Georges Besse - 92160 Antony - France Phone +33 (0) 146 744 674 Fax +33 (0) 146 744 670 [email protected] http://www.moria-surgical.com

Electrical Safety Standard, electromagnetic compatibility

IEC 60601-1

Annexe “Guidance and manufacturer’s declaration: electromagnetic emissions and immunity”

Refer to annexe document (#65073).

Customer Service Information

Contact your local dealer or MORIA.

EUROPE

0459

Classe I type BF

according to MDD 93/42/CEE

Product registered at the Food and Drug Administration (FDA). Caution USA only: Federal law restricts the use of this device to physicians or licensed practitioners.

USA

For EU customers only: this symbol indicates that within the European Union, the product must be discarded in a separate collection bin at the end of its useful life. This applies not only to this device, but also all accessories, including the footpedal and electrical motors, regardless of whether those accessories are marked with the symbol. Do not dispose as unsorted municipal waste. For users out of EU: please refer to local environmental regulatory regarding waste of electrical and electronic equipment.

VI.

INTENDED USE

The power unit has been designed to operate Moria keratomes by means of electric motor or turbine. Evolution 3E console must be used only by experienced ophthalmic surgeons with specific knowledge and training in corneal surgery.

If a battery change is necessary, the used battery is classified as waste, which must be dealt with according to the specific regulations for collection, treatment, recycling and disposal set out in directive 2006/66/EC of 9 September 2006 relating to batteries and accumulators and waste batteries and accumulators. As such the battery must be disposed of at an appropriate collection point. 1

The Evolution 3E control unit and the electrical motors / turbines must follow the following conditions: Temperature

Humidity rate (without condensation)

Transportation

5 - 45°C / 41°F – 113°F

30 - 90%

Storage

10 - 40°C / 50°F – 104°F

30 - 75%

Normal conditions of use

10 - 40°C / 50°F – 104°F

30 - 75%

Atmospheric pressure

70 - 106 kPa

#65060/INTL-K-10.2020

MORIA

6

VII. LABELING INFORMATION

VIII. INSTALLATION AND CONNECTION A. INSTALLATION RECOMMENDATIONS

XXXXXX

CATALOGUE NUMBER OR SKU

XXXXXXXX

SERIAL NUMBER

DATE OF MANUFACTURE

YYYY/MM/DD

MANUFACTURER

XXXXXXX

CAUTION : CONSULT INSTRUCTIONS FOR USE FOR ANY IMPORTANT INFORMATION ABOUT THE SECURITY

XXXXXX

CONSULT OPERATING INSTRUCTIONS

XXXXXX

DISCARD IN A SEPARATE COLLECTION BIN

Following is a list of general recommendations when installing the EVOLUTION 3E console: • Make sure the console is installed no more than 2 meters away from user • The console must remain in front of user during operation to visualize every indication (value, warning) • User must be able to hear signals from EVOLUTION 3E console properly • User must be able to disconnect suction from aspiration tubing connector • User must be cautious about EVOLUTION 3E console displacement due to its height, dimensions and connections • The EVOLUTION 3E console must not be installed above or close to a radiating device. • All applied parts must be used in normal condition of use, and on a routine surgical basis with respect to their intended use according to the instructions for use. WARNING : The microkeratomes electric motors and turbine can reach a temperature over 41°C. Moria recommends to use the motors and rings not longer than 1 min and to prevent any contact of motors with patient tissues. B. ELECTRICAL SETTING

WARNING AGAINST ELECTROSTATIC DISCHARGES

WARNING AGAINST INTERFERENCE RISK

What to do

1

Using the screw connector, plug in the footpedal connector (#19361, 19381, 19381C, 19281J) to the rear panel of the console

Finger tight only

B8 C

2

Connect the power supply cord to the main power supply

NEVER OPERATE WITHOUT MAIN POWER SUPPLY. Before using the EVOLUTION 3E, check if position of operating voltage (115 or 230V) is appropriate to your country’s power supply: - for a power supply of 100-120V: select position «115V» - for a power supply of 220-240V: select position «230V». To select position of operating voltage, see chapter XI.A. To change fuses, see chapter XI.C. If the unit has not been operated for four weeks or more, the battery level should be checked and recharged prior to use. To avoid electrical shock, the console must only be connected to a grounded power system. Position the console so that displays, connections and buttons remain visible and accessible. Always allow an easy access to the electric supply and power socket. In cases of emergency, disconnect the power socket or the supply cord connector.

B11

3

Switch on the control unit turning B9 button to “ON”

Visually check all LEDs are blinking (A3, A4, A5, A7, A9, A10, A11, A12, A14, A15, A16, A17, A18). Visually check A9 and A11 LEDs are ON. The display indicates the atmospheric pressure (approximately 760mmHg at sea level).

B9 LEDS (A9 and A11) ON

REFER TO USER MANUAL

SIGN OF GENERAL SAFETY

ALTERNATIVE CURRENT TYPE « BF » APPLIED PARTS: PROTECTION AGAINST ELECTRIC SHOCK : • LEAKAGE CURRENT • GROUNDED POWER SYSTEM 75%

40°C 10°C

30% 70%

35°C 15°C

30%

NORMAL CONDITIONS OF USE EVO3E CONTROL UNIT AND MOTORS/TURBINES: TEMPERATURE: 10°C – 40°C / 50°F – 104°F, HUMIDITY RATE: 30 - 75% NORMAL CONDITIONS OF USE SINGLE USE ITEM : TEMPERATURE: 15°C – 35°C / 59°F – 95°F, HUMIDITY RATE: 30 - 70%

IP X6

FOOTSWITCH PROTECTED AGAINST POWERFUL WATER JETS

IP X8

FOOTSWITCH PROTECTED AGAINST WATER SUBMERSION BEYOND 1 METER (3,3 FEET) THIS SIDE UP

Related picture

Steps

IMPORTANT WARNINGS

FRAGILE

KEEP DRY CAUTION FOR USA ONLY: US FEDERAL LAWS RESTRICT THIS DEVICE TO SALE BY, OR ON THE ORDER OF, A PHYSICIAN.

