IC60 Users Manual Ver 1.0 Oct 2011

The CE mark is a protected conformity mark of European Community. The products herewith comply with the requirements of the Medical Device Directive 93/42/EEC

Shanghai International Holding Corp. GmbH(Europe) Eiffestraße 80 20537 Hamburg GERMANY

Shenzhen Biocare Bio-Medical Equipment Co.,Ltd. 2/F West,4th Block,Dayang Road South,Fuyong sub-district,Bao'an District,518103 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Tel: 86-755-27960888 Fax: 86-755-27960643 Website: http://www.biocare.com.cn

Content

Content CHAPTER 1 BRIEF INTRODUCTION ... 1 1.1

Product Introduction ... 1

1.2

Safety Guide ... 3

1.3

Recommended clinical application... 5

CHAPTER 2

PRODUCT DESCRIPTION ... 6

2.1

Main interface introduction... 6

2.2

Standard compages ... 6

2.3

Display ... 7

2.4

Encoder description ... 8

2.5

Interface parameter description ... 8

2.6

System parameter interface ... 9

2.7

Printing control interface ... 9

2.8

Key description ... 10

2.9 Right and left panel description ... 11 CHAPTER 3 SET UP THE iC 60 ... 12 3.1

Unpacking the units ... 12

3.2

Connect power... 12

3.3

Load the paper ... 12

3.4

Set up the menu ... 13

CHAPTER 4 OPERATING INSTRUCTION ... 16 4.1

Preparation for use ... 16

4.2

FHR Monitoring ... 16

4.3

TOCO monitoring... 16

4.4

Pregnant woman Spo2 and HR monitoring ... 16

4.5

NIBP monitoring ... 17

4.6

Printing... 18

4.7

After use... 18

CHAPTER 5 CARE OF iC 60 ... 19 5.1

Handling ... 19

5.2

Except the cleaning, this fetal monitor needn’t any other maintenances ... 19

5.3

Disinfection ... 19

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Content

5.4

Clean the printer... 19

CHAPTER 6 TROUBLESHOOTING ... 20 CHAPTER 7 WARRANTY AND MAINTENANCE ... 21 CHAPTER 8 TECHNICAL DATE ... 22 ANNEX EMC-GUIDANCE AND MANUFACTURE’S DECLARATION………….……………………………… … 24

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iC 60 fetal/maternal monitor user’s manual

Chapter 1

Chapter 1 1.1

Brief introduction

Brief introduction

Product Introduction Thank you for your purchasing iC 60. iC 60 is an innovative full specification and designed to make

routine fetal monitoring simple and effective at low cost. It has been designed for maximum convenience and ease of use for both the clinician and the patient, it is ideal for use in any environment ranging for community to the labor ward This fetal/ maternal monitor equipped with ultrasound and toco transducers , Spo2 sensor, a cuff and Pregnant woman event market. The capability comply with newest standard of world . ● A big TFT color LCD displays the FHR, TOCO curve and maternal parameters and the monitoring states, meanwhile it has data storage and playback functions. ● The internal line thermal recorder can records FHR, TOCO , the life exceeds over 20 years. ● Advanced DSP technology, accurate and reliable. ● Multi-crystals, wide beam form, high sensitivity ultrasound transducer, 1MHz pulsed wave, low ultrasound power, safer to the fetal. ● A standard patient event marker and a clinical event marking button to separately mark clinical events. ● 3 in 1 transducers, no cable intertwisting. ● Maternal SpO2 and heart rate functions are an option. ● NIBP function is an option. ● Operate with an encoder for easy and convenient use. Many alarm functions are included: the monitoring time over alarm, no paper alarm. Working Principle We know a defined frequency ultrasound will reflect when transmission through different tissues in human body, if the tissue is in quiet, then the frequency of reflecting signal is the same as the frequency of transmission signal, once the tissue is moving, the reflecting frequency will changed a little, this is the so called Doppler Effect. When we put the probe on the pregnant woman’s belly, the reflecting frequency will changed with the moving of fetal heart. When we get the variance of the frequency, we can get the fetal hear rate(bpm: beats per minute). The artery oxygen saturation of SpO2 parameter measure function is the percentage of oxyhemoglobin in total of oxyhemoglobin and deoxyhemoglobin. When passing two wavelengths of light, one red (660nm) and the other infrared (890nm), through body tissue to a photo detector. Pulse identification is accomplished by using plethysmographic techniques, and oxygen saturation measurements are determined using spectrophotometric oximetry principles. During measurement, the signal strength resulting from each light source depends on the color and thickness of the body tissue, the sensor placement, the intensity of the light sources, and the absorption of the arterial and venous blood (including the time varying effects of the pulse) in the body tissues. iC 60

