Riester ri-magic HPLED Examination Light Instructions

: June 12, 2024
: Riester

Table of Contents

ri- magic® HPLED
References
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ri- magic® HPLED

Instructions

99230 Rev. E 2019-04 · Subject to alterations

CE 0124

Riester ri-magic HPLED Examination Light - 1 Light

Desk model

Wall model

ri- magic® HPLED 6252

Stand model

ri- magic® HPLED 6250

Stand model

1. Important information – read prior to start-up

You have acquired a high-quality Riester examination light manufactured in compliance with Directive 93/42/EEC for medical products and subject to continuous stringent quality control. Should you have any queries, please contact the Company or your Riester Agent who will be pleased to assist you. For addresses see last page of these Instructions for Use. The address of your authorised Riester Agent will be supplied to you on request. Please note that correct and safe operation of instruments will only be guaranteed when Riester instruments and accessories are used throughout.

Warning:
Please note that the proper and safe functioning of our instruments is only guaranteed if both the instruments and their accessories are exclusively from Riester. The use of other accessories may result in increased electromagnetic emissions or reduced electromagnetic immunity of the device and may lead to incorrect operation.

2. Purpose

The universally applicable examination lamp ri- magic® HPLED from Riester was made for lighting and thus for diagnostics in all areas of medicine. It provides illumination of approximately 130,000 lux at a distance of 400 mm.

3. Safety instructions and electromagnetic compatibility:

Meaning of symbols on power pack and light plinth:

Manufacturer

CE marking

Please observe the operating instructions

Device of protection class II

Attention: Do not stare into the beam

Attention: Used electrical and electronic equipment should not be treated as normal household waste but should be disposed of separately in accordance with national or EU directives

Not for outdoor use

Relative humidity

Alternating current

Direct current

LED light
Do not stare into the beam
Class 2 LED

“Green Dot” (country-specific)

Store in a dry place

Batch code

Serial number

Temperature limits
in °C for storage and transport

Temperature limits
in °F for storage and transport

Fragile, handle with care

Warning!
This symbol indicates a potentially dangerous situation.

The light complies with the requirements relating to stability and emission of electromagnetic interference. Please note that interference may not be completely ruled out under the increased influence of detrimental field strengths, i.e. when operating mobile telephones and radiological equipment.

Attention!

Don’t use the examination light for eye-examination.
There may be a risk of gas ignition when the light is used in the presence of inflammable drug mixtures such as air and/or oxygen or laughing gas!
The light should only be opened by skilled persons to avoid a risk of lethal electrocution.
Please use exclusively the included plug connector.
Manufacturer Glob Tek Type GTM96180-1507-2.0

4. Assembly instructions prior to start-up

a) ri- magic® HPLED desk model
Attach universal clamp (1) and screw set (2) to a desk or wall rail. Insert universal light (4) from top into the bore of the screw clamp and fix with the knurled bolt (5). Connect cable plug (6) of the power pack (7) to the socket (8) from below until engaging with a click. Connect a transformer (7) to the socket. The light is now ready for operation.
b) ri- magic® HPLED wall model
Hold wall bracket (1a) to the desired point on the wall and mark 4 holes for dowels. Remove wall bracket and drill the 4 marked holes. Insert dowels into the wall. Apply wall bracket and fix with screws. Insert light (4) into bracket from above and fix by the locking screw (3a) on the side. Connect cable plug (6a) of power pack (7a) to socket (8a) from below until it engages with a click. Connect transformer (7a) to the socket. The light is now ready for operation.

Attention:
The wall must absolutely be solid enough for a good and guaranteed fixation of the diagnostic lamp. Please only use the included screws and anchors. Possibility of alternative use of 6 mm anchors with lens head screw DIN 95 3 x 40 mm.

Installation instructions:
Please pay attention to the enclosed assembly instructions of the mounting systems when installing the accessories.

In order to ensure an all-pole disconnection from the power supply at all times, the ME device must be installed in such a way that the power cable is accessible and can be disconnected.

c) ri- magic® HPLED stand model
Assembly:
Please assemble the mobile stand first and thereby take note of the installation instruction attached. Connect cable plug (6b) of power pack (7b) to the socket (8b) on the side until an audible click is heard. The light is now ready for operation.

To be able to move properly, the flexible arm (head) must be bent downwards, so that the light is not too high and does not hit nearby objects and so that there is no excess weight when the lamp is slightly inclined.

