Why HBOT Scheduling Decides Whether a Chamber Earns Its Keep
A hyperbaric chamber is a fixed-cost asset whose output is counted in completed sessions, and completed sessions are a product of the schedule. Buyers spend weeks comparing pressure ratings, shell construction, oxygen delivery and certification, then discover in month two that the real constraint was never the machine — it was how many people could be moved through it safely on a Tuesday afternoon. Scheduling is where capital expenditure turns into cash flow, and it is also where most new programmes quietly lose money.
This guide is written for clinic owners, wellness-centre operators and distributors who advise them. It maps what actually happens inside a session slot, shows how to convert that map into a realistic daily capacity figure, and then covers the four levers that move the number: session templates, changeover, booking policy and space productivity. Everything here is operational method, not clinical advice, and nothing in it should be read as a claim of FDA clearance — HyperbaricO2Care chambers are CE-marked and manufactured under an ISO 13485 quality system.
The good news is that scheduling is the cheapest thing to fix. Pressure range, shell material and certification are settled at purchase; the schedule can be re-cut every quarter at no cost. Operators who treat the schedule as a designed artefact rather than a diary habit consistently get more out of the same room, the same chamber and the same staff.
That design work starts earlier than most buyers expect. Compression and decompression time, single-place versus multi-place configuration, oxygen delivery method and service access are all fixed at specification stage, and each one constrains what the schedule can later achieve. A distributor advising a buyer can add real value simply by raising these questions before the order, because a template that fights the equipment will lose minutes every day for the life of the asset.
The rest of this article walks the problem in order: what actually occupies a session slot, how to turn that into a capacity number, how to build a template around it, where changeover and booking policy quietly remove sessions, and how to measure the result against a baseline rather than a feeling.
Inside a Session: The HBOT Time-in-Chamber Map
Most scheduling errors start with an oversimplified idea of what a session is. A “60-minute session” is rarely 60 minutes of chamber occupancy, and the gap between the two is the source of almost every capacity surprise. Break the appointment into phases and the arithmetic becomes honest.
| Phase | What happens | What drives the duration | Where it usually slips |
|---|---|---|---|
| Arrival and check-in | Identity, consent, payment, belongings | Front-desk staffing, paperwork design | Late arrivals, missing consent |
| Screening and clearance | Health review, contraindication check, ear-equalisation briefing | Who is authorised to clear, how thorough the review is | Screening done inside the slot instead of before it |
| Change and preparation | Clothing, remove prohibited items, fit mask or hood | Client familiarity, changing space layout | First-time clients, no written prep instructions |
| Compression | Cabin pressurises to treatment pressure | Target pressure, compressor capacity, leak integrity | Compression time not budgeted at all |
| Treatment plateau | Client remains at pressure breathing oxygen | Protocol, client tolerance, monitoring cadence | Extensions requested by the client |
| Decompression | Controlled return to ambient pressure | Rate limits, client comfort, ear equalisation | Slowest phase to be cut, and should not be |
| Exit and observation | Disembark, brief check, re-entry to normal activity | Monitoring policy, lobby capacity | No defined discharge moment |
| Changeover | Cleaning, linen, oxygen consumables, log closing | Cleaning standard, staff allocation, supply layout | Fitting changeover into “gap” rather than scheduling it |
Two of these phases are fixed by the equipment, and HyperbaricO2Care publishes both: compression to treatment pressure takes between 5 and 25 minutes depending on the model and the target pressure, and the cabin is designed for a controlled decompression at the end of the session. Everything else on the list is set by the operator. That is the useful split — equipment time is a specification question, operator time is a design question.
| Item | Site-confirmed figure | Scheduling consequence |
|---|---|---|
| Treatment pressure range | 1.1–1.7 atm (POLARIS Duo 1.75 atm) | Higher target pressure generally means longer compression planning |
| Compression time | 5–25 minutes | Must be budgeted inside the slot, never assumed free |
| Oxygen delivery | Air-pressurised cabin with mask or hood; AURA One ≥80% oxygen, other models ≥90% | Mask and hood fitting belongs in the prep phase, not the plateau |
| Pressure relief | Triple system: mechanical + electromagnetic + manual | Safety checks are part of changeover, not optional extras |
| Emergency communication | 4G emergency call | Confirm coverage at site before the first booked day |
| Certifications | CE marked, ISO 13485 | Documentation supports payer and insurer conversations |
Screening deserves particular attention because it is the phase most often smuggled into the chamber slot. A client who arrives with an incompletely reviewed health history absorbs operator time that was priced as treatment time. The screening workflow — who reviews, what triggers escalation to a clinician, what is recorded — is covered in our HBOT client screening and contraindications guide; the scheduling point is only that clearance must happen before the slot opens, not during it.
