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Guidance on proper use and handling to prevent measurement errors or damage.
General information, copyright, and liability disclaimers.
Essential rules for safe and effective operation of the oximeter.
Alerts for hazardous conditions, improper use, and critical safety advice.
Key points to monitor for optimal performance and device longevity.
Statement affirming compliance with relevant medical device standards and directives.
Regulatory information detailing FCC rules applicable to the oximeter.
Introduction to the device and its purpose.
Detailed description of the oximeter's physical appearance and parts.
Identification of product name and various available models.
Specifies the medical applications and target users for the oximeter.
Lists the main functionalities and capabilities of the oximeter.
Step-by-step instructions for installing and replacing the device's batteries.
Guide on how to connect an external sensor for SpO2 measurements.
Comprehensive guide on device operation, display modes, and button functions.
Instructions for downloading and installing the oximeter's companion mobile application.
Important advice for accurate measurements and proper device handling.
Recommendations for routine maintenance and care to ensure longevity.
Detailed steps for cleaning and disinfecting the oximeter.
Solutions for common problems and error conditions.
Explanation of symbols used on the device and in the manual.
Answers to common user queries regarding SpO2, PR, and device functionality.
Interpretation of various measurement results and waveform patterns.
Electromagnetic compatibility data and guidance for device usage.
General| Category | Medical Equipment |
|---|---|
| Type | Patient Monitor |
| SpO2 Range | 0-100% |
| Pulse Rate Range | 30-250 bpm |
| Low Battery Indicator | Yes |
| Pulse Rate Accuracy | ±2 bpm or ±2%, whichever is greater |
| Parameters | SpO2, PR |
| Battery Type | Rechargeable Lithium-ion |
| Power Supply | AC 100-240V, 50/60Hz |
| Automatic Shut-off | Yes |
| Interface | USB |
| SpO2 Accuracy | ±2% (70-100%) |
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