CONTEC MEDICAL SYSTEMS PM50 User Manual
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CONTEC MEDICAL SYSTEMS PM50 User Manual

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  • Page 2: Table Of Contents

    Contents Chapter1 Introduction ........................1 1.1 General Information ......................3 1.2 Main Parameters ......................6 1.3 Button Functions ......................7 1.4 Interfaces......................... 9 1.5 Accessories ........................11 Chapter2 Getting Started ......................12 2.1 Open the Package and Check ..................12 2.2 Dry Battery Installation ....................
  • Page 3 3.2.6 SpO TABLE ...................... 24 3.2.7 TREND ......................25 Chapter4 SpO Monitoring ......................30 4.1 What is the SpO Monitoring ..................30 4.2 Precautions during SpO /Pulse Monitoring ..............31 4.3 Monitoring Procedure ....................32 4.4 Maintenance and Cleaning .................... 33 Chapter5 NIBP Monitoring ......................
  • Page 4 7.4 Design the Measurement Plan ..................48 7.5 Data Download ......................52 7.6 Choose Patient Data to Edit ..................53 7.7 Delete Data File ......................54 7.8 Data File Backup......................55 7.9 Edit Blood Pressure Data ....................57 7.10 Trend Edit ........................59 7.11 Display the Statistics Information ................

  • Page 5: Chapter1 Introduction

    Chapter1 Introduction For an overall introduction to the monitor, please refer to General Information.  For basic operating instructions, please refer to Button Function.  For allocation of interface sockets, please refer to Interfaces.  Warning Possible explosion hazard if used in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.
  • Page 6 Dispose of the packaging material, observing the applicable waste control regulations and keeping it out of children’s reach. Warning The monitor is only use on one patient in same times. Warning When the monitor is wetted, please stop using it and contact us. Warning A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter monitor.

  • Page 7: General Information

    Warning Please choose the computer which should be ensured compliance with the requirements of IEC60950, or else it may damage the device. Warning The software was developed per IEC60601-1-4. The possibility of hazards arising from errors in the software program is minimized. Warning The Patient Monitor shall comply with the standard EN1060 series: Part 1: General requirements;...
  • Page 8 Working 5~40 °C Transport and Storage -20~60 °C Humidity Working ≤ 80 % Transport and Storage ≤ 95 % Altitude Working -500 to 4,600m (-1,600 to 15,000ft) Transport and Storage -500 to 13,100m (-1,600 to 43,000ft) Power Supply 3 (V) DC Pmax ≤...
  • Page 9 of NIBP, Pulse Rate and SpO . it is applicable for adult, pediatric, and neonatal. It integrates parameter measuring modules function and display function in one device, featuring in compactness, lightweight. The POWER switch is on the front panel. The RUN indicator and the ALARM indicator flash one time when the device is powered on.

  • Page 10: Main Parameters

    the stored values of SpO in the monitor can be downloaded into the computer too. Alarm processing: The user may turn on the alarm monitor by hand. When alarm is on, SpO alarm is as follows: oxygen saturation and pulse rate displayed circularly for 5 times in 1scecond and tested the measured value whether it was exceeded or not at the same time;...

  • Page 11: Button Functions

    Measuring range: 30bpm~250bpm Accuracy: ±2bpm C. Measurement of blood pressure Measuring range: ADULT: SYS: 40-270 mmHg MAP: 20-235 mmHg DIA: 10-215 mmHg PEDIATRIC: SYS: 40-200 mmHg MAP: 20-165 mmHg DIA: 10-150 mmHg NEONATAL: SYS: 40-135 mmHg MAP: 20-110 mmHg DIA: 10-100 mmHg Maximum mean error of measurement: ±5 mmHg.
  • Page 12 of the buttons are above them. They are: Press the button for a long time, then the system will start. When turning on and off the monitor, the red light and the green both flash once to prompt that the on or off operation is successful. Press the button for 3 second, the instrument turns off.

  • Page 13: Interfaces

    Press the button to select the menu item and modify the setup. In main interface, press UP key to enter silence state, again press UP key to cancel silence state. DOWN The text in the right bottom of the screen indicate the function of this key. Press the button to select the menu item and modify the setup.
  • Page 14 monitor. ①the Socket for NIBP cuff At the top is the Socket for SpO Sensor and socket for NIBP cuff (Figure 1.4.1①) ②the Socket for SpO Sensor ② ① Figure1.4.1 Top ①the Socket for USB At the bottom is the socket for USB, as shown in Figure 1.4.2. ①...

