MD2-SD2 Instructions for Use March 2021

Table of Contents Doppler Measurement Sites and Recommended Probes ...3 1. Safety ...4 1.1 1.2

Warnings... 4 Patient Applied Parts ... 5

2. Introduction ...6 2.1 2.2 2.3 2.4

Unpacking / Preliminary Checks ... 6 Battery Insertion / Replacement ... 6 Product Controls... 7 Product Labelling... 7

3. Operation ...9 3.1 3.2 3.3

Vascular Mode ... 9 Obstetric Mode ... 11 After Use ... 12

4. Care and Cleaning ...13 4.1 4.2 4.3 4.4

General Care... 13 General Cleaning and Disinfecting ... 14 Cleaning and Disinfecting Patient Applied Parts ... 14 Maintenance and Repair... 15

5. Specifications ...16 5.1 5.2 5.3 5.4 5.5 5.6

Equipment Classification ... 16 Standards Compliance ... 16 FHR Performance... 16 Waveform Outputs (MD2 Only) ... 17 General ... 17 Environmental ... 17

6. End of Life Disposal...18 7. Warranty & Service ...19

Dopplex, and Huntleigh are registered trademarks of Huntleigh Technology Ltd. 2004. © Huntleigh Healthcare Ltd. 2004-2014

Doppler Measurement Sites and Recommended Probes 1 Jugular Vein VP4HS, VP5HS

11 Subclavian Artery VP4HS, VP5HS

2 Subclavian Vein VP4HS, VP5HS

12 Brachial Artery VP8HS, EZ8

10

13 Ulnar Artery VP8HS, EZ8

1

3 Fetus OP2HS, OP3HS 4 Femoral Vein VP4HS, VP5HS

9 11

2

14 Radial Artery VP8HS, EZ8

5 Great Saphenous Vein VP5HS, VP8HS, EZ8

12

15 Femoral Artery VP4HS, VP5HS

13 3 4

14 16

17 15

5 6 Small Saphenous Vein VP8HS, EZ8

18

7 Posterior Tibial Vein VP8HS, VP10HS, EZ8 8 Posterior Tibial Artery VP8HS, EZ8 9 Vertebral Artery VP4HS, VP5HS 10 Carotid Artery VP5HS, VP8HS, EZ8

16 Digital Artery VP8HS, VP10HS, EZ8 17 Penis VP10HS, EZ8

6

18 Popliteal Artery VP5HS

8 7

20 19

19 Metatarsal Artery VP8HS, VP10HS, EZ8 20 Dorsalis Pedis Artery VP8HS, VP10HS, EZ8

Safety

1.

Safety Before using this equipment, please study this manual carefully and familiarise yourself with the controls, display features and operation. Ensure that each user fully understands the safety and operation of the unit, as mis-use may cause harm to the user or patient, or damage to the product. We recommend that exposure to ultrasound should be kept As Low As Reasonably Achievable - (ALARA guidelines). This is considered to be good practice and should be observed at all times. Please keep these Instructions for Use to hand for future reference.

Attention, consult this manual. Refer to safety section. Attention, consult accompanying documents / Instructions for Use

1.1

Warnings Do not use in the presence of flammable gases such as anaesthetic agents. Do not use in the sterile field unless additional barrier precautions are taken. Do Not : • immerse in any liquid, • use solvent cleaner, • use high temperature sterilising processes (such as autoclaving), • use E-beam or gamma radiation sterilisation. Do not use on the eye. Do not dispose of batteries in fire as this can cause them to explode. Do not attempt to recharge normal dry-cell batteries. They may leak, cause a fire or even explode.

4

Safety

This product contains sensitive electronics, therefore, strong radio frequency fields could possibly interfere with it. This will be indicated by unusual sounds from the loudspeaker. We recommend that the source of interference is identified and eliminated. Any equipment connected to RS232 interface must be compliant with IEC60601-1:2005. Connect headphones only to the headphone socket. Dopplex Dopplers are screening tools to aid the healthcare professional and should not be used in place of normal vascular or fetal monitoring. If there is doubt as to vascularity or fetal well-being after using the unit, further investigations should be undertaken immediately using alternative techniques.