#65060/INTL-K-10.2020

MORIA

7

C. BATTERY TEST

E. VACUUM TEST Related picture

Steps

What to do

Check that battery charge level indicator (green LED) is switched on (wait 15 seconds)

B9 A11

1

Clamp the aspiration tubing at its end (close to the ring connector)

Before connecting the suction ring on the aspiration tubing, check that internal air lumen of the ring are not obstructed by surgical residues. This obstruction, resulting from insufficient or inappropriate cleaning, would create pseudo-aspiration and risk the loss of vacuum.

Switch EVOLUTION 3E console by turning button (B9) on «OFF»

Check that residual gas drain switch is working (audible sound)

B9 B4

2

Plug again the supply cord to the unit

Perform surgery on main supply only.

Press the test button (A8) The unit will check each pump: P1, then P2. Vacuum test ends with a short audible “beep”.

This test procedure will check the efficiency of the pumps and the pressure (if gas turbine is selected). The test should be made : • prior to surgery, • whenever tubing is changed, • whenever a red indicator light is illuminated The unit can only be operated if the test is passed. The display (A7) indicates: • “PE” • then atmospheric pressure (mmHg) • then “P1” • then the pressure obtained by pump P1 (mmHg) • then “P2” • then the pressure obtained by pump P2 (mmHg) • then atmospheric pressure (mmHg) When atmospheric pressure “PE” is indicated on the display, one can hear a single “beep”.

3

The test is passed if LED (A3) is ON

Steps

What to do

1

Switch EVOLUTION3E console off by turning button (B9) on «OFF» Unplug the supply cord Switch EVOLUTION3E console ON by turning button (B9) on «ON»

2

3

IMPORTANT WARNINGS

D. CONNECTING THE ASPIRATION TUBING Steps

What to do

1

Check the integrity of the aspiration tubing (#19138)

Visually check tubing integrity before and after set up. MORIA strongly advises against the re-use of aspiration tubing as it may damage connector, resulting in vacuum loss or damage the vacuum pumps.

2

Connect the sterile, single use aspiration tubing (#19138) to the unit: • place the chamber in position (H1) • then get it down (H2)

Change tubing for each patient. 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. Warning: • do not reverse the chamber position of the aspiration tubing (H3) • if liquid appears in the chamber, replace the chamber immediately (H4) • visually check tubing integrity before and after set up (H5) If moisture seeps into the console, activate vacuum to remove it. If water is sucked up, it is recommended to let the pumps run to let residual water out.

IMPORTANT WARNINGS

Related picture

A24 H

Related picture

IMPORTANT WARNINGS

A7 A8

Stopping suction is indicated by a “beep” sound”. The vacuum level provided by the console depends on the local atmospheric pressure, and thus on the elevation. The system displays the actual vacuum value (in mmHg). The higher the elevation, the less efficient the suction. The atmospheric pressure decreases with elevation (approx: 8 mmHg/100 m). The suction capacity is proportional to the difference in pressure between the lowest level of vacuum pump and the local atmospheric pressure. The higher the vacuum power, the smaller the value displayed.

A3 ON

When the ring is fixated on the eye the vacuum value must be less than 250mmHg. If the value displayed is above, the unit must be immediately turned off and sent back to Moria for a servicing. 760 mmHg

At sea level (Elevation = 0 m) Atmospheric pressure = 760 mmHg

4

526 mmHg

Elevation (for example 3000 m) Atmospheric pressure = 526 mmHg

Elevation

Atmospheric pressure mmHg

Indicative Vacuum level provided by the unit

0m

760

152 mmHg

1000 m

675

135 mmHg

2000 m

596

119 mmHg

2500 m

560

112 mmHg

3000 m

526

105 mmHg

Stop clamping the aspiration tubing. Control unit is ready to use. #65060/INTL-K-10.2020

MORIA

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F. LOW VACUUM FUNCTION Steps

What to do

1

Press on the vacuum footswitch (C1) then the “Low Vacuum” button (A6)

G. MANUAL MODE (CB, CBm, CBSU, ONE, ONE USE) IMPORTANT WARNINGS When “Low Vacuum” function is activated, LED A5 is ON. The “Low Vacuum” allows for a low level of vacuum of the suction ring on the eye. For safety reasons, when the low vacuum function is activated, the electrical motor can only be activated for a backward pass.

Related picture C1 A5 ON A6

Warning: Do not connect more than one keratome at a time to the EVOLUTION 3E console. 1. PNEUMATIC TURBINE CONNECTIONS Related picture

Steps

What to do

1

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.

2

Connect the Nitrogen/ Air Hose (#19120) to the control unit

3

Before opening the dry medical grade nitrogen gas tank, or dry and filtered medical grade air tank, always set the pressure to the minimum value by turning the knurled blue knob (B1) counterclockwise.

To operate the knurled blue knob (B1), pull it toward the back.

4

Pressurize the system The pressure to the generator should be between 4 and 6 bars (58 and 87 psi). Incoming pressure must not exceed 14 bars.

If the pressure going IN the console exceeds 8 bars (116 psi), the console detects excess pressure and opens the high pressure valve. The dry medical grade nitrogen gas, or dry and filtered medical grade air is ejected from the turbine connector (front panel) in order to protect the internal components. If so, have the system checked by MORIA.

5

Set the pressure in the console by turning the knob (B1) on the rear panel to obtain a pressure of 3.2 ± 0.2 bars (46 ± 3 psi)

Once the dry medical grade nitrogen gas tank, or dry and filtered medical grade air tank is opened, increase the pressure to the appropriate amount (3.2 bars): • turn the knurled blue knob (B1) clockwise to increase pressure • turn the knurled blue knob (B1) counterclockwise to decrease pressure. Once the correct pressure has been selected, lock the knob (B1) by pushing it. Do not use the unit if LED (A16) or (A18) are ON.

