AS 50
V. 1.2, 26.11.2009 1
AS 50
Cl. 2M
Instructions for Use
AS 50
V. 1.2, 26.11.2009 2
Contents
1. General Notes 4
1.1. Exclusion of liability ........................................................................................... 4
1.2. AS 50 standard ........................................................................................... 4
1.3. AS 50 principle of function ............................................................................ 4
2. Safety Precautions 5
3. Explanation of the pictograms 5
3.1. Position of the labels and warning signs ........................................................... 6
4. Shutdown in an emergency 6
4.1. Radiation injuries .............................................................................................. 6
4.2. Safeguarding against unauthorized usage ....................................................... 6
5. Intended use and personnel 7
5.1. Proper usage and field of application ................................................................ 7
5.2. Indication for use ............................................................................................... 7
6. Device description 8
6.1. Technical data ................................................................................................... 8
6.2. Technical data of the laser diodes (depending on the model) .......................... 9
6.3. Contents of delivery .......................................................................................... 9
7. Connectors and functional components 10
7.1. Indicators (LED, Display) ................................................................................ 10
8. Starting and using the device 11
8.1. Releasing the laser beam, 20 seconds energy timer ...................................... 11
8.2. Control displays .............................................................................................. 12
8.3.
Laser indicator lamp ........................................................................................ 12
8.4. Power control .................................................................................................. 12
8.5. Audible indicator ............................................................................................. 12
9. Charging the battery 13
10. Charging the battery 13
10.1. Charger Ansmann ACS 110 Traveller ............................................................ 14
11. Maintenance 15
11.1. Inspection of the device .................................................................................. 15
11.2. Cleaning / Disinfecting .................................................................................... 15
11.3. Maintenance/Calibration ................................................................................. 16
11.4. Disposal .......................................................................................................... 16
11.5. Warranty ......................................................................................................... 16
12. Electromagnetic compatibility - Warning instructions 17
12.1. Precautionary measures ................................................................................. 17
AS 50
V. 1.2, 26.11.2009 3
12.2. Influence of mobile and portable communication equipment .......................... 17
12.3. Guidelines and manufacturer’s declaration – Electromagnetic radiation ........ 17
12.4. Guidelines and manufacturer’s declaration - Electromagnetic immunity ....... 17
12.5. Guidelines and manufacturer’s declaration – Electromagnetic immunity – for
the laser device without life supporting function ........................................................... 18
12.6. Recommended protective distance between portable and mobile HF-
telecommunication devices and the laser device without life supporting function ....... 19
13. Manufacturer 20
14. Distributor 20
AS 50
V. 1.2, 26.11.2009 4
1. General Notes
These operating instructions must be read carefully before starting the device.
These operating instructions describe the correct usage of the AS 50 and also point out
any potential risks. These operating instructions are to be read and observed by all persons
who operate, use, service and inspect the device.
Please contact your supplier, representative for any related questions or you may direct your
inquiries to:
REIMERS & JANSSEN GmbH
Medical Laser Technology
Frohnacker 8, 79297 Winden, Germany
Tel. +49-7682-6558 Fax +49-7682-6640
www.rj-laser.com
Quality management according to EN ISO 13485:2003
1.1. Exclusion of liability
The AS 50 should only be used for the purpose described in these operating instructions.
The manufacturer will not be liable for any damage or injuries resulting from usage not
contained in these operating instructions. The manufacturer reserves the right to make
modifications in keeping with technological advances.
1.2. AS 50 standard
The AS 50 meets or exceeds the requirements of the following international standards:
EN 60825-1: 2003 Safety of Laser Devices
DIN EN 60601-1-2 Electro magnetic compatibility
1.3. AS 50 principle of function
The AS 50 will emit monochromatic, coherent laser light to for the irradiation of points and
smaller surfaces. Use always with 4 mm applicator.
Further information on the wide range of the use of laser devices can be found in technical
literature and with scheduled seminars RJ-LASER GmbH (www.rj-laser.com
).
AS 50
V. 1.2, 26.11.2009 5
2. Safety Precautions
Caution - Using the operating equipment or settings in a way not described here can result in
dangerous exposure to radiation. Do not look directly into the beam or with optical
instruments.
3. Explanation of the pictograms
IP 21 Equipment rating against harmful ingress of water as
defined in IEC529 (see std. 60601-1 clause 6.1(L) )
Protection against electric shock regarding allowable
leakage current limitations are specified in standard
60601-1.
