HUNTLEIGH DIOP8 Single Use 8 MHz Surgical Doppler Probe Instruction Manual

: June 12, 2024
: HUNTLEIGH

Table of Contents

Indications For Use
Warnings/Cautions & Safety
Operation
ACCESSORIES
Warranty and Service
References
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HUNTLEIGH DIOP8 Single Use 8 MHz Surgical Doppler Probe Instruction Manual

Please Note – Refer to Hand-held Doppler IFU for information regarding functions, controls and battery replacement.

Important – Adaptor Compatibility
Doppler Hand units – use compatible adaptors only.

Doppler	PA8XS	PA8
DMX / DMXR
Multi Dopplex II
Super Dopplex II
Mini Dopplex
Compatible
---	---
NOT Compatible

Indications For Use

The DIOP8 surgical Doppler is indicated for use by qualified healthcare practitioners in a sterile condition in the operating theatre for the assessment of vascular blood flow by direct application to the vessel wall.

Contraindications

Do not use the DIOP8 on the eye.
Do not use in the presence of flammable gases or oxygen rich environments.
Do not apply the DIOP8 to the patient when using high frequency (HF) surgical equipment. Make sure when using such equipment that the DIOP8 is not in contact with the patient.

Note. No pressure should be applied to the vessel wall.

Complications

The following are possible complications from using the DIOP8.
These should always be recognised when considering use of the DIOP8, and balanced against the benefits.

There is an additional risk of infection when using the DIOP8. To minimise this risk, always check that the packaging is intact and undamaged.
Ultrasound devices can cause cavitation within the blood. The DIOP8 ultrasound intensity levels are below the limits specified for intraoperative use in applicable international standards. The DIOP8 should only be applied for as short a time as possible in order to achieve the clinical objective.

Warnings/Cautions & Safety

The sterile Intraoperative Probes are delicate and should be handled with care. Do not drop or strike against hard surfaces. Avoid excessive tension on the probe cable.

These probes are supplied STERILE. Always ensure that the packaging is intact and undamaged before opening.

The DIOP8 is a screening tool to aid the healthcare professional and can not provide a diagnosis. If there is doubt as to the status of the vessel after using the unit, further investigations should be undertaken immediately using alternative techniques.

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.

The DIOP8 is for single use only. DO NOT REUSE. DO NOT STERILISE. Failure to follow this advice may result in failure of the product, compromised sterility and potential harm to the patient.

This equipment is for use only by suitably qualified healthcare practitioners.

This equipment must not be modified.

Note. The control unit and adaptor are NOT sterile. Refer to the hand- held Doppler IFU for details of cleaning.

Operation

Connect the probe adaptor to the Dopplex cable, using the alignment mark on the barrel.
Locate the probe adaptor into the probe holder at the side of the Dopplex control unit. The Dopplex control unit can then be mounted onto an IV pole using the clamp as shown in Fig.1.
Using aseptic procedure, remove the DIOP8 probe from its packaging and insert plug into adaptor. Always maintain sterility of the probe

Note: The Dopplex control unit will automatically switch off at a predetermined time after switching the unit on. See control unit IFU for more information.

The Dopplex control unit can be switched on by a member of staff positioned outside the sterile field.

Adjust the volume control accordingly.

Ensure that the probe connector is fully engaged in the socket on the probe adaptor.

Correct operation of the system should be confirmed by placing the DIOP8 tip wetted with patient’s body fluid in light contact with an artery which is known to have blood flowing through it. A clearly audible pulsatile Doppler sound should be heard. The audibility and amplitude of the signal will be optimised when the probe is at an angle of approximately 45° ±15° to the vessel.

