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MDK Med GRASEBY KC7 Series Instructions For Use Manual

Multi parametermodule patient monitor
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KC7 Series
Multi parameter module
Patient Monitor
Instruction for Use
MDKMed Medical Technology Co., Ltd.
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  • Page 1 KC7 Series Multi parameter module Patient Monitor Instruction for Use MDKMed Medical Technology Co., Ltd. 2 / 113...

  • Page 2: Table Of Contents

    Table of Contents Product Information ............4 Statement ..............5 Introduction ..............8 Chapter 1 Product Description ..........13 Chapter 2 Monitor Installation ..........18 Chapter 3 System Menu ............. 23 Chapter 4 Safety ............36 Chapter 5 Maintenance and Cleaning ........... 37 Chapter 6 Alarm ............41 Chapter 7 ECG and Respiration (ECG/RESP) ........

  • Page 3: Product Information

    Product Information The registered trademark used on the product is: Product name: Multi parameter Patient Monitor Specifications and models: This IFU is the KC7 series product manual, applicable to the following models: KC7: KC7A, KC7AC. Registered address: 502A, Building 7, No. 22, Xinyan Road, Donghu Street, Linping District, Hangzhou City, Zhejiang Province, P.

  • Page 4: Statement

    Statement This manual applies to our company's monitors, and the content may not be changed without consent. Our company reserves the right to improve products in terms of technology, parts, software and hardware. If you need further information about the product, you can contact our company or dealer.
  • Page 5 This product is not for home use.  This product is restricted to one patient at a time.  According to the requirements of YY9706.261-2023 (YY 0784-2010), claims for blood  oxygen saturation accuracy should be supported by clinical research measurements covering the entire range.
  • Page 6 of the equipment; irresistible natural disasters. Our company is not responsible for direct, indirect or final damages and delays caused by the following situations (including but not limited to): Components are disassembled, stretched, and re-adjusted; Replace accessories not approved by our company or have the machine repaired by personnel not authorized by the company.

  • Page 7: Introduction

    Introduction This manual introduces the performance, operation methods and other safety information of the monitor in detail. Reading this manual is the first step for users to familiarize themselves with and make full use of the product, ensuring proper use and ensuring patient and operator safety.
  • Page 8 Patients with intravenous fluids or catheters in their limbs; Patients with perfusion disorders or skin sensitivities. Danger Do not use this device in an environment rich in oxygen or containing flammable or  explosive items such as anesthetics to prevent fire or explosion. At the same time, the product and surrounding areas should be kept clean and dry.
  • Page 9 they will not strangle the patient or trip others. The back of this device must not be blocked to facilitate heat dissipation.  If liquid is spilled into the casing of this equipment, please disconnect the power supply  immediately and contact service personnel. The product should be stored in an environment with temperature (5℃~40℃), ...
  • Page 10 should pay attention to ensuring the safety of the patient being monitored. Packaging must be disposed of in accordance with current waste control practices and  kept out of the reach of children. For patients with a pacemaker, the heart rate monitor may include pacemaker pulses in ...
  • Page 11 Description of equipment symbol Alternating Warning current Protective Battery Equipotential ground (earth) computer NIBP Lead selection network Unlock graph recorder Input /Output gas output USB interface gas input Temperature Manufacturing Serial number limit date Non-ionizing Dangerous Video output radiation electric shock Manufacturing measuring pressure...

  • Page 12: Chapter 1 Product Description

    Chapter 1 Product Description For a complete understanding of the monitor, read this overview  For an introduction to the various information displayed on the screen, read Screen  Display Introduction To master the operation method, please read the monitor button functions and basic ...
  • Page 13 specifications claimed in Appendix II. Abbreviation definition: Name Definition, Abbreviation Name Definition, Abbreviation Electrocardiogram Heart rate RESP Breathe Respiratory rate TEMP Body temperature Temperature difference SPO2 Pulse oximetry SaO2 Blood oxygen saturation Pleth Plethysmography Perfusion index Non-invasive blood NIBP Systolic blood pressure pressure Mean arterial pressure Diastolic blood pressure...
  • Page 14 Figure 1-1 Main Display Interface Shortcut area button icon: More Patient information Mute Interface layout Blood pressure measurement Setting menu Interface selection Information area introduction: The information area is at the top of the screen and displays the current status of the monitor and patient.
  • Page 15 and the ECG filtering method. There is a 1mV scale on the left side of the ECG waveform. When a menu pops up during screen operation, the menu always occupies a fixed position on the left side of the waveform area, making part of the waveform temporarily invisible.
  • Page 16 the upper left and when an alarm occurs, this light flashes. The sensor jack is on the left side of the front panel of the product. The recorder is on the right side of the machine. Other jacks and power sockets are on the rear panel. This monitor has a user-friendly operation interface, and all operations can be completed through the buttons and knobs on the front panel.

