Dr. Mach Mach M5 Manuale utente

Mach M5 Dr. Mach

Lamps and Engineering

Instructions for use

MACH M5

Mach M5 ceiling lamp for room heights up to 2,8m, F- / F/H / DF- / DF/H-model

Mach M5 ceiling lamp for room heights between 2,8m – 3m, F- / F/H / DF- / DF/H-model

Dr. Mach GmbH u. Co., Floßmannstrasse 28, D-85560 Ebersberg

Tel.: +49 (0)8092 2093 0, Fax +49 (0)8092 2093 50

Internet: www.dr-mach.com, E-Mail: [email protected]

59270001 Edition 06 28.09.2004 / Bak page 1/26

Mach M5 Dr. Mach

Lamps and Engineering

List of contents

1. Safety instructions ....................................................................................page 4

2. Operating the lamp MACH M5..................................................................page 5

2.1 Brief description of the lamp ...............................................................page 5

2.1.1 Merging of light fields (F-model) ..................................................page 5

2.1.2 Focusing (DF-model)...................................................................page 5

2.1.3 Light intensity control (/H-model).................................................page 5

2.2 Turning the lamp ON/OFF ..................................................................page 6

2.3 Adjusting the illuminated area by........................................................page 6

merging of light fields (for F- and F/H-models)

2.4 Adjusting the illuminated area by........................................................page 6

merging of light and focusing –

Duo Focus system (for DF- and DF/H-models)

2.5 Overview of the lamp functions...........................................................page 7

2.6 Adjusting the light intensity .................................................................page 8

2.7 Positioning ..........................................................................................page 9

3. Cleaning....................................................................................................page 10

3.1 Sterilisable handle ..............................................................................page 10

3.2 Lamp housing, dispersing lens and support system ...........................page 12

4. Maintenance .............................................................................................page 12

4.1 Adjustments at the lamp head ............................................................page 12

4.2 Changing of spare parts .....................................................................page 13

4.2.1 Changing the halogen bulbs........................................................page 13

4.2.2 Changing the filter disk ................................................................page 15

4.2.3 Changing the dispersing lens ......................................................page 17

5. Data ..........................................................................................................page 19

5.1 Technical specifications......................................................................page 19

5.2 Electrical data .....................................................................................page 20

5.3 Environmental conditions....................................................................page 20

5.4 General remarks.................................................................................page 20

6. CE-mark....................................................................................................page 21

7. Disposal ....................................................................................................page 21

8. Spare parts ...............................................................................................page 22

9. Spare parts list..........................................................................................page 24

10. Appendix: Setting the primary voltage

at the block transformer 300VA ...............................................page 25

59270001 Edition 06 28.09.2004 / Bak page 2/26

Mach M5 Dr. Mach

Lamps and Engineering

Dear customer!

Congratulations for acquiring our new OT-lamp MACH M5.

The MachVISION optical system provides an illuminated field with improved contrast and

excellent homogenity. Combined with the Duo-Focus feature this offers a unique possibility

for adaptation to the wound area.

With this lighting system you profit from a whole range of new developments, based on 50

years of experience in the production of operating and doctor’s lights.

The lighting system is characterised by a previously unreceivable general colour rendition

value of Ra = 96. In other words, the colours are reproduced naturally and in high con-

trast. The wound area is shown in a comfortable light.

The different reds of a wound area can now be recognised very precisely. For the doctor or

surgeon this means a considerable improvement in the recognition of details in the wound

area.

The R96 lighting system uses computer-optimised cold-light filters that reduce both the un-

wanted build-up of heat in the head area and the heat radiated on the illuminated

wound area to a minimum.

Pay attention to the special mounting instructions for ceiling lamps.

All information quoted here relates only to the illuminants. Details of ceiling or wall installation

can be found in the mounting instructions.

59270001 Edition 06 28.09.2004 / Bak page 3/26

Mach M5 Dr. Mach

Lamps and Engineering

1. Safety instructions

Pay attention to the instructions for use when handling the lamp.

WARNING:

This device has not been designed for use in potentially explosive areas.

