RD2 Instructions for Use

CONTENU, INHALT, CONTENUTO, INNEH ÅLL, INHOUD, CONTENIDOS, INDHOLD, SISÄLLYS

R

IN RU FOR ST USE CTIONS

PILE, BATTERIE, BATTERIA, BATTERI, BATTERIJ, BATERÍA, BATTERI, PARISTO

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 Veins 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

9

1

10 2

13 Ulnar Artery VP8HS, EZ8

11

14 Radial Artery VP8HS, EZ8

12 13 3 4

14 16

17 15

5

6 8

16 Digital Artery VP8HS, VP10HS, EZ8 17 Penis VP8HS, VP10HS, EZ8 18 Popliteal Artery VP5HS

18

7

15 Femoral Artery VP4HS, VP5HS

20

19

19 Metatarsal Artery VP8HS, VP10HS, EZ8 20 Dorsalis Pedis Artery VP8HS, VP10HS, EZ8

GENERAL OPERATION & MAINTENANCE

Do not use Dopplers in the presence of flammable gases such as anaesthetic agents.

Refer to diagram on inside front cover for Doppler Measuring sites and Recommended Probes.

Do not use in the sterile field unless additional barrier precautions are taken.

During Use

Do not use the PPG probe on patients with fragile or broken skin e.g. Cushings syndrome, open wounds or other similar conditions.

An automatic noise reduction feature operates on low level signals to improve sound quality.

Do Not :

To replace battery see diagram.

Immerse in any liquid, use solvent cleaner, use high temperature sterilising processes (such as autoclaving), use E-beam or gamma radiation sterilisation.

After Use

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. Do not use on the eye.

1.

Press and release the On/Off button. If you forget to switch the unit off, it will automatically shut-off after 3 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.

The control unit and the body of the probe are robust and require no special handling. However, the probe tip is delicate and must be handled with care.

If outputs 1 and 2 are used simultaneously, the system should comply with EN60601-1-1. Any equipment connected to outputs 1 or 2 should comply with EN60601-1, EN60950, EN60065, EN60335 or EN61010

Cleaning Remove excess gel before parking the probe. Clean with a damp cloth impregnated with mild detergent. Do not allow fluid to seep into either unit.

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.

For disinfection use a soft cloth with Sodium Hypochlorite 1000ppm or alcohol.

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.

Alcohol saturated swabs can be used on the probe tip. Please be sure to check your local control of infection policies, or any equipment cleaning procedures. Phenolic, detergent based disinfectants containing cationic surfactants, ammonia based compounds, or antiseptic solutions such as Steriscol or Hibiscrub should never be used on any part of the system.

The RD2 uses low levels of infra-red light and low levels of ultrasound when a Doppler probe is used. 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.

Coupling Gel Use water based ultrasound gel ONLY.

Adhesive Pads These are important to ensure full performance, and only those supplied by Huntleigh Healthcare should be used.

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ENGLISH

WARNING/CAUTIONS & SAFETY

Using the Mode button, gain can be set to x1, x2, x4, x8.

OPERATING INSTRUCTIONS VASCULAR

Printouts It is essential that the PPG Curve is used to confirm the Refill Time using the RD2 connected to the Printa or Reporter software package.

®

The Rheo Dopplex II Doppler (RD2) will select vascular mode when a vascular probe is connected to the control unit. In this mode, bi-directional blood flow rate and direction are indicated on bar graphs (4 levels in each direction) and blood flow is audible in the loudspeaker. Probe frequency is displayed together with the bar graphs.

Connection to Printa Hard copy printing is automatically selected when the plug of the interface buffer box is inserted into the RS232 socket on the top panel of the RD2. Printing is then initiated by using the Start/Stop button.

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.

Connection to Software The RD2 can be connected to the Reporter Software Package, via the RS232 interface. Dopplex® Reporter software package is available as an accessory. Communicating is then initiated by using the Start/Stop button.

For best results, keep the probe as still as possible once the optimum position has been found. Adjust the audio volume as required.

Probes Five probes are available for vascular examinations:

Waveform Recording Separated waveform outputs are provided in analogue and digital formats. Analogue signals are provided for connection to a single channel chart recorder giving a combined bi-directional waveform, or to a dual channel recorder for separate forward and reverse flow waveforms. (Pin-out details on request). Digital signals are provided via the RS232 port for printing separate waveforms on a Dopplex Printa® or for communicating with Dopplex Reporter software package.

VP4HS

4MHz for deep lying vessels

VP5HS

5MHz for deep lying vessels and oedematous limbs

VP8HS

8MHz for peripheral vessels

EZ8

8MHz "Widebeam" for peripheral vessels.

VP10HS

10MHz for specialist superficial applications.

VPPG

This is an infra red sensor for lower limb venous investigation.

Symbols Displayed on LCD

Cal Function Indicates Venous Refilling time.

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 bi-directional pulses as shown below:

Indicates Venous Pump value. Indicates Invert Mode - press Mode button for 2 seconds to reverse displayed blood flow direction and invert Doppler waveforms.

Cal Pulse

In Doppler mode, indicates Bi-directional blood flow in real-time.

Gain Control To cope with the wide variety of signals detectable using your RD2, a gain control allows you to optimise the bar-graph display and increase the height of the waveforms.

In PPG mode, indicates size of PPG signal.

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OPERATING INSTRUCTIONS PPG It is important that stable conditions are obtained throughout the procedure.

Procedure 1. Ensure room temperature is comfortable, and the patient is free from distractions. 2. Patient must have been rested for several minutes before examination can begin. 3. The patient should be seated with stockings and footwear removed. The knees should be at an angle of 110° with the feet resting on a towel or other thermal insulating material. 4. The patient should be seated on a height adjustable seat and set to minimise the weight on the feet.

If trace is too large, move sensor towards rear of leg

Place cushion behind back to recline patient if obese

End of blue sleeving placed on malleolus Place insulating material under foot

Figure 1 - Patient Positioning 5. Obese patients in particular should be reclined to reduce venous compression on the thigh. 6. Fit the sensor 10cm above the medial malleolus. Use the length of the blue sleeving as a guide. 7. If the sensor has to be relocated, it should be moved towards the back of the leg and not up the leg. 8. Switch on the RD2 with the PPG probe fitted, explain the procedure and allow the patient to rest and RD2 trace to settle. 9. Deep breaths by the patient should be avoided to obtain consistent results and quicker settling times. 10. Press the Start/Stop button and increase the volume until clicks are heard from the unit. This is normal, these clicks will occur every 10 seconds, until the PPG signal is stable. 11. When the signal is stable, the unit will bleep twice and start the 5 second countdown sequence. The metronome will then beep to indicate when the foot should be raised to full extension and allowed to fall freely. The foot should be raised at every beep. 12. If the patient is unable to lift the foot sufficiently to obtain adequate VP values, manual calf compression can be given. 13. After the 10th beep, which is long, the foot must be laid flat on the ground and relaxed ensuring the patient does not put weight on the foot or move in any way. 14. After approximately 45 seconds, 3 beeps will be heard indicating the test is completed. 15. The refill curve should be smooth - refer to Figure 2. If the curve has bumps or dips the test should be repeated. A second test should be carried out shortly after the first test to verify that the results correlate. 16. When using a tourniquet, pressure should be increased with larger limbs to obtain the same level of occlusion. Refer to flowchart for limb sizes and pressures.

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OPERATING INSTRUCTIONS PPG Procedure (Continued)

L R No Tourn AKT BKT UTT

Venous emptying during exercise

Venous refilling during rest

Venous Refilling Time, RT > 45 seconds. Venous Pump, VP = 45 Half Amplitude Time = 14 seconds.

