LI 900 Instruction Manual 3 Edition Aug 2011

ENGLISH

DEUTSCH

FRANÇAIS

INSTRUCTIONS FOR USE LED Illumination

LI 900® 3. Edition / 2011 – 08

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Preface

We would like to thank you for your decision to purchase this HAAG-STREIT product. If the instructions in this manual are carefully followed we are confident that this product will give you reliable and trouble-free usage.

Purpose of use

The LED illumination LI 900 has been designed exclusively for use of the slit lamps BQ 900, BM 900 and BP 900. • Slit and background illumination are continuously variable controlled by an illumination control box. • It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment. • This set may not be used for other purposes. Caution: Federal law restricts this device to sale by or on the order of a physician or practitioner.

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Contents 1

1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.11

2.

2.1 2.1.1 2.1.2 2.2 2.2.1 2.2.2 2.2.3 2.3 2.3.1 2.3.2 2.3.3 2.3.4 2.3.5 2.4 2.4.1 2.4.2 2.5 2.5.1 2.5.2 2.6 2.7

3.

3.1 3.2 3.3 3.4 3.4.1 3.5 3.6 3.6.1

Safety ...4

Ambient conditions... 4 Transport and unpacking... 4 Installation warning notices... 4 Operation, environment... 5 Light toxicity... 5 Cleaning... 5 Guarantee and third-party product liability... 5 Pictographs and type plates... 6

Device description...7

Functions... 7 Normal operation... 7 Reduced operation... 7 PS-LED power supply unit... 8 Variant types... 8 Description... 8 LED indicator (Power supply)... 8 LED illumination LI 01x... 9 Variant types... 9 Description... 9 Blue filter... 9 LED indicator (Lamp cover)... 10 LED indicator (Power supply)... 10 Illumination control box IC 01 ... 11 Variant types... 11 Description... 11 Warnings / error messages... 11 Power supply unit PS-LED... 11 Illumination head LI 01... 12 Background illumination... 13 Mains connection accessories... 13

4.

Technical data...16

4.1 4.2 4.3

LI 01 / LI 01-plus... 16 Power supply unit PS-LED / PS-LED HSM901... 16 Dimensions... 16

5. 6. 7. 8.

Maintenance...17 Statutory regulations...17 Classification...17 EMC...17

A.

Additional information...17

A.1 A.1.1 A.1.2 A.1.3 A.1.4 A.1.5 A.1.6 A.1.7 A.1.8 A.1.9

B

Guidance and manufacturer’s declaration for EMC... 17 General... 17 System components... 17 Connecting cables... 17 Main features of performance... 17 Guidelines and manufacturer’s declaration on electromagnetic emissions... 18 Table 1: Emission... 18 Table 2: Immunity (all devices)... 19 Table 3: Immunity (not life-supporting devices)... 20 Table 4: Recommended separation distances (not life-supporting devices)... 21

Accessories...22

Device installation...13

Power supply unit on HSM 901 instrument table... 13 Head support on instrument table... 13 LED illumination on slit lamp... 14 Power supply and head support on units and non-HS tables, including HSM 801... 14 Directives for mounting on non-HS tables and HSM 801 ... 15 IC 01T illumination control box on non-HS table... 15 Non-HS illumination controllers... 15 Calibrating non-HS illumination controllers... 15 © HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220243.04030 – 3. Edition / 2011 – 08

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1. Safety

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1.2 Transport and unpacking • Before you unpack the instrument, check whether the packing shows traces

Symbols

Symbols correspond to EN 980 and ISO 15223-1. Other symbols that are used in these instructions: FORBIDDEN! Not observing these notes will lead to material damage and the endangering of patients. WARNING! These must be adhered to absolutely to ensure safe operation of the instrument and to avoid endangering users and patients. NOTE! Important notes! Please read carefully.

1.1 Ambient conditions

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Transport: Temperature Atmospheric pressure Relative humidity

-40°C to +70°C 500 hPa to 1060 hPa 10% to 95%

Storage:

Temperature Atmospheric pressure Relative humidity

-10°C to +55°C 700 hPa to 1060 hPa 10% to 95%

Operating: Temperature Atmospheric pressure Relative humidity

+10°C to +35°C 800 hPa to 1060 hPa 30% to 75%

• • •

of improper handling or damage. If this is the case, inform the haulier which has delivered the product to you. Unpack the instrument together with a representative of the haulier. Prepare a protocol describing parts that are possibly damaged. This must be signed by you and by the representative of the haulier. Leave instrument in the packing for several hours before unpacking (condensation). After unpacking, check if the instrument has been damaged. Return the defective equipment in an appropriate packaging.

