Philips 50 T Series User manual

Series 50 T (M1310A)
Fetal Telemetry System
INSTRUCTIONS FOR USE
M1310-9001B
Printed in Germany December 2001
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 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.
The following conventions for cautions and warnings are used in this guide:
Caution
A caution calls attention to a condition or possible situation that could damage or
destroy the product or the user’s work.
Warning
A warning calls attention to a condition or possible situation that could cause injury to
the user and/or patient.
2001 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 iii
Contents
1. Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Protective Earth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Maximum Input/Output Voltages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Intended Use Statement (M1310A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
About This Book . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Compatible Fetal Monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Application Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3. Setting Up the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Unpacking the Telemetry System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Connecting and Assembling the Antenna . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Remote Antenna . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Local Antenna . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Connecting the Receiver to the Fetal Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Connecting Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Setting Up the Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4. Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Prerequisites. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Underwater Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Switching On the Receiver and the Fetal Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Switching On the Transmitter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Monitoring Ambulant FHR Using Ultrasound. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Monitoring Ambulant FHR Using DECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Monitoring Ambulant Toco. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Monitoring Ambulant Intrauterine Pressure (IUP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Solving Common Monitoring Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

iv Contents
5. Fetal Movement Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Prerequisites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Solving Common Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
6. Marking Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Remote Event Marker. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Setting Up the Marker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
7. Nurse Call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Using the Nurse Call. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Setting the Nurse Call Volume. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
8. Mounting the Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Under a Fetal Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Series 50 IX/XM/XMO, 8040A and 8041A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Series 50 A and 50 IP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Under an Angle Mount. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
On a Flat Surface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
On Top of a Series 50 Mobile Cart or 8040A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
On Top of a Series 50 IX/XM/XMO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
On a Wall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
9. Maintenance and Performance Assurance . . . . . . . . . . . . . . . . . . . . . . . . . 51
Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Care and Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Testing the Parameter Signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Testing the Receiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Testing the Interface Between the Fetal Monitor and Receiver . . . . . . . . . . . . . . . 55
Testing the Interface Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Testing the Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Battery Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
10. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Solving General Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Series 50 Family . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
8040A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
8041A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Contents v
11. Accessories and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 63
Compatible Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Declaration of Conformity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

vi Contents

Chapter 1 - Safety 1
1
Safety
Warnings
Warning
FCC WARNING:
This equipment generates, uses and radiates radio-frequency energy,
and if it is not installed and used in accordance with this manual,
may cause interference to radio communications.
Operation of this equipment in a residential area may cause
interference, in which case the users, at their own expense, must take
whatever measures may be required to correct the interference.
Warning
Failure on the part of the responsible individual hospital or
institution employing the use of this equipment to implement a
satisfactory maintenance schedule may cause undue equipment
failure and possible health hazards.
Warning
EXPLOSION HAZARD: Do not use in the presence of flammable
anesthetics.

Warnings
2Chapter 1 - Safety
Warning
Disconnect receiver from AC power supply before servicing.
Warning
SHOCK HAZARD: The power receptacle must be a three-wire
grounded outlet. Never adapt the three-prong plug from the power
supply or accessory to fit a two-slot outlet. If the outlet only has two
slots, make sure that it replaced with a three-slot grounded outlet
before attempting to operate the monitor.
Warning
Replace fuse in the receiver with an identical one, as marked on the
rear of the receiver.
Warning
Do not use brown transducers to monitor patients under water.
Ultrasound and Toco transducers that are colored blue are watertight
and comply with IEC 529 (IP68).
You can immerse the BLUE Ultrasound and Toco tranducers in
water ONLY when connected to the telemetry transmitter. NEVER
connect blue transducers directly to the fetal monitor when they are
immersed in water, or likely to come in contact with water.
NEVER immerse the telemetry transmitter in water or other liquids
such as cleaning solutions.

Cautions
Chapter 1 - Safety 3
Warning
During ambulant FHR monitoring, the chance of losing the signal or
detecting the maternal heart rate is higher than during stationary
monitoring. We therefore recommend that you check the mother’s
pulse periodically during monitoring and compare this to the FHR
signal. Beware of mistaking a “doubled”maternal heart rate for
FHR.
Performing ultrasound imaging or Doppler flow measurements in
conjunction with ultrasound fetal monitoring may cause false
readings of FHR (recording of the trace may deteriorate).
Also, the frequency of the patient's walk may be detected. This is
more likely when the patient is overweight or has a breech
presentation.
Warning
Make sure that all four feet are located firmly in place
Cautions
Caution
SHOCK HAZARD: Do not remove the receiver covers. Service may
be performed by qualified service personnel only.
Caution
Check each time before use that the Telemetry System is in perfect
working order and the receiver is properly grounded.