  • Page 17: Chapter 2 Monitor Installation

    Chapter 2 Monitor Installation 2.1 Key functions and basic operations Operations on the monitor can be completed through buttons and knobs. Press and hold for 2 Start or stop blood pressure seconds to power on or off measurement. 2.2 Monitor external interface Figure 2-1 Monitor parameter interface Rear panel jack description: The upper part is the data transmission interface, and the lower part is the power...
  • Page 18 WARNING All analog and digital devices connected to this monitor must be products certified by specified IEC standards (such as IEC 60950 data processing equipment standard and IEC 60601-1 medical equipment standard). And all configurations should comply with the contents of the valid version of the IEC 60601-1-1 system standard. The person responsible for connecting additional equipment to the input/output signal ports configures the medical system and is responsible for the system's compliance with IEC 60601-1-1 standards.
  • Page 19 (1) Check for any mechanical damage. (2) Check all exposed wires. When installing, leave at least 2 inches (5 cm) of space around the monitor to allow air circulation. The environment in which the monitor is used must be reasonably free from vibration, dust, corrosive or explosive gases, extreme temperatures and moisture, etc.
  • Page 20 This monitor has no power-off time record. Power outage does not affect real-time operation, and logs are recorded according to time without change. 2.6 Power on and start up Press and hold the power button for 3 seconds. At this time, the alarm light flashes red once.
  • Page 21 1. Ensure patient monitoring has been completed. 2. Disconnect the cables and sensors from the patient. 3. Make sure to save or clear patient monitoring data as needed. 2.10 Disconnecting the network power method To unplug the adapter from the network power supply. 22 / 113...

  • Page 22: Chapter 3 System Menu

    Chapter 3 System Menu The configuration of this monitor is flexible, and the monitoring content, waveform scanning speed, etc. can be configured by the user according to needs. Press the "Menu" key on the front panel, the menu shown in Figure 3-1 will pop up, and you can perform the following operations: Image 3-1 Main menu 3.1 Patient information management...
  • Page 23 Project Illustrate Bed no. 1-200 beds optional Gender Patient gender Adults, children (with pacemaker (this monitor does not provide this Patient function)) In this menu, the user can select the "Update Patient" item to pop up the "Confirm Update Patient" dialog box to determine whether to clear the data.
  • Page 24 WARNING At this time, all configurations in the system will be replaced by "default configuration". 3.3 Review function After selecting the "Review Function" option in the "Main Menu", the menu as shown in Figure 3-5 will appear: Figure 3-5 Information review menu image Figure 3-6 NIBP measurement review When the "NIBP Measurement Review"...
  • Page 25 (2) The trend graph of the last 72 hours can be displayed with a resolution of one data every 1 minute, every 5 minutes or every 10 minutes. Select the "Trend Chart Display" item in the "Menu" and the following window will pop Figure 3-7 Trend chart display The ordinate represents the measured value, and the abscissa represents the measurement time.
  • Page 26 Get trend data at a certain moment on the current trend chart Use the cursor to select " "instruction, press this key to move to the left, the cursor will move to the left, and the moment it points to will also move to the left; use the cursor to select "...
  • Page 27 Figure 3-8 Trend table setting menu The time corresponding to each set of trend data is displayed in the leftmost column, and the date is in brackets. Listed under events are events that have been marked, corresponding to the time of the marked event. Each measured parameter value is recorded in the trend table, as shown in Figure 3-8.
  • Page 28 Select the "Interface Layout" option in the "Ribbon Area", and the menu as shown in Figure 3-9 will appear: Figure 3-9 Interface layout menu In the "Interface Layout" menu, you can adjust the parameters and layout of each waveform display. 3.5 Monitor information In "Maintenance", you can select "Monitor Information"...
  • Page 29 Figure 3-11 will appear: Figure 3-11 Monitor settings In the "Monitor Settings" menu, users can set the following items: 3.5.1 Work interface selection Select the "Work Interface Selection" item in the "Monitor Settings" menu, and you can see that the current option is the standard interface. 3.5.2 Alarm limit display By default, the alarm level is displayed next to each parameter.
  • Page 30 to set the alarm latch or non-latch. 3.5.5 Alarm volume Select "Alarm Volume" in the "Monitor Settings" menu and turn the knob to set the alarm volume. There are four levels available: "low", "medium", "high" and "off". "Off" means all volumes are turned off. WARNING When the alarm volume of the system is turned off ("Off "...
  • Page 31 Figure 3-12 System time setting Figure 3-13 Enter maintenance password Notice The system time should be set at boot (if the user needs to set it), otherwise incorrect time information may be provided when reviewing content with time prompt information, etc.! 3.5.8 Event settings Select the "Item Settings"...
  • Page 32 Figure 3-14 User maintenance Figure 3-15 Color customization Language selection: Users can set the text displayed on the screen to be "CHINESE" or "ENGLISH". The specific options are determined by the user's configuration. Lead naming style: Select "AHA" or "EURO". For details, please refer to the relevant content in "ECG/Respiratory Monitoring"...
  • Page 33 Figure 3-16 Demonstration function 3.8 Alarm settings Figure 3-17 Alarm settings Used to set alarm limits and alarm levels for each parameter. To enter the alarm management settings, you need advanced permissions and the password "2016" to enter, as shown in Figure 3-17 shown. Alarm management Click "Alarm Management"...
  • Page 34 Figure 3-18 Alarm management 3.9 Network settings When the monitor needs to perform wired or wireless networking and program upgrade related operations, it is necessary to set up the local network so that other devices can discover or connect to the device. Operation method: Settings - Maintenance - Enter user password 2016 - Confirm - Set IP.

