TITLE:SB86201180A-865214 (Expression System) – Test and Inspection Procedure Release
APPLIES TO:
Geography :
Worldwide
Commercial (Sales) Product
Number
Range of Serial Numbers
PMS Number:
865214
ALL
Part Number:
865214
SERVICE BULLETIN INFORMATION:
This service bulletin provides an updated test and inspection procedure for the 865214 (Expression
System). This supersedes any older versions and should be used for any future service events.
Rev. A SB86201180A-865214 (Expression System) – Test and Inspection Pro c edure Release Page 1 of 15
Page 2
When to
S
perform tests
Test and
Inspection
Matrix:
Preventive
Maintenance:
ServiceEventTestRequired
(Whenperforming……Completethesetests)
Installation
PreventativeMaintenance
AllRepairs
Upgrade
Allotherserviceevents
Perform Visual Inspection and Power On
Perform Visual Inspection, Power On, and
Performance Assurance Tests
Perform Visual Inspection, Power On, and
Performance Assurance Tests
Perform Visual Inspection, Power On, and
Performance Assurance Tests
Perform Visual Inspection, Power On, and
Performance Assurance Tests
TestBlockTestorInspectiontobePerformed
VisualInspect the unit and cables for damage.
PowerOn
Performance
ssurance
A
Safety
Perform Power On Test in (Section I). Do all the
steps in Section I pass?
Perform the Performance Assurance tests (Section
II) as described in the performance assurance block.
Do all the steps in Section II pass?
No safety test is required on this system. N/A
ExpectedTest
Results
If NO damage,
Visual test is passed
Expected answer is
“yes”.
If so, Power On test
passed.
Expected answer is
“yes”.
If so, Performance
Assurance test
passed
Recordthe
Results
V:P or V:F
P=pass and
PO:P or
P=pass and
eePAtable
PA1-PA11:P
PA1-PA11:F
P=Pass and
Perform the below blocks as part of preventative maintenance.
Visual Inspection, Power On and Performance Assurance Test.
where
F=fail
PO:F
where
F=fail
or
where
F=Fail
S:N/A
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Page 3
Test Equipment:
1. Patient simulator (Metron PS-416M or medsim 300 model) or equivalent
2. Invasive Pressure Simulator Capable of producing static pressure values of 0, 40, 100, 200
& 250mmhg
A. ( IBP/Simulator) Adapter cable (TBD)
3. TSI Model 4140 Flowmeter (453564178121 or 453563230731) or OMEGA FL-211
Flowmeter or equivalent
B. (with appropriate tubing, SBR,.250""X.125""X.0625"" Qty 2 Feet )
4. Baumanometer (Manometer) or equivalent
C. Invivo adapter (TBD)
5. A standard computer keyboard (PS2 only) and VGA computer monitor w/video port cable.
Additional Test Equipment ONLY for the Bench:
1. RF Test Station
The following accessories are necessary to perform this Test and Inspection procedure. In
most cases the customer’s accessories are preferable and should be used in testing and
verifying the system. However, the following is a list of the recommended part numbers.
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I Power on Test
1.0 Initial AC Power
With the Power Adapter connected to the AC power line, verify that the unit powers
up, and both Power Indicator LED’s are illuminated GREEN on the DCU and on the
Cart.
NOTE: ETCO2 or AGENTS option must remain active during test.
Interruptions should not occur from power up to ETCO2 or AGENTS testing
so that temperature is at optimal range.
ETCO2 OPTION ONLY. Attach the Low Flow ETCO2 Water Trap (clear with a blue
band) to the PCU and the blue sample line only to the water trap. Enter the SETUPS / PARAMETER SELECTION menu to turn ETCO2ON.
AGENTS OPTION ONLY. Attach the Clear Agents Water Trap to the PCU and the clear
sample line only to the water trap. Enter the SETUPS / PARAMETER SELECTION
menu to turn AGENTSON.
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II Performance Assurance Tests
2.0 COMMUNICATION VERIFICATION and ICON CHECK
2.1 With the DCU & Cart powered up and booted on DC power only, verify
communication (COMM) between the DCU, Cart, and the WECG and WSPO2
remotes. As shown in row one.
