HAAG-STREIT

IM 900 Imaging Module Instructions for Use 6 edition June 2019

Instructions for Use

20 Pages

File Type: PDF

File Size: 6.53 MB

File Name: HAAG-STREIT - IM 900 Imaging Module Instructions for Use 6 edition June 2019 - 2019-06.pdf

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Page 1

SVENSKA

NEDERLANDS

PORTUGUÊS

ESPAÑOL

ITALIANO

FRANÇAIS

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ENGLISH

INSTRUCTIONS FOR USE Imaging Module

IM 900 Accessory for the BQ 900 Slit Lamp 6. edition / 2019 – 06

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INSTRUCTIONS FOR USE Imaging Module

IM 900 Accessory for the BQ 900 Slit Lamp 6. edition / 2019 – 06

ITALIANO

ESPAÑOL

PORTUGUÊS

NEDERLANDS

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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, 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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Contents 1.

1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8

2.1 2.2 2.3 2.4 2.5 2.6

3.1 3.2 3.3 3.4 3.4.1

Safety ... 4

Areas of application of the device...4 Ambient conditions...4 Shipment and unpacking...4 Installation warnings ...4 Operation, environment...4 Disinfection...5 Warranty and product liability...5 Description of symbols...5

Introduction... 5

Description of the device...5 System components...5 LED illumination (prerequisite)...6 Camera module CM03...6 Release module RM02...6 Power supply...6

Device assembly / installation... 7

Placement of adhesive label for the automatic left/right detection...7 Connecting the CM03 in the beam path ...7 Weight compensation facility...7 Cabling of the CM03 and the RM02 (diagram)...8 Step-by-step cabling...8

5.9 5.10 5.11 5.12 5.13

LED display release module RM02...11 LED display camera module CM03 ...12 Error messages (illumination head)...12 Error messages release module RM02...12 Error messages camera module CM03 ...13

Decommissioning... 13

Technical data ... 13

Maintenance... 14

Appendix... 14

Statutory requirements... 14

Classification... 15

7.1 7.2 7.3 7.4 8.1 8.2 8.3 A.1

Power supply ...13 Dimensions...13 Minimum PC requirements ...13 Camera...13 Device inspection...14 Servicing...14 Cleaning and disinfection...14 Accessories / consumables / spare parts / upgrade...14

Startup... 9

Disposal... 15

Operation... 10

Observed standards... 15

Information and manufacturer's declaration concerning electromagnetic compatibility (EMC)... 16

4.1 5.1 5.2 5.2 5.3 5.4 5.5 5.5.1 5.5.2 5.6 5.7. 5.8

Switching on the device...9 Changing the image brightness...10 Camera Module CM03...10 Camera Module CM03 30/70...10 Field of view ...10 History trigger ...10 White balance ...10 Slit lamp preparation ...10 Conducting a white balance...11 Software / Help menu / error messages...11 LED display illumination head...11 LED display power supply...11

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F.1 F.2 F.3 F.4 F.5

General...16 Emitted interference (standard table 1)...16 Immunity (standard table 2)...17 Immunity for non-life support devices (standard table 4)...18 Safe distances for non-life support devices (standard table 6)...19

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Safety

Use:

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 to use in professional health care facility environment, like doctor's practices, hospitals and optometrists and opticians premises, except near of HF surgical equipment and RF shielded rooms of ME-systems for magnetic res‑ onance imaging. Some portable radio frequency equipment, like cell phones or RF telephone equipment including antennas may interference medical devices. Such equipment has to be kept in a distance of more than 30 cm (12 inches) from any part of the instrument. Inobservance of this precaution may lower the correct function of the instrument. The software may be stopped or needs to be restarted. If such unex‑ pected disturbances of the software are observed, the cause could be a cell phone or RF telephone in the immediate vicinity to the instrument. Increase the distance to the unit, until the interference disappears. The communication between imaging module and PC may also be disturbed or interrupted, if the device is exposed to a mains power supply delivering excessively transient disturbances or short voltage in‑ terruptions. If this happens, the USB connector needs to be disconnected for a short time or the PC needs to be restarted.