Figure 2 - Normal Trace

F

The RD2 results should be consistent with clinical symptoms.

Interpretation of Traces and Results Venous Insufficiency The refill time indicates the presence or absence of venous incompetence. There are 3 categories:Normal - RT greater than 25 seconds. Abnormal - RT less than 20 seconds.

Equivocal - RT between 20 and 25 seconds.

DVT Screening See Flowchart.

Error Codes The following Error Codes will be displayed if the test is not performed correctly.

• ER1 - Last movement was not detected. The last flex during the exercise was not detected indicating that the exercise was not performed correctly.

• ER2 - Exercise drainage volume was less than the baseline. Repeat the test. •

• • • •

The trace did not rise above the baseline. ER3 - Exercise drainage volume was very low in amplitude. Reapply sensor and repeat test. A very small PPG signal was received and the results could indicate a venous problem or that the patient is not lifting the foot high enough. Encourage patient to lift foot higher and repeat test. ER4 - The first timing point was not detected within 5 seconds. The software failed to detect the 10th flexion and therefore unable to mark the start of the venous refilling time. Reapply sensor and repeat test. ER5 - Recovery time was less than 1 second. The first timing point and end point were detected simultaneously. ER6 - The signal was outside the measurable range. The PPG deflection was too large for the system or deviates below the baseline. Reposition the sensor towards the back of the leg or reduce effort of flexion, and repeat test. ER7 - The Start/Stop button was pressed during the test.

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OPERATING INSTRUCTIONS PPG Decision Making Flowchart For Venous Incompetence PPG Trace

1.0

0.8 - 1.0

Arterial Disease Present

Normal No further investigation (beware of calcified arteries due to diabetes)

Calf Perforator/ Deep Vein Incompetence

Tourniquet Position

Limb Size S M L Tq Pressure mmHg

AKTq = Above Knee BKTq = Below Knee UTTq = Upper Thigh

60 40 60

70 50 70

HINT * If obvious varicosities present then repeat test with alternative flexion procedures

80 60 80

1) Plantar - raise heels - patient standing 2) Half knee bend - patient standing 3) Manual calf compression - patient standing

Decision Making Flowchart For DVT Screening PPG Trace RT < 21s

RT > 20s

Further investigation i.e. Duplex scanning or venography

DVT absent

Do not compress limb if DVT is suspected

The above procedure is only valid for clinically suspected acute lower limb DVTs. The PPG technique is not sensitive enough to detect a floating, non-occluding thrombosis. A distal (below knee) thrombosis may not be detected.

Flowcharts are for guidance only

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OPERATING INSTRUCTIONS OBSTETRICS

WARRANTY & SERVICE Huntleigh Healthcare’s standard terms and conditions apply to all sales. A copy is available on request.

Obstetric mode is automatically selected when an obstetric probe (OP2HS/OP3HS) is connected.

These contain full details of warranty terms and do not limit the statutory rights of the consumer.

The RD2 in obstetric mode provides audio only.

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.

Service Returns

1.

Clean the product, as described in the cleaning section.

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.

2.

Pack it in suitable packing.

3.

Attach the decontamination certificate (or other written statement declaring that the product has been cleaned) to the outside of the package.

4.

Mark the package “Service Department Rheo Dopplex II”.

If for any reason your Dopplex Unit is being returned, please:

A wind-like sound is heard from the placenta.

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 35 Portmanmoor Road Cardiff CF24 5HN UK Tel : +44 (0) 2920 485885 Fax: +44 (0) 2920 492520 Or your local distributor.

Manufactured in the UK by Huntleigh Healthcare. As part of the ongoing development programme the company reserves the right to modify specifications and materials of the Rheo Dopplex® II without notice. Dopplex, Huntleigh and ‘H’ logo are registered trademarks of Huntleigh Technology 2004. ÓHuntleigh Healthcare Ltd 2004

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TECHNICAL SPECIFICATION Rheo Dopplex® II RD2 Weight : 295 gms (10oz) (including probe and battery) Height : 140 mm (5.5”) Width : 74 mm (2.9”) Depth : 27 mm (1.1”) Max. Audio Output: 500mW rms typical Max. Headphones Output Power: 25 mW rms max. (32W headphones) (max. applied voltage +9Vdc) Auto Shut-Off: After 10 minutes continuous operation or 3 minutes no signal RS232: RS232C, 8 pin sub-miniature DIN connector (max. applied voltage +5Vdc) Product Name: Model No.: Physical Characteristics:

Via sub-miniature DIN socket on top panel in analogue and digital form. Zero crosser, 3.5V full scale per channel (forward and reverse). Conversion factor automatically adjusted to give full scale outputs at ±0.1% (±10%) of probe frequency (e.g. ±8kHz for VP8HS) Digital Data formatted to interface with Printa or Reporter software running on compatible computer. Conversion factors automatically set as per analogue outputs CAL Function: Automatic sequence of CAL levels set to ±0.05% (±10%) and ±0.1% (±10%) of probe frequency (e.g. ±4kHz & ±8kHz for VP8HS) with zero baseline at start and end of sequence. Battery Type Recommended: 9 volt alkaline manganese (e.g MN1604) Battery Life Typically, 250 x 1 minute examinations VPPG Transducer Transmitting wavelength: nominally 940nm Size: 27mm diameter x 10mm Cable length: 1.75m Weight: 10g Adhesive Pads: Size: 27mm diameter Specification: Double coated adhesive medical discs, hypo-allergenic pressure sensitive, non-irritating to skin. Probe Transmitter: Frequencies: OP2HS : 2.0 MHz ± 1% VP5HS : 5.0 MHz ± 1% OP3HS : 3.0 MHz ± 1% VP8HS/EZ8 : 8.0 MHz ± 1% VP4HS : 4.0 MHz ± 1% VP10HS: 10.0MHz ± 1% Effective Area of Active Transmitter Element: OP2HS, OP3HS: 233 mm² (± 15%) VP4HS, VP5HS: 22 mm² (± 15%) EZ8 : 16mm² (± 20%) VP8HS, VP10HS: 8 mm² (± 20%) Complies With: BS5724: Part 1 : 1989, IEC 601-1: 1988, EN60601-1 IEC601-1 Classification: Type of shock protection Internally powered equipment Degree of shock protection Type B equipment Protection against water ingress Ordinary equipment Degree of safety in presence of Equipment not suitable for use in flammable gases presence of flammable gases Mode of operation Continuous Operating Temperature: +10°C to +30°C Storage Temperature: -10°C to +40°C Relative Humidity: 10% to 95% Waveform Outputs Analogue:

Means, Attention consult this manual. ! Refer to Safety Section

Medical Devices Directive 93/42/EEC

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Ìç ÷ñçóéìïðïéåßôå Dopplers ðáñïõóßá åýöëåêôùí áåñßùí êáé áíáéóèçôéêþí ðáñáãüíôùí. Ìç ôïõò ÷ñçóéìïðïéåßôå óå áðïóôåéñùìÝíï ÷þñï ÷ùñßò åðéðëÝïí ðñïöõëÜîåéò. Ìç ÷ñçóéìïðïéåßôå ôïí áíé÷íåõôÞ PPG óå áóèåíåßò ìå åõáßóèçôï äÝñìá ð÷. Áíïé÷ôÜ ôñáýìáôá, ôï óýíäñïìï Cushings êáé Üëëåò ðáñüìïéåò êáôáóôÜóåéò.

