I N S T R U C T I O N S F O R U S E
Avalon Fetal Monitor
FM20 / FM30 / FM40 / FM50
Release F.0 with Software Revision F.01.xx
F E T A L M O N I T O R I N G
Printed in Germany 12/07
*M2703-9001D*
Part Number M2703-9001D 451261025621
S
M2703-9001D
Table Of Contents
1 |
Introduction |
1 |
|
Who this Book is For |
1 |
|
Confirm Fetal Life Before Using the Monitor |
2 |
|
Introducing the Avalon Family of Fetal Monitors |
3 |
|
Intended Use |
3 |
|
Contraindications |
3 |
|
Indications for Use |
3 |
2 |
Installation |
5 |
|
|
|
|
Installation Checklist |
5 |
|
Unpacking and Checking the Shipment |
6 |
|
Initial Inspection |
6 |
|
Claims for Damage |
6 |
|
Repacking |
6 |
|
Mounting the Monitor |
6 |
|
Connecting the Monitor to AC Mains |
7 |
|
How and When to Carry Out the Test Blocks |
7 |
|
Safety Tests |
8 |
3 |
Basic Operation |
9 |
|
|
|
|
Supported Measurements |
10 |
|
Avalon FM20 and FM30 |
11 |
|
Avalon FM20 |
11 |
|
Avalon FM30 |
11 |
|
Avalon FM40 and FM50 |
12 |
|
Avalon FM40 |
12 |
|
Avalon FM50 |
12 |
|
Cordless Monitoring |
13 |
|
Getting to Know Your Avalon FM20/FM30 |
14 |
|
Overview |
14 |
|
Right Side |
14 |
|
Rear |
14 |
|
Left Side |
15 |
|
Getting to Know Your Avalon FM40/FM50 |
16 |
|
Front |
16 |
|
Rear |
16 |
|
Transducers |
17 |
|
Operating and Navigating |
19 |
|
Keys |
21 |
|
Permanent Keys |
21 |
|
SmartKeys |
21 |
|
Pop-Up Keys |
22 |
i
Using the Touchscreen |
22 |
Disabling Touchscreen Operation |
22 |
Selecting Screen Elements |
22 |
Operating Modes |
22 |
Automatic Screen Layouts |
23 |
Settings |
23 |
Active Settings |
23 |
User Default |
24 |
Factory Default |
24 |
Global Settings |
24 |
Changing Measurement Settings |
24 |
Switching the Noninvasive Blood Pressure Measurement On and Off |
25 |
Changing Monitor Settings |
25 |
Adjusting the Screen Brightness |
25 |
Adjusting Touch Tone Volume |
25 |
Setting the Date and Time |
25 |
Checking Your Monitor Revision |
26 |
Preparing to Monitor a Patient |
27 |
Switching On: FM20/FM30 |
27 |
Switching On: FM40/FM50 |
27 |
Adjusting the Display Angle (FM20/FM30) |
27 |
Fastening Belts and Transducers |
28 |
Using Belts with Button Fixings |
29 |
Using Belt with Velcro Fixings |
30 |
Connecting a Transducer to the Monitor |
31 |
Checking/Setting Paper Scale |
33 |
Paper Guide: FM40/FM50 |
33 |
Removing the Paper Guide: FM40/FM50 |
33 |
Loading Paper: FM20/FM30 |
35 |
Loading Paper: FM40/FM50 |
36 |
Paper-Out Indication |
39 |
Choosing Paper Speed |
39 |
Tearing Off the Paper: FM20/FM30 |
39 |
Tearing Off the Paper: FM40/FM50 |
39 |
Using the Paper Guide |
40 |
Without the Paper Guide |
40 |
Switching the Recorder On and Off |
40 |
Advancing the Paper |
42 |
Marking an Event |
42 |
Entering Notes |
43 |
Signal Quality |
43 |
Starting Monitoring |
43 |
Switching the Monitor to Stand-by |
44 |
After Monitoring |
44 |
Disconnecting from Power |
44 |
Troubleshooting |
45 |
ii
4 |
Alarms |
47 |
|
Alarm Mode |
47 |
|
Visual Alarm Indicators |
48 |
|
Audible Alarm Indicators |
48 |
|
Alarm Tone Configuration |
48 |
|
Standard Philips Alarms |
48 |
|
ISO/IEC Standard 9703-2 Audible Alarms |
48 |
|
Changing the Alarm Tone Volume |
49 |
|
Acknowledging Alarms |
49 |
|
Acknowledging Disconnect INOPs |
49 |
|
Pausing or Switching Off Alarms |
50 |
|
To Pause All Alarms |
50 |
|
To Switch All Alarms Off |
50 |
|
To Switch Individual Measurement Alarms On or Off |
50 |
|
While Alarms are Paused or Off |
51 |
|
Restarting Paused Alarms |
51 |
|
Alarm Limits |
51 |
|
Viewing Individual Alarm Limits (Alarm Mode “All” Only) |
51 |
|
Changing Alarm Limits |
52 |
|
Reviewing Alarms |
52 |
|
Alarm Messages Window |
52 |
|
Review Alarms Window |
52 |
|
Latching Alarms |
52 |
|
Viewing the Alarm Latching Settings |
