EyeMag Pro F Head-worn Loupe Instructions for Use Issue 1.4 Oct 2022

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 3 Mittwoch, 5. Oktober 2022 8:28 08

2

1

3

4

5

10

7 6

8 9

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 24 Mittwoch, 5. Oktober 2022 8:28 08 EyeMag Pro F

Table of contents

Flip-up function...38 Replacing the optical system ...39

Parts of the head-worn loupe... 25 Care and maintenance...40 Safety measures ... 25 Hazard symbols...25 Basis of device design ...26 Indications of use ...26 Obvious misuse ...26 Notes for the user ...26 Avoiding injuries ...27 Avoidance of material damages ...27 Other safety measures...27 Notification of the manufacturer and authorities...27 Illustrations ...27 Symbols and labels...28

Storage ...40 Cleaning ...40 Disinfection...40 Disposal ...40 Device data ...41 Ordering data ...41 Specifications...42 Blank page for your notes... ...43

Description... 29 Head-worn loupe ...29 Components ...30 Preparations for use ... 31 Attaching the side shields...31 Replacing the protective caps...33 Attaching the sterilizable contact guard ...33 Operation... 34 Getting started...34 Adjusting the elastic headband ...35 Adjusting the interpupillary distance...36 Adjusting the viewing angle ...37 24

G-30-2085, 1.4

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 25 Mittwoch, 5. Oktober 2022 8:28 08 EyeMag Pro F

Safety measures

Parts of the head-worn loupe

Safety measures

The following components are included with your headworn 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

Elastic headband Earpieces System carrier F Nose bridge Optical system Lens protection device 2 contact guards (EyeMag Pro F/S) Side shields (left/right) Torx wrench Cleaning cloth for the optical components

The following items are also included in the delivery package:

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

Signal word

–

Soft case, small

WARNING!

–

Instructions for use for the EyeMag Pro F

Caution!

–

Quick guide for the EyeMag Pro F NOTE!

G-30-2085, 1.4

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

25

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 26 Mittwoch, 5. Oktober 2022 8:28 08 Safety measures

EyeMag Pro F

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 F 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

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

The head-worn loupe may not be used –

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

–

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

– •

List Prompt for an action

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

26

G-30-2085, 1.4

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 27 Mittwoch, 5. Oktober 2022 8:28 08 EyeMag Pro F

Safety measures

– –

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. •

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.

If the head-worn loupe is damaged, do not use it. Have it repaired by ZEISS Service.

Avoidance of material damages Mechanical stress damages the head-worn loupe. •

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.

Falling parts, bodily fluids and dirt may contaminate the patient or user.

Notification of the manufacturer and authorities

•

To minimize contamination, we recommend using side shields. If national regulations (e.g. in the United States) require the use of side shields, the user is obligated to use them.

•

•

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

It is essential to remove the Torx wrench after the optical system has been adjusted to your needs. Otherwise, it could become loose during a quick head movement and fall on the patient.

G-30-2085, 1.4

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.

27

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 28 Mittwoch, 5. Oktober 2022 8:28 08 Safety measures

EyeMag Pro F

Symbols and labels Symbol

Symbol Description

Description ZEISS logo (manufacturer)

UDI label Information contained: – MD designates the product as a medical device – Manufacturing date – 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 F – Item number: – CE marking: Magnification factor / working distance

28

G-30-2085, 1.4

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 29 Mittwoch, 5. Oktober 2022 8:28 08 EyeMag Pro F

Description

Description Head-worn loupe The head-worn loupe (fig. 2) consists of two main components: the optical system and the system carrier. The optical system is mounted on system carrier F, a clamp with earpieces and elastic headband. The optical system is available with various magnifications and working distances and system carrier F is available in various clamp sizes (see ordering data).

Fig. 2

G-30-2085, 1.4

Your new head-worn loupe is delivered with neutral lenses without any corrective effect. In the case of a visual impairment, upholding the technical data of the head-worn loupe can only be ensured if individual corrective lenses are used. Therefore, if you have a visual impairment, arrange for the neutral lenses to be replaced by corrective lenses by your on-site optician.

