Graco 8481 Car Seat User Manual
Contents
1. Fetal Heart FH monitoring 22 Freight policv GF Health Prod ucts Inc 10 Front panel features and illustra tion 12 G Guidance and manufacturer s declaration Appendix B 36 I Info statement significance 5 14423 INS LAB RevD11 Introduction 3 L Left panel features and illustra tion 16 M Maintenance 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 Dop pler 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 illustra tion 13 Recommended separation dis tances Appendix B 38 S Safety information 5 Specifications 29 START STOP button 16 42 T Telephone number Graham Field 34 Top panel features and illustra tion 15 U User manual contents of 3 V Volume control 16 W WARNING statement signifi cance 5 Warrantv limited 32 14423 INS LAB RevD11 43 USA Corporate Headquarters GF Health Products Inc 2935 Northeast Parkwav Atlanta Georgia 30360 telephone 770 368 4700 e GRAHAM FIELD www grahamfield com 144232. B equipment Shock Degree Degree of Non protected Protection against 2 0 MHz IPX8 Water Harmful Water Resistant Ingress Ingress of Probe Protection Wier Tao DC Water Resistant hi b Vascular Probe Ge WOH 8 0 MHz continuously Water Resistant for 5 hours Vascular Probe when being immersed in water less than 1 meter deep Degree of Equipment not suitable for use in Safety in presence of flammable gases Presence of Flammable Gases Working Continuous running equipment System Group l Class B 14423 INS LAB RevD11 29 Physical Size Widthx 13 35x 1 26 x 5 43 inches Characteristics Depth x Height 85 x 32 x 138 mm Weight 64 Ib 290 5g including a batterv and a probe Temperature 41 F 104 F 5 C 40 C Humidity lt 80 RH Atmospheric 12 47 15 37 psi Pressure 86 106 kPa Transport and Temperature 14 F 131 F Storage 10 C 55 C Humidity lt 93 RH Atmospheric 12 47 15 37 psi Pressure 86 106 kPa FHR FHR Measuring 50 bpm 210 bpm Performance Range Resolution Jibpm Audio Output Power Batterv Battery Type 9 volt DC alkaline battery IEC Type Recommended No 6LR61 6LF22 or equivalent Battery Stand gt 10 hours by Time 14423 INS LAB RevD11 30 Nominal 2 0 MHz Freguency Water Resistant Probe 4 0 MHz Water Resistant Vascular Probe 8 0 MHz Water Resistant Vascular Probe Working 2 0 MHz Freguency Water Resistant Prob
3. INS LAB RevD 11 2011 GF Health Products Inc
4. Pocket Doppler should be ob served to verifv normal operation If abnormal performance is observed additional measures mav be necessarv such as reorienting or relocating the Grafco Ultrasound 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 0 MHz to 800 MHz 800 MHz to 2 5 GHz of transmitter W i By E 0 1167 0 3689 1 1667 11 6667 283334 i 14423 INS LAB RevD11 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 freguency of the transmitter where P is the maximum output power rating of the transmitter in watts W according
5. removed or defaced Products subjected to negli gence abuse misuse improper operation improper main tenance improper cleaning improper storage or damages beyond GF Health 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 LIM ITED TO THE IMPLIED WARRANTIES OF MERCHANT ABILITY 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 RE PLACEMENT CREDIT AND OR REFUND OF THE DEFEC TIVE PRODUCT OR PART PURSUANT TO THE TERMS CONTAINED HEREIN GF HEALTH PRODUCTS INC SHALL NOT BE LIABLE FOR ANY CONSEQUENTIAL OR INCIDENTAL DAMAGES WHATSOEVER 14423 INS LAB RevD11 33 This warrantv give
6. 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 po tential 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 sus pected contact GF Health Products Inc Technical Service at the number on the back cover or your GF authorized distributor before use ZN WARNING The following safety checks tests must be performed at least once every two years or as speci fied 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 func tional damage e Ensure the safety labels are legible e Verify that the device functions properly as de scribed 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 speci fied limit Record the data and store with the Grafco Pocket Doppler If the device is not functioning prop erly 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 authorized distributor 14423 INS LAB RevD11 25 A NOTICE Keep the Pocket Doppler and its environ ment clean and dust free Protect the device from vi bration corrosive medicine and high t
