F15 Series Service Manual Ver 1.0 Sept 2020

injury or death. CAUTION

A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure.

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Content Chapter 1 Safety Guidance ... 7 1.1 Introduction ... 7 1.2 General Information ... 7 1.3 Safety Precautions ... 8 1.4 Definitions and Symbols ... 1 Chapter 2 Installation ... 5 2.1 Environmental Requirements ... 5 2.2 Electrical Requirements... 6 2.3 Safety Requirements ... 6 2.4 Installing the Monitor ... 6 2.4.1 Installing the Monitor on a Flat Surface ... 6 2.4.2 Mounting the Monitor on a Wall ... 7 2.4.3 Installing the Monitor on Trolley... 8 2.5 Connecting to AC Power ... 9 Chapter 3 Functional Checks ... 10 3.1 Switching on Check... 10 3.2 LCD Screen Check ... 10 3.3 Touch Screen Check ... 10 3.4 Printing Check ... 11 3.5 Alarms Check ... 11 Chapter 4 System Configuration ... 12 4.1 Opening System Setup Menu ... 12 4.2 Entering Demo Mode ... 12 4.3 Reloading Default Settings ... 12 4.4 Clearing Data ... 13 4.5 Checking Product Information ... 13 4.6 Calibrating Touch Screen ... 13 4.7 Changing the Device No. ... 14 4.8 Changing Net Version... 14 4.9 Configuring 485 Wireless Network ... 14 4.10 Configuring for Ethernet Connecting ... 15 4.11 Changing Trace Width ... 16 4.12 Changing Paper Style ... 16 4.13 Changing the Language ... 16 4.14 Changing FHR Algorithm ... 17 4.15 Pressure Verification ... 17 4.16 NIBP Leak Test... 17 4.17 NIBP Calibration ... 17 Chapter 5 Maintenance ... 19 5.1 Maintenance Inspection ... 19 5.2 Maintenance of the Monitor ... 19 5.3 Maintenance of the Transducers ... 20 5.4 Maintenance of the Recorder ... 20 Chapter 6 Principle Introduction ... 21 6.1 System Principle Block Diagram ... 21 6.1.1 Main Control Board ... 22 6.1.2 Bottom Interface Board ... 23 6.1.3 AC-DC Power Board ... 24 6.1.4 DC-DC Transfer Board... 25 6.1.5 iM X12 Parameter Board（wired model only） ... 26 IV

6.1.6 Edan Transducer Socket Board (wired model only) ... 28 6.1.7 NELL Transducer Socket Board (wired model only) ... 28 6.1.8 Wireless Charging Board (wireless model only) ... 29 6.2 Interface ... 30 6.2.1 DB15 Interface ... 30 6.2.2 Antenna ... 30 6.2.3 RJ45 Interface ... 30 6.2.4 HDMI Interface ... 31 Chapter 7 Troubleshooting ... 32 7.1 Monitor Booting Failures ... 32 7.2 Display Failures ... 32 7.3 Touch Screen Failures ... 33 7.4 Sound Failures ... 33 7.5 Recorder Failures... 33 7.6 Network Failures ... 34 7.7 Alarm Failures ... 34 7.8 Alarm Failures ... 35 7.9 FHR/TOCO Monitoring Failures ... 35 7.10 ECG Monitoring Failures ... 35 7.11 SpO2 Monitoring Failures ... 36 7.12 NIBP Monitoring Failures ... 36 7.13 TEMP Monitoring Failures... 37 Chapter 8 Modules’ Malfunction Verification ... 38 8.1 Verifying Malfunction of the Main Control Board ... 38 8.2 Verifying Malfunction of the iM X12 Parameter board... 42 8.3 Verifying Malfunction of Lower Case Interface Board ... 43 8.4 Verifying Malfunction of AC-DC Power Board ... 44 8.5 Verifying Malfunction of EDAN Transducer Socket Board (wired model only) ... 45 8.6 Verifying Malfunction of NELL Transducer Socket Board (wired model only) ... 46 8.7 Verifying Malfunction of Wireless Charging Board ... 46 Chapter 9 Disassembling the Monitor ... 48 9.1 Tools Required... 48 9.3 Disassembling the Main Unit ... 48 9.4 Disassembling the Lower assembly ... 50 9.4.1 Replacing the DC-DC Transfer Board... 50 9.4.2 Replacing the Fan ... 51 9.4.3 Replacing the Power Module ... 52 9.4.4 Replacing the WIFI Module ... 53 9.4.5 Replacing the Main Control Board ... 53 9.4.6 Replacing the iM X12 Parameter Board (wired model only) ... 54 9.4.7 Replacing the Loudspeaker ... 55 9.4.8 Replacing the Transducer Socket Board (wired model only) ... 56 9.4.9 Replacing the Bottom Interface Board ... 56 9.4.10 Replacing the Printhead ... 57 9.4.11 Replacing the AP Module (wireless model only) ... 58 9.4.12 Replacing the Wireless Transducer Bracket (wireless model only) ... 58 9.5 Disassembling the Upper Assembly ... 59 9.5.1 Replacing the LCD Assembly ... 59 Chapter 10 Periodic Tests ... 60 10.1 Safety Tests ... 60 10.2 Performance Tests... 60 10.2.1 FHR Performance Test ... 60 10.2.2 TOCO Performance Test... 61 10.2.3 ECG Performance Test ... 61