According to the Medical Device Regulation the lamp is classified under class I.

Store the OT-lamp in its package for at least 24 hours in the respective room before

mounting, in order to equal temperature differences.

Please read the instructions for use carefully to make the most of your lighting

system and to avoid any damages to the device.

The lamps may only be repaired and special assembly work may only be carried

out on the reflector or sockets by ourselves or a company that has been expressly

authorised by us.

The manufacturer can only be made responsible for the safety of the lamp if re-

pairs and alterations are carried out by the manufacturer himself or a company that

guarantees to observe the safety regulations.

The manufacturer cannot be made liable for personal or material damages if the

lamp is operated inexpediently or incorrectly or used for purposes other than

those for which it is intended.

The lamp is to be dismantled from the spring arm in reverse order to its assembly.

This may only be carried out after the spring arm has been adjusted in height at

horizontal position since the arm is under spring tension and can bounce up.

Make sure that the lamp is in perfect working order before every use.

Attention, external transformer!

The lamp works only with an external transformer 300VA.

The external transformer (Order No. 6701 0208) must be tested and validated ac-

cording to IEC 60601-1.

If the external transformer is not tested and validated according to IEC 60601-1, it

is not allowed to use it with Dr. Mach OT-lamps.

59270001 Edition 06 28.09.2004 / Bak page 4/26

Mach M5 Dr. Mach

Lamps and Engineering

2. Operating the lamp MACH M5

2.1 Brief description of the lamp

The OT-lamp MACH M5 is available in following versions:

- Standard OT-lamp (F) with merging of light fields

- Duo-Focus OT-lamp (DF) with merging of light fields and focusing

- F- or DF- lamps with light intensity control (/H)

2.1.1 Merging of light fields

(F- model)

The F-model offers light field adjustment by

merging the individual light fields of each

reflector by swiveling them.

NOTE: This feature is activated by turning the

sterilisable handle.

2.1.2 Focusing (DF- model)

The DF-model offers a second additional fa-

cility to further adjust the illuminated field to an

extra small or extra large size, depending on

the specific requirements, by focusing

through moving the bulbs up or down.

NOTE: This feature is activated by turning the

ring at the top of the sterilisable handle.

2.1.3 Light intensity control (/H- model)

The OT-lamp models offer an optional feature, the light intensity control.

You can adjust the light intensity between 50% and 100%; according to your requirements.

59270001 Edition 06 28.09.2004 / Bak page 5/26

Mach M5 Dr. Mach

Lamps and Engineering

2.2 Turning the lamp ON/OFF

The F- and DF-models are switched ON/OFF at the

main switch of the OT or at the ON/OFF switch at the

cardan bow (if ordered).

The F/H and DF/H models are switched ON/OFF

with the touch-button 1at the key-pad of the lamp.

2.3 Adjusting the illuminated area by

merging the light fields

(for F- and F/H-models)

All F and F/H lamp models offer the feature of “merg-

ing the light fields”. This feature is activated by turn-

ing the sterilisable handle 2.

Remark:

The ring 3 has no function here.

2.4 Adjusting the illuminated area by

merging the light fields and

focusing – Duo-Focus system

(for DF- and DF/H-models)

DF- and DF/H-models also have a “focusing” func-

tion (Duo-Focus).

The combination of merging the light fields and focus-

ing (Duo-Focus system) enables the ideal adjust-

ment of the light field to the wound area in a range

from 8cm to 35cm diameter. Such a large range of

adjustment is not possible with conventional tech-

nique.

To activate the focusing function turn the adjusting

ring 3on the handle, or – if the lamp is equipped with

a keypad at the cardan bow (for DF/H-models) –

press touch buttons 5 and 6.

Press touch button 5to expand the focus and touch

button 6to bundle the light to a minimum area. The

current focused diameter is shown in the LED-

display 4.

59270001 Edition 06 28.09.2004 / Bak page 6/26

Mach M5 Dr. Mach

Lamps and Engineering

2.5 Overview of the lamp functions

Merging of light fields and focusing

Merging the individual light fields of each reflector

is done by swivelling the reflectors. The light fields

overlap.

