Haag-Streit AT 900 D User manual

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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
DOC. no. 1500 1500.1400209.04000
INSTRUCTIONS FOR USE
Applanation tonometer
AT 900®D
18. Edition / 2020 – 01
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
INSTRUCTIONS FOR USE
Applanation tonometer
AT 900®D
18. Edition / 2020 – 01
Introduction
Thank you for choosing a Haag-Streit device. Provided you comply carefully
with the regulations in this instructions for use, we can guarantee the reliable and
unproblematic use of our product.
Purpose of use
The Goldman digital tonometer is an appliance that serves to measure intraocular
pressure, according to the Goldman method. The measuring of the pressure re‑
quires to maintain a uniform applanation of the surface of the cornea. It is specially
indicated in Glaucoma disease.
Contraindication
There is no absolute contraindication for execution of the tonometry. Appropriate
professional assessment and caution are necessary.
WARNING!
Applanation tonometry may only be conducted by appropriately trained
and qualied medical personnel.
WARNING!
Read the instruction manual carefully before commissioning this pro-
duct. It contains important information regarding the safety of the user
and patient.
NOTE!
Federal law restricts this device to sale by or on the order of a physician
or licensed practitioner.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
1. Safety ................................................................................... 4
1.1 Areas of application of the device...........................................................................4
1.2 Ambient conditions..................................................................................................4
1.3 Shipment and unpacking ........................................................................................4
1.4 Installation warnings ..............................................................................................4
1.5 Operation, environment ..........................................................................................4
1.6 Disinfection .............................................................................................................5
1.6.1 Cleaning and disinfection of the measuring prism ..................................................5
1.6.2 Visual inspection of the measuring prisms for damages.........................................5
1.6.3 Service life of reusable measuring prisms ..............................................................6
1.6.4 Tonosafe .................................................................................................................6
1.6.5 Monthly device checks............................................................................................6
1.7 Warranty and product liability..................................................................................6
1.8 Symbols ..................................................................................................................6
2. Introduction.......................................................................... 7
2.1 Overview ................................................................................................................7
2.2 System components ..............................................................................................7
2.3 Bluetooth adapter (optional)....................................................................................7
3. Appliance assembly / installation ...................................... 7
3.1 Model R...................................................................................................................7
3.2 Model T ...................................................................................................................7
3.3 Model BQ................................................................................................................7
3.4 Which slit lamp with which tonometer .....................................................................8
3.5 Description models .................................................................................................8
3.6 Magnet unit for automatic L/R detection .................................................................8
4. Commissioning.................................................................... 8
4.1 Switching the device on and off ..............................................................................9
4.2 Programming the settings .......................................................................................9
4.3 LED indicator ..........................................................................................................9
4.4 Setting the display brightness.................................................................................9
4.5 Adjusting the volume...............................................................................................9
4.6 BluetoothTM function ................................................................................................9
4.7 Battery status........................................................................................................10
5. Operation ........................................................................... 10
5.1 Measuring tips.......................................................................................................10
5.2 Astigmatism ..........................................................................................................10
5.3 How pressure is measured ...................................................................................10
5.4 Preparing the patient.............................................................................................10
5.5 Patient instructions................................................................................................10
5.6 Preparation of slit lamp and tonometer .................................................................10
5.7 Measuring correctly...............................................................................................11
5.8 Sources of error ....................................................................................................11
5.8.1 Incorrect distance to the patient ...........................................................................12
5.8.2 Position too far to the right/left ..............................................................................12
5.8.3 Position too high/low.............................................................................................13
5.8.4 Incorrect pressure.................................................................................................13
6. Software / Help menu / Error messages.......................... 13
6.1 Error messages on the tonometer display ............................................................13
7. Technical data.................................................................... 14
8. Maintenance....................................................................... 14
8.1 Repairs..................................................................................................................14
8.2 Cleaning and disinfection......................................................................................14
8.3 Checking the tonometer .......................................................................................15
8.4 Changing the battery.............................................................................................16
A. Appendix ............................................................................ 17
A.1 Accessory original HAAG‑STREIT measuring prism ............................................17
A.2 Accessory tonosafe...............................................................................................17
B. Legal regulations............................................................... 17
C. Classication ..................................................................... 17
D. Disposal ............................................................................. 17
E. Standards ........................................................................... 17
F. Information and manufacturer's declaration
regarding electromagnetic compatibility (EMC) ............ 18
F.1 General .................................................................................................................18
F.2 Emitted interference (standard table 1).................................................................18
F.3 Immunity (standard table 2) ..................................................................................19
F.4 Immunity for non‑life support devices (standard table 4) ......................................20
F.5 Safe distances for non‑life‑supporting devices (standard table 6)).......................21
Contents
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
1. Safety
DANGER!
Failure to comply with these instructions may result in material damage
or pose a danger to patients or users.
WARNING!
These warnings must absolutely be complied with to guarantee
safe operation of the product and to avoid any danger to users and to
patients.
NOTE!
Important information: please read carefully.
1.1 Areas of application of the device
The device is intended for use in doctor's practices, hospitals, and optometrists' and
opticians' premises.
