BTL 5000 Sono - Contraindications for Therapies; Electrotherapy Contraindications

BTL-5000 SERIES
USER'S MANUAL
page 48 of 56
Active area:
Ø 56 mm (25 cm
2
) Ø 56 mm (25 cm
2
)
BNR:
red: 4x 0.35 rad ± 0.05 rad
infrared: 4x 0.52 rad ± 0.17 rad
red: 4x 0.35 rad ± 0.05 rad
infrared: 4x 0.52 rad ± 0.17 rad
NOHD**:
8.5 m 12.1 m
*Laser class is classified according to IEC 60601-2-22:1995 and IEC 60825-1:1993/A2:2001.
**NOHD – nominal ocular hazard distance (nominal distance from the laser aperture in which the eye damage by
laser beam should not happen) .
7.7 APPLICABLE STANDARDS
Name IEC, EN, ISO, MDD
Medical electrical equipment.
Part 1: General requirements for safety
IEC 601-1
Amendments to IEC 601-1 A2, A11, A12
Medical electrical equipment
Part 1: General requirements for safety
1.Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-1
Medical electrical equipment
Part 1: General requirements for safety
2. Collateral Standard: Electromagnetic compatibility.
Requirements and tests
IEC 601-1-2
Industrial, scientific and medical (ISM) radio-frequency equipment - Radio
disturbance characteristics - Limits and methods of measurement
EN 55011
Electromagnetic compatibility (EMC) - Part 4: Testing and measurement techniques
- Section 2: Electrostatic discharge immunity test - Basic EMC Publication
IEC 61000-4-2
Electromagnetic compatibility (EMC) - Part 4: Testing and measurement techniques
- Section 3: Radiated, radio frequency, electromagnetic field immunity test
IEC 61000-4-3
Electromagnetic compatibility (EMC) - Part 4: Testing and measurement techniques
- Section 4: Electrical fast transients/burst immunity test - Basic EMC Publication
IEC 61000-4-4
Electromagnetic compatibility (EMC) - Part 4: Testing and measurement techniques
- Section 5: Surge immunity test
IEC 61000-4-5
Medical electrical equipment
Part 1: General requirements for safety
4.Collateral standard: Programmable electrical medical systems
IEC 601-1-4
Medical devices – Risk analysis EN 1441
Biological evaluation of medical devices - Part 1: Evaluation and testing ISO 10 993-1
The Medical Devices Directive 93/42/EEC MDD 93/42/EEC
Medical electrical equipment
Part 2: Particular requirements for the safety of ultrasonic therapy equipment
IEC 601-2-5
Medical electrical equipment - Part 2: Particular requirements for the safety of nerve
and muscle stimulators
IEC 601-2-10
Medical electrical equipment
Part 2: Particular requirements for the safety of diagnostic and therapeutic laser
equipment
IEC 601-2-22
Safety of laser products.
Part 1: Equipment classification, requirements and user's guide
IEC 60 825-1
Amendments to IEC 60 825-1 A1, A2
7.8 INTERCONNECTION OF DEVICES
BTL-5000 Puls can be interconnected with: BTL vac, BTL-5000 Sono, BTL-12, BTL-07p, BTL-4000 Sono
BTL-5000 Combi can be interconnected with: BTL vac, BTL-12
BTL-5000 Sono can be interconnected with: BTL-5000 Puls, BTL-4000 Puls