1.2

Ambient conditions

Transport: Storage:

Use:

Temperature Air pressure Relative humidity Temperature Air pressure Relative humidity Temperature Air pressure Relative humidity

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Storage: PORTUGUÊS

from −40°C to +70°C from 500 hPa to 1060 hPa from 10% to 95% from −10°C to +55°C from 700 hPa to 1060 hPa from 10% to 95% from +10°C to +35°C from 800 hPa to 1060 hPa from 30% to 90%

Air pressure Relative humidity Temperature Air pressure NEDERLANDS Relative humidity Temperature Air pressure Relative humidity

from 500 hPa to 1060 hPa from 10% to 95% from −10°C to +55°C fromSVENSKA 700 hPa to 1060 hPa from 10% to 95% from +10°C to +35°C from 800 hPa to 1060 hPa from 30% to 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 Haag-Streit (HS) replacement parts may be used. • The device must not be stacked or placed in close proximity to other electronic devices. • Grounding reliability can only be achieved when unit is connected to NOTE! a hospital grade receptacle. valid formust EU countries). The power supply unit's mains(Not connector 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 device must be switched off after every use. Otherwise there is a risk of overheating when a protective dust cover is used. © HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220551.04060 – 2019 – 06

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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 detec‑ tion works correctly from the release module. • The release module RM02 is affixed with strong magnets. Keep mag‑ net-sensitive storage media (e.g. credit cards) away from the magnet. NOTE! This equipment must only be operated by qualified personnel. The owner is responsible for their training. This device may only be used in accordance with the instructions in "Purpose of use".

1.6

Disinfection

NOTE! The device does not require disinfection. For more information on cleaning, please refer to the 'Maintenance' section.

1.8

Description of symbols Follow instruction for use

Read the instructions for use attentively

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2.1

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ENGLISH

Date of manufacture

Manufacturer

Serial number

HS reference number

European certificate of conformity

ETL Listed Mark with approval for USA and Canada

MET Listed Mark with approval for USA and Canada

Strong permanent magnets

On (Power)

Slit lamp illumination

Background illumination

Plug socket USB 3.0 on RM02 for camera

FRANÇAIS

Notes on disposal, see the 'Disposal' chapter

Plug socket on RM02 for power supply

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. For USA only: • This product is covered by a limited warranty, which may be reviewed at www.haag-streit-usa.com.

ITALIANO

Rotating knob on camera symbol = 70 % of the light goes to the camera Plug socket USB 3.0 micro B on RM02 for computer

Introduction

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 5

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1 2

2.3

3 4

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

10 11 12 13 14

Release module RM02

12. Release module RM02 13. Sticker left/right identification 14. Cable harness

2.6

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

15 14

16 15

Power supply

15. Power supply 16. Mains connector (country-dependent)

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Device assembly / installation

3.2

WARNING!

• Do not modify this equipment without authorization of the manufacturer. Installation and repairs may only be performed by trained specialists. Contact your Haag-Streit representative for installation, repairs and modification work on the system. The contact details are available at www.haag-streit.com. • Only original Haag-Streit replacement parts may be used.

3.1

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DEUTSCH

Connecting the CM03 in the beam path

17. Protective film 19. Roller rail 18. Rest of the sticker 20. Gliding plate • Remove rail cover (5) and place slit lamp aside. Clean surface of table. • Remove protective film (17) from the back of the adhesive label. Carefully start at the corner opposite the black surface. • Position the sticker against the right roller rail (19) and the gliding plate (20). Press firmly on the white/black surface, press away any air bubbles. • Carefully tear off the remainder of the adhesive label (18) (the 'positioning tool') along the perforation. • Reassemble the slit lamp and rail cover.

ENGLISH

21. Cover caps 22. Marking points 23. Arrow (lock) • Disassemble the breath shield. • Remove the black and white cover caps (21). • Align the marking points (22) on the upper side of the parts to be connected. • Turn the locking ring in the direction of the arrow shown (23) to tighten.