1.2 Ambient conditions
Transport: Temperature
Air pressure
Relative humidity
from
from
from
−40°C
500 hPa
10%
to
to
to
+70°C
1060 hPa
95%
Storage:
Temperature
Air pressure
Relative humidity
from
from
from
−10°C
700 hPa
10%
to
to
to
+55°C
1060 hPa
95%
Use:
Temperature
Air pressure
Relative humidity
from
from
from
+10°C
800 hPa
30%
to
to
to
+35°C
1060 hPa
90%
1.3 Shipment and unpacking
• Before you unpack the appliance, check whether the packaging shows traces of
incorrect handling or damage. If this is the case, notify the transport company that
has delivered the goods to you. Unpack the equipment together with a represen‑
tative of the transport company. Make a report of any damaged parts. This report
must be signed by you and by the representative of the transport company.
• Leave the device in the packaging for a few hours before unpacking it (conden‑
sation).
• Check the appliance for damage after it is unpacked. Return defective applianc‑
es in the appropriate packaging.
• Store packaging material carefully, so that it can be used for possible returns or
when moving.
NOTE!
Check the calibration of the instrument before rst use according to the
instructions in section 8.3.
1.4 Installation warnings
WARNING!
• Do not modify this equipment without authorization of the manufac‑
turer. Installation and repairs may only be performed by trained spe‑
cialists.
• Any third‑party device must be connected in compliance with the EN
60601‑1 standard.
• The optional magnet unit for automatic L/R detection may only be
used with the . Other measuring devices, especially mechanical to‑
nometers, may be affected by the strong magnetic eld.
• The device must not be stacked or placed in close proximity to other
electronic devices.
NOTE!
• When performing assembly on appliances from other manufacturers,
the connecting dimensions of the diverse tonometer models are to be
taken into account!
• Check: Are the connection parts properly positioned (tonometer on
the slit lamp, measuring prisms)?
1.5 Operation, environment
WARNING!
• The examination is to be performed at the medical professional’s dis‑
cretion and consideration in cases of active infections and lesions of
the eye. Certain conditions could falsify measured values and the pro‑
cedure may interfere with the patient’s condition.
• Use only original HAAG‑STREIT Goldmann tonometer measuring
prisms or the sterile disposable measuring prisms TonoSafe from
HAAG‑STREIT.
NOTE!
This appliance must only be operated by qualied and trained person‑
nel. The owner is responsible for their training.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
1.6 Disinfection
NOTE!
The device does not need to be disinfected. For more information on
cleaning, please refer to the 'Maintenance' chapter.
1.6.1 Cleaning and disinfection of the measuring prism
DANGER!
The measuring prisms are made of PMMA. Please take note of the
following restrictions:
- Do not disinfect with alcohol
- Do not clean with acetone
- Do not disinfect using UV radiation
- Do not sterilise using steam or ethylene oxide
- Do not expose to temperatures above 60°C
WARNING!
Reusable measuring prisms are not shipped disinfected and must
becleanedanddisinfectedbeforetheirrstuseinaccordance
with the separate instructions for use on the cleaning and dis-
infection of tonometer measuring prisms, contact glasses, and
DESINSET (HS item no. 7220315).
• Preparation may only be conducted by qualied and trained person‑
nel. Their training is the responsibility of the user.
• Appropriate professional assessment and caution are necessary.
• Only use clean, undamaged, and disinfected measuring prisms!
• Please observe the separate instructions for use on the cleaning and
disinfection of tonometer measuring prisms, contact glasses, and
DESINSET (HS item no. 7220315)!
• The operator shall be liable in the event of non‑observance of the
cleaning and disinfecting process!
NOTE!
• Only those disinfectants tested by HAAG‑STREIT for material com‑
patibility may be used for disinfection.
• The current list is enclosed with every tonometer and measuring
prism, and can also be found on the HAAG‑STREIT AG website
(www.HAAG‑STREIT.com).
• The separate instructions for use on the cleaning and disinfection of
tonometer measuring prisms, contact glasses, and DESINSET is to
be consulted regarding the exact functioning, concentration, working
times, and idle times.
• Improper preparation can result in the transmission of diseases to the
patient and user as well as damage to the measuring prism.
• Residue from cleaning agents and disinfectants may irritate and burn
the patient’s eye.
• As a rule, the measuring prisms may be prepared together with each
other, but not with any other products.
• In order to achieve a efcient disinfection and storage of tonometer
measuring prisms, we recommend the use of our DESINSET. For a
selection of cleaning and disinfection agents please refer to the in‑
structions for use “Cleaning and disinfection” and to our “List of Dis‑
infectants”. The efcacy of the disinfectants on tonometer measuring
prisms must be guaranteed by the user or the reprocessing responsi‑
ble person with the validation of their own disinfection process.
• The validation report is available from HAAG‑STREIT on request.
• A summary of the validation report can be found on the HAAG‑STREIT
website (www.HAAG‑STREIT.com).
• The operator accepts liability for the use of other disinfectants.
• Single‑use prisms must be replaced after every examination ‑ see
separate instructions for use.
• The instructions for use referred to above, the brief instructions on the
disinfection of tonometer measuring prisms and additional information
can be found on our website www.HAAG‑STREIT.com at any time.
1.6.2 Visual inspection of the measuring prisms for damages
DANGER!
Never use damaged measuring prisms.
Prior to every use, the contact surface of the measuring prism must be
inspected for contaminants or damage (scratches, cracks and sharp
edges). This must be performed with a slit lamp microscope at 10x
to16xmagnication.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
1.6.3 Service life of reusable measuring prisms
WARNING!