2.2 With the DCU & Cart powered up and booted on AC power with batteries installed,
verify communication (COMM) between the DCU, Cart, and the WECG and
WSPO2 remotes. As shown in row two.
2.3 With the DCU & Cart powered up and booted on AC power with no batteries
installed, verify communication (COMM) between the DCU, Cart, and the WECG
and WSPO2 remotes. As shown in row three.
2.4 With the DCU only powered up and booted on AC power with no batteries installed,
verify no communication (COMM) between the DCU, Cart, and the WECG and
WSPO2 remotes. As shown in row four.
DCU WPU WECG WSPO2
DC Power
(Batteries Only)
AC Power
w/ Batteries
Installed
AC Power
w/o Batteries
Installed
No COMM
Table 1: DCU System Icons
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3.0 WECG COMMUNICATION
3.1 Attach the ECG cable to the WECG module. Connect the ECG leads to the Patient
Simulator as indicated in Table 2 below (as a reference Table 3 illustrates the ECG
Leads to Lead Wires/Colors Scheme):
Table 2 Table 3
ECG Lead(s)
GREEN RL
WHITE RA
BLACK LA
RED LL
Patient Simulator
Terminals
3.1.1 Set the Patient Simulator to output a 1.0mV QRS pulse at 60BPM
(NORMAL SINUS mode).
3.1.2 Power up the WECG wireless sensor by inserting a rechargeable battery.
3.2 LEAD I (1.0mV)
ECG Lead(s)
Patient Simulator
Lead Wires
I WHITE, BLACK
II WHITE, RED
III BLACK, RED
Within the ECG menu set:
3.2.1 TRACE A LEAD to I
3.2.2 SCALE of 10 mm/mV
3.2.3 HR TONE SOURCE and select QRS
Then verify the following:
3.2.4 TRACE A shows a waveform sequence of moving QRS pulses without
jittering.
3.2.5 ECG numeric shows a count of 60 ±1BPM.
3.2.6 QRS Heart Rate Tone is present with NO double tones.
4.0 WSPO2 VERIFICATION
4.1.1 Connect a SpO2 probe to the WSPO2 sensor, and power up with a battery.
Verify PROBE OFF message is displayed when there is no finger in the
probe.
4.1.2 Within the SPO2 menu press the rotary/selector knob and select HR TONE
SOURCE. Within the HR TONE SOURCE select SPO2
4.1.3 With the tip of operator's finger is placed inside probe, verify an SPO2
(pulse) waveform with each heart rate count and tone.
4.1.4 With the tip of operator's finger is placed inside probe, verify a reasonable
SPO2 number displayed (95% to 100%) on DCU.
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5.0 NIBP VERIFICATION
Note: A number of tests in this section utilize the NIBP CAL window. Due to a
hardware timer, the NIBP CAL window should not be displayed for a period
longer than 3 minutes at a time. The NIBP CAL window can be closed via any
means within this 3 minute period to reset the timer. In the event the NIBP
CAL window is displayed for longer than 3 minutes, the NIBP hardware timer
will disable the NIBP parameter and the WPU will need to be power cycled to
reset the NIBP hardware. Verify that all parameters from the initial setup (step
1.0) are turned back on.
5.1 PNEUMATIC LEAK TEST
5.1.1 Pneumatic Leak Test High (1
With the patient setup as ADULT,connect an Adult cuff and hoseto the
NIBP ports. Tightly wrap the cuff around a fixed object, approx. 6” in
diameter. Within the SETUPS menu select SERVICE (BIO-MED)/NIBP TESTS and then select LEAK TEST. Verify that at the end of each leak test
cycle (a minimum of two cycles), the difference between PEAK and FINAL
is ≤10.
st
row)
5.1.2 Pneumatic Leak Test Low (2
nd
row)
With the patient setup as ADULT,connect an Adult cuff and hoseto the
NIBP ports. Tightly wrap the cuff around a fixed object, approx. 6” in
diameter. Within the SETUPS menu select SERVICE (BIO-MED)/NIBP TESTS and then select LEAK TEST. Verify that at the end of each leak test
cycle (a minimum of two cycles), the difference between PEAK and FINAL
is ≤10.
