EyeMag Light II Headlamp Instructions for Use V1.2 July 2022

Copyright © 2022, Carl Zeiss Meditec AG, Jena Trademarks All ZEISS products mentioned herein are either registered trademarks or trademarks of Carl Zeiss Meditec AG in Germany and/or other countries. All other trademarks used in this document are the property of their respective owners.

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DE EN ES FR IT NL PT ZH

Gebrauchsanweisung Instructions for Use Instrucciones de uso Le mode d’emploi Manuale di istruzioni Gebruiksaanwijzing Manual do utilizador 使用说明书

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EyeMag Light II

Contents

Instructions for Use

Contents EN

1. The instrument at a glance 50 1.1. Medical loupe with EyeMag Light II headlamp52 1.2. Accessories 53

5. Operation 5.1. Inserting battery packs 5.2. Charging battery packs 5.3. Mounting on medical loupes 5.4. Fastening the control unit 5.5. Fastening the supply cable 5.6. Fastening the orange filter 5.7. Operation

70 70 72 74 79 79 80 81

2. Safety measures 2.1. Reports to the manufacturer and government agencies

54

3. Notices 3.1. Intended use 3.2. Indications 3.3. Foreseeable misuse 3.4. Avoid injuries 3.5. Avoid material damage 3.6. Warnings and information plates 3.7. Information concerning EMC (Electromagnetic Compatibility)

56 56 56 56 57 58 59

6. Start-up checklist

82

7. Cleaning and wipe disinfection

84

8. Maintenance

84

9. Troubleshooting

85

65

10. Ordering data

87

4. Description 4.1. LED headlamp 4.2. Function indicator

67 67 67

11. Technical specifications of the LED headlamp

88

12. Disposal

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1. The instrument at a glance

EyeMag Light II Instructions for Use

1. The instrument at a glance EN

1

7 8

2 9

3

10

4

5

6

8 11

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1. The instrument at a glance

EyeMag Light II Instructions for Use

EN

13

14

12

1

Battery pack

12

Charging cradle

2

Battery pack removal button

13

Charger

3

Belt clip (rear)

14

4

Cable connection for LED headlamp

Country-specific power-plug adapter for charger

5

Function indicator

6

On/Dim switch

7

Rating plate (rear of housing)

8

Unlock mechanism for the LED headlamp

9

LED headlamp with power supply cable

10

Control unit

11

Orange filter

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1. The instrument at a glance

EyeMag Light II Instructions for Use

1.1. Medical loupe with EyeMag Light II headlamp

EN

The system consists of two main components: The LED headlamp and the appropriate headworn medical loupe that is used. The EyeMag Light II LED lighting kit can be used on various medical loupes from the ZEISS medical loupe product line or as a standalone application. The LED headlamp is fitted onto the medical loupe that is used by means of an adapter (see Accessories, Seite 53).

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1. The instrument at a glance

EyeMag Light II Instructions for Use

1.2. Accessories The following accessories make it possible to fasten the LED headlamp on the medical loupes from the ZEISS medical loupe product range and on the ZEISS teleloupe glasses:

EN

5 4

1

2

3

1

Adapter for EyeMag Smart

4

Cable clip

2

Adapter for EyeMag Pro F and EyeMag Pro S

5

Cable sleeve

3

Adapter for ZEISS teleloupe glasses: Teleloupe glasses GTX 2 (or GTX 2.5) Teleloupe glasses G 2.5 TTL Teleloupe glasses K bino TTL professional

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EyeMag Light II

2. Safety measures

Instructions for Use

2. Safety measures EN

Proper handling of the instrument is essential for safe operation. Before using the instrument, comply with these instructions for use, and with the instructions for use provided for other instrument equipment, such as medical loupes; also comply with the statutory accident prevention regulations. These instructions for use are a part of the product and must be accessible at all times. Keep the instructions for use of the product in a safe place for as long as you own and use the product. Ensure that the instructions for use are passed on to subsequent owners. Hazard symbols WARNING!

