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Dear Customer, Thank you for giving us the honor to serve you through our innovative product/s. We take this opportunity to express extreme happiness to append our esteemed customer list with your concern. All our products are delicately planned, designed and developed with combined dedicated efforts by our team that includes biomedical engineers, designers, doctors and other expertise to bring forth the latest technology to satisfy the ever changing needs of our customer. Immaterial to the size and location of the organization/hospital/clinic we never ever take chance to loose our customer who is a valid gem. With experience of more than a decade, we understand that the height of success is possible to be achieved only through CUSTOMER SATISFACTION, which we have almost achieved irrespective of sustained highly competitive market through our hi-tech quality products & regular customer survey. We at Maestros strengthen our tender relationship with our customer by providing the best of the best services right from installation, servicing and regular maintenance. With our wide spread channels in all major cities of the subcontinent, we update our customer with our new range of products developed from time to time*. We would appreciate your valuable time to go through our other range of products that include ECG machines, Pulse Oximeters, Spirometers, Physiological monitors & Fetal monitors. We have also acquired competency in the development of PC based monitoring systems like Central Nursing Station, Stress Test System and PC based ECG machine. We proudly acknowledge you that we have also designed and developed and launched recently, state of art telemedicine products like VitalTrack, Lotus-700 & Lotus-500, Event Recorder ER 5, Telespiro, CardioAssist, Coddle Assist, Electronic Stethoscope and many more under stream of production. We welcome your complaints/compliments/orders/suggestions to improve our products at:
Table of contents
INTRODUCTION........................................................................................1 PHYSICAL FEATURES................................................................................2 Figure 1.1 Front panel of the system.......................................................................................... 2 Figure 1.2 Encoder knob ........................................................................................................... 3 SIDE PANELS ................................................................................................................................. 4 Figure 1.3 Right hand side of the system.................................................................................... 4 Figure 1.4 Left hand side of the system ...................................................................................... 4 DISPLAY SCREEN ........................................................................................................................... 5 Figure 1.5 Display screen.......................................................................................................... 5 PRINCIPLE OF OPERATION ......................................................................7 Figure 2.1 Principle of operation............................................................................................... 7 INSTALLATION.........................................................................................8 TO OPERATE ON MAINS ................................................................................................................. 8 TO OPERATE ON INBUILT BATTERY................................................................................................ 8 PARAMETER SETTINGS .................................................................................................................. 9 FETAL AND MOTHER MENU ............................................................................................................ 9 Figure 3.1 Fetal & mother menu................................................................................................ 9 SYSTEMS SETUP MENU .................................................................................................................. 9 Figure 3.2 System setup menu.................................................................................................. 10 PRINTER CONTROL MENU ............................................................................................................ 10 Figure 3.3 Printer control menu .............................................................................................. 10 RECHARGING THE INBUILT BATTERY.....................................................12 LOW BATTERY INDICATION ......................................................................................................... 12 PRINTER COMPARTMENT........................................................................13 Figure 4.1 Printer compartment .............................................................................................. 13 LOADING PAPER .......................................................................................................................... 13 PRINTING DURING MONITORING ................................................................................................. 14 PRINTING DURING OFFLINE ........................................................................................................ 14 CONTROLLING THE VOLUME OF FETAL HEART SOUNDS ............................................................... 14 ALARM INDICATIONS.............................................................................14 VISUAL INDICATIONS .................................................................................................................. 14 AUDIO INDICATIONS ................................................................................................................... 14 NON STRESS TEST (NST) IN ANTENATAL PERIOD ..................................15 CONTRACTION STRESS TEST (CST) IN INTRAPARTUM PERIOD ..............15 FETAL ACOUSTIC STIMULATION TEST (FAST) ........................................16 TROUBLESHOOTINGS .............................................................................17 WARNING MESSAGES.............................................................................18 FHR ALM ................................................................................................................................... 18 PRT ALM F ................................................................................................................................ 18 PRT ALM B................................................................................................................................ 18 PRT ALM 7 ................................................................................................................................ 18 OVER ......................................................................................................................................... 18 MAINTENANCE SCHEDULE ......................................................................19 BATTERY MAINTENANCE .............................................................................................................. 19 STORAGE .................................................................................................................................... 20 PACKING / TRANSPORT .............................................................................................................. 20 TECHNICAL SPECIFICATIONS.................................................................21 WARRANTY ............................................................................................22 APPENDIX 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Introduction
New CoddleGraph, state-of-the-art portable fetal monitor from Maestros is used in Obstetrics procedures for conduction of NST (Non Stress Test) in the ante-natal period and CST (Contraction Stress Test) during intrapartum monitoring. Features: Light and compact design, simple to use front panel controls The color CSTN 5.7 320X240 LCD displays the FHR, UA curves and the monitoring states. The LCD panel tilted angle can be adjusted within 90 degrees. The system setup can be done very easy at any time and can be stored automatically A standard patient event marker and a clinical event marking button to separately mark clinical events Auto fetal movement Multi-crystals, wide beam form, high sensitivity ultrasound transducer, 1MHz pulsed wave, low ultrasound power, safer to the fetal AC or LI-battery operated More than 10 hours data storage, they can be played and reprinted Advanced DSP technology, accurate and reliable Zero noise processing, no undesired sound in the speaker Top lights flash synchronizing with heart beating 3 in 1 transducers, no cable intertwisting
DO NOT use CoddleGraph for: Underwater monitoring during labor or delivery Prolonged periods of time unless clinically indicated-typically antenatal tests can give a trace sufficient for interpretation in 20 to 30 minutes or less
Physical features
1. 2. 3. 4.
