Philips Series 50 (M1351-53) User manual

Series 50	A (M1351A)
Series 50	IP-2 (M1353A)

Fetal Monitors

I N S T R U C T I O N S F O R U S E

M1353-9001J

Printed in Germany February 2002

Philips makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Philips shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance or use of this material.

The information contained in this document is subject to change without notice.

Philips assumes no responsibility for the use or reliability of its software on equipment that is not furnished by Philips.

Responsibility of the Manufacturer

Philips only considers itself responsible for any effects on safety, reliability and performance of the equipment if:

•assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by Philips, and

•the electrical installation of the relevant room complies with national standards, and

•the instrument is used in accordance with the Instructions for Use or User’s Guide.

Intended Use (M1351A)

The intended use of this device is to monitor the condition of the fetus by measuring fetal heart rate (FHR), maternal uterine activity and optionally fetal movements simultaneously.

The M1531A is a fetal monitor designed for the antepartum testing area. The fetal heartbeat is detected by an ultrasound transmitter/receiver probe applied to the abdominal wall.

The intended use of this device is to provide information of both FHR and maternal uterine activity on a digital display, on a strip chart recorder and on an interface for optional remote data management.

Intended Use (M1353A)

The intended use of this device is to monitor the condition of the fetus by measuring fetal heart rate (FHR), maternal uterine activity and optionally fetal movements simultaneously.

The M1353A is a fetal monitor designed for the antepartum and intrapartum testing area. The fetal heartbeat may be detected by ECG electrodes connected to the fetal scalp or by an ultrasound transmitter/receiver probe connected to the abdominal wall. The uterine pressure may be detected by a pressure probe connected to the intrauterine pressure via a fluid filled tube or by a pressure probe connected to the abdominal wall.

The monitor should only be used by, or under the direct supervision of, a licensed physician or other health care practitioner who is trained in the use of fetal and maternal heart rate monitors and in the interpretation of fetal and maternal heart rate traces. US law restricts this device to sale by, or on the order of, a physician.

Conventions Used in This Guide

Warning

A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient.

Caution

A caution alerts you to situations where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury.

Note— A note calls your attention to an important point in the text.

On your monitor, this sign indicates that there is detailed information in this book which you must read before proceeding with your task

2002 Philips Medizinsysteme Boeblingen GmbH

All rights are reserved. Reproduction in whole or in part is prohibited without the prior written consent of the copyright holder.

Contents

1. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

About This Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

About the Monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Major Parts and Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Recorder Keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Major Keys at a Glance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Display Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2. General Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Fastening a Belt around the Mother . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Clipping a Transducer to the Belt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Attaching a Patient Module to the Belt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Connecting a Transducer or Patient Module

to the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Signal Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Suspected Fetal Demise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Marking an Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 After Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

3. Getting Started. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Before Connecting to the Power Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Connecting to the Power Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Loading Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Paper-Out Alert. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Choosing Paper Speed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Setting the Paper Speed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Tearing Off the Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Switching on the Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Displaying the Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Setting the Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Mounting the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Fitting the Monitor to a Wall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Fitting the Monitor to an Angle Mount. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Fitting the Monitor to a Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Contents

Fitting the Paper Take-Up Tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

4. Monitoring FHR and FMP Using Ultrasound . . . . . . . . . . . . . . . . 29

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Ultrasound Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

What You Need . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Fetal Movement Profile. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Switching FMP On and Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

FMP Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

5. Monitoring FHR Using DECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 DECG: Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 What You Need . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 With DECG legplate M1357A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 With Patient Module M1364A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Using the DECG Adapter Cable M1362B to Monitor DECG. . . . . . . . . . . . . . . . . . . . . 44 With DECG Legplate M1357A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 With Patient Module M1364A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Monitoring DECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Switching Arrhythmia Logic On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Why use Arrhythmia Logic?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Removing the Fetal Scalp Electrode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

6. Monitoring Twin FHRs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Things to Remember During Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Monitoring Internally . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Monitoring Externally . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Cross-Channel Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Separating Twin FHR Traces: “Twins Offset” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Using Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Using the Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Twins Offset: On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Twins Offset: Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Contents

7. Monitoring Uterine Activity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

What You Need . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

For External Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

For Internal Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

External Toco Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Internal Toco Monitoring (IUP Monitoring) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

External Toco . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Internal Toco . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

