CleanSpace Guide for Equipment Cleaning, Storage and Testing Guide

GUIDE FOR EQUIPMENT CLEANING, STORAGE AND TESTING To start, DISASSEMBLE the mask, neck support and harness from the respirator before cleaning. See User Instructions or wwwcleanspacehealth.com/videos for instructions on disassembly. Removing the Mask 1. Cleaning or Disinfectant Wipes ▪ Wipe down the mask (inside and outside) and head harness to remove macroscopic contaminants. Use a new wipe for inside the Exhalation Valve cover mask; outside; and head harness. ▪ Remove the exhalation valve cover (see figure), gently lift and wipe the leaf edge. Replace the exhalation valve cover before use. HEAD HARNESS AND NECK SUPPORT

Before washing the mask, remove the valve cover. ADD GRAPHIC HERE

2. Warm soapy water ▪ Use water and drying temperatures less than 50°C. ▪ For the mask exhalation valve gently wash the warm water solution through the valve. ▪ Rinse the mask, head harness and neck support thoroughly in fresh water to remove cleaning residue. IMPORTANT: Not rinsing the mask thoroughly, may result in agent residue causing irritation to the wearer. ▪ Replace the mask exhalation valve cover before use. 3. Industrial washer; Disinfection & Sterilization (below) ▪ An industrial washer can be used to clean the mask/head harness. CleanSpace Disinfection & Sterilization Guide (see below) outlines thermal and chemical cycling methods for the cleaning, disinfection and sterilization of the mask/head harness. See list of compatible disinfection agents (p3). Use water and drying temperatures less than 50°C. 4. Drying the mask ▪ After cleaning, allow the mask, head harness and neck support to air dry in a clean environment away from sunlight. ▪ The mask can also be hand-dried with a clean, lint-free cloth. Do not dry the mask, head harness and neck support by exposing directly to heat i.e. hair dryers or heaters or with the use of a cloth that may leave behind lint. 1. Preparation: ▪ Remove the used filter and dispose of appropriately. Remove the mask and head harness ▪ Insert the CleanSpace Cleaning & Storage Plug (CS3011) into the filter inlet and two bellow air outlets.

RESPIRATOR OR POWER UNIT (Electronic device)

2. Cleaning ▪ Use disinfectant wipes/cloth to clean the outside of the respirator See List of Compatible Disinfectant Agents (p3). ▪ If HEAVILY SOILED, with the Cleaning & Storage Plug inserted, the respirator can be rinsed under running water. The respirator is an electronic device - DO NOT SUBMERGE the respirator. ▪ After cleaning, remove the cleaning agent residue using a clean fresh cloth 3. Drying the Respirator ▪ Dry the respirator by i) Air dry in a clean environment or 2) Dry with a clean lint-free cloth. Note: Do not dry the respirator by exposing to heat (i.e. hair dryers or heaters) or compressed air. ▪ When dry, store the Respirator with Cleaning Storage Plug (CS3011) fitted to prevent dust/liquids entering the respirator airpath.

IMPORTANT: Cleaning can cause the exhalation valve leaf to stick. Before use, check the valve leaf by gently lifting the valve. Replace the exhalation valve cover before use.

Insert the CleanSpace Cleaning & Storage Plug

IMPORTANT: Using the Cleaning & Storage Plug (CS3011) prevents dust or liquids from entering the air path of the respirator.

2|Page IMPORTANT: CleanSpace Respirators are designed to be used with CleanSpace masks and filters to complete the respirator system. Occupational use of respirators must be in compliance with local industry health and safety standards. For example, by United States regulation employers must establish a written respirator protection program meeting the requirements of the Occupational Safety and Health Administration (OSHA) Respiratory Protection standard 29 CFR 1910.134 and any applicable OSHA substance specific standards. OSHA 1910.134 states that employers shall ensure that respirators are inspected, cleaned, and correctly stored under manufacturers recommended storage conditions.

GUIDE FOR EQUIPMENT CLEANING, STORAGE AND TESTING LIST OF DISINFECTANT AGENTS that are compatible with CleanSpace equipment material • Isopropyl alcohol • Hydrogen Peroxide • Chlorine and Apesin AP3 Didecyldimethyl ammonium chloride • Quaternary ammonium compounds, PH 7.3 at 0.75% solution • Magnesium Monoperoxyphthalate hexahydrate • Glucoprotamine. Cleaning with SOLVENTS IS NOT RECOMMENDED. Solvents can cause damage to plastic components including cracking, fogging, fading and decreased strength. If equipment is exposed to solvents, rinse well and check parts of cracking or fogging.