  • Page 15: Accessories

    Figure1.4.2 Bottom 1.5 Accessories A cuff for adult B a USB data line C an oximeter probe D a disk (PC software) E a pouch F a user manual Warning Please use the accessories supplied by the manufacturer or replace the accessories according to the requirements of the manufacturer in order to avoid making harms to patients.

  • Page 16: Chapter2 Getting Started

    Chapter2 Getting Started Open the package and check ■ Dry battery installation ■ Power on the monitor ■ Connect patient sensors ■ 2.1 Open the Package and Check Open the package and take out the monitor and accessories carefully. Keep the package for possible future transportation or storage.

  • Page 17: Connect Oximeter Probe

    monitoring screen of monitoring or ABPM, and you can perform normal monitoring now. Refer to System Menu for details. Warning If any sign of damage is detected, or the monitor displays some error messages, do not use it on any patient. Contact biomedical engineer in the hospital or our Customer Service Center immediately.

  • Page 18: Connect Nibp Cuff

    For information on correct connection, refer to Figure 2.4.. Probe Figure2.4 2.5 Connect NIBP Cuff Connect NIBP extension conduit between the monitor and the patient. Note For information on correct connection, refer to Figure 2.5.
  • Page 19 Figure2.5...

  • Page 20: Chapter3 Function Interface

    Chapter3 Function Interface Main Interface ■ System Menu ■ 3.1 Main Interface Press POWER to power on the monitor. The indicator will flash, the system will enter the main interface successfully. ABPM: If there is no key-press operation within the time set in the BACKLIGHT TIME item, the monitor will enter standby mode.

  • Page 21: System Menu

    Figure3.1.2 Monitoring main menu Note When the register is full will turn up at the top of the screen. The note of the last time needs to be cleared. 3.2 SYSTEM MENU Press the MENU button on the panel to call up the [SYSTEM MENU]. You can perform option operations by using UP and DOWN buttons.

  • Page 22: System Setup

    Figure3.2 System menu [PM SpO SETUP] and [SpO TABLE] are gray in the mode of ABPM. They cannot be set up. 3.2.1 System Setup Select the SYSTEM SETUP item in the [SYSTEM MENU]. The following menu will pop up.
  • Page 23 Figure3.2.1 System setup Users can set up the system time by selecting the [TIME] item. If users select [YES] in the [DEFAULT] item, the Monitor will come back to factory default. In the [LANGUAGE] item, users can select the words shown in Chinese or English in the screen.

  • Page 24: Bp Setup

    will turns up. In the [NEW PATIENT] item, if users select [YES], the "Clear the last value ?" dialog box will appear. Select [YES] again will delete the measure record of the last patient. Then select [NO] back to the [SYSTEM SETUP ]. Else, selecting [NO] at first, the monitor will do nothing. Please pay attention to this function.
  • Page 25 Figure3.2.2 BP setup In PM mode, When users select [ON] in the [AUTO MEASURE] item, the Monitor will measure blood pressure according to the time selected in the [INTERVAL] item. In ABPM mode, [AUTO MEASURE] and INTERVAL can not be set up and become gray. The interval time (Unit: minute) setup in the [INTERVAL] item can be selected from the following options: 5, 10, 15, 20, 30, 45, 60, 90,120.

  • Page 26: Setup

    The adjustable ranges of the high and low limits of the alarm are as follows: SYS: 40-270mmHg DIA: 10-215mmHg 3.2.3 SpO SETUP Select [PM SpO SETUP] in the "SYSTEM MENU". The following menu will pop up. Figure3.2.3 SpO setup For the [PULSE SOUND] item, you can choose its state. When the switch turns on, plug in finger and hear Pulse sound in Monitor mode.

  • Page 27: Patient Information

    occurs when PR value overflows. and PR ALARM analysis alarm limits: PARAMETERS Max. HI Min. LO Step 3.2.4 Patient Information Pick the [ABPM INF0] item in the “SYSTEM MENU” to call up the following menu. Figure3.2.4 ABPM information...

