Haag-Streit IM-900 User manual

1
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220551.04020 – 2016 – 08
INSTRUCTION MANUAL Imaging Module
IM 900
Accessory for the BQ 900 Slit Lamp
2. edition / 2016 – 08
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2
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220551.04020 – 2016 – 08
INSTRUCTION MANUAL Imaging Module
IM 900
Accessory for the BQ 900 Slit Lamp
2. edition / 2016 – 08
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
This device is an accessory for HAAG‑STREIT slit lamps BQ 900 or BP 900, which can be used to produce digital photographs and videos for documentation of the eye.
Contraindication
There are no absolute contraindications known for examinations with this device. Appropriate professional assessment and caution are necessary.
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.
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220551.04020 – 2016 – 08
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
1.7 Warranty and product liability ..................................................................................5
1.8 Symbols ..................................................................................................................5
2. Introduction ..........................................................................5
2.1 Description of the device .........................................................................................5
2.2 System components ...............................................................................................5
2.3 LED illumination (prerequisite) ................................................................................6
2.4 Camera module CM03 ...........................................................................................6
2.5 Release module RM02 ...........................................................................................6
2.6 Power supply ..........................................................................................................6
3. Device assembly / installation ............................................7
3.1 Placement of adhesive label for the automatic left/right detection ..........................7
3.2 Connecting the CM03 in the beam path ................................................................7
3.3 Weight compensation facility...................................................................................7
3.4 Cabling of the CM03 and the RM02 (diagram) .......................................................8
3.4.1 Step‑by‑step cabling ...............................................................................................8
4. Startup .................................................................................. 9
4.1 Switching on the device ..........................................................................................9
5. Operation ............................................................................10
5.1 Beam splitter 70/30 ...............................................................................................10
5.2 Field of view .........................................................................................................10
5.3 History trigger .......................................................................................................10
5.4 White balance ......................................................................................................10
5.4.1 Slit lamp preparation ............................................................................................10
5.4.2 Conducting a white balance ..................................................................................10
5.5 Software / Help menu / error messages................................................................11
5.6 LED display illumination head ...............................................................................11
5.7 LED display power supply .....................................................................................11
5.8 LED display release module RM02 .......................................................................11
5.9 LED display camera module CM03 .....................................................................12
Contents
5.10 Error messages (illumination head) ......................................................................12
5.11 Error messages release module RM02.................................................................12
5.12 Error messages camera module CM03 ...............................................................13
6. Decommissioning ..............................................................13
7 Technical data ...................................................................13
7.1 Power supply .......................................................................................................13
7.2 Dimensions ...........................................................................................................13
7.3 Minimum PC requirements ..................................................................................13
7.4 Camera .................................................................................................................13
8. Maintenance .......................................................................14
8.1 Servicing ...............................................................................................................14
8.2 Cleaning ................................................................................................................14
A. Appendix ............................................................................ 14
A.1 Accessories ...........................................................................................................14
B. Statutory requirements ..................................................... 14
C. Classication ..................................................................... 14
D. Disposal ..............................................................................14
E. Observed standards .......................................................... 14
F. Information and manufacturer's declaration ................. 15
concerning electromagnetic compatibility (EMC) .......... 15
F.1 General .................................................................................................................15
F.2 Emitted interference (standard table 1) .................................................................15
F.3 Interference immunity (standard table 2) ..............................................................16
F.4 Interference immunity for non‑life‑supporting devices (standard table 4) .............17
F.5 Safe distances for non‑life‑supporting devices (standard table 6) ........................18
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220551.04020 – 2016 – 08
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 device, check whether the packaging shows traces of in‑
correct handling or damage. If this is the case, notify the transport company that has delivered the goods to you. Unpack the device together with a representative of the transport company. Prepare a report for any possible 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 device for damage after it is unpacked. Return defective devices in the
appropriate packaging.
Store packaging material carefully, so that it can be used for possible returns or
when moving.
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. Any third-party device must be connected in compliance with the EN 60601-1 standard. Only original HS replacement parts may be used. The device must not be stacked or placed in close proximity to other
electronic devices.
NOTE!
The power supply unit's mains connector must be accessible in order to allow for disconnection from the mains at any time!
1.5 Operation, environment
DANGER!
Never use the device in potentially explosive environments where vola­tile solvents (alcohol, petrol, etc.) and flammable anaesthetics are in
use.
WARNING!
The imaging module is intended for documentation purposes. The
ocular image is critical for diagnosing a patient!
Before every examination, check that the automatic left to right de‑
tection works correctly from the release module!
The release module RM02 is afxed with strong magnets. Keep mag‑
net‑sensitive storage media (e.g. credit cards) away from the mag‑ nets!
NOTE!
This equipment must only be operated by qualified and trained person­nel. The owner is responsible for their training. This device may only be used in accordance with the instructions in "Purpose of use".
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220551.04020 – 2016 – 08
1.6 Disinfection
NOTE!
The device does not require disinfection. For more information on cleaning, please refer to the 'Maintenance' section.
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
Notes on disposal, see the
'Disposal' chapter
This appliance fulfills the Euro-
pean Directive 2011/65/EU
(RoHS)
Year of production Manufacturer
European certificate of
conformity
Earth (ground)
Direct current
Not protected from foreign
bodies
Serial number
HS reference number
Strong permanent magnets
Plug socket USB 3.0 micro B on RM 02 for computer
Plug socket on RM 02 for
power supply
Slit lamp illumination
Background illumination
Rotating knob on camera sym-
bol = 70 % of the light goes to
the camera
2. Introduction
2.1 Description of the device
The system allows for creation of digital images and videos that can be viewed in the right beam path of the microscope: The divider mirror can be switched off with a switch (rotating knob) so that 100% of the light reaches the eyepiece. With the re‑ lease module, it is possible to release images or videos and to change the camera's exposure time without letting go of the joystick.
2.2 System components
The imaging module IM 900 is a system made up of the following main compo‑ nents: A. Camera module CM03 B. Release module RM02 C. EyeSuite software D. Power supply
AB
CD
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220551.04020 – 2016 – 08
2.3 LED illumination (prerequisite)
1. Lamp cable with special connection plug for LI01 plus / LI02 plus
2. LED illumination head with periphery or background illumination (see separate instructions for use)
3. Fiber optic line for periphery or background illumination
4. Headrest (see separate instructions for use)
5. Rail cover
2.4 Camera module CM03
6. Camera module CM03
7. Switch (rotating knob) beam splitter
8. Diaphragm selection knob
9. Operational control LED
10. Camera cable (CM03 to RM02)
11. Cable holder
2.5 Release module RM02
12. Release module RM02
13. Sticker left/right identication
14. Cable harness
2.6 Power supply
15. Power supply
16. Mains connector (country‑dependent)
6 7 8 9 10 11 12 13 14
1 2 3 4
5
14 15
15 16
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