How long can measuring prisms be used?
Due to the large number of variables to be considered (type and con‑
centration of the disinfectant used, number of patients, handling, etc.)
it is practically impossible to provide exact information on how often
and/or how long a measuring prism can be used under safe conditions.
The measuring prisms are stamped with an expiry date ( YYYY‑MM).
They must not be used beyond this date. HAAG‑STREIT recommends
a maximum service life of two years before the expiry date. This ser‑
vice life applies subject to normal conditions of use, i.e., in compliance
with the instructions contained in these instructions for use. The ser‑
vice life starts with the rst use. The above-mentioned time periods do
not apply to damaged measuring prisms; these must be immediately
replaced.
01234 5
Service life:
Maximum two years
Service life:
Maximum two years
First use
First use
Replace
Replace
Year:
1.6.4 Tonosafe
NOTE!
Tonosafe was developed to avoid the necessary cleaning and disinfec‑
tion of measuring prisms from applanation tonometers. Tonosafe is a
disposable applanation and optical duplication prism for Goldmann and
Perkins applanation tonometers, for single use.
Additional details can be found in the separate instructions for use.
1.6.5 Monthly device checks
The tonometer must be checked on a monthly basis as described in the 'Mainte‑
nance' chapter. A check will be absolutely necessary if external force is applied
(e.g., striking or dropping the appliance).
NOTE!
If a repair is necessary, please contact your HAAG‑STREIT represent‑
ative.
1.7 Warranty and product liability
Haag-Streit products must be used only for the purposes and in the manner des-
cribed in the documents distributed with the product.
The product must be treated as described in the ‘Safety’ chapter. Improper hand-
ling can damage the product. This would void all guarantee claims.
Continued use of a product damaged by incorrect handling may lead to personal
injury. In such a case, the manufacturer will not accept any liability.
Haag-Streit does not grant any warranties, either expressed or implied, including
implied warranties of merchantability or fitness for a particular use.
Haag-Streit expressly disclaims liability for incidental or consequential damage
resulting from the use of the product.
This product is covered by a limited warranty granted by your seller.
This product is covered by a limited warranty, which may be reviewed at
www.haag-streit-usa.com.
•
•
•
•
•
•
For US
A only:
•
1.8 Symbols
Read the instructions for use
attentively
General warning: Read the ac‑
companying documentation
Disposal instructions. See
"Disposal" section.
Test symbol of CSA with ap‑
proval for USA
European certicate of con‑
formity Manufacturer
Year of production Serial number
HS reference number Product classication Type B
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
LOT number Must not be re‑used
Expiry date (2017‑10 = end of
October 2017)
2. Introduction
The applanation tonometer functions according to the 'Goldmann method': mea‑
surement of the pressure required to maintain a uniform applanation of the surface
of the cornea. The precise measurement of the applanation surface is conducted
with the slit lamp at 10x magnication.
The pressure measurement is conducted on a slit lamp with the patient sitting down
and is a routine test carried out as part of the standard slit lamp microscopy.
2.1 Overview
1. Measuring prisms (application part)
2. Sensor arm
3. Battery compartment lid
4. Battery compartment locking mechanism
5. Type plate (bottom side)
6. Function key
7. Insert for control weight
8. Digital display
9. Knob
10. Bluetooth adapter (optional)
1
2
3
4
5
6
7
8
9
2.2 System components
The Applanation Tonometer system is composed of the following devices:
• Applanation Tonometer
• Bluetooth adapter (optional)
• PC or laptop
2.3 Bluetooth adapter (optional)
There is an optional Bluetooth adapter available to transfer the measured data directly
to the patient management of the Eyesuite software. The activation of the Bluetooth
function is described in Chapter 4.6. The description of the software installation can be
found in the EyeSuite Setup Manual, the usage instructions for the Bluetooth adapter
and the description of the error messages are included in the Help section of the soft‑
ware. The help can be opened via the F1 key or in the [?] ‑ [Help] menu.
3. Appliance assembly / installation
WARNING!
Installation, repairs and modications may only be performed by
trained specialists.
3.1 Model R
A pivot is required for use of the Applanation Tonometer model R o n the BM 900 slit
lamp. It is assembled as follows:
1. Unscrew the mounting screw found at the top, on the microscope's middle cyl‑
inder housing.
2. Leave the spring in the aperture.
3. Position and screw on tightly the pivot for the tonometer.
4. Place the tonometer bearer arm on the pivot's pin and swivel the tonometer to
the right until it snaps into position. The tonometer will remain in this position
even when not in use.
5. When using the BI 900, BM 900 and BM 900 V, the stop peg must be assem‑
bled (a), and when using the BC 900 or BD 900, it must be removed (b).
(b)(a)
3.2 Model T
The Applanation Tonometer is tucked into one of the holes on the horizontal guide
plate over the slit lamp axis using the peg from the tonometer base.
3.3 Model BQ
Connect the tonometer at the provided interface to the right side of the microscope
arm.
NOTE!
The cover screw on the left side of the arm is loosened by turning it in
a clockwise direction using the screwdriver (applies only for late tonom‑
eter deliveries).
