33
Last revised 16.02.12
CE symbol
0366
Notified body
Accessories
• Protective Glasses – Therapist
• SoftCap Protective Glasses – Patient
• Rechargeable AA-size NiMH batteries – 2,600 mAh
Technical Data for 3B LASER PEN 200 mW
General
Product name
3B LASER PEN 200 mW
Device type
Low-level laser therapy device
Proper use
Low-energy laser system for the treatment of pain, trigger, and acupuncture
points as well as small skin areas
Classification and standards
Classification
Protection class II according to EN 60601-1
Application unit BF according to EN 60601-1
Class IIa according to RL 93/42 EEC
Laser class 3B according to EN 60825-1: 2008
EN 60825-1:2008 150 cm
Without moisture protection (IPX0)
Standards
EN60601-1: 2006 Medical electrical devices
EN60601-1: 2007 Medical devices, EMC standard
IEC 60601-2-22: 2007 (Ed. 3) Medical devices, laser application standard
EN60825-1:
EN60825-1: 2007 Safety of laser devices
Laser power
Effective laser output, wavelength
3B LASER PEN 200 mW–200 mW / 808 nm
Setting of laser power
From 10 % to 100 % of the effective output in increments of 10 %
Type of laser
Semiconductor laser 808 nm
Therapy programmes
See Appendix 1
Therapy time
20 minutes max.
Beam divergence
808 nm: x-direction 8–11°, y-direction 39–48°
Operation
Operating elements
“ON/OFF” key for switching the laser output on or off
“Laser” key for switching the laser output on or off
“SET”, “+”“, “-“keys for setting the therapy parameters (programmes,
power level, automatic operation)
Display elements
Green LED “POWER”: laser output is activated
Red LED “ERROR”: error message concerning laser power monitoring
LCD: 128 x 32 points to display the therapy parameters and error messages
Summary of Contents for Laser Pen 200 mW
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