An **overall check** of the monitor, including a **safety check** and **performance check**, should be performed by qualified personnel every **24 months or after service**.
These checks should be performed before using the monitor.
| Procedure | Description | Reference (Section & Page) |
|---|---|---|
| Visual Inspection | Inspect the monitor and accessories for obvious signs of damage. Check the external cables, power socket, and power cable. Do not use the monitor if damage is detected until repaired. | 4.1.1 (Page 10) |
| Power-on Test | Switch on the monitor (connected to power) and check the following:
|
4.1.2 (Page 10) |
| Key Test | Press the keys on the front panel in turn to check if they work properly, and a corresponding functional display appears. Verify that turning and pressing the trim knob moves the cursor and confirms the operation. | 4.1.3 (Page 10) |
| Recording Test | Check if the recorder can perform recording without problems and if all recorded traces are correct and clear on the paper. (Note: Ensure paper is well loaded and the setting is correct before recording). | 4.1.4 (Page 10) |
| Alarm Test | Trigger a signal (higher than upper limit or lower than lower limit) for a **physical alarm**. Disconnect an accessory for a **technical alarm**. Check if the audible and visible alarms work properly. | 4.1.5 (Page 11) |
A performance check should be performed once possible device malfunction emerges or after servicing the device.
| Parameter | Tools Required | Test Goal / Acceptance Criteria | Reference (Section & Page) |
|---|---|---|---|
| ECG | ECG simulator | HR=30bpm; displayed value should be **$30\text{bpm} \pm1\text{bpm}$ or $\pm1\%$ (whichever is greater)**. | 4.2.1 (Page 11) |
| $SpO_{2}$ | $SpO_{2}$ simulator | $SpO_{2}=70\%$; displayed value should be **$70\% \pm2\%$**. | 4.2.2 (Page 12) |
| NIBP Performance | NIBP simulator, T-fitting, Extension tube, Artificial limb | Compare displayed values to simulator configuration (e.g., Systolic=255mmHg, Diastolic=195mmHg, Mean=215mmHg); differences should be within **$\pm8\text{mmHg}$**. | 4.2.3 (Page 12) |
| NIBP Leakage Test | Cuff, Cylinder (or similar object) | System inflates to 180 mmHg. If the prompt of **"Leak Test OK"** appears, the airway is in good condition. | 4.2.4 (Page 13) |
| NIBP Calibration | T-fitting, NIBP extension tubes, Cylinder, Manometer | Apply fixed static pressure. Compare displayed static pressure on monitor with manometer values; difference within **$\pm3\text{mmHg}$** is reasonable. | 4.2.5 (Page 13) |
| TEMP | Resistance box | Set the resistance value to (6017 $\Omega$) $37^{\circ}C$ in the resistance box. A difference within the range of **$+0.1^{\circ}C$** is reasonable. | 4.2.6 (Page 14) |
| $CO_{2}$ | Nasal cannula | Place the nasal cannula below the nose and normally breathe; check for waveforms. Displayed concentration is supposed to be **$34\sim40\text{mmHg}$**. | 4.2.7 (Page 15) |
| IBP | Patient simulator | Perform zero calibration; dynamic pressure tolerances should be **$\pm4\text{mmHg}$ or $\pm4\%$**. | 4.2.8 (Page 15) |
| C.O. | Patient simulator | Configure Injection temperature: $0^{\circ}C$, Computation Const: $0.542$, and Flow: $5\text{l}/\text{min}$. Expected test result: **C.O.=$5\pm1\text{ l}/\text{min}$**. | 4.2.9 (Page 15) |
Perform safety tests using a standard safety analyzer such as Fluke 601 Pro Series or equivalent, and according to local regulations (e.g., IEC/EN 60601-1, IEC/EN 60601-1-1, UL60601-1).