Related Manuals for Infinium CLEO
Summary of Contents for Infinium CLEO
- Page 1 CLEO Patient Monitor USER’S MANUAL Ver 1.2 © 2014 Infinium Medical Inc. All rights reserved. Issued Date: November 20, 2014...
- Page 2 Toll Free (US call only): 866-918-8434 International: 1-727-531-8434 Fax: 1-727-531-8436 To obtain information about a warranty, if any, for this product, contact Infinium Medical Inc, Technical Services or your local Infinium Medical, Inc. representative. Nellcor is a trademark of NELLCOR OXIMAX...
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Page 3: Table Of Contents
User’s manual of CLEO Patient Monitor CONTENTS SAFETY INFORMATION ..................... 4 INTRODUCTION ......................... 7 INTENDED USE ........................7 ABOUT THIS MANUAL ......................7 CONTROLS, INDICATORS, AND SYMBOLS ..............8 FRONT AND SIDE PANEL ..................... 8 REAR PANEL .......................... 9 SYMBOLS ..........................10 DISPLAY SCREEN PARTITION .................. - Page 4 User’s manual of CLEO Patient Monitor NIBP MONITORING INITIALIZATION ................26 NIBP PARAMETER SETUP ....................26 NIBP LIST OBSERVATION....................28 MEASUREMENT LIMITATIONS ..................29 NIBP ERROR MESSAGES ....................30 MAINTAINENCE AND CLEANING ..................30 ETCO2 MONITORING....................... 31 THEORY OF OPERATION ....................31 WARNINGS, CAUTIONS AND NOTES ................
- Page 5 User’s manual of CLEO Patient Monitor FIGURES Figure 1: Front and Side Panel ..................8 Figure 2: Rear View for Main Unit ................9 Figure 3: Single SpO Display Screen ............... 12 Figure 4: Single EtCO Display Screen ..............12...
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Page 6: Safety Information
Read all text surrounding all precautionary information. The CLEO can be powered by an internal battery that provides 3 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor. - Page 7 [WARNING]: DO NOT use the CLEO to monitor patients who are linked to heart/lung machines. [WARNING]: To prevent electrical hazards to all personnel, CLEO Patient Monitor must be properly grounded.
- Page 8 Caution: When connecting the CLEO to any instrument, verify proper operation before clinical use. Both the CLEO and the instrument connected to it must be connected to a grounded outlet. Accessory equipments connected to this patient monitor must be certified according to the respective IEC standards (e.g.
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Page 9: Introduction
It must be used in conjunction with clinical signs and symptoms. ABOUT THIS MANUAL This manual explains how to set up and use the CLEO Patient Monitor. Important safety information relating to general use of the CLEO appears before this introduction. Other important safety information is located throughout the text where applicable. -
Page 10: Controls, Indicators, And Symbols
User’s manual of CLEO Patient Monitor CONTROLS, INDICATORS, AND SYMBOLS FRONT AND SIDE PANEL REAR PANEL SYMBOLS FRONT AND SIDE PANEL Figure 1: Front and Side Panel Function Icon Power Switch AC ON This LED indicates that the monitor is powered by AC. -
Page 11: Rear Panel
User’s manual of CLEO Patient Monitor REAR PANEL Figure 2: Rear View for Main Unit Function Icon Battery Access AC Input and Fuse 100/240V～50/60Hz, 30VA, The AC power connection is where facility F2AL 250V line power is connected to this monitor, the AC power fuses must be replaced with the same type and rating fuse. -
Page 12: Symbols
User’s manual of CLEO Patient Monitor SYMBOLS The following symbols may appear on the packaging, monitor or in user’s manual: Type BF Applied Part Manufacture’s Serial Number Fuse Information Date of Manufacture Manufacturer Fragile Contents of the transport package are fragile therefore it shall be handled with care. -
