Futrex HealthGuard-15 User manual

D-1
HealthGuard
®
-15
Owner’s Manual
FUTREX, INC.
130 Western Maryland Parkway
Hagerstown Maryland 21 40
For Assistance Call
301- 33-9368
[e-mail]
USA
EU Representative
DCK med GmbH
Echterdinger Str. 111 · D- 0 94 Filderstadt - Germany
Tel: [phone]
Fax: [phone]
[e-mail]
www.dck-med.de 0459
Manual Revisi n: O

D-2
TABLE OF CONTENTS
SECTION 1 – REGULATORY INFORMATION………………….……………….D-4
SECTION 2 – SAFETY INFORMATION…………………………….…….…D-5, D-6
SECTION 3 – BEFORE TAKING A MEASUREMENT……………..……………D-7
SECTION 4 – WARRANTY INFORMATION……………………….…………….D-8
SECTION 5 – CLEANING AND MAINTAINING THE HG-15……….….…..D-9
SECTION 6 – SERVICE REQUIREMENTS………………..………………………D-10
SECTION 7 – ELECTRICAL SAFETY……………………………….……………….D-11
SECTION 8 – ELECTROMAGNETIC TESTING AND SAFETY…..D-12 : D-16
SECTION 9 – ELECTROSTATIC DISCHARGE………………….……………….D-17
SECTION 10 – APPEARANCE AND PART NAMES…………….…………..D-18
SECTION 11 – ASSEMBLING AND SETTING UP YOUR HealthGuard-
15…………………………………………………………………………………….D-19 : D-22
SECTION 12 – USING THE HealthGuard-15…………...…………D-23 : D-28
SECTION 13 – PERFORMING A MEASUREMENT ………..……..D-29 : D-46
SECTION 14— TROUBLESHOOTING…..………………………………………..D-47
SECTION 15 – FCC STATEMENT…………………………………………………..D-48
SECTION 16 – HealthGuard-15 SPECIFICATIONS..………….……….……D-49
APPENDIX 1 – DEFINITIONS OF RATINGS…………………………D-50 : D-52
APPENDIX 2 – ESSENTIAL PERFORMANCE REPORT……..…….D-53 , D-54

D-3
SECTION 1
REGULATORY INFORMATION
Indicati ns f r Use
The HealthGuard-15 is a non-invasive screening device intended for use in
corporate wellness facilities and in health/fitness clubs. It is not for use in medical
facilities such as hospitals or doctor’s offices. This device measures systolic and diastolic
blood pressure, heart rate, percent body fat, and weight. It is operated by the client
supplied PC computer. The device is intended for users eighteen years and older.
130 WESTERN MARYLAND PARKWAY
HAGERSTOWN, MD 21740
301- 33-9368 • FAX: [phone] • E-mail: inf @futrex.c m
U.S. F d and Drug Administrati n
Medical Device
Trade Name: HealthGuard-15 Portable
Health Kiosk
Common Name: Non-invasive Blood
Pressure Measurement System
Classification Number: 21 CFR 8 0.1130
Classification: Class II
Panel: Circulatory System Device Panel
Product Code: DXN
Eur pean Uni n
Medical Device
LNE/G-MED
0459
Automatic electronic sphygmomanometer,
Body composition analyzer,
Pulse analyzer
Classification: Class IIa

D-4
SECTION 2
SAFETY INFORMATION
To assure correct use of this product, basic safety measures should
always be taken including the warning and cautions listed in this
section.
SAFETY SYMBOLS USED IN THIS OWNER’S MANUAL
WARNING
Indicates a potentially dangerous situation which, if not
avoided, could result in severe injury or death.
CAUTION
Indicates a potentially dangerous situation which, if not
avoided, could result in minor injury to the user or
patient or damage to the equipment or other property .
DEVICE OPERATING CAUTIONS & WARNINGS
Contact your physician for detailed information and advice about your
blood pressure. Self-diagnosis and treatment using measurement results
may be dangerous. Follow the instructions of a licensed healthcare
provider.
The HealthGuard-15 is not intended to be a diagnostic device and is
for screening purposes only.
Read all of the information in the Owner’s Manual before operating
the device.
This device is intended to measure blood pressure, weight, heart
rate, and percent body fat for adults. Do not use this device on children or
people who cannot express their intentions.
This device may cause discomfort or bruising on the upper arm. If
this develops press the STOP button on the side of the measurement
device or on the computer screen.

D-5
Operate the HealthGuard-15 only in the manner intended. Do not
use this device for any other purpose.
Dispose of the device and accessories according to applicable local
regulation.
Do not use a mobile device near the instrument. It could result in an
operational failure
Use only Futrex and HealthGuard authorized parts and accessories.
Parts and accessories not approved for use with the device may damage
the unit and void the warranty.
CARE AND MAINTENANCE
Do not subject the monitor to strong shocks, such as dropping the
device on the floor.
Do not expose the device or any of the components to water or
submerge in water.
Store the device and components in a cool, clean, dry, and safe
location.
Changes or modifications to the device not approved by the
manufacturer will void the warranty. Do not attempt to repair the unit or
components or disassemble the unit without expressed permission from
Futrex.
The HealthGuard
-
15 is limited for measurement of individuals with
arm circumference from 9 to 13 inches.