Capacity Maths: From Theoretical Slots to Achieved Sessions
Capacity has three distinct values and confusing them is the most common planning error. Theoretical capacity is what the opening hours allow. Planned capacity is what the template intentionally books. Achieved capacity is what actually happened, including no-shows, late starts, extended plateaus and maintenance downtime. Only the third number pays the bills.
| Capacity measure | Definition | Typical use | Common distortion |
|---|---|---|---|
| Theoretical | Opening hours divided by minimum slot length | Upper bound, marketing material | Ignores changeover entirely |
| Planned | Slots deliberately published in the template | Rostering and staffing | Built on optimistic changeover assumptions |
| Achieved | Sessions actually completed and logged | Revenue and utilisation tracking | Inflated if cancelled sessions are not logged |
| Billable achieved | Achieved sessions that were invoiced | Cash planning | Shrinks further under package discounts |
The calculation itself is simple, but only if each input is measured rather than assumed. Work through it in order: define opening hours, subtract a maintenance and deep-clean window, subtract changeover after every session, subtract a buffer for late arrivals, then divide. The buffer is the input operators omit, and it is the one that separates a schedule that survives contact with real clients from one that unwinds by 14:00.
| Step | Input needed | Output | Why teams get it wrong |
|---|---|---|---|
| 1. Available hours | Opening and closing time, staffed days | Gross chamber-hours per week | Counts hours with no staff |
| 2. Reserved hours | Preventive maintenance, deep clean, calibration | Net chamber-hours | Maintenance treated as reactive only |
| 3. Slot build-up | Compression + plateau + decompression + prep | Standard slot length | Compression omitted from the slot |
| 4. Changeover | Cleaning + linen + consumables + log closing | Turnaround minutes | Assumed to fit in “leftover” time |
| 5. Buffer | Late arrivals, extensions, resets | Effective slot pitch | Added once instead of per slot |
| 6. Attendance factor | Historical no-show and cancellation rate | Realistic booked-to-completed ratio | No history kept, so guessed |
Below is the shape of the calculation. The structural relationships are reliable; the numeric inputs are site-specific and marked for confirmation rather than invented.
| Line | Item | Value | Status |
|---|---|---|---|
| A | Staffed chamber-hours per day | [TO CONFIRM] | Operator input |
| B | Reserved for maintenance and deep clean | [TO CONFIRM] | Operator input |
| C | Net available chamber-hours (A − B) | Calculated | Formula |
| D | Standard slot length (build-up + turnaround) | [TO CONFIRM] | Operator input |
| E | Buffer per slot | [TO CONFIRM] | Operator input |
| F | Effective slot pitch (D + E) | Calculated | Formula |
| G | Theoretical slots per day (C ÷ F) | Calculated | Formula |
| H | Attendance factor | [TO CONFIRM] | Operator input |
| I | Expected completed sessions per day (G × H) | Calculated | Formula |
| J | Sessions actually completed, last 4 weeks | [TO CONFIRM] | Operator input |
| K | Variance (J − I) | Calculated | Formula |
Two notes on interpreting the result. First, if achieved sessions exceed the calculated figure consistently, the slot build-up is wrong — compression or changeover is taking less time than planned, which usually means something is being skipped. Second, if achieved sessions sit well below it, look at buffer and attendance before blaming demand; a schedule that is chronically behind is a design fault, not a marketing problem.