Power ON/OFF Display screen Encoder knob Printer compartment To increase the volume of the speaker. When at freeze state, It can be used to review the stored data backward To decrease the volume of the speaker. When at freeze state, It can be used to review the stored data forward. To freeze the trace Set the uterine pressure value to the preset value. This key is often as soon as the monitor is switched ON If a drug is administered or some other event is required to be noted on the trace , the expert/nurse can press this key Press this key at any time to print and press it again to stop printing Audio alarm mute key
NOTE: MARKER mark is printed on the top of the FHR scale. Each time, the button is pressed down to mark timing of fetal movement, contractions or other events felt by the patient. Rotate
NOTE: Encoder knob provides user interaction with the display and the monitor functions. Rotating and depressing the encoder allows user to navigate, make changes to the display elements and monitor functions.
1. Encoder knob is used to interact with the appropriate area on the display screen
2. The procedure is the same for all the operational & display changes a. Rotate the encoder until the Purple box encircles the desired menu b. Depress the encoder to select c. Rotate the encoder knob either clockwise or anticlockwise for selecting the desired sub menu The encoder knob is used to select the required options from the various menus.
Side panels
Display screen
Graphical area The LCD displays the FHR1 and TOCO, date, time, recorder state, recording speed, display state, display speed, volume, alarm state, remote marker, clinical marker and TOCO reference value. The upper one indicates the high threshold is 160 bpm (Beat per Minute) and the lower one indicates low threshold is 120 bpm. The toco range 0 to 100. At this menu, we can set the system parameters according to the key specifications above. Numeric area is illustrated as below: FHR1 The fetal heart rate is displayed in (bpm) beats per minute. In the absence of a signal (or with a signal of poor quality) the display reads --- The speaker volume, there are eight levels marked from 0 to 7. It means the FHR alarm function is enabled Relative strength of uterine activity. 0~100 is displayed Reference value of uterine activity, five levels are available, they are 0,5,10,15,20 This is the fetal movement counting value, the movements within 5 seconds are regarded as 1 time. It means the LCD display traces speed, four choices:X1, X2, X4, X8 the fastest speed display 4 points per second. 5
TOCO (10) FM X4
The system area is at the downright area: 13070701: The Pregnant Woman ID, the system can produce one new ID automatically when the monitor is switched ON and this ID can be changed during monitoring, and has effect on the data after ID change. If alarm happens, this place will display the alarm reasons. If the FHR alarm is enabled and happened, it will display FHR ALM. If no paper or the printer panel open or failures with the printer, it will display PRT ALARM. If monitoring time length is set, when the time is over, it will display TIME OVER. (Refer warning Messages) Date/time: The monitoring date and time for real-time or the stored working date & time in freeze state. (YY/MM/DD format) PRINT SPEED: The selected printer working speed, is also displayed Choices: 1, 2 and 3 (unit: cm/min) POWER SOURCE: It will display the AC (Plug icon) or DC (battery) icon according to the working power source.
