DMX Instructions for Use

EN

INSTRUCTIONS FOR USE

DMX

Contents 1. Introduction 1.1

Unpacking / Preliminary Checks

2. Safety 2.1 2.2 2.3 2.4 2.5

Warnings Patient Applied Parts Intended Use & Indications Contraindications Patient Population

3. Warranty & Service 3.1 3.2

Service Life Maintenance and Repair

4. Product Identification 4.1 4.2 4.3

Product Controls Symbol Identification Display Status Bar

5. Prepare the Doppler for Use 5.1 5.2 5.3

Battery Insertion / Replacement Probe Connection Change the Doppler Settings

6. Operation 6.1 6.2 6.3 6.4 6.5 6.6

Clinical Use Photoplethysmography (PPG) Mode Frozen Trace Battery Charging Data transfer to a PC After Use

7. Care and Cleaning 7.1 7.2 7.3

General Care Cleaning and Disinfecting the Doppler Cleaning and Disinfecting Probes

8. Troubleshooting 9. Specifications 9.1 9.2 9.3 9.4 9.5 9.6 9.7

Equipment Classification DMX Vascular Doppler Performance ABI and TBI Calculations APPG Systolic Pressure Performance General Environmental Standards Compliance

10.Electromagnetic Compatibility

EN

1.

Introduction

The DMX is a multi-function, battery powered, hand-held Doppler intended for vascular use. It is compatible with Huntleigh’s full range of ‘XS’ interchangeable probes. By the addition of a Photo Plethysmography (PPG) 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). This equipment is for use only by suitably qualified healthcare practitioners and is not intended for use by the patient. Before using this equipment, study this manual carefully and familiarise yourself with the controls, display features and operation. Experience with use of ultrasonic dopplers is preferable, but for novice users training material is provided with the online documents. Exposure to ultrasound should be kept As Low As Reasonably Achievable - (ALARA guidelines). Scan the QR code on the rear cover of this IFU with a smartphone, or visit the Huntleigh website for electronic copies of user literature. All documents are available to download as PDF files. To read them, you must have a PDF reader installed on your device. Alternatively paper copies are available upon request.

1.1

Unpacking / Preliminary Checks

On receipt of your Doppler, check that all items are present and undamaged. If items are missing or have been damaged in transit, inform Huntleigh Healthcare immediately. Digital Handheld Doppler

IFU (this document)

Batteries

Charger & USB lead*

Ultrasound Gel

Carry bag

*selected Dopplers

2.

Safety

2.1

Warnings

• • • • • • • • • •

Dopplers are screening tools to aid the healthcare professional. If there is doubt as to vascular status, further investigations should be undertaken immediately using alternative techniques. Do not use in the presence of flammable gases. Do not use in a sterile field* unless additional barrier precautions are taken. Do not sterilise the product or its accessories*. The product will be damaged. Do not expose to excessive heat, including prolonged exposure to sunlight. Do not dispose of batteries in fire as this can cause them to explode. The Doppler is not waterproof and must not be immersed. This product contains sensitive electronics, which are susceptible to interference, this will be indicated by unusual sounds. Any equipment connected to the USB port must be compliant with IEC 60601-1. This equipment must not be modified.

Note: *Does not apply to Intraoperative Probe. Refer to Intraoperative Probe IFU for details on cleaning/ sterilisation processes.

2.2

Patient Applied Parts

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

2.3

Intended Use & Indications

The Doppler is intended for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the assessment of vascular blood flow, to assist in diagnosis. It is indicated for the assessment of blood flow and direction, within veins and arteries, by audible and visual means.

EN

2.4 • •

2.5

Contraindications Do not use on broken or fragile skin. Do not use on the eye.

Patient Population

The DMX is suitable for use on all patient populations.

3.

Warranty & Service

Huntleigh Healthcare Diagnostic Products Division 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: To return the Doppler: • • • •

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. (Huntleigh Healthcare Ltd reserve the right to return product that does not contain a decontamination certificate). Mark the package ‘Service Department‘.

For further details, refer to NHS document HSG(93)26 (UK only). Service Department. Huntleigh Healthcare, Diagnostic Products Division, 35, Portmanmoor Rd., Cardiff. CF24 5HN United Kingdom.