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Chapter 1

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The monitor processes these signals, separating the time invariant parameters (tissue thickness, skin color, light intensity, and venous blood) from the time variant parameters (arterial volume and SpO2) to identify the pulse and calculate oxygen saturation. Oxygen saturation calculations can be performed because blood saturated with oxygen predictably absorbs less red light than oxygen depleted blood. NIBP MONITORING: The patient monitor uses oscillometric principles to calculate the systolic, diastolic, and mean arterial pressure (MAP) values. The MAP is calculated as the lowest cuff pressure that provides the maximum cuff oscillations. Therefore, MAP is the largest signal received and is the most accurate reading using oscillometric methods. Systolic pressure is calculated as the cuff pressure at which an increase in cuff oscillations is perceived. The diastolic pressure is the cuff pressure when oscillations are no longer decreasing as pressure is released from the cuff. The patient monitor first inflates the cuff to a pressure of around 20mmHg higher than the systolic pressure, then, slowly deflates the cuff. When the cuff pressure is higher than systolic pressure, the artery is blocked and there are small amplitude oscillometric waveforms. When the cuff pressure is equal to the systolic pressure, the oscillometric amplitude increases. With the decrease of the cuff pressure, the oscillometric amplitude increases. When the cuff pressure reaches a certain value, the oscillometric amplitude reaches a maximum value, then, the cuff pressure is mean arterial pressure. It is based on the changes of the oscillometric amplitude under different cuff pressure to identify mean pressure and calculate the systolic and diastolic pressure. this antepartum monitor is suitable for use in all conventional external fetal monitoring and maternal monitoring applications. DO NOT use this antepartum monitor 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.

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Chapter 1

1.2

Brief introduction

Safety Guide iC 60 Fetal/Maternal Monitor is ClassII device in conformity with IEC60601/EN60601 requirements with

protective earth (through three pin power plug). Type BF Applied Part: F-type applied part (floating/insulated) complying with the specified requirements of IEC 60601-1 Medical Standards to provide a higher degree of protection against electric shock than that provided by Type B applied parts. Type B Applied Part： B-type applied part complying with the specified requirements of IEC 60601-1 Medical Standards. Important notices: To avoid getting the potential harm, please operate this instrument complying with follows: Warning: ALARMS- Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to low level or off during patient monitoring may result in a hazard to the patient. Remember that the most reliable method of patient monitoring is the monitor be used and closely monitored.Alarm function must be validated timely. When several devices are used on the same patient, leakage current may increase and lead to danger to the patient. Before using, please consult professional people to do leakage current test and make sure the leakage current is within safety limits. Before use the monitor, please make sure the monitor is in normal working conditions and operation environment. When using High Frequency surgical equipment, you should put the patient cables and transducers far from the surgical operation in order to reduce the hazards of burns in the event of a defect in the High Frequency surgical equipment neutral electrode connection.Check the repeatedly used accessories at regular intervals. Replace the damaged parts if necessary and dispose them as medical waste according to local governing ordinances and recycling instructions. Warning： ：It should not switch off the volume during the monitoring, no fetal heart beating sound can be heard when the fetal heart is out of the ultrasound field for the movement or dead fetus reasons, so be care the FHR displayed on the LCD may be meaningless when it happens. Warning: Do not use iC 60 in the presence of flammable gases such as anesthetic agents. Warning: Don’t throw the battery into fire, or it may cause an explosion Warning: Don’t touch the signal input or signal output connectors and patient at the same time Caution: iC 60 must be maintained by qualified engineers. Caution: This instrument is designed to work continuously, and water drop proof type, and be care to avoid to be splashed. Caution: Keep iC 60 clean and avoid vibrating. Caution: This instrument is in conformity with IEC60601-1-2 EMC standards. But when the electromagnetic power is very high, it will still cause interference. Please do not use mobile phone, portable communication devices, etc nearby it. Caution: Before use the instrument, please check if there is any damage of equipment that may affect the patient’s safe or the instrument performance. The recommended check period is one month or iC 60

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Chapter 1

Brief introduction

shorter. If an obvious damage is found, it should be solved before use. Caution: the following safety check is done by the authorized person, normally one time per two years or according to test regulation by the public organization.