53 |
|
Alarm Latching Behavior |
53 |
|
Testing Alarms |
54 |
|
Alarm Behavior at On/Off |
54 |
5 Patient Alarms and INOPs |
55 |
|
|
|
|
|
Patient Alarm Messages |
55 |
|
Technical Alarm Messages (INOPs) |
57 |
6 Admitting and Discharging Patients |
61 |
|
|
|
|
|
Admit/Discharge on the Monitor |
61 |
|
Admitting a Patient |
61 |
|
Editing Patient Information |
62 |
|
Discharging a Patient |
62 |
|
New Patient Check |
62 |
|
OB TraceVue: via LAN |
62 |
|
OB TraceVue: via RS232 |
63 |
7 |
Non-Stress Test Timer |
65 |
|
|
|
|
Setting NST Autostart/Autostop |
65 |
|
Viewing the NST Timer |
65 |
|
Timer Expiry Notification |
65 |
iii
|
Accessing the NST Setup Pop-up Keys |
65 |
|
Via the Timer SmartKey (Route 1) |
66 |
|
Via the Main Setup SmartKey (Route 2) |
66 |
|
Via the NST Field (Route 3) |
66 |
|
Pop-up Keys for NST Timer Setup |
66 |
|
Run Time |
66 |
8 |
Monitoring FHR and FMP Using Ultrasound |
69 |
|
|
|
|
Misidentification of MHR as FHR |
69 |
|
Cross-Channel Verification |
70 |
|
What You Need |
70 |
|
Cordless Monitoring - Important Considerations |
70 |
|
Preparing to Monitor |
71 |
|
Selecting Fetal Heart Sound |
72 |
|
Changing the Fetal Heart Sound Volume |
72 |
|
Fetal Movement Profile |
72 |
|
FMP Statistics |
73 |
|
Switching FMP On and Off |
74 |
|
Troubleshooting |
74 |
|
Testing Ultrasound Transducers |
75 |
9 |
Monitoring Twin FHRs |
77 |
|
|
|
|
Important Considerations |
77 |
|
Monitoring Twins Externally |
78 |
|
Monitoring Internally |
79 |
|
Cross-Channel Verification |
80 |
|
Separating FHR Traces |
80 |
|
Switching Trace Separation On and Off |
80 |
|
Determining the Separation Order |
81 |
|
When Trace Separation is On |
81 |
|
‘Standard’ Separation Order |
81 |
|
‘Classic’ Separation Order |
82 |
|
When Trace Separation is Off |
82 |
|
Troubleshooting |
83 |
10 |
Fetal Heart Rate Alarms |
85 |
|
|
|
|
Changing Alarm Settings |
85 |
|
Turning Alarms On or Off |
85 |
|
Changing Alarm Limits |
85 |
|
Changing Alarm Delays |
85 |
|
Changing Signal Loss Delay |
86 |
11 |
Monitoring Triple FHRs |
87 |
|
|
|
|
Important Considerations |
87 |
|
Monitoring Triplets |
88 |
|
Cross-Channel Verification |
88 |
iv
Separating FHR Traces |
89 |
Switching Trace Separation On and Off |
89 |
When Trace Separation is On |
89 |
‘Standard’ Separation Order |
89 |
‘Classic’ Separation Order |
90 |
When Trace Separation is Off |
90 |
Troubleshooting |
91 |
12 Monitoring Uterine Activity Externally |
93 |
|
|
What You Need |
93 |
External Toco Monitoring |
93 |
Resetting the Toco Baseline |
94 |
Automatic Baseline Adjustment |
94 |
Toco Sensitivity |
94 |
Troubleshooting |
95 |
Testing Toco Transducers |
96 |
13 Monitoring Uterine Activity Internally |
97 |
|
|
What You Need |
97 |
Internal (IUP) Monitoring |
98 |
Zeroing the Monitor |
98 |
Selecting the IUP Scale |
98 |
Troubleshooting |
99 |
14 Monitoring FHR Using DECG |
101 |
|
|
Misidentification of MHR as FHR |
101 |
What You Need |
101 |
Making Connections |
103 |
Monitoring DECG |
103 |
Suppressing Artifacts |
104 |
Printing the Waveform |
105 |
Troubleshooting |
105 |
Testing DECG Mode |
106 |
15 Monitoring Noninvasive Blood Pressure |
107 |
|
|
Introducing the Oscillometric Noninvasive Blood Pressure Measurement |
107 |
Measurement Limitations |
108 |
Measurement Methods |
108 |
Reference Method |
108 |
Preparing to Measure Noninvasive Blood Pressure |
108 |
Correcting the Measurement if Limb is not at Heart Level |
109 |
Understanding the Numerics |
109 |
Starting and Stopping Measurements |
109 |
Enabling Automatic Mode and Setting Repetition Time |
110 |
Choosing the Alarm Source |
110 |
Assisting Venous Puncture |
111 |
v
Calibration |
111 |
Troubleshooting |
