CONSIDER certification documents

Documentation

Documentation and Certificates

Certification documents are published here. Model specification sheets, operating manuals, installation guides and OEM documentation are issued per model and destination, because their content changes with configuration.

Document set

What Is Issued and When

Issued with the quotation

Model Specification Sheet

Full specification for the selected model and configuration, including dimensions, pressure, oxygen supply, power and packed dimensions.

Supplied with the order

Operating Manual

Operation, ear equalization, session procedure, stop conditions and routine checks. Available in multiple languages for OEM orders.

Supplied with the order

Installation Guide

Room preparation, delivery route, power requirements, assembly and commissioning steps for the selected chamber.

Supplied with the order

Maintenance Schedule

Cleaning, filter care, zipper and seal checks, inspection logging and consumable replacement intervals.

Issued per OEM programme

OEM Documentation Pack

Branding specification, packaging artwork requirements, manual language list and market documentation checklist.

Viewable below, full set on request

Certificate Set

FDA clearance, CE and ISO 9001 certificates, with the applicable set confirmed for your model and destination.

Certificates

Certification Documents You Can View Now

Open any certificate at full size. The applicable set for your order is confirmed against model and destination.

CONSIDER FDA clearance letter
FDA Clearance Letter
CONSIDER CE certificate
CE Certificate
CONSIDER ISO 9001 quality management system certificate
ISO 9001 Quality Management System Certificate

Frequently asked questions

Questions About Documentation

Why are specification sheets not published as downloads?

Specification content changes with configuration, diameter, control system and destination voltage. Publishing one version would mean most buyers download the wrong one, so sheets are issued against the selected configuration.

Can CAD or drawing files be supplied?

Drawing files are released per project rather than published. Request them through WhatsApp or email with the model and intended use.

Which certificates apply to my order?

The applicable certificate set depends on model and destination. FDA clearance, CE and ISO 9001 are in the current portfolio; the COHL20 list also references ISO 13485 depending on configuration.

Are manuals available in languages other than English?

Yes. Multilingual manuals are prepared as part of OEM and ODM orders, with the language list agreed before production.

Direct manufacturer inquiry

Request the Document Set for a Specific Model

Name the model and destination and the team will issue the matching specification sheet, manual language list and certificate set.

+86 189 5204 6936[email protected]Model recommendation within 12 hours