Haag-Streit IM 900 Manual de usuario

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INSTRUCTIONS FOR USE

Imaging Module

IM 900

Accessory for the BQ 900 Slit Lamp

5. edition / 2018 – 04

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INSTRUCTIONS FOR USE

Imaging Module

IM 900

Accessory for the BQ 900 Slit Lamp

5. edition / 2018 – 04

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 pro-

duct. It contains important information regarding the safety of the user

and patient.

NOTE!

Federal law restricts this device to sale by or on the order of a physician

or licensed practitioner.

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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 Description of symbols............................................................................................5

2. Introduction.......................................................................... 5

2.1 Description of the device.........................................................................................5

2.2 System components ...............................................................................................6

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 Changing the image brightness ............................................................................10

5.2 Beam splitter CM03 1022538 ...............................................................................10

5.2 Beam splitter CM03 30/70 1023272 .....................................................................10

5.3 Field of view .........................................................................................................10

5.4 History trigger .......................................................................................................10

5.5 White balance ......................................................................................................10

5.5.1 Slit lamp preparation ............................................................................................10

5.5.2 Conducting a white balance..................................................................................11

5.6 Software / Help menu / error messages................................................................11

5.7. LED display illumination head...............................................................................11

5.8 LED display power supply.....................................................................................11

Contents

5.9 LED display release module RM02.......................................................................11

5.10 LED display camera module CM03 .....................................................................12

5.11 Error messages (illumination head) ......................................................................12

5.12 Error messages release module RM02.................................................................12

5.13 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 and disinfection......................................................................................14

A. Appendix...............................................................................................................14

A.1 Accessories...........................................................................................................14

B. Statutory requirements ..................................................... 14

C. Classication ..................................................................... 14

D. Disposal.............................................................................. 15

E. Observed standards.......................................................... 15

F. Information and manufacturer's declaration

concerning electromagnetic compatibility

(EMC) .................................................................................. 16

F.1 General .................................................................................................................16

F.2 Emitted interference (standard table 1).................................................................16

F.3 Immunity (standard table 2) ..................................................................................17

F.4 Immunity for non‑life support devices (standard table 4) ......................................18

F.5 Safe distances for non‑life support devices (standard table 6) .............................19

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1. Safety

DANGER!

Failure to comply with these instructions may result in material damage

or pose a danger to patients or users.

WARNING!

These warnings must absolutely be complied with to guarantee

safe operation of the product and to avoid any danger to users and to

patients.

NOTE!

Important information: please read carefully.

1.1 Areas of application of the device

The device is intended 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: Temperature

Air pressure

Relative humidity

from

−40°C

500 hPa

10%

+70°C

1060 hPa

95%

Storage:

Temperature

Air pressure

Relative humidity

from

−10°C

700 hPa

10%

+55°C

1060 hPa

95%

Use: Temperature

Air pressure

Relative humidity

from

+10°C

800 hPa

30%

+35°C

1060 hPa

90%

Transport: Temperature

Air pressure

Relative humidity

from

−40°C

500 hPa

10%

+70°C

1060 hPa

95%

Storage:

Temperature

Air pressure

Relative humidity

from

−10°C

700 hPa

10%

+55°C

1060 hPa

95%

Use: Temperature

Air pressure

Relative humidity

from

+10°C

800 hPa

30%

+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 vola-

tile 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.

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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 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 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.

1.7 Warranty and product liability

Haag-Streit products must be used only for the purposes and in the manner des-

cribed in the documents distributed with the product.

The product must be treated as described in the ‘Safety’ chapter. Improper hand-

ling can damage the product. This would void all guarantee claims.

Continued use of a product damaged by incorrect handling may lead to personal

injury. In such a case, the manufacturer will not accept any liability.

Haag-Streit does not grant any warranties, either expressed or implied, including

implied warranties of merchantability or fitness for a particular use.

Haag-Streit expressly disclaims liability for incidental or consequential damage

resulting from the use of the product.

This product is covered by a limited warranty granted by your seller.

This product is covered by a limited warranty, which may be reviewed at

www.haag-streit-usa.com.

