Ramsey Medical statMAP User manual

www.statmap.net
800-231-6370 or 813-289-5555 Patents Pending
Ramsey Medical, Inc.
Blood Pressure Measurement Device
Instructions For
REF # 7200-0001

Page 2
TABLE OF CONTENTS
Description 3
Explanation of Symbols 4
Important Information 5
Precautions for Use 6
Guidance and Manufacturer’s Declaration 9
Accessories 13
Controls and Indicators 14
Operating Instructions (semi-automatic mode) 17
Operating Instructions (manual mode) 22
Battery Replacement 23
Maintenance 24
Troubleshooting 26
Specifications 28
Warranty 30
Customer Service 30
Repairs 30

Page 3
DESCRIPTION
statMAP™ is a portable battery-powered blood pressure
measuring device. statMAP utilizes the oscillometric,
step deflate method for non-invasive blood pressure
determination.
statMAP measures all of the blood pressure parameters:
systolic, diastolic, mean arterial pressure and heart rate.
Heart rate is derived from the BP determination, which
measures peripheral pulses, not the electrical signal of an
EKG.
statMAP provides another unique and proprietary feature,
the “Nominal Session BP Value” (NSV). The NSV is displayed
for the user by cycling the power OFF then ON after a BP
measurement session is finished. All of the session’s readings
are then analyzed by the statMAP and a “Nominal Session
BP Value” is displayed. This “Nominal Session Value” is not an
average of the BP readings, but a substantially more robust
statistical measure of the nominal BP during the BP session
since it eliminates BP outliers in the presence of noise and/or
excessive motion.

Page 4
EXPLANATION OF SYMBOLS
Type BF applied part (defibrillation-proof)
IPX1 Drip –Proof
Attention, refer to accompanying documents
On / Off momentary switch
Multi-Function Button

Page 5
IMPORTANT INFORMATION
Indications for use:
statMAP is a prescription device and is indicated for use to
measure systolic and diastolic pressure, mean arterial pressure
(MAP) and heart rate of persons ages 12 and over using the
oscillometric method of measurement.
statMAP may be used in hospital departments (ICU, CCU,
step-down units, recovery, MedSurg, ED, L&D, Radiology),
outpatient settings, physician offices, EMS environments and
home health care.
Caution: Federal law (U.S.A.) restricts this device to sale by
or on the order of a physician.
Improper cuff size and improper cuff fit will result in inaccurate
(or no) BP readings.
Accurate BP readings require proper cuff size and a “snug-
tight” fit (allow 2 fingers between cuff and patient). Use the
appropriate cuff markings to ensure the cuff is the correct size.
See Table Below:
Mid-Arm Circumference Range Cuff
Small Adult: 20.0 to 27.0 cm size 10
Adult: 25.3 to 34.3 cm size 11
Large Adult: 32.1 to 43.4 cm size 12
Warning: A cuff that is too loose or too tight can result in
inaccurate readings. A cuff that fits too tightly can cause
venous congestion.

Page 6
PRECAUTIONS FOR USE
 Cuff Size – only use the cuff when the artery index marker
falls within the printed range indicated on the cuff, otherwise
erroneous readings may result.
 Use only cuffs approved by Ramsey Medical Inc. (refer to
Accessories section for ordering information).
 Do not allow the cuff to remain on the arm for more than
10 minutes when inflated above 10mmHg. Devices that
exert pressure on tissue have been associated with
purpura, skin avulsions, compartmental syndrome, ischemia
and/or neuropathy.
 When using statMAP, the operator should be monitoring the
pressure within the device at all times. When the device is
shut off (intentionally or accidentally) the pressure remains
within the cuff and the operator must manually deflate the
cuff.
 Care should be taken to avoid restriction or compression of
the cuff tubing.
 If disposable Lithium AAA batteries are used, they must
be UL recognized to standard UL1642. Ramsey Medical
recommends Energizer Lithium No. L92.
 When replacing the batteries, always replace both batteries
with ones that are known fresh and that are of the proper
type.
 Remove the batteries from statMAP if it will not be used for
an extended length of time.
 The statMAP, when used with Ramsey Medical approved
cuffs, is protected against defibrillator damage.

