sonicaidone User Guide

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UK: Huntleigh Healthcare, Diagnostic Products Division, 35 Portmanmoor Road, Cardiff CF24 5HN, UK Tel: +44 (0)2920 485885 Fax: 44 (0)2920 456433 Email: [email protected] www.huntleigh-diagnostics.com

SonicaidOne User Guide

SonicaidOne User Guide

Contents Classification and explanation of symbols ... 5 Intended use... 5 Copyright ... 6 The SonicaidOne explained ... 7 Description ... 9 Examination ... 9 Using a headset (optional) ... 11 Using the SonicaidOne for water births ... 11 Battery fitting or replacement ... 11 Servicing ... 12 Preventive maintenance ... 13 Accessories and consumables ... 13 Warranty ... 14 Environmental conditions ... 14 Disposal of equipment ... 15 Electrical interference suppression ... 15 Specifications ... 16 Ultrasound safety considerations and data ... 17

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SonicaidOne User Guide

The SonicaidOne has been designed and manufactured by Huntleigh Healthcare, an international company with an enviable reputation for innovation and quality of its products. The SonicaidOne is CE marked in accordance with the European Council Directive 93/42/EEC concerning medical devices.

Huntleigh Healthcare has been certified by Lloyd’s Register Quality Assurance (LRQA) as an approved medical devices manufacturer as meeting the requirements of BS EN ISO 9001, BS EN 46001 and the Medical Devices Directive (93/42/EEC). The SonicaidOne has been independently tested and successfully approved to the following medical safety standards: EN 60601-1/ IEC 60601-1

Medical Electrical Equipment Part 1: General Requirements for Safety

EN 60601-1-2/ IEC 60601-1-2

Standard for electromagnetic compatibility requirements for medical electrical equipment

UL 2601-1

American standard for safety for medical electrical equipment

CAN/CSA-C22.2 No. 601.1

Canadian standard for safety for medical electrical equipment

JIS T 0601-1

Japanese standard for safety for medical electrical equipment

EN61157/IEC 1157

Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment

Caution: in the USA federal law restricts this device to sale by, or on the order of, a physician

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Classification and explanation of symbols Type of protection against electric shock

Internally powered equipment.

Degree of protection against electric shock

Type B applied part.

Method of sterilization or disinfection

Main unit and probe: not suitable for sterilization; disinfect with 70% ethanol or isopropyl alcohol.

Suitability for use in the presence of flammable anesthetics

Not suitable.

Mode of operation

Continuous.

This symbol indicates a Type B applied part

This symbol indicates: refer to accompanying documents Definition: this symbol indicates that this product comes under the provisions of EU Directive 2002/96/EC on waste electrical and electronic equipment (WEEE) and that this unit was placed on the market after 12 August 2005. This directive covers EOL (end-of-life) disposal. Rules for the User: within the EU, at end-of-life, this product may be disposed of only through a government approved collection scheme or treatment facility. If in doubt contact your local Sonicaid representative.

Intended use The SonicaidOne is a portable battery-operated detector designed for the early detection of fetal life and confirmation of continued life during pregnancy and labour. Limitations on use The SonicaidOne is for use only by qualified medical personnel, and for use only on intact skin.

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SonicaidOne User Guide

Copyright All rights reserved. This guide contains proprietary information which is protected by copyright and may not be copied in whole or in part except with the prior written permission of Huntleigh Healthcare. The copyright and the foregoing restrictions on the copyright use extend to all media in which this information may be preserved. This copy of the SonicaidOne User Guide shall be used only in accordance with the conditions of sale of Huntleigh Healthcare or its distributors. Huntleigh Healthcare makes no representations or warranties of any kind whatsoever with respect to this document. Huntleigh Healthcare disclaims all liabilities for loss or damage arising out of the possession, sale or use of this document. Sonicaid® is a registered trademark of Huntleigh Healthcare in the UK and other countries.

