EyeMag Pro S head-worn Loupe Instructions for Use Issue 1.2 Oct 2022

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G_30_2088_V1_2_EyeMag_Pro_S_Book1.book Seite 24 Mittwoch, 5. Oktober 2022 8:38 08 Table of contents

Table of contents

EyeMag Pro S

Replacing the optical system ...38 Replacing the pads...38

Table of contents ... 24 Care and maintenance...39 Parts of the head-worn loupe... 25 Safety measures ... 25 Hazard symbols...25 Basis of device design ...26 Target group...26 Indications of use ...26 Obvious misuse ...26 Notes for the user ...26 Avoiding injuries ...27 Other safety measures...27 Notification of the manufacturer and authorities...27 Illustrations ...27 Symbols and labels...28

Storage ...39 Cleaning ...39 Disinfection...39 Disposal ...39 Device data ...40 Ordering data ...40 Specifications...41 Blank page for your notes... ...42

Description... 29 System description ...29 Components ...30 Preparations for use ... 31 Replacing the protective caps...31 Attaching the sterilizable contact guard ...32 Operation... 33 Getting started...33 Support configuration ...34 Optical system configuration ...36 24

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Parts of the head-worn loupe

Parts of the head-worn loupe

Safety measures

The following components are included with your head-worn loupe:

The correct use of the device is absolutely vital for safe operation. Before using the device, note the content of these Instructions for Use, the instructions for use of other equipment associated with the device, e.g. illumination, as well as the legal accident prevention provisions. These Instructions for Use are part of the product and must be accessible at all times. Keep the instructions for use throughout the life cycle of the product and give them to subsequent users.

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

Optical system Bridge Ball adapter Optical mount Clamping lever Height adjustment locking knob Front headband Upper headband Upper headband adjustment button 2 light guide clamps Upper headband hinge Rear headband Rear headband hinge Head circumference adjustment button 2 contact guards (EyeMag Pro F/S) Lens protection device Optics cleaning cloth Replaceable textile pads

Hazard symbols The following hazard symbols and signal words are incorporated into the safety information of these Instructions for Use. Symbol

Signal word WARNING! Caution! NOTE!

Failure to observe death or serious injuries may occur slight and medium injuries may occur material damages may occur

The following items are also included in the delivery package: –

Pro S soft case, large

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1 hex key

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EyeMag Pro S instructions for use

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EyeMag Pro S quick start guide

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EyeMag Pro S

Basis of device design

Indications of use

The product described in these instructions for use was constructed and tested in accordance with ZEISS safety standards as well as national and international regulations.

The EyeMag Pro S head-worn loupe is used for binocular spatial vision at close range, e.g. in the dental area or in surgical applications.

Carl Zeiss Meditec AG uses an EN ISO 13485 compliant QM system certified by DQS.

Obvious misuse The head-worn loupe may not be used

Target group These Instructions for Use are aimed at medical personnel who use, clean or dispose of the head-worn loupe.

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to look into bright light sources, e.g. laser

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if the device has been structurally changed

Notes for the user The following information symbols are used in these Instructions for Use: Symbol

Usage Additional information and tips

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List Prompt for an action

If the product is used incorrectly or in an improper state, this causes hazards. Please note the following instructions.

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Avoiding injuries WARNING! High levels of light radiation can cause irreversible damage to the eyes! • Do not look directly into the sun or strong sources of artificial light (e.g. lasers) when using the head-worn loupe.

Mechanical stress damages the head-worn loupe.

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Only use the head-worn loupe for its specified intended purpose.

NOTE! Risk of injury to the fingers resulting from improper use! • Read and follow each step of the instructions for use. Falling parts, bodily fluids and dirt may contaminate the patient or user. •

Safety measures

Avoidance of material damages

Before use, check the loupe for damage, loose parts and functionality. –

If the head-worn loupe is damaged, do not use it.

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Have it repaired by ZEISS Service.

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When putting on the optical system, ensure that there is sufficient distance from the eyes and avoid direct contact between the optical mount and the bridge of the nose.

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Do not expose the head-worn loupe to any significant mechanical stress, e.g. fall or jolt.

If any liquids infiltrate the head-worn loupe, this causes damage. Do not clean the head-worn loupe in the ultrasonic bath.

Other safety measures •

If the use of a loupe is essential for an intervention, carry out the intervention only with access to a replacement loupe of the same design.

Notification of the manufacturer and authorities •

If a serious incident occurs in connection with this medical device affecting the operator or another person, the operator (or person responsible) must report it to the manufacturer or seller of the medical device. In the European Union, the operator must report serious incidents of this kind to the competent authority in his/her country.