111 |
16 Monitoring SpO2 |
113 |
Selecting an SpO2 Sensor |
113 |
Applying the Sensor |
113 |
Connecting SpO2 Cables |
114 |
Measuring SpO2 |
114 |
Assessing a Suspicious SpO2 Reading |
115 |
Understanding SpO2 Alarms |
115 |
Alarm Delays |
115 |
Adjusting the SpO2 Alarm Limits |
115 |
Adjusting the Desat Limit Alarm |
116 |
Adjusting the Pulse Alarm Limits |
116 |
Setting Up Tone Modulation |
116 |
Setting the QRS Volume |
116 |
17 Monitoring Maternal Heart / Pulse Rate |
117 |
|
|
Priority for Maternal Heart / Pulse Rate |
117 |
Cross-Channel Verification |
117 |
MHR from MECG Electrodes |
117 |
Applying Electrodes |
118 |
Making Connections |
119 |
Monitoring MHR |
119 |
Monitoring MECG |
119 |
Applying Electrodes |
120 |
Viewing the Waveform on the Screen |
120 |
Printing the Waveform |
120 |
Pulse Rate from SpO2 |
120 |
Adjusting the Heart Rate / Pulse Alarm Limits |
121 |
Average Pulse Rate from Noninvasive Blood Pressure |
121 |
Troubleshooting |
121 |
Testing MECG Mode |
121 |
18 Printing the ECG Waveform |
123 |
|
|
19 Paper Save Mode for Maternal Measurements |
127 |
|
|
20 Recovering Data |
129 |
|
|
Recovering Traces on Paper |
129 |
Recovering Traces on an OB TraceVue System |
130 |
Recording Stored Data |
130 |
21 Care and Cleaning |
133 |
|
|
General Points |
133 |
Cleaning and Disinfecting |
134 |
vi
Cleaning Agents |
134 |
Disinfecting Agents |
135 |
Cleaning and Disinfecting Monitoring Accessories |
135 |
Sterilizing |
135 |
22 Maintenance |
137 |
|
|
Inspecting the Equipment and Accessories |
137 |
Inspecting the Cables and Cords |
137 |
Maintenance Task and Test Schedule |
138 |
Storing Recorder Paper |
138 |
Cleaning the Printhead |
139 |
Disposing of the Monitor |
139 |
23 Accessories and Supplies |
141 |
|
|
Information on Latex |
141 |
Transducers |
141 |
Fetal Accessories |
142 |
DECG Accessories: Component Compatibility |
143 |
MECG Accessories |
143 |
Noninvasive Blood Pressure Accessories |
144 |
Adult/Pediatric Multi-Patient Comfort Cuffs and Disposable Cuffs |
144 |
Adult Antimicrobial Coated Reusable cuffs |
144 |
Adult Soft Single Patient Single-Hose Disposable Cuffs |
144 |
SpO2 Accessories |
145 |
Recorder Paper |
147 |
24 Specifications and Standards Compliance |
149 |
|
|
Environmental Specifications |
149 |
Physical Specifications |
150 |
Performance Specifications |
151 |
Fetal / Maternal |
151 |
Noninvasive Blood Pressure |
154 |
SpO2 |
156 |
Recorder Specifications |
158 |
Alarm Defaults |
160 |
Compatible External Displays: FM40/FM50 Only |
160 |
Manufacturer’s Information |
161 |
Trademark Acknowledgement |
161 |
Regulatory and Standards Compliance |
161 |
Safety and Performance |
161 |
Electromagnetic Compatibility (EMC) |
161 |
EMC Testing |
162 |
Reducing Electromagnetic Interference |
162 |
System Characteristics |
163 |
Electromagnetic Emissions and Immunity |
163 |
Electromagnetic Immunity |
164 |
vii
Finding Recommended Separation Distances |
165 |
Recommended Separation Distances from Other RF Equipment |
167 |
Environment |
167 |
Monitoring After a Loss of Power |
168 |
ESU, MRI and Defibrillation |
168 |
Cardiac Pacemakers and Electrical Stimulators |
168 |
Fast Transients/Bursts |
168 |
Symbols on the System |
168 |
viii
1
This book is for trained healthcare professionals using the Avalon FM20, FM30, FM40 and FM50 fetal/maternal monitors. It describes how to set up and use the monitor and transducers. Familiarize yourself with all instructions including warnings and cautions before starting to monitor patients. Read and keep the Instructions for Use that come with any accessories, as these contain important information about application and care and cleaning that is not repeated in this book.
