Table of Contents
Advertisement
Quick Links
User Manual of Specialized Fetal &Maternal Monitor
Copyright
Version: B00
No: 046-001618-01
Revision Date: 09/2024
Product Name: Specialized Fetal & Maternal Monitor
Product Model: C10/C11
Software Version: V2
Date of Manufacture: Refer to the Nameplate
Service life: 10 years
Company name: Shenzhen Comen Medical Instruments Co., Ltd.
Address: Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building 2, FIYTA
Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen, Guangdong, 518106,
P.R. China.
Tel: +86-755-26431236
Fax: +86-755-26431232
Http: //en.comen.com
European Authorized Representative: Lotus NL B.V.
Address: Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Tel: +31644168999
Email: peter@lotusnl.com
UK Responsible Person
Company Name: Lotus Global Co Ltd
Address: 23 Maine Street, Reading, RG2 6AG, England, United Kingdom.
Tel: 0044-20-70961611
Email: peter@lotusglobaluk.com
I
Advertisement
Table of Contents
Subscribe to Our Youtube Channel
Related Manuals for Comen C10
Summary of Contents for Comen C10
- Page 1 Date of Manufacture: Refer to the Nameplate Service life: 10 years Company name: Shenzhen Comen Medical Instruments Co., Ltd. Address: Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building 2, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen, Guangdong, 518106, P.R.
-
Page 2: Warranty
No part of this user manual shall be photocopied, copied or translated into other languages without the prior written consent of Comen. Comen shall not be liable for errors contained in this Manual or for incidental or consequential damages resulting from the provision, actual performance and use of this Manual. Comen does not provide other parties with concessions under patent law. - Page 3 User Manual of Specialized Fetal &Maternal Monitor After-sales Service Department Name: Shenzhen Comen Medical Instruments Co., Ltd. Address: Floor 5 of Building 2 FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen, Guangdong, 518106, P.R. China Tel: +86-755-26431236, +86-755-8654386, +86-755-26074134...
-
Page 4: Intended Users
User Manual of Specialized Fetal &Maternal Monitor Preface This user manual provides details on the performance, operations and safety instructions about the product. Please read carefully and understand the content of this manual so as to ensure the safety of the patients and operator. -
Page 5: Table Of Contents
User Manual of Specialized Fetal &Maternal Monitor Contents Chapter 1 Safety ....................1-1 1.1 Safety Information................................1-1 1.2 Symbols ..................................... 1-4 Chapter 2 Overview ..................2-1 2.1 Intended Use ..................................2-1 2.2 Components ..................................2-1 2.3 Contraindications ................................2-1 2.4 Appearance Introduction ............................... 2-2 2.4.1 Front View................................. - Page 6 User Manual of Specialized Fetal &Maternal Monitor 5.3.4 Adjusting Fetal Volume ............................5-2 5.3.5 Adjusting Key Volume............................. 5-2 5.4 Viewing Monitor Info ..............................5-3 5.5 Demo....................................5-3 5.6 Network Settings ................................5-3 5.7 Freezing Waveform ................................. 5-4 Chapter 6 Patient Management................6-1 6.1 Admit a Patient ................................
- Page 7 User Manual of Specialized Fetal &Maternal Monitor 8.6.2 Setting the Auto Alarm Limit ..........................8-7 8.7 Setting Alarm Delay................................. 8-7 8.8 Alarm Pause..................................8-8 8.8.1 Setting Alar m Pause ..............................8-8 8.9 Alarm Off ................................... 8-8 8.10 Alarm Reset ..................................8-9 8.11 Alarm Preset...................................
- Page 8 User Manual of Specialized Fetal &Maternal Monitor 13.1 Fetal Monitor ................................13-1 13.1.1 Fetal Monitoring Principle ..........................13-1 13.1.2 Terms about Monitor ............................13-2 13.2 FHR Monitoring................................13-3 13.2.1 Confirming Fetal Life............................13-3 13.2.2 FHR measur ement steps ............................13-3 13.2.3 Cross-Channel Verification ..........................13-4 13.2.4 Trace Separation..............................13-5 13.2.5 FHR Settings .................................13-6 13.2.5.1 Setting the FHR Sound Channel ........................13-6 13.2.6 Confirming that the Fetus is the Signal Source ....................13-6...