•

For US

A only:

•

1.8 Description of symbols

Follow instruction for use

Read the instructions for use

attentively

Notes on disposal, see the

'Disposal' chapter Date of manufacture

Manufacturer Serial number

HS reference number

European certificate of

conformity

ETL Listed Mark with approval

for USA and Canada

Test symbol of CSA with

approval for USA

Strong permanent magnets On (Power)

Slit lamp illumination Background illumination

Plug socket on RM02 for

power supply

Rotating knob on camera sym-

bol = see chapter 5.2 and 5.2.1

Plug socket USB 3.0 on RM02

for camera

Plug socket USB 3.0 micro

B on RM02 for computer

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.

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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

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)

14 15

15 16

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3. Device assembly / installation

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 HS replacement parts may be used.

•

3.1 Placement of adhesive label for the automatic

left/right detection

17. Protective lm

18. Rest of the sticker

19. Roller rail

20. Gliding plate

• Remove rail cover (5) and place slit lamp aside. Clean surface of table.

• Remove protective lm (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 rmly 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.

3.2 Connecting the CM03 in the beam path

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.

21 23

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.

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3.4 Cabling of the CM03 and the RM02 (diagram)

WARNING!

• Only use the supplied USB 3.0 cable (3m long, HS art. no. 1022373)

for the connection to the PC.

• With lengths of over 3m, the cable with active signal amplication

(HS art. no. 1022441) must be used.

• Only use medically approved PCs or operate via a medically ap‑

proved 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

26. Med. approved isolating transformer

27. Instrument table (IT)

28. Med. approved power supply

29. Printer

30. Screen

31. Personal computer

32. Local network

33. Galvanic isolation (EN 60601‑1)

34. Headrest

35. Cable headrest / LED illumination /

RM02

36. Release module RM02

37. LED illumination

38. Camera module CM03

NOTE!

To ensure that the system works correctly, HAAG‑STREIT recom‑

mends not using laptops and using a high‑quality desktop computer

instead.

39. Fastening screw

40. Two‑pole connection plug

If the middle LED lights up red during

operation, the two‑pole connection

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).

180°

• 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

fulll 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

used for xing.

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 xed 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).

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• 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.

• 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. Connection plug headrest

42. Connector plug headrest / LED illumi‑

nation / RM02

43. Cable tie

44. Braided sleeving

45. Cable headrest / LED illumination /

RM02

46. Power supply cable

47. Computer cable USB 3.0 (3m long)

48. Camera (not shown)

49. Recess on the microscope arm

50. Connector plug camera cable

51. Release module RM02

52. RM02 operational control LED

53. On/Off key

54. Rotating knob, periphery or back‑

ground illumination

55. Rotating knob, slit illumination

56. Selector key A

57. Selector key B

58. Release key RM02

59. Socket camera cable

60. Socket for power supply connec‑

tor plug

61. Socket computer cable USB 3.0

micro B

62. Threaded bolt

63. Pin assignment

64. Cable cover

47 48

6159 60

14 15

15 16

4. 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 auto‑

matically when the PC is switched on.

• Turn the rotating knob on the slit illumination (55) to a position between '1' and

'10'.

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5. Operation

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.

5.1 Changing the image brightness

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

5.2 Beam splitter CM03 1022538

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 Beam splitter CM03 30/70 1023272

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 Field of view

WARNING!

The images and videos should only be used for documentation purpo-

ses. Only the image in the eyepiece may be used for diagnosis.

Field of view of the object, see table

Circle: The eld of view of the object observed through the microscope's

eyepiece.

Rectangle: Surface area of the sensor:

12.5 ×

6.3 ×

10 ×

16 ×

25 ×

40 ×

ø 33

ø 20

ø 12.7

ø 8

ø 5.1

34 x 46

21 x 28

13 x 17.5

8.3 x 11

5.2 x 7

Object image section in the

eyepiece (mm)

Object image section

in the camera

Recording mode 4:3

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‑STREIT 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 illumination. 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. Turn on the slit lamp

2. Filter position ‹open› (no lter)

3. Set magnication to 16x

4. Completely open the slit diaphragm

5. Connect the diffuser upstream

6. Position the HAAG‑STREIT greycard in front of the slit lamp and use it for fo‑

cusing

7. The brightness of the slit lamp's illumination should be set in such a way that

the greycard's structure is clearly discernible.

01-_IFU_IM900-7220551-04050_eng.indd 10 09.07.2018 14:10:54

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