5
Test and Material List
5.1 Test Procedure
5.1.1 Connection and Checking
Connect the simulators, power supply and test fixture properly to the DPM4 patient monitor, and power it on. Then, the patient monitor displays the start-up screen on the TFT screen and enters the system screen.
5.1.2 Functions of Buttons
Press every button on the button panel to check their functions as specified in DPM4 Operation
Manual. Rotate the control knob to check its functions.
5.1.3 ECG/RESP
The TFT screen displays the standard ECG waveform, and the error between the heart rate and the set value of the simulator is no more than ±1, namely 60±1; the RESP waveform is smooth, and the respiration rate is 20±1.
1. Select all leads in order, select all the four gains and AUTO, ensure the waveforms are displayed properly, and check whether the 50Hz/60Hz interference can be filtered.
2. Check, in all the above-mentioned cases, the consistency between the heartbeats, the flashes of the red heart-like indicator, and the R-wave.
3. The gain has no impact on the message “ECG signal over weak” in the HR calculation.
4. Verify the range and precision: Suppose that the amplitude of the GCG signal of the simulator is 1mV, the heart rates are respectively 30, 60, 120, 200, 240 and 300. Check leads I, II and III. The results should meet 29-31, 59-61, 119-121, 198-202, 238-242, and
297-303.
5. PACE pulse test: Set the simulator to PACE. You should be able to view the pace. Change
PACE amplitude to ±8 – 700mv, and pulse width to 0.1ms – 2ms. The PACE should be legible, and LEAD OFF is displayed properly.
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6.
RESP measurement: Set the baseline impedance to 1K, the respiration impedance to 0.5Ω and 3Ω, and the respiration rate to 30 and 120. The respiration rate should be 29 – 31, 118
–122.
7. PVC test: Set the simulator to the PVC mode, and set the occurrence times. The relevant
PVCS should be obtained.
8.
Set the simulator as follows: RR: 40, baseline impedance: 2KΩ, RESP waveform: 3:1.
Open the apnea alarm, set the respiration resistance to 0Ω, and set various alarm time.
Alarms should be given.
5.1.4 Temperature
1. YSI probe
Select YSI probe from the manufacturer menu, select YSI temperature probe as the test fixture, set the analog resistance to 1.471K, 1.355K and 1.249K. Then the TEMP parameter should be 35±0.1℃, 37±0.1℃ and 39±0.1℃.
2. CY-F1 probe
Select CY-F1 probe from the manufacturer menu, select CY-F1 temperature probe as the test fixture, set the analog resistance to 6.534K, 6.018K and 5.548K. Then the TEMP parameter should be 35±0.1℃, 37±0.1℃ and 39±0.1℃.
5.1.5 NIBP
Connect the NIBP simulator, adult cuff and accessories, and then connect the module CUFF and clockwise screw it tightly.
1. After the simulator self-test, press <ENT> to enter the ADULT analog blood pressure mode.
Set the blood pressure to the 255/195/215 mmHg level, SHIFT to +15, and the HR to
80BPM. Set DPM4 to the adult mode. Press <START>. Then the results will be obtained in about 30s. The measured results should be respectively 270±8mmHg, 210±8mmHg and
230±8mmHg.
2. Press <ESC> and <
↓> on the simulator to enter the NEONATE mode. Set the blood pressure to the 120/80/90 mmHg level, HR to 120bmp, and DPM4 to the pediatric mode.
Press <START>. Then the results will be obtained in about 30s. The measured results should be respectively 120±8mmHg, 80±8mmHg and 90±8mmHg.
3. Press <ESC> and <
↓> on the simulator to enter the NEONATE mode. Set the blood pressure to the 60/30/40 mmHg level, SHIFT to -20, HR to 120bmp, and DPM4 to the
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neonate mode. Change the simulator accessory to the neonatal cuff. Press <START>. Then the results will be obtained in about 30s. The measured results should be respectively
40±8mmHg, 10±8mmHg and 20±8mmHg.
5.1.6 SpO2
Select PLETH as the HR source of DPM4, and put the finger into the SpO
2
sensor. The screen should display the PR and SpO
2
values normally. The normal SpO
2
value is above 97%.
