Advanced Body Sensing POX001 Sensor User Manual Manual

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Document ID	995258
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Document Description	Manual
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Document Type	User Manual
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Date Submitted	2008-09-04 00:00:00
Date Available	2008-09-04 00:00:00
Creation Date	2008-09-04 00:42:03
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Document Title	Microsoft Word - BRU & Pulse Oximeter User's Manual with FCC Material.docm
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Document Author:	Yitzhak Mendelson

TM
Advanced Body Sensing, LLC
60 Prescott Street
Worcester, MA 01605
USA
(508) 831-4130
E-mail: Absensing.com
BALSM Receiver Unit
Pulse Oximeter Sensor
Operator’s Manual
Copyright © 2008 as an unpublished trade secret. This document and all information herein is the property of Advanced
Body Sensing, LLC. It is confidential and must not be made public or copied.
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Table of Contents
Introduction............................................................................................................................................... 4
Forehead Sensor Module .......................................................................................................................... 4
Power Supply............................................................................................................................................ 5
Forehead Sensor Activation...................................................................................................................... 5
Forehead Sensor Attachment.................................................................................................................... 6
BALSM Receiver Unit ............................................................................................................................. 7
Temperature Capsule Activation .............................................................................................................. 7
PC Application Program........................................................................................................................... 8
Data Log Files......................................................................................................................................... 10
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! Warnings
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This prototype device is intended for limited testing by PSI and is not certified for clinical use.
Do not use the unit in an explosive atmosphere.
Do not use the unit in an MRI environment.
Check frequently the application site of the sensor on the forehead to make sure that skin
circulation is not impaired and adverse skin reaction is not visible.
The material used in the headband and sensor module of this product version has not been
tested for biocompatibility and may cause allergic reactions.
Extended use of the forehead sensor is not recommended as this may cause tissue ischemia and
skin necrosis if not properly applied.
If discomfort or skin irritation occurs, discontinue the use of this device.
Follow the precautions and warnings regarding the activation and use of the temperature
capsule according to the capsule manufacturer.
! Cautions
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Do not use the unit in the vicinity of very bright light sources.
General operation of the unit may be affected by RF interferences.
General operation of the unit may be affected by motion artifacts. Proper operation of this unit
is limited to resting conditions.
Readings displayed by this prototype have not been calibrated or validated with a standard
clinical monitor.
The unit should only be used in conjunction with other medically approved devices to diagnose
clinical symptoms.
Significant levels of dysfunctional hemoglobins, such as carboxyhemoglobin or
methemoglobin, may affect measurement accuracy.
The unit may not function in cold environments due to reduced blood circulation to the
forehead.
Do not immerse the unit is liquid or other cleaning solutions as this may cause permanent
damage.
To prevent damage, do not sterilize the forehead sensor or receiver unit.
Do not clean the surface of the optical sensor with abrasive materials.
Do not use cleaning solutions other than wiping the optical window with a damp cloth
moistened with water.
To preserve battery life, turn off the unit if not in use.
Do not attempt to remove, replace, or dispose of the battery.
Changes or modifications not expressly approved by Advanced Body Sensing could void the
user’s authority to operate the equipment.
•
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This manual serves as a preliminary operator’s manual for the alpha prototype of the BALSM receiver
unit. Advanced Body Sensing reserves the right to make changes to the system and this manual at any
time without notice or obligations.
BRU FCC ID: WKC-BRU001
Pulse Oximeter FCC ID: WKC-POX001
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation.
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 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.
Introduction
This section describes the operation of the wireless BALSM receiver unit (BRU). The dual-use BRU is
designed to measure core body temperature from an ingestible capsule thermometer as well as arterial
oxygen saturation (SpO2), heart rate (HR), respiration rate (RR), body motion and posture from a
forehead-mounted optical wireless reflectance sensor. The BRU can be used to activate the two sensors
independently and record data wirelessly for real-time rapid status assessment of vital physiological
information. The unit is lightweight and is intended for monitoring of adult subjects in field
applications lasting up to 84 hours. It is not recommended during applications where excessive motion
artifacts are expected. The unit has not been calibrated or certified for clinical use.