Cautions
4Chapter 1 - Safety
Caution
Signal transmission can be disturbed when the patient passes
concrete walls or elevator doors.
Caution
Use only high quality batteries. Remove the batteries when the
transmitter is not in use.
Caution
Do not use accessories that are not approved by Philips. You may
damage the equipment and this type of damage is not covered by
warranty.
Caution
Although the transmitter and receiver are chemically-resistant to
most common hospital cleaners and non-caustic detergents,
different cleaners are not recommended and may stain the
transmitter and receiver.
Many cleaners must be diluted before use. Follow the
manufacturer’s directions carefully to avoid damaging the
transmitter and receiver. Never use an abrasive material such as steel
wool or metal polish.
Do not allow any liquid to enter the transmitter and receiver cases
and avoid pouring liquid on the receiver while cleaning. Do not
immerse the transmitter.

Patient Safety
Chapter 1 - Safety 5
Patient Safety
The Telemetry Receiver is a Protection Class 1, Type B instrument.
It is designed to fulfill safety requirements according to IEC 601-1, UL
544 and CSA-C22.2 No.601.1-M90.
The telemetry transmitter is a battery operated device, applied parts
(patient connectors) are Type CF .
Environment
Use the system in an environment which is reasonably free from
vibration, dust, corrosive or explosive gases, extremes of temperature,
humidity, and so forth. It operates within specifications at ambient
temperatures between 0 and +45°C. Ambient temperatures that exceed
these limits can affect the accuracy of the system, the transmitter radio
frequency transmission, and can damage the components and circuits.
The system can be stored at ambient temperatures between -40°C and
+75°C.
The blue Toco and Ultrasound transducers are water-tight to a depth of
0.5 meters.
Warning
Do not use brown transducers to monitor patients under water.
Ultrasound and Toco transducers that are colored blue are watertight
and comply with IEC 529 (IP68).
You can immerse the BLUE Ultrasound and Toco tranducers in
water ONLY when connected to the telemetry transmitter. NEVER
connect blue transducers directly to the fetal monitor when they are
immersed in water, or likely to come in contact with water.
NEVER immerse the telemetry transmitter in water or other liquids
such as cleaning solutions.

Safety Symbols
6Chapter 1 - Safety
Safety Symbols
This symbol indicates that you should consult the
Instructions For Use (thisguide),andparticularlyany
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.
Earth Terminal
This symbol identifies the terminal for connection
to an external protective earth system.
Battery 3 x 1.5V
This symbol identifies the transmitter battery
holder. It takes three 1.5 V batteries (AA size, LR6
type).

Protective Earth
Chapter 1 - Safety 7
Protective Earth
To protect hospital personnel and the patient, the cabinet must be
grounded. Accordingly, the receiver is equipped with a 3-wire power
cable which grounds it to the power line ground when plugged into an
appropriate 3-wire receptacle. Do not use a 3-wire to 2-wire adapter with
thereceiver. Anyinterruption of theprotectiveearthgroundingwill cause
a potential shock hazard that could result in serious personal injury.
Whenever it is likely that the protection has been impaired, the receiver
must be made inoperative and be secured against any unintended
operation.
The patient cable must be positioned so that it does not come into
contact with any other electrical equipment.
Before operation, make sure that the receiver 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.

Maximum Input/Output Voltages
8Chapter 1 - Safety
Maximum Input/Output Voltages
Receiver (Rear View)
Transmitter
1. Service Socket
Maximum voltage of ±12V.
2. Socket to Fetal Monitor
Maximum voltage of ±12V.
3. Power Input Socket
100-120V ~ or 220-240V ~
4. Event Marker/Service Socket
Maximum Voltage of +5V.
5. Toco Socket
Maximum Voltage of +5V.
6. Cardio Socket
Maximum Voltage of +5V.

