DR MACH 150F LED Surgical Light User Manual

: June 15, 2024
: DR MACH

Table of Contents

Instructions for safe use
Images on the device
Safety instructions
Operating the Mach LED 150 light
Operating the Mach LED 150MC light
Cleaning and disinfecting
Faults
Information on electromagnetic compatibility
Disposal
Documents / Resources

GERMAN MED-LIGHT SOLUTIONS
Mach LED 150
User manual MedEnvoy Switzerland
Gotthardstrasse 28
6302 Zug, SWITZERLAND

Congratulations on acquiring a new Mach LED 150 operating light.
Please read these Instructions for use very carefully.

Instructions for safe use

1.1 Intended user
The Mach LED 150 is a Class I medical product and may only be operated by trained medical staff.
1.2 Information and obligation of the user to check the product
Pay attention to the instructions for use when handling the lamp. These Instructions for use are part of the product and must therefore be stored in a place close to the product in order for the safety instructions and important information to be consulted at any time.
Make sure that the lamp is in satisfactory working order before every use. If there is obvious damage, unusual operating conditions, etc., the lamp must not be used.
1.3 Availability of the instructions for use
These instructions for use and a detailed manual with further tips on how to use the light can be found online at the following link: https://dr- mach.de/login/mach-led-150.html

https://dr-mach.de/login/mach-led-150.html

1.4 Intended use / contra-indications
The Mach LED 150 operating light is designed to illuminate an operating site in medical facilities (e.g. in a laboratory, in hospitals or doctor’s practice) with focused, low-glare, shadow-free light. It enables the user to perform a diagnosis or carry out medical interventions. The Mach LED 150 light is an operating light that is not fail-safe when used as a single light. This device is not designed to operate in areas which are subject to explosions.
Continuous illumination of the open human eye should be avoided when illuminating the face area.
1.5 Technical data

Class of protection	I
IP protection class	IP 42
Input voltage (power supply)	100-240 V AC, 50/60 Hz
Input voltage (light body)	24 V DC
Power consumption	24 W

29 W (Mach LED 150 MC P)
Current| 1.0 A max
1,2 A max. (MC P)
Examination time| Continuous operation possible
Expected life1| 10 years

¹At the end of the expected (designed) service life, the lamp must be serviced more frequently for safe operation (see the manual for details).
1.6 Lighting technical data

| Mach LED 150F| Mach LED 150| Mach LED 150FP| Mach LED 150MC| Mach LED 150MC P
---|---|---|---|---|---
Central illumi- nance (distance 1 m)| 110.000 Lux| 110.000 Lux| 130.000 Lux| 110.000 Lux| 130.000 Lux
Light field diameter d10| 163 mm| 187 mm| 157 mm| 206 mm| 205 mm
Light field diameter d50| 85 mm| 104 mm| 83 mm| 113 mm| 112 mm
Residual light in- tensity (one shadower)| 0 %| 0 %| 0 %| 0 %| 0 %
Residual light in- tensity (two shadowers)| 52 %| 46 %| 53 %| 46 %| 45 %
Residual light in- tensity (normed tube)| 100 %| 100 %| 100 %| 100 %| 100 %
Residual light density (normed tube, one shadower)| 0 %| 0 %| 0 %| 0 %| 0 %
Residual light density (normed tube, two shadowers)| 52 %| 46 %| 53 %| 47 %| 46 %
Depth of illumination (20%)| 1800 mm| 1544 mm| 1800 mm| 1755 mm| 1740 mm
Depth of illumination (60%)| 822 mm| 803 mm| 814 mm| 855 mm| 870 mm
Radiation inten- sity in the field (distance 1 m)| 439 W/m2| 406 W/m2| 489 W/m2| 393 W/m2| 471 W/m2
Radiation inten- sity in the field| 572 W/m2 (0,78 m)| 551 W/m2 (0,77 m)| 591 W/m2 (0,81 m)| 583 W/m2 (0,73 m)| 695 W/m2 (0,72 m)

For a complete overview of technical and lighting specifications, refer to the manual.
1.7 Installation/Maintenance/Repair
The lamp may only be installed, maintained or repaired by the manufacturer or by specially trained staff. Maintenance must be carried out at least every two years
1.8 Environmental conditions for operation

Ambient temperature:	+10°C to + 30°C
Relative air humidity	30% to 75% RH
Air pressure	700 hPa to 1060 hPa

1.9 Reporting obligations
All serious incidents which have occurred in connection with the product must be reported to the manufacturer and the competent authority.

Images on the device

****	This symbol indicates that the instructions for use must be followed.
Serial number of the product
Part number of the product
****	Address of the manufacturer
Date of manufacture and country of manufacture
EC conformity symbol
This symbol indicates that this is a medical device
Unique device identifier (ID) of the product
NRTL Test mark

The lamp was tested by a ‘Nationally Recognized Testing Laboratory’
| Reference to China RoHS / pollution control logo
****| Instruction for disposal of the device