D-6
SECTION 3
BEFORE TAKING A MEASUREMENT
To obtain the most reliable readings, follow these instructions:
1. Avoid eating, drinking alcohol, smoking, exercising and
bathing for 30 minutes before taking a measurement. Rest
for three to five minutes before taking a measurement.
2. Stress raises blood pressure. Avoid taking measurements
during times of stress.
3. Remove tight-fitting clothing from your left arm.
4. Remain still and do not talk during the testing.
5. Wait 2 to 3 minutes between measurements. The wait time
allows arteries to return to the condition prior to taking the
blood pressure measurement. You may need to increase the
wait time depending on your individual physiological
characteristics.
6. Ensure that your left palm is down and your arm is
comfortably resting on the arm rest.
. Keep a record of your blood pressure and heart rate
readings for your physician. A single measurement does not
provide an accurate indication of your true blood pressure.
You need to take and record several readings over a period
of time.

D-
SECTION 4
WARRANTY INFORMATION
The following warranty card is included with your
HealthGuard-15. Please read the card and return it to Futrex.
HealthGuard support is available by calling 301- 33-9368 or
e-mailing [email protected]om.

D-8
SECTION 5
CLEANING AND MAINTAINING THE
HealthGuard-15
The HealthGuard-15 can be cleaned using soapy warm
water. Alcohol swabs should be used to disinfect the cloth cuff
and other surfaces that the arm may come into contact.
In the event that harmful materials are used f r cleaning,
damaged equipment will n t be serviced with ut charges
regardless f the warranty peri d.

D-9
SECTION 6
SERVICE REQUIREMENTS
For service within the warranty period or following; please
contact Futrex Support and Service at 301- 33-9368 or via e-mail
[e-mail]. Futrex is the only authorized service
representative for HealthGuard products.
DO NOT attempt to repair equipment without Futrex’s
expressed approval. This is will result in a void of warranty.
Failure to follow the cleaning and maintaining requirements
outlines in SECTION 5 may result in failure of the equipment and
possible health hazards. If there are any problems with the
equipment, please take the following steps.
1. Gather the instrument model, serial number, date of
purchase, and a description of the problem.
2. Call Futrex Service at 301- 33-9368 or e-mail the
information to [e-mail].
3. If necessary, Futrex will issue a Return Materials
Authorization (RMA) number which you will need to
include with your instrument if it requires to be sent back
for service. More information will be provided to you
about this process during your call to Futrex Service.

D-10
SECTION 7
ELECTRICAL SAFETY
Prior to the operation of the HealthGuard-15, make sure to
check the following items:
•Is the battery that will be powering the HealthGuard-
15 the same battery that is described in the Client-
Supplied parts on Page D-20.
•Are the power connections properly made to the
equipment?
•Is the battery properly charged?
The answer to all of these questions should be YES. Once
you have checked for electrical safety, you may power on the
instrument as instructed in the “Getting Started” section below.
Electrical Safety is important to maintaining the instrument
and preventing fires. Use caution at all times you are using AC
power, like when connecting a personal computer or a battery
charger to AC power. DO NOT overload power strips, as this is a
common cause of electrical fires.

D-11
SECTION 8
ELECTROMAGNETIC TESTING AND SAFETY
The HealthGuard-15 has been manufactured in compliance
with current EMI/EMC requirements; however the use of this
system in the presence of an electromagnetic field can cause
temporary degradation of the HealthGuard-15. If this occurs,
Futrex suggests a review of the environment in which the system
is being used to identify possible sources of radiated emissions.
These emissions can be from other electrical devices used within
the same room or an adjacent room. Communication devices such
as cellular phones can cause these emissions. The existence of TV,
radio, or microwave transmission equipment located nearby can
cause these emissions. If EMI/EMC causes disturbances, it may be
necessary to relocate your system.
As is required by formal standards, Futrex has supplied four
tables applicable to the HealthGuard-15 EMC Testing and Safety.
These tables are available in the following 4 pages.

D-12
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The HealthGuard-15 is intended for use in the electromagnetic environment specified
below. The customer or user of the HealthGuard-15 should assure that it is used in such
an environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
RF Emissions
CISPR 11
Group 1
The HealthGuard-15 uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any
interference in nearby electronic equipment.
RF Emissions
CISPR 11 Class B
Harmonic Emissions
IEC 61000-3-2
Not Applicable
Voltage Fluctuations
/ Flicker Emissions
IEC 61000-3-3
Not Applicable
The HealthGuard-15 is suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network
that supplies buildings used for domestic
purposes.