5. Start-up and operation Initially

Connect the cable plug (6,a,b) to the socket (8,a,b). Connect power pack (7,a,b) to the mains socket. Voltages on the rating plate of the mains adapter must be noted at all times. There are two optional voltages: 230 V and 120 V.
On-Off
Turn the rheostat (9) in clockwise direction. When a click is heard, the light is switched on. Turn the rheostat (9) in counter-clockwise direction until a click is heard. The light is now switched off. The Diagnostic lamp can also be interrupted from the main power supply by removing the plug connector out of the socket.
Rheostat
The desired light intensity may be set by turning the rheostat (9). Increase light intensity by turning in clockwise direction and decrease by turning in counter-clockwise direction. Focusing A focusing ring (10) is provided at the front of the light head for controlling the light cone of the light.
Focusing
There is a focusing ring (10) on the front of the lamphead. This ring can be used to regulate the light cone of the lamp.

Note:

The flexible arm of the light should not be bent in a too small radius in order to prevent premature material fatigue.
For normal operation of the light, the bracket (4) and the universal clamp (1) and/ or the tripod bracket (17) will heat up around the socket (8,a,b).

6. Instruction for care

General information
The goal of cleaning and disinfection of medical products is the protection of patients, users and third persons and conserving the value of the medical products. On account of the product design and the used material, no defined limit of maximum processing cycles can be fixed. The lifetime of the medical products depends on their function and on a appropriate treatment of the devices. Before returning faulty products for repair they must have gone through the described reprocessing process.
Cleaning and disinfection
The ri- magic® HPLED examination light can be cleaned outside with a humid cloth until optical cleanness is given. Wipe disinfection according to the regulations given by the disinfectant manufacturer. Only disinfectants with approved efficiency and in accordance with the national standards can be used. Means for cleaning or disinfection may be a soft, possibly lint-free cloth or Q-tips. After disinfection the device must be cleaned with a humid cloth to remove all possible deposits of disinfectants.

Caution!
Prior to cleaning or disinfection of the light, disconnect plug from mains socket! The items are not permitted for machine cleaning and sterilisation as they will damaged!

7. Specification

Model: examination lamp ri- magic® HPLED
Table lamp / wall lamp / floor lamp
Input: 100 V – 240 V / 50 – 60 Hz / 0.6 A
Output: 5 V 3 A 15 W
Type of lamp: LED
Classification: Type B
Working temperature: 0° to +40° C, relative humidity between 30 and 75 %
(non-condensing)
Storage place: -5 ° to +50 ° C, up to 85 % relative humidity
(non-condensing)
Weight: Table and wall model: approx. 2.5 kg
Stand model: approx. 7.5 kg

8. Maintenance

The instruments and their accessories require no special maintenance. If an instrument needs to be inspected for any reason, please send it to us or to an authorised Riester dealer in your area, whom we will gladly name upon request.

9. Standards

Photobiological safety of lamps and lamp systems DIN EN 62471 IEC 60601-1

10. Disposal of the packaging

When disposing of the packaging material, pay attention to the appropriate waste regulations. Keep out of reach of children.
Risk of explosion
Do not use this device in the presence of flammable anesthetic gases, vapors or liquids.
Disposal of accessories and device
Disposable accessory is intended for a single use. It should not be reused for its function may be impaired or contaminated. The service life of this ri- magic HPLED is 10 years. At the end of the service life, the ri-magic HPLED and all accessories must be disposed of in accordance with the regulations of such products. If you have questions regarding disposal of the product, please contact the manufacturer.

11. ELECTROMAGNETIC COMPATIBILITY

ACCOMPANYING DOCUMENTS ACCORDING TO
IEC 60601-1-2, 2014, Ed. 4.0

Attention:
Medical electrical equipment is subject to special precautions regarding electromagnetic compatibility (EMC).
Portable and mobile radio frequency communication devices can affect medical electrical equipment.
The ME device is for operation in an electromagnetic environment for home health care and intended for professional facilities such as industrial areas and hospitals. The user of the device should ensure that it is operated within such an environment.

Warning:
The ME device may not be stacked, arranged or used directly next to or with other devices. When operation is required to be close to or stacked with other devices, the ME device and the other ME devices must be observed in order to ensure proper operation within this arrangement. This ME device is intended for use by medical professionals only. This device may cause radio interference or interfere with the operation of nearby devices. It may become necessary to take appropriate corrective measures, such as redirecting or rearranging the ME device or shield.

