Rossmax X9 User manual

www.rossmax.com
Model: X9
Blood Pressure Monitor

2
Blood pressure measurements determined with X9 are equivalent to those obtained by
a trained observer using cu/stethoscope auscultation method, within the limits pre-
scribed by the American National Standard, Electronic or Automated Sphygmomanom-
eters. This unit is to be used by adult consumers in home, physicians’ oces, hospitals,
clinics and other medical facilities. The patient is an intended operator. Do not use this
device on infants or neonates. X9 is protected against manufacturing defects by an es-
tablished International Warranty Program. For warranty information, you can contact
the manufacturer, Rossmax International Ltd.
Attention: Consult the accompanying documents. Please read this manual care-
fully before use. For specic information on your own blood pressure, contact your
physician. Please be sure to keep this manual.
Introduction
PARR(Pulse Arrhythmia) Technology
The upper chambers of the heart (the atria) do not contract, but quiver and thus blood
is driven irregularly and with lower eciency into the ventricles. Subsequently irregular
heartbeats occurs, which mostly are associated with a fast, yet highly instable heart rate.
Pulse Arrhythmia (PARR) technology specically detects the existence of pulse arrhyth-
mia, including atrial brillation (AFib), Atrial and / or Ventricular Premature Contractions
(PC), Tachycardia (TACH), and Bradycardia (BRAD). Pulse Arrhythmia may be related to
cardiac disorders, needs medical attention and thus early diagnosis is of paramount
importance. The PARR technology detects arrhythmia during regular blood pressure
checks without any additional user skills, user interaction and measurement prolonga-
tion. Beside the blood pressure diagnosis a specic pulse arrhythmia diagnosis is pro-
vided with PARR.
Note: The PARR detection of AFib, PC, TACH and BRAD is provided with a clinically
proven high detection probability [1]. However, the sensitivity and specicity is
limited, thus most, but not all pulse arrhythmia will be detected and displayed.
In certain patients with uncommon clinical conditions the PARR technology may
not be able to detect pulse arrhythmia. This partly comes from the fact that some
arrhythmia can only be found with an ECG diagnosis, but not with a pulse diagno-
sis. Thus PARR is not meant to replace any medical ECG diagnosis by your doctor.
PARR provides an early detection of certain pulse arrhythmia, which inevitably
need to be presented to your doctor in charge.
Remark: [1] Clinical Investigation of PARR - A new Oscillometric Pulse Arrhythmia Type
Discriminating Detection Technology
Atrial Fibrillation Detection (AFib)

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Extra abnormal heartbeats generated in irregular excitation sites of your heart, either in
the atria (PAC), the ventricle (PVC) or the cardiac conduction nodes (PNC). These extra
beats may disrupt your regular rhythm, they may come in early or cause a signicant
pauses regarding your perceivable pulse. This is called palpitations, which can be felt in
your chest. They may occur as isolated, single events, as a series of irregular pulses or can
be distributed all over your pulse beats. If they are not related to mental stress, or acute
demanding physical load, they may be a marker for a multitude of cardiac disorders.
Some of these disorders go along with an elevated risk prole for ischemic events, either
in the heart (e,g, coronary heart disease) or outside the heart, e.g. an elevated risk for a
stroke. Some PCs may indicate on valvular or myocardial disorders and become very
important if a myocarditis (infection of the heart muscle) is suspected. This unit is able to
detect premature contractions. The ARR and PC icons ( ) are displayed right after
the measurement if premature contractions have been detected.
Note: It is strongly recommended, that you consult your physician, if either the PC icon
occurs newly for several times, or, if your PC is known to your doctor, but the inci-
dence of PC readings changes over time. Your doctor will then be able to provide
all required medical test and possible therapeutic procedures.
This condition is associated with a higher risk for the formation of cardiac blood clots.
Amongst others, they may elevate the risk of brain strokes. Beside this atrial brillation
may contribute to the severity of a chronic or acute heart failure condition and may be
associated with other heart-related complications. Age dependent, about 10 %- 20 %
percent of patients who suer from an ischemic stroke also suer from atrial brillation.
Atrial brillation most often initially occurs with temporary periods of arrhythmia and
may progress to a permanent state of this disorder in the course of time. No matter,
whether you intent to safeguard yourself from an undetected AFib state, or you meas-
ure during an ongoing period of active atrial brillation, or you measure in between pe-
riods of AFib, the PARR technology can be applied at any of these conditions. This unit
is able to detect Atrial brillation (AFib). The ARR and AFib icons ( ) are displayed
right after the measurement if Atrial Fibrillation was detected.
Note: It is strongly recommended, that you consult your physician, if either the AFib icon
occurs newly for several times, or, if your AFib is known to your doctor, but the
incidence of AFib readings changes over time. Your doctor will then be able to
provide all required medical test and possible therapeutic procedures.
Note: The presence of a cardiac pacemaker may impair the AFib detection by PARR.
Premature Contraction Detection (PC)

