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Lepu Medical AIView VS Operator's Manual

Vital signs monitor
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Vital Signs Monitor
(AIView VS)
Operator's Manual

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Summary of Contents for Lepu Medical AIView VS

  • Page 1 Vital Signs Monitor (AIView VS) Operator’s Manual...

  • Page 2: Manual Purpose

    Preface Copyright This manual contains proprietary information protected by copyright law. All rights reserved. Without the prior written consent of the manufacturer, no part of this manual shall be copied or reproduced in any form or by any means. Manual Purpose The instructions for safe operation of the product in keeping with its function and intended use are contained in this manual.

  • Page 3: Contact Information

    Contact Information Manufacturer: Shenzhen Creative Industry Co., Ltd. Floor 5, BLD 9, BaiWangXin High-Tech Industrial Park, Songbai Road, Xili Street, Address: Nanshan District, 518110 Shenzhen, PEOPLE’S REPUBLIC OF CHINA Website: www.creative-sz.com E-mail: info@creative-sz.com Tel: +86 755 26431658 Fax: +86 755 26430930 Shanghai International Holding Corp.

  • Page 4: Manual Conventions

    Manual Conventions Illustrations Setup or data displayed on your monitor may not be necessarily showed in all illustrations in this manual, because they are used only as examples. All names mentioned in this manual and illustrations are fictitious. Any similarity is purely coincidental. General Notes Italic text is used to indicate prompt information or quote the...

  • Page 5: Table Of Contents

    Table of Contents Chapter 1 Safety ....................1-1 1.1 Safety Information ................1-1 1.2 Device Symbols ..................1-4 Chapter 2 Product Introduction ................ 2-1 2.1 Intended Use ..................2-1 2.2 Contraindication .................. 2-1 2.3 Features ....................2-2 2.4 Product View ..................2-3 Chapter 3 Quick Start ..................
  • Page 6 7.2 Measurement Interferences ..............7-2 7.3 SpO Display ..................7-3 7.4 PR Display ..................... 7-4 7.5 SpO Monitoring ................... 7-5 7.6 SpO and PR Setup................7-5 Chapter 8 Measuring Temperature (Temp) ............8-1 8.1 Safety Information ................8-1 8.2 Using the Wired Thermometer (THP59JU) ........8-1 8.3 Using the Bluetooth Thermometer (AOJ-20A) ........
  • Page 7 Chapter 14 Care and Maintenance ..............14-1 14.1 Safety Information ................14-1 14.2 Routine Inspections ................. 14-2 14.3 Regular Inspections ................. 14-2 14.4 Battery Maintenance ............... 14-2 14.5 Storage, Packaging and Transportation ........14-3 14.6 Viewing System Version ..............14-3 Chapter 15 Troubleshooting ................

  • Page 8: Chapter 1 Safety

    Safety Chapter 1 1.1 Safety Information This chapter provides important safety information related to the use of the device. In other chapters, it also contains relevant safety information for specific operations. 1.1.1 Warning Before putting the system into operation, the operator must verify Warning that the device, connecting cables, and accessories are in correct working order and operating condition.
  • Page 9 Equipments connected to the device must meet the requirements of Warning the applicable IEC standards (e.g. IEC 60950 safety standards for information technology equipment and IEC 60601-1 safety standards for medical electrical equipment). The device should not be used adjacent to or stacked with other Warning equipment.
  • Page 10 1.1.2 Caution All the parts of the monitor should not be replaced at will, Caution substitution of a component different from that supplied by the manufacturer might result in measurement error. If necessary, please use the components provided by the manufacturer or those that are of the same model and standards as the accessories along with the monitor which are provided by the same factory, otherwise, negative effects concerning safety and biocompatibility etc.

  • Page 11: Device Symbols

    1.2 Device Symbols Symbols Function Symbols Function Power switch USB connector Direct current power Serial number connector General warning sign Device or part of CF type (Background: yellow; with defibrillation proof Symbol and line: black) Refer to Operator’s Manual Non-ionizing electromagnetic radiation (Background: blue;...

  • Page 12: Chapter 2 Product Introduction

    Product Introduction Chapter 2 2.1 Intended Use The monitor is intended to be used for monitoring, displaying, reviewing, and storing multiple physiological parameters including ECG, body temperature (Temp), pulse oxygen saturation (SpO ), pulse rate (PR), and non-invasive blood pressure (NIBP). The monitor is to be used for triage and ward rounds in hospitals, clinics, community health centers, or other medical care facilities by qualified clinical professionals or under their guidance.