This feature is activated by turning the sterilizable

handle (1).

Focusing is done by moving the bulbs inside the re-

flectors up or down. This way you can further adjust

the illuminated field to an extra small or extra large

size, depending on the specific requirements.

This feature is activated by turning the ring (2) at the

top of the sterilisable handle.

FOCUSING

MERGING OF LIGHT FIELDS

Ring (2)

Handle (1)

Always activate merging of light fields first by turning the handle (1), then activate fo-

cusing when necessary by turning the ring (2). !!

59270001 Edition 06 28.09.2004 / Bak page 7/26

Mach M5 Dr. Mach

Lamps and Engineering

Key pad

2.6 Adjusting the light intensity

(for F/H- and DF/H-models only)

Select the desired light intensity before the opera-

tion.

At these models the adjustment is done by the key-

pad at the cardanic bow. The intensity can be ad-

justed continuosly between 50% and 100%.

Press push button 2 to increase the light intensity

and press push button 3 to reduce the light inten-

sity.

The set light intensity is shown by LED-display 1.

For other light models we recommend a dimmer in

the supply line.

59270001 Edition 06 28.09.2004 / Bak page 8/26

Mach M5 Dr. Mach

Lamps and Engineering

2.7 Positioning

Use the sterile handle 2 or the handle rails 1 to

position the lamp.

Use the handle rail to position the lights before the

operation.

Use the sterile handle for positioning during the

operation. This handle can be removed for sterilisa-

tion.

The working distance for the F-lamps is 0,7m to

1,4m.

The working distance for the DF-lamps is 0,6m to

1,5m.

The handle is supplied with a detectable mechanical

catching. When the handle catches in this position,

the lamp is optimally set for a working distance of 1

meter.

1,4m

(1,5m)

0,7m

(0,6m)

Two or more lamps can be used for an intensive

illumination of large operation fields.

It is also possible to illuminate two operation fields

simultaneously.

59270001 Edition 06 28.09.2004 / Bak page 9/26

Mach M5 Dr. Mach

Lamps and Engineering

3. Cleaning

3.1 Sterilisable handle

At delivery the lamp is equipped with the handle

sleeve 1. The handle sleeve is removable and ster-

ilisable. Before using the first time and before every

use the handle sleeve must be cleaned, disinfected

and sterilised.

The handle sleeve must be removed for sterilisation:

• To remove press the lock V and pull off the ster-

ilisable handle sleeve 1 while keeping the lock

pressed.

• To attach, push on and slightly twist the handle

until the lock V engages securely.

Handles often become unsterile during an operation.

Therefore always keep additional handles available

for exchange.

Cleaning / disinfection and sterilisation

Basics

Efficient cleaning / disinfection is an essential requirement for effective sterilisation of the handle.

Within the scope of responsibility for the sterility of the products it should be noted that only sufficiently

validated equipment and product specific processes are used for cleaning / disinfection and that the vali-

dated parameters are complied with in every cycle.

In addition, the hospital / clinic hygiene regulations must be observed.

Cleaning / disinfection

Cleaning and disinfection must be carried out immediately after use.

A mechanised process (disinfector) should be used for cleaning / disinfection. The efficiency of the proc-

ess used must be recognised and validated in principle (e.g. listed under disinfectants and disinfection

procedures tested and recognised by Robert-Koch-Institute / DGHM).

When using other procedures (e.g. a manual procedure), proof and process efficiency in principle must

be provided within the scope of validation.

Proof in principle of the suitability of the handles for efficient cleaning / disinfection was provided using a

cyclic cleaning system (Netsch-Bellmed T-600-IUDT/AN, programme 2 for small parts; code B).

It is not allowed to use agents / disinfectants, which contain the following substances, as these may

cause changes in the material:

- High-concentration organic and inorganic acids

- Chlorinated hydrocarbons

- 2-ethoxyethanol

59270001 Edition 06 28.09.2004 / Bak page 10/26

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