Chapter 2 - Overview 9
2
Overview
Intended Use Statement (M1310A)
In connection with a fetal monitor, the Series 50 T (M1310A) Fetal
Telemetry System allows continuous non-invasive or invasive wireless
monitoring of an ambulant patient during both antepartum testing and
labor and delivery in that the monitoring of the fetal heart rate (FHR) via
ultrasound or direct electrocardiogram (DECG), and the uterine activity
via an external Toco transducer or an internal intrauterine pressure (IUP)
transducer is possible.
The device isintended to be used in labor-rooms and delivery-rooms and
in antepartum-testing areas. It is not intended to be used for transport
monitoring and home use.
The FHR and uterine activity signals are transmitted continuously via
radio frequency from the telemetry transmitter to the telemetry receiver,
where they are displayed and recorded on the connected fetal monitor.
The Telemetry System 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 heart rate monitors and in the interpretation
of fetal heart rate traces. US federal law restricts this device to sale by, or
on the order of, a physician.

About This Book
10 Chapter 2 - Overview
About This Book
This describes how to set up and use the Series 50 T Fetal Telemetry
System with a fetal monitor.
You should be familiar with using medical devices and with standard
monitoring procedures, such as fastening belts, placing transducers and
so forth.
The information you need to use yourfetal monitor and transducersis in
the monitor’s Instructions for Use, or User’s Guide. Throughout this book,
Instructions for Use is used to cover both terms. Ensure that you read and
understand these instructions.
Refer also to the instructions that accompany any accessories and supplies
(for example, fetal scalp electrodes).
Compatible Fetal Monitors
Fetal Monitor FHR using
Ultrasound FHR using DECG Toco IUP FMP*
*. The monitor requires Fetal Movement Profile (FMP), and Telemetry FMP software revision
and interface.
Series 50 A (M1351A) ✔✘✔✘✔
Series 50 IP (M1353A) ✔✔✔✔✔
Series 50 IX (M1350A) ✔✔✔✔✔
Series 50 XM (M1350B) ✔✔✔✔✔
Series 50 XMO (M1350C) ✔✔✔✔✔
8040A ✔✔✔✔✘
8041A ✔✘✔✘✘

Product Overview
Chapter 2 - Overview 11
Product Overview
Telemetry Receiver (Front View)
1. Power On/Off Button Press to switch the receiver on.
Off position 0, On position |.
2. Power On Light Green LED, lit when the receiver is switched on.
3. Nurse Call Acknowledge/
Volume Control Button Pressed when Nurse Call activated on the transmitter to acknowledge the call and stop Nurse Call light flashing
and the intermittent tone sounding. It can also be used
to set Nurse Call volume.
4. Nurse Call Light Yellow LED, flashes when the Nurse Call Button is
pressed on the transmitter.
5. Transmission INOP Light Yellow LED, lit when the transmitter:
•is switched off.
•is out-of-range of the receiver
•is defective.
•and receiver do not have matching serial numbers
and channel frequency numbers.
•batteries are exhausted.
6. Battery Low Light Yellow LED, lit when batteries in the transmitter are
low.
7. Channel Frequency Label Showsthechannelnumberofthereceiver.Thisnumber
must match the number on the transmitter.

Product Overview
12 Chapter 2 - Overview
Telemetry Receiver (Rear View)
8. Service Socket
9. Output Socket to Fetal
Monitor
10. Antenna Input
11. Antenna
12. Product Serial Number
13. Voltage Switch 220-240V
100-120V
14. Fuses Fuses
100-120V: T300 mA 250V
220-240V: T125 L 250V
15. Mains Socket 100-120V/220V-240V
50-60Hz 19VA max.

Product Overview
Chapter 2 - Overview 13
Telemetry Transmitter (Top View)
1. Battery Compartment For 3 x 1.5V batteries
(AA size, LR6 type)
2. Remote Event Marker/
Service Socket For recording significant events on the fetal trace with the event marker.
It can also be used by service
engineers for servicing.
3. Toco Socket For connecting a Toco or IUP
transducer.
4. Cardio Socket For connecting an ultrasound or
DECG transducer.
5. On/Off Switch 0 | Off position 0, On position |.
6. On Light Green LED, lit when the transmitter
is switched on.
7. Nurse Call Button Pressed to give an optical and
acoustic signal to the receiver.
8. Channel Frequency
Label Shows the channel number of the
transmitter, the number on this label
must match the one on the receiver.

Product Overview
14 Chapter 2 - Overview
Telemetry Transmitter (Bottom View)
9. Carrying Belt Clips For attaching the carrying belt to the
transmitter.
10. Carrying Clip Clipped to patient’s clothes during
ambulant monitoring.
11. PTT Approval Label
12. Product Number and
Serial Number Label
Compatible Transducers
Telemetry transducers have shorter cables than standard but you can
also use standard Series 50 transducers with the Series 50 T. See
“Compatible Accessories”on page 64.