-
Page 9: Chapter 1 Safety
Chapter 1 Safety 1.1 Safety Information Warning Alerts you to situations that may result in serious consequences or adverse events or endanger personal safety. Failure to observe the warning information may cause severe injury or even death of the user or patient. - Page 10 Do not open the housing of this instrument to avoid potential electric shock. The monitor must be maintained and upgraded by service technicians trained and authorized by Comen. Observe the local laws and regulations or the waste disposal rules of the hospital when disposing of ...
- Page 11 Safety personnel. The use of this monitor is restricted to one patient at a time. When the monitor is used with HF surgical equipment, the transducer and the cables must be avoided conductive connection to the HF equipment to protect against burns to the patient. The ultrasound transducer chip is ceramic and should not be dropped or scratched.
-
Page 12: Symbols
European community Complies with Regulation (EU) representative 2017/745 Caution USB interface Network (connect with ON/OFF button Comen central monitor) AC power indicator Print/Stop key Defibrillation-proof type CF Alarm reset key applied part Equipotentiality Battery working status Freeze/Unfreeze key TOCO zero key... - Page 13 Safety (2) Package Symbols Symbol Description Symbol Description This way up Stacking limits Fragile, Handle with care Keep dry Temperature limits Humidity limitation Atmospheric pressure limitation...
-
Page 14: Chapter 2 Overview
Chapter 2 Overview The monitor is mainly used to monitor the fetal, maternal uterine activity. It can generate alarms from the fetal parameters, and display, store and record the corresponding patient data and related waveforms. The monitor is equipped with a 5.7-inch screen. And the monitor supports two operating modes: button and rotary knob. -
Page 15: Appearance Introduction
⑥ ② ⑦ ③ ⑧ ④ ⑨ ⑤ Figure 2-1 C10/C11 Front view ① Alarm indicator: When an alarm occurs, different lights flash according to different alarm levels. ② Trademark identification: COMEN ③ Press to reset the alarm system. Alarm reset button Freeze/Unfreeze Press to freeze or release all waveforms on the screen. -
Page 16: Right View
Paper compartment Lock: To Open and lock the paper compartment door 2.4.2 Right View Figure 2-2 C10/C11 Right view Interfaces: including four sockets with the same definition, used as Fetal Heart Rate (FHR) socket 1, FHR socket 2, socket of fetal movement marker sensor and TOCO socket. The FHR sensor, fetal movement marker sensor or TOCO sensor can be inserted into any of these sockets and the monitor recognizes it automatically. -
Page 17: Rear View
Overview waveforms and values appear in 5-30s. Note: twins are optional. Loudspeaker: loudspeaker for fetal heartbeat. Note: there are a cooling fan and an alarm loudspeaker on the left of the monitor 2.4.3 Rear View Note When tilting the display, first pull the display forward until the end and the display will be fixed, then ... -
Page 18: On-Screen Display
Power Socket grounding terminal Figure 2-3 C10/C11 Rear view Supporting shaft: to support the display. The tilting and folding of the display is realized by a one-way gear system. The display can only stay at 6 fixed positions of the bottom gear, and when the display is tilted to one of these positions, you hear a “click”. - Page 19 Overview Fig. 2-4 Main interface Physiological alarm message Display physiological alarm message. When there are multiple messages, they will be displayed circularly. Click here to directly access [View Physiology Alarm] window. Technical alarm message area Display technical alarm message and status message. When there are multiple messages, they will be displayed circularly.
- Page 20 Overview monitoring system has been connected successfully; indicates the battery charge level. indicates SD card status. indicates the monitor has connected with USB connecting line. Click here to enter [Monitor Setup] menu. Printing progress bar System Information System Time: Display the current system time.
