1. Manuals
  2. Brands
  3. Grafco Manuals
  4. Medical Equipment
  5. GRAFCO 14423-2
  6. User manual

Grafco 14423-2 User Manual

Ultrasound pocket doppler
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
14423-2 / 14423-4 / 14423-8
ULTRASOUND POCKET DOPPLER
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.
USER MANUAL
14423-INS-LAB-RevD11

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the GRAFCO 14423-2 and is the answer not in the manual?

Questions and answers

Related Manuals for Grafco GRAFCO 14423-2

Summary of Contents for Grafco GRAFCO 14423-2

  • Page 1 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...

  • Page 2: Table Of Contents

    CONTENTS 1 INTRODUCTION .................3 INTENDED USE OF THIS DEVICE ........3 INCLUDED FEATURES ............3 OPTIONAL ACCESSORIES ...........4 2 SAFETY INFORMATION..............5 SAFETY PRECAUTIONS ............5 SYMBOLS ................9 3 HANDLING ................10 GF HEALTH PRODUCTS, INC. FREIGHT POLICY ....10 UNPACKING ...............10 STORAGE ................11 4 ULTRASOUND POCKET DOPPLER AND ACCESSORIES ..12 APPEARANCE AND FEATURES ..........12 POCKET DOPPLER WATER-RESISTANT PROBES ....17 BATTERY ................17 5 SETUP ..................18 INSTALLING OR REPLACING THE BATTERY .....18 6 OPERATION ................20 PROBE OPERATION ............20 TURNING ON THE POCKET DOPPLER ......21 FETAL HEART (FH) MONITORING .

  • Page 3: Introduction

    1 INTRODUCTION 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.

  • Page 4: Optional Accessories

    OPTIONAL ACCESSORIES 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. Product 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...

  • Page 5: Safety Information

    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.
  • Page 6 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 in- structed by a qualified healthcare professional. WARNING: Do not use the Grafco Pocket Doppler in a flammable atmosphere where concentrations of flam- mable anesthetics or other materials may occur. WARNING: Do not expose batteries to heat. WARNING: Do not attempt to charge alkaline batter- ies; they may leak or catch on fire. WARNING: DO NOT simultaneously touch signal in- put or output connector and the patient. 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 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. WARNING: The Grafco Pocket Doppler is a tool to aid the healthcare professional and should not be used in place of normal fetal monitoring. 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. WARNING: Replace the battery at least 6 feet (1.5 me- ters) from the patient. 14423-INS-LAB-RevD11...
  • Page 7 WARNING: Do not the use Pocket Doppler if the bat- tery cover is open. WARNING: Use only those 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 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. 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: • Inspect the equipment for mechanical and func- tional damage. • Ensure the safety labels are legible. • Verify that the device functions properly as de- scribed in this manual. • 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...
  • Page 8 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 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 NOTICE: If the Pocket Doppler will not be used for a prolonged period of time, remove the battery from the device. s NOTICE: Keep the battery away from objects or mate- rials with static electric charges. s NOTICE: If the battery terminals become dirty, wipe them with a clean, dry cloth before using the battery. 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 monitor immediately. s NOTICE: For information on installing and removing the battery from the monitor, see Section 5, SETUP. s NOTICE: Dispose of the battery in accordance with lo- cal regulations. s NOTICE: Do not dispose of this device with house- hold waste. Dispose of this device in accordance with your local laws and regulations.

  • Page 9: Symbols

    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.

  • Page 10: Handling

    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.

  • Page 11: Storage

    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 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-RevD11...

