CSO Z800 User manual

COSTRUZIONE STRUMENTI OFTALMICI
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EN
COSTRUZIONE STRUMENTI OFTALMICI
phone: [phone] | fax: [phone]
[email protected] | www.csoitalia.it
Z800 / F900 / A900
INSTRUCTIONS FOR USE
APPLANATION TONOMETER

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1INTRODUCTION......................................................................................... 3
1.1 SYMBOLS .......................................................................................................... 3
1.1.1 Device symbols ..................................................................................................... 4
1.2 GENERAL WARNINGS ........................................................................................... 4
1.3 NORMATIVE REFERENCES ..................................................................................... 5
1.3.1Community directives ........................................................................................... 5
1.3.2 Technical standards.............................................................................................. 5
1.3.3 Quality management systems standards ............................................................. 5
1.4 WARRANTY ....................................................................................................... 6
1.5 MANUFACTURER IDENTIFICATION ........................................................................... 7
2SAFETY....................................................................................................... 8
2.1 SAFETY WARNINGS .............................................................................................. 8
2.2 DEVICE IDENTIFICATION ...................................................................................... 11
2.2.1 Registration data in the Medical Devices List ..................................................... 11
2.2.2 Device data plate................................................................................................ 11
2.3 INTENDED USE.................................................................................................. 12
2.4 MEDICAL DEVICES CLASSIFICATION ........................................................................ 13
2.5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION ......................................................... 14
2.6 ENVIRONMENTAL CONDITIONS ............................................................................. 14
2.7 DISPOSAL AT THE END THE USEFUL LIFE................................................................... 15
3DEVICE DESCRIPTION .............................................................................. 17
3.1 PROVISION DESCRIPTION..................................................................................... 17
3.1.1 Tonometer Z800 ................................................................................................. 20
3.1.2 Tonometer A900................................................................................................. 21
3.1.3 Tonometer F900 ................................................................................................. 22
3.2 TECHNICAL DATA .............................................................................................. 23
4DEVICE USE ............................................................................................. 24
4.1 HOW TO INSTALL THE TONOMETER Z800 ON THE SLIT LAMP .......................................24
4.2 HOW TO INSTALL THE TONOMETER A900 ON THE SLIT LAMP....................................... 25
4.3 HOW TO INSTALL THE TONOMETER F900 ON THE SLIT LAMP ....................................... 27
4.4 HOW TO PREPARE THE SLIT LAMP (Z800)............................................................... 28
4.5 HOW TO PREPARE THE SLIT LAMP (A900) .............................................................. 28
4.6 HOW TO PREPARE THE SLIT LAMP (F900)............................................................... 29
4.7 HOW TO PLACE THE MEASURING PRISM.................................................................. 29
4.7.1 How to place the reusable measuring prism ...................................................... 31
4.7.2 How to place the disposable measuring prism ................................................... 32
4.8 HOW TO PREPARE THE PATIENT ............................................................................ 33
4.9 HOW TO MEASURE THE INTRAOCULAR PRESSURE ......................................................34
4.10 HOW TO MEASURE THE INTRAOCULAR PRESSURE IN ASTIGMATIC PATIENTS......................35
4.11 CORRECTING THE WRONG ACQUISITIONS ................................................................ 36
4.12 HOW TO READ THE MEASURING SCALE ................................................................... 40

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4.13 HOW TO REMOVE THE MEASURING PRISM .............................................................. 41
4.14 HOW TO REMOVE THE TONOMETER Z800 FROM THE SLIT LAMP .................................. 42
4.15 HOW TO REMOVE THE TONOMETER A900 FROM THE SLIT LAMP ................................. 42
4.16 HOW TO REMOVE THE TONOMETER F900 FROM THE SLIT LAMP .................................. 42
5ORDINARY MAINTENANCE ......................................................................43
5.1 SAFETY WARNINGS ........................................................................................... 43
5.2 DEVICE CLEANING ............................................................................................. 44
5.3 MEASURING PRISM CLEANING ............................................................................. 45
5.3.1 Measuring prism disinfection ............................................................................. 46
5.4 TONOMETER FUNCTIONING CHECK ....................................................................... 49
5.4.1 Functioning check with measuring knob on 0..................................................... 50
5.4.2 Functioning check with measuring knob on 2..................................................... 52
5.4.3 Functioning check with measuring knob on 6..................................................... 54
5.5 SPARE PARTS AND ACCESSORIES LIST ..................................................................... 56
5.6 TROUBLESHOOTING .......................................................................................... 58

