Philips FM-2 User manual

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Fetal Monitoring

INSTRUCTIONS FOR USE

FM-2 Antepartum Fetal Monitor

(M2922A)

FOR USE WITH FM-2 FETAL MONITOR

Printed in Germany 10/04

*M2922-9001C*

Part Number M2922-9001C

4512 610 05781

Philips

M2922A

Instructions fo r Use

FM-2 Antepartum Fetal Monitor

S PAD

Part Number M2922-9001C

Printed in Germany 10/04

Notice

the prior written consent of the copyright holder. Philips Medizinsysteme Boeblingen GmbH

Hewlett-Packard-Str. 2 71034 Boeblingen, Germany

Caution

US law restricts this device to sale by, or on the order of, a physician.

Trademarks

Microsoft Windows Corp. All other product and company names mentioned may be the trademarks of their respective owners.

is a U.S. registered trademark of Microsoft Corp.

and Windows N T® are U.S. registered trademarks of Microsoft

Table of Contents

1. Quick Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Monitoring Screen Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

Ultrasound Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Toco Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Non-Stress Test (NST) Aid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Event Markers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Viewing Stored Fetal Traces on Screen . . . . . . . . . . . . . . . . . . . . . . . . .4

Printing and Transmitting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

2. Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Instructions for Safe Operation and Use of the FM-2 Monitor . . . . . . . . . . .7

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

3. Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

FM-2 Fetal Monitor Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

Check List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

Checking the Shipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Setting Up Your Monitor the First Time . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Connecting the Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Using the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

Connecting the Remote Marker Cable . . . . . . . . . . . . . . . . . . . . . . . .17

Mounting on Wall or Rollstand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

Choosing Your Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Setting the Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Setting the Paper Style and Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

iii

4. General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

More About the Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Monitoring Screen Frames . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Fetal Heart Rate Numeric (US1) Frame . . . . . . . . . . . . . . . . . . . . . . . 21

Heart Rate Trend Frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Toco Numeric Frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Toco Trend Frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Power Status Frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Communications Frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Time and Date Frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Patient ID Frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Monitor Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Changing Monitor Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Using the Navigation Wheel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Example of a Change Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Preparing for a Monitoring Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Fastening a Belt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Clipping a Transducer to the Belt . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Connecting a Transducer to the Monitor . . . . . . . . . . . . . . . . . . . . . . 29

Eliminating Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . 30

Configuring Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Adjusting Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Marking an Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Finishing a Monitoring Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Configuration Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Using the Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Low Power Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Recharging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Replacing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Storing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Getting the Best out of Your Battery . . . . . . . . . . . . . . . . . . . . . . . . . 35

Demonstration Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

5. Monitoring Fetal Heart Rate . . . . . . . . . . . . . . . . . . . . . . . . 37

FHR Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37

What You Need . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37

Preparing the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37

Finding the Fetal Heart Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38

Interpreting the Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

Monitoring Twins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

Finding the Second FHR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

Separating Two FHR Traces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

Adjusting Ultrasound Volume. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41

Understanding FHR Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

Configuring FHR Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43

Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44

Determining FHR Acceleration Using Grid Lines . . . . . . . . . . . . . . . . . . .45

6. Monitoring Uterine Activity . . . . . . . . . . . . . . . . . . . . . . . . . 47

Toco Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

What You Need . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

Preparing the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

Acquiring Uterine Activity Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

Setting the Toco Baseline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48

Using the Toco Grid Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50

7. Using Trend Scroll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Entering Trend Scroll. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51

What Data Will I See? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52

Printing a Trend Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53

Exiting Trend Scroll Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54

8. Printing and Transmitting Records . . . . . . . . . . . . . . . . . . . 55

Setting up the Modem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55

Number to Dial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Modem Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Printing and Transmitting Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Process Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Communication Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Recommended Modems and Printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Modems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Serial Port Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Parallel Port Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Cabling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

9. Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Transducers (Cleaning and Low Level Disinfection) . . . . . . . . . . . . . . . . . 68

Cleaning Belts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

10. Using the Recorder or Printer . . . . . . . . . . . . . . . . . . . . . . 73

Working with the Recorder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Installing the Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Loading Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Annotating Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Storing Recorder Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Using the Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Working with a Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Connecting a Printer to the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Using a Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Example Trace. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

11. Maintenance and Performance Assurance . . . . . . . . . . . . 83

Preventive Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

Calibration and Adjustment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

Performance Assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84

Testing the Monitor and Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . .84

Testing Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86

Disposing of the Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87

Obtaining Technical Assistance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87

Returning System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88

Supplies and Accessories Reordering Information . . . . . . . . . . . . . . . . . . .88

Response Center Contact Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . .90

12. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Printer and Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93

Toco Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94

FHR Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95

Printing and Transmitting Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96

13. Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

FM-2 Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99

Ultrasound Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100

Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .101

Paper. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102

14. Training Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

vii

viii

Quick Reference

This chapter is a quick reference only.You must familiarize yourself with the safety information in Chapter 2 in order to use the monitor safely.

6 78

What is this? Use this... Comments

... to switch the monitor on and

on/off

power

source

Quick Reference 1

off.

...as an indicator of the power source.

The monitor plays a jingle and displays a startup screen whilst performing a power-on self test.

Indicates whether monito r is pow e red from AC power source via the power supply or battery only.

Recharge the battery after use. It is recommended to keep it charged. Unlike a nickel-cadmium battery, lead acid batteries do not suffer from the “me mo ry” effect so there is no need to discharge it completely before recharging.,

What is this? Use this... Comments

volume/

alarm

silence

contrast

adjust

Toco zero

clinician

marker

trend

scroll

grid line

enable

...to silence a n alarm or set volume on an ultrasound channel.

...to enter/ex it contrast adjust mode.

...to zero the Toco data to the baseline.

...to annotate the trace w ith the clinician e vent marker.

...to enter/exit trend scroll mode.

...to enter/exit grid mode . Use during an NST to more easil y de te rmine duration and

If an alarm is sounding, press this button to silence it. If no alarm is sounding, press this once to select ultrasound channel

1, or twice for ultrasound channel 2 (if present). Then rotate the wheel to adjus t the alarm volume of the selected ch annel. Press it again to exit the adjustment mode. You can still change the volume on an ultrasound channel even if an alarm condition is present.

Press once to ente r adj ust mode an d aut oma tica ll y res et th e cont r ast to the factory default level. Rotate the wheel to alter the contrast. Press a second time to exit the mode.

New Toco data is shifted to the prese t baseline after you press this. Zero the baseline before you commence monitoring

Press once to make one annotat ion on patient trend data. Mult iple presses marks the trace multip le times.

Press once to enter trend scroll mode. Rotate the knob to slide the trend data across the screen. Press a second time to exit the mode.

frequency of FHR accelerations abo ve 15 BPM. Press once to set lines 15 BPM apart. Rot ate na vi gation wheel to

adjust the position of the paired lines. Press a second time to return to the previous monito r in g mode.

navigation

wheel

...to navigate around the screen. Turn the wheel to highlight an i tem. Pre s s the wh ee l t o sel ec t yo ur

choice. Use this to select frames, which allow you access to that frame’s associate menu. When in a menu, turn the whee l to cycle through items, values etc. Press the whee l to se lect the item or value. Full instructions on how to use nav igation wheel to change settings and alarms are gi ven on page 25.

2 Quick Reference

Monitoring Screen Display

24252627

US 1

2 3

4 5 6

7 8

US 2

TOCO

(5)

240

150 110

100

13 14 15 16 17 18

1. Ultrasound channel indicator

2. Hea r t rate icon for Fetal Heart Rate 1

3. FHR 1 on US1 (in FHR numeric frame)

4. FHR1 amplitude volume indicator (off)

5. Alarm status indicator for FHR1 (alarm on)

6. Hea rt r ate icon for FH R2

7. Fetal Heart Rate 2 on US 2

8. FHR2 amplitu de volu m e in dicator (high)

9. Trace offset se pa ration “on” indicator

10. Alarm status indicator for FHR2 (off)

11. Toco valu e (i n Toco numeric frame)

12. Present Toco baseline value

13. Communications frame (recorder attached)

14. Paper speed (3 cm/min)

cm/min

JANE DOE 194848

16:34:12 2/14/2001

15. Power status fram e (running from battery)

16. Time and....

17. .....Date (in Time/Date frame)

18. Toco baseline reference

19. Patient ID frame

20. Toco Trend frame

21. Clinician marker

22. Patient marker

23. Heartrate tre nd frame

24. Ultrasound grid lines (normocardia)

25. Ultrasound trend for FHR2 (lighter trace)

26. Ultrasound trend for FHR1 (darker trace)

27. Trend scroll indicator (active)

20 19

Quick Reference 3

Ultrasound Monitoring

U/S 1

Ultrasound Menu

Trace Separation 0 bpm FHR Upper Limit 150 bpm FHRLower Limit 50 bpm FHR Alarm Delay 30 sec Loss of FHR Delay 120 sec Alarm Status

Disable

1. Connect US transducer (red connector) to upper US red socket.

2. Go to Ultrasound menu, and check alarms. Adjust if necessary.

3. Adjust US speaker volume (press speaker key and turn wheel).

4. Fasten belt around patient.

5. Find fetal heart position.

Return

6. Apply US gel to transducer and apply transducer to patient.

7. Fasten transducer in position on belt when you get a good signal.

8. Verify this is FHR.

9. Start monitoring.

10. Periodically compare mother’s pulse with FHR signal to ensure you monitor FHR, not maternal heart rate.

11. Switch off when finished. Always switch off between patients.

Toco Monitoring

TOCO

TOCO Menu

TOCO Baseline (5)

Return

(5)

1. Connect Toco transducer (brown connector) to brown Toco socket.

2. Position transducer on fundus and obtain good signal.

3. Fasten belt and clip transducer to it. Check belt tension.

4. Go to Toco menu and check baseline value. Adjust if necessary.

5. Zero baseline once, between contractions.

6. Start monitoring.

7. Switch off when finished. Always switch off between patients.

Non-Stress Test (NST) Aid

1. Press the grid line key on the front of the monitor.

2. Turn wheel to position the 15 bpm apart grid lines on FHR to help you determine frequency and duration of accelerations.

Event Markers

1. Press the clinician mark er on the fron t of the monitor to mark the trace or

2. Patient presses button on remote marker cable to mark trace when she perceives fetal movement.

Viewing Stored Fetal Traces on Screen

1. Press the trend scroll key on the front of the monitor.

2. Turn the navigation wheel to scroll through stored traces).

4 Quick Reference

Printing and Transmitting

Communications Menu

Data Transfer Stopped Destination Paper Output Paper Speed Paper Style Modem Initialization

Number to Dial

Return

min.

