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Serv ic e G u id e

Avalon Fetal Monitoring


Avalon CL Transducer System
wi th Aval on FM Rele ase J. 3, Software Revis ion J.3x.x x

Fetal Monitoring
1 Table of Contents
1 General Information 5

Who Should Read This Guide 5


What to Do Next 5
Repair Strategy 6
When are Special Configurations Required? 6
Warnings and Cautions 6
Walkthrough 10

2 Site Preparation 13

Introduction 13
Roles and Responsibilities 13
Site Requirements 15
Site Planning 17

3 Installation 25

Installation Check List 25


Unpacking/Checking Shipment 26
Connection Options 27
Firmware Upgrades and Software Installation 30
Telemetry Interfaces 30
Safety Tests 41

4 Theory of Operation 43

Base Station Hardware Overview 43


CL Transducer Hardware Overview 45

5 Disassembly/Reassembly 47

Introduction 47
Tools Required 48
Disassembly Top Cover Avalon CL Base Station 48
Disassembly Short Range Radio Boards 52
Disassembly CL Pod Device Charger 54
Disassembly Charging Contacts 57
Disassembly Standby Button/Switchboard 62
Disassembly Bottom Cover Avalon CL Base Station 65
Disassembly CL Transducer Battery 67

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6 Spare Parts 77

7 Testing and Maintenance 79

Care and Cleaning 79


Terminology and Definition 79
Recommended Frequency 80
When to Perform Safety Tests 81
Testing Sequence 82
Visual Inspection 82
Safety Tests 84
System Test 84
Preventive Maintenance Procedures 84
Performance Assurance Test 88
Reporting of Test Results 94
Other Regular Tests 94

8 Troubleshooting 95

Overview 95
System is Completely Inoperative 95
System Reset 96
Checking the Fetal Monitor 96
Troubleshooting the Top Cover 96
Technical INOPs Avalon CL 98
Common Problems 102
RF Problems 105

9 Specifications 111

Environmental Specifications 111


Physical Specifications 112
Interface Specification 113
Performance Specifications 113
Regulatory and Standard Compliance 120
Symbols on the System 128

10 Upgrades 133

Software Option for CL Pods 133

Index 135

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1

1 General Information
This guide describes:
• how to service and repair the Avalon CL base station (866074) and the transducers CL Toco
(866075), CL US (866076), and CL ECG/IUP (866077) hardware and software
• how to diagnose operating and servicing problems
• how to test the system
The Avalon CL Fetal Transducer System Service Guide supplements the maintenance and
troubleshooting procedures, carried out by the operator that are described in the Instructions for Use,
and the Service Guides of the fetal monitors FM20/30 and FM40/50. Refer to the Instructions for
Use for maintenance and troubleshooting procedures that may be performed during normal operation.
For detailed information on the IntelliVue CL Pods that can be used with the Avalon CL base station,
please refer to their Instruction of Use and Service Guide.
Only authorized and qualified service personnel should attempt to install the system, disassemble the
base station, remove or replace any internal assemblies, or replace the transducer batteries or belt
buttons.

Who Should Read This Guide


This guide is for any authorized and qualified technical personnel servicing and repairing the Avalon
CL Fetal Transducer System.
You must:
– understand English
– be familiar with standard medical equipment installation procedures
– be familiar with current conventional technical terms as used throughout this guide

What to Do Next
Familiarize yourself with the contents of this guide and the Instructions for Use before attempting to
service or repair the system.

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1 General Information

Repair Strategy
The IntelliVue Support Tool software helps you to determine whether a fault is a hardware, software,
or an RF related problem. Any maintenance and repair procedures beyond the level covered in the
Instructions for Use are limited to:
Unit exchange for:
• base station
• transducers
• external power supply
Replacement of:
• top and bottom housing
• transducer battery
Repair or replacement of individual components on the boards is not supported, and should never be
attempted.

WARNING
Do not maintain or repair the device in patient vicinity.

When are Special Configurations Required?


There may be special configuration of the Avalon CL base station required:
• Setting fixed frequencies: This configuration should be carried out by authorized and qualified
service personnel, either from the hospital’s biomedical department, or from Philips.
• Considering country-specific regulations requiring special configuration (e.g. for Japan).

Warnings and Cautions


Warnings 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.

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1 General Information

Electric Hazards
WARNING
• Do not use additional AC mains extension cords or multiple portable socket-outlets. If a multiple
portable socket-outlet is used, the resulting system must be compliant with IEC 60601-
1:2005+A1:2012 / EN 60601-1:2006+AC:2010.
• Do not connect any devices that are not supported as part of a system.
• Do not use a device in the patient vicinity if it does not comply with IEC 60601-1:2005+A1:2012
/ EN 60601-1:2006+AC:2010. The whole installation, including devices outside of the patient
vicinity, must comply with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2010. Any non-
medical device, including a PC running an OB TraceVue/IntelliSpace Perinatal system, placed and
operated in the patient's vicinity, must be powered via a separating transformer (compliant with
IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2010) that ensures mechanical fixing of the
power cords and covering of any unused power outlets.
• Only the power cables provided with the system may be used. For reasons of safety, power (mains)
extension cables or adapters shall not be used.
• Observe ESD (electrostatic discharge) precautions when working within the unit.
• The use of accessories, transducers, and cables other than those specified may result in increased
electromagnetic emissions or decreased electromagnetic immunity of the device.
• Energized circuits are accessible with the covers open. Do not work on the base station with the
covers open while the base station is connected to a monitor. Only authorized and qualified
service personnel should open or disassemble the base station.
• Before attempting to open or disassemble the base station, disconnect it from the fetal monitor.

Radio Frequency Interference


WARNING
• Short range radio connections are subject to interruption due to interference from other radio
sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n), and
cordless phones. Depending on the strength and duration of the interference, the interruption may
occur for an extended period. A loss of connection, due to moving out-of-range, interference, or
for other reasons, is indicated with a No Host Monitoring INOP (here the host is the fetal monitor)
on the IntelliVue CL NBP or CL SpO2 Pods, or a No Host Monitoring, or cl NBP Disconnect, or cl
SpO₂ Disconnect INOP at the fetal monitor. Correct channel configuration is important, refer to
the Service Guides and the Configuration Guide for details.
• To avoid magnetic interference affecting the mode of the pacemaker, ensure that the
Avalon CL base station does not come into close contact with implanted pacemakers.
• This equipment generates, uses, and radiates radio-frequency energy, and if it is not installed and
used in accordance with its accompanying documentation, may cause interference to radio
communications. Operation of this equipment in a residential area may cause interference, in
which case the users must take whatever measures may be required to correct the interference.
• Do not use cordless/mobile phones or any other portable RF communication system within the
patient vicinity, or within a 1.0 m radius of any part of the fetal monitoring system.

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• For paced patients: The radiated SRR power of the CL SpO2 and CL NBP Pods, and other
sources of radio-frequency energy, when used in very close proximity of a pacemaker, might be
sufficient to interfere with pacemaker performance. Due to shielding effects of the body, internal
pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be
exercised when monitoring paced patients.
• In order to minimize the possibility of interference, avoid positioning and wearing the Cableless
Measurement Devices in very close proximity to a pacemaker. Consult the pacemaker
manufacturer for information on the RF susceptibility of their products.

Use Environment
WARNING
Liquid Ingress:
• Before operation, ensure that the base station 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.
Never immerse the base station in liquid. You must protect it against water sprays or splashes.
Place the base station where there is no chance of contact with, or falling into water, or other
liquids. The transducers are watertight to a depth of 1 meter/1.64 feet (rated IP 68). The base
station is protected against vertically falling water drops only (rated IP 31 according to
IEC 60529).
Explosion Hazard/Heat Exposure:
• 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°C and +45°C/32°F and +113°F. 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 -20°C and +60°C/-4°F and +140°F.

Installation
WARNING
• No modification of the fetal monitors, transducers, and the Avalon CL base station is allowed.
• Perform initial inspection of delivery, unpack, and check the shipment.
• The correct and accurate functioning of the equipment is ensured by the successful completion of
the safety tests, performance test, and the system test.

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1 General Information

• It is the customer's responsibility to have the attachment of the mounting hardware to the ceiling,
wall, or mounting rail and the construction of the ceiling, wall, or mounting rail evaluated for
structural integrity and compliance with all local, state, and any other required codes by a
registered, professional, structural, and/or mechanical engineer.
• Although considerable effort has been made to ensure the safety of the ceiling mount installation,
and the mounting guidelines, it is to be understood that the installation itself is beyond the control
of Philips Medical Systems. Accordingly, Philips Medical Systems will not be responsible for the
failure of any such installation.
• Check the mounting of the Avalon CL base station for integrity as part of your safety precautions.
Ensure that the base station is not able to slip, fall, or be pushed over by accident.
• The device should not be used adjacent to, or stacked with, other equipment unless otherwise
specified.
• NEVER run power cables through the same conduit or trunking used for system cables.

Maintenance, Repair, and Care


WARNING
Maintenance and Repair:
• Do not maintain or repair the device in patient vicinity.
• Failure on the part of the responsible individual hospital or institution using this equipment to
implement a satisfactory maintenance schedule may cause undue equipment failure and possible
health hazards.
• Performance verification: do not place the system into operation after repair or maintenance has
been performed, until all performance tests and safety tests listed in “Testing and Maintenance” of
this service manual have been performed. Failure to perform all tests could result in erroneous
parameter readings, or patient/operator injury.
• If the troubleshooting procedure requires you to disassemble the base station, be certain to follow
the disassembly and reassembly procedures given in “Disassembly/Reassembly”. Whenever parts
are replaced in the system, be certain to verify the hardware and software compatibility of the
repaired system.
• When replacing the front cover, do not over-torque the screws. Excessive torque may damage the
plastic screw mountings.
Batteries:
• Use only Philips batteries with the CL transducers (453564107871). Use of a different battery may
present a risk of fire or explosion.
• Do not open batteries, or dispose of them in fire, or cause them to short circuit. They may ignite,
explode, leak, or heat up, causing personal injury.
• If battery leakage should occur, avoid contact with skin.
• Dispose of used batteries promptly and in an environmentally-responsible manner. Do not dispose
of the battery in normal waste containers. Consult your hospital administrator to find out about
local arrangements. Do not expose batteries to liquids.
• Do not crush, drop, or puncture batteries - mechanical abuse can lead to internal damage and
internal short circuits which may not be visible externally.

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1 General Information

• If a battery has been dropped or banged against a hard surface, whether damage is visible
externally or not:
– discontinue use
– dispose of the battery in accordance with the disposal instructions above.
• Keep batteries out of the reach of children.
• Do not disassemble, heat above 100°C (212°F), or incinerate the batteries, to avoid the risk of fire
and burns. Keep batteries in their original package until you are ready to use them.
• Do not install or use pre-damaged batteries.
Care and Disinfection:
• To avoid contaminating or infecting personnel, the environment or other equipment, make sure
you disinfect and decontaminate the monitor appropriately before repairing or disposing of it in
accordance with your country's laws for equipment containing electrical and electronic parts.
• For disposal of parts and accessories such as thermometers, where not otherwise specified, follow
local regulations regarding disposal of hospital waste.

Walkthrough
The walkthrough provides an overview and a guideline for the service tasks from the site planing
through the troubleshooting.

Start with the “Site


Preparation”.

Check the “Site


Requirements”.

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1 General Information

Consult the local “Radio


Frequency Plan” or create
one.

Begin the “Installation”.

Work through the


“Installation Check List”.

Configure the “Telemetry


Interfaces”.

Perform the “Safety Tests”.

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1 General Information

Check the “Testing and


Maintenance” on page 79
schedules.

Use the “Troubleshooting”


section to analyze a problem.

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2

2 Site Preparation
Introduction
This section describes the procedures you should follow to plan and prepare a site for an Avalon CL
Transducer System installation.
• Roles and responsibilities for local and Philips personnel
• Site requirements
• Site planning

Roles and Responsibilities


This section describes the procedures necessary to prepare a site for a system installation. The
procedures are grouped into two parts: procedures that local staff or contractors are responsible for,
and procedures that Philips personnel are responsible for.

Site Preparation Responsibilities


Local Staff
• Ensure that all safety, environmental, and power requirements are met.
• Provide power outlets.
• Prepare mounts, and consult Philips for detailed mounting requirements.
• Pull cables, install conduit, and install wall boxes.
Philips Personnel
• Provide the customer with the safety, environmental, and power requirements.
• Assemble mounts, as necessary.
• Provide requirements for cabling.

Procedure for Local Staff


The following tasks must be completed before the procedures for Philips personnel may be started.
• Providing power outlets:
Provide a power outlet in the vicinity (1 m or 3 ft) or any peripheral equipment.

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2 Site Preparation

Preparing Mounts
Where ceiling, wall, or shelf mounts are required for mounting the equipment, the customer is
responsible for the following:
– Providing and installing all hardware which is required to install the mounting hardware
supplied by Philips as detailed in the Installation Notes.
– Making sure that all ceilings, walls, and mounting rails that supports mounting hardware are
suitable for their proposed load.

WARNING
It is the customer's responsibility to have the attachment of the mounting hardware to the ceiling, wall,
or mounting rail, and the construction of the ceiling, wall, or mounting rail evaluated for structural
integrity and compliance with all local, state, and any other required codes by a registered, professional,
structural, and/or mechanical engineer.
Although considerable effort has been made to ensure the safety of the ceiling mount installation and
or mounting guidelines, it is to be understood that the installation itself is beyond the control of Philips
Medical Systems. Accordingly, Philips Medical Systems will not be responsible for the failure of any
such installation.

• Providing Conduit
– Providing conduit and/or trunking of a sufficient cross-sectional area for the planned cables
and possible future expansion (for additional components or systems).
– Providing and/or installing suitable wall boxes to accommodate the face plates.
• Pulling Cables

WARNING
NEVER run power cables through the same conduit or trunking used for system cables.

• Installing Wall Boxes


It is the customer's responsibility to provide and install wall boxes to house face plates. The customer
must notify the Philips installation coordinator of which size is to be used.

Procedure for Philips Personnel


Before you begin the procedures in the installation sections, ensure that the customer has completed
all necessary preparations outlined in the previous section, “Procedure for Local Staff” on page 13.

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2 Site Preparation

Site Requirements
The site requirements are listed in this section.

Space Requirements
The situating of the Avalon CL base station should be planned such that the nursing staff are able to
monitor the patient with relative ease, with all patient connectors and controls readily available and the
displays clearly visible. The location should also allow access to service personnel without excessive
disruption and should have sufficient clearance all round to allow air circulation.
Dimensions and weight:
CL Base Station:
Size (W x H x D): 349 x 74 x 183 mm (13.7 x 2.9 x 7.2 in)
Weight; 0.985 kg (2.2 lb)
CL Transducer:
Size (diameter/height): 75.5 mm/ 36.6 mm (3.27 in)
Weight: 123 g (4.3 oz)

Environmental Requirements
The environment where the Avalon CL base station will be used should be reasonably free from
vibration, dust, and corrosive or explosive gases. The ambient operating and storage conditions for the
Avalon CL base station must be observed. If these conditions are not met, the accuracy of the system
will be affected and damage can occur.

Avalon CL Base Station 866074


Temperature Range Operating 0°C—45°C (32°F—113°F)
Storage/Transportation -20°C—60°C (-4°F—140°F)
Humidity Range Operating <95% relative humidity @ 45°C (113°F)
Storage/Transportation <90% relative humidity @ 60°C (140°F)
Altitude Range Operating -500—3000 m (-1640—9840 ft.)
Storage/Transportation -500—13100 m (-1640—43000 ft.)

Avalon CL Transducers (866075/866076/866077)


Temperature Range Operating 0°C—40°C (32°F—104°F)
Charging 0°C—35°C (32°F—95°F)
Storage/Transportation -20°C—60°C (-4°F—140°F)
Humidity Range Operating <95% relative humidity @ 40°C (104°F)
Storage/Transportation <90% relative humidity @ 60°C (140°F)
Altitude Range Operating -500—3000 m (-1640—9840 ft.)
Storage/Transportation -500—13100 m (-1640—43000 ft.)

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2 Site Preparation

Safety Requirements
The base station is an electrical Class II device in connection with M2702A/M2703A (FM20/FM30)
and M2704A/M2705A (FM40/FM50) in which the protection against electric shock does not rely on
basic insulation and a protective earth conductor, but on double and/or reinforced insulation.

Electrical Requirements
Line Voltage Connection
The Avalon CL base station is powered by the connected fetal monitor.

Essential Performance
Refer to the fetal monitor Service Guide for details on the essential performance for Avalon CL base
station in combination with the Avalon fetal monitors. The essential performance is maintained under
the electromagnetic conditions specified in chapter “Electromagnetic Compatibility (EMC)” on
page 121. The essential performance is specified separately for non-transient and for transient
electromagnetic interference.
Non-Transient Electromagnetic Phenomena:
• Radiated electromagnetic fields
• Conducted disturbances induced by RF fields
• Conducted disturbances induced by magnetic fields
• Voltage dips/voltage variations
Transient Electromagnetic Phenomena:
• Electrostatic Discharge (ESD)
• Electrical Fast Transients/Bursts
• Surges
• Voltage interruptions
• Electrosurgery (ESU)
Refer to the Service Guides of the FM20/30 and FM40/50 for further details.

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2 Site Preparation

Site Planning
The careful planning of the site for the Avalon CL Transducer System is essential for its safe and
efficient operation. A consulting schedule should be established between the customer and Philips
sales and support representatives, to ensure that all preparations are completed when the system is
delivered.
The site planning phases prior to equipment installation are:
Location: Planning the location of the system components.
Environment: Confirming and correcting, as necessary, the environment of the proposed installation
site(s).
Radio Frequency and area of reach plan: Consult the local radio frequency plan if available or
create one.
System Capabilities: Explaining the possibilities for system expansion.
Mounting: Referencing the mounting hardware information website for the listing of suitable
mounting hardware recommended for use with the various system components, and all details on the
available mounts and accessories.