Check whether there are damages in the mechanical and functions.

Check whether the relative safety label is easy to identify.

Check whether the function is the same as described in the user manual .

Caution: After the effective life of this instrument, Please send it back to the manufacturer according to local rules for recycling. Caution: The battery should be get properly treatment according to local rules after the capability of battery run out. Caution: If this instrument is to be stored for a long period of time ,the battery should be removed. Caution: The battery should be stored in a cool and dry environment. Caution: When the battery is stored, please don’t mix it with metal objects to avoid short-circuit accident. Caution: We recommend that exposure to ultrasound should be kept As Low As Reasonably Achievable---ALAEA. This is considered to be good practice and should be observed at all times. Caution: Don’t use this instrument immediately when it is transferred from a cold environment to a warm and moisture place. Caution: To ensure electric installation safety, the environment shall be reasonably dust free, without corrosive or combustible gas, or extreme temperature or humidity. Caution: Please stop operating if this instrument is splashed or has water drops. Caution: Although iC 60 is robust and designed to withstand the rigours of clinical use, the unit does contain delicate components and should be treated with care. This applies especially to the transducers which should not be dropped or knocked. Caution: 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. Caution: Excess gel should always be wiped off after use. The transducer faceplate, transducer body and main unit can be cleaned with a damp cloth impregnated with a mild disinfectant or detergent. Caution: To assist with disinfection a soft cloth dampened with sodium hypochlorite 1000ppm may be used and the units wiped dry. Please be sure to check your local control of infection policies or any equipment cleaning procedures. Caution: The main unit, transducers and other accessories can’t be disinfected by steam. Caution: TOCO transducer is non-waterproof type, don’t use Gel and avoid any liquids into it. Caution: The power wire should be inserted into the socket with three wires,the ground wire mustn’t be removed. Don’t use the socket with bad connection. Caution: After use, Do not wire the transducer cable together with the transducers , in case it is broken. Caution: It should not switch off the volume during the monitoring, no fetal heart beating sound can be heard when the fetal heart is out of the ultrasound field

for the movement reason, so be care the FHR

displayed on the LCD may be meaningless when it happens. Caution: The accuracy of FHR is decided by machine itself and can not be adjusted. If you are suspicious of --4--

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Brief introduction

accuracy of result, you can verify it through other devices like a stethoscope, also you can contact local distributors or manufacturers for help . Caution: Please turn on the loudspeaker while searching for FHR,then you can make the examination after hearing the FHR clearly.

：Refer the files attached。

1.3

Recommended clinical application

Use this antepartum monitor for: ● antenatal monitoring in any environment ranging from community to the labor ward ● hospital admission tests

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Chapter 2 Product description

Chapter 2 2.1

Product description

Main interface introduction. 12

1 2 3 4 5 6 7 8 9 10

13

14 15

11

1. freeze key

2. alarm off/on ,blood pressure off/on

3. marks key

4. twins monitoring key

5. volume up key

6. volume down key

7. printing key

8. preset TOCO value key

9. transducer socket

10. encoder key

11. loading paper place

12. indication lamp

13. LCD display

14. printer open/close

15. power off/on

2.2

Standard compages ● Main unit. ● Adapter and power wire. ● 3 in 1 transducer (U/S, TOCO and Remote Even market),maternal Spo2 sensor, blood pressure cuff. Main unit the main unit has the LCD module, recorder and electronic circuitry-microprocessor, signal processing, audio system, display systems and power supply. Signals from the transducers are processed and displayed on the large LCD display. And the menu can be adjust by encoder . the key on control panel can be set up the system parameter ,freeze display , adjust volume, printer control , alarm control and so on. Transducer 3-in-1 transducer (include U/S, TOCO and Remote Event marker). The transducer are held in Place on the abdomen by elastic straps. The pregnant woman hold the marker, push the button when she feels fetal moving or uterine activity. notice

the markers

are printed on the top paper of the FHR scale. The clinical event markers (the

operator using) also keep on the top of paper, the figure is

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Chapter 2 Product description

2.3

Display

The Figure of main screen The LCD displays the FHR,TOCO curves, date, time, recorder state,

recorder speed,

display state, display speed, volume, alarm state, remote marker, clinical marker and TOCO reference value. X4:it means the LCD display traces speed, four choices: X1,X2,X4,X8, the fastest speed display 4 points per second. The system indicating area is at the downright area: 07021001:

The Pregnant Woman ID, the system can produce one new ID automatically when power 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 ALARM. 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.

