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Mediana V10 Operator's Manual

Vital signs monitor
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OPERATOR'S MANUAL
V10
Vital Signs Monitor
EU representative
OBELIS S.A
Bd. Général Wahis, 53, 1030 Brussels, Belgium
Manufacturer
Mediana Co., Ltd.
132, Donghwagongdan-ro,
Munmak-eup, Wonju-si, Gangwon-do, Korea
Tel: (82) 2 542 3375 (82) 33 742 5400
Fax: (82) 2 542 7447 (82) 33 742 5483
Revised Date: 2024-08
Part Number: A7542-6
Copyright © 2024 All rights reserved.

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  • Page 1 Vital Signs Monitor EU representative OBELIS S.A Bd. Général Wahis, 53, 1030 Brussels, Belgium Manufacturer Mediana Co., Ltd. 132, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Korea Tel: (82) 2 542 3375 (82) 33 742 5400 Fax: (82) 2 542 7447 (82) 33 742 5483...
  • Page 2 The V10 conforms to the EMC standard IEC60601-1-2. Note that mobile phones should not be used in the vicinity of the V10. Note, however, any device not complying to the EMC standard that is used with the V10 renders the V10 as non-compliable to the EMC standard.

  • Page 3: Table Of Contents

    Safety Information ..........................9 Warning .............................. 10 Cautions ............................. 12 INTRODUCTION ............................13 Intended Use for the V10 ........................ 13 Indications for Use ..........................13 About this Manual ..........................14 Identifying the V10 Configurations ....................14 Features for the V10 ........................16 DESCRIPTION OF THE MONITOR ......................
  • Page 4 Description of Pulse Rate Operation ..................... 83 TEMPERATURE MONITORING ......................... 85 General ............................... 85 Temperature Measurement Modes ....................85 Measurement Method ........................85 Setup Connections ........................... 93 Description of Temperature Menu Functions................94 TRENDS ..............................99 General ............................... 99 Trend Data Printout .......................... 99 Displaying Stored Patient Data ......................
  • Page 5 Figures Figure 1. Front Panel Components ........................17 Figure 2. Front Panel Components (Turbo Temp thermometer option is installed) ........18 Figure 3. Front Panel Components (Filac 3000 thermometer option is installed) .......... 18 Figure 4. Front Panel Components (Genius 2 thermometer option is installed) ..........19 Figure 5.
  • Page 6 Figure 53. Location of Heat Pockets ........................89 Figure 54. Method of Filac 3000 Axillary Measurement ..................90 Figure 58. Temperature – Predictive Mode ......................94 Figure 59. Temperature Measurement Site Display (Oral probe is installed) ..........95 Figure 60. Temperature Measurement Part Display (Axillary probe is installed) ..........95 Figure 61.
  • Page 7 Table 14. Study results ..........................66 Table 15. Cuff Size ........................... 69 Table 16. Demographic Data ........................78 Table 17. SpO2 Accuracy for Mediana Sensors .................. 78 Table 18. Demographic Data ........................79 Table 19. SpO2 Accuracy for Mediana Sensors .................. 79 Table 20.
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  • Page 9: Safety Information

    SAFETY INFORMATION Safety Information General Safety Information This section contains important safety information related to general use of the V10. Other important safety information appears throughout the manual. The V10 will be referred to as the monitor throughout this manual.

  • Page 10: Warning

    Warning Warnings alert you to potential serious outcomes (death, injury, or adverse events) to the patient or user. Do not take into or use the monitor in locations where highly combustible anesthetics or flammable gases are used or in high- pressure oxygen rooms or inside oxygen tents, as this may cause a flammable explosion.
  • Page 11 This monitor is protected against the discharge of a defibrillator. However, do not touch the monitor when a defibrillator is being discharged (electrified), as doing so may cause electric shock. The following cautions apply when connecting the monitor with other equipment.

  • Page 12: Cautions

    IEC 60601-1 and the electromagnetic compatibility system standard IEC60601-1-2. If in doubt, consult Mediana Technical Support Representative Risk of explosion if battery is replaced with an incorrect type. Where the integrity of the external protective conductor in the installation or its arrangement is in doubt, equipment shall be operated from its internal electrical power source.

  • Page 13: Introduction

    Intended Use for the V10 The monitor is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

  • Page 14: About This Manual

    Identifying the V10 Configurations The following table identifies V10 configurations and how they are indicated. The reference number and serial number are located on the bottom of the monitor. All information in this manual, including the illustrations, is based on the monitor...
  • Page 15 LAN module (L: Wired LAN, W: Wireless LAN, B: Bluetooth, X: Not installed) Note: The third alphabet from numeric can be changed to N or C or T or A in accordance with the SpO2 /NIBP module. (N: Medtronic SpO2+TM-2915, C: Mediana SpO2+TM-2915, T: Medtronic SpO2+TM-2917, A: Mediana SpO2+TM-2917) Note: The fourth alphabet from numeric can be changed to R, Z, F, B or X in accordance with the Temperature module.

  • Page 16: Features For The V10

    Features for the V10 Physical The monitor is lightweight and compact vital signs monitor measuring 249 × 211 × 154 (mm) (W×H×D) for Standard configuration and weighting 3.0 kg. Its carrying handle is designed for instrument transport while battery-powered monitoring.

  • Page 17: Description Of The Monitor

    DESCRIPTION OF THE MONITOR Front Panel Components 5 6 7 8 9 10 11 1. AC Power Indicator 7. Review Button 2. Power On/Off Button 8. Alarm Set Button 3. Battery Charging Indicator 9. NIBP Auto Interval Button 4. Print Start/Stop Button 10.