  • Page 35: Chapter 4 Safety

    Chapter 4 Safety This system has anti-defibrillation and surgical knife protection with floating input. If the correct electrodes are used (see ECG and Respiratory chapter) and placed according to the manufacturer's instructions, the screen display can be restored within 5 seconds after defibrillation.

  • Page 36: Chapter 5 Maintenance And Cleaning

    Chapter 5 Maintenance and Cleaning 5.1 Inspection Before using this equipment, the following checks must be carried out: (1) Check the product for any mechanical damage. (2) Check all exposed wires, plug-in parts and accessories. (3) Check the functions of all products that may be used to monitor patients, and ensure that the products are in good working order.
  • Page 37 Please use accessories with corresponding specifications for different patient types. 5.2 General cleaning This device should be placed in a clean environment. It is recommended to clean the outer surface of the case and the monitor screen. To clean the case, use a non-abrasive cleaner such as soap and water. 5.3 Use of cleaning agents In addition to the solutions listed in the "Careful"...
  • Page 38 sponge pad with sterile or distilled water. Use this sponge pad to wipe all surfaces of the electrodes and cables; finally wipe all surfaces of the electrodes and cables with a clean, dry sponge pad; 5) Careful: The connector pins must not come into contact with cleaning fluid, otherwise it will cause damage to the monitoring equipment and human body.
  • Page 39 Careful: To prevent damage to the monitor, do not use gas (EtO) or formaldehyde to disinfect the monitor. 5.5 Sterilization Sterilization of this monitor, related products, or accessories is not permitted unless otherwise stated in the accompanying instructions. 5.6 Maintenance In order to ensure that the monitor is available at any time, routine maintenance of the monitor is required.

  • Page 40: Chapter 6 Alarm

    Chapter 6 Alarm This chapter introduces general information about alarms and the measures to be  taken when an alarm occurs. Information about alarms and prompts for each parameter can be obtained in the  chapters about each parameter setting. 6.1 Overview The so-called alarm means that when the patient being monitored undergoes abnormal changes in vital signs, or the machine itself malfunctions and the patient monitoring...
  • Page 41 The patient's heart rate was measured to be 114bpm, which Physiological alarm exceeded the heart rate alarm range set by the user. The patient was found to have ventricular fibrillation Physiological alarm The ECG measurement module found that the ECG lead was Technical alarm detached SPO2 measurement module failed...
  • Page 42 immediately. treatment. patient's Certain monitoring functions may not physiological signs level function properly due to machine abnormal, corresponding alarm failure or improper operation, but this measures or treatment may will not threaten patient safety. be required. Notice: It is recommended that operators treat alarm conditions that may result in minor injury and delayed generation of potential injury as low priority alarm conditions.
  • Page 43 alarm which sounds once every 25 yellow with a slow appears seconds (the interval count is from flashing frequency device the beginning of this sound to the screen beginning of the next sound) The mode is "beep-beep-", which "*" mark level sounds once every 25 seconds (the alarm light is...
  • Page 44 6.4.1 Overview For each alarm, there are two states: triggered state and cleared state. It can only be in one state at a time. Trigger state: The state when the alarm exists. Clear state: The state in which the alarm does not exist. All possible alarms are in the cleared state when starting work.
  • Page 45 Under normal conditions: 1. Press "PAUSE" to enter the alarm pause state, and press "SILENCE" to enter the alarm silent state. In paused state: 1. Press "PAUSE" to enter the normal state, and press "SILENCE" to enter the alarm silent state. 2.
  • Page 46 2. After the alarm description prompt entry, there is the system time of the last time it entered the trigger state. 6.5.4 Clearing the latch method Clearing the latch mode is also called alarm reset. The user can use the alarm pause function to reset the latch alarm.
  • Page 47 Pressure Alarm level Middle Alarm upper limit Adults: 110; Children: 90 Mean Alarm lower limit Adult: 60; Child: 50 Pressure Alarm level Middle Alarm upper limit Adult: 90; Child: 70 Diastolic Blood Alarm lower limit Adult: 50; Child: 40 Pressure Alarm level Middle Alarm upper limit...
  • Page 48 When a parameter alarm is turned off, " ” prompt symbol will display. The alarm switch of each parameter can be set independently. For parameters that set alarms, when the value of one or several parameters exceeds the alarm limit, the monitor automatically alarms and performs the following processing: 1) A prompt appears on the screen in the form described in Alarm Mode;...