1.2 GUIDE TO DISINFECTION AND STERILIZATION PROCEDURES (MASK & HEAD HARNESS ONLY) This guide is intended for single or multi-wearer use of a CleanSpace mask, neck support and head harness for the CleanSpace respirator where there is the risk of biological contaminants. If you use the mask as a single user setting where decontamination of biological hazards are not required refer to the User Guide for cleaning instructions. THESE PROCEDURES ARE NOT TO BE USED FOR THE POWER UNIT. Mask components should NOT be subjected to AUTOCLAVE sterilization. CleanSpace™ mask component1

High level thermal disinfection Thermal water bath 90°C (194°F) for 1 min

1 2

High level chemical disinfection

Thermal water bath 93-95°C (199.4-203°F) for 10 min

• Mask (Face piece)

-

• Head Harness

-

CIDEX™ OPA Ortho-phthalaldehyde 0.55% 12 min soak

Sterilization STERRAD™ 100S Short cycle (boosters not required)

Validated number of cycles2

STERRAD™NX Standard or advanced cycle 30

This mask may not be available in all regions. For full details regarding the correct use of this mask, please refer to the specific User Guide. If a healthcare facility requires an additional disinfection or sterilization cycle after reassembly, the number of validated cycles must be halved.

A

B

A

CleanSpace Half Mask

1

Exhalation valve assembly

B

Head Harness

1 3|Page IMPORTANT: CleanSpace Respirators are designed to be used with CleanSpace masks and filters to complete the respirator system. Occupational use of respirators must be in compliance with local industry health and safety standards. For example, by United States regulation employers must establish a written respirator protection program meeting the requirements of the Occupational Safety and Health Administration (OSHA) Respiratory Protection standard 29 CFR 1910.134 and any applicable OSHA substance specific standards. OSHA 1910.134 states that employers shall ensure that respirators are inspected, cleaned, and correctly stored under manufacturers recommended storage conditions.

GUIDE FOR EQUIPMENT CLEANING, STORAGE AND TESTING

DISINFECTION & STERLIZATION PROCEDURES (MASK & HEAD HARNESS ONLY) (continued) Disassembly

Disassemble the mask (face piece) from the power unit and remove the exhalation valve assembly from the front of the silicone mask according to the instructions in the User Guide. These procedures are NOT to be used for for the power unit as it contains electronics.

Mask (Face piece) and Head Harness

DO NOT USE FOR THE POWER UNIT

®

Cleaning and drying

1. Make a solution of Alconox by diluting with drinking quality water at 1%, ie, 10 g per liter, at 20-25°C (68-77° F) according to the manufacturer’s instructions. 2. Whilst in the solution, thoroughly clean the mask component with a soft bristle brush for 1 minute. Pay particular attention to all crevices and cavities. 3. Rinse the component by agitating it vigorously in drinking quality water, 5 liters per component at 20-30°C (68-86°F) for 1 minute. Repeat the process by using fresh water for another 1 minute. 4. Inspect and if required, repeat washing until visually clean. Failure to clean the mask component as indicated may result in inadequate disinfection and sterilization. 5. Allow the component to air dry out of direct sunlight.

In the procedures below, only one of the following three disinfection or sterilization procedures needs to be performed.

High level thermal disinfection Mask and Head Harness

Disinfection or sterilization and drying

Inspection Reassembly Packaging and storage

1. Fully immerse the mask/head harness component in a hot water bath using a temperature-time combination, ensuring there are no air bubbles: • 90°C (194°F) for 1 minute. 2. Remove the component from the hot water bath. 3. Shake the component to remove excess water. 4. Allow the component to air dry out of direct sunlight.