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
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PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
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3.4 Which slit lamp with which tonometer
Model R Model T Model BQ
Model R Model T Model BQ
BD 900
BM 900
BI 900
BP 900
BQ 900
BX 900
3.5 Description models
• The Applanation Tonometer model R can be left on the slit lamp permanently.
It is fastened to the microscope on a mounting base and swiveled in front of the
microscope for the examination. The observation of the applanated surface is
conducted monocularly – only through the left eyepiece.
• The Applanation Tonometer model T is set on the guide plate over the slit lamp
axis, for tonometry purposes. The instrument can be moved between two posi‑
tions on the guide plate for observation through the right or left eyepiece. The
sensor arm with the measuring prism projects from the bottom side into the
beam path of the microscope and the illumination.
• The Applanation Tonometer model BQ has a working position and two resting
positions. To set the correct angle of incidence of the illumination, the tonometer
is swiveled and the illumination apparatus is positioned to the left of the tonom‑
eter bracket. The patient's left and right eyes can be easily examined in this posi‑
tion (no 60° position). The applanated surface is observed monocularly through
the right eyepiece of the stereo microscope.
3.6 Magnet unit for automatic L/R detection
The magnet unit for the AT 900 D in combination with the EyeSuite Tonometry soft‑
ware makes it possible to display the intraocular pressure (IOP) and the information
on the eye in which the pressure was measured.
PROHIBITED
The magnet unit may not be used with conventional mechanical Gold‑
mann applanation tonometers, as the magnets can cause erroneous
results with these instruments.
NOTE!
The magnet unit cannot be used with the attachment cart with rail for
the Hruby lens. If you have this type of attachment cart afxed on your
head rest, please remove it.
• For metal chin rests (13), screw the magnet unit directly into the rear, closer to‑
gether holes on the chin rest using the knurled screws.
• For plastic chin rests (14), screw the two spacer sleeves into the provided
threaded sockets on the chin rest rst and then afx the magnet unit into the ex‑
ternal holes on the spacer sleeves using the knurled screws.
• Check that you can still see the bottom side label (15) after assembly when you
view the chin rest from below.
Nur mit von Haag-Streit zugelassenem
Digital-Tonometer verwenden
Utilisation qu'avec Tonomètre approuvé
par Haag-Streit
Use only with Digital Tonometer approved
by Haag-Streit
13
15
14
4. Commissioning
WARNING!
It is imperative to read the 'Safety' section and observe its precautions
before operating the equipment.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
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4.1 Switching the device on and off
Switch the tonometer on by pressing the function
key briey. We recommend checking the display ele‑
ments regularly to ensure they are functioning when
switching the tonometer on. [8.8.8] appear shortly and
then each individual LED segment lights up, follow‑
ing by the software version: a 3‑digit number. At the
same time, the red and green displays will ash alter‑
nately. If a display value appears after that, then the
device is ready for use. The digital display lights up
and displays the set tonometer value. The tonometer
switches off automatically after 90 seconds if no ad‑
justments are made. If the BluetoothTM function is dis‑
abled (Section 5), the tonometer can also be switched
off by pressing the function key.
4.2 Programming the settings 2 seconds
2 seconds
2 seconds
The display brightness, volume and Bluetooth func‑
tion can be changed. Press the function key and hold
it down for two seconds to access the programming
mode. The functions can be set in the following order
according to the following points:
1. Display brightness
2. Volume
3. Bluetooth function
4.3 LED indicator
The LED below the display value is used to check
whether the measuring prism is within the permitted
measuring range during measurement. It lights up
red as long as the tonometer is not in contact with the
cornea and changes to green as soon as the measur‑
ing prism makes good contact with the cornea. If the
tonometer is too close to the eye, the color changes
back to red and a warning tone alerts the user to the
fact that he/she has gone outside of the measuring
range and the sensor is in the safety distance. The
measuring range is between 3 and 75 mm Hg. Above
the measuring range, the display shows [HI], below
it [Lo].
4.4 Setting the display brightness
Hold the function key depressed for approx. 2 sec‑
onds. The display shows [‑ ‑ ‑] (three dashes) and a
signal sounds. Release the function key again. [br]
appears on the display, along with the brightness set‑
ting 1 to 3. The brightness is adjusted by pressing
the function key briey. We recommend leaving the
device in the basic setting [br1] to ensure long bat‑
tery life.
4.5 Adjusting the volume
Hold the function key depressed for approx. 2 sec‑
onds. The display shows [‑ ‑ ‑] (three dashes) and a
signal sounds. Release the function key again. [Ld]
appears on the display, followed by levels 1 to 6.
The volume is adjusted by pressing the function key
briey.
4.6 BluetoothTM function
Keep the function key depressed for approx. 2 sec‑
onds to switch to the BluetoothTM function menu.
Pressing the function key briey switches the Blue‑
toothTM function on [bon] / off [boF]. This function can
only be used together with the HAAG‑STREIT Blue‑
toothTM adapter (102623) and the corresponding soft‑
ware. Detailed information can be found in the corre‑
sponding operating instructions. Disable the function
[boF] if you do not require it, in order to avoid wast‑
ing the batteries' power. Pressing the function key
for more than two seconds returns you to the normal
measuring mode. The normal measuring mode can
also be reached by waiting until the device switches
itself off and then switching it back on again.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
4.7 Battery status
If [bAt] appears in the display instead of a numerical
value when the device is switched on, then the bat‑
teries should be replaced immediately (4x commer‑
cially available 1.5V LR03 (AAA) batteries). You can
continue measuring until the tonometer switches off
automatically.