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1INTRODUCTION
The device is the result of a long research period, conducted by
experts to give the product technical innovation, quality and design.
The device can be easily used in ophthalmology to measure the intra-
ocular eye pressure.
1.1 SYMBOLS
Within the instructions for use, on the package or on the device, there
can be the following symbols:
Symbol
Meaning
Caution
Read the instructions for use
General mandatory action sign
Note. Useful information for the user
General prohibition sign
Manufacturer
CE Marking (Directive 93/42/EEC) Identification number of the
notified body (IMQ)

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1.1.1 DEVICE SYMBOLS
Symbol
Meaning
Type B applied part
Class Im equipment
1.2 GENERAL WARNINGS
THIS INSTRUCTIONS FOR USE IS REFERRED TO THE DEVICES
Z800, F900 AND A900.
THE DEVICE Z800 IS AN ACCESSORY COMPATIBLE WITH THE
SLIT LAMP SL9800.
THE DEVICES A900 AND F900 ARE ACCESSORIES COMPATIBLE
WITH THE SLIT LAMP SL9900.
Within the instructions for use, the devices are identified by Z800,
F900 or A900.
When not specified, the indications are applicable to all the devices.
THE ORIGINAL TEXT IS IN ITALIAN.
Before using the device or if you don't use it since a long time, read
these instructions carefully. Read the instructions given in the
instructions manual and reported on the device.
Keep this manual close by for future consultation. If you should
decide to sell this appliance to other people, remember to also
include these instructions, complete and readable

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Keep the original box and packaging, as the free-of-charge service
does not cover any damage resulting from inadequate packaging of
the product when this is sent back to an Authorized Service Center.
Before using the device check that there is no sign of damages due to
transport or an incorrect storage, that c
ould compromise the correct
functioning of the device.
It is forbidden to reproduce, totally or partially, texts or images
contained in these instructions for use without the written
authorization of the Manufacturer.
The Manufacturer reserves
himself the right to modify the contents
of the instructions for use, without notice.
1.3 NORMATIVE REFERENCES
1.3.1 COMMUNITY DIRECTIVES
- Directive 93/42/EEC and subsequent modifications and
integrations concerning medical devices
- Directive 2008/98/EC on waste
1.3.2 TECHNICAL STANDARDS
- IEC 60601-1: 2005 + A1:2012 - Medical electrical equipment - Part
1: General requirements for basic safety and essential
performance.
- UNI EN ISO 15004-1:2009 - Ophthalmic Instruments. Fundamental
requirements and test methods - Part 1: General requirements
applicable to all ophthalmic instruments.
- UNI CEI EN ISO 14971:2012 - Medical devices. Application of risk
management to medical devices.
- UNI EN ISO 8612:2009 “Ophthalmic instruments - Tonometers".
1.3.3 QUALITY MANAGEMENT SYSTEMS STANDARDS
- UNI CEI EN ISO 13845:2016 - Medical devices. Quality management
systems - Requirements for regulatory purposes

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1.4 WARRANTY
The Manufacturer is responsible for the device conformity to the
Community directive 93/42/EEC as amended by the 2007/47/EC for:
- features
- safety and reliability
- CE marking
The Manufacturer refuses any responsibility for:
- installation and activation not activated in conformity to the
indications and the precautions reported in the instructions for use
- use not in compliance with the instructions for use and precautions
reported in the instructions for use
- use of accessories or spare parts not provided or suggested by the
Manufacturer
- repairs and safety controls not effectuated by expert, qualified,
trained and personnel authorized by the Manufacturer
- electrical system of the space where the device is installed not in
compliance with the technical standards, the laws and regulations
in effect in the country of installation of the device
- direct or indirect consequences or damages to objects or persons,
originating from the improper use of the device or erroneous
clinical analysis originating from its use
The Manufacturer guarantees the device for 24 months after invoicing
The Warranty includes the substitution, at the Manufacturer's or an
Authorized Service Center, of components and materials and the
relative labor. The shipping and transport fees are to be paid by the
client.
The warranty does not cover:
- reparations of faults originating from natural disasters, mechanical
shocks (fall, hit, etc), negligence, improper use, maintenance or
reparations carried out with non-original materials
- any other improper use or not intended by the Manufacturer
- damages caused by service lack or inefficiency, originating by
causes or circumstances out of the Manufacturers control

