Manual
Certification Exhibit
FCC ID: Z9O-FAS1527
IC: 10060A-FAS1527
FCC Rule Part: 15.249
IC Radio Standards Specification: RSS-210
ACS Project: 13-2002
Manufacturer: UltraClenz, LLC
Models: FAS1527-00, FAS1527-01, FAS1527-02
User Manual
3998 FAU Blvd. Suite 310 Boca Raton, FL 33431 Tel: 561-961-5585 Fax: 561-961-5587
Patient Safeguard System® (PSS)
Healthcare Worker Badge User’s Guide
FAS1527 DFU Revision 2
UltraClenz, LLC
Patient Safeguard System – Healthcare Worker Badge User’s Guide UltraClenz, LLC
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Table of Contents
1.0 Healthcare Worker (HWC) Badge ..................................................................................................................3
2.0 How the Badge works within PSS .......................................................................................................................4
3.0 Installing the System ...........................................................................................................................................6
3.1 Healthcare Worker (HCW) Badge Installation .................................................................................................6
Appendix A - System Component Care and Maintenance .........................................................................................6
Cleaning the Badge.................................................................................................................................................6
Handling the Badge.................................................................................................................................................6
Battery Replacement...............................................................................................................................................6
Healthcare Worker (HCW) Badge ...........................................................................................................................6
Appendix B - FCC and Industry Canada Statements .................................................................................................8
Class B Devices: .....................................................................................................................................................8
RF Exposure ...........................................................................................................................................................8
Industry Canada Statements: .................................................................................................................................8
Warranty .....................................................................................................................................................................9
Revision History ..........................................................................................................................................................9
Patient Safeguard System – Healthcare Worker Badge User’s Guide UltraClenz, LLC
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1.0 Healthcare Worker (HWC) Badge
The PSS badge is an integral component of the individual reminder system. Badges are assigned to
specific healthcare workers (HCW) and may not be interchanged. It is worn by HCWs, such as doctors and
nurses. Healthcare facilities may also choose to assign badges to therapists, visitors, students or any
persons with patient contact. It is through the badge that the HCW is made aware, in real-time, of their hand
hygiene status. The badge achieves this by providing both visual and audible status alerts. The badge’s
visual alerts are provided by three visual indicator LEDs located just behind the badge’s clear window (see
Figure 1). Only one visual indicator will flash at a time, with a flash occuring once every 1.5 seconds.
Each indicator LED (green, yellow and red) represents the current level or state of the HCW’s hand hygiene
compliance. Each badge has a unique programmed identification address.
The LED (see Figure 2) indicates a SANITARY state which occurs when a HCW has recently used a
PSS enabled soap or sanitizer dispenser.
The LED (see Figure 2) indicates a REMINDER state which occurs when a HCW is currently in a
patient zone or has recently come in contact with a patient bed. It may also indicate that the HCW has not
used a soap or sanitizer dispenser within the designated grace period. Please note that this is only a
reminder state and it does not imply non-compliance. The HCW must use a soap or sanitizer dispenser
before patient contact to remain compliant with the system’s hand hygiene requirements.
The LED (see Figure 2) indicates an ALERT state which occurs when a HCW comes in contact with
more than one patient bed without using a soap or sanitizer dispenser between patient contacts. It may also
indicate that the HCW has not used a soap or sanitizer dispenser within the designated grace period after
leaving a patient zone. When a HCW’s badge is in the alert state (red flashing LED), it is possible that they
may have already spread pathogens from one patient to another. They should use a soap or sanitizer
dispenser immediately and avoid contact with everyone until proper hand hygiene has occurred.
The audible alert is generated by a piezoelectric sounder. The piezoelectric sounder is basically a very small
speaker that produces pleasant sounding beeps and chimes. These beeps and chimes occur when the
badge’s state is changing or when the badge is in the alert state.
Figure 2. HCWs Badge LEDs: Green (Sanitary State), Yellow (Reminder State) and Red (Alert State)
Figure 1. HCWs Badge -Visual Alert Location
LED Window
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The badge can be worn at the waist, on a lanyard around the neck, on a chest pocket, inside a chest pocket
or under a lab coat. However, the clear window is designed so HCWs and patients can view the current
badge status.
2.0 How the Badge works within PSS
When a Healthcare Worker (HCW) begins their shift, they will attach their assigned badge to their clothing in a
location above the waist that is clearly visible to themselves and others. The badge will be dormant with no
blinking LED visible. This is normal because the badge will go into a “sleep” state to conserve battery power when
not in use for a designated time period.