High level chemical disinfection Mask and Head Harness

STERRAD Sterilization Mask and Head Harness

1. Fully immerse and soak the mask/head harness component in a commercially 1. Dry the mask/head harness component thoroughly. available solution according to the manufacturer’s instructions and agitate If the component is wet, the sterilization cycle may fail. to ensure there are no air bubbles: For example: 2. Package the component prior to sterilization as described in the manufacturer’s instructions for the STERRAD Sterilization System. • Ortho-phthalaldehyde 0.55% (eg, CIDEX OPA) at 20°C (68-77° F) for 12 minutes Note: The use of pouches is not recommended. 2. Rinse the component in drinking quality water, 7.5 liters per 3. Sterilize the component by following the manufacturer’s instructions. component: • STERRAD 100S: Short cycle (boosters not required) • 20-30°C (68-86°F) for 1 minute • STERRAD NX: Standard or advanced cycle Repeat the process by using fresh water for two more times. Failure to 4. Shake the component to remove excess water. adequately rinse parts may result in toxic levels of residual CIDEX OPA. 5. Allow the component to air dry out of direct sunlight. 3. Shake the component to remove excess water. 4. Allow the component to air dry out of direct sunlight.

Perform a visual inspection. If any visible deterioration is apparent (cracking, crazing, tears etc), the component should be discarded and replaced. Slight discoloration of the silicone components may occur and are acceptable. Reassemble the mask according to the instructions in the User Guide. Store in a dry, dust-free environment away from direct sunlight. Storage temperature: -20°C to 50°C (-4°F to 122°F).

▪ CleanSpace cannot give assurances that deviations from the procedures listed in this guide (eg, exceeding the number of reprocessing cycles), and their effect on the performance or safety of the GENERAL WARNINGS AND CAUTIONS

product, will be acceptable.

▪ Mask components should not be subjected to autoclave or ethylene-oxide gas sterilization. ▪ When using detergents, disinfectants or sterilization agents, always follow the manufacturer’s instructions. In the event of conflict, this guide takes precedence. ▪ Do not iron the headgear as the material is heat sensitive and will be damaged

4|Page IMPORTANT: CleanSpace Respirators are designed to be used with CleanSpace masks and filters to complete the respirator system. Occupational use of respirators must be in compliance with local industry health and safety standards. For example, by United States regulation employers must establish a written respirator protection program meeting the requirements of the Occupational Safety and Health Administration (OSHA) Respiratory Protection standard 29 CFR 1910.134 and any applicable OSHA substance specific standards. OSHA 1910.134 states that employers shall ensure that respirators are inspected, cleaned, and correctly stored under manufacturers recommended storage conditions.

GUIDE FOR EQUIPMENT CLEANING, STORAGE AND TESTING

2. STORAGE When not in use, store the CleanSpace Respirator with the Cleaning and Storage Plug (CS3011) inserted to prevent dust or liquids from entering the air path of the respirator. STORE the respirator in the CleanSpace Charging and Storage Station (CS3014) or a sealed clean container. Masks and other parts should be stored in a sealed clean container. New filters should be kept in original packaging until use. Guide to cleaning, filter replacement, infection and testing during periods of storage: CLEANING

FILTER REPLACEMENT

Prior to use

Wipe parts prior to use

Insert new filter prior to use.

Monthly

No cleaning required if stored in Charging & Storage Station or sealed container.

Store respirator without the Filter

Annual

Charging & Storage Station/ sealed container: Clean at Annual Service

Store respirator without the Filter

INSPECTION

TESTING & SERVICING

Inspect equipment for damage or Run the Flow Test and Alarm Test. missing parts Inspect equipment for damage or Run the Flow Test and Alarm Test. missing parts Every 3 mths Calibration Use an only trained and authorized technicians to perform an Equipment Service (Clean, Inspect, Run Test and Service Check). For more information contact CleanSpace customer support ([email protected]).

Below are the conditions for charging and storing the CleanSpace Respirator and accessories. Charging Conditions: Temperatures Recharge Time:

Charging Temperature Range: 0°C to 35°C

The battery will not accept charge outside of this range.

Maximum of 2 hours (to 95%)

To maintain the performance integrity of the internal battery, the respirator must be stored under the following conditions: Storage Conditions: Temperature and humidity Shelf Life:

Short term storage UNDER 30 days: -10°C to 35°C. (30% - 50% RH) Long term storage OVER 30 days: 18°C to 28°C (30% - 50% RH) The respirator can be stored either charged or uncharged without causing material loss of battery performance. Always store equipment out of direct sunlight/UV and in a clean, dry environment. Respirator: 3 years Mask, head harness and neck support: 3 years Particulate Filters: 3 years Provided parts are stored under recommended storage conditions

5|Page IMPORTANT: CleanSpace Respirators are designed to be used with CleanSpace masks and filters to complete the respirator system. Occupational use of respirators must be in compliance with local industry health and safety standards. For example, by United States regulation employers must establish a written respirator protection program meeting the requirements of the Occupational Safety and Health Administration (OSHA) Respiratory Protection standard 29 CFR 1910.134 and any applicable OSHA substance specific standards. OSHA 1910.134 states that employers shall ensure that respirators are inspected, cleaned, and correctly stored under manufacturers recommended storage conditions.