Forehead Sensor Module
The forehead worn sensor module (SM) contains a small and lightweight optical reflectance sensor,
signal processing circuitry, and a RF transceiver integrated into an elastic headband (Fig. 1). Dedicated
software is used to filter the signals and compute SpO2, HR, and RR based on the relative amplitude
and frequency content of the optical reflectance signals. Data from the SM are sent to the BRU via
low-power peer-to-peer short-range (~3 – 6ft) wireless communication. A tri-axis MEMS
accelerometer detects changes in body activity, and the information obtained through the tilt sensing
property of the accelerometer is used to determine the orientation of the person wearing the device.
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Optical Sensor
Fig. 1. Forehead Sensor Module
Power Supply
The SM is powered by a special coin cell battery which should allow for at least 200 hours of
continuous monitoring at room temperature. To extend battery life, the SM is turned off using a
magnet. Do not attempt to remove, replace, or dispose of the battery. The BRU receives power from
the PC through the USB interface cable.
Forehead Sensor Activation
The SM must be activated using a small activation magnet built into the BRU. To activate and pair the
pulse oximeter sensor with the BRU:
(1) Bring the pulse oximeter sensor up to the BRU (sensor should be on side as shown in diagram and
sensor label should be approximately in line with the white arrow on the BRU).
The sensor LED will turn red and start flashing.
(2) Within 10 seconds turn the sensor on its edge so the square detector is in front of the BRU optical
activation window.
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Press the Activate Sensor button on the BRU.
If successfully paired, then the Activate Sensor LED on the BRU will turn green and then flash green
at 1 second intervals. The sensor LED will glow constantly red.
If pairing fails, the sensor will turn off after 10 seconds. The sensor can be turned on again and pairing
tried again.
To turn off the sensor, bring it up to the BRU as described in step 1 until the sensor LED are turned
off.
Power LED
Step 1
Step 2
Fig. 2. Forehead Sensor Activation
Notes:
The BRU is currently running in a demo mode, i.e. every time the power is
cycled on the BRU, the SM must be activated again. If the activation is not
successful, the sensor LED will turn red for about 1 sec. Try again by repeating
the above steps.
Forehead Sensor Attachment
The monitoring site should be cleaned prior to sensor placement. Place the SM properly around the
forehead using the adjustable headband, as illustrated in Fig. 3. Orient the clear optical sensor window
towards the skin in the center of the forehead above the eyes. Make sure that the label affixed to the
side of the SM is oriented upward. To avoid inaccurate readings, ensure that the headband is not
applied too loosely or tightly around the head as this may cause erroneous readings.
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Fig. 3. Sensor Attachment on Forehead
After the SM is positioned on the forehead and is activated, it will begin sensing. Allow at least 20
seconds for the readings to stabilize. If you are not able to achieve stable readings, try repositioning the
SM on the forehead or adjusting the headband. Correct positioning of the sensor on the forehead is
critical to achieve accurate measurements. Note: a very loose or too tightly mounted sensor will cause
a degraded or loss of the PPG signals, leading to erroneous or inaccurate readings.
BALSM Receiver Unit
To turn on the BRU, plug the USB cable attached to the unit into any USB port on your PC. Once the
unit is connected with the PC, the green “Power” LED would turned on. Note that the “Sensor” and
“Capsule” LEDs will not light up unless the forehead sensor and temperature capsule have been
previously activated.
Temperature Capsule Activation
Note: Follow the precautions and warnings regarding the activation and use of the temperature capsule
according to the capsule manufacturer.
In order to activate the temperature capsule, place a non-activated temperature capsule into the IR port
on the side of the BRU housing indicated by the white capsule arrow as illustrated in Fig. 4.
1. Press the “Activate Capsule” button to start the activation process. During the activation
process, the “Capsule” LED will blink red for 10sec or until activation is complete.
2. If activation is successful, the capsule LED will turn green for about 1sec. Once the
temperature capsule is activated, the capsule LED will blink green every 15 sec when a
successful data packet is received. If the packet from the capsule is corrupt, or the
communication with the capsule failed, the capsule LED will blink red every 15 seconds.
3. If the activation failed, the capsule LED will turn red for about 1 sec. Remove and re-insert the
capsule into the activation port and repeat the activation process.
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Capsule LED
Capsule Activation Port
Fig. 4. Temperature Capsule Sensor Activation
PC Application Program
A special windows utility program is provided for real-time communication between the BRU and a
PC. The PC program has two user log files: One file is used to display the information received from
the SM and another file to display the data received from the temperature capsule.
