Gima 35111 User Manual
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Gima 35111 User Manual

Gima 35111 User Manual

Abpm pulse rate monitor with spo2
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PROFESSIONAL MEDICAL PRODUCTS
GIMA ABPM PULSE RATE MONITOR
WITH SpO
35111 / PM50
CONTEC MEDICAL SYSTEMS CO., LTD
No.112 Qinhuang West Street, Economic & Technical
Development Zone, Qinhuangdao, Hebei Province,
PEOPLE'S REPUBLIC OF CHINA
Made in China
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
2
IPX1
0123

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  • Page 1 PROFESSIONAL MEDICAL PRODUCTS GIMA ABPM PULSE RATE MONITOR WITH SpO 0123 35111 / PM50 CONTEC MEDICAL SYSTEMS CO., LTD No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei Province, PEOPLE’S REPUBLIC OF CHINA Made in China IPX1 Shanghai International Holding Corp. GmbH (Europe)
  • Page 2 Foreword Please read the User Manual carefully before using this product. The User Manual which describes the operating procedures should be followed strictly. This manual detailed introduce the steps must be noted when using the product, operation which may result in abnormal, the risk may cause personal injury and product damage and other contents, refer to the chapters for details.
  • Page 3 ⚫ Described each measurement results combined with clinical symptoms by qualified doctors. ⚫ The reliability and operation of using this product whether meets the operation of this manual relate to the maintenance instructions. ⚫ The intended operator of this product may be the patient. ⚫...
  • Page 4 Assembly, addition, debugging, modification or repair are carried out by personnel approved by our company. The electrical facilities in the room are in compliance with the relevant requirements and the device is used in accordance with the User Manual. The User Manual is written by our company. All rights reserved.

  • Page 5: Table Of Contents

    Contents Chapter 1 Introduction ..........................1 1.1 General Information ........................6 1.2 Button Functions ........................7 1.3 External Interfaces ........................9 1.4 Accessories ..........................10 Chapter 2 Installation ..........................13 2.1 Open Package and Check ......................13 2.2 Battery Installation ........................13 2.3 Power on ..........................
  • Page 6 Chapter6 Maintenance and Cleaning ......................46 Chapter 7 Software installation ......................... 50 7.1 Requirements of Hardware ....................... 50 7.2 Software Installation......................... 50 Chapter 8 Software Functions........................51 8.1 User Register ..........................51 8.2 Main Interface .......................... 53 8.3 Wear ............................54 8.4 Setting for Collection Plan .......................
  • Page 7 8.18 Print Report ..........................78 8.19 Help ............................81 Chapter 9 Key of Symbols ........................82 Chapter10 Specification ........................... 84 Appendix ..............................87...

  • Page 8: Chapter 1 Introduction

    Chapter 1 Introduction ◼ Operators do not need professional training, but should use this product after fully understanding the requirements in this manual. ◼ To prevent users from suffering damage or loss due to improper use, please refer to Safety Precautions and use this product properly. ◼...
  • Page 9 Contraindication No contraindications. Warning Do not use the device in the case of there are flammable anesthetic gasses mixing with the air or nitrous oxide. Otherwise it may cause risk. For children and the person who can't express oneself, please use the device under the guidance of a doctor.
  • Page 10 Otherwise it may cause risk. Dispose of the packaging material, observing the applicable waste control regulations and keeping it out of children's reach. Otherwise it may cause harm to the environment or children. Please use approved accessories for the device and check that the device and accessories are working properly and safely before use.
  • Page 11 local laws and regulations. The end-of-life products and materials are properly disposed of by the user in accordance with the authority’s decree. Replace accessories which not provided by our company may lead to the occurrence of errors. Without our company or other approved maintenance organizations trained service personnel should not try to maintain the product.
  • Page 12 This device is suitable for occasions with electrosurgical equipment, but when used with electrosurgical equipment, patient safety must be given the highest priority. When the monitor is wetted, please stop using it and contact us. After pressing the power button, if the device has display fault such as white screen, blurred screen or no display content, please contact our company.

  • Page 13: General Information

    1.1 General Information General instruction: The monitor not only measures the ambulatory blood pressure, but also monitors the parameters of NIBP and SpO .The monitor integrates parameter measuring modules function and display function in one device, features in compactness and lightweight. The POWER switch is on the front panel.

