Engineered for sterilizer uptime. Documented under ISO 13485 & IEC 60601-1 where applicable.
Service planning
Dental practices, ambulatory clinics, specialty rooms, distributors, home-health agencies, and skilled nursing teams do not run sterilizers the same way. Tuttnauer uses a guided intake to understand installed base, staff coverage, clinical hours, CMMS expectations, and regulatory documentation before recommending a plan under ISO 13485 service records.
Facility-matched plans
Multi-chamber coverage, 24/7 hotline options, on-site FSE targets when contracted, and UDI-driven recall sweeps. Your biomed team keeps Tier 1 ownership while Tuttnauer supports Tier 2–3 diagnostics, gasket/filter staging, and audit packets.
Pre-shift PM windows, AAMI ST91-aligned reprocessing checks, weekend response planning, and tray/pouch continuity so instrument release does not stall first-case starts.
Operator refreshers, spore-test cadence, chamber cleaner routines, and multi-site model standardization so assistants and administrators share one working language.
Annual calibration review, IFU refresh, billable accessory lists, and practical escalation for teams without a full biomed department.
Infection-control consumable replenishment, caregiver teach-back materials, and remote troubleshooting paths for distributed teams.
Bulk consumable cadence, infection-control bundle documentation, and shift-friendly cleaning intervals that survive staff turnover.
We augment. Field service engineers co-own Tier 2–3 escalations; your in-house team retains Tier 1 checks, local SOPs, and CMMS ownership. MTBF expectations and spare criticality are written into the plan so both sides know when a loaner is justified.
UDI-driven recall sweeps target a 24–48 hour review window after FDA Class I/II notice when records are complete. We help compare affected lots, document actions for quality/risk, and coordinate replacements without treating website summaries as the official MedWatch record.
Yes. Work orders, PM evidence, and escalation summaries can be formatted for common CMMS workflows via REST API or HL7 FHIR attachments where your IT allows. PHI is never the payload of a sterilizer service ticket.
A business associate agreement is executed before any remote session that may encounter PHI. Session scope is role-based and time-bounded; PHI is not logged or stored on Tuttnauer service servers. Most tabletop autoclave support remains on-site or phone-guided without PHI exposure.
Share device families, care setting, installed base size, CMMS platform, and urgent constraints. A Tuttnauer advisor will recommend support, training, and documentation next steps.