User Manual - Ultrasound Pocket Doppler
Contents
1. or damage If damage is discovered after delivery is made a concealed damage claim must be entered with the freight carrier When this occurs make a written request to the carrier for inspection This request for inspection must be made within 15 days of delivery The carrier will provide all paperwork necessary to file a concealed damage or loss claim since such damage or loss is the carrier s responsibility UNPACKING Info Unless the Pocket Doppler is to be used immediately retain containers and packing materials for storage until Pocket Doppler use is required 1 Check for obvious damage to the carton or its contents If damage is evident please notify the carrier and your GF Health Products Inc authorized distributor 2 Remove all loose packing from the carton 3 Carefully remove all the components from the carton 14423 INS LAB RevE13 10 Inspection Check the Pocket Doppler for nicks dents scratches mechanical or other damage Check all the cables and accessories STORAGE Store the repackaged Pocket Doppler in a dry area A NOTICE Ensure that the temperature at the Pocket Doppler s location during storage does not fall below 4 F 20 C or exceed 131 F 55 C A NOTICE Ensure that relative humidity at the Pocket Doppler s location during storage does not exceed 93 14423 INS LAB RevE13 11 4 ULTRASOUND POCKET DOPPLER AND ACCESSORIES APPEARANCE AND FEATURES The following figures illustra2. probe socket while cleaning The Pocket Doppler probe s acoustic surface is fragile and must be handled with care de To prolong the life of the probe after each use gently wipe off the remaining gel from the probe with a clean dry non abrasive cloth After thoroughly cleaning the probe replace it in the Pocket Doppler probe frame If necessary wipe the external surface of probe with 10 ethanol or isopropranol alcohol Allow to air dry NOTICE Do not allow any cleaning solution to remain on the surface of the Pocket Doppler or the probe after cleaning 14423 INS LAB RevE13 27 DISINFECTION Disinfecting the Pocket Doppler Probe A NOTICE Do not allow any liquid to enter the probe socket while disinfecting or immersing the probe 1 Clean the exterior surface of the probe as recommended in the previous section 2 To disinfect the probe immerse the probe in a solution of Benzalkonium Bromide 0 5 Chlorhexidine 2 Glutaraldehyde or 75 ethanol 3 Wipe the probe with a clean dry non abrasive cloth to remove any remaining moisture A NOTICE Do not allow any cleaning solution to remain on the surface of the Pocket Doppler or the probe after disinfecting 14423 INS LAB RevE13 28 8 SPECIFICATIONS Model Number Ultrasonic Pocket Doppler and Name with 2 0 MHz probe Ultrasonic Pocket Doppler with 4 0 MHz probe 14423 8 Ultrasonic Pocket Doppler with 8 0 MHz probe Safety Complies with EN 60601 1 1
3. 4002GF Coupling Gel 5 liter bottle 14423 2P 2 0 MHz Waterproof Probe 14423 4P 4 0 MHz Waterproof Vascular Probe 14423 8P 8 0 MHz Waterproof Vascular Probe 14423 INS LAB RevE13 2 SAFETY INFORMATION Safety Guidance This unit has internally Type B protection means that this powered equipment product is in accordance with and the degree of shock permitted leakage currents and protection is type B dielectric strengths of IEC 60601 1 SAFETY PRECAUTIONS The safety statements presented in this chapter refer to the basic safety information that the operator of the Pocket Doppler shall pay attention to and abide by There are additional safety statements in other chapters or sections which may be the same as or similar to the following or specific to the operations WARNING and CAUTION statements must be observed To avoid the possibility of injury observe the following precautions during the operation of the instrument Please note the following special statements used throughout this manual and their significance A WARNING Indicates a potential hazard situation or unsafe practice that if not avoided could result in death or serious personal injury ZA CAUTION Indicates a potential hazard or unsafe practice that if not avoided could result in moderate or minor personal injury A NOTICE Indicates a potential hazard or unsafe practice that if not avoided could result in product or property damage I