1.2

Patient Applied Parts As defined in IEC60601-1:2005, the patient applied parts of the Dopplex Dopplers are the ultrasound probes.

5

Introduction

2.

Introduction

2.1

Unpacking / Preliminary Checks Contents

IN RU FOR ST USE CTIONS

Delivery Inspection Huntleigh takes every precaution to ensure that goods reach you in perfect condition. However, accidental damage can occur in transit and storage. For this reason we recommend that a thorough visual inspection is made immediately the unit is received. Should any damage be evident or any parts missing, ensure that Huntleigh or your distributor is informed at once. Storage Should the unit not be required for immediate use, it should be re-sealed into its original packing after carrying out the initial delivery inspection, and stored under covered conditions at a temperature between -10°C to +40°C, and relative humidity of 10% to 93% non-condensing.

2.2

Battery Insertion / Replacement

1

2

Note: 6

3

Remove the battery if the unit is not likely to be used for some time.

Product Controls

1

3

2

MD2 SD2

1

●

2

4

6 5

●

Headphone Socket

●

Waveform Socket

●

RS232 Port

3

●

●

LCD Panel

4

●

●

Loud-speaker

5

●

●

On/Off Button

6

●

●

Probe Holder

7

●

●

Volume Control

8

●

Start/Stop Button

●

Cal Button

●

9

Introduction

2.3

Mode Button ●

Gain Button

10

●

●

Battery Compartment

11

●

●

Pocket Clip

11 10 7

9 2.4

8

Product Labelling Patient applied parts (ultrasound probes) are type BF according to the definitions in IEC 60601-1:2005.

7

Introduction

Attention, consult this manual. Attention, consult accompanying documents / Instructions for Use This symbol signifies that this product complies with the essential requirements of the Medical Device Directive (93/42/EEC) - Medical Device Regulation (EU/2017/745). Rx Only

Federal law restricts this device to sale by, or on the order of a licensed healthcare practitioner.

IP20

Protected against ingress of solid foreign objects >12.5mm diameter. Not protected against ingress of water.

Manufactured By:

Huntleigh Healthcare Ltd. 35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom T: +44 (0)29 20485885 [email protected] www.huntleigh-diagnostics.com

Legal Manufacturer in association with the CE mark in Europe ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, Sweden Power On/Off

Battery

Temperature Limitations

“MAX 93% RH”

Limits of Relative Humidity

SN

Serial Number

REF

Reference Number

MD

Medical Device

DI

Device Identifier

+40°C

-10°C

PVC

Fragile

Keep Dry

Headphone Socket

Volume

RS232 Interface

Alignment mark

Cardboard packaging can be recycled.

Do not use hook

PVC FREE Does not contain PVC

LATEX

LATEX FREE Does not contain Latex

Limits of Atmospheric Pressure

8

Note:

Product labelling should be read from a distance of no greater than 0.7m.

Operation Refer to diagram on page 3 for Doppler Measuring sites and Recommended Probes. To connect the probe, align the arrow on the connector with the slot on the probe and push firmly. To disconnect the probe, pull the connector sharply. DO NOT pull the cable. Note:

Operation

3.

During use, an automatic noise reduction feature operates on low level signals to improve sound quality.

Coupling Gel Use water based ultrasound gel ONLY.

3.1

Vascular Mode The Multi Dopplex II/Super Dopplex II Dopplers (MD2/SD2) will select vascular mode when a vascular probe is connected to the control unit. Vascular Probes Five probes are available for vascular examinations:

VP4HS

4MHz ±1% for deep lying vessels

VP5HS

5MHz ±1% for deep lying vessels and oedematous limbs

VP8HS

8MHz ±1% for peripheral vessels

VP10HS

10MHz ±1% for specialist superficial applications.

EZ8

8MHZ ±1% “Widebeam” for peripheral vessels.

In this mode, bi-directional blood flow rate and direction are indicated on bar graphs (4 levels in each direction) and blood flow is audible in the loudspeaker. Probe frequency is displayed together with the bar graphs.