1.3 Installation warning notices WARNING! Always mount the slit lamp and the headrest on an electric insulated and fire resistant table top. Only a hospital grade 3-conductor electrical power supply cable must be used. For USA and Canada: Detachable power supply cord set, UL listed, type SJE, SJT or SJO, 3-conductor, not smaller than 18 AWG. Plug, cable and ground lead connection of the socket have to be in perfect condition.

1.4 Operation, environment NOTE! Only qualified and trained personnel should operate the equipment, the training is at the owner’s responsibility. Use only HAAG-STREIT accessories. WARNING! To avoid the risk of electric shock, the equipment should preferably be connected to a supply network with ground connection.

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FORBIDDEN! Never operate the instrument in the same room with combustible gases, volatile solvents (alcohol, benzol) or flammable anaesthetic agents.

1.5 Light toxicity WARNING! Because prolonged intense light exposure can damage the retina, the use of the device for ocular examination should not be unnecessarily prolonged, and the brightness setting should not exceed what is needed to provide clear visualization of the target structures. This device should be used with filters that eliminate UV radiation (< 400 nm) and, whenever possible, filters that eliminate short-wavelength blue light (<420 nm). The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. If the value of radiance were reduced in half, twice the time would be needed to reach the maximum exposure limit. While no acute optical radiation hazards have been identified for slit lamps, it is recommended that the intensity of light directed into the patient’s eye be limited to the minimum level which is necessary for diagnosis. Infants, aphaques and persons with diseased eyes will be at greater risk. The risk may also be increased if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply particularly if the eye has been exposed to retinal photography.

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1.6 Cleaning • Clean the housing with a water dampened cloth only. • No liquids or corrosive agents, no alcohol. 1.7 Guarantee and third-party product liability • The instrument should be operated in accordance with the chapter 'Safety'. • •

Incorrect operation can damage the instrument. Thus no warranty claims can be accepted. Continued use of an instrument that has been damaged by incorrect operation can lead to personal injury. The manufacturer cannot accept liability in this case. Repairs and alterations on this equipment should only be carried out by HAAGSTREIT service technicians or by authorized persons.

WARNING! The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum output will exceed the safety guideline after 2.9 minutes with slit illumination or 2.4 minutes with both slit and peripheral illumination.

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1.8 Pictographs and type plate

b)

c)

d)

HAAG-STREIT AG Gartenstadtstrasse 10 3098 Koeniz Switzerland

XXXX Swiss made Product: Power Supply Type: PS-LED

e) f)

In case of LED illumination LI 900, the slit lamps BQ 900 (p), BM 900 (q) and BP 900 (r) are powered by the power supply PS-LED or PS-LED HSM901.

HAAG-STREIT AG

Input: 24VDC/1A 5VDC/200mA

IPXO DC AC

g) Serial number h) Manufacturer i) Date of manufacture j) Reference number k) IC 01, connection of illumination control box IC 01 l) Connection of non-HS illumination controller m) L1, LED indicator n) S1, pressure switch o) Environment

i)

l) o) k) a) g)

Caution: Federal law restricts this device to sale by or in the order of a Physician or Practitioner.

! IC01

SN XXXXX 1123 1020872 01000

REF XXXXXXX S1

HAAG-STREIT AG

Type: PS-LED HSM901

Output: 24VDC/1A 5VDC/200mA

h)

XXXX

HAAG-STREIT AG Gartenstadtstrasse 10 3098 Koeniz/Switzerland

SN XXXXX

XXXX XXXXXXX XXXXX

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L1

Caution: Federal law restricts this device to sale by or in the order of a Physician or Practitioner.

Input: 100-240VAC 50-60 Hz/60VA

6

m) j) n)

c)

REF XXXXXXX

a)

h) Ouput:100-240VAC 47-63Hz/60VA

a) Read very carefully (in the instruction for use) b) Always disconnect the electrical supply before opening the equipment! c) Functional earth ground d) Non protected against ingress of solid foreign objects e) Direct current f) Alternating current

g)

!

