Zimmer Biomet TRICERA SYSTEM Instrucciones De Uso página 17

The Tricera System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Tricera System can help prevent electromagnetic interference by maintaining the
minimum distance between portable and mobile RF communications equipment (transmitters) and the Tricera System as recommended below, according to the maximum output power of the communications equipment.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey
Interference may occur in the vicinity of equipment marked with the following symbol:
Rated maximum output power
of transmitter
(W)
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
a
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Tricera System is used exceeds the applicable RF
compliance level above, the Tricera System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Tricera System.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
APPENDIX H USER PROFILES
From the profile screen, the user has the option to select between DEFAULT and 14 different configurable profiles. When a profile other than DEFAULT is selected, the user will be able to name the profile (e.g. Dr.
Smith ACL) and set the default settings from the following table of options:
Profile Screen Setting
Oscillate Default
Forward/Reverse Default
Bone Cutting Default
Suction
Bone Burring Default
Ablation Default
Plasma Shaver Default
Oscillate Default
Forward Default
Speed Reverse Default
Bone Cutting Default
Bone Burring Default
Ablation Default
Plasma Shaver Default
RF
Coag Default
Coag Suction
Knee Pressure
Shoulder Pressure
Pressure
Hip Pressure
Small Joint Pressure
DCO-1394
Effective Date: 12-JAN-2022
Table 3: Recommended Separation Distances
Recommended separation distances between
portable and mobile RF communications equipment and the Tricera System
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 800 MHz
3 V/m
800 MHz to 2.5 GHz
should be less than the compliance level in each frequency range
a
150 kHz to 80 MHz
d = 1.2 √P
0.12
0.38
1.20
3.79
12.0
Left: User Profile Profile Selection Screen / Right: User Prorfile Insert Name Screen
Minimum
10%
10%
10%
10%
10%
10%
1500
1000
1000
3000
3000
1
1
1
0%
15 mmHg
15 mmHg
15 mmHg
15 mmHg
3 V
3 V/m
3 V/m
Separation distance according to frequency of transmitter
(m)
80 MHz to 800 MHz
d = 1.2 √P
0.12
0.38
1.20
3.79
12.0
Table 4: Profile Settings
Default Maximum Description
50% 100 Oscillate Suction
50% 100 Forward/Reverse Suction
50% 100 Bone Cutting Suction
50% 100 Bone Burring Suction
20% 30 Ablation Suction
50% 100 Plasma Shaver Suction
3000 5000 Oscillate RPM
3000 6000 Forward RPM
6000 6000 Reverse RPM
15000 15000 Bone Cutting RPM
15000 15000 Bone Burring RPM
10 10 Ablation Power Level
10 10 Plasma Shaver Power Level
2 3 Coag Power Level
20% 20% Coag Suction
45 mmHg 100 mmHg Default Pressure Setting when Knee Cavity is Selected
50 mmHg 100 mmHg Default Pressure Setting when Shoulder Cavity is Selected
50 mmHg 100 mmHg Default Pressure Setting when Hip Cavity is Selected
35 mmHg 100 mmHg Default Pressure Setting when Small Joint Cavity is Selected
d = 1.2 √P
d = 1.2 √P
d = 2.3 √P
b
800 MHz to 2.5 GHz
d = 2.3 √P
0.23
0.73
2.3
7.27
23.0
LBL 6028 Rev. K
Page 17 of 306