The program displays a scrolling horizontal trace and numerical values of the most recently acquired
data corresponding to HR, SpO2 and RR values received from the SM and core body temperature
received from the ingestible capsule. To start or stop the program, the user must click the “start” or
“stop” buttons, respectively. To log data into a text file, select the “log data” option before you start the
program. A sample log file is shown below. After the program and sensor are activated, numerical
values in the System Info window will indicate the corresponding receiver and sensor addresses and
the link status window will display “Good” in green. When the program is stopped, the Link Status
window will display “Stopped” in red. While the program is running and data is received by the USB
receiver, the Sensor Info window will display Sensor Status, Battery Status, Battery Voltage and
sensor Temperature information. The Activity window includes a horizontal green bar graph
corresponding to the relative level of sensor movements. In addition, changes in sensor orientation are
described by a text label and depicted by a corresponding icon.
Until a capsule is activated, the Capsule Link Status will display "NOT ACTIVATED" and all the
other capsule fields will be blank, including the temperature graph. Once a new capsule is activated,
the corresponding Capsule ID, Capsule Type, and the received Diagnostics byte from the capsule are
displayed in the respective information boxes. The Link Status will display "GOOD".
The last received temperature data from the capsule will be displayed both on the scrolling data graph
and data box. The temperature trace will scroll every second using the last received value even though
the capsule data is received and updated only every 15 seconds, so that a continuous graph can be
displayed.
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If another temperature capsule is activated, the new capsule will override the previous capsule data and
all the information will be updated accordingly.
Fig. 5b. Windows utility program
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Data Log Files
ABS Wireless PulseOximeter Log file created on 2/27/2008 4:20:17 PM.
Receiver ID = 1009, Receiver Version = 1.001
Time Stamp
Sensor ID
4:20:18 PM
4:20:19 PM
4:20:20 PM
4:20:21 PM
4:20:22 PM
4:20:23 PM
4:20:24 PM
4:20:25 PM
4:20:26 PM
4:20:27 PM
4:20:28 PM
4:20:29 PM
4:20:30 PM
4:20:31 PM
4:20:32 PM
4:20:33 PM
4:20:34 PM
4:20:35 PM
4:20:36 PM
4:20:37 PM
4:20:38 PM
4:20:39 PM
4:20:40 PM
4:20:41 PM
1009
1009
1009
1009
1009
1009
1009
1009
1009
1009
1009
1009
1009
1009
1009
1009
1009
1009
1009
1009
1009
1009
1009
1009
Heartbeat Rate
(bpm)
SpO2 (%)
60
59
59
57
58
57
56
56
57
56
54
56
55
56
56
57
57
58
58
58
58
58
58
58
94
94
94
95
95
95
96
96
96
96
96
97
96
96
96
96
96
96
96
95
94
94
94
94
Respiration
Rate (bpm)
13
13
13
13
11
11
11
13
13
13
16
16
16
16
16
16
16
16
16
16
13
13
13
15
Sensor Status Battery Status Battery Voltage (V)
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
OK
Environment
Temperature (C)
Orientation
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
28.5
STANDING
STANDING
STANDING
STANDING
STANDING
STANDING
STANDING
STANDING
STANDING
STANDING
STANDING
STANDING
STANDING
STANDING
STANDING
STANDING
STANDING
STANDING
STANDING
STANDING
LYING DOWN
LYING DOWN
LYING DOWN
LYING DOWN
3.15
3.15
3.13
3.15
3.13
3.13
3.15
3.15
3.13
3.15
3.13
3.15
3.15
3.15
3.13
3.15
3.15
3.13
3.15
3.15
3.09
3.11
3.11
3.11
Activity Link Status
10
20
175
185
15
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
GOOD
ABS BRU Capsule Log file created on 2/27/2008 4:20:17 PM.
BRU ID = 1009, BRU Version = 1.001
Time Stamp
4:20:19 PM
4:20:34 PM
4:20:49 PM
9/4/2008
Capsule ID Core Temperature (C) Capsule Diag Link Status
533
533
533
23.83
23.85
23.85
Proprietary and Confidential Information of Advanced Body Sensing LLC
GOOD
GOOD
GOOD
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