This is a warning notice that warns of hazards that can result in severe or fatal injuries if they are not avoided. The warning notice cites possible consequences. „ This is a measure that can prevent the hazards.

CAUTION!

This is a warning notice that warns of hazards that can result in injuries if they are not avoided. The warning notice cites possible consequences. „ This is a measure that can prevent the hazards.

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EyeMag Light II

2. Safety measures

Instructions for Use

NOTICE

This is a warning notice that warns of hazards that can result in material damage if the hazards are not avoided. EN

The warning notice cites possible consequences. „ This is a measure that can prevent the hazards.

Additional information and tips

Fundamentals of the instrument design The instrument described in these instructions for use has been designed and tested in compliance with ZEISS safety standards as well as national and international regulations. Target group These instructions for use are intended for medical personnel who use, clean or dispose of the LED lighting kit.

2.1. Reports to the manufacturer and government agencies If a serious incident occurs in conjunction with this medical product that affects the owner or another person, the owner (or the responsible party) must report this serious incident to the manufacturer or the distributor of the medical product. In the European Union the owner must report this serious incident to the competent authority in the owner's country.

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EyeMag Light II

3. Notices

Instructions for Use

3. Notices EN

3.1. Intended use The EyeMag Light II LED lighting kit is intended for use in dentistry or surgical applications and is designed for intensive illumination of fields of view. It is not approved for use in an oxygen-rich environment.

3.2. Indications Information concerning the intended medical indication, contraindications and the patient target group is provided in the table below: Intended medical indications Discipline

• Dentistry • Surgical applications

Indications

The EyeMag Light II is an LED headlamp for intensive illumination of fields of view.

Contraindications

No contraindications are known for use of the EyeMag Light II.

Patient target group

No restriction

Age

No restriction

Gender

All

3.3. Foreseeable misuse CAUTION!

Foreseeable misuse Use of the EyeMag Light II LED headlamp is not permitted • For opthalmological applications directly on the eyes. • If the instrument has been structurally modified.

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3. Notices

Instructions for Use

3.4. Avoid injuries „ Only use the LED headlamp for the intended use described above. „ According to European standard EN 62471:2008 (Photobiological safety of lamps and lamp systems) the LED headlamp is a lighting system with classification

EN

Risk class 2 CAUTION!

Risk of eye injury due to the light source! If during the medical intervention, the patient's eyes are exposed to light from the EyeMag Light II, there is risk of retinal damage. „ Before, during and after a medical intervention in the face area, ensure that the patient's eyes are not exposed to light from the EyeMag Light II. „ Do not use the instrument for opthalmological interventions on the patient (corneal reflex suppressed).

„ Falling parts or contaminated parts can infect patients or users! Before use, check the LED headlamp for damage, loose parts and proper function. - Do not keep using the LED headlamp, if it is damaged.

WARNING!

Risk of infection due to contaminated parts and/or parts falling into the surgical field! „ Prior to each use of the LED headlamp, check to ensure that the screws on the EyeMag medical loupe adapters for Pro F and Pro S are firmly tightened; also ensure that the LED headlamp is audibly locked in place in the selected adapter. „ Prior to first use, and prior to each use thereafter, clean the housing via wipe disinfection.

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EyeMag Light II

3. Notices

Instructions for Use

EN

„ Use only original, removable rechargeable battery packs. The battery pack housing is not intended to be opened, and the cells used inside the battery pack are not interchangeable. Use of battery packs other than the original battery packs may result in personal injury and material damage. „ When inserting the battery pack, pay attention to avoid pinching your fingers.

3.5. Avoid material damage „ Mechanical stress will damage the LED headlamp! Do not expose the LED headlamp to severe mechanical stress such as fall or impact.

NOTICE

Risk of product damage due to liquid ingress! „ Ensure that liquid does not get into the light source. „ When cleaning the LED headlamp, do not use an ultrasound bath or immerse the instrument in liquids.

