Instructions for Use
54 Pages
Preview
Page 1
Contents 1. Safety ... 5 1.1 1.2
Warnings... 5 Patient Applied Parts ... 6
2. Introduction ... 7 2.1 2.2 2.3
Intended Use ... 9 Contraindications ... 9 Unpacking / Preliminary Checks ... 10
3. Product Identification... 11 3.1 3.2 3.3
Product Controls... 11 Product Labelling... 12 Display ... 13 3.3.1 3.3.2
Setup Screen... 13 Status Bar... 14
4. Setup ... 15 4.1 4.2 4.3 4.4 4.5 4.6
Battery Insertion / Replacement & Micro SD Card Insertion ... 15 Battery Charging ... 16 Battery Status... 16 Probe Connection ... 16 Initial Setup... 17 System Connection ... 19
5. Operation ... 20 5.1 5.2.
Switching On ... 20 Vascular Mode ... 20
5.2.1 5.2.2 5.2.3
5.3 5.4
PPG Mode ... 24 Obstetric Mode ... 30 5.4.1 5.4.2
5.5
Obstetric Setup... 31 Obstetric Monitoring ... 33
Other functions ... 36 5.5.1 5.5.2 5.5.3
5.6 5.7 5.8
Vascular Setup ... 21 Vascular Monitoring ... 22 Measuring Doppler Pressures ... 24
Brightness ... 36 Bluetooth Device Pairing (Depending on Model) ... 36 Stored File Access... 37
After Use ... 38 Live data streaming to an external device... 38 Data transfer to an external device ... 38
6.1 6.2 6.3 6.4
General Care... 39 General Cleaning and Disinfecting ... 40 Cleaning and Disinfecting Patient Applied Parts ... 40 Maintenance and Repair... 42
7. Trouble Shooting ... 43 8. Specifications ... 44 8.1 8.2 8.3 8.4 8.5 8.6
Equipment Classification ... 44 Standards Compliance ... 44 FHR Performance... 44 General ... 45 Environmental ... 45 Accessories ... 46
Table of Contents
6. Care and Cleaning ... 39
9. Electromagnetic Compatibility ... 47 10. End of Life Disposal ... 51 11. Warranty & Service ... 52
3
Measurement Sites and Recommended Probes
Measurement Sites and Recommended Probes 1 Jugular Vein VP4XS, VP5XS
9 Vertebral Artery VP4XS, VP5XS
2 Subclavian Vein VP4XS, VP5XS
9
10 Carotid Artery VP5XS, VP8XS, EZ8XS
10
11 Subclavian Artery VP4XS, VP5XS
1
3 Fetus OP2XS, OP3XS 4 Femoral Vein VP4XS, VP5XS
11
2
12 Brachial Artery VP8XS, EZ8XS
5 Great Saphenous Vein VP5XS, VP8XS, EZ8XS
12 13 3 4
21
16 5
7 Posterior Tibial Vein VP8XS, VP10XS, EZ8XS
14
15 Digital Artery VP8XS, VP10XS, EZ8XS 16 Femoral Artery VP4XS, VP5XS
18
17 Penis VP10XS, EZ8XS
6
18 Popliteal Artery VP5XS
PPG Probe 21 Digits 22 Toes
19 Metatarsal Artery VP8XS, VP10XS, EZ8XS
8 7 22
4
14 Radial Artery VP8XS, EZ8XS
15
17
6 Small Saphenous Vein VP8XS, EZ8XS
8 Posterior Tibial Artery VP8XS, EZ8XS
13 Ulnar Artery VP8XS, EZ8XS
20 19
20 Dorsalis Pedis Artery VP8XS, VP10XS, EZ8XS
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.
Safety
1.
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.
Symbols General Warning Attention, consult this manual. Attention, consult accompanying documents / Instructions for Use Rx Only
1.1
Caution: Federal law restricts this device to sale by, or on the order of a licensed healthcare practitioner.
Warnings Do not use in the presence of flammable gases. Do not sterilise the product or its accessories. The product will be damaged, and there is a risk of patient and user harm. Do not use in the sterile field unless additional barrier precautions are taken. Do not immerse in any liquid. (Except waterproof probes - fitted on models SR2 and SR3). 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.