  • Page 18: Figure 2. Front Panel Components (Turbo Temp Thermometer Option Is Installed)

    Figure 2. Front Panel Components (Turbo Temp thermometer option is installed) Figure 3. Front Panel Components (Filac 3000 thermometer option is installed)

  • Page 19: Figure 4. Front Panel Components (Genius 2 Thermometer Option Is Installed)

    Figure 4. Front Panel Components (Genius 2 thermometer option is installed) Figure 5. Front Panel Components (ACIT-1 thermometer option is installed)

  • Page 20: Table 1. V10 Controls

    Table 1. V10 Controls Controls Description Power On/Off Button Turns the monitor on when pressed for over 1 second and turns off when pressed for over 1.5 seconds. NIBP Start/Stop Button Initiates NIBP measurement when pressed. If the NIBP Start/Stop Button is pressed again during the measurement, it will cancel the reading.

  • Page 21: Rear Panel Components

    Rear Panel Components 1. Handle 4. Battery Cover 2. AC Power Connector 5. External Communication Port (LAN) (Option) 3. Equipotential Terminal (Ground) Figure 6. Rear Panel Components...

  • Page 22: Figure 7. Rear Panel Components (Turbo Temp Thermometer Option Is Installed)

    Figure 7. Rear Panel Components (Turbo Temp thermometer option is installed) Figure 8. Rear Panel Components (Filac 3000 thermometer option is installed)

  • Page 23: Figure 9. Rear Panel Components (Genius 2 Thermometer Option Is Installed)

    Figure 9. Rear Panel Components (Genius 2 thermometer option is installed) ACIT-1 thermometer option is installed Figure 10. Rear Panel Components (...

  • Page 24: Left Panel Components

    Left Panel Components Printer USB Port (Mini USB B Type) USB Port (USB A Type) Nurse Call Port (RJ11 Type) Figure 11. Left Panel Components...

  • Page 25: Right Panel Components

    Right Panel Components 1. SpO Connector 2. NIBP Connector 3. Temperature Option Cover Figure 12. Right Panel Components...

  • Page 26: Figure 13. Right Panel Components (Turbo Temp Thermometer Option Is Installed)

    Figure 13. Right Panel Components (Turbo Temp thermometer option is installed) Figure 14. Right Panel Components (Filac 3000 thermometer option is installed)

  • Page 27: Figure 15. Right Panel Components (Genius 2 Thermometer Option Is Installed)

    Figure 15. Right Panel Components (Genius 2 thermometer option is installed) ACIT-1 thermometer option is installed) Figure 16. Right Panel Components (...

  • Page 28: Table 2. Panel And Label Symbols

    Table 2. Panel and Label Symbols Symbols Description Symbols Description Battery charging indicator Follow instructions for use AC power indicator CE mark Type CF- Defibrillator proof FCC mark NIBP connector Disposal instructions connector Manufacturer Reference number Date of manufacture Environmental shipping/storage Serial number altitude limitations Environmental shipping/storage...

  • Page 29: Displays

    Displays 26 27 12 13 1 IHB (Irregular Heartbeat) Indicator 17 USB Communication Indicator 2 Blood Pressure Unit Indicators 18 Pause Audio Alarm Indicator 3 Systolic Blood Pressure Display 19 Wireless Indicator 4 Patient Type Indicators 20 TCP/IP Module Indicator 5 Target Pressure Setting Indicator 21 USB Flash Drive Indicator 6 Diastolic Blood Pressure Display...

  • Page 30: Table 3. Display Symbols

    Table 3. Display Symbols Symbols Description Symbols Description Review indicator Pulse rate title IHB (Irregular Heartbeat) NIBP interval indicator indicator Service mode indicator Pause audio alarm indicator Barcode scanner indicator Patient type: Adult USB flash drive indicator Patient type: Pediatric TCP/IP module indicator Patient type: Neonatal Wireless indicator...

  • Page 31: Setting Up The Monitor

    Unpacking and Inspection The monitor is shipped in one carton. Examine the carton carefully for evidence of damage. Contact Mediana Technical Support Representative immediately if any damage is discovered. Refer to the Maintenance section for instructions on returning damaged items.

  • Page 32: List Of Components

    NIBP Cuff CUF-KS-A (22-32cm) 1 EA For Mediana SpO module 1 EA reusable sensor YM-1 extension cable MEX03 *Only when Mediana SpO module option is installed. For Covidien SpO module 1 EA reusable sensor DS-100A extension cable DOC-10 *Only when Covidien SpO module option is installed.

  • Page 33: Table 5. Optional Accessories

    Li-ion Battery Pack M-BPL-2(23) 1 EA Li-ion Battery Pack M-BPL-4(21) 1 EA Li-ion Battery Pack M-BPL-4(22) 1 EA disposable sensor D-MDA (for Mediana module) 1 EA disposable sensor D-MDNA (for Mediana module) 1 EA disposable sensor MAX-PACi (for Covidien module) 1 PACK...

  • Page 34: Power Cable Connections

    Power Cable Connections Do not connect to an electrical outlet controlled by a wall switch because the monitor may be accidentally turned off. If the integrity of the AC power source is in doubt, the monitor must be operated from its internal battery. AC Power Make sure that the AC outlet is properly grounded and supplies the specified voltage and frequency (100-240V~ 50-60 Hz).