Installation Scope
Depending on how many Avalon CL Transducer Systems were purchased, the site planning has to be
differentiated in relation to selecting in which room the systems are placed, and which fixed
frequencies are assigned to them. If the systems are installed in adjoining exam rooms the fixed
frequency channels have to be alternated, or an assigned CL transducer will report an INOP e.g. cl US
Disconnect.

In the frequency plan also include fetal monitors to which the Avalon CL base station may only be
temporarily connected (e.g. moving the base station with the patient to a different room). The
configuration of each fetal monitor determines the frequency settings of the connected Avalon CL
Transducer System. If the OBR settings have not been configured during the installation of a fetal
monitor, an Avalon CL Transducer System cannot be operated with it.
The physical structure of a building has an influence on the available range of the OBR radio. The
following structures can reduce the signal strength:
• steel enforced concrete walls
• metal doors
• elevators

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2 Site Preparation

Mounting Options
The Avalon CL Transducer System can be mounted:
• on top of a cart or a desk
• in a shelf or on top of an Avalon FM40/FM50 fetal monitor
• a wall channel
• the post of a rail stand
• a mounting plate

....

CAUTION
Check the mounting of the Avalon CL transducer System for integrity as part of your safety
precautions. Ensure that the base station is not able to slip, fall, or be pushed over by accident.

NOTE
Do not mount the Avalon CL Transducer System in an enclosed metal rack, cabinet, or carts drawer.
This will cause a marked decrease in the operating range.

Radio Frequency Plan


Part of the site planning is making a detailed frequency plan of the building (if not one is already
available). The Avalon CL base station uses a fixed frequency setting for the channel. If an Avalon CTS
base station is also installed in the area, or another device which can select and use random available
frequencies, we recommend setting these devices also to a fixed frequency to avoid interference and
malfunction. Refer also to “OBR Channel Settings” on page 33.

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2 Site Preparation

Example of a radio frequency plan:

Device Frequency Location


Alarm System 433.275 MHz Door 4, Floor 7
Alarm System 437.375 MHz ICU, Floor 7
Alarm System 434.375 MHz Floor 5
ECG telemetry Dev 1 433.850 MHz ICU
ECG telemetry Dev 2 434.120 MHz Exam room 123b, floor 4
ECG telemetry Dev 3 434.320 MHz ER room 2, floor 1
ECG telemetry Dev 4 434.520 MHz ER room 3, floor 1
Avalon CTS #1233 433.750 MHz Labor room 5, floor 3
Avalon CTS #1233 433.250 MHz Labor room 1, floor 3
Avalon CTS #1233 433.500 MHz Room 450, OB floor 3
Avalon CL ... ...
Avalon CL ... ...

Should there not be a frequency plan available for the site, use the Excel sheet Channel_Crosscheck
located on the Fetal Documentation DVD in the same folder as this Service Guide. The following
tutorial will use this Excel sheet to configure the OBR channels of various OBR devices.

Tutorial Frequency Planning


Gather the frequency information of all of the RF equipment used in the department, or your area of
responsibility. In example 1, a frequency plan is created for three types of devices:
• devices with a fixed frequency (M1310A)
• devices with the possibility of a frequency presetting (Avalon CTS)
• devices with a fixed channel to frequency association (Avalon CL)
As a planning aid, open the Excel sheet Channel_Crosscheck on the Fetal Documentation DVD.

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2 Site Preparation

Example 1
Situation
An OB department has three Avalon CTS and two M1310A. They bought three additional Avalon CL
systems. The Avalon CL systems are marked blue, the Avalon CTS systems green, and the M1310A
systems red.

Frequency Planning
In this example it is assumed that the fixed frequencies of the two M1310A are 610.15 MHz and
608.5 MHz.
1 Open the Excel sheet and write down the frequencies below the green frequency block.
2 Search for 610.15 MHz in the frequency block. You will find 610.1375 MHz and 610.1625 MHz
but not exactly 610.15 MHz. The fixed frequencies of the M1310A are not configurable. Since
their range in this example lies between two listed frequencies, it eliminates both the higher, and
the lower frequency from a possible selection. In this case, both frequencies must not be used by
any other equipment. Mark them with a red font color.
3 Now repeat the procedure with the second frequency 608.5 MHz. This leads to the exclusion of
608.4875 MHz and 608.5125 MHz.

4 Now configure the fixed frequencies for the Avalon CTS. Please refer to Avalon CTS Service
Guide on the Fetal Documentation DVD. One possible approach is, to place the Avalon CTS in
the higher part of the frequency band. Configure the three Avalon CTS as follows:
– 1st: 612.8125 MHz
– 2nd: 612.8875 MHz
– 3rd: 612.9625 MHz

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2 Site Preparation

5 Mark them also in a red font. Keep in mind, that each base station of the Avalon CTS uses three
frequencies of this block. Mark the consecutive used frequencies also in red font.

6 In the last step, you can choose the channels for the Avalon CL. Just check the appropriate box in
the channel block and verify that the channels are not already occupied. If the channels are already
occupied (you have marked them by setting the font color to red), you will see that those
frequencies are blocked out with a red bar.

7 In this example, channels 4, 6, and 8 were chosen. You can see the resulting spreadsheet below.
The frequencies now reserved for the Avalon CL systems are highlighted in red.

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2 Site Preparation

Example 2
Situation
An OB department has 12 rooms. They do not have any cableless systems so far, and want to install 12
new Avalon CL Transducer Systems. Part of the frequency band is occupied by the neighboring
department. The floor plan could look like this:

Frequency Planning
The frequencies in use are already determined and marked red in the spreadsheet.
The remaining channels are assigned to meet the two criteria as good as possible:
• Use at least alternate channels (3 and 5) for two adjoining rooms.
• Keep away from other RF equipment as far as possible.
Of course several combinations are possible. The resulting spreadsheet could look like this:

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2 Site Preparation

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3

3 Installation
Installation should be carried out by authorized and qualified service personnel, by Philips directly, or a
Philips certified service partner/dealer.
As the first step in preparing the Avalon CL Transducer System for use, follow the installation
instructions given in this chapter.
The Avalon CL base station is a system that can only be operated fully functional with the fetal
monitors FM20/30 and FM40/50.
The configuration of the fixed frequency channels should be carried out by authorized and qualified
service personnel, either from the hospital’s biomedical department, or from Philips service personnel.

Installation Check List


Use this checklist to document your installation.

Step Task Check when


done
1 Perform initial inspection of delivery, unpack and check the shipment
(see “Unpacking/Checking Shipment” on page 26)
2 Mount the Avalon CL base station as appropriate for your installation
(see “Mounting Options” on page 18)
3 Connect the base station to the monitor.
4 Perform Safety Tests described in the Service Guides of the fetal
monitors FM20/30 and FM40/50 and as described in “Testing and
Maintenance” on page 79.
5 Check that default settings of the connected fetal monitor (including the
line and radio frequency) are appropriate for your institution.
6 Perform System Test as necessary.
7 Test the CL transducers (see “CL Transducers Functional Tests” on
page 89).

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3 Installation

Unpacking/Checking Shipment
The cableless transducer system and any supporting options ordered are delivered packed in protective
shipping cartons.

Initial Inspection
1 Before unpacking, visually check the packaging and ensure that there are no signs of mishandling
or damage.
2 Open the package carefully and remove the instrument and accessories.
3 Check that the contents are complete, and that the correct options and accessories have been
delivered.
System Components, Accessories and Supplies Quantity Comments
Avalon CL Base Station 1 -
CL Ultrasound Transducer 1/2/3 -
CL Toco+ MP Transducer 1 -
CL ECG/IUP Transducer 1/2/3 -
Connection with red connector (connected to the fetal 1 -
sockets at the fetal monitors)
Connection cable with black connector (connected to the 1 Only for use with
telemetry socket at the rear of the FM20/50) FM40/50
Application Note 1 -

Claims for Damage


If the shipping cartons are damaged, contact the carrier.
If any of the equipment is damaged, contact both the carrier, and your local Philips service
organization for repair or replacement arrangements.

Repacking
Retain the original packing carton and material, in case you need to return equipment to Philips for
service. If you no longer have the original packing materials, Philips can advise you on alternatives.

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3 Installation

Connection Options
The fetal monitors FM20/FM30 and FM40/FM50 are compatible with the Avalon CL and
Avalon CTS Transducer Systems. Regard the following points for cableless monitoring:
• You can connect one Avalon CL base station with a red connector to an FM20/FM30 or an
FM40/FM50 (fetal socket), or one Avalon CL base station with a black connector to an FM40/
FM50 (telemetry socket).

• You can connect two Avalon CL base stations with black connectors to an FM40/FM50
(telemetry sockets)

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3 Installation

• You cannot connect two Avalon CL base stations to an FM40/FM50, if one Avalon CL base
station has a red connector, and the other Avalon CL base station has a black connector.

• You can connect one Avalon CTS system to an FM20/FM30 or FM40/FM50 at a time (either
fetal or telemetry socket).

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3 Installation

• You cannot connect an Avalon CTS and an Avalon CL at the same time to the same fetal monitor.

• Monitoring a multiple pregnancy using cableless transducers is supported by the Avalon CL system
only.
• Using a mixture of wired and cableless fetal transducers is not supported. You can use either wired
or cableless fetal transducers.
• If you cannot get sufficient signal quality using Avalon CTS transducers, switch to wired
transducers.

Connecting Two Avalon CL Base Stations at the FM40/50


At the FM40/50 two Avalon CL base stations can be connected at the same time. For this both
Avalon CL base stations have to be connected with the black connector (K40) to the two telemetry
sockets at the rear of the FM40/50. A mixed connection, one base station connected to the telemetry
socket, and one base station connected to the fetal socket, is not supported.

1 Left Telemetry socket


2 Right Telemetry socket

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3 Installation

The following rules apply with the connection of two base stations to the monitor:
1 The Avalon CL base station connected to the left telemetry socket takes over the radio
communication with the fetal monitor, if both base stations are connected when the FM40/FM50
is switched on.
2 If another base station is added while the first one is in use, the base station in use keeps the radio
communication with the fetal monitor (no matter which telemetry socket it is connected to), and a
message is issued Too many cableless transducer systems connected. When the FM40/50 is
switched off and on again, the base station connected to the left telemetry socket will resume the
radio communication with the fetal monitor again.
3 Both base stations can charge and assign CL transducers equally. You can switch cableless
monitoring to On or Standby toggle button of either base station.
4 When connecting two base stations to the FM40/50, mount the base station connected to the left
telemetry socket optimized for good radio transmission. The second base station can be placed,
for example, in a drawer since it does not have radio communication.
5 When updating the firmware of two connected base stations, update one base station after the
other, and always connect the one to be updated to the left telemetry socket. Also after both
updates have been done, and both base stations are again connected as desired, you have to cycle
the power of the fetal monitor to initialize the setup again.

Firmware Upgrades and Software Installation


The operation of the Avalon CL Fetal Transducer System is only supported with the software version
J.3 or higher. To operate the IntelliVue CL Pods (CL SpO2, CL NBP) the software option CL2 has to
also be installed (this option is license dependent and has to be purchased in advance). The software
option CL2 is not available for the FM20/30 #E25 battery option.
Please read the current Instruction for Use of the Support Tool to guide you through the installation
process.

Telemetry Interfaces
The Avalon CL base station is delivered with:

• OB Radio (OBR)

• Short Range Radio (SRR)

The base station has a built-in radio with an integrated antenna to communicate with CL transducers.
Host systems (Avalon fetal/maternal monitors) can control the transducers via the base station and
OBR.

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3 Installation

The base station is shipped with three corresponding frequency bands depending on the region it is
delivered to:
Frequency Bands:
• USA: WMTS 608 .. 614 MHz
• EU: ISM 433.05 .. 434.79 MHz
• Japan: T108 920.5 .. 923.5 MHz
The base station has a built-in radio interface with an integrated antenna to communicate with SRR
devices (IntelliVue CL NBP and CL SpO2 Pods). Host systems (Avalon fetal/maternal monitors) can
control the CL Pods via the base station and SRR.
The OBR has an operating range up to min. 100 m/300 ft (in line of sight). The SRR operating range
is limited to the parameter of the room (ca. 5 m) the base station is placed in. The actual effective area
of reach will vary according to the geographical and physical characteristics of the building where the
system is installed, and is also influenced by the presence of other radio frequency (RF) devices or
interference. We recommend that you define effective operating range prior to putting the system into
operation.
If the area of reach is adequate for the intended monitoring area, and the system’s operation is not
influenced by other RF sources, then the normal delivery configuration is sufficient.

WMTS Frequency Registration WMT


Frequency Coordination (USA only)
Frequency coordination is a registration and coordination process for wireless medical telemetry
devices used in the U.S.A. which operate in the FCC-allocated Wireless Medical Telemetry Service
(WMTS) bands (608-614 MHz, 1395-1400 MHz, 1427-1432 MHz).
Under U.S. Federal Communications Commission (FCC) rules, authorized healthcare providers must
register their WMTS devices with an authorized Frequency Coordinator designated by the FCC. The
American Society for Healthcare Engineering (ASHE) is the current designated Frequency
Coordinator. The 866074 Avalon CL operates in 608-614 MHz bands.
Registration/Coordination is a two-step process
Step 1: Registration: Register the healthcare facility on-line, from the ASHE website). Click on the
link for Wireless Medical Telemetry Service and come to the registration page. Fill out the details, and
pay the associated fee as per the instructions provided. You will receive confirmation of this
registration. Confirmation must be received before proceeding to the next step.
Step 2: Frequency Coordination: Along with confirmation of registration, you will receive access
information necessary to perform this second step, frequency coordination. This step involves logging
the equipment and frequencies used into the FCC’s database, so as to identify any existing potential
interference and to help prevent potential future interference. Coordination is accomplished via the
ASHE website. Click on the links for Wireless Medical Telemetry Service and then Frequency
Coordination. There is a separate fee for each coordination request, which varies between $250 and
$2000, depending upon the number of transmitting devices used and the band/s of operation.
Coordination is executed by a company named Comsearch, on behalf of ASHE.
To fill in the frequency coordination forms, you’ll need to know the following:
• The county.
• Latitude and longitude that represents the center of the area where the transmitting devices will be
deployed. Comsearch can help provide this information; www.comsearch.com provides contact
information.

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• The name/s of the Clinical Unit/s using the devices.


• The radius of deployment, expressed in meters. Imagine drawing a circle around the center of the
clinical unit, that encloses/encompasses the unit. What is its radius?
• The number of the highest floor on which a transmitting device will operate.
• How many transmitting devices will be used, i.e. the total number of 866074 Avalon CL base
stations
• The Effective Radiating Power:
– <20 mW (Avalon CL base station)
– <1 mW (Avalon CL transducers).
• The Equipment Manufacturer: Philips Medical Systems.
• The Model number: 866074 Avalon CL base station
• The Frequency Range to be used: 608-614 MHz
When both Registration and Frequency Coordination have been successfully completed, the Avalon
CL base station and its CL transducers can be activated. Note that this process is the responsibility of
the customer, as the final “operator” of the transmitting equipment.

OB Radio
You should consult the local radio frequency plan before configuring the OBR channels, or see “Radio
Frequency Plan” in this guide.

Setting Up OB-Radio
OB-Radio is set up at the fetal monitor. The base station is delivered with a fixed frequency band for
your region. Consult the local radio frequency plan for available frequency channels, or scan for an
available frequency channel and see also “OB-Radio Scan” on page 34.
1 Switch to the Configuration or Service Mode of the fetal monitor. Service Mode functions can be
used to identify channel assignment conflicts in the hospital environment.
2 Select Main Setup, Hardware, OBR. The revision shows which OBR setting revision is installed.

3 Select Frequency Band and select one of the options WMTS, ISM, or T108 depending for which
region your base station was configured. Check the base station label for it's type of frequency
band.

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4 Before you select a channel consult the hospital's frequency plan, or use the OB-Radio scan to
determine the availability of the channels.

OBR Channel Settings


Depending on your country, you have one of the following channel configuration options:
OBR provides a total of 36 channels on the WMTS band. The channels are labeled 1 to 36. Please
consult the local radio frequency plan before channel configuration.

Channel Number Frequency Channel Number Frequency


1 608.375 MHz 19 611.075 MHz
2 608.525 MHz 20 611.225 MHz
3 608.675 MHz 21 611.375 MHz
4 608.825 MHz 22 611.525 MHz
5 608.975 MHz 23 611.675 MHz
6 609.125 MHz 24 611.825 MHz
7 609.275 MHz 25 611.975 MHz
8 609.425 MHz 26 612.125 MHz
9 609.575 MHz 27 612.275 MHz
10 609.725 MHz 28 612.425 MHz
11 609.875 MHz 29 612.575 MHz
12 610.025 MHz 30 612.725 MHz
13 610.175 MHz 31 612.875 MHz
14 610.325 MHz 32 613.025 MHz
15 610.475 MHz 33 613.175 MHz
16 610.625 MHz 34 613.325 MHz
17 610.775 MHz 35 613.475 MHz
18 610.925 MHz 36 613.625 MHz

OBR provides a total of 11 channels on the ISM band. The channels are labeled 1 to 11. The ISM
band is not exclusively reserved for OBR. It is also used by, for example, SRR, Wireless LAN
(WLAN), and the OB TraceVue/IntelliSpace Perinatal Telemetry network. For this reason, depending
on the hospital’s existing wireless infrastructure, a number of OBR channels might already be occupied
by other wireless applications.

Channel Number Frequency Channel Number Frequency


1 433.125 MHz 7 434.025 MHz
2 433.275 MHz 8 434.175 MHz
3 433.425 MHz 9 434.325 MHz
4 433.575 MHz 10 434.475 MHz
5 433.725 MHz 11 434.625 MHz
6 433.875 MHz

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OBR provides a total of 14 channels on the T108 band. The channels are labeled 24 to 37. Wherefore
a selection of e.g. channel 24 uses both the channels 24 and 25, and channel 26 also uses 26 and 27,
and so on. The used channels are not available for other wireless devices.