  • Page 13: Features

    2.3 Features The view can be flexibly configured.  Lead-off detection function.  Support the commonly used clinical tool of early warning score (EWS).  Support large-capacity storage.  Support touch screen, multi-touch (zoom, multi-finger slip, etc.).  Protection against defibrillator discharge, resistance against the ...

  • Page 14: Product View

    2.4 Product View 2.4.1 Front Right View Touchscreen NIBP cuff connector Adapter connector: Connect the multi-functional adapter which connects the accessories of multiple parameters (ECG, SpO Temperature probe connector USB connectors (Base)
  • Page 15 2.4.2 Front Left View Power switch: Turn on/off the monitor. Power switch indicator: In the state of power-on, the battery is fully Green (Flashing) charged In the state of power-on, the battery is not Yellow (Flashing) fully charged In the state of power-on, no external DC White (Flashing) power is connected In the state of power-off, the battery is fully...
  • Page 16 properly The recorder work normally Open button for recorder door 2.4.3 Rear View of Main Unit Latch for main unit and base Camera and flash Speaker Main unit support...

  • Page 17: Base View

    2.4.4 Base View Main unit/base connector Main unit release button: When the main unit is connected to the base, press this button to release the main unit.

  • Page 18: Chapter 3 Quick Start

    Quick Start Chapter 3 1. Turn on the monitor 2. Connect Connect monitor, multi-functional adapter, and accessories  (ECG, SpO Connect the NIBP cable with the NIBP connector.  Connect the wired infrared thermometer to the temperature  probe connector on the base, or pair and connect the Bluetooth thermometer to the monitor.
  • Page 19 （Finger clip） (Finger cot) （Earlobe） （Wrapper） Temp Measurement site: forehead or earhole. NIBP 5. Enter Select the patient information area. new patient information Select [Menu] →[Work Mode] tab. 6. Select operating mode 7. Measure Spot-check mode: Ward round mode: and save 1.

  • Page 20: Chapter 4 Installation And Connection

    Installation and Connection Chapter 4 4.1 Environment Requirements The monitor can be installed on a wall, desktop, or a trolley. Select a place where the infrastructure and mains supply are well set up. Place the monitor in a safe and stable location where it can easily be viewed and operated.

  • Page 21: Preparing Recorder

    must be charged when the monitor cannot be turned on. The battery is charged whenever the device is connected to the DC Note power source regardless of whether or not the device is currently turned on. 4.3 Preparing Recorder You can use the recorder to print patient information, data, and ECG reports.

  • Page 22: Chapter 5 Functions

    Functions Chapter 5 5.1 Turning On/Off Monitor Turning Off the Monitor Turning On the Monitor Press the power switch for about Press the power switch for about 1-2 seconds, and a window will 2-3 seconds. pop up and select [ Power off After the monitor runs, it displays You can press and hold the...

  • Page 23: Work Modes

    5.2 Work Modes The monitor provides the operating modes as listed in the following table. Each mode is specially designed to meet the needs of different clinical scenarios. Select [ ] → [ ] tab to select the desirable mode. The Menu Work Mode default mode is spot-check mode.

  • Page 24: Main Screen

    Select the [Next] button on the main screen. All the conducted measurements are saved in a record in [Review]. Work Process for Ward Round Mode Select [Pat. List] button on the main screen. Select a patient from the pop-up window. Double-click the patient card in deep blue.
  • Page 25 Description Patient information area: displays the patient name, gender, identifier, and so on, as well as the barcode or QR code scanning icon Selecting this area to pop up the Patient Info window. Patient gender description: Male (blue): Adult /Pediactric /Neonate ...
  • Page 26 Description Indicates Wi-Fi signal strength  Selecting one of the icons to display the [Wireless] or [Connection] tab. Bluetooth icon: Indicates monitor's Bluetooth is turned on  Battery icon: Indicates that the battery is almost depleted and needs to be ...

  • Page 27: Entering Patient Information

    5.4 Entering Patient Information In the [Patient Info] screen, an asterisk (*) is placed behind the required information. Use any of the following methods to enter patient information: Enter patient information manually  Read patient ID with the device’s camera ...

