Keeler Z Series Manuale utente

SLIT LAMP

INSTRUCTIONS FOR USE

Z Series

A world without vision loss

1 EN

KSL-Z by KEELER

CONTENTS

1. INDICATIONS FOR USE ........................................................................................ 3

2. SAFETY................................................................................................................. 3

2.1 PHOTOTOXICITY ............................................................................................................................3

2.2 WARNINGS AND CAUTIONS..........................................................................................................4

2.3 CONTRAINDICATION.....................................................................................................................5

3. CLEANING AND DISINFECTION INSTRUCTIONS.................................................... 5

4. NAMES OF CONTROLS AND COMPONENTS ......................................................... 6

5. ASSEMBLY............................................................................................................ 8

5.1 TABLE TOP AND BASE ASSEMBLY PROCEDURE...............................................................................8

5.2 ILLUMINATION TOWER ASSEMBLY PROCEDURE.............................................................................9

5.3 CABLE ATTACHMENT PROCEDURE ..............................................................................................10

5.4 FITTING APPLANATION TONOMETERS, T TYPE AND Z TYPES.........................................................11

6. INSTRUCTIONS FOR USE .................................................................................... 12

6.1 SETTING THE BINOCULARS..........................................................................................................12

6.2 PREPARING THE PATIENT AND USING THE SLIT LAMP..................................................................13

6.3 DESCRIPTION OF FILTERS, APERTURES AND MAGNIFICATIONS.....................................................14

7. ROUTINE MAINTENANCE ................................................................................... 15

7.1 LED SYSTEMS ..............................................................................................................................15

7.2 REGULARLY INSPECT THE DEVICE FOR DAMAGE OR DIRT............................................................15

7.3 CLEANING THE ILLUMINATION PRISM .........................................................................................15

7.4 ELECTRICAL CONNECTIONS ........................................................................................................15

7.5 OPTICS........................................................................................................................................15

7.6 AXLE AND MECHANICAL PARTS ..................................................................................................15

8. WARRANTY ........................................................................................................ 15

9. SPECIFICATIONS AND ELECTRICAL RATINGS...................................................... 16

9.1 ELECTROMAGNETIC EMISSIONS..................................................................................................16

9.2 ELECTROMAGNETIC IMMUNITY ..................................................................................................17

9.3 RECOMMENDED SAFE DISTANCES ..............................................................................................18

9.4 TECHNICAL SPECIFICATIONS.......................................................................................................19

10. ACCESSORIES AND SPARES................................................................................ 21

11. PACKAGING AND DISPOSAL INFORMATION....................................................... 22

KSL-Z by KEELER

Consult instructions for use General warning sign

Date of manufacture Warning: Electricity

Manufacturer’s name and

address Warning: Floor level obstacle

Country of manufacture Warning: Non-ionizing

radiation

Waste Electrical and Electronic

Equipment (WEEE) recycling Warning: Optical radiation

This way up Warning: Hot surface

Keep dry Conformité Européene

Fragile Type B applied part

Do not use if package is

damaged Class II equipment

Temperature limit Atmospheric pressure

limitation

Authorised representative in

the European Community Humidity limitation

Use-by date Serial number

Catalogue number Medical device

Translation

The Keeler Slit Lamp is designed and built in conformity with Directive 93/42/EEC, Regulation (EU) 2017/745 and

ISO 13485 Medical Devices Quality Management Systems.

Classiﬁcation: CE: Class I

FDA: Class II

The information contained within this manual must not be reproduced in whole or part without the manufacturer’s

prior written approval. As part of our policy for continued product development we the manufacturer reserve the right

to make changes to speciﬁcations and other information contained in this document without prior notice.

This IFU is also available on the Keeler UK and Keeler USA websites.

3 EN

KSL-Z by KEELER

1. INDICATIONS FOR USE

This device is intended to be used only by suitably trained and authorised healthcare

professionals.

CAUTION: Federal Law restricts this device to sale by or on the order of a

physician or practitioner.

Intended use / purpose of instrument

The Keeler Slit Lamp facilitates an examination of the anterior segment, or frontal structures

and posterior segment, of the human eye, which includes the eyelid, sclera, conjunctiva, iris,

natural crystalline lens and cornea.The binocular slit-lamp provides stereoscopic magniﬁed

view of the eye structures in detail, enabling anatomical diagnoses to be made for a variety of

eye conditions.

