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Chapter 1: Introduction

UT100 Handheld Pulse Oximeter Operation Manual 1-1

Chapter 1: Introduction

1.1 About this Manual

The Operation Manual provides installation, operation, and maintenance

instructions for health-care professionals and other users, trained in

monitoring

respiratory and cardiovascular

activity.

These instructions contain important information for the safe use of the

product. Read the entire contents of these Instructions For Use, including

Warnings and Cautions, before using the monitor. Failure to properly follow

warnings, cautions and instructions could result in death or serious injury to

the patient.

1.2 Definition of Symbols

SYMBOLS

DEFINITION

Attention, see in instructions for use

BF Type Defibrillation

Power on/off

Alarm silence

Up and Down Arrows

Mode Change Key

Menu Key

SpO

Sensor

No Connect

SpO

Sensor Offline

Pulse search

Low perfusion

Date of Manufacturing

IPX1

Drip Proof (monitor only)

Collect Separately.

1.3 Warning Information

KEYWORD

DEFINITION

WARNING

Tells you something that could hurt the patient or hurt the

operator.

Содержание UT100

Страница 2: ......

Страница 3: ...or Front Panel 3 1 3 2 Monitor Operating keys 3 3 Chapter 4 Operating Instructions 4 1 4 1 Unpacking the Monitor 4 1 4 2 Install the Batteries 4 1 4 3 AC Power Adapter 4 2 4 3 1 Charging Ni MH batteries 4 2 4 4 Attaching the Sensor to the Patient 4 3 4 4 1 Choosing the Sensor 4 3 4 4 2 Care and Handling of the Sensor 4 4 4 4 3 Checking the Sensor and Oximetry Cable 4 5 4 4 4 Cleaning or Disinfecti...

Страница 4: ...em 6 1 6 3 Function of Main Menu 6 2 6 4 Trend Data Download 6 2 6 5 Open the Data Base 6 4 6 6 Data Analysis and Reports 6 5 Chapter 7 Accessories 7 1 7 1 Standard Configuration 7 1 7 2 Optional Accessories 7 1 Chapter 8 Maintenance and Troubleshooting 8 1 8 1 Schedule of Maintenance 8 1 8 2 Storage 8 1 8 3 Troubleshooting 8 2 8 4 EMI Interference 8 3 Chapter 9 Specification 9 1 9 1 Equipment Cla...

Страница 5: ...ny under this warranty will be repair or replace at its option products that prove to be defective during the warranty period The foregoing shall be the sole warranty remedy Except as set forth herein seller makes no warranties either expressed or implied including the implied warranties of merchantability and fitness for a particular purpose No warranty is provide if the products are modified wit...

Страница 6: ...on IV UT100 Handheld Pulse Oximeter Operation Manual NOTE Shipments received without a return number will be returned to sender Phone 86 23 8650 2468 Fax 86 23 8650 2468 E mail service chinautech com Web site http www chinautech com ...

Страница 7: ...tructions For Use including Warnings and Cautions before using the monitor Failure to properly follow warnings cautions and instructions could result in death or serious injury to the patient 1 2 Definition of Symbols SYMBOLS DEFINITION Attention see in instructions for use BF Type Defibrillation Power on off Alarm silence Up and Down Arrows Mode Change Key Menu Key SpO2 Sensor No Connect SpO2 Sen...

Страница 8: ...by persons trained in professional health care The operator must be thoroughly familiar with the information in this manual before using the device WARNING This device must be used in conjunction with clinical signs and symptoms This device is only intended to be an adjunct in patient assessment WARNING It is the operator s responsibility to set alarm limits appropriately for each individual patie...

Страница 9: ...ectrosurgery equipment WARNING Operation of this device may be adversely affected in the presence of computed tomograph CT equipment WARNING Use only SpO2 sensors supplied with or specifically intended for use with this device WARNING SpO2 measurements may be adversely affected in the presence of high ambient light Shield the sensor area with a surgical towel for example if necessary WARNING Dyes ...

Страница 10: ...structions Accessory equipment connected to the monitor s data interface must be certified according to the respective IEC standards i e IEC 60950 for data processing equipment or IEC 601 1 for electromedical equipment All combinations of equipment must be in compliance with IEC 601 1 1 systems requirements Anyone connecting additional equipment to the signal input port or the signal output port c...

Страница 11: ...clude but are not limited to patient motion low perfusion cardiac arrhythmias high or low pulse rates or a combination of the above conditions Failure of the clinician to recognize the effects of these conditions on pulse oximeter readings may result in patient injury WARNING Verify that all LEDs light emitting diodes on the display light up upon startup of the device Cautions CAUTION Do not autoc...