Placement of adhesive label for the automatic left/right detection

ITALIANO

23 22

3.3

Weight compensation facility

24. Setting screws weight compensation facility The slit lamp's crosstree carriage offers the option of bal‑ ancing the weight of the accessory so that the height ad‑ justment on the joystick remains smooth (24). To do so, please follow the instructions in the instruction manual for the slit lamp.

20 5 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220551.04060 – 2019 – 06

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3.4

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Cabling of the CM03 and the RM02 (diagram)

WARNING! • Only use the supplied USB 3.0 cable (REF 1022373) for the con‑ nection to the PC.Only use medically approved PCs or operate via a medically approved isolating transformer. • Auxiliary units on the PC (e.g. printer, monitor) must be operated through an isolating transformer. • Ethernet may only be used through a galvanic isolation in accor‑ dance with EN 60601-1. • The power supply unit's mains connector must be accessible in order to allow for disconnection from the electric mains at any time!

25. Power grid 32. Local network 26. Med. approved isolating transformer 33. Galvanic isolation (EN 60601-1) 27. Instrument table (IT) 34. Headrest 28. Med. approved power supply 35. Cable headrest / LED illumination / 29. Printer RM02 30. Screen 36. Release module RM02 31. Personal computer 37. LED illumination 38. Camera module CM03 26

36 28

NOTE! To ensure that the system works correctly, Haag‑Streit recommends not using laptops and using a high-quality desktop computer instead. 8

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NEDERLANDS

39. Fastening screw 40. Two-pole connection plug

SVENSKA 39 38

180°

If the middle LED lights up red during 39 40 operation, the two-pole connection 11 plug (40) is connected incorrectly. • Disconnect the device from the pow‑ er grid. • Remove the cover on the upper part of the illumination facility by loosen‑ ing the fastening screw (39). • Turn the two-pole connection plug (40) 180°. • Fix the cover on the upper part of the illumination facility with the fastening screw (39). • Connect the device to the power grid again. WARNING! • Keep magnet-sensitive storage media (e.g. credit cards) away from the magnets on the release module RM02! • Only external medical power supplies approved by Haag-Streit that fulfill EN 60601-1 may be used.

3.4.1 Step-by-step cabling • Place the release module RM02 over the slit lamp's cross slide. Four magnets are

29 34

PORTUGUÊS

used for fixing. NOTE! • No external USB devices may be connected to USB ports (59) and (61). • With BQ 900 slit lamps with a date of manufacture before 1998, the cover plate is fixed on the crosstree carriage with screws. The two screws at the back must be removed before the RM02 is mounted.

• Insert the camera cable connector plug (50) in the socket (59). • Press the camera cable into the cable holders (49). • Computer cable USB 3.0 (47), power supply cable (46) and cable headrest / LED illumination / RM02 (45) must be fed through in the braided sleeving (44).

• Insert the connector plug of the power supply cable (46) in the socket (59). • Insert the connector plug of the computer cable USB 3.0 (47) in the socket (60). • Pull on the braided sleeving taught and mount a cable tie (43) on each end. © HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220551.04060 – 2019 – 06

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• Connect the headrest cable (42) with the counterpart (40) on the headrest. • Mount the table top and place the slit lamp on the table. • Connect the computer cable USB 3.0 (47) to the PC. • Connect the electric power supply lead (15) to the power supply (14). • Connect the power supply connector plug to the power grid. • Plug the headrest cable (1) into the lamp head.

41 42 43 44 45 46 47

48 49 50 51

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DEUTSCH

50 52 53 47 46 45

53. On/Off key 41. Connection plug headrest 42. Connector plug headrest / LED illumi‑ 54. Rotating knob, periphery or back‑ ground illumination nation / RM02 43. Cable tie 55. Rotating knob, slit illumination 44. Braided sleeving 56. Selector key A 45. Cable headrest / LED illumination / 57. Selector key B 58. Release key RM02 RM02 46. Power supply cable 59. Socket camera cable 47. Computer cable USB 3.0 60. Socket for power supply connec‑ 48. Camera (not shown) tor plug 49. Recess on the microscope arm 61. Socket computer cable USB 3.0 50. Connector plug camera cable micro B 51. Release module RM02 62. Threaded bolt 52. RM02 operational control LED 63. Pin assignment 64. Cable cover 47