You should be:
•Trained in the use of fetal heart rate (FHR) monitors.
•Trained in the interpretation of FHR traces.
•Familiar with using medical devices and with standard fetal monitoring procedures.
For information on how to configure and service the monitor, refer to the Service Guide, or contact your authorized service provider.
Your monitor may not have all of the features and options described in this guide. The exact appearance of the monitor may differ slightly from that shown in the illustrations.
In this guide:
•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.
•A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury.
•Monitor refers to the entire fetal/maternal monitor. Display refers to the physical display unit. Screen refers to everything you see on the monitor’s display, such as measurements, alarms, patient data and so forth.
•Whenever a monitor’s identifier appears to the left of a heading or paragraph, it means that the information applies to that monitor only. Where the information applies to all models, no distinction is made.
1
1 Introduction |
Confirm Fetal Life Before Using the Monitor |
Confirm Fetal Life Before Using the Monitor
Fetal monitoring technology available today is not always able to differentiate a fetal heart rate (FHR) signal source from a maternal heart rate (MHR) source in all situations. Therefore, you should confirm fetal life by independent means before starting to use the fetal monitor, for example, by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or Pinard stethoscope. If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation, confirm fetal life using obstetric ultrasonography. Continue to confirm that the fetus is the signal source for the FHR during monitoring.
Be aware that:
•a MHR trace can exhibit features that are very similar to those of a FHR trace, even including accelerations and decelerations. Do not rely solely on trace pattern features to identify a fetal source.
•Fetal Movement Profile (FMP) annotations on a fetal trace alone may not always indicate that the fetus is alive. The body of a deceased fetus can move and cause the monitor to annotate fetal body movements.
Here are some examples where the MHR can be misidentified as the FHR.
•When using an ultrasound transducer:
–It is possible to pick up maternal signal sources, such as the maternal heart, aorta, or other large vessels.
–Misidentification may occur when the MHR is higher than normal (especially when it is over 100 bpm).
•When using a fetal scalp electrode:
–Electrical impulses from the maternal heart can sometimes be transmitted to the fetal monitor through a recently deceased fetus via the spiral scalp electrode cable, appearing to be a fetal signal source.
–The recorded MHR (and any artifact) can be misinterpreted as a FHR (especially when it is over 100 bpm).
•When Fetal Movement Profile (FMP) is enabled:
FMP annotations in the absence of fetal life may be a result of:
–Movement of the deceased fetus during or following maternal movement.
–Movement of the deceased fetus during or following manual palpation of fetal movement (especially if the pressure applied is too forceful).
–Movement of the ultrasound transducer.
–The ultrasound transducer detecting a maternal movement source, such as the mother’s aorta.
See also the chapters “Monitoring FHR and FMP Using Ultrasound” and “Monitoring FHR Using DECG”.
To reduce the possibility of mistaking the MHR for FHR, it is recommended that you monitor both maternal and fetal heart rates. The monitor’s cross-channel verification (CCV) facility can help by automatically detecting when a MHR coincides with a FHR. For further details, see “Cross-Channel Verification” on page 70.
2
Introducing the Avalon Family of Fetal Monitors |
1 Introduction |
Introducing the Avalon Family of Fetal Monitors
The Avalon family of fetal monitors consists of the Avalon FM20, FM30, FM40 and FM50. While the FM20/FM30 and the FM40/FM50 have different form factors, the method of operation is very similar for all monitors. The Avalon fetal monitors also share the same transducers and accessories, and are compatible with the Avalon CTS Cordless Fetal Transducer System (M2720A).