NOTICE

Danger of electrostatic discharge! „ Please watch out for electrostatic discharge when handling battery packs. „ Do not touch the contact side of the battery packs. „ Do not store unused battery packs in the control unit or charging tray. „ Always use the battery’s special static-shielding bag to store the battery packs.

NOTICE

Risk of damage to the battery if stored incorrectly! „ Fully charge the battery packs before storage. „ Store the battery packs at 15 °C to 25 °C. Storing them at excessively high temperatures will cause the cells to age faster and may damage them. „ Briefly charge the battery pack every three to four months to protect it against deep discharging.

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3. Notices

Instructions for Use

„ Do not paint the LED headlamp. Paint can impair the motion of the instrument's moving parts, clog cooling vents, reduce luminosity and impact proper operation. „ Only use the provided charger in combination with the charging cradle. EN

3.6. Warnings and information plates Comply with all warnings and information plates! Power rating plate for the control unit: 11

1 2

3 4

12

5 6 7

13

8

14

9 10 15

1

UDI GS-1 code

9

Medical device mark

2

UDI code in plain text

10

Warning – optical radiation

3

Instrument designation

11

Manufacturer identification

4

Power data

12

Manufacturer's address

5

Day-specific date of manufacture

13

FCC mark (USA)

6

Serial number of the control unit

14

Comply with the instructions for use

7

Material number of the control unit

15

8

CE mark (Europe)

WEEE mark: Do not dispose of the instrument as household waste

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EyeMag Light II

3. Notices

Instructions for Use

Power rating plate for the battery pack:

EN

16 17

22

18 19

23

20 21

24

16

Power data for the battery pack

17

Manufacturer address

18

Reverse polarity mark

19

Serial number of the battery pack

20 21

60

25

26

27

28

29

22

Designation of the rechargeable battery type

23

WEE mark: Contains a lithium-ion battery pack, do not dispose of the battery pack as household waste

Material number of the battery pack

24

Do not throw the battery pack into fire

Day-specific date of manufacture

25

Do not damage the battery pack

26

Comply with the instructions for use

27

Return the battery pack to the manufacturer for recycling

28

Mark for charge type

29

GS1 code serial number

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3. Notices

Instructions for Use

Power rating plate for the charger:

30

EN

35

31 32

36

33

37

34

30

Insulated housing – protection class II

35

Power supply specification

31

Charge level indicator (Red: Charging at 1.3 A 8.4 VDC, Green: Fully charged)

36

PSE mark (Japan)

37

32

CE mark (Europe)

WEEE mark: Do not dispose of the device as household waste

33

cUL mark (USA, Canada)

34

Mark: Indoor use only

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EyeMag Light II

3. Notices

Instructions for Use

EyeMag Light II identification plate:

EN

38 39 40

42

41

38

Manufacturer identification

41

Control unit material number

39

Control unit serial number

42

CE marking (Europe)

40

Device name

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3. Notices

Instructions for Use

UDI plate on EyeMag Light II:

EN

43

45

44 46

43

Medical Device marking

45

UDI GS-1 code

44

Day-specific date of manufacture

46

UDI code, plain text

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EyeMag Light II

3. Notices

Instructions for Use

Inner packaging: Label on individual EyeMag Light II packaging (bubble wrap) EN

Transport packaging: Labels on outer packaging (4 labels)

Warning label – Li-ion batteries

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3. Notices

Instructions for Use

3.7. Information concerning EMC (Electromagnetic Compatibility) WARNING!

Risk due to electromagnetic radiation! Electrical devices can influence each other due to their electromagnetic radiation. Use of non-approved components (accessories, transducers of any type, cables) can cause increased emissions or reduce the interference immunity of the instrument.

EN

„ Only use accessories, cables, and spare parts that are specified in these instructions for use. „ Do not use any portable or mobile high-frequency communication equipment or wireless devices in the immediate vicinity of the instrument. The possibility cannot be excluded that such equipment or devices will influence the function of the instrument. „ Comply with the EMC guidelines on the following pages.

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