Brief description of the instrument

This Keeler Slit Lamp can either be mounted onto a custom table top supplied by Keeler or can

be mounted on a third parties table top (refraction unit) by suitably trained technicians.

The Keeler Slit Lamp consists of 5 assemblies; illumination tower; observation system; XYZ

translation base; chinrest assembly and a table top with power supply and accessory drawer.

The light intensity is controlled by a variable rheostat located on the XYZ translation base.

There are a number of selectable ﬁlters allowing the user to control the characteristics of the

examination light.

2. SAFETY

2.1 PHOTOTOXICITY

CAUTION: 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 intensity will exceed the safety guideline after 81 seconds.

While no acute optical radiation hazards have been identiﬁed for slit

lamps, we recommend keeping the intensity of the light reaching the

patient’s retina to the minimum possible for the respective diagnosis.

Children, people with aphakia and people suffering from eye conditions

are most at risk. An increased risk may also occur if the retina is exposed

to the same or a similar device with a visible light source within 24 hours.

This applies, in particular, if the retina has been photographed with a

ﬂashbulb in advance.

Keeler Ltd shall on request, provide the user with a graph showing the

relative spectral output of the instrument.

KSL-Z by KEELER

2.2 WARNINGS AND CAUTIONS

Please note that the proper and safe functioning of our instruments is only guaranteed if

both the instruments and their accessories are exclusively from Keeler Ltd. The use of other

accessories may result in increased electromagnetic emissions or reduced electromagnetic

immunity of the device and may lead to incorrect operation.

Observe the following prescriptions in order to ensure safe operation of the instrument.

WARNINGS

• Never use the instrument if visibly damaged and periodically inspect it for signs of damage

or misuse.

• Check your Keeler product for signs of transport / storage damage prior to use.

• Do not use in the presence of ﬂammable gases / liquids, or in an oxygen rich environment.

• US Federal Law restricts this device to sale by or on the order of a physician or practitioner.

• This device is intended to be used only by suitably trained and authorised healthcare

professionals.

• This product should not be immersed in ﬂuid.

• Repairs and modiﬁcations to the instrument must be made only by the specialized

technicians of the manufacturer’s Technical Service Centre or by personnel trained and

authorised by the manufacturer. The manufacturer declines any and all responsibility for

loss and/or damages resulting from unauthorised repairs; furthermore, any such actions

will invalidate the warranty.

• The power switch and mains plug are the means of isolating the device from the mains

supply - ensure both the power switch and mains plug are accessible at all times.

• Do not position the equipment so that is difﬁcult to press the power switch or remove the

mains plug from the wall socket.

• Refraction stand variants or adaptors should only be used in combination with EN/IEC

60601-1 and EN/IEC 60601-1-2 compliant power supplies and devices.

• Route power cords safely to eliminate risk of tripping or damage to user.

• Before any cleaning of the instrument or the base unit ensure the power lead is

disconnected.

• LEDs can reach high temperatures in use – allow to cool before handling.

• Do not exceed maximum recommended exposure time.

• Should the instrument suffer shocks (for example, should it accidentally fall), and the

optical system or the illumination system are damaged it may be necessary to return the

instrument to the manufacturer for repair.

5 EN

KSL-Z by KEELER

• After removal of the LED, do not touch the Slit Lamp LED electrical contacts and patient

simultaneously.

• The owner of the instrument is responsible for training personnel in its correct use.

• Ensure the instrument or instrument table is placed on a level and stable surface.

• Use only genuine Keeler approved parts and accessories or device safety and performance

may be compromised.

• Shut down after every use. In case the dust cover is used: risk of overheating.

• For indoor use only (protect from moisture).

• Electrical equipment can be affected by electromagnetic interference. If this occurs whilst

using this equipment, switch the unit off and reposition.

• Do not touch accessible connectors and the patient simultaneously.

• Before use, the Slit Lamp should be allowed to adjust to the ambient room temperature for

several hours. This is especially important when the unit has been stored or transported in a

cold environment; this can cause severe condensation to develop on the optical elements.

Before use, the Slit Lamp should be allowed to adjust to the ambient

room temperature for several hours. This is especially important when the

unit has been stored or transported in a cold environment; this can cause

severe condensation to develop on the optical elements.