Channel Number Frequency Channel Number Frequency


24 920.6 MHz 32 922.2 MHz
25 920.8 MHz 33 922.4 MHz
26 921.0 MHz 34 922.6 MHz
27 921.2 MHz 35 922.8 MHz
28 921.4 MHz 36 923.0 MHz
29 921.6 MHz 37 923.2 MHz
30 921.8 MHz
31 922.0 MHz

To achieve the best OBR performance possible, follow these recommendations:


• Usage of WLAN together with OBR may cause interferences. If the use of WLAN cannot be
avoided, limit the number of channels used for the WLAN infrastructure to a minimum.
• Usage of Bluetooth devices together with OBR may cause interferences. Bluetooth devices
automatically change channels regardless of whether a channel is already used by another
component of the wireless infrastructure and therefore interfere with OBR connections.
• Usage of cordless phones using the ISM band in the vicinity of OBR devices may cause
interferences.
• Usage of wireless PC keyboards or mice using the ISM band in the vicinity of OBR devices may
cause interferences.
To assign OBR channels to all monitors in a unit that should be used with SRR connections,
1 Identify unused OBR channels. This can be done by using the built in OBR scan.
2 Obtain a floor plan of the unit and identify where the devices with an OBR interface are located.

OB-Radio Scan
With an OB-Radio scan you can scan the radio activity from other radio devices on available channels
in the direct vicinity of the fetal monitor for a set duration.
1 Switch to the Service Mode.
2 Select Main Setup, Hardware, OBR.
3 For the Scan Duration select either Single Scan, or a duration from 15 min—24 h.
4 Select Start Scan and the OB-Radio scan is started.
The OB-Radio scan runs until the set duration is reached, and then the recorder prints out an OB-
Radio scan result similar to the example report below.

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5 You can stop the scan anytime manually by selecting Stop Scan.
The values show how long1 a channel was occupied through the length of the duration, and how
high the traffic of radio devices was in that duration. The best choice for OB-Radio are channels
with low mean and max. values.
To calculate the ideal channel values, use the following formula:

1 Title with scan duration


2 RSSI scale (0—250)

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3 Available channels on the frequency band


4 Scanned channel minimum value. Due to noise, this value is always >0.
5 Scanned channel mean value: this value informs about the radio traffic on this channel. The lower
the mean value is, the more available is this channel.
6 Scanned channel maximum value
The overlays on the channels 7, 24, and 30 in the graphic represent an Avalon CL, Avalon CTS, and
another device occupying OBR channels during the scan. The min., mean, and max. values recorded
on the example scan for these devices are typical. The lines with arrows are always in reference to the
min., mean, and max. values recorded on the RSSI scale.

Avalon CL
Channel 7: (46/104/167)
Low min., high max., and mean Shows that an Avalon CL system was sending for about 50% of
values, typical for a radio the time within the scan duration.
signature like Avalon CL:  not
recommended for channel
selection
Avalon CTS
Channel 30: (117/138/154)
High min., max., and mean Shows an Avalon CTS with a high duty cycle sending
values, typical for a radio continuously.
signature like Avalon CTS: 
not recommended for channel
selection
Any RF device
any Channel: (40/50/120)
Low min., high max., and low Shows a short interference of a device using this OBR band
mean value, typical for a short infrequently. Making this channel available for channel selection.
time interferer: 
recommended for channel
selection
Indication of a free channel (20/
30/40).
Low min, max., and mean value, Use the best available channel for the OB-Radio channel setting.
typical for a channel which is
not in use at all:  highly
recommended for channel
selection

1 The closer the mean value is to the max. value, the longer the channel is occupied.

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RSSI Trace
With the RSSI Trace you can test the signal strength and range of the CL transducers.
1 Switch to Service Mode
2 Select Main Setup, Hardware, OBR, and Start RSSI Trace.
3 Undock a CL transducer and walk away from the monitor.
The RSSI trace will scan the signal from the CL transducer as you are walking and will print it out
at the recorder. Depending on where the signal trace is printed in the FHR section of the trace, you
can discern the strength and quality of the OB-Radio signal. The RSSI value corresponds to the
FHR scale.
4 You can stop the scan anytime by selecting Stop RSSI Trace
The following RSSI example traces were run on the channels 5 and 6 from the previous OBR scan
example.

Channel 6 (58/82/123): not Channel 5 (52/72/106): recommended


recommended

Channel 6 has a mean RSSI of 82 and a Channel 5 has a mean RSSI of 72 and a max
max. RSSI of 123. Using the OBR formula, RSSI of 106. Using the OBR formula, the
the result is an RSSI of 102.5 which is >100 result is an RSSI of 89 which is <100 and
and therefore should not be used. therefore very good. The appropriate RSSI
The appropriate RSSI trace also shows a trace shows a stable RF link with single
stable RF link, with a few package losses. package losses (approaching out-of-range).

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NOTE
Package losses: An Avalon CL base station queries the CL transducers in regular intervals for data. A
package loss occurs when the CL transducer does not answer the query from the Avalon CL base
station. A single loss of data is considered a package loss. It is indicated on the trace as a black line in
the FMP section of the trace. The more package losses occur, the less data reaches the base station and
the monitor. Most package losses are inconsequential, unless the connection is lost completely (out-of
range, or malfunction).

Short Range Radio


It is not required to perform a site survey before installing an SRR infrastructure.

Configuring SRR Channels


Fetal Monitor:
Hardware Setting: Main Setup, Hardware, SRR Channel
The SRR channel settings only apply to fetal monitors that have the software option CL2 installed.
They only have an effect when IntelliVue CL Pods are used. They must be set to match the hospital’s
wireless infrastructure. The SRR channel settings are hardware settings, and will typically be set by
service personnel during installation.
Refer to your Configuration Guide for details.

SRR Channel Settings Configuration


SRR provides a total of 16 channels in the ISM (2.4 GHz) band. The channels are labeled 11 to 26. Up
to four monitors (up to two monitors operated with WTAAP) can be configured to one SRR channel,
if they are operated in proximity to each other. The ISM band is not exclusively reserved for SRR
applications. It is also used by, for example, for Wireless LAN (WLAN) and the IntelliVue Telemetry
network. For this reason, depending on the hospital’s existing wireless infrastructure, a number of SRR
channels might already be occupied by other wireless applications.
To achieve the best SRR performance possible, follow these recommendations:
• Usage of WLAN together with SRR may cause interferences. Each WLAN network uses at least
four of the 16 SRR channels. If the use of WLAN cannot be avoided, limit the number of channels
used for the WLAN infrastructure to a minimum.
• Usage of Bluetooth devices together with SRR may cause interferences. Bluetooth devices
automatically change channels regardless of whether a channel is already used by another
component of the wireless infrastructure, and therefore interfere with SRR connections.
• Usage of cordless phones using the ISM band in the vicinity of SRR devices may cause
interferences.
• Usage of wireless PC keyboards or mice using the ISM band in the vicinity of SRR devices may
cause interferences.

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3 Installation

To assign SRR channels to the Avalon base station


1 Identify unused SRR channels. This can be done by using commercially available tools, such as
AirMagnet.
2 Obtain a floor plan of the unit and identify where devices with an SRR interface are located.
SRR Channel Restrictions with WLAN, IIT, and DECT Devices
The following table and graphic show the restrictions of WLAN, IIT, or DECT device usage together
with SRR.

For a successful SRR deployment, the SRR channels must be located in the RF spectra where they are
least likely to be interfered with. Choosing appropriate channels after reviewing the Spectrum Analyzer
data is critical. In hospitals, 802.11 systems are most the likely source of interference with SRR
channels. The figures above show the relationship between 802.11, IIT, and DECT devices. For
example, if the site uses European 802.11 channels 1, 7, 13 for WLAN and has no IIT or DECT
devices in the SRR channels 15, 16, 21 or 22, these channels can be used for SRR.

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3 Installation

NOTE
Short range radio signals are low power signals and therefore have a relatively short range. You can use
this fact if the number of unused channels is low, and you run out of channels. Provided the distance
between two SRR groups is large enough, i.e. none of the short range radio signals transmitted by the
one group can interfere with signals of the other group, you may attempt to assign the same SRR
channel to both groups. Take into consideration that portable components belonging to one group
may be temporarily used within the range of another group.
The range of SRR signals cannot be clearly defined as it depends on external factors such as the
components and structure of walls, ceilings, etc., but it is unobstructed ca.5 m.

Setting Expectations
No matter how good a telemetry system design is, it will always experience occasional loss of radio
communications, resulting in CL US/Toco/ECG drop-outs. A telemetry system will never be as
reliable as a hard-wired monitor that transmits its signal through a wire. If occasional loss of CL US/
Toco/ECG monitoring is not acceptable for certain patients, they should be connected to a hard-
wired bedside monitor.
Following are guidelines to set proper expectations of hospital staff and to improve system
performance:
• Clinicians will tend to see more motion related artifact on the US/Toco/ECG measurements of
ambulatory patients than on patients that are restricted to a bed.
• Patients should be restricted to the designated coverage area. Monitoring performance will
degrade if patients go outside the radius of coverage of the receiving antenna.
• Telemetry system performance will degrade as the system size increases. The larger a system is, the
greater the potential for receiving interfering signals.
• A patient location protocol is critical to a telemetry system. If a life-threatening event occurs, the
clinician must be able to locate the patient quickly.
• Philips Medical Systems has no control over the RF environment in the hospital. If interference
exists at the operating frequencies, telemetry system performance will be affected. Careful
selection of frequencies for all wireless devices used within a facility (telemetry transmitters,
walkie-talkies, ambulance radios, other wireless medical devices, etc.) is important to prevent
interference between them. Frequency management is the responsibility of the hospital.

Recommendations for Cableless Monitoring


• Make sure the channel you have configured is not already in use. Any radio equipment which
operates within your channel degrades the performance. Refer to the channel table in “OBR
Channel Settings” on page 33.
• A frequency plan for the complete radio equipment is strongly recommended.
• Do not use the same channel for two base stations within a radius of 50 m. This can lead to bad
signal quality and signal loss. Use an adjacent channel or better an alternate (two channels
separation) instead.
• If you want to use more than one base station in a room, be sure to separate those 3 m and use
alternate channels (two channels separation).
• The best radio range is achieved by placing the base station on top of a fetal monitor, or on any
other furniture. Putting the base station in a drawer reduces the radio range.

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3 Installation

Frequently Asked Questions


Q: Is it possible to receive vital parameters from a different system, for example on the same channel?
A: No, the communication between a base station and its transducers is secured by several
mechanisms. But signal loss can occur if two systems use the same channel.
Q: How can I check the radio range of the system?
A: Undock a CL transducer (or more) and walk away from the base station. Watch the Finder LED of
the CL transducer. A blue finder LED indicates a loss of the radio link. This can happen temporarily
when walking behind doors or thicker walls (architecture of environment). If the Finder LED remains
blue and the CL transducer emits a tone, you have reached the range limit.
Q: How can I check the stability of a radio link?
A: If you want to check the radio stability of your system, for example if there may is another system
which causes interference, go to:
1 Main Setup, Operating Modes, Demo Mode.
2 Undock a CL transducer.
The appropriate parameter should appear on the screen with demo data.
3 Start the fetal recorder. The demo data is written on the paper. If the radio link is disturbed for
approximately 10 seconds, the trace data shows a gap.

Safety Tests
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.

Refer to the chapter “Safety Tests” on page 84 for further details.

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3 Installation

42
4

4 Theory of Operation
This chapter describes the functional operation of the system, including the CL base station and CL
transducers. It incorporates features of the mechanical design, indicating the physical relationship of
the assemblies and components.

Base Station Hardware Overview


1 CL Pod connector
2 Holding frame
3 Short Range Radio
4 Switchboard/Standby
button
5 Switch cable
6 PCA board
7 Charging contacts
8 Antenna holder
9 Antenna board

Base Station PCA


The base station board contains a chip processor with a FLASH-ROM, RAM data flash. The chip
processor controls:
• the communication between the base station and the fetal monitor
• the communication with the docked transducers
• the balance and supervision of the charging process of the docked transducers
• the radio chip (the radio transceiver for ISM, WMTS, or T108 band, depending on the country/
frequency option)
• the SRR connector and SRR boards

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4 Theory of Operation

Antenna PCA
The base station has a built in antenna board for ISM, WMTS, and T108 band.

44
4 Theory of Operation

Transducer Charging Contacts


The transducer charging contacts serve:
• the transducer detection
• the safety features of the charge power switch
• the serial communication between base station and transducers
• the synchronization clock generation for the power supplied by the base station PCA.

Cableless Charging Interface


The charging interface provides the serial interface (USB) for the connectivity from the cableless
device to the charging station.

SRR PCA
The Short-Range-Radio (SRR) interface provides wireless connectivity with an IEEE 802.15.4 radio to
SRR enabled host devices. It allows wireless communication of the base station to the monitor with an
IntelliVue Instrument Telemetry Transceiver (e.g. cableless device, CL SpO2, CL NBP).

Switchboard PCA
The switchboard PCA contains the on/stand-by switch with which the operating modes stand-by and
on of the base station are controlled.

CL Transducer Hardware Overview


The system has three transducer types:
• Avalon CL Toco+ MP transducer
• Avalon CL US transducer
• Avalon CL ECG/IUP transducer
They share the same modulation and digital processor circuitry, power supply (battery), and an RF
transmitter. The processor software is also the same for all transducers. The front-ends however are
specific for each transducer type.

Functional Description of the RF/CPU Hardware


The RF/CPU section of the transducers is made up of the following functional blocks:
• CPU (micro controller)
• Base station communication
• EEPROM
• FLASH download port
• Clock generator
• Power supply and battery charger
• Modulator
• RF transmitter

45
4 Theory of Operation

CL Toco+MP Front-end Hardware


Uterine activity is measured by evaluating the hardness of the mother’s abdomen with a pressure
sensitive resistor bridge (DMS element). The DMS element requires an excitation voltage and its
differential output signal is proportional to the pressure applied to the DMS element. An AC excitation
voltage is used, and the resulting AC output signal is amplified and converted to a pressure
proportional DC voltage by a synchronous rectifier followed by a low pass filter.
In addition, the transducer is capable of providing the maternal pulse measurement by two included
infrared sensors. This front-end combines several parameter front-ends on one board. Toco, Maternal
Pulse (MP), and ECG. Supported parameters of the ECG part are DECG, MECG, and IUP.

CL Ultrasound Front-end Hardware


The ultrasound front-end is a pulsed doppler system with a 1.0 MHz ultrasound frequency, and a pulse
repetition rate of 3.0 kHz. Seven ultrasound crystals are used as transmitter and receiver.

CL ECG/IUP Front-end Hardware


Several parameter front-ends are combined on the ECG front-end board. Currently supported
parameters are DECG, MECG, and IUP.
A seven-pin ‘D-type’ socket carries all parameter related inputs and outputs. An external mode resistor
connected to one of the pins detects which ECG mode to set when an adapter cable is plugged in. The
Legplate Adapter 9898 031 37651, used with the M2738A patient module, is also used for the fetal
scalp or adult electrodes.

46
5

5 Disassembly/Reassembly

WARNING
• Performance verification: do not place the system into operation after repair or maintenance has
been performed, until all performance tests and safety tests listed in “Testing and Maintenance”
on page 79 of this Service Guide have been performed. Failure to perform all tests could result in
erroneous parameter readings, or patient/operator injury.
• Energized circuits are accessible with the covers open. Do not work on the base station with the
covers open while the base station is connected to a monitor. Only authorized and qualified
service personnel should open or disassemble the base station.
• Before attempting to open or disassemble the base station, disconnect it from the fetal monitor.

CAUTION
Observe ESD (electrostatic discharge) precautions when working within the unit.

WARNING
To avoid contaminating or infecting personnel, the environment or other equipment, make sure you
disinfect and decontaminate the monitor appropriately before disposing of it in accordance with your
country's laws for equipment containing electrical and electronic parts. For disposal of parts and
accessories such as thermometers, where not otherwise specified, follow local regulations regarding
disposal of hospital waste.

Introduction
• Remember to store all screws and parts in a safe place for later refitting.
• The disassembly sections detail the step-by-step procedures you use to access replaceable parts of
the base station.
• All the CL transducers are sealed at the factory and are not repairable. Replacement CL
transducers are supplied complete with both battery and belt button fitted.
– Exception: The battery of the CL transducers can be replaced.

47
5 Disassembly/Reassembly

The Avalon CL base station consists of two major assemblies:


• The top cover assembly
• The bottom assembly

Tools Required
CAUTION
When replacing the front cover, do not over-torque the screws. Excessive torque may damage the
plastic screw mountings.

You need the following tools:

Small flat-head screwdriver, 2.0-3.0 mm

Torx-head screwdriver, size T-10

Torx bit, for suitable driver, size T-10

Long-nosed pliers

Antenna cable removal tool (attached to the antenna


holder at first, and later stored in the designated interlock
in the bottom housing).

Disassembly Top Cover Avalon CL Base Station


Removing Top Cover Assembly CL Base Station
1 Remove CL transducers and turn the base station over.

48
5 Disassembly/Reassembly

2 Remove the screw on the cable cover first to open it.

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5 Disassembly/Reassembly

3 Gently remove the cable by pulling the adapter from its interlock (1), pulling too hard will damage
the connector. Disconnect the cable from the connector (2) located on the main PCA. The
procedure is same for all connector cables (red connector, black connector, and external power
supply).

4 Remove the six screws around the bottom housing.

5 After removing the screws, turn the base station back around, and lift the top housing from the
bottom housing by gently prying them apart.

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5 Disassembly/Reassembly

Top Cover Assembly Overview

1 CL Pod connector
2 Holding frame
3 Short Range Radio
4 Switchboard/Standby
button
5 Switch cable
6 PCA board
7 Charging contacts
8 Antenna holder
9 Antenna board

Replacing Top Cover Assembly CL Base Station


1 Set the top housing of the base station gently on the bottom housing.
2 Press gently on the top housing until it is arrested on the bottom housing.
3 Turn the base station over and fasten the six screws of the bottom housing.
4 Reconnect the cable to its connector on the PCA (1).
5 Arrest the cable adapter back into its interlock (2).
6 Set the cable in the left cable guide (3).
7 Replace the cable cover by inserting the arrestor on the right in its interlock (4), before closing the
cable cover.

