Reflex RX101 User manual

I
RX101 PPG Recorder
Instruction Manual
Version 1.3

II
Version Control
Date
Description
Version No.
Remark
May 12, 2012
Initialize first draft
-Set table of content
1.0
May 20, 2012
Complete User Instruction
1.1
May 21, 2012
Complete Safety and Introduction
1.2
June 28, 2012
Complete Frist Draft
1.3

III
User Instructions
This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for
medical devices and harmonized standards. In case of modifications and software upgrades, the
information contained in this document is subject to change without notice.
The Manual describes, in accordance with RX101 PPG Recorder’s features and requirements, main
structure, functions, specifications, correct methods for transportation, installation, usage, operation,
repair, maintenance, storage, etc. as well as the safety procedures to protect both the user and
equipment. Refer to the respective chapters for details.
Please read the User Manual carefully before using this product. The User Manual which describes
the operating procedures should be followed strictly. Failure to follow the User Manual may cause
measuring abnormality, equipment damage and human injury. The manufacturer is NOT responsible
for the safety, reliability and performance issues and any monitoring abnormality, personal injury
and equipment damage due to users' negligence of the operation instructions. The manufacturer’s
warranty service does not cover such faults.
Owing to the forthcoming renovation, the specific products you received may not be totally in
accordance with the description of this User Manual. We would sincerely regret for that.
This product is designed for medical research, education, and health and wellness applications.
WARNING:
It is recommended that the sensor should not be applied to the same finger for over 2
hours, as the device may disrupt microcirculation on the body part.
Be advised that the device cannot be clipped on the edema and tender tissue.
Do not stare directly at the LED lights as the light (the infrared is invisible) emitted
from the device is harmful to the eyes.
Please refer to the correlative literature about the clinical restrictions and caution.
Testee cannot use enamel or other makeup.
Testee’s fingernail cannot be too long.
This device is not intended for treatment.
The User Manual is published by ReFleX Wireless Inc. All rights reserved.

IV
Contents
1. SAFETY..............................................................................................................................................6
1.1 OPERATION PROCEDURES.................................................................................................6
1.2 WARNING .........................................................................................................................6
1.3 CAUTIONS ........................................................................................................................7
2. INTRODUCTION..............................................................................................................................8
2.1 INTENDED USE .................................................................................................................8
2.2 KEY FEATURES.................................................................................................................8
2.2 APPLICATION AND SCOPE .................................................................................................8
2.3 ENVIRONMENT REQUIREMENTS .......................................................................................8
3. SYMBOLS, CONTROLS, DISPLAY, AND INDICATOR.............................................................9
3.1 FRONT PANEL...................................................................................................................9
3.2 REAR PANEL...................................................................................................................10
4. SETUP OF RX101............................................................................................................................11
4.1 LIST OF COMPONENTS....................................................................................................11
4.2 INACCURATE MONITOR MEASUREMENTS.......................................................................11
5. BATTERY OPERATION ................................................................................................................12
5.1 BATTERY POWER............................................................................................................12
5.2 BATTERY INDICATOR ......................................................................................................12
5.3 BATTERY CHARGING ......................................................................................................12
6. RX101 OPERATION.......................................................................................................................13
6.1 TURN ON RX101............................................................................................................13
6.2 MENU ACCESS................................................................................................................14
6.3 ADJUST LED DISPLAY BRIGHTNESS...............................................................................14
6.4 SET ALARM LIMIT..........................................................................................................15
6.5 ENABLE/DISABLE PULSE SOUND....................................................................................15
6.6 CHANGE USER ID.........................................................................................................16
6.7 ENABLE DATA RECORDING (UNDER REVISION) .............................................................16
6.8 ENABLE BLUETOOTH COMMUNICATION.........................................................................16
6.9 CHANGE SCREEN ORIENTATION .....................................................................................16
6.10 EXIT MENU ....................................................................................................................17
6.11 SOFTWARE OPERATION...................................................................................................17
6.12 CAUTIONS ......................................................................................................................17
6.13 CLINICAL RESTRICTIONS................................................................................................18
7. PERFORMANCE CONSIDERATION..........................................................................................19
7.1 DYSFUNCTIONAL HEMOGLOBINS ...................................................................................19
7.2 ANEMIA .........................................................................................................................19
7.3 SATURATION (SPO2).......................................................................................................19
7.4 PULSE RATE (PR)...........................................................................................................19
7.5 OTHER INACCURACY CAUSES ........................................................................................19
7.6 OTHER PULSE SIGNAL LOSS CAUSES .............................................................................19
7.7 TO USE RX101 PPG RECORDER.....................................................................................20
7.8 HIGH AMBIENT LIGHT SOURCES THAT CAN INTERFERE WITH THE PERFORMANCE OF RX101