  • Page 49: Chapter 7 Ecg And Respiration (Ecg/Resp)

    Chapter 7 ECG and Respiration (ECG/RESP) 7.1 ECG monitoring instructions 7.1.1 Definition of ECG monitoring ECG monitoring generates a continuous waveform of the patient's cardiac electrical activity to accurately assess the patient's physiological state at that time. For this reason, the normal connection of the ECG cable should be ensured so that correct measurement values can be obtained.
  • Page 50 If operated according to the conditions specified in YY 9706.102-2021 (when the anti-radiation capability is 3V/m), the field strength exceeding 1V/m may cause errors in various frequency measurements. Therefore, it is recommended not to use the device in the vicinity of electrocardiographic/respiratory measuring equipment. Electrode pads should be of the same model and should not exceed their service life.
  • Page 51 (1) RA white (right arm) electrode 1 is placed under the clavicle, close to the right shoulder. (2) LA black (left arm) electrode 1 is placed under the clavicle, close to the left shoulder. Place it on the chest wall as shown below. (3) RL green (right leg) electrode 1 is placed on the right lower abdomen.
  • Page 52 example, for open-heart surgery, electrodes can be placed across the side or back of the chest. In the operating room, due to the use of surgical electrocautery equipment, sometimes artifacts may affect the ECG waveform. To help reduce artifacts, electrodes can be placed on the left and right shoulders, near the left and right sides of the abdomen, while chest leads can be placed on the left side of the chest center.
  • Page 53 Notice If the electrodes are attached correctly but the ECG waveform is inaccurate, the lead wires need to be replaced. Interference from ungrounded products near the patient and ESU interference can cause waveform problems. 7.3 ECG Menu ECG setup menu Turn the knob, move the cursor on the main screen to the ECG hotkey in the parameter area, and then press the knob to pop up the ECG setting menu, as shown in Figure 7-4: Figure 7-4 ECG setting menu...
  • Page 54 I, II, III, aVR, aVL, aVF, and V. ECG gain There are five options in total, namely×0.25 ×0.5, ×1, ×2 and automatic. Notice When the input signal is too large, the wave peak may be truncated. At this time, the user can refer to the actual waveform to manually change the gain level of the ECG waveform to avoid incomplete waveform display.
  • Page 55 Figure 7-5 ECG other settings menu The following functions are available in this submenu: (1) Heartbeat volume: You can choose the volume levels of "low", "medium", "high" and "off". (2) Pacing analysis: You can choose "On" or "Off". (3) Power frequency trap: Suppress grid interference. (4) ECG calibration: Select this option to automatically calibrate the ECG waveform.
  • Page 56 Alarms that may occur during ECG measurement are divided into physiological alarms and technical alarms. At the same time, the ECG measurement process may also generate various prompt messages. When these alarms or prompts occur, the visual representation and auditory representation of the monitor can refer to the relevant descriptions in the alarm function chapter.
  • Page 57 is too great signals are greatly quiet, ensure the electrodes are affected connected reliably, and the AC interference power supply system is well grounded. Prompt information (including general alarm information): Prompt message Cause Alarm level HR measurement HR measurement value exceeds High out of bounds measurement range...
  • Page 58 Notice Place the white RA and red LL electrodes diagonally to obtain the best respiratory waveform in the II lead, or place the RA and LA electrodes in order to obtain the I lead respiratory waveform. When selecting different respiratory leads, be careful to select the corresponding calculation lead in RESP Settings - Respiratory Lead Settings, otherwise the correct result cannot be measured.
  • Page 59 The optional respiratory wave speeds are 6.25mm/s, 12.5mm/s, and 25.0mm/s. (4) Breathing Gain Users can set the magnification display of RESP waveform, and the magnification options are 0.25, 0.5, 1, 2, and 4. (5) Default configuration Select this item to enter the "RESP Default Configuration" dialog box. The user can select "Manufacturer Default Settings"...