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5 Disassembly/Reassembly

8 Fasten the cable cover screw.

Disassembly Short Range Radio Boards


Removing the Short Range Radio Boards
1 Unplug the Short Range Radio (SRR) cables from both of the Short Range boards.

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5 Disassembly/Reassembly

2 Lift up the top holding frame (1), and pick up the SRR board (2) releasing it from its interlock.

Replacing the Short Radio Boards


1 Set SRR board at a steep angle with the bottom edge first so that the guiding eye matches the
arrestor.
2 Set the SRR board with its bottom edge under the holding frame.

3 Reconnect the SRR cable.

53
5 Disassembly/Reassembly

4 Reattach the holding frame.

Disassembly CL Pod Device Charger


Removing CL Pod Charger
1 Remove plastic mounting pins.

54
5 Disassembly/Reassembly

2 Lift CL Pod charger perpendicular up from its interlock.

Replacing CL Pod Charger


1 Set CL Pod charger perpendicular down into its interlock.

55
5 Disassembly/Reassembly

2 Replace the mounting pins.

56
5 Disassembly/Reassembly

Disassembly Charging Contacts


Removing Charging Contacts
1 First you have to remove the antenna removal tool that is attached to the antenna holder.
2 Break or cut off (using a side cutter/pilot punch) the tool gently off the antenna holder.

3 With the tool unplug the antenna cable from the antenna board.

4 Place the antenna removal tool into the designated interlock in the bottom housing with the fork
part facing up and bracing against the side wall from the bottom housing.

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5 Disassembly/Reassembly

5 Remove the antenna board from the antenna holder by extracting it from the bottom interlock
first.

6 Remove the three screws from the antenna holder.

7 Unplug the three charging connectors from the PCA board.

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5 Disassembly/Reassembly

8 Unwind the cable of the connector from its mounting at the antenna holder.

9 Remove the charging contact from its interlock by pressing the springs on each side of it. Assure
that the silicon sealing stays attached to the contact.

Replacing Charging Contacts


1 Insert the silicon sealing into the opening.
2 Take the new charging contact and place it in the sealing, and then in the interlock. Assure that the
charging contact is placed behind the middle interlock, or you will be unable to arrest the springs
in their interlocks.

59
5 Disassembly/Reassembly

3 Wind the charging contact cable back on its mounting.

4 Plug the charging connector back into the PCA board.

60
5 Disassembly/Reassembly

5 Assure that all charging connector cables are lined up in the cable guides of the antenna holder.

6 Fasten the three screws of the antenna holder.

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5 Disassembly/Reassembly

7 Replace the antenna board back into its interlock at the antenna holder.

8 Reconnect the antenna cable.

Disassembly Standby Button/Switchboard


Removing Standby Button/Switchboard
1 Unplug the switch cable from the switchboard.

62
5 Disassembly/Reassembly

2 Press with the screw driver on the release catch and gently slide the switchboard from its
mounting.

3 Remove the right SRR board as described in the topic “Removing the Short Range Radio Boards”
on page 52.
4 Remove the three screws (1) and slide the holding frame from its position out the interlock and lift
it up (2).

63
5 Disassembly/Reassembly

5 Remove the Standby button.

Replacing Standby Button/Switchboard


1 Replace Standby button.

NOTE
The Standby button and the light pipe are part of the support kit and are part of one silicon item.
Separate the parts using scissors, and extract the part you need.

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5 Disassembly/Reassembly

1 Slide the holding frame back in its interlock and fasten the three screws.

2 Reinsert the SRR board as described in “Replacing the Short Radio Boards” on page 53.
3 Slide/replace the switchboard in the interlock in the holding frame and reconnect the switchboard
cable.

Disassembly Bottom Cover Avalon CL Base


Station
Removing Bottom Cover Assembly CL Base Station
The bottom cover is removed the same way the top cover is removed “Removing Top Cover
Assembly CL Base Station” on page 48.

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5 Disassembly/Reassembly

Replacing Bottom Cover Assembly CL Base Station


1 If there is an antenna cable removal tool in the designated interlock in the old bottom cover
remove it.

2 To remove the name plate gently press the arrestors of the name plate with a small flat nose pliers
together as you pull it out its interlock.

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5 Disassembly/Reassembly

3 Insert the name plate into the designated interlock of the new bottom housing.

4 Take the new bottom housing and reassemble the base station as described in “Replacing Top
Cover Assembly CL Base Station” on page 51.

Disassembly CL Transducer Battery


Removing CL Transducer Battery
The new CL transducer battery replacement tool makes the battery replacement easier. The tool is
used to open and close the CL transducers. If the tool opens or closes the CL transducer depends on
to which side you flip the top part of the tool. The side depicted with the open lock opens the CL
transducer, and the side depicted with the closed lock is used to close it.

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5 Disassembly/Reassembly

1 Place a CL transducer in the bottom part of the tool.

2 Place the top cover from the tool on the bottom part, and fit the interlock on the sides together.

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5 Disassembly/Reassembly

3 Turn the top of the tool counter-clock-wise and back to the start position to open the CL
transducer housing within.

4 Take the opened CL transducer out of the tool and gently lift the top housing of the CL transducer
up.

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5 Disassembly/Reassembly

5 Unplug the charger cable and lift the battery and attached CPU board from the CL transducer
housing.

6 Unplug the battery connector (1), and pry the CPU board gently from the holding frame of the
battery (2). The CPU board and the battery are separated (3).

7 Remove the battery from its holder.

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5 Disassembly/Reassembly

Replacing CL Transducer Battery


1 Unpack the new battery and place it in the holder.

2 Push the battery down until the clamps hold it in place.

3 Place the CPU board on the holding frame (1) so that the clamps hold the board in place. Turn the
holding frame over and plug-in the battery connector (2) at the CPU board.

4 Place the battery with attached CPU board back into the CL transducer housing. Make sure you
place the nose of the CPU board exactly on the shelf, and not against the shelf within the CL
transducer head. This ensures that the connectors are lined up correctly (1).

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5 Disassembly/Reassembly

5 Push the CPU board lightly down on the left side and center it by wiggling it back and forth (2).
6 Push the CPU carefully down until you hear the connectors in the transducer shell arrest with a
clicking sound.

7 Wind the charger cable back on its mounting as shown in the graphic below:
– lay it over the first nose (1)
– under the second nose to the back (2)
– under the hook (3)
– and plug the connector into the CPU board (4)

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5 Disassembly/Reassembly

8 Remove the old sealing ring.

9 Replace it with one of the two sealing rings shipped together with the battery kit.

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5 Disassembly/Reassembly

10 Take the flat screw driver and move it one time under seal around the whole CL transducer cover
to ensure that the seal lays correctly in its groove, and is not twisted. This ensures the
watertightness of the CL transducer.

11 Set the top lightly on the bottom (1).


12 Turn the top slightly to the right until the stop (2).
13 Then press the top down.

CAUTION
Follow these instructions closely, or a part of the CPU board can be
damaged in the process.

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5 Disassembly/Reassembly

14 Set the still open CL transducer into the bottom of the transducer tool.

15 Place the top cover of the transducer tool with the symbol depicting a closed lock facing upward
onto the bottom of the tool.

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5 Disassembly/Reassembly

16 Turn the top of the tool clock-wise and back to the start position to close the CL transducer
housing within.

17 The CL transducer is closed, and you can take it out of the tool, and dock it back at the base
station.

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6

6 Spare Parts
Here all spare parts are listed with part numbers. All transducers and accessories are latex-free, unless
indicated otherwise.

Part Number Description


453564207661 CL_CHRG Connection Board Assembly
453564423141 AVCL-BASE Small Parts Kit
– 2x SRR cable
– 3x XDR charging contacts
– 3x gasket pins
– Silicon button and light pipe (Stand-by)
– Switch board
453564423221 AVCL-BASE MECH Housing w/o PCA
– Top housing (plastic)
– Bottom housing (plastic)
– Silicon button and light pipe (Stand-by)
– Holding frame SRR
– Antenna holder
– 3x XDR charging contacts
453564437641 AVCL-BASE CBL black plug
453564437651 AVCL-BASE CBL red plug
453564423241 AVCL-BASE MECH Cable slot cover
989803184861 AVCL BAT Battery replacement kit incl. Tool
– Battery
– 2x sealing rings
– Instruction sheet
– Opening tool
453564423261 AVCL-BASE Base station Exchange ISM
1 connection cable –black plug
1 connection cable –red plug
453564423271 AVCL-BASE Base station Exchange WMTS
1 connection cable –black plug
1 connection cable –red plug

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6 Spare Parts

Part Number Description


453564423281 AVCL-BASE Base station Exchange T108
1 connection cable –black plug
1 connection cable –red plug
453564423301 AVCL-US Replacement XDR ISM
453564423311 AVCL-TOCO Replacement XDR ISM
453564423321 AVCL-ECG Replacement XDR ISM
453564408281 IV2-FLEX SRR board
453564423411 AVCL-US Replacement XDR WMTS
453564423421 AVCL-TOCO Replacement XDR WMTS
453564423431 AVCL-ECG Replacement XDR WMTS
453564423441 AVCL-US Replacement XDR T108
453564423451 AVCL-TOCO Replacement XDR T108
453564423461 AVCL-ECG Replacement XDR T108

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7

7 Testing and Maintenance


This chapter contains maintenance and safety information for the Avalon CL base station and the CL
transducers. All checks that require the device to be opened must be made by authorized and qualified
service personnel. Contact your local Philips representative if you wish safety and maintenance checks
to be carried out by Philips personnel.
To ensure proper functioning of your system you must adhere to the standards described in this book
for:
• Cleaning
• Performance assurance checks (system self test, parameter test)
• Safety tests (safety test blocks, instrument safety test, system test)
• Accessory testing (transducer checks, patient module checks)

CAUTION
Failure on the part of the responsible individual hospital or institution using this equipment to
implement a satisfactory maintenance schedule may cause undue equipment failure and possible health
hazards.

Care and Cleaning


For detailed instructions on how to care for and clean the CL base station, CL transducers, and the
monitoring accessories, see the Instructions for Use.

Terminology and Definition


The following terms and definitions are used throughout this chapter and taken from the international
standards IEC 60601-1 and IEC 62353.
• Medical 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.
• Patient Environment: any area in which intentional or unintentional contact can occur between
the patient and parts of the medical system, or between the patient and other persons who have
had contact with parts of the medical system. The patient environment is defined anywhere within
1.5 m (5 feet) of the perimeter of the patient's bed and 2.5 m (8.2 feet) from the floor.

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7 Testing and Maintenance

• Separation Device/Transformer: a component or arrangement of components with input parts


and output parts that, for safety reasons, prevent a transfer of unwanted voltage or current
between parts of a medical system.
• Multiple Portable Socket-Outlet: a combination of two or more socket-outlets intended to be
connected to or integrated with flexible cables or cords, which can easily be moved from one place
to another while connected to the power mains.
• Functional Connection: an electrical connection for transfer of signals and/or power.
• Tests: Safety or Performance Assurance test procedures which may consist of several steps.

Recommended Frequency
Perform the procedures as indicated in the suggested testing timetable. These timetable
recommendations do not supersede local requirements.
Suggested Testing Time Table:

Test Frequency
Preventive maintenance Battery check Once every two years, or more
often if this is specified by local
laws.
Other regular test Visual inspection Before each use
Power on test
Performance assurance test Transducer functional test • Switch board/ silicon
Battery check button was replaced
• Transducer charging
contacts replaced
• Cableless connection board
replaced
• SRR board replaced
Safety test Visual inspection After each service event
Electrical (base station only) Electrical safety testing is not
required for the Avalon CL
base station. The base station
has the same status as a wired
transducer. The base station is
either connected to the red fetal
sensor socket (FM20/30/40/
50), or the black rear telemetry
socket (FM40/50 only). When
used as a charger station only,
the device is not intended to be
a medical device.

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7 Testing and Maintenance

When to Perform Safety Tests


This table tells you when to perform specific safety tests.

Service Event Test Blocks Required - Complete These Tests


“Installation” on page 25 Perform Visual, Power On, and Performance and Safety test
Installed by authorized and blocks
qualified service personnel.
“Testing and Maintenance” on Perform Visual test block, Performance test block
page 79
Preventive maintenance is the
responsibility of the customer.
“Disassembly/Reassembly” on Perform Visual, Power On, and Performance test blocks
page 47
This Service Guide contains
repair instructions for the
Avalon CL base station.
Upgrade Perform Visual, Power On, and Performance test blocks
Combining or Exchanging Perform the System test
System Components
“Connection Options” on
page 27
Other service events Perform Visual, Power On, and Performance test blocks

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7 Testing and Maintenance

Testing Sequence
Summary of the recommended sequence of testing:

NOTE
If any single test fails, testing must be discontinued immediately, and the device under test must be
repaired or labeled as defective.

Visual Inspection
Before Each Use
Check all exterior housings for cracks and damage. Check the condition of the interface cable,
especially for splits or cracks, and signs of twisting. If serious damage is evident, the cable should be
replaced immediately. On the CL Toco+ MP and CL ECG/IUP transducer ensure that the adapter
cable socket is not damaged. Check that all mountings are correctly installed and secure. Refer to the
instructions that accompany the relevant mounting solution.

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7 Testing and Maintenance

After Each Service, Maintenance, or Repair Event


Check:
• the integrity of mechanical parts, internally, and externally.
• any damage or contamination, internally, and externally.
• that no loose parts or foreign bodies remain in the device after servicing or repair.
• the integrity of all relevant accessories.

Warnings, Cautions, and Safety Precautions


• These tests are well established procedures of detecting abnormalities that if undetected, could
result in danger to either the patient or the operator.
• Disconnect the device under test from the patient before performing safety tests.
• Disconnect the device under test from mains before performing safety tests. If this is not possible,
ensure that the performance of these tests does not result in danger to the safety analyzer operator,
patients, or other individuals.
• Test equipment (for example, a Safety Analyzer) is required to perform the safety tests. Please refer
to Annex C of IEC/EN 62353 for exact requirements for the measurement equipment, and for
measurement circuits for protective earth resistance, and leakage currents. Refer to the
documentation that accompanies the test equipment. Only skilled technicians should perform
safety testing.
• The consistent use of a Safety Analyzer as a routine step in closing a repair or upgrade is
emphasized as a mandatory step to maintain approval agency status. You can also use the Safety
Analyzer as a troubleshooting tool to detect abnormalities of line voltage, and grounding plus total
current loads.
• During safety testing, mains voltage and electrical currents are applied to the device under test.
Ensure that there are no open electrical conductive parts during the performance of these tests.
Avoid that users, patients, or other individuals come into contact with touch voltage.
• For Europe and Asia/Pacific, the fetal monitor complies with: IEC 60601-1:2005+A1:2012/
EN 60601-1:2006+AC:2010
• For USA, the fetal monitor complies with: ANSI/AAMI
ES60601-1:2005+A1:2012+C1:2009+A2:2010
• For Canada, the fetal monitor complies with: CAN/CSA C22.2#60601-1-08
• Local regulations supersede the testing requirements listed in this chapter.
• If a non-medical device is connected to the medical electrical device during an installation, the
resulting medical electrical system must comply with IEC 60601-1:2005+A1:2012/
EN 60601-1:2006+AC:2010.
• Perform safety tests as described on the following pages.

Power On Test
1 Connect the base station to a fetal monitor and switch on the base station.
2 Press the On button of the base station and check if the LED lights up.
3 Open at the fetal monitor screen the Tele Info window and check if the monitor registers the
connected base station with the docked transducers.

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7 Testing and Maintenance

Safety Tests
Electrical safety testing is not required for the Avalon CL base station. The base station has the same
status as a connected wired transducer. The base station is either connected to the red fetal sensor
socket (FM20/FM30, FM40/FM50), or the black rear telemetry socket (FM40/FM50 only).

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.

Please refer to the Service Guides of the FM20/FM30 and FM40/FM50 for the detailed description of
required safety tests for the fetal monitors.

System Test
The Avalon CL base station does not function independently, and can only be operated if it is
connected to a fetal monitor. Therefore all system tests are done with the connected fetal monitor.
Please refer to the Service Guides of the FM20/30 and the FM40/50 for a detailed description of the
required system tests.

Preventive Maintenance Procedures


Please refer to the Service Guide Cableless Measurements for a detailed description of the required
NBP performance testing for the CL NBP Pod.

Battery Check
The CL transducers use a Lithium Ion battery (part no. 453564107871).

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7 Testing and Maintenance

The cableless transducers have a multi-color LED that indicates the status of the transducer with
specific colors. This LED remains visible when the transducer is correctly attached to the transducer
belt (Philips standard belt).

1 LED

LED Status Meaning


White The LED lights up to identify the transducer among other transducers,
and to easily verify the correct transducer assignment (transducer finder).
The transducer finder LED is controlled by the fetal monitor. Press the
numerics to identify the corresponding transducer.
The LED also lights up when the mother is paged with the Call Patient
SmartKey.
White one short blink The LED shortly lights up to indicate that the transducer successfully
opened a radio communication with the base station and that it is ready to
use.
Green The LED lights up green when the transducer is fully charged and docked
at the base station.
Yellow The LED lights up yellow when the transducer is charging and docked at
the base station.
Red The LED flashes red when the transducer is out of battery and has to be
recharged.
Cyan The LED lights up cyan to indicate a technical problem that needs your
attention. Check your fetal monitor for a related INOP.

To check the status of the transducer batteries open:


1 In the Service Mode the Main Setup, Tele Info window at the fetal monitor, and view the status of
the transducers assigned to the connected base station.

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7 Testing and Maintenance

Active cableless equipment information is displayed at the begin of the list inside the window.
Displayed information per active device is:
– Device symbol
– Assigned parameter label(s) (OBR equipment) or Equipment ID (SRR equipment)
– Radio link quality indicator
– Battery status symbol
– Remaining operating time (HH:MM)

Battery Cycle
Battery replacement is recommended after 500 charge/discharge cycles *2), or if the battery is older
than 4 years whatever is reached first. If the battery of a CL transducer has aged and an exchange of
the battery is highly recommended, a prompt message is displayed at the fetal monitor for ca.
60 seconds. The prompt is repeated whenever the Tele Info window is opened until the battery is
replaced.
Depending on the transducer type the following messages are displayed:
cl US battery has aged. Replacement strongly recommended
cl Toco battery has aged. Replacement strongly recommended
cl ECG/IUP batt has aged. Replacement strongly recommended

The date of manufacture and number of charge/discharge cycles can be inquired on the connected
fetal monitor.
For the battery cycle and battery life specification of the CL Pods (NBP and SpO2) please refer to the
Service Guide of the Cableless Measurements.
Charge Cycle
The CL transducer batteries are designed for frequent recharging. A complete charging cycle is only
reached and counted, when all recharging periods equal a 100% charge (900 mAh equal 8 hours
continued operation).