5
Safety
If this product is connected to another item of electrical equipment, it is important that the system is fully compliant with EN60601-1. This product contains sensitive electronics, therefore, strong radio frequency fields could possibly interfere with it, e.g. mobile phones. This will be indicated by unusual sounds from the loudspeaker. We recommend that the source of interference is identified and eliminated. 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. Do not expose the Doppler to excess heat, including prolonged exposure to sunlight.
Expected Service Life The Digital Handheld Doppler has an expected service life of 7 years.
1.2
Patient Applied Parts As defined in IEC60601-1:2012, the patient applied parts of the Digital Handheld Doppler are the ultrasound probes, PPG sensors and cuffs.
6
Introduction This manual is your introduction to the Dopplex® and Sonicaid® Doppler products. The Doppler is a multi-function, battery powered, hand-held Doppler intended for both vascular and obstetrics use. It works with Huntleigh’s full range of ‘XS’ interchangeable probes (depending on model).
Introduction
2.
The Vascular Doppler is indicated for the examination of blood flow in a range of vessel depths, from peripheral / superficial blood vessels down to deep vessels and vessels in oedematous limbs. It provides an indication of blood flow and direction by audible and (depending on model) visual means. By the addition of a Photo Plethysmography 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) in patients with intermittent claudication (walking pain) which is the first line assessment for anybody suspected of PAD. The Fetal Doppler is indicated for the detection of fetal life, at early gestation, from as early as 8 to 10 weeks and for fetal screening from early gestation through to delivery. It provides an audible fetal heart sound and a numeric/ graphical display of fetal heart rate. You must read, fully understand and comply with the instructions given in this manual before using the Doppler. Use this manual to initially set up the Doppler, and keep it as a reference for day-to-day routines and as a guide to cleaning and maintenance. If you have any difficulties in setting-up or using the Doppler, contact your local Huntleigh sales representative. The model (REF) number of your Doppler is shown on the front and rear panel labels.
Note:
Screen shots and product images are shown for illustration purposes only. These may vary from the actual product.
7
Introduction
This manual applies to the following products: VASCULAR DOPPLER
MODEL
FUNCTIONALITY
DMX
Vascular - Full Visual and audio functionality if a suitable vascular probe* is attached. Obstetric - Full Visual and audio functionality if a suitable obstetric probe* is attached. (Not suitable for underwater monitoring). PPG - PPG functionality if a PPG probe* is attached.
OBSTETRIC DOPPLER
MODEL FUNCTIONALITY SRX
Obstetric - Full Visual and audio functionality if a suitable obstetric probe* is attached. (Not suitable for under water monitoring). Vascular - Audio functionality only if a suitable vascular probe* is attached. Screen will display date/time, probe frequency and battery status only. PPG - No functionality.
SR2
Obstetric - Full Visual and audio functionality. 2MHz hard wired waterproof probe suitable for underwater monitoring. No Vascular or PPG functionality as probe is hard wired and cannot be changed.
SR3
Same as for SR2 model but with 3MHz hard wired probe.
* Please see relevant sections for full details of functionality and probe /sensor options and accessories.
8
Intended Use The DMX & SRX range of handheld Dopplers are intended for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the non-invasive assessment of vascular blood flow and/or fetal heart rate, to assist in diagnosis.
2.2
Contraindications
Introduction
2.1
The Doppler is not intended to be used on broken or fragile skin. The Doppler is not intended for use on the eye. The (Fetal) Doppler provides just one indicator of fetal condition. This should be assessed as part of an holistic approach to obstetric care together with other factors. A complete assessment must be made before taking appropriate action. If there is any doubt concerning the accuracy of any measurement, an alternative method should be used. The (Vascular) Doppler is a screening tool to aid the healthcare professional and should be used with clinical judgement before interventional procedures are undertaken. If there is doubt as to vascularity after using the unit, further investigations should be undertaken immediately using alternative techniques.
9
Introduction
2.3
Unpacking / Preliminary Checks Contents Item
Item
Item
1 x Digital Handheld Doppler
1 x Instructions for Use CD
Batteries
Charger*
USB lead*
Ultrasound Gel
Quick Reference Guide
Carry bag
* Depending on model Delivery Inspection Huntleigh Healthcare Ltd 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 Healthcare Ltd 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.
10
Product Identification
3.1
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
Loud-speaker
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
Product Identification
3.