The probe can now be used to assess blood flow in other vessels.
Aiming the probe proximally along the line of the vessel at an angle of 45° ±15° and ensuring that the tip is fully wetted at all times ( Fig.2.) will enable the optimal audio signal to be obtained.
(If you are using a DMX, Multi Dopplex II or Super Dopplex II, an indication of the blood velocity and its direction will be shown on the LCD display.)
Operation

The probe can then be moved along the length of the vessel, noting any change in pitch of the Doppler signal or height of the Doppler waveform. This may be indicative of a change in the lumen area.
The same procedure can then be carried out after a graft has been inserted to confirm that adequate blood flow has been restored. By placing the probe on the vessel distal to the anastamosis, confirmation of distal run off is provided.

Product Labelling

| 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)
| Legal Manufacturer in association with the CE mark in Europe ArjoHuntleigh AB, Hans Michelsensgatan 10 211 20 Malmö, Sweden| Shelf Life| 3 year from date of manufacture.
Manufactured by:| Huntleigh Healthcare Ltd. 35 Portmanmoor Road, Cardiff, CF24 5HN, United KingdomT: +44 (0)29 20485885 sales@huntleigh- diagnostics.co.uk www.huntleigh- diagnostics.com
| Sterile Barrier System (non sterile protective outer layer with an internal sterile barrier)| RxOnly| Federal law restricts this device to sale by, or on the order of a licensed healthcare practitioner.
| Attention, consult accompanying documents / Instructions for Use| | Single patient use| | Do Not Reuse
| Applied part is type CF| | Warning| | Do not resterilise| | Sterilised usingethylene oxide
| Medical Device| | Catalogue Number| | Batch Code| | Date of Manufacture
| Device Identification code| | Cardboard packaging can be recycled.| | Do not use if packaging is damaged| | Atmospheric Pressure Limitation
| Contents can be recycled| | Does not containLatex| | Use By date| | Fragile, handle with care
| Temperature Limitations| | Humidity Limitations| | Keep Dry| |
Technical Specifications – IEC60601-1 Classification

Type of shock protection| Internally powered equipment (Dopplex control unit)
Degree of shock protection| Type CF equipment
Protection against ingress of liquids| Probe Adaptor :
Ordinary Equipment
DIOP8 :
Suitable for use in contact with body fluids.
Degree of safety in presence offlammable gases| Equipment not suitable for use in presence of flammable gases or oxygenrich environments
Mode of Operation| Continuous
Ultrasound

Pr| < 1 MPa
Iob| < 20 mW/cm2
Ispta.3| < 100 mW/cm2
Thermal Indices and Mechanical Index are 1.0 or lessfor all device settings.
Standards

Complies With| IEC60601-1 :2012
EMC| IEC60601-1-2: 2014
CISPR11| Group 1 Class A
Environmental

ACCESSORIES

**PA8XS x 1 PA8 x 1

**

**ACC47 x 1

**

**DIPP10 – DIOP8 x 10

**

Warranty and Service

Huntleigh Healthcare‘s 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

There are NO USER SERVICEABLE PARTS inside the probe adaptor or probe. If for any reason your DIOP8 or probe adaptor is being returned, please:

Contact Service Dept. to obtain instructions and authorisation for the product to be returned.
Failure to do this may result in the product being returned without investigation.

FOR UK
For further details refer to the NHS document HSG(93)26.
For service, maintenance and any questions regarding this, or any other Huntleigh Healthcare Dopplex product, please contact: Huntleigh Healthcare Ltd, Diagnostic Products Division, 35 Portmanmoor Road, Cardiff, CF24 5HN UK,
Tel : +44 (0)29 20485885,
Fax: +44 (0)29 20492520 Or your local distributor.

FOR USA
For service, maintenance and any questions regarding this, or any other Huntleigh Healthcare Dopplex product, please contact: Service Department, ArjoHuntleigh Inc, Suite 250, 2349 West Lake Street, Addison, IL60101,USA
T: 1 800-323-1245 option 2
W: www.huntleigh-healthcare.us Or your local distributor.

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

UK Symbol:

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.

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.

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

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.

**** Distributed in the USA by:
ArjoHuntleigh, Inc.
2349 West Lake Street, Suite 250
Addison, IL 60101
T: 800-323-1245
www.huntleigh-healthcare.us
1001057-2

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
100105

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