B1

6

Select manual mode (A13)

Press « Mode » button (A13) until green LED (A12) is ON (« Manual Mode »)

A12 A13 A15

7

Proceed a vacuum test

Refer to chapter VIII.C

A8

8

Connect the hose (#19353) to turbine

Finger tight only. Check that the hose and the connector are not damaged and that the gasket is present and undamaged on the front panel of the console and on the rear of the turbine.

A23

9

Control unit is ready to use.

Refer to user manual : • CB, CBm, CBSU for LASIK: #65005 • CBm, CBSU for artificial chamber : #65078 • ONE, One Use : #65009 Always check intraocular pressure with a tonometer (#19042) prior to using any keratome.

IMPORTANT WARNINGS MORIA supplies a black hose (black is the international code for nitrogen). All questions regarding gas, gas bottles, or regulators should be addressed to the gas supplier. The hose is delivered with a copper quick connection on one end, and free on the other end. The free end has to be connected to your own gas supply system (dry and filtered medical grade air or nitrogen bottle with its dual stage gas regulator and male nozzle). MORIA recommends using: • a high-pressure dual stage regulator • dry medical grade nitrogen gas, or dry and filtered medical grade air to operate pneumatic turbines, available from your medical gas supplier MORIA does not supply the gas.

B2, B3 D1, D2

#65060/INTL-K-10.2020

MORIA

B1

9

2. DISASSEMBLY OF THE NITROGEN/AIR SUPPLY

H. AUTOMATED MODE (M2, M2SU, ONE USE-PLUS, EPI-K™)

Before disassembly the nitrogen/air supply, no nitrogen/air pressure must remain in the console. Steps

What to do

1

Close the gas tank.

2

IMPORTANT WARNINGS

Warning: Do not connect more than one keratome at a time to the EVOLUTION 3E console. Related picture

After each surgical session, the console must be disconnected from the dry medical grade nitrogen gas supply, or dry and filtered medical grade air supply (internal circuit or tank). For safety reasons, no nitrogen or air pressure must remain in the console.

Operate the turbine by pressing the Forward/ Turbine footpedal for few seconds until the turbine runs out of gas and comes to a stop.

C2

After surgery, switch off the vacuum by pressing the vacuum footpedal and remove the vacuum ring from the eye. Disconnect the tubing from the ring and the disposable head/ blade. Discard all in an appropriate container.

C1

After use, switch off the control unit and disconnect the turbine. Decontaminate and sterilize (by autoclave) the turbine.

B9

5

Press the Residual Gas Drain Switch until there is no pressure left in the console

B4

6

Disconnect the nitrogen/ air gas supply (internal circuit or tank) from the control unit.

3

4

Disconnect the gas supply hose: • first push the blue ring toward the unit (step 1), • then pull the hose towards the back (step 2)

B2–B3 D3a-D3b

Related picture

Steps

What to do

1

Select the automated mode

Press « Mode » button (A13) until green LED (A14) is ON according the selected microkeratome. « OP » appears on the display.

A13 A14 A15

2

Proceed a vacuum test

Refer to chapter VIII.C

A8

3

Plug the motor system into the control unit

To plug One Use-Plus handpieces: A19 To plug M2-M2SU handpiece: A21 To plug Epi-KTM handpiece: A22

A19 A21 A22

4

Select the advance speed (for M2, M2SU and One Use-Plus)

The advance speed 1 is slower than the advance speed 2. The blade oscillation rate is not modified. See applicable nomograms: • M2-M2SU : #65023 • One Use-Plus with plastic ring : #65041 • One Use-Plus with metal ring: #65067, 65077EN • One Use-Plus for artificial chamber : #65101

A20

5

Set the vacuum ring on the eye and press the vacuum footpedal. Assemble the keratome on the ring and activate forward footpedal to perform the cut. After the cut is performed, press backward footpedal.

Refer to user manual: • M2-M2SU: #65013 • One Use-Plus with plastic ring: #65039 • One Use-Plus with metal ring: #65040 • One Use-Plus for artificial chamber: #65106 • Epi-K™ with metal ring: #65043 • Epi-K™ with plastic ring: #65044

IMPORTANT WARNINGS

Always check intraocular pressure with a tonometer (#19042) prior to using any keratome.

6

After surgery, switch off the vacuum by pressing the vacuum footpedal and remove the vacuum ring from the eye. Disconnect the tubing from the ring and the disposable head/ blade. Discard all in an appropriate container.

C1

7

After use, switch off the control unit and disconnect the electrical motor. Decontaminate the motor (see instructions in each user manual).

B9

#65060/INTL-K-10.2020

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IX.

USE OF FOOTPEDAL

D. AUTOMATED MODE

A. COMPATIBILITY FOOTPEDAL-CONSOLE • •

What to do

Footpedals (#19361 and 19381) with serial number inferior to 7000 are not compatible with EVOLUTION 3E consoles (#19380) having a serial number superior to 7000. EVOLUTION 3E consoles (#19380) with serial number superior to 7000 are compatible only with footpedals (#19361, 19381, 19381C et 19381J) having a serial number superior to 7000. EVOLUTION 3E console (#19380)

Footpedal

(#19361, 19381, 19381C, 19381J)

5000 < sn < 7000

sn > 7000

5000 < sn

compatible

not compatible

5000 < sn < 7000

compatible

not compatible

sn > 7000

not compatible

compatible

Press the vacuum footswitch (C1) once: vacuum is ON Press again the vacuum footswitch (C1): vacuum is OFF

The system displays the actual vacuum value in mmHg (A7). When a suction ring is fixated on the eye, the vacuum value displayed must be less than 250 mmHg. If the value displayed is above 250 mmHg, please refer to chapter X.

C1

Press the forward footswitch (C2): • blade oscillation • forward pass of microkeratome

In case vacuum is not activated, the forward footswitch does not work. When the forward footswitch is not pressed any longer : • microkeratome stops • blade oscillation stops.

