Riester M30950EN System K-L.E.D with Charger Instruction Manual

: June 1, 2024
: Riester

Table of Contents

Riester M30950EN System K-L.E.D with Charger
Specifications
Product Usage Instructions
INTRODUCTION
SAFETY
K-L.E.D. HEADLAMP WITH SINGLE BATTERY PACK
FITTING THE K-L.E.D. HEADLAMP TO YOUR LOUPE FRAME
CLEANING INSTRUCTIONS
TECHNICAL INFORMATION
ANNEX I – EMC STATEMENT AND GUIDELINES
FAQ
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Riester M30950EN System K-L.E.D with Charger

Riester-M30950EN-System-K-L-E-D-with-Charger-PRODUCT

Specifications

Product Name: Riester K-L.E.D. Headlamp
Product Type: Binocular Loupes
Intended Use : Dental and surgical environments
Power Source : Single Battery Pack
Classification: CE Class I, FDA Class I

Product Usage Instructions

Charging the Single Battery Pack
Follow these steps to charge the single battery pack:

Connect the charger to a power source.
Insert the battery pack into the charger ensuring proper alignment.
Allow the battery to charge fully before use.

Fitting Your K-L.E.D. Headlamp to Your Loupe Frame
To fit the headlamp to your loupe frame:

Ensure the headlamp and loupe frame are clean and free of debris.
Align the headlamp with the designated mounting area on the loupe frame.
Secure the headlamp in place according to the manufacturer’sinstructions.

Cleaning Instructions
Proper cleaning is essential for maintaining performance:

Use a soft, dry cloth to clean the headlamp and loupe frame after each use.
Avoid using harsh chemicals or solvents that may damage theproduct.
Store the headlamp in a clean, dry place when not in use.

Technical Information
The technical details of the product are provided in the accompanying documentation for reference.

INTRODUCTION

Thank you for purchasing the Riester K-L.E.D. Headlamp.
The product has been designed and manufactured to ensure that you will enjoy many years of trouble-free and safe use. Please follow the User Instructions to ensure optimum performance.
The headlamp has been designed to be used in dental and surgical environments, to illuminate areas under examination by the user.

COPYRIGHT AND TRADEMARKS
The information contained within this manual must not be reproduced in whole or in part without the manufacturer’s prior written approval.
As part of our policy for continued product development, we reserve the right to make changes to specifications and other information contained in this document without prior notice.

SAFETY

Device classification

CE Regulation 93/42 EEC : Class I
FDA: Class I
Carefully read this Instruction Section before using your Riester product. For your safety and that of your customers observe all cautionary information provided in this section. The following information is intended to highlight potential safety hazards that can be associated with misuse, or damage.

WARNINGS AND CAUTIONS

Warning:

Check your Riester product for signs of transport/storage damage before use.
Do not use if the product is visibly damaged, and periodically inspect for signs of damage.
Do not shine directly into a person’s eye. Do not stare into the light when in use. May be harmful to the eyes.
Do not hold magnifying glasses or any other optical system in front of the light.
Do not use in the presence of flammable gases/liquids, or an oxygen-rich environment
This product should not be immersed in fluids.
Do not disassemble or modify the battery. There are no serviceable parts inside.
Do not dispose of the battery in the fire, puncture or short circuit.
Do not use a battery that is deformed, leaking, corroded or visually damaged. Handle a damaged or leaking battery with care If you come into contact with the electrolyte, wash the exposed area with soap and water. If it contacts the eye, seek medical attention immediately.

US Federal law restricts this device to sale by or order of a physician or practitioner.