Date/time:

The real working date and time for real-time monitoring or the stored working date for the freeze state.

PRINT SPEED: the current printer working speed, there are 3 choices:1 , 2 , 3 (unit:cm/min) POWER:

It will display the AC or DC(battery )icon according to the working power source.

SOURCE The two dashed lines at the FHR area mean the normal range of FHR, the upper one indicates the high threshould is 160 bpm ( Beat Per Minute ) and the lower one indicates low threshould is 120 bpm. The two dashed lines at the TOCO area mean the TOCO range 0 to 100 The bell icon

means there was an alarm happened at that time.

The triangle icon

means there was a clinical event happened at that time.

The arrow icon

means there was a patient event happened at that time.

The TOCO reset icon The FAS icon

means there was a reset operation at that time.

means the FAS was working at that time.

The time at the end line means the real-time monitoring time or the stored working time for the freeze state. At this menu, we can set the system parameters according to the key specifications above. iC 60

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Chapter 2 Product description

The right value display 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 (20) It indicates the twin offset value.

TOCO

Relative strength of uterine activity. 0~100 is displayed

(10)

Reference value of uterine activity, five levels are available, they are 0,5,10,15,20

FM

This is the fetal movement counting value, the movements within 5 seconds are regarded as 1 time.

2.4

Encoder description ENCODER is used for setting the system parameters. At normal scanning mode, rotate it, there will be a

purple rectanguler at the edge of values area or system items area alternatively, pressing it will enter the correspond configuration menu, rotate it again to select the item you want to adjust. The purpose item is the selected or the result you changed.

2.5

Interface parameter description

The figure of Fetal and mother menu ALM HI_LIMIT: the FHR alarm upper limit, there are 4 levels: 160,170,180,190(unit bpm) ALM LO_LIMIT: the FHR alarm lower limit, there are 4 levels: 90,100,110,120(unit bpm) ALM DELAY: 15 seconds or 30 seconds are available, if the successive FHR time above the ALM HI_LIMIT or below the ALM LO_LIMIT exceeds this length and alarm function is enabled, then FHR alarm happens. ALM ENABLE: on or off means enable or disable the alarm function. TOCO REFERENCE: the toco reference value, it can be set with 0,5,10,15,20 PREGNANT ID: the identifier for the pregnant woman. GESTATION AGE: input the pregnant woman gestation age .

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Chapter 2 Product description

2.6

System parameter interface

The figure of System setup menu DATE/TIME: the real date and time. PRINTER CONTROL: change the printer configuration. MONITORING TIME LEN: it can set the monitoring time length, when the time is over, it can alarm to reminder the user. DISPLAY SPEED: 4 levels adjustable, they are X1,X2,X4,X8. DISPLAY MODE: 2 modes available, monitoring mode or demo mode. CONTRAST: it can adjust the LCD contrast to a good display effect. POWER OFF: it can set the monitor working time, when the time is over, the system will power off automatically.

2.7

Printing control interface 

The figure of Printing control menu This system design is suitable for many kinds of 110mm wide printing paper with different specifications. PRT SPEED:

it can be set with 1,2,3 cm/min

PRT DENSITY:

it can be increased or decreased to a suitable printing effect.

TOCO 0 PRT POSITION: it can adjust the 0 printing position on the paper. TOCO 100 PRT POSITION: it can adjust the 100 printing position on the paper. FHR 90 PRT POSITION: it can adjust the 90 bpm printing position on the paper. iC 60

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Chapter 2 Product description

FHR 210 PRT POSITION: it can adjust the 210 bpm printing position on the paper. setting operation : When the curve scaled (figure 1). Rotate the encoder, there will have a thick wireframe in the values display area or system items area, press the encoder, enter to fetal and pregnant parameter interface, Rotate the encoder again to select the item you want ot adjust .the purple item is the selected or the result you changed. Press the encoder again, enter the adjustment state, encoder the encoder again ,you can adjust it .After setting ,press the encoder to confirmed it ,then rotate the encoder to choose returning ,it will return the normal display. returning operation: Under the selection status, select the RETURN, press the encoder , it will return the normal display. The system also can count the FHR and TOCO value when you are set up the manual. And the print also can work at the same time.

