Health Devices IPM System

INSPECTION AND PREVENTIVE MAINTENANCE

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Procedure No. 475-20010301 (Acceptance)

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Mobile High-Efficiency-Filter Air Cleaners

Used For:
Air Cleaners, High-Efficiency Filter, Mobile [18-113]

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Also Called: High-efficiency particulate-air (HEPA) cleaners, air filtration units, portable room-air HEPA
recirculation units

Commonly Used In: Patient isolation rooms, waiting areas, respiratory treatment rooms, autopsy
rooms

Risk Level: High

Type Interval Time Required

Major 12 months _____ hours

Minor 2 months _____ hours

Notes:
The minor interval can be adjusted based on the need for prefilter replacement; these filters are
typically changed every 1 to 3 months. Staff members other than service technicians can usually
perform minor inspections and change prefilters.
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Overview
Mobile high-efficiency-filter air cleaners are
movable devices intended to remove
Mycobacterium tuberculosis droplet nuclei from
room air and thereby reduce the risk of
tuberculosis (TB) transmission. These units also
reduce the amount of dust, pollen, and other
particles in the air they filter. A mobile air filtration
unit uses a fan or blower to move air into its
housing and through its filters and then to
recirculate it throughout the room. The filter
system typically includes a low-efficiency prefilter
to trap gross particulates and a high-efficiency
particulate air (HEPA) filter to trap fine particles,
such as TB droplet nuclei. Some units include
multiple prefilters, charcoal filters to remove
odors, and/or germicidal ultraviolet lamps (i.e., for
ultraviolet germicidal irradiation [UVGI]) intended
to supplement the HEPA filtration.
Some HEPA cleaners can be permanently wall or
ceiling mounted, and some can have room exhaust
connections. Many of the procedures described
herein can be applied to these units.
The U.S. Centers for Disease Control and
Prevention (CDC) recommends at least 12 air
changes per hour (ACH) to significantly reduce the

Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
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 Procedure No. 475-20010301 Mobile High-Efficiency-Filter Air Cleaners (Acceptance)

risk of transmitting TB. The volume of air
circulated by the mobile air filtration unit must be
in proper proportion to the room volume to
effectively supplement existing ACH provided by
the room's heating, ventilating, and air-
conditioning (HVAC) system or to produce at least
the recommended 12 ACH.
In addition, a mobile air filtration unit must be
positioned in a room so as to ensure that the room
air is thoroughly mixed. This can usually be
accomplished by positioning the unit so that the
filtered air is moved the greatest distance possible
in the room before being blocked or deflected by
walls or furniture or disturbed by other airflows.
The unit should also be positioned to prevent air
from being directed toward exhaust ducts and
areas occupied by healthcare workers.
As the filters become loaded (i.e., dirty), the flow
resistance increases, diminishing the amount of air
moved through the unit and, commensurately, the
amount of protection offered (i.e., the reduction of
contamination concentration). The filters must be
periodically replaced, typically every two months
for prefilters and every two years for HEPA filters,
depending on the filters' time in use and the
cleanliness of the room air.
Most mobile air filtration units have either a filter-
quality indicator or manufacturer-designated test
to determine when the filters should be changed.
The most widely used indicator is a differential
pressure gauge that measures the pressure drop
across the filters. This gauge is typically a relative
indicator; the pressure reading when the filters are
clean must be known to determine the state of the
filters at any given time. Depending on the mobile
air filtration unit, the gauge may provide a
measure of the condition of the HEPA filter and the
prefilter, or the condition of the HEPA filter alone.
Some units carry a label that describes the use of
the differential pressure gauge and provides a
chart for recording pressure measurements. In
addition, some use lights to signal the filter
condition based on pressure drop and/or an hour
meter to indicate time in use, a less reliable
method of gauging filter condition.
Because the units are used in patient rooms, filter
inspection and replacement should be performed
by nursing or clinical engineering staff, who should
also ensure that the unit is properly positioned in
the room. In either case, responsibility for testing
and replacement must be clearly established. If no
simple filter-condition test is available, filters
should be replaced at regular intervals, according
to the manufacturer's recommendations or as
determined by the procedure outlined herein.
Recording the minor inspections and indicating the
next date for filter replacement on a label or
inspection sticker attached to the unit will facilitate
routine filter replacement.
Citations
(from Health Devices if not otherwise noted)
Mobile high-efficiency-filter air cleaners
[Evaluation], 1995 Oct;24:370-418.
Mobile high-efficiency-filter air cleaners
[Evaluation update], 1997 Jun;26:233+.
Test Apparatus, Supplies,
Parts
 Leakage current meter or electrical safety
analyzer
 Ground resistance ohmmeter
 Airflow-measuring instrument (e.g., flow hood,
anemometer, pitot tube) and appropriate
ductwork
 Differential pressure gauge capable of
measuring 2 inches of water in 0.01-inch
increments
 Particle counter capable of measuring 0.3 μm
particles (optional; required for CDC testing)
 NIOSH-approved respirators
 Gloves
 Eye protection (from UVGI lamps)
 Leak test solution
Special Precautions
Because air filtration units can harbor potentially
infectious organisms, technicians should follow
universal precautions for infection control (e.g.,
wearing respirators approved by the National
Institute for Occupational Safety and Health
[NIOSH], wearing gloves), especially during
prefilter or HEPA filter replacement or any other
internal work on these units. Rubbing or shaking
filters can aerosolize trapped dust and thereby
create an infection risk. Some units incorporate
special features or designs to contain the filter and
minimize the potential for spread of
contamination. Used filters should be treated as
infectious waste. Most filters are disposable;

Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
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 Procedure No. 475-20010301 Mobile High-Efficiency-Filter Air Cleaners (Acceptance)
reusable filters can be disinfected with a soaking
spray of phenolic disinfectant or undiluted bleach.
(For more details on infection control, see IPM
Safety.)
The internal surfaces of the mobile air filtration
unit should be disinfected before internal cleaning
or maintenance. Refer to the manufacturer's
recommendations for unit disinfection procedures;
most recommend gas disinfection using
paraformaldehyde vapors. This type of disinfection
is best done outdoors.
If the mobile air filtration unit contains UVGI
lamps, eye protection may be needed for some
procedures. Otherwise, ensure that the lamps are
not activated whenever they can cause personnel
exposure.
Procedure
Before beginning an inspection, carefully read this
procedure and the manufacturer's instruction and
service manuals. Be sure that you understand how
to operate the equipment, the significance of each
control and indicator, and the alarm capabilities.
Also review special inspection and preventive
maintenance procedures or frequencies
recommended by the manufacturer.
Qualitative Tasks
Chassis/Housing. Check for shipping
damage; report any damage to the manufacturer,
shipper, or service organization, and arrange for
repair or replacement.
Check that the unit is suitably constructed to
withstand normal hospital use and abuse. For
instance, a unit with venting on the top of the
housing or poorly protected or sealed controls and
indicators may be prone to fluid entry. (Such
design deficiencies should usually be recognized
during prepurchase evaluation. However, if any are
evident, discuss corrective action with the
manufacturer. If not correctable, warn users or
take other preventive measures.)
Examine the exterior of the unit, including louvers
or grilles, for cleanliness and general physical
condition. Ensure that plastic housings are intact,
that all assembly hardware (e.g., screws,
fasteners) is present and tight.
Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
Mount/Fasteners. If the air filtration unit is
mounted on a stand or cart, examine the condition
of the mount. Ensure that the assembly and
weight distribution is stable and that the unit will
not tip over when pushed or when a caster is
jammed on an obstacle (e.g., line cord, threshold),
as may occur during transport.
Casters/Brakes. Verify that the correct
casters have been supplied with the air filtration
unit (e.g., size, correct swivel). (ECRI recommends
5 in [12.7 cm] diameter casters for mobile units to
reduce shock to the unit and to minimize the effort
required to roll the unit across elevator thresholds
and other uneven surfaces.) Verify caster and
brake operation, if the unit is so equipped.
AC Plug. A solidly constructed, good quality
plug with adequate strain relief is acceptable, but
the use of a Hospital Grade plug (identifiable by a
green dot and/or labeling) will eliminate
guesswork and ensure a plug of acceptable
construction quality. Right-angle plugs are
unacceptable for devices that are moved
frequently. A good quality two-prong plug is
acceptable for double-insulated devices. Replace
the plug or have the supplier replace it if it is not
Hospital Grade or otherwise suitable. Hospital
Grade molded plugs are acceptable.
Examine the AC power plug for damage. Attempt
to wiggle the blades to determine if they are
secure. Shake nonmolded plugs and listen for
rattles that could indicate loose screws.
Line Cord. Ensure that the line cord is long
enough for the unit's intended application; an
extension cord should not be required. (A length of
10 ft [3 m] is suitable for most applications.)
The cord should be of suitable quality and current-
carrying capacity. Hard Service (SO, ST, or STO),
Junior Hard Service (SJO, SJT, or SJTO), or an
equivalent-quality cord should be used.
Verify that the air filtration unit has adequate
protection against power loss (e.g., from
accidental disconnection of a detachable power
cord or disconnection of the power cord from the
wall). Equipment having a detachable power cord
should also have adequate capture devices, cleats,
or channels to hold the cord in place. If these are
absent, request that the supplier provide suitable
means of securing the cord. Verify that the unit
has adequate alarms or indicators for line-power
loss.
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 Procedure No. 475-20010301 Mobile High-Efficiency-Filter Air Cleaners (Acceptance)
Strain Reliefs. Examine the strain reliefs at
both ends of the line cord. Be sure that they hold
the cord securely.
Circuit Breaker/Fuse. If the air filtration
unit has a switch-type circuit breaker, check that it