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A fast heart rate of higher than 100 beats per minute (bpm) in adults. Unless being
caused by physical or mental stress, a tachycardia may be an indicator for both cardiac
(e.g. Coronary heart disease, valvular disorder), or extra-cardiac disorders (e.g. hyperthy-
roidism, fever, hypoxemia), as well as medication and stimulant substance side eects
(e.g. caeine). The unit is able to detect Tachycardia (TACH). The ARR and TACH icons (
) are displayed right after the measurement if tachycardia has been detected.
Note: It is strongly recommended, that you consult your physician, if either the TACH
icon occurs newly for several times, or, if your TACH is known to your doctor, but
the incidence of TACH readings changes over time. Your doctor will then be able
to provide all required medical test and possible therapeutic procedures.
Tachycardia Detection (TACH)
A slow heart rate of less than 55 beats per minute (bpm) in adults. Unless not genetically
determined or subsequent to a high cardiac endurance training adaptation, bradycar-
dia may be related to multitude of cardiac disorders (e.g. valvular heart disease, heart
failure) or extra-cardiac disorders (e.g. hypothyroidism, electrolyte imbalance) or medi-
cations (e.g. beta-receptor blocker). This unit is able to detect Bradycardia (BRAD). The
ARR and BRAD icons ( ) are displayed right after the measurement if bradycar-
dia was detected.
Note: It is strongly recommended, that you consult your physician, if either the BRAD
icon occurs newly for several times, or, if your BRAD is known to your doctor, but
the incidence of BRAD readings changes over time. Your doctor will then be able
to provide all required medical test and possible therapeutic procedures.
Bradycardia Detection (BRAD
Once the occurrence of pulse arrhythmia has been detected in the course of your blood
pressure measurement, the icon ARR is displayed. In the case, that the found pulse ar-
rhythmia can be specied by the PARR technology, the ARR icon is accompanied by the
specically detected type of arrhythmia, e.g. PC, AFib, TACH or BRAD. Once the kind of
found pulse arrhythmia cannot be safely determined by PARR, the device is displaying
ARR without any additional pulse arrhythmia type icon.
Note: It is strongly recommended, that you consult your physician, if either the ARR icon
occurs newly for several times, or, if your ARR is known to your doctor, but the in-
cidence of ARR readings changes over time. This is independent whether the ARR
icon is specied by another pulse arrhythmia icon or not. Your doctor will then
be able to provide all required medical test and possible therapeutic procedures.
Pulse Arrhythmia Detection (ARR)

5
The PARR technology is able to detect and display combined pulse arrhythmia ndings.
Display Results
- Normal nding
ARR Pulse Arrhythmia without type-specic detection
ARR PC Pulse Arrhythmia-Premature ventricular, atrial or nodal beat
detection
ARR AFib Pulse Arrhythmia-Atrial brillation detection
ARR TACH Tachycardia detection
ARR BRAD Bradycardia detection
ARR PC BRAD Combined Pulse Arrhythmia: Premature beats & Bradycardia
detection
ARR PC TACH Combined Pulse Arrhythmia: Premature beats & Tachycardia
detection
ARR AFib TACH Combined Pulse Arrhythmia: Atrial brillation & Tachycardia
detection
ARR AFib PC Combined Pulse Arrhythmia: Atrial brillation & Premature
beats detection
ARR AFib PC TACH Combined Pulse Arrhythmia: Detection of Atrial Fibrillation,
Premature Beats and Tachycardia.
This Blood Pressure Monitor complies with the European regulations and bears the CE
mark “CE 1639”. The quality of the device has been veried and conforms to the provi-
sions of the EC council directive 93/42/EEC (Medical Device Directive), Annex I essential
requirements and applied harmonized standards.
EN 1060-1: 1995/A2: 2009 Non-invasive sphygmomanometers - Part 1 - General require-
ments
Preliminary Remarks
This unit uses the oscillometric method to detect your blood pressure. Before the cu
starts inating, the device will establish a baseline cu pressure equivalent to the air
pressure. This unit will automatically determine the appropriate ination level based on
pressure oscillations, followed by cu deation.
During the deation, the device will detect the amplitude and slope of the pressure os-
cillations and thereby determine your actual the systolic blood pressure, diastolic blood
pressure, and pulse rate.
Real Fuzzy Measuring Technology