3.1

Tel: Fax: Email: Website:

+44 (0)29 20485885 +44 (0)29 20492520 [email protected] [email protected] www.huntleigh-diagnostics.com

Service Life

This is defined as the period during which the device is expected to remain safe and suitable to meet its intended use, and all risk control measures remain effective. The service life for this device is seven years.

3.2

Maintenance and Repair

There are no user serviceable parts inside the Doppler unit or probes. This product does not require periodic maintenance. 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. Any unusual sounds or intermittent behaviour should be investigated. Spare parts are available. Please refer to service manual for further information and part numbers. A full technical description is provided in the Service Manual 772490.

Caution Servicing cannot be carried out while the Doppler is in use.

EN

4.

Product Identification

4.1

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

EN

4.2

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

General Warning

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).

RxOnly

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

Made in in the UK 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

IP20

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

IPx1

Protected against vertically falling water drops. Power On/Standby

USB Port

DI

Device Identifier

SN

Serial Number

REF

Reference Number

MD

Medical Device

LATEX

Fragile

Keep Dry

Atmospheric Pressure Limitations

Relative Humidity Limitations

Temperature Limitations

Cardboard packaging can be recycled

LATEX FREE Does not contain Latex

PVC

PVC FREE Does not contain PVC

Headphone Socket

Alignment mark

Volume Up

Volume Down

Note: Product labelling should be readable from a distance of up to 0.7m.

EN

4.3

Display Status Bar The Status Bar appears at the top of most screens, the information displayed depends on the operating mode.

Status Bar Icons Battery Level Low

27/01/2015 14.30

Date / Time

USB Connected

5MHz

Probe Type

Forward Flow (Flow towards probe) Arterial Mode

Reverse Flow (Flow away from probe) Venous Mode

Heart Rate Indicator

5.

Prepare the Doppler for Use

5.1

Battery Insertion / Replacement

Disconnect the Doppler from other equipment before removing the battery cover.

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

Insert the batteries according to the diagram, observing polarity.

Use either alkaline LR6 (non-rechargeable) or NiMH HR6 (rechargeable) batteries. Do not mix rechargeable and non-rechargeable batteries.

Note: If the Doppler will not be used for an extended period, remove the batteries.

5.2

Probe Connection

To connect the probe, align the arrow on the connector with the slot on the probe and push together firmly.

To disconnect the probe, pull the connector from the probe. DO NOT pull the cable.

EN

5.3

Change the Doppler Settings

5.3.1

Setup Screen

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

to turn the unit ON, then press and hold button 3 to enter Setup mode.

Setup Screen Icons

Press Button 1

Brightness

Date and Time Setup

Battery type Selection

Lock screen

to move the selection, Button 2

5.3.2

Set the Screen Brightness

5.3.3

Set the Date and Time

to accept, Button 3

to exit menu.

Press to accept or discard the changes.

to

EN 5.3.4

Battery Type Selection

HR6 = rechargeable NiMH batteries, LR6 = non-rechargeable alkaline batteries

6. Press

6.1

Operation and hold for one second to turn the unit ON.

Clinical Use

Apply a liberal amount of water based ultrasound 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. Additional icons appear in the Setup mode.

Setup Screen Icons Freeze Trace Trace Options Set Timebase

6.1.1

Waveform Options

1. Freeze Live trace screen (refer to Frozen Trace section 6.3) 2. Switch between Venous and Arterial Modes

3. Switch between Forward and Reverse Flow

4. Select Timebase

EN 6.1.2

Measure Doppler Pressures

Patient Preparation

Pressure measurements rely on a bulb inflation / valve deflation system in combination with a tube and cuff attachment as shown below.

Brachial Systolic Pressure Place the cuff on the upper arm approximately 1 - 2 cm above the antecubital fossa. Connect the sphygmomanometer to the cuff. Note: Select a cuff size appropriate for the patient’s limb. Ensure that the index marker on the cuff falls within the range marker.