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10.2.4 SpO2 Performance Test ... 62 10.2.5 NIBP Performance Test ... 62 10.2.6 TEMP Performance Test ... 62 10.2.7 FECG Performance Test（Wireless Model Only） ... 63 Appendix 1 Renewal Parts ... 65 Appendix 2 Connecting to OB TraceVue System... 66

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F15 Series Fetal & Maternal Monitor Service Manual

Safety Guidance

Chapter 1 Safety Guidance NOTE: This service manual is written to cover the maximum configuration. Therefore, your model may not have some of the parameters/modules described, depending on what you have ordered.

1.1 Introduction This service manual is a reference for periodic preventive maintenance and corrective service procedures for the F15 and F15 Air fetal & maternal monitor. It provides troubleshooting information, assembly procedures, instructions for functional testing and performance verification. It is intended for use only by technically qualified service personnel. WARNING When performing a service procedure, follow the instructions exactly as presented in this manual. Failure to do so might damage the monitor, invalidate the product warranty or lead to serious personal injury.

1.2 General Information NOTE: In this manual, Monitor refers to both F15 and F15 air, and is used where the information applies to both models.  The monitor is designed to comply with the international safety requirements IEC/EN 60601-1 for medical electrical equipment. It is class I equipment.  The monitor operates within specifications at ambient temperatures between 0ºC (+41 ºF) and +40 ºC (+104 ºF). Ambient temperatures that exceed these limits could affect the accuracy of the instrument and cause damage to the modules and circuits. Allow at least 2 inches (5 cm) clearance around the instrument for proper air circulation.  You must check that the equipment, cables and transducers do not have visible evidence of damage that may affect patient safety or monitoring capability before each use. If damage is evident, replacement is recommended before use.  The monitor must be serviced only by authorized and qualified personnel. The manufacturer

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F15 Series Fetal & Maternal Monitor Service Manual

Safety Guidance

does not accept responsibility for safety compliance, reliability and performance if modifications or repairs are carried out by unauthorized personnel. Identical replacement parts must be used.  The typical operator's position is in front of the monitor. Please position the device in a location where the operator can easily see the screen and access the operating controls.  The protective degree against electric shock of the patient connections is: Ultrasound (FHR1, FHR2, FHR3) External TOCO Fetal Movement Mark (FM) Fetal Stimulator (FS) Type CF Intrauterine Pressure (IUP) Maternal Electrocardiography (MECG) Direct Electrocardiography(DECG) Fetal Electrocardiography (FECG) Non-invasive Blood Pressure (NIBP) Type CF, defibrillation-proof

Arterial Oxygen Saturation (SpO2) Temperature (TEMP)

The monitor described in this service manual is not protected against: a)

The effects of high frequency currents

b) The interference of electrosurgery equipment

1.3 Safety Precautions WARNING and CAUTION messages must be observed. To avoid the possibility of injury, observe the following precautions during the maintaining the instrument.