Page 7
PRECAUTIONS FOR USE (con’t)
 Caution: Care should be taken when using the statMAP to
observe the maximum allowed pump-up pressures as
follows:
Adults 280mmHg
Pediatrics (12 to 16 years) 200mmHg
 Do not immerse the statMAP in water. If the device is
splashed with water or becomes wet, wipe it immediately
with a dry cloth.
 Arrhythmias may extend the time required for blood pressure
measurement beyond the design capabilities of the statMAP.
 The statMAP may not meet its performance specifications
if stored or used outside of the specified temperature and
humidity ranges (refer to page 29).
 Blood pressure measurements determined with the statMAP
are equivalent to those obtained by a trained observer using
the cuff/stethoscope auscultatory method, within the limits
prescribed by the American National Standard, manual,
electronic, or automated sphygmomanometers. (ANSI/AAMI
accuracy standard, 2002).
 Precautions regarding Electromagnetic Compatibility (EMC)
are required when using Medical Equipment. The statMAP
should be placed into service according to the EMC
information provided in this manual.
 Portable and mobile RF communications equipment can
affect medical equipment.
 The measurement accuracy and user control functions
as specified in this manual are determined to be statMAP
essential performance.

Page 8
PRECAUTIONS FOR USE (CON’T)
 The statMAP is designed to conform to Electromagnetic
Compatibility (EMC) standard EN 60601-1-2, 2001 and
will operate accurately in conjunction with other medical
equipment which also meets this requirement. To avoid
interference problems affecting the statMAP, do not use
it in the presence of equipment which does not conform
to these specifications.
 There is potential for radio/television interference.
statMAP 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. The product 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 the product does cause harmful
interference to radio or television reception, which can be
determined by turning the product on and off, 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 product and
receiver.
 Consult the dealer or an experienced radio/TV
technician for help.
 Inaccurate readings may result when an electrosurgical unit
(ESU) is used while monitoring with the statMAP. If this is
suspected, discontinue use of the statMAP in semi-
automatic mode while the (ESU) is in use and use the
alternate manual mode for blood pressure measurement.

Page 9
GUIDANCE AND MANUFACTURER’S
DECLARATION
Electromagnetic Emissions
The statMAP is intended for use in the electromagnetic
environment specified below. The customer or user of the
device should assure that it is used in such an environment.
Emissions
test Compliance Electromagnetic environment - guidance
RF emissions -
CISPR 11 Group 1
The device 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
The device is suitable for use
in all establishments other than
domestic establishments and
those directly connected to the
public low-voltage power supply
network that supplies buildings
used for domestic purposes.
Harmonic
emissions
IEC 61000-3-2
not
applicable
Voltage
fluctuations/
flicker
emissions
IEC 61000-3-3
not
applicable

Page 10
Electromagnetic Immunity
The statMAP is intended for use in the electromagnetic
environment specified below. The customer or user of the
statMAP should assure that it is used in such an environment.
Immunity test IEC60601
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 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 not applicable
Surge
IEC 61000-4-5
± 1 kV
differential
mode
± 2 kV
common
mode
not
applicable not applicable
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
>95% dip in
0.5 cycle
60% dip in 5
cycles
30% dip for
25 cycles
>95% dip for
5 seconds
not
applicable not applicable
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m not
applicable not applicable

Page 11
Electromagnetic Immunity
The statMAP is intended for use in the electromagnetic
environment specified below. The customer or user of the
statMAP should assure that it is used in such an environment.
Immunity test IEC60601
test level Compliance Level Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150kHz to
80 MHz 3 Vrms
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz 3 V/m
d =(1.17) 80 - 800MHz
d =(2.33) 800Mhz - 2.5GHz
Note 1: At 80 MHz and 800 MHz,
the higher frequency range applies.
Note 2: These quidelines may not
apply in all situations. Electromag-
netic propagation is affected by
absorption and reflection from
structures, objects, and people.
where P is the maximum output power
rating of the transmitter in watts (W) and
is the recommended separation distance
in meters (m). 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:
aField 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 electromag-
netic site survey should be considered. If the measured field strength in the location
in which the device is used exceeds the applicable RF compliance level above, the
device should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating
the device.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.
d =(1.17)

