DMX-SRX Instructions for Use S/W V3

EN

6. Care and Cleaning... 42 6.1 6.2 6.3 6.4

General Care... 42 General Cleaning and Disinfecting ... 43 Cleaning and Disinfecting Patient Applied Parts... 43 Maintenance and Repair... 45

7. Troubleshooting... 46 8. Specifications ... 47 8.1 8.2

Equipment Classification ... 47 DMX / SRX Ultrasound Transducers’ Global Maximum ... Values... 47 47 8.3 SRX FHR Performance*... 48 8.4 DMX Vascular Doppler Performance... 48 8.5 ABI and TBI Calculations... 48 8.6 APPG Systolic Pressure Performance... 49 8.7 General ... 49 8.8 Environmental... 50 8.9 Standards Compliance... 50 8.10 Accessories ... 51

9. Electromagnetic Compatibility... 52 9.1

Manufacturers Performance Criteria Specification... 55

10.End of Life Disposal... 56 11.Warranty & Service... 57 12.Additional Obstetric Features... 58

Sonicaid®, Dopplex® and Huntleigh are registered trademarks of Huntleigh Technology Ltd. 2015. Instructions For Use

3

EN

Measurement Sites and Recommended Probes 1 Jugular Vein VP4XS, VP5XS

9 Vertebral Artery VP4XS, VP5XS

2 Subclavian Vein VP4XS, VP5XS 3 Fetus OP2XS, OP3XS 4 Femoral Vein VP4XS, VP5XS

9

1

10 Carotid Artery VP5XS, VP8XS, EZ8XS

10

11 Subclavian Artery VP4XS, VP5XS

11

2

12 Brachial Artery VP8XS, EZ8XS

5 Great Saphenous Vein VP5XS, VP8XS, EZ8XS

13 Ulnar Artery VP8XS, EZ8XS

12 13

14

14 Radial Artery VP8XS, EZ8XS

3 4

21

15

17 16

6 Small Saphenous Vein VP8XS, EZ8XS 7 Posterior Tibial Vein VP8XS, VP10XS, EZ8XS 8 Posterior Tibial Artery VP8XS, EZ8XS

15 Digital Artery VP8XS, VP10XS, EZ8XS

5

18

16 Femoral Artery VP4XS, VP5XS

6

17 Penis VP10XS, EZ8XS 18 Popliteal Artery VP5XS

PPG Probe (PPGA1)

8

21 Digits 22 Toes

7 22

20 19

19 Metatarsal Artery VP8XS, VP10XS, EZ8XS 20 Dorsalis Pedis Artery VP8XS, VP10XS, EZ8XS

4 Instructions For Use

EN

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. This equipment is for use only by suitably qualified healthcare practitioners. This product may be used in the home healthcare environment by a qualified healthcare practitioner only, and is for indoor use only. Experience with use of ultrasonic Dopplers is preferable, but for novice users training material is provided with the accompanying documents. This product is not intended for use by the patient.

Please keep these Instructions for Use to hand for future reference.

Symbols General Warning Rx Only

1.1

Attention, consult accompanying documents / Instructions for Use

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

Warnings Do not use in the presence of flammable gases or oxygen rich environments.

Do not use in the sterile field unless additional barrier precautions are taken.

Do not immerse in any liquid. (Except waterproof probes fitted on models SR2 and SR3)

Do not sterilise the product or its accessories.* The product will be damaged, and there is a risk of patient and user harm.

5 Instructions For Use

EN The main unit enclosure does not provide protection from water ingress. For homecare use, the protective pouch (ACC-OBS-080) must be used. However, this will not protect the unit from immersion in liquids.

The main unit is not waterproof and must not be immersed. For underwater use where contamination or cross-infection may occur, additional barrier precautions must be taken.

This product contains sensitive electronics, therefore, strong radio frequency fields could possibly interfere with it, e.g. mobile phones. This will be indicated by unusual sounds from the loudspeaker. We recommend that the source of interference is identified and eliminated. (Refer to Section 9).

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.

Do not expose the Doppler to excess heat, including prolonged exposure to sunlight.

If this product is connected to another item of electrical equipment, it is important that the system is fully compliant with IEC 60601-1 :2005.

Connect headphones only to the headphone socket.

This equipment must not be modified.

Do not dispose of batteries in fire as this can cause them to explode. * Note Does not apply to IOP8 Intraoperative Probe. Refer to Intraoperative Probe IFU for details on cleaning/sterilisation processes.

1.2

Patient Applied Parts

As defined in IEC 60601-1:2005, the patient applied parts of the Digital Handheld Doppler are the ultrasound probes, PPG sensors and cuffs.