Printer/Recorder Patient Records

3 cm/min

USA

1. Turn navigation wheel to highlight Communications Frame.

2. Press the wheel to activate the frame and view menu options.

3. Turn the wheel then press it to select each menu option in order.

How do I... ...this is how

...print stored fetal traces to a printer or the recorder?

Connect the monitor directly to the printer using the 25-pin to 36 pin cable that belongs to the printer.

...transfer stored fetal traces to FM-2 viewer utility software?

Connect the monitor directly to the comp ut er us in g the 9 -pi n ca ble M1380-61624 that comes wi th t he software OR

Connect the monitor to a modem using the 9-pin to 25 pin cable that came with the modem.

...print current fetal trace realtime to O B TraceVue?

Connect the monitor directly to OB TraceVue using the 9-pin cable M1380-61624.

...remotely transfer stored fetal traces to OB TraceVue

Connect monitor to modem using the 9-pin to 25 pin cable that came with the modem.

...print current fetal trace realtime to the recorder?

Connect the monitor directly to the recorder using the 25-pin to 36-pin cable that belongs to the recorder.

...print a summary list of stored trace IDs to a p r inter?

Connect the monitor directly to the printer using the 25-pin to 36 pin cable that belongs to the printer.

1. Paper output -> Patient records

2. Destination -> Printer/record er

3. Data Transfer -> Start data transfer -> Yes

4. Select: – “yes” for trace of displayed ID – “no” to display ID of next tr ace – “all” to print all remaining stored traces.

1. Destination -> FM-2 View e r

2. Data Transfer -> Start data transfer -> Yes

3. Select: – “yes” for trace of displayed ID – “no” to display ID of next tr ace – “all” to print all remaining stored traces.

1. Destination -> System Online

2. Data Transfer -> Start data transfer -> Yes

1. Destination -> System Batch

2. Data Transfer -> Start data transfer -> Yes

3. Select: – “yes” for current record – “no” to dis play ID of next re cord – “all” to print all stored traces.

1. Paper output -> Current record

2. Destination -> Printer/record er

3. Data Transfer -> Start data transfer -> Yes

1. Paper output -> Summary list

2. Destination -> Printer/record er

3. Data Transfer -> Start data transfer -> Yes

Quick Reference 5

6 Quick Reference

Safety

Instructions for Safe Operation and Use of the FM-2 Monitor

Visually inspect the monitor and accessories periodically to ensure that the monitor, cables, line cords, transducers and instruments have no visible evidence of damage that may affect patient safety or monitoring performance. Do not use if there is any visible sign of damage.

Only the power supply supplied with the monitor is approved for use in supplying external power for operating and recharging the monitor’s internal battery.

Only the supplied AC line cord, or its equivalent, is approved for use with the recorder.

Do not attempt to service the monitor or recorder. Only qualified service personnel should perform any needed internal servicing.

The monitor is not specified or intended for operation during the use of defibrillators or during defibrillator discharge.

The monitor is not specified or intended for use in the presence of electrosurgical equipment.

The monitor is not specified or intended for use i n conjunction with any o ther type of monitoring equipment except the specific devices identified for use in this book.

Perform safety testing in accordance with local legal requirements to ensure proper patient safety.

Do not use the monitor if it fails its power-on self-test procedure.

Safety 7

Warnings

WarningWarning

EXPLOSION HAZARD: Do not use the monitor in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur.

WarningWarning

SHOCK HAZARD: The power receptacle must be a three-wire grounded outlet. Never adapt the three-prong plug from the power supply or accessory to fit a two-slot outlet. If the outlet has only two slots, make sure that it is replaced with a three-slot grounded outlet before attempting to operate the monitor.

WarningWarning

Do not connect to an electrical outlet controlled by a wall switch.

WarningWarning

SHOCK HAZARD: Do no attempt to connect or disconnect a power cord with wet hands. Make certain that your hands are clean and dry before touching a power cord.

WarningWarning

Use only patient cables and transducers supplied with the monitor. Use of any other patient cables may result in out-of-specification performance and possible safety haz ards.

WarningWarning

Take care to position the monitor securely when overhead. Avoid insecure positioning.

WarningWarning

If the monitor has been exposed to temperature ranges outside the specified operating range, allow it to return to the correct operating range before turning it on.

8 Safety

Warnings

WarningWarning

Service may be performed by qualified service personnel only. The monitor has no user serviceable parts.

WarningWarning

Disconnect the printer or recorder from the AC power before connecting them to the monitor.

Safety

Cautions

Caution

US law restricts this device to sale by, or on the order of, a physician.

Caution

Keep the operating environment free of d ust, vibrations, corrosive, or flamma ble materials, and extremes of temperature and humidity. Keep the unit clean and free of transducer gel and other substances.

Caution

When installing the unit into a cabinet, allow for adequate ventilation, accessibility for servicing, and room for adequate visualization and operation.

Caution

Do not operate the unit if it is damp or wet because of condensation or spills. A voi d using the eq uipmen t immediat ely after mov ing it from a cold environment into a warm, humid location.

Caution

Never use sharp or pointed objects to operate the front-panel switches.

Caution

General purpose personal computers, printers and modems are not designed to meet the electrical safety requirements of medical devices. Connect them with a cable of sufficient length to locate them outside of the patient vicinity. This means a minimum distance of 1.5 meters from the patient’s bed or chair. Do not connect the FM-2 recorder to the monitor at the same time as a non-medical device (com puter, printer or modem) if the recorder is located in the patient vicinity. For additional information refer to IEC/EN Standard 60601-1-1.

10 Safety

Cautions

Caution

Do not autoclave or gas sterilize the monitor or any accessories. Follow cleaning and disinfection instructions. When washing the transducer belts, the water temperature must not exceed 60

C (140oF).

Caution

Do not use the transducer’s ring clip to secure the belt around the patient - you must use a fixing button on the belt for this. Using the transducer clip to secure the belt may damage the transducer and does not keep the belt in place reliably.

Caution

Do not mistake demonstration data for genuine patient data.

Safety

Cautions

12 Safety

FM-2 Fetal Monitor Intended Use

Getting Started

FM-2 is a Fetal Monitor for non-invasively measuring, and showing maternal uterine contractions and the fetal heart rate as a graphical display and optionally on a strip chart recorder, printer or OB TraceVue system. The data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy (Non-Stress Test). This device is for use only by trained medical personnel located in hospitals, clinics, doctors' offices and in the patient's home or during transport, under the direction of a licensed practitioner.

Getting Started 13

Check List

Familiarize yourself with the monitor and its components by reading this book. Use this check list to install, set up and configure your monitor.

Tasks

Task 1: Check shipment 15 ! Task 2: Attach power cables and switch on 16 ! Task 3: Set the language 18 ! Task 4: Set the time and date 19 ! Task 5: Set the paper style and speed 20 ! Task 6: Start monitoring 37 and 47

See

Page

Done

14 Getting Started

Checking the Shipment

Use this table to check your delivery. Retain the original packaging material in case you need to return the monitor.

Checking the Shipment

Monitor (M2922A) Shipped

1 x Ultrasound Transducer (or two, if additi ona l transducer ordered for twins)

2.5m cable

Ultrasound transmission Gel 1 bottle

Reusable Transducer Belts (M1562A)

1.3m long, 5cm wide, with button holes and pre-attached buttons. Can be further cut. Contains latex.

Toco Transducer

2.5m cable

Remote Event Marker 1

Transducer knob adapters 1 pack

Pocket Guide to Fetal Monitoring and Assessm ent by Susa n Martin Tucker, 4th edition, English language orders only ISBN: 0-323-00884-4

Instructions for Use and Service Guide 1

Power Supply and Power Cord (110 or 220V) 2 meter 1

Recorder (M2925A)

(110V or 220V as appropriate)

Power Cord 2 meter 1

2 belts

Shipped

PC parallel printer cable for connecting monitor to recorder. 1

Recorder Paper approp riate for country 1 pack

Getting Started

Setting Up Your Monitor the First Time

Connecting the Power Supply

One cable is permanently attached to the power supply. Connect this cable to the

rear of the monitor, at the input marked . Insert the AC line cord into

the three-pronged IEC receptacle on the power supply. Insert the other end into an appropriate wall outlet.

WarningWarning

Do not connect to an electrical outlet controlled by a wall switch

WarningWarning

SHOCK HAZARD: Do not attempt to connect or disconnect a power cord with wet hands. Make certain that your hands are clean and dry before touching a power cord.

5V ∼ 1

WarningWarning

16 Getting Started

Using the Battery

To run from the monitor’s internal battery, switch the monitor on, without the power supply connected. Recharge the battery using the power supply, either during monitoring or when the monitor is switched off.

Connecting the Remote Marker Cable

Insert the cable into the connector, marked , at the side of the monitor.

Mounting on Wall or Rollstand

Instructions for mounting your monitor come with the GCX mounting kit.

Setting Up Your Monitor the First Time

Getting Started

Setting Up Your Monitor the First Time

Choosing Your Language

The monitor is delivered with English as the default language. To choose a different language:

1. Switch on the monitor.

2. Rotate the navigation wheel

3. Push the wheel to display the Service Menu. The first item (“Set

4. Select “Set Language” to see a second menu with all language choices.

5. Rotate the wheel to highlight your language.

6. Press the wheel to select it.

Service Menu

“Set Language” menu

item

Power status frame

7. Turn the monitor off and switch on again to activate the new language.

until the Power status frame is highlighted.

Language”) shows the current operating language.

US 1

US 2

TOCO

(5)

cm/min

240

150 110

100

Service Menu

Set Language System On-Time Demo Mode

View Error Log View A/D Values

English

Deutsch

Svenska Italiano

Norsk

Dansk

Espanol

Francais

Nederlands Suomi

JANE DOE 194848

16:34:12 2/14/2001

current

operating

language

Caution

Selecting an unfamiliar language may make it difficult to resume normal operation.

1. See page 25 for full instructions about using the navigation wheel.

18 Getting Started

Setting the Time and Date

Use the Time and Date menu to set the current time and date, and their display formats. Remember to change the time when daylight saving time changes (unless realtime monitoring with an OB TraceVue system, when the system communicates the time and date change to the monitor).

1. Select the Time and Date frame.

2. Rotate and press the wheel to select the setting you want to change.

3. Rotate the wheel to change the values. Press the wheel to save the change.

4. Repeat until you have set the time, time format, date, and date format.

Time and Date Menu current settings

Setting Up Your Monitor the First Time

Changing the

Time or Date

During Moni-

toring

TOCO

time and date frame

(5)

cm/min

Time/Date Menu

Set Time Set Date Set Time Format Set Date Format

Return

12 Hour

MM/DD/YYY

DD.MM.YYYY YYYY/MM/DD

JANE DOE 194848

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selecting a different date

format

Always start a new monitoring sessio n after changing the time or date. Although the new time is shown on the monitoring screen, it is not stored within the fetal trace record.