4. 990 Classification Anti electric Internally powered equipment Shock Type Anti electric Type B equipment Shock Degree Degree of Main Unit Non protected Protection against 2 0 MHz IPX8 Water Harmful Waterproof Ingress Ingress of Probe Protection Code which mar HHz or limdicates this probe can work Vascular Probe continuously for 8 0 MHz 5 hours when Waterproof being immersed Vascular Probe in water within 1 meter Degree of Equipment not suitable for use in Safety in presence of flammable gases Presence of Flammable Gases Working Continuous running equipment System Group Class B 14423 INS LAB RevE13 29 Physical Size 3 50 x 1 34 x 5 55 inches Characteristics W x D x H 89 x 34 x 141 mm Weight 66 Ib lt 300 g including battery Temperature 41 F 104 F 5 C 40 C Humidity 25 80 non condensing Atmospheric 12 47 psi 15 37 psi Pressure 860hPa 1060 hPa Transport and Temperature 4 F 131 F Storage 20 C 55 C Humidity 25 93 non condensing Atmospheric 10 15 psi 15 37 psi Pressure 700hPa 1060 hPa FHR FHR Measuring 50 bpm 210 bpm Performance Range Resolution tbpm Audio Output Power Battery Battery Type 1 5V alkaline battery Recommended IEC 60086 LR6 AA or Ni MH 1 2V rechargeable battery Battery gt 9 hours Stand by Time 14423 INS LAB RevE13 30 Nominal 2 0 MHz Frequency Waterproof Probe 4 0 MHz
5. A NOTICE Batteries have life cycles If the battery use time shortens noticeably the battery s life cycle is over Replace the old battery with a new one of the same size and type Use only batteries recommended by GF Health Products Inc A NOTICE Remove a battery whose life cycle is over from the Pocket Doppler immediately A NOTICE Dispose of the old battery in accordance with local regulations 14423 INS LAB RevE13 19 6 OPERATION PROBE OPERATION Removing the Probe from the Pocket Doppler A NOTICE Do not drag or drop the probe Do not disconnect the probe from the Pocket Doppler 1 The probe is stored in the Pocket Doppler probe frame Hold the Pocket Doppler main unit with one hand and hold the top of the probe with the other hand 2 Gently remove the top of the probe from the Pocket Doppler probe frame 3 Remove the entire probe from the Pocket Doppler probe frame Placing the Probe in the Pocket Doppler A NOTICE Do not drag or drop the probe Do not disconnect the probe from the Pocket Doppler 1 Hold the Pocket Doppler main unit with one hand and hold the probe with the other hand 2 Gently guide the middle of the probe into the Pocket Doppler s probe frame 3 Gently replace the top of the probe entirely into the Pocket Doppler s probe frame 14423 INS LAB RevE13 20 Swapping Probes A NOTICE Do not drag or drop the probe or the probe connector The Pocket Doppler i
6. AGraham Field Brand ULTRASOUND POCKET DOPPLER USER MANUAL ZA 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 instructed by a qualified healthcare professional CONTENTS 1 INTRODUCTION nesesosonononononononenonenenenenenenenenenenenenenenenenenenenenenenen 3 INTENDED USE OF THIS DEVICE sesesesonononononononenenenenenenenenen 3 INCLUDED FEATURES esesosononononononononennnennnenenenenenenenenenenenenen 3 OPTIONAL ACCESSORIES rrnrnrnrnrnvnvnenenenenenenenenenenenenenenenenens 4 2 SAFETY INFORMATION s sssssssssssssssssssssssssesssessseneseseneseaeaees 5 SAFETY PRECAUTIONS nrnrnonenonenenenenenenenenenenenenenenenenenenenensnn 5 SYMBOLS NN 9 Re RANDLING oaz owo won nt tastet cant ei secs 10 GF HEALTH PRODUCTS INC FREIGHT POLICY 10 ONBACKINO Sorte eh eee A 10 STORAGE sne 11 4 ULTRASOUND POCKET DOPPLER AND ACCESSORIES 12 APPEARANCE AND FEATURES sononononononononononenenenenenenenensnn 12 POCKET DOPPLER WATERPROOF PROBES 1 1 111111111 1 17 BATTERY cessions YO EEEE SZEWSKA 17 GE SETUP used 18 INSTALLING OR REPLACING THE BATTERY 1 1 11111 1 1 18 6 OPERATIONS 20 PROBE OPERATION snrnvornvnrnsnsnsnsnsnsnsesesesesesesesesesesenenenenenen 20 TURNING ON THE POCKET DOPPLER 1 21 FETAL HEART FH MONITORING sesesosenonononenonenenenenenenenen 22 VASCULAR MONITORI
7. NG WITH 4 0 OR 8 0 MHZ PROBE OPTIONAL seere 23 TURNING OFF THE POCKET DOPPLER 1 1 1 1 1 24 REPLACING THE BATTERY sososononononononononnnenenenenenenenenenenenen 24 7 MAINTENANCE AND CLEANING nrnonononononononenenenenenenenenenenenenenn 25 MAINTENANCE snsnvnvnvnvnvnvnnnvnsnsnsnsnsnsnsesesesesesesesesesesesesesenenen 25 TT 26 DISINFECTION RR NE 28 SPECIFICATIONS cocci ce ect cedesccsecctance testa teta eta 29 Q LIMITED WARRANTY nrnrnononononononononenenenenenenenenenenenenenenenenenenenenn 32 10 APPENDIX A EC DECLARATION OF CONFORMITY 1 1 35 11 APPENDIX B EMC INFORMATION sesososononononononenenenenenenenenenenen 36 GUIDANCE AND MANUFACTURER S DECLARATION 36 12 APPENDIX C OVERALL SENSITIVITY snsensensensensenvonnnennensensensense 40 E d a EEA A E Zd ar ISO tree noe Norn 42 GF Health Products Inc is not responsible for typographical errors All illustrations specifications packaging and warranties contained in this literature are based on the latest product information available at the time of printing The most current product information including the most current version of these instructions can be found online at www grahamfield com Graham Field and Grafco are registered trademarks of GF Health Products Inc 14423 INS LAB RevE13 2 1 INTRODUCTION This user manual contains important information and safety precautions for the Grafco Ultrasound Pocket Doppler Before usi