  • Page 35: Measurement Cable Connections

    Measurement Cable Connections For best product performance and measurement accuracy, use only accessories supplied or recommended by Mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. Use only accessories that have passed the recommended biocompatibility testing in compliance with ISO10993-1.
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  • Page 37: Battery Operation

    BATTERY OPERATION The Battery Charging Indicator is used to acknowledge the absence of battery. If the AC power is connected with not having the battery power, the Battery Charging Indicator is not lit. Recharging the battery is strongly recommended when it has not been fully recharged for 3 or more months.

  • Page 38: Battery Status Indication

    Table 6. Front Panel Indications for Power Source Power Connections Front Panel Indications AC power source Battery Status Indicator disappears on the monitor display. AC indicator is lit. Battery Battery Status Indicator appears on the monitor display. A new, fully charged optional battery will provide 2, 5 or 8 hour(s) monitoring operation under the following conditions: ⚫...

  • Page 39: Charging A Low Battery

    8 hours (medium capacity battery) or 12 hours (large capacity battery) depending on the option. However, the charging time of the Li-ion Battery Pack M- BPL-4(21) takes up to about 6 hours. Note: Mediana recommends that a battery is always installed in the monitor.
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  • Page 41: Using The Monitor

    USING THE MONITOR If the Power On Self-Test is not completed successfully, do not try to use the monitor. Each time the monitor is used, check alarm limits to make sure that they are appropriate for the patient being monitored. If different alarm presets are used for the same or similar equipment in any single area, e.g.

  • Page 42: Turning On And Off The Monitor

    Turning On and Off the Monitor Before using the monitor, confirm that the monitor is working properly and is safe to use as described below. When power is turned on, the monitor automatically starts the Power-On Self-Test (POST), which tests the monitor circuitry, functions and check the checksum of program.

  • Page 43: Figure 21. Normal Mode Before Measurement

    Figure 21. Normal Mode before Measurement 5. To turn off the monitor, press the Power On/Off Button for about 1.5 seconds. Note: If the monitor doesn’t turn off normally, press the Power On/Off Button over 10 seconds. Note: If the monitor detects an internal problem during Power-On Self-Test (POST), the monitor will display an error code.

  • Page 44: Setting Date And Time

    Setting Date and Time You may set the date and time displayed on the monitor display and printed out a printer paper. With the monitor in the Normal mode: 1. Press and hold the Mode Button for 3 seconds or more until the monitor enters Configuration mode.

  • Page 45: Setting Patient Type

    Setting Patient Type This procedure will allow you to use by Patient Type: Adult, Pediatric or Neonatal of the monitor. The monitor can receive the patient ID via barcode reader. If the patient ID is entered, the Barcode Scanner Indicator is lit on the display. When pressing the Patient ID Clear Button in the state of entering Patient ID, the Patient ID is canceled.

  • Page 46: Setting Nibp Units

    Setting NIBP Units This procedure will allow you to select a NIBP measurement unit either mmHg or kPa. With the monitor in the Normal mode: 1. Press and hold the Mode Button for 3 seconds or more until the monitor enters Configuration mode.

  • Page 47: Setting Nibp Measurement Mode

    Setting NIBP Measurement Mode This procedure will allow you to select a NIBP measurement mode either Deflation or Inflation. This can be set on equipment with the TM-2917 NIBP module installed. With the monitor in the Normal mode: 1. Press the Mode Button less than 3 seconds to the monitor enters Setting mode. 2.

  • Page 48: Setting Temperature Units And Modes

    Setting Temperature Units and Modes This procedure will allow you to set temperature type and measurement units of the monitor with temperature option. You may select a temperature measurement unit either Celsius (°C) or Fahrenheit (°F) to be displayed. Also you may select whether to use Monitor mode for continuous measurement of temperature while using Turbo Temp thermometer and Filac 3000 thermometer.

  • Page 49: Setting Pulse Tone Volume

    Setting Pulse Tone Volume This procedure will enable you to set Pulse Tone Volume of the monitor. With the monitor in the Normal mode: 1. Press the Mode Button less than 3 seconds to the monitor enters Setting mode. 2. Press the Mode Button until the Pulse Amplitude Indicator and set pulse tone volume level are displayed.

  • Page 50: Setting Alarm Volume

    Setting Alarm Volume This procedure will enable you to set audible Alarm Volume of the monitor. With the monitor in the Normal mode: 1. Press the Mode Button less than 3 seconds to the monitor enters Setting Mode. 2. Press the Mode Button until the Alarm Volume setting indicator and alarm volume are displayed.

  • Page 51: Alarms And Limits

    ALARMS AND LIMITS Each time the monitor is used, check alarm limits to make sure that they are appropriate for the patient being monitored. If different alarm presets are used for the same or similar equipment in any single area, e.g. an intensive care unit or cardiac operating room, a potential hazard can exist.

  • Page 52: Visual And Audible Alarm Indication

    Visual and Audible Alarm Indication Do not pause the alarm audio or decrease its volume if patient safety could be compromised. Make sure that the monitor speaker is not obstructed. Failure to do so could result in an inaudible alarm tone. Table 10.

  • Page 53: Verifying Visual And Audible Alarm Indication

    Table 11. Alarm Audio Characteristics Alarm Category Tone Pitch Beep Rate High priority 540 Hz 10 beeps in 8 sec Medium priority 480 Hz 3 beeps in 11 sec Low priority 400 Hz 1 beeps in 15 sec Verifying Visual and Audible Alarm Indication If the monitor fails to perform as specified in this test, contact qualified service personnel or your local supplier for assistance.