ÃÅÍÉÊÇ ËÅÉÔÏÕÑÃÉÁ ÊÁÉ ÓÕÍÔÇÑÇÓÇ

ÌÇÍ:ÂïõôÜôå ôïí áíé÷íåõôÞ óå ïðïéïäÞðïôå õãñü, ×ñçóéìïðïéåßôå êáèáñéóôéêü äéáëõôéêü õãñü, ×ñçóéìïðïéåßôå äéáäéêáóßåò áðïóôåßñùóçò õøçëÞò èåñìïêñáóßáò (áõôüìáôïò êëßâáíïò), Áðïóôåéñþíåôå ìå áêôßíá Å Þ áêôßíåò ã.

Ãéá ôéò ìåôñÞóåéò Doppler êáé ôéò áíé÷íåýóåéò ðïõ óõóôÞíïíôáé áíáöåñèåßôå óôï äéÜãñáììá óôï åóùôåñéêü ôïõ åîþöõëëïõ.

ÊáôÜ ôç äéÜñêåéá ôçò ÷ñÞóçò. Ëåéôïõñãåß áõôüìáôç ìåßùóç ôïõ èïñýâïõ óå ÷áìçëÜ óÞìáôá ãéá âåëôßùóç ôçò ðïéüôçôáò ôïõ Þ÷ïõ. Ãéá ôçí áíôéêáôÜóôáóç ôçò ìðáôáñßáò äåßôå ôï äéÜãñáììá.

Ôï ðñïúüí áõôü ðåñéÝ÷åé åõáßóèçôá çëåêôñïíéêÜ åîáñôÞìáôá êáé ãéá ôï ëüãï áõôü ïé õøçëÝò óõ÷íüôçôåò ñáäéïöþíïõ ìðïñåß íá ðáñåìâÜëëïõí óôçí ëåéôïõñãßá ôïõ. Áí óõìâåß êÜôé ôÝôïéï èá áêïõóôïýí áóõíÞèéóôïé Þ÷ïé áðü ôï ç÷åßï ôïõ ìç÷áíÞìáôïò. Óõíéóôïýìå íá áíáãíùñßóåôå êáé íá áöáéñÝóåôå ôçí ïðïéáäÞðïôå ðáñåìâïëÞ.

ÌåôÜ ôç ÷ñÞóç 1.

2.

Íá ìç ÷ñçóéìïðïéåßôáé óôá ìÜôéá. Áí ïé Ýîïäïé 1 êáé 2 ÷ñçóéìïðïéïýíôáé óõã÷ñüíùò, ôï óýóôçìá ðñÝðåé íá áêïëïõèåß ôïí êáíïíéóìü ÅÍ60601-1-1. ÏðïéïóäÞðïôå åîïðëéóìüò óõíäÝåôáé ìå ôéò åîüäïõò 1 Þ 2 ðñÝðåé íá áêïëïõèåß ôïõò êáíïíéóìïýò ÅÍ60601-1, ÅÍ60950, ÅÍ60065, ÅÍ60335 Þ ÅÍ61010.

3.

ÐáôÞóôå ìéá öïñÜ ôï äéáêüðôç ON/OFF. Áí îå÷Üóåôå íá êëåßóåôå ôçí ìïíÜäá, áõôÞ èá áðåíåñãïðïéçèåß ìüíç ôçò ìåôÜ áðü Ýíá ëåðôü. ÁíáôñÝîôå óôï êåöÜëáéï ãéá ôçí áðïèÞêåõóç êáé ôïí êáèáñéóìü ôçò ìïíÜäáò, ðñéí ôçí ÷ñçóéìïðïéÞóåôå óå Üëëïí áóèåíÞ. Áðïèçêåýóôå ôçí ìïíÜäá ìáæß ìå ôïí áíé÷íåõôÞ êáé ôá ëïéðÜ åîáñôÞìáôá óôçí åéäéêÞ ìáëáêéÜ èÞêç ðïõ ðáñÝ÷åôáé.

Ç óõóêåõÞ êáé ï áíé÷íåõôÞò åßíáé áíèåêôéêÜ áíôéêåßìåíá êáé äåí áðáéôïýí åéäéêÞ ìåôá÷åßñéóç. Ðáñüëá áõôÜ ç Üêñç ôïõ áíé÷íåõôÞ åßíáé åõáßóèçôç êáé ðñÝðåé íá ìåôá÷åéñßæåôáé ìå ðñïóï÷Þ.

Ìçí ðåôÜôå ôéò ìðáôáñßåò óå öùôéÜ äéüôé ìðïñåß íá äçìéïõñãçèåß Ýêñçîç.

Êáèáñéóìüò

Ìçí ðñïóðáèÞóåôå íá öïñôßóåôå êáíïíéêÝò ìðáôáñßåò. Ìðïñåß íá õðÜñîåé äéáññïÞ Þ áêüìç êáé íá ãßíåé Ýêñçîç.

ÁöáéñÝóôå üôé ðïóüôçôá æåëÝ õðÜñ÷åé åðÜíù óôïí áíé÷íåõôÞ ðñéí ôïí ôïðïèåôÞóåôå óôç èÝóç ôïõ, ìåôÜ ôçí åîÝôáóç. Êáèáñßóôå ôïí ìå Ýíá õãñü ðáíß ðïõ Ý÷åé ìáëáêü áðïññõðáíôéêü. Ðñïóï÷Þ äåí ðñÝðåé íá ôñÝîåé õãñü åðÜíù óôéò ìïíÜäåò.

Ïé Doppler Dopplex åßíáé åñãáëåßá áíß÷íåõóçò ðïõ âïçèÜíå ôïí íïóçëåõôéêü åéäéêü êáé äåí ðñÝðåé íá ÷ñçóéìïðïéïýíôáé ãéá íá áíôéêáôáóôÞóïõí ôçí êáíïíéêÞ áããåéáêÞ Þ åìâñõúêÞ ðáñáêïëïýèçóç. Áí õðÜñ÷ïõí áìöéâïëßåò ãéá ôçí êáôÜóôáóç ôçò õãåßáò ôùí áããåßùí Þ ôïõ åìâñýïõ ìåôÜ ôç ÷ñÞóç ôçò ìïíÜäáò, èá ðñÝðåé íá ãßíïõí áìÝóùò ðåñáéôÝñù åîåôÜóåéò ìå åíáëëáêôéêÝò ôå÷íéêÝò. åíáëëáêôéêÝò ôå÷íéêÝò.

Ãéá áðïëýìáíóç, ÷ñçóéìïðïéåßóôå Ýíá ìáëáêü ðáíß ìå äéÜëõìá Õðï÷ëùñßïõ1000ppm Þ áëêïüë. Óôçí Üêñç ôïõ áíé÷íåõôÞ ìðïñåßôå íá ÷ñçóéìïðïéÞóåôå âáìâÜêé ìå áëêïüë.

63

EëëçíikÜ

Ôï RD2, ÷ñçóéìïðïéåß õðÝñõèñï öùò êáé õðÝñç÷ïõò óå ÷áìçëÜ åðßðåäá üôáí ÷ñçóéìïðéåßôáé ï áíÜëïãïò áíé÷íåõôÞò. Óõíéóôïýìå ç ÷ñÞóç ôùí õðåñÞ÷ùí íá ðáñáìÝíåé óôá ÷áìçëüôåñá äõíáôÜ åðßðåäá (óýìöùíá ìå ôçí êáèïäÞãçóç ALARA). ÁõôÞ èåùñåßôáé ç óùóôÞ ôáêôéêÞ êáé ðñÝðåé íá ðáñáêïëïõèåßôáé äéáñêþò.

ÏÄÇÃÉÅÓ ÁÓÖÁËÅÉÁÓ

Ãéá íá Ý÷åôå ôá êáëýôåñá äõíáôÜ áðïôåëÝóìáôá êñáôÞóôå óôáèåñÜ ôïí áíé÷íåõôÞ óôçí èÝóç ôïõ êáé ñõèìßóôå ôçí Ýíôáóç ôïõ Þ÷ïõ üðùò ÷ñåéÜæåôáé.

