4077 EXTERNAL FETAL MONITOR USER MANUAL Important: Do not use the External Fetal Monitor without first reading and understanding this manual! Save this manual for future use. Federal Law (USA) restricts this device to sale by or on the order of a physician. This product should not be used unless the operator has been instructed by a qualified healthcare professional.
CONTENTS 1 INTRODUCTION ...............................................................................................................................3 INTENDED USE OF THIS DEVICE....................................................................................................... 3 FEATURES .......................................................................................................................................... 3 2 SAFETY INFORMATION.....................................................
1 INTRODUCTION This user manual contains important information and safety precautions for the Grafco External Fetal Monitor. Before using the Fetal Monitor, please read and understand this entire user manual. Take special note of all safety precautions that begin “DANGER” and “WARNING”. Save this user manual for future reference.
2 SAFETY INFORMATION The safety statements presented in this chapter refer to the basic safety information that the operator of the Fetal Monitor shall pay attention to and abide by. There are additional safety statements in other chapters or sections, which may be the same as or similar to the following, or specific to the operations.
ULTRASOUND SAFETY GUIDE Fetal Use The Grafco Fetal Monitor is designed for continuous fetal heart rate monitoring during pregnancy and labor. Clinical interpretation of fetal heart rate trends can diagnose fetal and/or maternal problems and complications. Instructions for Use in Minimizing Patient Exposure The acoustic output of the Grafco Fetal Monitor is internally controlled and can not be varied by the operator in the course of the examination.
WARNING: The alarm must be configured to different situations of individual patients. Ensure that audio sounds can be activated when alarm occurs. WARNING: DO NOT switch on device power until all cables have been properly connected and verified. WARNING: DO NOT touch the signal input or output connector and the patient simultaneously. WARNING: Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g.
DEFINITIONS AND SYMBOLS Socket for Channel 1 Ultrasound Transducer (for connection with ultrasound transducer, Protection Category B) TOCO Socket (TOCO input socket—for connection with external contractions (TOCO) transducer, Protection Category B) Socket for Channel 2 Ultrasound Transducer (not used) Socket for DECG Cable (not used) Socket for Remote Marker (for connection with the marker, Protection Category B) EXT.
3 HANDLING GF HEALTH PRODUCTS, INC. FREIGHT POLICY For your protection, read carefully The carrier accepted this merchandise “in good condition” and is responsible for safe delivery. Before signing the freight bill, inspect the shipment carefully for damage or missing pieces. Apparent loss or damage Should visual inspection show loss or damage, this MUST be noted on the freight bill and signed by the carrier's agent. Failure to do so may result in the carrier failing to honor the claim.
4 FETAL MONITOR AND ACCESSORIES The Grafco Fetal Monitor and accessories are illustrated below. charge indicator display screen alarm indicator power indicator sockets, power switch keys recorder remote marker TOCO transducer ultrasound transducer Fetal monitor features FETAL MONITOR Key Functions and Operations The Grafco External Fetal Monitor is a user-friendly device with operation conducted by a few keys on the monitor.
Monitor Key Function and Operation Table Key Function Name and Description Set menu item Press this key to enter the menu interface. Move the cursor up and down among the menu items by pressing the / key. When the cursor is moved to the menu item to be executed or changed, this item will be encircled by a pane. Press the key to execute the relevant function, or press the key to highlight this item, then press the / key to change the relevant content, and press the key to confirm.
Freeze Press this key at the main interface, then press the / key to play back automatically. Press the key to play. Press the key continuously to increase play speed until desired speed is obtained. If you press the key at this time, the playback speed will be decelerated. Press the key to play backward. Press the key continuously to play backward until the desired speed is obtained. If you press the key at this time, the playback speed will be decelerated.
Display Screen The Fetal Monitor's LCD display shows the monitor's collected fetal parameters, trends, menus, information, etc (see pictures below). parameter frame parameter frame trend frame menu frame information frame information frame display screen (trend frame included) display screen (menu frame included) The screen display includes three frames: 1. information frame 2. trend/menu frame 3.
Trend/Menu Frame Example of trend (left picture below) and menu (right picture below). FHR trend AFM trend TOCO trend trend example menu example Under auto monitoring and load status, the trend frame may display three trends at most (see above left picture): FHR (US1) trend, AFM trend, and TOCO trend. Two horizontal graticules are included at the FHR trend frame to make it easier for the caregiver to observe heart rate trend or heart rates that exceed limits. The range is 120bpm -160bpm.
