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Summary of Contents for Gima FC-1400
- Page 1 FC-1400 Operation Manual FC-1400 OPERATION MANUAL Rev. 1.2...
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Page 2: Terms Of Warranty
FC-1400 Operation Manual Terms of Warranty This product is manufactured and passed through strict quality control and inspection. Compensation standard concerning repair, replacement, refund of the product complies with “Consumer’s protection law” noticed by Economic Planning Dept. We provide a 1-year warranty period for main body, but Accessory provides a 6 months warranty period.(2 years in Europe) -
Page 3: How To Reach Us
Web site URL : http://www.gimaitaly.com URL : http:// www.ebionet.com In the event of a malfunction or failure, contact Service Dept. of GIMA SPA along with the ※ model name, serial number, date of purchase and explanation of failure. FC 1400 Operation manual. Rev. 1.2... -
Page 4: Definition Of Warning, Caution, Note
FC-1400 Operation Manual Definition of Warning, Caution, Note For a special emphasis on agreement, terms are defined as listed below in operation manual. Users should operate the equipment according to all the Warning and Caution instructions. Manufacturer or Sales agency takes no responsibility for any kind of damage or breakdown that is caused by misuse and failure to maintain the equipment. -
Page 5: General Precaution On Environment
FC-1400 Operation Manual General Precaution on Environment Do not keep or operate the equipment in the environment listed below. Avoid placing in an area exposed to moist. Do not Avoid exposure to touch the equipment direct sunlight with wet hand . -
Page 6: General Precaution On Electric Safety
The equipment should not be placed in the vicinity of electric generator, X-ray, broadcasting apparatus to eliminate the electric noise during operation. Otherwise, it may cause incorrect result. Self-power line is important for FC-1400. To use same power source with other electric instruments may cause incorrect result. Note FC-1400 is classified as listed below ;... -
Page 7: Safety Symbols
FC-1400 Operation Manual Safety Symbols The International Electrotechnical Commission (IEC) has established a set of symbols for medical electronic equipment which classify a connection or warn of any potential hazards. The classifications and symbols are shown below. Save these instructions. -
Page 8: Table Of Contents
FC-1400 Operation Manual Table of Contents Terms of Warranty How to reach us Definition of Warning, Caution, Note General Precaution on Environment General Precaution on Electric Safety Safety Symbols Chapter 1. Introduction 1) Overview 2) Features 3) Configuration 4) Description... - Page 9 FC-1400 Operation Manual Chapter 3. Setup 1) Alarm/FHR setup 2) TOCO/FM setup 3) Print/Screen setup 4) Patient I.D setup 5) Time and Date setup 6) Screen Brightness setup Chapter 4. CTG Terminology Chapter 5. Trouble shooting Chapter 6. Specifications Product Warranty Without prior notice, the specifications and functions are subject to change to enhance the product in this manual.
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Page 10: Chapter 1. Introduction
FC-1400 irradiates the ultrasound wave to maternal abdomen, and detects the Doppler effect signal reflected from the heart of the fetus. FC-1400 extracts FHR and FM from this signal and provides the fetal heart beat sound with internal speaker. FC-1400 measures the uterine activity of a pregnant woman using toco sensor. -
Page 11: Configuration
FC-1400 Operation Manual 3) Configurations FC-1400 consists of the following. Unpack the package and check the followings are included. Also, be sure to check any damage to the main body and accessories. ▣ Default FC-1400 main body ① US Probe (1EA) ②... -
Page 12: Description
FC-1400 Operation Manual 4) Description ▣ General ① ⑥ ② ⑤ ④ ③ ① Main Body ② TOCO Probe ③ US Probe ④ US Probe for twins ( Optional ) ⑤ Patient Marker ⑥ Power Adaptor FC 1400 Operation manual. Rev. 1.2... - Page 13 FC-1400 Operation Manual ▣ Top view ① ② ③ ④ Printer door : Opens when replacing record paper. ① LCD display Screen : Shows the measured data and the status of equipment. ② Hand grip : Use when lifting and moving the equipment ③...
- Page 14 FC-1400 Operation Manual ▣ Front view Printer door release button: Slide button to open printer door ▣ Rear view ① ② ③ Power adaptor connector: Power adaptor of 18V, 2.5A is connected ① RS-232 Connector: Standard 9-pin male RS-232 connector ②...
- Page 15 To avoid an expected electric shock, do not open the equipment cover or disassemble the equipment. . Please do not use the device when the probe is damaged. Refer servicing to qualified personnel of GIMA SPA FC 1400 Operation manual. Rev. 1.2...