  • Page 28: Bp Table

    The information in this interface can't be changed until reinstall the parameter in software. 3.2.5 BP TABLE Pick the [BP TABLE] item in the “SYSTEM MENU” to call up the following menu. Figure3.2.5 NIBP table Users can press the UP and DOWN button to see the stored values. Press the MENU will exit. When data is much, long press UP key or DOWN key to appear to quickly turn over page, you can easily and quickly browse all datas.

  • Page 29: Trend

    Figure3.2.6 SpO table Users can press the UP and DOWN button to see the stored values. Press the MENU will be exit. The SpO is measured once per 1s, and the most number of times is 183000. Long press UP key or DOWN key, after a few second, will appear to quickly turn over page, you can easily see all records, the speed of turning over page is more quick than turning over blood pressure data.
  • Page 30 Figure3.2.7 TREND graph Select ABPM TREND to enter the following interface, display waveform is the measurement data in ABPM mode. Select PM TREND to enter the same interface, display waveform is the measurement data in PM mode. The time on the left of the horizontal axis topside is the start time for display waveform, the time on the right of the horizontal axis is the end time for display waveform.
  • Page 31 Figure3.2.8 Abpm or PM trend Select SpO TREND to enter the following interface, as shown in Figure 3.2.10 SpO TREND, Via UP key and DOWN key, you can turn over different time segment measurement SpO Pulse rate data waveform chart. The time on the left of the horizontal axis topside is the start time for display waveform, the time on the right of the horizontal axis is the end time for display waveform.
  • Page 32 Figure3.2.9 SpO trend Figure3.2.10 SpO Total trend chart Select DEMO to enter the following interface, in DEMO mode, press MENU key to exit DEMO...
  • Page 33 mode. Figure3.2.11 DEMO Note In clinical application, this function is forbidden because the DEMO will mislead the medical staff to treat the DEMO waveform and parameter as the actual data of the patient, which may result in the delay of treatment or mistreatment. When it is ambulatory blood pressure state, [PM SpO SETUP] and [SpO TABLE] can't...

  • Page 34: Chapter4 Spo 2 Monitoring

    Chapter4 SpO Monitoring 4.1 What is the SpO Monitoring Plethysmogram measurement is employed to determine the oxygen saturation of hemoglobin in the arterial blood. If, for example, 97% hemoglobin molecules in the red blood cells of the arterial blood combine with oxygen, then the blood has a SpO oxygen saturation of 97%.

  • Page 35: Precautions During Spo /Pulse Monitoring

    The update period of data is less than 5 seconds, which is changeable according to ■ different individual pulse rate. Please read the measured value when the waveform on screen is equably and ■ steady-going. The measured value is optimal value. And the waveform at the moment is the standard one.

  • Page 36: Monitoring Procedure

    Note waveform is not proportional to the pulse volume. Warning Do not use the SpO sensor once the package or the sensor is found damaged. Instead, you shall return it to the vendor. Warning Prolonged and continuous monitoring may increase jeopardy of unexpected change of dermal condition such as abnormal sensitivity, erubescence, vesicle, repressive putrescence, and so on.

  • Page 37: Maintenance And Cleaning

    Figure4.3 Mounting of the sensor 4.4 Maintenance and Cleaning Care and Cleaning Warning Turn off the monitor before cleaning the monitor or the sensor Warning Do not subject the sensor to autoclaving. Do not immerse the sensor into any liquid. Do not use any sensor or cable that may be damaged or deteriorated.

  • Page 38: Chapter5 Nibp Monitoring

    Chapter5 NIBP Monitoring 5.1 Introduction The Non-invasive Blood Pressure (NIBP) module measures the blood pressure using  the oscillometric method .It is that: using the blade to block artery blood, checking the oscillometric wave during degassing for sure that it was not affected by the operator’s subjective factors or the disruption of the environmental noise.

