Fetal2EMR Fetal Monitor User Manual Rev B Feb 2012

Statement The manufacturer makes no warranty of any kind with regard to this material, including, but not limited to the implied warranties of merchantability and fitness for a particular purpose. Wallach Surgical Devices (hereinafter called Wallach) assumes no responsibility for any error that may appear in this document, or for incidental or consequential damage in connection with the furnishing, performance or use of this material. No part of this document may be photocopied, reproduced or translated to another language without prior written consent of Wallach. All information contained in this publication is believed to be correct. Wallach shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this material. The information contained in this document is subject to change without notice.

Responsibility Wallach is responsible for any effect on safety, reliability and performance of the equipment if:  Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by Wallach.  The electrical installation of the relevant room complies with national standards, and  The instrument is used in accordance with the instructions for use. NOTE: This device is not intended for home use, Intensive Care Unit’s or Operating Rooms. WARNING

: This device is not intended for treatment.

Using This Label Guide This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal 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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Table of Contents Chapter 1 Safety Guide ... 1 1.1 Intended Use... 1 1.2 Instruction for Safe Operation... 1 1.3 Ultrasound Safety Guide ... 2 1.4 Safety Precautions ... 2 1.5 Definitions and Symbols ... 6 Chapter 2 Monitor and Accessories ... 8 2.1 Opening and Checking Package... 8 2.2 Overview ... 9 2.2.1 Keys and Control Knob... 11 2.2.2 Indicators ... 13 2.3 Accessories ... 14 2.3.1 Ultrasound (US) Transducer ... 14 2.3.2 TOCO Transducer ... 14 2.3.3 Belt ... 14 2.3.4 Remote Event Marker ... 15 2.4 Screen ... 15 2.4.1 Main Interface ... 15 2.4.2 Setup Interface ... 17 Chapter 3 Installation Guide... 18 3.1 Installing Battery ... 18 3.2 Installing Monitor ... 20 3.3 Loading Recorder paper ... 20 3.4 Tearing Off Recorder paper ... 23 3.5 Adjusting Screen Angle ... 23 3.6 Connecting Transducers ... 24 3.7 Placing Accessories in the Holder... 24 3.8 Connecting Power Cable ... 25 Chapter 4 Alarms ... 26 4.1 Alarms Classification ... 26 4.2 Audible Alarm... 26 4.3 Visual Alarm ... 26 4.4 Choosing Alarm Silence Duration ... 27 4.5 Choosing Alarm Display Form ... 27 4.6 Changing Alarm Volume ... 28 4.7 Reviewing Alarms ... 28 4.8 Alarm Treatment Measures ... 28 4.9 Testing Alarms ... 28 4.10 Patient Alarm Defaults ... 29 Chapter 5 Printing ... 30 5.1 Function Description ... 30 5.2 Printing Configuration ... 30 5.2.1 Switching Auto Start Printing On or Off ... 31 - II -

5.2.2 Choosing Paper Speed ... 31 5.2.3 Changing Print Timer ... 31 5.2.4 Switching Print Self-Check On or Off ... 32 5.3 Understanding Recorder Paper Printout... 32 Chapter 6 Pre-Monitoring Preparation ... 34 6.1 Confirming Fetal Life ... 34 6.2 Switching On... 34 6.3 Checking Recorder Paper ... 35 6.4 Setting Date and Time ... 35 6.5 Adjusting Volume ... 36 Chapter 7 Fetal Monitoring ... 37 7.1 Monitoring Fetal Heart Rate (FHR) with Ultrasound ... 37 7.1.1 Parts Required ... 37 7.1.2 FHR Monitoring Procedure... 37 7.1.3 Switching the FHR Alarm On or Off ... 39 7.1.4 Changing FHR Alarm Limits ... 39 7.1.5 Changing FHR Alarm Delay ... 39 7.2 Monitoring Twin FHRs ... 40 7.2.1 Monitoring Twins Externally ... 40 7.2.2 Signals Overlap Verification (SOV) ... 40 7.2.3 Changing FHR2/DFHR Offset... 40 7.3 Monitoring Uterine Activity Externally ... 41 7.3.1 Parts Required ... 41 7.3.2 TOCO Monitoring Procedure ... 41 7.3.3 Changing UA Baseline... 41 7.4 Monitoring Fetal Movement ... 42 7.4.1 Auto Fetal Movement Monitoring (AFM) ... 42 7.4.2 Enabling or Disabling AFM Trace... 42 7.4.3 Changing AFM Gain ... 42 7.4.4 Manual Fetal Movement Monitoring (MFM) ... 43 7.4.5 Changing MFM Volume ... 43 7.5 Starting Monitoring ... 43 7.6 Inputting Maternal Information (Mat. Info) ... 43 7.6.1 Auto ID... 43 7.6.2 Changing Maternal Information ... 44 7.6.3 Switching Mat. Info Inputting On or Off ... 44 Chapter 8 Understanding Measurement Results ... 45 8.1 Changing Screen Display Mode... 45 8.2 Traces ... 47 8.2.1 Changing Time Scale ... 48 8.2.2 Searching for a Patient’s Record ... 48 8.2.3 File Management (Optional) ... 49 8.2.4 Reviewing……………………………………………………………………………………52 8.3 Number Values... 51 8.4 Alarm Messages ... 52 Chapter 9 After Monitoring ... 54 9.1 Saving Data ... 54 - III -