  • Page 60: Chapter 8 Blood Oxygen Saturation (Spo2)

    Chapter 8 Blood Oxygen Saturation (SPO2) 8.1 Instructions for blood oxygen saturation monitoring The SPO2 can be used on adults and children, and the pulse oximeter device is calibrated to display functional oxygen saturation. The SPO2 accuracy of the pulse oximeter device is the root mean square of a difference and is less than or equal to 4.0%SpO2 in the range of 70% to 100%SaO2.
  • Page 61 pulse oximeter monitors. WARNING If carboxyhemoglobin, methemoglobin or dye diluting chemicals are present, the SPO2 value will be biased. Please use the blood oxygen sensor recommended in the manual and refer to its manual for use. Before use, users need to check the compatibility between the monitor, sensors, and cables, otherwise the patient may be injured or the equipment may be damaged.
  • Page 62 Do not place the sensor on a limb that has an arterial catheter or an intravenous line. Before starting monitoring, check whether the sensor cable is normal. When the SPO2 sensor cable is unplugged from the socket, the screen will display a "sensor off" error message and trigger an audible alarm.
  • Page 63 Notice If the test site and probe cannot be accurately positioned, it may lead to inaccurate blood oxygen saturation readings, or even failure to search for pulse waves and prevent blood oxygen monitoring. In this case, the probe should be repositioned. Excessive movement of the measurement part may cause inaccurate measurement.
  • Page 64 intravascular catheter. 9) High concentrations of dysfunctional hemoglobin such as carboxyhemoglobin and methemoglobin. 10) Blood oxygen saturation is too low. 11) Poor circulatory perfusion at the monitoring site. 12) Shock, anemia, hypothermia, and the use of vasoconstrictor drugs may reduce arterial blood flow to unmeasurable levels.
  • Page 65 Setting the SPO2 alarm upper limit to 100% is equivalent to turning off the upper limit alarm. High oxygen levels can cause premature infants to develop crystalline posterior fibrous tissue syndrome. Therefore, the upper alarm limit for blood oxygen saturation must be carefully selected based on accepted clinical practice experience.
  • Page 66 automatically output alarm parameter values ​ ​ and related measurement waveforms. The physiological alarms, technical alarms and prompt messages that may occur during SPO2 module measurement are listed in the table below. Physiological alarm: Prompt message Reason Alarm level SPO2 is too high The SPO2 measured value is higher than User selectable the upper alarm limit.
  • Page 67 PR measurement PR measurement value is out of range High out of bounds The SPO2 module is searching for a Search pulse No alarm pulse The SPO2 module cannot detect the Pulse not found High SPO2 signal for a long time. 8.6 Blood oxygen saturation accuracy The calculated value of the root mean square of the blood oxygen value (SPO2) measured by the monitor and the blood gas analysis value (SaO2) of the corresponding...
  • Page 68 (3) SPO2 and SaO2 scatter plot of blood oxygen probe with Zhongcang newborn package 69 / 113...

  • Page 69: Chapter 9 Body Temperature (Temp)

    Chapter 9 Body Temperature (TEMP) 9.1 Instructions for temperature monitoring The monitor can use a temperature probe to measure body temperature data. The operating mode adopted by this equipment is the direct mode, and the output temperature is an unadjusted temperature, which represents the temperature of the measurement part contacted by the probe.
  • Page 70 Figure 9-1 TEMP setting menu Alarm switch Select "On" to prompt and save the alarm when TEMP (body temperature) alarms. Select "Off" to not alarm and prompt " ". T1 alarm is based on the set high limit and low limit. When the temperature exceeds the high limit or is lower than T1, it represents the temperature of channel 1.
  • Page 71 Technical alarm: Alarm Prompt message Reason Countermeasures level TEMP sensor falls Temperature probe detaches Make sure the probe from monitor connection is reliable. Stop using the TEMP alarm function TEMP alarm limit notify biomedical Functional safety failure High error engineers company's maintenance personnel.

  • Page 72: Chapter 10 Non-Invasive Blood Pressure (Nibp)