Getting Started

Setting Up Your Monitor the First Time

Setting the Paper Style and Speed

1. Select the Communications frame.

2. Select Paper Style.

3. Rotate the wheel to change the values (USA or International). Press the wheel to save the change.

• USA: Orange paper 30-240 FHR scale

• International: Green paper, 50-210 FHR scale

4. Using the same technique, now set the paper speed (1, 2 or 3 cm/min).

communications menu

paper speed

paper style

communications frame

TOCO

Data Transfer

Destination

Paper Output Paper Speed Paper Style Modem Initialization

Number to Dial

Return

(5)

min.

Communications Menu

Stopped

Printer/Recorder Patient Records

3 cm/min

USA

International

JANE DOE 194848

16:34:12 2/14/2001

current settings

changing the paper

style

20 Getting Started

This chapter gives an overview of how to use your monitor, and its features. It shows an example fetal trace and gives some general practical information.

More About the Monitor

It can monitor fetal heart rate (FHR) and external uterine pressure (Toco), showing the patient data on its integral display, and saving up to 12 hours of patient data in its memory. It can output this data, realtime, on a strip chart recorder or OB TraceVue system. The data includes graphic trend data and text information about hardware and software configuration, date and time and so forth.

Additionally, you can download this stored data to a printer via a direct cable link, or to a remote obstetrical surveillance system such as OB TraceVue or to a PC running the FM-2 viewer utility software.

General Information

Monitoring Screen Frames

The monitoring screen is divided into frames.

Fetal Heart Rate Numeric (US1) Frame

This displays FHR, heart rate icon, alarm status icon, and speaker volume icon. The heart rate value shows the most recent calculated fetal heart rate. The heart rate icon blinks at the measured heart rate interval when a valid rate is present. The volume icon gives an indication of the speaker volume setting for the FHR

General Information 21

Monitoring Screen Frames

sounds. This icon changes when you adjust the speaker volume setting. The alarm icon is a bell. A diagonal line through the bell indicates alarms are disabled. A bell without a diagonal line indicates alarms are enabled.

When you connect a second ultrasound transducer, the heart rate frame includes the second fetal heart rate, heart rate icon, alarms status icon and speaker volume.

The trace offset icon appears in the heart rate frame if you have connected two ultrasound transducers and enabled the ultrasound trace offset.

Heart Rate Trend Frame

The heart rate trend frame displays a graphical representation of the fetal heart rate. The vertical scale corresponds to the selection of the recorder paper (30 to 240 BPM for US style paper, 50 to 210 for International style paper). The graph displays six minutes of data if the monitor is set for a print speed of three cm per minute, nine minutes of data when set for two cm per minute and 24 minutes when set to one cm per minute.

This frame shows two heart rate trends when you use two ultrasound transducers.

The normocardia lines make it easier for you to observe heart rate trend or heart rates that exceed limits. These are positioned at 110 and 150 BPM.

This graphic frame also displays heart rate data when you scroll through historical patient data in trend scroll mode.

Toco Numeric Frame

This frame contains the numeric value from the Toco transducer, representing uterine activity. It also shows the present Toco baseline value. You can adjust the Toco baseline.

Toco Trend Frame

The Toco trend frame displays uterine activity trend data. The scale is from zero to 100 in relative units. The graph displays six minutes of data if the monitor is set for a print speed of three cm per minute, nine minutes of data when set for

22 General Information

two cm per minutes, and 24 minutes when set to one cm per minute. This graphical frame also displays uterine activity data when you scroll through patient d a t a .

Power Status Frame

This frame displays an icon to indicate the monitor’s method of power. There is no indication of batte ry charge st atus when you are working from AC power.

Symbol Definition Symbol Definition

Monitoring Screen Frames

Monitor is powered by battery. Number of filled segments indicates battery charge status (battery fuel gauge). A fully charged battery shows all segments filled.

Communications Frame

This frame shows the status of devices connected to the monitor’s serial interface port. See Chapter 8, “Printing and Transmitting Records” for more details.

Time and Date Frame

This frame shows the current time and date for the monitor. You can change these when necessary; see “Setting the Time and Date” on page19.

Patient ID Frame

This displays the patient identification, generated automatically by the monitor each time you switch on. It uses a time and date encoded identification scheme to ensure no duplication of identification. You can change this, entering an ID (such as name) if you want; see “Configuring Patient ID” on page 30.

Monitor is operating from AC power.

General Information

Monitoring Screen Frames

Monitor Symbols

These symbols appear on the monitor and its associated equipment

Symbol Definition Symbol Definition

5V ∼ 1

RS-232

Remote marker input connector

Drip-proof equipment classification

Class II equipment symbol (double insulation)

Type BF applied part symbol

Power supply connector Refer to accompanying

documents

RS-232 connector (symbol on monitor housing)

RS-232 connector (symbol on monitor label)

Functional earth Printer connection

24 General Information

Changing Monitor Settings

Using the Navigation Wheel

You navigate through, and make changes to, screen elements by rotating and pressing the navigation wheel. Rotate the wheel to highlight frames on the screen. When a frame is selectable it has a heavy box drawn around it. Press the wheel to select the frame.

The monitor’s response may be effective immediately, or it may display a Level 2 menu that “pops up” on screen without removing the Level 1 menu.

Example of a Change Operation

To change the fetal heart rate alarm status:

1. Rotate the wheel to highlight the Ultrasound frame. A heavy border appears around that frame.

Changing Monitor Settings

US 1

select the

Ultrasound

frame

US 2

TOCO

General Information

(5)

cm/min

240

150 110

100

JANE DOE 194848

16:34:12 2/14/2001

Changing Monitor Settings

2. Press the wheel. The Ultrasound Menu appears. This is a Level 1 menu.

Trace Separation 0 bpm FHR Upper Limit 150 bpm FHRLower Limit 50 bpm FHR Alarm Delay 30 sec Loss of FHR Delay 120 sec

Alarm Status

Ultrasound Menu

(level 1 menu)

TOCO

Return

(5)

cm/min

3. Rotate the wheel to highlight Alarm Status.

Trace Separation 0 bpm

“Alarm Status”

highlighted

TOCO

FHR Upper Limit 150 bpm FHRLower Limit 50 bpm FHR Alarm Delay 30 sec Loss of FHR Delay 120 sec

Alarm Status

Return

(5)

cm/min

Ultrasound Menu

Disable

Jane Doe 194848

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Ultrasound Menu

Disable

Jane Doe 194848

16:34:12 2/14/2001

26 General Information

Changing Monitor Settings

4. Press the wheel. A Level 2 menu appears and the current value is highlighted. This illustration shows Disable.

Alarm status

level 2 menu

“disable”

TOCO

Ultrasound Menu

Trace Separation 0 bpm FHR Upper Limit 150 bpm FHRLower Limit 50 bpm FHR Alarm Delay 30 sec Loss of FHR Delay 120 sec Alarm Status

Return

(5)

cm/min

Jane Doe 194848

16:34:12 2/14/2001

5. Rotate the wheel to highlight the value “Enable”.

Alarm status level 2 menu

“enable”

TOCO

Ultrasound Menu

Trace Separation 0 bpm FHR Upper Limit 150 bpm FHRLower Limit 50 bpm FHR Alarm Delay 30 sec

Loss of FHR Delay 120 sec

Alarm Status

Return

(5)

Disable Enable

Jane Doe 194848

16:34:12 2/14/2001

“Return”

cm/min

6. Press the wheel to activate the change.

7. Rotate the wheel to highlight “Return”.

8. Press the wheel to return to the normal monitoring screen.

Changes take effect when you exit from the menu. While a menu is displayed, if no wheel or button activity occurs for 20 second s, the men u closes and return s to the monitoring screen.

General Information

Preparing for a Monitoring Session

When this Guide tells you to “Select” an item, it means you must rotate the wheel until the item you want is highlighted. “Confirm” means press the wheel to activate your selection.

Preparing for a Monitoring Session

Before you start monitoring, visually inspect the monitor, transducers and accessories to make sure that all are in good condition. If any part is broken or damaged you should not use it.

Fastening a Belt

Arrange the belt around the patient until it is tight but still comfo rt a ble. Fas ten it by pushing the fixing button through the over la ppi ng s ectio n of t he b e lt, w ith the point facing away from the patient. Ensure that the fixing button and the loose ends of the belt are at the patient’s side.

Do not overtighten the belt; excessive compression of the maternal abdomen is uncomfortable for the patient and may result in incorrect measurements.

28 General Information

Clipping a Transducer to the Belt

Secure the belt as described above. When you have positioned a transducer satisfactorily clip it to the belt, taking care not to catch the belt material in the edge of the ring clip. You can then slide the transducer along the belt to reposition it if necessary.

Every patient is different, and correct transducer placement is important to ensure proper monitoring.

Preparing for a Monitoring Session

Alternatively, you can fix a button to the transducer and use this to attach the transducer to the belt. See the Installation Note that comes with the Transducer Knob Adapter for assembly instructions.

Caution

Connecting a Transducer to the Monitor

Connect the color coded transducers (brown for Toco, red for Ultrasound) to the matching color socket at the side of the monitor.

General Information

Preparing for a Monitoring Session

Eliminating Electromagnetic Interference

An electromagnetic field can interfere with the ultrasound transducer and cause a false heart rate reading that does not originate from the patient. Although this is rare, it might happen in the vicinity of large machinery. To avoid the possibility of these signals being misinterpret ed as fetal heart rates, you should follow this procedure before you start monitoring whenever the monitor is used in a new location or if you know that electrical machinery is being operated in the vicinity.

Connect the ultrasound transducer to the monitor, do not yet posi tion on patient, and observe the heart rate indications on the screen for 30 seconds. An intermittent display of random heart rates (this is called artefact) is acceptable. However, if there is a constant display of a heart rate lasting more than five seconds, this is an indication that there is a source of electromagnetic interference in the vicinity.

You can use the monitor in this environment if the artefact heart rate indication ceases when you:

• Move all line cords and line-powered equipment at least six feet away from the monitor. Remember to check for extension cords running behind or under the bed and for equipment in adjacent rooms.

• Remove the power cord from the monitor’s power supply and operate from battery.

• Unplug the monitor’s recorder and move it out of the vicinity.

If these measures do not result in the cessation of the heart rate artefact, you cannot use the monitor safely in this environment.

Configuring Patient ID

When you switch the monitor on, it creates a Patient ID based on the current date and time. For example, if you turn the monitor on at 4:37:54pm on May 11 2001, the Patient ID will be 051101163754. (month.day.year.hour.minute.second).

