Installation Instructions
Automatic
Upper Arm
Blood Pressure
Monitor
Model: X3
Blood pressure measurements determined with X3 are equivalent to those obtained
by a trained observer using cu/stethoscope auscultation method, within the lim-
its prescribed by the American National Standard, Electronic or Automated Sphyg-
momanometers. This unit is to be used by adult consumers in a home environment.
The patient is an intended operator. Do not use this device on whole pediatric popu-
lation. X3 is protected against manufacturing defects by an established International
Warranty Program. For warranty information, you can contact the manufacturer, GMC
Inc.
Attention: Consult the accompanying documents. Please read this manual
carefully before use. For specic information on your own blood pressure, con-
tact your physician. Please be sure to keep this manual.
The GMC Upper Arm Automatic Blood Pressure Monitor, Model X3 is a non-invasive
blood pressure measurement device that is used for measuring systolic and diastolic
blood pressure and pulse rate using the oscillometric method for adults at home.
The device has an irregular heartbeat (IHB) indicator. The device detects the appear-
ance of an irregular heartbeat during measurement, and displays an IHB symbol on
the LCD with the reading once the irregular heartbeat is detected.
Introduction
Indications For Use
Real Fuzzy Measuring Technology
Name/Function of Each Part
Preliminary Remarks
This blood pressure monitor complies with :
• ISO 81060-2 :2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of
automated measurement type.
• IEC 80601-2-30: 2018 Medical electrical equipment - Part 2-30: Particular require-
ments for the basic safety and essential performance of automated non-invasive
sphygmomanometers.
• IEC 60601-1-2 : 2014 Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral Standard: Electromagnetic dis-
turbances - Requirements and tests
This blood pressure monitor was designed for long service time. Ensure continued
accuracy, it’s recommended that all digital blood pressure monitors require re-calibra-
tion. This monitor (under normal usage with approx. 3 measurements a day) does not
require re-calibration for 2 years. Once the unit should be re-calibrated the device will
display
. The unit should also be re-calibrated if the monitor sustains damage due
to blunt force (such as dropping) or exposure to uids and / or extreme hot or cold
temperature / humidity changes. When
appears, simply return to your nearest
dealer for re-calibration service.
/ grade 2 hypertension / grade 3 hypertension) of your result, making the meaning of
your ndings comprehensive.
Blood Pressure Standard World Health Organization (WHO) : 1999
Systolic Pressure
(mmHg)
Diastolic Pressure
(mmHg)
Optimal
<120
and
<80
Normal
120~129
or
80~84
High-normal
130~139
or
85~89
Grade 1 hypertension
(mild)
140~159
or
90~99
Grade 2 hypertension
(moderate)
160~179
or
100~109
Grade 3 hypertension
≥180
or
≥110
1. Arm Cu
2. LCD Display
3. Air Tube and Connector
4. Memory Key
5. ON/OFF/START key
1. Date/Time Indication
2. Weak Battery Mark
3. Movement Mark
4. Hypertension Risk Indication
5. Memory Mark
6. Memory Average Mark
7. Memory Zone
8. Systolic Pressure
9. Diastolic Pressure
10. Pulse Rate
11. Irregular Heartbeat Detection (IHB)
12. Pulse Mark
This unit uses the oscillometric method to detect your blood pressure. Before the cu
starts inating, the device will establish a baseline cu pressure equivalent to the air
pressure. This unit will automatically determine the appropriate ination level based
on pressure oscillations, followed by cu deation.
During the deation, the device will detect the amplitude and slope of the pressure
oscillations and thereby determine your actual the systolic blood pressure, diastolic
blood pressure, and pulse rate.
1
5
4
2
3
7
6
8
9
10
The “Movement Detection” helps reminding the user to remain still and is indicating
any adverse body movement during measurement. The specied icon appears once a
“body movement” has been detected during and after such a measurement.
Note: It’s highly recommended that you measure again if the icon
appears.
This monitor has a non-stored single measurement function. Press the User-Switching
key to select the memory zone of guest
, and follow the Measurement Procedure
to take a measurement correctly. When the measurement is completed, the measure-
ment value will not be stored in memory zone.