moves freely. If the air filtration unit is protected
by an external fuse, verify that the fuse type is
labeled and that all fuses and spares are the
proper current rating and type. If the value and
type are not labeled, check the manual for the
proper current rating and type and permanently
mark this information on the unit housing near the
fuse holder.
Verify that accessory outlets have independent
overcurrent protection (fuse or circuit breaker) so
that a short in a device plugged into the accessory
outlet or an accessory overload will not disable the
air filtration unit. If this is not available, then
consider labeling the air filtration unit to clearly
indicate where the unit's fuse or circuit breaker is
located, and/or install a fused Hospital Grade (or
similar quality) plug on any commonly used
accessories that are not already provided with
suitable overcurrent protection.
Tubes/Hoses. Check the presence and
condition of all hoses (including whether they are
attached to a differential pressure gauge). Be sure
that they are not cracked, kinked, or dirty.
Filters. Check the condition of all filters by
using the unit's filter-quality gauge or test feature
or by making a visual inspection. Inspect the
sealing surface in the unit for smoothness and
flatness to ensure that the HEPA filter gasket will
seat properly without leaking. Some units require
silicone grease on the HEPA gasket to aid in
sealing the joint. The HEPA filter should be
certified as HEPA quality. Ensure that clamps or
other fasteners used to hold the HEPA filter in the
unit are tight and that the HEPA filter cannot move
in its mounting.
Controls/Switches. Discuss appropriate
control settings with the department head and
users. If alarm capabilities are included, see the
Acceptance test for Alarms.
Examine all controls and switches for physical
condition, secure mounting, and correct motion. If
a control has fixed-limit stops, check for proper
alignment, as well as positive stopping. Ensure
that each control and switch performs its proper
function.
Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
Fan/Blower. Check the physical condition and
proper operation of the fan/blower. Check
mechanical alignment and proper adjustment of
any pulleys, gears, belts, chains, etc.
Indicators/Displays. Confirm proper
operation of all lights, indicators, meters, filter-
quality gauges, and visual displays on the unit.
Ensure that the filter-quality gauge is reading
properly by operating the unit and then blocking
the inlet or outlet. The indicator should change as
described in the manufacturer's literature. When
the unit is unplugged, the indicator should return
to zero or its lower stop.
Alarms/Interlocks. Verify that configurable
alarm features are appropriately set and consistent
among all units. It should not be possible for
critical alarms to be turned off, silenced, or
defeated without adequate warning to the operator
or automatic alarm reactivation after a short
delay. Such deficiencies should usually be
recognized during prepurchase evaluation.
However, if any are found, review the justification
for purchasing the air filtration unit and discuss
corrective action with the manufacturer. (Alarm
features may be optional or programmable.) If no
remedy is available, a user training program
should be instituted to reduce the risk of incorrect
use. A warning label on the air filtration unit or a
poster in the area of use may be appropriate.
Verify that alarms are loud, distinctive, and/or
bright enough to be noticed in the environment in
which the air filtration unit will normally be used. If
a remote alarm-indicator is required, verify that it
is available and functioning. Audible alarm-volume
controls should not allow the alarm to be turned
off or lowered to an indiscernible volume.
Induce alarm conditions to activate audible and
visual alarms. Check that all associated interlocks
or features function (e.g., the line power
disconnect alarm sounds when the unit is
unplugged). If the air filtration unit has an alarm-
silence feature, check the method of reset (i.e.,
manual or automatic) against the manufacturer's
specifications.
Labeling. Ensure that a filter test label is
attached to the unit. Such labels are generally
available from the manufacturer and are used to
record the filter-quality gauge readings, test dates,
and/or hour meter readings of the mobile air
filtration unit for future maintenance. Consider
attaching to the unit a chart of the unit's airflows
versus room volume versus ACH; such charts are
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 Procedure No. 475-20010301 Mobile High-Efficiency-Filter Air Cleaners (Acceptance)
available from the manufacturer. Ensure that the
HEPA filter is certified as HEPA quality by the
presence of a label with records of, at least, the