Principle of operation
CoddleGraph-D uses the proven technique of autocorrelation for calculating fetal heart rate. This method gives an accurate display of heart rate by eliminating any spurious signals. This is done by the use of Doppler principle of Ultrasound which states that Frequency of sound waves shifts as the source moves relative to the receiver High frequency ultrasound waves (2MHz) are transmitted by placing the Doppler/ Ultrasound transducer over the abdomen of the patient. A coupling medium like jelly is used between the transducer and the abdomen to exclude any air from the interface so as to have minimal attenuation of the ultrasound signal. The reflected ultrasound waves are sensed by receiving crystals. When the fetal heart wall moves, the frequency of the reflected ultrasound changes and this change is known as Doppler shift. With every heart cycle, the heart wall moves twice and hence twice there is a Doppler shift. This signal is electronically processed to find the fetal heart rate, which is displayed. The Doppler shift signal is in the audio range and hence can also be heard.
Transmitter
Fetus
Receiver
Analog Circuit
Speaker
For long term (Labour) monitoring, the uterine activity is monitored and recorded in terms of relative indication of the labour intensity by means of an external transducer known as Toco/UA-Transducer. The toco transducer is a spring-loaded displacement transducer, which is placed over the fundus where the contractions are maximum. During uterine contractions, the pressure signal is converted into an electrical signal to get the uterine activity, which is then plotted, on the recorder along with the heart rate.
Installation
Initially, check the earthing in the mains switch, which may result in a noisy tracings Connect the 3 in 1 transducer Plug in the adaptor Switch ON the power supply Make the desired parameter settings
This completes the installation procedure and CoddleGraph is now ready to be used.
To operate on mains
Connect the adaptor to the mains power supply on the wall Switch ON the power ON/OFF switch The system is now ready to operate on mains This is indicated on the screen with a symbol
NOTE: In condition of power failure the system automatically switches to The battery mode & will switch back to mains when power supply resumes.
Parameter settings
Fetal and mother menu
1. ALM HI_LIMIT: The FHR alarm upper limit, there are 4 levels: 160,170,180,190(unit bpm) 2. ALM LO_LIMIT: The FHR alarm lower limit, there are 4 levels: 90,100,110,120(unit bpm) 3. ALM MUTE: The time in minutes for audio alarm mute can be set from here by the user as desired. The counter starts decreasing displayed on the screen once the time elapses the audio alarm starts sounding (if ON). 4. ALM ENABLE: ON or OFF means enable or disable the alarm function. 5. TOCO REFERENCE: The toco reference value, it can be set with 0,5,10,15,20 6. PREGNANT ID: Patient ID can be changed from here 7. GESTATION AGE: User can input the pregnant woman gestation age.
MONITORING TIME LEN: This is used to set monitoring time length, when the time is over, the audio alarm sounds and stops monitoring the patient
DISPLAY SPEED: 4 levels can be adjustable i.e. X1 X2, X4 and X8. The selected speed is displayed the screen DISPLAY MODE: 2 modes available, monitoring mode or demo mode. CONTRAST: The LCD contrast for good display effect selected by the user as desired POWER OFF: This is used to set the monitor working time, when the time is over, the system will be switched OFF automatically.
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PRT DENSITY: This is used increased or decreased to a suitable printing effect. TOCO 0 PRT POSITION: This is used for toco 0 printing position on the paper. TOCO 100 PRT POSITION: This is used for toco 100 printing position on the paper. FHR 90 PRT POSITION: This is used for FHR 90 printing position on the paper. FHR 210 PRT POSITION: This is used for FHR 2109 printing position on the paper.
WARNING: Each time CoddleGraph is used, check the alarm settings limits and parameter settings to ensure that they are appropriate for the patient being monitored.
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Printer compartment
New CoddleGraph has inbuilt printer that requires Z fold thermal paper. Refer Parameter settings for printer settings. To open the printer compartment first unlock the printer lock by pushing it towards the display screen the printer flap opens. Pull the printer flap out the printer can be seen that is fitted on top as shown in the figure below.
Loading paper
a. On opening the printer compartment place the Z fold paper in the space provided b. Roll out a part of the paper on the printer flap and close the printer flap c. Then lock the printer lock
This completes the procedure of loading paper in the printer.
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Alarm indications
The new CoddleGraph has audio alarm indication and draws the users attention to patient or instrument condition that warrant immediate attention.
Visual indications
Whenever the high or low alarm limits for fetal heart rate are above or below the set values the visual alarm is needed on the top lights on the LCD.