Session Templates: Slot Length, Cadence and Time Blocks
A session template is the repeating pattern of slots the operator publishes. It is the main instrument for trading throughput against experience. Shorter slots raise theoretical capacity but increase the proportion of each hour spent on compression, decompression and changeover rather than on the plateau — the part the client actually values.
| Template | Slot pitch | Sessions per chamber per day | Best suited to | Main risk |
|---|---|---|---|---|
| Long-form | Long plateau, generous buffer | [TO CONFIRM] | Clinical protocols, first-time clients | Low daily volume |
| Standard | Balanced plateau and changeover | [TO CONFIRM] | Mixed clinic and wellness use | None dominant |
| Short-form | Shorter plateau, tight pitch | [TO CONFIRM] | Experienced repeat clients, wellness maintenance | Experience feels rushed |
| Blocked multi-place | One compression, several clients | [TO CONFIRM] | High-volume centres with POLARIS Duo | One late client delays the block |
Cadence is the second decision: how sessions sit within the day. Grouping sessions into blocks reduces the number of compression and decompression cycles staff supervise and creates predictable staffing, but it makes the day brittle — a single delay propagates through the whole block. Continuous staggered scheduling is more resilient and more staff-intensive.
| Block pattern | Structure | Strength | Weakness | Fits |
|---|---|---|---|---|
| Two-block day | Morning and afternoon clusters | Efficient staffing, clear deep-clean window | Inflexible for late bookers | Clinics with referral flow |
| Three-block day | Morning, midday, evening | Catches after-work demand | More staffed hours | Urban wellness centres |
| Continuous staggered | Even spacing across opening hours | Absorbs delays well | Higher supervision cost | Mixed demand, small teams |
| Maintenance-morning | Light morning, full afternoon | Protects preventive maintenance | Wastes prime morning demand | Single-chamber sites |
Multi-place configurations change the arithmetic fundamentally. A chamber such as the POLARIS Duo, built for high-throughput commercial use, compresses several clients together, so the schedule becomes a block schedule with a shared start time; the constraint moves from slot pitch to attendance punctuality. Single-place units such as the AURA One, the NEPTUNE Flow, the LUMINA One and the TITAN Duo are scheduled individually, so the constraint is changeover discipline. Matching the template to the configuration — not the other way round — is what keeps the plan realistic.
One refinement pays for itself quickly: separate the first-session slot from the repeat-session slot. A first-time client needs longer for screening, briefing, mask or hood fitting and reassurance, and that time cannot be recovered later in the day. Publishing a longer slot for first visits and a shorter one for established clients keeps the daily average honest without slowing the whole template to the pace of its slowest client.
| Slot variant | Who it serves | Extra time needed | Where the time goes |
|---|---|---|---|
| First-session slot | New clients, post-absence returns | [TO CONFIRM] | Screening, briefing, mask or hood fitting |
| Standard slot | Established clients on a course | Baseline | Normal prep and changeover |
| Observation slot | Clients needing longer post-session observation | [TO CONFIRM] | Supervised recovery area |
| Assisted slot | Clients needing physical assistance | [TO CONFIRM] | Transfers and additional staffing |
Turnaround and Changeover: Where Chamber Schedules Lose Minutes
Changeover is the least glamorous and most consequential part of the schedule. It is also the phase most likely to be squeezed, because it happens between the moments clients see. Treat it as a scheduled slot component with an owner, a standard and a measured duration.
| Turnover task | Owner | Target duration | Notes |
|---|---|---|---|
| Client exit and brief observation | Chamber operator | [TO CONFIRM] | Must not be rushed |
| Cabin interior wipe-down | Chamber operator | [TO CONFIRM] | Follow the site cleaning standard |
| Linen and contact-surface change | Attendant | [TO CONFIRM] | Linen stock must be pre-positioned |
| Mask or hood consumables | Chamber operator | [TO CONFIRM] | Single-use vs reusable policy must be defined |
| Oxygen and compressor check | Technician | [TO CONFIRM] | Includes pressure-relief function check |
| Session log closing | Chamber operator | [TO CONFIRM] | Closes the record before next client enters |
| Next-client preparation note | Front desk | [TO CONFIRM] | Flags first-time clients needing extra prep |
The cleaning standard itself is set out in our HBOT chamber cleaning and infection control guide. The scheduling relevance is direct: a standard that is written, audited and supplied will hold its turnaround time, whereas a standard that depends on whoever is on shift will drift, and the drift is paid for in lost slots.
| Failure mode | Typical cause | Fix | Metric to watch |
|---|---|---|---|
| Changeover drifts later through the day | No scheduled recovery window | Insert a short reset block mid-morning and mid-afternoon | Average turnaround by hour of day |
| Cleaning restarts from zero each time | Supplies not pre-positioned | Pre-stage linen and consumables in the chamber room | Items moved per session |
| Log closing delays the next entry | Logging done after the next client arrives | Make log closing part of changeover, before entry | Records closed before next entry |
| Maintenance found during changeover | No separate maintenance window | Reserve non-bookable maintenance hours | Unplanned maintenance events |
| One late client cascades | Slots touch with no buffer | Build buffer into every slot pitch | Sessions starting within target of schedule |
Measuring turnaround is the precondition for improving it. A two-week log of actual changeover minutes — start of exit to readiness for the next entry — will usually show a distribution wider than anyone expects, and the upper tail, not the median, is what determines whether the published template holds.