Page 13: Display Screen Partition
User’s manual of CLEO Patient Monitor DISPLAY SCREEN PARTITION There are six groups for module combination in all. The user can choose what to measure as required in Module Select Menu. The combination is as below: SpO EtCO ... -
Page 14: Single Spo2 Display
User’s manual of CLEO Patient Monitor SINGLE SPO2 DISPLAY Figure 3: Single SpO Display Screen SINGLE ETCO2 DISPLAY Figure 4: Single EtCO Display Screen - 12 -... -
Page 15: Spo2+Etco2 Display
User’s manual of CLEO Patient Monitor SPO2+ETCO2 DISPLAY Figure 5: SpO and EtCO Display Screen SPO2+NBP DISPLAY Figure 6: SpO and NBP Display Screen - 13 -... -
Page 16: Spo2 +Nbp+Etco2 Display
User’s manual of CLEO Patient Monitor SPO2 +NBP+ETCO2 DISPLAY Figure 7: SpO , EtCO and NBP Display Screen SPO2+NBP DISPLAY Figure 8: SpO2, NBP and Display Screen - 14 -... -
Page 17: System Setup
User’s manual of CLEO Patient Monitor SYSTEM SETUP System Setup includes: Factory Setup, Demo Switch, Sound Volume, Alarm Switch, Module Select, Default Config, Save Config and etc. Press the button of SETUP to pop the System Setup menu, the tree diagram is as... -
Page 18: Sound Volume
User’s manual of CLEO Patient Monitor simulation measurement. The Demo mode is for demonstration purpose only. To avoid that the simulated data are mistaken for the monitored patient’s data, you must not change into demo mode during monitoring, otherwise, improper patient monitoring and delayed treatment could result. -
Page 19: How To Monitor
5. Set monitoring parameters (see chapters below) ; 6. Enter the monitoring state. [CAUTION]: If the CLEO is to be stored for a period of 2 months or longer, notify service personnel to remove the battery from the monitor prior to storage. Recharge the battery when the battery has not been recharged for 2 or more months. -
Page 20: Alarm & Sound
When a low priority alarm occurs, a non-flashing alarm message appears in the message area. If more than one low priority alarm is present, the alarm messages “rotate”. On the CLEO the alarm led color will change to a solid yellow for a low priority alarm... -
Page 21: Sound
User’s manual of CLEO Patient Monitor SOUND ALARM SOUND Like the mild sound of BEEP. There are four items of Ⅰ, Ⅱ, III and Ⅳ for alarm levels in turn from low to high. The following encoded auditory alarm signals categorized by alarm condition and... -
Page 22: Spo2 Monitoring
User’s manual of CLEO Patient Monitor SPO2 MONITORING SPO2 MONITORING PRINCIPLE SPO2 SENSOR INSTALLLATION SPO2 WAVEFORM SETUP SPO2 PARAMETER SETUP MEASUREMENT LIMITATIONS SPO2 ERROR MESSAGES NELLCOR INFORMATION SPO2 MONITORING PRINCIPLE Arterial oxygen saturation is measured by a method called pulse oximetry. It is a continuous, non-invasive method based on the different absorption spectra of reduced hemoglobin and oxyhemoglobin. -
Page 23: Spo2 Parameter Setup
User’s manual of CLEO Patient Monitor CHOOSE MODULE There is one SpO modules for choice: Nellcor. More detail please contact with local distributor or service engineer SWEEP SPEED Choose from 12.5mm/s to 25.0mm/s, and the factory-set is 25 mm/s. SWEEP COLOR From Yellow, White, Blue, Red, Green and Cyan for choice, the default-set is Red. -
Page 24: Measurement Limitations
User’s manual of CLEO Patient Monitor MEASUREMENT LIMITATIONS The measurement is decided by the pulsating characteristic of blood stream in artery or arterial blood vessel. The arterial blood stream may decreased to the level which cannot be measured in conditions below: ... - Page 25 ECG based arrhythmia analysis. CLEO Patient Monitor should be considered an early warning device. As a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s condition.
