Philips Avalon CTS Cordless Use manual
Obstetrical Care
INSTRUCTIONS FOR USE
Avalon CTS
Cordless Fetal Transducer System
M2720A
FETAL MONITORING
Printed in Germany 08/04
*M2720-9001C*
Part Number M2720-9001C
4512 610 04471
S
Avalon CTS
Cordless Fetal Transducer System
M2720A
INSTRUCTIONS FOR USE
M2720-9001C
Printed in Germany
August 2004
ii
1 Introduction 1
Who This Book is For 1
Intended Use 2
Warnings, Cautions and Important Information 2
2 Installation 3
When is the Avalon CTS Customer Installable? 3
When Are Special Configurations Needed? 3
Installation Checklist 4
Checking the Shipment 4
Setting Up the System for the First Time 5
Connecting and Assembling the Standard Antenna 5
Mounting Solutions 6
Connecting the Base Station to a Fetal Monitor 7
How and When to Carry Out Tests 8
Safety Tests 8
Connecting the Base Station to AC Mains 9
System Test 9
What is a Medical Electrical System? 9
General Requirements for a System 9
System Example 10
Contents
3 Basic Operation 11
Base Station 11
Slot Arrangement 13
Transducers 14
MECG and DECG Transducers 15
4 Monitoring a Patient 17
What You Can Monitor 17
Flexible Monitoring 17
Radiated Transmission Power 17
Getting Ready to Monitor 18
Applying a Transducer 18
Using Transducers 19
Changing Between US and DECG Monitoring 19
Monitoring Twins 20
After Monitoring 20
Selecting Stand-by Mode 20
iii
Underwater Monitoring 21
About RF Signal Quality 21
Other Monitoring Considerations 22
5 Transducer Behavior 23
Docking Transducers 23
Removing a Transducer from the Base Station 24
Switching Off Transducers 24
6 Troubleshooting 25
Warnings and What To Do About Them 25
Error Handling 27
Error Messages 27
Displaying the Error Messages 28
Solving General Problems 29
Blocked Slots 31
7 Care and Cleaning 33
General Points 33
Cleaning 34
Disinfecting 34
Sterilizing 34
8 Maintenance 35
Battery Care 36
Performance Assurance 36
Parameter Test 36
Toco Transducer Ventilation Knob/Membrane 38
Testing Alarms 38
9 Accessories and Supplies 39
Information on Latex 39
Approved Accessories and Supplies 39
10 Specifications and Standards Compliance 41
General 41
Base Station 41
Transducers 42
Frequency Bands 43
Availability in EU and EFTA Countries 43
Frontends 44
Cables 45
Compatible Fetal Monitors 45
Standards Compliance 45
Safety 45
Electromagnetic Compatibility (EMC) 46
iv
EMC Testing 46
Reducing Electromagnetic Interference 47
System Characteristics 48
Electromagnetic Emissions 48
Radio Requirements 48
FCC Compliance (USA only) 49
Canadian Radio Equipment Compliance (Canada Only) 49
Environment 49
ESU, MRI and Defibrillation 50
Protective Earth 51
Maximum Input/Output Voltages 51
Statement of Conformity 51
11 Glossary 53
12 Advanced Configuration 55
Bed Label 55
Theft Protection Level 56
Theft Protection Alert Volume 56
Audible Alert Volume 57
Key Click Volume 58
Acoustical Alarm Default 58
13 Disposal 61
v
vi
1
1Introduction
Who This Book is For
This book describes how to set up and use the Avalon CTS Cordless Fetal Transducer System with a
fetal monitor. You should be familiar with using medical devices and with standard fetal monitoring
procedures, such as fastening belts and placing transducers. For details of installation procedures and
who should carry them out, see “Installation” starting on page 3.
The information you need to use your fetal monitor and transducers is in the fetal monitor’s
Instructions for Use. Ensure that you read and understand these instructions. Refer also to the
instructions that accompany any accessories and supplies.