Made in Switzerland

a)

o)

j)

© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220243.04030 – 3. Edition / 2011 – 08

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XXXX

Input: 24VDC/1A

use only PS-LED / PS-LED HSM901 HAAG-STREIT AG SN Gartenstadtstrasse 10 3098 Koeniz, Switzerland

XXXXX

Made in Switzerland

Product: Type:

Slit Lamp BM 900

XXXX

use only PS-LED / PS-LED HSM901

XXXXX

Made in Switzerland

Product: Type:

Slit Lamp BP 900

C

US

XXXX

use only PS-LED / PS-LED HSM901

Made in Switzerland

XXXXX

The PS-LED power supply can only be used in combination with an illumination control box IC 01 and a LI 01 or LI 01 plus type LED light.

2.1.1 Normal operation The light source is switched on when the rotary button on the illumination control is set to a position between ’1’ and ’10’. 2.1.2 Reduced operation In order to be able to ensure a long life time for the light source, fill lighting power will be slightly reduced once the maximum operating temperature has been reached. Full power can be used again after a couple of minutes. This operating state only arises when both light sources have remained switched on simultaneously for a considerable amount of time.

C

US

Caution: Federal law restricts this device to sale by or on the order of a Physician or Practitioner

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HAAG-STREIT AG

Input: 24VDC/1A

HAAG-STREIT AG SN Gartenstadtstrasse 10 3098 Koeniz, Switzerland

DEUTSCH

2.1 Functions

Caution: Federal law restricts this device to sale by or on the order of a Physician or Practitioner

REF XXXXX

r)

FRANÇAIS

US

HAAG-STREIT AG

Input: 24VDC/1A

HAAG-STREIT AG SN Gartenstadtstrasse 10 3098 Koeniz, Switzerland

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Caution: Federal law restricts this device to sale by or on the order of a Physician or Practitioner

REF XXXXX

q)

C

XXXX XXXXXXX XXXXX

Slit Lamp BQ 900

ESPAÑOL

2. Device description HAAG-STREIT AG

XXXX XXXXXXX XXXXX

Product: Type:

NEDERLANDS

XXXX XXXXXXX XXXXX

p)

REF XXXXX

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2.2 PS-LED power supply unit

2.2.1 Variant types 1. Power supply unit PS-LED, for mounting on non-HS tables and units 2. Power supply unit PS-LED HSM 901 Slide-in type for HSM 901 instrument table 2.2.2 Description 3. Mains switch Switch in position 0 = ‘OFF’ Power supply is disconnected from mains Switch in position 1 = ’ON’ Control lamp shines green 4. 3-pole mains connection 5. Connection for slit and background illumination 6. Type plate (on housing) 7. Connection for HAAG-STREIT illumination controller IC 01 (USB mini B) 8. Connection for non-HS illumination controller (power jack 2.1 mm) 9. Protective earth connection (M3) 10. L1, LED indicator (green ‒ red) 11. S1, Push button 2.2.3 LED indicator (Power supply) Operating state LED indicator Normal operation: Green

1

2

3 I O

5

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6

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2.3 LED illumination LI 01x

2.3.1 Variant types 12. LED illumination LI 01-plus with background illumination 13. LED illumination LI 01 without background illumination 2.3.2 Description 14. VDC connector cable 15. Filter wheel for blue filter 16. Background illumination connection 17. Cover 2.3.3 Blue filter 18. The rotating wheel allows the blue filter to be swivelled into position. Marker spots at same level = blue filter engaged.

12

13

14

15

16

17

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a)

b)

2.3.4 LED indicator (Lamp cover) Operating state Standby mode

Normal operation Slit and background illumination on Background illumination only

Slit illumination only

Reduced operation for background illumination Reduced operation for background illumination due to increased LED temperature

2.3.5 LED indicator (Power supply) Normal operation

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a)

b)

c)

c) Slit illumination

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Voltage reversal

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Background illumination

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Green, short flashes

X

Green, short flashes

green

X

Green

Green, short flashes

X

Green

green

X

Green, short flashes

Green flashes

X

Green flashes

LED indicator power supply Green

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2.4 Illumination control box IC 01

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2.4.1 Variant types 19. Illumination control box IC 01 20. Illumination control box IC 01-1 21. Illumination control box IC 01T 22. Illumination control box IC 01T-1 23. Illumination control box cable USB 2 m 24. Illumination control box cable USB 5 m WARNING! Illumination control cables may only be used to connect an IC 01 illumination control box with a PS-LED power supply unit. Do not connect the illumination control box to any other devices than those intended! 2.4.2 Description 25. Rotary button for background illumination 26. Rotary button for slit illumination Optional power cable connection 27. For use on the left side of the cross-slide 28. For use on the right side of the cross-slide 29. LED indicator (green - red)

19

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20

21

23

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22

24

25

28

27

26

2.5 Warnings / error messages

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29

2.5.1 Power supply unit PS-LED Operational state

Normal functioning

Green LED Indicator L1 (29)

Error

Error messages

Action

E12

Illumination control not recognized

Connect illumination control box or replace it if necessary.

