Graham Field 14423-8 manuale d’uso

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.  FederalLaw(USA)restrictsthisdevicetosale byorontheorderofaphysician.Thisprodu[...]

14423-INS-LAB-RevD1 1 2 CONTENTS 1 INTRODUCTION .........................................................................3 INTENDEDUSEOFTHISDEVICE ........................................ 3 INCLUDEDFEA TURES .......................................................... 3 OPTIONALACCESSORIES .........................[...]

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”. Save thi[...]

14423-INS-LAB-RevD1 1 4 OPTIONALA 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 .grahameld.com. ItemNo. ProductDescription 4001GF Coupling Gel, case of 12 0.25 liter bottles 4002GF Coupling Gel, 5 liter bot[...]

14423-INS-LAB-RevD1 1 5 2 SAFETYINFORMA TION SafetyGuidance 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. SAFETYPRECA UTIONS The safety statements pr esented i[...]

14423-INS-LAB-RevD1 1 6 WARNINGS  W ARNING:FederalLaw(USA)restrictsthisdeviceto salebyorontheorderofaphysician.Thisproduct shouldnotbeusedunlesstheoperatorhasbeenin- structedbyaqualiedhealthcareprofessional.  W ARNING:Donotuset[...]

14423-INS-LAB-RevD1 1 7  W ARNING:DonottheusePocketDopplerifthebat- terycoverisopen.  W ARNING:UseonlythoseprobesprovidedbyGF HealthProducts,Inc.intendedtobeusedwiththe GrafcoPocketDoppler .  W ARNING:Donotstretchtheprobecable?[...]

14423-INS-LAB-RevD1 1 8 NO TICES s  NOTICE:ThemainunitoftheGrafcoPocketDoppler isdesignedforcontinuousnormaloperation.Donot immerseorsubmergeinanyliquid. s  NOTICE:KeepthePocketDoppleranditsenviron- mentcleananddust-free.Protectthedevic[...]

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 . Indicates that the equipment should be disposed of according to local regulat[...]

14423-INS-LAB-RevD1 1 10 3 HANDLING GFHEAL THPRODUCTS,INC.FREIGHTPOLICY F ory ourpr otection,readcar 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. Appar ent[...]

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. ST ORAGE Stor e the repackaged Pocket Doppler in a dry area. s  NOTICE:EnsurethatthetemperatureatthePocket Doppler'slocationduringstoragedoes?[...]

14423-INS-LAB-RevD1 1 12 4 UL TRASOUNDPOCKETDOPPLER ANDA CCESSORIES APPEARANCEANDFEA 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. F rontPanel F ea tur e Function Display Panel Displays system info System status L[...]

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 Denition 1 Power Supply 2 Signal 3 Probe Coding 1 4 Probe Coding 2 5 Probe Coding 3 6 (Shell) GND[...]

14423-INS-LAB-RevD1 1 14 R earPanel F ea tur e Function P ock etClip Attachment Attaches Pocket Doppler to pocket Batter y Compar tment Opens to install/replace battery ProbeFrame Attaches probe to Pocket Doppler[...]

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 Signal War ning Refer to accompanying documents (this user manual)  W ARNING: Accessoryequipmentconnectedtothe analoganddig[...]

14423-INS-LAB-RevD1 1 16 LeftPanel F ea tur e Function V olumeControl Adjust volume Increase volume: Rotate volume knob clockwise Decrease volume: Rotate volume knob counter-clockwise MODEButton Not used ST ART/ST OPButton REC/PLA YButton[...]

14423-INS-LAB-RevD1 1 17 POCKETDOPPLERWA TER-RESIST ANTPR 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. The following table lists and describes the main information on each pr obe's label in or der of ap- pearance: P ock etDopplerWa [...]

14423-INS-LAB-RevD1 1 18 5 SETUP INST ALLING  OR  REPLACING  THE  B A TTER Y  W ARNING:EnsurethatPocketDopplerpowerisoff beforereplacingthebattery .  W ARNING:Install/replacethebatteryatleast6feet (1.5meters)fromthepatient.  W ARNING:Useonly9V?[...]

14423-INS-LAB-RevD1 1 19 s  NOTICE:Ifthebatteryterminalsbecomedirty ,wipe themwithaclean,dryclothbeforeusingthePocket Doppler . s  NOTICE:Batterieshavelifecycles.Ifthebatteryuse timeshortensnoticeably ,thebattery'slifecycleis over [...]

14423-INS-LAB-RevD1 1 20 6 OPERA TION PROBEOPERA TION R emo vingtheProbefr omthePoc k etDoppler s  NOTICE:Donotdragordroptheprobe.Donotdis- connecttheprobefromthePocketDoppler . 1. The pr obe is installed in Pocket Doppler probe frame (left pictur e above). Hold the Po[...]

14423-INS-LAB-RevD1 1 21 SwappingProbes s  NOTICE:Donotdragordroptheprobeortheprobe 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. Follow steps 1-3 in pr evious section, Removing the Pr obe fr om the Pocket Doppl[...]

14423-INS-LAB-RevD1 1 22 FET ALHEART(FH)MONIT ORING FHMonitoringwith2.0MHzWa ter-R esistantProbe Refer to pictur e at right. The au- dio fetal heart beat is sent out via the built-in speaker or attached earphone. 1. Palpate for the fetus position to nd the best location to place the pr obe and hear the fetal heart r[...]

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 supercial evaluation than the 4.0 MHz pr obe. Refer to the following probe site illustrat[...]