The first thing the HCW will do, after attaching their badge, is wash or sanitize their hands. The dispenser beacon
attached to the soap or sanitizer dispenser will communicate with the badge when the dispenser is activated.
Even though the badge is in a sleep state, it is always listening and the dispenser beacon’s communication will
wake it up. The badge will produce three quick beep tones with the second tone being lower in pitch than the first
or third tones. This indicates successful communications between the badge and the dispenser beacon. The
badge will then be set to the sanitary, or clean, state with the green LED blinking about once every 1.5 seconds.
The HCW is now ready to begin their normal work routine.
When the badge is set to the sanitary state, the badge starts an internal timer. If there is no interaction between
the HCW and a dispenser or patient bed, the timer will continue to increment. If the timer reaches the designated
grace period, the badge will automatically change from the sanitary state to the reminder state. When this
transition occurs, the badge will produce two quick beep tones with both having the same pitch. This indicates to
the HCW that the badge has automatically changed state. The badge’s yellow LED will then blink about once
every 1.5 seconds. The reminder state does not imply a violation of hand hygiene protocol. In this case, it is
indicating to the HCW, and anyone else able to see the badge’s yellow LED, that the HCW has not washed or
sanitized their hands for the designated grace period and that they may not approach a patient bed until doing so.
If the HCW does approach a patient bed while in the reminder state, this event will be considered a violation of
hand hygiene protocol and the badge will change from the reminder state to the alert state. The badge will
produce three quick beep tones with the second tone being lower in pitch than the first or third tones. This
indicates successful communications between the badge and the bed beacon located within the patient zone.
The badge’s red LED will then blink about once every 1.5 seconds. Immediately after changing to the alert state,
the badge will produce a rapid burst of four tones with each having a different pitch. This will be repeated four
more times over the next twenty seconds and will indicate to the HCW that they must wash or sanitize their hands
immediately.
If the HCW approaches a patient bed while in the sanitary state, the badge will change to the reminder state. The
badge will produce three quick beep tones with the second tone being lower in pitch than the first or third tones.
This indicates successful communications between the badge and the bed beacon located within the patient
zone. The badge’s yellow LED will then blink about once every 1.5 seconds. The reminder state does not imply a
violation of hand hygiene protocol. In this case, it is indicating to the HCW and anyone else able to see the
badge’s yellow LED that the HCW is currently in contact with a patient bed or has had contact with a patient bed
within the designated grace period.
While the HCW is inside the patient zone, their badge will remain in the reminder state. When the HCW leaves
the patient zone, the badge starts an internal timer. If there is no interaction between the HCW and a dispenser,
after leaving the patient zone, the timer will continue to increment. If the timer reaches the designated grace
period, the badge will automatically change from the reminder state to the alert state. When this transition occurs,
the badge will produce two quick beep tones both having the same pitch. This indicates to the HCW that the
badge has automatically changed state. Immediately after changing to the alert state, the badge will produce a
rapid burst of four tones with each having a different pitch. This will be repeated four more times over the next
twenty seconds and will indicate to the HCW that they must wash or sanitize their hands immediately. A HCW
may contact a patient bed, leave the patient zone briefly and then re-contact the same patient bed without
washing or sanitizing their hands. However, the HCW may not re-contact the patient bed without first using a soap
or sanitizer dispenser if they are outside of the patient zone for more than the designated grace period. As long as
Patient Safeguard System – Healthcare Worker Badge User’s Guide UltraClenz, LLC
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the HCW remains inside the patient zone, their badge will remain in the reminder state. When the HCW leaves
the patient zone, the badge starts an internal timer. If there is no interaction between the HCW and a dispenser,
after leaving the patient zone, the timer will continue to increment. If the HCW then reenters the patient zone and
the internal timer has not reached designated grace period, the badge will remain in the reminder state and the
internal timer will be reset. If the HCW reenters the patient zone and the internal timer has reached or passed
designated grace period, the badge will change to the alert state. The badge will produce three quick beep tones
with the second tone being lower in pitch than the first or third tones. This indicates successful communications
between the badge and the bed beacon located within the patient zone. The badge’s red LED will then blink about
once every 1.5 seconds. Immediately after changing to the alert state, the badge will produce a rapid burst of four
tones with each having a different pitch. This will be repeated four more times over the next twenty seconds and
will indicate to the HCW that they must wash or sanitize their hands immediately.