Refer to the denitions of the World Health Organization, the blood pressure ranges
can be classied into 6 grades. (Ref. 1999 WHO-International Society of Hypertension
Guidelines for the management of Hypertension). This blood pressure classication are
based on historical data, and may not be directly applicable to any particular patient. It
is important that you consult with your physician regularly. Your physician will tell you
your normal blood pressure range as well as the point at which you will be considered
at risk. For reliable monitoring and reference of blood pressure, keeping long- term re-
cords is recommended.
This unit is equipped with an innovative blood pressure risk indication, which visually
indicates the assumed risk level (optimal / normal / high-normal/ grade 1 hypertension
EE / Measurement Error: Make sure the L-plug is securely connected to the air sock-
et and calmly measure again. Wrap the cu correctly around your arm and keep arm
steady during measurement. If the error keeps occurring, return the device to your
local distributor or service centre.
E1 / Air Circuit Abnormality: Make sure the L-Plug is securely connected to the air
socket on the side of the unit and calmly measure again. If the errors still occur, return
the device to your local distributor or service centre for help.
E2 / Pressure Exceeding 300 mmHg: Switch the unit o and measure again quietly.
If the error keeps occurring, return the device to your local distributor or service centre.
E3 / Data Error: Remove the batteries, wait for 60 seconds, and reload. If the error
keeps occurring, return the device to your local distributor or service centre.
Er / Exceeding Measurement Range: Measure again quietly. If the error keeps oc-
curring, return the device to your local distributor or service centre.
This unit is equipped with an Irregular Heartbeat (IHB) Detection which allows those
who have an irregular heartbeat to obtain accurate measurements alerting the user of
the presence of an irregular heart beat during the measurement.
Note: It is strongly recommended that you consult your physician if the IHB icon (
) appears often.
1. Connect the AC adaptor with the AC adaptor jack on the right side of the unit.
2. Plug the AC adaptor into the socket. (AC adaptors with required voltage and current
indicated near the AC adaptor jack.)
Caution:
1. Please unload the batteries when operating with the AC mode for a longer
period of time . Leaving the batteries in the compartment for a long time may
cause leakage, which may lead to damage of the unit.
2. No batteries are needed when operating with the AC mode.
3. AC adaptors are optional. Please contact the distributor for the compatible AC adap-
tors.
4. Use only the authorized AC Adaptor with this blood pressure monitor. Information
for the authorized AC adaptor, please refer to APPENDIX 1.
Display Explanations
Using the AC Adaptor (Optional)
Movement Detection
Guest Mode
Hypertension Risk Indication (HRI)
Error Codes for your reference
Irregular Heartbeat (IHB) Detection
2
8
9
10
1
5
4
3
6
7
11
12
1. DO NOT adjust medication based on measurement results from this blood pressure
monitor. Take medication as prescribed by your physician. Only a physician is quali-
ed to diagnose and treat High Blood Pressure.
2. The monitor is not intended to be a diagnostic device.
3. Consult your physician before using the device for any of the following conditions:
common arrhythmias such as atrial or ventricular premature beats or atrial brilla-
tion, arterial sclerosis, poor perfusion, diabetes, age,pregnancy, pre-eclampsia, renal
diseases.
Cautionary Notes
1. Press down and lift the battery cover in the direction of the arrow to open the bat-
tery compartment.
2. Install or replace 4 “AA” sized batteries in the battery compartment according to the
indications inside the compartment.
3. Replace the battery cover by clicking in the bottom hooks rst, then push in the top
end of the battery cover.
4. Replace the batteries in pairs. Remove batteries when unit is not in use for extended
periods of time.
You need to replace the batteries when
1. Low battery icon appears on display.
2. The ON/OFF/START key is pressed and nothing appears on display.
Caution:
1. Batteries are hazardous waste. Do not dispose them together with the house-
hold garbage.
2. There are no user serviceable parts inside. Batteries or damage from old batteries are
not covered by warranty.
3. Use exclusively brand batteries. Always replace with new batteries together. Use
batteries of the same brand and same type.
Installing Batteries
6. User-Switching key
7. Battery Cover
8. Data Link Socket
9. AC Adaptor Jack
10. Cu Holder Design
4. Note that PATIENT motion, trembling, shivering may aect the measurement reading.
5. Do not use the device on the injured arm or the arm under medical treatment.
6. Do not apply the arm cu on the arm while on an intravenous drip or blood transfu-
sion.