29

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 30 Mittwoch, 5. Oktober 2022 8:28 08 Description

EyeMag Pro F

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

Side shields (fig. 3) The side shields serve as additional splash guards for surgical and dental applications.

–

Sterilizable contact guard (fig. 4) The sterilizable contact guard enables sterile use of the head-worn loupe's flip-up function. It must be sterilized before each use. This also applies to the first use after delivery.

–

Protective caps (fig. 5) The protective caps guard the objective lenses against dirt and mechanical damage during use.

Fig. 3

Fig. 4

Fig. 5

30

G-30-2085, 1.4

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 31 Mittwoch, 5. Oktober 2022 8:28 08 EyeMag Pro F

Preparations for use

Preparations for use Attaching the side shields WARNING! Risk of infection due to falling or contaminated side shields in the OP field. • Do not use damaged side shields. •

In order to avoid infections due to impurities and bodily fluids or infection by other users, clean and disinfect intake side shields before each use.

•

Ensure that the side shields are facing in the correct direction. The clamp must be located in the middle between the upper and lower bars.

Fig. 6

Caution! Risk of injury due to damaged side shields! • Do not use damaged side shields. Install the side shields as follows: Fig. 7

G-30-2085, 1.4

•

Guide the left bracket through the large loop of the black fastening tape on the inner side of the left side shield (fig. 6).

•

Hold the clamp and the side shield in place.

•

Pull the fastening tape outwards and backwards tightly, so that it is in the guide grooves and hangs into the rear flap (fig. 7).

31

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 32 Mittwoch, 5. Oktober 2022 8:28 08 Preparations for use

EyeMag Pro F

The side shield is now connected with the front part of the clamp and the brackets can be folded without the side shield moving. •

32

Repeat these steps for the right side.

G-30-2085, 1.4

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 33 Mittwoch, 5. Oktober 2022 8:28 08 EyeMag Pro F

Preparations for use

Replacing the protective caps The protective caps prevent the contamination and mechanical damage of the objective lenses. Attach the new protective cap to the lens clamp and screw in carefully (fig. 8).

Fig. 8

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. You'll find further information about sterilization in the enclosed reprocessing instructions entitled "G-30-1560". • Fig. 9

Push the previously sterilized sterilizable contact guards over the optical system (fig. 9). 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.

G-30-2085, 1.4

33

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 34 Mittwoch, 5. Oktober 2022 8:28 08 Operation

EyeMag Pro F

Operation The EyeMag Pro F 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:

34

–

adjusting the elastic headband

–

adjusting the interpupillary distance

–

adjusting the viewing angle

G-30-2085, 1.4

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 35 Mittwoch, 5. Oktober 2022 8:28 08 EyeMag Pro F

Operation

Adjusting the elastic headband •

Adjust the elastic headband to fit your head using the length adjustment WARNING! Risk of infection and injury due to falling head-worn loupe! • Put on the head-worn loupe. •

Tighten the fastener until you hear it clicking into place (fig. 10).

•

Check that the head-worn loupe is in a safe position. Adjust the length of the headband as necessary.

Fig. 10

G-30-2085, 1.4

35

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 36 Mittwoch, 5. Oktober 2022 8:28 08 Operation

EyeMag Pro F

Adjusting the interpupillary distance To ensure an optimal field of vision, the optical axes of the eyepieces must match those of your eyes.

Fig. 11

•

Adjust the interpupillary distance using the foldable bridge (fig. 11). If you see a circular field of vision in the focal plane (fig. 12), you have found the optimal setting.

•

Using the Torx wrench, tighten the clamping screw by twisting it to the right. Caution! The Torx wrench may fall and injure the patient. • Always remove the Torx wrench after use.