The Philips Avalon FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A) Fetal/Maternal Monitors are intended for non-invasive monitoring of the physiological parameters of pregnant women during antepartum testing and labor and delivery. The FM30 and FM50 are additionally intended for invasive monitoring.
All monitors are intended for monitoring fetal and maternal heart rates, uterine activity, maternal noninvasive blood pressure, and additionally for the FM30, FM40 and FM50, oxygen saturation (SpO2).
All monitors are intended for generating alarms from fetal and maternal parameters, for displaying, storing and recording patient data and related waves, transmitting patient data to a patient information and surveillance system on a network, and for postpartum monitoring of the mother.
All monitors are intended for use by trained health care professionals.
They are intended for use in labor and delivery rooms, antepartum testing areas and during postpartum recovery in the hospital environment. They are not intended for use in intensive care units or operating rooms. The FM20 and FM30 are additionally intended for use in healthcare facilities outside hospitals, for example in doctors’ offices, and for use in private households.
All monitors are NOT intended for:
–use during defibrillation, electro-surgery, or magnetic resonance imaging (MRI).
–ECG measurements on patients connected to external electrical stimulators or with cardiac pacemakers.
–use with the IUP/ECG patient module (M2738A) in domestic establishments and those connected directly to the public low-voltage supply network that supplies buildings used for domestic purposes.
CAUTION US federal law restricts this device to sale by, or on the order of, a physician.
The monitors are indicated for use by health care professionals for monitoring the physiological parameters of pregnant women.
3
1 Introduction |
Introducing the Avalon Family of Fetal Monitors |
4
2
Installation should be carried out by qualified service personnel, either by the hospital’s biomedical department, or by Philips Support.
As the first step in preparing the monitor for use, follow the installation instructions given in this chapter.
For a list of conventions used in this guide, see Chapter 2, “Basic Operation”.
Not all accessories and supplies may be available in all geographies. Please contact your local Philips sales representative for details of availability.
Use this checklist to document your installation.
Step |
Task |
Check Box |
|
|
when Task |
|
|
Done |
|
|
|
1 |
Perform initial inspection of delivery, unpack and check the shipment |
|
|
(see “Unpacking and Checking the Shipment” on page 6) |
|
2 |
Mount the monitor as appropriate for your installation |
|
|
(see “Mounting the Monitor” on page 6) |
|
3 |
Connect the fetal monitor to AC mains using the supplied power cord (see |
|
|
“Connecting the Monitor to AC Mains” on page 7) |
|
4 |
Perform Safety Tests (see “Safety Tests” on page 8) |
|
5 |
Check that default settings (including the line frequency) are appropriate for |
|
|
your institution |
|
6 |
Check/set the paper scale (see “Checking/Setting Paper Scale” on page 33) |
|
7 |
Load paper into the recorder (see “Loading Paper: FM20/FM30” on page 35 |
|
|
or “Loading Paper: FM40/FM50” on page 36, depending on your monitor) |
|
8 |
Check/set the time and date (see “Setting the Date and Time” on page 25) |
|
9 |
Check/set paper speed (see “Choosing Paper Speed” on page 39) |
|
10 |
Perform System Test as necessary (see the Service Guide) |
|
11 |
Test Transducers (see “Testing Ultrasound Transducers” on page 75 and |
|
|
“Testing Toco Transducers” on page 96) |
|
|
|
|
5
2 Installation |
Unpacking and Checking the Shipment |
Unpacking and Checking the Shipment
The monitor and any supporting options ordered are supplied packed in protective shipping cartons.
Before unpacking, visually check the packaging and ensure that there are no signs of mishandling or damage.
Open the package carefully and remove the instrument and accessories.
Check that the contents are complete and that the correct options and accessories have been delivered.
System Components, Accessories and Supplies |
FM20 |
FM30 |
FM40 |
FM50 |
|
|
|
|
|
Toco+ transducer (with belt clip) |
- |
1 |
- |
1 |
Toco transducer (with belt clip) |
1 |
- |
1 |
- |
US transducer (with belt clip) |
1 |
1 |
1 |
1 |
Patient Module for DECG/MECG/IUP |
optional1 |
optional |
optional1 |
optional |
IUP Adapter Cable2 |
|
1 |
|
1 |
DECG reusable legplate adapter cable |
- |
1 |
- |
1 |
MECG adapter cable |
- |
1 |
- |
1 |
Event Marker |
optional |
optional |
optional |
optional |
Fetal paper pack (country-specific, installed) |
1 |
1 |
1 |
1 |
Powercord |
1 |
1 |
1 |
1 |
Printed Instructions for Use |
1 |
1 |
1 |
1 |
Documentation DVD-ROM: includes FM20/30 Service |
1 |
1 |
1 |
1 |
Guide, FM40/50 Service Guide, Instructions for Use |
|
|
|
|
(including localized versions), and Training Guide |
|
|
|
|
1. For assessment of maternal heart rate only. |
|
|
|
|
2. Ships with Patient Module. |
|
|
|
|
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.
