Philips Series 50 (M1350) User manual

Series 50 XM (M1350B) Series 50 XMO (M1350C) Fetal/Maternal Monitors

INSTRUCTIONS FOR USE

M1350-9001S Printed in Germany March 2002 Edition 1

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 repa irs 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 (M1350B)

The Series 50 XM Fetal/Maternal Monitor (M1350B) allows non-invasive or invasive monitoring of an ambulant patient during both antepartum testing and labor and delivery in that the monitoring of the fetal hear t rate (FHR) via ultrasound or direct electrocardiogram (DECG), and uterine activity via an external Toco transducer or an internal intrauterine pressure (IUP) transducer is possible, additionally it allows maternal heart rate recording via the MECG transducer. Alarms are generated from maternal heart rate.

The Series 50 XM allows the non-invasive measurement of the Noninvasive Blood Pressure and the Oxygen Saturation parameters, generate alerts, and the generation of alerts and recordings on matern al patients.

The device is intended to be used in Labor-Rooms and Delivery-Rooms and in AntepartumTesting-Areas. It is not intended to be u sed for transport monitoring and home use.

Intended Use (M1350C)

The Series 50 XMO Fetal/Maternal Monitor (M1350C) allows non-invasive or invasive monitoring of an ambulant patient during both antepartum testing and labor and delivery in that the monitoring of the fetal hear t rate (FHR) via ultrasound or direct electrocardiogram (DECG), and uterine activity via an external Toco transducer or an internal intrauterine pressure (IUP) transducer is possible, additionally it allows maternal heart rate recording via the MECG transducer. Alarms are generated from maternal heart rate.

The Series 50 XMO allows the non-invasiv e measurement of the Noninvasive Blood Pressure and the Oxygen Saturation parameters, generate alerts, and the generation of alerts and recordings on maternal patients. Additionally, the Series 50 XMO allows you to record fetal pulse oximetry (FSpO

The device is intended to be used in Labor-Rooms and Delivery-Rooms and in AntepartumTesting-Areas. It is not intended to be u sed for transport monitoring and home use.

The Series 50 XMO (M1350C) is not available in the U.S.A.

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 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.

iii

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

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.

 2002 Philips Medizinsysteme GmbH

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

Contents

1. Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

General Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Maximum Input/Output Voltages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Service Socket for Upgrade Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Protective Earth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Spillage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Electromagnetic Compatibility (EMC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

EMC Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

System Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Avoiding Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

ESU, MRI and Defibrillation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Leakage Current. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

About This Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

About the Monitors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Major Parts and Keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Cardio, Toco a nd FSpO

Maternal Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Recorder Keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Setting Keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Channels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3. General Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Suspected Fetal Demise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Fastening a Belt. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Clipping a Transducer to the Belt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Attaching a Patient Module to the Belt. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Connecting a Transducer or Patient Module to the Monitor . . . . . . . . . . . . . . . . . . . . 23

Signal Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Input Channels at a Glance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Example Trace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Marking an Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Contents v

4. Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

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

Before Connecting Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Switching On the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Loading Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Switching on the Recorder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Displaying the Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Setting the Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Choosing Paper Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Setting the Paper Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Switching Off After Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

5. Monitoring FHR and FMP Using Ultrasound . . . . . . . . . . . . . . . . 39

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

What You Need . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Fetal Movement Profile. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

FMP Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Switching FMP Off and On. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Using Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Using the Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

6. Monitoring FHR Using DECG . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

What You Need . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Using the Traditional Open-wire Method to Monitor DECG . . . . . . . . . . . . . . . . . . . . 50

With DECG legplate M1357A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

With Patient Module M1364A or M1365A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Using the DECG Adapter Cable M1362B to Monitor DECG. . . . . . . . . . . . . . . . . . . . . 53

With DECG Legplate M1357A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

With Patient Module M1364A or M1365A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Monitoring DECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Why use Arrhythmia Logic? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

After Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Heart Rate Out of Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

vi Contents

7. Monitoring Twin FHRs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Things to Remember During Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Monitoring Internally . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Monitoring Externally. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Separating Twin FHR Traces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Twins Offset: On. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Twins Offset: Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

8. Monitoring Uterine Activity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

External Toco Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Internal Toco Monitoring (IUP Monitoring) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

External Toco . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Internal Toco . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

9. Fetal Pulse Oximetry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Before You Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

To Begin Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Understanding the Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Triggering an Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Acknowledging an Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Turning the Alarm On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Changing Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Inop Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

Loss of Pulse Signal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Inaccurate Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

10. Monitoring Using External Devices . . . . . . . . . . . . . . . . . . . . . . 83

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Recording From an External Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

What You Need . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Connecting the External Devices to the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Contents vii

Example Trace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Trace Display on External Monitoring Systems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

FSpO

2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90

External Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

11. Recording Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

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

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

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

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

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

Recording a Patient’s Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

12. Fetal Heart Rate Alerting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Recognizing an Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Acknowledging an Alert. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Turning Alerting ON or OFF. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

Changing Alert Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

13. Non Stress Test Timer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Setting the NST Timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

14. Maternal Monitoring - Overview . . . . . . . . . . . . . . . . . . . . . . . . 101

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Maternal Parameters - Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

Softkeys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Reset Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Power on Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

To Begin Monitoring Immediately . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Maternal Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Returning to the Maternal Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Alarms - Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Acknowledging an Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Reviewing All Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Setting an Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

viii Contents

Warning Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Acknowledging a Warning Message. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Volume and Contrast Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

15. Non-invasive Blood Pressure Monitoring. . . . . . . . . . . . . . . . . 111

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

To Begin Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Setup Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Measurement Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Changing Measurement Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

Pulse Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Turning Alarms On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

Changing Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

Recording. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Warning Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Measuring Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

16. Maternal ECG, Heart and Pulse Rate. . . . . . . . . . . . . . . . . . . . 121

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

To Begin Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

Connecting the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Applying the Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

Using MECG transducer M1359A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124

Using a Patient Module (M1364A or M1365A) . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Cross-Channel Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Displaying the MECG Waveform. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

Changing Display Speed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Freezing and Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Maternal Heartrate Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Alarm (MECG and SpO

Turning Alarms On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

Changing Alarm Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

17. Maternal Pulse Oximetry (SpO2) . . . . . . . . . . . . . . . . . . . . . . . 133

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

To Begin Monitoring Immediately . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Contents ix

Alarm (SpO2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Turning Alarm On and Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Changing Alarm Limit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Alarm (Pulse rate). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Warning Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

18. Maintenance and Performance Assurance . . . . . . . . . . . . . . . . 139

Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Visual Inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Routine Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Mechanical Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Calibration and Electrical Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Care and Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

Care of the Fetal Monitoring System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

Transducers and Patient Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Adapter Cables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

Sterilizing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Monitor, Patient Modules, Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Adapter cables M1347A, M1362B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Adapter cables M1362A, M1363A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

IUP (1290C/CPJ840J5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

IUP Transducer Adapter Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Belts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Reusable SpO

Non-invasive Blood Pressure Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Storing Recorder Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Self Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

Quick Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

Parameter Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

Testing Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

Toco . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

Ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

IUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Replacing the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Replacing the Fuses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

x Contents

19. Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

20. Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Standard Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Fetal Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Maternal Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Paper. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Gels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Transducers and Patient Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

MECG Electrodes and Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

DECG Cables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

Disposable Scalp Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

Fetal Oxygen Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

IUP Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

IUP Catheters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

Domes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170

IUP Transducer Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170

Maternal Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170

NIBP Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170

SpO

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

Adapter Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

Belts and Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172

21. Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

Operating and Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

Fetal Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

Maternal Non-invasive Blood Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

Maternal Pulse Oximetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177

Maternal ECG and Heart Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177

Maternal Display Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

Numerical Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

Maternal Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

Mode Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

Contents xi

Ultrasound, External and Internal Toco. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