5. Operation
5.1 Measuring tips
WARNING!
Reusable measuring prisms must be cleaned and disinfected after ev‑
ery examination.
5.2 Astigmatism
• If the cornea is spherical, measurements can be taken on any meridian, but it is
most convenient to measure on the 0° meridian.
• However, the choice of meridian is signicant when measuring eyes with corneal
astigmatism greater than 3 dioptres, since the attened area is not circular, but
elliptical.
• It has been calculated that, in cases of greater corneal astigmatism, a surface
of 7.354 mm2(ø 3.06 mm) is applanated if the measuring prism is at an angle of
43° (A) to the meridian of the greatest radius.
Example: If the corneal astigmatism measures
6.5 mm / 30°
8.5 mm / 120°
=
=
52.0 dpt / 30° and
40.0 dpt / 120°
(A) 43°
the 120° graduation mark on the prism is set on the mark (A)
of the prism holder.
If, on the contrary, the measurements are
6.5 mm / 120°
8.5 mm / 30°
=
=
40.0 dpt / 120° and
52.0 dpt / 30°
then the 30° graduation mark is set on the mark (A), meaning that simply the axis
position of the largest radius is placed on the mark (A).
5.3 How pressure is measured
The applanation tonometer functions according to the 'Goldmann method': mea‑
surement of the pressure required to maintain a uniform applanation of the surface
of the cornea.
• The readings obtained are based on the assumption that a cornea with a 'nor‑
mal' thickness is being measured; a different corneal thickness leads to changes
in the measured IOP. A 'normal' corneal thickness is considered to fall within the
range of 530 to 560 micrometers.
• If it is suspected that measuring results may be inaccurate, please conduct a
functional verication in accordance with the 'Maintenance' chapter.
5.4 Preparing the patient
NOTE!
A smooth operation can only be guaranteed with the use of original
HAAG‑STREIT measuring prisms and Tonosafe.
1. Anaesthetise each eye
2. Apply Fluorescein into the eye to be examined
3. The correct eye height of the patient can be set via the chin rest.
5.5 Patient instructions
1. Press the head rmly against the chin and forehead rests.
2. The patient must look straight forward. If necessary, the small xing light can be
used to steady the eyes.
3. It is recommended that the patient be repeatedly reminded to keep his eyes
open wide during the examination. It might be necessary for the examiner to
keep the eye open by splaying the eyelids with thumb and index nger.
4. This must be done without applying any pressure to the eye.
5.6 Preparation of slit lamp and tonometer
For all HAAG-STREIT slit lamps and tonometers
1. Before the examination, the eyepieces must be adjusted correctly to the exam‑
iner.
2. Set the magnication to 10x.
3. Adjust the illumination to medium intensity.
4. Position the blue lter in the beam path of the slit lamp's illumination apparatus
and open the slit diaphragm fully.
5. Insert the disinfected measuring prism into the (0° position) holder on the sen‑
sor arm. For Tonosafe, see the separate instructions for use.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
6. Snap the sensor arm into place so that the axes of the measuring prism and of
the microscope align.
7. Switch on the tonometer and set a value between 5 and 10 mm.
Model R and model BQ
1. Swing the illumination apparatus to the left.
2. Release the tonometer from the dwell position to the right of the microscope,
and swing it forward until it locks in the measuring position.
3. From the left, bring the illumination apparatus into contact with the tonometer
bearer arm. This is the only illumination position in which both the patient’s left
and right eyes can be easily examined (no 60° position). This arrangement fa‑
cilitates the splaying of the patient’s eyelids, should this be necessary for meas‑
urement. The illumination of the applanated surface through the measuring
prism is practically reection-free.
Observation: with model R in the left eyepiece
with model BQ in the right eyepiece
Model T
1. For an examination through the tonometer’s left or right eyepiece, the angle
between the illumination instrument and the microscope should be approx. 60°
so that the image is bright and reection-free. Alternatively: lighting through the
measuring prism at approx. 10°.
5.7 Measuring correctly
1. Immediately before taking measurements, the patient should close his eyes
briey so that the cornea becomes sufciently moistened with uorescein-im‑
pregnated tear uid.
2. By moving the slit lamp, the measuring prism comes into contact with the centre
of the cornea over the pupillary area.
3. During contact, the cornea's limbus takes on a bluish glow. This glow can be
best observed with the naked eye from the opposite side of the illumination ap‑
paratus.
4. When the limbus glows, stop moving the slit lamp immediately.
5. After contact is made, viewing is conducted through the microscope. The uni‑
form pulsation of the two semi circular uorescein bands, which could be of dif‑
ferent sizes in drum setting 1 depending upon inter‑ocular pressure, shows that
the tonometer is in the right measuring position.
6. Any necessary corrections are done using the slit lamp control lever, until the
attened surface is observed in the form of two semicircles of similar size in the
middle of the visual eld (A).
7. Smaller changes in the depth of the slit lamp using the control lever do not af‑
fect the size of the semicircles.
8. The pressure on the eye is increased by turning the tonometer knob until the in‑
ner borders of both uorescein bands just touch = correct setting (B).