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54 55 56 57 58 57 56 59 60 61 45

15 14

ENGLISH

16 15

Startup

4.1 Switching on the device • Connect the power supply to the power grid and press the On/Off key (53) on the release module RM02. The green operational control LED (52) illuminates when the device is switched on. The camera has no On/Off key and switches on au‑ tomatically when the PC is switched on. The status is displayed by the indicator light (8). • Turn the rotating knob on the slit illumination (55) to a position between '1' and '10'. 7

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Operation

5.1

Changing the image brightness

5.2

FRANÇAIS

ITALIANO

ESPAÑOL

NOTE! The slit lamp's eyepieces must be adjusted in accordance with the re‑ fraction of the examiner. See instructions for use for the slit lamp BQ 900 or BP 900.

SVENSKA

Object image section in the eyepiece (mm)

Object image section in the camera

12.5 ×

Recording mode 4:3

ø 33 ø 20 ø 12.7 ø8 ø 5.1

34 × 46 21 × 28 13 × 17.5 8.3 × 11 5.2 × 7

Camera Module CM03

Camera Module CM03 30/70

Set the switch (7) beam splitter to the camera symbol • 30% of the light goes to the camera and • 70% to the examiner Switch (7) beam splitter to the top • 100% of the light goes to the examiner (applies to both beam paths)

5.3

NEDERLANDS

6.3 × 10 × 16 × 25 × 40 ×

Select a diaphragm with the knob. 1 = Largest diaphragm (lowest depth of sharpness) 6 = Smallest diaphragm (highest depth of sharpness) Select the exposure time on the Release Module RM02. Image via trigger key on the Release Module RM02

Set the switch (7) beam splitter to the camera symbol • 70% of the light goes to the camera and • 30% to the examiner Switch (7) beam splitter to the top • 100% of the light goes to the examiner (applies to both beam paths)

5.2

PORTUGUÊS

Field of view WARNING! The images and videos should only be used for documentation purposes. Only the image in the eyepiece may be used for diagnosis.

Field of view of the object, see table Circle: The field of view of the object observed through the microscope's eyepiece. Rectangle: Surface area of the sensor:

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5.4 History trigger • Press the release key (58) on the release module RM02 • Select the desired image via selector key (56) or (57) • Press the release key (58) on the release module RM02 again – the image is saved

5.5

White balance

The Haag‑Streit IM 900 is optimized for maximum image quality with the Haag‑St‑ reit slit lamp BQ 900 and BP 900. The image quality is dependent, among other things, on the correct calibration of the color tones to the respective slit lamp illumi‑ nation. We recommend performing a white balance in order to improve the image quality and achieve a realistic color reproduction.

5.5.1 Slit lamp preparation 1. 2. 3. 4. 5. 6. 7.

Turn on the slit lamp Filter position ‹open› (no filter) Set magnification to 16 × Completely open the slit diaphragm Connect the diffuser upstream Position the Haag‑Streit greycard in front of the slit lamp and use it for focusing The brightness of the slit lamp's illumination should be set in such a way that the greycard's structure is clearly discernible. © HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220551.04060 – 2019 – 06

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5.5.2 Conducting a white balance

8. Start the ‹EyeSuite Imaging› software 9. Activate the intensity auto mode 10. Open the ‹White balance› application 11. Start the ‹White balance› by activating the ‹Calibration› function WARNING! To achieve an optimal result during the white balance, the image must be homogeneously illuminated.

ESPAÑOL

ITALIANO

5.7. LED display illumination head

a) b) c)

FRANÇAIS

DEUTSCH

Green, short flashes

ENGLISH c)

Slit lamp illumination

PORTUGUÊS

Polarity

NEDERLANDS

Periphery or background illumination

SVENSKA

Operating status Standby mode Normal operation Slit and periphery or background illumi‑ nation on

Set white balance greycards REF 1021485

Only slit illumination on Only periphery or background illumi‑ nation on

Image is blurry or overexposed

5.6

Structure is discernible

Software / Help menu / error messages

The software's Help section contains instructions and guidance for performing an examination as well as descriptions of the error messages. Help can be opened by pressing the F1 key or by going to the [?] - [Help] menu. WARNING! The software must be installed by trained personnel in accordance with separate installation instructions.

