Certification and documentation
We show you what sits underneath.
In this market almost every product carries the word CE. On its own that says little: it matters whether a signed declaration of conformity sits underneath it, which directives were assessed, and whether the exact model is named in the documents. We supply the full file with every system and tell you in advance what is in it.
ULTRA
Model OLV-YZD01
- EU declaration of conformity, signed by the manufacturer
- Low Voltage Directive 2014/35/EU, EN IEC 60335-1
- EMC Directive 2014/30/EU, EN IEC 55014 and 61000
- ISO 13485:2016 quality system, issued by TÜV SÜD
- Electrical safety and performance report, tested to IEC 60601-1
- Not a medical device under the MDR
Hard and soft chambers
DUO · PRO · NAVY · Boost Station 36 · Boost Seat 90
- CE marking as declared by the manufacturer
- Verification of the technical documentation available
- Full conformity file per model on request
- Warranty of up to three years
- Not a medical device under the MDR
IHHT and altitude training
IHHT MAX · IHHT PRO · IHHT HOME · HT LOW
- EMC Directive 2014/30/EU, test certificate at model level
- Conformity file per model on request
- Warranty of up to three years
- Not a medical device under the MDR
- Training and wellness application
Medical hyperbaric chambers
HPO TECH · TROJAN · ZEUGMA · TITAN
- CE marking as a medical device under Regulation (EU) 2017/745 (MDR)
- Class IIb active medical device, as stated by HPO TECH
- ISO 13485 quality management system
- Pressure vessel standards PED and ASME PVHO
- Medical use also involves requirements for the care provider; we start with an advisory meeting
What our systems are
Our systems are certified training and wellness equipment, used in recovery and performance centres, longevity clinics, sports clubs, practices and premium homes. We explain how each technology works, what users experience and how it fits into your programme. Alongside the range on this website we supply medically certified hyperbaric chambers from HPO TECH for applications where medical certification is required; those systems are configured per project.
What you receive
On handover you receive the conformity file, the manual, the safe-use instructions and the maintenance schedule. If an insurer, occupational health service or regulator asks, you can show immediately what you have on site.
Next step
Where would you like to go next?
Would you like to experience it?
That is the best way to choose.
Our showroom in Goes has many of our systems set up and running. Take a session, feel the difference between the technologies and work through with us what it would mean at your location.