The device meets the requirements EN 60825-1.
“Attention” Observe the instructions in the manual for
safe and effective usage of this device.
Symbol for the laser beam: “Warning for laser
beam”. Aiming of laser beam must be adhered to,
avoiding any other part of the body other than the
treatment area follow treatment protocol of this
manual.
AS 50
Carry case
“Caution” Explanatory Label Symbol (International):
"Laser radiation" including the standard which was
used for the classification of the laser, power, wave
length, pulse.
Aperture labels according to EN 60825-1:
- Laser aperture and laser beam direction
Label indicating technical data, serial number,
manufacturer.
AS 50
V. 1.2, 26.11.2009 6
3.1. Position of the labels and warning signs
Side/below
above (front panel)
4. Shutdown in an emergency
The laser can be shut down in the event of an emergency by pressing the ON/Off button or
by pulling out the safety plug.
4.1. Radiation injuries
Do not look directly into the laser beam outlet. Laser radiation can cause eye damage.
Do not look directly into the beam or with optical instruments.
4.2. Safeguarding against unauthorized usage
To safeguard against unauthorized usage, the AS 50 is equipped with a removable safety
plug. The laser can only be operated when the safety plug is inserted. If the AS 50 is not
being used store it separately to prevent unauthorized usage.
Warning sign Type plate
Technical sign
Laser warning sign
AS 50
V. 1.2, 26.11.2009 7
5. Intended use and personnel
5.1. Proper usage and field of application
The AS 50 is a laser device which is to be used with 4 mm applicator and exclusively in
anti-smoking and wellness offices and should only be operated under constant supervision.
In order to apply the laser position the probe tip above the irradiation area.
5.2. Indication for use
Illumination of smaller spots and surfaces.
AS 50
V. 1.2, 26.11.2009 8
6. Device description
6.1. Technical data
Laser therapy device type
AS 50
Laser class 2M
Protection class IP 21 (drip water proof)
Device Typ B
Absolute failure of the measurement of the laser
power
5%
Modulation frequency 10 Hz and cw
Current supply (charger) Model FRIWO FW 7555M/05, =5 V
Weight main unit 0,2 kg
Weight charger 0,5 kg
Dimension main unit (L x W x H) 15 cm x 3 cm x 3 cm
Dimension charger (L x W x H) 7 cm x 5 cm x 4 cm
Operating conditions
Room temperature + 10°C to +30°C
Relative humidity 30% to 75%
Atmospheric pressure 700 hPa to 1060 hPa
Transport and storage
Room temperature -20° C to +40 C
Relative humidity 30% to 75%
Atmospheric pressure 700 hPa to 1060 hPa
AS 50
V. 1.2, 26.11.2009 9
6.2. Technical data of the laser diodes
Nr.: Wave
length
Output power Laser type /
pulse duration
NOHD
*)
m Beam divergence
1 655 nm max. 25 mW cw 0,10 0,6 rad
*) Safety distance (NOHD). Distance at which the radiation intensity or the radiation is equivalent to the limiting value of the
maximum permitted radiation of the cornea (MZB).
For more information, please refer to the device plate.
6.3. Contents of delivery
AS 50 main unit with 4 mm applicator, 1 key (coding bridge), charger Ansmann ASC 110
Traveller, instruction manual, carry case.
AS 50
V. 1.2, 26.11.2009 10
7. Connectors and functional components
7.1. Indicators (LED, Display)
LED Color Status Meaning
L1/L2
red flashes
on
Pilot + laser beam lights in the rhythm of the
frequency
or continuous if one of the
Start-buttons
is pressed
L3
red on
Flashes two seconds after pressing the
Start
button
to warn you of the ensuing laser radiation
and then it is on continuous
to glow.
L4
red on
Will glow after pressing the
ON/OFF
to inform you
that the laser is READY.
L5
yellow on Will glow if the power is out of range.
Laser aperture
Pilot beam
Laser Start/Stop 10 Hz
20 seconds energy timer
ON/OFF switch
Indicator L3
Laser
Indicator L5
Laser out of range
Indicator L4
Laser ON
Socket for the char
g
erLaser Start/Stop cw
20 sec. energy timer
Coding bridge
Emergency OFF
AS 50
V. 1.2, 26.11.2009 11
8. Starting and using the device
Inserting the coding bridge
To safeguard against unauthorized use, the AS 50 is equipped with a removable coding
bridge. Insert the coding bridge in the socket on the back part of the case.