5.2 NIBP Offset Verification
With no pressure applied, bring up the SETUPS menu on the WPU using the
NAV command via the keyboard. Activate the SETUPS menu by pressing
F4 on the keyboard. Select SERVICE (BIO-MED), then NIBP TEST)/,
then CALIBRATE. Verify the offset reading on the primary (PRI) and
secondary (SEC) is within 10±2 in the NIBP CAL window. After verifying
these values, press ESC to exit the menu screens
5.3 Calibration Accuracy Check
While still in the NIBP CAL window, connect a Manometer and hand bulb to
the NIBP Pump (right) port and close the valve on the Manometer hand bulb.
Slowly increase the pressure until the Manometer reads 250mmHg. Verify
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the PRESS READING of the SEC transducer reads 250 ±5mmHg. Close
the NIBP CAL window by pressing Enter. Open the valve on the
Manometer hand bulb.
Connect the Manometer to the NIBP Sense (left) port and close the valve on
the Manometer hand bulb. Display the NIBP CAL window once again.
Slowly increase the pressure until the Manometer reads 250mmHg. Verify
the PRESS READING of the PRI transducer reads 250 ±5mmHg. Close the NIBP CAL window and open the Manometer hand bulb valve.
5.4 Overpressure Adult
5.4.1 Connect a Manometer and hand-bulb to the NIBP Pump (right) port. Close
the hand-bulb valve. If the NAV menu is not activated then type “nav” from
the keyboard connected to the WPU (Service Access Panel) and press F4 to
enter the SETUP menu. Within the SETUPS menu select the SERVICE
(BIO-MED) and then select NIBP TEST. From the NIBP TEST select
CALIBRATE and verify NIBP CAL window is displayed.
5.4.2 Squeeze the hand-bulb until SEC: PRESSREADING equals 295mmHg in
the NIBP CAL window. Verify over-pressure occurs (as indicated by
pressure fall) at 295 ± 4mmHg and “OVER PRES” is displayed in the Error
Message Display area. Press the number 2 key to enter STANDBY, then
press 2 again to remove message.
5.4.3 Switch/connect the Manometer to the NIBP Sense (left) port. Display the
NIBP CAL window as stated in test step 5.1.5 a. Close the hand-bulb valve;
squeeze the hand-bulb until PRI: PRESSREADING equals 285 ±4mmHg
and “OVER PRES” is displayed in the Error Message Display area. Press
the number 2 key to enter STANDBY, then press 2 again to remove message.
Note: Pressure will not fall during this test step.
5.5 Overpressure Neonatal
5.5.1 Connect a Manometer and hand-bulb to the NIBP Pump (right) port. Close
the hand-bulb valve. Within the SETUPS menu change the PATIENT
option from ADULT to NEO. If the NAV menu is not activated then follow
the NAV setup as stated in test step 5.4.1.1 (NIBP CAL window must be
displayed).
5.5.2 Squeeze the hand-bulb until SEC: PRESSREADING equals 150mmHg.
Verify over-pressure occurs (as indicated by pressure fall) at 150 ± 4mmHg
and “OVER PRES” is displayed in the Error Message Display area. Press
the number 2 key to enter STANDBY, then press 2 again to remove message.
Open the Manometer hand-bulb valve.
5.5.3 Repeat test step 5.5.2 to verify that if the pressure reading is >142 but
<150mmHg, the “OVER PRES” alarm will activate within 15 seconds.
Open the Manometer hand-bulb valve.
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5.5.4 Switch/connect the Manometer to the NIBP Sense (left) port. Display the
NIBP CAL window as stated in test step 5.4.1.1. Close the hand-bulb valve;
squeeze the hand-bulb until PRI: PRESSREADING equals 156 ±4mmHg
and “OVER PRES” is displayed in the Error Message Display area. Open
the Manometer hand-bulb valve. Note: Pressure will not fall during this test
step.
5.5.5 Repeat test step 5.5.4 to verify that if the pressure reading is ≥142 but
≤156mmHg, the “OVER PRES” alarm will activate within 15 seconds.
Open the Manometer hand-bulb valve.
To exit the navigation application press the “End” keyboard key, pause for the application
to respond and then press “y”. The “Esc” keyboard key will exit the navigation application
and return to the 865214 (3160P) normal screen. The “End” keyboard key must be pressed
to properly terminate/exit the navigation application. Disconnect the keyboard and VGA
monitor from the WPU.