  • Page 54: Table 12. Alarm Limits Ranges

    Alarm Limits Ranges Table 12 describes the possible alarm limits. The monitor is shipped with factory default settings. Note: Authorized personnel can define the way to save the power default: user setting, backup and factory default. The detailed information is described in the service manual.

  • Page 55: Figure 28. Systolic High Alarm Limit Setting

    NIBP Limits Alarm Alarm Limits determine the high and low points of patient data at which the monitor will sound an alarm. Systolic High and Low Alarm Limits With the monitor in the Normal mode: 1. Press the Alarm Set Button until Systolic high alarm limit is displayed. 2.

  • Page 56: Figure 30. Diastolic High Alarm Limit Setting

    Diastolic high and low alarm limits With the monitor in the Normal mode: 1. Press the Alarm Set Button until Diastolic high alarm limit is displayed. 2. Leave the limit unchanged or press the Up/Down Selection Buttons as needed to change the limit to another value.

  • Page 57: Figure 32. Map High Alarm Limit Setting

    MAP high and low alarm limits With the monitor in the Normal mode: 1. Press the Alarm Set Button until MAP high alarm limit is displayed. 2. Leave the limit unchanged or press the Up/Down Selection Buttons as needed to change the limit to another value.

  • Page 58: Figure 34. Pulse Rate High Alarm Limit Setting

    Pulse Rate Alarm Limits Alarm Limits determine the high and low points of patient data at which the monitor will sound an alarm. With the monitor in the Normal mode: 1. Press the Alarm Set Button until Pulse rate high alarm limit is displayed. 2.

  • Page 59: Figure 36. Spo High Alarm Limit Setting

    Alarm Limits Alarm Limits determine the high and low points of patient data at which the monitor will sound an alarm. With the monitor in the Normal mode: 1. Press the Alarm Set Button until SpO high alarm limit is displayed. 2.

  • Page 60: Figure 38. Temperature High Alarm Limit Setting

    Temperature Alarm Limits Alarm Limits determine the high and low points of patient data at which the monitor will sound an alarm. With the monitor in the Normal mode: 1. Press the Alarm Set Button until Temperature high alarm limit is displayed. 2.

  • Page 61: Alarm Audio Paused

    Alarm Audio Paused Do not pause the alarm audio or decrease its volume if patient safety could be compromised. When an alarm occurs, you can pause the alarm audio for the alarm audio paused period 90 seconds. To pause the audio alarm: 1.
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  • Page 63: Nibp Monitoring

    NIBP MONITORING For best product performance and measurement accuracy, use only accessories supplied or recommended by Mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. Inaccurate measurements may be caused by incorrect cuff application or use. This can include placing the cuff too loosely on the patient using the incorrect cuff size, or not placing the cuff at the same level as the heart, leaky cuff or hose or excessive patient motion.
  • Page 64 pregnancy, pre-eclampsia, renal diseases, patient motion, trembling and shivering. In the automatic mode, the monitor displays results of the last blood pressure measurement until another measurement starts. If a patient’s condition changes during the time interval between measurements, the monitor will not detect the change or indicate an alarm condition. Any excessive patient motion may cause inaccurate measurements of non-invasive blood pressure.

  • Page 65: General

    Mediana’s measurement technology utilizes a unique deflation technique, Dynamic Linear Deflation. This cuff deflation technique allows the Mediana monitor to measure each small change in the cuff pressure oscillations that directly correspond to the measurement’s systolic, mean and diastolic blood pressure values.

  • Page 66: Clinical Study

    Clinical Study Clinical studies conducted for the AND NIBP module [TM-2917] Overview Based on the ISO 81060-2 standard for the BP measurement function of the TM-2917 module, it provides clinical research data that can be evaluated and checked for accuracy. Method The blood pressure measured with auscultation sound was set as the reference value, and the accuracy was evaluated using the difference from the blood pressure...

  • Page 67: Figure 42. Conformity Analysis Results

    Criteria Results PASS or FAIL Standard deviation (criteria 2) SBP 5.36mmHg SBP: within 6.43mmHg DBP 6.12mmHg DBP: within 6.88mmHg Figure 42. Conformity analysis results Conclusion The accuracy of the systolic and diastolic blood pressures satisfies the allowable range, and the difference between the average measured value compared to the reference value was in accordance with the ISO 81060-2 standard.

  • Page 68: Setup Connections

    Setup Connections When performing the NIBP measurements, including hypertension blood pressure measurements, it is important to follow suitable procedures to ensure valid, accurate results. Follow these procedures: 1. Measure the patient’s limb and select a proper size cuff. As a general rule, cuff width should span approximately two-thirds of the distance between the patient’s elbow and shoulder.

  • Page 69: Nibp Measurement Modes

    Table 15. Cuff Size Model Number Arm circumference (cm) Subject TM9155 4.0 to 5.0 Neonatal TM9156 5.0 to 7.5 TM9157 7.5 to 10.5 TM9158 8.5 to 13.0 CUF-KS-SS 12.0 to 17.0 Adult/Pediatric CUF-KS-SA 16.0 to 24.0 CUF-KS-A 22.0 to 32.0 CUF-KS-LA 31.0 to 45.0 CUF-KS-LL...

  • Page 70: Figure 43. Initial Inflation Pressure

    Figure 43. Initial Inflation Pressure Initiating MANUAL Mode of NIBP Monitoring 1. Press the NIBP Start/Stop Button momentarily. A single blood pressure measurement will be made. As soon as an NIBP measurement begins, the MAP display dynamically shows the cuff pressure. Systolic, diastolic and MAP values are presented when the measurement is completed.