8. Products Inc s control are not covered by this warranty and that evaluation shall be solely determined by GF Health Products Inc This warranty shall not apply to problems arising from normal wear and tear or failure to follow instructions The warranty shall also not apply to products modified without GF Health Products Inc s express written consent nor shall it apply if parts not manufactured by GF Health Products Inc or if parts not complying with original equipment specifications are added to GF Health Products Inc products or if the product or part is serviced by an entity not authorized by GF Health Products Inc The foregoing warranty is exclusive and in lieu of all other express warranties and implied warranties including but not limited to the implied warranties of merchantability and fitness for a particular purpose and shall not extend beyond the duration of the express warranty provided herein and the remedy for violations of any implied warranty shall be limited to the repair replacement credit and or refund of the defective product or part pursuant to the terms contained herein GF Health Products Inc shall not be liable for any consequential or incidental damages whatsoever This warranty gives you specific legal rights and you may also have other legal rights which vary from state to state province to province Some states provinces do not allow the exclusion or limitation of incidental or consequential d
9. Waterproof Vascular Probe 8 0 MHz Waterproof Vascular Probe Working 2 0 MHz 2 0 MHz 10 Frequency Waterproof Probe 4 0 MHz 4 0 MHz 10 Waterproof Vascular Probe 8 0 MHz 8 0 MHz 10 Waterproof Vascular Probe CS CS Effective 2 0 MHz 245mm2 15 Radiating Area Waterproof of Transducer Probe 4 0 MHz 32mm 15 Waterproof Vascular Probe 8 0 MHz 14mm 15 Waterproof Vascular Probe 14423 INS LAB RevE13 31 9 LIMITED WARRANTY GF Health Products Inc warrants the Grafco Pocket Doppler and its components to be free from manufacturing defects for a period of one year This warranty is extended only to the original purchaser consumer or dealer non consumer of this new product and to no other purchaser or transferee The Warranty period for the consumer commences on the first date a product is delivered to consumer by seller dealer If the product is rented or leased the warranty period commences on the invoice date from GF Health Products Inc A copy of the invoice showing date of purchase must be provided when submitting warranty claims When proof of purchase date is not provided warranty coverage shall commence upon GF Health Products Inc s invoice date to the dealer purchaser If within the warranty period the product or component part is proven to GF Health Products Inc s satisfaction to be defective GF Health Products Inc shall provide at its option one of the following 1 repair or re
10. amage or limitation on how long an implied warranty lasts so the above exclusion and limitations may not apply to you 14423 INS LAB RevE13 33 The warranties contained herein contain all the representations and warranties with respect to the subject matter of this document and supersede all prior negotiations agreements and understandings with respect thereto The recipient of this document hereby acknowledges and represents that it has not relied on any representation assertion guarantee warranty collateral contract or other assurance except those set out in this document GF Health Products Inc Graham Field 2935 Northeast Parkway Atlanta GA 30360 Tel 770 368 4700 14423 INS LAB RevE13 34 10 APPENDIX A EC DECLARATION OF CONFORMITY EC Declaration of Conformity Manufactured for GF Health Products Inc 2935 Northeast Parkway Atlanta GA 30360 Ultrasound Pocket Doppler Classification MDD Annex IX Ila We herewith declare that the above mentioned product s meet the transposition into national law the provisions of Council Directive 93 42 EEC of 14 June 1993 concerning medical devices as amended by Directive 98 79 EC on in vitro diagnostic medical devices All supporting documentation is retained at the premises of the manufacturer Directives General Applicable Directives Medical Device Directive COUNCIL DIRECTIVE 93 42 EEC of 14 June 1993 concerning medical devices MDD 93 42 EEC Stand
11. ards applied EN ISO 9001 IS013485 EN 15014971 EN IS010993 1 IEC 601 1 EN 60601 1 1 BS EN 60601 1 4 IEC 60601 1 2 EN 61157 EN 1041 EN 60417 2 2000 IEC TR 60878 2003 EN 980 EN 55011 ISO 1000 YY 0111 93 EN 61266 EN ISO 780 GB T 14740 GB T 15464 Notified Body TUV SUD Product Service GmbH Ridlerstr 65 D 80339 Munchen Germany Identification number 0123 14423 INS LAB RevE13 35 11 APPENDIX B EMC INFORMATION GUIDANCE AND MANUFACTURER S DECLARATION Electromagnetic Emissions for all Equipment and Systems Guidance and manufacturer s declaration electromagnetic emission The Grafco Ultrasound Pocket Doppler is intended for use in the electromagnetic environment specified below Do not use the system in environments which do not comply with the specifications listed below Compliance Electromagnetic environment guidance RF emission The Grafco Ultrasound Pocket Doppler CISPR 11 uses RF energy only for its intemal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission Class B The Grafco Ultrasound Pocket Doppler CISPR 11 is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Electromagnetic Immunity for all Equipment and Systems Guidance an