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- the parts subject to usage and/or deterioration originating from
the normal use and those that might be broken because of an
improper use or maintenance carried out by personnel non-
authorized by the Manufacturer.
To ask maintenance interventions or to have technical information
about the device, address to an Authorized Service Center or directly
to the device Manufacturer.
The client will not be refunded for damages originating from the
device halt.
1.5 MANUFACTURER IDENTIFICATION
CSO S.r.l.
Costruzione Strumenti Oftalmici
Via degli Stagnacci, 12/E
50018 - Scandicci (FI) - ITALY
phone: [phone] - fax [phone]
[e-mail]
www.csoitalia.it

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2SAFETY
2.1 SAFETY WARNINGS
CAUTION
Do not use the device if visibly damaged.
Periodically inspect the
device to verify if there are damage signs.
CAUTION
Always keep the device out of the reach of children.
CAUTION
Danger of device fall. Check that the device is correctly fixed on the
slit lamp. Pay attention during the
device assembly operations. In
case of accidental fall, check the calibration and, if necessary,
contact the Manufacturer.
CAUTION
Before any measurement the contact surface of the measuring
prism must be inspected for damages. If there is any anomaly,
replace the prism.

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CAUTION
The measurement has to be carried out only with intact, clean and
disinfected prisms. Otherwise you could damage the patient's
cornea.
If the measuring prism is not intact, detergent or disinfectant
product residuals could enter the cracks and cause, during the
measurement, irritations and corrosion on the corneal surface.
Hence the prism has to be accurately rinsed with water after
disinfection and must be checked to be sure of its integrity.
Moreover, a wrong disinfection can cause cross-
contamination
between patients and operator and damages to the measuring
prism.
For indications on the cleaning and disinfection procedures refer to
the paragraph Measuring prism disinfection at page 46.
The only person responsible for not observing the cleaning and
disinfection procedure is the user.
If you use a reusable measuring prism, always disinfect it before
carrying of the measurement on the patient's eye surface and
immediately after the exam.
If you use a disposable measuring prism, before use always make
sure the package is intact and the content is st
erile. Immediately
after the exam make sure to dispose of the disposable prism.
CAUTION
If possible, avoid to carry out the measurement in case the patient
presents ocular infection or injured corneal surface
Touch the measuring prism only with disposable gloves. Touch the
prism only from the sides and never from the part that will be in
contact with the patient's eye surface.
The measuring prism shall not be disinfected with other instruments
or medical devices.

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Do not use the measuring prism beyond two years from the date
indicated on the production batch written on the package.
For patients affected by infective diseases always use the disposable
prisms.
It is forbidden to disinfect and reuse the disposable prisms.
It is
forbidden to carry out any technical operation on the device that
is not recalled or described in the instructions for use.
It is forbidden to place the device in humid, dusty places or
environments subject to sudden temperature and humidity
variations.
It is forbidden to use the device outdoors.
The measurement precision is influenced by corneal rigidity
variations and changes. The rigidity can be due to differences in the
corneal thickness, to intrinsic structural factors or refracti
ve corneal
surgery. keep these factors into account during the evaluation of the
intraocular pressure.
The device does not generate and does not receive any
electromagnetic interference if it is placed near other electrical
appliances. No preventive or corrective actions are required.

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2.2 DEVICE IDENTIFICATION
2.2.1 REGISTRATION DATA IN THE MEDICAL DEVICES LIST
CND (national medical devices classification)
Repertoire number (progressive system number attributed to the device)
Market release date
The device registration data can be verified on the Ministero della
Salute website on this page:
Ministero della Salute - Ricerca dispositivi
2.2.2 DEVICE DATA PLATE
Fig 1 - Plate position tonometer Z800
Fig 2 - Plate position tonometer A900
Fig 3 - Plate position tonometer F900
Pos
Description
A
Device data plate

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Fig 4 - Data plate for tonometer Z800
Fig 5 - Data plate for tonometer A900
Fig 6 - Data plate for tonometer F900
2.3 INTENDED USE
The applanation tonometer is an accessory device for the slit lamps
that enables to measure the intra-ocular eye pressure, for the
diagnosis of some ophthalmological diseases. The intra-ocular pressure
measurement is useful to evaluate the patient's risk of developing
glaucoma. The applanation tonometer functions according to the
'Goldmann method': the measurement of the intraocular pressure is
given by the required force to maintain a uniform applanation of the
corneal surface.
The intraocular pressure measurement is conducted on the patient by
means of the measuring prism in contact with the patient's cornea.
During the exam the measuring prism is installed on the tonometer
arm support. The tonometer is installed on the slit lamp.
Because of the direct contact with the corneal surface, it could be
necessary to apply a local anesthetic in the patient's eye.
High precision measurement device. The average deviation (standard)
in every single exam is ± 0,5 mmHg circa.