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F15 Series Fetal & Maternal Monitor Service Manual

Safety Guidance

WARNING 1

The monitor must be serviced by authorized and qualified personnel only. EDAN do not accept responsibility for safety compliance, reliability and performance if modifications or repairs are carried out by unauthorized personnel. Identical replacement parts must be used.

2

The service personnel should be familiar with the operation of this monitor. Refer to User Manual of the monitor for details.

3

EXPLOSION HAZARD - Do not use the monitor in the presence of flammable anesthetics or other materials.

4

SHOCK HAZARD - the power receptacle must be a three-wire grounded outlet. Never try to adapt the three-prong plug to fit a two-slot outlet. A hospital grade outlet is required. If the outlet has only two slots, make sure that it is replaced with a three-slot grounded outlet before attempting to operate the monitor.

5

Any non-medical equipment (such as the external printer) is not allowed to be used within the patient vicinity (1.5m/6ft.).

6

Do not use the additional multiple portable socket-outlet or extension cord in the medical electrical system, unless it’s specified as part of the system by manufacturer. And the multiple portable socket-outlets provided with the system shall only be used for supplying power to equipment which is intended to form part of the system.

7

If multiple instruments are connected to a patient, the sum of the leakage currents may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard. Consult your service personnel.

8

Multiple portable socket-outlets shall not be placed on the floor.

9

Make sure that the power is turned off and the power cord is disconnected from the AC socket before connecting or disconnecting equipment. Otherwise, the patient or operator may receive electrical shock or other injury.

10 Do not connect any equipment or accessories that are not approved by the manufacturer or that are not IEC 60601-1 approved to the monitor. The operation or use of non-approved equipment or accessories with the monitor is not tested or supported, and monitor operation and safety are not guaranteed. 11 SHOCK HAZARD - Don’t connect non-medical electrical equipment, which has been supplied as a part of the system, directly to the wall outlet when the non-medical equipment is intended to be supplied by a multiple portable socket-outlet with an isolation transformer.

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F15 Series Fetal & Maternal Monitor Service Manual

Safety Guidance

WARNING 12 SHOCK HAZARD - Don’t connect electrical equipment, which has not been supplied as a part of the system, to the multiple portable socket-outlets supplying the system. 13 Do not use the additional multiple portable socket-outlet or extension cord in the medical electrical system, unless it’s specified as part of the system by manufacturer. And the multiple portable socket-outlets provided with the system shall only be used for supplying power to equipment which is intended to form part of the system. 14 Do not exceed the maximum permitted load when using multiple portable socket-outlets to supply the system. 15 Do not touch accessible parts of non-medical electrical equipment and the patient simultaneously. 16 Do not switch on the monitor until all cables have been properly connected and verified. 17 Do not touch the signal input or output connector and the patient simultaneously. 18 Equipment and devices that connect to the monitor should form an equipotential body to ensure effective grounding. 19 Disconnect the power cord before changing fuses. Replace them with those of the same specifications only. 20 SHOCK HAZARD - Do not attempt to connect or disconnect a power cord with wet hands. Make certain that your hands are clean and dry before touching a power cord. 21 SHOCK HAZARD - Do not remove the top panel cover during operation or while power is connected. 22 Only connect accessories supplied or recommended by the manufacturer to the device. 23 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configurations shall comply with the valid version of the system standard IEC/EN 60601-1. Anybody who connects additional equipment to the signal input connector or signal output connector to configure a medical system must ensure that the system complies with the requirements of the valid version of the system standard IEC/EN 60601-1. If in doubt, consult our technical service department or your local distributor.

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F15 Series Fetal & Maternal Monitor Service Manual

Safety Guidance

WARNING 24 Parts and accessories used must meet the requirements of the applicable IEC 601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601-1 medical electrical systems standard. 25 Connect the grounding wire to the equipotential grounding terminal in the main system. If it is not evident from the instrument specifications whether a particular instrument combination is hazardous or not, for example due to summation of leakage currents, you should consult the manufacturer or an expert in the field, to ensure that the necessary safety of all instruments concerned will not be impaired by the proposed combination. 26 Electromagnetic Interference - Ensure that the environment in which the monitor is installed is not subject to any source of strong electromagnetic interference, such as CT, radio transmitters, mobile phone base stations, etc. 27 When installing the unit into a cabinet, allow for adequate ventilation, accessibility for servicing, and room for adequate visualization and operation. 28 Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine, dust area, high-temperature and humid environment.

