Rossmax X9 User Manual
Model: X9
Blood Pressure Monitor
www.rossmax.com
Introduction
Blood pressure measurements determined with X9 are equivalent to those obtained
by a trained observer using cu/stethoscope auscultation method, within the limits
prescribed by the American National Standard, Electronic or Automated Sphygmomanometers. This unit is to be used by adult consumers in home, physicians’ oces, 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
established 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 specic information on your own blood pressure, contact your
physician. Please be sure to keep this manual.
PARR(Pulse Arrhythmia) Technology
Pulse Arrhythmia (PARR) technology specically detects the existence of pulse arrhythmia, 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 prolongation. Beside the blood pressure diagnosis a specic pulse arrhythmia diagnosis is provided 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 specicity 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 diagnosis. 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)
The upper chambers of the heart (the atria) do not contract, but quiver and thus blood
is driven irregularly and with lower eciency into the ventricles. Subsequently irregular
heartbeats occurs, which mostly are associated with a fast, yet highly instable heart rate.
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 suer from an ischemic stroke also suer 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 measure during an ongoing period of active atrial brillation, or you measure in between periods 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 (
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.
) are displayed
Premature Contraction Detection (PC)
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 signicant
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 prole 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 incidence of PC readings changes over time. Your doctor will then be able to provide
all required medical test and possible therapeutic procedures.
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Tachycardia Detection (TACH)
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. hyperthyroidism, fever, hypoxemia), as well as medication and stimulant substance side eects
(e.g. caeine). 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.
Bradycardia Detection (BRAD)
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, bradycardia 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 medications (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 bradycardia 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.
Pulse Arrhythmia Detection (ARR)
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 arrhythmia can be specied by the PARR technology, the ARR icon is accompanied by the
specically 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 incidence of ARR readings changes over time. This is independent whether the ARR
icon is specied by another pulse arrhythmia icon or not. Your doctor will then
be able to provide all required medical test and possible therapeutic procedures.
The PARR technology is able to detect and display combined pulse arrhythmia ndings.
Display Results
- Normal nding
ARR Pulse Arrhythmia without type-specic detection
ARR PC
ARR AFib Pulse Arrhythmia-Atrial brillation detection
ARR TACH Tachycardia detection
ARR BRAD Bradycardia detection
ARR PC BRAD
ARR PC TACH
ARR AFib TACH
ARR AFib PC
ARR AFib PC TACH
Pulse Arrhythmia-Premature ventricular, atrial or nodal beat
detection
Combined Pulse Arrhythmia: Premature beats & Bradycardia
detection
Combined Pulse Arrhythmia: Premature beats & Tachycardia
detection
Combined Pulse Arrhythmia: Atrial brillation & Tachycardia
detection
Combined Pulse Arrhythmia: Atrial brillation & Premature
beats detection
Combined Pulse Arrhythmia: Detection of Atrial Fibrillation,
Premature Beats and Tachycardia.
Real Fuzzy Measuring Technology
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.
Preliminary Remarks
This Blood Pressure Monitor complies with the European regulations and bears the CE
mark “CE 0120”. The quality of the device has been veried and conforms to the provisions 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 requirements
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