  • Page 39: Nibp Monitoring

    5.2 NIBP Monitoring Warning Do not apply the cuff to a limb that has an intravenous infusion or catheter in place. This could cause tissue damage around the catheter when infusion is slowed or blocked during cuff inflation. Warning Make sure that the air conduit connecting the blood pressure cuff and the monitor is neither blocked nor tangled.
  • Page 40 Figure 5.2 Applying Cuff Note Don't let the cuff contact with skin directly, but the thickness of clothes shouldn't be more than 3 cm. Note The width of the cuff should be either 40% of the limb circumference (50% for neonates) or 2/3 of the upper arm length.
  • Page 41 Patient Type Limb perimeter Cuff width Hose Adult 25 ~ 35 cm 14 cm Child 18 ~ 26 cm 10.6 cm 1.5 m or 3 m Infant 10 ~19 cm Thigh 46 ~ 66 cm 21 cm Make sure that the cuff edge falls within the range of mark <->. If it does not, use a ...

  • Page 42: Nibp Message And Explanations

    5.3 NIBP Message and Explanations Message Explanation Cause Self-test failure Sensor or A/D sampling error. Loose cuff Cuff is not connected correctly. Air leakage Air leakage in the valve or airway. Atmospheric pressure error Valve cannot be open. Object measuring the pulse is too weak or the cuff Signal is too weak is loose.

  • Page 43: Maintenance And Cleaning

    5.4 Maintenance and Cleaning Warning Do not squeeze the rubber tube on the cuff. Do not allow liquid to enter the connector socket at the front of the monitor. Do not wipe the inner part of the connector socket when cleaning the monitor. Warning This product is calibrated before leaving factory, The calibration of the NIBP measurement is necessary for every two years (or as frequently as dictated by your...
  • Page 44 Figure5.4 Replace Rubber Bag in Cuff To replace the rubber bag in the cuff, first place the bag on top of the cuff so that the rubber tubes line up with the large opening on the long side of the cuff. Now roll the bag lengthwise and insert it into the opening on the long side of the cuff.

  • Page 45: Transportation And Storage

    Disposable Blood Pressure Cuffs Disposable cuffs are intended for one-patient use only. Do not use the same cuff on any other patient. Do not sterilize or use autoclave on disposable cuffs. Disposable cuffs can be cleaned using soap solution to prevent infection. Note For protecting environment, the disposable blood pressure cuffs must be recycled or disposed properly.

  • Page 46: Key Of Symbols

    5.6 Key of Symbols Signal Description Refer to instruction manual/booklet Systolic pressure MAP pressure Diastolic pressure %SpO The pulse oxygen saturation (%) Pulse rate (bpm) Close the sound Open the alarm sound indication Close the alarm sound indication Type BF defibrillator proofed applied parts Serial number 1.
  • Page 47 IPX1 Ingress of liquids rank This item is compliant with Medical Device Directive 93/42/EEC of June 14, 1993, a directive of the European Economic Community.

  • Page 48: Chapter6 Installation Of The Software

    Chapter6 Installation of the software Demand of editor  Installation of software  6.1 Demand of Editor Processor: Pentium IV 1.8G or more Operation System: Win2000/XP/Vista EMS memory: 256M and up Hard Disk: 40G or more Display: 17 inch or more CD-ROM Resolution of printer: 300 DPI or more 6.2 Installation of Software...

  • Page 49: Chapter7 Introduce The Software

    Chapter7 Introduce the Software 7.1 User Register Each time you open the software will appear the following dialog box for the user's name. Type in user's name. To change user go to "File" then click on "Change User". This feature is available to allow each user to store his or her configurations, such as thresholds.

  • Page 50: The Main Interface

    Figure7.1.2 Set file path "Patient File Path": Choose the downloading route of your case. As soon as the data are downloaded in computer, the case document will save this path. If you check the "Always use default path" checkbox, then data searches will always begin at the default path.
  • Page 51 Figure7.2 The main operating interface Menu bar The main operating menu of this software Tool bar Shortcut keys for functions of frequent use Displaying areas of the trending pictures.After choosing the case which is edited, it is used for displaying the trending picture. Status bar Display the name, ID, and the data collecting date of the patient.

