RHYTHM MASTER
Rhythm Master combines a reusable 6.8 g ECG recorder, a single-use electrode patch, and flexible application connectivity to bridge everyday patient recording with data access for healthcare professionals across a range of healthcare use scenarios.
FOR EACH AUDIENCE
Explore the products, information, and support that fit your needs.
Review setup, recording workflows, data access, and model-specific instructions for clinical use.
View user guide → 02 / PATIENTS & FAMILIESFind clear guidance on wearing the patch, completing a recording, and getting support.
View frequently asked questions → 03 / HEALTHCARE ORGANIZATIONSCompare connectivity options, system requirements, and technical considerations across product models.
Compare connectivity →
INTEGRATED ECG RECORDING SYSTEM
A lightweight ECG recorder, single-use electrode patch, and mobile or desktop access work together across the complete recording workflow.
U.S. REGULATORY MILESTONE
Beyond a lightweight experience, backed by reviewed safety and performance evidence.
PUBLIC 510(k) SUMMARY
The public FDA 510(k) Summary identifies the following testing and evaluation categories.
Evaluation of body-contacting components, including relevant cytotoxicity, skin sensitization, and irritation testing.
Evaluation of basic safety, electromagnetic compatibility, home healthcare use, and ambulatory ECG system performance under applicable standards.
Software lifecycle, system-requirement, and risk-control activities supporting verification and validation of the device software.
Cybersecurity assessment and testing conducted according to applicable FDA medical-device cybersecurity guidance.
Performance testing and evaluation associated with single-use ECG electrodes.
Follow three steps to start ECG recording.
Connect HM-15BB-AX to the Health Assistant mobile app by Bluetooth. Connect HM-15BW-AX or HM-15BW-DX to the Health Assistant desktop software through USB.
Follow the applicable user guide to install the ECG recorder on the single-use electrode patch and remove the protective film.
Follow the user guide for the applicable model to start ECG recording and access recorded data through the corresponding mobile or desktop software.
Note: Sensor end down. Suggested position is only suitable for individuals with heart on the left side.
Compare the connectivity and signal-processing mode for each model.
Connects to the Health Assistant mobile app through Bluetooth Low Energy 5.1.
Both wired models connect to a computer through USB and use different signal-processing modes.
KEY MODEL DIFFERENCES
The following parameters compare key technical differences and do not constitute the complete product specifications. For complete specifications, test conditions, and applicable requirements, refer to the product labeling and the user guide for the corresponding model.
| Parameter | HM-15BB-AX | HM-15BW-AX | HM-15BW-DX |
|---|---|---|---|
| Version | Bluetooth | Wired | Wired Pro |
| Connectivity | Bluetooth Low Energy 5.1 | USB | USB |
| Compatible software | Health Assistant (mobile) | Health Assistant (desktop) | Health Assistant (desktop) |
| Signal-processing mode | AC | AC | DC |
| Pacemaker signal detection | — | — | Supported |
| Dimensions | 37.0 × 22.5 × 7.7 mm | 37.0 × 22.5 × 7.7 mm | 37.0 × 22.5 × 7.7 mm |
| Weight | 6.8 g | 6.8 g | 6.8 g |
| Maximum recording period | Up to 3 days | Up to 7 days | Up to 4 days |
| Ingress protection rating | IP24 | IP24 | IP24 |
| Frequency response | 0.5–40 Hz | 0.5–40 Hz | 0.05–40 Hz |
| Data resolution | 15-bit | 15-bit | 20-bit |
| Dynamic range | ±10 mV | ±10 mV | ±10 mV |
| Sampling rate | 256 Hz | 256 Hz | 256 Hz |
| Charging time | Approx. 2 hours | Approx. 2 hours | Approx. 2 hours |
SOFTWARE BY RECORDER MODEL
Choose the applicable software for your ECG recorder model.
MOBILE APP
For the HM-15BB-AX ECG recorder, connected to a mobile device through Bluetooth Low Energy 5.1.
Scan the QR code to download the mobile app
DESKTOP SOFTWARE
For the HM-15BW-AX and HM-15BW-DX ECG recorders, connected to a computer through USB 2.0 Type-C.
System requirements: Windows 11 or later.
Scan the QR code to download desktop softwareHARDWARE AND APIs READY
We provide ECG recording hardware, data relay services, and SDK/API integration capabilities, enabling partners to connect device data with their own software platforms, business systems, and algorithm models.
Partners can independently develop user interfaces, data management functions, and analytical algorithms to create ECG solutions tailored to their brand and application needs.
WHAT WE PROVIDE
BUILT BY OUR PARTNERS
Standardized hardware and integration interfaces simplify device connectivity and data access, allowing your team to focus on software experiences, algorithm development, and product innovation.
RHYTHM MASTER QUESTIONS
Frequently asked questions about the Rhythm Master ECG Patch.
Yes. The device has an IP24 ingress protection rating and can withstand sweat generated during exercise, but it is not designed for immersion. Intense motion may interfere with ECG detection. Minimize movement during ECG Detection mode to support accurate results.
Yes, but keep the ECG recorder and electrode patch away from the shower head and cover them with plastic wrap. ECG recording and data transmission may be unavailable during a shower. After showering, check the connection between the ECG recorder and electrode patch and confirm that the patch remains attached to the skin.
No. The device is not designed for continuous water immersion. Bathing, swimming, or diving may cause temporary or permanent damage to the device.
No. The electrode patch is a single-use accessory and must not be reused. After removal, its adhesive performance decreases and may affect attachment and ECG signal quality.
Press the adhesive edges of the electrode patch to reattach it to the skin. If it does not remain securely attached, replace it with a new electrode patch or contact a healthcare professional.
Avoid repeatedly using the same application site and follow the applicable user guide for skin care. If significant itching, burning, or a rash occurs, discontinue use and contact a healthcare professional.
Check the device battery level and confirm that Bluetooth is enabled on the mobile device, then reconnect according to the user guide. The connection may be interrupted when the devices are out of range. If it does not reconnect after returning within range, restart the app and wait for reconnection.
This message indicates that transient electrical interference was detected during ECG signal acquisition. Remain still and wait a few seconds. If the message persists, identify possible interference sources or move to a location without electrical disturbance.
HM-15BB-AX connects to a mobile app through Bluetooth and uses AC signal processing. HM-15BW-AX and HM-15BW-DX both connect to a computer through USB; HM-15BW-AX uses AC signal processing, while HM-15BW-DX uses DC signal processing and supports pacemaker signal detection. Refer to the applicable user guide and guidance from a healthcare professional when selecting a model.
Check whether the ECG recorder is fully charged, or place it back in the charging dock and reinstall it on the electrode patch. If the issue persists, contact customer support or your distributor and describe the problem.
USER GUIDES AND PRODUCT HELP
Access the applicable user guide or contact the support team.
View the applicable user guide, use information, and safety precautions.
HM-15BB-AX user guide →HM-15BW user guide →Compare recorder models and connectivity options.
Compare models →Watch the video to learn how to use the desktop software.
Contact the support team for product support or more information.
Contact support →PRODUCT INFORMATION AND HELP
Contact us for product information, support, or further discussion.
PHONE+1 650 546 5942
EMAILsupport@smwmed.com
ADDRESS9920 Pacific Heights Blvd Ste 410, San Diego, CA 92121, USA