Reduced periphery or background illumination operation High LED temperature, thus reducing periphery or background illumination operation

5.8

Green

Green, flashing

5.9

× ×

Green

Green Green, short flashes

Green, flashing

LED display power supply Green

LED display release module RM02

Normal operation

Establishing connection

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Green, short flashes

Normal operation

LED illumination switched off

Green

Green, short flash‑ es

Green Green, pulsing Orange

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5.10 LED display camera module CM03 Normal operation

Green

Establishing connection

Orange

Measures

Incorrect supply polarisation

Contact your Haag‑Streit representative.

× Red

Illumination control not recognized

Connect illumination control or replace, if necessary.

Temperature is too high

No communication between power supply and illumination

The light sources’ power will be reduced. Normal operation is ensured once the permissible temperature has been reached.

General error

Slit lamp illumination

Error messages

Polarity

ERROR

a) b) c)

Periphery or background illumination

5.11 Error messages (illumination head)

Contact your Haag‑Streit representative.

Red, flashing Red, flashing 2 × Red, flashing 4 ×

Send PS-LED to the appropriate service branch.

Red × × × ×

× Red Red, flashing Red, flashing 2 × Red, flashing 4 ×

ERROR

5.12 Error messages release module RM02 Error messages

Measures

E14

No communication with LED illumination LI01 plus / LI02 plus

Contact your Haag‑Streit representative.

E16

General error

Send device to the appropriate service branch.

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Operational control LED (75) Red, flashing 2 × Red, flashing 4 ×

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ENGLISH

ERROR

5.13 Error messages camera module CM03 Error messages

Measures

E18

No communication with LED illumination LI01 plus / LI02 plus

Contact your Haag‑Streit representative.

Decommissioning

Press the On/Off key (53) on the release module RM02 briefly to switch off the LED illumination after the examination. This does not switch off the camera. This is sig‑ naled with pulsing green flashing. Pressing the key for approx. 3 sec. switches off the release module completely and the operational control LED (52) goes out. The camera has no separate On/Off switch. It switches off automatically when the PC is switched off. NOTE! The On/Off key on the release module RM02 does not disconnect the device from the electric mains. Disconnect the power supply from the power grid by unplugging the mains connector if you do not intend to use it for an extended period of time.

7.1

Technical data Power supply

Type Model Mains voltage Current consumption Operating frequency

7.2

ICCNEXERGY, ELPAC POWER SYSTEMS, MWA030018B-10A REF 1022106 100 − 240 V 0.8 A 50 − 60 Hz

Dimensions

Camera module CM03 Weight: 2.6 kg (incl. packaging) Dimensions L × W × H: 190 × 127 × 76 mm Packaging L × W × H: 380 × 270 × 130 mm

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7.3

Operational control LED (26)

Minimum PC requirements

Processor type

RAM

Hard disk Graphics Monitor Operating system PCI slot PCI Express card

7.4

Red

Camera

Camera beam: Interface: Frame rate: Power consumption:

Intel i5, 5th gen or higher with 4 cores. Note: 6th gen is not recommended. 2 cores with hyperthreading are not recommended. 8 GB RAM if PC is exclusively used to operate the imag‑ ing module. 16 GB RAM if third-party applications such as patient ad‑ ministration software are to be used alongside EyeSuite. Use 2 RAM module. At least 500 GB (NTFS data system). Graphics card with at least 2 GB memory (Nvidia or AMD chip set recommended). OpenGL 2.0 At least 19", 1920 × 1080 pixel resolution. Windows 7, Windows 8.1, Windows 10. 64-bit system only. PCI-Express 3.0 Chip set by Renesas / NEC. Beam path right (from the point of view of the doctor) USB 3.0 30 fps (frames per second) / 420 mA 5V

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DEUTSCH

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ESPAÑOL

PORTUGUÊS

Maintenance WARNING!

