Huntleigh FD1 Bedienungsanleitung
HIGH SENSITIVITY
POCKET DOPPLERS
FD1/FD2/FD3
Table of Contents
Doppler Measurement Sites and Recommended Probes ......3
1. Safety .................................................................................4
1.1 Warnings................................................................................................. 4
1.2 Patient Applied Parts............................................................................. 5
2. Introduction .......................................................................6
2.1 Unpacking / Preliminary Checks .......................................................... 6
2.2 Battery Insertion / Relacement ............................................................. 6
2.3 Product Controls.................................................................................... 7
2.4 Product Labelling................................................................................... 7
3. Operation ...........................................................................9
3.1 Vascular Mode (FD2 Only) .................................................................... 9
3.2 Obstetric Mode ...................................................................................... 10
3.3 After Use................................................................................................. 12
4. Care and Cleaning ..............................................................13
4.1 General Care........................................................................................... 13
4.2 General Cleaning and Disinfecting ..................................................... 14
4.3 Cleaning and Disinfecting Patient Applied Parts................................ 14
4.4 Maintenance and Repair........................................................................ 15
5. Specifications ....................................................................16
5.1 Equipment Classification ..................................................................... 16
5.2 Standards Compliance.......................................................................... 16
5.3 FHR Performance................................................................................... 16
5.4 General ................................................................................................... 17
5.5 Environmental........................................................................................ 17
6. End of Life Disposal............................................................18
7. Warranty & Service ............................................................19
Dopplex, and Huntleigh are registered trademarks of Huntleigh Technology Ltd.
2004.
© Huntleigh Healthcare Ltd. 2004-2014
Doppler Measurement Sites and Recommended
Probes
19
10
11
12
13
14
16
17
15
18
19
20
8
3
2
4
5
6
7
1 Jugular Vein
VP4HS, VP5HS
2 Subclavian Vein
VP4HS, VP5HS
3 Fetus
OP2HS, OP3HS
4 Femoral Vein
VP4HS, VP5HS
5 Great Saphenous Vein
VP5HS, VP8HS, EZ8
6 Small Saphenous Vein
VP8HS, EZ8
7 Posterior Tibial Vein
VP8HS, VP10HS, EZ8
8 Posterior Tibial Artery
VP8HS, EZ8
9 Vertebral Artery
VP4HS, VP5HS
10 Carotid Artery
VP5HS, VP8HS, EZ8
11 Subclavian Artery
VP4HS, VP5HS
12 Brachial Artery
VP8HS, EZ8
13 Ulnar Artery
VP8HS, EZ8
14 Radial Artery
VP8HS, EZ8
15 Femoral Artery
VP4HS, VP5HS
16 Digital Artery
VP8HS, VP10HS, EZ8
17 Penis
VP10HS, EZ8
18 Popliteal Artery
VP5HS
19 Metatarsal Artery
VP8HS, VP10HS, EZ8
20 Dorsalis Pedis Artery
VP8HS, VP10HS, EZ8
4
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 FD1/FD3 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.
5
Safety
Do not dispose of batteries in fire as this can cause them to
explode.
Do not attempt to recharge normal dry-cell batteries. They may
leak, cause a fire or even 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 RS232 interface 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.
6
Introduction
2. Introduction
2.1 Unpacking / Preliminary Checks
Contents
INSTRUCTIONS
FOR USE
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 / Replacement
123
Note: Remove the battery if the unit is not likely to be used for
some time.
7
Introduction
2.3 Product Controls
12
3
4
5
6
FD1
FD3 FD2
1●●Headphone Socket
2●RS232 Port
3●●LCD Panel
4●●Loud-speaker
5●●On/Off Button
6●●Probe Holder
7●●Volume Control
8●Start/Stop Button
9●Mode Button
10 ●●
Battery
Compartment
11 ●●Pocket Clip
8
9
10
11
7
2.4 Product Labelling
Patient applied parts (ultrasound probes) are type BF according to the
definitions in IEC 60601-1:2005.
8
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 sales@huntleigh-diagnostics.co.uk
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
+40°C
-10°C
Temperature Limitations
“MAX
93%
RH”
Limits of Relative Humidity
SN Serial Number REF Reference Number
MD Medical Device DI Device Identifier
Fragile Keep Dry
Headphone Socket Volume
RS232 Interface Alignment mark
Cardboard packaging can be
recycled. Do not use hook
PVC
PVC FREE
Does not contain PVC
LATEX
LATEX FREE
Does not contain Latex
Limits of Atmospheric Pressure
Note: Product labelling should be read from a distance of no greater than 0.7m.
9
Operation
3. Operation
Refer to diagram on inside front cover 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.
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.
Coupling Gel
Use water based ultrasound gel ONLY.
3.1 Vascular Mode (FD2 Only)
The FD2 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.
In this mode, blood flow is audible in the loudspeaker. Probe frequency is
displayed.
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.
10
Operation
3.2 Obstetric Mode
Fetal Dopplex II (FD2)
Obstetric mode is automatically selected when an obstetric probe (OP2HS/
OP3HS) is connected. Fetal Heart Rate (FHR) is displayed with 3 operating
modes, and an RS232 interface provides for FHR printing when connected to
the Dopplex Printa Package.
Obstetric Probes
Two probes are available for obstetric examinations:
OP2HS 2MHz ±1%
OP3HS 3MHz ±1%
Fetal Dopplex (FD1/FD3)
Operates in standard mode to provide FHR display. The probe/cable are
waterproof and can be fully immersed for use in waterbirths.
The FD1/FD3 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.
*Note: For FD1/FD3 : Gel is not required when probe is used underwater.
Standard Mode - FD1/FD2/FD3
In this mode the FHR, averaged over 4-heart beats, is displayed on the 3-digit
readout. The LCD displays an outline heart symbol.
Dieses Handbuch passt für folgende Modelle
2
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