FHR (Cardio) Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180

Testing Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180

Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

22. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183

Manufacturer’s Responsibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183

Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183

23. Training Evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .187

M1350 XM, XMO Fetal Monitoring Lab Evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

Competency Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

Performance Objectives. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

Maternal Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

Fetal SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

Fetal Telemetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

Resources. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

Fetal Monitor Lab Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189

Maternal Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

Fetal SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

Fetal Telemetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194

Answers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194

Maternal Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198

Fetal SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

Fetal Telemetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

xii Contents

General Safety Information

Safety

This symbol indicates that you should consult the Instructions For Use (this guide), and particularly any warning messages.

Equipotential Terminal

This symbol identifies terminals which are connected together, bringing various equipment or parts of a system to the same potential. This is not necessarily earth potential. The value of potentials of earth may be indicated adjacent to the symbol.

Protective Earth Terminal

This symbol identifies the terminal for connection to an external protective earth system.

2 x 1.5 V

The monitor is de signed to fulfil safety requirements according to IEC 60601-1/EN 60601-1 (Class I), UL 2601-1, CSA-C22.2 No 601.1M90.

It complies with the essential requirements of the Medical Device Directive 93/42/EEC. The monitor is classed:

Chapter 1 - Safety 1

Battery

This symbol identifies the battery holder conta ining two 1.5 V batteries.

2 x 1.5V

Electrical Safety

The Series 50 XMO and the Series 50 XM are not “ECG-Monitors”, are not defibrillator-protected, and are not designed for direct cardiac application.

Electrical Safety

Equipment Equipment Type Information

ORDINARY EQUIPMEN T - Enclosed equipment protected against ingress of water.

CONTINUOUS OPERATION - Can be operated continuously.

External Toco transduce r (M135 5A) and IUP quartz transducer (1290C) and IUP transducer (CPJ840J5)

Ultrasound transducer (M1356A)

DECG transducer (M1357A) and MECG transducer (M1359A)

US/MECG combi transducer (M1358A)

SpO

transducer (M1191A)

Adapter cable (M1940A) NIPB cuffs (M1574A and M1575 A)

Interco nn ect tubing (M1599A)

FSpO

/ECG patient module

(M1365A) ECG only patient module (M1364A)

B (Ultrasound) CF (MECG)

Patient Connector is electrically isolated. Connecting the transducer to the Toco channel results in CF condition.

Connecting the trans ducer to a Cardio channel results in a B condit i on .

Connecting the transducers to a Cardio channel results in a CF condition.

Connecting the combi transducer to the Cardio 1 channel results in a CF condition for MECG and a B condition for US application.

Connecting the SpO2 transducer results in a CF condition.

Connecting the NIBP tubing results in a CF condition.

Connecting a patient module results in a CF condition.

2 Chapter 1 - Safety

Maximum Input/Ou tp ut Volt a ges

The following diagram shows the sockets for peripheral devices.

Maximum Input/Output Volta ge s

Chapter 1 - Safety

Maximum Input/Output Voltages

1. Mains Socket.

2. Equipotential Grounding P oint. To use the monitor with other equipment in an operating room environment, connect the equipotential grounding point (2) to earth potential. Use the grounding cable supplied with the monitor.

3. +5V input socket for the HBSW8200 Barcode Reader.

4. Socket for the Philips M1310A Series 50 T Fetal Telemetry System. +5V input except for: Pins 1, 14, 15 and 16: ± 12V input Pin 2 -12V output Pin 3 +5V output Pin 4 ±12V output

5. RS232 Digital System Interface: Pin2 ±12V input Pin 3 ±12V output

6. Socket for one of the following:

• 80225A or 80235A/B Obstetrical Information Management System ( OBMS)

• M1370A Obstetrical Display Information System (ODIS)

• ±12V except for Pins 17, 18 and 22 which are +5V input.

