SR Range Instructions for Use

EN

INSTRUCTIONS FOR USE

SR range

Contents 1. Introduction 1.1

Unpacking / Preliminary Checks

2. Safety 2.1 2.2 2.3

Warnings Patient Applied Parts Intended Use & Indications

2.4 2.5

Contraindications Patient Population

3. Warranty & Service 3.1 Service Life 3.2

Maintenance and Repair

4. Product Identification 4.1 Product Controls 4.2 4.3

Symbol Identification Display Status Bar

5. Prepare the Doppler for Use 5.1 Battery Insertion / Replacement 5.2 5.3

Probe Connection Change the Doppler Settings

6. Operation 6.1 SRX Probe options 6.2 6.3

SR2 & SR3 Waterproof Probes Obstetric Monitoring

6.4

Frozen Trace

6.5 6.6

Battery Charging Data transfer to a PC

6.7 After Use 7. Care and Cleaning 7.1 7.2

General Care Cleaning and Disinfecting the Doppler

7.3 Cleaning and Disinfecting Probes 8. Troubleshooting 9. Specifications 9.1 Equipment Classification 9.2 9.3

FHR Performance General

9.4

Environmental

9.5

Standards Compliance

10. Electromagnetic Compatibility

EN

1.

Introduction

The SR range are multi-function, battery powered, hand-held Dopplers intended for obstetric use. The SRX is compatible with Huntleigh’s interchangeable probes. The range provides an audible fetal heart sound and a numeric/graphical display of fetal heart rate. 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 fetal status, further investigations should be undertaken immediately using alternative techniques. Always ensure that Maternal HR or any Artefacts are not misinterpreted as fetal heartrate. If in doubt, feel the mother’s pulse during the examination. 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.

• • • • • • • • • •

2.2

Patient Applied Parts

As defined in IEC 60601-1, the patient applied parts of the SR Doppler are the ultrasound probes.

2.3

Intended Use & Indications

The Dopplers are intended for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the assessment of fetal heart rate. They are indicated for routine screening of pregnant women of all ages from early gestation through to full term, and for low risk labour management.

2.4 • •

Contraindications

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

EN

2.5

Patient Population

The SR Range 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, 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. (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 and connector. 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) 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.

IPx7

Protected against ingress of water 1 m immersion for up to 30 minutes.

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

USB Transmitting

USB Receiving

Signal Strength

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

5.

Prepare the Doppler for Use

5.1

Battery Insertion / Replacement

Disconnect the Doppler from any 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 to the SRX Doppler, align the arrow on the connector with the slot on the probe and push together firmly. (Doppler models SR2 and SR3 have captive probes).

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. Date and Time Setup

Brightness

Press Button 1

Battery type Selection

Lock screen

FHR Averaging Mode

Trace Options

Audio Recording

Timer

to move the selection, Button 2

5.3.2

Set the Screen Brightness

5.3.3

Set the Date and Time

to accept, or Button 3

to go back.

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.

Operation

Press Screen.

6.1

and hold for one second to turn the unit ON. The Doppler displays the Obstetric Live Waveform

SRX Probe options

Two types of probe are available: OP2XS

2 MHz ± 1%

OP3XS

3 MHz ± 1%

The Obstetric FHR Numeric Screen is displayed when an obstetric probe is detected. The strength of the Doppler signal is displayed in the status bar at the top of the display.

6.2

SR2 & SR3 Waterproof Probes

SR2 is supplied with a captive waterproof 2 MHz probe and cable while SR3 is supplied with a captive waterproof 3 MHz probe and cable. When used underwater, refer to the Cleaning Instructions in section 7, to prevent cross-contamination.

Patient Preparation Make the patient comfortable in a semi-recumbant or sitting position. Apply a liberal amount of gel to the abdomen. Place the faceplate of the probe flat against the abdomen above the symphis pubis. Adjust the probe to get an optimum audio signal, ideally by angling the probe around while maintaining firm pressure. Avoid sliding the probe over the skin. Best performance is from the fetal heart itself, characterised by ‘slapping’ valve sounds rather than umbilical artery or placental sounds. The FHR, averaged over 4-heart beats, is displayed on the 3-digit readout. *Note: Gel is not required when SR2 and SR3 model probes are used underwater.

6.3

Obstetric Monitoring Obstetric FHR Numeric Mode Screen

In this Mode, the FHR is displayed (in beats per minute) in large digits and is continually updated. When the rate cannot be determined, 3 x dashes are displayed.

Press

to switch to FHR Trace Display.

EN 6.3.1

Obstetric FHR Trace Mode Screen*

Trace display mode is for indication only and is not a replacement for conventional fetal monitoring. If any concern arises from viewing this trace, alternative means (e.g. full CTG) must be used to determine fetal condition. This screen displays the FHR as a trace on a graph. The horizontal and vertical scales are determined in setup**. The trace displays from left to right until it fills the screen then scrolls to the left as each new data point is added.

FHR Trace Mode Icons Numeric Display Mode Register fetal movement and place marker Stop Trace and display Frozen Trace option

** Trace scaling is equivalent to 1 or 3 cm/min and 20 or 30 beats per cm, scaled down to screen size, maintaining the same aspect ratio to avoid distortion of the trace for easy visual interpretation. *Note: These options are only available if the FHR Trace Mode screen has been enabled.

6.3.2

Trace Scroll section Press

6.4

Frozen Trace

Press

at any time to return to the live trace screen.

To Save a trace:

To open a saved trace:

when the desired information is displayed.

EN

6.5 • • • • •

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 at the 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

6.6

.

Data transfer to a PC

The Doppler does not contain patient information however, stored traces 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.

6.7

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.

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.

Cautions • • • • • • • • •

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.

EN

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

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

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.

8.

Troubleshooting

This section lists some of the more common problems encountered during use together with possible causes. If the problem cannot be located after consulting the table in this section, turn off the Doppler and consult a qualified technician. Before attempting trouble-shooting, verify that the batteries are charged. SYMPTOM

POSSIBLE CAUSE / REMEDY

Doppler will not turn on.

Replace / recharge 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 Incompatible probe / sensor, or Incorrect Probe / sensor 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*, SR2/SR3 probes : IPX7 Protective Pouch : IP22

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

FHR Performance

Standard Mode

Range: 60 - 210 bpm Averaging: 4 beats

Resolution: 1 bpm Accuracy: ± 3 bpm Range

Smoothed Mode

Range: 60 - 210 bpm Averaging: 8 beats

Resolution: 1 bpm Accuracy: ± 3 bpm

Manual Mode

Range: 60 - 210 bpm Averaging: 10 beats

Resolution: 1 bpm Accuracy: ± 3 bpm

9.3

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:

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

USB Port

Micro USB

SD Card Slot

Real Time clock battery

RENATA CR1025, 3V Lithium

Battery Type

LR6 (Alkaline cells 1.5V) or 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

Weight

Micro SD

280 g

EN

9.4

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

9.5

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.

IEC 60601-1-2: 2014

9.6

Accessories

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

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.

EN

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.

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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

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

Vertrieben in Deutschland Durch: Huntleigh Healthcare GmbH: Industriering Ost 66 47906 Kempen, Germany T: +49 02152 551110 F: +49 02152 551120 https://www.huntleigh.de 1001058-2

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 2021 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.

1001048-3

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