  • Page 12: Ultrasound Pocket Doppler And Accessories

    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 accompanying tables describe labeled features. Front Panel Feature Function Display Displays system info Panel System status The system status LED is at the left bottom corner of the display panel.
  • Page 13 Power Turns the Ultrasound Pocket Doppler ON or Button Probe The probe connects here to the Ultrasound Pocket Doppler Socket Jack Definition Power Supply Signal Probe Coding 1 Probe Coding 2 Probe Coding 3 (Shell) GND 14423-INS-LAB-RevD11...
  • Page 14 Rear Panel Feature Function Pocket Clip Attaches Pocket Doppler to pocket Attachment Battery Opens to install/replace battery Compartment Probe Frame Attaches probe to Pocket Doppler 14423-INS-LAB-RevD11...
  • Page 15 Top Panel Feature Function Socket Name Picture Function Charge Not used Socket Earphone Connect earphone Socket Signal Interface Signal Signal Signal Signal Warning Refer to accompanying documents (this user manual) 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 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.
  • Page 16 Left Panel Feature Function Volume Control Adjust Increase volume: 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-RevD11...

  • Page 17: Pocket Doppler Water-Resistant Probes

    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...

  • Page 18: Setup

    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 9V alkaline batteries (IEC Type 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 arrow on the battery cover (see above picture). 2. If replacing the battery, remove the old battery. 3.
  • Page 19 s NOTICE: If the battery terminals become dirty, wipe them with a clean, dry cloth before using the Pocket Doppler. s NOTICE: Batteries have life cycles. If the battery use time shortens noticeably, the battery's life cycle is over. 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: Dispose of the old battery in accordance with local regulations. 14423-INS-LAB-RevD11...

  • Page 20: Operation

    6 OPERATION PROBE OPERATION Removing the Probe from the Pocket 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.

  • Page 21: Turning On The Pocket Doppler

    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 Dop- pler probe: 1. Follow steps 1-3 in previous section, Removing the Probe from the Pocket Doppler. 2. Remove the connector: Grasp probe connector body and gen- tly pull out from Pocket Doppler probe socket.

  • Page 22: Fetal Heart (Fh) Monitoring

    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 to find the best location to place the probe and hear the fetal heart rate.

  • Page 23: Vascular Monitoring With 4.0 Or 8.0 Mhz Probe (Optional)

    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.

  • Page 24: Turning Off The Pocket Doppler

    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 45º to the vessel to be examined. 3. Adjust the position of the probe to obtain the loudest audio signal.

  • Page 25: Maintenance

    7 MAINTENANCE WARNING: Failure on the part of the responsible facil- ity employing the use of this equipment to implement a satisfactory maintenance schedule may cause un- due equipment failure and possible health hazard. MAINTENANCE 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 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. 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: • Inspect the equipment for mechanical and func- tional damage. • Ensure the safety labels are legible. • Verify that the device functions properly as de- scribed in this manual. • 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...

  • Page 26: Cleaning

    s NOTICE: Keep the Pocket Doppler and its environ- ment clean and dust-free. Protect the device from vi- bration, corrosive medicine, and high temperatures. s NOTICE: Do not use high-temperature sterilizing pro- cess, low temperature steam, E-beam, and/or gamma radiation sterilization on this device or its accesso- ries. CLEANING WARNING: Before cleaning the Pocket Doppler or probes, turn the Pocket Doppler power off and re- move the battery. s NOTICE: Do not use strong solvent such as acetone to clean Pocket Doppler or probe. s NOTICE: Do not use an abrasive such as steel wool or metal polish to clean Pocket Doppler or probe. s NOTICE: Do not allow any liquid to enter the probe socket while cleaning the Pocket Doppler or probe. Cleaning the Pocket Doppler s NOTICE: Do not immerse Pocket Doppler. Do not al- low liquid to enter the ultrasound system. s 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.
  • Page 27 Cleaning the Pocket Doppler Probe s NOTICE: Do not allow liquid to enter the ultrasound system. s NOTICE: Do not pour liquids on the probe while cleaning. The Pocket Doppler 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.

  • Page 28: Disinfection

    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 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.