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F15 Series Fetal & Maternal Monitor Service Manual

Safety Guidance

1.4 Definitions and Symbols

F15 Series Fetal & Maternal Monitor

1

Fetal monitoring socket, ultrasound transducers, TOCO transducer and Fetal&Maternal Module can be connected to it( Type CF applied part)

2

Socket for Remote Event Marker ( Type CF applied part)

3

Socket for Fetal Stimulator ( Type CF applied part)

4

Socket for ECG cable ( Type CF applied part)

5

Socket for TEMP Transducer ( Type CF applied part) TEMP

6

Socket for NIBP Cuff ( Type CF applied part) NIBP

7

Socket for SpO2 Transducer ( Type CF applied part) SpO2 (EDAN)

8

Socket for SpO2 Transducer ( Type CF applied part) SPO2 （Nellcor）

9

DB9 interface

10

RJ45 Interface

11

Battery check

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F15 Series Fetal & Maternal Monitor Service Manual

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Alternating Current

13

Direct Current

14

Stand-by

15

Power Supply switch

Safety Guidance

Warning

16

(Background: Yellow; Symbol & outline: Black)

17

Caution

18

Operating instructions Refer to User Manual

19

(Background: Blue; Symbol: White)

20

TYPE CF APPLIED PART

21

DEFIBRILLATION-PROOF TYPE CF APPLIED PART

22

IP68

Dust-tight and protected against the effects of continuous immersion in water

23

IPX2

Protected against vertically falling water drops when enclosure tilted up to 15o

24

CE marking

25

General symbol for recovery/recyclable

26

Part Number

27

Date Of Manufacture

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F15 Series Fetal & Maternal Monitor Service Manual

Safety Guidance

28

Manufacturer

29

AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

30

Disposal method

31

Non-ionizing electromagnetic radiation

32

USB Port

33

Ethernet Port

34

Serial Number

35

Catalogue number

36

Federal (U.S.) Law restricts this device to sale by or on the order of a physician

37

This way up

38

Fragile, handle with care

39

Keep dry

40

STACKING LIMIT BY NUMBER

41

HANDLE WITH CARE

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F15 Series Fetal & Maternal Monitor Service Manual

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DO NOT STEP ON

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Safety Guidance

F15 Series Fetal & Maternal Monitor Service Manual

Installation

Chapter 2 Installation WARNING The system installation should be operated by serviceman authorized by the manufacturer.

2.1 Environmental Requirements Working Environment Temperature:

0 ºC ~ + 40 ºC ( +32 ºF ~ +104 ºF)

Relative Humidity:

15% ~ 95% (non-condensing)

Atmospheric Pressure:

86 kPa ~ 106 kPa

Transport and Storage Temperature:

-20 ºC ~ +55 ºC (-4ºF ~ +131 ºF)

Relative Humidity:

15% ~ 93% (non-condensing)

Atmospheric Pressure:

70 kPa ~ 106 kPa

Classification Anti-electric Shock Type:

Class I equipment with internal power supply

Anti-electric Shock Degree:

MECG,FHR1,FHR2,FHR3 ,TOCO,MARK,EXT.1, CF DECG, IUP,FECG SpO2, NIBP , TEMP

CF (Defibrillating-proof)

Main Unit: IPX2, protected against vertically falling water drops when enclosure tilted up to 15o (provided recorder Degree of Protection against drawer is shut and the monitor is not mounted on the wall vertically) Harmful Ingress of Water: US/TOCO/Fetal&Maternal Modules: IP68, dust-tight and protected against the effects of continuous emersion in water FT20 Telemetry Transmitter: IPX2 Degree of Safety in Presence of Equipment not suitable for use in presence of Flammable Gases: flammable gases Disinfection/Sterilizing Method:

Refer to User Manual for details -5-

F15 Series Fetal & Maternal Monitor Service Manual

EMC:

Group I Class A

Working System

Continuous running equipment

Installation

 If the monitor is installed in a cabinet, allow at least 2 inches (5 cm) clearance around the monitor for proper air circulation; allow adequate accessibility for servicing, and adequate room for visualization and operation.  Ensure the monitor is not subject to any source of strong electromagnetic interference, such as CT, radio transmitters, mobile phones base stations, etc.  Do not install the monitor in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur.  Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine, dust area, high-temperature and humid environment.