E14

No communication with LED illumination LI 01

Check the cable connection between the PS-LED and LI 01. If no errors were found in the cable connection, send the device to the appropriate service location.

Red flashes 2x

E17

Calibration process for illumination controller has failed

Unsuitable illumination controller, resistance value falls outside 5 ‒ 50 k .

Red flashes 3x

E16

General error

Send device to the appropriate service location.

Red flashes 4x

Software compatibility error Send device to the appropriate service location. E19© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220243.04030 – 3. Edition / 2011 – 08

Red flashes 5x

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Red

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a)

b)

c)

Voltage reversal

Slit illumination

c) Background illumination

b)

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Error

a)

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Error messages

Action

E1

Incorrect polarization of power supply unit

Rotate two-pole connection in lamp head electronics through 180°

X

Red

X

Illumination control not recognized

Connect illumination control or replace it if necessary

Red

X

Red

Temperature is too high

The performance of the light sources is reduced. When permitted temperature is reached, a resumption of normal operation is ensured.

2.5.2 Illumination head

E2

E3

E4

E5

E6

E9

No communication between power supply unit and illumination

Check the cable connection between the PS-LED and LI 01. If no errors were found in the cable connection, send the device to the appropriate service location

Red flashes

X

Red flashes

Red flashes 2x

X

Red flashes 2x

Voltage error

Send PS-LED to the appropriate service location

Red flashes 3x

X

Red flashes 3x

General error

Send PS-LED to the appropriate service location

Red flashes 4x

X

Red flashes 4x

Software compatibility error

Send PS-LED to the appropriate service location

Red flashes 5x

X

Red flashes 5x

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2.6 Background illumination

Background illumination can only be used with an LI 01-plus LED illumination. 30. Background illumination fixed 31. Background illumination pivoting

2.7 Mains connection accessories 32. Mains cable CH 2500 mm 33. Mains cable USA 3100 mm 34. Mains cable USA 760 mm

30

31

3. Device installation

3.1 Power supply unit on HSM 901 instrument table NOTE! HAAG-STREIT recommends to connect the aluminum tray with the protective earth circuit of the power supply, even if the standards (IEC/ EN 60601-1) does not prescribe this.

32

33

34

35. Connection for slit and background illumination 36. Mains connection 37. Type plate on housing

3.2 Head support on instrument table WARNING! Cable must never be clamped in, as this may lead to the possibility of a short circuit! Any work on cables or device components that come into connection with the power network should only be undertaken by qualified personnel.

• Connect multi-pole plug-type connector between head support and instrument table according to the illustration. (38)

• Screw head support tightly into correct position on table with the two cylinder

35

36

+5V Gnd Gnd +24V

38 37

screws. Mount handgrips and connect main lamp cable to lamp housing.

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NOTE! See instruction for use 'HSM 901' instrument table!

WARNING! When assembling the guide rail and head support, make sure no electrical connection exists to any metal part of the table whatsoever. Otherwise it will be necessary to mount an earth wire on the head support. The power supply unit must always be connected with an earth wire on the mains side! Cable must never be clamped in, as this may lead to the possibility of a short circuit! Any work on cables or device components that come into connection with the power network should only be undertaken by qualified personnel.

3.3 LED illumination on slit lamp • If the middle LED shines red during operation, the 24 V plug (b) has been connected in reverse.

• Turn off the device with the mains switch. • Remove cover from upper part of light by releasing the screw (a). • Rotate two-pole 24 V plug connector (b) through 180°. 3.4 Power supply and head support on units and non-HS tables, including HSM 801 • Connect all cables. If necessary, relieve strain on mains cable with cable tie. • Mount power supply PS-LED firmly with 4 screws. • Connect multi-pole electric plug connector between head support and instrument table.

• HSM 801: HAAG-STREIT recommends to connect the aluminum tray with the • •

protective earth circuit of the power supply (c). Units / non-HS tables: Only connect ground wire (c) if necessary. Screw head support tightly into correct position on table with the two cylinder screws. Mount handgrips and connect main lamp cable (d) to the upper part of light.

