Benutzeranleitung / Produktwartung 14423-2 des Produzenten Graham Field
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14423-2 / 14423-4 / 14423-8 UL TRASOUND POCKE T DOPPLER USER MANUAL 14423-INS-LAB-RevD11 Impor tant: Do not use the Pocket Doppler without rst reading and understanding this manual! Save this manual for future use. FederalLaw(USA)restrictsthisdevicetosale byorontheorderofaphysician.
14423-INS-LAB-RevD1 1 2 CONTENTS 1 INTRODUCTION .........................................................................3 INTENDEDUSEOFTHISDEVICE ........................................ 3 INCLUDEDFEA TURES .............
14423-INS-LAB-RevD1 1 3 1 INTR ODUCTION This user manual contains important information and safety pr ecautions for the Grafco Ultrasound Pocket Dop- pler . Before using the Pocket Doppler , please r ead and understand this entir e user manual. T ake special note of all safety pr ecautions that begin “W ARNING” and “CAUTION”.
14423-INS-LAB-RevD1 1 4 OPTIONALA CCESSORIES The following accessories for use with the Grafco Ultrason- ic Pocket Doppler ar e available from your GF Health Pr od- ucts, Inc. authorized distributor or www .grahameld.com. ItemNo. ProductDescription 4001GF Coupling Gel, case of 12 0.
14423-INS-LAB-RevD1 1 5 2 SAFETYINFORMA TION SafetyGuidance This unit has internally powered equipment, and the degree of shock protection is type B T ype B protection means that this product is in accordance with permitted leakage currents and dielectric strengths of IEC 60601-1.
14423-INS-LAB-RevD1 1 6 WARNINGS W ARNING:FederalLaw(USA)restrictsthisdeviceto salebyorontheorderofaphysician.Thisproduct shouldnotbeusedunlesstheoperatorhasbeenin- structedbyaqualiedhealthcareprofessional.
14423-INS-LAB-RevD1 1 7 W ARNING:DonottheusePocketDopplerifthebat- terycoverisopen. W ARNING:UseonlythoseprobesprovidedbyGF HealthProducts,Inc.intendedtobeusedwiththe GrafcoPocketDoppler .
14423-INS-LAB-RevD1 1 8 NO TICES s NOTICE:ThemainunitoftheGrafcoPocketDoppler isdesignedforcontinuousnormaloperation.Donot immerseorsubmergeinanyliquid. s NOTICE:KeepthePocketDoppleranditsenviron- mentcleananddust-free.
14423-INS-LAB-RevD1 1 9 SYMBOLS Attention: Refer to accompanying documents (this manual). This item is compliant with Medical Device Directive 93/42/ EEC of June 14, 1993, a directive of the European Economic Community . This symbol consisting of two parts, see below .
14423-INS-LAB-RevD1 1 10 3 HANDLING GFHEAL THPRODUCTS,INC.FREIGHTPOLICY F ory ourpr otection,readcar efull y The carrier accepted this mer chandise “in good condition” and is r esponsible for safe deliver y . Before signing the fr eight bill, inspect the shipment carefully for damage or missing pieces.
14423-INS-LAB-RevD1 1 1 1 Inspection Check the Pocket Doppler for nicks, dents, scratches, me- chanical or other damage. Check all the cables and acces- sories.
14423-INS-LAB-RevD1 1 12 4 UL TRASOUNDPOCKETDOPPLER ANDA CCESSORIES APPEARANCEANDFEA TURES The following gur es illustrate the Pocket Doppler with the 2.0 MHz water-resistant pr obe, and accompanying tables describe labeled featur es.
14423-INS-LAB-RevD1 1 13 Pow e r Button T urns the Ultrasound Pocket Doppler ON or OFF Probe Sock et The probe connects here to the Ultrasound Pocket Doppler Jack Denition 1 Power Supply .
14423-INS-LAB-RevD1 1 14 R earPanel F ea tur e Function P ock etClip Attachment Attaches Pocket Doppler to pocket Batter y Compar tment Opens to install/replace battery ProbeFrame At.