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7 Testing and Maintenance

Battery Report
You can generate a battery report for all docked CL devices at the Avalon CL base station. The battery
report lists:
For the fetal monitor:
• Product number
• Serial number
• Software revision
• OBR band and current channel configured
For the Avalon CL base station
• Firmware version
• Serial number
• OBR band
For the Avalon CL transducers:
• Serial number
• Firmware version
• Manufacture date
• Capacity (mAh)
• Charge cycles
1 To generate a battery report switch to the Service Mode.
2 Open the Tele Info window either by selecting Main Setup, Tele Info, or the Tele Info SmartKey
(configurable), or selecting the

symbol on the monitor display.


3 Select the Battery Report SmartKey. The recorder prints out a battery report.

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7 Testing and Maintenance

Battery Exchange
If the CL transducer battery requires replacement, use the transducer battery kit. This contains:
• a replacement battery
• a special tool for removing the battery drawer
• an instruction sheet
For details on how to replace the battery, see the Instruction Sheet “Removing and Replacing the
Transducer Battery” that accompanies the battery replacement kit, or refer to “Disassembly CL
Transducer Battery” on page 67 in this guide.
For details how to exchange the battery of a CL Pod (NBP and SpO2) refer to the Service Guide of the
Cableless Measurements.

Battery Storage
Battery recharging period within Philips’ factories and warehouses
The CL transducer and battery replacement kits require recharge within:
• 12 months for the transducer (with battery integrated), starting with the date of manufacture of
the battery, as shown in the battery report on the fetal monitor or on the battery label (yww).
• 18 months for a replacement battery, starting with the date of manufacture shown after the LOT
number on the battery replacement kit label (yyyy-ww) or on the replacement battery label (yww).
Battery recharging requirements during storage outside of Philips
Stored batteries and stored CL transducers should be partially charged to 40%—50% of their capacity
every 6 months.

Battery Disposal
Batteries should be disposed of in an environmentally-responsible manner. Consult the hospital
administrator or your local Philips representative for local arrangements.
Discharge the batteries and insulate the terminals with tape before disposal. Dispose of used batteries
promptly and in accordance with local recycling regulations.

Performance Assurance Test


This tests the entire signal path from the individual CL transducers connected via radio frequency,
through the CL base station, to the fetal monitor with artificially generated test signals. We recommend
you perform this test once a day, and whenever you doubt the reliability of the measurements. The
parameter test does not test the transducers themselves, there is a separate test for this (see “CL
Transducers Functional Tests” on page 89).
For details on the performance assurance test of a CL Pod (NBP and SpO2) refer to the Service Guide
of the Cableless Measurements.

Testing Alarms
Details of how to test alarms is given in the Instructions for Use.

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7 Testing and Maintenance

CL Transducers Functional Tests


If any of the following tests fail, repeat the test using another CL transducer. If the second CL
transducer passes the tests, confirming that the first CL transducer is defective, exchange the defective
CL transducer.
If the second CL transducer also fails the tests, contact your Philips Service Engineer or Response
Center.

CL Ultrasound Transducer Functional Check

CAUTION
Use of ultrasound gel that is not approved by Philips may reduce signal quality and may damage the CL
transducer. This type of damage is not covered by warranty.

To test the CL ultrasound transducer:


1 Switch on the monitor and the recorder.
2 Connect the Avalon CL base station to the fetal monitor.
3 Remove the charged CL US transducer from its docking slot at the base station.
4 Select the fetal heart sound for this channel.
5 Increase the loudspeaker volume to an audible level.
6 Set the transducer into the CL transducer opening tool.

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7 Testing and Maintenance

7 The CL ultrasound transducer contains seven piezoelectric crystals. Basic functioning of each can
be verified by holding a flat bottomed pen or similar above each crystal and moving it up and
down as shown. A sound should be heard for each crystal tested. The pen should be held two to
three centimeters from the CL transducer surface when the test is carried out.

8 A sound should also be heard when the CL transducer is moved back and forth over a solid
surface, or the hand as shown.

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7 Testing and Maintenance

CL Toco+ MP Transducer Functional Check


To test a CL Toco+ MP transducer:
1 Switch on the monitor and the recorder.
2 Connect the Avalon CL base station to the fetal monitor.
3 Remove the charged CL Toco+ MP transducer from its docking slot at the base station.
4 Press the Toco baseline key to re-adjust the Toco display to 20±1.
5 Turn the CL transducer over so that the Toco sensor is resting on the flat surface. You should see
a marked increase in the value of the Toco numeric in the Toco display.
6 Press the Toco Baseline Key to re-adjust the Toco display to 20±1.
7 Turn the transducer over again. You should see a marked decrease in the value of the Toco
numeric in the Toco display.

CL ECG/IUP and CL Toco+ MP with DECG Check


1 Switch on the monitor and the recorder.
2 Connect the Avalon CL base station to the fetal monitor.
3 Remove the charged CL transducer from its docking slot at the base station.
4 Attach the DECG adapter cable M1362B to the socket on the CL ECG/IUP or CL Toco+ MP
transducer.
5 Ensure that the DFHR channel display on the fetal monitor shows the DFHR x Leads Off INOP
with the DECG adapter cable attached.
6 Take a Fetal Scalp Electrode, and connect it to the DECG adapter cable.
7 Either hold the reference electrode between the thumb and index finger of one hand, and touch
the spiral electrode with the index finger of the other hand, as illustrated below. This makes a short
between the spiral electrode and the reference electrode (it is best to wet your fingers first). Use a
sterile Fetal Scalp Electrode.

CAUTION
The tip of the spiral electrode is sharp. Take care not to injure your fingers.

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7 Testing and Maintenance

Or cut off the plastic tip of the fetal scalp electrode (containing the spiral and reference electrodes)
from the end of the wires. Strip the insulation from the end of the wires, and connect them to a
patient simulator.

NOTE
We do not recommend the use of a specific patient simulator. The use of a patient simulator does
not allow checking the specification of the ECG-functionality; it allows only a check of the general
function.
1 Result: the DFHR x Leads Off INOP should disappear.
2 Viewing the ECG wave: when configured, you can view the DECG wave on the screen, and any
noise will be visible as additional verification of the effectiveness of the test.
If the test results are not as outlined above, repeat the test with another ECG transducer. If this
does not solve the problem, try the following:
3 Check all connections.
4 If the DFHR x Leads Off INOP is still displayed, the DECG adapter cable may be defective. Replace
the adapter cable.
5 If the problem persists, replace the CL transducer.

CL ECG/IUP and CL Toco+ MP with MECG Check


1 Switch on the monitor and the recorder.
2 Connect the Avalon CL base station to the fetal monitor.
3 Remove the charged transducer from its docking slot at the base station.
4 Attach the MECG adapter cable M1363A to the red color-coded socket on the CL ECG/IUP or
CL Toco+MP transducer.
5 Either attach electrodes to the M1363A adapter cable, and apply the electrodes to the skin (for
example on the wrists), or attach the M1363A adapter cable to a patient simulator.

NOTE
We do not recommend the use of a specific patient simulator. The use of a patient simulator does
not allow checking the specification of the ECG-functionality; it allows only a check of the general
function.

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7 Testing and Maintenance

6 Result: You should see MECG values displayed on the maternal display, or annotated on the
recorder trace.
If the test results are not as outlined above, repeat the test with another ECG/IUP transducer. If
this does not solve the problem:
7 The MECG adapter cable may be defective. Replace the adapter cable, and repeat the test.
8 Check all connections.

CL ECG/IUP and CL Toco+MP with IUP Check


To test the IUP functionality of the CL ECG/IUP or the CL Toco+ MP transducer, you need the
following:

1 Three lengths of silicone


tubing with a ‘T’ adapter
2 Expansion chamber
3 Manometer
4 CL ECG/IUP
transducer
5 IUP adapter cable
6 IUP catheter

1 Switch on the monitor and the recorder.


2 Connect the Avalon CL base station to the fetal monitor.
3 Remove the charged CL transducer from its docking slot at the base station.
4 Attach the IUP adapter cable (989803143931) to the socket on the CL ECG/IUP or
CL Toco+ MP transducer.
5 Cut the sensor tip off an IUP catheter (M1333A).
6 Connect the catheter to the IUP adapter cable.
7 Connect the silicone tubing to the test volume chamber and the manometer as shown in the
picture.
8 Connect the cut end of the catheter to the silicone tubing.
9 Apply a pressure of 80 mmHg ± 5 mmHg with the manometer. Check that the value on the
display and on trace corresponds to this pressure. Slowly release the pressure, and check that the
value on the display and on trace shows this change in pressure.

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7 Testing and Maintenance

Reporting of Test Results


Philips recommends all test results are documented in accordance with local laws. Authorized Philips
personnel report the test result back to Philips. While hospital personnel (biomedical engineers or
technicians) do not need to report results to Philips, Philips recommends that they record and store the
test results in accordance with local laws.
Refer to the Service Guide FM20/FM30 and FM40/FM50 to record the test results in the empty
column in the Test and Inspection Matrix.
The following is a guide as to what your documentation should include:
• Identification of the testing body (for example, which company or department carried out the
tests).
• Name of the person(s) who performed the tests and the concluding evaluation.
• Identification of the device(s) and accessories being tested (serial number, etc.).
• The actual tests (incl. visual inspections, performance tests, safety and system tests) and
measurements required.
• Date of testing and of the concluding evaluation.
• A record of the actual values of the test results, and whether these values passed or failed the tests.
• Date and confirmation of the person who performed the tests and evaluation.
The device under test should be marked according to the test result: passed or failed.

Other Regular Tests


No other regular tests are required except visual inspection and Power on tests.

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8

8 Troubleshooting
A guide for recognizing system error messages and for troubleshooting problems you may encounter
while using the system is given in the Instructions for Use. This chapter provides a guide for qualified
service personnel for troubleshooting problems that cannot be resolved by the user.

CAUTION
If the troubleshooting procedure requires you to disassemble the base station, be certain to follow the
disassembly and reassembly procedures given in “Disassembly/Reassembly” on page 47. Whenever
parts are replaced in the system, be certain to verify the hardware and software compatibility of the
repaired system.

Overview
Troubleshooting a cableless system presents some unique challenges. These arise from several
assemblies acquiring signals, processing signals, and transmitting/receiving signals. Problems can result
from hardware and communications failures, or can be RF-related. In the case of a suspected
malfunction it is important to first verify that the malfunction is a genuine failure. This can be checked
by:
• Resetting the system
• Checking/cleaning the charge/communication contacts
• Checking the connected fetal monitor

System is Completely Inoperative


If the base station the LED of the On/Standby button does not light up when pressed
• Reset the system (see <Undefined Cross-Reference>).
• Check that the interface cable is firmly connected to the fetal monitor.
• Check if the fetal monitor is on.
• Check the condition of the interface cable, and replace it if damaged, or if there are any defective
connections.

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8 Troubleshooting

System Reset
Always reset the system as the first troubleshooting step. With the transducers docked in the
appropriate slots, disconnect the interface cable from the fetal monitor. Wait until the LED is of the
base station is off, then reconnect the system to the fetal monitor. A persistent problem indicates a
genuine malfunction.
If you think that the display information is suspicious, initiate the power-on self test by switching the
base station to standby, and then switching it on again. All display elements of the CL transducer and
base station should be displayed briefly before the normal registration process starts.

Checking the Fetal Monitor


If parameter measurements are not possible, first check that the system is connected correctly to the
fetal monitor using the appropriate interface cable as described in the technical specifications. Is the
mode annotated on the recorder trace, or does it appear on the displays? If not, check that the interface
cable is properly connected. Also ensure that the fetal monitor’s recorder is switched on.
The fetal monitor screen shows the status of the connected Avalon CL base station.

No Tele symbol The base station is either not properly connected to the fetal monitor, or the
displayed fetal monitor cannot recognize it.
Check the connections, and ensure the fetal monitor has the required software
version for the base station installed.
The fetal monitor recognizes the connected base station, but the base station is
still in Stand-by mode.
Switch the base station on.
The base station and the fetal monitor are ready for monitoring.
A base station is connected to the monitor but no CL transducers and no CL
Pods are currently active. All are still docked at the base station, or none are
assigned.
A base station is connected to the monitor, it is on, and minimum one CL
transducer or CL Pod are active and assigned.

The CL transducer is moved away from the base station approaching out-of-
range. The US sound is replaced by an artificial QRS sound (like DECG). The
DECG and MECG waves are no longer displayed.

Troubleshooting the Top Cover


A malfunction of the top cover can be due to board failures. In this case, repair is effected by
exchanging the whole top cover, or the entire CL base station.
The following parts can be replaced without a whole unit exchange:
• charging contacts CL transducer
• charging contacts of IntelliVue CL Pods

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8 Troubleshooting

• power switch and power silicon keypad


All other issues related to the top cover require a whole unit replacement of the CL base station.
If after opening the top cover, or following a repair, the On/Standby button fails to work, check
connection to the boards.
The top cover contains the following items:
• Charge/communication contacts
• On/Standby buttons
• On/Standby button and Pod LEDs

Checking Contacts
If the CL transducer is not assigned to the base station, or you suspect that the CL transducer is not
behaving normally while it is docked, check that the spring-loaded charge/communication contacts are
clean and free of dirt and ultrasound gel.
Check that the springs function correctly by applying pressure with a finger on the contacts. The
contacts should offer some resistance, deflect and return to their normal position; if they do not, then
they have to be replaced, “Replacing Charging Contacts” on page 59.

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8 Troubleshooting

Technical INOPs Avalon CL


INOP Message, Indication Source What to do
cl US Batt Low Battery Transducer The remaining monitoring time with this CL
transducer is below 30 minutes.

cl Toco Batt Low Charge the battery.

cl ECG/IUP BattLow

cl US Batt Empty Battery Transducer The remaining monitoring time with this CL
!!cl US Batt Empty
transducer is below 15 minutes.

!!!cl US BattEmpty
Charge the battery.

cl Toco Batt Empty

!!clToco BattEmpty

!!!clTocoBattEmpty

cl ECG/IUP Empty

!!cl ECG/IUP Empty

!!!clECG/IUP Empty

cl US Batt Malf Battery Transducer Malfunction of the battery system (charger


INOP tone circuit or battery) detected (e.g. persistent
communication error, over-voltage, over-
cl Toco Batt Malf current, battery incompatible).
INOP tone Exchange the battery.
clECG/IUP BattMalf

INOP tone
Check OBR Config Monitor OBR (OB Radio) channel configuration is
INOP Tone invalid or settings are not present.
Check the channel configuration and hardware
option.
Run an OBR scan with the fetal monitor.
cl US Check Temp Monitor/Transducer/Battery The temperature of the CL transducer or its
INOP tone battery is critically high. If the CL transducer is
docked on the base station, charging is
cl Toco Chk Temp interrupted.
INOP tone Check that device is not covered and do not
clECG/IUP Chk Temp expose device to heat sources.
INOP tone If INOP persists, remove device from patient.

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8 Troubleshooting

INOP Message, Indication Source What to do


cl US Malfunction Monitor Malfunction of the CL transducer. The numeric
INOP tone is replaced by a “?” at the fetal monitor.

cl Toco Malf
Check if the CL transducer is properly assigned
at the base station currently in use.
INOP tone
Check if the CL transducer is out-of-range, or if
cl ECG/IUP Malf
the signal is blocked by a structure in the
INOP tone building.
Check if the CL transducer has interference
from another base station or CL transducer in
direct proximity.
cl US Disconnect Monitor The CL transducer has lost the connection to
INOP tone the base station.

cl Toco Disconnect

INOP tone
cl ECG/IUP Disconn

INOP tone
cl NBP Batt Empty Battery CL NBP Pod The remaining battery time of the
!!cl NBP BattEmpty
CL NBP Pod is below 30 minutes.

!!!cl NBP BatEmpty


Charge the battery.

INOP tone
cl NBP Batt Incomp Battery CL NBP Pod The battery in use with the CL NBP Pod is
INOP tone incompatible.
Replace it with one approved for use with the
CL NBP Pod.
cl NBP Batt Low Battery CL NBP Pod The remaining battery time of the
INOP tone CL NBP Pod is below 2 hours.
Charge the CL NBP Pod on the base station.
cl NBP Batt Malf Battery CL NBP Pod There is a malfunction in the CL NBP Pod's
INOP tone battery system.
Check if the CL NBP Pod is properly assigned
at the base station currently in use.
Check if the CL NBP Pod is out-of-range, or if
the signal is blocked by a structure in the room.
Check if the CL NBP Pod has interference
from another wireless device.
cl NBP Batt Temp Battery CL NBP Pod The temperature of the battery in the CL NBP
INOP tone Pod is critically high.
Check that the CL NBP Pod is not covered or
exposed to a heat source.

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8 Troubleshooting

INOP Message, Indication Source What to do


cl NBP Check Batt Battery CL NBP Pod The battery in the CL NBP Pod is nearing the
INOP tone end of its useful life. Only 50 charge/discharge
cycles remain.
Replace the battery.
cl NBP Serv Batt Battery CL NBP Pod The battery in the CL NBP Pod has reached
INOP tone the end of its useful life. It can no longer be
charged.
Replace the battery.
cl NBP Disconnect Base station The CL NBP Pod has lost the connection to
INOP tone the base station.
Check if the CL NBP Pod is properly assigned
at the base station currently in use.
Check if the CL NBP Pod is out of range, or if
the signal is blocked by a structure in the room.
Check if the CL NBP Pod has interference
from another wireless device.
cl NBP No Cradle CL NBP Pod The CL NBP Pod is not in its cradle.
INOP tone Set the CL NBP Pod back into its cradle.
cl NBP Remove CL NBP Pod The temperature of the battery in the CL NBP
INOP tone Pod is too high.
Remove the CL NBP Pod from the patient and
check that the pod is not covered or exposed to
a heat source.
cl SpO₂ Batt Low Battery CL SpO2 Pod The remaining battery time of the CL SpO2
!!cl SpO₂ BatEmpty
Pod is below 30 minutes.

