DR MACH 300MC LED Ceiling Mounted Surgical Light User Manual

DR MACH 300MC LED Ceiling Mounted Surgical Light

Introduction

Congratulations on acquiring a new Mach LED 300 operating light.
Please read these Instructions for use very carefully.

Instructions For Safe Use

Intended user

The Mach LED 300 is a Class I medical product and may only be operated by trained medical staff.

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.

Availability of the instructions for use
These instructions for use and a detailed handbook with a list of accessoires and further tips on how to use the light can be found online at the following link:

https://dr-mach.de/login/mach-led-300.html

Intended use / contraindications

The Mach LED 300 operating light is designed to illuminate an operating site in medical facilities (e.g. in a laboratory, in hospitals or doctor’s practice) with focussed, low-glare, shadow-free light. It enables the user to perform a diagnosis or carry out medical interventions.
The Mach LED 300 light is an operating light that is not fail-safe when used as a single light. It is not intended for use in areas where explosions are likely although it is permissible to use it in the vicinity of HF surgical equipment.
Permanent illumination of the open human eye should be avoided when illuminating the face area.

Technical Data

Input voltage
(power supply 200W / 190W)| 100-240 V AC, 50/60 Hz
Input voltage (light body)| 24-30 V DC
Power consumption| 32 W (Mach LED 300DF SC Spot)

46 W (Mach LED 300DF SC – camera preparation)

53 W (Mach LED 300DF SC – camera)

32 W (Mach LED 300MC – camera preparation)

39 W (Mach LED 300MC – camera)

Current| 2.0 A max.(Mach LED 300DF SC Spot)

2.0 A max. (Mach LED 300DF SC – camera preparation)

2.3 A max. (Mach LED 300DF SC – camera)

1.3 A max. (Mach LED 300MC – camera preparation)

1.7 A max (Mach LED 300MC – camera)

Operating time| Continuous operation possible
Expected life (1)| 10 years

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

Lighting technical data

| Mach LED 300DF SC| Mach LED 300DF SC Spot| Mach LED 300MC
---|---|---|---
Central light strength (distance 1 m)| 160,000 lux| 160,000 lux| 160,000 lux
Light field diameter d10| 189 mm| 185 mm| 184 mm
Light field diameter d50| 100 mm| 97 mm| 104 mm
Residual light intensity (one shadower)| 41 %| 38 %| 44 %
Residual light intensity (two shadowers)| 42 %| 47 %| 44 %
Residual light intensity (normed tube)| 100 %| 100 %| 100 %
Residual light intensity (normed tube, one shadower)| 41 %| 38 %| 44 %
Residual light intensity (normed tube, two shadowers)| 42 %| 47 %| 44 %
Illumination depth (20%)| 965 mm| 1520 mm| 915 mm
Illumination depth (60%)| 552 mm| 628 mm| 510 mm
Radiation intensity in the field (distance 1 m)| 584 W/m2| 582 W/m2| 574 W/m2
Max. radiation intensity in the field (distance 0.94 m)| 588 W/m2| –| –
Max. radiation intensity in the field (distance 0.90 m)| –| –| 674 W/m2
Max. radiation intensity in the field (distance 0.85 m)| –| 602 W/m2| –

For a complete overview of technical and lighting specifications, refer to the manual.

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.

Environmental conditions for operation

• Ambient temperature : +5°C to +40°C
• Relative air humidity : 30% to 75% RH
• Air pressure. 700h Pat o 1060h Pa

Reporting obligations

Every serious incident which has 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.
• Reference to China RoHS / pollution control logo
• Positioning arrows
• 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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| Pay attention to the instructions for use when handling the lamp.
| Warning: 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 sterilizable 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) ap- proved 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.
| Do not allow the laser beam to enter the eyes of the patient or user. The eyelid closing reflex of patients, in particular, may be impaired by this.
| 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 300 light