  • Page 71: Figure 45. Auto Interval Mode Of Measurement

    Initiating AUTO Interval Mode of NIBP Monitoring 1. Press the NIBP Auto Interval Button. The latest selected interval is displayed. 2. Press the Up/Down Selection Buttons to cycle through the options, which include (-), STAT and a range of intervals: 1, 2, 3, 4, 5, 10, 15, 30, 45, 60, 90, 120, and 240 minutes for taking automatic blood pressures.

  • Page 72: Figure 46. Stat Mode Measurement

    Initiating STAT Mode of NIBP Monitoring 1. Press the NIBP Auto Interval Button. The latest selected interval is displayed. 2. Press the Up/Down Selection Buttons to set STAT. Upon selection, automatic measurement is activated and the initial measurement will be made after you press the NIBP Start/Stop Button.
  • Page 73 Stopping Blood Pressure Measurements 1. Press the NIBP Start/Stop Button at any time that you wish to stop the measurement and deflate the cuff. If AUTO or STAT mode is underway, the mode including interval time will be reset. Note: During AUTO mode, pressing the NIBP Start/Stop Button at the time before the next auto measurement starts will cancel the AUTO mode and will be made a single blood pressure measurement (MANUAL mode).
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  • Page 75: Spo Monitoring

    Use only pulse oximetry sensors and pulse oximetry cables manufactured by Covidien Healthcare Inc. or supplied by Mediana when connecting to the sensor connector. Connecting any other cable or sensor influences the accuracy of the sensor data, which may lead to adverse results.

  • Page 76: General

    Reusable sensors may be used on the same site for a maximum of 4 hours, provided the site is inspected routinely to ensure skin integrity and correct positioning. Refer to the notice below if the Covidien SpO module is installed. Note: Purchase of this instrument confers no express or implied license under any Covidien patent to use the instrument with any sensor that is not manufactured or licensed by Covidien.

  • Page 77: Figure 44. Oxyhemoglobin Dissociation Curve

    Figure 47. Oxyhemoglobin Dissociation Curve 1 % Saturation Axis 3 Increased pH; Decreased Temperature, PCO and 2,3-DPG 2 PO (mmHg) Axis 4 Decreased pH; Increased Temperature, PCO and 2,3-DPG Data Upload Period, Data Averaging and Signal Processing The advanced signal processing of the Oximax™ algorithm automatically extends the amount of data required for measuring SpO and pulse rate depending on the measurement conditions.

  • Page 78: Clinical Studies

    Comparisons will be made between the SpO measurement determined using the Mediana MD1 Oximetry module and a measurement calculated with oxy- and deoxyhemoglobin concentrations determined from an arterial blood sample using a co-oximeter. Monitor safety will be monitored closely throughout the Clinical Investigation.

  • Page 79: Table 18. Demographic Data

    Olive 5 people Dark olive/Medium black 3 people Extremely dark/Blue black 1 people Study Results Accuracy was calculated using the root mean square difference (RMSD). Table 19. SpO Accuracy for Mediana Sensors MAX-A MAX-N MAX-FAST Decade Data Arms Data Arms...

  • Page 80: Figure 48. Modified Bland-Altman Plot

    Figure 48. Modified Bland-Altman Plot Test Sensor: Avg CO-Oximeter Value 70-100% SpO Avg CO-Oximeter Value 70-100% SpO Oximetry board with MAX-A sensor Trendline of MAX-A sensor Oximetry board with MAX-N sensor Trendline of MAX-N sensor Oximetry board with MAX-FAST sensor Trendline of MAX-FAST sensor Adverse Events or Deviations The study was conducted as expected with no adverse events and no deviations from the...

  • Page 81: Setup Connections

    When selecting a sensor, consider the patient’s weight and activity, adequacy of perfusion, availability of sensor sites, need for sterility and anticipated duration of monitoring. Refer to Table 20, or contact Mediana sales department for ordering information. 1. Select the proper sensor for the patient.

  • Page 82: Description Of Spo Menu Functions

    Description of SpO Menu Functions Operation Figure 49. SpO Operation Adjusting Pulse Tone Volume from SpO signal For the setting the pulse tone volume, you may refer to Figure 26 of this manual. 1. Press the Mode Button until the Pulse Amplitude Indicator and the pulse tone volume level are displayed.

  • Page 83: Description Of Pulse Rate Operation

    Description of Pulse Rate Operation The monitor displays the pulse rate during SpO measurements. It displays NIBP pulse information only if no SpO reading is available. During the measurement period, the Pulse Amplitude Indicator rises and falls in rhythm with the monitored pulse rate. The Pulse Amplitude Indicator is a segmented display showing the relative strength of the detected pulse.
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  • Page 85: Temperature Monitoring

    Filac 3000 thermometer, Genius thermometer, and ACIT-1 thermometer recommended by Mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. Note: The user should check that the monitor is functioning while measurements are being made and check display periodically.

  • Page 86: Figure 51. Method Of Turbo Temp Oral Probe

    For oral measurement 1. Insert the probe completely and firmly into a probe cover to ensure a secure fit. 2. Use the probe with a blue cap. 3. Place the tip of the probe in the hollow under the tongue. 4.

  • Page 87: Figure 53. Method Of Ejecting The Turbo Temp Probe Cover

    Ejection of the Turbo Temp probe cover After the end of measurement, hold the body temperature probe in the same way as in the instructions for a syringe, press the probe cover removal button and dispose of the used probe cover in a waste container. And return the body temperature probe to the probe holder.