A HCW may not go from one patient zone to another without washing or sanitizing their hands in between. While
a HCW is in a patient zone, their badge will be in the reminder state. When they leave the patient zone, their
badge will remain in the reminder state for a designated grace period beyond which time their badge will
automatically change to the alert state or until they wash or sanitize their hands, at which time their badge will
then change to the sanitary state. If the HCW leaves a patient zone and then enters a different patient zone
without first interacting with a soap or sanitizer dispenser, the badge will change from the reminder state to the
alert state. The badge will produce three quick beep tones with the second tone being lower in pitch than the first
or third tones. This indicates successful communications between the badge and the bed beacon located within
the patient zone. The badge’s red LED will then blink about once every 1.5 seconds. Immediately after changing
to the alert state, the badge will produce a rapid burst of four tones with each having a different pitch. This will be
repeated four more times over the next twenty seconds and will indicate to the HCW that they must wash or
sanitize their hands immediately.
Below is a table that compares the various badge states.
State
Index
Badge
State
LED
Color
Description
Next Action
0
SANITARY
HCW has recently used a soap or sanitizer
dispenser.
May freely enter a patient zone.
1
REMINDER
HCW is in sanitary contact with a patient bed or has
recently had sanitary contact with a patient bed but
not yet used a soap or sanitizer dispenser.
Wash or sanitize hands
immediately after leaving patient
zone. Do not enter a different
patient zone.
2
ALERT
HCW has had contact with more than one patient
bed without using a soap or sanitizer dispenser
between contacts.
Leave patient zone immediately
and wash or sanitize hands.
3
ALERT
HCW had contact with patient bed, left patient zone
for more than the designated grace period and then
reentered same patient zone without using a soap
or sanitizer dispenser between contacts.
Leave patient zone immediately
and wash or sanitize hands.
4
REMINDER
HCW was in the sanitary state for more than the
designated grace period without using a soap or
sanitizer dispenser.
Wash or sanitize hands before
entering a patient zone.
5
ALERT
HCW was in the reminder state for more than the
designated grace period after leaving a patient zone
without using a soap or sanitizer dispenser.
Wash or sanitize hands
immediately. Do not enter a
patient zone.
Table 1 - HCW Badge States
Patient Safeguard System – Healthcare Worker Badge User’s Guide UltraClenz, LLC
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3.0 Installing the System
3.1 Healthcare Worker (HCW) Badge Installation
A new badge is supplied with a pull tab to protect battery life during shipment. Remove by firmly pulling this
tab out and discarding before initial use. For best performance, the badge should be worn above the waist in
a location that is clearly visible to the HCW as well as the patients and other healthcare staff. The badge was
designed to easily attach to a lanyard or a vinyl strap and clip. Both attachment methods are commonly used
by HCWs to carry credentials such as identification and RFID cards. For convenience, the badge was also
designed so that a HCW’s credentials may be attached to the base of the badge with a vinyl strap (see Figure
3).
Appendix A - System Component Care and Maintenance
Cleaning the Badge
The badge should be cleaned by wiping with a soft cloth. The cloth should be damp but not wet. A pre-moistened
alcohol swab may also be used. Only the exterior of each component may be cleaned. Do not attempt to clean
any interior surface of a component as this will damage the component’s circuitry. Do not use abrasive cleaners
or cleaning products in aerosol cans as they will damage the component’s finish.
Handling the Badge
The badge is an electronic device and should be handled with care. Like other electronic devices such as a cell
phone, the badge must be protected from extreme heat, cold and moisture. Avoid handling the badge with wet
hands or exposing it to rain. Avoid dropping or tossing the badge. The shock can damage the badge’s sensitive
internal electronics.
Battery Replacement
Healthcare Worker (HCW) Badge
The badge is powered by a single 3 volt coin cell battery (CR2032). The PSS dashboard software monitors the
badge battery good or low status flag to indicate when a replacement is required. The PSS dashboard software
will send out a maintenance email to a designated administrator, alerting the email recipient of the low badge
battery status along with any badge assignment information to locate and provide a replacement battery. It is
recommended that only one badge battery is replaced at a time to avoid mixing up the identifier addresses that
Figure 3. HCWs Badge (ID Credentials can be attached at the bottom)
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are assigned to the HCWs. Take care to return the badge to the HCW in which it is assigned upon battery
replacement.
Tools needed to replace the badge’s battery:
Quantity 1 - #2 Phillips head screwdriver
Step 1 - Using the #2 Phillips head screwdriver, remove the two back cover screws. Save the screws.
Step 2 - Flip the badge over and remove the front cover to expose the pc board and battery holder.