6 Instructions For Use

EN

2.

Introduction

This manual is your introduction to the Dopplex® and Sonicaid® Doppler products. The Doppler is a multi-function, battery powered, hand-held Doppler intended for both vascular and obstetrics use. It is compatible with Huntleigh’s full range of ‘XS’ interchangeable probes (depending on model). The DMX Vascular Doppler is indicated for the examination of blood flow in a range of vessel depths, from peripheral / superficial blood vessels down to deep vessels and vessels in oedematous limbs. It provides an indication of blood flow and direction by audible and visual means. By the addition of a Photo Plethysmography Probe, the Doppler can be used in determining the Ankle Brachial Pressure Index, (ABPI) or Toe Brachial Pressure Index, (TBI), for the detection of Peripheral Artery Disease, (PAD) in patients with intermittent claudication (walking pain) which is the first line assessment for suspected PAD. The SRX, SR2, SR3 Fetal Doppler are indicated for the detection of fetal life, at early gestation, from as early as 8 to 10 weeks and for fetal screening from early gestation through to delivery. It provides an audible fetal heart sound and a numeric/graphical display of fetal heart rate. You must read, fully understand and comply with the instructions given in this manual before using the Doppler. Use this manual to initially set up the Doppler, and keep it as a reference for day-to-day routines and as a guide to cleaning and maintenance. If you have any difficulties in setting-up or using the Doppler, contact your local Huntleigh sales representative. The model (REF) number of your Doppler is shown on the front and rear panel labels.

Note Screen shots and product images are shown for illustration purposes only. These may vary from the actual product

7 Instructions For Use

EN This manual applies to the following products: VASCULAR DOPPLER

MODEL

FUNCTIONALITY

DMX

Vascular - Full Visual and audio functionality if a suitable vascular probe* is attached. Obstetric - Full Visual and audio functionality if a suitable obstetric probe* is attached. (Not suitable for underwater monitoring). PPG - PPG functionality if a PPG probe* is attached.

OBSTETRIC DOPPLER

MODEL FUNCTIONALITY SRX

Obstetric - Full Visual and audio functionality if a suitable obstetric probe* is attached. (Not suitable for under water monitoring). Vascular - Audio functionality only if a suitable vascular probe* is attached. Screen will display date/time, probe frequency and battery status only. PPG - No functionality.

SR2

Obstetric - Full Visual and audio functionality. 2MHz hard wired waterproof probe suitable for underwater monitoring. No Vascular or PPG functionality as probe is hard wired and cannot be changed.

SR3

Same as for SR2 model but with 3MHz hard wired probe.

* Please see relevant sections for full details of functionality and probe /sensor options and accessories.

8 Instructions For Use

EN

2.1

Intended Use & Indications

The DMX & SRX range of handheld Dopplers are intended for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the assessment of vascular blood flow and/or fetal heart rate, to assist in diagnosis.

2.2

Contraindications The Doppler is not intended to be used on broken or fragile skin. Do not use on the eye or scrotum. The (Fetal) Doppler provides just one indicator of fetal condition. This should be assessed as part of an holistic approach to obstetric care together with other factors. A complete assessment must be made before taking appropriate action. If there is any doubt concerning the accuracy of any measurement, an alternative method should be used. The (Vascular) Doppler is a screening tool to aid the healthcare professional and should be used with clinical judgement before interventional procedures are undertaken. If there is doubt as to vascularity after using the unit, further investigations should be undertaken immediately using alternative techniques.

2.3

Battery Requirements

All models in the DMX and SRX range are compatible with the following battery types: •

Alkaline LR6 (non-rechargeable)

•

NiMH HR6 (rechargeable)

Refer to Section 4.3.1 to set the battery type on the Doppler. NiMH batteries can be charged by connecting the Doppler to the charger provided via the USB port (refer to Section 3.1). Do not attempt to recharge normal dry-cell batteries. They may leak, cause a fire or even explode. Do not mix non-rechargeable and rechargeable batteries.

9 Instructions For Use

EN

2.4

Unpacking / Preliminary Checks

Contents Item

Item

Item

1 x Digital Handheld Doppler

Instructions for Use

Batteries

Charger *

USB lead *

Ultrasound Gel

Quick Reference Guide

Carry bag

* Depending on model Delivery Inspection Huntleigh Healthcare Ltd 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 Healthcare Ltd is informed at once. Storage Refer to Section 5.8 and 8.8. Note Remove the batteries if the unit is not likely to be used for some time.

2.5

Service Life

This has been defined as the minimum time period during which the device is expected to remain safe and suitable to meet its intended use, and all risk control measures remain effective. Huntleigh Healthcare Ltd’s commitment is that the expected service life for this Device has been defined as 7 years.