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NOTE! See instruction for use 'HSM 901' instrument table!

a)

b)

180°

PS-LED c) d)

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38 3 7

R5

R12

R5

38

38

3.4.1 Directives for mounting on non-HS tables and HSM 801 If a power supply unit is mounted on a non-HS table the following directive will apply: 93/42/EEC or the appropriate national standards IEC/EN 60601-1 Medical electrical equipment ‒ General requirements for basic safety and essential performance IEC/EN 60601-1-2 Electromagnetic Compatibility

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R5

R5

3.5 IC 01T illumination control box on non-HS table

38. Recess in table top for IC 01T or IC 01T-1 illumination control box 39. Sufficient space must be available underneath the table top. 40. The illumination control is fastened to the table top with self-adhesive tape.

connection (42) on the PS-LED power supply.

39 14

3.6 Non-HS illumination controllers • An illumination controller from a foreign supplier can be plugged into the

76

• Prior calibration to the appropriate potentiometer value is necessary. • Controllers can be calibrated between 5 and 50 kΩ. 3.6.1 Calibrating non-HS illumination controllers • Remove protective cap to access connector (41). • Connect external illumination controller (power jack 2.1 mm) and set to maximum illumination (turn adjustment knob to right until limit stop). • Switch on PS-LED power supply unit. • Press button S1 for longer than 1 second. The device will change over to calibration mode. The orange LED (L1) indicates that the illumination controller is being calibrated. • After approx. 1 to 3 seconds (depending on the type of illumination controller) the calibration process will be complete. This will be indicated by two short blinks of the green LED (L1).

40

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4. Technical data

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A

4.1 LI 01 / LI 01-plus Input 24 VDC / 1 A Brightness levels, slit illumination: Level 1 (min.) Approx. 10'000 lx Level 10 (max.) Approx. 450'000 lx

A = Spectrum Slit illumination B = Spectrum background illumination X = Rel. intensity Y = Wavelength (nm)

4.2 Power supply unit PS-LED / PS-LED HSM901 Input Output 1 Output 2 Classification Protection

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100 to 240 VAC (±10%) 50 – 60 Hz 60 VA 24 VDC / 1 A 5 VDC/ 200 mA class I IPX0 Continuous operation Not suitable for operation in vicinity of flammable anaesthetic products!

100%

60% 40%

X

20% 0% 300

B

IR

UV

80%

Brightness levels, background illumination fixed: Level 1 (min.) Approx. 30 lx Level 10 (max.) Approx. 15'000 lx Brightness levels, background illumination pivoting: Level 1 (min.) Approx. 60 lx Level 10 (max.) Approx. 30'000 lx

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Y [nm] 400

500

600

700

800

900

1000

1100

900

1000

1100

100%

60% 40%

IR

UV

80%

X

20% 0% 300

Y [nm] 400

500

600

700

800

4.3 Dimensions PS-LED Length Width Height Weight

164 mm 140 mm 60 mm 450 g

PS-LED HSM901 Length 316 mm Width 146 mm Height 69 mm Weight 750g

IC 01 Length Width Height Weight

75 mm 35 mm 33 mm 32 g

IIC 01T Length Width Height Weight

90 mm 51 mm 33 mm 32 g

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5. Maintenance NOTE! The LI 900 illumination set can be operated without maintenance throughout its lifetime.

6. Statutory regulations

• The LI 900 illumination set has been designed to conform to the IEC / EN • • • • •

60601-1 and ISO 15004-2 standards. Manufacturing procedures, testing, commissioning, maintenance and repair are conducted in compliance with international regulations. The 'CE' mark confirms that the LI 900 illumination set complies with directive 93/42/EEC. The lighting set should only be used when operating type B application parts (device offering special protection against electric shock, especially with regard to reliable discharge current and reliability of the ground wire connection). When combining different medical and/or non-medical electrical equipment standard IEC/EN 60601-1 applies. A copy of the declaration of conformity for the present instrument may be requested at any time from HAAG-STREIT. All statutory accident prevention regulations are to be observed.