12. ce from vibration corrosive medicine and high temperatures A NOTICE Do not use high temperature sterilizing process low temperature steam E beam and or gamma radiation sterilization on this device or its accessories CLEANING ZA WARNING Before cleaning the Pocket Doppler or probes turn the Pocket Doppler power off and remove the battery A NOTICE Do not use strong solvent such as acetone to clean Pocket Doppler or probe A NOTICE Do not use an abrasive such as steel wool or metal polish to clean Pocket Doppler or probe A NOTICE Do not allow any liquid to enter the probe socket while cleaning the Pocket Doppler or probe Cleaning the Pocket Doppler A NOTICE Do not immerse Pocket Doppler Do not allow liquid to enter the ultrasound system A NOTICE Do not pour liquids on the Pocket Doppler while cleaning 1 Keep the exterior surface of the Pocket Doppler clean and free of dust and dirt 2 Clean the exterior surface of the unit with a clean dry nonabrasive cloth 3 If necessary clean the unit with a clean cloth dampened with soap and water then immediately wipe dry with a clean dry non abrasive cloth A NOTICE Do not allow any cleaning solution to remain on the surface of the Pocket Doppler or the probe after cleaning 14423 INS LAB RevE13 26 Cleaning the Pocket Doppler Probe A NOTICE Do not allow liquid to enter the ultrasound system A NOTICE Do not pour liquids on the ultrasound system or
13. d manufacture s declaration electromagnetic immunity The Grafco Ultrasound Pocket Doppler is intended for use in the electromagnetic environment specified below Do not use the system in environments which do not comply with the specifications listed below Immunity IEC 60601 Compliance Electromagnetic test test level level environment guidance Electrostatic 6 kV 6 kV Floors should be wood discharge contact 8 contact 8 concrete or ceramic tile If ESD IEC kV air kV air floor is covered with synthetic 61000 4 2 material the relative humidity should be at least 30 RH 14423 INS LAB RevE13 36 Electromagnetic Immunity for all Equipment and Systems that are not Life Supportin Guidance and manufacturer s declaration electromagnetic immunity The Grafco Ultrasound Pocket Doppler System is intended for use in the electromagnetic environment specified below Do not use the system in environments which do not comply with the specifications listed below Immunity IEC 60601 Compliance Electromagnetic test test level level environment guidance Radiated RF IEC 61000 4 3 14423 INS LAB RevE13 Portable and mobile RF communications equipment should be used no closer to any part of the Grafco Ultrasound Pocket Doppler including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation dista
14. eter deep Vascular probes are used to monitor arteries and veins BATTERY See Section 5 SETUP for battery installation and replacement instructions ZA WARNING Use only 1 5V alkaline battery AA LR6 or Ni MH 1 2V rechargeable battery in this device 14423 INS LAB RevE13 17 5 SETUP INSTALLING OR REPLACING THE BATTERY A WARNING Ensure that Pocket Doppler power is off before replacing the battery ZA WARNING Install replace the battery at least 6 feet 1 5 meters from the patient ZA WARNING Use only 1 5V alkaline battery AA LR6 or Ni MH 1 2V rechargeable battery in this device battery cover battery installation 1 Open the battery compartment Turn the Pocket Doppler upside down Hold the main unit with one hand press with thumb of other hand on the cover notch and push it upward and forward The battery compartment will be open 2 If replacing the battery remove the old battery 3 Install the battery using 1 5V alkaline battery or Ni MH 1 2V battery A NOTICE Ensure battery direction matches cover symbols 4 Close the battery compartment A NOTICE If the Pocket Doppler will not be used for a prolonged period of time remove the battery from the device 14423 INS LAB RevE13 18 A NOTICE Keep the battery away from objects or materials with static electric charges A NOTICE If the battery terminals become dirty wipe them with a clean dry cloth before using the Pocket Doppler