7. Consult your physician before using the device on the arm with an arterio-venous
(A-V) shunt.
8. Do not use the device with other medical electrical (ME) equipment simultaneously.
9. Do not use the device in the area of HF surgical equipment, MRI, or CT scanner, or in
an oxygen rich environment.
10. The air tube or the AC adapter cable may cause accidental strangulation in infants.
11. Contains small parts that may cause a choking hazard if swallowed by infants.
12. Always consult your physician. Self-diagnosis of measurement results and self-treat-
ment are dangerous.
13. Consult your physician before using the device for any of the following conditions:
• If you have had a mastectomy.
• Do not take measurements more than necessary. It may cause bruising due to
blood ow interference.
• People with severe blood ow problems or blood disorders as cu ination can
cause bruising.
14. Remove the arm cu if it does not start deating during the measurement.
15. Do not use this device on infants or persons who cannot express their intentions.
16. Do not use the device for any purpose other than measuring blood pressure.
17. Use only the approved arm cu for this device. Use of other arm cus may result in
incorrect measurement results.
18. Do not disassemble the monitor or arm cu. This may cause an inaccurate reading.
19. Do not use in a location with moisture, or a location where water may splash on the
device. This may damage the device.
20. Do not use the device in a moving vehicle (car, airplane).
21. Leaky batteries can damage the unit. Remove the batteries when the unit is not used
for a long time.
22. Do not forcibly crease the arm cu or the air tube excessively.
23. Do not press the air tube while taking a measurement.
24. To unplug the air plug, pull on the air plug at the connection with the monitor, not
the tube itself.
25. Do not drop the monitor or subject device to strong shocks or vibrations.
26. Do not inate the arm cu when it is not wrapped around your arm.
27. Do not use the device outside the specied environment. It may cause an inaccurate
reading.
28. Dispose of the device, components and optional accessories according to applica-
ble local regulations. Unlawful disposal may cause environmental pollution.
29. Used cu may be contaminated medical waste and should be disposed of in ac-
cordance to your local regulations. If blood or other soil cannot be removed, the
contaminated reusable cu should be disposed. Skin contagious diseases (eg
Staphylococcus aureus, vancomycin-resistant Enterococcus) that a patient possibly
has, and should either follow a full disinfection process in this case before reusing it
or dispose of the cu completely without reuse.
30. This unit is not eld serviceable. You should not use any tool to open the device nor
should you attempt to adjust anything inside the device. If you have any problems,
please contact the store or the doctor from whom you purchased this unit or please
contact GMC Inc.
31. To stop operation at any time, press the ON/OFF/START key, and the air in the cu
will be rapidly exhausted.
32 Batteries can be fatal if swallowed. You should therefore store the batteries and prod-
ucts where they are inaccessible to small children. If a battery has been swallowed,
call a doctor immediately.
33 Do not service or maintain device and cu while in use.
34 This device should not be used adjacent to or stacked with other equipment.
35 Please do not use any other cables or accessories not approved by the manufacturer
in this manual to avoid negative inuence on electromagnetic compatibility.
36 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 of the device.
Federal Communications Commission (FCC) Statement
15.105(b)
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 pro-
vide reasonable protection against harmful interference in a residential installation.
This equipment generates, uses and can radiate radio frequency energy and, if not in-
stalled 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 o
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 dierent from that to which the
receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
15.21
You are cautioned that changes or modications not expressly approved by the part
responsible for compliance could void the user’s authority to operate the equipment.
FCC RF Radiation Exposure Statement:
1. This Transmitter must not be co-located or operating in conjunction with any other
antenna or transmitter.
2. For body worn operation, this device has been tested and meets FCC RF exposure
guidelines. When used with an accessory that contains metal may not ensure com-
pliance with FCC RF exposure guidelines.
1. Unwrap the arm cu, leaving the end of the cu through the D-ring of the cu.
2. Put your left arm through the cu loop. The color strip indication should be posi-
tioned closer to you with the tube pointing in the direction of your arm (Fig. ).
Turn your left palm upward and place the edge of the arm cu at approximately 1.5
to 2.5 cm above the inner side of the elbow joint (Fig. ). Tighten the cu by pulling
the end of the cu.
Applying the Cu
GMC_IB_X3(2)NA17_EN_AH_ver2034.indd 1 2020/8/18 上午 11:33:26