  • Page 88: Figure 54. Filac 3000 Thermometer

    Filac 3000 Thermometer Figure 54. Filac 3000 Thermometer Applying and removing probe covers 1. Open probe cover box by lifting tab at top corner and pulling to remove top panel. 2. Insert box of prove covers into top of isolation chamber. (To aid infection control, never switch boxes between blue (oral/axillary) and red (rectal) isolation chambers.

  • Page 89: Figure 52. Method Of Changing Filac 3000 Isolation Chambers And Probes

    Figure 55. Method of Changing Filac 3000 Isolation Chambers and Probes For oral measurement 1. Make certain that the blue isolation chamber/probe unit is attached. 2. Withdraw probe and apply a probe cover. The thermometer turns on automatically. 3. For oral temperatures, insert the probe tip deep into the sublingual pocket next to the frenulum linguae, (vertical fold of tissue in middle of tongue), on one side or the other, toward the back of the mouth.

  • Page 90: Figure 54. Method Of Filac 3000 Axillary Measurement

    For axillary measurement 1. Have the patient raise the arm, then place the probe tip in the axilla. Press gently to assure good contact. For the most accurate temperature the probe tip should be placed directly against the patient’s skin. 2.
  • Page 91 Genius 2 Thermometer Measurement of body temperature is accomplished by using Genius 2 thermometer. The measurement data is displayed on the thermometer and the monitor. Detailed of using Genius 2 thermometer is as follows. Image Description Visually inspect the patient’s ear canal. Remove the Genius 2 thermometer from the base.

  • Page 92: Table 21. Genius 2 Thermometer Symbols

    Table 21. Genius 2 Thermometer Symbols Symbols Description Symbols Description Eject button Temperature limitations °C/°F button Keep away from sunlight Timer button Keep dry Dispose of as electrical and Scan button electronic waste Non-ionizing electromagnetic Choking hazard radiation Non-Sterile Catalog number By prescription only Serial number DEHP-free...

  • Page 93: Setup Connections

    ACIT-1 Thermometer Measurement of body temperature 1. The forehead should be clear of hair and perspiration. 2. Aim at the center forehead area 3 to 7cm away from skin surface. Be sure the thermometer is perpendicular to the skin surface. 3.

  • Page 94: Description Of Temperature Menu Functions

    Description of Temperature Menu Functions Setting the Temperature Measurement Mode For the setting the Temperature measurement mode, you may refer to Figure 25 of this manual. 1. Press the Mode Button until the Temperature units and modes are on (a selected unit/mode is shown flashing).

  • Page 95: Figure 59. Temperature Measurement Site Display (Oral Probe Is Installed)

    Turbo Temp thermometer: A final temperature is displayed with an audible beep. To obtain this temperature, the probe tip measures the rate of change in temperature when the thermistor comes into contact with surrounding tissue. A final temperature is calculated based on this rate of change.
  • Page 96 Filac 3000 thermometer: A final temperature is displayed with an audible beep. Always uses the standard prediction algorithm on any patient temperature measurement. Axillary and rectal measurements take longer to complete than oral measurement due to typical instability of probe placement. This is automatically accommodated by the algorithms for this mode. When the oral / axillary probe is pulled out from the well, the measurement site is displayed for 1 second and the state of device is change to ready.

  • Page 97: Figure 61. Temperature - Monitor Mode

    Figure 61. Temperature – Monitor Mode If the measured temperature remains below the minimum measurable temperature for 5 minutes, the temperature cycle is terminated and the temperature display goes blank. To reactivate the probe, remove a used probe cover, insert the probe into the probe well and extract it again with loading a new probe cover.
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  • Page 99: Trends

    TRENDS General The trend data is stored in internal memory. The monitor saves all physiological and technical alarm conditions and the data when completing the NIBP and Predictive temp measurement. In the SpO measurement or Temperature monitoring mode, the monitor saves data every 1 minute and the monitor saves data at once when the limit alarm occur or Loss of pulse after 5 seconds the measurement.

  • Page 100: Erasing Patient Data

    Erasing Patient Data Please erase the patient information before disposal of equipment for prevention of the personal data leakage. To erase patient data during Normal mode; 1. Press and hold the Review Button for 3 seconds to erase data in the memory after enter the Review mode.

  • Page 101: Menu Structure

    MENU STRUCTURE SETTING MODE MENU - Patient Type - - Adult - - Pediatric - - Neonate - Target Pressure - - Adult (NIBP module : AND TM-2915) - - 120 mmHg - - 140 mmHg - - 160 mmHg - - 180 mmHg - - 200 mmHg - - 220 mmHg...
  • Page 102 - - 4 - - 5 - - 6 - - 7 - - 8 - Alarm Volume - - 1 - - 2 - - 3 - - 4 - - 5 - - 6 - - 7 - - 8 CONFIGURATION MODE MENU - BP Units - - mmHg...

  • Page 103: Printing

    PRINTING General The monitor can print real-time measurement and trend data as follows. Printer is an option and is not available on all monitors. When the optional printer is installed, the monitor allows the user to print in Manual mode or Stream mode.

  • Page 104: Setting Manual Or Stream Printing Type

    Setting Manual or Stream Printing type This procedure will allow you to select Print mode either Manual or Stream. With the monitor in the Normal mode: 1. Press and hold the Mode Button for 3 seconds or more until the monitor enters Configuration mode.

  • Page 105: Printing Patient Data (Manual Mode)

    Printing Patient Data (Manual Mode) You can print vital-signs measurement data each time you press the Print Start/Stop Button (Manual printing), or you can store patient data and then print all of it at one time. Follow the instructions to print stored data if an optional printer is installed. 1.