5.6 Adult Verification
5.6.1 Connect an adult cuff and hose to the NIBP ports and place cuff on arm.
Within the SETUPS menu set the PATIENT option to ADULT. Press the
NIBP START/STOP function key. Verify cuff inflates to approximately
170mmhg and the cuff deflates when a blood pressure determination has been
reached. Verify those systolic, mean and diastolic pressure numerics are
present in the NIBP menu. Remove cuff from arm.
5.6.2 ADULT Dead Man Cuff
With the Adult cuff still connected; place cuff around a fixed object, approx.
6” in diameter arm. Press the NIBP START/STOP function key. Verify the
unit displays a Zero reading at the end of the NIBP cycle. Disconnect the
adult cuff.
5.7 Neonatal Verification
5.7.1 Connect a neonatal cuff and hose to the NIBP ports. Within the SETUPS
menu set the PATIENT option to NEO. Press the NIBP START/STOP
function key. Hold hand with cuffed finger above shoulder height to insure
measured blood pressure is below 100mmHg. Verify cuff inflates to
approximately 130mmHg and the cuff deflates when a blood pressure
determination has been reached. Verify that systolic, mean, and diastolic
pressure numeric are present in the NIBP menu and values are normal for the
operator’s neo finger pressure. Remove cuff from finger.
5.7.2 Neonatal Dead Man Cuff
With the neo cuff still connected, place cuff around fixed object, approx. 1”
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Page 10
in diameter. Press the NIBP START/STOP function key. Verify the unit
±
±
±
±
±
±
displays a Zero reading at the end of the NIBP cycle. Disconnect the neo
cuff. Set the SETUPS/PATIENT option back to ADULT.
5.8 Leak Time-Out
5.8.1 Leak Time Out ADULT
With the PATIENT mode set to ADULT, all cuff connections removed, all
NIBP ports open, and the NIBP function started:
Verify that the pump shuts off within 6 seconds ±1.5 seconds and that the
error message NOT INFLATING is displayed in the NIBP menu.
5.8.2 Leak Time Out Neonatal
With the PATIENT mode set to NEONATAL, all cuff connections removed,
all NIBP ports open, and the NIBP function started:
Verify that the pump shuts off within 6 seconds ±1.5 seconds and that the
error message NOT INFLATING is displayed in the NIBP menu.
5.9 Calibrate Error
Connect a Manometer to the NIBP Sense (left) port. Note: unit must NOT be
in STANDBY for this test. Inflate the mercury column to 15mmHg. Press
the NIBP START/STOP key. Verify that the pump does not start and
CALIB message appears within 30 seconds. Release the pressure from the
Manometer and disconnect it from the NIBP port
6.0 INVASIVE PRESSURE VERIFICATION (N/A if option is not installed)
6.1 With P1 & P2 turned on in the SETUPS/PARAMETERS SELECTION, and the IBP
Simulator connected to the P1 port, set the Pressure Simulator to output 000mmHg.
Using the selector knob, enter the P1 menu and select ZERO SET . Verify the P1
numeric and waveform return to zero. Then verify that P1 on the DCU displays the
pressures within the given tolerances as listed in Table 4.
Table 4
Pressure Transducer
Simulator
0
200
0
40
100
200
Trace P1 (P2)
Numeric Display
0
200
0
40
100
200
1
2
1
1
1
2
250 OVR
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NOTE: The systolic, diastolic and mean values should read within ±1mmHg of one
another.
6.2 With P1 & P2 turned on in the SETUPS/PARAMETERS SELECTION, and the IBP
Simulator connected to the P2 port, set the Pressure Simulator to output 000mmHg.
Using the selector knob, enter the P2 menu and select ZERO SET. Verify the P2
numeric and waveform return to zero. Then verify that the P2 menu on the DCU
displays the pressures within the given tolerances as listed in Table 4.
7.0 AGENTS VERIFICATION (N/A if option is not installed)
NOTE: Gas measurement performance requirements are met after the
warm-up period (20 minutes).