Step 3 - Take care not to disturb or damage the antenna on the left hand side of the board, or any of the
components while changing the battery. If you need to remove the board from the badge housing to
replace the battery, hold the board securely from the right hand top and bottom edges only.
Step 4 - Remove the battery from the battery holder and discard the old battery safely. Wait 30 seconds to allow
all of the remaining energy to dissipate from the old battery.
Step 5 - Install the new battery with the "+" side facing the installer and slide into the battery the holder.
Step 6 - Once the battery is installed in the badge, it will perform a power on self-test by scrolling through the LED
badge states and emitting an audio tone when complete to indicate it is functioning properly. If the audio
tone is heard during the LED sequence instead of after, repeat the battery replacement process with a
second replacement battery. If there is still no indication of proper function, request a replacement badge
immediately.
Step 7 - Replace the board assembly with the battery holder face down, then the back cover and tighten the
screws into place.
Step -1
Step - 2
Step 3
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Appendix B - FCC and Industry Canada Statements
Warning: Changes or modifications to this device not expressly approved by UltraClenz,
LLC could void the user’s authority to operate the equipment.
Class B Devices:
“NOTE: This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This equipment
generates, uses, and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver
is connected.
• Consult the dealer or an experienced radio/TV technician for help.”
RF Exposure
“This equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment. This equipment should be installed and operated with minimum distance 20cm
between the radiator and your body. This transmitter must not be co-located or operating in
conjunction with any other antenna or transmitter.”
Industry Canada Statements:
Under Industry Canada regulations, this radio transmitter may only operate using an antenna
of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To
reduce potential radio interference to other users, the antenna type and its gain should be so
chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that
necessary for successful communication.
Conformément à la réglementation d'Industrie Canada, le présent émetteur radio peut
fonctionner avec une antenne d'un type et d'un gain maximal (ou inférieur) approuvé pour
l'émetteur par Industrie Canada. Dans le but de réduire les risques de brouillage
radioélectrique à l'intention des autres utilisateurs, il faut choisir le type d'antenne et son gain
de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas l'intensité
nécessaire à l'établissement d'une communication satisfaisante.
Patient Safeguard System – Healthcare Worker Badge User’s Guide UltraClenz, LLC
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This device complies with Industry Canada licence-exempt RSS standard(s). Operation is
subject to the following two conditions: (1) this device may not cause interference, and (2) this
device must accept any interference, including interference that may cause undesired
operation of the device.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio
exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil
ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage
radioélectrique subi, même si le brouillage est susceptible d'en compromettre le
fonctionnement.
Warranty
This device is warranted against defective materials and workmanship for one year from the date of delivery.
Equipment covered by this warranty will be repaired or replaced in the United States and Canada, WITHOUT
CHARGE, except for shipping and handling, by our Factory Service Center.
When returning equipment for warranty service, you must first call your distributor’s Warranty Service
Department for your Return Merchandise Authorization Number (RMA), the RMA must be on your return label,
also the shipping charges must be pre-paid and a copy of your receipt must be enclosed.
This warranty covers all defects incurred from normal use of the equipment and does not apply in the following
cases:
a. Loss or damage to the equipment due to abuse, mishandling, accident or failure to follow mounting
instructions.
b. If the equipment is defective as a result of leaking batteries.
c. If the equipment has been serviced or modified by someone other than our authorized agents.
THE AFOREMENTIONED IS IN LIEU OF ALL WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING BUT
NOT LIMITED TO, ANY WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR
PURPOSE. IN NO EVENT SHALL THE VENDOR BE LIABLE FOR CONSEQUENTIAL, INCIDENTAL,
INDIRECT OR SPECIAL DAMAGES OR LIABILITY, TRANSPORTATION, INSTALLATION OR SUBSTITUTION
COSTS, DELAYS, OR FOR ANY OTHER DAMAGES, COSTS, OR EXPENSES INCURRED, IRRESPECTIVE
OF HOW THEY OCCUR. THIS WARRANTY SHALL NOT EXTEND TO ANY OTHER PERSON OTHER THAN
THE ORIGINAL PUCHASER OF THIS EQUIPMENT OR THE PERSON FOR WHOM IT WAS PURCHASED AS
A GIFT.
This warranty gives you specific legal rights, and you may also have other rights, which may vary from state to
state. This warranty is given with respect to equipment purchased in the United States.
Revision History
Revision
Date
By
Description
0
3/14/12
MES
Initial Release
1
08/09/12
DLS
Corrected TOC and replaced FCC class A statement with class B statement
2
01/27/14
KAS
Updated to Directions for Use