Solos 42-0001417 User manual

SOLOS
Automatic Lens Analyzer
Instruction For Use
Cod. 42-0001417 SOLOS
Rev. 05 – 2022

en Instruction manuals in official languages
of the Member States of the European
Union are available on the follow-
ing website using password "harlem":
https://www.visiaimaging.com/manuals.php
sk Inštrukˇcné manuály v úradných
jazykoch ˇclenských štátov Európskej
únie sú k dispozícii na tejto we-
bovej stránke pomocou hesla "harlem":
https://www.visiaimaging.com/manuals.php
fr Les manuels d’instructions dans les
langues officielles des États mem-
bres de l’Union européenne sont
disponibles sur le site web suivant en
utilisant un mot de passe "harlem":
https://www.visiaimaging.com/manuals.php
de Bedienungsanleitungen in den
Amtssprachen der Mitgliedstaaten
der Europäischen Union sind auf
der folgenden Website verfüg-
bar Passwort verwenden "harlem":
https://www.visiaimaging.com/manuals.php
cs Návody k použití v úˇredních jazy-
cích ˇclenských stát˚u Evropské unie
jsou k dispozici na následující we-
bové stránce pomocí hesla "harlem":
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sl Navodila za uporabo v uradnih
jezikih držav ˇclanic Evropske unije
so na voljo na naslednjem splet-
nem mestu z uporabo gesla "harlem":
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es Los manuales de instrucciones en
las lenguas oficiales de los Estado
miembros de la Unión Europea es-
tán disponibles en el siguiente sitio
web usando contraseña "harlem":
https://www.visiaimaging.com/manuals.php
pl Instrukcje obsługi w j˛ezykach urz˛edowych
pa´nstw członkowskich Unii Europejskiej
s ˛a dost˛epne na nast ˛epuj ˛acej stronie
internetowej u˙ zywaj ˛ac hasła "harlem":
https://www.visiaimaging.com/manuals.php
it I manuali di istruzioni nelle lingue uf-
ficiali degli Stati membri dell’Unione
Europea sono disponibili sul seguente
sito web utilizzando la password "harlem":
https://www.visiaimaging.com/manuals.php
hu Az Európai Unió tagállamainak hi-
vatalos nyelvein található használati
utasítások a következ˝o weboldalon
érhet˝ok el jelszó használatával "harlem":
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sv Instruktionsmanualer på officiella språk
för EU:s medlemsstater finns på följande
webbplats använder lösenord "harlem":
https://www.visiaimaging.com/manuals.php
lt Instrukciju rokasgr¯ amatas Eiropas
Savien¯ ıbas dal¯ ıbvalstu ofici¯ alaj¯ as
valod¯ as ir pieejamas šaj¯ a t¯ ımekl
,a
vietn¯ e izmantojot paroli "harlem":
https://www.visiaimaging.com/manuals.php

da Brugsanvisninger på officielle sprog i
Den Europæiske Unions medlemsstater
er tilgængelige på følgende websted
ved hjælp af adgangskode "harlem":
https://www.visiaimaging.com/manuals.php
pt Os manuais de instruções nos id-
iomas oficiais dos estados-membros
da União Europeia estão disponíveis
no seguinte site usando senha "harlem":
https://www.visiaimaging.com/manuals.php
ro Manuale de instruct
,iuni în limbile ofi-
ciale ale statelor membre ale Uniunii
Europene sunt disponibile pe urm˘a-
torul site web folosind parola "harlem":
https://www.visiaimaging.com/manuals.php
nl Instructiehandleidingen in de officiële
talen van de lidstaten van de Europese
Unie zijn beschikbaar op de volgende
website wachtwoord gebruiken "harlem":
https://www.visiaimaging.com/manuals.php
fi Euroopan unionin jäsenvaltioiden vi-
rallisilla kielillä olevat käyttöohjeet
ovat saatavilla seuraavalla verkko-
sivustolla salasanan avulla "harlem":
https://www.visiaimaging.com/manuals.php
no Instruksjonshåndbøker på offisielle språk i
EUs land er tilgjengelige på følgende
nettsted bruker passord "harlem" :
https://www.visiaimaging.com/manuals.php
gr Εγχειρίδια οδηγιών στις επίσημες γλώσσες
των κρατών μελών της Ευρωπαϊκής ΄Ενωσης
είναι διαθέσιμα στον ακόλουθο ιστότοπο
με χρήση κωδικού πρόσβασης "harlem" :
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Manufacturer Distributor
VISIA imaging S.r.l. Topcon Europe Medical B.V.
Via Martiri della Libertà 95/e Essebaan 11
52027 San Giovanni Valdarno (AR) 2908 LJ Capelle a/d IJssel
Italy The Netherlands
www.topconhealthcare.eu
[email protected]
3

