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Table of Contents
Summary of Contents for Reflex RX101
- Page 1 RX101 PPG Recorder Instruction Manual Version 1.3...
- Page 2 Version Control Date Description Version No. Remark May 12, 2012 Initialize first draft Set table of content May 20, 2012 Complete User Instruction May 21, 2012 Complete Safety and Introduction June 28, 2012 Complete Frist Draft...
- Page 3 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.
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Page 4: Table Of Contents
..................8 NVIRONMENT EQUIREMENTS 3. SYMBOLS, CONTROLS, DISPLAY, AND INDICATOR ............. 9 ........................9 RONT ANEL ........................10 ANEL 4. SETUP OF RX101 ..........................11 ....................11 IST OF OMPONENTS ............... 11 NACCURATE ONITOR EASUREMENTS 5. BATTERY OPERATION ........................ 12 ...................... - Page 5 ....................21 ORRECTIVE CTIONS EMI (E ) ..............21 LECTROMAGNETIC NTERFERENCE ....................22 ECHNICAL SSISTANCE 9. MAINTENANCE ..........................23 RX101 ......................23 ETURN RX101 ....................23 O RETURN THE ......................... 23 ERVICE ..................... 23 ERIODIC AFETY HECKS ........................23 LEANING MENU STRUCTURE ....................
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Page 6: Safety
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. -
Page 7: Cautions
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. -
Page 8: Introduction
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 HbO in the total Hb in the blood, also known as the concentration in the blood. -
Page 9: Symbols, Controls, Display, And Indicator
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 Lower Limit Lower Limit Alarm Threshhold (set in the Alarm Menu) -
Page 10: Rear Panel
3.2 Rear Panel Figure 2: RX101 Back Panel Table 2: RX101 Back Panel Description Index Name Description USB Port For battery charging or attaching external sensor probe Through Hole For lanyard installation Device Label The label contains the technical specifications, manufacturing details and certification information. -
Page 11: Setup Of Rx101
Setup of RX101 WARNING: To ensure patient safety, do not place RX101 in any position that might cause it to fall on the patient. WARNING: As with all medical equipment, carefully route patient’s cables to reduce the possibility of patient entanglement or strangulation. -
Page 12: Battery Operation
WARNING: Dispose of battery in accordance with local ordinances and regulations. 5.1 Battery Power RX101 uses rechargeable Lithium Polymer battery to power the PPG Recorder. Depending on usage, the battery can last from 5 hours to 40 hours per charge cycle. The battery will drain faster if the Bluetooth connectivity is switched on. -
Page 13: Rx101 Operation
RX101 Operation The parameters of RX101 are set at the factory according to Table 2. The parameters can be customized for each individual user. Parameters remain in effect until changed by the user. Table 5: Default Parameter Settings Parameter Value Range... -
Page 14: Menu Access
To exit the Settings Menu, simply give the “Home Button” a few quick pushes until the menu selector highlights “Exit”, and then push the “Home Button” for two seconds to exit the menu. Figure 5: Exit Settings Menu RX101 PPG Recorder Instruction Manual... -
Page 15: Set Alarm Limit
Give the “Home Button” a few quick pushes until the menu selector highlights “Pulse Sound” and then push the “Home Button” for two seconds to change the setting to “on” to turn on the Pulse RX101 PPG Recorder Instruction Manual... -
Page 16: Change User Id
PC application and use the passcode “7762” to have the data from the PPG Recorder stream to the software applications. Figure 10: Enable Wireless Communication 6.9 Change Screen Orientation On the measuring interface, press the "Home Button" to change the display orientation. RX101 PPG Recorder Instruction Manual... -
Page 17: Exit Menu
Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy of the sensor reading. Please clean and disinfect the device after each use according to the User Manual. RX101 PPG Recorder Instruction Manual... -
Page 18: Clinical Restrictions
SpO measure. d) As the SpO value serves as a reference value for judgment of anemic anoxia and toxic anoxia, some people with serious anemia may also report good SpO measurement. RX101 PPG Recorder Instruction Manual... -
Page 19: Performance Consideration
• a blood pressure cuff is inflated on the same extremity as the one with the PPG Recorder attached • there is arterial occlusion proximal to the PPG Recorder • poor peripheral perfusion • loss of pulse/cardiac arrest RX101 PPG Recorder Instruction Manual... -
Page 20: To Use Rx101 Ppg Recorder
• Periodically check to ensure that the PPG Recorder remains properly positioned on the testee’s finger. 7.8 High ambient light sources that can interfere with the performance of RX101 PPG Recorder are: • surgical lights (especially those with a xenon light source) •... -
Page 21: Troubleshooting
Warning: There are no user-serviceable parts inside RX101. The cover should only be removed by qualified service personnel. Caution: Do not spray, pour, or spill any liquid on RX101, its accessories, connectors, switches, or openings in the enclosure as this may damage the device. -
Page 22: Technical Assistance
RX101 may cause harmful interference with other devices in the vicinity. 8.3 Technical Assistance For technical information and assistance, or to order parts or a service manual, contact ReFleX Wireless’s Technical Service Department at: support@reflexwireless.com Or call your local ReFleX Wireless representative. -
Page 23: Maintenance
RX101. 9.2 To return the RX101 1. Pack RX101 in its original shipping carton. If the original carton is not available, use a suitable carton with appropriate packing material to protect it during shipping. - Page 24 • use a soft cloth saturated with a solution of 10% chlorine bleach in tap water To clean and disinfect a reusable sensor probe: • read the directions for use enclosed with the sensor probe Each sensor probe model has cleaning and disinfecting instructions specific to that sensor. RX101 PPG Recorder Instruction Manual...
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Page 25: Menu Structure
10. Menu Structure RX101 PPG Recorder Menu Structure Figure 12: Settings Menu Structure RX101 PPG Recorder Instruction Manual... - Page 26 To transmit the data wirelessly via Bluetooth, the wireless feature in the device menu needs to be enabled using the “Home Button” next to the device display. Alarm feature can also be activated via the same menu. RX101 PPG Recorder Instruction Manual...
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Page 27: Specifications
±1%. F. Power supply requirement 3.6 V DC ~ 4.2V DC. G. Optical Sensor Red light (wavelength is 660nm, 6.65mW) Infrared (wavelength is 880nm, 6.75mW) H. Adjustable alarm range: : 0%~100% Pulse Rate: 0bpm~254bpm RX101 PPG Recorder Instruction Manual... -
Page 28: Key Symbols
Menu Change Screen Orientation BF Type application part Serial number 1. The measured part falls off ( no measured part inserted) 2. Probe error 3. Signal inadequacy indicator IPX1 Ingress of liquids rank WEEE (2002/96/EC) RX101 PPG Recorder Instruction Manual... -
Page 29: Device Functions
Battery Requirement 3.7 V rechargeable lithium polymer battery × 1 Battery working life Charge and discharge no less than 500 times Power Adapter Input Voltage 100 ~ 240 VAC, 50/60 Hz Output Voltage 5 V (DC) RX101 PPG Recorder Instruction Manual... -
Page 30: Appendix
Weight About 175 g (with the lithium polymer battery*1) Appendix State Alarm condition delay Alarm signal generation delay Low voltage alarm 20ms alarm 330ms 20ms Pulse rate alarm 330ms 20ms Probe error alarm 16ms 20ms RX101 PPG Recorder Instruction Manual...
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