Huntleigh Healthcare Diagnostic Products Division 35 Portmanmoor Road Cardiff CF24 5HN, UK Tel: +44 (0)2920 485885 Fax: 44 (0)2920 456433 Email: [email protected] www.huntleigh-diagnostics.com

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The SonicaidOne explained

Key 1 On/off button 2 Display 3 Controls 4 Loudspeaker 5 Probe cable 6 Probe

The display 1 Fetal heart rate 2 Heartbeat/confidence indicator 3 Battery low indicator Controls 1 Manual count button 2 Volume down 3 Volume up When you press a button, there is an audible beep.

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SonicaidOne User Guide

Key: 1 Probe holder 2 Battery compartment cover 3 Battery compartment release catch

1 Headset socket

1 Probe holder

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Description The SonicaidOne operates at a nominal frequency of 2MHz, using Doppler ultrasound to detect the fetal heart. The fetal heart may be detected from early pregnancy, but more easily in pregnancies later than 15 weeks gestation. It is light, fits comfortably into a pocket, and is suitable for use in the antenatal or labour period. A headset is an optional extra. The SonicaidOne has a waterproof probe and cable. The main unit is not waterproof. The SonicaidOne is suitable for labour use, and for use in the clinical management of water births, provided the main unit is kept dry.

Examination Caution: 1 Use the SonicaidOne only on intact skin. 2 Take care at all times not to drop the unit. 3 Always inspect the unit for damage prior to use. Notes: Always use ultrasound gel between the transducer face and the mother’s abdomen. To ensure that the signal detected is fetal in origin, always take the maternal pulse prior to attempting fetal heart detection. During very early pregnancy, it is often difficult to obtain the fetal heartbeat. If you do have difficulty finding a signal, please try not to alarm the patient. Reassure her that this is quite normal. 1 Apply a small amount of ultrasound gel to the probe face. 2 Switch on by holding down the green button for 2 or 3 seconds. 3 In early pregnancy: place the probe face on the medial line just above the symphysis pubis with moderate pressure; tilt slowly in various directions until the heart beats are heard. If no beats are detected, move the transducer a few centimetres higher and repeat the procedure. Note that the patient should be advised, if possible, to have a full bladder as this would facilitate the transmission of ultrasound.

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SonicaidOne User Guide

In later pregnancy: Once fetal position has been determined by abdominal palpation, start by placing the probe face between the shoulder blades of the fetus, then move or angle the probe until the clearest heart sounds are obtained (under normal circumstances, this will sound like galloping horses). With each beat the heart symbol flashes on the display. At first only the outer part of the symbol is illuminated but as more beats are clearly detected the inner part is also shown. This acts as a signal confidence indicator for a valid rate. After a few seconds the heart rate is displayed, averaged over three to five beats, and accurate to ±2bpm. If you are in any doubt as to the accuracy of the rate, use the manual count facility (see below), or use continuous fetal monitoring equipment. When you have completed the examination, switch the unit off by pressing the green button. Wait at least five seconds before switching on again. Wipe the probe clean before stowing.

Automatic switch-off The SonicaidOne automatically switches itself off after 2 minutes if no signal is detected, and after 5 minutes if a rate has been displayed. Volume control When the SonicaidOne is switched on, the volume is the same as the last time the instrument was used. To increase the volume, press or hold down the volume up button. To decrease the volume, press or hold down the volume down button. Manual count In difficult circumstances a rate may be audible, yet the signal not strong enough for a rate to be displayed. In this situation you can use the manual count feature. The manual count requires ten pulse intervals, so press the button on the first beat and release it on the eleventh. 1 2 3 4

Find an audible fetal heartbeat. Press and hold the manual count button. ‘T’ is shown on the display. Count 10 consecutive beats. On the count of the 11th beat, release the manual count button. The heart rate is displayed.

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The manually-timed rate is shown for about 12 seconds, without a heart symbol and with the ultrasound switched off. The SonicaidOne then switches itself off. To restart the SonicaidOne during the manual count period, release the manual count button, then hold it down again. If ‘E’ is shown on the display, this indicates operator error. Release the manual count button, and try again.

Using a headset (optional) For private listening, or in a noisy environment, use a headset with the SonicaidOne. Insert the headset jack securely into the headset socket. When the headset is connected, the speaker is muted.