Do not fit mains power adapter into a damaged mains outlet socket
Route power cords safely to eliminate the risk of tripping or damage to equipment
LEDs can reach high temperatures in use – allow them to cool before handling
After removal of the LED do not touch the LED contacts and the patient simultaneously

Caution:

Use only genuine Riester-approved parts and accessories or device safety and performance may be compromised.
Use only Riester-approved batteries, chargers and power supplies as per the accessories listed in section 11.
Ensure the equipment is positioned in such a way that it can be disconnected from the mains easily.
The product has been designed to function safely when at an ambient temperature between +10°C and +35°C.
Keep out of the reach of children.
To prevent condensation from forming, allow the instrument to come to room temperature before use.
Do not hold magnifying glasses or any other optical system in front of the light.
For indoor use only (protect from moisture).
When replacing the lithium battery pack, turn the K-LED off and attach a new pack.
Remove the battery pack when the device may not be used for prolonged periods.
Do not charge the battery in any environment where the temperature may exceed 40˚C or fall below 0˚C There are no user serviceable parts inside. Contact the authorised service representative for further information.
Ensure the device is securely held in a docking station to minimise the risk of injury or damage to equipment.
Follow guidance on cleaning / routine maintenance to prevent personal injury/damage to equipment.
Switch off the electrical supply and disconnect it from the main electrical supply before cleaning and inspection. Dispose of batteries in line with local environmental regulations.
At product end of life dispose of by local environmental guidelines (WEEE).
Note : Lithium Ion batteries contain no toxic heavy metals such as mercury, cadmium or lead.

K-L.E.D. HEADLAMP WITH SINGLE BATTERY PACK

DESCRIPTION OF THE PRODUCT

A Rechargeable Battery Pack
B Power Supply and Adaptors
C Battery Charger
D LED Light Source
E Connector

Riester-M30950EN-System-K-L-E-D-with-Charger-FIG-1

CHARGING THE SINGLE-BATTERY PACK

The battery pack can be used at any time during the charging cycle and will automatically resume charging when replaced in the charging well.
The battery pack can be left in the charger storage unit when it is not being used. The charger will automatically stop charging the battery pack when fully charged.

Charging storage unit

Green LED Charging storage unit powered
No yellow LED Battery charged
Flashing yellow LED Top-up charge
Solid yellow LED Rapid charge

Battery pack

Flashing LED Battery requires charging

Charging cycle
The battery will take approximately 3 hours to fully charge.

FITTING THE K-L.E.D. HEADLAMP TO YOUR LOUPE FRAME

To remove the loupes from the frame, hold the loupe bar between your thumb and forenger of one hand and pull away from the hinge held in your other hand.
Attach the LED light to the loupe bar. Ensure that the LED light is fitted correctly and held securely in position, as shown.
Re-attach the loupes and LED light to the frame hinge by holding the loupe bar as before. Locate the hinge pins into the loupe bar holes and push the loupes onto the hinge.
If the LED light is to be used on its own without loupes, attach the Light to the Spacer bar as shown.
Attach the cable to the frame sides using the cable clips provided.
Connect the LED light lead into the connector port on top of the battery pack.’

CLEANING INSTRUCTIONS

Only manual non-immersion cleaning as described should be used for this light source. Do not autoclave or immerse in cleaning fluids.
Do not autoclave or immerse in cleaning fluids.

WARNING: Always disconnect the power supply from the source before cleaning.

a Wipe the external surface with a clean absorbent, nonshedding cloth dampened with a water/detergent solution
(2% detergent by volume) or water/isopropyl alcohol solution (70% IPA by volume). Avoid optical surfaces.
b Ensure that excess solution does not enter the instrument. Use caution to ensure the cloth is not saturated with solution.
c Surfaces must be carefully hand-dried using a clean nonshedding cloth.
d Safely dispose of used cleaning materials.
e Do not operate the LED light until it thoroughly dry.

TECHNICAL INFORMATION

Input mains data: 100-240V – 50/60Hz 700mA
Power supply rating: 12V : 2.5amps
Operation: Continuous
Classification: Class II equipment Type B protection against shock

Transport, storage and operating conditions

to 95%

| 10%

to 95%

| 30%

to 74%

DISPOSAL OF OLD ELECTRICAL AND ELECTRONIC EQUIPMENT
(Applicable in the European Union and other European Countries with separate Collection Systems).

This Symbol on the Product or on its Packaging and instructions indicates that it was put on the marketplace after August 2005 and that this product shall not be treated as Household Waste.
To Reduce the Environmental impact of WEEE (Waste Electrical Electronic Equipment) and minimise the volume of WEEE entering landfills we encourage at the Product end of life that this Equipment is recycled and reused.