2.3 CONTRAINDICATION

There is no restriction to patient population this device can be used with other than those

outlined in the contra-indications stated below.

Slit lamps can produce discomfort in some photophobic patients due to the high illumination.

Additionally patients must be co-operative and capable of sitting upright for the duration of

the examination, therefore the technique may not be suitable for patients who are unable to sit

upright for long periods of time or those with limited neck and back mobility.

3. CLEANING AND DISINFECTION INSTRUCTIONS

Before any cleaning of the instrument or the base unit, ensure the power

lead is disconnected.

Only manual non-immersion cleaning as described should be used for this instrument. Do not

autoclave or immerse in cleaning ﬂuids. Always disconnect power supply from source before

cleaning.

1. Wipe the external surface with a clean absorbent, non-shedding cloth dampened with

de-ionised water / detergent solution (2% detergent by volume) or water / isopropyl

alcohol solution (70% IPA by volume). Avoid optical surfaces.

2. Ensure that excess solution does not enter the instrument. Use caution to ensure cloth is

not saturated with solution.

KSL-Z by KEELER

3. Surfaces must be carefully hand-dried using a clean non- shedding cloth.

4. Safely dispose of used cleaning materials.

4. NAMES OF CONTROLS AND COMPONENTS

Headrest Assembly

1. Fixation light cable

2. Forehead rest band

3. Patient’s eye height marker

4. Fixation light

5. Chinrest

6. Chinrest height adjuster

7. Patient grab handles

KSL-Z Series

8. Eyepiece assembly securing knob

9. Yellow ﬁlter knob (up = out)

10. Illumination prism

11. Slit offset by rotating prism housing

12. Filter control wheel

13. Slit rotation knob

14. Slit width control knob

15. Aperture control wheel

16. Test bar & tonometer plate hole and cover

17. Illumination arm locking knob

18. Microscope arm locking knob

19. Diffuser

7 EN

KSL-Z by KEELER

20. Joystick base locking knob

21. Joystick control (X Y Z movement)

22. Illumination control rheostat

23. Axle

24. Runner covers

25. Z type tonometer mounting hole

26. Yellow ﬁlter knob (up = out)

27. Lock for securing magniﬁcation body

28. Magniﬁcation change drum

29. Eyepieces – adjustable for PD and dioptre correction

30. Breath shield securing knob

31. Main power switch

32. Power supply unit

33. Glide plate

KSL-Z by KEELER

5. ASSEMBLY

Your Keeler Slit Lamp has been designed to ﬁt on to an electric insulated medical table base or on

to an electric insulated and ﬁre resistant medical table top, e.g. a refraction stand or combi unit.

Take care when unpacking your Slit Lamp that you do not accidentally damage or discard any

of the contents.

Leave the Slit Lamp in the packing for several hours after delivery before

unpacking to reduce the risk of condensation forming.

Keeler Slit Lamps can be ﬁtted to most Refraction Stands / Combi units. Keeler advises that this

shall be carried out by a suitably trained technicians to ensure performance and safety are not

affected.

The refraction stand, combi unit or table leg must be IEC 60601-1

compliant.

If you are ﬁtting or have ﬁtted your Slit Lamp to a medical or Keeler table leg / base ensure it is

situated on a ﬁrm and level ﬂoor.

If the table leg / base has castors ensure the following before moving it to another location:

1. The table is at its lowest position.

2. The power cord is removed.

3. The Slit Lamp arm and base locking knobs are tightened.

4. The runner covers are securely located.

5. The system is moved by grasping it at its lowest practical point.

5.1 TABLE TOP AND BASE ASSEMBLY PROCEDURE

1. Attach the Slit Lamp table top to your table leg using the M6 x 20mm screws and

washers. Note that the power supply and accessory drawer should face the operator.

The security of the ﬁtment of the table top to the table leg is critical for

patient and Slit Lamp safety

2. Using the wrench provided, ﬁt the headrest assembly to the tabletop using the hex bolts

and washers. The headrest assembly locates on the underside of the tabletop. Take care

not to over tighten the hex bolts.

3. Attach the patient grab handles (7) to the headrest assembly.

4. Place the Slit Lamp base on the runners. Ensure that the wheels are in line with each

other. Check that the guide wheels are tight.

5. Fit the runner covers to the runners by gently sliding them inwards, towards each other.

Runners

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