2.2 Electrical Requirements Operating Voltage:

100V-240V ~

Operating

50Hz/60Hz

Frequency:

Input Power:

110VA

Battery:

10.8VDC/5100mAh

2.3 Safety Requirements  SHOCK HAZARD- The power receptacle must be a three-wire grounded outlet. A hospital grade outlet is required. Never adapt the three-prong plug from the monitor to fit a two-slot outlet. If the outlet has only two slots, make sure that it is replaced with a three-slot grounded outlet before attempting to operate the monitor.  Do not touch signal input or output connector and the patient simultaneously.  Equipment and devices that connect to the monitor should form an equipotential body to ensure effective grounding.  Do not switch on the monitor until all cables have been properly connected and verified.

2.4 Installing the Monitor 2.4.1 Installing the Monitor on a Flat Surface Place the monitor on a flat surface. Make sure the surface does not vibrate, and is free of corrosive medicine and dust.

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Installation

2.4.2 Mounting the Monitor on a Wall CAUTION 1 The monitor should only be mounted on a solid concrete or brick wall. 2 Shut the display completely flat before mounting the monitor to the wall. 3 Make sure the wall mounting board is firmly fixed to the wall. If there is any doubt, do not hang the monitor to this board. 4 Make sure the monitor is safely hung on the posts of the board before releasing your hands from the monitor. To mount the monitor on a wall, 1

Order a wall mounting board (01.52.107983), a retaining board (01.52.01983) and a connecting board (01.52.107984) from the manufacturer.

2

Turn the monitor over and fix the retaining board to the bottom panel using six pan head screws and then fix the connecting board to the retaining board with two pan head screws.

Figure 2-1 Fixing Retaining Board and Connecting Board

3

Fix the wall mounting board to the wall with six self-tapping screws.

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F15 Series Fetal & Maternal Monitor Service Manual

Installation

Wall

Wall Mounting Board

Figure 2-2 Fixing Wall Mounting Board

4

Lift the monitor with the bottom panel facing the wall. Let the four posts on the board stretch into wall-mounting holes and then release your hands from the monitor slowly.

5

Secure the connecting board to the wall mounting board with a pan head screw.

2.4.3 Installing the Monitor on Trolley An Assembling Instruction will be delivered with the trolley. Refer to that instruction for details of installing the monitor on a trolley.

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F15 Series Fetal & Maternal Monitor Service Manual

Installation

Figure 2-3 the Monitor on a Trolley (Sketch Map)

2.5 Connecting to AC Power Apply the power cable provided with the monitor. Plug one end of the power cable to the power socket of the monitor. Connect the other end to a grounded 3-slot power output special for hospital usage.

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F15 Series Fetal & Maternal Monitor Service Manual

Functional Checks

Chapter 3 Functional Checks This section describes the procedure of a complete functional test to support recommended preventive-maintenance schedules. You are not required to open the device case for functional checks. WARNING Only qualified service personnel should perform a full functional check procedure. Whenever the monitor is serviced or problems are suspected, the manufacturer recommends a full functional check procedure.

3.1 Switching on Check Press the POWER switch on the right panel to switch on the monitor. Check if the power indicator lights up, if a start-up tone is heard, and if the screen lights up in a few seconds. If any failure is detected, refer to section 7.1 Monitor Booting Failures for details.

3.2 LCD Screen Check Observe if some characters are missing, or if there are bright spots and dark shadows on the LCD screen. Observe if the waveforms, fonts and symbols displayed on the LCD screen are normal. If any failure is detected, refer to section 7.1 Monitor Booting Failures for details.

3.3 Touch Screen Check Touch any available keys on the screen to check if the screen is working properly. If you touch the center of a key but the monitor does not execute the right operation, calibrate the touch screen. Refer to section 4.6 Calibrating Touch Screen for details. If any operation failure is detected, refer to section 7.3 Touch Screen Failures for details.

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