The exact appearance of your system, regarding details of product livery, may vary slightly from that
illustrated.
For information on how to service the system, refer to the Service Guide.
1
1 Introduction Intended Use
Intended Use
When connected to a compatible fetal monitor, the Avalon CTS Cordless Fetal Transducer System
(M2720A) lets you perform continuous, cordless patient monitoring in the antepartum period and
during labor and delivery.
You can continuously monitor the fetal heart rate (FHR) non-invasively using ultrasound, or invasively
by direct electrocardiogram (DECG), and the uterine activity using an external Toco transducer.
The fetal parameters are measured and transmitted continuously via radio frequency from the
transducer to the base station, eliminating the need for patient cables. The fetal monitor, connected to
the base station, displays and records the parameters.
All the transducers are watertight. You can continuously monitor patients in a bath or shower using the
Toco (M2725A) and the Ultrasound (M2726A) transducers.
The 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 FHR monitors and in the interpretation of FHR
traces.
Warnings, Cautions and Important Information
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 circumstances 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, damage to the
product or other property, and possibly in a remote risk of more serious injury.
On your system, this sign indicates that there is detailed information in this book which
you must read before proceeding with your task.
In this book, graphical symbols (indicators or elements of the base station or transducer
displays) depicted in this way indicate that they are blinking.
© Copyright 1995-2004 Koninklijke Philips Electronics N.V. All Rights Reserved.
2
2Installation
This chapter describes how to install the Avalon CTS.
When is the Avalon CTS Customer Installable?
The Avalon CTS is intended to be customer installable under the following conditions:
• The system in its standard configuration is an “out-of-the-box”, standalone system, delivered with
automatic frequency allocation, and is intended to be used with the standard antenna supplied,
giving a line-of-sight operating range up to 100m/300ft.
• There are less than ten stand-alone systems in the institution.
• Connection to an antenna system is not planned.
• No other telemetry devices are used in the institution that can influence, or be influenced by, the
Avalon CTS.
2
• There are no other sources of RF interference that influence the operation of the Avalon CTS.
• There are no country-specific regulations requiring special configuration.
Installation should be carried out by qualified technical personnel.
If you need to mount the Avalon CTS, or use the antenna extension mounting kit (M1361A Option
1AA), see the Service Guide for further details.
When Are Special Configurations Needed?
If one or more of the conditions above are not met, you need a special configuration of the Avalon
CTS. For instance, you may need to:
• Set fixed frequencies when there are other telemetry systems installed in the same institution (always
applies to Japan). This configuration should be carried out by qualified service personnel, either
from the hospital’s biomedical department, or from Philips (see the Service Guide).
• Connect the Avalon CTS to an antenna system because the standard antenna is not sufficient to
cover the area intended for cordless monitoring. Site preparation, antenna system design (including
guidelines for mixed telemetry equipment installations), and installation should be carried out by
qualified service personnel from Philips.
3
2 Installation Installation Checklist
Installation Checklist
Use this checklist for customer installable configurations. Refer to the Service Guide and/or contact
Philips Support for installation requirements for all other delivery configurations.
Check Box
Step Task
when Task
Done
Perform initial inspection of delivery, unpack and check the shipment
1
(see page 4)
2 Connect and assemble the antenna (see page 5)
3 Mount the monitor as appropriate for your installation
(see page 6)
4 Connect the base station to the fetal monitor (see page 7)
5 Perform Safety Tests (see page 8)
6 Connect the base station to AC mains using the supplied power cord
(see page 9)
7 Perform System Test as necessary (see “System Test” on page 9)
8 Perform Parameter Test (see “Parameter Test” on page 36)
Checking the Shipment
Unpack the system carefully. Retain the packing materials in case you need to return the system to
Philips or transport your system. Use this table to check your delivery. Inspect all system components,
accessories and supplies for damage before setting up your system.