Using the SonicaidOne for water births The SonicaidOne probe will withstand submersion up to a depth of one metre. Submersion should be limited to the time necessary to carry out an examination. Ask the mother to raise herself if necessary so that her abdomen is out of the water for the short time it takes to obtain a satisfactory rate. After use, dry the probe thoroughly with a soft cloth. If it is soiled, follow the cleaning and disinfection procedure detailed in the preventive maintenance section.

Battery fitting or replacement Use only two size AA (LR6) alkaline batteries or two fully charged 1.2V nickelcadmium rechargeable size AA batteries. New alkaline batteries will give more than 1000 one-minute examinations. Rechargeable nickel-cadmium batteries will give approximately 250 one-minute examinations. When the battery low indicator is displayed, change the batteries at the earliest opportunity.

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SonicaidOne User Guide

To fit or replace the batteries: 1 Open the battery compartment cover. 2 Remove the old batteries. Dispose of them in accordance with local regulations.

Battery compartment empty

Battery polarity

3 Fit the new batteries. Make sure the polarity corresponds with the battery compartment diagram. 4 Close the battery compartment cover. Care of batteries z Recharge nickel-cadmium batteries away from the patient area. z Do not put dry-cell (alkaline) batteries in a charging device. z Remove batteries if the unit is not in regular use. z Do not dispose of any type of battery by burning.

Servicing The probe and its cable may be replaced by the user’s appropriately qualified technical personnel. A service guide (part number 046W002) is available for this purpose. All other servicing and repairs should be carried out by Huntleigh Healthcare.

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Return of goods To return a SonicaidOne for repair: 1 Clean the product, and return in suitable packaging. 2 Attach a Certificate of Decontamination or other written declaration that the product has been cleaned to the outside of the package. 3 Mark the package ‘Service Department, SonicaidOne’.

Preventive maintenance Checking for damage Once a month, check the SonicaidOne probe for damage or cracks which may allow the ingress of liquids or gel. Cleaning and disinfecting the probe After each use, clean the probe with a cloth which has been dampened in soap or detergent solution. Dry it with a clean cloth. Disinfect it using an alcoholimpregnated wipe (70% ethanol or isopropyl alcohol). Cleaning the main unit In normal use the main unit needs occasional cleaning, and will not need disinfection. Once a week, clean the case with a cloth which has been dampened in soap or detergent solution, then dry it with a clean cloth. If soiled, disinfect using an alcohol-impregnated wipe (70% ethanol or isopropyl alcohol). Note : the SonicaidOne is an electronic device and therefore must not be sterilized.

Accessories and consumables Accessories: 230V UK charger including rechargeable nickel-cadmium batteries 230V Euro charger including rechargeable nickel-cadmium batteries 110V US charger including rechargeable nickel-cadmium batteries Headset The only accessory which can be connected to the SonicaidOne is the optional headset. No other equipment should be connected.

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SonicaidOne User Guide

Consumables: Aquasonic Gel: 60g tube Aquasonic Gel: 0.25 litre dispenser AA alkaline batteries: box of 40 AA rechargeable nickel-cadmium batteries: pack of 4

Warranty The SonicaidOne main unit and probe are guaranteed for 1 year from the date of purchase against defects in materials or workmanship. Consumables are guaranteed for 90 days. Any unit or probe proven to be defective within the warranty period shall, at the option of Huntleigh Healthcare, be either repaired or replaced free of charge, providing that: 1 it has not been damaged by misuse, mishandling, incorrect techniques of cleaning or disinfection, or attempted repair; and 2 the whole unit is returned to Huntleigh Healthcare carriage-paid (see above, ‘Return of goods’, in the section on ‘Servicing’).

Environmental conditions Transport and storage While packed for transport or storage, the equipment can be exposed to the following environmental conditions . Remove batteries if the unit is not in regular use. Temperature Relative humidity Atmospheric pressure

–10°C to +60°C 10 to 85% RH non-condensing 500 to 1060 hPa

Operating conditions Temperature Relative humidity Atmospheric pressure

+10°C to +40°C 30 to 75% RH non-condensing 700 to 1060 hPa

Do not leave the SonicaidOne exposed to direct sunlight. When not in use, store the SonicaidOne in the pouch provided. Damage may result if the SonicaidOne is knocked or dropped.

