CleanSpace HALO - Fit Factor Requirements and Product Approvals

33
WARNING
If a satisfactory quantitative fit factor or passing qualitative test cannot be achieved with any of
the masks, CleanSpace HALO must not be used. A satisfactory quantitative fit factor is
Test Type
Half Mask
Full Face Mask
Power On
1000
1000
Power Off
100
500
At the end of the fit test, do the following to prepare your mask for use.
• Remove the Sensing Ball from the socket. Refit the orange plug to the Sensing Ball socket. Push it all the
way in.
• Remove the sensing tube from the fit test port. Refit the plug to the fit test port.
• Lower the rain cover. If the rain cover is raised during use the exhalation valve can vibrate.
WARNING
To check that the test port plug is fitted correctly (after using the on-board fit test ports), a
negative pressure Seal Check shall be performed – see page 19.
WARNING
Using a full-face mask with the rain cover raised can cause the exhalation valve to vibrate,
which you may notice as a buzzing noise. Lower the rain cover for correct operation.
22. Approvals
Area
Description
Europe (CE)
Notified Body: BSI (2797)
Notified Body Address:
Say Building, John M. Keynesplein 9, 1066 EP Amsterdam,
Netherlands
Standard: EN12942:1998/A2:2008
Australia
Standard: AS/NZS 1716:2012
Tests were undertaken by BSI to validate that the CleanSpace HALO is a Category III PPE with class design TM3,
according to REGULATION (EU) 2016/425 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL and
EN12942:1998/A2:2008. HALO is intended to protect against substances and mixtures which are hazardous to
health and harmful biological agents, as listed in Annex I of EU 2016/425. The conformity assessment undertaken to
verify the risk classification was a Module B EU-type examination and a Module D quality assurance of production
processes. These Modules are listed in Annex V and VIII of Regulation (EU) 2016/425. CleanSpace HALO Filters
are Class TM3P R SL Particulate Filters as listed in I.S. EN 12942:1998/A2:2008. Requirements 6.1 to 6.17 of
EN12942 were satisfied by the CleanSpace HALO respiratory system when tested by BSI as a part of a Module B
EU-type examination.
WARNING
European users should be aware that all markings on the HALO filters refer to the standard EN
12942 (1998) + A2 (2008), Class III, TM3 and should not be confused with any other standard.
The Declaration of Conformity for CE can be accessed at: cleanspacetechnology.com/eu2016-425/