• • • •

• • •

Palpate the artery. Apply a liberal amount of ultrasound gel. Place the probe over the vessel at an angle of 45°. Move the probe laterally across the limb to locate the strongest audio signal.

Inflate the BP cuff by compressing the bulb of the sphygmomanometer until the pulse sound disappears and then further inflate by 10 – 20 mmHg. Gradually deflate the cuff at a rate of about 2 – 3 mmHg/s. Note the pressure displayed on the sphyg as soon as the Doppler signal is heard. For best results, keep the probe as still as possible after the optimum position has been found.

Ankle Systolic Pressure

6.2

•

Place the appropriately sized cuff 1-3 cm above the lateral malleolus

•

Connect the sphygmomanometer to the cuff

•

Repeat the inflation procedure described above, but this time monitor the desired foot artery (e.g. Posterior Tibial shown).

Photoplethysmography (PPG) Mode

An arterial PPG probe is available for arm, ankle and toe systolic pressures and PPG waveforms.The PPG probe is attached to the arm, ankle or toe as appropriate, and uses infra-red light to make a relative measurement to detect the return of bloodflow.

EN 6.2.1

APPG Home Screen APPG Home Screen Icons Freeze Trace Change Timebase

Waveform Options 5. Freeze Trace (Refer to Frozen Trace section 6.3) 6. Select Timebase (Refer to Vascular Timebase section 6.1.1)

6.2.2

Measuring Pressures with PPG

Prepare the patient as described in section 5.1.2. Connect the cuff, sphyg, APPG adaptor and probe as shown:

Once a full screen of regular pulses is displayed, inflate the Cuff slowly. • As soon as the cuff pressure exceeds 30 mmHg, a deflate bar appears at the top of the screen. • When no regular traces are visible on the screen, begin to deflate the cuff by lightly squeezing the trigger release valve. .

• Keep the deflate line within the green range.

To measure brachial pressure, the cuff is positioned 2-3cm above the antecubital fossa while the ppg probe is placed on any digit of the same arm. Carry out the procedure as described above.

6.2.3

Trace Scroll section

Make sure that the first pulse is aligned with the vertical line. Note that the left and right arrows move the trace, not the marker line. Use the arrows to scroll back and forward. In PPG mode, as the trace moves, the recorded pressure indicator is updated. Press Tick when the desired information is displayed.

EN

6.3

Frozen Trace

Press

at any time to return to the live trace screen.

To Save a trace:

To Open a Saved trace:

6.4 • • • • •

Battery Charging Only HR6 (NiMH) batteries can be charged. Check the battery type before connecting the charger. Do not attempt to recharge normal alkaline batteries. They may leak, cause a fire or even explode. Only use the charger and USB lead supplied by Huntleigh. Switch off the Doppler before charging. Do not use the Doppler on patients when the charger is connected. • •

Insert the supplied charger lead into the USB socket on top of the Doppler. Connect the charger and switch on mains power.

Charging will take approximately 5 - 6 hours, depending on battery status.

If the battery level is low, a During charging, a

symbol will appear on the Status bar. symbol will be displayed on the screen.

When fully charged, the symbol will change to

6.5

.

Data transfer to a PC

The Doppler does not contain patient information however, stored waveforms and data can be transferred to a PC running Huntleigh reporting software, via the same USB socket as for battery charging. Consult your local sales representative for details. Note: Please observe the safety warnings in the Huntleigh software IFU.

6.6

After Use

Press and hold the On/Off button for one second to switch the unit off. Refer to the cleaning section before storing or using the unit on another patient.

EN

7.

Care and Cleaning

7.1

General Care

The Doppler contains 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 this IFU. If there are any defects, contact Huntleigh or your distributor for repair or to order a replacement.

Caution • • • • • • • • •

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). If detergent or disinfectant wipes are used ensure that excess solution is squeezed from the wipe prior to use. Always switch off the Doppler and disconnect from the AC supply before cleaning and disinfecting. Always wipe off disinfectant using a cloth dampened with clean water. Do not allow any fluid to enter the products and do not immerse in any solution. Do not use abrasive cloths or cleaners. Do not use automatic washers or autoclaves. Do not use Phenolic detergent based disinfectants, solutions containing cationic surfactants, ammonia based compounds or perfumes and antiseptic solutions.