Booking Rules, No-Shows and Late Arrivals
Throughput is destroyed at the front desk as often as in the chamber room. A schedule with no booking policy will be filled by whoever asks most persuasively, and the resulting pattern is optimised for neither revenue nor safety. Written rules, applied consistently, protect the plan.
| Rule | Suggested default | Rationale | Exception path |
|---|---|---|---|
| Booking lead time | [TO CONFIRM] | Allows screening to complete before the slot | Clinical urgency reviewed by the responsible clinician |
| Cancellation window | [TO CONFIRM] | Gives a real chance to refill | Documented extenuating circumstances |
| Late-arrival cut-off | [TO CONFIRM] | Protects the following slot | Manager approval when the next slot is free |
| No-show handling | [TO CONFIRM] | Recovers some lost capacity | First occurrence, documented reason |
| Deposit or prepayment | [TO CONFIRM] | Aligns commitment with reserved capacity | Waived for clinical bookings if policy allows |
| Standby list | Maintained daily | Converts cancellations into completed sessions | None needed |
Late arrivals deserve a defined cut-off rather than a judgement call. Because compression and decompression cannot be shortened to accommodate a late start, admitting a late client without an available buffer means either truncating the plateau or pushing every subsequent slot. Neither is acceptable, so the rule has to be written before the situation arises.
| Situation | Immediate action | Follow-up | Record to keep |
|---|---|---|---|
| Client arrives before cut-off | Proceed, note shortened prep | Rebook if plateau would be materially cut | Late-arrival log entry |
| Client arrives after cut-off | Offer next available slot | Apply policy consistently | Incident or exception note |
| Same-day cancellation | Activate standby list | Review cancellation reasons monthly | Cancellation reason code |
| No-show | Apply policy, free the slot | Contact client, decide on rebooking | No-show record |
| Repeat no-show | Escalate to manager | Consider prepayment requirement | Decision note |
| Clinical urgency overrides | Manager and clinician decide together | Document the deviation and why | Deviation record |
Consistency matters as much as the content of the rules. An exception made once without a record becomes the expected precedent the next time, and within a quarter the published schedule no longer describes reality.
A standby list is the cheapest recovery tool available and the one most often omitted. Cancellations inside the window are unpredictable, but they are rarely zero, and a list of clients willing to come in at short notice converts dead capacity into completed sessions. Keeping it alongside the deposit policy also changes behaviour: clients who have committed something to a slot are measurably more likely to honour it or cancel early enough to be refilled.
Neither tool should be used to squeeze the schedule beyond what the equipment supports. Compression and decompression cannot be shortened to create a slot, and a template that only works when everything goes perfectly will fail on a normal day. Build the rules to protect the plan, then let the plan run slightly below theoretical capacity.
Matching Session Cadence to Client Type and Programme Design
Different client groups want different cadences, and a schedule that serves all of them with one template will serve none well. Segment the demand first, then design slots around it.
| Client type | Typical cadence | Slot implication | Scheduling note |
|---|---|---|---|
| Clinical or referred | Prescribed series on a defined schedule | Longer slots, higher supervision | Protect recurring slots in the template |
| Wellness maintenance | Weekly or fortnightly | Standard slots, medium plateau | Ideal filler for off-peak hours |
| Athletes and performance | Intensive blocks around training or events | Short pitch, high frequency | Needs evening and early-morning availability |
| Spa and beauty clients | Course-based with adjunct treatments | Paired with other services | Coordinate the chamber with treatment rooms |
| First-time clients | Single introductory session | Extra prep time built in | Never back-to-back with a tight slot |
| Home users | Self-managed after training | Outside the commercial schedule | Handover and training session required |
Programme design and scheduling are the same decision seen from two sides. A course of sessions sold as a package commits capacity weeks ahead, which improves planning certainty but reduces flexibility to respond to higher-value demand. Single-session booking is the reverse.