Страница 12: ...cal distributor for help CAUTION Chemicals used in some cleaning agents may cause brittleness of plastic parts Follow cleaning instructions in this manual Notes NOTE Batteries are user replaceable Follow local governing ordinances and recycling instructions regarding disposal or recycling of device components including batteries NOTE When using AC power the Oximeter is a class II device with funct...

Страница 13: ...nts from neonatal to adult This device isintended for continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals NOTE The monitor was not designed or tested to be an apnea monitor 2 2 Monitor Features Provides fast reliable SpO2 pulse rate and pulse strength measurements Ideallysuited for use in intensive care units outpatient clinics emergency rooms an...

Страница 14: ...ent s information such as ID Sex Type can be managed Data can be transferred to PC through a data line for storage review and analysis 2 3 Theory of Operation The pulse oximeter determines SpO2 and pulse rate by passing two wavelengths of low intensity light one red and one infrared through body tissue to a photodetector Information about wavelength range can be especially useful to clinicians Wav...

Страница 15: ...oxygen depleted blood WARNING Since measurement of SpO2 depends on a pulsating vascular bed any condition that restricts blood flow such as the use of a blood pressure cuff or extremes in systemic vascular resistance may cause an inability to determine accurate SpO2 and pulse rate readings WARNING Under certain clinical conditions pulse oximeters may display dashes if unable to display SpO2 and or...

Страница 16: ...Chapter 2 Intended Use and General Information 2 4 UT100 Handheld Pulse Oximeter Operation Manual This page is intentionally left blank ...

Страница 17: ...e connected between the monitor and the sensor 2 SpO2 Numeric Display A number shows the patient s SpO2 value in percent Dashes mean the monitor is not able to calculate the SpO2 value 3 Mute icon The mute icon is displayed at the status bar and it has three statuses this icon means the normal status of pulse alarm sound this icon is displayed during temporary two minute pulse alarm silence this i...

Страница 18: ...he information bar displays patient s ID type battery level icon date time 9 Battery level Icon This icon is displayed at the information bar and has four levels It flashes when there is only 15 minutes left for the monitor shut down it self 10 Status Bar The status bar displays the there measuring modes sensor off finger off pulse search low perfusion icon and volume icon 11 Current Alarm Limits ...

Страница 19: ...onds at the upper right corner of the screen Pressing the Silence key twice disables the pulse alarm tone indefinitely until canceled or the monitor isturned off The icon will flash about 3 seconds at the upper right corner of the screen To cancel either the indefinite or the two minute pulse alarm and alert tone silenced condition press the Silence keyonce The Silence indicator will turn off 3 Up...

Страница 20: ...Chapter 3 Controls and Features 3 4 UT100 Handheld Pulse Oximeter Operation Manual 5 Menu Key Press this key to change the settings like patient s information high low alarm limits time and date ...

Страница 21: ...oms This device is only intended to be an adjunct in patient assessment 4 1 Unpacking the Monitor 1 Carefully remove the monitor and its accessories from the shipping carton Save the packing materials in case the monitor must be shipped or stored 2 Compare the packing list with the supplies and equipment you received to make sure you have everything you ll need 4 2 Install the Batteries Figure 4 1...

Страница 22: ...eplacement 4 3 AC Power Adapter The AC power adapter can be used as the monitor s power supplier and Ni MH cells charger NOTE Do not plug the monitor into an outlet controlled by a wall switch NOTE When using AC power the Digital Oximeter is a class II device with functional earth This earth connection is for device electromagnetic compatibility and does not provide protection to the patient or us...

Страница 23: ...nt use and do not require cleaning or disinfecting 4 Attach the sensor to the patient 4 4 1 Choosing the Sensor WARNING Before use carefully read the sensor directions for use including all warnings cautions and instructions Choose the appropriate sensor from the following chart PATIENT SITE DESCRIPTION Adult 45Kg Finger Finger or toe Ear Sensor Adult reusable Sensor Disposable Adult Finger Sensor...

Страница 24: ...he cable when connecting or disconnecting the sensor to the device as shown in Figure 4 2 Cable Connector Figure 4 2 Disconnecting or connect the sensor Do not use excessive force or unnecessary twisting when connecting disconnecting storing or when using the sensor Place an adult pediatric SpO2 sensor When placing the sensor on the patient allow the cable to lay the back of hand as shown in Figur...

Страница 25: ...ensor onto the foot or hand Secure the wrap about 20mm long to ensure the correct position of the sensor as shown in Figure 4 6 Do not secure the wrap too tight as it may affect the blood flow Figure 4 6 Placing Neonatal SpO2 Sensor 4 4 3 Checking the Sensor and Oximetry Cable Followthese instructions each time before you attach the sensor to the patient This helps ensure the sensor and oximetry c...

Страница 26: ...e monitor 4 If not using the oximetry cable connect the sensor to the monitor Push the connector firmly into the monitor 5 If the monitor is not already on press the On Off key to turn on the monitor WARNING If any of the integrity checks fail do not attempt to monitor the patient Use another sensor or oximetry cable or contact the equipment dealer for help if necessary 6 Before the sensor isattac...

