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V I T R O N

2020
Portable
VITRECTOMY UNIT

BEDIENUNGS-
ANWEISUNG
VERSION 1
SEITE 1 - 17

OPERATING
INSTRUCTIONS
VERSION 1
PAGE 18 - 34
Vitron 2020

All rights reserved. This manual contains information protected by copyright.


Without Geuder AG’s express written permission, neither the manual itself nor
excerpts thereof may be duplicated in any manner whatsoever.

The manufacture reserves the right to make changes to this manual without prior
notification. Due to continuous development, the technical data and illustrations
in the manual may not correspond entirely with the current state of the product.

GEUDER AG, the manufacturer of the Vitron 2020, is not liable for any damages
to the device or consequential damages resulting from incorrect use and nonob-
servance of the manual.

Any servicing of the device or repairs to it may only be conducted by the manu-
facturer or by persons authorized by the manufacturer for this purpose. Unsu-
pervised opening of the device and unauthorized services and repairs to the de-
vice relieve GEUDER AG of any liability for the safe operation and warranty of
the device.

GEUDER AG
Manufacturer of Ophthalmic Surgical Instruments and Systems

Hertzstraße 4
D-69126 Heidelberg, Germany
Phone: +49 (0)6221 / 306-6, Fax: +49 (0)6221 / 303-122
Email info@geuder.de, Web: http://www.geuder.de

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Handbook and Operating Instructions, version 1.0
Vitron 2020

INDEX

1 Preliminary Remarks....................................................................................................................... 20
2 Introduction...................................................................................................................................... 21
3 Safety and Warning notices ............................................................................................................ 22
3.1 General Remarks................................................................................................................... 22
4 Device Description .......................................................................................................................... 23
4.1 Front panel and footswitch..................................................................................................... 23
4.2 Back panel ............................................................................................................................. 24
5 Setting Up the Device ..................................................................................................................... 25
6 Operating the device ....................................................................................................................... 26
7 Cleaning and sterilisation ................................................................................................................ 27
8 Exchanging the electronic fuses ..................................................................................................... 28
9 Accessories ..................................................................................................................................... 29
10 Pollution Control .............................................................................................................................. 30
11 Technical Safety Inspections .......................................................................................................... 31
12 Repair / Service............................................................................................................................... 32
13 Symbols/Icons/terms/Abbreviations ................................................................................................ 33
13.1 Symbols and Icons................................................................................................................. 33
14 Technical Data ................................................................................................................................ 34

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1 PRELIMINARY REMARKS
This manual is meant to help you use Vitron 2020 in the most optimal manner. It serves as an intro-
duction to the device and its functions.
Please read this manual carefully before operating the system.
Please take note of all warnings, precautionary measures and helpful hints.

Warnings are meant to protect humans against harm.

Precautionary measures are meant to protect the system


against damage.

Helpful hints provide useful information for the correct operation


of the device.

The annex contains descriptions of all symbols depicted in this manual and on the device.
Should you have any further questions or require any further information, please feel free to contact
your dealer or Geuder AG’s sales department:

GEUDER AG
Hertzstraße 4
D-69126 Heidelberg, Germany
Phone: +49 (0)6221 / 306-6, Fax: +49 (0)6221 / 303-122
Email info@geuder.de, Web: http://www.geuder.de

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2 INTRODUCTION
The Vitron 2020 is an ophthalmic surgical device for performing vitrectomies in the anterior segment
of the eye.

During a vitrectomy, vitreous body is removed from the eye. The vitreous tissue is first cut with a
pneumatic vitrector handpiece and then aspirated manually with a syringe. The cutting frequency can
be preset on the front panel at 1 cut/min. and from 100 to 800 cuts/min. at regular intervals of 100.
Please make note that the desired cutting frequency has only been attained if the corresponding LED
light is glowing. This may require pushing the soft touch button several times. The cutting can then be
activated via the footswitch.

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3 SAFETY AND WARNING NOTICES


Before operating on a patient’s eye with the Vitron 2020 for the very first time, it is necessary to
inform oneself about its set-up, how it works, how it is used and what kinds of results it offers.
We recommend operating on the human eye only after having practiced all necessary steps.
Only then can a safe application of the device and a trouble-free procedure be assured.

3.1 General Remarks


The Viron 2020 may only be operated by trained personnel who have been
instructed in the proper operation of the device.
In the treatment of any device accessories which come in contact with
patients, protective measures must be met to minimize the transfer of germs.
The Vitron 2020 must not be operated in areas prone to explosion.
The Vitron 2020 may only be used in rooms used for medical purposes.
Only GEUDER accessories may be used with the Vitron 2020. Other
accessories may lead to system malfunctions. Sterile accessories are meant
for single use. They are not to be resterilized.

Please refer to the additional safety and warning notices on the documentation accompanying the
individual handpieces.

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4 DEVICE DESCRIPTION

4.1 Front panel and footswitch

Two soft touch buttons and the connector for the vitrectomy handpiece are located on the front panel
of the Vitron 2020.

5 3

(1) Connector for the pneumatic vitrectomy handpiece


(2) Button for decreasing the cutting frequency
(3) Button for increasing the cutting frequency
(4) LED lights indicating the preset cutting frequency
(5) Footswitch

The footswitch serves to activate the vitrectomy cutter. It is an on/off switch and does
not facilitate linear control of the cutting frequency.

Pushing the soft touch buttons with sharp instruments may damage them and/or cause
the Vitron 2020 to malfunction.

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4.2 Back panel

(6) Main cable socket


(7) Footswitch connection point
(8) Power switch
(9) Micro-fuse drawer

8
6

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5 SETTING UP THE DEVICE

Place the Vitron 2020 on a suitable and stable surface.