12 13 14 9 10 11
11
Product Identification
3.2
Product Labelling Applied parts (ultrasound probes) are type B according to the definitions in IEC60601-1:2012. 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. 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 Devices Directive 93/42/EEC as amended by 2007/47/EC Class II, double insulated according to the definitions in BS EN 60601-1:2012
Power On/Off
50°C
Temperature Limitations
SN
Serial Number
REF
Reference Number
Manufacturer/ Date of Manufacture
DI
Device Identifier
Keep Dry
Contents can be recycled
Fragile
Cardboard packaging can be recycled.
Headphone Socket
USB Port
Volume Up /Scroll Up
Volume Down / Scroll Down
Alignment mark
PVC
12
Limits of Relative Humidity Max 90% RH
-10°C
PVC FREE Does not contain PVC
LATEX
LATEX FREE Does not contain Latex
Display
3.3.1
Setup Screen Vascular Setup Screen
Obstetric Setup Screen
Date and Time Setup
Brightness
Lock screen (Not yet implemented)
Bluetooth Device Pairing (If fitted - depending on model)
Heartrate Display Selection (Vascular)
FHR Averaging Mode (Obstetric)
DDNR Hiss suppression (Vascular)
Trace Options (Obstetric)
Move Highlight
Select
Product Identification
3.3
Exit Setup
13
Product Identification
3.3.2
Status Bar
The Status Bar is visible at the top of the display on most screens, (not available in Setup). The information displayed differs depending on the operating mode of the Doppler. - Status Bar (Vascular shown)
All Modes Battery Status
27/01/2015 14.30
Date / Time
USB Connected
Bluetooth Connected
USB Receiving
Bluetooth Receiving
USB Transmitting
Bluetooth Transmitting
Vascular Mode
5MHz
Forward Flow
Reverse Flow
Arterial Mode
Venous Mode
Probe Type
Obstetric Mode
Note:
14
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
Signal Strength
Other Display icons will be explained throughout the manual in their respective sections.
Battery Insertion / Replacement & Micro SD Card Insertion Disconnect unit from any other equipment before removing the battery cover. Do not dispose of batteries in fire as this can cause them to explode. Do not mix non-rechargeable and rechargeable batteries. If you are fitting a Micro SD Card into the Doppler, this must be done BEFORE inserting the batteries. Use Huntleigh recommended Micro SD cards only. The Doppler is supplied with the batteries removed. Insert as shown below.
1
Remove the battery cover : Insert a suitable tool into recess to release the clip and gently lever off the battery cover.
Insert the Micro SD Card. (If fitting).
2
!
!
AA
Ensure card clicks into place.
AA
(To remove the Micro SD card, press it in to release and pull gently to remove.)
Insert batteries, positive terminal first, ensuring correct polarity.
Note:
!
!
AA
3 AA
4.1
Setup
4. Setup
Replace the battery cover.
Remove the batteries if the unit is not likely to be used for some time.
15
Setup
4.2
Battery Charging Only rechargeable batteries can be recharged. Confirm battery type before connecting to charger. Do not attempt to recharge normal dry-cell batteries. They may leak, cause a fire or even explode. Only use charger and lead supplied by Huntleigh. Do not use the Doppler on patients when connected to the charger. Note:
We recommend the Doppler is charged prior to first use. Insert the supplied charger lead into the USB socket at the top of the Doppler. Connect to mains supply and switch on mains power. Charging will take approximately 5 hours.
Note:
4.3
The Doppler must be switched off for battery charging.
Battery Status The level of charge in the batteries is displayed on the top right corner of the display. (Not displayed in setup screen).
EMPTY
FULL
Fully charged batteries will show a solid symbol. The status bar will empty as the batteries are used. In low battery state, the battery symbol will be empty and will flash. When the battery is fully depleted, the Doppler will switch itself off. Approximately 500 x 1 minute examinations can be performed with fully charged batteries, depending on use.
4.4
Probe Connection Note:
Models SR2 and SR3 are fitted with hard wired probes which cannot be removed.
To connect the probe, align the arrow on the connector with the slot on the probe and push firmly.
16
To disconnect the probe, pull the connector. DO NOT pull the cable.
Initial Setup When the Doppler is switched on for the first time, you will need to set the time and date. Note: Press
Setup
4.5
A probe must be connected before initial setup can be performed. to turn the unit ON.
Press and hold Button 3 to access the Setup screen. (The screen shown is with a vascular probe attached). Use the 3 buttons below the screen to navigate and select each function. Press Button 1 and Time icon.
to move the highlight to Date
Press Button 2
to accept your selection.
