Philips Fm2 Service Manual

							Introduction
Chapter 8 - Test and Inspection Matrix
79
Caution
General-purpose personal computers and modems are not designed to 
meet the electrical safety requirements of medical devices. The RS-232 and 
parallel connectors on the monitor are electrically isolated to permit safe 
connections to non-medical devices, which should be connected with a 
cable of sufficient length to prevent the non-medical equipment from 
contacting the patient.
If  a non-medical device is connected to the serial port, a recorder or 
printer connected at the same time to the parallel port should be located 
outside the patient vicinity, as the two interfaces are not isolated against 
each other.
Introduction
This chapter contains maintenance and safety information for the FM-2 
antepartum fetal monitor and its accessories.
All checks that require the instrument to be opened must be made by qualified 
service personnel. Please contact your local Agilent representative when you wish 
safety and maintenance checks to be carried out.
To ensure that your monitor functions properly and safely, you must adhere to 
the standards stated in this manual. 
						

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80Chapter 8 - Test and Inspection Matrix
When to Perform Tests Blocks
Table 20 shows which test blocks to perform after repair and preventive 
maintenance tasks. 
Table 20 FM-2: When to Perform  Test Blocks
Service EventTest Block(s) Required
(See Table 21 on page 81)
Installation
The product is customer installed.
Refer to the Instructions for Use.Visual and Power On
Preventive
Maintenance
Preventive maintenance is limited 
to exchanging the batteryPo we r  O n
Safety Tests
Repairs
Unit Exchange Visual and Power On
Unit opened Visual and Power On
Front End Connector Board 
exchangedPo we r  O n
Performance Tests for Trans-
ducers
Safety Tests
Rear Connector Board exchanged Power On
Safety Tests
Power Supply exchanged Power On
Battery exchanged Power On
Safety Tests 
						

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Chapter 8 - Test and Inspection Matrix
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Table 21 Test and Inspection Matrix
Test Block 
NameTest Expected ResultsWhat to 
Record
Visual Test
(See 20)Inspect exterior of fetal 
monitor for damage.No Visual Damage V:P or V:F
Pow e r - O n  Se l f -
Te s t
(See 20)Power on the monitor Displays Normal Monitoring 
Screen Configuration and 
emits tonesPO:P or PO:F
Safety Tests:
• Safety Test 1
(See 86)Enclosure Leakage 
Current - S.F.C. Open 
SupplyAll Safety Test results are in 
range of Table 22 on page 87S:P or S:F
 Safety Test 2
(See 88)Patient Leakage Cur-
rent - S.F.C. Open 
SupplyAll Safety Test results are in 
range of Table 23 on page 89S:P or S:F
Key to Table:P = Pass F = Fail 
						

							Battery Charging and Maintenance
82Chapter 8 - Test and Inspection Matrix
Battery Charging and Maintenance
Before attempting to perform any tests, it is important to verify that the battery 
is charged and functional.
Using the Battery
You can run the monitor for approximately six hours on battery power at room 
temperature of 25o C from a fully charged battery (with a minimum of two 
hours monitoring at 10o C from a fully charged battery). The age of the battery, 
operating temperature and number of recharge cycles affects this. A battery life 
cycle is approximately 200 charge/discharge cycles.
Low Power Warning
A low power warning occurs when the battery power is running low. The battery 
fuel gauge flashes, and a repetitive audible tone sounds. Remaining monitoring 
time is typically 30 minutes with a new battery at room temperature of 25
o C. In 
an older monitor, in which the battery has had a number of recharge cycles, it 
may occur when fewer minutes remain.
The warning continues until the low power condition disappears (when you 
connect the monitor to an AC power supply) or until the system stops 
functioning because of the low power.You cannot silence it, and you cannot 
adjust its volume.
The monitor retains any stored fetal traces, even if it shuts down because of lack 
of battery power. 
						

							Preventive Maintenance
Chapter 8 - Test and Inspection Matrix
83
Recharging the Battery
Use the power supply to recharge the battery from an AC power source. This 
takes a maximum of 14 hours when monitoring simultaneously, or eight hours if 
no monitoring occurs. Typical times are 11 hours if you are monitoring 
simultaneously, or 4.75 hours if no monitoring occurs.
Storing
A stored battery loses capacity over time. To minimize loss of capacity, recharge 
the battery at least every six months. A battery typically has three to five years 
shelf life.
Preventive Maintenance
The only preventive maintenance task required for the monitor is battery 
exchange. Life expectancy of a battery depends on the frequency and duration of 
use. The battery should be replaced every two years.
See “Removing the Battery” on page 43, and “Replacing the Battery” on page 
44. 
						

							Safety Testing
84Chapter 8 - Test and Inspection Matrix
Safety Testing
This section defines the test and inspection procedures applicable to the FM-2 
fetal monitors. Use the tables in the following section to determine what test and 
inspection results must be reported after a repair has been carried out. 
Test Blocks in Table 20 tells you when to carry out the tests blocks
Test and Inspection Matrix in Table 21 tells you the expected results of the 
tests and what to record.
Warning
Apply the safety test limits set by the local standards and statutes applicable 
to the country of installation, such as IEC 601-1, UL2601, CAN/CSA-
C22.2 No. 601.1.M90.
The safety tests defined in this chapter are derived from local and 
international standards but may not be equivalent. They are NOT a 
substitute for local safety testing.
Caution
Successful completion of the patient safety tests does not ensure the correct 
and accurate functioning of the equipment. 
						