15. ion of the system standard IEC 60601 1 1 Anyone who connects additional equipment to the signal input connector or signal output connector configures a medical system and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC 60601 1 1 If in doubt consult your GF Health Products Inc authorized distributor 14423 INS LAB RevE13 15 Left Panel i ai _ nm Control ra Control FEN Increase volume volume Rotate volume knob clockwise Rein volume Rein volume knob counter clockwise MODE Button START STOP Button he iC REC PLAY Button 14423 INS LAB RevE13 16 POCKET DOPPLER WATERPROOF PROBES The 2 0 MHz 4 0 MHz and 8 0 MHz waterproof probes connect to the main unit of the Grafco Pocket Doppler via the probe socket The following table lists and describes the main information on each probe s label in order of appearance Pocket Doppler Waterproof Probe Label Table Picture of Probe Probe Label Text Waterproof Waterproof Waterproof Probe Vascular Vascular Probe Probe cD Continuous Wave Doppler X 0 Central Central Central Central Frequency frequency frequency frequency 2 0 MHz 4 0 MHz 8 0 MHz Probe Version Number SNooooG Probe Serial Number Waterproof The Probe is Waterproof IPX8 Water Ingress Protection Code which indicates Waterproof this probe can work continuously for 5 hours when immersed in water up to one m
16. ions Electromagnetic propagation is affected by absorption and reflection from structures objects and people 14423 INS LAB RevE13 39 12 APPENDIX C OVERALL SENSITIVITY Overall Sensitivity 2 MHz Probe Diameter sa Reflection Two way Attenuation B B tB f d Target Reflector 2B B B mm i mm B dB dB dB Doppler Frequency Hz 14423 INS LAB RevE13 40 Overall Sensitivity 2 MHz Probe Diameter n 3 Overall of M S m s Sensitivity Target V V S A d B C dB 186 i Reflector mm o N co 5 N Doppler Velocity of Target cm s Hz 14423 INS LAB RevE13 41 13 INDEX A Accessories optional 4 Accessory equipment certification of 6 Address GF Health Products Inc 34 Appendix A EC Declaration of Conformity 35 Appendix B EMC information 36 Appendix C Overall Sensitivity 40 B Battery installing replacing 18 Battery terminals cleaning 19 C CAUTION statement significance 5 Cleaning 26 D Display panel 12 E Electromagnetic emissions for all equipment and systems Appendix B 36 Electromagnetic immunity for all equipment and systems Appendix B 36 Electromagnetic immunity for all equipment and systems that are not life supporting Appendix B 37 F Fetal Heart FH monitoring 22 Freight policy GF Health Products Inc 10 Front panel features and illustration 12 G Guidance and manufacturer s declaration A
17. ispose of the battery in accordance with local regulations A NOTICE Do not dispose of this device with household waste Dispose of this device in accordance with your local laws and regulations 14423 INS LAB RevE13 8 SYMBOLS Attention Refer to accompanying documents this manual This item is compliant with Medical Device Directive 93 42 ous 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 regulation for separate collection after its useful life Do not dispose of this device with household waste Indicates that the equipment is put on the market after 13 August 2005 14423 INS LAB RevE13 9 3 HANDLING GF HEALTH PRODUCTS INC FREIGHT POLICY For your protection read carefully The carrier accepted this merchandise in good condition and is responsible for safe delivery Before signing the freight bill inspect the shipment carefully for damage or missing pieces Apparent loss or damage Should visual inspection show loss or damage this MUST be noted on the freight bill and signed by the carrier s agent Failure to do so may result in the carrier failing to honor the claim Please contact the carrier to obtain the paperwork necessary to file a claim or contact GF Health Products Inc Customer Service at the number on the back cover of this manual Concealed loss
18. itor FHR unless an audible fetal heart signal is present The fetal pulse can be distinguished from the maternal pulse by feeling the mother s pulse during the examination ZA WARNING For best quality audio place the probe in the optimum position ZA WARNING For best quality audio avoid positions with strong placental sounds swishing or fetal cord pulse indistinct pulse at fetal rate A WARNING If the fetus is in the cephalic position and the mother is supine the clearest heart sound will normally be found on the midline below the umbilicus During monitoring prolonged lying in the supine position should be avoided Sitting up or lateral positions are preferable and may be more comfortable for the mother 14423 INS LAB RevE13 22 VASCULAR MONITORING WITH 4 0 OR 8 0 MHZ PROBE OPTIONAL The 4 0 MHz and 8 0 MHz probes can be used to perform vascular monitoring assessment of blood flow The 8 0 MHz probe is used for more superficial evaluation than the 4 0 MHz probe Refer to the following probe site illustration to determine the best probe to utilize Vertebral Artery 4 0MHz Carotid Artery 4 0 8 0MHz Jugular Vein 4 0MHz Carotid Artery 4 0 8 0MHz Subclavian Artery 4 0MHz Subclavian Vein 4 0MHz Brachial Artery 8 0MHz JJ Ulner Artery 8 0MHz Radial Artery 8 0MHz Femoral Artery 4 0MHz Femoral Vein 4 0MHz Popliteal Artery 4 0MHz Great Saphenous Vein 4 0 8 0MHz Smal
