HIFU Service, Warranty and Parts: What to Demand in Writing

The invoice you never see

Picture a Thursday in December. Your best operator has six clients booked, the handpiece throws a fault code at nine, and by half past ten you're refunding deposits. Nobody bills you for that day. You pay it anyway.

That's the invoice buyers never model. Console price is one visible number. Downtime is invisible, it repeats, and clauses you skimmed decide how much of it you get.

Argue about the machine for an hour. Argue about the service annex for a day.

Read the warranty backwards, starting from what voids it

Every supplier tells you the warranty is one year. Fine. The text that decides your December sits two pages later, under a heading nobody reads aloud.

The after-sales chapters in our own device manuals are ordinary for this industry, so use them as a template. Cover runs one year from the purchase date, for failure traced to materials or process defects under correct use and maintenance. Mail and freight costs are excluded in plain words. Certain accessories sit outside free service. Parts replaced during a repair carry a further three months of cover, and paid maintenance continues for the machine's life after that.

Then the exclusions. Damage from improper installation, use or custody: severe impact, vibration, drops. Repair by anyone the manufacturer didn't authorise, or a console the owner opened himself. Missing, incomplete or altered proof of purchase. Fire, earthquake, the usual acts of God. Handles, power cords and foot switches damaged through mishandling are charged at spare-parts cost, warranty year or not.

None of that is unfair. It's still a list of ways to lose cover, and three describe accidents a busy room has.

One clause deserves a blunt question: who may touch this machine? The US FDA separates servicing, defined as repair or preventive and routine maintenance returning a device to the safety and performance specifications its original manufacturer set, from remanufacturing, which changes them. Ask in writing whether a local engineer working on the servicing side of that line voids anything.

Parts lead time is a per-class question, not one number

"We ship spares fast" tells you nothing. Lead time is four numbers, because parts fail differently and hurt differently.

Break it down by class and make the supplier fill every blank. Test it against a real machine: the HF-01 4D HIFU platform carries two handles across seven focus depths from 1.5 to 16mm, so "the handpiece" is already two objects, and losing one doesn't close the room.

Part class	What stops when it fails	The clause to insist on
Cartridges and transducers	One depth, so part of your menu	Dispatch window in business days, stated per depth you sell
Handpiece or handle assembly	Every treatment on that handle	Dispatch window plus a named alternative: repair, exchange unit or standby handle
Power supply, driver board, generator	The whole console, and the diary with it	Dispatch window, plus whether the board is field-swappable or return-to-factory
Screen, foot switch, cabling, trolley	Usually nothing, if one sits in your cupboard	Cheap enough to stock on day one. Ask for the list

Two follow-ups turn that table into an obligation. What starts the clock: your email, their diagnosis, or your payment? And what happens if they miss it?

Freight runs in two directions and somebody pays each leg

Your Incoterm covers the machine's journey to you. It says nothing about a handpiece flying back to a factory in month seven, which is when arguments start.

Carry the ICC's guidance with you. Under EXW the seller only makes the goods available at its premises and the buyer picks up cost and risk from there, export formalities included, which is why the ICC points buyers to FCA instead. Under DAP and DDP the seller arranges and pays carriage to the named destination; the split is import clearance and duties, buyer's job under DAP, seller's under DDP.

Warranty freight is a separate negotiation. Four legs.

• The replacement part out to you. Who books it, who pays, at what service level.
• The faulty part back, when the factory wants it for analysis.
• The repaired unit out to you a second time.
• Duty and import tax on a warranty replacement, nobody's favourite surprise.

Our manuals exclude mail costs from free service. So do most. That's normal, and negotiable, and far easier settled before the deposit clears than after the fault.

Remote diagnosis before anything gets on a plane

Plenty of faults aren't faults. A mains configuration nobody checked, poor coupling, an operator past an interlock, a cartridge the console locked out because its line count is spent. Shipping a handpiece across a continent to learn that is an expensive way to read an error code.

Put a diagnostic step ahead of the RMA, with a clock on it. Our own service and support terms are the shape to hold a supplier to: a 30-minute first response to technical questions, remote diagnostics, factory spare parts, one-year warranty, lifetime maintenance after. Response time and repair time are different promises. Get both, in numbers.

Ask who picks up, too. An engineer or an account manager? Which channel, and is the thread logged?

A machine fault and a clinical event are not the same ticket. Prolonged swelling, blistering or post-inflammatory hyperpigmentation, which the clinical skin atlas in our engineering archive lists among the complications of energy-based facial treatment and flags for stricter caution above Fitzpatrick type III, goes to a clinician and into your adverse-event log, not to the spares desk.