8. Measurements Using External Devices . . . . . . . . . . . . . . . . . . . . 71

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Supported External Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Connecting External Devices to the Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Trace Display on Obstetrical Surveillance Systems . . . . . . . . . . . . . . . . . . . . . . . . . 74

Monitoring Maternal NIBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Example Maternal NIBP Trace. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Monitoring FSpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Example FSpO2 Trace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

FSpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78

External Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

9. Monitoring Maternal ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Monitoring Maternal ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

To Begin Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Using MECG Transducer M1359A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Using a Patient Module M1364A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Cross-Channel Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

10. Fetal Heart Rate Alerting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Recognizing an Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Acknowledging an Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Turning Alerting ON or OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Contents

vii

Changing Alert Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

11. Non Stress Test Timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Setting the NST Timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

12. Recording Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Recording A Note. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Deleting a Barcode Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Recording a Patient’s Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Recording Several Barcodes as One Note. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Recording Several Barcodes as Separate Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

13. Modem Interface Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Connecting the Modem Interface Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Connecting Peripheral Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Connecting to the Telephone System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99 PCMCIA Modem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 Entering and Storing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 Setting Phone Numbers and Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 Keeping Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 Clearing Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 Clearing Trace Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 Storing Fetal Trace Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Displaying Memory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Stopping Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Transmitting Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 Trace Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 Stopping Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 Troubleshooting and Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 Error Message 77 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 Power Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

14. Upgrade Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

viii

Contents

Upgrade Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

15. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Self Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Quick Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

Parameter Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Testing Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

Toco . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

Ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

IUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Testing Patient Modules and Legplates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Testing a Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

A. Care and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

Cleaning the Monitor and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Cleaning Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

Disinfecting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Sterilizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

Belts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

Storing Recorder Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Routine Inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Mechanical Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

Calibration and Electrical Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

B. Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

General Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Electrical Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Series 50 A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Series 50 IP-2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

ESU, MRI and Defibrillation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Leakage Current. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Maximum Input/Output Voltages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Service Socket for Upgrade Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Contents

Combined Interface Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

Modem Interface Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Protective Earth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Spillage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

EMC Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

System Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

Avoiding Interference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

C. Replacing Fuses and Batteries . . . . . . . . . . . . . . . . . . . . . . 143

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Replacing the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Replacing the Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

D. Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Standard Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

Gels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

Heart Rate Transducers and Patient Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

Electrodes and Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

Disposable Scalp Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

IUP Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

IUP Catheters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

Domes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

IUP Transducer Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Belts and Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Barcode Booklets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Modem Interface Module Barcode Sheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Digital Interface Protocol Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

E. Manufacturer’s Information . . . . . . . . . . . . . . . . . . . . . . . . 159

Manufacturer’s Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

USA Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Operating and Environmental. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Contents

Ultrasound, External and Internal Toco . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

Testing Facilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

Contents

xii

Contents

1 Overview

Introduction

This chapter contains general information about your Instructions for Use and about your fetal monitor. You will learn about:

•The most important functions of your monitor

•The major parts and keys of your monitor.

About This Guide

This book tells midwives, nurses, and other health care professionals how to use the Philips Series 50 A fetal monitor and the Philips Series 50 IP-2 fetal monitor.

It discusses and illustrates all the parameters and features of both monitors. Your monitor may not have every one of these features and may look slightly different to the monitor shown in the illustrations in this guide. A label in the margin of the book will indicate whether the text refers to:

•Both the Series 50 A and the Series 50 IP-2 fetal monitors

•The Series 50 A fetal monitor only

•The Series 50 IP-2 fetal monitor only.

Chapter 1 - Overview

About the Monitors

Series 50 A Dual Ultrasound Model

Series 50 IP-2

Series 50 A The Series 50 A Single Ultrasound model monitors a single fetal heart rate. The Series 50 A Dual Ultrasound model can monitor one or twin fetal heart rates.

The Single Ultrasound model looks slightly different from the Dual Ultrasound model. For the illustrations, we have used the Dual Ultrasound model.

Series 50 IP-2 The Series 50 IP-2 can monitor one or twin fetal heart rates, one using ultrasound and the second using ECG or ultrasound. It looks very similar to the Series 50 A Dual Ultrasound model.