19. l Saphenous Vein 8 0MHz Posterior Tibial Artery 8 0MHz Dorsalis Podis Artery 8 0MHz Posterior Tibial Vein 8 0MHz 14423 INS LAB RevE13 23 1 Apply a liberal amount of gel on the site to be examined 2 Place the probe so that the head is at least at 45 to the vessel to be examined 3 Adjust the position of the probe to obtain the loudest audio signal For best results keep the probe as still as possible once the optimum position is located 4 Adjust the audio volume as necessary Info Arteries emit high pitched rhythmical pulsation sounds while veins emit non rhythmical pulsation sounds similar to rushing wind TURNING OFF THE POCKET DOPPLER 1 When the session is finished press the front panel POWER button to turn off the Pocket Doppler 2 Use a clean dry non abrasive cloth to gently wipe off the remaining gel from the probe After thoroughly cleaning the probe replace it in the Pocket Doppler probe frame REPLACING THE BATTERY When the Pocket Doppler battery power is low turn the power off and replace the battery See Section 5 SETUP for instructions on battery replacement 14423 INS LAB RevE13 24 7 MAINTENANCE AND CLEANING ZA WARNING Failure on the part of the responsible facility employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazard MAINTENANCE A WARNING Before use inspect the Pocket D
20. nce de Fi 80 MHz to E 800 MHz d BU 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 9 37 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 reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Grafco Ultrasound Pocket Doppler is used exceeds the applicable RF compliance level above the Grafco Ultrasound Pocket Doppler should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Grafco Ul
21. nfo Provides application recommendations or other useful information to ensure that you get the most from your product 14423 INS LAB RevE13 5 WARNINGS ZA WARNING 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 instructed by a qualified healthcare professional A WARNING Do not use the Grafco Pocket Doppler in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur A WARNING Do not expose batteries to heat ZA WARNING Do not attempt to charge alkaline batteries they may leak or catch on fire ZA WARNING DO NOT simultaneously touch signal input or output connector and the patient ZA WARNING Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards e g IEC 950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC 60601 1 1 Anyone who connects additional equipment to the signal input connector or signal output connector configures a medical system and is therefore responsible for verifying the system complies with the requirements of the valid version of the system standard IEC 60601 1 1 If in doubt consult your GF Health Products Inc authorized distributor A WARNING The Grafco Pocket Doppler is a t
22. ng the Pocket Doppler please read and understand this entire user manual Take special note of all safety precautions that begin WARNING and CAUTION Save this user manual for future reference Info The most current version of this manual can be found at www grahamfield com INTENDED USE OF THIS DEVICE The Grafco Ultrasound Pocket Doppler is intended for clinical use as an obstetrical evaluation tool The Grafco Ultrasound Pocket Doppler may also be used for optional vascular monitoring The Pocket Doppler is not intended to be used for treatment or diagnosis Use the Pocket Doppler only as prescribed by a physician ZA WARNING This device is not intended to be used for treatment or diagnosis If Pocket Doppler results are ambiguous please use other methods such as a stethoscope to verify immediately Z WARNING To ensure patient safety use this device only with accessories recommended by GF Health Products Inc your GF Health Products Inc authorized distributor or your physician INCLUDED FEATURES Alkaline Battery LR6 AA 1 5V Low Battery Detector Indicator Obstetrical or Vascular Monitoring 14423 INS LAB RevE13 3 OPTIONAL ACCESSORIES The following accessories for use with the Grafco Ultrasonic Pocket Doppler are available from your GF Health Products Inc authorized distributor or www grahamfield com Item No Product Description 40016F Coupling Gel case of 12 0 25 liter bottles