-
Page 21: Chapter 3 Installation
To ensure the safe operation, please only use the accessories (like FHR transducer) and consumable materials provided or designated by Comen. Please connect Comen equipment to the monitor only. If you connect any other electrical equipment or device to the monitor, there could be safety problems caused by superimposed leakage current. -
Page 22: Turn On The Monitor
I f there is any evidence of failure or any error messages are displayed, do not use this monitor. Contact a service technician of Comen or a biomedical engineer in your hospital. 3.4 Connection of Sensors Connect the required sensor to the monitor and the monitoring part of patient. For the correct connection... -
Page 23: Chapter 4 Patient Safety
Chapter 4 Patient Safety 4.1 Safety Instructions The monitor is designed in accordance with international safety standards for medical electrical equipment. It is provided with defibrillation-proof and electrosurgical protection with a floating ground input. 4.2 Environmental Requirements The following guidance should be followed to ensure the safety of electrical installations. The monitor should be used in an environment that can reasonably avoid vibration, dust, corrosive or explosive gases, extreme temperature and humidity, etc. -
Page 24: Equipotential Grounding
Patient Safety Connect the ground wire to the equipotential connector of the monitor. If you have any doubts about whether equipment used may cause any electrical risks, such as risks caused by the accumulation of leakage current, consult an expert in this field to ensure the safety of all equipment. 4.5 Equipotential Grounding The monitor must be connected to a power outlet with protective grounding. - Page 25 Patient Safety Warning I n order to avoid fire or explosion, never use this monitor in an environment with inflammables such as anesthetics. DO NOT use the monitor during MRI inspection; or the induced current will cause burns. ...
-
Page 26: Chapter 5 Basic Operations
Chapter 5 Basic Operations 5.1 Entering the Main Menu Press the key on the front panel to enter the [Main Menu] window, where you can set up system menus easily. See the figure below: Figure 5-1 Main Menu button: Press this button to exit the current menu. Note The system settings are saved once you set them up and remain valid until you modify them or restore ... -
Page 27: General Settings
Basic Operations 5.3 General Settings 5.3.1 Setting System Time 1. Access [Main Menu] → [Maintain] → [Time Setup]. 2. Set the system time according to your local time. 3. Return to [Time Setup] and click [Enter] in the top bar. 5.3.2 Changing System Language Access [Main Menu] →[Maintain] and enter the password 5188;... -
Page 28: Viewing Monitor Info
Basic Operations 5.4 Viewing Monitor Info The software version is used for maintenance or tracing of the monitor. Enter [Main Menu] → [Monitor Info] (Monitor Information) to view the monitor’s software version. 5.5 Demo To enable Demo function: Access [Main Menu] →[Maintain] and enter the password; Click [Demo]. -
Page 29: Freezing Waveform
Basic Operations Icon indicates the network between this monitor and central monitoring system has not been connected successfully; Icon indicates the network between this monitor and central monitoring system has been connected successfully. Note The network bed number must be unique and cannot be the same as that of any other monitor ... -
Page 30: Chapter 6 Patient Management
Chapter 6 Patient Management You can enter the [Patient Management] menu in two ways: Enter the main menu and select [Patient Manage] Click patient info area on the upper menu bar. 6.1 Admit a Patient Once a patient is connected to the monitor, even if no patient is admitted, the monitor can also display and store the physiological data of the patient. -
Page 31: Patient Information
Patient Management admitted, the prompt message [Apply the monitoring data to the patient to be admitted?] will be shown. [Yes]: Apply the monitor data to the new patient. [No]: Clear the stored data on the monitor. Enter the [Patient Info] window, set up [Pat Type] and [Pacer], and then close the window. 6.3 Patient Information When the user adopts the [Quick Admit] mode, only [Pat Type] (Patient Type) and [Pacer] (Pacemaker) in [Patient Info] (Patient Information) are set, and other information of the patient needs to be completed later. - Page 32 Patient Management If there are multiple patient files found, click the keys to select the one you want to view; click the keys to show more information of the patient. To manage patient file, do the followings: Enter [Main Menu] → [Document Manage]. Enter a patient name in the input field at the lower left corner of the window.