  • Page 29: Specifications

    8 SPECIFICATIONS Model Number 14423-2 Ultrasonic Pocket Doppler and Name 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 Internally powered equipment Shock Type Anti-electric Type B equipment Shock Degree...
  • Page 30 Physical Size (Width x 3.35 x 1.26 x 5.43 inches Characteristics Depth x Height) (85 x 32 x 138 mm) Weight .64 lb (290 ±5g) (including a battery and a probe) Environment Working Temperature 41°F ~ 104°F (5°C ~ 40°C) Humidity ≤80% RH Atmospheric...
  • Page 31 Ultrasound Nominal 2.0 MHz 2.0 MHz Frequency Water-Resistant Probe 4.0 MHz 4.0 MHz Water-Resistant Vascular Probe 8.0 MHz 8.0 MHz Water-Resistant Vascular Probe Working 2.0 MHz 2.0 MHz ±10% Frequency Water-Resistant Probe 4.0 MHz 4.0 MHz ±10% Water-Resistant Vascular Probe 8.0 MHz 8.0 MHz ±10% Water-Resistant...

  • Page 32: Limited Warranty

    9 LIMITED WARRANTY GF Health Products Inc. warrants this product to be free from manufacturing defects in material and workmanship for its period of warranty that is in accordance with industry standards. 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.
  • Page 33 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 sat- isfactory warranty service, please contact GF Health Products, Inc.
  • Page 34 This warranty gives you specific legal rights and you may also have other legal rights which vary 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.

  • Page 35: Appendix A, Ec Declaration Of Conformity

    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.

  • Page 36: Appendix B, Emc Information

    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. Emission Compliance Electromagnetic environment–...
  • Page 37 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...
  • Page 38 Info 1: At 80 MHz and 800 MHz, the higher frequency range applies. Info 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and 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- cally with accuracy.
  • Page 39 For transmitters rated at a maximum output power not listed previously, the recommended separation distances in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

  • Page 40: Appendix C, Overall Sensitivity

    12 APPENDIX C, OVERALL SENSITIVITY Overall Sensitivity (2 MHz Probe) Diameter Distance Reflection Two-way Attenuation B=∑B Loss A Target (mm) ∑B Reflector (dB) (mm) (T:mm :dB) (dB) 1.58 45.7 4.8 4.0 57.6 A=45.7dB Ba 40 9.6 8.0 @2 MHz 45.7 4.8 3.4 56.4 Ba 40 9.6 6.8 45.7 4.8 3.4 56.4 Ba 40...
  • Page 41 Overall Sensitivity (2 MHz Probe) Diameter Overall (r.m.s.) (r.m.s.) Sensitivity Target (S=A(d)+B+C) Reflector (mm) 1.58 5.93 109.2 A=45.7dB 5.78 107.8 @2 MHz 5.82 107.9 5.68 100.9 2.38 6.02 110.0 A=43.2dB 5.52 107.1 @2 MHz 5.76 105.3 5.49 100.2 Doppler Velocity of Target 12.5 Frequency (cm/s) (Hz) 14423-INS-LAB-RevD11...

  • Page 42: Index

    13 INDEX Introduction 3 Accessories, optional 4 Accessory equipment, certifica- Left panel features and illustra- tion of 6 tion 16 Address, Graham-Field 34 Appendix A, EC Declaration of Maintenance 25 Conformity 35 Appendix B, EMC information 36 NOTICE statement, significance Appendix C, Overall Sensitivity Operation 20 Battery, installing / replacing 18 Battery terminals, cleaning 19...
  • Page 43 Telephone number, Graham-Field Top panel features and illustra- tion 15 User manual, contents of 3 Volume control 16 WARNING statement, signifi- cance 5 Warranty, limited 32 14423-INS-LAB-RevD11...
  • Page 44 USA Corporate Headquarters: GF Health Products, Inc. 2935 Northeast Parkway Atlanta, Georgia 30360 telephone: 770-368-4700 www.grahamfield.com 14423-INS-LAB-RevD11 © 2011 GF Health Products, Inc.

This manual is also suitable for:

14423-414423-8

Table of Contents