Clinical Use Apply a liberal amount of gel on the site to be examined. Place the probe at 45° to the skin surface over the vessel to be examined. Adjust the position of the probe to obtain the loudest audio signal. High pitched pulsatile sounds are emitted from arteries while veins emit a non-pulsatile sound similar to a rushing wind. For best results, keep the probe as still as possible once the optimum position has been found. Adjust the audio volume as required.

9

Operation

Waveform Recording (MD2 only) Separated waveform outputs are provided in analogue and digital formats. Analogue signals are provided for connection to a single channel chart recorder giving a combined bi-directional waveform, or to a dual channel recorder for separate forward and reverse flow waveforms. (Pin-out details on request). Digital signals are provided via the RS232 port for printing separate waveforms on a Dopplex Printa II or for communicating with Dopplex Reporter software package.

Cal Function The baseline and sensitivity of the chart recorder can be set up using the Cal function. This generates a zero velocity baseline and a sequence of bidirectional pulses as shown below: Cal Pulses

Gain Control To cope with the wide variety of signals detectable using your MD2/SD2, a gain control allows you to optimise the bar-graph display and increase the height of the waveforms. Using the Mode button on the MD2 (Gain button for SD2), gain can be set to x1, x2, x4, x8.

Connection to Printa II (MD2 Only) Hard copy printing is automatically selected when the plug of the interface buffer box is inserted into the RS232 socket on the top panel of the MD2. Printing is then initiated by using the Start/Stop button.

Connection to Software (MD2 Only) The MD2 can be connected to the Reporter Software Package, via the RS232 interface. Dopplex Reporter software package is available as an accessory. Communicating is then initiated by using the Start/Stop button.

10

Obstetric Mode Obstetric mode is automatically selected when an obstetric probe (OP2HS/ OP3HS) is connected. Obstetric Probes Two probes are available for obstetric examinations:

OP2HS

2MHz ±1%

OP3HS

3MHz ±1%

Operation

3.2

In this mode, MD2 provides fetal heart rate (FHR) display with 3 operating modes, and outputs FHR for printing on the Printa II. The SD2 in obstetric mode provides audio only.

Clinical Use Apply a liberal amount of gel to the abdomen. Place the faceplate of the probe flat against the abdomen above the symphysis pubis. Adjust the probe to obtain an optimum audio signal ideally by angling the probe around. Avoid sliding it over the skin. In early pregnancy a full bladder may improve sound detection. In later pregnancy the best signals are generally located higher on the abdomen. The fetal heart sounds like a galloping horse at approximately twice the maternal rate. A wind-like sound is heard from the placenta.

Standard Mode - MD2 Only In this mode the FHR, averaged over 4-heart beats, is displayed on the 3-digit readout. The LCD displays an outline heart symbol.

Smoothed Mode - MD2 Only This mode is used to obtain more stable heart rate readings. In this mode, FHR is averaged over 8 beats. The LCD displays a solid heart symbol.

Manual Mode - MD2 Only This mode is used when a fetal heart beat is audible in the loudspeaker or headphones but, due to noise or a low signal level, the MD2 cannot reliably calculate the heart rate. In this mode, the heart rate can be manually counted over a period of 10 audible heart beats (see below). The MD2 will automatically calculate and display the derived FHR on the LCD. The LCD displays a clock symbol.

11

Operation

Mode Selection

Press the Mode button to select mode.

Use of Manual Mode 1.

Press and hold Start/Stop button and immediately count the audible heart beats, counting the first beat as the button is pressed. The LCD displays the flashing clock symbol and the FHR reading is shown as three dashes.

2.

Release the Start/Stop button immediately on the count of 10 (i.e. After nine beat intervals). The MD2 will automatically calculate the derived FHR averaged over the 10 beat period and display the result. This rate value is retained until the measurement is repeated or the unit is switched off. If the button is held for a period less than about 3 seconds the display will clear the previous rate value and reset.

Connection to Printa II (MD2 Only) Hard copy printing is automatically selected when the plug of the interface buffer box is inserted into the RS232 socket on the top panel of the MD2. Printing is then initiated by using the Start/Stop button.

3.3

12

After Use 1.

Press and release the On/Off button. If you forget to switch the unit off, it will automatically shut-off after 3 minutes.

2.

Refer to the cleaning section before storing or using the unit on another patient.