9. When the eye pulsates, both semi circles cross over each other.
10. The width of the uorescein band around the contact point of the measuring
prism should be about 1/10 of the diameter of the applanation surface (0.3 mm).
11. Display value in mm Hg.
(A) (B)
NOTE!
If the tonometer is too close to the
eye, the color of the LED changes
to red and a warning tone alerts the
user to the fact that he has left the
measuring range and the sensor is
in the safety distance.
5.8 Sources of error Ocular images
Fluorescein band incorrect 1 – 2
Wrong distance to patient 3 – 9
Position too far to the right/left 5 – 9
Position too high/low 10 – 14
Incorrect pressure 15 – 18
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
Fluorescein band too wide (1)
The measuring prism was not dried after cleaning or the eye‑
lids came into contact with the measuring prism during mea‑
surement.
1
The slit lamp must be pulled back and the measuring
prism dried with a lint-free cloth (e.g., made of cellulose).
Fluorescein band too small (2)
The tear uid has dried up during a prolonged measuring pro‑
cess.
2
Allow the patient to close his/her eyes a few times and
then repeat the measurement.
5.8.1 Incorrect distance to the patient
No semicircular image, only center line is visible (3)
The measuring prism is not coming into contact with the cor‑
nea! If the patient draws his/her head back slightly, irregular pul‑
sations will be caused because the measuring prism is touching
the eye only intermittently. If the patient pulls back even further,
the uorescein rings will disappear completely.
3
Instruct the patient to adopt the correct position.
Only parts of both oversize semicircles are visible (4)
If the slit lamp is pushed too far against the patient, or if the
patient moves toward the slit lamp, the sensor arm will push
against a spring stop. The applanation surface is too large.
4
The image does not change when the tonometer knob is
turned. Pull the slit lamp back until the uniform pulsations
of a correspondingly smaller surface show the correct
measuring position and pressure changes immediately
cause applanation surface changes.
5.8.2 Position too far to the right/left
Only part of the upper semicircle (5)
Measuring prism not centered on the eye, eye much too far to
the right.
5
Using the control lever, move the slit lamp to the right.
Whole upper semicircle – part of the lower semicircle (6)
Measuring prism not centered on the eye, eye still too far to
the right.
6
Using the control lever, move the slit lamp to the right.
Whole lower semicircle – part of the upper semicircle (7)
Measuring prism not centered on the eye; eye still too far to
the left.
7
Using the control lever, move the slit lamp to the left.
Only part of the lower semicircle (8)
Measuring prism not centered on the eye; eye much too far to
the left.
8
Using the control lever, move the slit lamp to the left.
Correct setting! (9)
Two semicircles appear exactly in the middle of the eyepiece.
9
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
5.8.3 Position too high/low
Only part of a semicircle in the upper half (10)
Measuring prism not centered on the eye; eye far too high.
10
Using the control lever, move the slit lamp upwards.
Nearly entire circle above, incomplete circle below (11)
Measuring prism not centered on the eye; eye still too high.
11
Using the control lever, move the slit lamp upwards.
Two incomplete circles, the larger one on top (12)
Measuring prism not centered on the eye; eye still too high.
12
Using the control lever, move the slit lamp upwards.
Correct setting! (13)
Two semicircles appear exactly in the middle of the eyepiece.
13
5.8.4 Incorrect pressure
Theoutsidebordersoftheuoresceinbandsareincontact
with each other (14)
Not enough pressure.
14
Increase the pressure slightly by rotating the knob on the
tonometer.
Fluorescein bands are superimposed to form a band (15)
Pressure slightly too low.
15
Increase the pressure slightly more by rotating the knob
on the tonometer.
Bands are no longer in contact (16)
Pressure is too high.
16
Lower the pressure by rotating the tonometer knob in the
opposite direction.
Correct setting! (17)
The inside borders of the uorescein bands are contacting each
other.
17
6. Software / Help menu / Error messages
The software's help section contains instructions and help for performing an exami‑
nation and descriptions of the error messages. The help can be opened via the F1
key or in the [?] ‑ [Help] menu.
WARNING!
The software must be installed by trained personnel in accordance with
separate installation instructions.
6.1 Error messages on the tonometer display
Description Measures
The measurement is outside the
permitted tolerances.
The position of the sensor arm is
defective.
If one of these errors appears per‑
manently, send the device to the
corresponding service branch.
The minimum operating voltage
has not been achieved; the device
switches off.
Replace the dead batteries.
Battery voltage too high.
Incorrect battery type tted.
Insert the correct batteries.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
to
The tonometer electronics is de‑
fective.
If one of these errors appears per‑
manently, send the device to the
corresponding service branch.
7. Technical data
Generation of measuring force through leverage weight.
Measurement range 5 ― 70 mm Hg
Measurement de-
viation
The measurement deviation in the measuring prism is in the measuring
range from 4.91 – 58.84 mN and amounts to a maximum of ±1.5% and to
a minimum of ±0.49 mN of the nominal value.