  • Page 14: Button Functions

    measurement set by the user. It is useful that the software at the state of monitoring as the ambulatory blood pressure. Refer to Software Functions for details. 1.2 Button Functions User can switch the interface by the buttons to achieve the functions of parameter setting, blood pressure measuring, SpO measuring and result checking, the detailed functions for each button are as followings:...
  • Page 15 to switch between prompt and silence( displays on the top left corner). Other interfaces: select upward items or page turning. ⚫ DOWN button Select downward items or page turning. ⚫ Measure button Press it to inflate the cuff for blood pressure measuring. During measuring, press it to stop measuring and deflate.

  • Page 16: External Interfaces

    1.3 External Interfaces For the convenience of operation, the different kinds of interfaces are in different parts of the monitor. (1)At the top is the Socket for SpO Sensor and socket for NIBP cuff. Note NIBP airway tube has been fixed to the Socket for NIBP cuff. ①the Socket for NIBP cuff ②the Socket for SpO Sensor...

  • Page 17: Accessories

    ① Figure 1.3.2 Bottom 1.4 Accessories a cuff for adult a USB data line a SpO probe a disk (PC software) a pouch 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 18 Note The length of the inflated part of the cuff should be sufficient to surround 50% to 80% of the limb. Unsuitable cuffs can produce erroneous readings. If there is a problem with the size of the cuff, use a larger cuff to reduce the error. Reusable Cuff for adult: Patient type Limb circumference...
  • Page 19 Note When the product and accessories described in this manual are about to exceed the period of use, they must be disposed according to relevant product handling specification. If you want to know more information, please contact our company or representative organization.

  • Page 20: Chapter 2 Installation

    Chapter 2 Installation 2.1 Open Package and Check Open the package and take out the monitor and accessories carefully. Keep the package well for possible future transportation or storage. Check the components according to the packing list. ■ Check whether there is any mechanical damage. ■...
  • Page 21 ① Demount the battery cover in the direction of the arrow. ② Install two "AA" batteries according to polarities ③ Slide to close the battery cover. Note Icon “ ”: the batteries power will exhaust, the device prompts “Low battery” at the same time. Replace with two new batteries (the same sort) at this time.

  • Page 22: Power On

    2.3 Power on Turn on the power switch , the indicator will flash once, the system will enter the main interface successfully. The backlight is always light in monitoring and blood pressure mode. In ABPM mode, the backlight will be turned off according to the backlight time when there is no button operation, press any button to lighten the screen.
  • Page 23 patient’s upper arm. For SpO measurement, insert one end of the senor into the SpO socket and the other end grip the finger. As shown below:...

  • Page 24: Chapter3 Function Interface

    Chapter3 Function Interface 3.1 Main Interface Turn on the power switch, the indicator will flash once, the system will enter the main interface successfully. In ABPM mode, if there is no button operation within the time set in the BACKLIGHT TIME item, the monitor will turn off LCD and enter standby mode.
  • Page 25 Figure 3.1.1 ABPM Main Menu...
  • Page 26 Figure 3.1.2 Monitoring Main Menu...
  • Page 27 Figure 3.1.3 BP Main Interface After measuring, patient’s measurement results will be displayed, the details are as follows: SYS: systolic pressure MAP: mean pressure DIA: diastolic pressure PR: pulse rate %SpO : oxygen saturation...

