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Start with the change notice, not the old protocol

Open a change record when a manufacturer issues a revised IFU, a device or accessory is replaced, software is changed through the authorized support route, or observed behavior no longer matches the approved instructions. Name an owner and identify the equipment and functions affected. An unexplained difference should trigger clarification, not an improvised workaround.

Before rewriting instructions, collect the manufacturer’s notice, the applicable IFU revision and written confirmation of the supported configuration. Record the device identity, hardware revision if available, installed software or firmware version where documented, and accessory identifiers. Ask how the manufacturer confirms the current version; do not enter service menus or modify the device to discover it.

Separate confirmed changes, confirmed unchanged items and unknowns. A statement that an update is “minor” does not explain whether an operator’s task changes. Ask about controls, displayed units, warnings, supported accessories and any required checks. Do not assume an unknown update increases power, changes frequency or leaves output unchanged.

In its healthcare guidance, the UK Medicines and Healthcare products Regulatory Agency (MHRA) calls for tracking revised manufacturer instructions, distributing updates to relevant users and considering training changes. Those principles are useful here as indirect management guidance; they are not a salon-specific law or proof of a device’s classification. [1]

Use an impact matrix to decide what must change

This proposed matrix turns a notice into reviewable decisions. For each row, record the source, reviewer, action and status. “No change” needs a reason; “unknown” stays open. Do not fill gaps with settings from a similar machine.

On a narrow screen, scroll the table within its own frame.

Keep technology boundaries visible in the assessment. Low-frequency nonfocused cavitation, focused mechanical ultrasound, thermal high-intensity focused ultrasound (HIFU), equipment described only as 1 MHz, and radiofrequency (RF) are not interchangeable operating categories. A frequency label alone cannot fill the configuration record. Review each relevant attachment against its own matched documentation.

A supplier’s resource library groups manuals by series and model. That illustrates why a broad machine label is a poor document identifier; it establishes neither current-version compatibility nor clinical effectiveness. [2]

A worked example: a revised function-selection screen

Hypothetical training example: a manufacturer confirms that a supported software revision changes where an existing function is selected and supplies a matching revised IFU. This is an invented document-control scenario, not a reported update to any named device or a claim about output.

1. Capture the baseline. The owner links the currently approved SOP and IFU to the equipment file, saves the new notice and records which unit will be affected. The proposed SOP remains a draft.
2. Resolve the scope. The owner requests written confirmation of the supported software/hardware/accessory combination and whether any operating limits, units, warnings or output-related instructions change. Silence on those questions is recorded as unresolved.
3. Assess the tasks. The matrix identifies function selection, the quick-reference image and staff demonstration as affected. Screening, cleaning and record fields are marked unchanged only where the review has a documented basis.
4. Revise the affected material. The revised appendix explains the changed selection task using the matched IFU. Each screenshot carries its configuration and instruction reference. Obsolete images are removed from active training packs.
5. Confirm readiness. The authorized support route provides the applicable completion/check record. Affected users demonstrate the changed task in a manufacturer-permitted training context. This article supplies no device test procedure.
6. Release and follow up. The approver records the equipment scope, completed prerequisites and effective time. The owner replaces active copies, retains the superseded set and checks that subsequent records reference the released version.

If the screen does not match the revised IFU, stop the handover and seek clarification. A successful software installation is a technical event; SOP release is a separate management decision. Neither is a clinical performance study.

Keep the old records tied to the version actually used

Do not overwrite historical session records with the new software version or relabel earlier appointments as if the new SOP had always applied. Preserve the original record. If a correction is necessary, use a dated, attributable amendment that retains the original information and explains the reason.

For each SOP revision, retain its identifier, approval date, effective start and end, equipment/configuration scope and superseding revision. Record the effective time when a change occurs during a working day. The software change time and SOP effective time are separate fields; any interval between them needs a clear hold or restriction record.

Example timeline: an earlier appointment references the previous SOP and documented configuration. The affected function is then held for the change and readiness review. Later appointments reference the released revision after its effective time. Archiving the previous SOP preserves that sequence; it does not authorize continued use of an obsolete procedure.

Keep the associated IFU, notice, impact matrix, training evidence and approval together or linked through a stable record identifier. Store historical copies away from the active instruction set and label them “superseded—historical reference.” Set retention and access rules for the applicable jurisdiction, insurer and privacy obligations; there is no universal retention period supplied here.

Confirm skills for the affected users, not just attendance

Identify people by task: operators, trainers, relief staff, cleaners or maintenance personnel as relevant. Someone who missed the update remains outside the new task authorization until the required confirmation is complete. Record individual coverage rather than assuming one team briefing reached everyone.

MHRA’s guidance addresses training updates for device/software upgrades and recording training and understanding. It is used as a limited supporting principle, not as a qualification scheme for salon operators. [1]

A proposed local skills confirmation should record the user, assessor, date, configuration, SOP revision, tasks assessed, observed result and any restriction or reassessment needed. Ask the user to locate the current IFU, explain the changed task, identify a mismatch and describe the stop/escalation route. Where a demonstration is appropriate, use only a manufacturer-permitted training method; do not use a client as an experiment or invent a dry-run method.

A signature records acknowledgment. An observed task or explanation records what was assessed. Keep those outcomes distinct. Neither a completed training form nor an internal release signature grants a professional license or establishes that every client is suitable.

Release only when the prerequisites are documented

Use a release decision that names the responsible approver and specifies exactly what is permitted. The following is a proposed management checklist, not a technical acceptance-test standard:

• ✓ Applicable notice, current IFU and supported configuration confirmed.
• ✓ Impact matrix completed; safety-critical unknowns resolved or affected functions held.
• ✓ Required manufacturer-specified checks completed through the appropriate support route, with evidence retained.
• ✓ Revised appendix, forms and training materials agree with the matched instructions.
• ✓ Affected users’ required training and skills confirmations recorded.
• ✓ Effective date/time, equipment scope and any restrictions approved.
• ✓ Active copies replaced; superseded versions and original records preserved.
• ✓ Follow-up owner and response to discrepancies assigned.

After release, sample subsequent records for the correct configuration and SOP reference, and ask staff about mismatches. If a discrepancy emerges, reopen the change record and reassess the affected activity. Do not solve a documentation conflict by increasing settings or informally reverting software.

Common mistakes that break the handover

• Renaming the file “latest” without a revision or effective period.
• Assuming unchanged model branding means unchanged instructions.
• Copying an old preset or screenshot without confirming its applicability.
• Training only permanent staff while relief staff keep the old card.
• Backdating approval or rewriting earlier session records.
• Treating an update as proof of better results, greater safety or regulatory authorization.

The handover is complete when it is traceable

An SOP update should make it possible to answer three questions: which instructions applied to this unit, which users were ready to follow them, and when the new procedure took effect. Keep that chain intact so an old protocol never silently becomes a new-device instruction.