Installing the storage batteries or the rechargeable batteries
The battery compartment is located at the back of the AS 50.
Remove the cover. Insert three new storage batteries or three fully-charged rechargeable
batteries. Please observe the proper polarity when installing the batteries
. Replace the
battery cover.
8.1. Releasing the laser beam, 20 seconds energy timer
1. Press one of the Start button. The Pilot (L1, L2) will indicate the beam direction.
The READY LED L4 will light continuously thereafter.
a) Pressing button [Start cw] and will run on continuous mode for 40 (60) seconds (energy
timer: supply of 2 Joule at 50 mW).
b) Pressing [Start 10 Hz] and will run on 10 Hz frequency mode for 40 (60) seconds (energy
timer: supply of 1 Joule at 50 mW).
Pressing the button again will shut of the laser prior to 40 seconds.
L3 will glow continuously as long as the laser is active.
L5 will glow if the power is out of range.
Battery compartment
Coding bridge
Socket for the char
g
er
O/I Switch
AS 50
V. 1.2, 26.11.2009 12
8.2. Control displays
The indicator lamps indicate that the AS 50 various functions are operating faultlessly. All
of the functions are continually checked using special electronic devices and the values
registered are compared with programmed values. A breakdown is indicated if the lamps do
not illuminate while the unit is operating.
8.3. Laser indicator lamp
The red pilot diodes in the AS 50 head under and above the laser outlet indicates the
direction of the invisible laser beam (pilot beam). The pilot beam meets the laser beam 20
mm away from the laser outlet.
The lamps (L4) indicate if the AS 50 is READY.
The lamps (L3) indicate if the AS 50 is operating.
8.4. Power control
The output is adjusted for value selection once the laser has been switched on. The output is
indicated L3.
L5 will glow when the power has not been reached (e.g. broken laser diode, empty battery),
+/- 20%.
8.5. Audible indicator
An audible signal (beep) is heard as soon as the laser is activated, one beep every five
seconds. This signal does not differentiate between types of frequency modulation.
AS 50
V. 1.2, 26.11.2009 13
9. Charging the battery
In order to charge the batteries attach the plug of the Ansmann ACS 110 Traveller
into the socket on the devices. Shut off the device with the O/I switch.
10. Charging the battery
The display will indicate the condition of the battery. If it is on low the battery shall be
charged. For charging insert the plug of the charger into the socket on the back side of the
AS 50 and connect it with the mains supply.
The batteries can be charged at any time because they do not have a memory effect.
LED indicators on the charger
Power (mains
current)
red continuous Charge is connected to the mains supply
Charge red continuous Accumulators will be charged
Ready green flashing Charging still in progress
Ready green continuous Accumulators are fully charged
Batter
y
com
p
artmen
t
Socket for charging
AS 50
V. 1.2, 26.11.2009 14
10.1. Charger Ansmann ACS 110 Traveller
AS 50
V. 1.2, 26.11.2009 15
11. Maintenance
11.1. Inspection of the device
We recommend an inspection and calibration at least one year from the purchase date
(various test are performed in order to insure that the device is operating within the
tolerances that the device was originally designed). This annual inspection/calibration must
be submitted to an authorized facility. Repairs or maintenance performed by an unauthorized
facility or personnel will void your warranty.
Inclusive with your device will be shipping labels and instructions for deliver to the repair and
maintenance facility.
For repair and maintenance, devices must be sent directly to:
REIMERS & JANSSEN GmbH
Medical Laser Technology
Frohnacker 8 79297 Winden,
Germany
Tel. +49-7682-6558 Fax +49-7682-6640
www.rj-laser.com
Quality management according to EN ISO 13485:2003
11.2. Cleaning / Disinfecting
Please observe that cleaners for plastics, soap are used for periodic cleaning of the plastic
parts. No penetrative or corrosive agents (such as acetone) should be used. Keep fluids from
entering the housing. Standard disinfectants may be used. When this is done, the unit is to
be wiped with a soft cloth which has been dampened with a mild, approved disinfectant (50%
diluted propyl alcohol solution).