Note— Not all parameters and features detailed in this manual are available on all monitors

2	Chapter 1 - Overview

About the Monitors

Series 50 A Using the Series 50 A antepartum fetal monitor you can monitor

•Fetal heart rate (FHR), externally using ultrasound

•Uterine activity

•Fetal pulse oximetry, by connecting an external fetal pulse oximeter to your fetal monitor (optional)

•Maternal blood pressure, externally, by connecting an NIBP monitor to your fetal monitor (optional)

•Fetal movement (optional)

Using the Series 50 A Single Ultrasound model you can monitor a single fetal heart rate; the Dual Ultrasound model lets you monitor one or twin fetal heart rates.

With the Series 50 A fetal monitor you can also use an optional Modem Interface Module to send fetal trace information to a Philips obstetrical surveillance system, such as OB TraceVue.

Series 50 IP-2 Using the Series 50 IP-2 intrapartum fetal monitor you can monitor

Fetal heart rate, including twins

Series 50 A and

Series 50 IP-2

–externally using ultrasound or

–directly using ECG

•Uterine activity

–externally using an Toco transducer or

–internally using an IUP catheter

•Maternal heart rate (MHR) using DECG

•Fetal pulse oximetry, by connecting an external fetal pulse oximeter to your fetal monitor (optional)

•Maternal blood pressure, externally (NIBP), by connecting a NIBP monitor to your fetal monitor (optional)

•Fetal movement (optional)

Both monitors offer you the following features:

•Automatic printing of maternal and fetal parameters on the trace paper

Chapter 1 - Overview

About the Monitors

•Transmission of maternal and fetal parameters to an obstetrical review system

•Audible and visual alarms

•Twin heart rate separation for ease of interpretation

•Non stress test (NST) timer

•Paper-end alarm

•Significant event marking on the trace paper.

4	Chapter 1 - Overview

Major Parts and Keys

Recorder Keys

1.Recorder on/off key switches the recorder on and off. It also starts the NST timer (switch off the recorder and press the recorder on/ off key for two seconds).

2.Recorder on/off light is on when the recorder is working. It flashes when the monitor detects five pages or less remaining in the pack, and if the paper runs out.

3.Event marker key records events on the paper trace.

4.Paper advance key advances paper automatically to the next fold. Tear the paper along the perforations and never pull it to advance it.

Chapter 1 - Overview

Philips Series 50 (M1351-53) User manual

Major Parts and Keys

Major Keys at a Glance

6	Chapter 1 - Overview

Major Parts and Keys

1.Mains socket

2.Monitor on/off switch

3.Equipotential grounding point

4.Monitor on/off light

5.Display panel

6.Time and date key

7.Paper speed key

8.Test key

9.Recorder on/off light

10.Recorder on/off key

11.Event marker key (Alert acknowledge key)

12.Paper advance key

13.Loudspeaker

14.Battery compartment

15.Paper table

16.Service socket

17.Series 50 A: US2 Socket (not present on Single Ultrasound

model)

Series 50 IP-2: US2/ECG Socket

18.Toco socket

19.Series 50 A: Single Ultrasound Model: US Socket

Double Ultrasound Model: US1 socket

Series 50 IP-2: US1 socket

20.Socket for remote event marker

21.Lock-release button

22.Combined interface module

23.Integrated carrying handle

24.Cable clamp

Chapter 1 - Overview

Major Parts and Keys

Display Panel

1.Monitor on/off light

2.Telemetry indicator is on when the fetal ultrasound telemetry receiver is connected and switched on

3.Function key: selects menus for twins offset, FMP and logic

4.US/US1 display. Shows the FHR detected by the US transducer

5.US/US1 signal quality indicator shows the quality of the heart rate signal detected by the US transducer:

–Green (good)

–Yellow (fair to potentially poor)

–Red (unacceptable)

6.US/US1 speaker light is on when the US/ US1 heartbeat is the one you hear

7.US/ US1 volume keys set the volume and select the US channel to which you are listening. Use them also to change current setting of FMP, twins offset, logic, and FHR alert.

8.Toco display shows uterine activity

9.Toco baseline key zeros the Toco display and trace to 20 units when you are monitoring uterine activity externally or 0 units when you are monitoring uterine activity internally

8	Chapter 1 - Overview

Major Parts and Keys

10.US2/ECG display shows the FHR detected by the US2 or DECG transducer.

11.US2/ECG signal quality indicator shows the quality of the signal detected by the US2 or DECG transducer.

12.US2/ECG speaker light is on when the US2 or DECG heartbeat is heard.

13.US2/ECG volume keys set the volume and select the US2 or DECG heartbeat.