1. The monitor always uses this form at for the ID, ev en if you h ave chosen 12 hour time format, or DD.MM.YYYY date format.

30 General Information

Preparing for a Monitoring Session

If you want to give a more meaningful identification, you can change the ID to, for example, the patient’s name, or perhaps medical record number. A subsequen t change (or correction) of this patient ID automatically closes th e current record and starts a new record with a new ID.

Use the Patient ID Menu to change the default patient identification.

1. Select the Patient ID frame. Patient ID Menu

Patient ID Menu

Patient ID 0214961630

TOCO

current patient ID

2. Select the patient whose ID you want to enter.The monitor displays the

Set Patient ID menu.

3. Rotate the wheel to highlight a character in the Patient ID.

4. Press the wheel to activate the character.

5. Rotate the wheel until the monitor displays the character you want.

Available characters are 0-9, A-Z (uppercase only) and “space”, with 24 character maximum.

6. Press the wheel to save the change. Repeat until you have completed the

Patient ID.

7. Select:

– OK to store this new Patient ID. – Clear reset the Patient ID to blanks.

(5)

cm/min

Return

0214961630

16:34:12 2/14/2001

patient ID frame

General Information

Preparing for a Monitoring Session

Cancel to abandon your changes and leave the original patient ID unchanged.

patient ID sub-menu

Adjusting Alarm Limits

Always check that the current alarm limits are appropriate for your patient. If they are not, adjust them. Instructions for checking and adjusting alarms are given in the chapter for the parameter you are measuring. When you switch off the monitor, the most recently set alarm limits are retained. They are not reset to factory defaults when you next switch on.

TOCO

(5)

cm/min

press Cancel to

abandon changes

Patient ID Menu

Patient ID (0214961630)

Set Patient ID

0214961630

Return

0214961630

ClearCancel

16:34:12 2/14/96

press “Clear” to reset

patient ID

Marking an Event

Use the remote marker to record significant events (for example, when pain medication is administered or when the mother changes position). This marker time is recorded on the fetal trace. There are two markers:

32 General Information

Clinician marker: clinician presses the marker key on the monitor. The

trace is marked with a downwards facing arrow, in the uterine activity area of the trace.

Patient marker: patient presses the button on the remote event marker cable. The trace is marked with an upwards facing arrow in the heart rate area of the trace.

Multiple rapid presses result in partial printing of all mar ker arrows and full printing of the last one.

Finishing a Monitoring Session

Always switch off the monitor between patients to ensure that a new fetal trace and ID are generated when you switch on ag ain for the nex t patien t. If you allo w the monitor to run without switching off between patients, it will store this “empty trace” in its memory. This is confusing when you use the scroll feature, and wasteful of paper when you print the fetal trace.

Configuration Settings

The monitor ships with some factory-set defaults for user-con figurable items (such as alarm limits, alarm delays and so forth). In most cases, the monitor retains the most recent change to these values after it is switched off and then on again.

There are two exceptions. US trace separation value always returns to 0 and the monitor always generates a new patient ID when the power is cycled (that is, when the monitor is switched off and then on again).

General Information

Using the Battery

You can run the monitor for approximately six hours on battery power at room temperature of 25 monitoring at 10 operating temperature and number of recharge cycles affects this. A battery life cycle is approximately 200 charge/discharge cycles.

Low Power Warning

A low power warning occu rs when the battery power i s ru nning low. The battery fuel gauge flashes, and a repetitive audible tone sounds. Remaining monitoring time is typically 30 minutes with a new battery at room temperature of 25 an older monitor, in which the battery has had a number of recharge cycles, it may occur when fewer minutes remain.

The warning continues until the low power condition disappears (when you connect the monitor to an AC power supply) or until the system stops functioning because of the low power.You cannot silence it, and you cannot adjust its volume.

The monitor retains any stored fetal traces, even if it shuts down because of lack of battery power.

Recharging the Battery

C from a fully charged battery (with a minimum of two hour s

C from a fully charged battery). The age of the battery,

C. In

Use the power supply to recharge the battery from an AC power source. This takes a maximum of 14 hours when monitoring simultaneously, or 8 hours if no monitoring occurs. Typical times are 11 hours if you are monitoring simultaneously, or 4.75 hours if no monitoring occurs.

Replacing the Battery

Life expectancy of a battery depends on the frequency and duration of use. We recommend replacing the battery every 2 years.

34 General Information

Only a trained service professional should change the battery; instructions are given in the Service Guide.

Replace the battery if it is known to be fully charged and the following conditions occur:

• battery discharges quickly when you are using it

• the remaining time in the battery after the battery alarm first occurs is less than 10 minutes.

• the battery does not recharge to full capacity (indicated by the battery fuel gauge on the monitor).

Storing

A stored battery loses capacity over time. To minimize loss of capacity, recharge the battery at least every six months. A battery typically has three to five years shelf life.

Getting the Best out of Your Battery

Unlike a nickel-cadmium battery, a lead acid battery does not have a “memory”, and so there is no need to discharge it before recharging it. Here are some tips to help you get the best out of your battery:

Demonstration Mode

• Run the monitor from its power supply where possible.

• Recharge a stored monitor periodically.

• For convenience, recharge the battery fully after use.

Demonstration Mode

The monitor has a demonstration mode in which the monitor can perform all normal monitoring display, communications and printing activity using the internally generated data (except ultrasound audio output). You can change alarm limits, status and so forth. You enable and disable Demo mode using the Power status frame’s Service Menu. Switching the monitor off and then on again also disables Dem o mode.

General Information

Demonstration Mode

Points to note about Demo mode:

• The monitor displays the word >>Demo!<< in the Patient ID so that you can see that you are not viewing or monitoring real patient data.

• Connecting a transducer does not disable the Demo mode.

• Disabling Demo mode via the Service Menu, or switching the monitor off and then on again, automatically starts a normal record.

• The demo trace is stored in the memory each time you enter Demo mode. The Demo trace always has the ID >>Demo<< and contains the same trace data.

Caution

Do not mistake demonstration data for genuine patient data.

36 General Information

Monitoring Fetal Heart Rate

Monitoring fetal heart rate using ultrasound is recommended from the 25th week of gestation for non-stress or normal routine fetal monitoring. Performing imaging at the same time as ultrasound fetal monitoring may cause false FHR readings, and the trace recording may deteriorate.

FHR Monitoring

What You Need

• Ultrasound transducer

• Ultrasound gel

• Transducer belt and button

Preparing the Monitor

1. Switch the monitor on and make sure the normal monitoring screen appears on the display.

2. Check the monitor’s power source. If you are using battery power, check the power status frame to ensure that the battery has sufficient charge to complete the monitoring session. Use the power supply if the charge is too low.

3. Check for electromagnetic interference (see page 30).

4. Plug the Ultrasound transducer into the monitor’s US1 socket.

5. Check, and if necessary change, the alarm settings (see page 43).

1. Never start a new monitoring se ssion if the monito r has been left o n from a previous session. Cycle the power (switch off then on again) be fore starting to monitor. This ensures that the monitor generates a new fetal trace record, with unique ID.

Monitoring Fetal Heart Rate 37

FHR Monitoring

6. Adjust US1 speaker volume to mid level. If you are monitoring twins, adjust US2 to off.

Finding the Fetal Heart Rate

1. Fasten the belt around the patient.

2. Find the fetal heart position by palpation, auscultation or ultrasound imaging.

3. Apply a small amount of ultrasound gel in a thin layer to the transducer.

4. Apply the transducer to the patient, working it in a circular motion to ensure the gel layer makes good contact.

5. When you have a good signal clip the transducer in position on the belt. It can take approximately 10 seconds to get a valid HR signal.

6. Verify that the monitor is displaying a numeric fetal heart rate value. The heart rate icon flashes at the measured heart rate interval when a valid rate is present.

WarningWarning

Periodically compare the mother’s pulse with the FHR signal coming from the monitor to ensure that you are monitoring fetal heart rate and are not accidentally recording maternal heart rate. Do not mistake a doubled maternal heart rate for FHR. For the same reason, be very careful when interpreting a trace if you suspect fetal demise. The maternal heartrate may be atypically high and therefore confused with that of a live fetus.

38 Monitoring Fetal Heart Rate

WarningWarning

Never immerse the ultrasound transducer in liquid when it is connected to the monitor unless the monitor is running on battery power only, and is not directly connected to the AC power supply, and/or an other device (such as a printer).

Interpreting the Data

However, interpretation of the trace is left to the clinician’s judgement. Remember that cardiac arrhythmias or other abnormalities can cause erratic trace data.

Disconnect unused ultrasound transducers. Continuous mechanical influence of the unused transducer could result in an artificial trace.

Monitoring Twins

If you have two ultrasound transducers, you can monitor a second fetus on the second ultrasound channel. You require a second belt.

Finding the Second FHR

Connect the second transducer to the second ultrasound socket (US2). Follow the previous steps to acquire the heart rate for the first fetus. Decrease the speaker volume for US1, and increase the volume on US2 so that you will be able to hear the second heart. Locate the second fetus, and verify that the monitor displays the numeric fetal heart rate values for both fetuses. The second heart rate icon flashes at the measured heart rate interval when a valid rate is present.

Monitoring Fetal Heart Rate

Monitoring Twins

Separating Two FHR Traces

To help you distinguish between fetal traces, you can offset the second fetal heart rate by 20 BPM. The second heart rate appears on the trace 20 BPM lower than it really is. The heart rate value shown in the numeric frame is not affected.

Use the Ultrasound menu to activate trace separation:

1. Select the FHR numeric frame to display the Ultrasound menu

Ultrasound Menu

Trace separation

TOCO

Ultrasound Menu

Trace Separation 0 bpm FHR Upper Limit 150 bpm FHRLower Limit 50 bpm FHR Alarm Delay 30 sec Loss of FHR Delay 120 sec

Alarm Status

Disable

Return

(5)

cm/min

2. Select Trace Separation. When trace separation is active, flashes next to the US2 numeric value.

3. Rotate the wheel to display either 0 (no trace separation) or 20 (traces separated by 20 BPM). Confirm your choice.

Jane Doe 194848

16:34:12 2/14/2001

40 Monitoring Fetal Heart Rate

Adjusting Ultrasound Volume

Press the speaker button and rotate the navigation wheel to increase or

decrease the amplitude of the ultrasound heart volume. The volume icon gives you an indication of the speaker volume.

US1 You do not need to connect a transducer to the US1 channel to change the

volume of US1.

1. Press the speaker button once to select the volume for US1.

2. Rotate the wheel to adjust volume.

3. Press the speaker button to save the setting.

US2 Connect a transducer to US2 channel. It is not necessary to connect a transducer

to US1 first.