  • Page 106: Figure 66. Review Stream (A Type Only) Print Out

    Stream Modes Print Out If the Print Start/Stop Button is pressed while the monitor is in Stream mode, the monitor prints out the all of the data stored in the monitor when the NIBP and Temperature data are saved. Patient ID : 12345678910 =============================== SYS DIA MAP...

  • Page 107: Figure 67. Service Mode (A Type Only) Print Out

    Service Mode Print out If the Print Start/Stop Button is pressed while the monitor is in Service mode only accessed by qualified authorized personnel, the monitor prints out the internal settings of the monitor as shown in Figure 67 or Figure 68. Figure 67.

  • Page 108: Figure 68. Service Mode (A Type Only) Print Out - None Wi-Fi Module

    31-Jan-2015 17:52:03 - - - - - - - - - - - - - - - - - - - - Patient Type : Adult NIBP units : mmHg NIBP target press(mmHg) : Temperature mode : Predict Temperature units : Print mode : Manual Night panel :...

  • Page 109: External Interface

    EXTERNAL INTERFACE General The monitor provides external connectors to support communication with external equipment and functions such as a nurse call or PC connection. Refer to Figure 6 and Figure 11. The monitor, with its optional built-in network (LAN, Wi-Fi, Bluetooth), functionally performs the same as the monitor connected to the central system.

  • Page 110: Cable Connection

    Cable Connection USB Interface The monitor will update the main program through USB and transmit the trend to PC through mini USB. The USB unit consists of Host and Device. USB Host A will be used for the connector of USB Host and USB Mini 5 Pin will be used for the connector of device. Following table is the USB interface connection.

  • Page 111: Nurse Call Interface

    RJ11 Nurse Call Interface The Pin layouts of 6-pin Nurse Call interface are illustrated below. Figure 71. Nurse Call Interface Pin Layout Table 25. Nurse Call Interface Connections Pin # Signal Nurse call normally close Nurse call common lead Nurse call normally open Nurse Call Interface The nurse call feature is not functional whenever the monitor alarms are paused.
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  • Page 113: Pairing Mode

    PAIRING MODE General Pairing mode is the mode for pairing the device with the thermometer using Bluetooth. The Bluetooth board must be installed in the device, and when receiving the Bluetooth firmware version, it will display on the SYS LED and automatically search for the thermometer device when entering pairing mode.
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  • Page 115: Maintenance

    MAINTENANCE The cover should be removed only by qualified service personnel. There are no internal user-serviceable parts except for the battery. Do not spray, pour, or spill any liquid on the monitor, its accessories, connectors, switches or openings in the chassis. Unplug the power cord from the monitor before cleaning the monitor.

  • Page 116: Cleaning

    Do not charge the battery with polarities reversed, as it may swell or explode. Do not use any chargers not specified by Mediana. Do not use the battery with other maker’s batteries, different types or models of batteries such as dry batteries, nickel-metal hydride batteries, or Li-ion batteries together, as they might leak electrolyte heat or explode.

  • Page 117: Loading Printer Paper

    Loading Printer Paper Use only printer paper specified by Mediana. Note: The paper roll is easier to load if it is held horizontally with your thumb on top and your forefinger and/or index finger underneath it.
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  • Page 119: Troubleshooting

    TROUBLESHOOTING If you are uncertain about the accuracy of any measurement, check the patient’s vital signs by alternate means; then make sure the monitor is functioning correctly. The cover should be removed only by qualified service personnel. There are no user-serviceable parts inside except for the battery. General If the monitor detects an error, it can display an error code.
  • Page 120 Error Corrective Action heard and the monitor cannot be turned off. Faulty of SpO Check perfusion at the measurement site. Loss of pulse Check that the sensor is applied properly. error Make sure the sensor site has a pulse. Relocate the sensor to another site with improved circulation. If the error occurs due to NBP measurement on the same limb, wait until the NBP measurement is finished.

  • Page 121: Emi (Electromagnetic Interference)

    EMI (Electromagnetic Interference) Keep patients under close surveillance when monitoring. It is possible, although unlikely, that radiated electromagnetic signals from sources external to the patient and monitor can cause inaccurate measurement readings. Do not rely entirely on the monitor readings for patient assessment.
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  • Page 123: Factory Defaults

    FACTORY DEFAULTS General The monitor is shipped with factory default settings. Authorized personnel can use the procedures described in the service manual to change default settings. Parameter Ranges and Default Settings Table 26. Parameter Ranges and Factory Defaults Factory Defaults Parameter Ranges/Selections Adult...
  • Page 124 Factory Defaults Parameter Ranges/Selections Adult Pediatric Neonatal 3.3 to 26.6 kPa (Adult/Pediatric (but not neonatal)) 25 to 90 mmHg (Neonatal) 3.3 to 11.9 kPa (Neonatal) (5 mmHg / 0.6 or 0.7 kPa steps) NIBP DIA Lower Alarm Limits 20 to 195 mmHg (Adult/Pediatric (but not neonatal)) 2.6 to 25.9 kPa (Adult/Pediatric (but 50 mmHg...
  • Page 125 Factory Defaults Parameter Ranges/Selections Adult Pediatric Neonatal NO (Nurse call Open), NC (Nurse call NO (Nurse call Open), Nurse call state Close) Date format YY/MM/DD, DD/MM/YY YY/MM/DD Sound mode 1(Full), 2(Mid), 3(Mute) 1(Full) Print Control Manual, Stream Manual °C, °C/M, °F, °F/M °F Temperature Unit/Mode Print Wave...
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  • Page 127: Specification

    SPECIFICATION Display Digital Display 7-Segment LED Controls 11 buttons (Power On/Off Button, NIBP Start/Stop Button, Pause Audio Alarm Button, Up/Down Selection Buttons, Standard Print Start/Stop Button, Review Button, NIBP Auto Interval Button, Alarm Set Button, Mode Button, Patient ID Clear Button) Alarms Categories...

