En 60601-1-2 Compliance; Troubleshooting; Overview; Troubleshooting Steps - Boston Scientific Rezum Manuel D'utilisation

Table 12: Separation Distances
Recommended Separation Distances Between Portable and Mobile RF
Communications Equipment and the Rezūm™ Generator
The Rezūm Generator is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of the
Rezūm Generator can help prevent electromagnetic interference by maintaining a
minimum distance abetween portable and mobile RF communications equipment
(transmitters) and Rezūm Generator as recommended below, according to the
maximum output power of the communications equipment.
Separation Distance According to Frequency of
Rated Maximum Output 150 kHz to 80
Power of Transmitter MHz
(W) D = 1.2√P
0.01 0.12
0.1 0.38
1 1.2
10 3.8
100 12
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (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.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
Note 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80
MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283
MHz; and 40.66 to 40.70 MHz.
Note 3: An additional factor of 10/3 is used in calculating the recommended
separation distance for transmitters in the ISM frequency bands between 150 kHz
and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood
that mobile/portable communications equipment could cause interference if it is
inadvertently brought into patient areas.
Note 4: These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.

EN 60601-1-2 COMPLIANCE

Warning: RF Interference - Known RF sources, such as cell phones, radio or TV
stations, and two-way radios, may cause unexpected or adverse operation of this
generator. Consult qualified personnel regarding system configuration.
Warning: The generator should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, test the generator to verify
normal operation. Refer to the Electromagnetic Immunity information provided in this
operator's manual.
Warning: The generator needs special precautions regarding Electromagnetic
Compatibility (EMC) and needs to be put into service according to the EMC information
provided in this operator's manual.
Caution: The generator conforms to the requirements of the EMC standard (IEC 60601-
1- 2:2009). However, it may be affected by electrical scalpels and microwave treatment
devices and there may be an impact on measurement precision for patients using cardiac
pacemakers and other similar devices. Check the operation of this generator during and
after use of the above-mentioned equipment and with patients potentially affected.

TROUBLESHOOTING

Overview

This section contains troubleshooting steps, error message description, error message
table, and how to obtain technical assistance.

Troubleshooting Steps

If you experience a problem while using the generator, please use the Error Message
table to troubleshoot the issues. If you are unable to correct it, write down the error
message and error code, if applicable, and contact qualified service personnel in your
institution or contact Boston Scientific Technical Service.

Error Messages

Error messages will be displayed on the screen. There are 3 types of error messages -
Critical, Non-Critical Error, and Informational Error.
Transmitter (m)
80 MHz to 800 800 MHz to 2.7
MHz GHz
D = 1.2√P D = 2.3√P
0.12 0.23
0.38 0.73
1.2 2.3
3.8 7.3
12 23
17

Critical Error Message

Figure 46: Example Critical Error Message

Non-Critical Error message

Figure 47: Example Error Message

Informational Error message

Figure 48: Example Informational Error Message
Black (K) ∆E ≤5.0