Adjusting U ltrasound Volume

1. Press the speaker button twice to select the volume for US2.

2. Rotate the wheel to adjust volume.

3. Press the speaker button to save the setting.

Monitoring Fetal Heart Rate

Understanding FHR Alarms

---

Understanding FHR Alarms

The monitor can alert you if the fetal heart rate goes above or below the alarm threshold for a time that exceeds the alarm delay setting, or if it loses the heart rate signal entirely. You can configure these limits and times. You must ensure the alarm status is set to enable (via the ultrasound menu, see page 44) if you want the monitor to warn you if an alarm condition occurs.

Alarm type what you see and hear

Alarm limit exceeded

Signal loss alarm F et al heart rate frame flashes

Fetal heart rate numeric val ue flashes. Monitor sounds a warning tone.

. Monitor sounds a warning tone.

Silencing the alarm

Press

...what happens

The monitor is silenced. The alarm icon is crossed through, and the FHR value con tinues t o flas h whil e alarm condition persists. When alarm condition ends, visual and audible alerts are reactivated . The alarm icon is no longer crossed through.

The monitor is silenced. The alarm icon is crossed through and the FHR value continues to display dashes while alarm condition persists. When alarm condition ends, visual and audible alerts are reactivated . The alarm bell icon is no longer crossed through.

42 Monitoring Fetal Heart Rate

Configuring FHR Alarms

1. Select the Ultrasound Menu

Understanding FHR Alarms

Ultrasound Menu

alarm parameters

TOCO

Ultrasound Menu

Trace Separation 0 bpm FHR Upper Limit 150 bpm FHRLower Limit 50 bpm FHR Alarm Delay 30 sec Loss of FHR Delay 120 sec

Alarm Status

Disable

Return

(5)

cm/min

alarm status parameter

2. Rotate the wheel to highlight the alarm limit you want to change.

3. Press the wheel to select it. The monitor highlights the current val ue.

4. Rotate the wheel until the desired new limit is shown.

5. Press the wheel to confirm this choice.

6. Select “Return” to go back to the main monitoring screen when you have configured the alarm parameters appropriately for your patient.

Jane Doe 194848

16:34:12 2/14/2001

enabled or disabled

These settings remain active even after the monitor is switched off and then on again. Always check that the settings are appropriate for each patient before you start monitoring her.

Monitoring Fetal Heart Rate

Understanding FHR Alarms

Alarm Settings

Alarm Comments

FHR upper limit Fetal heart rate value at or above which the alarm so und s.

Range: 110-220 BPM (increments of 5) Factory default: 150 BPM

FHR lower limit Fetal heart rate value at or below which the alarm sounds .

Range: 50-120 BPM (increments of 5) Factory default: 110 BPM

FHR alarm delay Time during which the fetal heart rate is at, or exceeds, alarm limit

before alarm sounds. Range: 10-120 seconds (10 second increments) Factory default: 60 seconds

Loss of FHR delay Time delay between monitor losing a valid fetal heart rate and then

sounding the alarm. Range: 10-120 seconds (10 second increments) Factory default: 120 seconds

Alarm status Enable: All alarms are on.

Disable: All alarms are off (default)

Alarm Defaults The monitor saves alarms settings until they are next changed. When you switch

the monitor on it uses the most recently set alarm settings. It does not revert to a factory-set default.

Monitoring

Twins

44 Monitoring Fetal Heart Rate

When you are monitoring twins, the alarm settings apply to both FHR1 and FHR2.

Determining FHR Acceleration Using Grid Lines

During normal monitoring, the screen displays two parallel horizontal lines in the ultrasound trend frame, located at 110BPM and 150 BPM to provide a reference for estimating heart rate (normocardia).

To help you determine heart rate accelerations, particularly when performing a non stress test (NST), you can narrow the distance between these lines to 15 BPM. You can also move this pair of lines on the trace. For example, turn the navigation wheel until the lower grid line lies on the heart rate baseline; use the other grid line as a reference to determine the duration and frequency of accelerations of at least 15 BPM. The timing marks are one minute apart.

1. Press , located on the monitor’s front panel. This automatically relocates the horizontal lines to a distance of 15 BPM

apart.

Ultrasound trend frame

timing marks

grid lines

2. Rotate the navigation wheel to move these lines, as a pair, up and down. They return to their normal position (at 110 and 150 BPM) if you do not

use the wheel for 30 seconds or if you press again.

Monitoring Fetal Heart Rate

Determining FHR Acceleration Using Grid Lines

The first time you use grid line mode in a monitoring session the lines are at 120 BPM and 135 BPM. If you re-enter the mode during the same session, the monitor redraws them at their most recent location.

46 Monitoring Fetal Heart Rate

The monitor records the frequency and duration of contractions but not their intensity. The intensity is a relative measurement that depends on patient size and anatomy, patient position, transducer position and belt tension.

To obtain an absolute measurement, you must monitor intrauterine pressure (not possible using this monitor).

Toco Monitoring

What You Need

• Toco transducer

• Transducer belt and button

Monitoring Uterine Activity

Preparing the Monitor

1. Switch the monitor on and make sure the normal monitoring screen appears on the display.

2. Check the monitor’s power source. If you are using battery power, check the power status frame to ensure battery has sufficient charge to complete the monitoring session. Use the power supply if the charge is too low.

3. Plug the Toco transducer into the monitor’s Toco socket.

Acquiring Uterine Activity Data

1. Fasten the belt around the patient.

2. Place the transducer face on the uterus’s fundus

1. The pressure-sensing button is on the transducer face.

Monitoring Uterine Activity 47

Toco Monitoring

3. Clip the transducer in position on the belt. Tension the belt enough to keep the transducer in complete contact with the skin.

4. Go to Toco menu and check baseline value. Adjust if necessary.

5. Press the Toco Baseline button once, between contractions. This zeroes the display and trace to the Toco baseline value.

6. Start monitoring.

The following example trace shows three contractions.

Setting the Toco Baseline

Use the TOCO menu to change the Toco baseline value:

1. Select the Toco frame.

2. Select Toco Baseline menu item.

3. Choose a baseline value. A pop-up menu allows you to choose a baseline value of 5, 10, 15 or 20. The current value has an arrow next to it. Rotate the wheel to move the

48 Monitoring Uterine Activity

Toco Monitoring

cursor up and down the list. Confirm when the required baseline value is highlighted.

Toco Menu

TOCO

TOCO Menu

TOCO Baseline

Return

(5)

cm/min

JANE DOE 194848

16:34:12 2/14/2001

Toco baseline selected

10 15 20

current Toco

baseline value

Monitoring Uterine Activity

Using the Toco Grid Line

The Toco trend frame has a line, with timing marks, to help you easily locate the Toco baseline. If the baseline changes, this line relocates to the new value.

US 1

US 2

TOCO

(5)

cm/min

240

150 110

100

Toco grid line

JANE DOE 194848

16:34:12 2/14/2001

Toco trend

frame

50 Monitoring Uterine Activity

The monitor can store up to 12 hours of patient data. Usually, you see only the most recent few minutes of this data on screen. If you want to see earlier data from the present monitoring session, or historical data from previous monitoring sessions of other patients, you can use the trend scroll. The Patient ID changes as you scroll through the fetal traces so you always know whose data you are viewing.

While in trend scroll data you can still see the vital signs for the current monitoring session in the US and Toco numeric frames.

Entering Trend Scroll

Using Trend Scroll

Press to enter trend scroll mode. This marker appears on the screen to show that you are in trend scroll mode. Turn the navigation wheel clockwise to review older data, counter-clockwise to show more recent data.

The trend screen does not display data from two patients at the same time. When you get to the end of one fetal trace, you will see an empty frame. If you continue to scroll, the screen begins to fill with data from the previously stored fetal trace. You can view all stored fetal traces in this way.

When you get to the end of all stored fetal traces, the monitor beeps if you try to turn the wheel further.

Rotate the wheel slowly and the trend scrolls slowly. If you rotate it slightly more quickly, the scrolling speed increases. The top scroll speed is fixed and not determined by how quickly you rotate the wheel.

Using Trend Scroll 51

Entering Trend Scroll

What Data Will I See?

Stored Data

240

150 110

150

TOCO

100

(5)

cm/min

JANE DOE 194848

16:30:12 2/14/2001

1. Trend scroll mode “on” indicator.

2. ID of patient whose trend data is being reviewed (you may scroll to a

patient other than the patient currently being monitored).

3. Time and date when data values shown at reference line were recorded.

4. Toco value at reference line.

5. Vertical reference line centered in the Toco trend frame.

6. Vertical reference line centered in the heart rate trend frame.

7. FHR value at reference line.

The lines, (5 and 6) centered in the FHR and Toco trend frames, are the reference points through which Toco and FHR values pass as the data scrolls through the display.

52 Using Trend Scroll

Entering Trend Scroll

Current Data When you are in trend scroll mo de you will still see important (unscrolled)

numeric data for the current monitoring session.

1. FHR of current monitoring session

2. Toco value of current monitoring session

3. Current communications status

4. Current power status

Printing a Trend Section

While in trend scroll mode you can mark the start and end boundaries of a section of trend and print it. Ensure that you have a printer or the recorder attached when you request a print.

TOCO

150 110

100

(5)

cm/min

240

150

JANE DOE 194848

16:30:12 2/14/2001

1. While in trend scroll mode, press the navigation wheel. The monitor displays the Mark Print Boundary menu.

2. Choose “Yes” to accept the time at the center of the screen as the first boundary of the section you want to print.

3. Rotate the wheel to scroll through the trend until the time at the center of the screen represents the second boundary of the section you requir e. Take care that this is still within the same patient fetal trace.

4. Press the wheel again to display the Mark Boundary and Print menu.

Using Trend Scroll

Entering Trend Scroll

5. Select Yes to mark the second boundary and send this to the printer or recorder. If you press “Clear Boundary” now, the first boundary marker is cleared, allowing you to reset it.

Exiting Trend Scroll Mode

Press the trend scroll button a second time to leave this mode. The monitor automatically returns to the main monitoring screen if you do not touch the navigation wheel for 30 seconds.

54 Using Trend Scroll

Printing and Transmitting Records

This chapter tells you how to transmit fetal traces from the monitor to

• the monit or’s own recorder

•a PC printer

• a system, suc h as OB TraceVue or a PC running FM-2 viewer utility

software.

Setting up the Modem

Before you can transmit fetal traces to a remote system you need to install, setup and initialize an approved modem at the monitor, and also at the remote system.

Number to Dial

Into the monitor you must program the telephone number of the remote modem it must contact. If you transmit to only one remote modem, you will only need to enter this number only one time. However, if you dial a variety of remote modems, you must set this each time you want to dial a different modem.