GUIDE FOR EQUIPMENT CLEANING, STORAGE AND TESTING

3. INSPECTION & TESTING (FLOW TEST & ALARM TEST) INSPECTION REGULAR USE STORAGE: Prior to use Monthly Annual

Prior to use: Wearers should inspect device for damage or missing parts. Prior and after cleaning: Inspect the equipment for damage or missing parts.

TESTING & SERVICING Monthly: Run the Flow Test and Alarm Test. Annual: Perform the Annual Equipment Check

Inspect equipment for damage or missing parts Run the Flow Test and Alarm Test. Inspect equipment for damage or missing parts Run the Flow Test and Alarm Test. Every 3 months perform Calibration. Use an only trained and authorized technicians to perform an Equipment Service (Clean, Inspect, Run Test and Service Check). For more information contact CleanSpace customer support ([email protected]).

Below is the Steps to perform the 1) Parts Inspection 2) Calibration 3) Flow Test and 4) Alarm Test 1. PARTS INSPECTION DAMAGE & MISSING PARTS If parts are missing or damaged, replace only with approved parts before proceeding. Failure to do so may affect respirator performance and reduced protection.

2. AUDIBLE ALARM TEST

▪ Check the RESPIRATOR & MASK for cracks, holes or other damage or missing parts. Do not use the device if there is any damage or signs of misuse. Check the BATTERY is fully charged by pressing the Power button. The Green battery LEDs must light up. ▪ Check the MASK to ensure that there are no cracks, tears or dirt; check the mask is not distorted. Check the mask exhalation valve for damage or dirt build up. If it is dirty, remove the exhalation valve cover. Remove any dirt, hairs or anything that could affect the seal of the valve against its seat. Check that the valve seat is clean. Reinstall the valve cover. If the valve is damaged, replace the mask. ▪ Before use, check the FILTER carefully. The foam seal must be clean and free from damage.. Examine the visible internal surfaces for any sign that dust or cracks. If dust is found, do NOT use the filter. The body of the filter must be free of cracks or signs of damage. If any sign of impact or scratching is found, discard the filter. Fit the filter to the Respirator. Inspect Filter Expiry Date on the label.

Steps to test the audible alarms 1. 2. 3. 4.

Ensure the Mask and Filter are removed from the respirator. Securely fit the Cleaning & Storage Plug to the Respirator: filter inlet and bellows unsealed Press the Power Button and put the Respirator into Standby Mode (Green LEDs and no motor on) Press the Power Button again to run the Alarm Test. During the test, the motor/airflow will run fast.

6|Page IMPORTANT: CleanSpace Respirators are designed to be used with CleanSpace masks and filters to complete the respirator system. Occupational use of respirators must be in compliance with local industry health and safety standards. For example, by United States regulation employers must establish a written respirator protection program meeting the requirements of the Occupational Safety and Health Administration (OSHA) Respiratory Protection standard 29 CFR 1910.134 and any applicable OSHA substance specific standards. OSHA 1910.134 states that employers shall ensure that respirators are inspected, cleaned, and correctly stored under manufacturers recommended storage conditions.

GUIDE FOR EQUIPMENT CLEANING, STORAGE AND TESTING The functionality of the audible alarms should be tested once a month. 3. FLOW TEST The Flow Test checks the Respirator is able to deliver the Manufacturer’s Minimum Design Flow of 120 litres/minute.

After 8 seconds the Respirator Alarms should sound and the Red Filter Alarm will flash. If this does not happen, check the Cleaning & Storage Plug is fitted correctly and repeat the test. If the unit fails a second time, do NOT use the Respirator.