7.2

Cleaning and Disinfecting the Doppler

Always keep the external surfaces clean and free of dirt and fluids using a clean dry cloth. • • • •

Wipe any fluids from the surface of the product using a clean dry cloth. Wipe with a cloth dampened in 70% Isopropyl Alcohol. Completely dry with a clean, dry cloth. If the product has been contaminated use the methods described for probes.

7.3

Cleaning and Disinfecting Probes

(Does not apply to IOP8/DIOP8 Intraoperative Probe. Refer to Intraoperative Probe IFU for details on cleaning/sterilisation processes). Clean the probes before examining a patient using the 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

Definitions

Procedure

Low

Normal use or low risk situations include patients having intact skin and no known infection.

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

Caution Repeated and unnecessary use of concentrated solutions will result in damage to the product. Do not allow Sodium Hypochlorite solutions to come into contact with metal parts. The use of disinfectant materials other than those listed is the responsibility of the user for their efficacy and compatibility with the device.

EN Cuffs:Clean the cuffs before examining a patient using the low risk cleaning method below. Following patient examination, clean and/or disinfect the cuffs by the appropriate method based upon the level of cross contamination risk. Before fitting the cuffs to the patient, evaluate the cross-contamination risk according to the definitions in the tables below: Risk

Definitions

Procedure

Low

Normal use or low risk situations including patients with intact skin and no known infection.

1. Clean with soft cloth and a mild, neutral detergent @ 40°C (104°F) 2. Disinfect using a 70% isopropyl alcohol wipe or chlorine releasing agent @ 1000ppm available chlorine 3. Wipe with a cloth dampened in clean water. 4. Completely dry with a clean lint-free cloth

Medium/ High

The patient has a known infection, or skin is not intact.

Because of the nature of the cuff materials, effective cleaning and disinfection in medium/high risk situations is not practical. Therefore, we recommend to dispose of according to local procedures

Refer to the cuff IFU for cleaning guidance and restrictions.

Caution • • •

Do not allow any fluid to enter the cuff tubing. Do not use alternative cleaning agents or methods as permanent damage is likely. Inspect cuffs after cleaning and prior to use.

Cuff Inspection: Cuffs should be regularly inspected. Examine the outer cuff surfaces for material damage, splitting, fraying etc. Make sure that labelling is clearly legible. Check the cuff tubing and connections for damage, splits etc. If in any doubt as to the condition, the cuff(s) should be replaced. In any case, cuffs should be replaced every two years.

Caution After using chemicals ALWAYS rinse off / remove the chemical with absorbent material, dampened in clean water and dry with a clean cloth.

8.

Troubleshooting

This table lists some of the common problems found during use, with possible solutions. If the problem cannot be located after consulting this table, turn off the Doppler and consult a qualified technician. Before attempting trouble shooting, make sure that the batteries are charged. SYMPTOM

POSSIBLE CAUSE / REMEDY

Doppler will not turn on.

Replace / re-charge batteries.

Audio Only

Doppler model does not support visual functionality

No Audio signal

Incorrect volume setting

Poor Signal

Probe / sensor incorrectly positioned, or Insufficient Gel

No Signal

Damaged probe / sensor, or Incorrect probe / sensor

Screen displays:

Damaged probe / sensor, or No Probe

Screen displays:

Incompatible probe / sensor, or Incorrect Probe / sensor

Screen displays:

Incorrect battery fitted

EN

9.

Specifications

9.1

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 against harmful ingress of particles and/or water.

Main Unit: IP20*, Probes: IPx1

Degree of safety of application in the presence of a flammable anaesthetic

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

*For home use, this can be upgraded to IPx2 when using the protective pouch (ACC-OBS-080).