2.8

Key description Pressing this key, the system enters the freeze state, the center of LCD will display FREEZE , press it again , the freeze state will be canceled . Under the freeze state ,if you want to inter the system manual ,you must be cancel freeze firstly

▲and ▼

When at freeze state, it can be used to review the past date backward and forward. When at display state, it can be adjust the volume at the main screen

Press this key at any time if the recording is needed and press it again to stop the recording. The LCD right corner will display PRINTING.

When the alarm function is enabled ( there is a yellow alarm bell beside the fetal heart rate value), when there is an FHR alarm, an alarm bell icon will be displayed at the curve area, meanwhile an alarm sound can be heard, this alarm can be cancelled by pressing any key. When an alarm is happening, the alarm reason can be displayed at the right bottom area of the LCD, totally there are three alarm reasons: FHR alarm, monitoring time over and printer alarm. If a drug is administered or some other event is required to be noted on the trace , the nurse can press this key and the recorder marks

on the paper.

Set the uterine pressure value to the preset value, this key is often used when begin to monitor

measure the mother NIBP

When at the occasion of twin monitoring, Press this button to for select which heart beat sound will be monitored.

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iC 60 fetal/maternal monitor user’s manual

Chapter 2 Product description

Key function specifications: real time display status

freeze state forward review or backward

adjusting the volume

review quickly Cancel the freeze state

freeze state Recorder marks for operator Uterine value preset Printer key

Store and print the current pregnant’ data

Measure/ stop measure the pregnant woman’s blood pressure

2.9 Right and left panel description

DC15V3.3A +

the left side panel DC15V3.3A Adapter input socket, the inner pole is positive.

TEMP

SpO2

NIBP

WAKER

FHR2

FHR1

the right side panel FHR1：

The socket of 3 in 1 transducer

FHR2：

The second ultrasound transducer socket when doing twin monitoring(option)

SpO2：

Maternal Spo2 socket(option)

NIBP：

Maternal NIBP socket (option)

TEMP： Maternal temperature socket (option) WAKER： Fetal waker socket(option) iC 60

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Chapter 3 Set up the iC 60

Chapter 3

Set up the iC 60

This section shows you how to: ● unpack ● connect power ● Load paper ● set up the unit for use

3.1

Unpacking the units 3.1.1 Carefully remove the main unit and accessories from the carton. 3.1.2 Check that the content of the carton corresponds with the list below and that all items are undamaged . ♦ 1 main unit of fetal monitor

3.2

♦

3 in 1 transducer(ultrasound transducer ,contraction transducer, remote event marker)

♦

2 transducer belts

♦

1 mains power cord and adaptor

♦

2 paper pads

♦

Warranty card

♦

1 250ml bottle of gel

♦

Use’s manual

♦

One Spo2 sensor

♦

One blood pressure cuff

Connect power This fetal monitor use a.c.100-240V,50/60Hz or Li-ION battery inside. 3.2.1 If using AC ,connect the adaptor output to the DC socket on the left panel . 3.2.2 Connect the other end of adaptor to a main power source. 3.2.3 Switch the unit on by pressing the POWER switch at the front panel of the unit.

3.3

Load the paper When you take delivery of this fetal monitor, you need to insert paper as following: 3.3.1 Open the front panel of the printer, open the uppermost page of one pack of paper from inside to

outside, make FHR grids on the left side, TOCO grids on the right side. 3.3.2 Pull out the paper, make sure the both sides are paralleled with the printer Panel side. 3.3.3 Close the front panel of the recorder

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iC 60 fetal/maternal monitor user’s manual