Date and Time Press options.
to cycle through the Date format
Press
to confirm and enter Date Edit Mode.
Press
or
to change the values
to Accept the value and move to next Press item . When the final item of the date has been accepted, Time Format Selection mode is entered.
17
Setup
Press to cycle through the Time format options. (i.e. 12H or 24H). Press
to confirm and enter Time Edit Mode.
Press
or
to change the values
to Accept the value and move to next Press item . When the final item of the Time has been entered, Date and Time Confirmation mode is entered.
Press screen.
to return to the Date Format Selection
Press accept and save the changes or to discard the changes and return to the Setup screen. Here you can also set the Brightness, Lock/Unlock Screen and Pair a Bluetooth device (Bluetooth function is model dependant). Depending on whether a Vascular or Obstetric probe is attached, this screen also allows you to access the Heartrate Display Selection Screen and DDNR Hiss Suppression Screen (Vascular), and FHR Averaging Mode screen and Trace Options screen (Obstetric). If a PPG probe is attached, this screen will allow access to PPG monitoring functionality (Vascular). ATP and ABI kits are available to purchase as optional extras. These functions will be explained in the Operation section. Note:
18
The Setup screen can be accessed by pressing and holding Button 3 in the main monitoring screens, i.e. Vascular Live Waveform screen, APPG Home screen and Obstetric Numeric/ Trace mode screens.
System Connection WARNING: These requirements must be met when the Doppler is connected to any other electrical equipment, such as a PC. 1
Non-medical equipment must comply with the relevant IEC or ISO safety standard. For Information Technology equipment, this standard is EN60950.
2
The configured system must comply with the requirements of IEC60601-1:2012; clause 16.
3
If non-medical equipment (e.g. the PC or printer) with enclosure leakage currents greater than those allowed by EN60601-1 is to be used in the patient environment (within 1.5m of the patient), the enclosure leakage currents must be brought within the limits laid down by EN60601-1. This may be achieved by using a medical grade isolating transformer. Suitable types are available via Huntleigh sales agents.
4
Anyone who connects additional equipment to signal input or signal output parts of the system is configuring a medical system, and is therefore responsible for ensuring that the system complies with the requirements of IEC60601-1:2012; clause 16. If there is any doubt as to whether your system complies, consult the technical service department or your local Huntleigh representative.
Setup
4.6
19
Operation
5.
Operation Refer to diagram on Page 4 for Doppler Measuring sites and Recommended Probes. Please note: All functions and screen displays are model dependent. Please see table in ‘Introduction’ section for details on the functionality available on each model. Please note: The Setup screen can be accessed by pressing and holding Button 3 in the main monitoring screens, i.e. Vascular Live Waveform screen, APPG Home screen and Obstetric Numeric/Trace mode screens. Coupling Gel Use water based ultrasound gel ONLY.
5.1
Switching On Press
5.2.
to turn the unit ON.
Vascular Mode If a vascular probe is inserted into the SRX model Doppler, there will be audio functionality only. The Doppler screen will display date/time, probe frequency and battery status but no waveform or button details. The Vascular Live Waveform screen is displayed automatically if a vascular probe is detected when the device is powered on, or when a vascular probe is subsequently inserted into the device. Vascular Probes Six probes are available for vascular examinations:
20
VP4XS
4MHz for deep lying vessels
VP5XS
5MHz for deep lying vessels and oedematous limbs
VP8XS
8MHz for peripheral vessels
VP10XS
10MHz for specialist superficial applications.
EZ8XS
8MHZ “Widebeam” for peripheral vessels.
PA8XS
Intraoperative Probe pod
The patient must lie supine, be relaxed, remain still, and refrain from talking, coughing etc. 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 and point the probe tip towards the heart. 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.
5.2.1
Operation
Patient Preparation
Vascular Setup Heartrate Display Selection Screen
This selection determines if the heartrate figure is displayed when the trace is frozen. Press
to move the highlight between
displaying the heartrate the heartrate
and not displaying
.
The sample heartrate figure disappears accordingly.
appears and
Press to accept your selection or to discard the changes and return to Setup.
DDNR Hiss Suppression Selection Screen This selection determines if the DDNR applies hiss suppression to the audio signal. To disable hiss suppression select
.
To enable hiss suppression select
.
to move the highlight between Press selections. Press to accept your selection or to discard the changes and return to Setup.
21