Installation and repairs may only be performed by trained specialists. Contact your Haag-Streit representative for installation, repairs and modification work on the system. The contact details are available at www.haag-streit.com. • Only original Haag-Streit replacement parts may be used.

Device inspection

To check the correct function, proceed as follows: • Insert the test piece in the radial movement bearing, while aligning the surface at a right-angle to the Microscope • Set the slit length to 8 or 14mm • Illumination intensity to 50% • Set the magnification of the Microscope to max. • Set the ocular so that the structure on the test piece is shown in focus. In doing so, turn the ocular from the (+) to the (-) side. • Switch on camera • For all magnifications, the structure of the test piece in the ocular and in the cam‑ era image must be sharply imaged • Turn on the illumination of the 0.2mm diaphragm • Turn on the crosshairs in EyeSuite, the cross must be inside the illuminated dot

8.2

Servicing

To ensure a long service life, the device should be cleaned weekly as described and covered with a dust cover when not in use. We recommend having the device in‑ spected by an authorized service technician annually.

8.3

Cleaning and disinfection

The Haag-Streit slit lamps and their accessories can, if required, be carefully wiped down with ready-for-use disposable 70% ethanol disinfectant wipes. Surface-friend‑ ly disinfectants (containing aldehyde or aldehyde-free) are also permitted, such as Kohrsolin FF.

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SVENSKA

WARNING! • The preparation instructions provided do not apply to tonometer mea‑ suring prisms! • Tonometer measuring prisms must be prepared in accordance with a different manual • Do not use sprays • Observe the manufacturer's safety instructions • Do not use any cloths that drip. • Wring out any soaked cloths before use when necessary • Ensure that no liquid penetrates the device • Comply with the stipulated exposure time • Clean optical surfaces after disinfection with a very soft cloth

• Do not modify this equipment without authorization of the manufacturer.

8.1

NEDERLANDS

NOTE! IP code: IPX0 (device is not protected against liquids)

Appendix

A.1 Accessories / consumables / spare parts / upgrade Components

Set white balance greycards Power supply ICCNEXERGY Computer cable USB 3.0 Release module RM02

REF

1021485 1022106 1022373 7220546

Statutory requirements

• The imaging module IM 900 was designed and built taking the EN 60601-1 and EN 60601-1-2 standards into account.

• The EN 60601-1 standard must be observed when using different medical and/or non-medical electrical devices in combination.

• Compliance of the imaging module IM 900 with the Directive 93/42/EEC is con‑ firmed by the CE-designation.

• You can request a copy of the declaration of conformity for this instrument from Haag‑Streit at any time.

• Statutory accident regulations are to be observed.

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WARNING! The imaging module IM 900 may only be operated in an environment in which standard values pursuant to standard EN 60601-1 are ob‑ served.

Classification

Standard EN 60601-1

Slit lamp accessories as per protection class I

Operating mode

Continuous operation

CE Directive 93/42/EEC

Class I

FDA

Accessory for slit lamps

Disposal

Observed standards

Electrical and electronic devices must be disposed of separately from household waste! This appliance was made available for sale after the 13th 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. EN 60601-1

EN 60601-1-2

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Information and manufacturer's declaration concerning electromagnetic compatibility (EMC) General

The Imaging Module IM 900 system fulfills the requirements on electromagnetic compatibility according to EN 60601-1-2:2007 (IEC 3. Edition) + EN 60601-1-2:2015 (IEC 4th Edition). The instrument is built so that the generation and emission of elec‑ tromagnetic interference is limited to the extent that other devices are not disturbed in their use in accordance with the regulations and so that the instrument itself is suitably immune to electromagnetic interference. WARNING! Avoid damages due to high electrostatic discharges (ESD). Electrosta‑ tic discharges with voltages exceeding 6 kV to some parts of the slit lamp like joystick or metallic parts on the instrument base may influen‑ ce the instrument. • The communication between Imaging Module and PC could be inter‑ rupted, which would require a restart of the EyeSuite software.

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WARNING! • Electrical medical devices and systems are subject to special EMC measures and must be installed in accordance with the EMC instructions 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 interference. • Third-party devices may only be connected in compliance with the EN 60601-1 standard.