9.2

DMX Vascular Doppler Performance

Doppler bandwidth (+0; -3 dB)

Doppler Shift Maximum Frequency Display Error*

VP4XS, VP5XS

170 to 4,600 Hz

Typically < 5%; maximum 10%

VP8XS, EZ8XS

270 to 6,000 Hz

VP10XS

270 to 8,000 Hz

Doppler Heart Rate**

IOP8/DIOP8

110 to 7,400 Hz

Range

40 – 200 ± 3 bpm

*Measured using a Doppler string phantom in water, **Heart rate indications may be unreliable if the signal is weak or irregular

9.3

ABI and TBI Calculations

Right ABI

Highest Pressure in Right Foot Highest Brachial Systolic Pressure

Right TBI

Highest Pressure in Right Toe Highest Brachial Systolic Pressure

Left ABI

Highest pressure in Left Foot Highest Brachial Systolic Pressure

Left TBI

Highest pressure in Left Toe Highest Brachial Systolic Pressure

9.4

APPG Systolic Pressure Performance

Range

0 - 260 ± 3 mmHg

Resolution

1 mmHg

Indication Type

On-Screen digital numeric display

Pressure Generation / Reduction

Bulb / Manual air release valve

EN

9.5

General

Charger- ‘R’ models only (Part No. 772559)

Protection : Class II Input Voltage : 100-240 V AC ±10% Output Voltage : 5VDC ± 5% Input Frequency : 50 - 60Hz Standby power consumption: 230V AC ≤ 0.1W

Max. Audio Output

500 mW rms typical (loudspeaker)

Auto shut-off

3 minutes

Headphone output

Max. output Power: Connector:

USB Port

Micro USB

Real Time clock battery

RENATA CR1025, 3V Lithium

Battery Type

LR6 (Alkaline cells 1.5V), HR6 (NiMH rechargeable 1.2V)

Battery Life

Typically, 500 x 1 minute examinations Note: Battery life is typically 2 years or 500 charge/discharge cycles

Size

140 x 33 x 75 mm

9.6

25 mW rms (32Ω) 3.5mm stereo jack socket SD Card Slot

Weight

Micro SD

280 g

Environmental

Operating Temperature range

+5°C to +40°C

Relative Humidity

15% to 90% (non condensing)

Pressure

700 hPa to 1060 hPa

Transport and Storage between uses Without relative humidity control

-25°C to +5°C

At a r.h. of up to 90% non-condensing

+5°C to +35°C

At a water vapour pressure up to 50 hPa

>+35°C to +70°C

9.7

Standards Compliance

IEC 60601-1: 2012

IEC 60601-1-11: 2015

EN 60601-2-37: 2015 Thermal Indices (TI) and Mechanical Index (MI) are below 1.0 for all device settings. BS EN 81060-1: 2012

9.8

IEC 60601-1-2: 2014

Accessories

Use only the recommended accessories. See www.huntleigh-diagnostics.com for a list of accessories.

EN

10.

Electromagnetic Compatibility

Make sure the environment in which the Doppler is installed is not subject to strong sources of electromagnetic interference (e.g. radio transmitters, mobile phones). This equipment generates and uses radio frequency energy. If not installed and used properly, in strict accordance with the manufacturer’s instructions, it may cause or be subject to interference. Type-tested in a fully configured system, complies with IEC 60601-1-2, the standard intended to provide reasonable protection against such interference. 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: • • •

Reorient the equipment Relocate the equipment with respect to the source of interference Move the equipment away from the device with which it is interfering

Warnings • • •

The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the Doppler as replacement parts for internal components, may result in increased emissions or decreased immunity of the Doppler. The Doppler should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Doppler should be observed to verify normal operation in the configuration in which it will be used. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Doppler including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

This section is only applicable to United Kingdom (UK) market when UK marking is applied to the Arjo medical device labelling. UK Symbol:



UK marking indicating conformity with UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) Figures indicate UK Approval Body supervision.

UK Responsible Person: Arjo (UK) Ltd., ArjoHuntleigh House, Houghton Regis. LU5 5XF Is the appointed UK Responsible Person as defined in UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended). For Northern Ireland (NI) CE marking will still apply until further amendment to applicable regulations.

1001071-1

EN

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.