Recorder If the transducers and connectors are correctly connected, press the key to print. The date, time, paper speed, and bed No., etc. will be printed at the beginning of the paper. After printing the information mentioned above, “FHR”, “AFM”, “TOCO ext”/“TOCO int” will be printed at the relevant trace.
example of printing pattern (international standard record paper) Printed Indicator Table Indicator Description Indicates the monitoring alarm status information ↑ Indicates the fetal movement event marked by the patient ↓ Indicates the event marked by the physician Indicates the auto zero information ■ Indicates an automatic fetal movement event Note: When paper is empty, the recorder will stop printing and the data waiting to be printed will be kept in memory.
Monitor Right Side Features Monitor right side features—sockets and power switch—are shown below, followed by descriptions. fuse socket power socket power switch Features on the right side of the monitor Feature Description Power Switch AC ON/OFF switch Fuse Specification Size: 5 x 20 mm T1.6AL 250V Power Socket Input socket for the AC supply Rated AC supply voltage 100V-240V (alternating current) Monitor Base Panel Features Base panel features are shown below.
ACCESSORIES (TRANSDUCERS AND CABLES) The ultrasound transducer, TOCO transducer, and fetal remote marker are connected to the front panel of the monitor. Each cable has a corresponding tab located on the connector housing to ensure proper insertion into the appropriate socket on the monitor. Ultrasound Transducer A multi-crystal, broad beam ultrasound transducer is used to monitor fetal heart rate (FHR). The ultrasound transducer operates at a frequency of 2.0MHz.
5 MENU DESCRIPTION The Fetal Monitor features flexible configurations. The setup of functions such as alarm parameters, fetal monitoring configuration, print configuration, interpartum configuration, auto monitoring, and date and time can be performed by the user or configured accordingly. Press the monitor panel's key continuously to display the menus. Move the cursor up and down among the menu items by pressing the / key.
Load The load window will display (figure follows). Load window After pressing the key, the loaded trend can be played back by pressing the / key (the longest playback time is 12 hours). Press the key to play forward. Press the key continuously to play back forward increasingly fast until the desired key is pressed during this, the speed of playback is deceleratspeed is obtained. If the ed. Press the key to play back backward.
FHR Alert • Enabled: Enable / Disable audio alarm when FHR exceeds the alarm limit; ON means enabled, OFF means disabled, and the default is ON. • Lower: The lower limit of acceptable FHR range; The adjustable range is 50bpm130bpm, the default is 120bpm, and the increment is 5bpm. • Upper: The upper limit of acceptable FHR range; The adjustable range is 150bpm210bpm, the default is 160bpm, and the increment is 5bpm.
FETAL MONITORING CONFIGURATION Figure follows. Fetal Monitor configuration menu • BedID: 1-99 (optional). • UABaseline: Uterine activity baseline; 5-20 optional, the default is 10, and the increment is 5. • FMSource: Fetal movement count chooses patient remote mark or result of AFM analysis; Manual and Automatic optional, and the default is Manual. • AFM Enabled: ON and OFF optional, and the default is ON.
PRINT CONFIGURATION Figure follows. Print configuration menu • PSpeed: Paper advance speed; 1, 2, 3cm/min optional, the default is 2cm/min, and the increment is 1. • PrintTimeLen: The duration of printing; 0-250 minutes optional, the default is 0 minutes, and the increment is 5 minutes. 0 means no printing time limit. • PrintTest: To set whether printing test baseline or not when power is on; ON and OFF optional, and the default is OFF. AUTO MONITORING Figure follows.
DATE AND TIME Figure follows. Date and time menu • Year: 2000-2050 (optional), and the increment is 1. • Month: 1-12 (optional), and the increment is 1. • Day: 1-31 (optional), and the increment is 1; needs to be set according to the year and month set. Invalid date has no effect. • Hour: 0-23 (optional), and the increment is 1. • Minute: 0-59 (optional), and the increment is 1. • Second: 0-59 (optional), and the increment is 1. SYSTEM The system menu is only available to the service engineer.
