Moyo Fetal Heart Rate Monitor User Guide Rev E

Contents 1 Overview 2 Cautions & Warnings 3 Get Started 4 Alarms 5 Cleaning & Charging 6 Features in Detail 7 Troubleshooting 8 Technical Description

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Overview Items included: 1 Moyo main unit with ultrasound sensor, 1 neck strap, 3 reusable abdominal transducer belts, 1 charger, 1 charger cable and this User Guide.

Speaker Status Light

Display Maternal heart rate pads (electrodes) * Power on/off button Speaker on/off button History graph button

Ultrasound transducer (sensor) *

Cable

* Patient applied part (intended for patient contact)

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Cautions & Warnings Please ensure that following precautions are taken to ensure that Moyo functions properly during use.

This product is intended for use by authorized healthcare professionals only. Read this User Guide and become familiar with the operation of the device prior to use. The device is intended for monitoring only one fetus at a time. In case of monitoring of multiple fetuses, alternative devices/methods should be used. In case the device displays erratic or unreliable FHR, try to reposition the ultrasound transducer or use alternative monitoring devices/methods. Excessive handling and movement of the product may cause lost or erroneous heart rate readings. Do not connect the charger to Moyo while in use with a patient. The device shall be turned off and cleaned/disinfected between patient uses. Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative or the technical service department. Do not modify this equipment without authorization of the manufacturer. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe operation. Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical equipment.You must operate your monitoring equipment according to the EMC information provided: • Measurements can be affected by ESD, portable and mobile RF communications equipment. • Use of high frequency electrosurgical equipment in the vicinity of this equipment may produce interference and cause incorrect measurements. Do not immerse this product in liquid. Use of Moyo does not replace clinical supervision. 5

3 Get Started To start operating Moyo, you need to learn the basic functions first.

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Get Started To get started, this manual will take you through a few simple scenarios where you will learn the main functions of Moyo.

What you need: MOYO

Ultrasound gel

Abdominal transducer belt

Only water-based ultrasound gel should be used. If ultrasound gel is not available, water can be used for short time monitoring. You should charge Moyo's battery regularly to ensure that it is always ready for use. To learn more about how to charge Moyo, refer to page 28.

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Get Started

Use sequence

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To start using Moyo, press and hold the power button

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PRACTICE

OBSERVE

Turn on Moyo.

Do you see 97 the display turning on? Do you hear the startup sound? If you encountered a problem, go to

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Troubleshooting on page 43. 9

97

Use sequence

Get Started

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?

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means that no heart rate (HR) is found by the sensor.

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SIMULATION NOTE

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You can tap on the sensor to manually simulate a HR when there is no dedicated FHR simulator available.

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Get Started

To measure fetal heart rate (FHR), you first need to apply gel on the ultrasound sensor and place it on the mother’s abdomen (if possible over the fetal back). If no HR sound is heard, reposition the ultrasound sensor until you hear the rhythmic HR sound.

Palpate to identify fetal position. Best results will be achieved with the ultrasound sensor placed over the fetus’s back.

PRACTICE Apply gel on the ultrasound sensor. Place the ultrasound sensor on the mother’s abdomen. (Reposition the ultrasound sensor if you do not hear a rhythmic HR sound) 11

Get Started

Moyo shows a HR number. Green color means that HR is in the normal range for a fetus. You can hear rhythmic HR sound from the speaker. Notice when FHR is shown, the status light blinks at the same rate as the FHR together with the rhythmic HR sound.

OBSERVE Do you hear the rhythmic HR sound? Do you read the numbers on the display?

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Get Started

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If you are not sure that the found heart rate is the fetal, you can instruct the mother to hold the pads to measure mother’s HR. If the two numbers are similar, then the HR found by the ultrasound sensor might be the maternal HR.

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The ultrasound sensor might measure or be affected by mother's HR, a twin (multiples) or excessive patient movement/handling. In case the device displays unreliable or erratic FHR, try to reposition the ultrasound transducer or use alternative monitoring devices/ methods. Refer to page 32 for details about the maternal HR display.

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PRACTICE 97 135

Instruct the mother to hold the pads. Compare the HR found by the ultrasound sensor with the maternal HR.

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Get Started

When you are sure that you have found the FHR, keep the ultrasound sensor in place using the abdominal transducer belt.

PRACTICE Keep the sensor in place using the abdominal transducer belt.

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4 Alarms Moyo provides alarms if the FHR is lost or if prolonged abnormal FHR is detected. In this chapter, you will learn about the alarms.

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Alarms

Use sequence Ox2O

Lost FHR alarm

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Moyo will give an alarm if the ultrasound sensor 97has not picked up any HR for 60 seconds. On the display, you will see the blinking.

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If you hear the alarm, press the speaker button ? alarm.

PRACTICE Remove the ultrasound sensor from the mother, or stop simulating FHR, and wait more than 60 seconds.

to silence (acknowledge) the

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OBSERVE

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Did you hear the alarm sound? Did you silence the alarm?

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Alarms

When

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is shown, reposition the ultrasound sensor to find a HR.

If HR is not found after repositioning the sensor, continue with standard procedures according to your medical facility, e.g. using alternative devices to obtain FHR. If you are not sure that the detected heart rate is the fetal, you can instruct the mother to hold the pads to obtain the mother’s HR.

PRACTICE Search and find the FHR.

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Alarms Abnormal FHR alarm Moyo is designed to monitor FHR, and provide visual and auditory alarm when abnormal FHR is present over a prolonged period. Moyo shows the number and status light in 3 different colors as shown below:

More than 160 bpm

Abnormally high FHR (yellow and red)

Between 110 - 160 bpm

Normal FHR (green)

Less than 110 bpm

Abnormally low FHR (yellow and red)

Yellow color turns red when abnormal FHR is present for a period of time.

To learn more about abnormal FHR alarm rules, refer to page 36.

PRACTICE Simulate / tap on the sensor for 3 minutes at the rate of e.g. 80 bpm (beats per minute) to trigger an abnormal FHR alarm. After you have triggered the alarm, continue to the next page. 18

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Alarms

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? 97 135 Moyo will give an alarm when the FHR has been abnormal for a prolonged time. You can 134sound. 134 134 see the number in red color, and hear the alarm If you hear the alarm, press the speaker button alarm.

to silence (acknowledge) the

OBSERVE Did you hear the alarm sound? Did you silence the alarm? Continue standard procedures - respond in a timely and appropriate manner. 19

5 Reprocessing In this chapter, you will learn how to clean, disinfect and inspect Moyo, and how to charge its battery so that it is ready for the next use.

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Reprocessing Moyo and its accessories must be cleaned and disinfected between patient uses to minimize the risk of cross-contamination. Moyo must also be inspected for damage between patient uses. Turn off Moyo before starting the cleaning process.

Main unit, cable and sensor Cleaning

Thoroughly clean all surfaces using a cloth dampened with soapy water. A toothbrush dipped in soapy water can be used to remove difficult soil from the sensor. The main unit must not be scrubbed with a brush to avoid getting water into the device.

Wipe Moyo with a clean cloth dampened with clean water, then leave to dry.

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Reprocessing

Inspect Moyo to confirm that it is clean and dry. Repeat cleaning process until all visual soil has been removed.

Disinfecting Effective disinfection is not possible without first performing a thorough cleaning. Care should be taken while handling the product between cleaning and disinfection.

Spray 70% ethanol on the surface of Moyo, or wet Moyo with a clean cloth dampened with 70% ethanol. 23