C2 B6

M2/One Use-Plus keratomes and turbines for ONE and CB: footpedals #19361 and 19381 operate at only one forward speed. Epi-K™ only (footpedal #19381): 3 forwards speeds available when press the footpedal (slow – medium – fast): • 1st step: slow forward speed, with a continuous tone • 2nd step: medium forward speed, with a louder tone than with 1st step • 3rd step: fast forward speed, with a louder tone than with 2nd step Use B6 button to vary tone level.

B. COMPATIBILITY FOOTPEDAL-HANDPIECE • •

Footpedal #19361 can be used with M2 and One Use-Plus handpieces, as well with turbines for ONE and CB. Footpedal #19361 can not be used with the Epi-K™ handpiece. Footpedal #19381 can be used with M2, One Use-Plus and Epi-K™ handpieces, as well with turbines for ONE and CB.

C. MANUAL MODE What to do Press the vacuum footswitch (C1) once: vacuum is ON Press again the vacuum footswitch (C1): vacuum is OFF

IMPORTANT WARNINGS

Related picture

The system displays the actual vacuum value in mmHg (A7). When a suction ring is fixated on the eye, the vacuum value displayed must be less than 250 mmHg. If the value displayed is above 250 mmHg, please refer to chapter X.

C1

Press the forward footswitch (C2): blade oscillation

In case vacuum is not activated, the forward footswitch does not work. Blade oscillation stops once forward footswitch is not pressed any longer.

C2

Press the backward footswitch (C3): no action

Do not press footpedal (C2) and (C3) at the same time.

C3

Related picture

IMPORTANT WARNINGS

Press the backward footswitch (C3): • backward pass of microkeratome • no blade oscillation

X.

Pressing the backward footswitch induces a backward pass of the microkeratome even if: • vacuum is OFF • “Low Vacuum” option is ON Do not press footpedal (C2) and (C3) at the same time.

C3

TROUBLE SHOOTING

A. POWER SUPPLY Message

Reason

Intervention

LED (A9-A11) ON + Audible tone

Loss of main power supply during surgery AND Battery charged (>90%)

The system runs automatically on the backup battery: check LED A11 is OFF. At the end of the surgery case, connect the console to the main power supply to recharge the battery immediately: check LED A11 is ON.

Control unit runs on battery supply LED (A10) ON + Audible tone

Loss of Main Power supply: Main power supply is defective during surgery AND Battery discharged

Connect the console to the main power supply to recharge the battery immediately.

Control unit runs on a discharged battery supply

#65060/INTL-K-10.2020

MORIA

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B. VACUUM LOSS Message

Reason

Intervention

LED (A3–A4) ON + audible tone

Loss of vacuum has been detected on pump P1 or P2. Display (A7) shows « P1 » or « P2 » depending on the defective pump, then current atmospheric value.

One of the two pumps has failed. The second pump will automatically and instantaneously take over to provide vacuum power. Even if there is a vacuum loss, the microkeratome will continue to function. At the end of the case, run a test. Then if problem still persists, check that aspiration tubing is well clamped, then run a test. Then if problem still persists, check aspiration tubing and change it if any doubt, then run a test. If unable to solve the problem, do not use the console and contact your distributor or MORIA to have it checked.

LED (A4) ON + double audible tone

Loss of vacuum has been detected during surgery on pump P1 and P2. Displays (A7) shows simultaneously P1/P2 then “---“

The two pumps have failed. Then if problem still persists, check that aspiration tubing is well clamped, then run a test. Then if problem still persists, check aspiration tubing and change it if any doubt, then run a test. If unable to solve the problem, do not use the console and contact your distributor or MORIA to have it checked. Note: Even if there is a vacuum loss during the case, the microkeratome will continue to function.

C. RESIDUAL VACUUM If the vacuum cannot be interrupted by pressing the vacuum footpedal while suction ring is on patient’s eye, cut or disconnect the vacuum tubing from the console to decrease pressure. Then lift keratome carefully taking care not to harm the corneal hinge.

Please contact MORIA for any other servicing. A. HOW TO SELECT THE OPERATING VOLTAGE (115V OR 230V POSITION) Steps

What to do

1

Switch OFF the control unit.

2

Gently open the door.

3

Remove the selector (A) and select the right voltage

4

Reposition the selector and close the door

Reason

Intervention

LED (A16) ON + audible tone

Loss of turbine pressure

The yellow LED will turn ON (as soon as the pressure is below 2.5 bars). At the end of the case, check the system and run a test procedure. Note: The loss of turbine pressure will decrease the blade oscillation rate.

Nitrogen/Air going out by the hose

XI.

Too much turbine pressure

If the pressure going in the console exceeds 8 bars (116 psi), it may damage the unit. 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.

CARE & MAINTENANCE

B9 B10 E1-E2-E3

For a power supply of 100-120V: select position «115V». For a power supply of 220-240V: select position «230V».

E4

E5

If the battery can not be charged, or does not hold a charge, a new battery must be installed in the console. See draws F. Related picture

Steps

What to do

1

Switch OFF the control unit.

2

Completely unscrew the 2 screws located at the back of the control unit

F1 – B14

3

Slide the cover toward the front

F2

4

Lift the cover from back to front in 2 steps

F3

5

Unplug the battery

F4

6

Unscrew the 2 screws

F5

7

Remove the metal piece (while keeping screws in place)

F6

8

Lift the battery with the plastic strap

Maintenance guide requires returning out of order batteries to Moria for treatment.

F7

9

Replace with a new battery, reposition and screw in the metal piece, plug in the new battery, replace and screw down the cover

Battery: 12 V - 7 Ah (Pb) Use only the original manufacturer’s parts. The use of a different battery may result in severe damage to the unit, or in malfunction. To recycle the battery, please contact your dealer or MORIA. NEVER USE THE CONTROL UNIT WITHOUT A BATTERY INSTALLED INSIDE AND PLUGGED IN. Important: the used battery is classified as waste, which must be dealt with according to the specific regulations for collection, treatment, recycling and disposal set out in directive 2006/66/EC of 9 September 2006 relating to batteries and accumulators and waste batteries and accumulators. As such the battery must be disposed of at an appropriate collection point.

