PD Care System
PainDrainer AB · Model Version 1.X
A digital health software solution designed to support individuals with long lasting pain and facilitate remote monitoring by healthcare professionals.
Intended use: An application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.
Key tips
- ·A no-signal/flatline alarm gets checked on the patient first, not the monitor - rule out a real clinical event before troubleshooting.
- ·Recalibrate NIBP against a reference manometer, not just a self-test pass.
- ·Reused patient cables (SpO2, ECG leads) are a common source of intermittent-fault complaints - swap the cable before the module.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Routine cable and lead-wire inspection for fraying/wear
- ·Battery conditioning cycle
- ·NIBP calibration check against a reference manometer
- ·ECG / SpO2 accuracy verification against a patient simulator
- ·Annual electrical safety test
Technical Specs
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- Prescription use
- OTC
- FDA distribution status
- Not in Commercial Distribution
- Device type (GMDN)
- Self-care monitoring/reporting software
- FDA product classification
- Medical Device Data System; Reminder, Medication
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- ICU / CCU
- Emergency Department
- OR / PACU
- General med-surg floors
- Step-down units
- Telemetry units
Documents & Manuals
No documents available for this device yet.
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