5.1.7 IBP
1. Test fixture
Physiological signal simulator
2. Test procedure
① IBP1 test:
Set the BP sensitivity of the ECG simulator to 5uv/v/mmHg, BP to 0mmHG, and the IBP channel 1 to ART. Enter the IBP PRESSURE ZERO menu of the DPM4, zero Channel 1, and then return to the main screen. Set the BP of the simulator to 200mmHg. Enter the IBP
PRESSURE CALIBRATE menu of the DPM4, conduct calibration, and then exit the IBP
PRESSURE CALIBRATE menu.
Set the BP value of the simulator respectively to 40mmHg, 100mmHg and 200mmHg. Then the screen of the DPM4 should display 40±1mmHg, 100±2mmHg and 200±4mmHg.
Set the simulator output to ART wave. Then the screen of the DPM4 should display relevant waveform properly.
Unplug the IBP probe. Then the screen should prompt “IBP: Transducer 1 OFF!” and “IBP:
Transducer 2 OFF!”
Plug the OHMEDA cable to the IBP1 channel. Then the prompting message “IBP:
Transducer 1 OFF!” disappears.
② IBP2 test:
Plug the IBP cable to the IBP2 channel, and repeat the procedure in Section ①.
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5.1.8 CO2
1. Test fixture
CO2 steel bottle (containing 10% CO2)
2. Test procedure
①Sidestream CO2 measurement: Set the calculation compensation of DPM4 to
COMMON.
Plug the water trap to the water trap socket, connect the sampling tube with the CO2 steel bottle, and open//close the valve of the CO2 steel bottle based on the interval of 3s. The
CO2 value should be the calibration gas pressure value: 76±5%mmHg. When the valve is opened permanently, the patient monitor prompts “APNEA ALARM”.
Unplug the water trap. The patient monitor prompts “CO2 water trap OFF”. Plug the water trap again. The prompting message disappears.
②When the measured value exceeds the high limit of CO2, the patient monitor prompts “CO2 too high” on the main screen. When the measured value is lower than the low limit, the patient monitor prompts “CO2 too low”.
5.1.9 Watertrap
1. Connect the airway and block the inlet of the sampling line with your finger. Check if the message CO2 SAMPLE LINE ABNORMAL is displayed and the current pump rate in the
CO2 USER MAINTAIN menu drops below 5ml/min. If yes, it indicates the airway is normal. Otherwise, proceed with step 2.
2. Remove the sampling line and block the inlet of the watertrap with your finger. Check if the message CO2 SAMPLE LINE ABNORMAL is displayed and the current pump rate in the
CO2 USER MAINTAIN menu drops below 5ml/min. If yes, it indicates there may be a problem with the connection between the sampling line and watertrap or a leakage in the sampling line. Otherwise, proceed with step 3.
3. Remove the watertrap and block the two inlets in the receptacle for the watertrap. Check if the message CO2 SAMPLE LINE ABNORMAL is displayed and the current pump rate in the CO2 USER MAINTAIN menu drops below 5ml/min. If yes, it indicates there may be a problem with the connection between the watertrap and its receptacle or a leakage in the watertrap. Otherwise, there may be a problem with the internal airway in the monitor. The internal airway has two parts, one part in the receptacle and the other part in the module.
Block the small tubes between the watertrap receptacle and module with your fingers and check if the message CO2 SAMPLE LINE ABNORMAL is displayed and the current pump
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rate in the CO2 USER MAINTAIN menu drops below 5ml/min. If yes, it indicates there is a problem with the airway in the receptacle. Replace the receptacle. Otherwise, replace the module.
5.1.10 Recorder
1. Print the ECG waveform. The recorder should print it normally and clearly. Set the recorder to the fault of lack of paper and abnormal clip. There should be relevant prompting messages on the main screen. When the fault is cleared, the patient monitor should become normal.
2. Print the alarm messages of all parameters. Set the alarm print switch to ON for all parameters, and set different alarm limits. Then the recorder should print the alarm message in case of an alarm.
5.1.11 Power Supply
When the patient monitor is supplied with the external AC power, the Battery indicator becomes
ON. When it is disconnected from the external AC power, the Battery indicator becomes OFF.
After the patient monitor is started without assembling the batteries, “x” is displayed in the battery indication frame on the main screen. After the batteries are assembled, the battery electricity is displayed in the battery indication frame on the main screen. The patient monitor can work normally with or without batteries. It, however, should give an alarm when the batteries are exhausted.
5.1.12 Clock
Verify the correctness of the clock in the system test, and then set the clock to the current time.