7. Grafco A Graham Field Brand 14423 2 14423 4 14423 8 ULTRASOUND POCKET DOPPLER USER MANUAL A 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 pro fessional 14423 INS LAB RevD11 CONTENTS WT E EE 3 INTENDED USE OF THIS DEVICE sesenenzznnznnnnznnnnnnnznznzza 3 INCLUDED FEATURES eeuse se se se se se se see se se see ee ee ee ee ee ee 3 OPTIONAL ACCESSORIES ssrenenenenenenenenzzenenennnnnnnnznznzzzza 4 2 SAFETY INFORMATION 5 SAFETY PRECAUTIONS srurananananananannenenznznznznznnnznznznznza 5 SYMBOLS adita do aka 9 B HANDLING ii eebe ee ec E 10 GF HEALTH PRODUCTS INC FREIGHT POLICY een 10 UNPACKING i ie onse Re EE nnna 10 STORAGE ii ee ee ees ee asse TAL se ER Ee 11 4 ULTRASOUND POCKET DOPPLER AND ACCESSORIES 12 APPEARANCE AND FEATURES sserenanananennnanznenznznnzznzzza 12 POCKET DOPPLER WATER RESISTANT PROBEG 17 BATTERY sees ves des ouens rs Be Be ee ee 17 E SET 18 INSTALLING OR REPLACING THE BATTERY ees sesse see 18 E EE 20 PROBE OPERATION eneen 20 TURNING ON THE POCKET DOPPLER eessen 21 FETAL HEART FH MONITORING sesenezzznznnnnnnnnnznznznzzz 22 VASCULAR MONITORING WITH 4 0 OR 8 0 MHZ PROBE OPTIONAL J eersten 23 TURNING OFF THE POCKET DOPPLER eessen 24 REPLACING THE BATTERY ssssssssssssssssssnsssesnsnsn
8. 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 A WARNING For best quality audio place the probe in the optimum position A 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 umbili cus During monitoring prolonged lying in the supine position should be avoided Sitting up or lateral posi tions are preferable and may be more comfortable for the mother 14423 INS LAB RevD11 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 Arterv 4 0MHz Carotid Arterv 4 0 8 0MHz Jugular Vein 4 0MHz Carotid Artery 4 0 8 0MHz Subclavian Artery 4 0MHz Subelavian Vein 4 0MHz Brachial Artery 8 0MHz Une Anen 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 Small Saphenous V
9. cts Inc authorized distributor 14423 INS LAB RevD11 15 Left Panel FT j F Volume Control IO MODE Button gll START STOP Button HH RECIPLAY Button kk n Control Function EE Increase volume volume Rotate volume knob clockwise Ed volume Ed volume knob counter clockwise MODE Button Button od Button de RECIPLAY Button Button 14423 INS LAB RevD11 16 POCKET DOPPLER WATER RESISTANT PROBES The 2 0 MHz 4 0 MHz and 8 0 MHz water resistant 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 ap pearance Pocket Doppler Water Resistant Probe Label Table Picture of Probe Probe Label Text Vascular Vascular Probe Probe CD o Continuous Wave Doppler X 0 Central Central Central Central Frequencv frequency frequency frequency 2 0 MHz 4 0 MHz 8 0 MHz Probe version number San Probe Serial Number Water Resistant The probe is water resistant IPX8 l Water Ingress Protection Code which indicates Water Resistant this probe can work continuousiv for 5 hours when immersed in water up to one meter deep Vascular probes are used to monitor arteries and veins BATTERV See Section 5 SETUP for batterv installation and replace ment instructions A WARNING Use only 9V alkaline batteries IEC Type No 6LR61 6LF22 or equ
10. e 4 0 MHz Water Resistant Vascular Probe 8 0 MHz Water Resistant Vascular Probe 2 0 MHz 410 4 0 MHz 410 8 0 MHz 410 P EET EN og James en Jeftbmwiemt Effective 2 0 MHz Radiating Area Water Resistant of Transducer Probe 4 0 MHz Water Resistant Vascular Probe 8 0 MHz Water Resistant Vascular Probe 14423 INS LAB RevD11 245mm 415 32mm 415 14mm 15 31 9 LIMITED WARRANTV GF Health Products Inc warrants this product to be free from manufacturing defects in material and workmanship for its period of warrantv that is in accordance with industrv standards This warrantv is extended only to the original purchaser consumer or dealer non consumer of this new product and to no other purchaser or transferee GF Health Products Inc warrants the Grafco Pocket Doppler and its components to be free from defects in workmanship and materials for a period of one vear The Warrantv 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 com mences 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 es invoice date to the dealer purchaser If within the warranty period the product or component
11. e Pocket Doppler is not intended to be used for treatment or diagnosis Use the Pocket Dop pler only as prescribed bv a phvsician AN 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 verifv immediatelv A WARNING To ensure patient safety use this device only with accessories recommended by GF Health Products Inc vour GF authorized distributor or vour phvsician INCLUDED FEATURES Alkaline Batterv 9V Low Batterv Detector Indicator Obstetrical or Vascular Monitoring 14423 INS LAB RevD11 3 OPTIONAL ACCESSORIES The following accessories for use with the Grafco Ultrason ic Pocket Doppler are available from vour GF Health Prod ucts Inc authorized distributor or www grahamfield com Item No Product Description 14001GF Coupling Gel case of 12 0 25 liter bottles uer Coupling Gel 5 liter bottle 114423 2P 2 0 MHz Water Resistant Probe 14423 4P 4 0 MHz Water Resistant Vascular Probe 14423 8P 8 0 MHz Water Resistant Vascular Probe 14423 INS LAB RevD11 4 2 SAFETV INFORMATION Safetv Guidance This unit has internallv Tvpe B protection means that this powered equipment product is in accordance with and the degree of shock permitted leakage currents and protection is tvpe B dielectric strengths of IEC 60601 1 SAFETV PRECAUTIONS The safetv statements presented in this chapt