!!!cl SpO₂ BtEmpty


Charge the battery.

INOP tone
cl SpO₂ Batt Incmp Battery CL SpO2 Pod The battery in use with the CL SpO2 Pod is
INOP tone incompatible.
Replace it with one approved for use with the
CL SpO2 Pod.
cl SpO₂ Batt Low Battery CL SpO2 Pod The remaining battery time of the CL SpO2
INOP tone Pod is below 2 hours.

cl SpO₂ Batt Malf Battery CL SpO2 Pod There is a malfunction in the CL SpO2 Pod's
INOP tone battery system.
Check if the CL SpO2 Pod is properly assigned
at the base station currently in use.
Check if the CL SpO2 Pod is out-of-range, or if
the signal is blocked by a structure in the room.
Check if the CL SpO2 Pod has interference
from another wireless device.

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8 Troubleshooting

INOP Message, Indication Source What to do


cl SpO₂ Batt Temp Battery CL SpO2 Pod The temperature of the battery in the CL SpO2
INOP tone Pod is critically high.
Check that the CL SpO2 Pod is not covered or
exposed to a heat source.
cl SpO₂ Check Batt Battery CL SpO2 Pod The battery in the CL SpO2 Pod is nearing the
INOP tone end of its useful life. Only 50 charge/discharge
cycles remain.
Replace the battery.
cl SpO₂ Serv Batt Battery CL SpO2 Pod The battery in the CL SpO2 Pod has reached
INOP tone the end of its useful life. It can no longer be
charged.
Replace the battery.
cl SpO₂ Disconnect Base station The CL SpO2 Pod has lost the connection to
INOP tone the base station.
Check if the CL SpO2 Pod is properly assigned
at the base station currently in use.
Check if the CL SpO2 Pod is out-of-range, or if
the signal is blocked by a structure in the room.
Check if the CL SpO2 Pod has interference
from another wireless device.
cl SpO₂ No Cradle CL SpO2 Pod The CL SpO2 Pod is not in its cradle.
INOP tone Set the CL SpO2 Pod back into its cradle.
cl SpO₂ Remove CL SpO2 Pod The temperature of the battery in the CL SpO2
INOP tone Pod is too high.
Remove the CL SpO2 Pod from the patient and
check that the CL SpO2 Pod is not covered or
exposed to a heat source.
SRR Incompatible Monitor The connected SRR (Short Range Radio) board
INOP tone or FW cannot be used with this base station
SW revision.
Install the current software version required.
SRR Malfunction Base station/CL SpO2 Pod Malfunction in the SRR (Short Range Radio)
INOP tone module(s).
Check if the CL SpO2 Pod is properly assigned
at the base station currently in use.
Check if the CL SpO2 Pod is out-of-range.
Check if the CL SpO2 Pod has a signal
interference in direct proximity.
SRR Invalid Chan Monitor The channel configuration of the Short Range
INOP tone Radio is invalid.
Check channel and channel mask
configuration.

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8 Troubleshooting

INOP Message, Indication Source What to do


SRR Interference Monitor The short range radio connection has
INOP tone interference from another device.
Try using another channel.
Tele Malfunction Base station Malfunction of the connected base station.
INOP tone Read the section “Checking the Fetal Monitor”
on page 96
Tele Unsupported Monitor The base station is not supported by the
INOP tone monitor.
Check for the current software revisions.

Common Problems
Symptoms Possible Reasons Action
A CL transducer is removed from the The base station cannot establish 1 Check if there are already the
base station, and the base station a connection to the CL maximum of 4 CL transducers active
issues a descending tone sequence. transducer. and removed from the CL base
The parameters of this CL transducer station (check the Tele Info window at
are not activated. the monitor).
2 An ISM band CL transducer is being
used with a WMTS band CL base
station.
3 Open the top cover and check if the
antenna is connected correctly to the
PCA board.
4 Scan for RF interference by making
an OBR scan.
5 Check the hardware type of the CL
transducer and the CL base station
(WMTS, ISM, and T108). If they are
not the same, they cannot
communicate.
The INOP Check OBR Config is General incompatibility: For 1 Check the OBR configuration setting
issued at the monitor. example, you have a CL base at the fetal monitor.
station that is delivered for the use
of the T108 band and the fetal
monitor is configured for the ISM
band.
The OBR configuration has to be
completed, or the OBR
configuration does not match
with the CL base station type
(WMTS, ISM, or T108).

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8 Troubleshooting

Symptoms Possible Reasons Action


Part 1 The distance between the CL base 1 Check if the CL transducers are
Numeric is replaced by a blank space station and the CL transducer properly charged (a Disconnect INOP
at the fetal monitor, and possibly exceeds the area of reach. would only be issued if previous Batt
Empty INOPs are ignored).
followed by a Disconnect INOP. Malfunction of the CL transducer.
The CL transducer LED turns cyan, 2 Are the transducers moved out-of-
and an intermittent INOP is issued. range by a patient? Inform the
personnel of the CL transducers area
of reach of min. 100 m/300 ft (in line
of sight) and run an RSSI trace
(“Setting Up OB-Radio” on page 32)
to visualize the available range.
3 Is the base station incorrectly
mounted in e.g. a metal drawer?
Ensure the proper mounting of the
base station (“Mounting Options” on
page 18) so that the operating range is
as expected.
4 Is the CL transducer signal
obstructed by a building structure e.g.
elevator doors?
Consider the building plan and a
possible location change for the base
station.
5 Are there other Avalon CL systems in
the same location with the same
frequency range?
If an Avalon CTS system is used in
close proximity to the Avalon CL
system, assign a free fixed frequency
to the Avalon CTS system to stop the
interference.

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8 Troubleshooting

Symptoms Possible Reasons Action


Part 2 Malfunction of the CL transducer. If several Avalon CL systems are used in
Numeric is replaced by a blank space the same building, some may operate on
at the fetal monitor, and possibly the same channel. The CL systems
followed by a Disconnect INOP. operating on the same channel do not
pick up the signal of a CL transducer
The CL transducer LED turns cyan, assigned to another system, because the
and an intermittent INOP is issued. signals are encrypted and secured. But the
CL transducers may interfere with each
other. E.g. two patients meet in the range
of both base stations and as a result both
their worn CL transducer signals drop
out.
To solve this, avoid assigning the
same channel to base stations in
neighboring rooms, or close
proximity.
1 Check the local radio frequency plan.
2 Read the section “RF Interference”
on page 108 and “Area of Reach” on
page 107.
3 Interference can be caused by the
following devices:
– radio-frequency process heating
– baby alarms (BabyFon)
– key-less care keys
– AM radio
– alarm systems
– medical diathermy machines.
– microwave oven (will not be in
the same frequency range, but
might disturb by high energy)
One of the INOPs cl US Malfunction, Hardware problems of the Exchange the CL transducer.
cl Toco Batt Malf, or clECG/IUP BattMalf CL transducer
is issued at the monitor.
cl US Malfunction Firmware problems possible – Check if firmware update of the
cl ECG/IUP Malf base station and the CL
cl Toco Malf transducers is completed. After
an update the CL base station
and the CL transducers need ca. 1
minute to load new firmware.
The LED of the base station
turns red during this minute and
the CL transducer blink yellow.

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8 Troubleshooting

Symptoms Possible Reasons Action


CL Pods cannot be charged Battery or interface defect Try to isolate the issue by cross-swapping
the CL Pods:
– replace the CL Pod
– replace its battery
– replace the cableless charging
contacts
– whole unit replacement of the
base station
– check the Cableless Measurement
Service Guide for further details
CL Pods are not activated when they Software option issue 1 Check if the software option CL2 is
are picked up from the CL base available at the fetal monitor in use.
station (This option is licensed, and has to be
purchased in advance to be installed.)
CL Pods are not recognized at the Out-of-range, missing software 1 Check if the CL Pods are correctly
monitor option, CL charging interface assigned to the base station in use.
defect 2 Check if the CL Pods are out-of-
range.
3 Check if the CL Pods are properly
charged.
4 Check the Cableless Measurement
Service Guide for further details.
CL transducer cannot be charged, Battery malfunction, charging Try to isolate the issue by cross-swapping
and its LED remains off when the contacts defect CL transducer(s) and slot(s):
CL transducer is docked at the CL – either replace the battery
base station
– the charging contacts
– whole unit replacement of the
base station

RF Problems
An RF problem can be summarized as a loss of monitoring capability due to signal corruption in the
RF link (transmitter to receiver). A lack of parameter measurements, or the inability of the transducer
to reach the registered, ready state may indicate an RF-related problem. A problem is likely to be an RF
problem if it causes any of the following conditions:
• Weak or intermittent signals, or signal loss (see “Area of Reach” on page 107).
• Interference (see also “RF Interference” on page 108).
Follow the RF troubleshooting operations in this chapter, starting at “Gathering Data” on page 106.

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Carrier to Noise Ratio


At any time, the performance of the RF reception of a cableless system is dependent on two factors:
• The signal strength of the desired or “carrier” signal.
• The power level of any background RF activity or “noise” at the same frequency.
In order for the cableless system to receive the RF signal without errors (corrupted or invalid data) the
carrier power level must be significantly above the power level of any background noise. If data
corruption occurs, it indicates that at that time the carrier to noise ratio (CNR) was too low.
When RF data corruption occurs, the most obvious symptoms are signal loss, degradation of the area
of reach, or US noise.
The CNR can drop below the critical level for one or both of the following reasons:
• Low signal - the signal strength of the carrier is lower than expected.
• Interference - the background noise level at the receiver frequency is higher than expected.
Ultimately, all of the RF problems within your system occur because of these reasons.

Gathering Data
Gathering the information to troubleshoot a potential RF problem will probably account for around
fifty percent of your job in determining if in fact you do have an RF problem. To gather data, you
should:
• Observe system performance
• Question the user

Observe System Performance


While cableless monitoring offers many advantages, it can also provide challenges. The reliability and
quality of the signal transmission through the air and hospital walls is governed by a number of
variables which can be difficult to control. A cableless system cannot be as dependable as a hard-wired
system that transmits its signal through a wire. This is because signals traveling through a wire are not
subject to factors in the RF environment. The effect of problems in the RF environment on the
cableless system ranges from momentary loss of the signal to complete inoperability, depending on the
situation. While momentary signal loss is to be expected, frequent extended periods of signal loss need
to be investigated.
Observe the system in operation. Does the system operation appear normal? If not, what seems
abnormal about it? What warning indicators are on?

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Question the User


Determining exactly what the user is complaining about can be difficult. RF signals are subject to
interference and are inherently less reliable than signals passing through cables. Troubleshooting a
cableless system is therefore more difficult than a wired system, and requires special equipment and
techniques. The following checklist will assist you, when questioning the user, to gather data helpful
for technical support:
If you observed problems during system operation, confirm they are problems of which the user is
complaining:
• Has the system always had these problems or are they a recent development?
• Is the symptom occurring on one channel, some channels, or all channels?
• Is the symptom occurring in a specific area or place?
• Is the symptom continuous or intermittent?
• How long does the symptom last?
• How often does the symptom appear?
• Does the symptom only occur at specific times?
• Does the symptom have “quiet” and “noisy” periods?

Area of Reach
The effective operating range, or the area of reach, of the system will vary depending on the
geographical and constructional characteristics of the building where the system is installed. We
recommend that you define the effective operating range prior to putting the system into operation.

Range Definition
The average range of the Avalon CL transducers is min. 100 m/300 ft (in line of sight), the CL Pods
only have a range of ca. 5 m within the parameters of a room. You can define the area of reach by
performing a walk-test wearing the CL transducers on bare skin.
The area of reach can be determined by observing how far from the base station the transducers will
still work normally allowing continuous monitoring.
There are two ways to define the area of reach:
• Watching the LED of the transducers: The transducer LED is off in normal monitoring mode. If
the transducer is out of range an INOP is triggered and displayed at the monitor. The numerics of
the transducer at the monitor are then replaced by ? (a question mark). The LED of the transducer
lights up cyan and a beep tone is emitted to notify the walking patient that she is out of range.
• Running an RSSI (received Signal Strength Indicator) trace at the monitor. The RSSI trace records
the RSSI values of all OBR devices (base station and all active CL transducers as a trace on the
recorder.
1 If you want to test the range and signal quality of the base station and its assigned CL transducers
make an RSSI trace.
2 Click on Start RSSI Trace to start recording the RSSI values of all OBR devices (base station and all
active CL transducers as trace on the recorder).

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8 Troubleshooting

3 Click on Stop RSSI Trace to stop the recording of the RSSI values.

RF Interference
You may encounter RF-related problems other than those associated with the area of reach. Problems
concerning RF link stability are due to RF interference. There are two categories of interference:
• On-channel or narrow-band interference
• Broadband interference

One-Channel or Narrow-band Interference


This is defined as an interference source that occupies the same bandwidth as the transmitter and only
interferes with one channel or two frequency adjacent channels.
It is likely that the channel is set to the same frequency as another telemetry unit, or there is
interference from an external source, such as a broadcasting station. Be sure to check for adult and
fetal telemetry channels. Also check for other radio devices such as walkie-talkies, paging systems,
ambulance systems, and so forth.
If you encounter narrow-band RF interference you can:
Identify the “problem” frequencies or frequency ranges (see “Scanning the Available Frequency
Range” on page 109).

Broadband Interference
A broadband interference source occupies the bandwidth of many channels causing degradation of the
carrier-to-noise ratio (CNR) on all of the telemetry channels for as long as it is present. This results in
an increase in dropouts on all of the channels. The system has quiet and noisy periods. When the noise
source is on, the system is noisy. When the noise source is off, the system performs well. To try to
eliminate the problem:
• Troubleshoot the problem as it is occurring. Use the RSSI scan to scan the RF environment for
interference). Ask users to determine if there is a pattern, when the episodes occur, and how long
they last. If there is a pattern (for example, every morning between 6 and 8 AM), try to predict
when it will happen again, and prepare to troubleshoot.

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• Locate where the interference signal is entering the system. If an antenna system is being used,
remove branches from the antenna system to see when the interference quiets down. Remember
that you will not be able to monitor patients that are being received by antennas that have been
removed.
• Remember that interference sources can move, making troubleshooting a little more difficult.
Work quickly!
• Solve the problem by trying to eliminate or repair the source. In the case of an antenna system,
relocate or permanently remove the antenna where the signal is entering. Things to check for that
cause broadband RF interference are other pieces of electrical equipment, especially RF devices
using the same frequency range.

Scanning the Available Frequency Range


If interference is evident or suspected the first step is to open the OBR menu at the fetal monitor and
to start an OBR channel scan. When the scan is stopped the recorder prints out the scan results on the
trace paper.
1 Select Scan Duration (Service Mode only) to select the duration you want an OBR scan to run.
Available are: Single Scan, 15 min, 30 min, 45 min, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, and
24 hours.
2 Select Start Scan to start the OBR channel scan.
3 Select Stop Scan to stop the OBR channel scan. The recorder prints out the scan results on the
trace paper.
See also “OB-Radio Scan” on page 34.

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8 Troubleshooting

110
9

9 Specifications
Specifications for the accuracy of heart rate measurements are given in the Instructions for Use of the
fetal monitor.

Environmental Specifications
Avalon CL Base Station 866074
Temperature Range Operating 0°C—45°C (32°F—113°F)
Storage/Transportation -20°C—60°C (-4°F—140°F)
Humidity Range Operating <95% relative humidity @ 45°C (113°F)
Storage/Transportation <90% relative humidity @ 60°C (140°F)
Altitude Range Operating -500—3000 m (-1640—9840 ft.)
Storage/Transportation -500—13100 m (-1640—43000 ft.)

Avalon CL Transducers (866075/866076/866077)


Temperature Range Operating 0°C—40°C (32°F—104°F)
Charging 0°C—35°C (32°F—95°F)
Storage -20°C—60°C (-4°F—140°F)
Humidity Range Operating <95% relative humidity @ 40°C (104°F)
Storage <90% relative humidity @ 60°C (140°F)
Altitude Range Operating -500—3000 m (-1640—9840 ft.)
Storage -500—13100 m (-1640—43000 ft.)

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9 Specifications

Physical Specifications
Avalon CL Base Station
Dimension and Weight Width min. 349 mm -5%, — max. width 350 mm
Size mm/(in) (min. 13.7 in -5%, — max. width 13.8 in)
Depth 183 mm ± 5% (7.2 in ± 5%)
Height 74 mm ± 5% (2.9 in ± 5%)
Weight 0.985 kg (2.2 lbs)
Electrical Class When the CL base station is connected to the fetal monitors M2702A/M2703A/
M2704A/M2705A it is a Class II equipment.
Electrical Power Source External (powered by fetal monitor)
Mode of Operation Continuous operation
Interface cable connector type Connector color Red for FM20/30 left side or FM40/50 front fetal
connector socket
Black for FM40/50 rear telemetry connector
socket
Interface cable length 1.5 m (4.11 ft.)
Ingress Protection IP 31

Avalon CL Transducers (866075/866076/866077)


Shock Resistance Withstands a 1.5 m drop to concrete surface with possible
cosmetic damage only.
Water Ingress Protection Code IP 68 (immersion up to 1 m water depth for 5 hours)
Dimensions and Avalon Cableless Toco+ MP Size (diameter/height) 75.5 mm/36.6 mm (2.9 in/1.4 in)
Weight Transducer 866075 Weight 123 g ±10% (4.3 oz ±10%)
Avalon Cableless US Size (diameter/height) 75.5 mm/36.6 mm (2.9 in/1.4 in)
Transducer 866076 Weight 131 g ±10% (4.6 oz ±10%)
Avalon Cableless ECG/IUP Size (diameter/height) 75.5 mm/36.6 mm (2.9 in/1.4 in)
Transducer 866077 Weight 121 g ±10% (4.2 oz ±10%)
Degree of Protection Against Electrical Shock Type CF
Transducer Identification Optical Signal Element (Finder LED).