❏
❏
❏
❏
❏
❏
❏
❏
System Components, Accessories and Supplies Quantity
Base station 1
Ultrasound transducer, cordless, waterproof 1*
Ultrasound transmission gel 1 bottle*
Transducer belts, waterproof, reusable 3*
Toco transducer, cordless, waterproof 1*
ECG transducer 1 (optional)
Antenna with rectangular BNC connector 1
Interface cable, for connection to fetal monitor 1
Power cable 1
Service cable 1
Instructions for Use 1
Documentation CD-ROM (Instructions for Use, Service Guide, and Service Support Tool)1
* Delivered quantity depends on which option you ordered.
4
Setting Up the System for the First Time 2 Installation
Setting Up the System for the First Time
Item Description
1 Standard AC mains socket.
2 Equipotential Terminal. See “Symbols
on the System” on page 50.
3
Service Socket. 3.5 mm stereo jack for
connecting the Service Support Tool
(service personnel only).
4 Interface to Fetal Monitor. Use the
supplied M2720-61603 cable to
connect the base station to a Series 50
fetal monitor. Do not use any other
cable.
5 Antenna Input. Use supplied
antenna if the base station is not
connected to a hospital’s antenna
system.
(1) (2)
View of the Underside of the Base Station
(3)
(4)
(5)
Connecting and Assembling the Standard Antenna
1
Line up the nodules on the right angle connector with the spaces on the antenna connector.
2 Push in and twist.
3 Connect the antenna
antenna so that the two spaces (B) are positioned at the top and bottom. These fit over the two
notches (C) on the base station antenna socket.
4 Push the antenna onto the input socket at the rear of the base station.
5 Turn the connector collar (A) clockwise until it stops. The antenna should be positioned vertically
to ensure the best operating range.
1
to the base station by turning the connector collar (A) at the base of the
B
C
A
1.Please note that the antenna may differ slightly from the illustration.
5
2 Installation Mounting Solutions
To remove the antenna from the base station, turn the connector collar (A) anti-clockwise and pull the
antenna out of the socket.
A remote antenna system, if ordered, is sent separately with its own installation documentation.
Connect the remote antenna cable to the antenna socket at the rear of the base station.
Mounting Solutions
You can mount the Avalon CTS as follows:
• In a standard cart drawer. The base station with docked transducers fits into Philips Carts CL, CX
and CM.
Note: if you mount the base station in a cart or in such a way that the standard antenna cannot be
attached directly to the base station, or does not provide sufficient transmission range, use the
antenna extension mounting kit (M1361A Option 1AA).
• On top of carts, desks or other flat surfaces using the mounting brackets.
• In a wide variety of situations using the GCX mounting adapter for mounting the base station
(order directly from GCX, part number PH-0042-80).
• On top of Series 50 IX/XM/XMO fetal monitors using the mounting brackets.
Contact your local Philips representative for additional cart mounting options.
Mounting Brackets
Refer to the Service Guide for further details of how to mount your device.
6
Connecting the Base Station to a Fetal Monitor 2 Installation
Connecting the Base Station to a Fetal Monitor
1 Connect the interface cable to the fetal monitor interface socket on the base station.
2 Connect the other end of the interface cable to the telemetry socket (B) on the fetal monitor.
B
Series 50 IX/XM/XMO
B
Series 50 A and 50 IP/IP-2
To use the fetal monitor with wired transducers, switch the base station to stand-by. (You do not need
to disconnect the telemetry interface cable.)
7
2 Installation How and When to Carry Out Tests
How and When to Carry Out Tests
The following table defines which test or inspections need to be performed, and when they are
required.
Test Test or Inspection to be Performed Test Required for
Which Events?
Visual Inspect the base station, transducers and
cables for any damage.
Are they free of damage?
Power On Power on the base station.
Does the self-test complete successfully? (See
page 18)
Safety Tests (1) to (4) Perform safety tests (1) to (4), as described in
the Service Guide, if required by local
regulations.
Performance Perform the parameter test with all
parameters (see page 36).