ÃÅÍÉÊÇ ËÅÉÔÏÕÑÃÉÁ ÊÁÉ ÓÕÍÔÇÑÇÓÇ Êáèáñéóìüò (óõíÝ÷åéá)

ÊáôáãñáöÞ ôçò ìïñöÞò êõìÜôùí.

Âåâáéùèåßôå üôé åëÝãîáôå ôïõò ôïðéêïýò êáíïíéóìïýò ðåñß ìüëõíóçò êáé áêïëïõèåßôå ïðïéåóäÞðïôå äéáäéêáóßåò êáèáñéóìïý ôïõ åîïðëéóìïý ðïõ áðáéôïýíôáé. Ôá áðïëõìáíôéêÜ ìå âÜóç ôç Öáéíüëç ðïõ ðåñéÝ÷ïõí êáôéïíéêïýò åðéöáíåéïäñáóôéêïýò ðáñÜãïíôåò, ìå âÜóç ôçí áììùíßá, Þ áíôéóçðôéêÜ õãñÜ üðùò Steriscol & Hibiscrub äåí ðñÝðåé íá ÷ñçóéìïðïéïýíôáé ðïôÝ óå ïðïéïäÞðïôå ìÝñïò ôïõ óõóôÞìáôïò.

ÐáñÝ÷ïíôáé áðïôåëÝóìáôá ôçò ìïñöÞò ôùí êõìÜôùí óå áíáëïãéêÞ êáé øçöéáêÞ ìïñöÞ. Ôá áíáëïãéêÜ óÞìáôá ðáñÝ÷ïíôáé ãéá óýíäåóç óå Ýíá ìïíü êáíÜëé êáôáãñáöÞò äéáãñÜììáôïò, ðïõ äßíåé Ýíá óõíäõáóìü ìïñöÞò êõìÜôùí äéðëÞò êáôåýèõíóçò Þ óå Ýíá äéðëü êáíÜëé êáôáãñáöÞò ðïõ äßíåé ôá êýìáôá ìå ìðñïóôéíÞ êáé ïðßóèéá êáôåýèõíóç îå÷ùñéóôÜ. (ÐáñÝ÷ïíôáé ëåðôïìÝñåéåò áí æçôçèåß).

×ñçóéìïðïéåßôå ìüíïí æåëÝ õðåñÞ÷ùí ìå âÜóç ôï íåñü.

Ôá øçöéáêÜ óÞìáôá ðáñÝ÷ïíôáé áðü ôçí Ýîïäï RS232 ãéá åêôýðùóç ôùí êõìÜôùí óôïí Dopplex Printa Þ ãéá åðéêïéíùíßá ìå ôï ëïãéóìéêü Dopplex Reporter.

Áõôïêüëëçôá ÅðéèÝìáôá

Ç ëåéôïõñãßá Cal

ÆåëÝ

Ç ãñáììÞ âÜóçò êáé ç åõáéóèçóßá ôïõ êáôáãñáöÝá ôïõ äéáãñÜììáôïò ìðïñåß íá ñõèìéóôåß ìå ôçí ëåéôïõñãßá Cal. ÁõôÞ åíåñãïðïéåß ìéá ãñáììÞ âÜóçò ìçäåíéêÞò ôá÷ýôçôáò êáé ìéá óõíÝ÷åéá ðáëìþí äéðëÞò êáôåýèõíóçò üðùò öáßíåôáé ðáñáêÜôù:

Ôá åðéèÝìáôá áõôÜ ðáßæïõí ðïëý óçìáíôéêü ñüëï óôçí áðüäïóç êáé ðñÝðåé íá ÷ñçóéìïðïéïýíôáé ìüíïí áõôÜ ðïõ ðáñÝ÷ïíôáé áðü ôçí åôáéñßá Huntleigh Healthcare.

ÏÄÇÃIÅÓ ËÅÉÔÏÕÑÃIÁÓ ÃÉÁ ÔÇÍ ÁÃÃÅÉÏËÏÃÉÊ ÅÎEÔÁÓÇ

Cal

¼ôáí óõíäåèåß Ýíáò áíé÷íåõôÞò áããåßùí óôçí ìïíÜäá ôï Rheo Dopplex® II Doppler (RD2) èá åðéëÝîåé ôçí áããåéêÞ áíß÷íåõóç. ¼ôáí ç ìïíÜäá ëåéôïõñãåß óå áõôÞ ôç ìïñöÞ, åíäåßêíõíôáé ãñáöéêÜ óå ìðÜñåò, ç áíáëïãßá ôçò ñïÞò ôïõ áßìáôïò êáé ç êáôåýèõíóç (4 åðßðåäá óå êÜèå êáôåýèõíóç). Ç ñïÞ ôïõ áßìáôïò áêïýãåôáé êáé áðü ôï ç÷åßï. Ç óõ÷íüôçôá ôïõ áíé÷íåõôÞ åìöáíßæåôáé åðßóçò ìáæß ìå ôéò ìðÜñåò ôùí ãñáöéêþí.

¸ëåã÷ïò êéíÞóåùí. Ãéá íá áíôéìåôùðéóôåß ç ìåãÜëç ðïéêéëßá óçìÜôùí ðïõ áíé÷íåýïíôáé áðü ôï RD2 ç ëåéôïõñãßá áõôÞ óáò åðéôñÝðåé íá ñõèìßóåôå ôçí Ýíäåéîç áðü ôéò ìðÜñåò óôá ãñáöéêÜ êáé íá áõîÞóåôå ôï ýøïò ôùí êõìÜôùí. ×ñçóéìïðïéþíôáò ôïí äéáêüðôç Mode ç Ýíôáóç ìðïñåß íá ñõèìéóôåß x1, x2, x4, x8.

ÊëéíéêÞ ×ñÞóç

Åêôõðþóåéò

ÂÜëôå ìéá ìåãÜëç ðïóüôçôá æåëÝ åðÜíù óôçí ðåñéï÷Þ ðïõ èá åîåôáóôåß. Ôïðïèåôåßóôå ôïí áíé÷íåõôÞ óå èÝóç 45 ìïéñþí åðÜíù óôçí åðéöÜíåéá ôïõ äÝñìáôïò ðÜíù áðü ôï áããåßï ðïõ èá åîåôáóôåß. Ôïðïèåôåßóôå ôïí áíé÷íåõôÞ óå èÝóç ôÝôïéá ðïõ íá ëáìâÜíåôå ôïí êáèáñüôåñï Þ÷ï áðü ôï ç÷åßï. Ïé õøçëïß ðáëìéêïß Þ÷ïé åêðÝìðïíôáé áðü ôéò áñôçñßåò åíþ ïé öëÝâåò åêðÝìðïõí Ýíáí ìç ðáëìéêü Þ÷ï ðáñüìïéï ìå ãñÞãïñï öýóçìá.

Ç êáìðýëç öùôïðëçèõóìïãñáößáò ðñÝðåé áðáñáßôçôá íá ÷ñçóéìïðïéåßôáé ãéá íá åðéâåâáéþíåôáé ï ×ñüíïò ÅðáíáéìÜôùóçò ìå ôç âïÞèåéá ôïõ RD2 óõíäåäåìÝíïõ ìå ôï ðáêÝôï ëïãéóìéêïý Printa Þ Reporter.