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9 Specifications

Interface Specification
Avalon CL Radio
Avalon CL Radio Interface Specifications
Electronic Article Surveillance (EAS) EAS tag inside the housing (58 kHz)
Short Range Radio Interface* Type Internal SRR interface
Technology IEEE 802.15.4
Frequency Band 2.4 GHz ISM (2.400—2.483 GHz)
Modulation Technique DSSS (O—QPSK)
Effective radiated power max. 0 dBm (1 mW)
Range ca. 5 m without any physical obstructions as walls
and doors
OBR (WMTS)* Frequency Band 608—614 MHz
Effective radiated power <20 mW (base station)
<1 mW (CL transducers)
Range min. 100 m/300 ft (in line of sight)
OBR (ISM)* Frequency Band 433.05—434.79 MHz
Effective radiated power <10 mW (base station)
<1 mW (CL transducers)
Range min. 100 m/300 ft (in line of sight)
OBR (T108)* Frequency Band 920.6—923.4 MHz
Effective radiated power <20 mW (base station)
<10 mW (CL transducers)
Range min. 100 m/300 ft (in line of sight)
*Wireless transmissions are encrypted for security.

Performance Specifications
Battery Specifications
Avalon CL Transducer Battery Performance
Operating time With a new and fully charged battery 8 hours
Charge time From a "low battery" indication to a <3 hours
"fully charged" indication.
Charge time with Avalon From a "low battery" indication to a >6 hours
FM20/30 Battery Option "fully charged" indication.
#E25

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9 Specifications

453564107871 Battery Specifications for Rechargeable Lithium


Ion Battery Pack (1S1P)
Physical Specifications
WxDxH 5.5 mm (0.21 in) x 0.8 mm (0.03 in) x 49.5 mm (1.94 in)
Performance Specifications
Nominal Voltage 3.7 Volt
Rated Capacity at discharge C/5 1012 mAh
Continuous Discharge Capability 100 mA
Environmental Specifications
Temperature Range Discharge 0—50°C (32—122°F)
Charge 0—45°C (32—113°F)
Storage and Transportation: -20—60°C (-4—140°F)
Humidity Range Operating: 15%—95% Relative Humidity (RH)
Storage and Transportation: 5 %—95 % Relative Humidity (RH)
Battery Type Smart Battery 3.7 V, 6000 mAh, Lithium Ion
Safety complies with UL 2054
Electromagnetic Compatibility (EMC) complies with the requirements for FCC Type B computing Device,
and EN 61000-4-2 and EN 61000-3-2
Communication Standard complies with the SMBus specification v 1.1

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9 Specifications

Fetal/Maternal Specifications

Ultrasound
Complies with IEC 60601-2-37:2007 / EN 60601-2-37:2008

Performance Specifications
Ultrasound
Measurement Method Ultrasound Pulse Doppler
Measurement Range US 50—240 bpm
Resolution Display 1 bpm
Printer 1/4 bpm
Jitter @ 200 bpm ≤3 bpm
Display Update Rate 1 per second
US Intensity (M2736A/AA) Average output power P = (7.4 ± 0.4) mW
Peak-negative acoustic pressure p_ = (40.4 ± 4.3) kPa
Output beam intensity (Iob) Isata = (2.38 ± 0.59) mW/cm2
(= spatial average - temporal average
intensity)
Spatial-peak temporal average intensity Ispta = (15.0 ± 3.2) mW/cm2
Effective radiating area @ -12 dB (3.11 ± 0.74) cm2
Thermal index (TI) and mechanical index (MI) are always below 1.0.
US Intensity CL (866076) Average output power P = (12.4 ± 0.4) mW
Peak-negative acoustic pressure p_ = (49.1 ± 5.2) kPa
Output beam intensity (Iob) Isata = (2.77 ± 0.56) mW/cm2
(= spatial average - temporal average
intensity)
Spatial-peak temporal average intensity Ispta = (21.1 ± 5.1) mW/cm2
Effective radiating area @ -12 dB A-12dB = (4.47 ± 0.89) cm2
Thermal index (TI) and mechanical index (MI) are always below 1.0.
Signal Quality Indication Poor Quality empty
Acceptable Quality half-full
Good Quality full
Beat-to-Beat change (max.) for Ultrasound 28 bpm
US Frequency 1 MHz ± 100 Hz
US Signal range 3.5 μVpp—350 μVpp @ 200 Hz
US Burst Repetition Rate 3.0 kHz
Duration ≤100 μs
FMP Signal Range @ 33 Hz 200 μVpp—40 mVpp

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9 Specifications

Toco

Performance Specifications
Toco
Measurement Method Strain Gauge Sensor Element
Sensitivity 1 unit = 2.5 g
Resolution Display 1 unit
Printer 1/4 unit
Measurement Range 400 units
Signal Range 0—127 units
Maximum Offset Range -300 units
Baseline Setting 20 units
Update Rate Display 1 per second
Printer ~4 per second
Auto Offset Correction 3 seconds after connecting the transducer, the Toco value is set
to 20 units
Auto Zero Adjust Toco value is set to zero following a negative measurement
value for 5 seconds

Performance Specifications
Maternal Pulse from Toco
Emitted Light Energy ≤15 mW
Wavelength Range 780—1100 nm
Range 40—240 bpm
Resolution 1 bpm
Display Update Rate 1 per second
Accuracy ± 2% or 1 bpm, whichever is greater
Update Rate every 4 seconds

IUP

Performance Specifications
IUP
Measurement Method Passive Resistive Strain Gauge Elements
Measurement Range -100—+300 mmHg
Signal Range -99—127 mmHg or (-13.2—16.9 kPa)
Resolution Display 1 mmHg
Printer 1/4 mmHg
Sensitivity 5 μV/V/mmHg
Offset Compensation +100—-200 mmHg
Accuracy (not including sensor accuracy) ±0.5% per 100 mmHg

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9 Specifications

Performance Specifications
Update Rate Display 1 per second
Printer ~4 per second
Auto Offset Correction 3 seconds after connecting the transducer, the IUP value is
set to 0 mmHg

ECG
Complies with IEC 60601-2-27:2011+AC:2012/EN 60601-2-27:2006+AC:2006 except clauses listed
below:
• 201.6.2, 201.8.5.5
• 201.12.1.101
• 202.6.2.101
Sub clause 201.12.1.101.15 on heart rate range and accuracy is passed.

Performance Specifications
ECG
Performance Specifications Type DECG Single Lead ECG (derived from
Fetal Scalp Electrode)
MECG Single Lead ECG (derived from RA
and LA electrodes)
Measurement Range 30—240 bpm
Resolution Display 1 bpm (display update rate 1/s)
Recorder 1/4 bpm
Wave Speed (Global Speed) 6.25 mm/sec, 12.5 mm/sec,
25 mm/sec, 50 mm/sec
Accuracy ±1 bpm or 1%, whichever is greater
(non-averaging)
Beat-to -Beat (max.) MECG: 28 bpm
DECG: 28 bpm (with Artifact
Suppression On)
Differential Input Impedance >15MΩ
Electrode Offset Potential Tolerance ±400 mV
INOP Auxiliary Current (Leads Off Detection) <100 µA
Input Signal Range DECG 20 µVpp—6 mVpp
MECG 150 µVpp—6 mVpp
Dielectric Strength 1500 Vrms
Defibrillator Protection None
ESU Protection None
Paced pulse detection None

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9 Specifications

WARNING
The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal
ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the
ECG waveform.
When in doubt, it can be used to identify sources of compromised signal quality, such as noise or
muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them
(e.g., checking ECG cable connections or adapting the fetal ArtifactSuppress configuration).
The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e., P, QRS and T
segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated.

Fetal Heart Rate (Ultrasound/DECG) Alarm Specifications


FHR Alarm Limits Range Bradycardia 60—200 bpm
(low limit) adjustable in 10 bpm steps
Default: 110 bpm
Tachycardia 70—210 bpm
(high limit) adjustable in 10 bpm steps
Default: 170 bpm
FHR Alarm Delay Range Bradycardia 10—300 seconds in steps of 10 s
(low limit) Delay +system alarm delay
Default: 240 s
Tachycardia 10—300 seconds
(high limit) Delay in steps of 10 s +system alarm
delay
Default: 300 s
Signal Loss Delay 10—30 seconds
in steps of 10 s +system alarm
delay

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9 Specifications

MECG Alarm Range Adjustment Alarm Delay


Specifications
MECG Alarm Limits High Range: 31—240 bpm 1 bpm steps (30—40 bpm) System alarm delay (see
Default: 120 bpm 5 bpm steps (40— Performance
240 bpm) Specifications in the
Low Range: 30—235 bpm Instruction for Use).
Default: 50 bpm
Extreme Tachycardia Difference to high limit: 0— 5 bpm steps
50 bpm
Default: 20 bpm
Clamping at: 150—240 bpm 5 bpm steps
Default: 200 bpm
Extreme Bradycardia Difference to low limit: 0— 5 bpm steps
50 bpm
Default: 20 bpm
Clamping at: 30—100 bpm 5 bpm steps
Default: 40 bpm

Maternal ECG Supplemental Information as required by IEC 60601-2-27


Heart Rate Averaging Method The maternal heart rate is computed by averaging the 12 most recent RR intervals.
If each of 3 consecutive RR intervals is greater than 1200 ms (i.e. rate less than
50 bpm), then the 4 most recent RR intervals are averaged to compute the HR.
Display Update Rate 2s
Ventricular tachycardia alarm for No heart rate is detected for waveforms B1 and B2, resulting in “*** Extreme
waveforms B1 and B2 Brady” alarm
Response Time of Heart Rate HR change from 80—120 bpm: 10 sec.
Meter to Change in Heart Rate HR change from 80—40 bpm: 14 sec.
Tall T-Wave Rejection Capability M2735A 1.2 mV T-Wave amplitude
M2738A 1.4 mV T-Wave amplitude
CL Toco MP+, 1.2 mV T-Wave amplitude
CL ECG
Response Time of Heart Rate M2735A, M2738A HR change from 80—120 bpm Average: 12 sec
meter to Change in Heart Rate HR change from 80—40 bpm Average: 15 sec
CL Toco MP+, HR change from 80—120 bpm Average: 10 sec
CL ECG HR change from 80—40 bpm Average: 12 sec

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Maternal ECG Supplemental Information as required by IEC 60601-2-27


Heart Rate Meter Accuracy and M2735A, M2738A Ventricular bigeminy 40—60 bpm
Response to Irregular Rhythm Slow alternating ventricular bigeminy 45 bpm
Rapid alternating ventricular bigeminy 163 bpm
Bidirectional systoles 63—73 bpm
+, Ventricular bigeminy 40—60 bpm
CL Toco MP
CL ECG Slow alternating ventricular bigeminy 30 bpm
Rapid alternating ventricular bigeminy 70—163 bpm
Bidirectional systoles 63—73 bpm

Regulatory and Standard Compliance


Safety and Performance
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.

WARNING
No modification of the Avalon CL base station and the cableless transducers is allowed.

The base station is an electrical Class II device in connection with M2702A/M2703A (FM20/FM30)
and M2704A/M2705A (FM40/FM50). The device complies with the following major international
safety and performance standards:
• IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2010
• IEC 60601-1-6:2010 / EN 60601-1-6:2010
• IEC 60601-1-8:2006 / EN 60601-1-8:2007+AC:2010
• IEC 60601-2-49:2011 / EN 60601-2-49:2001
• ANSI/AAMI ES60601-1+C1:2009+A2:2010
• CAN/CSA C22.2#60601-1-08+TC2:2011
• JIS T 1303 2005
• AS/NZS 3200.1.0-1998
The possibility of hazards arising from hardware and software errors was minimized in compliance
with ISO 14971:2012, IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2010.
Alarm sounds are compliant with Standard IEC 60601-1-8:2006 / EN 60601-1-8:2007+AC:2010.

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Radio
The Avalon CL Transducer System complies with the following major international radio standards:
• ETSI EN 300 220-1:2012
• ETSI EN 300 220-2:2012
• ETSI EN 301 489-1:2011
• ETSI EN 301 489-3:2003
• FCC 47 CFR Part 95
• IC RSS-210 Issue 8
• ARIB STD-T108
• ETSI EN 300 328:2006
• ETSI EN 301 489-17:2009
• FCC 47 CFR Part 2 & 15
• AS/NSZ 4268
• AS/NSZ 4771:2000+A1:2003
• ARIB STD-T66

Electromagnetic Compatibility (EMC)


The device and its accessories, listed in the accessories section, comply with the following EMC
standards:
• IEC 60601-1-2:2007 / EN 60601-1-2:2007+AC:2010
Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical
equipment. You must operate your monitoring equipment according to the EMC information
provided in this book. Before using the device, assess the electromagnetic compatibility of the device
with surrounding equipment.
This ISM device complies with Canadian ICES-003:2012. Cet appareil ISM est conforme à la norme
NMB-003 du Canada.

CAUTION
The use of accessories, transducers and cables other than those specified may result in increased
electromagnetic emissions or decreased electromagnetic immunity of the device.

WARNING
Do not use cordless/mobile phones or any other portable RF communication system within the
patient vicinity, or within a 1.0 m radius of any part of the fetal monitoring system.

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WARNING
For paced patients: The radiated SRR power of the CL SpO2 and NBP Maternal Cableless
Measurement Devices, the CL Transmitter, and other sources of radio-frequency energy, when used in
very close proximity of a pacemaker, might be sufficient to interfere with pacemaker performance.
Due to shielding effects of the body, internal pacemakers are somewhat less vulnerable than external
pacemakers. However, caution should be exercised when monitoring paced patients.
In order to minimize the possibility of interference, avoid positioning and wearing the Cableless
Measurement Devices in very close proximity to a pacemaker. Consult the pacemaker manufacturer
for information on the RF susceptibility of their products

EMC Testing
CAUTION
Fetal parameters, especially ultrasound and ECG, are sensitive measurements involving small signals,
and the monitoring equipment contains very sensitive high gain front-end amplifiers. Immunity levels
for radiated RF electromagnetic fields and conducted disturbances induced by RF fields are subject to
technological limitations. To ensure that external electromagnetic fields do not cause erroneous
measurements, it is recommended to avoid the use of electrically radiating equipment in close
proximity to these measurements.

Reducing Electromagnetic Interference


WARNING
The device should not be used adjacent to, or stacked with, other equipment unless otherwise
specified.

The product and associated accessories can be susceptible to interference from continuous, repetitive,
power line bursts, and other RF energy sources, even if the other equipment is compliant with
EN 60601-1-2 emission requirements. Examples of other sources of RF interference are other medical
electrical devices, cellular products, information technology equipment, and radio/television
transmissions.
When electromagnetic interference (EMI) is encountered, for example, if you can hear spurious noises
on the fetal monitor's loudspeaker, attempt to locate the source. Assess the following:
• Is the interference due to misplaced or poorly applied transducers? If so, re-apply transducers
correctly according to directions in this book, or in the Instructions for Use accompanying the
accessory.
• Is the interference intermittent or constant?
• Does the interference occur only in certain locations?
• Does the interference occur only when in close proximity to certain medical electrical equipment?

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Once the source is located, there are a number of things that can be done to mitigate the problem:
1 Eliminating the source. Turn off or move possible sources of EMI to reduce their strength.
2 Attenuating the coupling. If the coupling path is through the patient leads, the interference may be
reduced by moving and/or rearranging the leads. If the coupling is through the power cord,
connecting the system to a different circuit may help.
3 Adding external attenuators. If EMI becomes an unusually difficult problem, external devices such
as an isolation transformer or a transient suppressor may be of help. Your service provider can be
of help in determining the need for external devices.
Where it has been established that electromagnetic interference is affecting physiological parameter
measurement values, a physician, or a suitably qualified person authorized by a physician, should
determine if it will negatively impact patient diagnosis or treatment.

System Characteristics
The phenomena discussed above are not unique to this system, but are characteristic of fetal patient
monitoring equipment in use today. This performance is due to very sensitive high gain front end
amplifiers required to process the small physiological signals from the patient. Among the various
monitoring systems already in clinical use, interference from electromagnetic sources is rarely a
problem.

Electromagnetic Emissions and Immunity


The EMC standards state that manufacturers of patient-coupled equipment must specify immunity
levels for their systems. See Tables 1 to 4 for this detailed immunity information. See Table 5 for
recommended minimum separation distances between portable and mobile communications
equipment and the product.
Immunity is defined in the standard as the ability of a system to perform without degradation in the
presence of an electromagnetic disturbance.
Caution should be exercised in comparing immunity levels between different devices. The criteria used
for degradation are not always specified by the standard, and can therefore vary with the manufacturer.
In the table below, the term "device" refers to the Avalon FM20/30/40/50 fetal monitor together with
its accessories. The table gives details of the electromagnetic emissions, and how these are classified,
for the device, and the electromagnetic environments in which the device is specified to technically
function.

Table 1 - Guidance and Manufacturer's Declaration: Electromagnetic Emissions


Emissions Test Compliance Avoiding Electromagnetic Interference
Radiofrequency (RF) emissions Group 1 The device uses RF energy only for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause any interference
in nearby electronic equipment.
Harmonic emissions IEC 61000-3-2 Class A
Voltage fluctuations and flicker IEC 61000-3-3 complies

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Table 1 - Guidance and Manufacturer's Declaration: Electromagnetic Emissions


Emissions Test Compliance Avoiding Electromagnetic Interference
RF emissions CISPR 11 Class B The device is suitable for use in all
For the Avalon FM20/30 fetal monitor with all establishments, including domestic
accessories except the IUP/ECG patient establishments and those directly connected to
module M2738A. the public low-voltage supply network that
supplies buildings used for domestic purposes1.
RF emissions CISPR 11 Class A The device is suitable for use in all
For the Avalon FM40/FM50 with all establishments other than domestic
accessories. establishments and those directly connected to
the public low-voltage supply network that
For the Avalon FM20/30 fetal monitor supplies buildings used for domestic purposes.
whenever used with the IUP/ECG patient
module M2738A.
For the Avalon CTS Interface Cable (M2731-
60001/M2732-60001) whenever used with the
Avalon CTS Cableless Fetal Transducer System.
For the Avalon CL Base Station with cableless
transducers whenever used with the fetal
monitors.
1 Note that the device is not intended for home use.