  • Page 28: System Menu

    Pressure values can be compared in this interface: connect the device with the NIBP Simulator, long press "Measure" button for 5 seconds to enter the real-time pressure comparison mode to compare the pressure values measured by the device and the NIBP Simulator. 3.2 System Menu Under the main interface, press the "MENU"...
  • Page 29 "ABPM SETUP" in monitoring mode and BP mode is unavailable, it is gray font, switch current working mode to ABPM mode to change ABPM setup. 3.2.1 System Setup Select the "SYSTEM SETUP" item in the "SYSTEM MENU" interface, press the middle button to enter "SYSTEM SETUP"...
  • Page 30 password display area, press the middle button, when the rectangle frame turns to red selected state, adjust the number by the "Up" and "Down" button, then press the middle button again to exit the selected state after adjusting. After entering the 4-bit password, move the cursor to "CONFIRM", then press the middle button, the prompt setting can be changed if the password is correct.
  • Page 31 Adjustable prompt range: "SYS HIGH": higher than the low limit of systolic pressure prompt, ≤ 270 mmHg "SYS LOW": lower than the high limit of systolic pressure prompt, ≥ 40 mmHg "DIA HIGH": lower than the high limit of systolic pressure prompt, higher than the low limit of diastolic pressure prompt.
  • Page 32 3.2.4 ABPM SETUP Select "ABPM SETUP" in the "SYSTEM MENU" to enter its sub-menu shown as below. Figure 3.2.4 ABPM SETUP Adjustment increment for "Asleep Time" and "Awake Time" is 30 minutes, adjustment range is 00:00~23:30. Adjustment increment for "Special Start" and "Special End" is 30 minutes, adjustment range is 00:00~23:30 and "NONE".
  • Page 33 and NONE. When one of "Special Start" and "Special End" is set "NONE", "Special Interval" is invalid. 3.2.5 BP TABLE Select "BP TABLE" in "SYSTEM MENU" to enter its sub-menu shown as below. Figure 3.2.5 BP TABLE Display the corresponding blood pressure data according to current working mode, press UP/DOWN button to turn page.
  • Page 34 3.2.6 SpO TABLE Select "SpO TABLE" in "SYSTEM MENU" to enter its sub-menu shown as below. Figure 3.2.6 SpO TABLE Display the corresponding SpO data according to current working mode, press UP/DOWN button to turn page.
  • Page 35 3.2.7 DEMO Select "DEMO" in "SYSTEM MENU" to enter its sub-menu. In DEMO interface, press "MENU" button to return to trend graph interface, as shown below: Figure 3.2.7 DEMO Interface 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.

  • Page 36: Chapter4 Spo 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 37 ◼ The SpO value and the PLETH waveform can be displayed in the main screen. ◼ 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 38: Precautions During Spo /Pulse Monitoring

    4.2 Precautions during SpO /Pulse Monitoring Note ◎Make sure the nail covers the light. The probe cable should be on the backside of the hand. Improper probe placement or improper contact with the test site will influence the measurement. ◎SpO value always displays in the fixed place.
  • Page 39 temperature value is measured by a temperature measuring device. ◎The device does not provide over-limit alarm function, so it is inapplicable for using in places where need such function. ◎The SpO probe has been calibrated before leaving factory. It does not need to be calibrated during maintenance.
  • Page 40 ◎Clinical report records data of 12 healthy volunteers, including 6 females and 6males. Volunteers’ age ranges from 21 to 29. Skin color is distributed from dark to light, including 3 dark black skins, 2 medium black skins, 5 light skins, 2 white skins. ◎When using the device, please keep it away from the instruments that can generate strong electric or magnetic field.
  • Page 41 according the clinical situations and symptoms. ◎Pulse oxygen has only reference significance for anemia and toxic hypoxia, as some patients with severe anemia still show better pulse oxygen measurements. ◎Measurement accuracy can be affected by the interference of electrosurgical equipment. ◎Do not install the SpO probe on an extremity with arterial catheter or receiving intravenous injection.

  • Page 42: Monitoring Procedure

    microcirculation barrier patients. It is recommended that the measurement should not be taken at the same position for over 2 hours. Continuous, long measurements may increase the risk of unwanted changes in the skin characteristics, such as exceptionally sensitive, reddish, blistering or oppressive necrosis, especially for neonates or the patients with perfusion disorder and change or immature skin form.
  • Page 43 If the SpO works abnormally, after connecting the SpO probe to the device, the device will not display any data under the SpO interface. plethysmogram measurement 1.Switch on the patient monitor. 2.Attach the sensor to the appropriate site of the patient finger. 3.Plug the connector of the sensor extension cable into the SpO socket, please pay attention to the connection direction of the socket.
  • Page 44 ⚫ Intravenous dyestuff. ⚫ Excessive patient movement. ⚫ External light. ⚫ Improper SpO probe installation or incorrect contact position of the patient. ⚫ Temperature of SpO probe(optimal temperature range: 28°C ～ 40°C). ⚫ Place the SpO probe on an limb that has a blood pressure cuff, arterial catheter, or intravascular line.

  • Page 45: 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 46: Nibp Monitoring

    Warning You must not perform NIBP measurements on patients with sickle-cell disease or under any condition which the skin is damaged or expected to be damaged. For a thrombasthemia patient, it is important to determine whether measurement of the blood pressure shall be done automatically.
  • Page 47 Prolonged non-invasive blood pressure measurements may be associated with purpura, ischemia and nerve injury in the limb wearing the cuff. When monitoring a patient, examine the color, warmth and sensitivity of the distal part of limb frequently. If any abnormality is observed, stop the measurement immediately or replace the cuff location.
  • Page 48 ◆ Ensure the cuff is completely deflated. ◆ Apply the appropriate size cuff to the patient, and make sure that the symbol "φ" is over the appropriate artery. Ensure that the cuff is not wrapped too tightly around the limb. Excessive tightness may cause discoloration and eventual ischemia of the extremities.
  • Page 49 based on the regular pulse wave generated by arterial pressure. In the case where the patient condition makes such a detection method difficult, the measured value becomes unreliable and the measuring time increases. The user should be aware that the following conditions will make the measurement unreliable or measurement time extended.