Illustrations The figures may differ from the original.

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EyeMag Pro S

Symbols and labels Symbol

Description UDI label Information contained: – MD designates the product as a medical device – Date of manufacture – Machine-readable label (barcode) – UDI Device Identifier (UDI-DI) – UDI Production Identifier (UDI-PI) Equipment marking label Information contained: – Manufacturer (company name): Carl Zeiss Meditec AG – Symbol for "manufacturer" – Manufacturer's address: Goeschwitzer Strasse 51-52 07745 Jena, Germany – Serial number: – Device name: EyeMag Pro S – Item number: – CE marking: Magnification factor / working distance ZEISS logo (manufacturer)

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Description

Description System description The optical system is mounted on system carrier S (support). This consists of a flexible clamp with joints and ligaments. The optical system is available with various magnifications and working distances (see ordering data).

Fig. 2

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EyeMag Pro S

Components The following components may be attached to the headworn loupe to protect the patient and user:

Fig. 3

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Sterilizable contact guard (fig. 3) The sterilizable contact guard enables sterile use of the headworn loupe's flip-up function. It must be sterilized before each use. This also applies to the first use after delivery.

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Protective caps (fig. 4) The protective caps guard the objective lenses against dirt and mechanical damage during use.

Fig. 4

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Preparations for use

Preparations for use Replacing the protective caps The protective caps prevent the contamination and mechanical damage of the objective lenses. Damaged protective caps can be replaced as follows:

Fig. 5

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Unscrew the damaged protective cap.

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Attach the new protective cap to the lens clamp and screw in carefully (fig. 5).

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EyeMag Pro S

Attaching the sterilizable contact guard The sterilizable contact guard enables sterile use of the head-worn loupe. It must be sterilized before each use. This also applies to the first use after delivery. For more information about sterilization, please refer to the included reconditioning guide, "G-30-1560". Fig. 6

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Push the previously sterilized sterilizable contact guards over the optical system (fig. 6). WARNING! Risk of infection! • Do not touch any unsterile surfaces. If you can no longer ensure that the sterilizable contact guard is sterile, have another person operate the flip-up function.

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Operation

Operation The EyeMag Pro S head-worn loupe is delivered in flawless condition. Before use, note the following. Getting started WARNING! Risk of infection due to loose or falling parts of the head-worn loupe. • Before use, check the loupe and its components for damage, loose parts and functional safety. •

Place the head-worn loupe on your head and check whether the loupe is appropriately configured to meet your particular needs.

If the loupe needs to be adjusted, change the following settings as described below:

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Support configuration

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Optical system configuration

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EyeMag Pro S

Support configuration To attain optimal wearing comfort, the system carrier S (support) must be individually adjusted to the size and shape of your head. To do this, proceed as follows:

Fig. 7

Fig. 8

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Swivel the optical system upwards.

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Screw the locking knob (6) tightly and swivel the optical system upwards until the last grating.

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Turn the head circumference adjustment button (14) so that the support can be placed on the head comfortably (fig. 7). The rear headband (12) can be swiveled up or down as necessary.

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Align the support so that the optical mount (4) sits symmetrically above the bridge of the nose and the lower edge of the front headband (7) is approx. 35 to 45 mm above the centre of the eyes (fig. 8).

The upper headband (8) is fitted with a basic setting which can be changed individually as necessary. The upper headband hinge (13) enables the setting to be fixed in freely chosen locking positions.

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Operation

Pushing the two-part upper headband (8) together enables optimal adjustment to the head height (fig. 9). To pull the two-part upper headband apart, push the upper headband adjustment button (9) (fig. 10). In principle, the support setting only needs to be carried out once. For safety reasons, it should be carried out in front of a mirror. Fig. 7

Fig. 6

Fig. 93

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To remove the support, turn the head circumference adjustment knob (14) and lift the support upwards. If the rear headband (12) is swiveled upwards, the support may also be removed from the front (fig. 11).

Fig. Fig.104

Fig. 11

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EyeMag Pro S

Optical system configuration By adjusting the support as described on the previous pages, the optical system is initially in the upper position.

Fig. 12

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Now catch the optical system (on the touch guard (15), as applicable) and swivel it downwards (fig. 12).

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Hold the optical system firmly in your left hand and loosen the fixing. To do this, turn the height adjustment locking knob (6) and the clamping lever (5). (Fig. 13 and 14). The optical system (1) can now be freely moved and the viewing height, slant and interpupillary distance adjusted.