F8

10

Test battery

Refer to chapter VIII.C

In cases of unusual vibrations or noises, instability, unusual performance, or failure to pass the vacuum test, do not use the unit and contact MORIA or your distributor for servicing. MORIA strongly recommends having the system thoroughly inspected by MORIA on a routine basis every year. WARNING: Wipe the control unit with a lint-free surgical wipe moistened with disinfecting solutions.. Do not use solvents, abrasives, fluids, or solutions on the control unit and footpedals. Do not pour liquids or solutions on the control unit, footpedals and connectors.

Before opening the control unit, switch OFF the control unit and remove the cord.

B. INSTALLING A NEW BATTERY

D. TURBINE PRESSURE (MANUAL MODE) Message

Related picture

IMPORTANT WARNINGS

IMPORTANT WARNINGS Before opening the control unit, switch off the control unit and remove the cord.

#65060/INTL-K-10.2020

MORIA

B9

12

XIII. DRAWINGS

C. REPLACING FUSES Steps

What to do

1

Switch OFF the control unit.

2

Gently open the door with screwdriver

3

Remove the cartridge and change the 2 fuses

4

Close the door

IMPORTANT WARNINGS Before opening the control unit, switch OFF the control unit and remove the cord.

Related picture B9 B10 G1-G2

500 mA high switching power

G3-G4-G5 G1

XII. WARRANTY A. SCOPE OF WARRANTY DESCRIPTION

MORIA reference

EVOLUTION 3E Console (Except Battery)

19380

EVOLUTION 3-3E Control Footpedal

19361

EVOLUTION 3E Control Footpedal Epi-K™

19381

EVOLUTION 3E Footswitch - China

19381C

EVOLUTION 3E footswith - Japan

19381J

• •

The above items as well as spare parts and labor necessary for their repair are covered by warranty. Any items returned must be sent in their original packaging, after having previously been decontaminated. The maintenance operations and the replacement of spare parts will be exclusively carried out by technicians authorized by MORIA.

B. NON-APPLICATION OF WARRANTY The warranty will not be applicable under any of the following conditions: • Defects or malfunction that occur out of the warranty period (paragraph XII.C.). • Normal wear and tear. • Negligence or usage that does not comply with the specifications in the user manual. • The use of supplies, spare parts, or accessories other than those supplied by MORIA (for example: blades and tubing not supplied by MORIA). • Disassembly, modification, or intervention carried out on the devices by a person not authorized by MORIA. C. WARRANTY PERIOD • •

The warranty takes effect on the date the material is dispatched. The duration of the warranty is 12 months from the date of effect.

D. LIABILITY • •

The liability of MORIA is limited to the supply of the services mentioned in paragraph XII.A. MORIA will not be held responsible for any direct or indirect damage notably financial, suffered by the client owing to the interventions within the scope of this warranty. For any dispute concerning the interpretation or the execution of the present contract or the present general terms and conditions, the Commercial Court of Nanterre, France will have sole jurisdiction.

A. CONTROL UNIT (FRONT) Figure Description 1 Cover 2 Chamber holder 3 Pump indicator – green LED 4 Pump indicator – red LED 5 Low Vacuum LED indicator 6 Low Vacuum switch 7 Vacuum Level Indicator 8 “TEST” switch 9 Battery Level Indicators : Acceptable – green LED 10 Battery Level Indicators: Low – red LED 11 Main Power Supply Indicator – green LED 12 Manual mode indicator 13 Mode selection switch 14 Mode Display : automated 15 Mode Display and pressure display 16 Low pressure display – yellow LED 17 Correct pressure display – green LED 18 High pressure display – yellow LED 19 One Use-Plus blue connector 20 Speed 1/Speed 2 Switch (for M2, M2SU and One UsePlus) 21 M2 grey connector 22 Epi-K™ yellow connector 23 Turbine connector 24 Aspiration tubing connector B. CONTROL UNIT (BACK) Figure Description 1 Control knob to adjust gas pressure to the turbine 2 Quick Connector for Nitrogen/Air supply 3 Connector release 4 Residual Gas Drain Switch 5 MORIA reference and Serial Number 6 Volume of Epi-K™ Footpedal Steps 7 CE mark, manufacturer address 8 Footpedal Connector 9 Main OFF (0) /ON (1) Switch 10 Fuse Housing and 115V – 230V Selector 11 Main Power Supply Connector 12 Power supply informations 13 Pumps air release 14 Screws C. FOOTPEDAL Figure Description 1 Vacuum footpedal 2 Forward keratome pass or Turbine ON 3 Backward pass 4 IPX6 (serial number above 8000)

E. HOW TO SELECT THE OPERATING VOLTAGE (115V OR 230V POSITION) Figure Description 1 Switch OFF the control unit. 2 Gently open the door. 3-4 Remove the selector and select the right voltage 5 Reposition the selector and close the door F. CHANGING THE BATTERY Figure Description 1 Unscrew completely the 2 screws located at the back of the control unit 2 Slide the cover towards the front 3 Lift the cover from back to front in 2 steps (1 – 2) 4 Unplug the battery 5 Unscrew the 2 screws 6 Remove the metal piece (while keeping screws in place) 7 Lift the battery with the plastic strap 8 Replace with a new battery, reposition and screw the metal piece, plug the new battery, replace and screw the cover 9 Discard the battery in an appropriate collection bin. The used battery is classified as waste, which must be dealt with according to the specific regulations for collection, treatment, recycling and disposal set out in directive 2006/66/EC of 9 September 2006 relating to batteries and accumulators and waste batteries and accumulators. As such the battery must be disposed of at an appropriate collection point. G. CHANGING FUSES Figure Description 1 Switch OFF the control unit. 2 Gently open the door with screwdriver 3 Remove the cartridge 4 Change the 2 fuses 5 Replace the 2 fuses H. INSTALLING TUBING Figure Description 1 Place the chamber in position 2 Get the chamber down in the chamber maintener 3 Do not reverse chamber position of the aspiration tubing 4 If liquid appears in the chamber, replace it immediately 5 Visually check tubing integrity before and after set up

D. CONNECTING AND DISCONNECTING NITROGEN/ AIR HOSE (#19120) Figure Description 1 To connect : approach the hose… 2 … then screw it 3a To disconnect : first push the blue ring toward the unit… 3b … then pull the hose towards the back #65060/INTL-K-10.2020

MORIA

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SOMMAIRE I. AVERTISSEMENTS... 15 A. MAINTENANCE... 15 B. UTILISATION DE PRODUITS GÉNÉRIQUES OU RÉUTILISATION DE CONSOMMABLES À USAGE UNIQUE... 15 II.