Under no circumstances is the unit to be flooded with the disinfectant or to be treated with
solvents! Autoclaving must not be used on the unit.
AS 50
V. 1.2, 26.11.2009 16
11.3. Maintenance/Calibration
The laser diodes will be calibrated by the software at each start. RJ recommends an annual
service of the laser at the RJ service facilities or an authorized service station.
Always ensure that operational and sufficiently charged batteries are used.
The interior of the AS 50 contains no elements or components which require servicing by
the user.
Therefore, there is no need to open the housing. To meet the requirements of DIN VDE
0837, “Radiation safety for laser devices,” the unit is to be tested and recalibrate after one
year of use to ensure that the laser is operating properly. Please send the unit to the
manufacturer for testing and recalibration.
The producer will supply spare parts up to 10 years after delivery date.
11.4. Disposal
Due to the hazards of laser beams, the AS 50 is not to be disposed of as standard
electronic scrap. The device is to be delivered to either the supplier or to the manufacturer for
proper disposal.
11.5. Warranty
There is a 2 years warranty from the manufacturer. The manufacturer guarantees operation
of all AS 50 features described in the user’s guide, provided the equipment is used in
accordance with the instructions detailed in the user’s guide and is treated with proper care.
New settings, maintenance or repairs may only be performed by the manufacturer or an
authorized workshop; otherwise the warranty is rendered null and void. Interventions in the
device by third parties will lead to loss of warranty claims and will release the manufacturer
from all product liability.
AS 50
V. 1.2, 26.11.2009 17
12. Electromagnetic compatibility - Warning instructions
12.1. Precautionary measures
There are special precautionary measures for medical electric devices as fare as electromagnetic
compatibility is concerned. This device may be used only for the purpose described in the manual, set
up and put into operation according to the notes for electromagnetic compatibility.
12.2. Influence of mobile and portable communication equipment
High-frequency energy radiation from mobile communication equipment may influence on the
operation of the medical electric device. It is not allowed to use those devices (for instance mobile
phones and GSM telephones) close to the medical electric device.
12.3. Guidelines and manufacturer’s declaration – Electromagnetic radiation
The laser device is designed for the operation only with original accessories in ambient conditions
indicated below. Client and user have to make sure that the device is operated in such ambient
conditions.
Radiated disturbance
measurements
Conformity Electromagnetic ambient conditions - guideline
HF-radiation to
CICPR 11
Group 1 The laser device uses HF-energy only for its internal function.
Therefore HF radiation is very low. The influence on neighbouring
electric devices is unlikely...
HF-radiation to
CICPR 11
Class B The laser device may be used in all kinds of buildings, including
residential buildings and those directly connected to mains for the
public supply which are also servicing buildings used for residential
purposes.
Radiation of harmonic oscillation
according to
EC 61000-3-2
Conforms
Radiation of voltage variations/
Flicker effect according to IEC 61000-
3-3
Not applicable
12.4. Guidelines and manufacturer’s declaration - Electromagnetic immunity
Immunity tests IEC 60601-Test level Conformit
y level
Electromagnetic ambient conditions -
guidelines
Discharge of static electricity
(ESD )according to IEC 61000-
4-2
± 6 kV Contact discharge
± 8 kV Air discharge
conforms The floor should be made from wood or concrete
or covered with ceramic tiles. If the floor is
covered with synthetic material the relative
humidity should be minimum 30%
Fast transient electric
disturbance variable / Bursts
according to IEC 61000-4-4
± 2kV
for network leads
± 1 kV
for input and output leads
conforms The quality of the supply voltage should be
typical for business or hospital ambient
conditions.
Impulse voltage (Surges)
according to IEC 61000-4-5
± 1 kV
opposed mode voltage
± 2 kV
common mode voltage
conforms The quality of the supply voltage should be
typical for business or hospital ambient
conditions.
Voltage dips, short
interruptions and voltage
variations according to IEC
61000-4-11
< 5% U
T
(> 95% dip of U
T
) for ½
period
conforms The quality of the supply voltage should be
typical for business or hospital ambient
conditions. If the user wants to continue
operation in case of an interrupted energy
AS 50
V. 1.2, 26.11.2009 18
40% U
T
(60% dip of U
T
) for 5
periods
70% U
T
(30% dip of U
T
) for 25
periods
< 5% U
T
(> 95% dip of U
T
) for 5 s
supply it is recommended to feed the laser
device from a system without interruption or a
battery.