Loaner, standby, or a shelf you stocked yourself

Loaner clauses are common domestically and rare across borders: a loaner console clears customs twice and somebody insures it in the middle. Ask anyway. If the answer is no, negotiate the substitute instead of dropping it.

Three substitutes work. Buy a spare handpiece at a discount with the machine, a loaner you own outright. Write an advance-replacement clause, where the good part ships before the faulty one comes back, secured by a deposit. Or cap repair turnaround with a remedy attached: a credit, a warranty extension, free cartridges. The remedy is what separates a commitment from a sentiment.

Cartridge supply, and the promise nobody can enforce

Cartridge supply outlives every other clause, because you keep buying for as long as the room earns. We've worked the arithmetic elsewhere in our buyer guides. Here it's contractual.

Pin down four things. Which depths the supplier commits to keep available. For how many years. On what pricing mechanism. And whether third-party cartridges are permitted.

That last one has a regulatory edge in Europe. Article 23 of the EU medical device regulation lets any person supply an item replacing a defective or worn part to maintain or restore the device's function, provided it doesn't change performance, safety characteristics or intended purpose and doesn't adversely affect the device; an item that significantly changes those characteristics counts as a device in its own right. What your supplier's warranty says about non-original consumables is a different matter. Put both in one paragraph and let the tension show.

"We'll look after you" is not a pricing mechanism. A price list valid for a stated period is. So is a cap on annual increase, or a volume tier you can actually reach.

Year three, and the annex you staple to the order

Models get superseded. Yours will. The question is whether your machine turns orphan the week its replacement launches.

Ask for an end-of-life clause in three parts: written notice before the platform is discontinued, a last-time-buy window for cartridges and critical spares, and a stated number of years of parts support after the final unit ships. Suppliers who expect to be trading in year three answer without flinching.

Why insist on paper when everyone has been so friendly? Because the law makes friendliness hard to use. Under the UN convention on contracts for the international sale of goods, a sales contract needs no writing and may be proved by any means including witnesses, which sounds generous until you try to prove a phone call from eighteen months ago. The same convention sets an outer limit: notify the seller of a lack of conformity within a reasonable time of discovery, and in any event within two years of handover, unless a contractual guarantee period says otherwise. Two years is shorter than your machine's working life. The guarantee period is the part you write.

Write it down. Ten lines, attached to any purchase order, returned signed.

1. Warranty term, the event that starts it (shipment, arrival or commissioning), and the evidence you keep.
2. The exclusions list in full, quoted rather than summarised.
3. Whether third-party servicing or non-original consumables affect cover.
4. Parts dispatch commitment by class, naming the event that starts the clock.
5. Freight responsibility for all four warranty legs, plus duty and tax.
6. Remote diagnosis step, first-response time, support channel and language.
7. Loaner, advance replacement or turnaround cap, with the remedy if it slips.
8. Cartridge availability by depth, the term of that commitment, the pricing mechanism.
9. End-of-life notice, last-time-buy window, years of parts support after production ends.
10. The legal entity that owes all of it, matched to the name on your invoice.

Send it with your request for quotation, not after the deposit. How a supplier handles a one-page annex tells you more about the next five years than any brochure.

Evidence and further reading

Educational material for equipment buyers and operators. It is not medical advice, an operating protocol or a promise of clinical outcome.

• US FDA, Remanufacturing and Servicing of Medical Devices (final guidance, May 2024): servicing is the repair and/or preventive or routine maintenance of parts in a finished device after distribution, to return it to the safety and performance specifications established by the original equipment manufacturer
• ICC Academy, Incoterms 2020: DAP or DDP? Under both rules the seller arranges and pays carriage to the agreed destination; under DAP the buyer carries out and pays for import clearance, under DDP the seller does
• ICC Academy, Incoterms 2020: EXW or DDP? Under EXW the seller only makes the goods available at its premises and the buyer bears onward cost and risk including export formalities, with FCA recommended instead where the buyer cannot complete export clearance
• Regulation (EU) 2017/745 on medical devices, Article 23 (Parts and components): a replacement item that maintains or restores function without changing performance, safety characteristics or intended purpose must not adversely affect the device, while an item that significantly changes them is itself a device
• UNCITRAL, United Nations Convention on Contracts for the International Sale of Goods (Vienna, 1980): Article 11, a contract of sale need not be in writing and may be proved by any means including witnesses; Article 39, notice of lack of conformity within a reasonable time and in any case within two years of handover unless inconsistent with a contractual guarantee period