V
PPG RECORDER ARE:..........................................................................................................................20
8. TROUBLESHOOTING...................................................................................................................21
8.1 CORRECTIVE ACTIONS ...................................................................................................21
8.2 EMI (ELECTROMAGNETIC INTERFERENCE)....................................................................21
8.3 TECHNICAL ASSISTANCE ................................................................................................22
9. MAINTENANCE .............................................................................................................................23
9.1 RETURN RX101 .............................................................................................................23
9.2 TO RETURN THE RX101 .................................................................................................23
9.3 SERVICE .........................................................................................................................23
9.4 PERIODIC SAFETY CHECKS.............................................................................................23
9.5 CLEANING......................................................................................................................23
10. MENU STRUCTURE .................................................................................................25
12. SPECIFICATIONS .....................................................................................................27
13. KEY SYMBOLS..........................................................................................................28
14. DEVICE FUNCTIONS...............................................................................................29
APPENDIX ...........................................................................................................................................30

RX101 PPG Recorder Instruction Manual
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1. Safety
1.1 Operation Procedures
Check the main unit and all accessories periodically to look for visible damages that may affect
patient’s safety and monitoring performance. It is recommended that the device be inspected
once a week, and when a damage is observed, stop using the device.
Technical maintenance must be performed by qualified service engineers ONLY.
The device cannot be used together with devices not specified in the User Manual. Only the
accessories appointed or recommended by the manufacturer can be used with this device.
The product is pre-calibrated at the factory.
1.2 Warning
Warnings are identified by the WARNING symbol shown above.
Warnings alert the user to potential serious outcomes, such as death, injury, or adverse events to
the user.
Explosive hazard—DO NOT use the PPG Recorder in environment with inflammable gas such
as some ignitable anesthetic agents.
DO NOT use the PPG Recorder while the testee is measured by MRI and CT.
DO NOT strand the lanyard in order to avoid device drop and damage. The lanyard is made of
non-sensitive material. Please do not use lanyard if the user is allergic to lanyard. Do not
enwind neck with lanyard in order to avoid accident.
Follow the local laws and regulations when disposing a defective instrument, its accessories
and packaging (including battery, plastic bags, foams and paper boxes).
Please ensure that all items are present in the package prior using the device.
Only use accessories and probe approved or manufactured by the manufacturer to prevent
damages to the PPG Recorder.
Please choose the battery chargers that are compliant with the requirements of IEC 60601-1
People who are allergic to rubber cannot use this device.
RX101 is not defibrillator-proof. However, it may remain attached to the testee’s finger
throughout defibrillation or while an electrosurgical unit is in use. The measurements may be
inaccurate throughout the defibrillation, or use of an electrosurgical unit, and shortly thereafter.
To avoid shock, caregiver should not hold RX101 while using a defibrillator on a person.
To ensure accurate performance and prevent device failure, do not subject RX101 to extreme
moisture, such as direct exposure to rain. Such exposure may cause inaccurate performance or
device failure.
Please do not use the device during charging.
This device can only be matched with compatible probe.

