Manual Instructions For Use AT 900 English
Manual Instructions For Use AT 900 English
Manual Instructions For Use AT 900 English
AT 900® / AT 870
26. Edition / 2020 – 03
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7006000.04260 – 26. Edition / 2020 – 03 1
AT 900® / AT 870
unproblematic use of our product.
Purpose of use
26. Edition / 2020 – 03 The manual operated Goldman tonometer is an appliance that serves to measure
intraocular pressure, according to the Goldman method. The measuring of the pres‑
sure requires 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. The list of known contraindica‑
tions includes, but is not limited to:
• active corneal infections
• corneal epithelium defects
• eye burns
• history of recurring epithelial erosion
etc.
WARNING!
Applanation tonometry may only be conducted by appropriately trained
and qualified 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.
2 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland − HS-Doc. no. 1500.7006000.04260 – 26. Edition / 2020 – 03
Contents
1. Safety ........................................................................4 6. Technical data.........................................................12
1.1 Areas of application of the device........................................................... 4 6.1 Applanation tonometer AT 900.............................................................. 12
1.2 Ambient conditions.................................................................................. 4 6.2 Applanation tonometer AT 870.............................................................. 12
1.3 Shipment and unpacking........................................................................ 4
1.4 Installation warnings .............................................................................. 4 7. Maintenance............................................................12
1.5 Operation, environment.......................................................................... 4 7.1 Repairs.................................................................................................. 12
1.6 Disinfection............................................................................................. 5 7.2 Cleaning and disinfection...................................................................... 12
1.6.1 Cleaning and disinfection of the measuring prism.................................. 5 7.3 Checking the Tonometer AT 900........................................................... 13
1.6.2 Visual inspection of the measuring prisms for damages......................... 5 7.4 Checking the Tonometer AT 870........................................................... 14
1.6.3 Service life of reusable measuring prisms.............................................. 5
A. Appendix.................................................................16
1.6.4 Tonosafe................................................................................................. 6
A.1 Accessories / consumables / spare parts / upgrade............................. 16
1.6.5 Monthly device checks............................................................................ 6
A.2 Original Haag‑Streit measuring prism................................................... 16
1.7 Warranty and product liability.................................................................. 6
A.3 Tonosafe disposable prisms.................................................................. 16
1.9 Description of symbols............................................................................ 6
B. Legal regulations....................................................16
2. Introduction...............................................................6
2.1 Overview................................................................................................. 7 C. Classification..........................................................16
3. Appliance assembly / installation...........................7 D. Disposal...................................................................16
3.1 AT 900 model R...................................................................................... 7
3.2 AT 900 model T....................................................................................... 7 E. Standards................................................................16
3.3 AT 900 model BQ.................................................................................... 7
3.4 Tonometer AT 870 .................................................................................. 7
3.5 Which slit lamp with which tonometer..................................................... 7
3.6 Description of models............................................................................. 8
4. Commissioning.........................................................8
5. Operation ..................................................................8
5.1 Astigmatism............................................................................................ 8
5.2 How pressure is measured..................................................................... 8
5.3 Preparing the patient............................................................................... 8
5.4 Patient instructions.................................................................................. 9
5.5 Preparation of slit lamp and tonometer................................................... 9
5.6 Measuring correctly................................................................................. 9
5.7 Sources of error.................................................................................... 10
5.7.1 Wrong distance to patient .................................................................... 10
5.7.2 Position too far to the right / left............................................................ 10
5.7.3 Position too high / low........................................................................... 11
5.7.4 Incorrect pressure................................................................................. 11
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7006000.04260 – 26. Edition / 2020 – 03 3
1. Safety must be signed by you and by the representative of the transport company.
DANGER!
• Leave the device in the packaging for a few hours before unpacking it (condensa‑
tion).
Failure to comply with these instructions may result in material damage
• Check the appliance for damage after it is unpacked. Return defective appliances
or pose a danger to patients or users. in the appropriate packaging.
WARNING! • Store packaging material carefully, so that it can be used for possible returns or
These warnings must absolutely be complied with to guarantee when moving.
safe operation of the product and to avoid any danger to users and to NOTE!
patients. Check the calibration of the instrument before first use according to the
instructions in section 7.3.
NOTE!