filter efficiency and airflow resistance.
Battery. Determine the replacement interval for
the alarm batteries (if present) and document the
interval(s) in an equipment control system or a
hard copy file for the air filtration unit.
UVGI Lamps (if present). Confirm that
the lamps activate. Some units have visual
indicators for lamp activation. If these are not
present, the lamps can be directly observed in
operation; be sure to use suitable eye protection.
Area of Use. Whenever a new unit is put into
service, determine the volume of the room in
which it will be used. Ensure that the unit's
measured airflow (see the Airflow task) will
provide or supplement the room's HVAC to
produce at least 12 ACH. Record the fan/blower
setting needed to produce this airflow. Determine
the position of the cleaner in the room that will
produce the best mixing of the room air.
HEPA Seal. CDC recommends that a HEPA seal
test be performed (1) when the HEPA filter is new,
(2) whenever a HEPA filter is replaced or
reinstalled or the air filtration unit is moved, and
(3) every six months. ECRI believes that a slight
reduction in filtration efficiency of units that are
being used only to recirculate air within the same
room will not significantly increase the risk to
people in the area of use and questions the need
for such frequent testing. However, units that
exhaust air to the outside of the room should be
tested to verify that contaminated air is not
bypassing or being entrained downstream of the
HEPA filter.
If it is not necessary to comply with CDC (or
similar) guidelines, the following alternative can be
considered for units that do not exhaust any air
outside the room. The integrity of the filter and its
mounting should be closely inspected. Examine
each HEPA filter for any rips, tears, or dents in the
filter medium and for gouges or tears in the
sealing gasket. Should such defects be found,
replace the filter. If practical, use a leak-checking
fluid with the unit operating to detect leaks around
the HEPA filter gasket. (Leak testing cannot be
performed on units on which the filter seal is not
completely accessible.)
If CDC testing is required, ensure that the HEPA
filter is properly secured and sealed in the mobile
air filtration unit. Using a particle counter, measure
Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
the concentration of 0.3 μm particles in the room air. With
the mobile air filtration unit operating, measure the
concentration of 0.3 μm particles in the clean airstream by
inserting the particle sampling probe well into the exhaust
duct of the cleaner to minimize the entrainment of
room air particles. The reduction in the number of
particles should be at least 99.97%. If a particle
counter is not available, it will be necessary to
have testing performed by an outside agency.
Quantitative Tasks
Grounding Resistance. Using an
ohmmeter, electrical safety analyzer, or
multimeter with good resolution of fractional
ohms, measure and record the resistance between
the grounding pin of the power cord and exposed
(unpainted and not anodized) metal on the
chassis. Grounding resistance should not exceed
0.5 . If the air filtration unit is double insulated,
grounding resistance need not be measured; indicate "DI"
instead of the ground resistance value.
Chassis Leakage Current. Note: Some
units (especially devices incorporating a
microprocessor, motor, or compressor) may be
damaged by switching polarity while the unit is on.
If you perform reverse polarity testing, turn off the
unit until the motor stops or for at least 10 sec
before switching polarity. Although reversed
polarity testing is not required, it may be advisable
on an air filtration unit of questionable quality.
With the polarity of the power line normal and the
equipment ground wire disconnected, measure
chassis leakage current with the air filtration unit
operating in all normal modes, including on,
standby, and off. Record the maximum leakage
current; it should not exceed 300 µA for patient-
care equipment used in a patient-care vicinity
[NFPA 99 7-5.1.3.5(a)]. ECRI does not recommend
chassis leakage current tests of double-insulated
devices.
The measurements should be made with all
accessories that are normally powered from the
same line cord connected and turned on. This
applies to devices that are plugged into accessory
outlets on the air filtration unit and to units that
are plugged into a multiple-outlet strip so that the
devices are grounded through a single line or
extension cord.
Leakage current must be measured with the air
filtration unit powered by a conventional
(grounded) power system, even if it is normally
used in an area with isolated power. If the air
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 Procedure No. 475-20010301 Mobile High-Efficiency-Filter Air Cleaners (Acceptance)

