Philips M2922A FM-2 User manual

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

16:34:12 2/14/2001

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

+ 87 hidden pages