Important information: please read carefully. 1.4 Installation warnings
WARNING!
Do not modify this equipment without authorization of the manufacturer.
1.1 Areas of application of the device Installation and repairs may only be performed by trained specialists.
The device is intended to use in professional health care facility environment, like
doctor's practices, hospitals and optometrists and opticians premises, except near NOTE!
of HF surgical equipment and in RF shielded rooms of ME-systems for magnet‑ • When performing assembly on appliances from other manufacturers,
ic resonance imaging. Some portable radio frequency equipment, like cell phones the connecting dimensions of the diverse tonometer models are to be
or RF telephone equipment including antennas may interference medical devices. taken into account!
Such equipment has to be kept in a distance of more than 30 cm (12 inches) from • Check: Are the connection parts properly positioned (tonometer on
any part of the instrument. Inobservance of this precaution may lower the correct the slit lamp, measuring prisms)?
function of the instrument. 1.5 Operation, environment
1.2 Ambient conditions WARNING!
Transport: Temperature from −40°C to +70°C • The examination is to be performed at the medical professional’s dis‑
Air pressure from 500 hPa to 1060 hPa cretion and consideration in cases of active infections and lesions of
Relative humidity from 10% to 95% the eye. Certain conditions could falsify measured values and the pro‑
Storage: Temperature from −10°C to +55°C cedure may interfere with the patient’s condition.
Air pressure from 700 hPa to 1060 hPa
• Use only original Haag‑Streit Goldmann tonometer measuring prisms
or the sterile disposable measuring prisms Tonosafe from Haag‑St‑
Relative humidity from 10% to 95%
reit.
Use: Temperature from +10°C to +35°C • Strong magnetic fields may falsify the measurement results.
Air pressure from 800 hPa to 1060 hPa
Relative humidity from 30% to 90% NOTE!
• This appliance must only be operated by qualified and trained per‑
1.3 Shipment and unpacking sonnel. The owner is responsible for their training.
• Before you unpack the appliance, check whether the packaging shows traces of • It is known that refractive surgery has an effect on GAT values, as the
incorrect handling or damage. If this is the case, notify the transport company that procedure changes the biomechanical properties of the cornea.
has delivered the goods to you. Unpack the equipment together with a represen‑ • The biomechanical properties of the cornea have an effect on the
4 tative of the transport company. Make a report of any damaged parts. This report measurement
© HAAG‑STREIT readings.
AG, 3098 Koeniz, Switzerland − HS-Doc. no. 1500.7006000.04260 – 26. Edition / 2020 – 03
1.6 Disinfection • Improper preparation can result in the transmission of diseases to the
NOTE! patient and user as well as damage to the measuring prism.
The device does not need to be disinfected. For more information on • Residue from cleaning agents and disinfectants may irritate and burn
cleaning, please refer to the 'Maintenance' chapter. the patient’s eye.
• As a rule, the measuring prisms may be prepared together with each
1.6.1 Cleaning and disinfection of the measuring prism other, but not with any other products.
DANGER!
• In order to achieve efficient disinfection of tonometer measuring
The measuring prisms are made of PMMA. Please take note of the prisms, we recommend using the disinfectant 'Sekusept Forte S'. It
following restrictions: was successfully used by the accredited testing laboratory HS Sys‑
- Do not disinfect with alcohol tem-und Prozesstechnik GmbH, 65779 Kelkheim, Germany, when
- Do not clean with acetone validating the cleaning and disinfection process − see separate in‑
- Do not disinfect using UV radiation struction manual on the cleaning and disinfection of tonometer mea‑
- Do not sterilise using steam or ethylene oxide suring prisms and contact glasses.
- Do not expose to temperatures above 60°C • The validation report is available from Haag‑Streit on request.
• A summary of the validation report can be found on the Haag‑Streit
WARNING! website (www.haag‑streit.com).
Reusable measuring prisms are not shipped disinfected and must • The operator accepts liability for the use of other disinfectants.
be cleaned and disinfected before their first use in accordance • Single-use prisms must be replaced after every examination − see
with the separate instruction manual on the cleaning and disinfec- separate instructions for use.
tion of tonometer measuring prisms and contact glasses. • The above-mentioned instruction manual, the brief instructions Disin‑
• Preparation may only be conducted by qualified and trained person‑ fection of tonometer measuring prisms and contact glasses, and addi‑
nel. Their training is the responsibility of the user. tional information can always be found on our website www.haag-st‑
• Appropriate professional assessment and caution are necessary. reit.com.