  • Page 50: Nibp Error Messages And Causes

    ⚫ Heart Rate Extremes Measurements can not be made at a heart rate of less than 40 bpm or higher than 240 bpm. ⚫ Obesity patient The thick fat layer under the limb will decrease the measurement accuracy, as the vibration from artery can not arrive to the cuff, which is arisen from the fat damping.
  • Page 51 No error Low battery Cancel measuring Loose cuff Cuff is not connected, or it is too loose. Air leakage Air leakage in the valve or airway. Atmospheric Valve can not open. pressure error The pulse of measured subject is too weak or the Weak signal cuff is loose.
  • Page 52 System airway leakage is found in leakage Air leakage detection. Possible failure caused by pump, A/D sampling, System failure pressure sensor error or software operation error. The measuring time is longer than specified,adult Time out and pediatric: 150 s, neonate: 90 s ——...

  • Page 53: Chapter6 Maintenance And Cleaning

    Chapter6 Maintenance and Cleaning *Please do obey the precautions and correct operating methods in this user manual. Otherwise, we will not responsible for any fault. Warning ⚫ Remove the batteries before cleaning the device or peripheral equipment. The accessories and main unit must be separated for cleaning.
  • Page 54 Reusable Blood Pressure Cuff The cuff can be sterilized by means of conventional autoclaving, gas, or radiation sterilization in hot air ovens or disinfected by immersion in decontamination solutions, but remember to remove the rubber bag if you use these methods. The cuff should not be dry-cleaned. It can be machine-washed or hand-washed, the latter method may prolong the service life of the cuff.
  • Page 55 To insert 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 56 To avoid device damage, keep the device out the reach of children and pets. Avoid the device close to extreme high temperature such as fireplace, otherwise the device performance may be affected. Do not store the device with chemical medicine or corrosive gas. Do not place the device where there is water.

  • Page 57: Chapter 7 Software Installation

    Chapter 7 Software installation 7.1 Requirements of Hardware Processor: Intel Celeron 2.5G or more Operation System:Windows XP/Win7/Win8 EMS memory: 1GB and more Hard Disk: 250G or more Display: 17 inch or more CD-ROM USB: 2 or more Resolution of printer: 600 DPI 7.2 Software Installation 1.

  • Page 58: Chapter 8 Software Functions

    Chapter 8 Software Functions 8.1 User Register Double-click the software icon, then the dialog box shown as below appears. Figure 8.1.1 User Register Enter the user name, click "Okay", then the "Configuration Set" dialog box shown as Figure 8.1.2 will appear. Click "Delete" to delete the configuration information of the user. "Delete all"...
  • Page 59 Figure 8.1.2 Configuration Set "Case path": select the default storage path for case, after getting the data from the device, the case file will be saved in this path. If you select "Always use default path", then the case file will be automatically saved in the...

  • Page 60: Main Interface

    installation path. 8.2 Main Interface The device will enter to the main interface(shown as below) after setting the configuration information. Figure 8.2 Main Interface...

  • Page 61: Wear

    8.3 Wear After clicking the shortcut key , the following figure appears. Before using the device, please read "Matters need" carefully, and wear the device according the following figure. Figure 8.3 Wear...

  • Page 62: Setting For Collection Plan

    8.4 Setting for Collection Plan Click the shortcut key or "Upload" from menu, after selecting the connection mode, the dialog box "Select the status of the device" will appear. Figure 8.4.1 Select the Device Status...
  • Page 63 If you choose "ABPM", the following dialog box will appear. Figure 8.4.2 Set the Collection Plan...
  • Page 64 The doctor can set the parameters according to patient's status and diagnosis requirements, after correct settings and communicating, the device will perform the collection task. Parameters descriptions are as followings: Patient Name: patient's name. Patient ID: patient's ID number, it is used to identify the patient, it is unique. Current Time: the time displayed in the computer, it is used to update the device system time.
  • Page 65 If you choose "Patient Monitor", the following dialog box will appear. Figure 8.4.3 Parameters Setting Parameters descriptions are as followings: Patient Name: patient's name...