Fig. 12

36

G-30-2085, 1.4

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 37 Mittwoch, 5. Oktober 2022 8:28 08 EyeMag Pro F

Operation

Adjusting the viewing angle To ensure an optimal field of vision, the optical axes of the eyepieces must match those of your eyes. Ensure that the distance between the eyepieces and the system carrier is as short as possible. This enlarges the field of vision and gives you optimal wearability and comfort. Fig. 13

Fig. 14

•

Put on the loupe with the inserted Torx wrench.

•

Change the distance from the test card (fig. 21) so that the test card is in the focal plane of the optical system (fig. 13).

•

Rotate the Torx wrench to the left to loosen the clamping screw. The height and inclination of the optical system can now be adjusted (fig. 14). You can see from this example of adjustment (fig. 15) that the head-worn loupe enables you to maintain an upright posture with your head inclined only slightly at any time. Thanks to the proximity of the eyepieces to the eyeglass lenses, you obtain large, homogeneous fields of vision that provide you with an optimal overview of the treatment area.

Fig. 15

G-30-2085, 1.4

37

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 38 Mittwoch, 5. Oktober 2022 8:28 08 Operation

EyeMag Pro F

Flip-up function The optical system may be swiveled upwards and downwards. NOTE! Quick and jerky movements may damage the carrier, optical system or eyeglass lens. • Always take care when swiveling the optical system upwards or downwards. Fig. 16

•

Catch one half of the system and swivel the optical system upwards (fig. 16) or downwards (fig. 17). The mobility of the swivel device can be changed using the locking screw (fig. 18).

Fig. 17

Fig. 18

38

G-30-2085, 1.4

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 39 Mittwoch, 5. Oktober 2022 8:28 08 EyeMag Pro F

Operation

Replacing the optical system The optical system can be replaced with a different optical system with the aid of the Torx wrench. To do this, proceed as follows: NOTE! Loose parts of the head-worn loupe can fall off. • Before use, check the loupe for damage, loose parts and functionality. Should you be unable to restore functionality, do not continue to use the head-worn loupe. Have it repaired by ZEISS Service.

Fig. 19

•

Open the clamping collar so that you can remove the optical system.

•

Insert an appropriate optical system of your choice and tighten the clamping collar again (figures 19, 20).

To adjust the viewing angle and the interpupillary distance, proceed as described above. Fig. 20

G-30-2085, 1.4

39

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 40 Mittwoch, 5. Oktober 2022 8:28 08 Care and maintenance

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 (small 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. 40

EyeMag Pro F

•

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

•

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.

G-30-2085, 1.4

G_30_2085_V1_4_EyeMag_Pro_F_Book1.book Seite 41 Mittwoch, 5. Oktober 2022 8:28 08 EyeMag Pro F

Device data

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.

Pcs.

EyeMag Pro F

000000-1463-679 1

System carrier GF Titanium 50-18 304156-9113-000 1 System carrier GF Titanium 53-20 304156-9112-000 1 System carrier GF Titanium 56-18 304156-9111-000 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

Optical system K 3.6 x/ 350 mm

304156-9353-000 1

Optical system K 5.0 x/ 300 mm

304156-9305-000 1

Optical system K 4.0 x/ 300 mm

304156-9304-000 1

Elastic headband

000000-1167-412 1

Earpiece for system carrier, right

000000-1167-360 1

Earpiece for system carrier, left

000000-1167-362 1

Nose bridge, 18mm

000000-1012-423 1

Nose bridge, 20mm

000000-1012-425 1

2 protective caps, packaged

304156-9901-000 1

Torx wrench

304156-8002-000 1

Cleaning cloth

304111-8200-000 1

2x contact guard (EyeMag Pro F/S) incl. G-30-1560

304156-9900-000 1

Side shields (left/right)

304111-8170-000 1

Soft case, small

000000-1408-910 1

EyeMag Light II*

304121-9010-000 1

304156-9453-000 1

EyeMag Pro F Instructions for Use

000000-2386-068 1

Optical system K 4.3 x/ 400 mm

304156-9404-000 1

Quick guide for the EyeMag Pro F 000000-1459-323 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

G-30-2085, 1.4

41