ActivePure F170A Manuale utente

READ MANUAL CAREFULLY FOR PROPER USE AND OPTIMAL OPERATION.

MODEL F170A

The Aberdeen Bldg.

14841 Dallas Parkway, Suite 500

Dallas, TX 75254

IMPORTANT SAFETY & USE INSTRUCTIONS FOR THE ACTIVEPURE®

MEDICAL GUARDIAN

Read all instructions before using this device.

• Use only as described in this manual

• Do not attempt to repair or adjust any electrical or mechanical functions of the ActivePure® Medical Guardian. Contact Customer Service for

service support at 1.800.572.0317

• This device will automatically turn off when the door is open

• Do not use filters other than authorized ActivePure® Medical Guardian filters

• Do not place or operate device outdoors or on wet surfaces

• Do not look directly at the UV light inside unit when operating; eye damage may occur

• Do not allow device to be used as a toy; do not permit children to operate device

• Do not use with damaged cord or plug; if device is not working as intended, has been dropped, damaged, left outdoors, or is wet, contact

Customer Service for support at 1.800.572.0317

• Never pull or carry by cord, use cord as a handle, close door on cord, or pull cord around sharp edges or corners; keep cord away from

heated surfaces

• Do not unplug by pulling on cord; to unplug, grasp the plug to remove, not the cord

• Never handle plug or device with wet hands

• Keep hair, loose clothing, fingers, and all parts of body away from openings and moving parts

• Always turn off before unplugging

• To avoid electric shock or fire hazards, plug directly into an appropriate electrical outlet (see voltage listed on unit) using cable provided

• To reduce the risk of electrical shock, this device has a grounded plug (with a third prong); this plug will fit in a grounded outlet only one

way; if it does not fit, do not change the plug in any way; do not use adapters; contact a qualified electrician to install the proper outlet

• This device should not be used near the presence of combustible gasses

• Place this device in a location that allows air to move freely into, around and out of the device

When using an electrical device, basic precautions should always be taken.

WARNING:

SAVE THESE INSTRUCTIONS

This device should be maintained in accordance with the device Manual to prevent damage or risk of re.

CAUTION:

To reduce risk of re, electrical shock, or injury to persons, observe the following:

WARNING:

First, read this user manual in its entirety to ensure that the ActivePure® Medical Guardian device is used as intended. Then plug it in, turn it on to the appropriate

fan setting. The ActivePure® Medical Guardian is designed for quiet operation, as not to disturb people in a professional healthcare environment.

BEFORE YOU BEGIN USING THE ACTIVEPURE® MEDICAL GUARDIAN

INTENDED USE

FILL IN AND SAVE

Locate the serial number of your new ActivePure® Medical Guardian and write it here.

Retain it for future reference.

Model No. __________________________________________________________________

Serial No. __________________________________________________________________

Date of Purchase ____________________________________________________________

Distributor _________________________________________________________________

Distributor’s Oce Phone No.__________________________________________________

Distributor’s Oce Address ___________________________________________________

CONTENTS

Important Safety & Use Instructions . . . . . . . . . . . . 2

Intended Use . . . . . . . . . . . . . . . . . . . . . . . 3

Device Description . . . . . . . . . . . . . . . . . . . . 4

Product Features . . . . . . . . . . . . . . . . . . . . . 5

Device Specications . . . . . . . . . . . . . . . . . . . 6

Operation. . . . . . . . . . . . . . . . . . . . . . . . . 6

Treatment Space . . . . . . . . . . . . . . . . . . . . . 7

Settings. . . . . . . . . . . . . . . . . . . . . . . . . . 8

General Maintenance Instructions . . . . . . . . . . . . . 8

Cleaning/Disinfecting and Filter Replacement Instructions . 9

ActivePure® Cell Replacement Instructions. . . . . . .11 - 12

Replacement Parts . . . . . . . . . . . . . . . . . . . .12

FAQs . . . . . . . . . . . . . . . . . . . . . . . . . . .12

Warranty Information . . . . . . . . . . . . . . . . . . .13

Device IEC 60601-1-2:2014 EMC Information . . . . . . . .14

The ActivePure® Medical Guardian, model F170A is a device intended for medical purposes that is used for the reduction of staphylococcus epidermidis and

erwinia herbicola bacteria, MS2 and Phi-X174 viruses and aspergillum niger fungal spores and bacillus globigii bacterial spores from the air in a temperature-

controlled professional healthcare environment of 70~71°F, 40~45% RH.

