
Medical-Grade Ni-MH Pack Extends Monitor Uptime to 72 Hours
A medical device maker needed longer uptime and predictable swap behavior for ward-based monitors. EPT delivered a smart Ni-MH pack with fuel gauging, audit logs, and IEC 60601-1 compliance.
At a Glance
Project snapshot
- Industry: Medical devices — portable patient monitoring
- Challenge: Extend runtime to 72h with hot-swap and compliance traceability
- Solution: 9.6V Ni-MH smart pack with fuel gauge and sealed audit trail
- Outcome: 72h typical runtime, IEC 60601-1 aligned design, FDA audit-ready docs
- Regulatory: IEC 60601-1, ISO 13485 manufacturing controls
Key outcomes
- Runtime
- 72 hours
- Hot-swap
- < 5 sec
- Cycle life
- 500+ cycles
- Compliance
- IEC 60601-1
The Challenge
Hospital procurement required demonstrable uptime improvements and documented safety evidence. Legacy packs failed mid-shift and lacked cycle-count traceability for compliance audits.
- 72-hour target on mixed alarm + Wi-Fi telemetry load
- Hot-swap without rebooting the monitor
- Full lot traceability for FDA-style audits
Our Approach
EPT specified a 9.6V Ni-MH configuration for stable duty cycles and safer handling in clinical environments. An embedded fuel gauge and EEPROM log captured cycle count, temperature peaks, and swap events.
Manufacturing ran under ISO 13485 controls with batch records linked to cell serials and PCM firmware revisions.
- Low-self-discharge Ni-MH chemistry for shelf-ready spares
- Custom dock connector rated for 10K mate cycles
- Complete DHF documentation package for the client QA team
Results
Ward nurses reported fewer mid-shift swaps, and biomedical engineering signed off after successful audit sampling. The pack became the standard power module across three monitor models.
- 72h median runtime in ward telemetry profile
- Audit-ready traceability on 100% of shipped packs
- Adopted as platform battery for the client's monitor family
FAQ
Frequently asked questions
- Does EPT support medical device battery documentation?
- We provide lot traceability, test reports, and manufacturing records aligned with ISO 13485 workflows to support your DHF and supplier audits.
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