Backlash width ≤0.49 mN
Net weight model R
model T
model BQ
0.500 kg (without accessories)
0.330 kg (without accessories)
0.550 kg (without accessories)
Batteries 4 x LR03 (AAA) 1.5 V
Bluetooth Contains TX IC: 1520A‑LMX9838
Contains TX FCC ID: EDQLMX9B38
model BQmodel R model T
1. Nominal value
2. Maximum limiting deviation
3. Limiting deviation of 0 to 32.66
mN: Maximum = 0.49 mN
4. Limiting deviation from 32.67
mN: Maximum = 1.5% of nomi‑
nal value
(4)(3)
‑ 0.49 mN
+0.49 mN
32.66 mN0 mN
(1)
(2)
(2)
8. Maintenance
WARNING!
Installation, repairs and modications may only be performed by
trained specialists.
8.1 Repairs
To ensure a long service life, the device must be cleaned every week as described
and covered with a dust cover when not in use. We recommend having the device
checked annually by an authorised service technician.
8.2 Cleaning and disinfection
Tonometer housing and Sensor arm can, if required, be carefully wiped down with
ready‑for‑use disposable 70% ethanol disinfectant wipes. Surface‑friendly disinfec‑
tants (containing or not containing aldehyde) are also permitted, such as Kohrso‑
lin FF.
WARNING!
• The preparation instructions provided do not apply to tonometer mea‑
suring prisms!
• The tonometer measuring prisms must be prepared according to a
separate manual.
• Do not use sprays
• Observe the manufacturer's safety instructions
• Do not use any cloths that might drip.
• Wring out any soaked cloths completely before use wherever
necessary
• Ensure that no liquid penetrates into the device
• Comply with the stipulated exposure time
NOTE!
IP code: IPX0 (device is not protected against liquids)
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
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8.3 Checking the tonometer
NOTE!
This check must be carried out once a month. If the check yields erro‑
neous results, please check the following points:
1. Is the measuring prism properly positioned?
2. Is the control weight correctly set?
3. Repeat the check.
Defective equipment must be sent immediately to your HAAG‑STREIT represent‑
ative.
NOTE!
HAAG‑STREIT offers a repair and service package. For further infor‑
mation, please contact your HAAG‑STREIT representative directly.
60 mm Hg
20 mm Hg
0 mm Hg
20 mm Hg
60 mm Hg
(a)
Test at 20 mm Hg
A control weight is used for the check. The weight rod is engraved with ve rings.
The middle ring corresponds to 0 mm Hg, the rings immediately to its left and right
correspond to a value of 20 mm Hg, and both outside scale rings have a value of
60 mm Hg.
One of the test position marks (20 or 60 mm Hg) is set exactly to the index line on
the holder. The weight is tted on the feeler axis (a) so that the longer part points to
the examiner.
Check position 19.5
The sensor arm must not move from the free‑movement area toward the limit stop
in the direction of the examiner before the display shows 19.5 mm Hg or after the
display shows 20.5 mm Hg.
Check position 20.5
The sensor arm must not move from the free‑movement area toward the limit stop
in the direction of the patient before the display shows 20.5 mm Hg or after the dis‑
play shows 19.5 mm Hg.
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
Test at 60 mm Hg
Set the weight rod to 60 on the scale so that the longer part points to the examiner.
Check position 59
The sensor arm must not move from the free‑movement area toward the limit stop
in the direction of the examiner before the display shows 59.0 mm Hg or after the
display shows 61.0 mm Hg.
Check position 61
The sensor arm must not move from the free‑movement area toward the limit stop
in the direction of the patient before the display shows 61.0 mm Hg or after the dis‑
play shows 59.0 mm Hg.
8.4 Changing the battery
1. Push the HAAG‑STREIT logo (HS) on the side of the digital display carefully
downward and remove the battery lid by tilting it backward.
2. Pull the tab at the bottom of the battery compartment carefully. The batteries
are released from the holder and can be easily removed.
WARNING!
• Pay attention to the polarity when inserting the batteries.
• Always replace all the batteries with new ones
• Only use type LR03 (AAA) batteries.
• Never mix old and new batteries.
2.1.
WARNING!
Pay attention to the polarity when inserting the batteries.
3. Pay attention to the correct order as written in the compartment when inserting
the batteries.
4. Once you have replaced the batteries, close the lid again carefully. Insert the
centering tab at the bottom of the battery lid into the corresponding groove in
the housing and close the lid by tilting it upward.
5. Gently press the lid upward against the housing and lock the battery compart‑
ment by pushing the HAAG‑STREIT logo back up again.
NOTE!
Dispose of used batteries properly.
5.
4.
3.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
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A. Appendix
NOTE!
Order numbers are written in italics
An asterisk (*) shows that you should contact your HAAG‑STREIT rep‑
resentative for further information.
A.1 Accessory original HAAG-STREIT measuring prism
The original HAAG‑STREIT measuring prisms are made of
PMMA and guarantee the best optical and mechanical quality.
Reusable measuring prisms must be cleaned and disinfected
after every examination. See Chapter '1.6.1, Cleaning and dis‑
infecting the measuring prism' and the separate instructions for
use. HS art. no. 7220316
A.2 Accessory tonosafe
Tonosafe disposable prisms are a comfortable and effective
solution to reduce the risk of cross‑infection in patients. Tono‑
safe is available in sterile packages with 5 supports and 100
disposable prisms.
HS art. no. 7220345
HS art. no. 7220346 (USA)
B. Legal regulations
• HAAG‑STREIT maintains a quality management system in accordance with EN
ISO 13485. The device was developed and designed in observance of all the
standards listed in section 'EMC'.