  • Page 128: Electrical Characteristics

    sensor Temperature: Temperature probe Mode of Operation Continuous Liquid ingress IPX2: Protection against vertically dripping water Classification Class IIb (MDD Annex IX Rule10:MEDDEV 2.4/1 Rev.9) Printer (Option) Type Thermal Weight 180g (without the printer paper) Resolution 320 dots/line (about 200 DPI) Number of Channels 1 channel Paper Type...

  • Page 129: Environmental Conditions

    battery capacity and for full recharge with monitor turned on/off. However, 10.8 V / 3400 mAh Battery is 6 hours. Life Cycle Battery life cycle: 2 years or 500 charge/discharge cycles (about 60% of the standard capacity). The battery life cycle may vary depending on storage conditions, temperature, and the number of charge and discharge cycles.

  • Page 130: Tone Definition

    Tone Definition High Priority Alarm Tone Volume level Adjustable (level 1~8) Pitch (± 5%) 540 Hz (IEC60601-1-8) Pulse width (± 5%) 130 msec (IEC60601-1-8) Number of pulses 10 pulses per 3 sec, 8 sec inter burst (IEC60601-1-8) Repetitions Continually Medium Priority Alarm Tone Volume level Adjustable (level 1~8) Pitch (±...

  • Page 131: Measurement Parameters

    Measurement Parameters NIBP Pulse Rate Pulse Rate Range Adult/Pediatric (but not neonatal) 30 to 240 BPM Neonatal 30 to 240 BPM Pulse Rate Accuracy ±2 BPM or ±5%, whichever is greater NIBP (Non-Invasive Blood Pressure) Technique Oscillometric Measurement Measurement Modes Manual, Auto interval and STAT NIBP AUTO Mode Automatic NIBP measurements at intervals of 1, 2, 3, 4,...
  • Page 132 Covidien module: 20 to 300 BPM Mediana module: 30 to 300 BPM Accuracy Covidien module: 20 to 250 beats per minute (bpm) ±3 digits Mediana module: ±2% or 2BPM, whichever is greater Range Covidien module: 1 to 100 % Mediana module:...
  • Page 133 Predictive mode: One-time measurement in a single temperature reading which is displayed at the end of the brief measurement period Monitoring mode: Continuous measurement over an indefinite period Genius 2 thermometer: Predictive mode: One-time measurement in a single temperature reading which is displayed at the end of the brief measurement period ACIT-1 thermometer: Predictive mode: One-time measurement in a...

  • Page 134: Internal Memory

    Internal Memory Trend Data saves total 2,000data saves Patient ID and type, date and time saves alarm condition saves Pulse Rate data from SpO and NIBP saves NIBP, SpO , Temp Measuremets Error Code saves last 18,000 error codes detected by the monitor...

  • Page 135: Compliance

    Compliance Item Standard Description Classification IEC 60601-1:2005 + A1:2012 Medical electrical equipment - Part 1: General +A2:2020 requirements for basic safety and essential EN 60601-1:2006+A2:2021 performance Type CF – Applied part Type of protection IEC 60601-1:2005 + A1:2012 +A2:2020 EN 60601-1:2006+A2:2021 Mode of operation IEC 60601-1:2005 + A1:2012 Continuous...
  • Page 136 Item Standard Description Restriction of Chemicals (REACH) Quality systems - Medical Devices – ISO 13485:2016 Requirements for regulating purposes EN ISO 13485:2016 Alarms Medical electrical equipment - Part 1-8: General IEC60601-1- requirements for basic safety and essential 8:2006+A1:2012+A2:2020 performance - Collateral Standard: General EN 60601-1-8:2007+A2:2021 requirements, tests and guidance for alarm systems in medical electrical equipment and...

  • Page 137: Fcc(Federal Communications Commission) Information

    FCC(Federal Communications Commission) Information Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment FCC Compliance Statement This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: ⚫...

  • Page 138: Manufacturer's Emc Declaration

    Manufacturer’s EMC Declaration For best product performance and measurement accuracy, use only accessories supplied or recommended by Mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. The use of accessories, transducers, and cables other than those specified may result in increased emission and/or decreased immunity of the monitor.

  • Page 139: Table 29. Electromagnetic Immunity (Iec60601-1-2)

    Immunity Test IEC 60601-1-2 Compliance Electromagnetic Test Level Level Environment Guidance 70 % U T 70 % U T (30 % dip in UT ) (30 % dip in UT) for 25 cycles for 25 cycles <5 % U T <5 % U T (95 % dip in UT ) (95 % dip in UT)

  • Page 140: Table 30. Recommended Separation Distances

    Immunity Test IEC 60601 Compliance Electromagnetic environment test level level guidance Note: At 80 MHz and 800 MHz, the higher frequency range applies. Note: 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 radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy.

  • Page 141: Table 32. Cables (Iec60601-1-2)

    Test Maximu Immunity Band Modulation Distance frequency Service m power test level (MHz) (MHz) (V/m) 800/900, Pulse 800 – TETRA 800, modulation iDEN 820, 18 Hz CDMA 850, LTE Band 5 GSM 1800; CDMA 1900; 1720 GSM 1900; Pulse 1700 – 1845 DECT;...

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