7. Socket (9-pin) for an external device: Pin 3 ±12V

8. Socket (25-pin) for an external device: Pin 2 ±12V Pins 9 and 10 +5 Volt

4 Chapter 1 - Safety

Service Socket for Upgrade Key

The Service En gineer can conne ct a compatible PC to this socket (1) to carry out extended configuration and service functions.

Maximum voltage of ±12V.

Service Socket for Upgrade Key

Protective Ea rth

To prote ct hospital personnel and the patien t, the monitor’s casing must be ground ed. Accordingly, the monitor has a 3-wire power cable that grounds it to the power line ground when plugged into an appropriate 3wire receptacle. Do not use a 3-wire to 2-wire adapter with the monitor. Any interruption of the protective earth grounding will cause a potential shock hazard that could result in serious personal injury.

Whenever it is likely that the protection has been impaired, the monitor must be made inoperative and be secured against any unintended operation.

Chapter 1 - Safety

Environment

Warning Check each time before use that the monitor is in perfect working

order and properly grounded.

Position the patient cable so that it does not come into contact with any other electrical equipment. The cable connecting the patient to the monitor must be free of electrolyte.

Make sure that during operation, the monitor is free from condensation. This can form when equipment is moved from one building to another, and is exposed to moisture and differences in temperature.

Warning Possible explosion hazard if used in the presence of flammable

anaesthetics.

Environment

Use the monitor in a n environment that is r easonably fr ee from vibration, dust, corrosive or explosive gases, flammable agents, extremes of temperature, humidity and so forth. It operates within specifications at

ambient temperatures between 0 and 55 exceed these limits can affect the accuracy of the monitor and cause damage to the components and circuits. Only products that fulfil the necessary safety and electrical standards should be used in conjunction with the monitor (contact your local response center for details).

Allow at least 5cm (2in) clearance around the monitor for proper air circulation. If the monitor is mounted in a cabinet, allow sufficient space at the front for operation and at the rear for servicing with the cabinet door open.

6 Chapter 1 - Safety

C. Ambient temperatures that

Spillage

When the maternal display is in a tilted position, take additional care to prevent spillage of liquid. If liquid accidentally enters the monitor through the maternal display recess, you must cease using the monitor immediately. Contact an authorized engineer for a safety inspection.

Electromagnetic Compatibility (EMC)

The electromagnetic compatibility (EMC) validation includes testing performed according to the international standard for EMC with medical devices. See the Manufacturer’s Declaration for details.

EMC Testing

Caution If operating under conditions according to the EMC-st andard

60601-1- 2 (Radiated I mmunity 3 V /m), fi eld st rength s a bove 1 V/m may cause erroneous measurements at various frquencies. Therefore it is recommended to avoid the use of electr ical ly r adiating equipment in close proximity to these measurem en ts.

Spillage

Chapter 1 - Safety

During the test prog ram the monitor was sub j e cted to international standard and Philips proprietary EMC tests. During most of the testing no anomalies were observed. Some reduced performance was observed with the IEC 801-3 Radiated Immunity and IEC 801-4 Fast Transient/ Bursts Immunity tests.

IEC 801-3 specifies that the pro duct must be subjected to a field of 3 V/m over a frequency range of 26 to 1000 MHz with no degradation of performance. At many of the test frequencies over the specified range no anomalies were ob served. However increase d jitter of SpO

values and

DECG derived fetal heartrate values was observed at a number of test points. For these test points the radiated field was reduced to the level at which the trace returned to normal. These reduced levels are shown in the following table.

Electromagnetic Compatibility (EMC)

Parameter Sensor Frequency Range

SpO

IEC 801-4 specified that the pro duct is subjected to high speed p ulses up to 1000 V applied to the powe r cord and al l I/O cables. D uring and af ter most of the test pulses, no anomalies were observed. However in rare cases the ultrasound channel had been triggered.