23. not functioning properly or fails any of the above tests contact GF Health Products Inc Technical Support at the phone number on the back cover or your GF Health Products Inc authorized distributor 14423 INS LAB RevE13 NOTICES A NOTICE The main unit of the Grafco Pocket Doppler is designed for continuous normal operation Do not immerse or submerge in any liquid A NOTICE Keep the Pocket Doppler and its environment clean and dust free Protect the device from vibration corrosive medicine and high temperatures A NOTICE Do not use high temperature sterilizing process low temperature steam E beam or gamma radiation sterilization on this device or its accessories A NOTICE If the Pocket Doppler will not be used for a prolonged period of time remove the battery from the device A NOTICE Keep the battery away from objects or materials with static electric charges A NOTICE If the battery terminals become dirty wipe them with a clean dry cloth before using the battery A NOTICE Batteries have life cycles If the battery use time shortens noticeably the battery s life cycle is over Replace the old battery with a new one of the same size and type Use only batteries recommended by GF Health Products Inc A NOTICE Remove a battery whose useful life cycle is over from the monitor immediately A NOTICE For information on installing and removing the battery from the monitor see Section 5 SETUP A NOTICE D
24. ool to aid the healthcare professional and should not be used in place of normal fetal monitoring ZA WARNING Exposure to ultrasound should be kept as low as reasonably achievable This is considered to be good practice and should be observed at all times ZA WARNING Replace the battery at least 6 feet 1 5 meters from the patient 14423 INS LAB RevE13 6 ZA WARNING Use only probes provided by GF Health Products Inc intended to be used with the Grafco Pocket Doppler ZA WARNING Do not stretch the probe cable further than 6 5 feet 2 meters ZA WARNING Electromagnetic Interference Before operation ensure that the environment in which the device is operated is not subject to any source of strong electromagnetic interference such as radio transmitters mobile telephones etc ZA WARNING The following safety checks tests must be performed at least once every two years or as specified in your facility s test and inspection protocol by a qualified person with adequate training knowledge and practical experience e Inspect the equipment for mechanical and functional damage e Ensure the safety labels are legible Verify that the device functions properly as described in this manual e Test according to the pregnant woman s leakage current IEC 60601 1 1988 Limit 100 uA B The leakage current should never exceed the specified limit Record the data and store with the Grafco Pocket Doppler If the device is
25. oppler and probe s to ensure there is no visible evidence of damage which may affect the functioning of the device or pregnant woman s safety or create the potential for the device to operate in an unsafe manner Thereafter inspect the device for evidence of damage at least once each week If damage is evident or suspected contact GF Health Products Inc Technical Service at the number on the back cover or your GF Health Products Inc authorized distributor before use ZA WARNING The following safety checks tests must be performed at least once every two years or as specified in your facility s test and inspection protocol by a qualified person with adequate training knowledge and practical experience e Inspect the equipment for mechanical and functional damage e Ensure the safety labels are legible Verify that the device functions properly as described in this manual e Test according to the pregnant woman s leakage current IEC 60601 1 1988 Limit 100 uA B The leakage current should never exceed the specified limit Record the data and store with the Grafco Pocket Doppler If the device is not functioning properly or fails any of the above tests contact GF Health Products Inc Technical Support at the phone number on the back cover or your GF Health Products Inc authorized distributor 14423 INS LAB RevE13 25 A NOTICE Keep the Pocket Doppler and its environment clean and dust free Protect the devi
26. placement of any defective or nonconforming part or product or 2 a credit and or refund of the original selling price GF HEALTH PRODUCTS INC S SOLE OBLIGATION AND YOUR EXCLUSIVE REMEDY UNDER THIS WARRANTY SHALL BE LIMITED TO SUCH REPAIR REPLACEMENT CREDIT AND OR REFUND This warranty does not include any labor charges incurred in replacement part s installation or any associated freight or shipping charges to the manufacturer For warranty service please contact the authorized dealer from whom you acquired your GFHealth Products Inc product Upon receiving notice of an alleged defect in a product GF Health Products Inc will issue a return authorization The defective product or part s must then be returned at the purchaser s cost for warranty inspection using the serial number as identification 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 14423 INS LAB RevE13 32 satisfactory warranty service please contact GF Health Products Inc at the address below DO NOT return products to our factory without prior authorization LIMITATIONS AND EXCLUSIONS The foregoing warranty shall not apply to serial numbered products if the serial number has been removed or defaced Products subjected to negligence abuse misuse improper operation improper maintenance improper cleaning improper storage or damages beyond GF Health