| Programme form | Capacity commitment | Revenue predictability | Flexibility | Scheduling risk |
|---|---|---|---|---|
| Single sessions | Low | Low | High | Empty slots |
| Short course | Medium | Medium | Medium | Course abandonment leaves gaps |
| Long course or membership | High | High | Low | Over-commitment at peak times |
| Block booking by a third party | High and concentrated | High | Low | Displaces retail demand |
| Standby or off-peak rate | Very low | Low | High | Only fills otherwise idle slots |
Multi-site operators face an additional layer, because a template that works in one location may not transfer to another with different demand shape and staffing. The standardisation approach for that case — same template structure, local slot parameters — is covered in our multi-site fleet scaling playbook.
Space Productivity: Revenue per Chamber-Hour and per Square Metre
Throughput is only half the productivity question; the other half is what the throughput costs in space and capital. A chamber that runs at high utilisation in an oversized room is less productive than the same chamber in a right-sized one, and the difference shows up in rent, fit-out and staffing rather than in the chamber’s own cost line.
| Metric | Definition | Why it matters | Target setting |
|---|---|---|---|
| Chamber-hour utilisation | Booked chamber-hours ÷ staffed chamber-hours | Shows whether hours or slots are the constraint | Set per site, [TO CONFIRM] |
| Completed sessions per chamber-hour | Sessions completed ÷ chamber-hours | Rewards short effective slot pitch | Track weekly |
| Revenue per chamber-hour | Revenue ÷ staffed chamber-hours | Ties schedule to cash, not occupancy | Track monthly |
| Revenue per square metre | Revenue ÷ total treatment-area floor area | Exposes oversized rooms and dead space | Track quarterly |
| Sessions per labour hour | Sessions completed ÷ operator hours worked | Shows whether staffing or schedule limits output | Track monthly |
The site-side input to this calculation is the room itself. Floor area, access route, clearance for service and the space taken by support equipment are settled long before the first booking, which is why the room budget belongs in the site preparation and pre-delivery checklist rather than being discovered at fit-out.
| Space category | What it contains | Sizing input | Scheduling consequence |
|---|---|---|---|
| Chamber footprint | The unit and its service clearance | [TO CONFIRM] per model | Determines single vs multi-unit rooms |
| Client prep and changing | Changing, belongings, mask fitting | [TO CONFIRM] | Too small and prep spills into the slot |
| Waiting and recovery | Arrival, post-session observation | [TO CONFIRM] | No waiting space forces clients out early or in late |
| Consumables and linen | Stock positioned near the chamber | [TO CONFIRM] | Distance adds minutes to every changeover |
| Plant and support | Compressors, oxygen supply, ventilation | [TO CONFIRM] | Access conflicts create maintenance downtime |
| Staff circulation | Operator movement during sessions | [TO CONFIRM] | Poor circulation slows supervision response |
The cost side of the same picture — what an idle chamber-hour actually costs once power, oxygen supply, labour, maintenance and capital are included — is modelled in our total cost of ownership and maintenance article. Read together, the two views tell an operator whether to chase more sessions, a smaller room, or a lower cost base.
| Lever | Impact on productivity | Effort to change | Typical sequence |
|---|---|---|---|
| Buffer and slot pitch correction | High | Low | First |
| Changeover standard and supply layout | High | Low to medium | First |
| Booking policy and standby list | Medium to high | Low | First |
| Off-peak pricing to fill idle hours | Medium | Low | Second |
| Room re-layout for prep and linen | Medium | Medium | Second |
| Additional chamber unit | High | High | Last, after utilisation is proven |
The sequence matters. Adding a second chamber to a schedule that has not been corrected simply multiplies the inefficiency across two assets and two rooms.
There is also a ceiling that should be respected. Utilisation pushed towards its theoretical maximum leaves no room for the maintenance window, no slack for a client who needs longer, and no margin for the day when something goes wrong. A schedule that runs permanently hot tends to defer maintenance, and deferred maintenance converts a small planned cost into a large unplanned stoppage. Most operators find a deliberate margin is cheaper than the downtime it prevents.