  • Page 66: Data Download

    Patient ID: patient's ID number, it is used to identify the patient, it is unique. Current Time: the time displayed in the computer, it is used to update the device system time. After setting, click "OK" to set this plan to the device. "Prompt Sound": after selecting "ON"...

  • Page 67: Open Data File

    8.6 Open Data File Click "Open Data" to open the case interface shown as below: Figure 8.6 Case Selection In this interface, you can operate the drive and folder selection on top left part to load the specified disk and folder content, if case file exists in this folder, the basic information of...

  • Page 68: Delete Data File

    these case files will be displayed in the form of list, contents including: patient name, patient ID, start time and file name. Click to select the case file to be opened, then click "Okay" to open and load the case file information. When there are many case data, select one inquiry item, enter the key information, then click "Search"...

  • Page 69: Data File Backup

    Many files can be deleted at the same time. Push “Ctrl” and click the file you want to delete at the same time, click "Okay", to delete the case file selected. Click "Cancel" to cancel deleting. 8.8 Data File Backup The software has the function of case backup.
  • Page 70 After selecting files, click "Okay", then a dialog box which is used to set the storage files of backup files appears. After setting, click "Okay" to save. The destination directory interface is shown as below: Figure 8.8.2 Backup Path Settings...

  • Page 71: Edit Ip Data

    8.9 Edit IP Data After opening the case file, blood pressure data can be edited. Click the shortcut key select "Bp data" from menu to enter the interface shown as below: Figure 8.9 Data Edit Interface...

  • Page 72: Trend Graph

    All the BP readings are shown in the above dialog box. *=5/192(2.6 %): 192 represents the data sum, 5 represents the data amount deleted, 2.6 % is the percentage of data deleted in all collection data. Number: stands for data collection serial number. Time: stands for collection time.
  • Page 73 Click the shortcut key to its sub-menu. Two graph types: color filling trend and dotted line trend. The trend graph is shown as below. Figure 8.10.1 Color Filling Trend Ggraph...
  • Page 74 Figure 8.10.2 Dotted Line Trend Graph You can switch the two trend graph types by "Graph Type" button in the bottom of the software interface. When you move the mouse on the trend area, the detail data information on this location will display in the top of the tread area, including the data serial number, collection time and collection date, high/low blood pressure value, pulse rate, comment, etc.
  • Page 75 8.10.2 SpO trend graph When you open the case file with SpO data, click "SpO Trend" to enter SpO trend interface. Figure 8.10.3 SpO Trend Graph 4 buttons are used to set the time length of one page, that is how long...
  • Page 76 data will be visible at the same time in the window area from left to right. current screen displays 1-minute trend graph. current screen displays 10-minute trend graph. current screen displays 1-hour trend graph. one dialog box will appear after pressing this button, then you can set the time length according to requirements.
  • Page 77 Figure 8.10.4 Analysis Parameters Settings The setup in the dialog box above indicates: (desideration) event: the SpO value reduces at least 4%, whose continuous time is at least 10 seconds. Pulse Rate event: the pulse rate fluctuates at least 6bpm, whose continuous time is at least 8 seconds.

  • Page 78: Display Of Statistics Information

    8.11 Display of Statistics Information Press the shortcut key or select "Report" from menu to enter its sub-menu shown as below. Figure 8.11 BP Statistics Information The upper half part of the figure shows the average of blood pressure data and the measurement number under "Awake"...

  • Page 79: Patient Information Settings

    8.12 Patient Information Settings Select "Patient Data" from the menu to enter its sub-menu shown as below. Patient information including: patient information, current medications, diagnose information and physician information. Figure 8.12 Edit Patient’s Information Recent medication information of patient can be entered in "Current Medications" column. Blood pressure data description and diagnosis information can be entered in "Diagnose...

  • Page 80: Sleep Time Setting

    Information" column. Doctor name and doctor advice can be entered in "Physician Info" column. 8.13 Sleep Time Setting Awake and Asleep time can be set by manual mode, after setting, the software will calculate the data again under "Awake" and "Asleep" state, then update the trend graph and calculate the statistic data automatically.

  • Page 81: Bp Threshold Setting

    8.14 BP Threshold Setting The BP threshold can be changed by manual mode, after changing, the corresponding trend graph and analysis data will be automatically renewed. Select "Threshold" to enter its sub-menu shown as below. Figure 8.14 BP Threshold Setting...