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Disposal of equipment When the equipment comes to the end of its operating life, it should be disposed of in accordance with local waste disposal regulations. Advice on this can usually be obtained from the local waste regulation authority, which is typically found within the local government office.

Electrical interference suppression The following notes are intended as a guide to identifying and suppressing electrical interference that may affect apparatus. Possible sources of artefact: Microphony, audio feedback, fluorescent lights, electronic dimmers, diathermy, radio and TV, cell phones, computers, other electronic or electrical equipment Make sure the environment in which SonicaidOne is used is not subject to strong sources of electromagnetic interference (see the examples listed above). This equipment generates and uses radio frequency energy. It may cause or be subject to interference. It has been type-tested and found to comply with IEC 601-1-2/EN 60601-1-2, the standard for electromagnetic compatibility of medical electrical equipment. Whether the equipment causes interference may be determined by turning the equipment off and on. If it does cause or is affected by interference, one or more of the following measures may correct the interference: z Reorienting the equipment z Switching off the source of the interference (eg mobile phones) z Relocating the equipment further away from the source of interference z Moving the equipment away from the device with which it is interfering

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SonicaidOne User Guide

Specifications General Dimensions

Main unit: 128mm x 68mm x 38mm Probe: 71mm x 32mm Ø

Weight

230g

Functions

Audio output: 50mm speaker Headset output Fetal heart rate display Manual count Battery state indicator Volume control, 32 levels

Controls

On/Off switch Volume up Volume down Manual count

Main unit

Battery-powered

Probe and cable

Permanently attached to main unit Frequency: 2.0 MHz Watertight: for use in water births Replaceable (by user’s approriately qualified technical personnel)

Display Displayed items

Displayed FHR

Digital FHR Heart pulse indicator Confidence indicator Battery low indicator Range: Accuracy: Resolution: Averaging: First display:

50-210 bpm better than 2bpm in range 100-180 bpm 1 bpm 3–5 beats within 6 beats

SonicaidOne User Guide Ultrasound specification Transmitter

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Frequency: fixed frequency at 2.0 MHz

Receiver

Audio bandwidth at headset output: 350Hz to 1.0kHz –6db typical

Probe

Beam width: (-6dbs) between 20 and 40mm at depths of 4 to 16cm

Ultrasound safety considerations and data General Diagnostic ultrasound has been in use for over 35 years with no confirmed adverse effects on patients or operators at the intensities typical of present diagnostic instruments. However, available data are not wholly conclusive, and the possibility that biological effects may be identified in the future remains. It is therefore deemed desirable by medical and scientific authorities that exposure to ultrasound be limited to the duration and intensity appropriate for the clinical objective. Because fetal tissue could be more sensitive to biological effects by reason of rapid cell division, it is particularly desirable that ultrasound exposure of pregnant subjects be kept to a minimum. At present, there is a clear consensus that the benefits to patients of prudent use of diagnostic ultrasound outweigh the risks, if any, that may be present. See: a) Report No. 24, National Council on Radiation and Protection: Biological Effects Of Ultrasound, Clinical Effects And Observations. b) Ziskin M.C. in: World Policies on the Use of Diagnostic Ultrasound in Obstetrics: The American Institute of Ultrasound Policy and Statement on Safety. Ultrasound in Medicine and Biology 12: 711-714, 1986. Description of the ultrasound signal Operating mode Continuous wave Doppler Frequency 2MHz Intended use Fetal heartbeat detection Intended for fetal use Yes Control settings None

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SonicaidOne User Guide

Minimizing patient exposure The acoustic output of the SonicaidOne cannot be varied by the operator. The duration of exposure, however, is fully under his or her control. The examination technique we have recommended will allow you to get the maximum amount of diagnostic information with the minimum amount of exposure. Acoustic output data SonicaidOne is exempt from the declaration of acoustic output information in accordance with clause 4 of IEC 1157 (EN 61157). This is because the maximum probable levels of the following three parameters are below the limits specified in clause 6, namely: peak negative pressure output beam intensity spatial-peak temporal-average intensity

< 1MPa < 20mW/cm2 < 100mW/cm2

Power measurements were made by the National Physical Laboratory, Teddington, Middlesex, UK in accordance with NEMA UD-2 (1998)