    Chapter 10 Non-Invasive Blood Pressure (NIBP) 10.1 Instructions for non-invasive blood pressure monitoring Non-invasive blood pressure (NIBP) measurement uses the oscillation method and  is suitable for adults and children. The blood pressure value measured by the monitor is equivalent to the value ...
  • Page 73 cannulation, as infusion slowdown or blockage may occur during measurement inflation, which may result in damage to tissue surrounding the measurement site. Continuous cuff pressure caused by bends in the connecting tubing can lead to blood flow disruption and harm to the patient. Do not take blood pressure measurements too frequently as this may cause injury to the patient due to interference with blood flow.
  • Page 74 Do not wrap the limb too tightly, otherwise it may cause discoloration or even ischemia in the distal limb. Notice The cuff width should be 40% of the limb circumference. (50% for children), or 2/3 of the length of the upper arm. The inflated portion of the cuff should be long enough to surround 50 to 80% of the limb.
  • Page 75 return to long-term automatic mode or manual mode. The operator can also intentionally activate short-term automatic mode again. 2) Stop automatic measurement Pressing the "NIBP" key at any time during the automatic measurement process will stop the automatic measurement. 3) Carry out a manual measurement a.
  • Page 76 (1) Patient movement If the patient is moving, shaking or spasming, monitoring will be unreliable or even impossible because these conditions may interfere with the detection of arterial pressure pulses and the pressure measurement time will be extended. (2) Arrhythmia If the patient shows arrhythmia resulting in irregular heartbeats, monitoring will be unreliable or even impossible, and the pressure measurement time will be extended.
  • Page 77 "Settings" menu, as shown in Figure 10-2. Figure 10-2 NIBP setting menu Alarm switch Select "On" to prompt and store the alarm when the pressure alarm occurs. Select "Off" to not alarm and prompt next to NIBP in the parameter area of ​ ​ the screen. The pressure alarm is based on the set high limit and low limit.
  • Page 78 30, 60, 90,120, 180, 240, 480 minutes. After selecting the interval, the prompt "Please press the 'blood pressure' (start) key" will appear in the NIBP prompt area. This is the first automatic measurement of inflation by pressing the "NIBP" key. To end automatic measurement, select "Manual"...
  • Page 79 following details. Air leak detection It is used to detect whether the NIBP measurement pump is leaking. When the NIBP cuff is connected, you can use this key to start the NIBP inflation process to find out whether the sealing condition of the NIBP air path is good. If the air leak test passes, the system will not give any prompt;...
  • Page 80 Default configuration Select this item to enter the NIBP default configuration dialog box, where you can select the system default configuration. In the dialog box, the user has two options to choose from, namely "Factory Default Configuration" and "User Default Configuration". After selecting any item and exiting the dialog box, the system will pop up a dialog box asking the user to confirm their selection.
  • Page 81 no cuff Check and replace leaking parts, Cuff inflation Damaged cuff, and if necessary, notify biomedical tube leaking hose or connector engineers or our company's maintenance personnel. Unable to obtain Check whether the hose is tangled. stable pressure If the fault persists, notify the Air pressure error value, such as hose biomedical engineer or our...
  • Page 82 measurement monitoring, and measure again. analysis or calculations while a measurement is being taken. Prompt information (displayed in the prompt area below the NIBP pressure value): Prompt message Cause Alarm level Manual During manual measurement measurement… Continuous During continuous measurement measurement…...

  • Page 83: Chapter 11 End-Tidal Carbon Dioxide (Co2)

    End-Tidal Carbon Dioxide (CO2) Chapter 11 11.1 CO2 monitoring instructions (This function is optional, and the instrument you are using may not be equipped with this function) This module measures the carbon dioxide pressure of the patient's airway and can obtain the end-tidal carbon dioxide content (EtCO2), the minimum amount of carbon dioxide inhaled (InsCO2) and the airway respiratory rate, and display the CO2 pressure waveform.
  • Page 84 Figure 11-1 EtCO2 module connection Figure 11-2 EtCO2 adapter connection diagram diagram Figure 11-3 Airway adapter connection Figure 11-4 Nasal oxygen tube connection diagram diagram The respiratory rate can be adjusted from 0 to 150 with a step size of 5 using a respiratory rhythm fixture.
  • Page 85 Careful Do not use the instrument in an environment containing flammable anesthetic gases. The instrument can only be operated by professionals who have received professional training and are familiar with this manual. Notice If the package has been opened or the accessory inside is damaged, please do not use the accessory and return it to the supplier.
  • Page 86 Figure 11- 5CO2 settings CO2 alarm settings (1) Alarm switch: "On" will prompt and store the alarm when there is an alarm in the CO2 parameter, "Off" will not alarm. (2) Alarm level: There are three options, namely "high", "medium" and "low". "High" indicates the most serious alarm, followed by "medium"...
  • Page 87 measured value is greater than the upper alarm limit of InsCO2, the message "INS too high" appears on the screen. This message disappears when the measured value returns to normal. (6) AWRR alarm high limit: used to adjust the alarm upper limit of AwRR. When the measured value is greater than the upper alarm limit of AwRR, the message "RR too high"...
  • Page 88 Default values: Adult: 15 mmHg Pediatric: 20 mmHg Neonate: 30 mmHg InsCO2 alarm upper limit: When the parameter value is higher than this limit, an upper limit alarm will be issued. Default values: Adult: 4 mmHg Pediatric: 4 mmHg Neonate: 4 mmHg AwRR alarm upper limit: When the parameter value is higher than this limit, an upper limit alarm will be issued.
  • Page 89 alarm limit AWRR is too AwRR measurement value is higher than the set User selectable high alarm high limit AWRR is too The AwRR measurement value is lower than the User selectable set alarm low limit CO2 breathing Respiratory arrest(No breathing detected within High asphyxia the set delay time)