Страница 27: ...mbient light Prolonged patient movement Loss of pulse signal can occur for the following reasons The sensor is too tight A blood pressure cuff is inflated on the same extremity as the one with the sensor attached There is arterial occlusion proximal to the sensor Select an appropriate sensor apply it as directed and observe all warnings and Cautions presented in the directions for use accompanying...

Страница 28: ...t to fall on the patient WARNING As with all medical equipment carefully route patient cabling to reduce the possibility of patient entanglement or strangulation WARNING Ensure that the speaker is clear of any obstruction Failure to do so could result in an inaudible alarm tone 1 To turn on the monitor press and held the ON OFF key for about five seconds When turned ON the monitor does the followi...

Страница 29: ...or longer than five minutes in the Spot check and Monitoring measuring modes The screen brightness will be decreased when no finger is in the device and no operation for longer than three minutes in the Recording measuring modes 4 6 1 Four Display Modes There are four Display Modes of the monitor you can switch between them by pressing the Mode Key The modes are shown as below A Big Display Mode B...

Страница 30: ...rgy save or not NO NO YES Alarm or not YES YES NO In the Record measuring mode if you don t press any key for 3 minutes the monitor will display the following interface in order to save energy Figure 4 8 Interface of Record Measuring Mode 4 7 Turning Off the Monitor After monitoring is complete remove the sensor from the patient and store or dispose of the sensor according to governing rules Turn ...

Страница 31: ...e down the information of the patient who is going to be monitored like Patient s ID from 000 to 999 Sex Male or Female Type Adult pediatric neonatal and Mode Spot Check Record Monitor Figure 5 2 Managing the patient s information 1 Press the Menu key to enter into the Main Menu interface 2 Press the Down key and the Menu key to enter the Patient submenu 3 Press the Up Down key to choose items you...

Страница 32: ...wo groups of dee dee dee d ee dee Period 10 secs PR exceed the pre set limits Medium Yes 1 Numbers of SpO2 will flash 2 Alarm event will be displayed in yellow at the Alarm Bar Two groups of dee dee dee Period 18 secs Sensor off High NO 1 The icon will be displayed at the Status Bar 2 Sensor off will be displayed in red at the Alarm Bar Two groups of dee dee dee d ee dee Period 10 secs Finger off ...

Страница 33: ...ow alarm limit setting 1 Press the Menu key to enter into the Main Menu interface 2 Press the Down key twice and the Menu key to enter the Alarm Set submenu 3 Press the Up Down key to choose items you want to change and press the Menu key to active the items 4 Press the Up Down key increase decrease the setting and then use the Menu key again to exit 5 Press the Up Down key to OK Cancel button to ...

Страница 34: ...same time NOTE Alarms may be tested while the monitor is in use by setting alarm limits such that the measured parameter is outside alarm limits Return limits to the required settings after testing 5 4 Changing the date and time Figure 5 4 Changing the date and time 1 Press the Menu key to enter into the Main Menu interface 2 Press the Down key thrice and the Menu key to select the Date Time subme...

Страница 35: ...in Menu interface 2 Press the Down key for four times and the Menu key to select the Reset option NOTE If you choose to reset your settings all settings will be restored to the Factory Default Settings except the Date and Time Factory Default Settings SpO2 PR Patient ID 987 Alarm Alarm On On Sex Male Upper 99 100 Type Adult Lower 92 60 Mode Spot Check Level Senior Medium ...

Страница 36: ...Chapter 5 Changing the Monitor s Settings 5 6 UT100 Handheld Pulse Oximeter Operation Manual This page is intentionally left blank ...

Страница 37: ...out trend data through USB interface so that the data can be stored analyzed and printed An additional USB Data Cable is required to connect the device to a PC Figure 6 1 PC Communication Setup 6 2 Installing the Oximetry Data Management System The Oximetry Data Management System ODMS is a management and analysis system for oximetry data It supplies functions like data download data review case in...

Страница 38: ...atient files and study records 2 Case Information Allows user to immediately refer back to patient information while viewing study data 3 Down Load All Allows user to access to the patient database and transfer all trend data from the oximeter to ODMS for analysis 4 Print Report Allows user to print statistical desaturation SpO2 or full reports 5 Option Allows user to setup serial communication Ba...

Страница 39: ...or Case Info at the main menu the following interface will pop up Figure 6 3 Case Information Patient Fill in the basic and detail information of the patient Case Date Time Means the time to collect the patient s data DownLoad Date Time Means the time to stop collecting the patient s data Medical Information Fill in the name of physician indication of the patient and comments on the patient After ...