7. Classification

IEC/EN Standard 60601-1 Equipment safety class I Operation mode: continuous operation CE Directive 93/42/EEC Class I

8. EMC NOTE! The LED illumination set LI 900 meets the electromagnetic compatibility requirements of IEC / EN 60601-1-2. The appliance is designed to keep the generation and emission of electromagnetic interferences to a level that does not affect the normal operation of other items of equipment. The appliance is likewise designed to provide a certain level of resistance to outside sources of electromagnetic interference. © HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220243.04030 – 3. Edition / 2011 – 08

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A. Additional information A.1 Guidance and manufacturer’s declaration for electromagnetic compatibility (EMC) A.1.1 General WARNING! Electrical medical appliances and systems are subject to special measures regarding EMC and should be installed in accordance with these accompanying instructions. Portable and mobile high frequency communications equipment can negatively influence electrical medical appliances. A.1.2 System components The slit lamp with LED illumination system includes the following equipment: • Slit lamp BQ 900, BM 900 or BP 900 • LED illumination LI 900 • Power supply unit PS-LED HSM 901 A.1.3 Connecting cables The following connecting cables are required: • Power Supply Unit CH: maximum length = 2500 mm • Power Supply Unit USA: maximum length = 3100 mm WARNING! Any connecting cables or accessories used to run the appliance other than those indicated can lead to increased emissions or to a reduced interference factor in the slit lamp with LED illumination system. A.1.4 Main features of performance The slit lamp with LED illumination system serves to examine and diagnose the human eye. This is achieved by projecting onto the eye a very narrow beam of light, which can be adjusted to vary its length and width.

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A.1.5 Guidelines and manufacturer’s declaration on electromagnetic emissions The slit lamp with LED illumination system is intended for use in the following type of environment. The customer or user of the slit lamp with LED illumination system should ensure that it is only operated in such an environment. A.1.6 Table 1: Emission Emission test

Compliance

Electromagnetic environment / guidance

RF emissions CISPR 11

Group 1

The slit lamp with LED illumination system 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.

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

The slit lamp with LED illumination system 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.

Voltage fluctuations / flicker emissions IEC 61000-3-3

Complies

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A.1.7 Table 2: Immunity (all devices) Guidance and manufacturer’s declaration – electromagnetic immunity The slit lamp with LED illumination system is intended for use in the electromagnetic environment specified below. The customer or the user of the slit lamp with LED illumination system should assure that it is used in such an environment Immunity test standard

IEC 60601 test level

Compliance level

Electromagnetic environment / guidance

Electrostatic discharge (ESD) IEC 61000-4-2

± 6 kV contact ± 8 kV air

± 6 kV contact ± 8 kV air

Electrical fast transient / burst IEC 61000-4-4

±2 kV for input lines ±1 kV for input and output lines

±2 kV for input lines ±1 kV for input and output lines

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%

Surge IEC 61000-4-5

±1 kV line to line ±2 kV line to earth

±1 kV line to line ±2 kV line to earth

Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000-4-11

<5% UT (0,5 cycle) 40% UT (5 cycles) 70% UT (25 cycles) <5% UT for 5s

<5% UT (0,5 cycle) 40% UT (5 cycles) 70% UT (25 cycles) <5% UT for 5s

Note: UT = the a.c. mains voltage prior to application of the test level. Power frequency (50/60Hz) magnetic field IEC 61000-4-8

3 A/m

3 A/m

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Mains power quality should be that of a typical commercial or hospital environment

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

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A.1.8 Table 3: Immunity (not life-supporting devices) Guidance and manufacturer’s declaration / electromagnetic immunity The slit lamp with LED illumination system is intended for use in the electromagnetic environment specified below. The customer or the user of the slit lamp with LED illumination system should assure that it is used in such an environment. Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the slit lamp with LED illumination system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Immunity test standard

IEC 60601 test level

Compliance level

Recommended separation distance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz ‒ 80 MHz

3 Vrms 150 kHz ‒ 80 MHz

D = 1.2

P 150 kHz ‒ 80 MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz ‒ 800 MHz

3 V/m 80 MHz ‒ 800 MHz

D = 1.2

P 80 MHz ‒ 800 MHz

Radiated RF IEC 61000-4-3

3 V/m 800 MHz ‒ 2,5 GHz

3 V/m 800 MHz ‒ 2,5 GHz

D = 2.3

P 800 MHz ‒ 2.5 GHz

Where (P) is the maximum output power rating of the transmitter 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

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Note 1

At 80 MHz and 800 MHz, the higher frequency range 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 the slit lamp with LED illumination system is used exceeds the applicable RF compliance level above, the slit lamp with LED illumination system or the device, which contains it should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device containing the slit lamp with LED illumination system.

b)

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

c)

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