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Page 26: Nellcor Information
User’s manual of CLEO Patient Monitor bilirubin lamp, or sunlight. A blood pressure cuff is inflated on the same extremity as the one with a SpO sensor attached. The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia. -
Page 27: Nibp Monitoring
User’s manual of CLEO Patient Monitor NIBP MONITORING SUMMARY ON NIBP MONITORING NIBP CUFF FITTING NIBP MONITORING INITIALIZATION NIBP PARAMETER SETUP NIBP LIST OBSERVATION MEASUREMENT LIMITATIONS NIBP ERROR MESSAGES MAINTAINENCE AND CLEANING... -
Page 28: Nibp Monitoring Initialization
User’s manual of CLEO Patient Monitor [WARNING] The width of the cuff should be 40% of the limb circumference. The inflatable part of the cuff should be long enough to encircle 50-80% of the limb. The wrong size of cuff can cause erroneous readings. If the cuff size is in question, then use a larger cuff. - Page 29 User’s manual of CLEO Patient Monitor PRESSURE UNIT mmHg or kPa, the factory–set is mmHg. PATIENT TYPE ADULT TYPE In the initiated measurement, inflate the cuff to 180mmHg (24kPa), if the NIBP value cannot be measured, then inflate the cuff to higher than the form value by 50mmHg (6.7kPa), the maximum value cannot exceed 280mmHg (37.3kPa), and the enduring...
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Page 30: Nibp List Observation
User’s manual of CLEO Patient Monitor [WARNING] Prolonged non-invasive blood pressure measurements in Auto mode may be associated with purport, isocheimal and neuropathy in the limb wearing the cuff. When monitoring a patient, examine the extremities of the limb frequently for normal color, warmth and sensitivity. -
Page 31: Measurement Limitations
User’s manual of CLEO Patient Monitor Figure 14: Window for NIBP List Observation The NIBP list can save 260 groups of data. [NOTE]: Only after the NIBP value has been measured can it be added to the NIBP Data List. NIBP list can save 260 groups of data at all, if exceed, the new data will kick the most former data out of the list and be added to the list automatically. -
Page 32: Nibp Error Messages
User’s manual of CLEO Patient Monitor NIBP ERROR MESSAGES Message indicating area may display messages like below： Serial error Patient moving！ NIBP renew self-check... Pressure < 10 mmHg！ NIBP self-check... Pressure < 1.3 kPa！ Pressure > 325 mmHg！ NIBP self-check error！... -
Page 33: Etco2 Monitoring
User’s manual of CLEO Patient Monitor ETCO2 MONITORING THEORY OF OPERATION WARNINGS, CAUTIONS, NOTES ABBREVIATIONS AND TERMINOLOGY ZEROING THE CO2 MODULE PATIENT AND TUBING PREPARATION ETCO2 WAVEFORM SETUP ETCO2 PARAMETER SETUP ADVANCED SETUP ... -
Page 34: Abbreviations And Terminology
User’s manual of CLEO Patient Monitor appearance the patient and the sampling line. Replace line if needed. DO NOT operate the CO Module when it is wet or has exterior condensation. DO NOT apply excessive tension to any cable. -
Page 35: Patient And Tubing Preparation
EtCO icon on the left panel of monitor. [WARNING]: Don’t hot plug EtCO module, that is make sure that the CLEO is powered off before Insert the connector of CO sensor into EtCO socket. Otherwise... -
Page 36: Etco2 Waveform Setup
User’s manual of CLEO Patient Monitor Some patients are prone to mouth breathing. The Oral/Nasal sampling cannula should be used on these patients, as most, if not all of the CO is exhaled through the mouth. If a standard nasal CO... -
Page 37: Etco2 Parameter Setup
User’s manual of CLEO Patient Monitor Waveform Scale ETCO Waveform Sweep Speed Setup Sweep Color Figure 15: Tree Diagram for EtCO Waveform Setup Menu WAVEFORM SCALE Use this setting to adjust the amplitude measurement (size) of the displayed EtCO waveform scale manually. The label will be displayed in the screen. -
Page 38: Advanced Setup
User’s manual of CLEO Patient Monitor ETCO2 ALARM HIGH The range is 20～100 mmHg，and the factory-set is 60 mmHg. ETCO2 ALARM LOW The range is 1～95 mmHg，and the factory-set is 15 mmHg. AWRR ALARM HIGH The range is 10～150 mmHg，and the factory-set is 30 mmHg. -
Page 39: Calibration