The ActivePure® Medical Guardian, model F170A has demonstrated the reduction of staphylococcus epidermidis and erwinia herbicola, bacteria MS2 and Phi-X174

viruses and aspergillum niger fungal spores and bacillus globigii bacterial spores under the following conditions;

Organism Type Organism Name Test Temp/RH Exposure Time (m) Avg Log-Reduction

Bacteria Staphylococcus epidermidis 72°F/50% 60 5.95

Bacteria Erwinia herbicola 72°F/50% 60 5.12

Virus MS2 bacteriophage 72°F/50% 60 5.58

Virus Phi-X174 72°F/50% 60 4.19

Fungal spore Aspergillus niger 72°F/50% 60 4.12

Bacterial spore Bacillus globigii 72°F/50% 60 4.22

DEVICE DESCRIPTION

The ActivePure® Medical Guardian, model Number F170A is a free-standing portable device, manufactured in the USA, constructed of aluminum

and steel, dimensionally measures 11.5” W x 26.5” H x 21.0” D and weighs 48 lbs. The device operates using a standard 120 VAC, 60Hz power source.

Power consumption ranges from 1 watt in standby mode to 117 watts on high speed. The device includes: a HEPA lter; multipoint ionizer; a

photocatalyst module consisting of two 10-watt UVGI bulbs operating at a wavelength of 254nm; two pieces of polycarbonate honeycomb material

with a combined surface area of 708 square inches, coated with a TiO2 based catalyst called ActivePure®; power switch; circuit board which controls

the device operations and an internal fan to draw air through the device, as shown in the general device design (Figure 1).

Lab test results demonstrated the ActivePure® Medical Guardian, model F170A device using ActivePure® to expose Staphylococcus epidermis and MS2

bacteriophage to hydroxyl radicals and super ions formed as the result of UV exposure on the photo catalyst, has the ability to destroy the tested bio

organisms on the lter as shown in Table 1 below.

The bio organisms selected, Staphylococcus epidermidis, a bacteria and MS2 bacteriophage, a virus would provide a strong challenge against the

ActivePure® hydroxyl radicals and super ions exposure.

"ActivePure®"

Figure 1

Organism Type Organism Name Test Temp / RH Exposure Time (H) Avg Log – Reduction

Bacteria, gram + Staphylococcus epidermidis 73.2°F / 50% 1 5.77

Virus, RNA MS2 bacteriophage 73.2°F / 50% 72 4.15

Table 1

PRODUCT FEATURES

It is important to be familiar with the components of the ActivePure® Medical Guardian. If any components are missing, contact Customer Service

for support at 1.800.572.0317 or email at [email protected].

HEPA Filter Chamber

(Filter not shown)

Airflow

Input

Door Pull

Handle

ActivePure® Cell

Power Cord

(Plug not

shown)

UNIQUE FEATURES

• Flow-through air design provides less air resistance

• Multi-point ionization creates negatively charged particles which ow out from a series of carbon brushes

• Carbon to remove odors

• Hydrophobic polypropylene pleated media lter designed to reduce airborne contaminants

• Powerful UVGI bulbs

• Photo catalyst module using ActivePure®

• 4-Speed fan draws airborne contaminants through the device

• All steel and aluminum construction for durability and long life

• Automatic ambient light sensor automatically dims display in darkened environment

• Safety shutdown which prevents continued device use once lter and/or ActivePure® Cell replacement time is reached

• Made in the USA

Airflow

Output

On/Off

Speed Control

Front

Panel

Back

Panel

MODEL: F170A

Operation Voltage: 120 VAV, 60 Hz

Power Button Function: ON / 1 / 2 / 3 / 4 / OFF

Operational Indicators:

Green ring – power on, device in operation

Filter change – activates after 180 days of usage

Photocatalyst cell (ActivePure®) – activates after 365 days of usage

Reset Button:

