Page 2 - CONTENTS
14423-INS-LAB-RevD11 2 CONTENTS 1 INTRODUCTION .........................................................................3 INTENDED USE OF THIS DEVICE ........................................3INCLUDED FEATURES ..........................................................3OPTIONAL ACCESSORIES ..............
Page 3 - INTRODUCTION; INTENDED USE OF THIS DEVICE; WARNING: This device is not intended to be used; INCLUDED FEATURES
14423-INS-LAB-RevD11 3 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...
Page 4 - OPTIONAL ACCESSORIES; Item No. Product Description; Coupling Gel, case of 12 0.25 liter bottles
14423-INS-LAB-RevD11 4 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 40...
Page 5 - SAFETY INFORMATION; Safety Guidance; SAFETY PRECAUTIONS
14423-INS-LAB-RevD11 5 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 ...
Page 6 - WARNINGS
14423-INS-LAB-RevD11 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 a...
Page 8 - NOTICES
14423-INS-LAB-RevD11 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 medic...
Page 9 - SYMBOLS
14423-INS-LAB-RevD11 9 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 shou...
Page 10 - HANDLING; For your protection, read carefully; UNPACKING; Check for obvious damage to the carton or its contents.
14423-INS-LAB-RevD11 10 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....
Page 11 - Inspection; STORAGE; Store the repackaged Pocket Doppler in a dry area.; NOTICE: Ensure that the temperature at the Pocket
14423-INS-LAB-RevD11 11 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 storag...
Page 12 - APPEARANCE AND FEATURES
14423-INS-LAB-RevD11 12 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 Panel Displays system info S...
Page 16 - Adjust; MODE Button; Not used
14423-INS-LAB-RevD11 16 Left Panel Feature Function Volume Control Adjust volume Increase volume: Rotate volume knob clockwiseDecrease volume: Rotate volume knob counter-clockwise MODE Button Not used START/STOP Button REC/PLAY Button
Page 17 - SETUP
14423-INS-LAB-RevD11 17 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-pearanc...
Page 18 - SETUP; INSTALLING OR REPLACING THE BATTERY; Open the battery compartment: Slide the battery cover
14423-INS-LAB-RevD11 18 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 ...
Page 20 - OPERATION; PROBE OPERATION; Removing the Probe from the Pocket Doppler
14423-INS-LAB-RevD11 20 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 un...
Page 21 - TURNING ON THE POCKET DOPPLER
14423-INS-LAB-RevD11 21 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 Pocke...
Page 22 - FH Monitoring with 2.0 MHz Water-Resistant Probe
14423-INS-LAB-RevD11 22 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 hea...
Page 25 - MAINTENANCE
14423-INS-LAB-RevD11 25 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 Do...
Page 26 - CLEANING; Cleaning the Pocket Doppler; Keep the exterior surface of the Pocket Doppler clean
14423-INS-LAB-RevD11 26 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 ster...
Page 27 - After thoroughly cleaning the probe, replace it in the; NOTICE: Do not allow any liquid or cleaning solution
14423-INS-LAB-RevD11 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...
Page 28 - DISINFECTION; Disinfecting the Pocket Doppler Probe; Clean the exterior surface of the probe as recommend-
14423-INS-LAB-RevD11 28 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 th...
Page 29 - SPECIFICATIONS; Model Number
14423-INS-LAB-RevD11 29 8 SPECIFICATIONS Model Number and Name 14423-2 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 ...
Page 31 - Ultrasound
14423-INS-LAB-RevD11 31 Ultrasound Nominal Frequency 2.0 MHz Water-Resistant Probe 2.0 MHz 4.0 MHz Water-Resistant Vascular Probe 4.0 MHz 8.0 MHz Water-Resistant Vascular Probe 8.0 MHz Working Frequency 2.0 MHz Water-Resistant Probe 2.0 MHz ±10% 4.0 MHz Water-Resistant Vascular Probe 4.0 MHz ±10% 8....
Page 32 - LIMITED WARRANTY; GF Health Products Inc.
14423-INS-LAB-RevD11 32 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 de...
Page 33 - GF Health
14423-INS-LAB-RevD11 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, ple...
Page 35 - EC Declaration of Conformity
14423-INS-LAB-RevD11 35 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 pro...
Page 36 - 1 APPENDIX B, EMC INFORMATION
14423-INS-LAB-RevD11 36 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 env...
Page 40 - 2 APPENDIX C, OVERALL SENSITIVITY
14423-INS-LAB-RevD11 40 12 APPENDIX C, OVERALL SENSITIVITY Overall Sensitivity (2 MHz Probe) Diameter of Target Reflector (mm) Distance (d) (mm) Reflection Loss A (d) Two-way Attenuation B=∑B a +B w ∑B a (T:mm B a :dB) B w (dB) B (dB) 1.58 A=45.7dB @2 MHz 50 45.7 T 20 4.8 4.0 - 0 57.6 Ba 40 9.6 8.0 ...