1INTRODUCTION
Thank you for purchasing SOLOS. To ensure safe and effective use of the instrument, care-
fully read "DISPLAY AND SYMBOLS FOR SAFE USE" and "GENERAL SAFETY INFOR-
MATION" and then use the instrument as instructed. Keep the INSTRUCTION MANUAL
at hand for future reference.
1.1 INTENDED USE
SOLOS is an instrument intended for use by an optometric/ ophthalmic professional to
monitor the visual defects through the measurements of spectacles and single lens optical
properties.
1.2 INTENDED USERS
The device must be used by qualified personnel: eye specialists, ophthalmologists, opti-
cians and optometrists.
1.3 PLACE OF USE
Health centers, optician shops, eye hospitals and other eye-care related facilities.
1.4 SERIOUS INCIDENT REPORTING
In case any serious incident occurs in relation to the device, please report it to the manu-
facturer. If you are in the EU area, please report the incident to the manufacturer, and the
competent authority of the Member State.

2PRECAUTIONS AND SAFETY
To encourage safe and proper use and to prevent danger to the operator and others or po-
tential damage to property, important cautionary messages are placed on the instrument
body and inserted in the INSTRUCTION MANUAL. We suggest that everyone using the
instrument understand the meaning of the following displays, icons and text before read-
ing the "SAFETY CAUTIONS" and observe all listed instructions.
2.1 DISPLAY AND SYMBOLS FOR SAFE USE
Table 1: Symbol
Symbols Standard
Reference Description
Class I Product compliant with Regulation (EU)
2017/745
IEC 60417-5032 Alternate current
ISO 7010-M002 Read the instructions for use before usage
ISO 7010-W001 Warning Sign
Symbol used to alert users to potential hazards
ISO 7000-3082 Manufacturer
ISO 7000-2497 Date of Manufacture
ISO 7000-2493 Catalogue number
Group 0IEC 62471 Product classifiable as Group 0(risk exempt) in
accordance with IEC 62471
5

Table 1: Symbols (continue)
Symbols Standard
Reference Description
ISO 15223-1Medical device
ISO 7000-0632
Temperature limitation Indicates the temperature
limits to which the medical device can be safely
exposed
ISO 7000-0224
Humidity limitation
Indicates the range of humidity to which the medical
device can be safely exposed
ISO 7000-2621
Atmospheric pressure limitation
Indicates the range of atmospheric pressure to which
the medical device can be safely exposed
ISO 7000-0626
Keep dry
Indicates a medical device that needs to be protected
from moisture
ISO 7000-0621 Fragile, Handle with care
ISO 7000 -
0623
This way up
Indicates correct upright position of the transport
package
Wifi
ISO 7000-2498 Serial Number
IEC 60417-5016 Fuses

Table 1: Symbols (continue)
Symbols Standard
Reference Description
This symbol is solely applicable in EU countries. In order to avoid any negative
consequences on the environment and possibly also on human health, this
instrument must be disposed of according to the current provisions (i) in EU
countries in compliance with the WEEE provision (Directive for waste consisting
of electrical and electronic devices), or (ii) for all the other countries, in
compliance with the local provisions and laws on recycling.
2.2 SAFETY GUIDELINES
•SOLOS device can only be used for the design purposes described in this manual.
•The device must be used in the environmental conditions as specified in this docu-
ment.
•The least favorable environment is defined as the maximum values of temperature
for the unit to be operating in, while the unit is consuming the maximum current.
The environmental value is stated as +40 °C.
•The device must be connected to an appropriate power source, otherwise its perfor-
mance may be reduced.
•Position the unit so that it is not difficult to disconnect the plug for connection
to the main supply.
•Keep this manual at hand and close to the device at all times.
•Turn off the device if it is not going to be used for a long period of time.
•Only use original SOLOS Series accessories and spare parts.
•Do not use the device in the vicinity of highly flammable materials or in areas with
an explosion risk.
•Unauthorized software installation in the device is not permitted.
2.3 ELECTRICAL SAFETY
•To avoid the risk of electric shocks, this equipment must only be connected to
supply mains with protective ground.
•The device has an onboard power supply unit installed. For connection to the mains,
use only the manufacturer-approved cables provided with the device.
•Before performing maintenance on the device, turn it off and disconnect the power
cable.
7