Chapter 1 - Overview

Major Parts and Keys

10	Chapter 1 - Overview

2 General Information

Introduction

This section contains information about tasks you will need to perform regularly. You will learn how to:

•Fasten a belt around the mother

•Attach a transducer or patient module to the belt

•Connect a transducer or patient module to the monitor

•Mark a significant event on the trace paper

•Be aware of possible fetal demise

•Care for the monitor and accessories after monitoring.

Fastening a Belt around the Mother

1.Place the transducer belt across the bed, ensuring that the fixing button will face away from the mother when it is fastened. Use two belts if you are monitoring uterine activity and FHR at the same time.

2.Lie the mother on the bed and arrange the belt around her until it is tight but still comfortable.

3.Fasten the belt by pushing the fixing button through the overlapping section of the belt.

Chapter 2 - General Information

Clipping a Transducer to the Belt

Ensure that the fixing button and the loose ends of the belt are at the patient’s side.

Clipping a Transducer to the Belt

When you have positioned a transducer satisfactorily, you can clip it to the belt using the snap-shut mechanism. The clip is designed to allow the transducer to slide along the belt for easy repositioning.

Alternatively, you can fix a button to the transducer and use this to attach

12	Chapter 2 - General Information

Attaching a Patient Module to the Belt

the transducer to the abdominal belt. See the Installation Note that comes with the Transducer Adapter Button for assembly instructions,

Attaching a Patient Module to the Belt

You can attach a patient module to the belt by pushing the fixing knob

(1) on the patient module through one of the holes in the belt.

Connecting a Transducer or Patient Module to the Monitor

To connect a transducer or patient module to the monitor, first switch on the monitor and the recorder. When you connect a transducer or a patient module to either the US/US1 socket, the Toco socket, or the US2/ECG socket:

•The dashes in the corresponding digital display will go out.

•The signal quality light for the heart rate display turns red, as the transducer or patient module is not yet receiving a good signal from the patient.

•The monitoring mode will be printed on the trace paper, and repeated every three to four pages. Depending on the parameter you are monitoring, this could be US, US1, US2, DECG, TOCO int or TOCO ext.

Chapter 2 - General Information

Signal Quality

•You will hear the fetal heartbeat from the loudspeaker.

If the Fetal Scalp Electrode and the electrode wires are connected correctly and a good signal is being produced, the signal quality indicator should be green. If an inadequate signal is being produced, or there is a bad contact, the signal quality indicator will be red. The message nop may also be displayed. See Chapter 15, “Troubleshooting,” for more details.

Warning

NEVER immerse a transducer in liquid when it is connected to the fetal monitor.

Signal Quality

During monitoring, if the signal quality indicator fluctuates between red, yellow and green, it does not necessarily mean that the transducer needs repositioning. The fluctuation may be caused by fetal movement. Allow time for the signal to stabilize before deciding whether to reposition the transducer (ultrasound) or apply a new electrode (ECG). A trace is possible when the indicator is yellow, but for the best trace it should be continuously green.

Suspected Fetal Demise

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. Apparent fetal movement may also be detected by the monitor but this may be a result of maternal movement causing the fetus to move within the amniotic fluid.

Please refer to “Cross-Channel Verification” on page 84.

14	Chapter 2 - General Information

Marking an Event

Use the event marker key or the remote event marker to record significant events on the trace paper (for example, when pain medication is administered or when the mother changes position). The mother can use the remote event marker to mark events herself. To mark an event on the trace paper you can either:

•Press the event marker key “Mark” on the monitor (1)

•Or press the button on the remote event marker. The remote event marker is connected to the monitor via the socket to the left of the US/US1 transducer socket.

Chapter 2 - General Information

Marking an Event

A small arrow is printed on the heart rate scale on the trace paper. The arrow starts with the peak to show the exact time when the key or button has been pressed.

If the key or button is not released, a black bar is printed on the paper. The width of the bar corresponds to the length of time the key or button is pressed.

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16	Chapter 2 - General Information

After Monitoring

1.Switch off the recorder.

2.Press and release the paper advance key to advance the paper automatically to the next fold.

3.Remove the transducer from the patient and, using a soft tissue, remove any gel from it.

4.Tear off the paper at the fold.

Don’t pull on the paper to advance it and only tear off the paper at the fold.

5.Switch off the monitor.

Chapter 2 - General Information

After Monitoring

18	Chapter 2 - General Information

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