• ON/OFF switch of the light (To turn off the lamp, press and hold the (ON/OFF) button for one second.)
• Regulation of the brightness Switching on the endoscopy mode
• Regulation of electronic focus
• Adjustment of the color temperature

Operating The Camera Remote Control

Camera Controls

• ON/OFF:
  Switch between operation and stand-by

• Rotate:
  Rotate video image

• Zoom:
  Magnification of the video image
  

• White balance:
  adjusting the colour temperature to the actual environment

• Still image
  

• Focusing:
  Autofocus – Switch on/off
  Near/far – Adjust to near or far objects

• Exposure
  AE – Switching the automatic exposure control on/off.
  Sun/Moon – Increase or decrease the brightness

Operating The Mach LED 300 Manual Remote Control

• Light ON/OFF switch

• Transfers the settings of light intensity, colour temperature, focus and endo-mode to other lights

• Adjustment of light intensity

• Adjustment of the electronic focussing

• Adjustment of the colour temperature

Pairing

Option A: Pairing manual remote lamp control

Start pairing by pressing and holding (min. 3 sec.) of the key combination 1 (+), 2 (-) and 3 (ON/OFF)

Flashing LED 2 and LED 3 – pairing mode activated
Press any key of the remote control to transmit Sync address and WCOM address to the lamp Note: No other hand-held remote control may be active or activated during pairing Further information and overview of SYNC and WCOM addresses can be found in the manual for downloading.

Option B: Pairing Camera

Radio receiver connection:
Pull the top cover 3 upwards

Insert receiver module 4 into the wall bracket

Radio receiver is now in configuration mode – green status LED 3 flashes continuously for approx. 1 minute After one minute radio receiver is in normal operating mode – (green LED 3 flashes briefly)

Connect the monitor or other compatible device (recording device, splitter, etc.) with an HDMI cable to the HDMI connection 4 of the wall bracket.

Connect the power cable to connector 5

1. Switch on the camera with the remote control with the ON/OFF button in standby mode (permanently lit yellow LED in the camera)
2. Press the red button on the radio receiver and hold it pressed for at least 5 seconds (yellow LED flashes quickly)
3. Press freeze button of the remote control camera (facing the camera) five times in a row within 15 sec. – yellow LED of the camera flashes – pairing starts
4. Pairing takes a few minutes; after completion, the yellow LED in the camera and the blue LED on the radio receiver are lit continuously
5. Switch on the camera using the remote control – if there is a picture on the monitor – pairing successful; no picture on the monitor – repeat the procedure Status of the radio link by displaying the blue LED 6:
   • LED lights up permanently: radio connection stable and permanent
   • LED flashes quickly: Radio connection established, but video not displayed on monitor – check monitor cable
   • LED flashes slowly: No radio connection established
     

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 or phenols. Cameras must be removed and the camera bay cover put on prior to cleaning and disinfection.
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 anti-static 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 operating conditions or a fault message displayed on the display, 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, stating the error code.

Information On Electromagnetic Compatibility

Medical electrical equipment is subject to special precautionary measures with regard to electromagnetic compatibility (EMC). They may only be installed and put into service in accordance with the EMC instructions in the accompanying documents. The Mach LED 300 operating light has been tested for use in professional equipment of the healthcare system.

| The lamp is suitable for use with an RF surgical device. There must be a distance of at least 50 cm between the surgical light, including the suspension system, and the RF electrode cables.
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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 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.

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.

Customer Support

MedEnvoy Switzerland
Gotthardstrasse 28
6302 Zug, SWITZERLAND

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

References

• MACH - der Digitalisierungspartner für die öffentliche Verwaltung - MACH AG
• Dr. Mach – Das beste Licht für Mediziner. Weltweit.: Dr. Mach
• español - Spanisch-Deutsch Übersetzung | PONS
• Login: Dr. Mach
• MACH LED 300DF SC | Shop Surgical Lights Here

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