7.1 Agents Flow Test (Adult & Neo)
7.1.1 With AGENTS turned ON and PATIENT set to ADULT in the
SETUPS/PARAMETER Selection menu, the exhaust port open, a sample
line connected to the agents water trap, and the Flowmeter connected to the
end of the sample line, verify that the flow is 200ml/min ±20ml/min.
7.1.2 With AGENTS turned ON and PATIENT set to ADULT in the
SETUPS/PARAMETER Selection menu, the exhaust port open, a sample
line connected to the agents water trap, and with the sample line input
blocked, verify that message CO2 OCCLUSION is displayed within 30
seconds.
7.1.3 With AGENTS turned ON, a sample line connected to the agents water trap,
and the Flowmeter connected to the end of the sample line, and the exhaust
port blocked, verify that the flow drops to 0ml/min.
7.1.4 With AGENTS turned ON and PATIENT set to NEO in the
SETUPS/PARAMETER Selection menu, the exhaust port open, a sample
line connected to the agents water trap, and the Flowmeter connected to the
end of the sample line, verify that the flow is 150ml/min ±15ml/min.
7.1.5 With the water trap removed, the Flowmeter connected to the left port (as
seen looking at the monitor) of the water trap receptacle, and the right port of
the water trap receptacle left open, verify that the flow is 35ml/min
±15ml/min.
7.1.6 With the water trap removed, the Flowmeter connected to the right port (as
seen looking at the monitor) of the water trap receptacle, and the left port of
the water trap receptacle left open, verify that the flow is 165ml/min
±15ml/min.
7.1.7 Connect 9010F (10%CO2/ 50%N2O) check gas to agent sample line. Apply
9010F check gas and verify the unit detects CO2 and measures 76mmHg
±9mmHg, also verify the unit detects N2O and measures 50% ±5%. The
check gas flow should be flowing for at least 2 minutes before a CO2 reading
is recorded.
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7.2 O2 Sensor Verification
7.2.1 With Artema O2 Sensor into sensor port at the back of the Cart, and GAS
CAL / O2 INIT CAL selected in SERVICE MENU, verify that:
7.2.1.1 The O2 sensor is within its expiration date
7.2.1.2 An O2 value of 21% is displayed (at ambient air) in Agents box after
the calibration is completed.
8.0 ETCO2 VERIFICATION (N/A if option is not installed)
8.1ETCO2 Flow Test
NOTE: Gas measurement performance requirements are met after the
warm-up period (20 minutes).
8.1.1 With ETCO2 turned ON in the SETUPS/PARAMETER Selection menu, a
sample line connected to the ETCO2 water trap, the warm-up period
satisfied, and ZERO CAL selected verify “READJUSTING CO2 ZERO” is
displayed at the top center of the DCU screen.
8.1.2 With a water trap installed, a sample lin e connected to the water trap, and the
Flowmeter connected to the end of the sample line, verify that the flow is 80
ml/min ±16ml/min.
8.1.3 With the sample line input blocked, verify that the message CO2
OCCLUSION is displayed within 30 seconds.
8.1.4 Connect a nasal cannula to CO2 sample line. Place nasal cannula on self and
breathe normally through the nose. Verify the CO2 reading displayed is
within (34-43). Also verify the CO2 waveform displayed is consistent with
the operator’s normal respiration rate typically (10-16BPM).
9.0 RESPIRATION VERIFICATION (N/A if option is not installed)
9.1 With REPSIRATION turned ON, a respiration bellows connected to the WSPO2
respiration port, and the bellows attached to the operator’s chest/stomach region,
verify the Expression DCU respiration displays a rate consistent with the operator’s
normal respiration rate (typically 10-16BPM).
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10.0 TEMPERATURE VERIFICATION (N/A if option is not installed)
10.1 With the PATIENT mode set to ADULT, and the SETUPS / PARAMETER
SELECTION / TEMP setting set to ON, the body temp probe connected to the
865214 Temperature port:
10.1.1 Verify that the ambient temperature reading is displayed.
11.0 RF TEST
Run an MRI test scan and verify no noise on image. Or perform procedure below:
OR
Perform the below procedure if using an RF chamber:
At the RF Test station, ensure that all equipment is turned on including 1) Agilent 34970A Data
Acquisition / Switch Unit, 2) HP 8560E Spectrum Analyzer, 3) Agilent 8447D Amplifier (inside
of shield room), 4) test computer, 5) display and 6) printer
11.1 On computer display, double click the “Shortcut to RF Test.vi” icon. This
brings up the LabView Test main window.