Emitted interference (standard table 1)

The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rd edition) and EN 60601-1-2:2015 (IEC 4th 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 environment. Emission test RF emissions CISPR 11

Compliance Group 1

RF emissions CISPR 11 Emission of harmonics according to EN 61000-3-2

Class A Class A

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Electromagnetic environment - guidance 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. 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.

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Immunity (standard table 2)

EN 60601 test level ± 6 kV contact ± 8 kV air

Compliance level ± 6 kV contact ± 8 kV air

Electrical fast transient / burst EN 61000-4-4 Surge EN 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply lines EN 61000-4-11

± 2 kV for power supply lines

± 1 kV for symmetrical voltages

< 5% UT (> 95% drop in UT) for ½ cycle < 40% UT (> 60% drop in UT) for 5 cycles < 70% UT (> 30% drop in UT) for 25 cycles < 5% UT (> 95% drop in UT) for 5 s 3 A/m

< 5% UT (> 95% drop in UT) for ½ cycle < 40% UT (> 60% drop in UT) for 5 cycles < 70% UT (> 30% drop in UT) for 25 cycles < 5% UT (> 95% drop in UT) for 5 s 100 A/m

Power frequency (50/60Hz) magnetic field EN 61000-4-8

Electromagnetic environment – guidance Floors should be wood, concrete or ceramic tile. If floors are covered withs ynthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. 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 uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT= the AC mains voltage prior to application of the test level.

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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 specified below. The customer or the user of this product should assure that it is used in such an environment. 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 calculated from the equation applicable to the frequency of the transmitter. Immunity test standard Conducted RF EN 61000-4-6 Radiated RF EN 61000-4-3

EN 60601 test level 3 Vrms 150 kHz – 80 MHz 3 V/m 80 MHz – 2.7 GHz

Compliance level 5 Vrms

Recommended distance(c): D = 0.7

3 V/m 80 MHz – 2.7 GHz

D = 1.2 D = 2.3

80 MHz – 800 MHz 800 MHz – 2.7 GHz

Where P is the maximum output power rating of thet ransmitter in watts (W) according to the transmitter manufacturer and D is the recommended separation distance in metres (m). Field strengths from fixed 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 fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field 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. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 5 Veff. c. Possible shorter distances outside the ISM bands do not contribute to improved application in this table.

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Safe distances for non-life support devices (standard table 6)

The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rd edition).

Recommended safe distances between portable and mobile HF communication devices and this device. This product is designed to be operated in an electromagnetic environment in which radiated HF interference is controlled. The customer or user of this product can help to prevent electromagnetic interference by maintaining minimum distances between portable and mobile HF communication systems (transmitters) and this product, as recommended below in accordance with the maximum output of the communication system. Safe distance according to transmission frequency (m) 80 MHz – 800 MHz 800 MHz – 2.5 GHz 150 kHz – 80 MHz Nominal output of the transmitter (W) D = 1.2 D = 2.3 D = 0.7 0.01 0.07 0.12 0.23 0.1 0.22 0.38 0.73 1 0.7 1.2 2.3 10 2.2 3.8 7.3 100 7 12 23 For transmitters with a nominal output not listed in the table above, the distance D can be calculated in meters (m) using the equation for the respective column, in which P is the nominal output of the transmitter in watts (W) NOTE 1: At 80 MHz and 800 MHz the higher frequency applies. NOTE 2: To calculate the recommended safe distance of transmitters in the frequency range of 80 MHz to 2.5 GHz an additional factor of 10/3 was used to reduce the probability of a mobile/portable communication device causing interference if inadvertently brought into the patient area. NOTE 3: These guidelines may not apply in all situations. Electromagnetic wave propagation is influenced by absorption and reflection of buildings, objects and people.

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Should you have any further questions, please contact your Haag‑Streit representative at:

http://www.haag-streit.com/contact/contact-your-distributor.html

Phone Fax eMail Internet 20

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HAAG-STREIT AG Gartenstadtstrasse 10 3098 Koeniz, Switzerland +41 31 978 01 11 +41 31 978 02 82 [email protected] www.haag-streit.com

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