Digital Pulseoximeter Including:
- Oxygen Saturation (SpO2)
- Pulse Rate (PR)
- Plethysmograph Waveform
- Perfusion Index (PI)
- Temperature High Accuracy and Precision of Parameters on Low Perfusion Condition
Setting for all Patient Type:
- Adult
- Pediatric
- Neonate
Technical Specification
- Self-designed PM2019TM digital oximetry module
- Configurable patient profile settings for: Adult, Pediatric, and Neonate
- Eliminate motion artifacts
- Record and save measured parameters (Trend)
- Internal rechargeable Li-ion battery, within 5 hours of continuous monitoring
- Ethernet out complying HL7 protocols
- USB connection with computer software
- Rotating and adjustable 7.8” widescreen with capacitive touch
- Audible and visual alarms based on IEC standard
- Variable pitch pulse tone for change in saturation
Oximetry performance is the most critical right when conditions are most difficult. That’s when you can count on
our PM2019™ (Oximetry Noise Elimination) technology.
PM2019™ technology is the system that uses a patented digital sensor – all others still use an analog sensor.
PM2019™ sensors both amplify and digitize the signal in the sensor, resulting in a stronger and higher quality
signal. Parsian Medical’s OEM oximetry modules are designed to substantially improve performance and eliminate nuisance
alarms associated with motion and low perfusion. Parsian Medical’s OEM modules interface directly with the PM2019™
family of sensors and the host platform to-calculate the SpO2 and pulse rate.
| Electrical Characteristics | |
|---|---|
| Power Requirements (AC Line) | 80~264 VAC; 47~63 Hz; 30VA |
| Battery | Li-Ion 7.4 V, Rechargeable, Maximum Protection Battery Operating Time: 5 hours Battery Charging Time: 3 hours |
| Fuse | 500 mA |
| Resolution | |
|---|---|
| SpO2 | 1% |
| Pulse Rate | 1 bpm |
| Temperature | 0.1°C |
| Sensor LEDs | |
|---|---|
| Nominal wavelength and nominal power output values | (RED) 660 nm – 1.8 mw and
(IRED) 905 nm – 2.0 mw |
| Alarm Limits | |
|---|---|
| Low SpO2 | 0% – 99% |
| High SpO2 | 1% – 100% |
| Low Pulse Rat | 30 bpm – 229 bpm |
| High Pulse Rate | 31 bpm – 230 bpm |
| Measurment Range | |
|---|---|
| SpO2 | 30% – 100% |
| Pulse Rate | 30 – 240 bpm (beat per minute) |
| Temperature | 0.0° – 60.0°C (32.0° – 138.9°F ) |
| Perfusion | 0.2% – 20% |
| Unit Dimensions & Weight | |
|---|---|
| Dimensions (W x H x D ) | 25 x 8 x 22cm |
| Weight | 1 kg |
| Display | |
|---|---|
| Type | High Quality TFT Full Colors Liquid Crystal Display (LCD) with LED Backlight |
| Data Displayed | SpO2, Pulse Rate, Plethysmograph waveform, Temperature, Alarms and Status Message |
| Note: There is no display delay for the calculated value. | |
| Accuracy | ||
|---|---|---|
| SpO2 (Functional) | No Motion and Normal Perfusion | (70-100%) ±2% |
| Pulse Rate | No Motion and Normal Perfusion | (30-240 bpm) ±3 bpm |
| SpO2 (Functional) | Neonatal* No Motion and Normal Perfusion |
(70-100%) ±2% |
| SpO2 (Functional) | Motion, Low Perfusion <0.2% | (70-100%) ±3% |
| Pluse Rate | Motion, Low Perfusion <0.2% | (30-240 bpm) ±5 bpm |
| Temperature | Not Including Sensor Accuracy | (0-70°C) 1-2% |
| *Neonatal testing was completed on healthy adult subject and 1% was added to the % arms to account for fatal haemoglobin effects. | ||
| IEC (International Electrotechnical Commission) Classifications | |
|---|---|
| Type of Protection | CLASS I |
| Degree of Protection | Type BF |
| Mode of Protection | Continuous |
| Degree of Protection Against Ingress of Liquids | Ordinary (IPX2) |
| Recommended Methods of Sterilization or Disinfection | Using a soaked swab with alcohol for the external parts of system, SpO2 sensor and extension cable for appropriate cleaning instructions. |
| Degree of Safety of Application in the Presence of a Flammable Anesthetic | Not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide. |
| Do not use functional tester to assess the accuracy of pulseoximeter probes and monitor. | |
| List of Relevant Standard | ||
|---|---|---|
| 1 | ISO 80601-2-61:2017 | Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
| 2 | IEC 60601-1-8:2006 | Medical electrical equipment – Part 1-8: General requirements for safety – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| 3 | IEC 60601-1:2023 | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance |
| 4 | ISO 14971:2019 | Medical devices – Application of risk management to medical devices |
| 5 | IEC 60601-1-2:2014 | Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests |
| 6 | ASTM F2761-09 | Medical Devices and Medical Systems — Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) — Part 1: General requirements and conceptual model |
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