  • Page 82: Histogram

    The default recommended thresholds for calculating Blood Pressure Load are 140/90 for wake periods and 120/80 for sleep periods. These are the default values when you select the Factory Defaults button. 8.15 Histogram Press the shortcut key , the following interface will appear. Figure 8.15 Histogram...

  • Page 83: Pie Chart

    "All", "Day" and "Night" can respectively display the analysis values in each period. 8.16 Pie Chart Press the shortcut key , the following interface will appear: Figure 8.16 Pie Chart...

  • Page 84: Correlation Line

    The pie chart interface is divided into four regions, from left to right, the first region is value display area which displays the Maximum, Minimum and Average values among the measurement values, the second region is pie chart display area, the third is the setting area for pie chart color and values, and the last is the time display area, it has three options: "All", "Day"...

  • Page 85: Print Report

    The horizontal axis is the systolic pressure axis, the vertical axis is the diastolic pressure axis. Red represents the dependence for diastolic pressure to systolic pressure; blue represents the dependence for systolic pressure to diastolic pressure. The hollow circle is the BP value measured in the day, and the solid circle is the BP value measured at night.
  • Page 86 Figure 8.18.1 Configure Report...
  • Page 87 You can select a report configured for printing, or click "Edit Report" to edit the selected report. Figure 8.18.2 Edit Report...

  • Page 88: Help

    The SpO analysis report can only be printed when the case file contains the SpO and "SpO report" is selected. Click "Add Report" to add a new report. If you don't need the current report, you can also click "Delete Report" to delete it. Click the shortcut key or select "Report"...

  • Page 89: Chapter 9 Key Of Symbols

    Chapter 9 Key of Symbols Signal Description Systolic pressure MAP pressure Diastolic pressure %SpO The pulse oxygen saturation (%) Pulse rate (bpm) Adult ABPM Ambulatory blood pressure monitoring mode Patient monitoring mode INFO Information Close the sound Open the prompt sound indication...
  • Page 90 Close the prompt sound indication 1. the finger clip falls off ( no finger inserted)] 2. Probe error 3. Signal inadequacy indicator Low battery Full battery Product code Serial number Lot number Follow instructions for use Keep in a cool, dry place WEEE disposal Keep away from sunlight Covering Protection rate...

  • Page 91: Chapter10 Specification

    Chapter10 Specification Name Patient Monitor The degree of protection IPX1 against ingress of water Display mode 2.4" color LCD Display Operating mode Continuous operating NIBP specification Measurement method Oscillography method Working mode Automatic Blood pressure Measurement range Pressure:0~290 mmHg(0~38.67 kPa) Cuff Pressure Accuracy Static pressure: ±3 mmHg(±0.4 kPa) Overpressure protection...
  • Page 92 Measurement range 0 %~100 % Resolution Measured value in range of 70%~100％, absolute error is ±2％, Error below 70% unspecified. Measurement and pulse rate can be shown correctly when pulse-filling ratio Performance Weak is 0.4 %, SpO error is ±4%; the Pulse rate error is ±2 bpm or ±2 %, Filling Condition: whichever is greater.
  • Page 93 Working：-500 to 4,600m (-1,600 to 15,000ft) Altitude Transport and Storage：-500 to 13,100m (-1,600 to 43,000ft) Power Supply DC 3 V When the temperature is 23ºC, limb circumference is 270mm, the Battery service life measured blood pressure is normal, 2 "AA" alkaline batteries can be used about 150 times.

  • Page 94: 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. Electromagnetic environment –...
  • Page 95 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 96 Guidance and manufacture’s declaration – electromagnetic immunity 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...
  • Page 97 800 MHz to 2.5 GHz 3 V/m 3 V/m Radiated RF 80 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) 61000-4-3 according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
  • Page 98 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. 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 99 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 100 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.
  • Page 101 requirements of the corresponding national standard. ●The device requires special precautions for electromagnetic compatibility (EMC) and requires qualified personnel to install and use in accordance with the EMC information provided below. ●The device should not contact the pins of connectors marked with an ESD warning symbol, unless electrostatic discharge precautions are used, the device should not connect to these connectors.
  • Page 102 Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of this equipment by bringing it to a specific recycling point for electric and electronic equipment. GIMA WARRANTY TERMS The Gima 12-month standard B2B warranty applies.

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