1. Select Communications Menu -> Number to Dial.

2. In the “Set Phone Number” window, turn the navigation wheel to highlight the first character position and press to select. Rotate the navigation wheel to cycle through the available characters and digits for this position. Press the wheel to fix your chosen digit.

3. Move to the next position and repeat, until the complete telephone number is entered.

4. Select “OK

Printing and Transmitting Records 55

Setting up the Modem

Modem Initialization

For full details, see the FM-2 Service Guide.

Default Initiali-

zation String

Pulse/Tone

Dial

Local Branch

Exchange

FM-2 uses the modem’s default values. If data transfer works with these, then you do not have to enter any modem initialization string.

1. Select Communications Menu -> Modem Initialization.

2. If you need to enter any initialization data, the procedure is the same as described for entering the modem telephone number.

A telephone system may use either pulse, or tone, dialling. The modem needs to know which. If the modem’s default value is not appropriate for your telephone system, you will have to change it. Enter either “P” for pulse, or “T” for tone in the modem initialization string, as appropriate for your system.

The modem expects a public line with a continuous tone. If you use a local branch exchange, this might not occur. Therefore you should enter “X0” (this is known as the ‘blind dial’) in the initialization string.

Communications Menu

TOCO

Communications Menu

Data Transfer Stopped Destination

Set Mode m Init String

Paper Output Paper Speed

Paper Style Modem Initialization

Number to Dial

Return

(5)

min.

OK Cancel Clea r

JANE DOE 194848

16:34:12 2/14/2001

Printer/Record er Current Reco rd

(3 cm/min)

Set Modem

Initialization String

entering tone dialling (T), and blind dial (X0)

56 Printing and Transmitting Records

Printing and Transmitting Records

You can print realtime to the recorder, or to an OB TraceVue system. You cannot print realtime to a printer, or to FM-2 viewer. You cannot simultaneously print a paper trace and link realtime to OB TraceVue.

A fetal trace is never deleted from the monitor after transmission or retransmission. The only way a fetal trace is erased from the monitor is if the memory space is needed by the current monitoring session. The current fetal trace gradually overwrites the oldest fetal trace completely.

Process Overview

The steps are

1. Choose Paper Output Type (recorder/printer only)

2. Choose Output Destination

3. Start Data Transfer

4. Choose which records to transfer (system batch, FM-2 viewer, patient records only).

Printing and Transmitting Records

Note—The monitor ignores any choice that is not appropriate for the task you

are performing (for example, if you choose “System Batch” the monitor will ignore all “Paper Output” settings).

Choosing

Paper Output

Type

Printing and Transmitting Records

For output to the printer or recorder, you need first to specify what type of printed output you require. Select Communications Me nu - > P aper Output. Choose from:

Summary list a list of all stored patient IDs (available for printer

only).

Current Record print the current patient fetal trace, realtime, on the

recorder, from now until data transfer stops (available for recorder only).

Patient Records one or more patient fetal traces (available for both

printer and recorder).

Printing and Transmitting Records

Choosing Out-

put Destina-

tion

After choosing the printed output type, you must specify a destination. For all other types of output, you only have t o specify th e output destination. Select

Communications Menu -> Destination. Choose from:

Printer/Recorder • use with “summary list”, “current record” or

“patient records”.

FM-2 viewer • use to send stored fetal traces either directly, or

via a modem, to FM-2 viewer software. With a modem connection, the destination phone is automatically dialled before the first fetal trace is transferred and hung up after the completion of the final fetal trace transfer.

System Online • send the current patient fetal trace, realtime, to

OB TraceVue, from now until data transfer stops. Note that a simultaneous printed trace output is not possible with this choice.

System Batch • use to send stored fetal traces to OB TraceVue

via a modem link. The destination phone is automatically dialled before each fetal trace is transferred and hung up after the completion o f each transfer.

58 Printing and Transmitting Records

Printing and Transmitting Records

Starting the

Transfer

After choosing the destination, you must start the transfer. Select Communications Menu -> Data Transfer and then “Yes” to start the transfer.

Select “Data Transfer”

TOCO

(5)

Communications Menu

Data Transfer

Destination

Paper Output Paper Speed

Modem Initialization Number to Dial

Return

min.

Start Data Transfer?

Yes No

Yes

JANE DOE 194848

16:34:12 2/14/2001

select “Yes” to start data transfer

Stopped

Printer/Recorder Current Record

(3 cm/min)

Printing and Transmitting Records

Choosing

Which Fetal

Traces

When you choose “Patient Records”, “System Batch”, or “FM-2 viewer” the monitor prompts you with the ID of the most recent patient

Communications Menu

TOCO

(5)

Communications Menu

Data Transfer Stopped Destination System Batch Paper Output Patient Rec ords

Paper Speed 3 cm/min

Print JANE DOE 194848?

Paper Style USA Modem Initialization

Modem Number To Dial

Return

cm/min

No All CancelYes

No All

JANE DOE 194848

16:34:12 2/14/2001

(3 cm/min) (U.S.)

1978555122

abc d

You can choose:

a. Yes: print/transfer this fetal trace. b. No: do not print/transfer this fetal trace, display next patient ID. c. All: print/transfer current patient fetal trace and all subsequent

patient fetal traces.

d. Cancel: return to the Communications Menu.

During realtime printing on the recorder, or realtime monitoring on OB TraceVue, if the communication is interrupted, the monitor tries to re-establish communication once the problem is cleared.

60 Printing and Transmitting Records

Communication Status

Printing and Transmitting Records

Communica-

tion status

You see this when... Comments Port

...the monitor has successfully detected its modem an d i s tr yi n g t o connect with another modem

...the modem successfu lly c onnect s with another modem

...the monitor detects that a PC is connected to the commu n ications port

...the monitor is starting to print at the recorder.

The data transfer dialog box shows the dialing number, and dialing starts au to matically. You will he ar t he dial tone, and dialing process fro m the modem speaker.

Transfer occurs automatically when the monitor and remote computer are connected. The data transfer dialog box shows the ID of the fetal trace bein g transferred, the total number of traces for transfer, and th e percentag e o f the transfer that has already happened. Each fetal trace contains an integrity check. If it fails the check, the fet al trace is automatically retransmitted. If it fails a second time, the monitor displays a warning m essa ge and c an cels the transfer.

The monitor and external PC can communicate directly with each other. If a sla sh appears through the PC this means that communication has been interrupted. The slash will go away when communication resumes.

The icon is d isplayed when data transfer is initiated. The icon is accompanied by the present setting for the print speed. When it flashes, this indicates that the device needs attention, for exampl e when the paper is low or runs out, or if the monitor detects a recorder error. If a slash appears through the PC this means that communication has been interrupted. The slash will go away when communication resumes.

Serial

Parallel

...the monitor is starting to print at the printer.

The icon is d isplayed when data transfer is initiated. The icon is accompanied by the present setting for the print speed.

Parallel

Printing and Transmitting Records

Recommended Modem s and Printers

Recommended Modems and Printers

These have been tested and are supported by Agilent. The list is correct at time of print, but the list of recommended modems and printers may be revised or updated periodically. Check with you r l ocal Res pon se C e nter i f y ou n eed further details.

Modems

Multi-Tech MT-5600ZDX (use modem’s default initialization string) Nokia 6210 cellular phone modem.

Printers

HP DeskJet 640c HP DeskJet 840c HP Deskjet 990Cxi

62 Printing and Transmitting Records

Communications

Serial Port Communications

The monitor has an RS232 interface port for communications to:

• a modem

• a cellular telephone modem

• a PC/AT computer.

The RS232 communications protocol supports:

• direct connection to OB TraceVue

• direct patient data transfers to FM-2 viewer

• communications with a Nokia 6210 cellular phone modem

• communications with a MultiTech systems model MT-5600ZDX modem.

Parallel Port Communications

The monitor has a PC parallel port for communications with

Communications

•printer

• FM-2 (M2925A) recorder

Printing and Transmitting Records

Communications

Cabling

Recorder M2925A

Printer

Printer Cable

HP C2951A

Printer cable

(eg HP C2951A)

FM-2 Fetal

Monitor

M2922A

Direct link RS-232

9P female - 9P female

null-MODEM cable

Direct link RS-232

9P female - 9P female

null-MODEM cable

OB TraceVue

Client or other

system

FM-2 viewer

software

M2926A

(running on

PC)

Modem

AT Serial MODEM cable

25P Male - 9P Female

3 ft minimum

64 Printing and Transmitting Records

Cable to.... Comments

...Recorder Comes with recorder.

Replacement can be ordered under: HP C2951 or replaced with PC parallel printer cable (conforming to IEEE

1284)

...Printer Might come with printer or buy locally.

Replacement can be ordered under: HP C2951A or replaced with PC parallel printer cable (conforming to IEEE

1284)

...OB TraceVue client Order OB TraceVue M1380C option K10 ...PC running FM-2 viewer Comes with FM-2 viewer software. ...Modem Comes with modem

(if not, locally source 25P Male -9P female, minimum length 3ft)

Communications

...Cellular telephone with supporting-modem capability

Comes with cell phone. If not, source 25P Male - appropriate cell phone connection from cell phone manufacturer or other supplier.

Printing and Transmitting Records

Communications

66 Printing and Transmitting Records

Monitor

Cleaning

This chapter tells you how to care for your system.

WarningWarning

Unplug the monitor and recorder from the AC power source and detach all accessories before cleaning. Do not immerse the monitor in water or allow liquids to enter casing.

Caution

Take extra care when cleaning the display surfaces, which are sensitive to rough handling. Rub the lens that covers them with a soft, dry cloth.

Keep the external surface clean and free of dust, dirt and residual liquids. Clean with a damp cloth using mild soap and water or hospital approved, non-abrasive disinfectants.

Cleaning 67

Transducers (Cleaning and Low Level Disinfection)

Before starting cleaning or disinfection, carefully review the technical information and follow all the precautions for use, safety, storage and disposal of the cleaning and disinfecting agents as listed by their manufacturers.

For devices intended for use on immunocompromised patients, use sterile water for rinsing and a sterile towel for drying the device during the cleaning and disinfection process.

The Blue Ultrasound and Toco transducers are protected against the effects of continuous immersion in water according to IEC 529 IP 68.

Do not:

• immerse a transducer in water when it is connected to the monitor if the monitor is running on AC power.

• handle transducers roughly. This could damage the cover, piezoelectric crystals and mechanical movement. Transducer covers are made of soft plastic; avoid contact with hard or sharp objects.

• flex the cables excessively.