ANNEX I – EMC STATEMENT AND GUIDELINES

The Riester K-LED and chargers are medical electrical instruments. These instruments require special care concerning elec-tromagnetic compatibility (EMC). This section describes the suitability in terms of electromagnetic compatibility of these instru-ments. When installing or using these instruments, please read carefully and observe what is described here.
Portable or mobile-type radio frequency communication units may harm these instruments, resulting in malfunctioning.

Guidance and manufacturer’s declaration – electromagnetic emissions

The Riester K-‐LED and chargers are intended for use in the electromagnetic environment specified below. The customer or user should assure that they are used

in such an environment.

Therefore, the RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions

CISPR 11

| Class B| The Riester K-‐LED chargers are 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

The Riester K-‐LED is considered to be inherently EMC benign¹, and therefore is not covered by the statements in this section

|

Note UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic emissions

The Riester K-‐LED and chargers are intended for use in the electromagnetic environment specified below. The customer or user should assure that they are used

in such an environment.

Therefore, the RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions

CISPR 11

| Class B| The Riester K-‐LED chargers are 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

The Riester K-‐LED is considered to be inherently EMC benign¹, and therefore is not covered by the statements in this section

|

The Riester K-LED is considered to be inherently EMC benign¹, and therefore is not covered by the statements in this section
¹ Refer to section 1.1.4 of the Guide for the EMC Directive 2004/108/EC (published 21st May 2007).

Guidance and manufacturer’s declaration – electromagnetic immunity

The Riester K-‐LED and chargers are intended for use in the electromagnetic environment specified below. The customer or user should assure that they are used

in such an environment.

Immunity test| IEC 60601 Test level| Compliance level| Electromagnetic environment -‐ guidance
| | | Portable and mobile RF communications equipment should be used no closer to any part of the Riester K-‐LED or chargers, including cables, than the recommended separation distances calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = 1.2 √ p

Conducted RF IEC 61000-‐4-‐6

Radiated RF IEC 61000-‐4-‐3

| 3 Vrms

150 kHz to 80 MHz

3 V/m 80MHz to 2.5GHz

| 3 V

3 V/m

|

d = 1.2 √ p 80MHz to 800 MHz d = 2.3 √ p 800MHz to 2.5GHz

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 survey¹, should be less than the compliance level in each frequency range.²

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

Note 1 At 80MHz and 800MHz, 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.
¹ Field strengths from fixed transmitters, such as base stations (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcasts 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 Riester K-LED / charger is used exceeds the applicable RF compliance level above, the Riester K-LED / charger should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the Riester K-LED / charger.
² Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the Riester K-‐LED / charger

The Riester K-‐LED and charger are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Riester K-‐LED / charger can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Riester K-‐LED / charger as recommended below, according to the maximum output power of the

communications equipment.

Rated maximum| Separation distance according to frequency of transmitter
output power of| m
transmitter| 150 kHz to 80MHz| 80MHz to 800MHz| 800MHz to 2.5GHz
W| d = 1.2√ p| d = 1.2√ p| d = 2.3√ p
0.01| 0.12| 0.12| 0.23
0.1| 0.37| 0.37| 0.74
1| 1.2| 1.2| 2.3
10| 3.7| 3.7| 7.4
100| 12| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the

equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Rudolf Riester GmbH | P.O. Box 35

Germany Tel.: (+49) +7477-9270-0
Fax.: (+49) +7477-9270-70
E-Mail: [email protected]
www.riester.de

FAQ

Q: Can I use the headlamp in outdoor settings?
- A: The headlamp is designed for indoor use only to protect it from moisture and ensure proper performance.
Q: How often should I charge the battery pack?
- A: It is recommended to fully charge the battery pack before each use to ensure uninterrupted operation.
Q: What should I do if the headlamp shows signs of damage?
- A: Do not use the headlamp if it is visibly damaged. Contact the manufacturer for assistance in repairing or replacing the product.