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. 4. Adj[...]

14423-INS-LAB-RevD1 1 25 7 MAINTENANCE  W ARNING:Failureonthepartoftheresponsiblefacil- ityemployingtheuseofthisequipmenttoimplement asatisfactorymaintenanceschedulemaycauseun- dueequipmentfailureandpossiblehealthhazard. MAINTENANCE  W ARNING:Befor[...]

14423-INS-LAB-RevD1 1 26 s  NOTICE:KeepthePocketDoppleranditsenviron- mentcleananddust-free.Protectthedevicefromvi- bration,corrosivemedicine,andhightemperatures. s  NOTICE:Donotusehigh-temperaturesterilizingpro- cess,lowtemperaturesteam,E-beam,and[...]

14423-INS-LAB-RevD1 1 27 CleaningtheP ock etDopplerPr obe s  NOTICE:Donotallowliquidtoentertheultrasound system. s  NOTICE:Donotpourliquidsontheprobewhile cleaning. The Pocket Doppler pr obe’ s acoustic surface is fragile and must be handled with car e. 1. T o prolong the [...]

14423-INS-LAB-RevD1 1 28 DISINFECTION DisinfectingtheP ock etDopplerPr obe s  NOTICE:Donotallowanyliquidtoentertheprobe socketwhiledisinfectingorimmersingtheprobe. 1. Clean the exterior surface of the pr obe as recommend- ed in the pr evious section. 2. T o disinfect the probe, immer[...]

14423-INS-LAB-RevD1 1 29 8 SPECIFICA TIONS ModelNumber andName 14423-2 Ultrasonic Pocket Doppler with 2.0 MHz probe 14423-4 Ultrasonic Pocket Doppler with 4.0 MHz probe 14423-8 Ultrasonic Pocket Doppler with 8.0 MHz probe Safety Complies with: EN 60601-1/1990 Classication Anti-electric Shock T ype Internally powered equipment Anti[...]

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 12.47 ~ 15.37 psi (86 ~ 106 kPa) T ransport and Storage [...]

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% 4.0 MHz W ater-Resistant V ascular Probe 4.0 MHz ±10% 8.0 MHz W ater-Resistant V ascular Pro[...]

14423-INS-LAB-RevD1 1 32 9 LIMITEDWARRANTY 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. This warranty is extended only to the original pur chaser/consumer or dealer/non-consumer of this new pr o[...]

14423-INS-LAB-RevD1 1 33 pur chaser’ s cost, for warranty inspection using the serial number as identication (or , if the product is not serialized, lot number and date code) within thirty (30) days of return authorization issue date. In the event you do not receive sat- isf act or y war ran ty service , plea se cont act GF Heal th Prod uct[...]

14423-INS-LAB-RevD1 1 34 Thi s war rant y giv es you spec ic 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). Some states (pr ovinces) do not allow the ex clu sio n or limi tat io n of inci de nta l or con seq uen tia l dama ge, or limitation on how long an implied warranty la[...]

14423-INS-LAB-RevD1 1 35 10 APPENDIXA,ECDECLARA TIONOF CONFORMITY ECDec lar ationof Confor mity Manufactured for GF Health Products, Inc., 2935 Northeast Parkway , Atlanta, GA 30360 Product Ultrasound Pocket Doppler Classication (MDD, Annex IX): IIa We herewith declare that the above mentioned product(s) meet the tr[...]

14423-INS-LAB-RevD1 1 36 11 APPENDIXB ,EMCINFORMA TION GUID ANCEANDMANUF ACTURER’S DECLARA TION Electroma gneticEmissions—forallEquipment andSystems Guidanceandmanufacturer’sdec lar ation— electroma gneticemission The Grafco Ultrasound Pocket Doppler is intended for use in the electromagnet[...]

14423-INS-LAB-RevD1 1 37 Electroma gneticImmunity—forallEquipment andSystems thatarenotLife-Suppor ting Guidanceandmanufacturer’sdec lar ation— electroma gneticimmunity The Grafco Ultrasound Pocket Doppler System is intended for use in the electromagnetic environment specied below . Do not use the sys[...]

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 reection from struc- tures, objects and people. a: Field strengths from xed transmitters, such as base stations for radio (cellular/c[...]

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 to the frequency of the transmitter , where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufactu[...]

14423-INS-LAB-RevD1 1 40 12 APPENDIX  C,  O VERALL  SENSITIVITY Ov er allSensitivity(2MHzProbe) Diameter of T arget Reector (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) 1.58 A=45.7dB @2 MHz 50 45.7 T 20 4.8 4.0 - 0 57.6 Ba 40 9.6 8.0 - 75 45.7 T [...]

14423-INS-LAB-RevD1 1 41 Ov er allSensitivity(2MHzProbe) Diameter of T arget Reector (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 5.82 107.9 173 90 5.68 100.9 2.38 A=43.2dB @2 MHz 178 89 6.02 1 10.0 170 90 5.52 107.1 165 85 5.76 105.3 [...]

14423-INS-LAB-RevD1 1 42 13 INDEX A Accessories, optional 4 Accessory equipment, certica- tion of 6 Address, Graham-Field 34 Appendix A, EC Declaration of Conformity 35 Appendix B, EMC information 36 Appendix C, Overall Sensitivity 40 B Battery , installing / r eplacing 18 Battery terminals, cleaning 19 C CAUTION statement, signicance 5[...]

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 arranty , limited 32[...]

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.[...]