4423-2 / 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 professional.
Contents 1 2 3 4 5 6 7 8 9 10 11 12 13 IntroduCtIon .........................................................................3 Intended use of thIs devICe ........................................3 InCluded features..........................................................3 optIonal aCCessorIes ...................................................4 safety InformatIon..............................................................5 safety preCautIons .......................................................
1 IntroduCtIon This user manual contains important information and safety precautions for the Grafco Ultrasound Pocket Doppler. 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.
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 4001GF Coupling Gel, case of 12 0.25 liter bottles 4002GF Coupling Gel, 5 liter bottle 14423-2P 2.0 MHz Waterproof Probe 14423-4P 4.0 MHz Waterproof Vascular Probe 14423-8P 8.
2 safety InformatIon safety guidance This unit has internally powered equipment, and the degree of shock protection is type B. Type B protection means that this product is in accordance with permitted leakage currents and 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.
WarnIngs 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. WARNING: Do not use the Grafco Pocket Doppler in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur. WARNING: Do not expose batteries to heat. WARNING: Do not attempt to charge alkaline batteries; they may leak or catch on fire.
WARNING: Use only probes provided by GF Health Products, Inc. intended to be used with the Grafco Pocket Doppler. WARNING: Do not stretch the probe cable further than 6.5 feet (2 meters). 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.
notICes 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 environment clean and dust-free. Protect the device from vibration, corrosive medicine, and high temperatures. s NOTICE: Do not use high-temperature sterilizing process, low temperature steam, E-beam, or gamma radiation sterilization on this device or its accessories.
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 2005.
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.
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. s 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). s NOTICE: Ensure that relative humidity at the Pocket Doppler's location during storage does not exceed 93%.
4 ultrasound poCket doppler and aCCessorIes appearanCe and features The following figures illustrate the Pocket Doppler with the 2.0 MHz waterproof probe, and accompanying tables describe labeled features. front panel Display Panel POWER Button Probe Speaker Probe Socket feature function display panel Displays system info 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.
speaker The built-in speaker makes the fetal sounds audible power Turns the Ultrasound Pocket Doppler ON or button OFF probe The probe connects here to the Ultrasound Pocket Doppler socket Jack definition 14423-INS-LAB-RevE13 1 Power Supply 2 Signal 3 Probe Coding 1 4 Probe Coding 2 5 Probe Coding 3 6 (Shell) GND 13
rear panel Probe Frame Battery Compartment Probe Socket feature function battery Compartment probe frame Opens to install/replace battery Stores probe when not in use 14423-INS-LAB-RevE13 14
top panel Earphone Socket feature socket function name picture function Charge Socket Not used Earphone Socket Connect earphone Warning Signal Interface 1 GND 2 Signal 3 Signal 4 Signal 5 Signal Refer to accompanying documents (this user manual) 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).
left panel Volume Control feature volume Control function Adjust volume Increase volume: Rotate volume knob clockwise Decrease volume: Rotate volume knob counter-clockwise mode button Not used start/stop button 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 2.0 mhz Waterproof probe 4.0 mhz Waterproof vascular probe * Cd Continuous Wave Doppler x.0 (Central frequency) Central frequency = 2.
5 setup InstallIng or replaCIng the battery WARNING: Ensure that Pocket Doppler power is off before replacing the battery. WARNING: Install/replace the battery at least 6 feet (1.5 meters) from the patient. 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.
s NOTICE: Keep the battery away from objects or materials with static electric charges. 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.
6 operatIon probe operatIon removing the probe from the pocket doppler s 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.
swapping probes s 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 Doppler probe: 1. Follow steps 1-3 in previous section, Removing the Probe from the Pocket Doppler. 2. Grasp probe connector body and gently pull out from Pocket Doppler probe socket. 3. Connect the new probe's connector: Grasp probe connector body and gently insert into Pocket Doppler's probe socket.
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.
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.
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 45º 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.
7 maIntenanCe and CleanIng 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 WARNING: Before use, inspect the Pocket Doppler 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.
s NOTICE: Keep the Pocket Doppler and its environment clean and dust-free. Protect the device from vibration, corrosive medicine, and high temperatures. s 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 WARNING: Before cleaning the Pocket Doppler or probes, turn the Pocket Doppler power off and remove the battery.