9.2 Completing the Monitoring ... 54 9.3 Switching Off ... 54 Chapter 10 Maintenance and Cleaning... 55 10.1 Maintenance ... 55 10.1.1 Maintaining Inspection... 55 10.1.2 Maintenance of Monitor ... 55 10.1.3 Maintenance of Transducers ... 56 10.1.4 Storage of Recorder Paper ... 56 10.1.5 Maintenance of Recorder ... 56 10.2 Cleaning ... 57 10.2.1 Cleaning of the Monitor ... 57 10.2.2 Cleaning of Accessories ... 58 10.3 Disinfecting ... 59 10.4 Sterilizing ... 59 Chapter 11 Warranty and Service Policy ... 60 Appendix 1 Product Specifications ... 61 A1.1 Environmental Specifications ... 61 A1.2 Physical Specifications ... 61 A1.3 Performance Specifications ... 62 A1.4 Recorder Specifications... 63 A1.5 Rechargeable Lithium-ion Battery Specifications ... 64 A1.6 Low Output Summary Table ... 65 Appendix 2 Signal Input/Output Connector ... 66 Appendix 3 Troubleshooting ... 67 A3.1 No Display... 67 A3.2 Noise... 67 A3.3 Recorder Error ... 67 A3.4 Trouble with Ultrasound FHR Monitoring ... 68 A3.5 Troubles with Contractions Monitoring (External) ... 68 A3.6 Blown Fuses ... 69 A3.7 Paper Jam ... 70 Appendix 4 Abbreviation ... 72 Appendix 5 Ordering Information ... 73 Appendix 6 EMC Information – Guidance and Manufacturer’s Declaration ... 74 A6.1 Electromagnetic Emissions – for all EQUIPMENT and SYSTEMS ... 74 A6.2 Electromagnetic Immunity – for all EQUIPMENT and SYSTEMS ... 75 A6.3 Electromagnetic Immunity – for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING ... 77 A6.4 Recommended Separation Distance ... 79 Appendix 7 Limitations of Ultrasonic Monitoring... 80 A7.1 How Does Ultrasound Work ... 80 A7.2 Artifacts in Fetal Heart Monitoring ... 80 A7.3 Audio Output and Screen Reading ... 82 - IV -

Chapter 1: Safety Guide

Chapter 1 Safety Guide NOTE: For Operator and Patient safety, please read through this instruction manual before using the Wallach Fetal2EMR Fetal Monitor.

1.1 Intended Use The Wallach Fetal2EMR (Model F3) Fetal Monitor (hereinafter called Fetal2EMR) is intended for non-invasive monitoring of a single or twin fetuses during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. The Fetal2EMR provides fetal monitoring. It can externally monitor the Fetal Heart Rates (FHRs) using ultrasound and uterine activity via a TOCO transducer. Contraindications: The Fetal2EMR Monitor is not intended for use in intensive care units, operating rooms or for home use.

1.2 Instruction for Safe Operation  The Fetal2EMR Monitor is designed to comply with the international safety requirements IEC/EN 60601-1 for medical electrical equipment. It is class I equipment.  The Fetal2EMR Monitor operates within specifications at ambient temperatures between +5ºC (+41ºF) and +40ºC (+104ºF). Ambient temperatures that exceed these limits could affect the accuracy of the instrument and cause damage to the modules and circuits. Allow at least 5 cm (2 inches) 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 use. If damage is evident, replacement is recommended.  The Fetal2EMR Monitor must be serviced only by authorized and qualified personnel. Wallach Surgical Devices 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.  Perform periodic safety testing to ensure proper patient safety. This should include leakage current measurement and insulation testing. The recommended testing interval is once per year.  The protective categories against electric shock of the patient connections are: -1-

Chapter 1: Safety Guide

1) Ultrasound (FHR1, FHR2)

2) External TOCO

3) Intrauterine Pressure (IUP)

4) Fetal Movement Mark (FM)

This symbol indicates that the electric shock defend grade of this applied part is Type BF.