Chapter 3

3.4

Set up the iC 60

Set up the menu 3.4.1 Set up the date/time 3.4.1.1 Rotate the encoder, move the purple frame to system items area. Press the encoder to enter the SYSTEM SET UP MANU 3.4.1.2 Rotate the encoder, choose the DATE or TIME, press the encoder again , then enter the adjustment state, rotate the encoder to adjust the value. 3.4.1.3 A After set up, press the encoder to confirmed it, then rotate the encoder to choose RETURN, it will return the normal display. 3.4.2 Set up the monitoring time length 3.4.2.1 Rotate the encoder, move the purple frame to system items area. Press the encoder to enter the SYSTEM SET UP MANU 3.4.2.2 Rotate the encoder ,choose the MONITORING TIME LEN, press the encoder again ,then enter the adjustment state, rotate the encoder to set up the monitoring time .0 means no this function 3.4.2.3 A After set up, press the encoder to confirmed it ,then rotate the encoder to choose RETURN ,it will return the normal display. 3.4.3 Set up the display speed 3.4.3.1Rotate the encoder, move the purple frame to system items area. Press the encoder to enter the SYSTEM SET UP MANU 3.4.3.2 Rotate the encoder, choose the DISPLAY SPEED, press the encoder again, enter the adjustment state. Rotate the encoder, there will have X1,X2,X4,X8 for choice After set up, press the encoder to confirmed it ,then rotate the encoder to choose RETURN ,it will return the normal display. 3.4.4 Set up the display mode 3.4.4.1 Rotate the encoder, move the purple frame to system items area. Press the encoder to enter the SYSTEM SET UP MANU 3.4.4.2 Rotate the encoder, choose the DISPLAY MODE, press the encoder again, enter the adjustment state. Rotate the encoder to choose monitoring mode or demo mode. 3.4.4.3 After set up, press the encoder to confirmed it ,then rotate the encoder to choose RETURN ,it will return the normal display 3.4.5 set up the working time 3.4.5.1 Rotate the encoder, move the purple frame to system items area. Press the encoder to enter the SYSTEM SET UP MANU 3.4.5.2 Rotate the encoder, choose the POWER OFF, press the encoder again, enter the adjustment state. Rotate the encoder to set up the working time. 3.4.5.3 After set up, press the encoder to confirmed it, then rotate the encoder to choose RETURN ,it will return the normal display

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Chapter 3 Set up the iC 60

3.4.6 Set up the printing speed 3.4.6.1 Rotate the encoder, move the purple frame to system items area. Press the encoder to enter the SYSTEM SET UP MANU, choose the PRINTER CONTROL. Press the encoder will enter the figure of PRINTER CONTROL 3.4.6.2 Rotate the encoder, choose the PRT SPEED, press the encoder again, enter the adjustment state. 3.4.6.3 After set up, press the encoder to confirmed it ,then rotate the encoder to choose RETURN ,it will return the normal display 3.4.7 Set up the printing density 3.4.7.1 Rotate the encoder, move the purple frame to system items area. Press the encoder to enter the SYSTEM SET UP MANU, choose the PRINTER CONTROL. Press the encoder will enter the figure of PRINTER CONTROL 3.4.7.2 Rotate the encoder, choose the PRT DENSITY, press the encoder again, enter the adjustment state, it can be increased or decreased to a suitable printing effect. 3.4.7.3 After set up, press the encoder to confirmed it, then rotate the encoder to choose RETURN ,it will return the normal display 3.4.8 set up the Printing Position 3.4.8.1 Rotate the encoder, move the purple frame to system items area. Press the encoder to enter the SYSTEM SET UP MANU, choose the PRINTER CONTROL. Press the encoder will enter the figure of PRINTER CONTROL 3.4.8.2 Rotate the encoder, choose the printer adjustment items, there will have for items for you choose, TOCO 0 PRT POSITION, TOCO 100 PRT POSITION, FHR 90 PRT POSITION, FHR 120 PRT POSITION. press the encoder again ,enter the adjustment .the printer will be working at the same time when you adjust it. 3.4.8.3 After set up, press the encoder to confirmed it , then rotate the encoder to choose RETURN ,it will return the normal display 3.4.9 Set up the Alarm HI_LIMIT and LO_LIMIT 3.4.9.1 Rotate the encoder, move the purple frame to values area. Press the encoder to enter the figure of fetal and mother menu 3.4.9.2 Rotate the encode , choose the ALM HI_LIMIT or ALM LO_LIMIT . press the encoder again, enter the adjustment state, rotate the encoder to adjust it . 3.4.9.3 After set up ,press the encoder to confirmed it ,then rotate the encoder to choose RETURN ,it will return the normal display 3.4.10 set up the FHR alarm enable 3.4.10.1 Rotate the encoder, move the purple frame to values area. Press the encoder to enter the figure of fetal and mother menu 3.4.10.2 Rotate the encoder, choose the ALM ENABLE press the encoder again, enter the adjustment state, ON or OFF for you choose. 3.4.10.3 After set up, press the encoder to confirmed it ,then rotate the encoder to choose RETURN ,it --14--