14423-INS-LAB-RevD1 1 15 To p Panel F ea tur e Function Sock et Name Picture Function Charge Socket Not used Earphone Socket Connect earphone Signal Interface 1 GND 2 Signal 3 Signal 4 Signal 5 .
14423-INS-LAB-RevD1 1 16 LeftPanel F ea tur e Function V olumeControl Adjust volume Increase volume: Rotate volume knob clockwise Decrease volume: Rotate volume knob counter-clockwise MODE.
14423-INS-LAB-RevD1 1 17 POCKETDOPPLERWA TER-RESIST ANTPR OBES The 2.0 MHz, 4.0 MHz, and 8.0 MHz water-resistant pr obes connect to the main unit of the Grafco Pocket Doppler via the pr obe socket.
14423-INS-LAB-RevD1 1 18 5 SETUP INST ALLING OR REPLACING THE B A TTER Y W ARNING:EnsurethatPocketDopplerpowerisoff beforereplacingthebattery . W ARNING:Install/replacethebatteryatleast6feet (1.
14423-INS-LAB-RevD1 1 19 s NOTICE:Ifthebatteryterminalsbecomedirty ,wipe themwithaclean,dryclothbeforeusingthePocket Doppler .
14423-INS-LAB-RevD1 1 20 6 OPERA TION PROBEOPERA TION R emo vingtheProbefr omthePoc k etDoppler s NOTICE:Donotdragordroptheprobe.Donotdis- connecttheprobefromthePocketDoppler .
14423-INS-LAB-RevD1 1 21 SwappingProbes s NOTICE:Donotdragordroptheprobeortheprobe connector . The Pocket Doppler is shipped with one pr obe connected. T o replace the connected pr obe with another Pocket Dop- pler pr obe: 1.
14423-INS-LAB-RevD1 1 22 FET ALHEART(FH)MONIT ORING FHMonitoringwith2.0MHzWa ter-R esistantProbe Refer to pictur e at right.
14423-INS-LAB-RevD1 1 23 V ASCULAR MONIT ORING WITH 4.0 OR 8.0 MHZ PROBE (OPTIONAL) The 4.0 MHz and 8.0 MHz pr obes can be used to perform vascular monitoring assessment of blood ow . The 8.0 MHz pr obe is used for more supercial evaluation than the 4.
14423-INS-LAB-RevD1 1 24 1. Apply a liberal amount of gel on the site to be exam- ined. 2. Place the pr obe so that the head is at least at 45º to the vessel to be examined. 3. Adjust the position of the pr obe to obtain the loudest audio signal. For best r esults, keep the probe as still as possible once the optimum position is located.
14423-INS-LAB-RevD1 1 25 7 MAINTENANCE W ARNING:Failureonthepartoftheresponsiblefacil- ityemployingtheuseofthisequipmenttoimplement asatisfactorymaintenanceschedulemaycauseun- dueequipmentfailureandpossiblehealthhazard.
14423-INS-LAB-RevD1 1 26 s NOTICE:KeepthePocketDoppleranditsenviron- mentcleananddust-free.Protectthedevicefromvi- bration,corrosivemedicine,andhightemperatures.
14423-INS-LAB-RevD1 1 27 CleaningtheP ock etDopplerPr obe s NOTICE:Donotallowliquidtoentertheultrasound system. s NOTICE:Donotpourliquidsontheprobewhile cleaning. The Pocket Doppler pr obe’ s acoustic surface is fragile and must be handled with car e.
14423-INS-LAB-RevD1 1 28 DISINFECTION DisinfectingtheP ock etDopplerPr obe s NOTICE:Donotallowanyliquidtoentertheprobe socketwhiledisinfectingorimmersingtheprobe. 1. Clean the exterior surface of the pr obe as recommend- ed in the pr evious section.
14423-INS-LAB-RevD1 1 29 8 SPECIFICA TIONS ModelNumber andName 14423-2 Ultrasonic Pocket Doppler with 2.0 MHz probe 14423-4 Ultrasonic Pocket Doppler with 4.