  • Page 52: Wear

    7.3 Wear Press the shortcut key , will pop up the following dialog box. Figure7.3 Wear You can wear the device according to the picture above. Please read the "Note" Carefully before use. 7.4 Design the Measurement Plan Note: Before you upload the test parameters to the device, make certain: 1.
  • Page 53 Steps: 1. Press the shortcut key , or from the menu select "Upload", the following dialog box will appear. Figure7.4.1 Select the status of the device 2. If the item you choose is "ABPM" the following dialog box will appear.
  • Page 54 Figure7.4.2 Upload test parameters Patient Name, Patient ID: mark the patient. Current Time: That is the time of beginning to collect the parameter. Study Start Time: Collecting start time. It defaulted in the 5 minutes after setting the collecting parameter. Start Key: Whether supporting the manual collecting.
  • Page 55 Take the above picture as an example: the range of un-sleeping time is 7:00-22:00, the range of sleeping time is 22:00-7:00, the intervals of the un-sleeping time are 5 minutes, and the intervals of the sleeping time are 30 minutes. The range of sleeping time, the range of un-sleeping time, the range special testing time are displayed by the picture forms in the right corner of the screen.

  • Page 56: Data Download

    7.5 Data Download Before you download the measurement data from device, make certain: 1. The device is connected to the computer via the serial port. 2. The device is turned on. 3. Disconnect the device from patient before you connecting it to any piece of hardware such as your personal computer (to avoid electric shock) The downloaded patient data will be saved in your default computer path.

  • Page 57: Choose Patient Data To Edit

    Figure7.5.1 Select the status of the device The following dialog box will appear to show the progress as the data is transferred. Figure7.5.2 Downloading progress bar After completion, a dialog box will prompt for where the data file was saved. 7.6 Choose Patient Data to Edit Press shortcut key , or from the menu select "File"...

  • Page 58: Delete Data File

    following dialog box will appear: Figure7.6 Patient file select The above dialog box lists the data files found in your current directory. You may use the drive and directory boxes to select a different drive or directory to search for patient files. Select a data file by highlighting the patient's name, and then press the "Okay"...

  • Page 59: Data File Backup

    Figure7.7 Data file delete You are able to delete one single file or some files at the same time, to delete some files at the same time; you could push “Ctrl”, and click the file you want to delete at the same time. After selection, click "Okay"...
  • Page 60 Figure7.8.1 Data file copy Select or deselect items by clicking on the rows using the mouse .When all desired selections have been made, select "Okay". The following dialog box will appear, permitting you to select the disk drive or directory to copy...

  • Page 61: Edit Blood Pressure Data

    Figure7.8.2 Backup path settings Once you have selected the destination drive or directory, select "Okay" .You may also select "Cancel" to end the dialog without copying patient data. 7.9 Edit Blood Pressure Data Press the shortcut key , or from the menu select "Edit" and then select "Bp Data" the following dialog box will pop up.
  • Page 62 Figure7.9 Data edit page All the BP readings are shown in the above dialog box. *=3/192(1.6%): 192 represents the total data sum, 3 represents the data amount deleted, 1.6% stands for data present deleted. Number: stands for data collection serial number. Time: stands for collection time.

  • Page 63: Trend Edit

    Comment: comment. 7.10 Trend Edit BP Trend Edit When you selected the data file, the BP trend will be shown in the screen automatically .In other interfaces you can press shortcut key enter the "BP trend" interface .The "Bp Trend" has two graph types: color filler type, dotted line type.
  • Page 64 Figure7.10.2 Dotted line type BP trend When you move the mouse on the trend area, on the top of the trend area the detail data information about the mouse points will show, including the data serial number, collection time and collection date, high/low blood pressure value, pulse rate, comment, etc. Press mouse’ left button to delete or add the data point to be shown.
  • Page 65 Figure7.10.3 Stretch BP Trend (time axis) Figure7.10.4 Shrink BP Trend (time axis)
  • Page 66 Figure7.10.5 Stretch BP Trend (y-axis) Figure7.10.6 Shrink BP Trend (y-axis) Trend Edit Press the short cut key, will appear the SpO trend interface.
  • Page 67 Figure7.10.7 SpO Trend The following picture show different parts of the data area. Move the mouse in the data area, you will see a yellow line, and on top of the data area is the "Selected data info", where you will see the exact SpO and pulse value according to the time.
  • Page 68 data will be visible at the same time in the window area from left to right. "1": 1 minute. "10": 10 minute. "60": one hour. : Manual set, click this button will pop up a dialog box, and you can set the length you want. This 4 buttons are used to move the data offset, that is what time is at the left of the window.

  • Page 69: Display The Statistics Information

    Figure7.10.8 Analysis parameters settings The setup in the dialog box above indicates: (desideration) event: the SpO value reduces at least 4% while the time keeps at least 10 seconds. Pulse Rate event: the pulse rate fluctuates at least 6bpm while the time keeps at least 8 seconds. 7.11 Display the Statistics Information Press the shortcut key , or from the menu select "Report"...