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Chapter 3

Set up the iC 60

will return the normal display

3.4.11 set up the Alarm Delay 3.4.11.1 Rotate the encoder, move the purple frame to values area. Press the encoder to enter the figure of fetal and mother menu 3.4.11.2 Rotate the encoder, choose the ALM DELAY press the encoder again, enter the adjustment state, then , Rotate the encoder to adjust it . 3.4.11.3 After set up, press the encoder to confirmed it , then rotate the encoder to choose RETURN ,it will return the normal display 3.4.12 set up the TOCO reference 3.4.12.1 Rotate the encoder , move the purple frame to values area. Press the encoder, it will enter the figure of fetal and mother menu 3.4.12.2 Rotate the encoder, choose the TOCO REFERENCE press the encoder again, enter the adjustment state, then ,Rotate the encoder will change it .Normally ,set it with 10 . 3.4.12.3 After set up, press the encoder to confirmed it ,then rotate the encoder to choose RETURN ,it will return the normal display 3.4.13 Set up the pregnant woman ID, and age 3.4.13.1 Rotate the encoder, move the purple frame to values area. Press the encoder, it will enter the figure of fetal and mother menu 3.4.13.2 Rotate the encoder, choose the PREGNANT ID or GESTAION AGE, press the encoder again, enter the adjustment state, then , Rotate the encoder will change the ID and age. 3.4.13.3 After set up, press the encoder to confirmed it , then rotate the encoder to choose RETURN ,it will return the normal display

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Chapter 4

Operating instruction

Chapter 4 4.1

Operating instruction

Preparation for use Insert the 3 in 1 transducer, Spo2 sensor, blood pressure cuff into the sockets on the right side, press the

Switch on the front panel several second, the LCD displays should illuminate.

4.2

FHR Monitoring 4.2.1 Determine fetal position by palpation 4.2.2 Apply gel to the center of the ultrasound transducer face. 4.2.3 Place the transducer on the abdomen ensuring that the gel makes good contact between the skin and the transducer. The best signal will be achieved by positioning the transducer over the fetus’s upper back over the left scapula. Adjust the position slowly until the best signal is obtained. 4.2.4 When the fetal heartbeat is heard, keep the transducer in position and move one end of the belt into position. 4.2.5 Reposition the transducer to obtain a good fetal heart beat signal. An indication of this is given by the signal quality indicator.

4.3

TOCO monitoring 4.3.1 Position the TOCO transducer over the fundus of the uterus. 4.3.2 With the transducer still in position, move on end of the belt into position over the transducer. While maintaining belt tension. 4.3.3 Once satisfied with the transducer position and belt tension, set the contractions read-out to reference value by pressing

4.4

. The TOCO display should respond to contractions and maternal breathing.

Pregnant woman Spo2 and HR monitoring

Warning: During MRI scan, SpO2 sensor may cause serious burnt. To minimize this risk, ensure the cable position will not make a circuit. If the sensor doesn’t work well, remove it from patient immediately. Warning: Do not attach sensor in an environment over 37℃because long time attachment can cause serious burn. Warning: Do not apply the SpO2 sensor to an extremity where there is arterial catheter or injection tube. Warning: Make sure the light emitting part and light detecting part face each other. All the emitting lights should get through patient tissue. Warning: During prolonged monitoring, check and change the sensor position regularly in order to avoid damage to the patient’s skin. Special patients need special treatment. Caution: SpO2 sensors are precise and fragile and shall be handled with great care. We are not responsible for the damage caused by negligent use. Caution: The infusing dye may cause wrong reading. Caution: Outside interference: strong ambient light and patient motion may impact measurement of blood oximetry. --16-- iC 60 fetal/maternal monitor user’s manual