Quell 2.0 Specifications
Looking for all the details you can handle? You’ll find them right here.
Output |
|
|---|---|
| Configurations | 1 stimulator (2-lead) |
| Waveform | Biphasic with alternating lead phase, asymmetrical, rectangular |
| Regulated Current or Voltage | Current |
| Net Charge per Pulse | Nominally 8 µC into 500Ω per pulse; nominally 0 µC per sequential pair of pulses; zero net current |
| Maximum Output Voltage (±5%) | 118 V |
| Maximum Output Current (<1KΩ load) (±10%) | 100 mA |
| Pulse Duration | 380 µsec (includes inter-phase delay) |
| Pulse Frequency (±4%) | 60-100 Hz, randomly varying, 30-50Hz randomly varying, or 120-200Hz randomly varying |
| Pulse Pattern | Continuous |
| Maximum Phase Charge | 18 µC |
| Maximum Current Density (r.m.s.) | 0.85 mA/cm2 into 500Ω load |
| Maximum Average Current | 5.6 mA into 500Ω load |
| Maximum Average Power Density | 10 mW/cm2 into 500Ω load |
| Maximum Pulse Energy (pulse duration < 0.1s) | 3.3 mJ per Pulse |
Output Trips |
|
|---|---|
| No Load | Device not connected to patient |
| Insufficient Charge | Delivered charge below target |
| Over Load | Delivered charge above target |
| Electrode Peel | Electrode dislodging from skin |
Therapy Session |
|
|---|---|
| Timer | 60 or 30 minutes |
| Start Stimulation | Via mobile app Control or automatically upon placing of device on leg |
| Halt Stimulation | Via mobile app or two taps to the enclosure within 1.5 seconds (double-tap) |
| Intensity Increase/Decrease | 0.5 – 2 mA/sec |
| Habituation Compensation | Stepwise increase in intensity of 0.3%/min during session |
User Interface |
|
|---|---|
| Tap | Ability to recognize double-tap to the enclosure for stimulation halt |
| Mobile App | Mobile App control to calibrate, therapy start, stimulation halt, and, intensity adjustment |
| USB | Micro USB B socket for charging |
| LEDS | 1 white, 1 orange |
| Bluetooth | Device supports Bluetooth LE 4.2 |
Electrode |
|
|---|---|
| Type | Cutaneous electrode, disposable |
| Materials | Conductive hydrogel, PET, silver |
| Number of Electrodes | Four pads, configured as two electrically connected pairs |
| Connector | Male snap |
| Dimensions | Skin contact area: 33 cm2 inner pair, 28 cm2 outer pair |
Power |
|
|---|---|
| Source | Permanent rechargeable battery |
| Battery Type | Rechargeable 3.7V Lithium-Ion battery |
| Charging Source | AC line adapter |
| Line Current Isolation | Patient disconnected when charging |
| Patient Leakage Current, DC | <10 μA |
| Patient Leakage Current, Enclosure | <100 μA |
Physical |
|
|---|---|
| Dimensions | 9.4mm x 51.4mm x 77.4mm |
| Weight | 32g |
Environmental |
|
|---|---|
| IP Classification | IP22 |
| Operating Temperature Range | 5° C to 35° C |
| Operating Atmospheric Pressure Range | 70 kPa to 106 kPa |
| Operating Relative Humidity Range | 15% to 93% |
| Transport and Storage Temperature Range | -25° C to 70° C |
| Transport and Storage Atmospheric Pressure Range | 70 kPa to 106 kPa |
| Transport and Storage Relative Humidity Range | 10% to 93% |
Guidance Documents & Standards |
|
|---|---|
| IEC 60601-1 | Medical Electrical Equipment Part 1: General requirements for basic safety and electrical performance |
| IEC 60601-1-2 | Electromagnetic disturbances – requirements and tests |
| IEC 60601-1-11 | Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| IEC 60601-2-10 | Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
| ISO 10993-1 | Biological evaluation of medical devices |
| CISPR 11 | Radiated and Conducted Emissions Standard for Industrial, Scientific, and Medical (ISM) equipment |
| ETSI EN 301-489-1, -17 | Electromagnetic compatibility and Radio Spectrum matters for Radio Equipment |
Bluetooth®
The Bluetooth word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by NeuroMetrix, Inc. is under license.
Communication between the Quell device and the Smartphone is via Bluetooth.
Disabling Bluetooth
If Bluetooth is disabled on your smartphone or tablet, then the Quell Relief app will not function. Your Quell device will only function if you have previously enabled Automatic Start within the app.
Bluetooth Specifications |
|
|---|---|
| Bluetooth Pre-Qualified Design: | Nordic nRF52832 4.2 Low Energy |
| FCC Rules: | Part 15C |
| Security: | Encryption |
The Quell Relief app requires iOS 10 or later, or Android 6 or later.
iOS and Android devices must have Bluetooth Low Energy (LE, also called Bluetooth Smart) compatibility.