DIRECTIVES ET DECLARATIONS DU FABRICANT : EMISSIONS ET IMMUNITES ELECTROMAGNETIQUES... 15

III. LISTE DES EQUIPEMENTS ET ACCESSOIRES... 15 A. LISTE DES EQUIPEMENTS... 15 B. LISTE DES ACCESSOIRES... 16

XIII. FIGURES... 26 A. CONSOLE (PANNEAU AVANT)... 26 B. CONSOLE (PANNEAU ARRIERE)... 26 C. PEDALE... 26 D. COMMENT CONNECTER ET DECONNECTER LA TUBULURE D’ALIMENTATION EN AZOTE/AIR (#19120)... 26 E. COMMENT SELECTIONNER LA TENSION D’UTILISATION (POSITION 115V OU 230V)... 26 F. COMMENT CHANGER LA BATTERIE... 26 G. COMMENT CHANGER LES FUSIBLES... 26 H. COMMENT INSTALLER LA TUBULURE D’ASPIRATION... 26

IV. SPECIFICATIONS TECHNIQUES... 19 V.

INFORMATIONS REGLEMENTAIRES... 19

VI. USAGE REVENDIQUÉ... 19 VII. INFORMATIONS RELATIVES AUX ETIQUETTES... 20 VIII. INSTALLATION ET CONNEXION... 20 A. RECOMMANDATIONS GENERALES D’INSTALLATION... 20 B. INSTALLATION ELECTRIQUE... 20 C. TEST DE LA BATTERIE... 21 D. CONNEXION DE LA TUBULURE D’ASPIRATION... 21 E. TEST DU VIDE... 21 F. FONCTION « VIDE FAIBLE »... 22 G. MODE MANUEL (CB, CBm, CBSU, ONE, ONE USE)... 22 1. BRANCHEMENT DE L’ALIMENTATION AZOTE/AIR... 22 2. DÉMONTAGE DE L’ALIMENTATION AZOTE/AIR... 23 H. MODE AUTOMATIQUE (M2, M2SU, ONE USE-PLUS, EPI-K™)... 23 IX. FONCTIONNEMENT DE LA PEDALE... 23 A. COMPATIBILITÉ PÉDALE-CONSOLE ... 23 B. COMPATIBILITÉ PÉDALE-PIÈCE À MAIN ... 24 C. FONCTIONNEMENT EN MODE MANUEL... 24 D. FONCTIONNEMENT EN MODE AUTOMATIQUE... 24 X. A. B. C. D.

DEPANNAGE... 24 PROBLEME ELECTRIQUE... 24 PERTE D’ASPIRATION... 24 VIDE RESIDUEL... 24 PROBLEME DE PRESSION DANS LA TURBINE (MODE MANUEL)... 25

XI. ENTRETIEN & MAINTENANCE... 25 A. COMMENT SELECTIONNER LA TENSION D’UTILISATION (POSITION 115V OU 230V)... 25 B. COMMENT INSTALLER UNE NOUVELLE BATTERIE... 25 C. COMMENT REMPLACER LES FUSIBLES... 26 XII. GARANTIE... 26 A. CHAMP D’APPLICATION DE LA GARANTIE... 26 B. CAS DE NON APPLICATION DE LA GARANTIE... 26 C. PERIODE DE GARANTIE... 26 D. RESPONSABILITES... 26

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SUMARIO I. DESCARGO DE RESPONSABILIDAD... 24 A. MANTENIMIENTO... 24 B. USO DE PRODUCTOS GENÉRICOS O REUTILIZACIÓN DE CONSUMIBLES DE UN SÓLO USO.24 II.

DIRECTRIZ Y DECLARACIÓN DEL FABRICANTE: EMISIONES E INMUNIDAD ELECTROMAGNÉTICAS... 24

III. LISTA DE EQUIPAMIENTO Y ACCESORIOS... 24 A. LISTA DE EQUIPAMIENTO... 24 B. LISTA DE ACCESORIOS... 24

XIII. ILUSTRACIONES... 33 A. UNIDAD DE CONTROL (FRONTAL)... 33 B. UNIDAD DE CONTROL (PARTE TRASERA)... 33 C. PEDAL... 33 D. CONEXIÓN Y DESCONEXIÓN DE LA MANGUERA DE NITRÓGENO / AIRE (#19120)... 33 E. CÓMO SELECCIONAR LA TENSIÓN DE FUNCIONAMIENTO (POSICIÓN 115V o 230V)... 33 F. CAMBIO DE BATERIA... 33 G. CAMBIO DE FUSIBLES... 33 H. INSTALACIÓN DEL TUBO... 33

IV. ESPECIFICACIONES TÉCNICAS... 25 V.

INFORMACIONES REGLAMENTARIAS... 26

VI. USO PREVISTO... 26 VII. INFORMACION DEL ETIQUETADO... 26 VIII. INSTALACIÓN Y CONEXIÓN... 27 A. RECOMENDACIONES PARA MONTAJE... 27 B. AJUSTE ELÉCTRICO... 27 C. TEST DE BATERÍA... 27 D. CONEXIÓN DEL TUBO DE ASPIRACIÓN... 27 E. TEST DE VACÍO... 28 F. FUNCIÓN DE “BAJO VACÍO”... 28 G. MODO MANUAL (CB, CBm, CBSU, ONE, ONE USE)... 29 1. CONEXIONES PNEUMÁTICA PARA FUNCIONAMIENTO CON TURBINA... 29 2. DESCONEXIÓN DEL GAS NITRÓGENO / AIRE MÉDICO... 29 H. MODO AUTOMATIZADO (M2, M2SU, ONE USE-PLUS, EPI-K™)... 30 IX. USO DEL PEDAL... 30 A. COMPATIBILIDAD PEDAL-CONSOLA... 30 B. COMPATIBILIDAD PEDAL-ELEMENTO MANUAL... 30 C. MODO MANUAL... 30 D. MODO AUTOMÁTICO... 31 X. A. B. C. D.