12. ean and dust free Protect the device from vi bration corrosive medicine and high temperatures A NOTICE Do not use high temperature sterilizing pro cess low temperature steam E beam or gamma ra diation 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 mate rials 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 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 Dispose of the battery in accordance with lo cal regulations A NOTICE Do not dispose of this device with house hold waste Dispose of this device in accordance with your local laws and regulations 14423 INS LAB RevD11 8 SVMBOLS Attention Refer to accompanying documents this manual This item is compliant with Medical Device Directive 93 42 Cais EEC of June 14 1993 a directive of the European Economic Community This s
13. ein 8 0MHz Posterior Tibial Artery 8 0MHz Dorsalis Pedis Artery 8 0MHz Posterior Tibial Vein 8 0MHz 14423 INS LAB RevD11 23 1 Apply a liberal amount of gel on the site to be exam ined 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 RevD11 24 7 MAINTENANCE A WARNING Failure on the part of the responsible facil itv emploving the use of this equipment to implement a satisfactorv maintenance schedule mav cause un due equipment failure and possible health hazard MAINTENANCE A WARNING Before use inspect the Pocket Doppler and probe s
14. emperatures A NOTICE Do not use high temperature sterilizing pro cess low temperature steam E beam and or gamma radiation sterilization on this device or its accesso ries CLEANING A WARNING Before cleaning the Pocket Doppler or probes turn the Pocket Doppler power off and re move 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 al low 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 witha clean dry non abrasive cloth A NOTICE Do not allow any liquid or cleaning solution to remain on the surface of the Pocket Doppler or probe after cleaning 14423 INS LAB RevD11 26 Cleaning the Pocket Doppler Probe A NOTICE Do notallow liquid to enter the ultrasound svstem A NOTICE Do not pour liquids on the probe while cleaning The Pocket Doppler probe s acoustic su
15. ensnsnsnenes 24 7 TUS TOT ne 25 MAINTENANCE ese se se see see ee Be ee Be ee Ge ee ee ee ee ee ee 25 CLEANING SE ee en eners ee ee ee ese Ee ee EE 26 DISINFECTION Eie e tege 28 8 SPECIFICATIONS iste aests ese ese see sege gesek see ee eke RS 29 9 LIMITED WARRANTY EEN 32 10 APPENDIX A EC DECLARATION OF CONFORMITY en 35 11 APPENDIX B EMC INFORMATION u eeuse se se see ee ee ee ee ee 36 GUIDANCE AND MANUFACTURER S DECLARATION 36 12 APPENDIX C OVERALL SENSITIVITVW mmsensnnenzanrenenennnnnennennznz 40 13 INDEX EE 42 Graham Field and Grafco are registered trademarks of GF Health Products Inc Packaging warranties products and specifications are subject to change without notice GF Health Products Inc is not responsible for tvpographical errors 14423 INS LAB RevD11 2 1 INTRODUCTION This user manual contains important information and safetv precautions for the Grafco Ultrasound Pocket Dop pler Before using the Pocket Doppler please read and understand this entire user manual Take special note of all safetv 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 mav also be used for optional vascular monitoring Th
16. er refer to the basic safetv information that the operator of the Pocket Doppler shall pav attention to and abide bv There are additional safetv statements in other chapters or sec tions which mav be the same as or similar to the follow ing or specific to the operations WARNING and CAUTION statements must be observed To avoid the possibilitv of injurv observe the following precautions during the opera tion of the instrument Please note the following special statements used through out 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 injurv N CAUTION Indicates a potential hazard or unsafe practice that if not avoided could result in moderate or minor personal injurv A NOTICE Indicates a potential hazard or unsafe prac tice that if not avoided could result in product or propertv damage Info Provides application recommendations or other useful information to ensure that vou get the most from your product 14423 INS LAB RevD11 5 WARNINGS ZN WARNING Federal Law USA restricts this device to sale bv oron the order of a phvsician This product should not be used unless the operator has been in structed bv a qualified healthcare professional N WARNING Do not use the Grafco Pocket Doppler in a flammable atmosphere where concentrations of flam mable anesthetics or other materials mav occu