3.

Store unit together with probe and accessories in the soft carry case provided.

Care and Cleaning

4.1

General Care All Huntleigh products have been designed to withstand normal clinical use, however they can contain delicate components, for example the probe tip, which should be handled and treated with care. Periodically, and whenever the integrity of the system is in doubt, carry out a check of all functions as described in the relevant section of the IFU. If there are any defects to the housing contact Huntleigh or your distributor for repair or to order a replacement.

Care and Cleaning

4.

Please ensure that you check with your facility’s local infection control policy and medical equipment cleaning procedures. Observe warnings and guidance on cleaning fluid labelling regarding use and personal protective equipment (PPE). Do not use abrasive cloths or cleaners.

Do not use automatic washers or autoclaves. Phenolic detergent based disinfectants, solutions containing cationic surfactants, ammonia based compounds or perfumes and antiseptic solutions such as Steriscol or Hibiscrub should never be used. If detergent or disinfectant wipes are used ensure that excess solution is squeezed from the wipe prior to use. Do not allow any fluid to enter the products and do not immerse in any solution. Always wipe off disinfectant using a cloth dampened with clean water.

13

Care and Cleaning

4.2

General Cleaning and Disinfecting Always keep the external surfaces clean and free of dirt and fluids using a clean dry cloth. 1.

Wipe any fluids from the surface of the product using a clean dry

2.

Wipe with a cloth dampened in 70% Isopropyl Alcohol.

3.

Completely dry with a clean, dry lint free cloth.

4.

If the product has been contaminated use the methods described for

cloth.

patient applied parts.

4.3

Cleaning and Disinfecting Patient Applied Parts Clean the probes before examining a patient using low risk cleaning method below. Following patient examination, clean and/or disinfect the probes by the appropriate method based upon the level of cross contamination risk, as defined below: Risk

14

Definitions

Procedure

Low

Normal use or low risk situations include patients having intact skin and no known infection and the probes have not been contaminated with blood.

1. Remove soiling, wipe with a mild neutral detergent and then wipe with a cloth dampened in water. 2. Completely dry with a clean lint free cloth.

Medium

The patient has a known infection, skin is not intact, the part is heavily soiled.

1. Follow low risk procedure then wipe with a cloth dampened in Sodium Hypochlorite (1,000ppm). 2. After two minutes wipe with a cloth dampened in water and then dry with a clean lint free cloth.

High

This procedure should only be used when the part has been contaminated by blood.

1. Follow low risk procedure then wipe with a cloth dampened in Sodium Hypochlorite (10,000ppm). 2. After two minutes wipe with a cloth dampened in water and then dry with a clean lint free cloth.

The use of disinfectant materials other than those listed is the responsibility of the user for their efficacy and compatibility with the device.

4.4

Maintenance and Repair

Care and Cleaning

Warning: Sodium Hypochlorite @ 10,000 ppm for disinfecting should only be used in situations described in the High Risk definition. Unnecessary use of this concentrated solution for Low and Medium risk situations may result in damage to the product. Do not allow Sodium Hypochlorite solutions to come into contact with metal parts.

Inspection is recommended each time the product is used, paying particular attention to the tip of the probes, checking for cracks etc., and to the cable and connector. Any crackling or intermittent behaviour should be investigated. This product does not require periodic maintenance. Suitable test equipment and a full range of spare parts are also available. Please refer to service manual for further information and part numbers. A full technical description is provided in the Service Manual 726374.

15

Specifications

5.

Specifications

5.1

Equipment Classification Type of protection against electric shock.

Internally powered equipment

Degree of protection against electric shock

Type BF - equipment with an applied part.

Mode of operation.