Press Power Button

Steps to run the Manufacturers Minimum Design Flow Test 1. Ensure the Mask and Cleaning/Storage Plug are removed from the respirator. 2. Fit a clean or new filter to the Respirator 3. Press the Power Button and put the Respirator into Standby Mode (Green LEDs and no motor on) 4. Press “Flow Test” Button on the key pad to run the Flow Test. During the test, the motor/airflow will run fast and air will blow from the left bellow. 5. After 8 seconds the motor/airflow will stop. The Respirator reports the Flow Test result using the battery GREEN LEDs on the keypad. Use the table below to interpret the LEDs. GREEN LIGHTS 3 LEDs: 2 LEDs: 1 LED: ALL LEDs FLASH

Definition and indication of Airflow PASS - Excellent (Airflow >180 l/min) PASS - Good PASS - Acceptable FAIL – Do NOT use (Airflow <120 l/min) Do not use the respirator. Fit a new filter, fully charge the battery and repeat Flow Test. If the respirator fails the Flow Test filter with a new and battery fully charged, do NOT use the respirator and contact your supplier or CleanSpace Technology ([email protected])

Press Flow Test Button

The Test Flow Rate is NOT a battery charge test. During the Flow Test, 3 LEDs means the unit can deliver a high air flow. It does not mean the battery is full. You must check the battery charge separately. 4. CALIBRATION Calibrate the Respirator if i) temperature changes more than 20°c (up or down); or iii) Temperatures are unknown (ie in transport) or iii) Respirator is in storage > 3 mths

Steps to run the Calibration 1. 2. 3. 4.

Ensure the Filter and Mask are removed from the respirator Switch the CleanSpace respirator ON to Standby Mode (ie green LEDs on and no airflow), To run the calibration test, on the keypad press the “Power” and “Test Flow” Buttons at the same time. The Red and Blue LEDS will light up (solid), and the green battery LEDS will flash. The Respirators will be silent for 10 seconds and then run the motor for 5 seconds. The Calibration runs for total 15 seconds. Press both Buttons simultaneously

7|Page IMPORTANT: CleanSpace Respirators are designed to be used with CleanSpace masks and filters to complete the respirator system. Occupational use of respirators must be in compliance with local industry health and safety standards. For example, by United States regulation employers must establish a written respirator protection program meeting the requirements of the Occupational Safety and Health Administration (OSHA) Respiratory Protection standard 29 CFR 1910.134 and any applicable OSHA substance specific standards. OSHA 1910.134 states that employers shall ensure that respirators are inspected, cleaned, and correctly stored under manufacturers recommended storage conditions.

GUIDE FOR EQUIPMENT CLEANING, STORAGE AND TESTING 5.

Hold the respirator still until the red and blue LEDs turn off. The Green LEDS return to solid/flashing indicative of battery status. Calibration is complete.

REPLACING THE FILTER & ACCESSORIES The following guide is for filter replacement, use of accessories and equipment cleaning in a healthcare environment where i) there is the risk of biohazards and ii) the air concentration of particles/dust is low. Refer to the latest information from regulators such as US Centers for Disease Control and Prevention (US, CDC, NIOSH/CDC), European Centre for Disease Prevention and Control (ECDC) and the World Health Organisation (WHO) regarding selection, use, maintenance and cleaning of personal protective equipment for biohazards. RISK LEVELS

SCENARIOS

FILTER REPLACEMENT

▪ Routine procedures where the wearer may be at risk of Level 1 – Low Routine procedures ie sputum induction, bronchoscopy Level 2 – Medium Diseases may include tuberculosis, severe acute respiratory syndrome (SARS), measles, and varicella. Level 3 – High Diseases may include Viral haemorrhagic Fevers ie Ebola

biohazard inhalation ie Sputum induction, administration of aerosolized medications, bronchoscopy, and pulmonary function testing ▪ No suspected/confirmed patient ▪ Clean environment with minimal airborne contaminants

▪ Suspected/confirmed patient suffering from high risk disease required to be managed or treated in airborne isolation. ▪ Clean environment with minimal airborne contaminants

▪ Viral Haemorrhagic Fevers (i.e Ebola); Pandemic or emerging diseases AND

▪ Highly contaminated and “dirty” area or task (washing or disposal of contaminated material)

Replace monthly Replace filter if media is exposed to water

USE OF ACCESSORIES CleanSpace Cover/Prefilter (PAF-0058)

EQUIPMENT CLEANING & CONSUMABLES DISPOSAL ▪ Mask/Harness: Disinfect after use or between wearers

Face Visor recommended

▪ Respirators: Disinfect after use or between wearers

Replace weekly or between patient use

CleanSpace Cover/Prefilter (PAF-0058)

▪ Cover/Pre-filter: Dispose Between patients, after

Replace filter if media is exposed to water

Hood/visor recommended CleanSpace Cover/Prefilter (PAF-0058)