D-13
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The HealthGuard-15 is intended for use in the electromagnetic environment specified below. The
customer or the user of the HealthGuard-15 should assure that it is used in such an environment.
Immunity Test IEC 60601
Test Level
Compliance Level Electromagnetic
Environment – Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
± 6 kV Contact
± 8 kV Air
± 6 kV Contact
± 8 kV Air
Floors should be wood,
concrete or ceramic tile. If
the floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical Fast
Transient / Burst
IEC 61000-4-4
± 2 kV for power supply
lines
± 1 kV for input/output
lines
Not Applicable
The HealthGuard-15 does
not use AC Power / Power
Supply Lines during
operation
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth Not Applicable
The HealthGuard-15 does
not use AC Power / Power
Supply Lines during
operation.
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
) for 0,5
cycle
40% U
T
(60% dip in U
T
) for 5
cycles
70% U
T
(30% dip in U
T
) for 25
cycles
<5% U
T
(>95% dip in U
T
) for 5 s
Not Applicable
The HealthGuard-15 does
not use AC Power / Power
Supply Lines during
operation.
Power
Frequency
(50/60 Hz)
Magnetic Field
IEC 61000-4-8
3A/m 3A/m The HealthGuard-15 was
tested and performs
normally within the
specification limits.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.

D-14
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The HealthGuard-15 is intended for use in the electromagnetic environment specified below. The customer or the user
of the HealthGuard-15 should assure that it is used in such an environment.
Immunity Test IEC 60601 Test
Level Compliance Level Electromagnetic Environment – Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the HealthGuard-
15, including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended Separation Distance:
d= 1.2√P
d= 1.2√P 80 MHz to 800 MHz
d= 2.3√P 800 MHz to 2.5 GHz
Where Pis the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and dis the recommended separation
distance in meters.
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey
a
should be less than the
compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz to 800 MHz, the higher frequency range applies
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the HealthGuard-15 is used exceeds the applicable
RF compliance level above, the HealthGuard-15 should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the HealthGuard-
15.
b
Over the frequency range of 150kHz to 80MHz, field strengths should be less than 3 V/m.

D-15
Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and the HealthGuard-15
The HealthGuard-15 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the HealthGuard-15 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the HealthGuard-15 as recommended below,
according to the maximum output power of the communications equipment.
Separation Distance According to Frequency of Transmitter
m
Rated Maximum
Output Power of
Transmitter
W 150 kHz to 80 MHz
d= 1.2√P
80 MHz to 800 MHz
d= 1.2√P
800 MHz to 2.5GHz
d= 2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

D-16
SECTION 9
ELECTROSTATIC DISCHARGE
Electrostatic Discharge (ESD), commonly referred to as static
shock, is a common naturally occurring phenomenon. ESD is most
common in conditions with low humidity, which can be caused by
heating or air conditioning. In low humidity conditions, electrical
charges naturally build up on individuals and can create static
shocks. An ESD condition occurs when a person with an electrical
energy build-up comes in contact with objects such as metal
doorknobs, file cabinets, other people, or electronic equipment.
The static shock is a discharge of the electrical energy build-up
from a charged person to a lesser or non-charged individual or
object.
ESD can also build up from actions such as wearing socks on
carpet. The HealthGuard-15 takes weight measurements and
some clients may prefer to remove their shoes. It is important to
note that the level of electrical energy discharged from a user of
the HealthGuard-15 to the instrument can be significant enough
to cause damage to the equipment. The following precautions can
help to reduce ESD:
•Anti-Static Spray on Carpets & Linoleum
•Anti-Static Mats
•Grounding between the HealthGuard system and the table

D-1
SECTION 10
APPEARANCE AND PART NAMES
Cuff Housing Arm Rest
Optical Standard Software CD Communications Cable
Health-o-Meter Medical Scale Scale Cable
The HealthGuard-15 should include all of the components identified above.

D-18
SECTION 11
ASSEMBLING AND SETTING UP YOUR
HealthGuard-15
Step 1 – Provide enough room to place the Scale, Cuff Housing, Arm Rest, and your
computer as shown in the illustration below.
Figure 1
Step 2 - Attach the Cuff Housing to the table top using the supplied thumbscrews as
shown below. Then attach the Arm Rest. The arm rest will be held in place by the Velcro
strips that are attached to the Arm Rest and to the Cuff Housing
Figure 2

D-19
Step 3: Installing the HealthGuard-15 S ftware
Insert the Software CD into your CD drive. The CD will start automatically, and you will
see the following screen:
Note: If the CD does not start automatically, view the contents of the CD and double
click the setup.exe file.
Figure 3
Client Supplied
Parts
–
Minimum Requirements
Personal Computer
•PC Running Windows XP or higher version
•Pentium Class Processor
•One Available Communications Port
•1 GB RAM
•500MB Available Hardware Space
•1024 x 68 Resolution
Battery
•Talentcell 6000 mAh Li-Ion Battery Pack (Battery Charger supplied with Battery)
PRECAUTION
The HealthGuard-15 is designed to be powered and operated only using the Talentcell
battery pack described above. Do not attempt to use an alternative power supply.
Using a power supply other than the battery pack above will void your warranty.

D-20
After selecting the ‘Next’ button displayed in the lower right hand corner of the installer
the installation will begin. You will shortly see the dialog box below:
Figure 4
Select ‘OK’ to continue. When instructed, press enter and the driver installation will be
completed. After this set you will see the following message:
Figure 5