Continuous

Degree of protection Main Unit: IP20 against harmful ingress Probes (Tip only): IPX1 of particles and/or water. Degree of safety of application in the presence of a flammable anaesthetic

5.2

Equipment not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR, OXYGEN OR NITROUS OXIDE

Standards Compliance IEC60601-1: 1988 + A1:1991 +A2:1995 UL60601-1 : 2006 CSA C22.2 No 601.1-M90 (R2005)

5.3

FHR Performance* Standard Mode

Range - 60-210bpm Averaging - 4 beats

Resolution - 1bpm Accuracy - ±3bpm

Smoothed Mode

Range - 60-210bpm Averaging - 8 beats

Resolution - 1bpm Accuracy - ±3bpm

Manual Mode

Range - 60-210bpm Averaging - 10 beats

Resolution - 1bpm Accuracy - ±3bpm *(excluding user error)

16

5.5

5.6

Waveform Outputs (MD2 Only) Analogue

Zero crosser, 3.5V full scale per channel (forward and reverse). Conversion factor automatically adjusted to give full scale outputs at ±0.1% (±10%) of probe frequency (e.g. ±8kHz for VP8)

Digital

Data formatted to interface with Printa II or Recorder software running on compatible computer. Conversion factors automatically set as per analogue outputs.

CAL Function

Automatic sequence of CAL levels set to ±0.05% (±10%) and ±0.1% (±10%) of probe frequency (e.g. ±4kHz & ±8kHz for VP8) with zero baseline at start and end of sequence.

Specifications

5.4

General Max. Audio Output (Loudspeaker)

500mW rms typical

Auto shut-off

3 minute no signal 10 minute unconditional

Headphones

Max. output Power: 25 mW rms (32Ω) Connector: 3.5mm stereo jack socket Max. applied voltage: +9Vdc

RS232 Interface (MD2 only)

Data format: RS232C Connector: 8pin subminiature DIN socket Max. applied voltage: +5Vdc

Battery Type

IEC 6LR61 or IEC 6LP3146

Battery Life

Typically, 250 x 1 minute examinations

Size

Height 140mm, Depth 27mm, Width 74mm

Weight

295g

Environmental Operating

Storage

+10°C to +30°C

Temperature range

-10°C to +40°C

10% to 90% (non condensing)

Relative Humidity

93% maximum

860mb to 1060mb

Pressure

860mb to 1060mb

17

End of life Disposal

6.

End of Life Disposal

This symbol signifies that this product, including its accessories and consumables is subject to the WEEE (Waste Electrical and Electronic Equipment) regulations and should be disposed of responsibly in accordance with local procedures.

18

Warranty & Service Huntleigh Healthcare Ltd. standard terms and conditions apply to all sales. A copy is available on request. These contain full details of warranty terms and do not limit the statutory rights of the consumer.

Service Returns If for any reason Dopplex unit has to be returned, please: •

Clean the product following the instructions in this manual.

•

Pack it in suitable packing.

•

Attach a decontamination certificate (or other statement declaring that the product has been cleaned) to the outside of the package.

•

Mark the package ‘Service Department - MD2 / SD2’

Warranty & Service

7.

For further details, refer to NHS document HSG(93)26 (UK only). Huntleigh Healthcare Ltd reserve the right to return product that does not contain a decontamination certificate. For service, maintenance and any questions regarding this, or any other Huntleigh Healthcare Dopplex product, please contact: Customer Care Department. Huntleigh Healthcare, Diagnostic Products Division, 35, Portmanmoor Rd., Cardiff. CF24 5HN United Kingdom. Tel: Tel: Fax: Email:

+44 (0)29 20496793 - Service (24hr answer machine) +44 (0)29 20485885 +44 (0)29 20492520 [email protected] [email protected] www.huntleigh-diagnostics.com

19

If a serious incident occurs in relation to this medical device, affecting the user, or the patient then the user or patient should report the serious incident to the medical device manufacturer or the distributor. In the European Union, the user should also report the serious incident to the Competent Authority in the member state where they are located. Manufactured in the UK by Huntleigh Healthcare Ltd on behalf of; ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, Sweden

Huntleigh Healthcare Ltd. 35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom T: +44 (0)29 20485885 [email protected] www.huntleigh-diagnostics.com

Registered No: 942245 England & Wales. Registered Office: ArjoHuntleigh House, Houghton Hall Business Park, Houghton Regis, Bedfordshire, LU5 5XF ©Huntleigh Healthcare Limited 2004-2014 A Member of the Arjo Family ® and ™ are trademarks of Huntleigh Technology Limited As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice.

AW:: 1001048-2

726331EN-13 (ENGLISH)

03/2021