Electromagnetic Immunity
The monitor is suitable for use in the specified electromagnetic environment. The user must ensure
that it is used in the appropriate environment as described below.

Table 2 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity


Immunity Test IEC 60601-1-2 Compliance Level Electromagnetic Environment
Test Level Guidance
Electrostatic discharge ±6 kV contact ±6 kV contact Floors should be wood, concrete, or
(ESD) ±8 kV air ±8 kV air ceramic tile. If floors are covered with
IEC 61000-4-2 synthetic material, the relative humidity
should be at least 30%.
Electrical fast transient/ ±2 kV for power ±2 kV for power supply Mains power quality should be that of a
burst supply lines lines typical commercial and/or hospital
IEC 61000-4-4 ±1 kV for input/ ±1 kV for input/output environment
output lines lines
Surge ±1 kV differential ±1 kV differential mode Mains power quality should be that of a
IEC 61000-4-5 mode ±2 kV common mode typical commercial and/or hospital
±2 kV common environment
mode

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Table 2 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity


Immunity Test IEC 60601-1-2 Compliance Level Electromagnetic Environment
Test Level Guidance
Voltage dips, short <5% UT (>95% <5% UT (>95% dip in UT) Mains power quality should be that of a
interruptions and voltage dip in UT) for for 0.5 cycles typical commercial and/or hospital
variations on power 0.5 cycles environment. If the user of the device
supply input lines 40% UT (60% dip 40% UT (60% dip in UT) for requires continued operation during
IEC 61000-4-11 in UT) for 5 cycles 5 cycles power mains interruptions, it is
recommended that the device is
70% UT 70% UT (30% dip in UT) for powered from an uninterruptible power
(30% dip in UT) for 25 cycles supply.
25 cycles
< 5% UT < 5%UT (>95% dip in UT)
(>95% dip in UT) for 5 sec
for 5 sec
Power frequency (50/ 3 A/m 3 A/m Power frequency magnetic fields should
60 Hz) magnetic field be at levels characteristic of a typical
IEC 61000-4-8 location in a typical commercial and/or
hospital environment
Key: UT is the AC mains voltage prior to application of the test level.

Radio Compliance Notice


Avalon CL with WMTS
Operation of this equipment requires the prior coordination with a frequency coordinator designated
by the FCC for the Wireless Medical Telemetry Service.
This device complies with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is
subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this
device must accept any interference received, including interference that may cause undesired
operation. Any changes or modifications to this equipment not expressly approved by Philips Medical
Systems may cause harmful radio frequency interference and void your authority to operate this
equipment.

Radio Information Canada


Installation of this telemetry device is permitted in hospitals and health care facilities only. This device
shall not be operated in mobile vehicles (including ambulances and other vehicles associated with
health care facilities). The installer/user of this device shall ensure that it is at least 80 km from the
Dominion Radio Astrophysical Observatory (DRAO) near Penticton, British Columbia. The
coordinates of DRAO are: latitude N 49E 19' 15", longitude W 119° 37′ 12″. For medical telemetry
systems not meeting this 80 km separation (e.g. the Okanagan Valley, British Columbia) the installer/
user must coordinate with, and obtain the written concurrence of, the Director of DRAO before the
equipment can be installed or operated. The Director of DRAO may be contacted at 250-497-2300
(telephone) or 250-497-2355 (fax). (Alternatively, the Manager, Regulatory Standards, Industry Canada,
may be contacted.)
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts
de licence. L'exploitation est autorisée aux deux conditions suivantes: (1) l'appareil ne doit pas produire

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de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si
le brouillage est susceptible d'en compromettre le fonctionnement.
L'utilisation de cet appareil de télémesure est permise seulement dans les hôpitaux et établissements de
soins de santé. Cet appareil ne doit pas être mis en marche dans des véhicules (y compris les
ambulances et autres véhicules associés aux établissements de santé). La personne qui installe/utilise
cet appareil doit s’assurer qu’il se trouve à au moins 80 km de l’Observatoire fédéral de
radioastrophysique (OFR) de Penticton en Colombie-Britannique. Les coordonnées de l’OFR sont:
latitude N 49° 19’ 15», longitude O 119° 37 12 ′′. La personne qui installe/utilise un système de
télémesure médicale ne pouvant respecter cette distance de 80 km (p. ex. dans la vallée de l’Okanagan
(Colombie-Britannique), doit se concerter avec le directeur de l’OFR et obtenir de sa part une
autorisation écrite avant que l’équipement ne puisse être installé ou mis en marche. Le directeur de l’
OFR peut être contacté au 250-497-2300 (tél.) ou au 250-497-2355 (télécopieur). (Le Directeur des
Norm es réglementaires d’Industrie Canada peut également être contacté).

Avalon CL with T108


Japanese Radio Law and Japanese Telecommunications Business Law Compliance.

This device should not be modified (otherwise the granted designation number will become invalid).

Finding Recommended Separation Distances


In the following table, P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer, and d is the recommended separation distance in meters (m).
Portable and mobile RF communications equipment should be used no closer to any part of the
device, including cables, than the recommended separation distance calculated from the equation
appropriate for the frequency of the transmitter.
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be
less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with this symbol:

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Table 3 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity


Conducted RF Immunity Test EN/IEC 61000-4-6
Electromagnetic Environment Guidance:
IEC 60601-1-2 Test Level Recommended Separation Distance (d)
Compliance Level
over 150 kHz to 80 MHz
(in Meters, at Frequency Range Tested)
for Ultrasound and ECG Measurements

3.0 VRMS 3.0 VRMS d = 1, 2√P


Key: d = Recommended separation distance in meters (m)
P = maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer
V1 = Tested compliance level (in Volts) for the Conducted RF Immunity test IEC 61000-4-6
The device meets the compliance level of 3.0 VRMS according to IEC 60601-1-2 over the specified test frequency
range. Over the frequency range 150 kHz—80 MHz, the recommended separation distance in meters (d) is found by
the following equation:
For a compliance level of 3.0 VRMS: d = 1, 2√P

Table 4 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity


Radiated RF Immunity Test EN/IEC 61000-4-3
Electromagnetic Environment Guidance:
IEC 60601-1-2 Test Level Recommended Separation Distance (d)
Compliance Level
over 80 MHz to 2.5 GHz
(in Meters, at Frequency Range Tested)
for Ultrasound and ECG Measurements

3.0 V/m 3.0 V/m Over 80 MHz—800 MHz:d = 1, 2√P


Over 800 MHz—2.5 GHz:d = 2, 3√P
Key: d = Recommended separation distance in meters (m)
P = maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer
E1 = Tested compliance level (in Volts/meter) for the Radiated RF Immunity test IEC 61000-4-3
The device meets the compliance level of 3.0 VRMS according to IEC 60601-1-2 over the specified test frequency
range.
Over the frequency range 80 MHz—800 MHz, the recommended separation distance in meters (d) is found by the
following equation:
For a compliance level of 3.0 VRMS: d = 1, 2√P

Over the frequency range 800 MHz—2.5 GHz, the recommended separation distance in meters (d) is found by the
following equation:
For a compliance level of 3.0 VRMS: d = 2, 3√P

Field strengths from fixed transmitters, such as base stations, or radio, (cellular, cordless) telephones,
and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the

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location in which the device is used exceeds the applicable RF compliance level above, it should be
observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the device.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects, and people.
If you require further information or assistance, please contact Philips Support.

Recommended Separation Distances from Other RF Equipment


The device is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or user of the device can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment and the
device as recommended below, according to the maximum output power of the communications
equipment.

Table 5 - Separation Distance (d) in Meters According to Frequency of Transmitter at IEC 60601-1-2 Test
Compliance Level
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Rated Maximum Output
Power (P) of Transmitter
(in Watts)

0.01 W d= 0.1 m d= 0.1 m d= 0.23 m


0.1 W d= 0.4 m d= 0.4 m d= 0.7 m
1W d= 1.2 m d= 1.2 m d= 2.3 m
10 W d= 3.8 m d= 3.8 m d= 7.3 m
100 W d= 12.0 m d= 12.0 m d= 23.0 m

Radio Frequency Radiation Exposure Information


The radiated output power of the device is far below the FCC radio frequency exposure limits.

Symbols on the System


This caution/warning symbol Connection direction indicator
indicates that you should consult FM20/FM30 with battery option
the Instructions for Use (this
document), and particularly any
warning messages.
This symbol indicates that you Mouse connection indicator
should consult the Instructions (optional)
for Use (this document).

Power-On/Off Switch - FM20/ Keyboard connection indicator


FM30 without Battery Option (optional)

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Power-On/StandBy button - Serial/MIB connector


FM40/FM50 and FM20/30 with (optional)
Battery Option
Power-On LED USB interface
(optional)
Electrical Class II equipment, in Analog interface indicator for
which the protection against Video connection to any analog video
electric shock relies on double or display (VGA resolution)
reinforced insulation (FM20/ FM40/FM50
FM30)
Fetal Sensor Socket symbol IP 67 Ingress Protection code according
to IEC 60529. The IUP/ECG
patient module (M2738A) is rated
IP 67 (protection against dust,
access to hazardous parts, and the
effects of continuous immersion
in water to a depth of 0.5 meter
for 30 minutes).
SpO2 Socket symbol IP 68 Ingress Protection code according
to IEC 60529. All transducers
(excluding M2738A) are rated
IP 68 (protection against dust,
access to hazardous parts, and the
effects of continuous immersion
in water to a depth of 1.0 meter
for five hours).
Noninvasive Blood Pressure IP X1 Ingress Protection code according
Socket symbol to IEC 60529. The monitors and
interface cable for the Avalon CTS
(M2731-60001/M2732-60001) are
rated IP X1 (protection against
water dripping vertically only).
Type BF IP 31 Ingress Protection code according
to IEC 60529 (protection against
condensation only).
Symbol indicating the monitor IP 21 Ingress Protection code according
has the triplets option to IEC 60529 (protection against
ingress of water when the water is
dripping vertically)
Symbol indicating the monitor is Type CF equipment, not
capable of intrapartum defibrillation proof
monitoring

129
9 Specifications

Button to open paper drawer/ Indicates location of service


paper eject. (FM40/FM50) number

Protective earth terminal (FM40/ Indicates location of serial number


FM50)

Equipotential grounding point Indicates location of catalog


(FM40/FM50) number

Socket for connecting Indicates location of the date of


Avalon CTS interface cable manufacture and/or name and
M2732-60001 or Avalon CL address of manufacturer
interface cable (with black
connector, FM40/FM50)
Symbol indication for non- Identifies year and month of
ionizing radiation manufacture

China RoHS Symbol indicating separate


collection for waste electrical and
electronic equipment

GOST-R mark CSA US mark

FCC ID Federal Communications CMIIT ID Chinese Radio marking: CMIIT


Commission: FCC ID xxxx ID (China Ministry of Industry
and Information Technology)
Industrial, Scientific, & Medical CE marking accompanied by the
radio frequency band (Avalon CL VDE NB number 0366
frequency band used e.g. in the
EU)
Association Of Radio Industries Wireless Medical Telemetry
And Businesses T108 (Avalon CL Service (Avalon CL frequency
frequency band used e.g. in Japan) band used e.g. in North America)
IC-ID (Industry Canada ID)
One IC-ID labeling for each built in radio: OBR, SRR
Japanese Radio marking: Radio mark + [R]-symbol + ID

130
9 Specifications

Taiwan Radio Label (NCC Logo) + ID

Korea radio mark: KC logo, KCC ID number, and


Conformity assessment information

131
9 Specifications

132
10

10 Upgrades
The bus master and CL transducer firmware of the base station and the CL transducers can be
upgraded by the M3086A IntelliVue Support tool from a PC (component upgrade).
The Avalon CL base station needs to be connected through the common connection cable to the fetal
monitor.

See the M3086A IntelliVue Support tool Instruction for Use for details on how to perform a
component upgrade.

Software Option for CL Pods


To support the IntelliVue CL Pods (CL SpO2, CL NBP), the software option CL2 has to be installed,
or the Avalon CL base station only supports the CL transducers. Check this option during installation
in the support tool.

NOTE
This software option is not available for a FM20/30 #E25. The IntelliVue CL Pods are not supported
for the battery option of the FM20/30.

133
10 Upgrades

134
1 Index
A Configuring SRR Channels 38 I
Connecting Two Avalon CL Base Stations
After Each Service, Maintenance, or Repair at the FM40/50 29 Initial Inspection 26
Event 83 Installation 8, 25
Connection Options 27
Antenna PCA 44 Installation Check List 25
Area of Reach 107 D Installation Scope 17
Avalon CL Radio 113 Interface Specification 113
Disassembly Bottom Cover Avalon CL
Avalon CL with T108 126 Base Station 65 Introduction 13, 47
Avalon CL with WMTS 125 Disassembly Charging Contacts 57 IUP 116
B Disassembly CL Pod Device Charger 54
M
Disassembly CL Transducer Battery 67
Base Station Hardware Overview 43 Disassembly Short Range Radio Boards 52 Maintenance, Repair, and Care 9
Base Station PCA 43 Disassembly Standby Button/ Mounting Options 18
Battery Check 84 Switchboard 62
Battery Cycle 86 Disassembly Top Cover Avalon CL Base O
Battery Disposal 88 Station 48
OB Radio 32
Battery Exchange 88 Disassembly/Reassembly 47
OBR Channel Settings 33
Battery Report 87 E OB-Radio Scan 34
Battery Specifications 113 Observe System Performance 106
Battery Storage 88 ECG 117
One-Channel or Narrow-band
Before Each Use 82 Electric Hazards 7 Interference 108
Broadband Interference 108 Electrical Requirements 16 Other Regular Tests 94
Electromagnetic Compatibility (EMC) 121 Overview 95
C Electromagnetic Emissions and
Immunity 123 P
Cableless Charging Interface 45
Electromagnetic Immunity 124
Care and Cleaning 79 Performance Assurance Test 88
EMC Testing 122
Carrier to Noise Ratio 106 Performance Specifications 113
Environmental Requirements 15
Checking Contacts 97 Physical Specifications 112
Environmental Specifications 111
Checking the Fetal Monitor 96 Power On Test 83
Essential Performance 16
CL ECG/IUP and CL Toco+ MP with Preventive Maintenance Procedures 84
DECG Check 91 Example 1 20
Procedure for Local Staff 13
CL ECG/IUP and CL Toco+ MP with Example 2 22
Procedure for Philips Personnel 14
MECG Check 92
F Q
CL ECG/IUP and CL Toco+MP with IUP
Check 93 Fetal/Maternal Specifications 115
Question the User 107
CL ECG/IUP Front-end Hardware 46 Finding Recommended Separation
CL Toco+ MP Transducer Functional Distances 126 R
Check 91 Firmware Upgrades and Software
CL Toco+MP Front-end Hardware 46 Installation 30 Radio 121
CL Transducer Hardware Overview 45 Frequently Asked Questions 41 Radio Compliance Notice 125
CL Transducers Functional Tests 89 Functional Description of the RF/CPU Radio Frequency Interference 7
CL Ultrasound Front-end Hardware 46 Hardware 45 Radio Frequency Plan 18
CL Ultrasound Transducer Functional Radio Frequency Radiation Exposure
G Information 128
Check 89
Claims for Damage 26 Gathering Data 106 Radio Information Canada 125
Common Problems 102 General Information 5 Range Definition 107
Recommendations for Cableless

135
Monitoring 40 SRR Channel Settings Configuration 38
Recommended Frequency 80 SRR PCA 45
Recommended Separation Distances from Switchboard PCA 45
Other RF Equipment 128 Symbols on the System 128
Reducing Electromagnetic System Characteristics 123
Interference 122
System is Completely Inoperative 95
Regulatory and Standard Compliance 120
System Reset 96
Removing Bottom Cover Assembly CL
Base Station 65 System Test 84
Removing Charging Contacts 57 T
Removing CL Pod Charger 54
Technical INOPs Avalon CL 98
Removing CL Transducer Battery 67
Telemetry Interfaces 30
Removing Standby Button/
Switchboard 62 Terminology and Definition 79
Removing the Short Range Radio Testing Alarms 88
Boards 52 Testing and Maintenance 79
Removing Top Cover Assembly CL Base Testing Sequence 82
Station 48 Theory of Operation 43
Repacking 26 Toco 116
Repair Strategy 6 Tools Required 48
Replacing Bottom Cover Assembly CL Top Cover Assembly Overview 51
Base Station 66
Transducer Charging Contacts 45
Replacing Charging Contacts 59
Troubleshooting 95
Replacing CL Pod Charger 55
Troubleshooting the Top Cover 96
Replacing CL Transducer Battery 71
Tutorial Frequency Planning 19
Replacing Standby Button/Switchboard 64
Replacing the Short Radio Boards 53 U
Replacing Top Cover Assembly CL Base
Station 51 Ultrasound 115
Reporting of Test Results 94 Unpacking/Checking Shipment 26
RF Interference 108 Upgrades 133
RF Problems 105 Use Environment 8
Roles and Responsibilities 13 V
RSSI Trace 37
Visual Inspection 82
S
W
Safety and Performance 120
Walkthrough 10
Safety Requirements 16
Warnings and Cautions 6
Safety Tests 41, 84
Warnings, Cautions, and Safety
Scanning the Available Frequency
Precautions 83
Range 109
What to Do Next 5
Setting Expectations 40
When are Special Configurations
Setting Up OB-Radio 32
Required? 6
Short Range Radio 38
When to Perform Safety Tests 81
Site Planning 17
Who Should Read This Guide 5
Site Preparation 13
WMTS Frequency Registration WMT 31
Site Preparation Responsibilities 13
Site Requirements 15
Software Option for CL Pods 133
Space Requirements 15
Spare Parts 77
Specifications 111

136
Part Number 453564526801
Published in Germany 11/2014

*453564526801*

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