Does this test complete without errors?
System Perform the system test according to IEC
60601-1-1, after combining equipment to
form a system (see “System Test” on page 9).
For test and inspection information regarding repairs, upgrades and all other service events, refer to the
Service Guide.
Installation
Preventive Maintenance
Installation
Preventive Maintenance
Installation
Combining or
exchanging system
components
Installation
Preventive Maintenance
Combining system
components
Safety Tests
Details of the safety tests and procedures required after an installation or an exchange of system
components are described in the Service Guide.
WARNING Safety test requirements are set acccording to international standards, such as IEC/EN 60601-1 and
IEC 60601-1-1, their national deviations, such as UL2601-1, CAN/CSA-C22.2 No. 601.1-M90 and
No 601.1-S1-94, and specific local requirements.
The safety tests detailed in the Service Guide are derived from international standards but may not be
sufficient to meet local requirements.
CAUTION The correct and accurate functioning of the equipment is ensured by the successful completion of the
safety tests, performance test, and the system test.
8
Connecting the Base Station to AC Mains 2 Installation
Connecting the Base Station to AC Mains
WARNING This equipment is intended for use only within healthcare facilities. It is not suitable for use in
domestic establishments and in establishments directly connected to a low voltage power supply
network, which supplies buildings used for domestic purposes.
Do not use additional AC mains extension cords or multiple portable socket-outlets. If a multiple
portable socket-outlet without a separation transformer is used, the interruption of its protective
earthing may result in enclosure leakage currents equal to the sum of the individual earth leakage
currents.
Connect the base station to the AC mains using the supplied power cord.
Important for users in the USA: Before connecting the base station to a 240 V AC mains supply system
(instead of the usual 110 V), ensure that the system is a center-tapped single phase circuit.
If the AC power fails, the base station’s power failure recovery system ensures that, after the return of
power, the system resumes normal operation automatically.
System Test
After mounting and setting up a system, perform sytem safety tests.
What is a Medical Electrical System?
A medical electrical system is a combination of at least one medical electrical device and other electrical
equipment, interconnected by functional connection or use of a multiple portable socket-outlet.
General Requirements for a System
After installation or subsequent modification, a system must comply with the requirements of the
system standard IEC/EN 60601-1-1. Compliance is checked by inspection, testing or analysis, as
specified in the IEC 60601-1-1 or in this book.
Medical electrical equipment must comply with the requirements of the general standard IEC/EN
60601-1, its relevant particular standards and specific national deviations. Non-medical electrical
equipment shall comply with IEC and ISO safety standards that are relevant to that equipment.
Relevant standards for some non-medical electrical equipment may have limits for enclosure leakage
currents higher than required by the standard IEC 60601-1-1. These higher limits are acceptable only
outside the patient environment. It is essential to reduce enclosure leakage currents when non-medical
electrical equipment is to be used within the patient environment.
WARNING Do not connect any devices that are not supported as part of a system.
9
2 Installation System Test
System Example
This illustration shows a system where both the medical electrical equipment and the non-medical
electrical equipment is situated at the patient’s bedside.
Non-Medical Devices
Personal
Computer
Distance to patient
must be >= 1.5m
Isolation
Transformer
Key:
Power cables:
Data cables:
WARNING Any non-medical device placed and operated in the patient’s vicinity must be powered via an approved
Medical Devices
Avalon CTS
Fetal Monitor
separation device.
If the personal computer (or any other non-medical electrical device) is situated outside the medically
used room, you must take measures to reduce leakage currents, such as providing an additional
protective earth, a non-conducting enclosure, or a separation device.
10
We highly recommend using a separation device whenever you connect non-medical electrical
equipment.
This chapter describes the operational features of the Avalon CTS base station and transducers,
including details of keys, displays and indicators.
Base Station
Your base station is shipped with a default bed label. This is the last two digits of the serial number.