-
Page 33: Chapter 7 User Screens
Chapter 7 User Screens 7.1 User Screen Styles This monitor provides 2 types of user interface: Fetal Screen and Big Font. The information displayed on the screen is different in these two types. Enter [Main Menu] → [Screens] to select Fetal Screen or Big Font. 7.1.1 Fetal Screen FHR value, FHR trace, TOCO and its waveform, manual/auto fetal movement (FM) marks and FM waveform are displayed on this interface. -
Page 34: Tailoring Your Screens
User Interface Fig. 7-2 Big Font screen 7.2 Tailoring Your Screens You can tailor your monitor’s screen by setting, such as: Wave sweep speed. Color of parameters and waveforms displayed. You can set up the visual style for all parameters using the method described in this section. 7.2.1 Changing the Waveform Sweep Speed Select the FHR waveform, and in the pop-up [FHR setup] window, select [Sweep] to set sweeping speed of waveforms (options: 1 cm/min, 2 cm/min, and 3 cm/min). -
Page 35: Chapter 8 Alarms
Chapter 8 Alarms 8.1 Alarm Type Alarms generated by the monitor are classified into physiological and technical alarms. (1) Physiological alarm A physiological alarm is generated when a certain physiological parameter of the patient is beyond the high/low alarm limit or the patient has physiological disorder. Physiological alarm messages are displayed in the physiological alarm area in the upper part of the screen. -
Page 36: Alarm Mode
Alarms normal monitoring vital physiological parameters. Low-level alarm Abnormality is detected in the Some device failures or mis- patient’s vital signs; treatment may operation may result in certain be necessary. malfunctions, will endanger the patient’s safety. The levels of all technical alarms and certain physiological alarms have been set before delivery of the monitor and cannot be changed by the user. -
Page 37: Audible Alarm
Alarms 8.3.2 Audible Alarm The monitor indicates alarm levels with audio alarm with different intervals. High-level: beep-beep-beep--beep-beep----beep-beep-beep--beep-beep. Medium-level: beep-beep-beep. Low-level: beep. Warning Both the bedside monitor and the CMS are provided with audible alarm function. When this monitor is connected to the CMS, you can use the same alarm levels and alarm limits for the ... -
Page 38: Alarm Parameter Flash
Alarms 8.4 Alarm Parameter Flash When a parameter reaches the alarm limit, the parameter and its upper and lower limits will flash once every second, indicating the measured result is beyond the upper or lower limit. 8.5 Alarm Volume 8.5.1 Minimum Alarm Volume The minimum alarm volume is set to avoid the situation that the alarm cannot be heard due to the alarm volume being set too low. -
Page 39: Setting The Reminder Sound
Alarms Warning When the alarm volume of the system is set to 0, the monitor cannot make any alarm sound even if a new alarm is generated. Therefore, the operator should use this function with caution. Set an appropriate alarm volume. It hinders the operators from distinguishing an alarm when the alarm ... -
Page 40: Setting Parameter Alarm
Alarms 8.6 Setting Parameter Alarm 8.6.1 Setting the Alarm limit Warning When setting alarm limits to extreme values, the alarm system may be useless. Before monitoring, please ensure that the current alarm limit is only applicable for the current patient. ... -
Page 41: Setting The Auto Alarm Limit
Alarms Select the check box at the lower left corner of the Setup window for the corresponding parameter to switch the alarm level. Switch the alarm ON/OFF icon to [ON]. Select the triangle icon , and rotate the knob to change the range of alarm limit, press the knob again. -
Page 42: Alarm Pause
Alarms Enter [Maintain] → [Alarm Setup] → [Alarm Delay]. Set the appropriate delay time. 8.8 Alarm Pause You can press the key on the control panel to quickly enter the alarm pause state: Alarm sound, alarm light and alarm message are disabled for physiological alarms, and no physiological ... -
Page 43: Alarm Reset
Alarms parameter, switch the alarm ON/OFF icon of that parameter to “ON”. Warning I f the alarm function is set to [OFF], the monitor cannot trigger alarm when there is an alarm condition. Therefore, the operator should use this function with caution. 8.10 Alarm Reset You can reset the current alarm with the [Alarm Reset] soft key: ... -
Page 44: Alarm System Test
