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...

When to Perform Tests Blocks
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...

When to Perform Tests Blocks
Chapter 8 - Test and Inspection Matrix
81
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...

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...

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...

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...

Safety Testing
Chapter 8 - Test and Inspection Matrix
85
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...

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...

Safety Testing
Chapter 8 - Test and Inspection Matrix
87
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....

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...