Audio indications
Whenever the high or low alarm limits for fetal heart rate UA are above or below the set values the audio alarm sounds (if ON) Bell icon appears on the screen as well as in the print out (If printing is ON).
Maestros Medline Systems Limited
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The volume intensity of the audio alarm can be increased or decreased by the user using the UP/DOWN arrow keys respectively. WARNING: Do not silence the audible alarm or decrease its volume, patient
safety could be compromised.
NOTE: Muting the audio alarms does not affect the visual alarm indications.
IMPORTANT: Place the entire probe face in contact with the skin surface to get good results.
NOTE: The Toco or the UA transducer is not used while conducting a NST.
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Same procedure is followed as above fro NST with addition steps mentioned below Toco transducer is placed on the fundus( i.e. part of the womb where maximum contraction is felt) Printouts of the CTG and the UA waveform can be obtained
IMPORTANT: Before starting, execute the UA Ref function in order to nullify the pressure due to the belt.
NOTE: The use of water based gel supplied by certificated suppliers is strongly recommended. Oil based gels can damage the transducer and must not be used. The use of oil based gels will invalidate your warranty.
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Troubleshootings
Problem No response / system does not turn ON No response on connecting to the mains No fetal heart sounds No audio alarms Likely cause No power supply Mains switch OFF ON/OFF switch OFF Power cable faulty Corrective action Check for the power supply Switch ON the mains supply Switch ON the ON/OFF switch Replace the cable
FHR volume control decreased completely Volume control is completely decreased in the parameter settings
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Warning messages
An warning message will be displayed in place of PATIENT ID when a malfunction is detected that prevents further use of the monitor until the malfunction is corrected
FHR ALM
This message appears when the FHR1 is high or low to the set values. This message disappears once the readings come back to normal.
PRT ALM F
This message appears when the printer flap is open or not closed properly and disappears on closing the printer flap properly.
PRT ALM B
This message appears when the paper in the printer is exhausted and disappears when paper is loaded in the printer compartment (Refer Loading paper section).
PRT ALM 7
This message appears when the printer lock is not locked properly and locking the printer lock this message disappears.
OVER
When ever the set monitoring length is over this message appears in the screen follow the instructions on the screen.
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Maintenance schedule
New CoddleGraph is extremely user friendly and with no routine service other than cleaning, battery maintenance and recharging, and that, which is mandated by the users institution. For better performance, operation and safety, regular routine maintenance is to be performed by the end user. Look for the standard power supply as specified in the technical specifications before getting started Check for the proper connection of cables / transducers Check for the proper functioning of the 3 in 1 transducer Ensure for the fully charged battery while using on battery Clean the panel /cables/ transducers with dry damp smooth cloth Do not expose the device to either humidity, dust or direct sunlight extreme temperatures,
Make sure to service the system once in a year by an authorized and fully trained engineer for proper functioning and trouble free operation of the system
Battery maintenance
If the New CoddleGraph has not been used for a one month, the battery needs charging. To charge the battery refers inbuilt battery charging section. CAUTION: If the CoddleGraph is to be stored for a period of 2 months or longer, notify service personnel to remove the battery prior to storage
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Cleaning
Do not immerse the system into caustic or abrasive cleaners Unplug the 3 in 1 transducer from the system before cleaning or disinfecting Clean or disinfect the 3 in 1 transducer before attaching to a new patient Clean the monitor and the cables with dry damp smooth cloth Do not use rough and sharp instrument to clean the cable and the sensors
NOTE: Make sure that the system is completely OFF while cleaning any part. CAUTION: Phenolic or antiseptic solutions such as Steriscol or Hibiscrub should never be used on any part of the system as these chemicals are known to spoil the quality of the product.
Storage
While storing New CoddleGraph, make sure that the system is switched OFF completely and preferably disconnect all the cables. Storing the system for long period of time without charging the battery may degrade the battery capacity. Store in the system in as per the specifications provided.