Óýíäåóç ìå ôï Printa Ç åêôýðùóç åßíáé åðéëïãÞ ðïõ ãßíåôáé áõôüìáôá üôáí ç ðñßæá ôïõ êáëùäßïõ ôïõ óõíäåôéêïý åéóÜãåôáé ìÝóá óôçí åóï÷Þ ôïõ RS232 óôï åðÜíù ðÜíåë ôïõ RD2. Êáôüðéí ç åêôýðùóç îåêéíÜ ðáôþíôáò ôïí äéáêüðôç Start/Stop.

64

ÏÄÇÃÉÅÓ ËÅÉÔÏÕÑÃÉÁÓ PPG Åßíáé óçìáíôéêü íá õðÜñ÷åé óôáèåñÞ êáôÜóôáóç êáôÜ ôç äéÜñêåéá üëçò ôçò äéáäéêáóßáò. Äéáäéêáóßá 1. Âåâáéùèåßôå üôé õðÜñ÷åé ç óùóôÞ èåñìïêñáóßá óôï äùìÜôéï êáé üôé äåí õðÜñ÷åé êÜôé ðïõ íá åíï÷ëåß ôçí áóèåíÞ. 2. Ç áóèåíÞò ðñÝðåé íá Ý÷åé îåêïõñáóôåß ãéá áñêåôÜ ëåðôÜ ðñéí îåêéíÞóåé ç åîÝôáóç. 3. Ç áóèåíÞò äåí ðñÝðåé íá öïñÜ êáëóüí Þ êÜëôóåò êáé ðáðïýôóéá. Ôá ãüíáôá èá ÐñÝðåé íá âñßóêïíôáé óå ãùíßá 110 ìïéñþí êáé ôá ðüäéá íá áêïõìðïýí óå ìéá ðåôóÝôá Þ êÜðïéï Üëëï èåñìáíôéêü, ìïíùôéêü ðáíß. 4. Ç áóèåíÞò ðñÝðåé íá êÜèåôáé óå êáñÝêëá üðïõ ñõèìßæåôáé ôï ýøïò, Ýôóé þóôå íá õðÜñ÷åé ôï ëéãüôåñï äõíáôü âÜñïò óôá ðüäéá.

Ôïðïèåôåßóôå ôï ìáîéëÜñé ðßóù áðü ôçí ðëÜôç ãéá íá Ýñèåß óå áíÜêëçóç ï áóèåíÞò ðïõ åßíáé ðá÷ýóáñêïò.

Áí ç áíß÷íåõóç åßíáé ðïëý ìåãÜëç ìåôáêéíÞóôå ôïí áéóèçôÞñá ðñïò ôï ðßóù ìÝñïò ôïõ ðïäéïý. Ôï ôÝëïò ôïõ ìðëå ðåñéôõëßãìáôïò ôïðïèåôåßôáé óôçí óöýñá

Ôïðïèåôåßóôå ôï ìïíùôéêü õëéêü êÜôù áðü ôï ðüäé.

Ó÷Þìá 1 ÈÝóç áóèåíÞ. 5. Ïé ðá÷ýóáñêåò áóèåíåßò ðñÝðåé íá åßíáé óå èÝóç áíÜêëçóçò ãéá íá áðïöåõ÷èåß ç ðßåóç óôéò öëÝâåò ôïõ ìçñïý. 6. ÔïðïèåôÞóôå ôïí áéóèçôÞñá 10 åê. ðÜíù áðü ôç ìåóáßá óöýñá. 7. Áí ðñÝðåé íá ìåôáêéíÞóåôå ôïí áéóèçôÞñá, èá ðñÝðåé íá ãßíåé ðñïò ôï ðßóù ìÝñïò ôïõ ðïäéïý êáé ü÷é ðñïò ôï åðÜíù. 8. Åíåñãïðïéåßóôå ôï RD2 ìå ôïí áíé÷íåõôÞ PPG óõíäåäåìÝíï, åîçãÞóôå ôç äéáäéêáóßá óôçí áóèåíÞ êáé åðéôñÝøôå ôçò íá ÷áëáñþóåé êáé íá óôáèåñïðïéçèåß ç áíß÷íåõóç ôïõ RD2. 9. Ç áóèåíÞò èá ðñÝðåé íá áðïöýãåé ôéò âáèéÝò áíáðíïÝò ãéá íá ðÜñåôå óõíå÷Þ áðïôåëÝóìáôá êáé íá åßíáé ôá÷ýôåñç ç óôáèåñïðïßçóç. 10. ÐéÝóôå ôï äéáêüðôç Start/Stop ãéá íá áõîÞóåôå ôçí Ýíôáóç ôïõ Þ÷ïõ ìÝ÷ñé íá áêïõóôïýí ôá êëéê áðü ôç ìïíÜäá. Ôá êëéê áõôÜ åßíáé öõóéïëïãéêüò Þ÷ïò. Èá áêïýãïíôáé êÜèå 10 äåõôåñüëåðôá ìÝ÷ñé íá óôáèåñïðïéçèåß ôï óÞìá PPG. 11. ¼ôáí óôáèåñïðïéçèåß ôï óÞìá, èá áêïõóôåß Ýíáò Þ÷ïò áðü ôç ìïíÜäá äýï öïñÝò êáé èá áñ÷ßóåé ç áíôßóôñïöç ìÝôñçóç ãéá 5 äåõôåñüðëåðôá. ÌåôÜ èá áêïõóôåß ï ìåôñçôÞò ãéá íá äåßîåé ðüôå ðñÝðåé íá áíáóçêùèåß ôï ðüäé óå ðëÞñç Ýêôáóç êáé íá ôåíôùèåß êáé ðüôå ìðïñåß íá ðÝóåé ÷áëáñÜ. Ôï ðüäé ðñÝðåé íá áíáóçêþíåôáé êÜèå öïñÜ ðïõ áêïýãåôáé ï Þ÷ïò.

66

ÏÄÇÃÉÅÓ ËÅÉÔÏÕÑÃÉÁÓ PPG

ÅÃÃÕÇÓÇ ÊÁÉ ÓÕÍÔÃÑÇÓÇ Óôáèåñïß üñïé éó÷ýïõí ãéá üëåò ôéò ðùëÞóåéò ôçò Huntleigh Healthcare. Ôï áíôßãñáöü ôùí üñùí åßíáé äéáèÝóéìï áí ôï æçôÞóåôå. ÐåñéÝ÷åé üëåò ôéò ëåðôïìÝñåéåò ó÷åôéêÜ ìå ôïõò üñïõò ôçò åããýçóçò êáé äåí ðåñéïñßæåé ôá äéêáéþìáôá ôïõ êáôáíáëùôÞ.

Äéáäéêáóßá (óõíÝ÷åéá). Êùäéêïß ÓöáëìÜôùí Ïé ðáñáêÜôù êùäéêïß óöáëìÜôùí èá åìöáíéóôïýí óôçí ïèüíç åÜí ôï ôåóô äåí ãßíåôáé óùóôÜ.

• ER1 – Äåí áíé÷íåýôçêå ç ôåëåõôáßá êßíçóç. Ç ôåëåõôáßá

ÅðéóôñïöÝò ãéá ÓõíôÞñçóç Áí ãéá ïðïéïíäÞðïôå ëüãï åðéóôñÝöåôáé ìéá ìïíÜäá Dopplex, ðáñáêáëïýìå:

êÜìøç êáôÜ ôçí Üóêçóç äåí áíé÷íåýôçêå ðïõ óçìáßíåé üôé ç Üóêçóç äåí Ýãéíå óùóôÜ.

• ER2 – Ï üãêïò ôçò áðïóôñÜããéóçò êáôÜ ôçí Üóêçóç Þôáí ìéêñüôåñïò ôçò âáóéêÞò ãñáììÞò. ÅðáíáëÜâåôå ôï

1. ôéò

Êáèáñßóôå ôç ìïíÜäá óýìöùíá ìå

2.