• Only use clean, undamaged, and disinfected measuring prisms! 1.6.2 Visual inspection of the measuring prisms for damages
• Please observe the separate instruction manual on the cleaning and
disinfection of tonometer measuring prisms and contact glasses! DANGER!
Never use damaged measuring prisms.
• The operator shall be liable in the event of non-observance of the
cleaning and disinfecting process! Prior to every use, the contact surface of the measuring prism must be
inspected for contaminants or damage (scratches, cracks and sharp edg‑
NOTE! es). This must be performed with a slit lamp microscope at 10× to
• Only those disinfectants tested by Haag‑Streit for material compatibil‑ 16× magnification.
ity may be used for disinfection.
• The current list is enclosed with every tonometer and measur‑ 1.6.3 Service life of reusable measuring prisms
ing prism, and can also be found on the Haag‑Streit website (www. WARNING!
haag‑streit.com). How long can measuring prisms be used?
• The separate instruction manual on the cleaning and disinfection of Due to the large number of variables to be considered (type and concen‑
tonometer measuring prisms and contact glasses is to be consulted tration of the disinfectant used, number of patients, handling, etc.) it is
regarding the exact functioning, concentration, working times, and practically impossible to provide exact information on how often and/or
idle times. how long a measuring prism can be used under safe conditions.
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7006000.04260 – 26. Edition / 2020 – 03 5
The measuring prisms are stamped with an expiry date ( ). They must 1.7 Warranty and product liability
not be used beyond this date. Haag‑Streit recommends a maximum ser‑ • Haag-Streit products must be used only for the purposes and in the manner des-
vice life of two years before the expiry date. This service life applies sub‑ cribed in the documents distributed with the product.
ject to normal conditions of use, i.e., in compliance with the instructions • The product must be treated as described in the ‘Safety’ chapter. Improper hand-
contained in these instructions for use. The service life starts with the first ling can damage the product. This would void all guarantee claims.
use. The above-mentioned time periods do not apply to damaged mea‑ • Continued use of a product damaged by incorrect handling may lead to personal
suring prisms; these must be immediately replaced. 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
Year: resulting from the use of the product.
• This product is covered by a limited warranty granted by your seller.
For USA only:
• This product is covered by a limited warranty, which may be reviewed at
First use
Service life:
Replace
www.haag-streit-usa.com.
Maximum two years
Service life:
Maximum two years
1.9 Description of symbols
First use Replace European certificate of General warning: Read the ac-
conformity companying documentation
1.6.4 Tonosafe
NOTE! Date of manufacture Manufacturer
Tonosafe was developed to avoid the necessary cleaning and disinfection
of measuring prisms from applanation tonometers. Tonosafe is a dispos‑
able applanation and optical duplication prism for Goldmann and Perkins HS reference number Serial number
applanation tonometers, for single use.
Additional details can be found in the separate instructions for use. Expiry date
LOT number
(YYYY-MM-DD)
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., 2. Introduction
striking or dropping the appliance). The applanation tonometer functions according to the Goldmann method: measure‑
NOTE! ment of the pressure required to maintain a uniform applanation of the surface of
the cornea. The exact measurement of the applanation surface is performed at 10×
If a repair is necessary, please contact your Haag‑Streit representative.
magnification on the slit lamp.
The pressure is measured on the slit lamp with the patient seated and is part of a
routine examination within the scope of conventional slit lamp microscopy.
6 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland − HS-Doc. no. 1500.7006000.04260 – 26. Edition / 2020 – 03
2.1 Overview 1
3.3 AT 900 model BQ
1. Measuring prisms 2 Connect the tonometer at the provided interface to the right side of the microscope
2. Sensor arm arm.
3. Insert for control weight 3
4. Rotating knob with measuring drum
5. Type plate (underside)
4
5 3.4 Tonometer AT 870
NOTE!
The instructions for appliances from other manufacturers are to be ob‑
3. Appliance assembly / installation served.
WARNING!