• allow cleaning solutions or transducers to exceed a temperature of 45

• autoclave the transducers and cables or heat them above 70

• permit the Toco transducer’s ventilated cable connector to become wet as

(113

F).

liquid can enter the ventilation tube through capillary action.

C (158oF).

Caution

Do not immerse the transducer connectors during any stage of the cleaning/ disinfection process.

Caution

Do not autoclave. Do not gas sterilize.

The following cleaning and low level disinfection procedures have been validated.

68 Cleaning

Transducers (Cleaning and Low Level Disinfection)

The cleaning procedure will be more effective in reducing contamination if cleaning is done prior to drying of adherent visible soil (for example, organic matter or other debris) on the transducer.

Do not reuse alcohol for disinfection. Cidex instructions).

Cleaning and Disinfecting

® is reusable (see manufacture’s

Cleaning

1. Clean the transducer thoroughly using potable tap water and then a cleaning agent such as an

enzymatic detergent. Prepare the detergent as recommended by its manufacturer. Scrub the transducer in the detergent using a soft bristled brush for five (5) minutes.

2. Rinse the device with clean tap water for at least one (1) minute to remove detergent.

3. Visually inspect the transducer. If adherent soil is still present, repeat step s 1 and 2.

4. Dry the transducer thoroughly with a clean, soft towel.

Disinfecting

Use only one agent for disinfecting at any given time.

Using 70% Isopropanol

Using Cidex®

5. Submerge the transducer in 70%

Isopropanol for a minimum of ten (10) minutes, but not more than thirty (30) minutes.

Cleaning

5. Submerge the transducer in activated 2.4% Glutaraldehyde solution (Cidex®). Prepare the solution according to the manufacturer’s recommendations. Soak the transducer in the solution for a minimum of ten (10) minutes, but no more than thirty (30) minutes at 20-25

°C.

Transducers (Cleaning and Low Level Disinfection)

Cleaning and Disinfecting

6. Rinse the transducer with potable tap

water, ensuring that all parts are in contact with the water, for at least one (1) minute to remove residual alcohol.

6. Rinse the device by immersing it in three separate copious volumes of potable tap water. Each rinse should be a minimum of one (1) minute in duration. Use fresh portions of water for each rins e. ( Residues of Cidex® that remain on the transducer may cause adverse reactions such as skin irritation in the patient.)

7. Dry the transducer thoroughly with a clean soft towel.

8. Follow your facility's post-processing handling procedures to eliminate or minimize

recontamination of the device before reuse. Contact your facility's Infection Control Office or Epidemiologist for information regard i ng su ch procedu res .

a. For more information regarding cleaning agent compatibility, refer to the instructions/information supplied by the manufacturer.

The following disinfecting brands are believed to be compatible with the materials of the transducers described in this manual. However the performance of these disinfectants has not been validated for use with the transducers described here.

Aldehyde-based

Buraton liquid Gigasept®, Kohrsolin

, dilution of formaldehyde (3-6%),

Alcohol-based

Ethanol 70%, Cutasept forte, Sagrosept

, Hospisept®, Kodan®-Tincture

, Spitacid®, Sterilium fluid

70 Cleaning

Cleaning Belts

Wash soiled belts with soap and water.

Recorder

Caution

Water temperature must not exceed 60

WarningWarning

Unplug the recorder from the AC power source and detach all accessories before cleaning. Do not immerse the recorder in water or allow liquids to enter the case.

Clean the print head at least once a year or more often if necessary. Wipe the printhead and roller with a cottonbud soaked in isopropyl alcohol.

C (140oF).

Cleaning

Recorder

72 Cleaning

Using the Recorder or Printer

This chapter tells you how to install, set-up, and use the optional recorder (M2925A) and how to connect the monitor to a recommended printer.

In an antepartum environment, you can stand the monitor on top of, or close to the recorder for printing realtime. In a shared-recorder configuration where several monitors are used without a recorder, the monitors containing stored fetal traces collected from monitoring session(s) are brought to the printer for printing at a later time.

WarningWarning

Disconnect the printer or recorder from the AC power before connecting them to the monitor.

Caution

General purpose personal computers, printers and modems are not designed to meet the electrical safety requirements of medical devices. Connect them with a cable of sufficient length to locate them outside of the patient vicinity. This means a minimum distance of 1.5 meters from the patient’s bed or chair. Do not connect the FM-2 recorder to the monitor at the same time as a non-medical device (computer, printer or modem) if the recorder is located in the patient vicinity. For additional information refer to IEC/EN Standard 60601-1-1.

Using the Recorder or Printer 73

Working with the Recorder

Installing the Recorder

Place the recorder on a solid surface. Connect the communications cable to the connector at the back of the recorder, marked . Connect the other end to

its mating connector at the back of the monitor .

Attach the AC line cord to the IEC receptacle at the back of the recorder. Connect the other end to an appropriate AC outlet.

WarningWarning

The power receptacle must be a three-wire grounded outlet. Never adapt the three-prong plug from the power supply or accessory to fit a two-slot outlet. If the outlet has only two slots, make sure that it is replaced with a three-slot grounded outlet before attempting to operate the monitor.

WarningWarning

Do not connect to an electrical outlet controlled by a wall switch

74 Using the Recorder or Printer

Loading Paper

Working with the Recorder

WarningWarning

SHOCK HAZARD: Do no attempt to connect or disconnect a power cord with wet hands. Make certain that your hands are clean and dry before touching a power cord.

The printer is configured for Philips fetal monitor paper. Do not use paper from any other manufacturer. It might damage the printer.

1. Unwrap the paper.

2. With the printed grid visible, unfo ld o ne p a ge from t he to p o f t h e pack and lay it forwards across the top of the paper drawer. Make sure the Toco grid area is closest to the recorder keys.

3. Slide the paper into the paper tray:

4. Slide the paper drawer into the recorder.

Annotating Paper

Some types of pens may distort the paper. It is advisable to try out the pen on a piece of the same type of recorder paper.

Using the Recorder or Printer

Working with the Recorder

Use only the following types of paper:

Product Number

M1910A USA/Canada 30-240 Orange No Yes M1911A International 50-210 Green Yes No M1913A Interna-

a. Not available in Europe. Used mainly in Japan.

Storing Recorder Paper

Recorder paper is not intended for long-term archival storage. Another medium should be considered if this is required.

Dyes contained in thermal papers tend to react with solvents and other chemical compounds that are being used in adhesives. If these compounds come into contact with the thermal print, the print may be destroyed over time. Y ou can take the following precautionary measures to help avoid this effect.

• Store the paper in a cool, dry and dark place.

• Do not store the paper at temperatures over 40°C (104°F).

• Do not store the paper where the relative humidity exceeds 60%.

• A void intensive light (UV light), as this may cause the paper to turn gray or the thermal print to fade.

• Avoid storing the thermal paper in combination with the fol lowi ng conditions:

– Papers that contain organic solvents. This includes papers with

– Carbon paper and carbonless copy paper. – Products containing polyvinyl chlorides or other vinyl chlorides for

– Detergents and solvents, such as alcohol, ketone, ester and others,

– Products containing solvent-based adhesives such as (but not

Country

FHR Scale

Color

of Grid

kPa

Scale

Highlighted

3cm Lines

50-210 Green No Yes

tional

tributyl and/or dibutyl phosphates, for example recycled paper.

example (but not exclusively) document holders, envelopes, letter files, divider sheet s.

including cleaning and disinfecting agents.

exclusively) laminating film, transparent film or labels sensitive to pressure.

76 Using the Recorder or Printer

To ensure long lasting legibility and durability of thermal printouts, store your documents separately in an air-conditioned place and use

• only plasticizer-free envelopes or divider sheets for protection.

• laminating films and systems with water-based adhesives.

Using such protective envelopes cannot prevent the fading eff ect caused by other , external agents.

Using the Recorder

Connect the recorder to the monitor. Switch the recorder on using the AC switch on the rear of the recorder. An LED on the front confirms that the recorder is attached to an AC source and powered on.

Enable the recorder using:

1. Select Communications Frame

2. Select Communications menu -> Destination -> Printer/Recorder. The

3. Select Paper Output -> Current Record (or Patient Records)

4. Select Data Transfer -> Start Data Transfer? -> Yes

See “Printers” on page 62 for full details of how to select which fetal traces to transfer.

Working with the Recorder

recorder icon displays in the Communications frame.

Check that the recorder is feeding paper and the power on test pattern prints properly.

Using the Recorder or Printer

Working with the Recorder

As you monitor a patient, the trace is automatically printed on the trace paper

key/icon Use this... Comments

Paper advance

Printing Enable/Disable

Power-on Indicator

...to fast forward the recorder paper

...to toggle recorder mode between printing and standby

...to check that the recorder is ready to print.

Press and hold to advance paper at high speed (approximately 30 cm/minute) until you release the button.

Any text and graphics being printed during paper advance are lost. Printing resumes when you release the button.

The indicator LED next to the button is lit when printing is enabled. Printing is enabled by default when you switch the monitor on.

It flashes when the paper runs out. This is NOT a power on/off switch. That is located on

the rear of the recorder. This indicator is lit when the monitor is connected to

an AC line source, and the mains switch on the rear of the recorder is on.

78 Using the Recorder or Printer

Working with a Printer

Use a printer that is supported by Philips; other printers may give incomplete printouts, or may not work at all.

Connecting a Printer to the Monitor

Connect the printer to the 25 pin connector on the monitor, marked . Always follow the manufacturer’s instructions for setting up and using your

printer.

Using a Printer

You cannot use the printer in realtime mode, only for printing out traces stored in the monitor, or a list of stored fetal traces, showing patient ID. The printout mimics the data from the recorder.

Working with a Printer

Using the Recorder or Printer

Example Trace

You can print a fetal trace directly during monitoring to the recorder or, later from stored data, to a printer.

Monitor

details

FHR traces (twins monitoring - FHR1

is the darker of the two traces)

Patient ID, time, and date

monitoring

mode and

legend

twins separation on

A trace may show:

• FHR and Toco traces

• Clinician and patient markers

• Paper speed

• Paper style, US or International (on recorder-trace only)

• Time and date

80 Using the Recorder or Printer

event markers

Toco trace

Example Trace

• Installation or removal of a second ultrasound transducer

• Ultrasound trace separation

• Toco baseline value change

• Toco baseline adjust

• Patient ID

• Monitor software rev i sion

• US1, US2, Toco and legend, depending on whether the transducer is

attached or removed.

Each time you press print enable, the following header information appears (recorder only)

• Present time and date

• US1, US2, Toco and legend, if transducer is attached.