  • Page 28: Settings And Operation Overview

    5.5 Settings and Operation Overview An item marked with * indicates that it is followed by relevant Note warning or prompt information at the end of this section. 5.5.1 Setup Items Function Entry Date & Time Set system date, time, as Select [Menu]→...
  • Page 29 5.5.2 Operations Operations Functions Entry Editing Patient Modify the current patient Select patient information Information information, including area→modify patient patient type, name, age, etc. information→[OK]. Select [Menu] →[System] Pairing the Pair the detected Bluetooth →[Detect Device] → select Bluetooth device with the monitor thermometer the device in [Unbound devices].

  • Page 30: Chapter 6 Ecg Acquisition

    ECG Acquisition Chapter 6 The monitor provides 4-electrode ECG acquisition if your device is configured with this function. The function is intended for adult and pediatric patients. 6.1 Safety Information Only use the lead wires provided by the manufacturer. Using those Warning from other suppliers may cause improper performance or poor protection during defibrillation.

  • Page 31: Ecg Measurement Preparation

    waveforms. When the monitor is inoperable due to overload of ECG signal or Note saturation of any part of the amplifier, it will prompt “Lead off” to remind the operator. Transient caused by cable circuitry blocks while monitoring may Note cause artifact on ECG signals yielding wrong heart rate reading and even triggering false alarm.
  • Page 32 Connect the electrode to the limb, and make sure that the metal part is placed on the electrode area above the ankle or the wrist. Refer to the following section for ECG electrode placements, or follow the doctor’s instructions. The electrode identifier and color code are classified into IEC (European standard) and AHA (American standard).

  • Page 33: Ecg Display

    Incorrect placement of electrodes.  Use expired electrodes or use disposable electrodes repeatedly.  The skin on which the electrodes are placed is unclean or poor contract  caused by scurf and hair. 6.3 ECG Display The ECG area can be set to be displayed on the main screen. To display the ECG area, select [Menu] →...

  • Page 34: Ecg Setup

    In the pop-up ECG waveform screen, select [Diagnose]. In the field of [Diagnosis], enter or edit the analysis result. Select [OK]. The diagnosis is saved. Select [Export] to export a PDF report to a USB drive, or select [Print] to print the report in the printer or recorder. 6.6 ECG Setup Items Functions...
  • Page 35 the wave valley might not be displayed. In this case, you should change the waveform gain appropriately.

  • Page 36: Chapter 7 Measuring Pulse Oxygen Saturation

    Measuring Pulse Oxygen Saturation Chapter 7 (SpO monitoring is intended for adult, pediatric, and neonatal patients. 7.1 Safety Information Check the SpO sensor and cable before use. Do not use the Warning damaged SpO sensor. Check the compatibility of the monitor, probe, and cable before use Warning to avoid patient injury.

  • Page 37: Measurement Interferences

    MRI imaging, or burn may be caused by faradism. For disposal SpO sensor, if the sterile packaging is damaged, do Caution not use it any more. When the temperature of SpO sensor is abnormal, do not use it any Caution more.

  • Page 38: Spo Display

    The high-pressure oxygen environment can affect measurement  accuracy. Peripheral vasospasm, or constriction of blood vessels caused by a  decrease in temperature, can affect measurement accuracy. Avoid placing the sensor on extremities with an arterial catheter, an  NIBP cuff or an intravascular venous infusion line. Do not apply tape to secure the sensor in place or to tape it shut;...

  • Page 39: Pr Display

    Layout 2: SpO area (Parameter and Plethysmogram) Layout icon unit value Pulse intensity bar Perfusion index Plethysmogram Layout icon: Select the layout icon to display the plethysmograph or  not. The Plethysmogram (Pleth) waveform is processed by amplitude Note normalization. 7.4 PR Display PR source When the measured value exceeds the measurement range, “--”...

  • Page 40: Spo Monitoring

    7.5 SpO Monitoring Select the proper SpO sensor according to the characteristics of each type, and then place the sensor according to the following. Finger clip Finger cot (Middle finger preferred, (Middle finger preferred, index index or ring finger) and ring finger) Ear clip L-type Wrapper (Earlobe)

  • Page 41: Chapter 8 Measuring Temperature (Temp)

    Measuring Temperature (Temp) Chapter 8 The monitor supports two types of infrared thermometers. You can select one of them to measure the ear or forehead temperature, and the measurement will transfer to the monitor. The thermometer type and measurement site are as follows: Bluetooth thermometer (Ear/Forehead) ...

  • Page 42: Temp Display

    Select [Menu] →[System] →[Detect Device]. Select your device in the area of [Unbound devices]. Select [Bind]. Then the device will appear in the area of [Bound devices]. Select the device and then select [Connect]. The device Connected connection status will turn to Apply the thermometer probe to the measurement site.