Page 12
Recommended separation distances between portable
and mobile RF communications equipment and the
statMAP
The statMAP is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or
user of the device can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the device as
recommended below, according to the maximum output power
of the communications equipment.
Separation distance according to frequency of
transmitter (m)
Rated max.
output power of
transmitter (W)
0.01 0.11667 0.11667 0.23333
0.1 0.36894 0.36894 0.73785
1 1.1667 1.1667 2.3333
10 3.6894 3.6894 7.3785
100 11.667 11.667 23.333
For transmitters rated at a maximum output power not listed above,
the recommended separation distanced 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.
150kHz to
80 MHz
d =(1.17)
800MHz to
2.5GHz
d =(2.33)
180 MHz to
800MHz
d =(1.17)

ACCESSORIES
The following blood pressure cuffs are approved for use
with statMAP :
Page 13
Cuffs:
Reorder No.
8061
8062
8063
Type
Small Adult
Adult
Large Adult
Arm Circumference
Range
20.0 to 27.0 cm
25.3 to 34.3 cm
32.1 to 43.4 cm
Cuff
Size 10
Size 11
Size 12

CONTROLS AND INDICATORS
Power Button: Power button turns the device On/Off.
(In order to conserve battery life, the statMAP will
automatically shut off after 10 minutes of “no use”).
Multi-Function Button: The Multi-Function button is used
to control two features of the statMAP:
1) Brightness of LED display.
2) Blood pressure display to the nearest mmHg.
(refer to page 21).
Power Multi-Function
Battery Change Screw
Zero Indicator (with no pressure, needle should be in oval)
Status Indicator
Low Battery
Indicator
Power/Status
Indicator
Gauge
Needle
Page 14

Page 15
Power/Status Indicator: This LED indicator illuminates
GREEN to inform the user Power is ON.
Status Indicators: At the end of a determination, the LEDs
in the status ovals will flash AMBR and the automatic valve
will open releasing pressure in the cuff. The user must
purge the cuff by squeezing and holding the deflate trigger
until all air is released from the cuff. At that time, the LEDs
will stop flashing and the GREEN Power ON LED will re-
main illuminated, indicating that the statMAP is ready for
use. During an automatic determination, the measuring
LED will illuminate green indicating a measurement is in
progress.
Low Battery Indicator: The low battery indicator may
illuminate during a determination. This is a warning for
battery replacement. When the light remains illuminated,
battery replacement is required. Always replace both AAA
batteries at the same time to ensure proper performance.
Observe the proper orientation of the batteries, since the
unit will not function, and may potentially be damaged, if
the batteries are not inserted properly.
Zero Indicator: The zero indicator is used to verify the
gauge needle accuracy. When the cuff is completely
deflated, the gauge needle should be over the Zero
Indicator. If it is not, open the deflate trigger (see pg. 16)
to release any pressure that remains inside the cuff.
CONTROLS AND INDICATORS (con’t)

Cuff Connector: Attach cuff
connector securely to device
connector.
Inflation Bulb: Use
to inflate cuff.
Page 16
Deflate Trigger:
When the red deflate trigger is in the up position (valve
closed), cuff is ready for inflation.
When the red deflate trigger is in the down position
(valve open), air is released from the cuff.
Deflate Trigger up
(valve closed) Deflate Trigger down (valve open)
CONTROLS AND INDICATORS (con’t)

Page 17
OPERATING INSTRUCTIONS:
Semi-Automatic Mode
1. The ideal circumstance for accurate BP measurement
is to have the subject relaxed and seated comfortably
with the arm free of clothing. The cuffed arm should be
supported to maintain the cuff at the patient’s heart
level.
2. Turn the statMAP ON.
Note: the unit should be switched ON before the
cuff is attached to assure no input pressure, this is
essential for accurate readings.
3. Select the appropriate cuff size. Place cuff so that the
artery mark is aligned with the artery index marker.
Wrap cuff snugly around the patient’s arm, ensuring
that the cuff index marker (line) falls within the range
markings.
4. Connect the cuff hose to the statMAP, ensuring that
the connection is tight.
5. Open the deflate trigger and verify the needle is located
in the zero indicator. This assures zero pressure in the
system. (If needle is not in zero indicator, contact
customer service).
6. If there is a “Nominal Session BP Value” (NSV)
from the previous BP measurement session, it will
be displayed until the cuff pressure is raised over
30 mmHg, at which time previous BP measurement
data will be erased and removed from the memory, so
make sure it has been recorded before starting a new
BP session.