ÓõóêåõÜóôå ôï êáôÜëëçëá.

3.

Ôïðïèåôåßóôå ôï ðéóôïðïéçôéêü áðïëýìáíóçò (Þ ïðïéïäÞðïôå Üëëï Ýããñáöï ðïõ ðéóôïðïéåß üôé ôï ìç÷Üíçìá Ý÷åé êáèáñéóôåß) óôï åîùôåñéêü ìÝñïò ôçò óõóêåõáóßáò.

4.

Óçìåéþóôå åðÜíù óôçí óõóêåõáóßá "Service Department" (ÔìÞìá ÓõíôÞñçóçò) – Rheo Dopplex II.

ôåóô. Ç áíß÷íåõóç äåí îåðÝñáóå ôçí âáóéêÞ ãñáììÞ.

• ER3 – Ï üãêïò êáôÜ ôçí Üóêçóç Þôáí

ðïëý ÷áìçëüò óå åýñïò. Åöáñìüóôå îáíÜ ôïí áéóèçôÞñá êáé êÜíôå ðÜëé ôï ôåóô. Ôï óÞìá PPG ðïõ ëÜâáôå Þôáí ðïëý ìéêñü êáé ôá áðïôåëÝóìáôá ìðïñåß íá äåß÷íïõí ðñüâëçìá óôç öëÝâá Þ üôé ç áóèåíÞò äåí óçêþíåé ôï ðüäé áñêåôÜ øçëÜ. ÆçôÞóôå áðü ôçí áóèåíÞ íá óçêþóåé ôï ðüäé ðéï øçëÜ êáé êÜíôå ðÜëé ôï ôåóô.

ïäçãßåò ðïõ ðáñÝ÷ïíôáé óôï ó÷åôéêü êåöÜëáéï

Ãéá åðéóêåõÝò, óõíôÞñçóç êáé ïðïéáäÞðïôå Üëëç ðëçñïöïñßá ó÷åôéêÜ ,ìå áõôü Þ ïðïéïäÞðïôå Üëëï ðñïúüí Dopplex ôçò åôáéñßáò Huntleigh Healthcare, ðáñáêáëïýìå áðåõèõíèåßôå óôçí : Huntleigh Healthcare 35 Portmanmoor Road, Cardiff CF24 5HN UK

• ER4 – Ôï ðñþôï ÷ñïíéêü óçìåßï äåí

áíé÷íåýèçêå ìÝóá óå 5 äåõôåñüëåðôá. Ôï ëïãéóìéêü äåí áíß÷íåõóå ôç äÝêáôç êÜìøç êáé ãéá ôï ëüãï áõôü äåí ìðüñåóå íá óçìåéþóåé ôïí ÷ñüíï óôïí ïðïßï ç öëÝâá Üñ÷éóå íá îáíáãåìßæåé. Åöáñìüóôå ôïí áéóèçôÞñá êáé êÜíôå ðÜëé ôï ôåóô.

ÔçëÝöùíï: 0044 (0) 2920 485885 Öáî: 0044 (0) 2920 492520 Ç óôïí ôïðéêü ðñïìçèåõôÞ óáò. ÊáôáóêåõÜóôçêå óôï ÇíùìÝíï Âáóßëåéï áðü ôçí Huntleigh Healthcare. Ùò ìÝñïò ôïõ ôñÝ÷ïíôïò ðñïãñÜììáôïò áíÜðôõîçò ç åôáéñßá äéáôçñåß ôï äéêáßùìá íá ôñïðïðïéÞóåé ÷áñáêôçñéóôéêÜ êáé õëéêÜ ôïõ Rheo Dopplex II ÷ùñßò ðñïåéäïðïßçóç.

• ER5 – Ï ÷ñüíïò áíÜññùóçò Þôáí

®

ìéêñüôåñïò áðü 1 äåõôåñüëåðôï. Ôï ðñþôï óçìåßï ÷ñüíïõ êáé ôï ôåëåõôáßï áíé÷íåýôçêáí óõã÷ñüíùò.

• ER6 – Ôï óÞìá äåí Þôáí äõíáôüí íá

Ôá ëïãüôõðá Dopplex, Huntleigh & “H” åßíáé êáôï÷õñùìÝíá óÞìáôá êáôáôåèÝíôá ôçò Huntleigh Technology 2004.

ìåôñçèåß. Ç áðüêëéóç ôïõ PPG Þôáí ðïëý ìåãÜëç ãéá áõôü ôï óýóôçìá Þ ðÝöôåé êÜôù áðü ôçí âáóéêÞ ãñáììÞ. ÔïðïèåôÞóôå ôïí áéóèçôÞñá îáíÜ ðñïò ôï ðßóù ìÝñïò ôïõ ðïäéïý Þ ìåéþóôå ôçí ðñïóðÜèåéá ãéá êÜìøç êáé åðáíáëÜâåôå ôï ôåóô.

ãHuntleigh Healthcare Ltd 2004.

• ER7 – Ï äéáêüðôçò Start/Stop ðéÝóôçêå êáôÜ ôç äéÜñêåéá ôïõ ôåóô.

69

ÔÅ×ÍÉÊÁ ×ÁÑÁÊÔÇÑÉÓÔÉÊÁ ¼íïìá Ðñïúüíôïò: Êùäéêüò ÌïíôÝëïõ: ÄéáóôÜóåéò:

Rheo Dopplex® II RD2 ÂÜñïò 295 ãñ.(óõìðåñéëáìâÜíïíôáé ï áíé÷íåõôÞò êáé ç ìðáôáñßá) ¾øïò: 140mm ÐëÜôïò : 74mm ÂÜèïò : 27mm. ÌÝãéóôç éó÷ýò åîüäïõ: 500 mW rms ÌÝãéóôç áðüäïóç Áêïõóôéêþí: 25 mW rms (áêïõóôéêÜ 32 W) (ìÝãéóôç ôÜóç +9Vdc) Áõôüìáôç Áðåíåñãïðïßçóç: ÌåôÜ áðü 5 ëåðôÜ óõíå÷ïýò ÷ñÞóçò Þ 1 ëåðôü ÷ùñßò óÞìá RS232: RS232C, ìéêñüò óõíäåôÞñáò DIN 8 pin(ìÝãéóôç ôÜóç +5Vdc) Êýìáôá ÌÝóá áðü åßóïäï DIN óôï åðÜíù ðÜíåë óå áíáëïãéêÞ êáé øçöéáêÞ ìïñöÞ. ÁíáëïãéêÞ: Ìçäåíéêüò äåßêôçò 3,5 V ïëéêÞ êëßìáêá áíÜ êáíÜëé (ìðñïóôÜ êáé ðßóù). Ï ðáñÜãïíôáò ìåôáôñïðÞò ñõèìßæåôáé Ýôóé þóôå íá äþóåé áðïôåëÝóìáôá ïëéêÞò êëßìáêáò óå 0.1% (10%) óõ÷íüôçôáò áíß÷íåõóçò (ð÷. 8kHz ãéá VP8HS). ØçöéáêÞ: ÄåäïìÝíá öïñìáñéóìÝíá ãéá óýíäåóç ìå ôï Printa Þ ëïãéóìéêü Reporter, ðïõ ôñÝ÷åé óå óõìâáôü õðïëïãéóôÞ. Ïé ðáñÜãïíôåò ìåôáôñïðÞò áõôüìáôá ñõèìßæïíôáé üðùò êáé óôçí áíáëïãéêÞ ìïñöÞ áðïôåëåóìÜôùí. Ëåéôïõñãßá CAL: áõôüìáôç óõíÝ÷åéá åðéðÝäùí CAL ñõèìéóìÝíá óå 0.05% (10%) êáé 0.1% (10%) óõ÷íüôçôáò áíß÷íåõóçò (ð÷ 4kHz & 8kHz ãéá VP8HS) ìå ìçäåíéêÜ âáóéêÞ ãñáììÞ óôçí áñ÷Þ êáé ôï ôÝëïò ôçò óõíÝ÷åéáò. Ôýðïò ìðáôáñßáò ðïõ ÓõíéóôÜôáé: ÄéÜñêåéá Ìðáôáñßáò: ÌåôáãùãÝáò VPPG:

Áõôïêüëëçôá ÅðéèÝìáôá:

Áíé÷íåõôÞò:

(MN1604) ÁëêáëéêÞ ìáããáíßïõ 9V ÓõíÞèùò 250 åîåôÜóåéò ôïõ åíüò ëåðôïý Ìåôáäßäåé ìÞêïò êõìÜôùí: 940nm ÌÝãåèïò: 27÷éëéïóôÜ äéÜìåôñï åðß 10 ÷éëéïóôÜ ÌÞêïò êáëùäßïõ: 1.75 ì ÂÜñïò: 10ãñ ÌÝãåèïò: 27 ÷éëéïóôÜ äéÜìåôñï ×áñáêôçñéóôéêÜ: ÉáôñéêÜ áõôïêüëëçôá äéðëïý óôñþìáôïò, õðïáëëåñãéêÜ åõáßóèçôá óôçí ðßåóç, ðïõ äåí åñåèßæïõí ôï äÝñìá. Óõ÷íüôçôåò: ÏÑ2HS: 2.0MHz ±1% OP3HS: 3.0MHz ±1% VP4HS: 4.0MHz ±1% VP5HS: 5.0MHz ±1% EZ8/VP8HS: 8.0MHz±1% VP10HS:10MHz ±1%

Ðåñéï÷Þ Åíåñãïý óôïé÷åßïõ ìåôÜäïóçò:

OP2HS, OP3HS: 233mm² (±15%) VP4HS,VP5HS: 22mm²(±15%) EZ8 : 16mm² (±20%) VP8HS, VP10HS: 8 mm2 (±20%) Óýìöùíá ìå: BS5724: ÌÝñïò 1 : 1989, IEC 601-1: 1988, EN60601-1 IEC601-1 ÊáôÜôáîç: Ôýðïò ðñïóôáóßáò áðü óïê Åîïðëéóìüò ðïõ åíåñãïðïéåßôáé åóùôåñéêÜ Âáèìüò ðñïóôáóßáò áðü óïê. Åîïðëéóìüò Ôýðïõ  Ðñïóôáóßá áðü åéóñïÞ íåñïý Áðëüò åîïðëéóìüò Âáèìüò ðñïóôáóßáò ðáñïõóßá Ï åîïðëéóìüò äåí åßíáé åðáñêÞò ãéá åýöëåêôùí áåñßùí ÷ñÞóç ðáñïõóßá åýöëåêôùí áåñßùí. ÌïñöÞ ëåéôïõñãßáò. Óõíå÷Þò Èåñìïêñáóßá Ëåéôïõñãßáò: +10C ùò +30C Èåñìïêñáóßá ÁðïèÞêåõóçò: -10C ùò +40C Ó÷åôéêÞ Õãñáóßá: 10% åùò 95% Ðñïóï÷Þ á íáöåñèåßôå óå áõôü ôï åã÷åéñßäéï. ! Áíáöåñèåßôå óôï êåöÜëáéï ÁóöÜëåéá.

Medical Devices Directive 93/42/EEC

70

WARNING/CAUTIONS & SAFETY WARNING

Federal law restricts this device to sale by or on the order of a licensed practitioner.

IMPORTANT

Before using your Rheo Dopplex, please study this manual carefully and familiarize yourself with the controls, displays, features and operating techniques.

IMPORTANT

Printouts - It is essential that the PPG Curve is used to confirm the Refill Time using the RD2 connected to the Printa or Reporter software package.

Do not use Dopplers in the presence of flammable gases such as anesthetic agents.

The RD2 uses low levels of infra-red light and low levels of ultrasound when a Doppler probe is used.

Do not use in the sterile field unless additional barrier precautions are taken.

Acoustic Safety

Do not use the PPG probe on patients with fragile or broken skin e.g. Cushings syndrome, open wounds or other similar conditions.

Continuous wave Doppler ultrasound instruments such as the RD2 have been used extensively for medical diagnosis in the United States for over 25 years. Throughout this period, there have been no reports of adverse effects to patients or instrument operators at the acoustic intensities recommended for diagnostic use. Despite this highly favorable safety experience, available data are not conclusive and the possibility remains that unwanted biological effects might be identified in the future. Authorities therefore recommend that ultrasound procedures be performed in accordance with the "ALARA" principle, which states that the energy delivered to the patient should always be kept As Low As Reasonably Achievable. With the RD2, the transmitted acoustic power is fixed and cannot be adjusted by the operator. Therefore, the user can best observe the ALARA principle by ensuring that each examination is medically indicated and by limiting the duration of the study to the extent appropriate for the clinical objectives.

Do not :

• Immerse in any liquid • Use solvent cleaner • Use high temperature sterilizing processes (such as autoclaving) • Use E- beam or gamma radiation sterilization 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 be identified and eliminated. Do not use on the eyes or scrotum. If outputs 1 and 2 are used simultaneously, the system should comply with EN60601-1-1. Any equipment connected to outputs 1 or 2 should comply with EN60601-1, EN60950, EN60065, EN60335 or EN61010. 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. 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. 71

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WARNING/CAUTIONS & SAFETY Acoustic Safety (continued) Acoustic intensity data (ISPTA.3) for probes available for use with the RD2 are summarized in the following table. The values cited are based on measurements in water using a calibrated hydrophone and are stated as the estimated derated intensities. The derated intensity constitutes the most biologically relevant parameter available since true determinations of actual absorbed dose in tissue would require invasive measurement techniques. The derated intensity is therefore calculated mathematically using a derating factor consisting of a constant (the assumed attenuation coefficient) and allowing for the frequency of the probe and the distance from the probe face to the hydrophone. The calculated derated intensity values for the RD2 compare very favorably with previously reported acoustic safety data for Doppler ultrasound instruments and are appropriate for all clinical applications recommended in this manual. As the operating mode of the Dopplex range of probes is continuous wave, ISPPA figures are not applicable.

Acoustic Output Table, Track1, Non-Auto-Scanning Mode Model

Max. Value ISPTA.3

Wo

fc

Zsp

A-6 6, (Zsp)

EBD

OP2 HS

55

41

2.0

2.5

1.1

1.2 x 2.5

OP3 HS

55

32

3.0

2.0

1.2

1.2 x 2.5

VP4 HS

92

7.5

4.0

0.8

0.14

0.365 x 0.8

VP5 HS

92

8.2

5.0

0.8

0.12

0.365 x 0.8

VP8 HS

92

4.0

8.0

0.48

0.026

0.215 x 0.5

EZ8

92

14.3

8.0

0.67

0.064

0.635 x 0.22

VP10 HS

92

1.4

10.0

0.48

0.022

0.215 x 0.5

NOTES 1. Measurement uncertainty: varies with probe and measurement Random - typically ±20% (max. ±32%) Systematic - typically ±6.5% (max. ±8%)

Definition of Terms ISPTA.3

is the derated spatial-peak, temporal-average intensity (milliwatts per square centimeter) Wo is the ultrasonic power (milliwatts) fc is the center frequency (MegaHertz) Zsp is the axial distance used to calculate the derated intensity (centimeters) A-6 6 (Zsp) is ( /4) x (X-6 x Y-6) where X-6, Y-6 are respectively the in-plane (azimuthal) and out-of-plane (elevational) -6dB dimensions in the X-Y plane where Zsp is found (centimeters) EBD are the entrance beam dimensions for the azimuthal and elevational planes (centimeters)

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Cleaning

Refer to diagram on inside front cover for Doppler Measuring Sites and Recommended Probes.

