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14423-2 / 14423-4 / 14423-8
ULTRASOUND POCKET DOPPLER
USER MANUAL
Important: Do not use the Pocket Doppler
without first 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 product
should not be used unless the operator has
been instructed by a qualified healthcare pro -
fessional.
14423-INS-LAB-RevD11
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CONTENTS 1 INTR ODUCTION ......................................................................... 3 INTENDED USE OF THIS DEVICE ........................................ 3 INCL UDED FEA TURES .......................................................... 3 OPTION AL A CCESSORIES ................................................... 4 2 SAFETY INFORMA TION .............................................................. 5 SAFETY PRECA UTIONS ..............................................
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1 INTR ODUCTION This user manual contains important information and safety 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 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 int
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OPTION AL A CCESSORIES The following accessories for use with the Grafco Ultrason- ic Pocket Doppler are available from your GF Health Prod- ucts, Inc. authorized distributor or www.grahamfield.com. Item No . Pr oduct Description 4001GF Coupling Gel, case of 12 0.25 liter bottles 4002GF Coupling Gel, 5 liter bottle 14423-2P 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-RevD1 1 4
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2 SAFETY INFO RMA TION Saf ety 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 PRECA UTIONS 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 c
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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 qualified healthcare professional. W ARNING: Do not use the Grafco Pocket Doppler in a flammable atmosphere where concentrations of flam- mable anesthetics or other materials may occur . W ARNING: Do not expose batteries to heat. W ARNING: Do not attempt to charge alkaline batter - ies; they may leak or ca
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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 further than 6.5 feet (2 meters). W ARNING: 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- te
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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 device from vi - bration, corrosive medicine, and high temperatures. s 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. s
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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 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
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3 HANDLING GF HEAL TH PR ODUCTS, INC . FREIGHT POLICY F or y our pr otection, r ead car efull y 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. A ppar ent loss or dama ge 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
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Inspection Check the Pocket Doppler for nicks, dents, scratches, me- chanical or other damage. Check all the cables and acces- sories. ST ORA GE Store the repackaged Pocket Doppler in a dry area. s 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). s NOTICE: Ensure that relative humidity at the Pocket Doppler's location during storage does not exceed 93%. 14423-INS-LAB-RevD1 1 1 1
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4 UL TRASOUND POCKET DOPPLER AND A CCESSORIES APPEARANCE AND FEA TURES The following figures illustrate the Pocket Doppler with the 2.0 MHz water-resistant probe, and accompanying tables describe labeled features. F r ont P anel F ea tur e Function Display Displays system info P anel System status The system status LED is at the left bottom corner of the display panel. Please see LED the following table for significance of LED indicators. LED LED Significance Illumina tion Illumina t
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Power Turns the Ultrasound Pocket Doppler ON or Button OFF Pr obe The probe connects here to the Ultrasound Pocket Doppler Soc k et Jack Definition 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 13
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R ear P anel F ea tur e Function P oc k et Clip Attaches Pocket Doppler to pocket Attac hment Ba tter y Opens to install/replace battery Compar tment Pr obe F r ame Attaches probe to Pocket Doppler 14423-INS-LAB-RevD1 1 14
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Top P anel F ea tur e Function Soc k et Name Pictur e Function Charge Not used Socket Earphone Connect earphone Socket Signal 1 GND Interface 2 Signal 3 Signal 4 Signal 5 Signal W ar ning Refer to accompanying documents (this user manual) W ARNING: 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 configuratio
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Left P anel F ea tur e Function V olume Contr ol Adjust Increase volume: volume Rotate volume knob clockwise Decrease volume: Rotate volume knob counter-clockwise MODE Button Not used ST AR T/ST OP Button REC/PLA Y Button 14423-INS-LAB-RevD1 1 16
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POCKET DOPPLER WA TER-RESIST ANT PR OBES 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: P oc k et Doppler W a ter-R esistant Pr obe La bel T a ble Pictur e of Pr obe Pr obe La bel 2.0 MHz 4.0 MHz 8.0 MHz Text W a ter-R esistant W a ter-R esistant W a ter-R esistant Pr obe V ascular V a
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5 SETUP INST ALLING OR REPLA CING 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 alkaline batteries (IEC T ype No. 6LR61/6LF22 or equivalent) in this device. battery socket battery compartment battery connector battery cover battery installation 1. Open the battery compartment: Slide the battery cover in the direction of the ar
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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 . Replace the old battery with a new one of the same size and type. Use only batteries recommended by GF Health Products, Inc. s NOTICE: Remove a battery whose life cycle is over from the Pocket Doppler immediately . s NOTICE:
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6 OPERA TION PR OBE OPERA TION R emo ving the Pr obe fr om the P oc k et Doppler s 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 f
