Philips Avalon CTS Cordless Use manual

Obstetrical Care

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

Avalon CTS

Cordless Fetal Transducer System

M2720A

F E T A L M O N I T O R I N G

Printed in Germany 08/04

*M2720-9001C*

Part Number M2720-9001C

4512 610 04471

S

Avalon CTS

Cordless Fetal Transducer System

M2720A

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

M2720-9001C

Printed in Germany

August 2004

ii

		Contents
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
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

Introduction

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

2

Installation

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.

•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
	1	Perform initial inspection of delivery, unpack and check the shipment
		(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	(1)	(2)	(3)	(4)	(5)
	connected to a hospital’s antenna
		View of the Underside of the Base Station
	system.

Connecting and Assembling the Standard Antenna

1Line up the nodules on the right angle connector with the spaces on the antenna connector.

2Push in and twist.

3Connect the antenna1 to the base station by turning the connector collar (A) at the base of the 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.

B

C

A

4Push the antenna onto the input socket at the rear of the base station.

5Turn the connector collar (A) clockwise until it stops. The antenna should be positioned vertically to ensure the best operating range.

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

1Connect the interface cable to the fetal monitor interface socket on the base station.

2Connect 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	Installation
	cables for any damage.	Preventive Maintenance
	Are they free of damage?
Power On	Power on the base station.	Installation
	Does the self-test complete successfully? (See	Preventive Maintenance
	page 18)
Safety Tests (1) to (4)	Perform safety tests (1) to (4), as described in	Installation
	the Service Guide, if required by local	Combining or
	regulations.
		exchanging system
		components
Performance	Perform the parameter test with all	Installation
	parameters (see page 36).	Preventive Maintenance
	Does this test complete without errors?
System	Perform the system test according to IEC	Combining system
	60601-1-1, after combining equipment to	components
	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.

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

Medical Devices

Personal

Computer

Avalon CTS

Distance to patient must be >= 1.5m

	Isolation
	Transformer
Key:
Power cables:
Data cables:	Fetal Monitor

WARNING Any non-medical device placed and operated in the patient’s vicinity must be powered via an approved 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.

We highly recommend using a separation device whenever you connect non-medical electrical equipment.

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3

Basic Operation

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.

1

2

3

4

5

6

7

8

9

11

3 Basic Operation

Base Station

Item	Key or	Comments
	Symbol
1	Numeric	Two-digit display: shows unique base station identification number (bed label), error and warning codes,
	display	configuration settings.
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,
		transducer batteries charge continuously.
4		Audible Alerts Off Symbol: Indicates that audible alerts are off.
5		Navigation Keys to move through the configuration setting menus.
		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.
6		On/Stand-by: switches between stand-by (charge only) and On (operating mode).
7		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.
8	Docking	Store, charge and register transducers. Slot is color coded to match transducer color. Charges batteries
	Slots	when transducer is docked, even in stand-by.
9	Docking	Red - US or optional ECG transducer with DECG or MECG adapter cable.
	slot color	Brown - Toco
	code
		Neutral colored optional ECG transducer (without adapter cables attached) can go in Slot 1 or Slot 3.
	indicator

12

Slot Arrangement

3 Basic Operation

Slot Arrangement

You can use transducers in the following slot positions:

Slot 1	Slot 2	Slot 3
Cardio-1	Toco	Cardio-2

	US		US
	or	Toco	or
	ECG		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.

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.

		3	4	5
2

1

7

6

(Shows Toco transducer)

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 color-
		coded 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