27. ppendix B 36 14423 INS LAB RevE13 I Info statement significance 5 Introduction 3 L Left panel features and illustration 16 M Maintenance 25 Maintenance and cleaning 25 N NOTICE statement significance 5 O Operation 20 P Pocket Doppler handling 10 Pocket Doppler inspection 11 Pocket Doppler intended use 3 Pocket Doppler storage 11 Pocket Doppler turning off 24 Pocket Doppler turning on 21 Pocket Doppler unpacking 10 Pocket Doppler and accessories 12 Probe disinfection 28 Probe FH monitoring with 22 Probe placing in the Pocket Doppler 20 Probe removing from the Pocket Doppler 20 Probe swapping 21 Probe operation 20 Probes vascular 17 Probe socket 13 R Rear panel features and illustration 13 Recommended separation distances Appendix B 38 42 S Safety information 5 Specifications 29 START STOP button 16 T Telephone number GF Health Products Inc 34 Top panel features and illustration 15 U User manual contents of 3 V Volume control 16 W WARNING statement significance 5 Warranty limited 32 14423 INS LAB RevE13 43 Medical Office Supplies Georgetown Texas Phone 512 868 5800 Fax 512 868 0600 Toll Free 800 378 1191 www acscatalog com
28. s shipped with one probe connected To replace the connected probe with another Pocket Doppler probe l Follow steps 1 3 in previous section Removing the Probe from the Pocket Doppler Grasp probe connector body and gently pull out from Pocket Doppler probe socket Connect the new probe s connector Grasp probe connector body and gently insert into Pocket Doppler s probe socket NOTICE Place the unused probe in a secure location When the Pocket Doppler is not used for a long time store Doppler and probe in original packaging see Maintenance Storage section for proper storage conditions TURNING ON THE POCKET DOPPLER Press the front panel POWER button to turn on the Pocket Doppler 14423 INS LAB RevE13 21 FETAL HEART FH MONITORING FH Monitoring with 2 0 MHz Waterproof Probe Refer to picture at right The audio fetal heart beat is sent out via the built in speaker or attached earphone 1 Palpate for the fetus position to find the best location to place the probe and hear the fetal heart rate 2 Apply a liberal amount of gel to the probe head 3 Place the probe head on the desired location Assure that good coupling of the gel to the skin is achieved the Fetal Heart rate will not be heard if adequate gel is not used and air is between the probe head and skin 4 Slowly move the probe until a clear heart rate is heard 5 Adjust the volume to the desired level ZA WARNING It is not possible to mon
29. te the Pocket Doppler with the 2 0 MHz waterproof probe and accompanying tables describe labeled features Front Panel Display Panel POWER Button Speaker Probe Socket Display Panel corner of the display panel Please see the following table for significance of LED indicators LED LED Significance Illumination Illumination Color Condition Power on Probe disconnected or not properly connected Orange Battery too low for operation replace battery immediately Grafco The Probe is used to perform ultrasound monitoring 14423 INS LAB RevE13 12 The built in The built in speaker makes the fetal sounds audible makes the fetal sounds audible 14423 INS LAB RevE13 Probe The probe connects here to the uresound Pocket Doppler cl Jack ___ Definition 4 PowerSupply Ss Probe Coding 1 Probe Coding 2 Probe Coding 3 13 Rear Panel Probe Frame Battery Opens to install replace battery Compartment Stores probe when not in use 14423 INS LAB RevE13 14 Top Panel Earphone Socket Charge Socket Refer to accompanying documents this user manual ZA WARNING Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards e g IEC 950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the valid vers
30. trasound Pocket Doppler Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the Grafco Ultrasound Pocket Doppler The Grafco Ultrasound Pocket Doppler is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Grafco Ultrasound Pocket Doppler as recommended below according to the maximum output power of the communications equipment Rated Separation distance according to maximum _ frequency of transmitter m output power 80 MHz to 800 MHz 800 MHz to 2 5 GHz of transmitter W d e I E 0 1167 0 3689 1 1667 11 6667 23304 i 14423 INS LAB RevE13 38 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 manufacturer Info 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Info 2 These guidelines may not apply in all situat
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