DECG (Direct Electrocardiography) (Not available in this model) This symbol indicates that the protection against electric shock of this applied part is Type CF.  The monitor described in this User Manual is not protected against: a) The effects of defibrillator shocks b) The effects of defibrillator discharge c) The effects of high frequency currents d) The interference of electrosurgery equipment

1.3 Ultrasound Safety Guide Fetal Use The monitor is designed for continuous fetal heart rate monitoring during pregnancy and labor. Clinical interpretation of fetal heart rate traces may be helpful in the diagnoses of fetal and/or maternal problems and complications. Instructions for Use in Minimizing Patient Exposure The acoustic output of the Fetal2EMR Monitor is internally controlled and cannot be varied by the operator in the course of the examination. The duration of exposure is, however, fully under the control of the operator. Mastery of the examination techniques described in the User Manual will facilitate obtaining the maximum amount of diagnostic information with the minimum amount of exposure. Exercising clinical judgment in monitoring low risk patients will avoid unnecessary insonation.

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

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Chapter 1: Safety Guide

WARNING Usage Safety Precautions: 1

The monitor is provided for the use of qualified physicians or personnel professionally trained. They should be familiar with the contents of this user manual before operation.

2

Only qualified service technicians can install this equipment. Only service technicians authorized by Wallach Surgical Devices can open the case.

3

This device is not intended for use in intensive care units, operating rooms or for home use.

4

EXPLOSION HAZARD - Do not use this device in the presence of flammable anesthetic mixture with air, with oxygen or with nitrous oxide.

5

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.

6

Do not apply this monitor and other ultrasonic equipment simultaneously on a same patient, due to the potential of leakage current superposition.

7

Do not apply this monitor simultaneously with other PATIENT-connected equipment, such as, a cardiac pacemaker or other electrical stimulators.

8

Do not use the monitor with RF surgical equipment.

9

Do not switch on device power until all cables have been properly connected and verified.

10 Do not touch the signal input or output connector and the patient simultaneously. 11 Equipment and devices that connect to the Monitor should form an equipotential body to ensure effective grounding. 12 Disconnect power cord before changing fuses. Replace the fuses with those of the same specifications only. 13 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. 14 SHOCK HAZARD - Do not remove the top panel cover during operation or while power is connected. Only authorized service personnel could remove the unit cover. 15 The monitor is not protected against defibrillation. Do not apply it during electrosurgery or MRI; as it might result in harm to the patient or the operator. 16 Only connect accessories supplied or recommended by Wallach Surgical Devices to the device. 17 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). All configurations shall comply with the valid version of the system standard IEC/EN 60601-1-1. Anyone who connects additional equipment to the signal input connector or signal output connector configures a medical system and therefore is responsible that the system complies with the requirements of the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult our -3-

Chapter 1: Safety Guide

technical service department or your local distributor. Proper Monitoring Safety Precautions: 1

Clinical decision making based on the output of the device is left to the discretion of the provider.

2

Alarms may be set up based on different situations. Audio should be activated when monitor is in use.

Battery Safety Precautions: 1

Before using the rechargeable lithium-ion battery (hereinafter called battery), be sure to read the user manual and safety precautions thoroughly.

2

Do not connect the battery cable connector or battery socket with metal objects, which can result in short circuit.

3

Do not unplug the battery when monitoring.

4

Do not heat or throw the battery into a fire.

5

Do not use or leave battery close to fire or other places where the temperature may be above +60 ºC (+140 ºF).

6

Do not allow the battery to get wet.

7

Do not destroy the battery: Do not pierce battery with a sharp object such as a needle; do not hit with a hammer, step on or throw or drop to cause strong shock; Do not disassemble or modify the battery.

8

Use the battery only in this Monitor. Do not connect battery directly to an electrical outlet or cigarette lighter charger.

9

If the liquid leak from the battery gets into eyes, do not rub the eyes. Wash them well with clean water and see a doctor immediately.

10 Do not solder the leading wire and the battery terminal directly. 11 If the liquid leaks from the battery and spills onto your skin or clothes, wash well with fresh water immediately. 12 Keep battery away from flames. If leakage or foul odor is detected discontinue use. 13 Stop using the battery if abnormal heat, odor, discoloration, deformation or abnormal condition is detected during use, charge, or storage. Keep it away from the monitor. 14 Do not use a battery that is visually damaged. 15

Proper disposal is required. Follow your Local Regulations for disposal.