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Page 16: Display Screen
FC-1400 Operation Manual 5) Display Screen ① ② ③ ▣ Description of Main Monitoring Screen ⑫ ④ ⑪ ⑩ ⑤ ⑨ ⑧ ⑦ ⑥ ① Setting the location of base line of FHR wave ② Screen Contrast setting menu ③ Power Status Area ④... - Page 17 FC-1400 Operation Manual ▣ Monitoring Mode US1 Connected US1 Connected US1 not Connected US1 not Connected US2 Connected US2 not Connected US2 Connected US2 not Connected TOCO Connected TOCO Connected TOCO Connected TOCO not Connected FC 1400 Operation manual. Rev. 1.2...
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Page 18: Description Of Operation Panel
FC-1400 Operation Manual 6) Description of Operation Panel ⑨ ⑩ ③ ④ ② ① ⑧ ⑤ ⑥ ⑦ Power On/Off Button ① Turn on/off the power of the main body ② Volume adjusting button Press the button and select a channel of which volume needs to be adjusted in US1 and US2. - Page 19 FC-1400 Operation Manual You can print data on paper at high speed in tracing mode. ⑧ Trim Knob Turn the knob right or left or press it like a button. In monitoring mode, you can select the menu and change system settings.
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Page 20: Power
FC-1400 Operation Manual 7) Power When DC is connected to the device, DC power indication light turns light green and when battery is installed inside, it automatically starts to charge the battery. When you turn on the device without DC power, battery provides power and the remains of battery is showed in “Power Status Area”... -
Page 21: Description Of Print Form
FC-1400 Operation Manual 8) Description of Print Form ① FHR wave of US1, US2 ② When a woman pressed Patient Marker, it shows when the marker is pressed. ③ When a nurse or a doctor pressed Clinician Mark button of the device, it shows when the button is pressed. -
Page 22: Ctg Analysis Results Report
FC-1400 Operation Manual 9) CTG(Cardio-Toco Graph) Analysis Results Report (Option) Middle Report Final Report Period : Time during which CTG analysis was performed Average Baseline FHR(bpm) : Average number of Baseline FHR during the analysis period Number of UC : Number of UC and frequency of UC per hour during the analysis... -
Page 23: Installation
Criteria NOT MET : It means if FC1400 has not found enough evidence that the trace is reassuring 10) Installation ▣ Suggestions for installation Please keep in mind those listed below when installing FC-1400. ① Temperature: 10 to 40 ℃ Humidity: 30 to 85％... - Page 24 FC-1400 Operation Manual Note When US or TOCO cable is connected the power of device must be turned off ▣ Installing printing paper You can open printer cover by pushing “Printer cover open” button to the right. Load paper with printable side up and close the cover.
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Page 25: Chapter 2. How To Use Fc -1400
FC-1400 Operation Manual Chapter 2. How to use? 1) Basic Instruction ① Connect power cable to the device and press the power button. ② Make sure that all the settings are as you want. ③ Change the settings as you would like. -
Page 26: Tracing The Saved Data
FC-1400 Operation Manual 2) Tracing the saved data If power switched on, FHR, UA and FM data is saved in the memory automatically and you can trace the saved data on the screen. Follow the steps. ① Press the tracing mode button in monitoring mode and icon pops up on the top left of the screen and you go into search mode. -
Page 27: Fhr(Fetal Heart Rate) Measurement
FC-1400 Operation Manual 3) FHR Measurement It gets fetal heart sound by using ultrasound Doppler effect and calculates heart rate by minutes and saves it. Please get rid of air layer by putting enough of ultrasound gel on US probe to avoid diminution of ultrasound in the air. - Page 28 FC-1400 Operation Manual ⑤ Stick the button on the top of US probe to the fixing belt hole and fix it to avoid slipping of US probe. Note Fix the Probe Cable toward the head part of a pregnant woman in order to prevent it from being damaged, and for moving to some degree comparatively.