FR

En cas d’incident grave lié à ce dispositif médical, affectant l’utilisateur ou le patient, celui-ci doit signaler l’incident grave au fabricant du dispositif médical ou au distributeur. Au sein de l’Union européenne, l’utilisateur doit également signaler l’incident grave à l’autorité compétente de l’État membre où il se trouve

DE

Wenn im Zusammenhang mit diesem Medizinprodukt ein schwerwiegender Vorfall auftritt, der den Benutzer oder den Patienten betrifft, ist dieser vom Benutzer oder Patienten dem Hersteller bzw. Vertriebshändler des Medizinproduktes zu melden. In der Europäischen Union sollte der Benutzer den schwerwiegenden Vorfall zudem der zuständigen Behörde des Mitgliedstaates, in dem er sich befindet, melden.

IT

Se in relazione a questo dispositivo medico si verifica un incidente grave che interessa l’utente o il paziente, l’utente o il paziente deve segnalare l’incidente grave al produttore o al distributore del dispositivo medico. Nell’Unione europea, l’utente è anche tenuto a segnalare l’incidente grave all’Autorità competente nello stato membro in cui si trova.

ES

Si se produce un incidente grave en relación con este producto sanitario que afecte al usuario o al paciente, el usuario o el paciente deberán notificarlo al fabricante o al distribuidor del producto sanitario. En la Unión Europea, el usuario también debe notificar el incidente grave a la autoridad competente en el Estado miembro en el que se encuentra.

PT

Se ocorrer um incidente grave em relação a este dispositivo médico, afetando o utilizador ou o paciente, o utilizador ou paciente deve informar o incidente grave ao fabricante ou ao distribuidor do dispositivo médico. Na União Europeia, o utilizador também deve informar o incidente grave à autoridade competente no Estado-Membro em que esteja localizado.

NL

Als er zich een ernstig voorval voordoet in relatie met dit medische hulpmiddel dat de gebruiker of de patiënt treft, dan moet de gebruiker of de patiënt dit ernstige voorval melden aan de fabrikant of distributeur van het medische hulpmiddel. In de Europese Unie dient de gebruiker het ernstige voorval ook te melden aan de bevoegde autoriteit in de lidstaat waar deze zich bevindt.

SV

Om en allvarlig incident inträffar i samband med den här medicintekniska produkten som drabbar användaren eller patienten, ska användaren eller patienten rapportera den allvarliga incidenten till tillverkaren av den medicintekniska produkten eller distributören. I EU ska användaren också rapportera den allvarliga incidenten till den behöriga myndigheten i den medlemsstat där de befinner sig.

DA

Hvis der skulle opstå en alvorlig hændelse med relation til dette medicinske udstyr, som påvirker brugeren eller patienten, skal brugeren eller patienten indberette den alvorlige hændelse til producenten af det medicinske udstyr eller dennes distributør. I EU skal brugeren tillige indberette den alvorlige hændelse til den kompetente myndighed i den medlemsstat, hvor denne befinder sig.

NO

Hvis en alvorlig ulykke oppstår i forbindelse med dette medisinske utstyret og rammer brukeren eller pasienten, skal brukeren eller pasienten rapportere den alvorlige ulykken til produsenten av det medisinske utstyret eller distributøren. I Den europeiske union skal brukeren også rapportere den alvorlige hendelsen til ansvarlige myndigheter i medlemslandet hvor brukeren bor.

FI

Jos tähän lääkinnälliseen laitteeseen liittyen ilmenee vakava haittatapahtuma, joka vaikuttaa käyttäjään tai potilaaseen, käyttäjän tai potilaan pitää ilmoittaa tästä vakavasta haittatapahtumasta lääkinnällisen laitteen valmistajalle tai jälleenmyyjälle. Euroopan unionissa käyttäjän pitää ilmoittaa vakavasta haittatapahtumasta myös asuinmaansa toimivaltaiselle viranomaiselle.

CS

Pokud dojde k závažné nehodě v souvislosti s tímto zdravotnickým prostředkem, která se dotkne uživatele nebo pacienta, musí ji tento uživatel nebo pacient nahlásit výrobci zdravotnického prostředku nebo dodavateli. V Evropské unii musí uživatel hlásit závažné nehody také odpovědnému orgánu členského státu, ve kterém se nachází.

Manufactured in the UK by Huntleigh Healthcare Ltd on behalf of; ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, Sweden

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