Magnetic field at supply
frequency (50/60 Hz)
according to IEC 61000-4-8
3 A/m conforms Magnetic fields at mains frequency should have
the typical values for business and hospital
ambient conditions.
Note: U
T -
alternating voltage mains before the application of the test level.
12.5. Guidelines and manufacturer’s declaration – Electromagnetic immunity – for
the laser device without life supporting function
Immunity tests IEC 60601-test level Conformity
level
Electromagnetic ambient conditions -
guidelines
HF-disturbance variables
(transmission) according to IEC
61000-4-3
HF-disturbance variables
(radiation) according to IEC
61000-4-3
3 Veff
150 kHz up to 80 MH
3 V/m
80 MHz up to 2,5
GHz
conforms
conforms
Portable and mobile radio sets must not be
operated in a distance to the laser device and the
leads less than the recommended protective
distance what was calculated according to the
equation for the transmission frequency.
Recommended protective distance:
d = 1,2 √ P
d = 1,2 √ P for
80 MHz up to 800 MHz
d = 2,3 √ P for
800 MHz up to 2,5 GHz
with P as power rating of the transmitter in Watt
(W) according to data from the manufacturer of
the transmitter and as recommended protective
distance in meter (m).
According to a local
a
investigation the field
intensity for all frequencies of immobile radio
transmitters should be less than the conformity
level
b
.
Interference is possible in the surroundings of
devices carrying the following signs.
Note 1 At 80 MHz and 800 MHz the higher frequency range is applied.
Note 2 These guidelines are not applicable in all cases. The propagation of electromagnetic quantities is influenced by the absorption and reflection of buildings, items
and human beings.
a
It is not possible to predict theoretically the field strength of immobile transmitters like base stations of mobile phones and mobile land radio sets, amateur radio
stations, AM and FM television and radio broadcasting transmitters. In order to determine electromagnetic ambient conditions with regard to immobile transmitters a study
of the location should be taken into consideration. If the field strength measured in the place where the laser device is operated exceeds the above mentioned conformity
level the laser device should be watched to proof its function in accordance to the requirements. Unusual performance data may require additional measures, for instance
change of orientation or different location of the laser device.
b
Above the frequency range from 150 kHz to 80 MHz the field strength should be less than 3 V/m.
AS 50
V. 1.2, 26.11.2009 19
12.6. Recommended protective distance between portable and mobile HF-
telecommunication devices and the laser device without life supporting function
Recommended protective distance between portable and mobile HF-telecommunication devices and the
laser device
The laser device is designed for the operation in electromagnetic ambient conditions where HF-disturbance
variables are controlled. Client or user of the laser device can help to avoid electromagnetic disturbances by
keeping the minimum distance between portable and mobile HF-telecommunication devices (transmitters) and the
laser device as indicated below, dependent on the power output of the communication device.
Power rating of the
transmitter
W
Protective distance dependent on the transmitting frequency
m
150 kHz up to 80 MHz
d = 1,2 √ P
80 MHz up to 800 MHz
d = 1,2 √ P
800 MHz up to 2,5 GHz
d = 2,3 √ P
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
If the maximum power rating for certain transmitters is not given in the above table the recommended protective
distance d in metres (m) can be determined by using the equation indicated in the respective column, where P is
the maximum power rating of the transmitter in Watt (W) according to the manufacturer of the transmitter.
Note 1 At 80 MHz and 800 MHz the higher frequency range is applied
Note 2 These guidelines are not applicable in all cases. The propagation of electromagnetic quantities is
influenced by the absorption and reflection of buildings, items and human beings.
AS 50
V. 1.2, 26.11.2009 20
13. Manufacturer
REIMERS & JANSSEN GmbH
Medical - Laser - Technology
Frohnacker 8 79297 Winden,
Germany
Tel. +49-7682-6558 Fax +49-7682-6640
www.rj-laser.com
Quality management according to EN ISO 13485:2003
14. Distributor
AlexanderMüller|GeneralManager
FacilitasHealthcare|Centroallee263a|46047Oberhausen
phone+49.(0)208.88.22.74.95|Fax+49.(0)208.88.22.74.96|Mobil+49.(0)179.11.00.675
|www.facilitas.de|www.jetztaufhoeren.de|www.lipovanish.de
/