Cleaning the pocket doppler probe s NOTICE: Do not allow liquid to enter the ultrasound system. s NOTICE: Do not pour liquids on the ultrasound system or probe socket while cleaning. The Pocket Doppler probe’s acoustic surface 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, dry, non-abrasive cloth. 2. After thoroughly cleaning the probe, replace it in the Pocket Doppler probe frame. 3.
dIsInfeCtIon disinfecting the pocket doppler probe s NOTICE: Do not allow any liquid to enter the probe socket while disinfecting or immersing the probe. 1. Clean the exterior surface of the 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.
8 speCIfICatIons model number 14423-2 and name Ultrasonic Pocket Doppler with 2.0 MHz probe 14423-4 Ultrasonic Pocket Doppler with 4.0 MHz probe 14423-8 Ultrasonic Pocket Doppler with 8.0 MHz probe safety Complies with: EN 60601-1/1990 Classification Anti-electric Shock Type Internally powered equipment Anti-electric Shock Degree Type B equipment Degree of Protection against Harmful Ingress of Water Main Unit Non-protected 2.
physical Size Characteristics (W x D x H) environment Weight (including battery) .66 lb (<300 g) Working Temperature 41°F ~ 104°F (5°C ~ 40°C) Humidity 25% - 80% (non-condensing) Atmospheric Pressure 12.47 psi ~ 15.37 psi (860hPa ~ 1060 hPa) Temperature -4°F ~ 131°F (-20°C ~ 55°C) Humidity 25% - 93% (non-condensing) Atmospheric Pressure 10.15 psi ~ 15.37 psi (700hPa ~ 1060 hPa) Transport and Storage fhr performance audio output power battery 3.50 x 1.34 x 5.
ultrasound Nominal Frequency Working Frequency 2.0 MHz Waterproof Probe 2.0 MHz 4.0 MHz Waterproof Vascular Probe 4.0 MHz 8.0 MHz Waterproof Vascular Probe 8.0 MHz 2.0 MHz Waterproof Probe 2.0 MHz ±10% 4.0 MHz Waterproof Vascular Probe 4.0 MHz ±10% 8.0 MHz Waterproof Vascular Probe 8.0 MHz ±10% P- < 1MPa Iob < 10 mW/cm2 Ispta < 100mW/cm2 Working Mode Continuous Wave Doppler Effective Radiating Area of Transducer 2.0 MHz Waterproof Probe 245mm2 ±15% 4.
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.
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 Products, Inc.
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.
10 appendIx a, eC deClaratIon of ConformIty eC declaration of Conformity Manufactured for GF Health Products, Inc., 2935 Northeast Parkway, Atlanta, GA 30360 Product Ultrasound Pocket Doppler Classification (MDD, Annex IX): IIa 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.
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.
electromagnetic Immunity—for all equipment and systems that are not life-supporting 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 3 V/m 80 MHz to 2.
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.
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 situations.
12 appendIx C, overall sensItIvIty overall sensitivity (2 mhz probe) Diameter of Target Reflector (mm) Distance Reflection (d) Loss A (mm) (d) Two-way Attenuation B=∑Ba+Bw (T:mm 1.58 50 A=45.7dB @2 MHz 75 100 200 2.38 50 A=43.2dB @2 MHz 75 100 200 45.7 45.7 45.7 45.7 43.2 43.2 43.2 43.2 T ∑Ba Ba:dB) 20 4.8 4.0 - Ba 40 9.6 8.0 - T 20 4.8 3.4 - Ba 40 9.6 6.8 - T 20 4.8 3.4 - Ba 40 9.6 6.8 - T 20 4.8 - - Ba 40 9.6 - - T 20 4.8 3.4 2.2 Ba 40 9.6 6.8 4.4 T 20 4.8 3.
overall sensitivity (2 mhz probe) Diameter of Target Reflector (mm) Vn (r.m.s.) mV Vn (r.m.s.) mV dB Overall Sensitivity (S=A(d)+B+C) dB 1.58 186 A=45.7dB @2 MHz 175 174 94 5.93 109.2 90 5.78 107.8 89 5.82 107.9 173 90 5.68 100.9 2.38 178 A=43.2dB @2 MHz 170 165 89 6.02 110.0 90 5.52 107.1 85 5.76 105.3 160 85 5.49 100.2 Doppler Frequency (Hz) Velocity of Target 12.
13 Index A Accessories, optional 4 Accessory equipment, certification of 6 Address, GF Health Products, Inc.
S Safety information 5 Specifications 29 START/STOP button 16 T Telephone number, GF Health Products, Inc.
GF Health Products, Inc. 2935 Northeast Parkway Atlanta, Georgia 30360 telephone: 770-368-4700 www.grahamfield.com 14423-INS-LAB-Reve13 © 2013 GF Health Products, Inc.