Страница 40: ...f the patient whose trend data have already been download follow the same steps and click this button to save your changes B Click the icon or DownLoad All to download all trend data from the oximeter 6 5 Open the Data Base Click the icon or Open DataBase to open the data base the following window will pop up Figure 6 4 Data Base Case Search Put ID Frist Name Last Name to search patient files you ...

Страница 41: ...nt will be displayed at the right side Delete Select patient file you want to delete and then click the button to delete it 6 6 Data Analysis and Reports Select one period from the case test list to analyze trend data Press the OK button to enter the main analysis interface as shown below Figure 6 5 The Main Analysis Interface The main analysis interface displays two bar charts and one list of SpO...

Страница 42: ...rt Date Time represents when the monitor began collecting data Screening End Date Time Time when monitor stopped collecting data either because of power off or memory full and is calculated by the software based on the amount of data downloaded Total Screening Duration calculated by software Total Valid Sample Duration Total Screening duration minus the excluded sample time Total Excluded Sample T...

Страница 43: ...PR The highest pulse rate value taken from the valid sample and the SpO2 value time the highest pulse rate occurred Low PR The lowest pulse rate taken from the valid sample and the SpO2 value time the lowest pulse rate occurred 2 Desaturation Report Lists up to 50 of the deepest lowest SpO2 values desaturation events The events are listed in order of depth beginning with the deepest event Figure 6...

Страница 44: ... desaturation events Number of events with 88 SpO2 or below 5 minutes or longer Duration of longest single event with 88 SpO2 or below time it occurred Number of events with 85 SpO2 or below 5 minutes or longer Duration of longest single event with 85 SpO2 or below time it occurred 3 Graphic Report it contains three trend graphs of SpO2 and PR per page Figure 6 8 The Graphic Report ...

Страница 45: ...tional Accessories CAT NO DESCRIPTION QTY UTPW0920 AC Adapter Each DAS3000 Data Analysis Software CD Each FC100 Flexible Case Each 1616 AA size Ni MH Batteries Four 3422 USB Data Cable Each 4210 Reusable sensor Adult Finger Each 4211 Reusable sensor Pediatric Finger Each 4212 Reusable sensor Neonatal infant Foot Each 4213 Single patient use sensor Adult 30kg Each 4214 Single patient use sensor Ped...

Страница 46: ...Chapter 7 Accessories 7 2 UT100 Handheld Pulse Oximeter Operation Manual This Page is intentionally left blank ...

Страница 47: ... Use only a cloth that is dampened not wet CAUTION Do not allow isopropyl alcohol or water to enter any of the openings on the monitor Evidence that liquid has been allowed to enter the monitor voids the warranty 8 2 Storage WARNING To ensure accurate performance and prevent device failure do not subject the UT100 to extreme moisture such as direct exposure to rain Such exposure may cause inaccura...

Страница 48: ...d Patient motion Reposition the sensor Patient must remain still to obtain an accurate measurement SpO2 value is erratic intermittent or incorrect Poor patient perfusion Patient motion Reposition the sensor Patient must remain still to obtain an accurate measurement No PR and SpO2 values Defective sensor or patient cable or monitor Try a new sensor or contact your authorized repair center for help...

Страница 49: ... of electrical noise in the heath care and home environments for example cellular phone mobile two way radios electrical appliances it is possible that high levels of such interference due to close proximity or strength of a source may result in disruption of performance of this device The monitor is designed for use in environments in which the signal can be obscured by electromagnetic interferen...

Страница 50: ...oting 8 4 UT100 Handheld Pulse Oximeter Operation Manual Increase the separation between the interfering equipment and this equipment If assistance is required contact the UTECH Co Ltd after service department or your local representative ...

Страница 51: ... 9 3 Pulse Rate Range Accuracy Resolution 9 4 Default Settings of Alarms Limits High Alarm Limits Low Alarm Limits Adult Pediatric Neonatal Adult Pediatric Neonatal SpO2 99 99 99 92 92 92 PR 100 110 120 60 70 80 9 5 Power Requirements AC power supply 100 240VAC 47 63Hz Or four standard AA alkaline or Ni MH cells IEC Type LR6 0 100 2 at 70 100 70 undefined 1 The display is to functional saturation ...

Страница 52: ...ls 20 hours Ni MH Cells charging time 6 hours 9 7 Dimensions Width Height Depth Weight 9 8 Environmental Specification Operating Temp Storage Temp Relative Humidity 75mm 2 95 inches 135mm 5 31 inches 28mm 1 10 inches 500grams 17 64 ounces with batteries 0 to 45 20 to 60 30 to 95 operating 10 to 95 storage ...

Страница 53: ...Students Pioneer Park A 10 10 No 77 Kecheng Road Chongqing China Phone 86 23 8650 2468 Fax 86 23 8650 2468 E mail service chinautech com Web site http www chinautech com ...

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