17. ion Removing the Probe from the Pocket Doppler 2 Remove the connector Grasp probe connector body and gen tiv pull out from Pocket Doppler probe socket 3 Connect the new probe s con nector Grasp probe connec tor bodv and gentiv insert into Pocket Doppler s probe socket Pocket Doppler is shown at right with disconnected probe A 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 con ditions TURNING ON THE POCKET DOPPLER Press the front panel POWER button to turn on the Pocket Doppler 14423 INS LAB RevD11 21 FETAL HEART FH MONITORING FH Monitoring with 2 0 MHz Water Resistant Probe Refer to picture 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 Ze to find the best location to t place the probe and hear the i 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 A WARNING It is not possible to monitor FHR unless
18. ises 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 Standards applied EN ISO 9001 ISO13485 EN ISO14971 EN ISO10993 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 GBIT 15464 Notified Body TUV SUD Product Service GmbH Ridlerstr 65 D 80339 MUnchen Germany Identification 14423 INS LAB RevD11 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
19. ivalent in this device 14423 INS LAB RevD11 17 5 SETUP INSTALLING OR REPLACING THE BATTERV A WARNING Ensure that Pocket Doppler power is off before replacing the batterv A WARNING Install replace the battery at least 6 feet 1 5 meters from the patient AN WARNING Use only 9V alkaline batteries IEC Type No 6LR61 6LF22 or equivalent in this device battery socket battery connector battery installation 1 Open the battery compartment Slide the battery cover in the direction of the arrow on the battery cover see above picture 2 If replacing the battery remove the old battery 3 A battery connector is located in the battery compart ment Attach a new 9V battery to the connector 4 Install the connected battery in the battery compart ment 5 Slide the battery cover back to close the compartment 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 mate rials with static electric charges 14423 INS LAB RevD11 18 A NOTICE If the batterv terminals become dirtv wipe them with a clean drv cloth before using the Pocket Doppler A NOTICE Batteries have life cvcles If the battery use time shortens noticeabiv the batterv s life cvcle is over Replace the old batterv with a new one of the same size and type Use only batteries recommended bv GF Health Products Inc A NOTICE Rem
20. n replace battery immediately Brand Brand of Pocket Doppler Probe The Probe is used to perform ultrasound monitoring Speaker The built in speaker makes the fetal sounds audible 14423 INS LAB RevD11 12 Power Turns the Ultrasound Pocket Doppler ON or Probe The probe connects here to the Ultrasound Pocket Doppler sore Jack Definition 1 Power Supply Is ProbeCoding3s 6 Shet GND 14423 INS LAB RevD11 13 Rear Panel Pocket Clip Attaches Pocket Doppler to pocket Attachment Batterv Opens to install replace batterv Compartment Attaches probe to Pocket Doppler 14423 INS LAB RevD11 14 Top Panel E sed Charge Socket Refer to accompanving documents this user manual ZN WARNING Accessorv equipment connected to the analog and digital interfaces must be certified accord ing to the respective IEC standards e g IEC 950 for data processing equipment and IEC 60601 1 for medi cal equipment Furthermore all configurations shall comply with the valid version of the system stan dard IEC 60601 1 1 Anyone who connects additional eduipment 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 Produ
21. nded to be used with the Grafco Pocket Doppler AN WARNING Do not stretch the probe cable further than 6 5 feet 2 meters Z WARNING Electromagnetic Interference Before op eration ensure that the environment in which the de vice is operated is not subject to any source of strong electromagnetic interference such as radio transmit ters mobile telephones etc Z WARNING The following safety checks tests must be performed at least once every two years or as speci fied 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 func tional damage e Ensure the safety labels are legible e Verify that the device functions properly as de scribed 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 speci fied limit Record the data and store with the Grafco Pocket Doppler If the device is not functioning prop erly 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 authorized distributor 14423 INS LAB RevD11 7 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 environ ment cl