• Paper speed

• Paper style - US or International (on recorder-trace only)

• Patient ID

Using the Recorder or Printer

Example Trace

82 Using the Recorder or Printer

Maintenance and Performance

Preventive Maintenance

The monitor requires a new battery at least every two years, or sooner if the performance does not meet your expectation. After changing the battery, the monitor requires tests as specified in the Service Guide. Only qualified service personnel may change the battery.

There are no user serviceable parts within the monitor, only qualified service personnel are permitted to service or repair the monitor.

Calibration and Adjustment

Assurance

The monitor, recorder and accessories require no calibration and adjustment.

Maintenance and Performance Assurance 83

Performance Assurance

Testing the Monitor and Recorder

When any of the events listed in this table occur, you must perform the appropriate test. The tests are detailed below.

Event Required Test(s)

Monitor installation Visual and monitor power-on tests Monitor reinstallation (after

repair) Recorder installation Visual and recorder power-on tests Power supply replacement

Visual Test Visually inspect the monitor and accessories before use to ensure that the

monitor, cables, line cords, transducers and instruments have no visi ble evidence of damage that may affect patient safety or monitoring performance. Do not use if there is any visible sign of damage.

Monitor

Power-on Test

When you press , the monitor plays a power-on tone sequence while performing a power-on test. It displays a startup screen showing revision

information about the software release. In less than 15 seconds you will see the monitoring screen. If the monitor fails its self test, it will display an error screen, and monitoring functions will not be available. Remove the monitor from service.

To check the monitor, (and recorder if applicable):

1. Check that the monitor and recorder are properly connected together.

2. Check that the recorder has paper loaded in it.

3. Connect the monitor to the power supply.

4. Turn on the monitor and the recorder.

Visual and monitor power-on tests

Power-on

84 Maintenance and Performance Assurance

Performance Assurance

5. Check that the monitor successfully powers on, and displays the main monitoring screen. If an error occurs, it will display the error screen. Remove the monitor from service if this happens.

6. Check that the recorder is feeding paper, and that the power on test p attern prints properly. Remove the recorder from service if this does not occur.

Recorder

Power-on Test

Check that the recorder is feeding paper and the power on test pattern prints properly when you switch it on.

Error Handling If the monitor detects a problem, it displays an error screen, showing an error

reference number and discontinues monitoring. The error number is written into the error log for diagnostic use by qualified service personnel .

If either of the two following error conditions occur, call your representative or Response center for assistance.

• If an operational error occurs that the monitor cannot self-detect, it shuts down. No warning tones or indicator lights occur.

• If a self-detectable error occurs, the monitor displays the error screen, sounds an error tone, and discontinues all monitoring functio ns . Switch it off and call a qualified service professional.

Checking the

Error Log

You can view the error log by selecting Power Status Frame. This displays the Service Menu. Select “View Error Log”. The error log has eight lines and can show up the most recent eight error types. The monitor keeps a count of errors for each error category. You can have many errors of one type and it only occupies one line in the error log. It also shows the date and time of the most recent error. If the limit of eight errors is exceeded, the newest error replaces the oldest.

The A/D values are diagnostic aids for qualified service personnel. They are detailed in the Service Guide.

Maintenance and Performance Assurance

Performance Assurance

Error Trouble-

shooting

Most errors have no user remedy and require qualified service personnel to interpret them. However if you see:

• Error 10: try charging the battery.There is some possibility that charging

• Error 15:This is a non-fatal error that occurs from time to time. It is

Testing Transducers

Te sting an

Ultrasound

Transducer

If the following test fails, contact your Philips Service Engineer or Response Center. Do not use a faulty transducer. Ideally, test with a different ultrasound transducer to determine if it is the original transducer or the monitor that is faulty.

To test an ultrasound transducer:

1. Switch on the monitor .

2. Connect the transducer to the first ultrasound (US) socket.

3. Increase the loudspeaker volume to an audible level.

4. Holding the transducer in one hand, gently tap the transducer surface with

5. You should hear a noise from the loudspeaker.

the battery could fix the situation, though normally a low battery is indicated with the low power warning and forces a moni tor shutdown.

logged in the error log but not normally on the monitoring screen. The only time a user would see this error is by examining the error log. It is not necessary to call a service professional.

your finger. You may find it easier if you use a small amount of gel on transducer surface.

Te sting a Toco

Transducer

86 Maintenance and Performance Assurance

If the following test fails, contact your Philips Service Engineer or Response Center. Do not use a faulty transducer. Ideally, test with a different Toco transducer to determine if it is the original transducer or the monitor that is faulty.

To test a Toco transducer:

1. Switch on the monitor .

2. Connect the transducer to the Toco socket.

3. Zero the transducer, by pressing the Toco Baseline button

4. Gently apply pressure to the button centered on the transducer’s face.

5. Check that the value on the display shows this change in pressure.

Disposing of the Equipment

Arrangements for the di spo sal o f your monitor, recorder, battery and t r ans ducers at the end of their working life should conform to your country’s laws regarding the disposition of equipment containing electrical parts. Adhere to all applicable laws regarding disposal and recycling.

Disposing of the Equipm ent

Obtaining Technical Assistance

For technical information and assistance, call your Philips Response Center or your local representative.

Maintenance and Performance Assurance

Returning System Components

Have all equipment serial numbers available when calling. You will find the unit’s serial number on its rear panel.

To pack the unit for return, disconnect all transducers and cables. It is not necessary to return the transducers, event marker, or power cord. Pack the unit into its original shipping carton if available. If not, use a suitable carton with appropriate packing material to protect the unit during shipping.

Supplies and Accessories Reordering Information

These part numbers and descriptions are correct at the time of printing, but may be revised or updated subsequently. To re-order supplies for your monitor contact your local representative or order via the internet at http:// shop.medical.philips.com/hsgstore/catalog/supplies_dept.asp

Supply/Accessory Part Number and Description

Ultrasound Transducer M1356A

Latex free.

Toco Transducer M1355A

Ultrasound transmission gel

88 Maintenance and Performance Assurance

Latex free.

40483A: water-soluble, box of 12 x 250ml bottles, shelf life 24 months maximum, 6 months minimum.

40483B: 5-liter refill containe r. She lf life 24 m ont hs maximum, 6 months minimum

Supplies and Accessories Reordering Information

Supply/Accessory Part Number and Description

Paperb for FM-2 Recorder (M2925A)

Transducer Belts M1562A: Elastic, reusable, 1.3m (52”) brown, box of five

Transducer knob adapters M1356-43203: Pack of 3.

Belt buttons M1569A: Pack of 10.

Remote Event Marker 15249A.

Canvas Tote Bag M3919A: Canvas carrying bag with room for monit or a nd

M1910A: Z-Fold paper, 150 sheets per pack, 30-240 FHR scale, Orange (USA), No kPA scale, 3cm hi ghl ig hted l ines, Case of 40.

M1911A: Z-fold paper, 150 sheets per pack, 50-210 FHR scale, Green (International) , kPA scale, no highlighted 3 c m lines. Case of 40.

M1913A:Z-fold paper, 150 sheets per pack, 50-210 FHR scale, Green (International), no kPA scale, highlighted 3 cm lines. Case of 40.

belts. Contains latex.

M2208A: Foam, dispos able, 1.3m (52”), blue/pink, box of 100 belts (50 blue, 50 pink). Conta ins latex.

Latex free.

accessories.

GCX Wallmounting M3904A.

GCX Rollstand M3909A.

a. Use only the approved gel. Using ultrasound gel that is not approved by Philips may reduce the signal quality and may damage the transducer. This type of damage is not covered by warranty b. Do not use pape r with s procket holes intende d for HP 8040A/ 8041A fetal monitors as the trace may not be legible and a paper jam may occur. Use only the approved paper.

Maintenance and Performance Assurance

Response Center Contact Information

Country Telephone Phone Number Address

Australia (Toll free) 1800 033-397

Austria +43 1 25125 333

BENELUX (Belgium & Netherlands)

Brazil 0-800-553-329

China (Toll free) 86-800-810-0038

from Belgium:+32-2-

404.9102; from Netherlands:+31-20-

547.25.55

Medical Products Group 347 Burwood Highway Forest Hill VIC 3151 AUSTRALIA

Dresdnerstrasse 81-85 1200 Vienna Austria

Boulevard de la Woluwe 100 1200 Brussels Belgium

Alameda Araguaia 1142 Alphaville - Barueri CEP 06455-0000 Sao Paulo, BRASIL

HP Building No 2, Dong San Huan Nan Lu Chaoyang District, Beijing PR China

Finland +358-10-855.2455

France 01.64.53.50.00 1 Rue Galvani,

90 Maintenance and Performance Assurance

Piispankalliontie 17 02200 Espoo - Finland

F-91745 Massy Cedex, France

Philips FM-2 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Quick Reference

What is this? Use this... Comments

Monitoring Screen Display

Ultrasound Monitoring

Toco Monitoring

Non-Stress Test (NST) Aid

Event Markers

Viewing Stored Fetal Traces on Screen

Printing and Transmitting

Safety

Instructions for Safe Operation and Use of the FM-2 Monitor

Warnings

Cautions

FM-2 Fetal Monitor Intended Use

Getting Started

Check List

Checking the Shipment

Setting Up Your Monitor the First Time

Connecting the Power Supply

Using the Battery

Connecting the Remote Marker Cable

Mounting on Wall or Rollstand

Choosing Your Language

Setting the Time and Date

Setting the Paper Style and Speed

More About the Monitor

General Information

Monitoring Screen Frames

Fetal Heart Rate Numeric (US1) Frame

Heart Rate Trend Frame

Toco Numeric Frame

Toco Trend Frame

Power Status Frame

Symbol Definition Symbol Definition

Communications Frame

Time and Date Frame

Patient ID Frame

Monitor Symbols

Symbol Definition Symbol Definition

Changing Monitor Settings

Using the Navigation Wheel

Example of a Change Operation

Preparing for a Monitoring Session

Fastening a Belt

Clipping a Transducer to the Belt

Connecting a Transducer to the Monitor

Eliminating Electromagnetic Interference

Configuring Patient ID

Adjusting Alarm Limits

Marking an Event

Finishing a Monitoring Session

Configuration Settings

Using the Battery

Low Power Warning

Recharging the Battery

Replacing the Battery

Storing

Getting the Best out of Your Battery

Demonstration Mode

Monitoring Fetal Heart Rate

FHR Monitoring

What You Need

Preparing the Monitor

Finding the Fetal Heart Rate

Interpreting the Data

Monitoring Twins

Finding the Second FHR

Separating Two FHR Traces

Adjusting Ultrasound Volume

Understanding FHR Alarms

Configuring FHR Alarms

Alarm Settings

Alarm Comments

Alarm Defaults The monitor saves alarms settings until they are next changed. When you switch

Determining FHR Acceleration Using Grid Lines

Toco Monitoring