10 Instructions For Use

EN

3.

Product Identification

3.1

Product Controls

1 2 3 6 5 4 7 8

1

Headphone Socket

2

USB Port

3

LCD Panel

4

Function Button 1 / On/Off Button

5

Function Button 2

6

Function Button 3 / Setup

7

Loudspeaker

8

Probe Holder

9

Trolley Mount

10

Volume Up

11

Volume Down

12

Pocket Clip

13

Battery Compartment + Micro SD Card Slot

14

Rear Panel Label

12 13 14 9 10 11 11 Instructions For Use

EN

3.2

Symbol Identification Patient applied parts (ultrasound probes) are type BF according to the definitions in IEC 60601-1:2005. 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. 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. Attention, consult accompanying documents / Instructions for Use

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 YYYY-MM

50°C

-25°C

ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, Sweden

General warning

Power On/Standby

Temperature Limitations

Limits of Relative Humidity

SN

Serial Number

REF

Model Number

MD

Medical Device

DI

Device Identifier

Fragile

Contents can be recycled

Headphone Socket

Cardboard packaging can be recycled.

USB Port

Alignment mark

Volume Up

Volume Down

12 Instructions For Use

EN

PVC

PVC FREE Does not contain PVC Limits of Atmospheric Pressure

3.3

Display

3.3.1

Setup Screen

Vascular Setup Screen

LATEX

LATEX FREE Does not contain Latex Keep Dry

Obstetric Setup Screen

Date and Time Setup

Brightness

Lock screen

Battery Selection

Heartrate Display Selection (Vascular)

FHR Averaging Mode (Obstetric)

DDNR Hiss suppression (Vascular)

Trace Options (Obstetric)

Audio Recording (Obstetric)

Timer (Obstetric)

Move Highlight

Select

Exit Setup

13 Instructions For Use

EN

3.3.2

Status Bar

The Status Bar is visible at the top of the display on most screens, (not available in Setup). The information displayed differs depending on the operating mode of the Doppler. - Status Bar (Vascular shown)

All Modes Battery Level Low USB Connected

27/01/2015 14.30

Date / Time USB Transmitting

USB Receiving Vascular Mode

5MHz

Forward Flow (Flow towards probe)

Reverse Flow (Flow away from probe)

Arterial Mode

Venous Mode

Probe Type

Obstetric Mode Standard Mode - FHR outside user set range

Standard Mode - FHR within user set range

Smooth Mode - FHR outside user set range

Smooth Mode - FHR within user set range

Manual Mode

Signal Strength

Note Other Display icons will be explained throughout the manual in their respective sections.

14 Instructions For Use

EN

4. Setup 4.1

Battery Insertion / Replacement & Micro SD Card Insertion Disconnect unit from any other equipment before removing the battery cover. If you are fitting a Micro SD Card into the Doppler, this must be done BEFORE inserting the batteries. Use Huntleigh recommended Micro SD cards only.

The Doppler is supplied with the batteries removed. Insert as shown below. Note. Refer to section 8.4 for the specifications of suitable batteries. Remove the battery cover :

1

Insert a suitable tool into recess to release the clip and gently lever off the battery cover.

Insert the Micro SD Card. (If fitting).

2

!

!

AA

AA

Ensure card clicks into place. (To remove the Micro SD card, press it in to release and pull gently to remove.)

Insert batteries in accordance with the diagram, positive terminal first, ensuring correct polarity. !

!

AA

AA

3

Replace the battery cover.

Note We recommend the Doppler is charged prior to first use. (Charge ONLY if Doppler is fitted with rechargeable batteries - See Section 5.6). Instructions For Use

15

EN

4.2

Probe Connection

Note Models SR2 and SR3 are fitted with hard wired probes which cannot be removed. 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. DO NOT pull the cable.

4.3

Setup Screen

Note A probe must be connected before the Setup screen can be accessed. Press

to turn the unit ON.

Press and hold Button 3 to access the Setup screen. (The screen shown is with a vascular probe attached). Use the 3 buttons below the screen to navigate and select each function. .

Press Button 1

to move the highlight to each option

Press Button 2

to accept your selection.

16 Instructions For Use

EN

4.3.1

Battery Selection

The Doppler can operate from either alkaline or rechargeable NiMH batteries, but it is important that the correct battery type is selected in the settings menu to correspond with the battery type fitted. In the Setup menu, press Press

to move the highlight to Battery Selection

.

to accept your selection. Press

to move highlight between selections. - Select for Alkaline batteries.

- Select for NiMH rechargeable batteries. Press

4.3.2

to confirm and return to Setup screen.