Press and hold power button for 10 seconds to reset lter and/or cell

indicators

Ionizer Voltage: 4.5 ~ 5.5 kV

Negative Ion Output (Avg): 8.73 x 106/ cm3

Treatment Area: 3,000 ft3with ceilings 8 ~ 10 ft

Recommended Fan Speed: High

Fan Speeds / Fan Indicators: 4

Whisper | 1 blue bar is illuminated

Low | 2 blue bars are illuminated

Medium | 3 blue bars are illuminated

High | 4 blue bars are illuminated

Nominal Airow Rate:

Whisper | 90 CFM | 53 m3/h

Low | 100 CFM | 59 m3/h

Medium | 180 CFM | 305 m3/h

High | 300 CFM | 509 m3/h

OPERATION

DEVICE SPECIFICATIONS

Place the ActivePure® Medical Guardian in a location that allows air to move freely into, around and out of the unit. Allow minimum of 12" of

clearance around intake grill (airow input).

DO NOT place the unit:

• Directly on or near soft furnishing (such as bedding or curtains)

• Near sources of heat (such ad radiators, replaces or ovens)

• Near combustible gasses

• Near water, outdoors or in a damp or wet area

WARNING:

Nominal Wattage:

Standby 1

Whisper 41

Low 46

Medium 60

High 117

Average Sound (dbA)(i):

Whisper 43

Low 48

Medium 64

High 70

(measured @1m from front)

Dimensions:

26.5"H x 11.5"W x 21.0"D

673mm H x 292mm W x 533mm D

Weight:

48 lbs.

21.8 kg

Power Cord: 6 ft.

ActivePure® Medical, LLC reserves the right to change or modify any

specications without notice. Consult www.ActivePureMedical.com for the

latest device information or consult Customer Service at 1.800.572.0317.

Life:

3-years minimum operational life

TREATMENT SPACE

The ActivePure® Medical Guardian, model F170A is a device intended for medical purposes that is used in professional healthcare environments. The device

is designed to treat a space approximately 3,000 cubic feet that would have 8’ to 10’ ceilings. Recommended mode of action is to operate the device on the

highest speed possible continuously. The device recirculates ambient air continuously through the device where the lter using straining and attraction reduces

airborne contaminants from the air. Hydroxyl radicals and super ions created by the photo catalyst ActivePure® are mixed with the contaminant reduced air

which then enters the treatment space. The ActivePure® photo catalyst reduces the viability of microorganisms 4-6 log such as Staphylococcus epidermidis and

MS2 as tested, shown in Table 3. Larger spaces or operating on lower fan speeds may require multiple devices. Operational guidelines are provided to users in

the form of an Owner’s Manual. The length of time required to reach optimal reduction varies as a function of space volume and the dynamics of what occurs

within the treatment space including:

• Degree of contaminants in the air or being introduce by activities in the space

• Movement of people or equipment within the space

• Rates of ventilation

The device is intended to result in a 4-6 log reduction of airborne microorganisms from initial concentrations in 60 minutes as shown in Table 1. The ActivePure®

Medical Guardian, model F170A is not a sterile device and is not intended to create a sterile environment.

Organism

Type Organism Name Initial Load of

Microorganisms

Avg Log-Reduction after

60 minutes

Bacteria (gram +) Staphylococcus epidermidis 2.6e5cfu/L 5.95

Bacteria (gram -) Erwinia herbicola 1.9e5cfu/L 5.12

Virus (RNA) MS2 8.1e5cfu/L 5.58

Virus (DNA) Phi-X174 7.63e3cfu/L 4.19

Fungal spore Aspergillus niger 2.61e4cfu/L 4.12

Virus (DNA) Baillus globigii 7.95e5cfu/L 4.22

Fan Speed CFM of Air Movement Cubic Feet Air

Movement in 1 Hour

Air Exchanges per Hour

based on 3,000 ft3

Whisper 90 5,400 1.8

Low 100 6,000 2.0

Medium 180 10,800 3.6

High 300 18,000 6.0

Table 1

Table 2

Table 3

The information on the device CFM performance and air exchanges for the dierent speed settings is shown in Table 2, to illustrate the inuence of treatment

space to air exchanges on dierent fan speeds. These are provided to assist in determining the number of devices or fan speed settings necessary for a given space.