• The tonometer is a Class I device with measurement function in accordance with
Appendix IX of Directive 93/42/EEC. By afxing the CE mark we conrm that our
device complies with the applicable standards and directives.
• You can request a copy of the declaration of conformity for the appliance from
HAAG‑STREIT at any time.
C. Classication
Standard EN 60601‑1 Applanations tonometer in accordance with protection
class I.
Operating mode: Continuous operation
CE Directive 93/42/EEC Class Im (measuring function)
D. Disposal
Electrical and electronic devices must be disposed of separately from
household waste!
This appliance was made available for sale after the
13
th August 2005. For correct disposal, please contact your Haag-Streit
representative.
This will guarantee that no hazardous substances
enter the environment and that valuable raw materials are recycled.
E. Standards
EN 60601‑1 EN ISO 8612
EN 60601‑1‑2 EN ISO 15004‑1
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
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F. Information and manufacturer's declaration
regarding electromagnetic compatibility (EMC)
F.1 General
The Tonometer system fullls fullls the requirements on electromagnetic compat‑
ibility according to EN 60601‑1‑2:2007 (IEC 3. Edition). The instrument is built so
that the generation and emission of electromagnetic interference is limited to the ex‑
tent that other devices are not disturbed in their use in accordance with the regula‑
tions and so that the instrument itself is suitably immune to electromagnetic inter‑
ference.
WARNING!
• Electrical medical devices and systems are subject to special EMC
measures and must be installed in accordance with the EMC instruc-
tions contained in this accompanying document.
The operation of other lines or equipment than those listed may lead
to higher emissions or may reduce the device's resistance to interfe-
rence.
Third-party devices may only be connected in compliance with the
EN 60601-1 standard.
•
•
F.2 Emitted interference (standard table 1)
The information is based on the requirements of EN 60601‑1‑2:2007 (IEC 3rd edition).
Guidance and manufacturer's declaration – electromagnetic emissions
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an envi-
ronment.
RF emissions CISPR 11 Group 1 This product uses RF energy only for its internal function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class B This product is suitable for use in all establishments, including domestic establishments and those
directly connected to the public low-voltage power supply network that supplies buildings used for
domestic purposes.
Emission of harmonics according to
EN 61000-3-2
Not applicable
Voltage fluctuations / flicker emissions
according to EN 61000-3-3
Not applicable
Emission test Compliance Electromagnetic environment - guidance
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
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F.3 Immunity (standard table 2)
The information is based on the requirements of EN 60601‑1‑2:2007 (IEC 3rd edition).
Guidance and manufacturer's declaration – electromagnetic immunity
This product is intended for use in the electromagnetic environment specifi ed below. The customer or the user of this product should assure that it is used in such an envi-
ronment.
Immunity test standard EN 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic discharge (ESD)
EN 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should
be at least 30%.
Electrical fast transient / burst
EN 61000-4-4
Not applicable Not applicable Mains power quality should be that of a typical commercial
or hospital environment.
Surge
EN 61000-4-5
Not applicable Not applicable Mains power quality should be that of a typical commercial
or hospital environment.
Voltage dips, short interruptions
and voltage variations on power
supply lines
EN 61000-4-11
Not applicable Not applicable Mains power quality should be that of a typical commercial
or hospital environment. If the user of this product requires
continued function even in the event of interruptions in the
energy supply, this product should be powered from an un-
interruptible power supply or a battery.
Power frequency (50/60Hz)
magnetic fi eld EN 61000-4-8
3 A/m Power frequency magnetic fi elds should be at levels char-
acteristic of a typical location in a typical commercial or hos-
pital environment.
NOTE: U
T
= the AC mains voltage prior to application of the test level.
30 A/m
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220067.04180 – 18. Edition / 2020 – 01
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
F.4 Immunity for non-life support devices (standard table 4)
The information is based on the requirements of EN 60601‑1‑2:2007 (IEC 3rd edition).
Guidance and manufacturer's declaration – electromagnetic immunity
This product is intended for use in the electromagnetic environment specifi ed below. The customer or the user of this product should assure that it is used in such an envi-
ronment.
Electromagnetic environment – guidance
Portable and mobile RF communications equipments hould be used no closer to any part of this product, including cables, than the recommended separation distance cal-
culated from the equation applicable to the frequency of the transmitter.
Immunity test standard EN 60601 test level Compliance level Recommended distance(c):
Conducted RF EN 61000-4-6 3 Vrms
150 kHz – 80 MHz
5 Vrms D= 0.7
Radiated RF EN 61000-4-3 3 V/m
80 MHz – 2.5 GHz
5 V/m
80 MHz – 2.5 GHz
D= 1.2 80 MHz – 800 MHz
D= 2.3 800 MHz – 2.5 GHz
Where Pis the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and Dis the recommended separation
distance in meters (m). Field strengths from fi xed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level
in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz the higher frequency applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a. Field strengths from fi xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broad-
cast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fi xed RF transmitters, an electromagnetic
site survey should be considered. If the measured fi eld strength in the location in which this product is used exceeds the applicable RF compliance level above, this
product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating
this product.
b.
c.
Over the frequency range 150 kHz to 80 MHz,
Possible shorter distances outside the ISM bands do not contribute to improved application in this table.
fi eld strengths should be less than 5 V/m.
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