14423-INS-LAB-RevD1 1 30 Physical Characteristics Size (Width x Depth x Height) 3.35 x 1.26 x 5.43 inches (85 x 32 x 138 mm) Weight (including a battery and a probe) .64 lb (290 ±5g) En vironment Working T emperature 41°F ~ 104°F (5°C ~ 40°C) Humidity ≤80% RH Atmospheric Pressure 12.
14423-INS-LAB-RevD1 1 31 Ultrasound Nominal Frequency 2.0 MHz W ater-Resistant Probe 2.0 MHz 4.0 MHz W ater-Resistant V ascular Probe 4.0 MHz 8.0 MHz W ater-Resistant V ascular Probe 8.0 MHz Working Frequency 2.0 MHz W ater-Resistant Probe 2.0 MHz ±10% 4.
14423-INS-LAB-RevD1 1 32 9 LIMITEDWARRANTY GF Health Products Inc. warrants this pr oduct to be fr ee fr om manufacturing defects in material and workmanship for its period of warranty that is in accor dance with industr y standar ds.
14423-INS-LAB-RevD1 1 33 pur chaser’ s cost, for warranty inspection using the serial number as identication (or , if the product is not serialized, lot number and date code) within thirty (30) days of return authorization issue date.
14423-INS-LAB-RevD1 1 34 Thi s war rant y giv es you spec ic lega l righ ts and you may also have other legal rights which var y fr om state to state (pr ov- ince to province).
14423-INS-LAB-RevD1 1 35 10 APPENDIXA,ECDECLARA TIONOF CONFORMITY ECDec lar ationof Confor mity Manufactured for GF Health Products, Inc.
14423-INS-LAB-RevD1 1 36 11 APPENDIXB ,EMCINFORMA TION GUID ANCEANDMANUF ACTURER’S DECLARA TION Electroma gneticEmissions—forallEquipment andSystems Guidance.
14423-INS-LAB-RevD1 1 37 Electroma gneticImmunity—forallEquipment andSystems thatarenotLife-Suppor ting Guidanceandmanufacturer’sdec lar ation— electroma gneticimmunity The Grafco Ultrasound Pocket Doppler System is intended for use in the electromagnetic environment specied below .
14423-INS-LAB-RevD1 1 38 Info 1: At 80 MHz and 800 MHz, the higher frequency range applies. Info 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from struc- tures, objects and people.
14423-INS-LAB-RevD1 1 39 For transmitters rated at a maximum output power not listed previously , the recommended separation distances in meters (m) can be estimated using the equation applicable t.
14423-INS-LAB-RevD1 1 40 12 APPENDIX C, O VERALL SENSITIVITY Ov er allSensitivity(2MHzProbe) Diameter of T arget Reector (mm) Distance (d) (mm) Reflection Loss A (d) T wo-way Attenuation B=∑B a +B w ∑B a (T :mm B a :dB) B w (dB) B (dB) 1.
14423-INS-LAB-RevD1 1 41 Ov er allSensitivity(2MHzProbe) Diameter of T arget Reector (mm) V n (r .m.s.) mV V n (r .m.s.) mV dB Overall Sensitivity (S=A(d)+B+C) dB 1.58 A=45.7dB @2 MHz 186 94 5.93 109.2 175 90 5.78 107.8 174 89 5.82 107.
14423-INS-LAB-RevD1 1 42 13 INDEX A Accessories, optional 4 Accessory equipment, certica- tion of 6 Address, Graham-Field 34 Appendix A, EC Declaration of Conformity 35 Appendix B, EMC inform.
14423-INS-LAB-RevD1 1 43 T T elephone number , Graham-Field 34 T op panel features and illustra- tion 15 U User manual, contents of 3 V V olume control 16 W WARNING statement, signi- cance 5 W a.
USA Corporate Headquar ters: GF Health Products, Inc. 2935 Nor theast Parkway Atlanta, Georgia 30360 telephone: 770-368-4700 www .grahamfield.com 14423-INS-LAB-RevD11 © 2011 GF Health Products, Inc.
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