Parameter Sensor

Ultrasound M1356A

SpO

with adapter

cable M1940A

System Characteristics

M1191A M1192A M1194A

M1358A M1191A

M1192A M1194A

52 MHz to 70 MHz

Immunity

Level

2.3 V/m

Burst Immunity

Level

600 V

≤ 200V

The phenomena discussed above are not unique to the monitor but are characteristic of pat ient monitors in use today. This performance is due to very sensitive high gain front end amplifiers used to process the physiological signals from the patien t. Among the many similarly performing monitors already in use by customers, interference from electromagnetic sources is rarely a problem.

8 Chapter 1 - Safety

Avoiding Interference

When electromagnetic interference (EMI) is encountered there are a number of things that can be done to mitigate the problem.

1. Eliminate the source. Possible sources of EMI can be turned off or moved away to reduce their strength.

2. Attenuate the coupling. If the coup ling path is through the patient cables the interference may be reduced by moving and/or rearranging th e cables to a diffe rent location of the monitor. If the coupling path is throu gh the power cord, plugg ing the monitor into a differen t mains circuit may help.

3. Connect the equipotential terminal of the moni tor to the corresponding terminal of your mains installation.

4. Add external attenuators. If EMI becomes an unusually difficult problem, external devices such as an isolation transformer or a transient suppressor may help. An Philips customer engineer can assist you in determining the need for external devices.

ESU, MRI and Defibrillation

Warning Remove all transducers, patient modules, sensors and accessor ies

before performing electrical surgery, defibrillation, and MRI. High frequency current can flow through the equipment and burn the skin.

The equipment has not been tested with defibrillators.

Chapter 1 - Safety

Leakage Current

Leakage current can be hazardous to the patient.

Warning If the monitor is connected directly to other equipment, such as an

additional patient monitor, or a second monitor is to be connected directly to the mother, you must carry out all relevant safety tests in accordance with safety standard IEC 60601-1-1.

10 Chapter 1 - Safety

About This Guide

This guide tells midwives, nurses and other healthcare professionals how to use the Series 50 XMO fetal/maternal monitor and the Series 50 XM fetal/maternal monitor . I t discusses and ill ustrates all possible featur es and parameters of both mo nitors. Your monitor may not have every one o f these features and may lo ok slightly different to the monito r shown in t he illustrations in this guide. It can be upgraded to incorporate them.

About the Monitors

Both monitors let you observe and record:

Overview

• Fetal heart rate (inclu ding twins)

• Uterine activity

• Maternal heart rate (MHR) and ECG waveform

• Maternal pulse oximetry (SpO

• Fetal movement profile (FMP)

• Maternal blood pressure, non-invasively.

The Series 50 XMO also allows you to record fetal pulse oximetry (FSpO

You can monitor fetal heart rate externally with u ltrasound from approximately 20 weeks and with the other parameters internally during labor and delivery.

Not all parame ters and features detai led in this manual are ava ilable on all monitors.

Chapter 2 - Overview 11

)

Major Parts and Keys

The display panel can be viewed flat in the monitor, or tilted at an angle.

1. Monitor on/off switch

2. Monitor on/off light

3. Recorder keys

4. Recorder

5. Maternal parameters

6. Cardio 2 channel

7. Toco channel

9. Function key

10. Telemetry indicator

11. FSpO

parameter

12. Opening recess

13. Socket for remote event marker

14. Setting keys

15. Service socket

8. Cardio 1/ combi channel

12 Chapter 2 - Overview

Cardio, Toco and FSpO2 Channels

Major Parts and Keys

Chapter 2 - Overview

1. Toco Display shows uterine activity.

2. Fetal SpO

display shows fetal pulse indicator, signal quality,

alarm status, and cross channel verifi cation plus indicator.

3. Cardio Display shows the FHR.

4. Signal Quality Indicator shows the quality of heart rate signal detected by the transducer:

– Green (good). – Yellow (fair to potentially poor). – Red (unacceptable).