You can change this to any two-digit value between 00 and 99 (see page 55). We recommend that you
give each base station in the hospital its own bed label. This lets you know to which base station an
active transducer belongs. Normally, you would not have to change the bed label. The base station
display and a registered transducer each display the bed label and bed symbol.
3
3Basic Operation
1
2
3
4
5
6
7
8
9
11
3 Basic Operation Base Station
Item Key or
Comments
Symbol
1Numeric
display
2 Bed Symbol: lights to show that the bed label (not error code) is currently shown in the numeric display.
3 Power-on or Stand-by LED. When the base station is connected to the mains, even in stand-by mode,
4 Audible Alerts Off Symbol: Indicates that audible alerts are off.
5 Navigation Keys to move through the configuration setting menus.
6 On/Stand-by: switches between stand-by (charge only) and On (operating mode).
7
8Docking
Slots
9Docking
slot color
code
indicator
Two-digit display: shows unique base station identification number (bed label), error and warning codes,
configuration settings.
transducer batteries charge continuously.
Function Key: multi-function key for clearing blocked slots, acknowledging alarms, and confirming
configuration changes.
Test Key: press and hold down to test all system components and links to fetal monitor. Numerics are
displayed/recorded on the fetal monitor.
Audible Alerts Off: switches alerts on and off.
RF Link Indicator
Continuously on - transducer removed and active.
Blinking together with the Warning Indicator - indicates that signal is too weak because patient is out of
receiving area, or interference from stronger RF signal, or transducer has auto shutdown due to low
battery.
Battery/Ready Indicator
Continuously on - indicates that the transducer is ready to use. It goes out as soon as you remove the
transducer from its slot.
Blinking together with the Warning Indicator shows that the battery of the active transducer which belongs
to this slot is nearly empty.
Orange Warning Indicator
Slot, or the transducer which belongs to the slot, requires attention.
Usually, this warning indicator comes on together with another blinking symbol, that is, the battery symbol
or the RF link indicator.
Store, charge and register transducers. Slot is color coded to match transducer color. Charges batteries
when transducer is docked, even in stand-by.
Red - US or optional ECG transducer with DECG or MECG adapter cable.
Brown - Toco
Neutral colored optional ECG transducer (without adapter cables attached) can go in Slot 1 or Slot 3.
12
Slot Arrangement 3 Basic Operation
Slot Arrangement
You can use transducers in the following slot positions:
Slot 1
Cardio-1
Slot 2
US
or
Toco
ECG
Twins monitoring is not possible.
The slot position indicator on the transducer display (here showing Slot 2, Toco) always
tells you in which slot to dock the active transducer after use.
CAUTION The base station generates a magnetic field. Do not store magnetic media (such as magnetic tapes and
disks, identity cards or credit cards with magnetic strips) near to the base station, as the data may be
damaged.
Slot 3
Cardio-2Toco
US
or
ECG
13
3 Basic Operation Transducers
Transducers
You can switch a transducer on, charge its battery, and register it to a base station only when it is
docked in a base station slot.
2
3
4
5
1
7
(Shows Toco transducer)
6
Item Key or Symbol Comments
1 Display Displays bed label, error codes, and operating conditions.
2 Take-out aid Colored aid makes removal of transducer easier and helps you to ensure correct
transducer placement in docking slot. Red for US, brown for Toco, blue for ECG (can
go in any slot when adapter cables are not attached and the connector socket is colorcoded red).
3 Indicates that the numeric display is showing the bed label.
4 Numeric display Shows bed label number during normal operation, and if an error occurs, the error code
number.
5 The filled dot indicates from which docking slot you removed the transducer, that is, the
one to which the transducer is registered. Helps you to find the correct docking slot
when you replace the transducer in the base station.
6 Indicates available battery capacity. Does not predict remaining operating time, as
capacity of fully-charged batteries varies.
If there is only one segment in the display, you have less than one hour’s operating time
left.
7 Indicates that the number shown in the numeric field is a warning code. During normal
use you see only the bed symbol.
14
Loading...