•To avoid fire and electric shock, install the instrument in a place free of water
and other liquids.
•To avoid fire and electric shock, do not put cups or other containers with liquids
near the instrument.
•To avoid electric shock, do not insert metal objects into any openings, etc.
•To avoid fire in the event of an instrument malfunction, immediately turn off the
power switch and unplug the cable if you see smoke coming from the instrument
or if you detect other problems. Don’t install the instrument where it is difficult to
disconnect the power plug from the outlet. Ask your dealer for repairs.
•Modification of this instrument is not permitted.
•To avoid electric shock and fire, do not disassemble, modify or repair the equip-
ment. Ask your dealer for repairs.
•Electric shock may cause bums or a possible fire. Turn the power switch OFF
and unplug the power cord before replacing the fuses. Replace only with fuses of
the correct rating.
•To avoid injury caused by electric shock, do not open the cover. Ask your dealer
for service.
•To avoid fire and electric shock in case of leakage, be sure to use a grounded
outlet. Do not connect to outlets that are not grounded.
•To avoid electric shock, be sure to remove the power cable from the instrument
body before removing the fuse cover for replacement. Also, do not connect the
power cable to the instrument body with the fuse cover left unfixed.
•To avoid fire in the event of an instrument malfunction, use a properly rated fuse.
2.4 LED EMISSION SAFETY
SOLOS has a series of LEDs of various types and powers installed.
The device is classified as group 0(risk exempt) according to IEC 62471:2006.
2.5 INTERACTIONS WITH EXTERNAL DEVICES
SOLOS complies with the CE marking requirements.

•Before connecting an external device, such as a computer, printer, monitor, key-
board, mouse or other devices, make sure that they comply with the EN 60950-1
standard and have the CE marking.
•Connecting electrical equipment to the device actually results in the creation of
medical equipment, and may jeopardize safety.
•When SOLOS is installed in rooms for medical use, the PC and the connected printer
must be powered using an IEC 60601-1compliant insulating transformer.
•If SOLOS is installed in rooms for medical use without a computer, it is not necessary
to use an insulating transformer.
•Do not use mobile phones or other devices not compliant with the requirements of
class B EMC in the vicinity of SOLOS.
•Every external device that has to be connected to SOLOS must have a connection
cable (USB or LAN) with a maximum length of 3 m.
The purpose of SOLOS connection to an IT network is data export and remote technical
assistance.
The SOLOS USB port must be connected to printer with USB or LAN interface. Ask
Topcon technical assistance for printer driver installation.
The SOLOS can be connected to a Local Area Network (LAN) through the LAN connector.
The network must have Ethernet protocol (IEEE 802.3). Ask Topcon technical assistance
and the system administrator for SOLOS and network settings.
Connection of SOLOS to a computer network that includes other equipment could result
in previously unidentified RISKS; identify, analyze, and control such RISKS (refer to IEC
60601-1:2005).
Subsequent changes to a computer network could introduce new RISKS and require new
analysis.
Changes to the computer network include:
•changes in computer or data network configuration;
•connection of additional items to computer network;
•disconnecting items from computer network;
•update of equipment connected to computer network;
•upgrade of equipment connected to computer network.
The term computer network used here corresponds to the term network/data coupling in
IEC 60601-1:2005.
9

2.6 TRANSPORT AND PACKAGING
•The device must be transported and stored in its original packaging.
•For the storage and transport conditions please refer to the specifications contained
in this document.
•Keep the original packaging with care in case the device needs to be transported
again.
2.7 CLEANING
•Regularly clean the device removing dust using a soft cloth. In the case of more
persistent surface dirt, use a soft cloth soaked with water or alcohol (70% max).
•Be careful not to wet the device and clean it only as indicated to prevent damag-
ing it. Never use solvents or other abrasive agents.