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.
The monitor can be rested on a flat surface, set at an angle using the built-in stand, or mounted on a wall, on a cart or on a rollstand. See the Service Guide for details.
The monitor can be rested on a flat surface, or on a cart. See your monitor’s Service Guide for details.
6
Connecting the Monitor to AC Mains |
2 Installation |
Connecting the Monitor to AC Mains
The monitor is an electrical Class II device 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.
The monitor is an electrical Class I device. Protection against electric shock is provided by a protective earth conductor.
The monitor has a wide-range power supply that allows you to operate the monitor from an AC (alternating current) power source of 100 V to 240 V (± 10%) and 50 or 60 Hz (± 5%).
WARNING • Always use the supplied power cord with the earthed mains plug to connect the monitor to an earthed AC mains socket. Never adapt the mains plug from the power supply to fit an unearthed AC mains socket.
•Check that the line frequency is correctly set for your institution (50 Hz or 60 Hz) before putting the monitor into service.
•FM20/FM30 only: The protective earth conductor is required for EMC purposes. It has no protective function against electric shock! The protection against electric shock in this device is provided by double and/or reinforced insulation.
•Do not use AC mains extension cords or multiple portable socket-outlets.
The following table defines which test and inspection blocks need to be performed, and when they are required.
Test Block |
Test or Inspection to be Performed |
Test Block Required for |
|
|
Which Events? |
|
|
|
Visual |
Inspect the monitor, transducers and cables for |
Installation |
|
any damage. |
Preventive Maintenance |
|
|
|
|
Are they free of damage? |
|
Power On |
Power on the monitor. Does it boot up |
Installation |
|
successfully without errors? After boot up the |
Preventive Maintenance |
|
monitor sounds a tone, and can you see the |
|
|
|
|
|
monitoring main screen. |
|
|
If recorder power-on auto-start is configured to |
|
|
On, does the recorder print “Selftest OK” across |
|
|
the trace paper? (See page 26 for details.) |
|
Safety Tests (1) to (4) |
Perform safety tests (1) to (4), as described in your |
Installation |
|
monitor’s Service Guide, for standalone devices if |
Preventive Maintenance |
|
required by local regulations, and each time you |
|
|
|
|
|
combine equipment to form a system, or exchange |
|
|
system components. |
|
|
|
|
7
2 Installation |
Safety Tests |
Test Block |
Test or Inspection to be Performed |
Test Block Required for |
|
|
Which Events? |
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Test the transducers (see “Testing Ultrasound |
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Transducers” on page 75 and “Testing Toco |
Preventive Maintenance |
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Transducers” on page 96). |
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System |
Perform the system test according to IEC/EN |
Combining system |
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components |
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For test and inspection information regarding repairs, upgrades and all other service events, refer to your monitor’s Service Guide.
Safety Tests
Details of the safety tests and procedures required after an installation or an exchange of system components are described in your monitor’s Service Guide. These safety tests are derived from international standards but may not be sufficient to meet local requirements.
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/EN 60601-1-1.
•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/EN 60601-1. The whole installation, including devices outside of the patient vicinity, must comply with IEC/EN 60601-1-1. Any non-medical device, including a PC running an OB TraceVue system, placed and operated in the patient’s vicinity must be powered via a separating transformer (compliant with IEC/EN 60601- 1-1) that ensures mechanical fixing of the power cords and covering of any unused power outlets.
8
3
This chapter gives you an overview of the monitor and its functions. It tells you how to perform tasks that are common to all measurements (such as entering data, switching a measurement on, changing some monitor settings, and setting up the recorder). The alarms section gives an overview of alarms.
The remaining sections tell you how to perform individual measurements, and how to care for and maintain the equipment.
9
3 Basic Operation |
Supported Measurements |
Supported Measurements
Fetal
Monitor
Model
Key:
The following measurements are supported:
Supported Measurements
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Fetal |
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Maternal |
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HeartFetalRate |
via(FHR)US |
IncludingTwins |
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FHRTriplevia US |
Toco |
FHR |
DirectviaECG |
(DECG) |
IntrauterinePressure |
(IUP) |
MaternalHeart Rate |
via(MHR)maternal |
electrodesECG |
MaternalECG |
(MECG) |
NoninvasiveBlood Pressure |
PulsewithRate |
OximetryPulse |
(MaternalSpO |
PulsewithRate |
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10
Avalon FM20 and FM30 |
3 Basic Operation |
Avalon FM20 and FM30
This section outlines the capabilities of your monitor.