  • Page 70: Edit Of Diagnose Information

    Statistics" will pop-up the following dialog box. Figure7.11 BP statistics information 7.12 Edit of Diagnose Information. Diagnose information including following items: Patient information, Interpretation, Current Medication and Physician information. From the menu select "Edit" and then select "Patient Data" will pop up the following dialog box.

  • Page 71: Sleep Period Change

    Figure7.12 Edit patient’s information Click "Current Medications" switch to Current Medications interface, then you can modify the medications for the patient. Click "Interpretation" switch to Interpretation interface. Click "Physician Info" switch to the page of doctor's advice. 7.13 Sleep Period Change Sleep period includes: wake time and sleep time.

  • Page 72: Bp Thresholds

    Figure7.13 Sleep period dialog box 7.14 BP Thresholds After BP Thresholds being set up, the trend graph will renew automatically, statistic data will be recalculated. From the view select "Edit" and then select "Thresholds" will appear the following dialog box.

  • Page 73: Histogram

    Figure7.14 Thresholds dialog box The default recommended thresholds for calculating Blood Pressure Load are 140/90 for wake periods and 120/80 for sleep periods. These are the defaults used when you select the Factory Defaults button. 7.15 Histogram Press the shortcut key , will appear the following interface:...

  • Page 74: Pie Chart

    Figure7.15 Histogram All: Show all BP data statistics. Day: Show only daytime statistics. Night: Show only nighttime statistics. 7.16 Pie Chart Press the shortcut key , will appear the following interface:...

  • Page 75: Correlation Line

    Figure7.16 Pie chart You can adjust to show the percentage of above normal value, normal value and below normal value. On the left, some statistics can be displayed, such as BP value, PR maximum, minimum, and average value etc. All: Show all BP data statistics. Day: Show only daytime statistics.

  • Page 76: Print Report

    Figure7.17 Correlation line Red line represents systolic; blue line represents diastolic .White small circle represents day time BP value; black small circle represents night time BP value. Histogram, Pie chart and Correlation line are useful for your observation about the data. 7.18 Print Report After previous data edit, diagnose information edit, trend edit, and so on, the software will create a series of diagnose reports, you can select these pages or some of them for printing.
  • Page 77 Figure7.18.1 Configure Report You can select an already exist report for print; you may also click "Edit Report" edit the selected report. Figure7.18.2 Edit Report You can select all pages or some of them for printing. Only when the data file include SpO data and you checked the "SpO Report"...

  • Page 78: Help

    Of course you can also click "Add Report" adds a new report. If you don't need the current report, you can also click "Delete Report" to delete it. The default paper size is: A4. From the menu select "Report" and then select "Report", you can preview the page you selected.

  • Page 79: Chapter8 Troubleshooting Guide

    Chapter8 Troubleshooting Guide Code Description in Report Editor Solution No signal Check position of cuff, tighten cuff Overreach movement Remain still during BP reading Check air hose connections and make certain Measurement timeout cuff is tight Check air hose connections and make certain Airway obstructed air tubing is not crimped.

  • Page 80: Appendix

    Appendix Guidance and manufacture’s declaration-electromagnetic emission For all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic emission The Patient Monitor is intended for use in the electromagnetic environment specified below. The customer of the user of the Patient Monitor should assure that it is used in such and environment. Emission test Compliance Electromagnetic environment –...
  • Page 81 Guidance and manufacture’s declaration – electromagnetic immunity For all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic immunity The Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of Patient Monitor should assure that it is used in such an environment. Electromagnetic environment - Immunity test IEC 60601 test level...
  • Page 82 For EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacture’s declaration – electromagnetic immunity The Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of Patient Monitor should assure that it is used in such an environment. Compliance Immunity test IEC 60601 test level Electromagnetic environment - guidance...
  • Page 83      800 MHz to 2.5   Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey ,a should be less than the...
  • Page 84 telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Patient Monitor is used exceeds the applicable RF compliance level above, the Patient Monitor should be observed to verify normal operation.
  • Page 85 Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM – For EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the Patient Monitor The Patient Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
  • Page 86 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

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