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EN 1060-3: 1997/A2: 2009 Non -invasive sphygmomanometers - Part 3 - Supplementary
requirements for electro-mechanical blood pressure measuring systems
EN 1060-4: 2004 Non-invasive sphygmomanometers - Part 4: Test Procedures to deter-
mine the overall system accuracy of automated non-invasive sphygmomanometers.
ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical investigation of
automated measurement type.
This blood pressure monitor was designed for long service periods. In order to ensure
continued accuracy, it’s recommended that all digital blood pressure monitors require
re-calibration. 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 de-
vice 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 your device to your
nearest dealer for re-calibration service.
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
Refer to the denitions of the World Health Organization, the blood pressure ranges
can be classied into 6 grades. (Ref. 1999 WHO-International Society of Hypertension
Guidelines for the management of Hypertension). This blood pressure classication are
based on statistical 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 your blood pressure, keeping long-term
records is recommended. Please download the blood pressure log at our website www.
rossmax.com.
Blood Pressure Standard

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Name/Function of Each Part
1. Arm Cu
2. Backlight LCD
3. Air Tube and
Connector
4. Battery Cover
5. Auto/Auscultation
Key
6. ON/OFF/START key
7. Memory/Marker key
8. Data Link Socket
9. AC Adaptor Jack
10. Cu Holder Design
8
9
1
5
4
2
37
6
10
Display Explanations (Bluetooth® Optional)
1. Arrhythmia Detection (ARR)
2. Atrial Fibrillation Detection (AFib)
3. Premature Contraction Detection (PC)
4. Tachycardia Detection (TACH)
5. Bradycardia Detection (BRAD)
6. Date/Time Indication
7. Movement Mark
8. Weak Battery Mark
9. Hypertension Risk Indication
10. Cuff Wrap Detection
11. Auto Mode
12. Auscultation Mode
13. Bluetooth®Mark
14. Systolic Pressure
15. Diastolic Pressure
16. Pulse Rate
17. Pulse Mark
18. Memory Mark
714
13
1 2 3 4 5
15
16
17
6
10
9
8
11
12
18

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If the cu was applied too loosely, it may cause unreliable measurement results or
measurements can fail to start. The “Loose Cu Detection” can help to determine if
the cu is wrapped snugly enough. The specied icon appears once a “loosen
cu” has been detected during measurement. Otherwise the specied icon ap-
pears if the cu is wrapped correctly during measurement.
Loose Cu Detection
The “Movement Detection” helps reminding the user to remain still and is indicat-
ing any adverse body movement during measurement. The specied 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.
Movement Detection
The World Health Organization, classifying blood pressure ranges into 6 grades. This
unit is equipped with an innovative blood pressure risk indication, which visually indi-
cates the assumed risk level (optimal / normal / high-normal/ grade1 hypertension /
grade 2 hypertension / grade 3 hypertension) of your result, making the meaning of
your ndings comprehensive.
Hypertension Risk Indication (HRI)
EE / Measurement Error: Make sure the L-plug is securely connected to the air
socket 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 qui-
etly. 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
occurring, return the device to your local distributor or service centre.
Error Codes for your reference

9
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 adap-
tors 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 com-
partment 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
adaptors.
4. Use only the authorized AC Adaptor with this blood pressure monitor. Information
for the authorized AC adaptor, please refer to APPENDIX 1.
Using the AC Adaptor
AC Adaptor
(Ø4.0 / Ø1.7)
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 alkaline batteries in the battery compartment accord-
ing 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

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1. Select cu according to arm size (Fig. ).
Applying the Cu
Index Line
Artery Mark
Arm Circumference Indicator
Rossmax
Cu size Arm circumference
L size 34~46 cm
(13.4”~18.1”)
M size 24~36 cm
(9.4”~14.2”)
S size 16~26 cm
(6.3”~10.2”)
2. Connect the air tube securely.
• Connect the air tube to the main unit by securing the air plug to the base of the
air connector.
• Securely connect the air tube and the cu set by rotating Luer connector (Fig. ).
3. Place the cu over the bare upper arm, wrap it with the tube pointing your palm,
and the artery mark over your main artery (Fig. ).
4. The edge of the cu should be at approximately 1.5 to 2.5 cm above the inner side
of the elbow joint. If the index line falls within the range of the arm circumference
indicator, the cu circumference is suitable, otherwise you may need a cu with a
dierent circumference (Fig. ).