filtration unit has a special plug (e.g., explosion

proof), a corresponding adapter is required.

Though confirmation of grounding integrity

provides reasonable assurance of safety for
devices with permanent redundant grounding,
NFPA 99 calls for measurement of chassis leakage
current with the redundant ground intact [NFPA 99
7-5.1.3.5]. Where practical, verify that these
devices meet appropriate chassis leakage current
requirements before installation or connection to
ground during acceptance testing.

Be alert for leakage current of the air filtration unit

in the off mode that is greater than about 30 µA
and is greater than or equal to the leakage current
in the on mode. Although this may be normal and
proper for the unit, it may indicate that the on/off
switch is incorrectly wired in the neutral (instead
of the hot) line. Incorrect switch wiring poses a
risk to service personnel who believe that the
power is disconnected when the switch is off.
Check the wiring, or contact the manufacturer.

Airflow. (Note: If the manufacturer provides

unit-specific airflow measurements, this task can
be waived.) Using a flow hood, anemometer, pitot
tube, or other airflow measuring device, determine
the actual airflow produced by a representative
unit at high, medium and/or operating speeds.
Airflow measurement can be difficult to perform
accurately; carefully follow the instrument's
instructions for use. To reduce air turbulence and
allow accurate readings, measure airflow within or
exhausting from a long (at least four times the
size of the exhaust opening), straight duct that has
a large cross-sectional area and that is connected
to the unit's inlet or exhaust. Airflows should be
80% of the manufacturer-specified airflows.

Before Returning to Use

Return controls to their preinspection or normal
pre-use settings.

Confirm that the unit is positioned for the most

effective air cleaning of the room. The
manufacturer's literature should provide guidance
in this matter. In general, the unit should be
positioned so that the filtered air is moved the
farthest distance possible in the room before being
blocked or deflected by walls or furniture or
disturbed by other airflows. The unit should also
be positioned to prevent air from being directed
toward HVAC exhaust ducts and areas occupied by
healthcare workers.

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