Installation, repairs and modifications may only be performed by trained 3.5 Which slit lamp with which tonometer
specialists.
3.1 AT 900 model R
A pivot is required for use of the Applanation Tonometer AT 900 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 AT 900 model R AT 900 model T AT 900 model BQ
even when not in use. Model R Model T Model BQ AT 870
5. When using the BI 900, BM 900 and BM 900 V, the stop peg must be assembled BD 900
(a), and when using the BC 900 or BD 900, it must be removed (b).
BM 900
BI 900
BP 900
BQ 900
BX 900
(a) (b)
Various
3.2 AT 900 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.
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7006000.04260 – 26. Edition / 2020 – 03 7
8 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland − HS-Doc. no. 1500.7006000.04260 – 26. Edition / 2020 – 03
flattened surface is observed in the form of two semicircles of similar size in the Fluorescein band too small (2) 2
middle of the visual field (A).
The tear fluid dried during the longer-lasting measuring.
7. Smaller changes in the depth of the slit lamp using the control lever do not affect
the size of the semicircles. Allow the patient to close his eyes a few times and then re-
8. The pressure on the eye is increased by turning the tonometer measuring drum peat the measurement.
until the inner borders of both fluorescein bands just touch = correct setting (B).
9. When the eye pulsates, both semi circles cross over each other. 5.7.1 Wrong distance to patient
10. The width of the fluorescein band around the contact point of the measuring No semi circular image, only centre line is visible (3)
prism should be about 1/10 of the diameter of the applanation surface (0.3 mm).
11. Reading the scale value: The measuring prism is not coming into contact with the cor‑ 3
• Reading the value nea! If the patient draws his head back slightly, irregular pulsa‑
• and multiplying by 10 tions will be caused because the measuring prism is touching
• yields the inter-ocular pressure in mm Hg the eye only intermittently. If the patient retreats even further,
the fluorescein rings will disappear completely.
(A) (B)
Instruct the patient to adopt the correct position.
Measuring prism not centred on the eye, eye still too far to the
right.
Using theAG,
control lever,Switzerland
move the− slit lampno.to the right.
10 © HAAG‑STREIT 3098 Koeniz, HS-Doc. 1500.7006000.04260 – 26. Edition / 2020 – 03
Whole lower semicircle – part of the upper semicircle (7) 7 Correct setting! (14) 13
Measuring prism not centred on the eye, eye still too far to the Two semicircles appear exactly in the middle of the eyepiece.
left.
Using the control lever, move the slit lamp to the left.
5.7.3 Position too high / low Bands are no longer in contact (17) 16
Only part of a semicircle in the upper half (10) 10
Pressure is too high.
Measuring prism not centred on the eye, eye far too high.
Lower the pressure by rotating the tonometer knob in the
Using the control lever, move the slit lamp upwards. opposite direction.
Measuring prism not centred on the eye, eye still too high.
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7006000.04260 – 26. Edition / 2020 – 03 11
12 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland − HS-Doc. no. 1500.7006000.04260 – 26. Edition / 2020 – 03
NOTE!
IP code: IPX0 (device is not protected against liquids)
6 2 0 2 6
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6 2 0 2 6
• Check position 1.95
Move calibration mark 2 on the measuring drum downwards, opposite the fixed in‑
dex, by a width of one marking. With light pressure to the feeler arm in the direction
of free movement, the feeler arm must start to move independently towards the limit
stop in the direction of the examiner.
• Check position 2.05
Move calibration mark 2 on the measuring drum upwards, opposite the fixed index,
by a width of one marking. The feeler arm must start to move into direction of the 1.95 2.05
stop-piece on the patient's side.
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7006000.04260 – 26. Edition / 2020 – 03 15
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7006000.04260 – 26. Edition / 2020 – 03 19
Should you have any further questions, please contact your Haag‑Streit representative at:
http://www.haag-streit.com/contact/contact-your-distributor.html
HAAG-STREIT AG
Gartenstadtstrasse 10
0297 3098 Koeniz, Switzerland
Phone +41 31 978 01 11
Fax +41 31 978 02 82
eMail info@haag-streit.com
Internet www.haag-streit.com
20 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland − HS-Doc. no. 1500.7006000.04260 – 26. Edition / 2020 – 03