RX101 PPG Recorder Instruction Manual
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1.3 Cautions
Cautions are identified by the CAUTION symbol shown above.
Cautions alert the user to exercise care necessary for the safety and effective use of RX101
handheld PPG Recorder.
All combinations of equipment must be in compliance with IEC Standard 60601-1-1 systems
requirements.
Keep the PPG Recorder away from dust, vibration, corrosive substances, explosive materials,
hightemperature and moisture.
If the PPG Recorder gets wet, please stop operating it.
If the device was previously stored in cold environment, please wait for the device to accustom
to the environment before using.
DO NOT operate the button on front panel with sharp materials.
High temperature or high pressure steam disinfection of the PPG Recorder is not permitted.
Refer to User Manual in the relative chapter (10.5) for instru ctions of cleaning and
disinfection.
Do not have the PPG Recorder immerged in liquid. When it needs cleaning, please wipe its
surface with medical alcohol by soft material. Do not spray any liquid on the device directly.
When cleaning the device with water, the temperature should be lower than 60oC.
If the testee’s finger is too thin or cold. The readings may not be accurate. Please clip the PPG
Recorder on the thicker finger such as thumb or middle finger with sufficient depth to obtain
better reading.
The PPG Recorder is designed for adult measurements only.
Proper measurement should take less than 5 seconds; how this may change depending on each
individual’s pulse rate.
Please take the measurement when the waveform on screen becomes stabilized to ensure the
accuracy of the readings.
If some abnormal conditions appear on the screen during test process, remove the PPG
Recorder from the finger and then re-clip the recorder on the finger to reset the reading on the
display.
The device has normal useful life of three years counting from its first day of use.
This device has an alarm function. Please refer to chapter 6.4 for reference.
The device has audible alert which is sounded when the highest or lowest limit are reached.
The device has the function of alarming, this function can either be paused, or closed (default
setting). To access the device MENU please refer to chapter 6.1 for reference.
The device may not obtain accurate readings on all users.
When the device is connected with USB cable, always pick up the device itself and do not hold
it by the USB cable.
Stopping using the device if the device is unable to obtain stable readings.

RX101 PPG Recorder Instruction Manual
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2. Introduction
WARNING: Do not make any clinical judgments based on RX101. The monitor is
intended only for health and wellness applications.
2.1 Intended Use
The pulse oxygen saturation is the percentage of HbO2in the total Hb in the blood, also known as the
O2concentration in the blood. It is an important bio-parameter for the respiration. In addition to O2
Saturation, the device can also measure heart rate and record the heart waveform (AKA
photoplethysmogram). The device brings excellent value for scientific research, education, and
health and wellness applications.
To operate the PPG Recorder, simply clip the recorder on a finger and the photoplethysmogram, heart
rate and oxygen saturation will display on the LED screen of the device.
2.2 Key Features
A. Easy to operate using the Home Button located next to the LED screen.
B. Rechargeable battery
C. Low power consumption
D. Support wireless data transmission of heart rate, Oxygen Saturation and heart waveform
(photoplethysmogram)
2.2 Application and Scope
The PPG Recorder measures oxygen saturation and pulse rate through a person’s fingers and toes (in
some cases). It is designed to be used in scientific research, education, health and wellness
applications.
Warning: The problem of over-estimation may occur when the person is suffering from
toxicosis which is caused by carbon monoxide. Thus, the device is not recommended to be used
under this circumstance.
2.3 Environment Requirements
Storage Environment
a) Temperature :-40oC~+60oC
b) Relative humidity :5%~95%
c) Atmospheric pressure :500hPa~1060hPa
Operating Environment
a) Temperature:10oC ~40oC
b) Relative Humidity :30%~75%
c) Atmospheric pressure:700hPa~1060hPa

RX101 PPG Recorder Instruction Manual
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3. Symbols, Controls, Display, and Indicator
3.1 Front Panel
This section identifies the symbols, controls, displays, and indicators on RX101.
Figure 1: RX101 Front Panel
Table 1: RX101 Front Panel Description
Index
Name
Description
1
SpO2Lower Limit
Lower Limit Alarm Threshhold (set in the Alarm Menu)
2
Home Button
Use this button for Powering Up, change Screen Orientation,
Scroll Down and other features
3
SpO2
Oxygen Saturation Reading
4
Alarm Indicator
To indicate if the alarm is on, off or temporarily muted
5
Pulse Beat Sound
To indicate if the pulse beat sound is on/off
6
Battery Indicator
To show the current battery status
7
Charging Indicator
The Blue LED indicates the device is charging
8
Wireless Indicator
To indicate if Bluetooth is on.
9
Pulse Rate
To indicate the number of pulse per minute
10
Pulse Amplitude
To indicate the normalized pulse strength
11
Waveform Screen
To show the photoplethysmogram (Heart Waveform)

RX101 PPG Recorder Instruction Manual
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3.2 Rear Panel
Figure 2: RX101 Back Panel
Table 2: RX101 Back Panel Description
Index
Name
Description
1
USB Port
For battery charging or attaching external sensor probe
2
Through Hole
For lanyard installation
3
Device Label
The label contains the technical specifications, manufacturing
details and certification information.
4
Speaker Hole
The is where the alarm speaker is mounted.