CAUTION 1

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

2

Only qualified personnel shall service the unit.

3

The device is designed for continuous operation. -4-

Chapter 1: Safety Guide

4

Keep the working environment clean. Avoid vibration. Keep it far from corrosive medicine, dust areas, high-temperature and humid environments.

5

When installing the unit into a cabinet, allow for adequate ventilation, accessibility for servicing, and room for adequate visualization and operation.

6

Do not operate the unit if it is damp or wet because of condensation or spills. Avoid using the equipment immediately after moving it from a cold environment to a warm, humid location.

7

Do not sterilize the monitor or any accessory with autoclave or gas.

8

Turn off the monitor and unplug it before cleaning. Cleaning consists of removing all dust from the exterior surface of the equipment with a soft brush or cloth. Use a brush to dislodge any dirt on or around the connectors and panel edges. Remove dirt with a soft cloth, slightly dampened with a mild detergent solution or 70% ethanol or isopropranol.

9

When washing the belts, the water temperature must not exceed +60 ºC (+140 ºF).

10 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. 11 Do not use mobile phones near monitoring. 12 While the battery is charged, used or stored, keep it away from objects or materials with static electric charges. 13 If the terminals of the battery become dirty, wipe with a dry cloth before using the battery. 14 The recommended charge temperature range is from 0 ºC (+32 ºF) to +40 ºC (+104 ºF). Do not exceed this range. 15 Batteries have life cycles. If the time that the monitor runs on the battery becomes shorter than usual, the battery life is at an end. Replace the battery with a new one the same as the one provided or recommended by Wallach Surgical Devices. 16 When not using battery for an extended period, remove it from the monitor and store it in a place with low humidity and low temperature. 17 Remove a battery whose life cycle has expired from the monitor immediately. 18 For information on installing and removing the battery from the monitor, thoroughly read the user manual. 19 The device and accessories are to be disposed of in accordance with all applicable Federal, State and local medical/hazardous waste practices at the end of their useful lives. Alternatively, they can be returned to the manufacturer for recycling or proper disposal.

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Chapter 1: Safety Guide

1.5 Definitions and Symbols Socket for ultrasound transducer 1 (Type BF applied part)

Socket for ultrasound transducer 2 (Type BF applied part)

Socket for DECG cable ( Type CF applied part)

Socket for TOCO transducer or IUP cable (Type BF applied part)

Socket for Remote Event Marker (Type BF applied part)

Reserved Type BF applied part Type CF applied part Charge Indicator AC (Alternating Current) Indicator Power Indicator ON/OFF switch for the device Start Alarm silence Auto-zero Event marker Print

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Chapter 1: Safety Guide

Channel selection Equipotential Grounding System Fuse Attention See Instructions for use Antenna USB (Universal Serial Bus) Connection Serial interface Network port The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning medical devices. The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life. Reorder Number Serial Number Date of Manufacture Manufacturer General symbol for recovery/recyclable

Rx Only (U.S.)

U.S. Federal Law restricts this device to sale by or on the order of a physician. With respect to electrical shock, fire and mechanical hazards only in accordance with UL 60601-1, CAN/CSA C22.2 No. 601.1, IEC 60601-2-37 and IEC 60601-2-49.

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Chapter 2: Monitor and Accessories

Chapter 2 Monitor and Accessories 2.1 Opening and Checking Package Visually examine the package prior to unpacking. If any signs of mishandling or damage are detected, contact the carrier and file a claim for damage. Open the package and take out the monitor and accessories carefully. Keep the package for possible future transportation or storage. Check the components according to the packing list.  Check for any mechanical damage.  Check all cables and accessories. Packing List Item

Quantity

Fetal Monitor

1

FHR Probe/Ultrasound Transducer

2

TOCO Transducer

1

Event Marker

1

Belt

Pack of 3

Ultrasound Gel

1

Recording Paper

Pack of 3

T1.6A Fuse

2

Power Cord

1

Screw Driver

1

User Manual

1

Quick Start Guide

1

Qualification Certificate

1

If there is any problem, contact the manufacturer or your local distributor immediately.