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The scleral stiffness shall not be considered because the small
volumetric displacement of 0,56 mm3increases the intraocular tension
of only the 2,5% circa.
The tonometers have to be installed on the slit lamp by means of their
support accessory.
The tonometers A900 and Z800 can be left on the slit lamp even when
they are not in use, and if necessary, they can be placed in front of the
microscope during the exam.
The CSO applanation tonometer is suitable for the majority of slit
lamps from other suppliers.
2.4 MEDICAL DEVICES CLASSIFICATION
Technical data
Value
Classification in compliance with the
attached IX to the Directive 93/42/EEC
and successive modifications
Class Im

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2.5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION
Classification in compliance with the technical specification EN 60601-
1:2005 + A1:2012
Technical data
Value
Type of protection against the direct
and indirect contacts
Class I
Applied parts
Type B
Protection degree against humidity
IP20 (no protection against liquid
infiltration)
Sterilization or disinfection method
This device can be disinfected
Protection degree in presence of
anesthetics or inflammable detergents
No protection
Electrical connection degree between
device and patient
Appliances with part applied on the
patient
Use conditions
Continuous functioning
2.6 ENVIRONMENTAL CONDITIONS
Phase
Technical data
Min
Max
Transport
Temperature
-10°C
+60°C
Atmospheric pressure
500 hPa
1060 hPa
Relative humidity
10%
90%
Storage
Temperature
-10°C
+60°C
Atmospheric pressure
500 hPa
1060 hPa
Relative humidity
10%
90%
Use
Temperature
+15°C
+30°C
Atmospheric pressure
700 hPa
1060 hPa
Relative humidity
30%
70%

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CAUTION
Danger of device
damages. During transport and storage, the
device can be exposed to the environmental conditions for a
maximum period of 15 weeks, only if kept in the original packaging.
2.7 DISPOSAL AT THE END THE USEFUL LIFE
Instruction for disposal of product correctly according to European
Directive 2008/98/EC on waste.
At the end of its useful life, the device must not be disposed of as
urban waste. The device can be delivered to the appropriate
separate waste collection centers set up by municipal
administrations or to retailers that offer this service. Separately
disposing a device prevents possible negative consequences for the
environment and health caused by its improper disposal, and lets the
materials it is made of to be recycled so as to achieve a significant
savings of energy and resources.
The user has to consider the effects potentially dangerous for the
environment and the human health originating from an improper
disposal of the whole device or its parts.
In case the user wishes to dispose of the device used at the end of its
useful life, the Manufacturer facilitates the possibility of its reuse and
the recovery and recycling of the materials contained therein. This to
prevent the release of hazardous substances into the environment and
to promote conservation of natural resources. Before disposing the
device, it is necessary to take into consideration the European and
national regulations that order what follows:
- not to dispose as urban waste but collect it separately and address
to a firm specialized or to the local administration in charge for
waste collection.

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- in the event that a new device is purchased from the same
Manufacturer to replace an old one placed on the market before
13 August 2005, equivalent and with the same functions of the new
device, the Distributor or Manufacturer are legally required to
collect the old device.
- if the user decides to dispose a used device, put on the market
after the 13th August 2005, the Distributor or the Manufacturer
have to collect it.
- the Manufacturer takes care, by joining a consortium for the
technological devices waste, of the treatment and the recycling of
the used device by paying its costs.
The Manufacturer is available to give the user all the information
about the dangerous substances contained in the dev
ice, and on the
recycling modalities of those substances and about the possibility of
a reuse of the used device.
Strict sanctions for transgressors are provided for by law.
For specific information about the disposal in other countries than
Italy, contact the local Dealer.

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3DEVICE DESCRIPTION
3.1 PROVISION DESCRIPTION
Device Z800
Fig 7 - Provision description
Pos
Denomination
A
Device
B
Hex key
C
Measuring prism
D
Functioning check accessory
E
Tonometer support (optional)

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Device A900
Fig 8 - Provision description
Pos
Denomination
A
Device
B
Measuring prism
C
Functioning check accessory
D
Tonometer support (optional)