In Practice: A 90-Day Throughput Improvement Plan
The following is a plan template rather than a case study; it contains no client names and no invented results, because the inputs are site-specific. Worked honestly, it produces the operator’s own baseline and the operator’s own improvement curve.
| Phase | Weeks | Focus | Deliverable | Owner |
|---|---|---|---|---|
| Measure | 1–2 | Log actual phase durations, changeover minutes, no-show rate | Baseline dashboard | Operations lead |
| Redesign | 3–4 | Rebuild slot pitch with buffer; write booking rules | New session template and policy | Operations lead |
| Pilot | 5–8 | Run the new template; hold a weekly review | Variance log and adjustments | Chamber supervisor |
| Standardise | 9–11 | Freeze what worked; train the whole team | Written standard and training record | Operations lead |
| Review | 12–13 | Compare achieved against baseline; decide on next step | Improvement report | Owner or manager |
The dashboard is the part that must exist before anything is changed. Without a baseline, every improvement claim is an opinion, and without weekly cadence the new template drifts back towards the old habits within a month.
| Metric | Definition | Baseline | Target | Review cadence |
|---|---|---|---|---|
| Completed sessions per day | Sessions logged as completed | [TO CONFIRM] | [TO CONFIRM] | Daily |
| Average changeover minutes | Exit to next-entry readiness | [TO CONFIRM] | [TO CONFIRM] | Daily |
| On-time start rate | Sessions starting within target of schedule | [TO CONFIRM] | [TO CONFIRM] | Weekly |
| No-show rate | No-shows ÷ booked slots | [TO CONFIRM] | [TO CONFIRM] | Weekly |
| Chamber-hour utilisation | Booked ÷ staffed chamber-hours | [TO CONFIRM] | [TO CONFIRM] | Weekly |
| Unplanned maintenance hours | Hours lost to unplanned downtime | [TO CONFIRM] | [TO CONFIRM] | Monthly |
| Revenue per chamber-hour | Revenue ÷ staffed chamber-hours | [TO CONFIRM] | [TO CONFIRM] | Monthly |
A short weekly review keeps the plan alive. Fifteen minutes, the same agenda, the same four questions each time.
| Agenda item | Question | Output |
|---|---|---|
| Variance | Where did achieved sessions differ from plan, and why | Variance entry |
| Changeover | Did the upper tail of changeover times shrink | Action or acceptance |
| Attendance | Did booking policy hold, were exceptions recorded | Policy confirmation or revision |
| Blockers | What stopped sessions that was within our control | Owner and due date |
The most common failure of this plan is not a wrong target but a fading one: weeks one to four are measured carefully, and by week eight the log is being filled in from memory. Assigning the dashboard to a named person and reviewing it on the same day each week is what keeps the numbers real, and the numbers are the only thing that distinguishes a genuine improvement from a busy month.
Distributors and buyers planning a new site can run the same plan from a standing start, using conservative inputs for the first two weeks and tightening them as real data arrives. Teams who want a second view on their template before committing to it can reach the project team through the HyperbaricO2Care contact page.
Conclusion: Design the Schedule, Then Scale the Chamber
Pressure, shell construction, oxygen delivery and certification are purchase decisions, and they are settled once. Scheduling is an operating decision, revisited every quarter at no capital cost, and it is the larger of the two in determining what a chamber returns. Build the slot from compression and decompression outward, pay for changeover explicitly, defend the template with written booking rules, and measure the result against a baseline rather than a feeling.
The practical sequence is short: map the session, calculate honest capacity, set the template, standardise changeover, publish booking rules, then measure for twelve weeks. Only when achieved sessions are close to the calculated figure does it make sense to add a second chamber or a second site — until then, the spare capacity is already paid for and simply unused.
For operators still specifying equipment, the scheduling consequences are worth raising during the purchase conversation: compression time, single-place versus multi-place configuration, noise behaviour in the room, oxygen delivery method and service access all shape what the schedule can achieve. Well-run centres treat the schedule as part of the specification, not an afterthought to be discovered once the crate is unpacked.
Medical disclaimer: This article is provided for general operational and informational purposes only and is not medical advice. Hyperbaric oxygen therapy should be undertaken only under appropriate clinical supervision, and untreated pneumothorax is an absolute contraindication. HyperbaricO2Care chambers are CE-marked devices manufactured under an ISO 13485 quality system; no claim of FDA clearance is made or implied. Always follow your local regulations, your responsible clinician’s instructions and the manufacturer’s instructions for use.