20 Pages
Preview
Page 1
D900/D920/D930
HIGH SENSITIVITY POCKET DOPPLERS
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 / Relacement ... 6 Product Controls... 7 Product Labelling... 7
3. Operation ... 9 3.1 3.2 3.3
Vascular Mode (D900 Only) ... 9 Obstetric Mode ... 10 After Use ... 11
4. Care and Cleaning ... 12 4.1 4.2 4.3 4.4
General Care... 12 General Cleaning and Disinfecting ... 13 Cleaning and Disinfecting Patient Applied Parts ... 13 Maintenance and Repair... 14
5. Specifications ... 15 5.1 5.2 5.3 5.4
Equipment Classification ... 15 Standards Compliance ... 15 General ... 16 Environmental ... 16
6. End of Life Disposal... 17 7. Warranty & Service ... 18
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
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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
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15 Femoral Artery VP4HS, VP5HS
13 3 4
14 16
17 15
5 6 Small Saphenous Vein VP8HS, EZ8
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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, (except D920/D930 probe) • use solvent cleaner, • use high temperature sterilising processes (such as autoclaving), • use E-beam or gamma radiation sterilisation. 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. Do not use on the eye.
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Do not attempt to recharge normal dry-cell batteries. They may leak, cause a fire or even explode.
Safety
Do not dispose of batteries in fire as this can cause them to explode.
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 the waveform output socket 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.
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Introduction
2.
Introduction
2.1
Unpacking / Preliminary Checks Contents D900 Only
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 / Relacement
1
2
Note: 6
3
Remove the battery if the unit is not likely to be used for some time.
Product Controls
1
3
D900
D920 D930
1
●
●
2
●
3
●
●
LED Panel
4
●
●
Loud-speaker
5
●
●
On/Off Button
6
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●
Probe Holder
7
●
●
Volume Control
8
●
9
●
●
Battery Compartment
10
●
●
Pocket Clip
2
4
6 5
Headphone Socket Waveform Socket
Introduction
2.3
Cal Button
10 9 7 8 2.4
Product Labelling Patient applied parts (ultrasound probes) are type BF according to the definitions in IEC 60601-1:2005.
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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
Waveform Output Socket
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
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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.
Operation
3.
To disconnect the probe, pull the connector sharply. DO NOT pull the cable. Note:
During use, an automatic noise reduction feature operates on low level signals to improve sound quality.
LED Indicators Green LED - indicates power ON Yellow LED - flashes when battery is low Coupling Gel Use water based ultrasound gel ONLY.
3.1
Vascular Mode (D900 Only) The D900 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.
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Operation
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. Waveform Recording - D900 Only The D900 can be connected to a chart recorder by using a suitable lead that plugs into the Waveform socket. (For more information on the chart recorder, refer to the manufacturer’s handbook). 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 pulses as shown below: Cal Pulse
Two levels of calibration pulses are provided. While Cal is active, calibration tones synchronised to the calibration pulses are superimposed on the audio signal. If the button is pressed and held, then the calibration sequence is repeated. When the calibration sequence is complete, normal operation is resumed.
3.2
Obstetric Mode D900 only Obstetric mode is automatically selected when an obstetric probe (OP2HS/ OP3HS) is connected to the control unit. In this mode the waveform output and Cal function are disabled.
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Two probes are available for obstetric examinations:
OP2HS
2MHz ±1%
OP3HS
3MHz ±1%
Operation
Obstetric Probes
Audio / Flexi Dopplex (D920/D930) Both the Audio Dopplex and the Flexi Dopplex have fixed waterproof probes (IPX7) for underwater use. The D920/D930 main unit is not waterproof and must not be immersed.
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. The Dopplex units can detect fetal heart sounds from as early as 9 to 10 weeks gestation. Note that early detection (9-12 weeks) is highly depedent on operator skill and other factors and may not always be possible. *Note: For D920/D930 : Gel is not required when probe is used underwater.
3.3
After Use 1.
Press and release the On/Off button. If you forget to switch the unit off, it will automatically shut-off after 5 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.
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Care and Cleaning
4.
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. 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. (Except D920/D930 probes). Always wipe off disinfectant using a cloth dampened with clean water.
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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
Care and Cleaning
4.2
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
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, or the patient has given birth in a water bath.
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.
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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. 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 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.
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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
Specifications
5.
Degree of protection Hand Unit: Ordinary Equipment against harmful ingress D920/D930 probes : IPX7 of particles and/or water. All other probes (Tip only): IPX1 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
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Specifications
5.3
5.4
General Max. Audio Output (Loudspeaker)
500mW rms typical
Auto shut-off
After 5 minutes continuous operation
Headphones
Max. output Power: 25 mW rms (32Ω) Connector: 3.5mm stereo jack socket Max. applied voltage: +9Vdc
Waveform Output (D900 only)
Zero crosser, 0.5V/kHz, 3.5V full scale Cal levels: 1kHz + 2kHz, Max. applied voltage +9Vdc Connector: 3.5mm mono socket
Battery Type
IEC 6LR61 or IEC 6LP3146
Battery Life
Typically, 500 x 1 minute examinations
Size
Height 140mm, Depth 27mm, Width 74mm
Weight
295g
Environmental Operating
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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
End of Life Disposal
End of life Disposal
6.
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.
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Warranty & Service
7.
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 - D900 / D920 / D930’
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:
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+44 (0)29 20496793 - Service (24hr answer machine) +44 (0)29 20485885 +44 (0)29 20492520 [email protected] [email protected] www.huntleigh-diagnostics.com
Dopplex, and Huntleigh are registered trademarks of Huntleigh Technology Ltd. 2004. © Huntleigh Healthcare Ltd. 2004-2014
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
734321EN-12 (ENGLISH)
03/2021