LBL 61876 rev. E, March 2018
EN
14
Electromagnetic Compatibility Guidance – Separation Distances
Recommended separation distances between portable and mobile RF communications equipment and the Model 825DP
The Generator Model 825DP is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Generator Model 825DP can
help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Generator Model 825DP as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power
of transmitter
(W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated 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.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.
Essential Performance
Generator Model 825DP maintains safe and effective performance in the delivery of IVL therapy when operated in the electromagnetic environment specified in the table
above.
9.
Appendix B: Symbols
The IVL Generator bears the following symbols:
Symbol
Description
Symbol
Description
Refer to instruction manual
Read and understand the Operator’s Manual before use.
Temperature limit
Consult instructions for use
Humidity limitation
Caution
Date of manufacture
Non-sterile
Manufacturer
Type CF
The IVL Generator is classified for use without equipment damage in the
presence of cardiac defibrillators. The applied part meets electrical
safety requirements for cardiac use.
Keep dry
Catalogue number
Do not use if package is damaged
Serial number
Authorized Representative in the European Community
Protect from heat and radioactive sources
Do not stack
Warning dangerous voltage
Waste from Electrical and Electronic Equipment Directive
The Generator and Connector Cable should not be disposed of in
the normal waste stream and should be sent to separate collection
facilities for recovery and recycling.
Caution: Federal (USA) Law restricts this device to sale by or on the
order of a physician.
Conformité Européenne
PAT
Patents. Refer to
www.shockwavemedical.com/
patents
Refurbished
The process or combination of processes applied during the
expected service life to restore used equipment to a condition of
safety and performance comparable to when new.
IVL
Generator
Intravascular Lithotripsy (IVL) Generator
10%
35°C
10
°
C
70%