Packing / Transport
If available, use the original carton and packing materials (if not available use suitable carton) Disconnect all the cables Make sure that the system is completely turned OFF Fill the bottom of the carton with at least two inches of packing material After packing the system fill the box with packing material Make sure to mark the UP positioning of the system that if original carton is not used Make sure to seal the carton with packing tape Ensure to write the return address
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Technical specifications
Ultrasound Transducer Frequency Measurement range Resolution Intensity High alarm range Low alarm range Scaling FHR chart width Toco Measurement range Chart width Resolution Recorder Type Chart speed Record paper Electrical Power supply Power consumption Inbuilt battery Battery operating time Speaker Memory Display Screen Physical characteristics Weight Dimensions Operating condition Temperature Pressure Humidity Storage & Transport condition Temperature Pressure Humidity Optional Facility Pulsed Doppler 1 MHz 50 to 210 bpm 1 bpm < 10m W/sq cm 160,170,180 bpm 90,100,110,120 bpm 20 bpm 7cm 0 to 100 units 4 cm 1 mmHg High resolution thermal printer 1/2/3 cm/min Z fold ,Thermal 100-240 V AC 50Hz 10% < 40 W Rechargeable 8.4 V Li-ion 2 hours (No printer working) 1W 10 hours Color LCD with tilt adjustment < 2 kgs 73 H X 295 W X 240 D (mm) 400C 50 to 160 Kpa Upto 90% non condensing 600C 50 to 160 Kpa Upto 90% non condensing Fetal Acoustic Stimulator
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Warranty
This warranty is not applicable to any defect, due to an accident, misuse, mishandling, neglect, improper installation, improper repair or improper modification by personnel other than recommended qualified Mediline personnel. This warranty also does not apply if the system has not been operated and maintained in accordance with the operating and maintenance manuals, instructions or bulletins issued in respect thereof by Mediline. This warranty is strictly limited to replacement or repair of the part, which is found to be defective in material or workmanship. Mediline reserves the right to make changes in the design and material of system without incurring any obligations to incorporate such changes in system already completed on the effective date of any such change or changes. This is the only warranty of this product and is expressly in lieu of all other warranties, express or implied by law or otherwise, including any implied warranties of merchantability and of fitness for a particular purpose. Without regard to the alleged defect, Mediline does not, under any circumstances, assume any responsibility of the loss of time, inconvenience or other consequential damages, including but not limited to, loss or damage to personal property, or loss of revenue. Mediline has neither assume nor authorized any other person (including any distributor authorized to sell its system) to assume for it any other liability in connection with the sale of system. All rights reserved. Reproductions of any part of this manual in any form whatsoever without the written permission from Mediline is forbidden. The contents of this manual are subject to change without notice. All efforts have been made to ensure the accuracy of the content of this manual. However if any error found, Mediline would appreciate being informed. For any further details or for returning the damaged items contact:
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Appendix
Accelerations: A visually apparent, abrupt increase (defined as onset of acceleration to peak in <30 seconds) in FHR above the baseline. The peak is 15 bpm above the baseline, and the acceleration lasts =15 seconds. Antenatal period: Period before labour. Baseline FHR: Approximate mean FHR rounded to increments of 5 bpm during a 10-minute segment. Bradycardia FHR < 110 bpm and Tachycardia FHR >160 bpm. Decelerations: A visually-apparent, gradual decrease (defined as onset of deceleration to lowest point = 30 seconds) and return to baseline FHR associated with a uterine contraction. Expected Due Date: The due date or estimated date of delivery (EDD) is the date when a baby's birth is expected. It is set by a doctor or midwife and is usually based on the first day of a woman's last menstrual period. An ultrasound "dating scan" may be used to give a more accurate estimate of the due date based on measurements of the baby's size. Fetal distress: Compromise of the fetus during the antepartum period (before labor) or intrapartum period (birth process). The term "fetal distress" is commonly used to describe fetal hypoxia (low oxygen levels in the fetus). The concern with fetal hypoxia is it may result in fetal damage or death if not reversed or if the fetus is not promptly delivered. Fetal Heart Rate (FHR): The normal heart rate for a full term infant is 110-160 beats per minute. Fetal movement: Motion of a fetus within the uterus (usually detected by the 16th week of pregnancy). Gestation period: The period during which an embryo develops (about 266 days in humans). Intrapartum period: Period during labour. Short Term Variability: The fetal heart rate per minute changes calculated from one beat of the heart to the next. Transducer: Any device or component that converts an input signal of one form to an output signal of another form-for instance, a piezoelectric transducer converts pressure waves into electrical signals, or vice versa. Uterine contraction: A rhythmic tightening in labor of the upper uterine musculature that contracts the size of the uterus and pushes the fetus toward the birth canal. *******
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