5. Function Key: selects menus for:

– FMP, twins offset, logic, FHR alert and FSpO

– returns to the normal display.

6. MECG Indicator shows when MECG is being measured through this channel. (Indicator location different for Series 50 XM.)

Major Parts and Keys

7. Fetal SpO2 display shows current value of FSpO2.

8. Speaker Lamp shows which heartbeat is heard from the loudspeaker.

9. Volume Keys set the volume and select the channel to which you are listening. Changes current setting of FMP, twins offset, logic, FHR alert and FSpO

alarms.

10. Recess for use when tilting the display.

11. Remote Event Marker Socket for connecting remote event marker (15249A).

12. Cardio 1/Combi Transducer Socket for connecting:

– FSpO

/ECG combined patient module (M1365A).

– ECG patient module (M1364A). – Ultrasound transducer (M1356A). – DECG transducer (M1357A). – US/MECG Combi transducer (M1358A). – MECG transducer (M1359A).

13. Transducer Socket for connecting:

– external Toco transducer (M1355A). – IUP transducer (1290C, 13972A, or M1333A).

14. Toco Baseline Key zeroes the Toco display and trace to 20 units (when monitoring uterine activity externally) or 0 units (when monitoring uter ine activity internally).

15. Cardio 2 Transducer Socket for connecting:

– ECG patient module (M1364A). – US transducer (M1356A). – DECG transducer (M1357A). – MECG transducer (M1359A).

14 Chapter 2 - Overview

Maternal Parameters

1. NBP Transducer Socket for connecting:

2. SpO

Major Parts and Keys

– NBP cuff interconnect tubing (M1599A) and blood pressure

cuff.

Transducer Socket for connecting:

–SpO2 transducer (M1940A adapter cable connected to M1191A

transducer).

Chapter 2 - Overview

3. Softkeys for setting maternal parameters.

– selects modes and alarm limits for NBP. – selects modes and alarm limits for MHR. – selects modes and alarm limits for SpO

4. Reset Key acknowledges al arms and re turns monitor from setting mode to maternal parameter display.

5. SpO

Value indicates the current reading for patient’s SpO2 level.

Major Parts and Keys

6. Maternal heart/pulse rate icon indicates measurement source of maternal heart/pulse rate.

indicates heart rate value comes from MECG.

indicates pulse rate value comes from SpO

indicates average pulse rate value comes from NIBP.

7. Maternal Heart Rate shows the current heart/pulse rate .

8. Systolic Value shows the value for the systolic parameter of th e non-invasive blood pressure measurement.

9. Diastolic Value shows the value for the diastolic parameter of the non-invasive blood pressure measurement.

16 Chapter 2 - Overview

Recorder Keys

Major Parts and Keys

1. Recorder On/Off Light lights when the recorder is working. Flashes when monitor detects five or fewer pages remaining in the pack, or if the paper runs out.

2. Recorder On/Off Key switches recorder on and off. Also starts NST timer (switch off recorder and press for two seconds).

3. Event Marker Key records event on paper. Acknowledges all alerts and alarms.

4. Paper Advance Key advances paper automatical ly to the next fold. Tear paper at fold. Never pull paper to advance it.

5. Paper-Eject Key unlocks drawer when you press it once. Press a second time and hold when removing paper.

Chapter 2 - Overview

Major Parts and Keys

Setting Keys

1. Time and Date Key for changing the time and date. Press to show the current time in the Cardio 1/Combi and Toco di splays, to cycle through the settings to be ch anged (hours, minutes, day, month and year ) and to return to the normal display.

2. Paper Speed Key for changing the paper speed. Press to show the current paper speed in the Cardio 1/Combi display, and to return to the normal display.

3. Test Key for starting monito r’s self test.

18 Chapter 2 - Overview

+ 187 hidden pages