11.2 Place the UUT (unit under test) in the shield room so that the wheels are
properly aligned with the notches on the plywood floor system. This ensures that the
test is conducted uniformly across all units tested. Close shield room door and lock
with handle.
11.3 On the main window, click the “START TEST” icon. This brings up another
widow so that the following information can be added for documentation:
-UUT model # (always enter 865214)
-UUT serial #
-operator’s initials
When finished adding this information, select “DONE”. The test will start from this
point and run through a number of frequency spectrums checking for acceptable
noise levels.
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Performance
Assurance
Tests:
11.4 A test report will be printed automatically upon completion. This report will
say “PASS” or “FAIL”. If a unit fails, it will also include all portions of the test that
did not pass. Attach report with system documentation.
Section/Test Description
2.0 Verify communication (COMM) between the DCU, WPU, and
the WECG and WSPO2 remotes. And ICON verification.
3.0 Perform WECG COMM Verification. Do all steps in section 3.0
pass?
4.0 Perform WSPO2 COMM Verification. Do all steps in section 4.0
pass?
5.0 Perform NIBP Verification. Do all steps in section 5.0 pass?
6.0 Perform IBP Verification. If IBP option is not installed, do not
perform. Do all steps in section 6.0 pass?
7.0 Perform AGENTS Verification. If AGENTS option is not
installed, do not perform. Do all steps in section 7.0 pass?
8.0 Perform ETCO2 Verification. If ETCO2 option is not installed,
do not perform. Do all steps in section 8.0 pass?
9.0 Perform RESPIRATION Verification. If Respiration option is not
installed, do not perform. Does section 9.0 pass?
Expected Test
Results
Expected
answer is “yes”.
If so
Communication
verification is
Passed.
Expected
answer is “yes”.
If so WECG
COMM
Verification is
passed.
Expected
answer is “yes”.
If so WSPO2
COMM
Verification is
passed.
Expected
answer is “yes”.
If so NIBP
Verification is
passed.
Expected
answer is “yes”.
If so IBP
Verification is
passed.
Expected
answer is “yes”.
If so AGENTS
Verification is
passed.
Expected
answer is “yes”.
If so ETCO2
Verification is
passed.
Expected
answer is “yes”.
If so
Respiration
Verification is
passed.
Record
the
Results
PA2:P or
PA2:F
where
P=pass
and F=fail
PA3:P or
PA3:F
where
P=pass,
F=fail
PA4:P or
PA4:F
where
P=pass,
F=fail
PA5:P or
PA5:F
where
P=pass,
F=fail
PA6:P,
PA6:F or
PA6:N/A
where
P=pass,
F=fail,
and
N/A=not
performed
PA7:P,
PA7:F or
PA7:N/A
where
P=pass,
F=fail,
and
N/A=not
performed
PA8:P,
PA8:F or
PA8:N/A
where
P=pass,
F=fail,
and
N/A=not
performed
PA9:P,
PA9:F or
PA9:N/A
where
P=pass,
F=fail,
and
N/A=not
performed
Actual
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Page 15
10.0 Perform TEMPERATURE Verification. If Temperature option
is not installed, do not perform. Do all steps in section 10.0 pass?
11.0 Perform RF Test. Do all steps in section 11.0 pass?
Recommended
frequency of
Testing:
TestFrequency
Performance Assurance.
Regular Preventative Maintenance. Recommended once a year.
RELATED DOCUMENTS: N/A
ECNUMBER: 2975-2010-10-01929
SuggestedTestingTimetable
Recommended once a year (or as specified by local
laws) and after any type of repair of the unit.
Expected
answer is “yes”.
If so
Temperature
Verification is
passed.
Expected
answer is “yes”.
If so RF Test is
passed.
PA10:P,
PA10:F or
PA10:N/
A where
P=pass,
F=fail,
and
N/A=not
performed
PA11:P or
PA11:F
where
P=pass
and F=fail
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