The rated ME device does not exhibit any basic performance features in the sense of EN60601-1, which would present an unacceptable risk to patients, operators or third parties should the power supply fail or malfunction.

Warning:
Portable RF communications equipment (radios) including accessories, such as antenna cables and external antennas should not be used in closer proximity than 30 cm (12 inches) to parts and cables of the ri-magic HPLED specified by the manufacturer. Failure to comply may result in a reduction of the device`s performance features.

Guidance and manufacture’s declaration – electromagnetic emission

The Examination Light ri-magic® HPLED is intended for use in the electromagnetic environment specified below. The customer of the user of the Examination Light ri-magic should assure that it is used in such an environment.

Emission test

| Compliance|

Electromagnetic environment – guidance

RF emissions
CISPR 11|

Group 1

| The Examination Light ri-magic® HPLED use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emission
CISPR 11|

Class A

| The Examination Light ri-magic® HPLED is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2|

Class A

Voltage fluctuations/ flicker emissions
IEC 61000-3-3|

Complies

Guidance and manufacture’s declaration – electromagnetic immunity

The Examination Light ri-magic® HPLED is intended for use in the electromagnetic environment specified below. The customer or the user of Examination Light ri-magic should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
Electrostatic discharge (ESD)
IEC 61000-4-2| Con:±8 kV
Air:±2,4,8,15 kV| Con:±8 kV
Air:±2,4,8,15 kV| Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst
IEC 61000-4-4| ±2 kV for power supply lines| ±2kV for power supply lines| Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5| ± 1 kV line(s) to line(s)| ±1 kV differential mode| Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11| <5% UT
(>95% dip in UT)
for 0.5 cycle40% UT
(60% dip in UT)
for 5 cycles70% UT
(30% dip in UT)
for 25 cycles<5% UT
(>95% dip in UT)
for 5 sec| <5% UT
(>95% dip in UT)
for 0.5 cycle40% UT
(60% dip in UT)
for 5 cycles70% UT
(30% dip in UT)
for 25 cycles<5% UT
(>95% dip in UT)
for 5 sec| Mains power quality should be that of a typical commercial or hospital environment. If the user of the Examination Light ri-magic requires continued operation during power mains interruptions, it is recommended that the Examination Light ri-magic be powered from an uninterruptible power supply or a battery.
Power frequency (50Hz/60Hz) magnetic field IEC 61000-4-8| 30A/m| 30A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacture’s declaration – electromagnetic immunity

The Examination Light ri-magic® HPLED is intended for use in the electromagnetic environment specified below. The customer or the user of Examination Light ri-magic® HPLED should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6| 3 Vrms
150 kHz to 80 MHz
Outside ISM bandsa| 3 Vrms| Portable and mobile RF communications equipment should be used no closer to any part of the Examination Light ri-magic® HPLED, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

26 MHz to 800 MHz

800 MHz to 2.7 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol:

| |
Radiated RF
IEC 61000-4-3| 3 V/m
26 MHz to 2.7 GHz| 3V/m
NOTE 1 At 26 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.

b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,7 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in these frequency ranges.

c Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Examination Light ri- magic® HPLED is used exceeds the applicable RF compliance level above, the Examination Light ri-magic® HPLED should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Examination Light ri-magic® HPLED.

d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

WARRANTY

This product has been manufactured under the strictest quality standards and has undergone a thorough final quality check before leaving our factory. We are therefore pleased to be able to provide a warranty of 2 years from the date of purchase on all defects, which can verifiably be shown to be due to material or manufacturing faults. A warranty claim does not apply in the case of improper handling. All defective parts of the product will be replaced or repaired free of charge within the warranty period. This does not apply to wearing parts. For R1 shock-proof, we grant an additional warranty of 5 years for the calibration, which is required by CE-certification. A warranty claim can only be granted if this Warranty Card has been completed and stamped by the dealer and is enclosed with the product. Please remember that all warranty claims have to be made during the warranty period. We will, of course, be pleased to carry out checks or repairs after expiry of the warranty period at a charge. You are also welcome to request a provisional cost estimate from us free of charge. In case of a warranty claim or repair, please return the Riester product with the completed Warranty Card to the following address:

Serial number or batch number Box a1