22. nless the Pocket Doppler is to be used immediatelv 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 notifv the carrier and vour GF Health Products Inc authorized distributor 2 Removeall loose packing from the carton 3 Carefullv remove all the components from the carton 14423 INS LAB RevD11 10 Inspection Check the Pocket Doppler for nicks dents scratches me chanical or other damage Check all the cables and acces sories STORAGE Store the repackaged Pocket Doppler in a drv area A NOTICE Ensure that the temperature at the Pocket Doppler s location during storage does not fall below 14 F 10 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 RevD11 11 4 ULTRASOUND POCKET DOPPLER AND ACCESSORIES APPEARANCE AND FEATURES The following figures illustrate the Pocket Doppler with the 2 0 MHz water resistant probe and accompanving tables describe labeled features Front Panel Displav Panel corner of the displav 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 operatio
23. ove a batterv whose life cvcle is over from the Pocket Doppler immediatelv A NOTICE Dispose of the old batterv in accordance with local regulations 14423 INS LAB RevD11 19 6 OPERATION PROBE OPERATION Removing the Probe from the Pocket Doppler A NOTICE Do not drag or drop the probe Do not dis connect the probe from the Pocket Doppler 1 The probe is installed in Pocket Doppler probe frame left picture above 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 center picture above 3 Remove the entire probe from Pocket Doppler probe frame right picture above Placing the Probe in the Pocket Doppler A NOTICE Do not drag or drop the probe Do not dis connect 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 center picture above 3 Gently replace the top of probe entirely into the Pocket Doppler s probe frame left picture above 14423 INS LAB RevD11 20 Swapping Probes A NOTICE Do not drag or drop the probe or the probe connector The Pocket Doppler is shipped with one probe connected To replace the connected probe with another Pocket Dop pler probe 1 Follow steps l 3 in previous sect
24. part is proven to GF Health Products Inc s satisfaction to be defec tive GF Health Products Inc shall provide at its option one of the following 1 repair or replacement of anv 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 REMEDV UNDER THIS WARRANTV SHALL BE LIMITED TO SUCH REPAIR RE PLACEMENT CREDIT AND OR REFUND This warrantv does not include anv labor charges incurred in replacement part s installation or anv associated freight or shipping charges to the manufacturer For warrantv service please contact the authorized dealer from whom vou acquired vour GF Health Products Inc prod uct 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 14423 INS LAB RevD11 32 purchaser s cost for warrantv inspection using the serial number as identification or if the product is not serialized lot number and date code within thirtv 30 davs of return authorization issue date In the event you do not receive sat isfactory 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
25. r A WARNING Do not expose batteries to heat AN WARNING Do not attempt to charge alkaline batter ies thev mav leak or catch on fire ZN WARNING DO NOT simultaneously touch signal in put or output connector and the patient Z WARNING Accessory equipment connected to the analog and digital interfaces must be certified accord ing to the respective IEC standards e g IEC 950 for data processing equipment and IEC 60601 1 for medi cal equipment Furthermore all configurations shall comply with the valid version of the system stan dard IEC 60601 1 1 Anyone who connects additional eduipment 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 A WARNING The Grafco Pocket Doppler is a tool to aid the healthcare professional and should not be used in place of normal fetal monitoring A 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 A WARNING Replace the battery at least 6 feet 1 5 me ters from the patient 14423 INS LAB RevD11 6 A WARNING Do not the use Pocket Doppler if the bat terv cover is open A WARNING Use only those probes provided by GF Health Products Inc inte
26. rface is fragile and must be handled with care 1 To prolong the life of the probe after each use gently wipe off the remaining gel from the probe with a clean drv non abrasive cloth 2 After thoroughly cleaning the probe replace it in the Pocket Doppler probe frame 3 If necessary wipe the external surface of probe with 70 ethanol or isopropranol alcohol 4 Allow to air dry A NOTICE Do not allow any liquid or cleaning solution to remain on the surface of the probe after cleaning 14423 INS LAB RevD11 27 DISINFECTION Disinfecting the Pocket Doppler Probe A NOTICE Do notallow anv liquid to enter the probe socket while disinfecting or immersing the probe 1 Clean the exterior surface of the probe as recommend ed in the previous section 2 To disinfect the probe immerse the probe in a solution of Benzalkonium Bromide 0 5 Chlorhexidine 2 Glu taraldehyde 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 liquid or cleaning solution to remain on the surface of the probe after cleaning 14423 INS LAB RevD11 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 1990 Classification Anti electric Internally powered equipment Shock Type Anti electric Type