5.1.13 System Test
Load all parameters, and conduct operations respectively on the loaded parameters. During the synchronization, no exceptions (for example, mutual interference) occur. Set all parameter setups in menus to the default values which are those at the time of software loading, and conduct operations on the menus, for example, managing the patient information, recalling data, and so on. All the operations should be done normally, and the corresponding functions should be correct and meet the product requirements.
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5.2 NIBP Calibration
Figure 5-1 NIBP Calibration
Calibration method:
Based on the precision of 50mmHg (6.7kPa), increase the pressure step by step. The maximum error at any pressure point within the NIBP measurement range of the patient monitor should be no more than ±3mmHg (±0.4kPa). Decrease the pressure step by step. The maximum error at any pressure point within the NIBP measurement range of the patient monitor should be no more than ±3mmHg (±0.4kPa).
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5.3
IBP
Calibration
5.3.1 IBP Transducer Zero
Press the ZERO button on the IBP module to call up IBP PRESSURE ZERO menu as shown below:
Figure 5-2 IBP PRESSURE ZERO
Zero Calibration of Transducer
Select CH1, the system will zero IBP1. Select CH2, the system will zero IBP2.
Cautions:( Use the PM-6000 IBP module as a example)
Turn off patient stopcock before you start the zero procedure.
The transducer must be vented to atmospheric pressure before the zero procedure.
The transducer should be placed at the same height level with the heart, approximately mid-axially line.
Zero procedure should be performed before starting the monitoring and at least once a day after each disconnect-and-connect of the cable.
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Figure 5-3 IBP Zero
IBP Calibration
Press CAL button on the IBP module to call up the IBP PRESSURE CALIBRATE menu as shown below:
Figure 5-4 IBP Calibration Menu
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Calibrate the transducer:
Turn the knob to select the item CH1 CAL VALUE, press and turn the knob to select the pressure value to be calibrated for channel 1. Then turn the knob to select the item CALIBRATE to start calibrating channel 1.
Turn the knob to select the item CH2 CAL VALUE, press and turn the knob to select the pressure value to be calibrated for channel 2. Then turn the knob to select the item CALIBRATE to start calibrating channel 2.
The pressure calibration of DPM4:
Figure 5-5 IBP Calibration
You will need the following pieces of equipment:
Standard sphygmomanometer
3-way stopcock
Tubing approximately 25 cm long
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The Calibration Procedure:
1. Close the stopcock that was open to atmospheric pressure for the zero calibration.
2. Attach the tubing to the sphygmomanometer.
3. Ensure that connection that would lead to patient is off.
4. Connect the 3-way connector to the 3-way stopcock that is not connected to the patient catheter.
5. Open the port of the 3-way stopcock to the sphygmomanometer. .
6. Select the channel to be calibrated in the menu and select the pressure value to which the
IBP is to be adjusted.
7. Inflate to make the mercury bar rise to the setup pressure value.
8. Adjust repeatedly until the value in the menu is equal to the pressure value shown by the mercury calibration.
9. Press the Start button, the device will begin calibrating.
10. Wait for the calibrated result. You should take corresponding measures based on the prompt information.
11. After calibration, disassemble the blood pressure tubing and the attached 3-way valve.
Calibration completion message: “SUCCESSFUL CALIBRATE”
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5.4 DPM4 Material List
Material Code
115-001437-00
043-000087-00
8002-30-36342
8002-30-36378
8002-20-36167-51
8002-20-36167-52
021-000166-00
009-005261-00
009-005260-00
8002-30-36209
9210-30-30150
051-000007-00
630D-30-09121
051-000058-00
M03A-30-26050
115-031392-00
8002-30-36165
0010-30-43089
8001-30-25667
8002-20-36175
8002-20-36195
115-031469-00
8000-20-10290
9211-30-87429
0000-10-11020
8002-30-36204
8002-30-36155
9201-30-35910
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Name & Specification
Front bezel assembly
Front bezel
Back housing assembly
Back housing assembly (supporting wireless network adapter)
Back housing
Back housing (supporting wireless network adapter)
TFT Screen 8.4"(800X600)
Cable MB to LCD
Cable BP to LCD
CF Card Module
9210 Host Board
812B ECG module
630D NIBP module
9008 SpO2 module
IBP board
Screen assembly
Keyboard
Encoder board
Alarm indicators board
Screen supporter
Fan
TR6F Recorder
Anti-glare mask
Water trap assembly
Inverter TPI-01-0207-M
Parameter connector assembly
Power board
Battery charger board
FOR YOUR NOTES
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