User’s manual of CLEO Patient Monitor Oxygen Balance Gas EtCO Setup Advanced Setup Anesthetic BARO. Gas Temp Figure 17: Tree Diagram for EtCO Advanced Setup SET GAS COMPENSATIONS The measurement of CO is affected by temperature, pressure, and gas compensations. -
Page 40: Status/Error Messages
User’s manual of CLEO Patient Monitor STATUS/ERROR MESSAGES Messages Descriptions Sensor Off The CO sensor is not connected Sensor Warm Up One of the following conditions exist: Sensor under temperature Temperature not stable Source Current unstable Sensor Over Temp Make sure sensor is not exposed to extreme heat (heat lamp, etc.). -
Page 41: Recall Data
The user can set by touching the patient ID area at the top left corner to pop up patient setup menu. You can have settings as below. CLEO Patient Monitor can save five groups patient information for recall in total. -
Page 42: Clock Setup
User’s manual of CLEO Patient Monitor CLOCK SETUP In order to review data easily and intuitively, you should have set a right time. Touch the time area at the top right corner to pop up time setup menu. You can have... -
Page 43: Figure 23: Tabular Trend For Spo 2
User’s manual of CLEO Patient Monitor SPO2 REVIEW The SpO History Data review is as below: Figure 21: Tabular Trend for SpO ETCO2 REVIEW The EtCO History Data review is as below: Figure 22: Tabular Trend for EtCO - 41 -... -
Page 44: Figure 25: Tabular Trend For Nbp
User’s manual of CLEO Patient Monitor NBP REVIEW The NBP History Data review is as below: Figure 23: Tabular Trend for NBP - 42 -... -
Page 45: Battery Operation
It is recommended that the internal battery is replaced by qualified service personnel every 24 months. [CAUTION]: If the CLEO is to be stored for a period of 2 months or longer, notify service personnel to remove the battery from the monitor prior to storage. Recharge the battery when it has not been charged for 2 or more months. -
Page 46: Disposal Of Device Components
User’s manual of CLEO Patient Monitor DISPOSAL OF DEVICE COMPONENTS Follow local governing ordinances and recycling instructions regarding disposal or recycling of device components, including batteries. - 44 -... -
Page 47: Cleaning
User’s manual of CLEO Patient Monitor CLEANING To clean the CLEO, dampen a cloth with a commercial, nonabrasive cleaner and wipe the exterior surfaces lightly. Do not allow any liquids to come in contact with the power connector or switches. Do not allow any liquids to penetrate connectors or openings in the instrument. -
Page 48: Specifications
User’s manual for CLEO Patient Monitor SPECIFICATIONS SAFETY Meet the requirement of EN60601 series, CE marking according to MDD93/42/EEC Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide... - Page 49 User’s manual for CLEO Patient Monitor Measuring Interval in AUTO Mode: 1min～4h Resolution: 1mmHg Overpressure Protection: Adult Mode 280 (mmHg) Alarm Limit: 30～240 mmHg 15～180 mmHg Mode of Sampling: Sidestream Measurement technology: Infrared Absorption Principle of Operation: Non-dispersive infrared (NDIR)
- Page 50 User’s manual for CLEO Patient Monitor RJ45 interface and USB port POWER Source: External AC Power and Internal Battery AC Power: 100/240 VAC, 50/60 Hz, 150V Battery: Rechargeable Lithium ion battery, 7.2 V/2000 Operating time under the normal condition: 3 hrs...
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Page 51: Emc
ELECTROMAGNETIC IMMUNITY This section constitutes the guidance and CLEO Patient Monitor’s declaration regarding electromagnetic immunity. The CLEO Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the CLEO Patient Monitor should assure that it is used in such an environment. - Page 52 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CLEO Patient Monitor is used exceeds the applicable RF compliance level above, The CLEO Patient Monitor should be observed to verify normal operation.
- Page 53 Recommended separation distances between portable and mobile RF communications equipment and the CLEO Patient Monitor The CLEO Patient Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CLEO Patient Monitor can help prevent electromagnetic...