Alarms 8.12 Alarm System Test You can know whether the alarm system works normally by the state of the sound-light alarm. For example: (1) Click FHR1 parameter area to enter [FHR Setup] menu; (2) Select [Alarm Limit Setup] and switch the alarm on. (3) Set the [FHR1] upper limit as 120 and lower limit as 80. -
Page 45: Chapter 9 Battery
Chapter 9 Battery 9.1 Overview The monitor is equipped with a built-in rechargeable battery. When AC power supply is connected, the battery is charged automatically until it is full whether the equipment is turned on or not. In the event of unexpected power failure, the system automatically uses the battery to supply power for the running of the equipment. -
Page 46: Low Battery Alarm
Battery 9.2 Low Battery Alarm The monitor will automatically shut down in case of two low battery. When the battery icon turns to indicating the battery power is less than 10%, the monitor will trigger a technical alarm with alarm message of [Low Battery]. -
Page 47: Battery Recycling
Battery the battery is damaged or no battery. (b) Check whether the battery can be normally charged when the battery is connected to alternating current; (c) Disconnect the monitor from the patient and suspend all monitoring and measuring procedures. (d) When charging the battery, at least six hours of charging should be ensured until it is fully charged. (e) Disconnect the AC power supply, power on the monitor with the battery until it is fully discharged and the monitor shuts off automatically Record the start and stop time. -
Page 48: Chapter 10 Printing
Chapter 10 Printing 10.1 Loading Recording Paper Warning You must use required folded thermal recording paper, otherwise it may lead to inability to record, record quality degradation or damage to the thermal head. Do not use hands or other rough material to touch the thermal head, or it will result in damage to the ... -
Page 49: Printing
Printing Record paper Thermal print head Paper Paper roller compartment lock Fig 11-1 Loading record paper Unlock the paper compartment with your right hand and open the compartment door outwards; Put new record paper into paper slot with the grid side facing up and top of the paper (210) toward the left of the monitor;... -
Page 50: Real-Time Printing
Printing Stop recording manually: Select on the front panel of the monitor or the corresponding record button in the current menu. The recorder stops recording automatically in the following situations: The recording task is fulfilled The recorder is out of paper ... - Page 51 Printing 2. Confirm the patient information and score results and click [Enter]. The monitor starts to print the fetal waveform according to the speed set in [Real Speed] and the time set in [Real Time]. 3. To stop printing during printing process, just press the print key on the front panel or click the [Record] on- screen key.
-
Page 52: Alarm Printing
Printing 10.2.3.2 Alarm printing Alarm printing only supports external printer, the steps are as follows: 1. Connect the external printer. 2. Access [Main Menu]→[Printer Setup (USB)]→[Print Report]; 3. Click [Alarm Event Review Report] to print. 10.2.4 Print Setup Enter [Main Menu] → [Record Setup] [Record Setup] mainly includes: ... - Page 53 Printing NST score criterion is as follows: NST Score 0 score 1 score 2 score Value Score Item Baseline FHR (bpm) <100, >180 100~109,161~180 110~160 Var .Range (bpm) <5 5~9,>30 10~30 FHR Rise Time with <10 s 10~14 s >14 s FM (s) FHR Rise Amp.
- Page 54 Printing Fischer score criterion is as follows: Fischer Score 0 score 1 score 2 score Value Score Item Baseline FHR (bpm) <100,>180 100~109,161~180 110~160 Var .Range (bpm) <5 5~9,>25 10~25 Var. Freq. (cpm) <2 >5 None LD or SVD None OXFORD grade criterion is as follows: I tems Result...
-
Page 55: Chapter 11 Cleaning And Disinfection
If it is necessary to send back the device to Comen for repair, first clean it. Please observe the following precautions: Please dilute detergent and disinfectant as specified by the manufacturer, or use a concentration as low ... - Page 56 Cleaning and Disinfection After cleaning, wipe off the cleaning agent with a dry soft cloth; Allow the monitor, accessory cable and sensor to air dry. To avoid damage to the monitor and accessories, disinfection is recommended only when regulated as necessary in the Hospital Maintenance Schedule.