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Chapter 2: Monitor and Accessories

2.2 Overview 1 1 Alarm Indicator 2

2 LCD

3

3 Keys 4 Control Knob

4

5 Paper Drawer

7

6 Accessory Ports

8

7 Indicators 8 Paper Drawer Latch 5

6 Figure 2-1 Front View

9 Accessory Holder

Figure 2-2 Left Panel

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Chapter 2: Monitor and Accessories

10 DECG Socket 11 TOCO/IUP Socket 12 FHR1 Socket 13 FHR2 Socket 14 MARK Socket 15 EXT.1 Socket

10 11

12 13 14 15

Figure 2-3 Front Panel

16 Power Socket 17 Equipotential Grounding Terminal 18 DB9 Socket 19 RJ45Socket 20 USB Socket

16 17

18

19 20

Figure 2-4 Rear Panel

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Chapter 2: Monitor and Accessories

21 Handle

22 Battery Compartment

Figure 2-5 Bottom Panel

2.2.1 Keys and Control Knob

Figure 2-6 Keys and Control Knob

The Fetal2EMR monitor is a user-friendly device with operation controlled by a few keys on the front panel and the control knob. Their functions are as follows:

(1) POWER switch Function: Switch on or off the monitor. (2) START key Function: Start monitoring or return to the main interface Press this key to start monitoring (the monitor automatically stops printing data of the last monitoring, checks transducer connection, clears the MFM count and the monitoring timer, zeroes the pressure). When inputting maternal information, or when changing the monitor settings, press this key to return to the main interface. - 11 -

Chapter 2: Monitor and Accessories

(3) SILENCE key Function: Switch on/off the alarm sound Press this key to switch on/off the alarm sound. (4) AUTO ZERO key Function: TOCO zero Adjust the external TOCO contractions trace/value to preset unit (external monitoring contractions) or the IUP trace/value to reference point 0 (internal monitoring contractions). (5) MARK key Function: Make record of an event. Press this key to make an event mark. (6) PRINT key Function: Start / stop printing Press this key to toggle between starting and stopping printing. (7) CHANNEL key Function: Switch the channels Press this key and the fetal heart sound toggles between US1 channel and US2 channel. (8) CONTROL KNOB Function: Adjust volume, setup and review control. The control knob can be pressed like other keys and be rotated clockwise or counterclockwise. All the operations on the screen or in the menu are completed by using the control knob. The highlighted rectangular mark on the screen that moves with the rotation of the control knob is called the “cursor”. Operations can be performed in the position on the screen indicated by cursor placement. When the cursor is located on a particular function, press the control knob to open the submenu or confirm the operation. Press the control knob again, and the cursor will be able to move around on the interface/menus. Operation Procedure: 1) Rotate the control knob to select an item with the cursor. 2) Press the control knob and one of the following will happen: - 12 -

Chapter 2: Monitor and Accessories

a) A menu pops up on the screen, or the menu is replaced by another one. b) A submenu with several options appears. If this item has more than 6 options, they will be displayed on more than one page. Select Prev to switch to the previous page, or select Next to switch to the next page. c) The function operates immediately. NOTE: 1 The word “select” hereinafter stands for rotating the control knob cursor to an item and then pressing the knob. 2 If the key sound is enabled, the monitor gives a normal key sound when the operation is valid, and gives a sharp “Di” sound when the operation is invalid.

CAUTION This monitor is a medical device. Please avoid violent operation such as continuously pressing the keys or control knob.

2.2.2 Indicators There are four groups of indicator lights on top of the screen and the front panel. From the top down they are: alarm indicator, CHARGE indicator, AC indicator and Power indicator. Table 2-1 lists their meanings: Indicator

Status of Indicator

Alarm Indicator

Flash or light in orange

An alarm is active.

Off

No alarm is active.

On

The battery is being charged.

Off

No battery is loaded or the battery is fully charged.

On

The monitor is connected to AC power supply.

Off

The monitor is not connected to AC power supply.

On

The monitor is powered on.

Off

The monitor is powered off.

Charge Indicator

AC Indicator

Power Indicator

Meaning

Table 2-1 Indicator description

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Chapter 2: Monitor and Accessories

2.3 Accessories 2.3.1 Ultrasound (US) Transducer 1 US Transducer (Pink Labeled)

2 1

2 Transducer Cable 3

3 Transducer Connector

Figure 2-7 US Transducer

2.3.2 TOCO Transducer

1 TOCOS Transducer (Blue Labeled)

2 1

2 Transducer Cable 3

Figure 2-8 TOCO Transducer

2.3.3 Belt

Figure 2-9 Belt

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3 Transducer Connector

Chapter 2: Monitor and Accessories

2.3.4 Remote Event Marker

1 Marker Plug 2 Press Key

2 1

Figure 2-10 Remote Event Marker

2.4 Screen 2.4.1 Main Interface 1

2

3

4 5 6

7

17 16

15

14

13 12

11

10

9

Figure 2-11 Main Interface

Item Screen element 1 2

Description

Alarm messages displaying area Alarm reviewing key

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