The Avalon FM20 fetal/maternal monitor provides a solution for external fetal monitoring applications, and optional non-invasive maternal vital signs.
You can monitor fetal heart rates (FHRs) externally using ultrasound, uterine activity using an external Toco transducer, and the maternal heart rate (MHR) via maternal ECG electrodes, and optionally, non-invasive blood pressure.
Measurements are displayed on a 6.5-inch color display as numerics. The display is a touchscreen, and you operate the monitor using this touchscreen interface. The integrated recorder documents fetal and maternal measurements as well as user defined annotations.
You can connect the monitor to an OB TraceVue obstetrical documentation and surveillance system via the RS232 connection, or over a LAN connection (with OB TraceVue Revision E.00.00 and later).
The Avalon FM30 fetal/maternal monitor offers a solution for both external and internal fetal monitoring applications, and optional non-invasive maternal vital signs.
The Avalon FM30 shares all the features and capabilities of the Avalon FM20. In addition, you can monitor one FHR internally via direct fetal electrocardiogram (DECG), uterine activity internally using an intra-uterine pressure (IUP) catheter together with a Toco+ transducer or patient module, and optionally, maternal oxygen saturation (SpO2).
The Avalon FM30 carries the label, indicating that it is capable of intrapartum monitoring.
11
3 Basic Operation |
Avalon FM40 and FM50 |
Avalon FM40 and FM50
This section outlines the capabilities of your monitor.
The Avalon FM40 fetal/maternal monitor provides a solution for external fetal monitoring applications, and optional non-invasive maternal vital signs.
You can monitor fetal heart rates (FHRs) externally using ultrasound, uterine activity using an external Toco transducer, and the maternal heart rate (MHR) via maternal ECG electrodes, and optionally, non-invasive blood pressure and maternal oxygen saturation (SpO2).
Measurements are displayed on a 6.5-inch color display as numerics. The display is a touchscreen, and you operate the monitor using this touchscreen interface. The integrated recorder documents fetal and maternal measurements as well as user defined annotations.
You can connect the monitor to an OB TraceVue obstetrical documentation and surveillance system via the RS232 connection, or over a LAN connection (with OB TraceVue Revision E.00.00 and later).
The Avalon FM50 fetal/maternal monitor offers a solution for both external and internal fetal monitoring applications, and optional non-invasive maternal vital signs.
The Avalon FM50 shares all the features and capabilities of the Avalon FM40. In addition, you can monitor one FHR internally via direct fetal electrocardiogram (DECG), and uterine activity internally using an intra-uterine pressure (IUP) catheter together with a Toco+ transducer or patient module.
The Avalon FM50 carries the label, indicating that it is capable of intrapartum monitoring.
12
Cordless Monitoring |
3 Basic Operation |
Cordless Monitoring
All monitors are compatible with the Avalon CTS Cordless Fetal Transducer System (M2720A). Note the following points regarding cordless monitoring:
•One Avalon CTS Cordless Fetal Transducer System can be connected at a time.
•Monitoring multiple pregnancies using cordless transducers is not supported.
•Using a mixture of wired and cordless fetal transducers is not supported. You can use either wired or cordless fetal transducers.
•When the monitor recognizes an Avalon CTS interface cable M2731-60001 (red connector) or M2732-60001 (black connector, for rear connection on FM40/FM50 only), it gives confirmation by showing the following status indicator in the lower right-hand corner of the screen:
Indicator |
Meaning |
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Avalon CTS interface cable is connected to the monitor, but the Avalon CTS base station is not connected to the interface cable, disconnected from AC mains, or is in Stand-by.
Avalon CTS interface cable is connected to the monitor, Avalon CTS base station is connected, powered on, and cordless transducers are ready to use, but no cordless transducers are currently active (all are still docked in the base station).
Avalon CTS interface cable is connected to the monitor, Avalon CTS base station is connected, powered on, and at least one cordless transducer has been taken out of the base station and is active. As cordless transducers have priority over wired transducers, any connected wired transducers are disabled.
•Cordless transducers have priority over wired transducers. When an Avalon CTS base station is connected via the appropriate interface cable to the fetal monitor, and there are also wired transducers connected to the monitor, the wired transducers are disabled whenever a cordless transducer is active. To change back to using wired transducers, dock the cordless transducers in the Avalon CTS base station or switch the base station to Stand-by, and continue monitoring with the wired transducers.