- Page 57 Cleaning and Disinfection Detergents containing phenolic compound base Alkaline detergents Acid detergents Do not use the following disinfectants unless otherwise stated: Disinfectant containing chlorine dioxide Disinfectant containing trichloroisocyanuric acid Disinfectant containing peracetic acid Disinfectant containing benzalkonium bromide or benzalkonium chloride Disinfectant containing chlorhexidine gluconate or chlorhexidine acetate Disinfectant containing quaternary ammonium salt Disinfectant containing potassium persulfate...
-
Page 58: Cleaning The Probe Strap
Cleaning and Disinfection 11.3 Cleaning the probe strap The probe strap should be cleaned with soapy water with temperature lower than +60°C. 11-4... -
Page 59: Chapter 12 Maintenance
The circuit diagrams of the monitor can be provided by Comen as per customer demands. Qualified technicians can use it to help the user repair some apparatus that Comen classifies as “can be maintained by the user”. Warning I f the hospital or agency that is responsible for using the monitor does not follow a satisfactory ... -
Page 60: Maintenance Schedule
12.2 Maintenance Schedule The following safety and maintenance check can be conducted by professional persons approved by Comen. You can contact the customer service technicians if you need the following maintenance. Before the inspection or maintenance, the facilities should be cleaned and disinfected. -
Page 61: Testing Toco Transducers
Maintenance 12.4 Testing TOCO Transducers (1) After starting the monitor, please connect the TOCO transducer. (2) Apply appropriate pressure to the middle of the sensor surface. (3) Check whether the screen displays the press change. Please check all TOCO transducers mentioned above. If there is any error, please contact our After-sales engineers. -
Page 62: Chapter 13 Fetus Monitoring
Chapter 13 Fetus Monitoring There are two basic types of fetus monitors: antepartum monitor for pre-delivery use and intrapartum monitor for in-delivery use. The antepartum monitor does not have the internal monitoring ability and thus cannot monitor the fetal heart rate (FHR) directly through the fetus scalp electrode or monitor the internal uterine pressure (IUP) of the mother through the internal pressure pipe. -
Page 63: Terms About Monitor
Fetus Monitoring identical with the transmitting frequency. If the obstacle moves, the reflection frequency will change: become higher (or lower) when the obstacle faces the sound source with the front (or back). The faster the obstacle moves, the greater change the reflection frequency will experience. That is the Doppler Effect. In clinical application, the ultrasound transducer is used to transmit the ultrasound wave into the human body. -
Page 64: Fhr Monitoring
Fetus Monitoring 13.2 FHR Monitoring 13.2.1 Confirming Fetal Life Fetal monitoring with ultrasound cannot differentiate a fetal heart rate signal source from a maternal heart rate source in all situations. These are some of the signal sources that might be taken as FHR signal source by mistake: - High maternal heart rate signal. -
Page 65: Cross-Channel Verification
Fetus Monitoring (3) Connect the ultrasound transducer to the abdomen of the pregnant woman and then adjust its position until you find loud fetal heart signal. (4) Fix the ultrasound transducer with the belt. Fasten the sensor belt with appropriate tightness. (5) Make sure you can hear the fetal heart beats in the monitoring process. -
Page 66: Trace Separation
Fetus Monitoring 13.2.4 Trace Separation The trace separation function is to help you interpret traces with similar baselines. Enable Trace Separation Select FHR waveform, in the pop-up [FHR Setup] menu, select [FHR Separation of Trace] and select [+20bpm] or [-20bpm]. [+20bpm] or [-20bpm] means the FHR2 trace is displayed and recorded 20bpm higher or lower than it really is respectively. -
Page 67: Fhr Settings
Fetus Monitoring 13.2.5 FHR Settings 13.2.5.1 Setting the FHR Sound Channel FHR sound channel means which channel the FHR sound comes from. The available options include [FHR 1] and [FHR2]. When there is only one FHR transducer connected, the FHR sound channel will be locked as [FHR1] and when there are two FHR transducers connected, the users can select the FHR sound channel as needs. -
Page 68: Toco Monitoring