6 SETUP FETAL MONITOR CONNECTIONS Connecting the Power Cable 1. Ensure the AC power supply of the you will be plugging the monitor into complies with the following specification: AC 100V-240V, 50/60 Hz. 2. Plug one end of the power cable provided with the Fetal Monitor to the monitor power socket (on monitor's right side). 3. Connect the other end of the power cable to a grounded 3-phase hospital-grade power output.
Fixing a Paper Jam When the recorder malfunctions or sounds unexpectedly, open the recorder door to see if there is a paper jam. Remove the paper jam as follows: 1. Cut the record paper from the paper notch edge. 2. Open the recorder door and revolve the left recorder gear. 3. Pull out the paper. 4. Reload the paper. TURNING ON THE FETAL MONITOR WARNING: If any sign of damage is detected, or the monitor displays any error messages, DO NOT use the Fetal Monitor on a patient.
7 FETAL MONITOR OPERATION ULTRASOUND MONITORING OF FHR Ultrasound monitoring is a method to obtain FHR through the maternal abdominal wall. Place the FHR transducer on the maternal abdomen to transmit the low-energy ultrasound wave to fetal heart, then receive the echo signal. Ultrasound monitoring can be used for antepartum monitoring. Components required are ultrasound transducer, aquasonic coupling gel, and belt. Read the following warnings, then perform the following procedure, to monitor FHR.
MONITORING UTERINE ACTIVITY (CONTRACTIONS) External monitoring of the maternal contractions is obtained through the TOCO transducer on the mother's abdominal wall. Components required are ultrasound transducer and belt. Preparing the Monitor 1. Turn the monitor on and verify that the normal monitoring screen appears on the display. 2. Check the TOCO transducer to verify proper attachment to the monitor. 3. Check for the appropriate setting for TOCO baseline; adjust as needed.
REMOTE PATIENT MARKER RECORDING OF FETAL MOVEMENT 1. Insert the fetal movement marker cable into its socket in the Fetal Monitor's front panel. 2. When FHR is monitored, instruct the mother to hold the marker in her hand and operate the marker's press-switch when sensing fetal movement. As she operates the press-switch, the ↑ symbol of fetal movement will show at the display screen and print on the record paper. AFTER MONITORING Operation after monitoring: 1. Remove transducers from patient.
8 MAINTENANCE, CARE AND CLEANING WARNING: Failure on the part of the responsible facility employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazard. PREVENTIVE MAINTENANCE Visual Inspection Perform a visual inspection to ensure that the equipment, cables and transducers have no visible evidence of damage before use. Thereafter, perform such visual inspection at least once weekly.
Caution: Do not pour liquids on the monitor while cleaning. Caution: Use a clean, damp cloth to wipe up any agent remaining on the monitor.
Cleaning the transducer Follow these steps to clean a transducer: 1. Clean the transducer with a clean cloth soaked in a solution of soap and water, or a cleaning solution. Do not immerse the transducer in the solution. Use only the following cleaning solutions: 1. 2. 3. 4. 5. Buraton Liquid Mikrozid Ethanol 70% Sporacidin Cidex Caution: Many cleansers must be diluted before use. Follow the cleanser manufacturer’s directions carefully to avoid damaging the transducer.
STERILIZATION To avoid damage to the equipment, sterilization is only recommended when stipulated as necessary in the facility's maintenance schedule. Use the following table to choose a sterilant. Recommended Sterilant: Component: Ethylate Acetaldehyde Monitor √ √ Ultrasound Transducer √ √ TOCO Transducer √ √ Caution: Many cleansers must be diluted before use. Follow the cleanser manufacturer’s directions carefully to avoid damaging the equipment.
CARE OF RECORD PAPER When storing recorder paper (including used paper with traces): Caution: Do not store in plastic envelopes. Caution: Do not expose to direct sunlight or ultraviolet light. Caution: Do not exceed a storage temperature of 104°F (40°C). Caution: Do not exceed a storage relative humidity of 80%. Caution: Storage conditions outside these limits may distort the paper, adversely affect the accuracy of grid lines, and/or make the trace unreadable.
9 TROUBLESHOOTING The following tables list troubleshooting solutions for potential problems. If the problem persists, please contact your Graham-Field equipment provider.
