Haag-Streit AT 870, AT 900 Instructions For Use Manual
1
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7006000.04220 – 22. Edition / 2016 – 06
INSTRUCTIONS FOR USE
Applanation tonometer
AT 900® / 870
22. Edition / 2016 – 06
01-IFU_AT900-7006000-04220_eng.indd 1 09.06.2016 13:50:52
2
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland − HS‑Doc. no. 1500.7006000.04220 – 22. Edition / 2016 – 06
INSTRUCTIONS FOR USE
Applanation tonometer
AT 900® / 870
22. Edition / 2016 – 06
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 device is an accessory to slit lamps used to measure intraocular pressure.
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 qualied medical personnel.
WARNING!
Read the instruction manual carefully before commissioning this product. 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.
01-IFU_AT900-7006000-04220_eng.indd 2 09.06.2016 13:50:52
3
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7006000.04220 – 22. Edition / 2016 – 06
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 ............................................................................................4
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
3. Appliance assembly / installation ..........................7
3.1 AT 900 Model R .....................................................................................7
3.2 AT 900 Model T ......................................................................................7
3.3 AT 900 Model BQ ...................................................................................7
3.4 Tonometer AT 870 .................................................................................7
3.5 Which slit lamp with which tonometer ....................................................8
3.6 Description of models ............................................................................8
4. Commissioning ........................................................8
5. Operation .................................................................8
5.1 Measuring tips ........................................................................................8
5.2. Astigmatism ...........................................................................................9
5.3 How pressure is measured ....................................................................9
5.4 Preparing the patient ..............................................................................9
5.5 Patient instructions .................................................................................9
5.6 Preparation of the tonometer .................................................................9
5.7 Measuring correctly ..............................................................................10
5.8 Sources of error ...................................................................................11
5.8.1 Wrong distance to patient ...................................................................11
5.8.3 Position too high / low ..........................................................................12
5.8.4 Incorrect pressure ................................................................................12
6. Technical data ........................................................12
6.1 Applanation tonometer AT 900 .............................................................12
6.2 Applanation tonometer AT 870 .............................................................13
7. Maintenance ...........................................................13
7.1 Repairs .................................................................................................13
7.2 Cleaning ...............................................................................................13
7.3 Checking the Tonometer AT 900 ..........................................................14
7.4 Checking the Tonometer AT 870 ..........................................................15
A. Appendix ................................................................17
A.1 Accessories – Original HAAG‑STREIT measuring prisms ...................17
A.2 Accessories – Tonosafe .......................................................................17
B. Legal regulations ...................................................17
C. Classication .........................................................17
D. Disposal ..................................................................17
E. Standards ...............................................................17
Contents
01-IFU_AT900-7006000-04220_eng.indd 3 09.06.2016 13:50:52
4
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland − HS‑Doc. no. 1500.7006000.04220 – 22. Edition / 2016 – 06
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 device 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 appliances
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 7.3.
1.4 Installation warnings
WARNING!
Do not modify this equipment without authorization of the manufacturer.
Installation and repairs may only be performed by trained specialists.
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
discretion and consideration in cases of active infections and lesions
of the eye. Certain conditions could falsify measured values and the
procedure 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.
• Strong magnetic elds may falsify the measurement results.
NOTE!
This appliance must only be operated by qualied and trained personnel.
The owner is responsible for their training.
1.6 Disinfection
NOTE!
The device does not need to be disinfected. For more information on
cleaning, please refer to the 'Maintenance' chapter.
01-IFU_AT900-7006000-04220_eng.indd 4 09.06.2016 13:50:53
5
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7006000.04220 – 22. Edition / 2016 – 06
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
becleanedanddisinfectedbeforetheirrstuseinaccordance
with the separate instructions for use on the cleaning and disinfection of tonometer measuring prisms, contact glasses, and
DESINSET (HS item no. 7220315).
• Preparation may only be conducted by qualied 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 efcient 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
instructions for use “Cleaning and disinfection” and to our “List of Dis‑
infectants”. The efcacy 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 edg‑
es). This must be performed with a slit lamp microscope at 10x to
16xmagnication.
01-IFU_AT900-7006000-04220_eng.indd 5 09.06.2016 13:50:54
6
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland − HS‑Doc. no. 1500.7006000.04220 – 22. Edition / 2016 – 06
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 concen‑
tration 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 mea‑
suring 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 service life applies
subject to normal conditions of use, i.e., in compliance with the instruc‑
tions contained in these instructions for use. The service life starts with
the rst use. The above-mentioned time periods do not apply to damaged
measuring prisms; these must be immediately replaced.
2015 - 10
Service life:
Maximum two years
Service life:
Maximum two years
First use
First use
Replace
Replace
Year:
1.6.4 Tonosafe
NOTE!
T onosafe was developed to avoid the necessary cleaning
and disinfection of measuring prisms from applanation to‑
nometers. T onosafe is a disposable applanation and opti‑
cal duplication prism for Goldmann and Perkins applana‑
tion tonometers, for single use.
Additional details can be found in the separate instruc‑
tions 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 r epresentative.
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 handling 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
European certificate of
conformity
Manufacturer
Year of production
Serial number
HS reference number
LOT number
Expiry date (2017-10 = end of
October 2017)
01-IFU_AT900-7006000-04220_eng.indd 6 09.06.2016 13:50:57
Loading...