Fetus Monitoring 13.3 TOCO Monitoring Uterine contraction pressure is a criteria of labor intensity. It is clinically proven that contraction status has a direct influence on fetal heart activity and labor. For example, it can cause increased or decreased FHR. The curves recorded by the monitor provide important information such as uterine contraction level, frequency, duration, pattern, all of which, combined with FHR monitoring, help medical personnel to make diagnosis on FHR changes. -
Page 69: Setting The Toco Zero Value
Fetus Monitoring (3) When the TOCO transducer is placed on the pregnant woman, please observe the TOCO value on the screen. Note Before measurement, press the TOCO zero key manually. Do not apply conductive gel to TOCO transducer or probe contact area. ... -
Page 70: Counting Fetal Movement Automatically
Fetus Monitoring Note I f fetal movements are counted manually, remind the pregnant woman that movements lasting for 5 seconds are counted as only one movement and that she should press the marker only once. If the marker is pressed for multiple times in 5 seconds, they are counted as one. 13.4.2 Counting Fetal Movement Automatically The auto fetal movement is detected by Doppler heart rate signals. -
Page 71: Appearance Introduction
Fetus Monitoring There are three working modes: Fast mode Vibration time: 0.2s, vibration period: 1.4s (frequency 0.714Hz) Slow mode Vibration time: 0.8s, vibration period: 2s (frequency 0.5Hz) Manual mode Fast mode or Slow mode vibrates for 3 periods, then stops 13.5.1 Appearance Introduction ①... - Page 72 Fetus Monitoring Note The fetus-awakening acoustic stimulator cannot contact with the pregnant women’s skin directly. When using the acoustic stimulator, its vibration part should be coated with one layer of disposable medical gauze and stuck firmly with medical proof fabric. Replace gauze for each patient to avoid cross infection.
-
Page 73: Appendix I Product Configuration
Appendix I Product Configuration Model Function Parameter FHR1 √ √ FHR2 √ TOCO √ √ √ √ √ √ Recorder Rotary knob √ √ Note ① “√” indicates that the device is equipped with the function. ② Blank indicates that the device does not have this function. ③... -
Page 74: Appendix Ii Accessories
Appendix II Accessories Here we recommend the following accessories for the Monitor. Warning Use the accessories of designated types only, or the Monitor may be damaged. To prevent reduced performance and cross infections, please do no reuse any disposable accessory. ... -
Page 75: Appendix Iii Replacement Plan For Accessories
Appendix III Replacement Plan for Accessories Name Service life TOCO probe, waterproof Two years FHR probe, waterproof Two years FM Mark, waterproof Two years Wake probe Two years III-1... -
Page 76: Appendix Iv Product Specifications
Appendix IV Product Specifications Monitor Type Classified by Type Electric shock protection Externally powered Class-I equipment or internally powered; classification BF applied parts: TOCO, FHR, FM IEC 60601-1, Safety standards IEC 60601-1-8, IEC 60601-1-2 IEC60601-2-37. IEC60601-1-6 IEC60601-1-9 IP grade IPX0 Safety level if there is any The monitor is not allowed to be used if there is any mixture of flammable mixture... - Page 77 Product Specifications Item Specification Working Work environment 5℃～40℃ conditions ≤83%, non-condensing Barometric pressure 700hPa ～1060hPa Power supply AC input voltage 100-240V～ requirement AC input frequency 50Hz/60Hz Input power 80VA Transport Protect the device against violent impact, vibration, rain and snow during requirement transportation.
-
Page 78: Acoustic Output Reporting Table
Product Specifications <5mW/cm （Intensity of output beam） (spatial peak - temporal average <100mW/cm spta intensity) FHR measuring range 30bpm～250bpm FHR measuring accuracy ±1bpm FHR 1/2 alarm preset limit a. The monitor can produce a continuous sound alarm signal, the fetal heart rate exceeds the limit to the start of the alarm time is not more than 30s b. - Page 79 Product Specifications Z at max I pi,a ∮1.2 ∮1.2 Dim of ∮1.2 ∮1.2 aprt 903.9 1250 Other at max I 0.018 information at max I at max 0.00 pa,a Operating Control 1 control Control 2 conditions Control 3 NOTE 1 Data should only be entered in one of the columns related to TIS NOTE 2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or neonatal cephalic uses NOTE 3 If the requirements of 201.12.4.2a) are met, it is not required to enter any data in the columns...