  • Page 90: Chapter 11 Common Troubleshooting Methods

    Chapter 11 Common Troubleshooting Methods Fault Fault name Possible causes of failure Solution description 1. The screen wire is loose; 1. Re-plug the cable plug; Turn on but Black screen black screen 2. The display or KC7 2. Replace the display or appears motherboard is damaged.
  • Page 91 not inserted in place. connect the lead wires. 3. Reconnect the ECG 3. The ECG lead falls off or leads or replace the lead the wire is broken; wires; 4. There is too much interference from 4. ECG clutter; peripheral electronic equipment;...

  • Page 92: Chapter 12 Accessories

    Chapter 12 Accessories The supporting accessories recommended by our company are as follows: 14.1 Electrocardiogram (ECG) accessories Test Material Patient Name Model Illustrate Manufacturer Options Number category Anti defibrillation, Shenzhen push button, SINO-K Medical SG5143S 12.02.0051C √ five-lead, 2.9m, Technology reusable Co.,Ltd.
  • Page 93 14.3 Temperature (TEMP) accessories Test Material Patient Name Model Illustrate Manufacturer Options Number category Shenzhen SINO-K Body cavity ST2305 12.02.0056C Medical Technology √ sensor.3m.reusable Co.,Ltd 体温探头 Shenzhen SINO-K Body surface ST1305 12.02.0055C Medical Technology √ sensor.3m.reusable Co.,Ltd 14.4 Non-Invasive Blood Pressure (NIBP) Accessories Test Material Patient...
  • Page 94 Co.,Ltd. 14.5 CO2 Accessories Test Material Patient Name Model Illustrate Manufacturer Options Number category main Suzhou Troline √ TL1000A 12.01.0063C Sensor stream Technology Co., Ltd. external Suzhou Troline side-strea √ TL2000A 12.01.0064C Technology Co., Ltd. Suzhou Troline Airway Airway √ TL_Madapter 12.02.0061C Technology Co., Ltd.
  • Page 95 connector Xinlong Ding 35.52wh Technology Ltd. lithium battery WARNING Please use recommended accessories. Using other accessories may damage the monitor or fail to achieve the accuracy of each parameter specification claimed in the manual. The listed accessories must be used in conjunction with our company's equipment. Before using the accessories, please read the instructions of the equipment and accessories to confirm the compatibility of the accessories with the product.

  • Page 96: Appendix I Product Specifications

    Appendix I Product Specifications Ⅰ.1 Monitor type (classified according to GB9706.1) Standard electric shock Class I, equipment with internal power supply resistance type EMC category Class A Standard level ECG (RESP), SPO2, TEMP: type CF; resistance electric NIBP and CO2: type BF. shock Degree liquid...
  • Page 97 (3) After the first low battery alarm, it can continue to work for 10 minutes, and then it will automatically shut down. (4) The battery charging time is not more than 5 hours, and the AC indicator will be steady on when charging. (5) The charging time for charging the battery from depleted to 90% capacity is 5 Hour.
  • Page 98 10µs ~ 100µs When the pacing analysis switch is turned on, pacing pulses that meet the following conditions can be suppressed without affecting heart Pacing pulse rate calculation; suppression Amplitude: ±2 mV ~ ±700mV; Width: 0.1ms ~ 2ms; Rise time: 10µs ~ 100µs Baseline recovery...
  • Page 99 Ⅰ.6 TEMP specifications Standards compliant YY 9706.256-2023 Applicable temperature sensor YSI series, CYF series Number of channels 2 channels Measuring range 0℃～50℃ Measurement accuracy 25℃～45℃, error ±0.2℃; other range accuracy is ±0.4℃ Ⅰ.7 NIBP specifications Standards compliant YY 9706.230-2023 Measurement method pulse wave oscillation method Manual measurement/automatic...
  • Page 100 Resolution 0.1%(1 mmHg) Airway respiratory rate measurement display 0～160 brpm range Airway respiratory rate measurement accuracy ±1 brpm Airway respiratory rate measurement resolution 1 brpm Rated respiratory rate 0-150 times/minute An overview of test methods for determining the The rated breathing rate is set at rated respiratory rate range and the corresponding 30,60,100,140 times/minute, using 5% effects...