							Safety Testing
Chapter 8 - Test and Inspection Matrix
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Safety Test Procedures
The test procedures outlined in this section are to be used only for verifying the 
safe installation or service of the product. “Safety checks at installation refer to 
safety aspects directly related to the installation and setup activities and not to 
intrinsic safety features that have already been checked during final acceptance 
testing at the factory.” 
[FDA 97-4179 Medical Quality Systems Manual: A Small Entity Compliance 
Guide (QSR manual). First Edition December 1996. Chapter 14: Storage, 
Distribution and Installation. This document may be viewed at http://
www.fda.gov.
When running safety tests on the peripheral components of the system, refer to 
the documentation included with those products.
When performing safety tests, you must use a standard safety tester. You can use 
testers complying with IEC 601-1 internationally. You may also use testers 
complying with any local standards and statutes applicable to the country of the 
installation. For safety test procedures see the operation instructions of the safety 
tester used.
If using the Metron safety tester use your local regulations to perform the test, 
for example
in Europe: IEC60601-1/IEC60601-1-1
in the US: UL2601-1
The Metron Report should print results as detailed in this chapter, along with 
other data. 
Note—For information and ordering guides for Metron products contact:
Metron AS, Travbaneveien 1, N-7044 Trondheim, Norway
Tel. (+47) 73 82 85 00; Fax (+47) 73 91 70 09; 
E-mail: [email protected]/[email protected]
www: http://www.metron-biomed.com
There are two general categories of safety test:
Ground integrity
Electrical Leakage 
						

							Safety Testing
86Chapter 8 - Test and Inspection Matrix
Ground Integrity
The FM-2 is a Class 2, Type BF instrument. It has an external power supply, and 
is constructed with double insulation. The FM-2
 does not require an isolated 
Earth Ground terminal, neither is one installed. No Protective Ground 
Continuity check is required.
Electrical Leakage
The following tests verify the electrical leakage of the monitor:
Enclosure leakage Current
Patient Leakage Current
Safety Test 1: Enclosure Leakage Current Test
Normal
ConditionThis test is applicable to Class 1 and 2 equipment, type B, BF, and CF Applied 
Parts. The test measures leakage current of exposed metal parts of the 
Instrument Under Test. It tests both normal and reversed polarity. 
For type BF and CF Applied Parts the test measures AP/GND.
Safety Test according IEC 601-1 (Clause 19).
Report the highest value.
Single Fault
Condition
(S.F.C.) Open
SupplyThis test is applicable to Class 1 and 2 equipment, type B, BF, and CF Applied 
Parts. The test measures leakage current of exposed metal parts of the 
Instrument Under Test with one supply lead interrupted. It tests both normal 
and reversed polarity. 
For type BF and CF Applied Parts the test measures AP/GND.
Safety Test according IEC 601-1 (Clause 19).
Report the highest value. 
						

							Safety Testing
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Te s t  S t e p s1. Connect the external power supply output cord to the monitor. Then 
connect the appropriate external power supply input power cord to the 
analyzer as recommended by the analyzer operating instructions. 
2. Using the appropriate test cable, connect the analyzer to a fixing nut of 
the RS-232 connector on the back of the monitor.
3. Turn the monitor on.
4. Perform the test as recommended by the analyzer operating instructions.
The analyzer leakage current indication must not exceed the values listed in 
Table 22.
Table 22 Enclosure Leakage Current
Test Condition PolarityMaximum Leakage Current 
(µA)
IEC 601-1 ES1AAMI/ANSI 
Standard
NormalNormal 100 µA 100 µA
Reversed 100 µA 100 µA
S.F.C.1 (Open Supply)
1. S.F.C. = Single Fault Condition
Normal 500 µA 300 µA
Reversed 500 µA 300 µA 
						

							Safety Testing
88Chapter 8 - Test and Inspection Matrix
Safety Test 2: Patient Leakage Current Test
Normal
ConditionThis test is applicable to Class 1 and 2 equipment, type B, BF, and CF Applied 
Parts. The test measures patient leakage current from any individual patient 
connection to earth (power ground) in parallel. It tests both normal and reversed 
polarity.
Safety Test according IEC 601-1 (Clause 19).
Report the highest value.
Single Fault
Condition
(S.F.C.) Open
SupplyThis test is applicable to Class 1 and 2 equipment, type B, BF, and CF Applied 
Parts. The test measures patient leakage current from any individual patient 
connection to earth (power ground) in parallel, with one supply lead 
interrupted. It tests both normal and reversed polarity.
Safety Test according IEC 601-1 (Clause 19).
Report the highest value.
Te s t  S t e p sThis test requires a sample patient cable for each device parameter. These must 
be configured as recommended by the safety analyzer operating instructions.
1. Configure the electrical safety analyzer as recommended by the analyzer 
operating instructions.
2. Connect the appropriate external power supply input power cord to the 
analyzer as recommended by the analyzer operating instructions. Connect 
the external power supply output cord to the monitor.
3. Turn the monitor on.
4. Perform the test as recommended by the analyzer operating instructions.
For each test condition, the measured leakage current must not exceed that 
indicated in Table 23.