Monitoring contractions Symptom Possible Cause Poor trace quality or fluctuating 1)Belt is too tight TOCO baseline 2)Belt is too loose 3)Belt has insufficient elasticity 4)Fetal movement 5)Maternal movement TOCO sensitivity > 100 units 4077-INS-LAB-RevB09 Solution 1)Loosen belt until signal is normal 2)Tighten belt until signal is normal 3)Ensure that belt has been correctly positioned; replace if necessary 4)Retry 5)Ensure that patient is comfortable and relaxed Body pressure from uterus Ensure that T
10 SPECIFICATIONS MONITOR Dimensions W x D x H: 13.0 x 10.6 x 3.9 in. (330 x 270 x 100 mm) Weight 7.7 lb (3.
MONITOR continued Ultrasound Technique: Peak-peak detection technique and autocorrelation Pulse Repetition Rate: 3.2KHz Pulse Duration: 114µs Nominal Frequency: 2.0MHz Ultrasound Frequency: 2.0MHz±10% P- <1 MPa Iob<10 mW/cm2 Ispta<100 mW/cm2 FHR Range: 50bpm-210bpm Resolution: 1bpm Accuracy: ±2bpm Earth Leakage Current: <10 uA @ 264 VAC applied to transducer Dielectric Strength: >4000Vrms Contraction TOCO Range: 0% - 100%, 135g strength corresponding to 100% (External Sensitivity: 3.
TRANSDUCERS AND CABLES Ultrasound Transducer System: Pulsed Doppler Weight: .35 lb (160g) Cable Length: 98 in. (2.5m) Dimensions: 3.5 x 2.6 in. (90 × 65 mm) Latex free TRANSDUCERS AND CABLES continued TOCO Transducer System: Passive strain gauge Weight: .33 lb (150g) Cable Length: 98 in. (2.5m) Dimensions: 4.0 x 2.0 in. (102 × 50 mm) Latex free Remote Marker Length: 98 in. (2.5m) Weight: .
11 LIMITED WARRANTY GF Health Products Inc. warrants this product to be free from manufacturing defects in material and workmanship for its period of warranty that is in accordance with industry standards. This warranty is extended only to the original purchaser/consumer or dealer/ non-consumer of this new product and to no other purchaser or transferee. GF Health Products, Inc.
THE DURATION OF THE EXPRESS WARRANTY PROVIDED HEREIN, AND THE REMEDY FOR VIOLATIONS OF ANY IMPLIED WARRANTY SHALL BE LIMITED TO THE REPAIR, REPLACEMENT, CREDIT AND/OR REFUND OF THE DEFECTIVE PRODUCT OR PART PURSUANT TO THE TERMS CONTAINED HEREIN. GF HEALTH PRODUCTS, INC. SHALL NOT BE LIABLE FOR ANY CONSEQUENTIAL OR INCIDENTAL DAMAGES WHATSOEVER. This warranty gives you specific legal rights and you may also have other legal rights which vary from state to state (province to province).
12 APPENDIX A, EC DECLARATION OF CONFORMITY EC Declaration of Conformity Manufactured for GF Health Products, Inc., 2935 Northeast Parkway, Atlanta, GA 30360 Product External Fetal Monitor Model 4077 Classification (MDD, Annex IX): IIb We herewith declare that the above mentioned product(s) meet the transposition into national law, the provisions of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—as amended by Directive 98/79/EC on in vitro diagnostic medical devices.
13 INDEX A Acquiring the (single) Fetal Heart Signal 26 Acquiring uterine activity data 27 Address, Graham-Field 40 AFM enabled 21 AFMGain 21 AFMThreshold 21 After monitoring 28 Alarm parameter configuration menu 19 Appendix A, EC Declaration of Conformity 41 Auto monitoring menu 22 Avoiding damage to the transducer 30 B Base panel features 16 BedID 21 C Cable specifications 38 Care and cleaning of accessories 30 Care and cleaning of Monitor 29 Care of record paper 33 Cleaning the belt 31 Cleaning the recor
Turning off the Fetal Monitor 25 Turning on the Fetal Monitor 25 U UABaseline 21 Ultrasound monitoring of FHR 26 Ultrasound monitoring of FHR, troubleshooting 34 Ultrasound safety guide 5 W Warranty, limited 39 4077-INS-LAB-RevB09 43
USA Corporate Headquarters: GF Health Products, Inc. 2935 Northeast Parkway Atlanta, Georgia 30360 telephone: 800-347-5678, 770-447-1609 fax: 800-726-0601, 678-291-3232 www.grahamfield.com 4077-INS-LAB-RevB09 © GF Health Products, Inc.