Fig. 13

Fig. 14

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Operation

Fig. 15

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Select the distance from the test card (fig. 20) in such a way that you can always see the test card clearly (fig. 15).

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Place the optical system in the desired position and set the interpupillary distance (fig. 16) in such a way that a uniform, circular and clearly delineated field of vision is created (fig. 17).

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Fix your settings by turning the height adjustment locking knob and the clamping lever.

Fig. 16

Fig. 17

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EyeMag Pro S

Replacing the optical system The optical system may be replaced in order to achieve varying sizes of field of vision, working distances or magnifications (fig. 18).

Fig. 18

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Turn the clamping lever (5) to the left and open the small screw at the side of the optical mount using the hex key.

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Swivel the optical system forwards until the stop.

The optical mount (4) can now be removed from the front via a guide with the optical system (1). •

Place an optical system of your choice in the optical mount and attach it firmly to the support.

Replacing the pads

Fig. 19

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For wearing comfort and hygiene reasons, the inside of the support is fitted with pads at various points (fig. 19). The replaceable pads (18) are attached firmly using velcro fasteners. They are washable (+40°C delicates).

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Care and maintenance The head-worn loupe (including components) is a sensitive optical device and must be handled with care. Therefore, observe the following recommendations. Storage When the head-worn loupe is not in use, store it in its original container (large soft case). Cleaning WARNING! Risk of infection due to surface parts becoming loose and falling off. • Do not use solvents or sharp and grinding cleaning agents as this may cause particles to be released from the surface. Caution! Incompatibility of cleaning agents. • To avoid allergic reactions, observe the specifications of the cleaning agent manufacturer. NOTE! The head-worn loupe is not watertight. If liquids infiltrate, they may damage the head-worn loupe. • Do not clean the head-worn loupe in the ultrasonic bath.

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Care and maintenance

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Clean the head-worn loupe with industry-standard cleaning agents after each use.

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Clean the contaminated glass surfaces using the cleaning towel included in the delivery package.

Disinfection To disinfect your head-worn loupe, we recommend using a disinfectant containing alcohol. Follow the manufacturers' specifications when using the disinfectant. Disposal Protect the environment! Caution! Observe notes on disposal. If the device is disposed of inappropriately, this can result in environmental damages. • Dispose of the device appropriately in accordance with the valid environmental protection regulations. Each component is composed of iron, light metals, glass and plastics and may be disposed of at a recycling center. ZEISS accepts no responsibility for the improper disposal of the device or packaging.

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EyeMag Pro S

Device data Ordering data Operate the device using ZEISS-approved components and accessories which are included in the delivery package only. Spare parts can be ordered from ZEISS. The ZEISS representative for your country can be found online at: www.zeiss.com/med

Description

Order No.

EyeMag Pro S

000000-1463-680 1

System carrier, S (support)

304160-9100-000 1

Pro S soft case, large

000000-1460-441 1

Optical system, K 4.0 x/500 mm

304156-9504-000 1

Optical system, K 3.2 x/500 mm

304156-9503-000 1

Optical system, K 4.0 x/450 mm

304156-9454-000 1

Optical system, K 3.3 x/450 mm

304156-9453-000 1

Optical system, K 4.3 x/400 mm

304156-9404-000 1

Optical system, K 3.5 x/400 mm

304156-9403-000 1

Optical system, K 4.5 x/350 mm

304156-9354-000 1

Optical system, K 3.6 x/350 mm

304156-9353-000 1

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Pcs.

Optical system, K 5.0 x/300 mm

304156-9305-000 1

Optical system, K 4.0 x/300 mm

304156-9304-000 1

2x contact guard (EyeMag Pro F/S) 304156-9900-000 1 incl. G-30-1560 2 protective caps, packaged

304156-9901-000 1

Textile pad, front

304160-8012-000 1

Textile pads, rear and upper

304160-8011-000 1

Cleaning cloth

304111-8200-000 1

EyeMag Light II*

304121-9010-000 1

Instructions for Use EyeMag Pro S 000000-2386-071 1 EyeMag Pro S quick start guide

000000-1460-652 1

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Device data

Specifications Magnification

4x 4x 4.3x 4.5x 5x 3.2x 3.3x 3.5x 3.6x 4x

Working distance, from eye 500 450 400 350 300 measured in mm Free object distance in mm

425 375 325 275 220 430 380 330 280 230

Field of vision in mm

93 81 68 115 100 86

Weight with system carrier in g (approx.)

330

Average service life

6 years

56 71

44 56

Rights to change in design and scope of delivery as a result of ongoing technical development reserved.

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