  • Page 43: Chapter 9 Measuring Non-Invasive Blood Pressure (Nibp)

    Measuring Non-Invasive Blood Chapter 9 Pressure (NIBP) The monitor uses the oscillometric method to measure non-invasive blood pressure (NIBP). NIBP measurement is based on the principle that pulsatile blood flow through an artery creates oscillations of the arterial wall. A cuff is used to occlude the artery by inflating it above the patient’s systolic pressure, the oscillometric devices measure the amplitude of pressure changes with pulsation in the cuff as the cuff pressure decreases.

  • Page 44: Measurement Interferences

    NIBP monitoring is prohibited to those who have severe Warning hemorrhagic tendency or with sickle cell disease, otherwise, partial bleeding will appear. Do not apply or pressurize the cuff on the arm on the side of a Warning mastectomy or lymph node clearance. Do not take the measurement when the patient uses diuresis or Caution vasodilator.
  • Page 45 Speak or motion during measurement may affect the measurement  accuracy. The measurement interval should not be too short (should be greater  than 2 minutes). For continuous blood pressure measurements, if the interval is too short, it can cause the arm to be compressed, resulting in a decrease in blood volume and thus a decrease in blood pressure.

  • Page 46: Nibp Display

    9.3 NIBP Display 1 NIBP unit 2 Measurement site 3 Start/Stop measurement button 4 Mean arterial pressure 5 Systolic/diastolic pressure If NIBP measurement fails, “XX” is displayed in the numerics area; if Note NIBP measurement is untaken, stopped, reset is completed, no numerics is displayed.

  • Page 47: Starting And Stopping Nibp Measurements

    Locate the cuff in such a way that the “ARTERY” mark “ ” is at a location where the clearest pulsation of brachial artery is observed. The cuff should fit snugly, but with enough room for two fingers to be placed between the cuff and the patient’s arm. The cuff should be at the same level with the heart, and the lower end of the cuff should be 2 cm above the elbow joint.

  • Page 48: Nibp Setup

    9.7 NIBP Setup Item Functions Details Measurement Set NIBP NIBP measurement site includes left Site measurement site arm, right arm, left leg, right leg. Initial Set the initial cuff See A.6 NIBP Specifications for inflation Pressure inflation pressure range. Unit Set the NIBP unit mmHg or kPa, in which 1 kPa=7.5 mmHg...

  • Page 49: Chapter 10 Early Warning System

    Early Warning System Chapter 10 Early Warning System (EWS) is an evaluation system, that provides an overall score based on vital signs measurements and observation, followed by corresponding action suggestions. The EWS system is not applicable to pregnant women and people Warning under 16 years old.
  • Page 50 Types of Scoring System The monitor supports NEWS, MEWS, and CART scoring systems. Scoring Scoring Parameters Result Description System 0-4 points, with the numerics in  blue: indicates a low risk National Consciousness, Supply 0-4 points, with the numerics in ...
  • Page 51 Before calculating the score, select [Clear] to clear the previous Caution score. You can get the score only when all required parameters have been Note measured or entered. 10-3...

  • Page 52: Chapter 11 Observation Parameters

    Observation Parameters Chapter 11 The monitor provides a set of parameters from the physician’s clinical observations or patient’s complaints. Physicians can enter the values of these parameters and output them in a record. Observation Parameter Area The Observation Parameter area is not displayed by default. Select [Menu] →...
  • Page 53 To edit the parameters in the preset [Triage] and [General Ward] groups, follow the steps below: Select [Menu] → [More parameters>]. Select [Edit] and select the desired fields. Select [OK]. 11-2...

  • Page 54: Chapter 12 Review

    Review Chapter 12 Select [Review] to enter the Review screen. You can view all the measuring records of all patients. Current record: Current record is in blue background. The measurements of this record display on the right side. Selected records: The checked records are selected records. These selected records can be operated by exporting, deletion, and printing.
  • Page 55 Delete the selected records.  Modify the value of observation parameters.  Re-measure the parameters.  If the device storage has 20% remaining, it will promote insufficient Caution storage space. If the device storage has 10% remaining, the earliest patient records will be automatically deleted. 12-2...