Remove excess gel before replacing the probe. Clean with a damp cloth impregnated with mild detergent. Do not allow fluid to seep into either unit. For disinfection use a soft cloth with Sodium Hypochlorite 1000ppm or alcohol. Alcohol saturated swabs can be used on the probe tip. Please be sure to check your local control of infection policies, or any equipment cleaning procedures. Phenolic, detergent based disinfectants containing cationic surfactants, ammonia based compounds, or antiseptic solutions such as Steriscol or Hibiscrub should never be used on any part of the system.

During Use An automatic noise reduction feature operates on low level signals to improve sound quality. To replace battery see diagram on page 2. After Use 1.

2. 3.

Press and release the On/Off button. If you forget to switch the unit off, it will automatically switch off after 3 minutes. Refer to the cleaning section before storing or using the unit on another patient. Store unit together with probe and accessories in the soft carry case provided.

Coupling Gel Use water-based ultrasound gel ONLY. Adhesive Pads These are important to ensure full performance. Use adhesive pads supplied by Huntleigh Healthcare only.

The control unit and the body of the probe are robust and require no special handling. However, the probe tip is delicate and must be handled with care.

OPERATING INSTRUCTIONS VASCULAR RD2) will The Rheo Dopplex II Doppler (R select vascular mode when a vascular probe is connected to the control unit. In this mode, bi-directional blood flow rate and direction are indicated on bar graphs (4 levels in each direction) and blood flow is audible in the loudspeaker. Probe frequency is displayed together with the bar graphs.

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 Separated waveform outputs are provided in analogue and digital formats. Analogue signals are provided for connection to a single channel chart recorder giving a combined bi-directional waveform, or to a dual channel recorder for separate forward and reverse flow waveforms. (Connection details on request).

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.

Digital signals are provided via the RS232 port for printing separate waveforms on a Dopplex Printa or for communicating with Dopplex Reporter software package. 73

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GENERAL OPERATION & MAINTENANCE

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OPERATING INSTRUCTIONS VASCULAR

OPERATING INSTRUCTIONS VASCULAR

Cal Function

Probes

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 bi-directional pulses as shown below:

Five probes and a sensor are available for vascular examinations:

Cal Pulses

VP4 HS

4MHz ±1% for deep lying vessels

VP5 HS

5MHz ±1% for deep lying vessels and edematous limbs

VP8 HS

8MHz ±1% for peripheral vessels

VP10 HS 10MHz ±1% for specialist superficial applications.

Gain Control To cope with the wide variety of signals detectable using your RD2, a gain control allows you to optimize the bar-graph display and increase the height of the waveforms. Using the Mode button, gain can be set to x1, x2, x4, x8.

EZ8

8MHz ±1% “Widebeam” for peripheral vessels

VPPG

This is an infra red sensor for lower limb venous investigation.

Symbols Displayed on LCD

Connection to Printa™ Hard copy printing is automatically selected when the plug of the interface buffer box is inserted into the RS232 socket on the top panel of the RD2. Printing is then initiated by using the Start/Stop button.

Indicates Venous Refilling time

Connection to Software

Indicates Invert Mode - press Mode button for 2 seconds to reverse displayed blood flow direction and invert Doppler waveforms

Indicates Venous Pump value

The RD2 can be connected to the Reporter Software Package, via the RS232 interface. Dopplex Reporter Software Package is available as an accessory. Communicating is then initiated by using the Start/Stop button.

In Doppler mode, indicates Bidirectional blood flow in realtime. In PPG mode, indicates the size of the PPG signal.

74

It is important that stab ble cond ditions are ob btained d throughout the proced dure. Procedure 1. 2. 3. 4.

Ensure room temperature is comfortable and the patient is free from distractions. Patient must have rested for several minutes before examination can begin. The patient should be seated with stockings and footware removed. The knees should be at an angle of 110° with the feet resting on a towel or other thermal insulating material. The patient should be seated on a height adjustable seat and set to minimise the weight on the feet.

Figure 1 - Patient Positioning If trace is too large, move sensor towards rear of leg

End of blue sleeving placed on malleolus Place cushion behind back to recline patient if obese

Place insulating material under foot

5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16.

Obese patients in particular should be reclined to reduce venous compression on the thigh. Fit the sensor 10cm above the medial malleolus. Use the length of the blue sleeving as a guide. If the sensor has to be relocated, it should be moved towards the back of the leg and not up the leg. Switch on the RD2 with the PPG probe fitted, explain the procedure and allow the patient to rest and the RD2 trace to settle. Deep breaths by the patient should be avoided to obtain consistent results and quicker settling times. Press the Start/Stop button and increase the volume until clicks are heard from the unit. This is normal. These clicks will occur every 10 seconds until the PPG signal is stable. When the signal is stable, the unit will beep twice and start the 5 second countdown sequence. The metronome will then beep to indicate when the foot should be raised to full extension and allowed to fall freely. The foot should be raised at every beep. If the patient is unable to lift the foot sufficiently to obtain adequate VP values, manual calf compression can be given. After the 10th beep, which is long, the foot must be laid flat on the ground and relaxed, ensuring the patient does not put weight on the foot in any way. After approximately 45 seconds, 3 beeps will be heard indicating the test is complete. The refill curve should be smooth - refer to Figure 2. If the curve has bumps or dips, the test should be repeated. A second test should be carried out shortly after the first test to verify that the results correlate. When using a tourniquet, pressure should be increased with larger limbs to obtain the same level of occlusion. Refer to flowchart for limb sizes and pressures. 75

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OPERATING INSTRUCTIONS PPG

ENGL LISH (USA)

OPERATING INSTRUCTIONS PPG Procedure (Continued) VP

Figure 2 - Normal Trace

Venous emptying during exercise

Venous refilling time RT>45 sec Venous Pump, VP = 45 Half Amplitude Time = 14 sec

Venous refilling during rest

Time exercise

rest

0 L R No Tourn

60 sec

The RD2 results should be consistent with clinical symptoms. Interpretation of Traces and Results Venous Insufficiency The refill time indicates the presence or absence of venous incompetence. There are 3 categories:Normal - RT greater than 25 seconds Abnormal - RT less than 20 seconds

Equivocal - RT between 20 and 25 seconds

DVT Screening See Flowchart Error Codes The following Error Codes will be displayed if the test is not performed correctly. • • •

•

• •

•

ER1 - Last movement was not detected. The last flex during exercise was not detected indicating that the exercise was nor performed correctly. ER2 - Exercise drainage volume was less than the baseline. Repeat the test. The trace did not rise above the baseline. ER3 - Exercise drainage volume was very low in amplitude Reapply sensor and repeat test. A very small PPG signal was received and the results could indicate a venous problem or that the patient is not lifting the foot high enough. Encourage patient to lift foot higher and repeat test. ER4 - The first timing point was not detected within 5 seconds. The software failed to detect the 10th flexion and therefore unable to mark the start of the venous filling time. Reapply sensor and repeat test. ER5 - Recovery time was less than 1 second. The first timing point and end point were detected simultaneously. ER6 - The signal was outside the measureable range. The PPG deflection was too large for the system, or deviated below the baseline. Reposition the sensor towards the back of the leg or reduce effort of flexiion, and repeat the test. ER7 - The Start/Stop button was pressed during the test. 76