Ensure that the power switch (8) located on the back panel is in the off position.
Connect the main cable to socket (6) located on the back panel.
Connect the main cable to the power supply.
Connect the footswitch line to the connection point (7) located on the back panel.

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6 OPERATING THE DEVICE

Check if the Vitron 2020 has been set up as described in section 5.


After having checked the set-up, switch the Vitron 2020 on by flipping the power switch (8) lo-
cated on the back panel to the on position.
Place the infusion tubing (10) on the aspirating cannula (11) of the vitrector.
Connect the blue luer-lock of the vitrector’s pneumatic tubing (12) to the connector (1) located on
the front panel.
Connect the aspiration tubing (13) of the vitrector to the tubing (15) of the aspiration syringe.
Connect the irrigation tubing (14) of the vitrector to the tubing of the infusion bottle.
Use the soft touch buttons (2) or (3) to select the appropriate cutting frequency. The cutting
frequency is indicated by the LED lights (4) located on the front panel.

10 11
13

12

14

15

To check the cutting frequency, activate the vitrector.

All connections between the Vitron 2020 and its pneumatic accessories can be made
in a non-sterile environment.

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7 CLEANING AND STERILISATION


The Vitron 2020 and its footswitch can be cleaned with standard disinfectants and a mildly damp cloth.
Avoid using strong, abrasive solvents and ensure that liquids do not penetrate the device and the foot-
switch!

All sterilizable device accessories must be sterilized before being used in an opera-
tion.
The device must be switched off before being cleaned. This especially applies if
flammable cleaning agents are used. Do not clean the device while it is on.
Do not directly apply cleaning agents to the Vitron 2020 or to its footswitch. Direct
exposure to liquid could cause them to malfunction.
Do not clean the Vitron 2020 with an extremely damp cloth. Ensure that cleaning
agents do not penetrate the device.
Do not use gasoline, diluents and similar substances or cloth which has been
treated chemically.
Avoid scratching the soft touch buttons when cleaning the Vitron 2020.
Should the Vitron 2020 and its footswitch have been cleaned and disinfected with
flammable liquids, then they must be left out to air dry for at least one hour before
being operated.
The Vitron 2020 and its footswitch must not be sterilized. They are not autoclav-
able.
When cleaning the Vitron 2020, ensure that the footswitch line is still connected to
the device. This will help prevent liquid and other contaminants such as dirt and
dust from entering the device at the connection point.

Sterile accessories are meant for single use only. Resterilization is not allowed. For
exact cleaning and sterilization instructions for accessories, please refer to the docu-
mentation accompanying them. These instructions must be strictly adhered to.

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8 EXCHANGING THE ELECTRONIC FUSES


Electrical fuses must be exchanged as follows:
Switch the device of by flipping the main power switch located on the back panel to the off
position.
Pull the main cable out of its socket.
Open the drawer located under the main cable’s socket.
Remove the defective fuse and replace it with a new one.
Close the drawer and plug in the main cable.
The device can now be switched on again.

Only fuses of the type:

T 2,0 A may be used.

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9 ACCESSORIES
G-23006 VITRON 2020 FOOTSWITCH

G-28169 VITRECTOR Vitron 2020


- Pneumatic vitrector, 20 PSI, 20G / 0.9mm, limited reusability
- Infusion tubing
- VACUUM SYRINGE
Spring-loaded syringe for manually controlled tissue aspiration

TRANSPORT CASE
Robust case for safe transportation of items

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10 POLLUTION CONTROL
The disposal of Vitron 2020 and its accessories must be in accordance with local guidelines.

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11 TECHNICAL SAFETY INSPECTIONS


In order to ensure a safe and correct running of the Vitron 2020, it must un-
dergo a yearly technical safety inspection in accordance with the requirements
of MPBetreibV §6.
Only trained personnel may carry out a technical safety inspection.
The results of the technical safety inspection must be documented in the medi-
cal device logbook.

Technical Safety Inspections include:


Cleaning the device
A visual inspection for sound condition of the device and its accessories
An inspection of the electronics
An inspection of all the connections and sockets
Testing of the functions
A safety test in accordance with VDE 0751

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12 REPAIR / SERVICE
If you send the Vitron 2020 to GEUDER AG for the technical safety inspection or for repair, please
repackage the device in its original packaging. This helps ensure that the Vitron 2020 is not damaged
during shipment.

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13 SYMBOLS/ICONS/TERMS/ABBREVIATIONS

13.1 Symbols and Icons

Connection
Electronic fuse
Pneumatic Cutter

Attention,
Connection
general hazard, see instruc-
Footswitch
tions

Warning Connection
Danger for people for a Type BF device

Note Attention
Useful additional informa- Hazard for the device or for acces-
tion sories connected to it

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14 TECHNICAL DATA
The technical data applies to the basic device and to all versions presently available.

General Details
Name of device Vitron 2020
Electrical protection class Protection class I
Housing protection class IP20
Dimensions 160 x 260 x 240 mm
Weight 5.9 kg, without accessories

Surrounding conditions
Operating conditions Air pressure 800 … 1100 hPa
Rel. Air humidity 10 … 90 %, without condensate
Operating temp. +10 ... + 40°C
Storage and transport conditions Air pressure 800 … 1100 hPa
Rel. Air humidity 10 … 90 %, without condensate
Storing temperature -10 ... + 40°C

Power supply
Voltage 115…230 VAC
Power frequency 50 … 60 Hz
Power consumption ca. 70 W
Fuses 2 x T 2,0 A

Vitrectomy
Classification application part Type BF

Functional principle Pneumatic

Cutting rate 1… 800 / min, adjustable

Nominal pressure (pneumatic) 20 psi

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