  • Page 101: Appendix Ii Summary Of Performance Requirements Of Gb 9706.227-2021

    Appendix II Summary of Performance Requirements of GB 9706.227-2021 Requirements Minimum/Maximum Unit Min./Max. value Description Normal working conditions Ambient temperature scope ℃ 0~40 Relative humidity scope ≤85% (no condensation) Atmospheric pressure scope 700~1060 Network (power) scope 50±1 frequency Network (power scope 100-240V supply) voltage (rms)
  • Page 102 Display heart rate for signals with repetition rate = smallest 350bpm (children) Alarm system requirements Alarm limit range Maximum limit (adult) smallest 100~200 Upper limit (children) smallest 100~250 Lower limit (adults and children) smallest 30~100 Alarm resolution, or smallest Alarm limit error, or maximum ±10 Or (whichever is greater)
  • Page 103 Electrode weighting factor smallest ±5 Offset 15mm hysteresis effect maximum Scaling voltage See 4.2.8.9 of YY1079 Common mode rejection allows 10V line maximum frequency noise Baseline control and stability Recovery time after reset maximum Drift rate within 10s maximum uV/s Baseline drift within 1 hour maximum Line drift under operating temperature...
  • Page 104 Require Announce WARNING information on whether overloading electrosurgical equipment will damage No damage equipment Breathing, lead detection, active noise Not more than 30μA suppression High T-wave suppression capability: The heart rate displays the maximum T-wave amplitude within Diagnosis and monitoring mode 0.9mV Surgical the specified error limit.
  • Page 105 Electrode Polarization: Cautionary Statement Electrodes from the manufacturer specified by the Regarding the Impact of Electrode Type on System company should be used, otherwise the recovery Overload Recovery, Particularly Post-Defibrillation time after defibrillation will be affected. Recovery Time Auxiliary outputs: If auxiliary outputs are provided,...
  • Page 106 40ms or less before the QRS wave initiation; There is an identical pulse with a time lead of 150ms to 250ms before the pacing pulse mentioned above Pacemaker pulse suppression with overshoot: Pacemaker pulse suppression with overshoot (charging) time constant between 4ms and 100ms is published in the operator's instructions and maintenance instructions.

  • Page 107: Products

    Appendix III Declaration Table of Toxic and Harmful Substances or Elements in Products Toxic and harmful substances or elements Hexavalent Polybrominated Polybrominated Part Name Lead Cadmium chromium biphenyls diphenyl ethers (pb) (hg) (cd) (cr(vi)) (pbb) (pbde) Shell ○ ○ ○ ○...

  • Page 108: Appendix Ⅳ Emc

    Appendix Ⅳ EMC This equipment generates and radiates radio frequency energy. This equipment can cause electromagnetic interference between other medical or non-medical equipment and radio communications. According to the statement in YY 9706.102-2021, this product belongs to the first group of emission restrictions, Class A medical equipment, and corresponding protection measures should be provided to avoid interference.
  • Page 109 exceed specified values. Please turn off this type of equipment when near it. It is the operator's responsibility to instruct the patient or other persons accessing this device to fully comply with the above requirements. The manufacturer will not be responsible for any interference caused by the use of non-recommended internal connecting cables or by unauthorized changes or modifications to this equipment.
  • Page 110 Table I Guidance and Manufacturer's Statement---Electromagnetic Emissions [Systems and equipment] are expected to be used in the electromagnetic environment specified below. The purchaser or user should ensure that it is used in this electromagnetic environment. Electromagnetic Environment - Launch test Conformity Guidance [The system or device] uses radio...
  • Page 111 Power frequency magnetic Power frequency fields should have power magnetic field frequency magnetic field (50/60Hz) 3 A/m 3 A/m level characteristics typical of IEC 61000-4-8 a typical location in a typical GB/T17626.8 commercial or hospital environment. Note: UT refers to the AC network voltage before applying the test voltage. Table 3 Guidance and Manufacturer's Statement---Electromagnetic Immunity [Systems and equipment] are expected to be used in the electromagnetic environment specified below.
  • Page 112 absorption and reflection from buildings, objects and people. aFixed transmitters, such as base stations for wireless (cellular/cordless) telephones and land mobile radios, amateur wireless, AM and FM radio broadcasts, and television broadcasts, the field strengths of which cannot be predicted accurately theoretically. To assess the electromagnetic environment of fixed RF transmitters, a survey of the electromagnetic field should be considered.
  • Page 113 Contact information Registrant/production unit/after-sales service: MDKMed Medical Technology Co., Ltd. Registered address: 502A, Building 7, No. 22, Xinyan Road, Donghu Street, Linping District, Hangzhou City, Zhejiang Province, P. R China 311323 Production address: No.22, Cangling Rd, Huzhen Town, Jinyun County, Lishui City, Zhejiang Province, P.

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