Date and Time

When the Doppler is switched on for the first time, you will need to set the time and date. Highlight the Date and TIme option

in the Setup menu and press

.

Press

to cycle through the Date format options.

Press

to confirm and enter Date Edit Mode.

Press

or

to change the values

Press to Accept the value and move to next item . When the final item of the date has been accepted, Time Format Selection mode is entered.

17 Instructions For Use

EN

Press to cycle through the Time format options. (i.e. 12H or 24H). Press

to confirm and enter Time Edit Mode.

Press

or

to change the values

Press to Accept the value and move to next item . When the final item of the Time has been entered, Date and Time Confirmation mode is entered.

Press

to return to the Date Format Selection screen.

Press accept and save the changes or to discard the changes and return to the Setup screen.

4.3.3

Brightness Press Button 1 to decrease Brightness and Button 3 to increase brightness. Press Button 2 screen.

to confirm and return to the Setup

18 Instructions For Use

EN

4.3.4

Vascular, PPG and Obstetric Setup

Depending on whether a Vascular or Obstetric probe is attached, the Setup screen allows you to access the Heartrate Display Selection Screen and DDNR Hiss Suppression Screen (Vascular), and FHR Averaging Mode screen and Trace Options screen (Obstetric). If a PPG probe is attached, this screen will allow access to PPG monitoring functionality (Vascular). ATP and ABI kits are available to purchase as optional extras. These functions will be explained in the Operation section. Note The Setup screen can be accessed by pressing and holding Button 3 in the main monitoring screens, i.e. Vascular Live Waveform screen, APPG Home screen and Obstetric Numeric/Trace mode screens.

4.4

System Connection WARNING: These requirements must be met when the Doppler is connected to any other electrical equipment, such as a PC.

1

Non-medical equipment must comply with the relevant IEC or ISO safety standard. For Information Technology equipment, this standard is EN60950.

2

The configured system must comply with the requirements of IEC 60601-1:2005; clause 16.

3

If non-medical equipment (e.g. the PC or printer) with enclosure leakage currents greater than those allowed by IEC 60601-1 is to be used in the patient environment (within 1.5m of the patient), the enclosure leakage currents must be brought within the limits laid down by IEC 60601-1. This may be achieved by using a medical grade isolating transformer. Suitable types are available via Huntleigh sales agents.

4

Anyone who connects additional equipment to signal input or signal output parts of the system is configuring a medical system, and is therefore responsible for ensuring that the system complies with the requirements of IEC 60601-1:2005; clause 16. If there is any doubt as to whether your system complies, consult the technical service department or your local Huntleigh representative.

19 Instructions For Use

EN

5.

Operation Refer to diagram on Page 4 for Doppler Measuring sites and Recommended Probes.

Note All functions and screen displays are model dependent. Please see table in ‘Introduction’ section for details on the functionality available on each model. Note The Setup screen can be accessed by pressing and holding Button 3 in the main monitoring screens, i.e. Vascular Live Waveform screen, APPG Home screen and Obstetric Numeric/Trace mode screens Coupling Gel Use water based ultrasound gel ONLY.

5.1

Switching On

Press

to turn the unit ON.

5.2.

Vascular Mode If a vascular probe is inserted into the SRX model Doppler, there will be audio functionality only. The Doppler screen will display date/time, probe frequency and battery status but no waveform or button details.

The Vascular Live Waveform screen is displayed automatically if a vascular probe is detected when the device is powered on, or when a vascular probe is subsequently inserted into the device. Vascular Probes Six probes are available for vascular examinations:

20

VP4XS

4MHz for deep lying vessels

VP5XS

5MHz for deep lying vessels and oedematous limbs

VP8XS

8MHz for peripheral vessels

VP10XS

10MHz for specialist superficial applications.

EZ8XS

8MHZ “Widebeam” for peripheral vessels.

PA8XS

Intraoperative Probe adaptor Instructions For Use

EN

Patient Preparation The patient must lie supine, be relaxed, remain still, and refrain from talking, coughing etc. 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 and point the probe tip towards the heart. 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.

5.2.1

Vascular Setup Heartrate Display Selection Screen

This selection determines if the heartrate figure is displayed when the trace is frozen. Press heartrate

to move the highlight between displaying the and not displaying the heartrate

The sample heartrate figure disappears accordingly.

.

appears and

Press to accept your selection or changes and return to Setup.

to discard the

DDNR Hiss Suppression Selection Screen This selection determines if the DDNR applies hiss suppression to the audio signal. To disable hiss suppression select

.

To enable hiss suppression select

.

Press

to move the highlight between selections.

Press to accept your selection or changes and return to Setup.

to discard the

21 Instructions For Use