  • Page 56: Chapter 13 Cleaning And Disinfection

    Cleaning and Disinfection Chapter 13 13.1 Safety Information Do not immerse the device and accessories in liquid. Warning Do not pour liquid on the device or accessories. Do not allow the Warning liquid permeate into the device. Do not use abrasive materials or any strong corrosive solvents for Warning cleaning to avoid scratches or damages to the device.

  • Page 57: Disinfection

    Wipe off all the cleaning agent residue with a clean dry cloth. Dry your monitor in a ventilated, cool place. Keep the cleaning agent away from the connectors of the monitor Caution and accessories while cleaning the device housing. Use non-aggressive cleaning agent to clean the surface of the Caution monitor and the display screen.

  • Page 58: Cleaning, Disinfection And Sterilization Of Accessories

    Gently wipe around the print head using cotton swabs dampened with Ethanol. After the Ethanol has completely been dried, reload the paper and close the printer door. 13.7 Cleaning, Disinfection and Sterilization of Accessories For the cleaning, disinfection, and sterilization methods of reusable accessories, refer to the instructions for use that accompany the accessories.

  • Page 59: Chapter 14 Care And Maintenance

    Care and Maintenance Chapter 14 To ensure the normal operation of the monitor and maintain its service life, please pay attention to the maintenance of the monitor. 14.1 Safety Information No modification of this device is allowed. Warning This device contains no user serviceable parts. Warning The safety checks or maintenance involving any disassembly of the Warning...

  • Page 60: Routine Inspections

    14.2 Routine Inspections Before using the monitor, the checks below should be carried out: Check the monitor for any mechanical damages.  Inspect the exposed parts and the inserted parts of all the cables and  the accessories. Examine all the functions of the monitor that are likely to be used for ...

  • Page 61: Storage, Packaging And Transportation

    Do not condition the monitor battery while a patient is under Caution monitoring. If the battery conditioning has not been conducted for a long time, Caution the battery capacity display may be inaccurate, causing the incorrect judgment of remaining battery runtime. The operating time of the battery reflects its performance directly.
  • Page 62 Select [Menu] →[System]→enter the password→[Maint.], and you can view the system software version, hardware version, module version, etc. 14-4...

  • Page 63: Chapter 15 Troubleshooting

    Troubleshooting Chapter 15 Status Possible Causes Handling Measures Contact the service personnel and Battery cannot Battery is defective replace the battery. be recharged and/or fully Main board is Contact the service personnel and charged defective replace the main board. Check that the electrodes are Adjust the electrode placement properly located...

  • Page 64: Chapter 16 Accessories

    Accessories Chapter 16 The accessories listed in this chapter comply with the requirements of IEC 60601-1-2 when in use with the monitor. The accessory material that contacts the patients has undertaken the bio-compatibility test and is verified to be in compliance with ISO 10993-1. For details about the accessories, refer to the instructions for use provided with the accessory.

  • Page 65: Ecg Accessories

    availability with your local supplier. For the replacement cycle and replacement method of the Note accessories, refer to the instructions for use provided with the accessory. 16.1 ECG Accessories Applicable Accessories Model/Part No. Description Patient 4-electrode, Adult/ ECG lead KE-DGB041 defibrillation-proof, wire Pediatric...

  • Page 66: Nibp Accessories

    16.4 NIBP Accessories Accessories Model/Part No. Description Applicable Patient 10 cm-19 cm, Cuff KN-231 reusable 18 cm-26 cm, Cuff KN-233 reusable 25 cm-35 cm, Cuff KN-241 reusable Adult/ Pediatric 33 cm-47 cm, Cuff KN-243 reusable 7.1 cm-13.1 cm, Cuff KN-114 disposable 8 cm-15 cm, Cuff...

  • Page 67: Appendix A Technical Specifications

    Appendix A Technical Specifications A.1 Overall Specifications Classifications Anti electric-shock type Class I and internally powered device Anti electric-shock Type CF with defibrillation protection degree Degree of protection Main unit: IPX2 against harmful ingress Main unit + base: IPX1 of water Disinfection/sterilization Refer to Chapter 13 Cleaning and Disinfection.
  • Page 68 Environmental Specifications Main unit Relative Humidity Environment Temperature Atmospheric pressure (Non-condensing) Operating 15%- 95% 57.0 kPa ~107.4 kPa 0℃- 40℃ Transport & 10％- 95% 50.0 kPa-107.4 kPa -20℃- +60℃ Storage Power Supply Specifications External power supply Input AC 100-240 V voltage Input power 0.6 A-0.2 A...
  • Page 69 protection depletion. The monitored information will be automatically from power saved. Upon recharging or reconnecting to external power, the failure monitor will return to its pre-shutdown state. Physical Specifications Main unit 254 mm×185 mm×28 mm size Weight Main unit: 1.4 kg Base: 1.2 kg Display 10.1 inches, 1280×800, color LCD screen with multi-touch...
  • Page 70 Wi-Fi Module Frequency 2.4 G/5 G dual-band WLAN communication Standard compliance 802.11 a/b/g/n and 802.11 ac Transmission rate ≥2 MB/s Bluetooth Version Support BT 5.0 Communication 10 m distance Network Security Network The monitor is connected to LAN through a wireless module condition and TCP/IP protocol.