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Page 29: Ua Measurement
FC-1400 Operation Manual 4) UA Measurement You can detect UA by using pressure sensor externally sticked. Put TOCO probe on the maternal abdomen and it detects the relative pressure which changes as the maternal abdominal contraction and record UA. ▣... -
Page 30: Fetal Movement Measurement
FC-1400 Operation Manual 5) Fetal Movement measurement ▣ Using Patient Marker It is designed to record the occuring moment of FM by the woman’s acknowledgement of it. When the woman press mark jack after having the quickening of the womb, you will see “|” in FHR wave marking area. -
Page 31: Warning Message
FC-1400 Operation Manual 9) Warning Message It notifies you with sound in situations listed below when using the device. ① When US cable is came off the device in use, ② ” pops up. When running out of paper in printing the message”... -
Page 32: Chapter 3. Setup
FC-1400 Operation Manual Chapter 3. Setup Modes 1) Alarm/FHR Setup U/S CONFIGURATION ALARM FHR LOW 120 BPM FHR HIGH 160 BPM DELAY TIME 20 SEC LINE COLOR US 1 US2 ( + 20 ) US 2 GUIDE US2 OFFSET OFFSET... -
Page 33: Toco/Fm Setup
FC-1400 Operation Manual 2) TOCO/FM SetUp TOCO/FM CONFIGURATION TOCO BASELINE GRATH THRESHOLD LINE COLOR US2 ( + 20 ) TOCO DEMO MONITOR NUM. TOCO + FM [ Cancel ] [ OK ] (10) 01/JAN/00 00:02:21 123456789 3cm/min ① Turning the knob and select TOCO marking area in monitoring mode. TOCO Configuration pops up when pressing the knob. -
Page 34: Print/Screen Setup
FC-1400 Operation Manual 3) Print /Screen Setup PRINT CONFIGURATION SPEED SPEED 1 CM/MIN PAPER GRID SIZE CONTRAST AUTO PERIOD PRINT US2 ( + 20 ) REAL TIME 20 MIN TRACE 00 MIN TOCO + FM [ OK ] [ Cancle ]... -
Page 35: Patient Id Setup
FC-1400 Operation Manual 4) Patient ID Setup ① Turn the knob and select patient ID setting menu in monitoring mode. You can set ID by icon changes into icon. pressing the knob. Here, ② Turn the knob and move to where you want to set figures. -
Page 36: Time And Date Setup
FC-1400 Operation Manual 5) Time and date Setup US2 ( + 20 ) TOCO + FM (10) 123456789 01/JAN/00 00:02:21 3cm/min ① Turn the knob and select Time and Date setting menu in monitoring mode. You can set icon changes into icon. -
Page 37: Screen Brightness Setup
FC-1400 Operation Manual 6) Screen Brightness Setup US2 ( + 20 ) TOCO + FM (10) 01/JAN/00 00:02:21 123456789 3cm/min ① Turn the knob and select icon in monitoring mode. You can adjust the brightness of the screen by pressing the knob. -
Page 38: Chapter 4. Ctg Terminology
FC-1400 Operation Manual Chapter 4. CTG Terminology 1) Baseline FHR Mean FHR rounded to increments of 5 bpm during a 10 minute segment excluding periodic or episodic changes, periods of marked variability and, segments of baseline that differ by >25bpm. Duration must be ≥2 minutes. - Page 39 FC-1400 Operation Manual 4) EARLY DECELERATION Visually apparent gradual decrease(onset to nadir is ≥ 30 sec.) of FHR below baseline. Return to baseline associated with a uterine contraction. Nadir of deceleration occurs at the same time as the peak of the contraction. Generally, the onset, nadir, and recovery of the deceleration occur at the same time as the onset, peak and recovery of the contraction.
- Page 40 FC-1400 Operation Manual 5) Variable DECELERATION Visually apparent abrupt decrease ( onset to nadir is <30sec) in FHR below baseline. Decrease is ≥15 bpm. Duration is ≥ 2 min and < 10 min. FC 1400 Operation manual. Rev. 1.2...
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Page 41: Chapter 5. Trouble Shooting
FC-1400 Operation Manual Chapter 5. Trouble Shooting 1) Trouble Shootings and the Solutions ① When the probe comes off the device in running, “US1 off” or “US2 off” or “TOCO off” pops up with “ding dong” sound. Check the connection of the probe and reconnect it. - Page 42 FC-1400 Operation Manual 3) Regular Inspection Like every medical equipment, please take a regular test for FC-1400 for safety. For test categories, please see the service manual provided by us. FC 1400 Operation manual. Rev. 1.2...
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Page 43: Chapter 6. Specifications
FC-1400 Operation Manual Chapter 6. Specifications ■ Environmental Specifications Operating Temperature：15°C to 30°C (59°F to 86°F) Storage Temperature：- 10°C to 60°C (14°F to 140°F) Operating/Storage Humidity：20% to 95% RH, non-condensing Operating Altitude：70(700) to 106Kpa(1060mbar) ■ Power Specifications Use Power Adaptor Power Adaptor Input 100~240V, 50~60Hz, 1.2A... - Page 44 FC-1400 Operation Manual Fetal Movement Measurement Detection Source : Ultrasound Pulsed Doppler Recording Method: ① Spike-like waveform denotes relative intensity and duration of Fetal Movement. ② Dot marks when FM intensity exceeds selected threshold. Physical Characteristic Dimensions: 296(W) x 305.5(H) x 97.5(D)mm Weight: Approx.
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Page 45: Product Warranty
Name : TEL : Sales Agency Manufacturer ※ Thank you for purchasing FC-1400. ※ This product is manufactured and passed through strict quality control and thorough inspection. ※ Compensation standard concerning repair, replacement, refund of the product complies with consumers protection law noticed by Ministry of Finance and Economy. - Page 46 After Sales Service Center - GIMA SPA VIA MARCONI, 1 – 20060 GESSATE (MI) ITALY Tel : ++39 02 953854209 Fax : ++39 02 95380056 E-mail : export@gimaitaly.com Product name : FC-1400 Rev. 1.2 FC 1400 Operation manual. Rev. 1.2...
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