•When using a cordless ultrasound transducer from an Avalon CTS system, the monitor automatically sets the Fetal Movement Profile (FMP) to Off. You can enable the FMP again should you wish, (see “Switching FMP On and Off” on page 74), but you should refer to the sections “Cordless Monitoring - Important Considerations” on page 70 and “Fetal Movement Profile” on page 72.
13
3 Basic Operation |
Getting to Know Your Avalon FM20/FM30 |
Getting to Know Your Avalon FM20/FM30
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14
Getting to Know Your Avalon FM20/FM30 |
3 Basic Operation |
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15
3 Basic Operation |
Getting to Know Your Avalon FM40/FM50 |
Getting to Know Your Avalon FM40/FM50
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16
Transducers
1
2
Toco Transducer
(M2734A)
3
Ultrasound Transducer
(M2736A)
4
3 Basic Operation
1Transducer Finder LED - lights up on the transducer providing the measurement source.
2Belt Button
3Cable - connects to any of the four Fetal Sensor Sockets on the monitor
4Connector - for connecting ECG/IUP adapter cables
(M2735A Toco+ transducer only)
Toco+ Transducer with ECG/IUP capability (M2735A)
17
3 Basic Operation |
Transducers |
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Butterfly belt clip (shown |
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fitted; for use with belts |
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Close-up of MECG adapter |
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Close-up of active Finder LED |
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Connector - for connecting |
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monitor |
Patient module for ECG/IUP (M2738A)
18
Operating and Navigating |
3 Basic Operation |
Operating and Navigating
Your monitor has a touchscreen. Everything you need to operate the monitor, other than to turn it on and off, is contained on its screen. Most screen elements are interactive. Screen elements include measurement numerics, screen keys, information fields, status indicators, alarms fields and menus.
If an optional external touch display is connected to the monitor, you can operate the monitor using the external touch display.
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Silence Toco |
Paper |
Admit |
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Main |
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Baseline |
Stop |
Advance |
Dischrge |
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Screen |
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13 |
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11 |
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Screen Elements
Item |
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Description |
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Monitor Information Line |
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1 |
INOP and alarm status area - shows active alert messages |
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2 |
LAN connection status indicator only. RS232 system connection is not indicated. |
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Monitor connected to OB |
LAN cable connected, but no |
If no indicator is shown, there |
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TraceVue |
connection to OB TraceVue |
is no network connection. |
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3 |
Patient identification |
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4 |
Date and time |
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5 |
Bed label (when connected to a Philips OB TraceVue system) |
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6 |
Fetal heart sound volume adjust/indicator |
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19
3 Basic Operation |
Operating and Navigating |
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Screen Elements |
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Item |
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Description |
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7 |
Alarm volume adjust/indicator |
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Other Screen Elements |
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8 |
Numeric/measurement values |
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9 |
Status indicator - for fetal trace recorder |
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Fetal recorder On |
Fetal recorder Off |
Fetal recorder Off |
Recorder problem that can |
Fetal recorder is |
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(when Paper Save |
(when Paper Save |
be solved by the user (for |
defective. Call service. |
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Mode is off) |
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Mode is on) |
example, paper out, paper |
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jam, wrong paper scale set) |
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10 |
Status indicator - for Avalon CTS system: |
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Avalon CTS interface cable is |
Avalon CTS interface cable is |
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Avalon CTS interface cable is |
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connected to the monitor, but |
connected to the monitor, Avalon CTS |
connected to the monitor, Avalon CTS |
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Avalon CTS base station is not |
base station is connected, powered on, |
base station is connected, powered on, |
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connected to the interface cable, |
and cordless transducers are ready to |
and at least one cordless transducer has |
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disconnected from AC mains, or is |
use, but no cordless transducers are |
been taken out of the base station and |
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in Stand-by. |
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currently active (all are still docked in |
is active. Any connected wired |
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the base station). |
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transducers are disabled. |
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11 |
Close all open menus and windows and return to main screen |
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12 |
Scroll to display more SmartKeys |
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13 |
SmartKeys - these can vary according to your monitor’s configuration |
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14 |
Silence - key which acknowledges all active alarms by switching off audible alarm indicators |
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15 |
Status line - shows status and prompt messages |
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16 |
Signal quality indicator: |
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Good/full |
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Acceptable/medium |
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Poor/no signal |
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17 |
Measurement label (a cordless measurement from a connected Avalon CTS system is indicated by the |
symbol) |
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18 |
NST timer, if configured (default is off) |
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20