Replace after exiting contaminated area / shower

Recommended PPE protocols: coveralls, hood/visor, booties, gloves

use or between wearers

▪ Mask/Harness: Disinfect after use or between wearers

▪ Respirators: Disinfect after use or between wearers Between patients or leaving the contaminated area. ▪ Decontamination Shower (Facility to confirm) ▪ Dispose of all consumables including filter and cover ▪ Mask/Harness: Disinfection or Sterilization ▪ Respirator: Disinfection

IMPORTANT NOTES ON FILTERS WATER & DECONTAMINATION SHOWERS: CleanSpace Particulate filters are comprised of an unwoven glass media. Contact with water ie significant splash or during a decontamination shower, has potential to damage the filter media on drying and decrease the protection factor of the filter. If the filter media comes in contact with water or after use in a decontamination shower, the filter must be removed and replaced with a new filter before use. FILTER ALARMS: CleanSpace Filter Alarms are triggered when the filter is close to being blocked. A blocked filter can occur in very high dust environments or if material covers the filter media blocking air flow through the filter. Alarm will sound when the filter is 80% blocked and allows time for the wearer to leave the contaminated area and change the filter or address the

8|Page IMPORTANT: CleanSpace Respirators are designed to be used with CleanSpace masks and filters to complete the respirator system. Occupational use of respirators must be in compliance with local industry health and safety standards. For example, by United States regulation employers must establish a written respirator protection program meeting the requirements of the Occupational Safety and Health Administration (OSHA) Respiratory Protection standard 29 CFR 1910.134 and any applicable OSHA substance specific standards. OSHA 1910.134 states that employers shall ensure that respirators are inspected, cleaned, and correctly stored under manufacturers recommended storage conditions.

GUIDE FOR EQUIPMENT CLEANING, STORAGE AND TESTING blocking issue. In a clean environment such as a healthcare setting, the filters will are unlikely to block with particulate matter. In these circumstance if the filter Alarm sounds, the wearer should leave the contaminated area and check the filter. Check clothing or scarfs are not resting against the filter inlet. Long hair should be tied up.

CLEANSPACE HEALTHCARE RANGE: LIST OF PARTS * Parts have a different code in North America - see brackets. † Not available in the North American market.

MAIN PARTS CS3000 (*3020) CS3003 CS3004 CS3005 CS3006 CS3007

SPARES Respirator Inc filter, harness, storage bag, charger & cap. Exc mask Half Mask – Small Half Mask – Medium Half Mask – Large Full Face Mask - Small Full Face Mask – Medium/Large

CONSUMABLES CS3002 (*3022) PAF-0097 † PAF-0058 †

CS3008 CS3009 CS3010 PAF-1101 (*1100) PAF-0028

Head Harness Neck Support - Small Neck Support - Large Battery Charger Universal – Multi Mask Exhalation Valve Replacement Set

ACCESSORIES Filter - HEPA/P3/TM3 Particulate Filter (NIOSH Approved) Hood with visor (resistant to blood and fluids) Protective cover and pre-filter for power unit

CS3011 CS3013 CS3015 CS3014

Cleaning and decontamination Plug CleanSpace Respirator ID panels (different colours) CleanSpace Mask ID badges (different colours) Docking Station (Charges and holds 8 units)

This guide describes CleanSpace Technology’s suggested procedures for cleaning, disinfection and sterilization, storage, inspection and testing. Refer to the CleanSpace Respirator User Instructions that came with your CleanSpace device for specific information on product assembly and use. Refer to the latest information from regulators such as US Centers for Disease Control and Prevention (US, CDC, NIOSH/CDC), European Centre for Disease Prevention and Control (ECDC) and the World Health Organisation (WHO) regarding selection, use, maintenance and cleaning of personal protective equipment for specific biohazards. This guidelines do not support or make any claims for the validation of disinfection or sterilisation methods for specific pathogens. Any validation listed in this guidelines are for material compatibility only.

9|Page IMPORTANT: CleanSpace Respirators are designed to be used with CleanSpace masks and filters to complete the respirator system. Occupational use of respirators must be in compliance with local industry health and safety standards. For example, by United States regulation employers must establish a written respirator protection program meeting the requirements of the Occupational Safety and Health Administration (OSHA) Respiratory Protection standard 29 CFR 1910.134 and any applicable OSHA substance specific standards. OSHA 1910.134 states that employers shall ensure that respirators are inspected, cleaned, and correctly stored under manufacturers recommended storage conditions.