SOLUCIÓN DE PROBLEMAS... 31 FUENTE DE ALIMENTACIÓN... 31 PÉRDIDA DE VACÍO... 31 VACÍO RESIDUAL... 31 PRESIÓN DE LA TURBINA (MODO MANUAL)... 31

XI. CUIDADO Y MANTENIMIENTO... 31 A. CÓMO SELECCIONAR LA TENSIÓN DE FUNCIONAMIENTO (POSICIÓN 115V o 230V)... 32 B. INSTALAR UNA BATERÍA NUEVA... 32 C. REEMPLAZAR LOS FUSIBLES PRINCIPALES... 32 XII. GARANTÍA... 32 A. CAMPO DE APLICACIÓN DE LA GARANTÍA... 32 B. CASO DE NO APLICACIÓN DE LA GARANTÍA... 32 C. PERIODO DE GARANTÍA... 32 D. RESPONSABILIDADES... 32

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INDICE I. ESCLUSIONE DELLA RESPONSABILITA’... 35 A. MANUTENZIONE... 35 B. UTILIZZO DI PRODOTTI GENERICI O RIUTILIZZO DI MATERIALI DI CONSUMO MONOUSO... 35 II.

GUIDA E DICHIARAZIONE DEL PRODUTTORE: EMISSIONI ELETTROMAGNETICHE E IMMUNITÀ... 35

III. ELENCO APPARECCHIATURE ED ACCESSORI... 35 A. ELENCO APPARECCHIATURE... 35 B. ELENCO ACCESSORI... 35

XIII. IMMAGINI... 44 A. UNITÀ DI COMANDO (PANNELLO FRONTALE)... 44 B. UNITÀ DI COMANDO (PANNELLO POSTERIORE)... 44 C. PEDALE... 44 D. CONNESSIONE E DISCONNESSIONE TUBO AZOTO/ARIA (#19120)... 44 E. COME SCEGLIERE LA TENSIONE DI ESERCIZIO (POSIZIONE 115 V O 230 V)... 44 F. SOSTITUIRE LA BATTERIA... 44 G. SOSTITUZIONE FUSIBILI... 44 H. INSTALLAZIONE TUBI... 44

IV. SPECIFICHE TECNICHE... 36 V.

DATI REGOLAMENTARI... 37

VI. USO PREVISTO... 37 VII. ETICHETTE INFORMAZIONI... 37 VIII. INSTALLAZIONE E COLLEGAMENTO... 38 A. CONSIGLI PER L’INSTALLAZIONE... 38 B. COLLEGAMENTO ELETTRICO... 38 C. TEST DELLA BATTERIA... 38 D. COLLEGAMENTO DEL TUBO DI ASPIRAZIONE... 38 E. TEST DEL VUOTO... 39 F. FUNZIONE LOW VACUUM... 39 G. MODALITÀ MANUALE (CB, CBm, CBSU, ONE, ONE USE)... 40 1. COLLEGAMENTO TURBINA A GAS... 40 2. SCOLLEGARE GLI ELEMENTI DELLA BOMBOLA DI AZOTO... 40 H. MODALITÀ AUTOMATICA (M2, M2SU, ONE USE-PLUS, EPI-KTM)... 41 IX. UTILIZZO DEL PEDALE... 41 A. COMPATIBILITÀ PEDALE-CONSOLE... 41 B. COMPATIBILITÀ PEDALE-MANIPOLO... 41 C. MODALITÀ MANUALE... 41 D. MODALITÀ AUTOMATICA... 42 X. A. B. C. D.

RICERCA DEI GUASTI... 42 ALIMENTAZIONE ELETTRICA... 42 PERDITA DEL VUOTO... 42 VUOTO RESIDUO... 42 PRESSIONE DELLA TURBINE (MODALITÀ MANUALE)... 42

XI. MANUTENZIONE... 42 A. COME SCEGLIERE LA TENSIONE DI ESERCIZIO (POSIZIONE 115 V O 230 V)... 43 B. COME INSTALLARE UNA BATTERIA NUOVA... 43 C. COME SOSTITUIRE I FUSIBILI PRINCIPALI... 43 XII. GARANZIA... 43 A. CAMPO D’APPLICAZIONE DELLA GARANZIA... 43 B. CASI IN CUI NON VIENE APPLICATA LA GARANZIA... 43 C. PERIODO DI GARANZIA... 43 D. RESPONSABILITÀ... 43

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INHOUDSOPGAVE I. AANSPRAKELIJKHEIDS STELLING... 57 A. ONDERHOUD EN GARANTIE... 57 B. GEBRUIK VAN ALGEMENE PRODUCTEN OF HERGEBRUIK VAN DISPOSABLES... 57 II.