27. s vou specific legal rights and vou mav also have other legal rights which varv from state to state prov ince to province Some states provinces do not allow the exclusion or limitation of incidental or consequential damage or limitation on how long an implied warranty lasts so the above exclusion and limitations may not apply to you The warranties contained herein contain all the representa tions 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 Parkwav Atlanta GA 30360 Tel 770 368 4700 14423 INS LAB RevD11 34 10 APPENDIX A EC DECLARATION OF CONFORMITV EC Declaration of Conformitv 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 prem
28. t Doppler including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance ta EA 80 MHz to E 800 MHz d Did 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 Co 37 Info 1 At 80 MHz and 800 MHz the higher freguency range applies Info 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from struc tures 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 theoreti callv with accuracv To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be consid ered If the measured field strength in the location in which the Grafco Ultrasound Pocket Doppler is used exceeds the applicable RF compli ance level above the Grafco Ultrasound
29. to the public low voltage power supply network that supplies buildings used for domestic purposes Electromagnetic Immunity for all Equipment and Systems Guidance and 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 48 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 RevD11 36 Electromagnetic Immunitv for all Equipment and Svstems that are not Life Supportin Guidance and manufacturer s declaration electromagnetic immunitv The Grafco Ultrasound Pocket Doppler Svstem is intended for use in the electromagnetic environment specified below Do not use the svstem 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 RevD11 Portable and mobile RF communications equipment should be used no closer to any part of the Grafco Ultrasound Pocke
30. to the transmitter manufacturer Info 1 At 80 MHz and 800 MHz the separation distance for the higher freguency range applies Info 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from struc tures objects and people 14423 INS LAB RevD11 39 12 APPENDIX C OVERALL SENSITIVITV Overall Sensitivitv 2 MHz Probe Diameter SE Reflection Two way Attenuation B B B f d Target Reflector 2B B B mm lt mm B dB dB dB Doppler Freguency Ha 14423 INS LAB RevD11 40 Overall Sensitivitv 2 MHz Probe Diameter B S Overall of M S M S m Sensitivity Target V V S A d B C dB 186 l Reflector mm on N CO 5 N o Doppler Velocity of Target cm s Hz 14423 INS LAB RevD11 41 13INDEX A Accessories optional 4 Accessorv equipment certifica tion of 6 Address Graham Field 34 Appendix A EC Declaration of Conformitv 35 Appendix B EMC information 36 Appendix C Overall Sensitivitv 40 B Batterv installing replacing 18 Batterv terminals cleaning 19 C GAUTION statement significance 5 Cleaning 26 D Display panel 12 E Electromagnetic emissions for all equipment and systems Appendix B 36 Electromagnetic immunity for all eduipment and systems Ap pendix B 36 Electromagnetic immunitv for all equipment and svstems that are not life supporting Ap pendix B 37 F
31. ymbol 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 RevD11 9 3 HANDLING GF HEALTH PRODUCTS INC FREIGHT POLICV For your protection read carefully The carrier accepted this merchandise in good condition and is responsible for safe deliverv Before signing the freight bill inspect the shipment carefullv 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 mav result in the carrier failing to honor the claim Please contact the carrier to obtain the paperwork necessarv to file a claim or contact GF Health Products Inc Customer Service at the number on the back cover of this manual Concealed loss or damage If damage is discovered after deliverv 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 with in 15 davs of deliverv The carrier will provide all paper work necessary to file a concealed damage or loss claim since such damage or loss is the carrier s responsibility UNPACKING Info U
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