Safety instructions

| This symbol indicates possible sources of danger.
Please also note the safety instructions and the hazard specification in the associated installation and operating instructions for the support arm system.
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| The instructions for use must be observed for safe handling of the lamp
| To avoid the risk of an electric shock, this device must only be connected to a supply network that has a protective earthing conductor.
| A primary-side ON/OFF switch to isolate the system from the supply network must be provided on site. The switch must meet the requirements of IEC 61058-1 for nominal
voltage peaks of 4 kV.
| This device is not designed for operation in environments enriched with oxygen.
| The lamp may only be used for the intended purpose. Otherwise, the manufacturer will not be liable for personal injury or damage to property.
| The lamp is equipped with a sterilisable handle at the factory and must only be used with this handle.
| Changes to the light are prohibited and will invalidate the manufacturer’s certificate of conformity and all warranty claims.
| Use only the mains units (or transformers) approved or supplied by the manufacturer.
Non-observance will void the conformity of the product and release the manufacturer from any claims under warranty.
| Installation, maintenance and repair work may only be carried out by the manufacturer or by specially trained staff.
| Maintenance must be carried out on the light at least every two years
| Additional equipment that is connected to medical electrical equipment, must conform to the relevant IEC- or ISO standards (e.g. IEC 60950 or IEC 62368 for data processing equipment). Moreover, all configurations must meet the requirements for medical electrical systems (see Section 16 of the latest version of IEC 60601-1). Anyone who connects additional equipment to medical electrical equipment, is configuring a medical system and is therefore responsible for ensuring that the system meets the
requirements for medical electrical systems. In case of doubt, contact your local representative or our technical customer services.
| The simultaneous use of several lights to illuminate a wound area may result in the maximum allowed energy input being exceeded (1,000 W/m²) and thus excessive heat development. It is the user’s responsibility to ensure that the maximum allowed limit is not exceeded.
| The unprotected human eye can be damaged by direct light. Do not look directly into the light beam of the lamp. Do not point the light beam at the patient’s unprotected eye continuously.
| When positioning the light body, there is a risk of injury (e.g. crushing) and collisions with other objects (inventory) or walls.
| Parts that fall off could injure the patient or lead to an infection of the wound area.
| Do not remove the rating plate or the warning labels.
| It is forbidden to carry out servicing or repair activities whilst the lamp is in use.
| Simultaneous touching of parts on the luminaire and the patient is not permitted.

Operating the Mach LED 150 light

ON/OFF switch of the light (to switch off, hold for one second) (1).

Adjust the brightness in six levels between 50 and 100% (2 and 3) (lowest leve l= endoscopy light).
Display of the set brightness (4), the uppermost LED will flash in Standby.
If only the top LED lights up, the light is in endoscopy mode.
Focus the light field by turning the handle (5).

Position the lamp body using the handle (5) or the handle bar (6).

Operating the Mach LED 150MC light

| Switching the light on/off (to turn off the light, press and hold the (ON/OFF) button for one second).
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| Adjusting the brightness Switching on the endoscopy mode
| Adjusting the colour temperature

Cleaning and disinfecting

Cleaning and disinfecting work must only be done by trained staff. The respective requirements must be observed for all cleaning and disinfection work (details can be found in the manual).
Housing/protective screen
The housing and the protective screen of the lamp body can be cleaned and disinfected with many common/commercially available materials. Do not use cleaning agents or disinfectants containing active substances based on biguanides, phenols, chlorides or percompounds.
Furthermore, only cleaning agents approved for polycarbonate (PC) may be used to clean the protective screen. To protect against mechanical damage, always use a damp cloth (never a dry one) to wipe the protective screen and after cleaning, wipe with an antitatic agent (lint-free cloth).
Sterilisable handle
The handle must be cleaned/disinfected before each use. It can be steam sterilised (max. 200 sterilisation cycles for max. 5 minutes at a max. temperature of 134°C); details can be found in the manual.
Before installing the handle, check it for visible damage, fouling and the specified manufacturing date. Do not use damaged or dirty handles or handles that are more than two years old.

Faults

In the event of unusual examination conditions, the lamp must not be used, as safe operation cannot be guaranteed. For troubleshooting, disconnect the lamp from the mains for about 30 seconds. In the event of continuous faults, a suitably trained service technician must be contacted.

Information on electromagnetic compatibility

Medical electrical equipment is subject to special precautionary measures with regard to electromagnetic compatibility (EMC). It may only be installed and put into service in accordance with the EMC instructions in the accompanying documents. The Mach LED 150 and Mach 150MC operating light are intended for use in professional healthcare facilities.

| The emission characteristics of this device permit its use in industrial and hospital environments (CISPR 11, Class A). When used in a residential environment (which usually requires Class B according to CISPR 11), this device may not provide adequate protection of radio services. The user may need to take remedial action such as relocating or reorientating the device.
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| Portable and mobile RF communications equipment can affect medical electrical equipment and must not be used within 30 cm of the light, including the cable.
| The light is suitable for use in conjunction with an RF surgical device. A minimum distance of 50 cm must be maintained between the surgical light, including its suspension system, and the RF electrode cables.
| The use of this equipment immediately next to other equipment or with other equipment in stacked form should be avoided since this may result in faulty operation. Should use in the aforementioned manner nevertheless be necessary, this device and the other equipment should be kept under observation to ensure that they are working properly.
| The use of different accessories, converters or cables to those that the manufacturer of this device has stipulated or made available may result in increased electromagnetic interference or reduced immunity to electromagnetic interference and to faulty operation.
| Furthermore, the light must not be operated if the housing, cable or electromagnetic shielding is damaged.
| To avoid adverse effects on patients and operators due to electromagnetic interference, lights must not be operated outside of their intended EMC environment.

Additional information on electromagnetic compatibility can be found in the manual.

Disposal

**** The light does not contain any harmful substances. The components of the light should be disposed of appropriately at the end of the product’s life.
Take care that the material is carefully separated: The electrical circuit boards should be recycled appropriately. The housing of the light and the other components should be disposed of according to the materials they contain.

https://www.praxisdienst.com/en/Furniture/Lighting+and+Viewing/
Surgical+Lamps/MACH+LED+150FP+with+4+feet+stand.html

GERMAN MED-LIGHT SOLUTIONS
Dr. Mach GmbH & Co. KG
Am Brucker Feld 4
85567 Grafing, GERMANY
Tel. +49 (0)8092 2093 0
Fax +49 (0)8092 2093 999
www.dr-mach.de
info@dr-mach.de
59321001
Mach LED 150
V6
2023-09-19