-
Page 80: Appendix V Alarm Message
Appendix V Alarm Message 1. Physical Alarm Message Alarm Messag e Adjustable Level Cause Solution FHR1 Too High High, medial, low Measured value Check if alarm limit is FHR1 Too Low High, medial, low parameter is higher than the reasonable and if patient is upper limit or lower than the in good condition. -
Page 81: Appendix Vi Default Settings
Key Volume Alarm Records Print Alarm Delay Time Not Allowed Alarm Pause Time 2min Language English Auto Grade Paper Type 30-240 (COMEN) Select Printer Built-in printer Score Select FHR1 Score Criterion Advanced FISCHER Print time 20 minutes FHR1 default configuration... - Page 82 Default Settings FHR2 default configuration I tem Default Factory Adult Config uration Note FHR1 display color Purple FHR2 display color Blue Fetal Movement Count Manual Fetal Sound Channel FHR1 The FHR sound channel will be locked if there is only on FHR transducer connected FHR2 Trace Separation 0bpm...
-
Page 83: Appendix Vii Emc
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the C10/C11, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. - Page 84 4. Fetal awakening function Guidance and manufacturer’ s declaration – electromag netic emissions The C10/C11 is intended for use in the electromagnetic environment specified below. The customer or the user of the C10/C11 should assure that it is used in such an environment.
- Page 85 ; 25/30 cycles 0 % U ; 1 cycle during power mains interruptions, it is Single phase: at 0° voltage change on recommended that the C10/C11 be 70 % U ; 25/30 mains input wire powered from an uninterruptible cycles 0 % U ;...
- Page 86 Guide and Manufacturer’ s Statement – Electromag netic I mmunity The monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the monitor should assure that it is used in such an environment. I EC 60601-1-2 Coincidence Electromag netic Environment –...
- Page 87 If the measured field strength in the location in which C10/C11 is used exceeds the applicable RF compliance level above, CB11 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re- orienting or relocating C10/C11.
- Page 88 I mmunity to proximity fields from RF wireless communications equipment C10/C11 is intended for use in an electromagnetic environment in which RF wireless communications equipment are controlled. Immunity IEC60601 test level Compliance Electromagnetic test level environment - Test Modulation Maximum...
-
Page 89: Appendix Viii Limitations Of Ultrasound Monitoring
Appendix VIII Limitations of Ultrasound Monitoring Principle When the ultrasound waves strike an object, they bounce back and create an echo. If the object moves toward the sound source, the frequency of the echo increases. If the object moves away from the sound source, the frequency of the echo decreases. - Page 90 Limitations of Ultrasound Monitoring movements of one heartbeat. This produces a heart rate curve that is half the actual heart rate. This phenomenon usually occurs during tachycardia, and the heart rate curve suddenly switches to half of the actual heart rate value, which the physician may consider to be a "deceleration." However, when the doubling or halving occurs, the fetal heart sound emitted by the monitor is still reliable.
-
Page 91: Appendix Ix Abbreviation List
Appendix IX Abbreviation List Electromagnetic Compatibility Electro-static Discharge Radio Frequency Magnetic Resonance Imaging High Frequency Intensive Care Unit NICU Neonatal Intensive Care Unit Cardiac (Coronary) Care Unit Operating Room Central Monitoring System Identification Internet Protocol Liquid Crystal Display Light Emitting Diode Adult Alm. - Page 92 Abbreviation List IEEE Institute of Electrical and Electronic Engineers Underwriters Laboratories Direction for Use Non-stress Test Mechanical Index Soft-tissue Thermal Index Cranial-bone Thermal Index Bone Thermal Index IX-2...
Need help?
Do you have a question about the C10 and is the answer not in the manual?
Questions and answers