Organism Type Organism Name Test Temp / RH Exposure Time (H) Avg Log – Reduction

Bacteria, gram + Staphylococcus epidermidis 73.2°F / 50% 1 5.77

Virus, RNA MS2 bacteriophage 73.2°F / 50% 72 4.15

The ActivePure® Medical Guardian is designed to reduce airborne contaminants with minimal maintenance.

Filter: The ActivePure® Medical Guardian HEPA Filter is replaced when the change lter light illuminates after 180 days

(approx 6 months) of use.

Cell Module: The ActivePure® Medical Guardian ActivePure® Cell is replaced when the change cell light illuminates after

365 days (1 year) of use.

The ActivePure® Medical Guardian has a safety shutdown feature to ensure the lter and/or cell replacement is performed

at the appropriate times. When the lter and/or cell replacement time is reached, the appropriate LED indicator will

illuminate. However, if the replacement indicator(s) are ignored or if the one or both LED's fail to illuminate, by design

the device will shut down 3 days of operation after reaching the replacement time. This is to ensure the device does not

continue to operate with a lter and/or cell past its stated life.

Cabinet: Wipe the exterior of the cabinet with a clean, soft cloth as needed to remove nger prints, smudges, etc. Clean

and disinfect device after each lter change as detailed in the Cleaning/Disinfecting and Filter Replacement

Instructions.

Important Points:

• Always unplug device before cleaning

• Never use gasoline, chemical solvents or any type of corrosive material to prevent damage to the device

• Use genuine ActivePure Medical® parts to maintain the warranty (See Warranty on Page 11)

SETTINGS

NOTE: Safety switch automatically turns power o when door is opened.

There are four fan settings on the ActivePure® Medical Guardian:

1. Whisper (one blue light illuminated)

2. Low (for normal use... two blue lights illuminated)

3. Medium (for a larger areas... three blue lights illuminated)

4. High (when maximum airow is desired... four blue lights illuminated)

When operating the ActivePure® Medical Guardian device for the rst time, set the fan speed to the

highest appropriate speed for the area its placed. Then adjust fan as appropriate for the area if needed.

GENERAL MAINTENANCE INSTRUCTIONS

On/Off

Speed Control

(green light illuminates

when power is on)

Disconnect power before servicing.

CAUTION:

CLEANING/DISINFECTING AND FILTER REPLACEMENT INSTRUCTIONS

The ActivePure® Medical Guardian, model F170A is a device intended for medical purposes that is used for the reduction of staphylococcus

epidermidis and erwinia herbicola bacteria, MS2 and Phi-X174 viruses and aspergillum niger fungal spores and bacillus globigii bacterial spores from

the air in a temperature-controlled professional healthcare environment of 70~71°F, 40~45%RH.

The following instructions cover device cleaning, disinfecting and replacement of the lter. Thoroughly read all of the instructions before starting. It

is recommended to clean and disinfect the device each time the lter is replaced or when device becomes visibly soiled.

FILTER REPLACEMENT

Metrex CaviWipes are required to clean the device when replacing the lter, but they are not provided with the unit or lter.

Step 1: Always disconnect (unplug) device from electrical power source before cleaning, disinfecting or replacing the lter.

Step 2: If necessary, relocate the device to an appropriate area to perform the cleaning, disinfecting and lter replacement. It is not recommended

to perform these tasks in areas such as patient room, operating room, examination room, etc., where patient exposure may occur.

Step 3: Open the replacement lter carton which includes the following items inside.

• 1 replacement lter in a sealed wrapper

• 1 disposable surgical mask

• 1 pair disposable latex free gloves, large

• 1 disposable 8-quadrant wiping cloth

• 1 large plastic bag

• 1 red bio hazard sticker

• 1 plastic bag seal

• 1 printed copy of instruction for use, cleaning, disinfecting, lter replacement sheet

Step 4: Before removing and handling the used lter, put on the disposable mask and gloves.

Step 5: Slide (remove) the used lter from the device, placing it inside the large plastic bag provided for disposal,

then set it aside.