RICHTLIJN EN VERKLARING VAN DE FABRIKANT: ELEKTROMAGNETISCHE EMISSIES EN IMMUNITEIT... 57

III. ONDERDELEN EN ACCESSOIRELIJST... 57 A. ONDERDELEN OVERZICHT... 57 B. ACCESSOIRELIJST... 57

XIII. TEKENINGEN... 66 A. BEDIENINGSEENHEID (VOORZIJDE)... 66 B. BEDIENINGSEENHEID (ACHTERZIJDE)... 66 C. VOETPEDAAL... 66 D. AAN- EN AFSLUITEN STIKSTOF/ZUURSTOF SLANG (#19120)... 66 E. HOE DE WERKSPANNING SELECT (115V OF 230V POSITIE)... 66 F. VERVANGING VAN DE ACCU... 66 G. VERVANGEN ZEKERINGEN... 66 H. SLANG AANSLUITING... 66

IV. TECHNISCHE SPECIFICATIES... 58 V.

REGISTRATIE-INFORMATIE... 59

VI. BEOOGD GEBRUIK... 59 VII. ETIKET INFORMATIE... 59 VIII. INSTALLATIE EN AANSLUITING... 60 A. AANBEVELINGEN VOOR DE INSTALLATIE... 60 B. ELEKTRISCHE INSTELLING... 60 C. BATTERIJTEST... 60 D. AANSLUITEN VAN DE ASPIRATIE SLANG... 60 E. VACUUM TEST... 61 F. LAAG VACUÜM... 61 G. MANUELE MODUS (CB, CBm, CBSU, ONE, ONE USE)... 62 1. PNEUMATISCH TURBINE AANSLUITINGEN... 62 2. ONTMANTELING VAN DE STIKSTOF/ZUURSTOF AANVOER... 62 H. AUTOMATISCHE MODUS (M2, M2SU, ONE USE-PLUS, EPI-KTM)... 63 IX. GEBRUIK VAN DE VOETSCHAKELAAR... 63 A. COMPATIBILITEIT VAN DE VOETPEDAAL-CONSOLE... 63 B. COMPATIBILITEIT VAN DE VOETPEDAAL-HANDSTUK... 63 C. MANUELE MODUS... 63 D. AUTOMATISCHE MODUS... 64 X. A. B. C. D.

OPLOSSEN VAN PROBLEMEN... 64 STROOMTOEVOER... 64 VACUÜM VERLIES... 64 RESTVACUÜM... 64 TURBINEDRUK (MANUELE MODUS)... 64

XI. ZORG & ONDERHOUD... 64 A. HOE DE WERKSPANNING SELECT (115V OF 230V POSITIE)... 65 B. HOE EEN NIEUWE ACCU PLAATSEN... 65 C. HOE DE HOOFDZEKERINGEN VERVANGEN... 65 XII. GARANTIE... 65 A. TOEPASSINGSGEBIED VAN DE GARANTIE... 65 B. UITSLUITINGGEVALLEN VAN DE GARANTIE... 65 C. GARANTIEPERIODE... 65 D. AANSPRAKELIJKHEID/VERANTWOORDELIJKHEID... 65

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CONTEÚDOS I. TERMO DE RESPONSABILIDADE... 68 A. CUIDADOS E MANUTENÇÃO... 68 B. UTILIZAÇÃO DE PRODUTOS GENÉRICOS OU REUTILIZAÇÃO DE CONSUMÍVEIS DESCARTÁVEIS... 68 II.

GUIA E DECLARAÇÃO DO FABRICANTE: EMISSÕES E IMUNIDADE ELETROMAGNÉTICA.. 68

III. LISTA DE EQUIPAMENTO E ACESSÓRIOS... 68 A. LISTA DE EQUIPAMENTOS... 68 B. LISTA DOS ACESSÓRIOS... 68

XIII. DESENHOS... 77 A. UNIDADE DE CONTROLO (FRENTE)... 77 B. UNIDADE DE CONTROLO (TRASEIRA)... 77 C. PEDAL... 77 D. CONECTAR, DESCONECTAR A MANGUEIRA DE NITROGÉNIO/AR (#19120)... 77 E. COMO SELECIONAR A TENSÃO DE OPERAÇÃO (115 V OU 230 V POSITION)... 77 F. TROCAR A BATERIA... 77 G. MUDAR OS FUSÍVEIS... 77 H. INSTALAÇÃO DA TUBAGEM DE ASPIRAÇÃO... 77

IV. ESPECIFICAÇÕES TÉCNICAS... 69 V.

INFORMAÇÕES DE REGULAÇÃO... 70

VI. USO A QUE SE DESTINA... 70 VII. INFORMAÇÕES DE ROTULAGEM... 70 VIII. INSTALAÇÃO E LIGAÇÃO... 71 A. RECOMENDAÇÕES PARAM A INSTALAÇÃO... 71 B. CONFIGURAÇÃO ELÉTRICA... 71 C. TESTE DA BATERIA... 71 D. VÁCUO... 71 E. TESTE DE VÁCUO... 72 F. VÁCUO BAIXO... 72 G. MODO MANUAL (CB, CBm, CBSU, ONE, ONE USE)... 73 1. LIGAÇÕES DA TURBINA PNEUMÁTICA... 73 2. DESMONTAGEM DO FORNECIMENTO DE NITROGÉNIO OU AR SECO... 73 H. MODO AUTOMÁTICO (M2, M2SU, ONE USE-PLUS, EPI-K™)... 74 IX. USO DO PEDAL... 74 A. COMPATIBILIDADE CONSOLA-PEDAL... 74 B. COMPATIBILIDADE DO PEDAL-PEÇA DE MÃO... 74 C. MODO MANUAL... 74 D. MODO AUTOMATIZADO... 75 X. A. B. C. D.

RESOLUÇÃO DE PROBLEMAS... 75 ALIMENTAÇÃO ELÉTRICA... 75 PERDAS DE VÁCUO... 75 VÁCUO RESIDUAL... 75 PRESSÃO NA TURBINA (MODO MANUAL)... 75

XI. CUIDADO E MANUTENÇÃO... 75 A. COMO SELECIONAR A TENSÃO DE OPERAÇÃO (115 V OU 230 V POSITION)... 76 B. COMO INSTALAR UMA BATERIA NOVA... 76 C. COMO SUBSTITUIR OS FUSÍVEIS ELÉCTRICOS... 76 XII. GARANTIA... 76 A. CAMPO DE APLICAÇÃO DA GARANTIA... 76 B. NÃO APLICAÇÃO DA GARANTIA... 76 C. PERÍODO DE GARANTIA... 76 D. RESPONSABILIDADES... 76

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