Page 18
7. If there is no NSV stored in the unit, there will be a sequential
illumination of each of the LEDs to verify that all are function-
ing properly. (Subsequently, several other LEDs will then
flash indicating the version of the operating software. These
can be ignored unless needed by customer support.) When
a single steady GREEN light appears in the Power/status
indicator, the device is ready for cuff inflation to make a BP
determination.
8. Verify that the deflate trigger is in the closed (up) position.
9. Inflate the cuff by squeezing the bulb firmly, but gently.
Avoid accidentally opening the deflate trigger while inflating
the cuff. Inflate the cuff 40 – 50 mmHg higher than the
expected systolic pressure. DO NOT OVER-INFLATE.
Over-inflation (pressures beyond 260 mmHg) may cause
damage to the statMAP and harm the patient. The gauge
needle and the illuminated LED should track together and
agree during the inflation. (If during inflation the gauge
needle and LED are not in agreement within approximately
+/- 5 mmHg, see Troubleshooting, page 26).
10. After cuff inflation, leave the deflate trigger in the closed (up)
position. The statMAP’s internal electronic valve will
automatically deflate the cuff pressure in a series of steps.
As the deflate needle steps down, an LED will light at each
step down point. A green light in the status indicator area
will illuminate, indicating that a measurement is in progress.
OPERATING INSTRUCTIONS:
Semi-Automatic Mode (con’t)

Page 19
11.When both AMBR lights flash in the status indicator areas,
the BP determination is complete. The remaining air must
be released from the cuff by squeezing the deflate trigger.
The statMAP will indicate BP and Heart Rate at the end of
the deflation on the LEDs to the nearest 5mmHg tic mark.
To obtain a BP reading to the nearest 1mmHg, refer to
page 21.
Solid LED Illuminations Flashing LED Illumination
Highest reading - Systolic Heart Rate
Lowest reading - Diastolic
12. To obtain another reading, just re-inflate the cuff. statMAP
“remembers” the last 10 readings in a session and uses
them to compute the NSV.
NOTE: statMAP remembers all readings but can only
generate a good NSV if there are 3 or more readings
made in a session.
13. The NSV is displayed for the user by cycling the power
OFF then ON after a BP measurement session is finished.
All of the session readings are then analyzed by the
statMAP and a “Nominal Session BP Value” is displayed.
OPERATING INSTRUCTIONS:
Semi-Automatic Mode (con’t)
Systolic
Heart Rate
(Flashing)
Diastolic
NOTE:
If there is only 1
solid LED &
1 flashing LED,
the flashing LED
represents the
HR, AND either
the Systolic or
the Diastolic
pressure.

14. Resetting statMAP to clear the NSV
Clearing the NSV from statMAP occurs automatically or manually.
Automatic
1) Turn Unit OFF and back ON. (Record the NSV on the patient’s
chart.)
2) Begin new BP Session with same or next patient by inflation of
the cuff.
3) Unit is cleared of all previous session NSV readings.
Manual
1) Turn Unit Off and back ON.
2) Inflate Cuff to approximately 160 mmHg, wait for 1 step down
deflation.
3) Open the Deflate Trigger in the down position.
4) The LEDs will light in sequence sweeping from 20 to 280, the
Cuff Site and Mode amber light will flash once or twice and go
out, the 20 LED will light and remain solid.
5) Unit is cleared of all previous session NSV readings.
NOTE: If for any reason the statMAP is unable to get a BP reading,
all LEDs will sequence around the dial once to indicate the failure
to determine the BP. The AMBR LEDs will flash to indicate to the
user to completely purge the cuff, which the user should do by fully
opening the deflate trigger (down position). Determine and correct
the reason for the BP measurement difficulty. Often the problem is
one or more of:
1) movement during the determination
2) cuff is not proper size or snugness (check size/fit)
3) initial cuff inflation is too low (pump cuff higher)
Page 20
OPERATING INSTRUCTIONS:
Semi-Automatic Mode (Con’t)