Step 6: Use Metrex CaviWipes to clean the device. These are NOT provided with the device or replacement lter.

NOTE: Metrex CaviWipes are required to clean the device when replacing the lter, but they are not provided with the

unit or lter.

Step 7: Remove a Metrex CaviWipe from its package. Beginning by cleaning the surface “A”. Wipe the CaviWipe over the surface area,

thoroughly wetting the soil. Then using hand pressure rub the wipe over the surface until soil is no longer visible on this part of

the device. If soil is heavy or is still visible, repeat step with a new CaviWipe until soil is no longer visible.

Step 8: Remove a Metrex CaviWipe from its package. Beginning by cleaning the surface “B”. Wipe the CaviWipe over the surface area,

thoroughly wetting the soil. Then using hand pressure rub the wipe over the surface until soil is no longer visible on this part of

the device. If soil is heavy or is still visible, repeat step with a new CaviWipe until soil is no longer visible.

Step 9: Remove a Metrex CaviWipe from its package. Beginning by cleaning the surface “C”. Wipe the CaviWipe over the surface area,

thoroughly wetting the soil. Then using hand pressure rub the wipe over the surface until soil is no longer visible on this part of

the device. If soil is heavy or is still visible, repeat step with a new CaviWipe until soil is no longer visible.

Step 10: Remove a Metrex CaviWipe from its package. Beginning by cleaning the surface “D”. Wipe the CaviWipe over

the surface area, thoroughly wetting the soil. Wait 1 minute, then using hand pressure rub the wipe over the

surface until soil is no longer visible on this part of the device. If soil is heavy or is still visible, repeat step with a

new CaviWipe until soil is no longer visible.

Step 11: Remove a Metrex CaviWipe from its package. Beginning by cleaning the surface “E”. Wipe the CaviWipe over

the surface area, thoroughly wetting the soil. Wait 1 minute, then using hand pressure rub the wipe over

the surface until soil is no longer visible on this part of the device. If soil is heavy or is still visible, repeat step

with a new CaviWipe until soil is no longer visible.

Step 12: Remove a Metrex CaviWipe from its package. Beginning by cleaning the surface “F”. Wipe the

CaviWipe over the surface area, thoroughly wetting the soil. Wait 1 minute, then using hand

pressure rub the wipe over the surface until soil is no longer visible on this part of the device. If

soil is heavy or is still visible, repeat step with a new CaviWipe until soil is no longer visible.

Step 13: Remove a Metrex CaviWipe from its package. Beginning by cleaning the surface “G”. Wipe the

CaviWipe over the surface area, thoroughly wetting the soil. Wait 1 minute, then using hand

pressure rub the wipe over the surface until soil is no longer visible on this part of the device. If

soil is heavy or is still visible, repeat step with a new CaviWipe until soil is no longer visible.

Step 14: Remove a Metrex CaviWipe from its package. Beginning by cleaning the surface “H”. Wipe the

CaviWipe over the surface area, thoroughly wetting the soil. Wait 1 minute, then using hand

pressure rub the wipe over the surface until soil is no longer visible on this part of the device. If

soil is heavy or is still visible, repeat step with a new CaviWipe until soil is no longer visible.

Step 15: Allow the device to dry, no visible wetting remains. No rinsing is required. With the device

cleaned, it is ready for disinfecting.

DISINFECTING

Disinfectants are typically provided as a concentrate to be mixed with water or ready to use (RTU) with no mixing required. Use Clorox

Healthcare Fuzion Cleaner Disinfectant RTU in a spray bottle. As an RTU product, no mixing is necessary. Clorox recommended disinfectant

wait time is 1 minute with no rinsing required.

In Steps 16 - 24, spray Clorox Healthcare Fuzion Cleaner Disinfectant liberally on each surface until that surface is thoroughly wetted.

Step 16: Take the 8-quadrant wiping cloth from the lter carton, folding it as before so quadrant 1 is showing.

Step 17: Spray disinfecting solution over surface A. Wait 4 minutes, ± 5 seconds, then thoroughly wipe with the cloth folded to quadrant 1. Continue wiping