  • Page 71: Ecg Specifications

    mechanism Permission of medical staff: No password. The monitor  automatically enter the monitoring screen after starting up, and can be set according to requirements, for example, all the modules can be accessed and set except maintenance functions. Permission of manufacturer's maintenance personnel: Enter the ...

  • Page 72: Spo Specifications

    Notch filter 50 Hz/60 Hz Filter 0.05 Hz-150 Hz, 0.67 Hz-150 Hz, Off Measurement Adult: 15 bpm-300 bpm range and error Pediatric: 15 bpm-350 bpm Error: ± 1% or ± 1 bpm, whichever is greater A.3 SpO Specifications Compliant ISO 80601-2-61: 2017 standard 0％-100％...

  • Page 73: Temp Specifications

    Measurement 30 bpm-250 bpm, error ±2 bpm or ±2%, whichever is range and greater accuracy A.5 Temp Specifications Compliant ISO 80601-2-56: 2017 standards Measurement Infrared thermal temperature method Measurement Direct mode mode Measurement 0.0℃- 50.0℃ range Measurement AOJ-20A THP59JU accuracy 5.5℃...
  • Page 74 2.0-34.6 2.0-28.6 mmHg 10-250 10-200 1.3-33.3 1.3-26.6 Measurement The measurement error of blood pressure simulator accuracy should be ≤ 8 mmHg (1.07 kPa)

  • Page 75: Appendix B Prompt Messages

    Appendix B Prompt Messages Parameter-related prompts Prompt Causes Messages ECG lead off All ECG leads fall off or ECG cable is not connected. The electrode is not firmly connected with the patient or ECG xx lead off falls off, resulting in the corresponding ECG lead falling off.
  • Page 76 Prompt Causes Messages timeout pediatric mode and over 90 seconds in neonatal mode. The blood pressure cannot be obtained. Cuff and patient The cuff used does not match the preset patient type: use type mismatch neonatal cuff in adult mode. NIBP airway leak Air moving part, tube, or cuff leak air.
  • Page 77 Prompt Causes Messages Recorder initialization error, communication error, or Recorder error！ recorder unavailable Recorder out of Recorder runs out of paper, or recorder door not closed. paper Recorder not Recorder not connected exist Parameter board communication Communication error with parameter board error...

  • Page 78: Appendix C Emc Compliance

    Appendix C EMC Compliance Table 1 Guidance and manufacturer’s declaration-electromagnetic emission for all EQUIPMENT and SYSTEMS The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment or system should assure that it is used in such an environment.
  • Page 79 the relative humidity should be at least 30%. ±2 kV for power Mains power quality Electrostatic supply lines should be that of a transient / ±2 kV for power typical commercial or ±1 kV for burst supply lines hospital input/output IEC61000-4-4 environment.
  • Page 80 Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING The equipment 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 electromagnetic environment.
  • Page 81 NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a： Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
  • Page 82 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined 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.

  • Page 83: Appendix D Abbreviations

    Appendix D Abbreviations alternating current analog to digital American Heart Association CART Cardiac Arrest Risk Triage cardial floating CMOS complementary metal oxide semiconductor direct current Demo demonstration electrocardiogram EEPROM electrically erasable programmable read-only memory electromagnetic compatibility early warning system hospital information system Health Level Seven identification International Electrotechnical Commission...
  • Page 84 Temp temperature universal serial bus WLAN wireless local area network electromyogram...
  • Page 85 Shenzhen Creative Industry Co., Ltd. Manufacturer address: Floor 5, BLD 9, BaiWangXin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, 518110 Shenzhen, PEOPLE’S REPUBLIC OF CHINA Tel: +86-755-26431658 Fax: +86-755-26430930 Website: www.creative-sz.com Email: info@creative-sz.com...