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Contents
1. 40 C to 70 C e Relative Humidity 10 to 100 including condensation e Atmospheric Pressure 500 hPa to 1060 hPa Cleaning the Instrument Clean the outside of the instrument as needed First turn off the power and unplug the battery charger Remove dust with a soft cloth or small paint brush Wash with a soft cloth dampened in a mild solution of detergent and water Never use abrasive cleaners To disinfect surface use a soft cloth dampened with liquid disinfectant or use a surface germicidal cloth After cleaning germicidal agent dries remove any residue with a soft cloth dampened with water Never let the inside of the instrument get wet recs the Probes Remove the gel with a soft tissue after each probe use Wash any dried gel off the probe with running water DO NOT scrape off dried gel to avoid damaging the coating over the crystals User may opt to wipe probe with alcohol surface germicidal cloth or liquid disinfectant rinse probe with warm water to remove any residue after cleaning germicidal agent dries Do not use bleach 1S Sterilizing the Probes Preparation for Sterilization 1 Wash the probe with warm soapy water 2 Inspect the epoxy covering that protects the crystal If it has cracks or has pulled away from the probe housing organic material can become trapped and the probe cannot be sterilized successfully Sterilization If you need to sterilize PARKS pencil probes they should be sterilized by2. 1 0 Liter 1 5 m 5 ft 2 1m 7 ft 3 0 m 10 ft Parks part 748 0003 00 Parks part 748 0001 00 PARKS 811 B CE Operating Service Manual 14 Parks part 051 811B 00 811 B Ultrasonic Doppler Flow Detector Technical Information and Notes When ordering replacement parts refer to the Instrument Identification Information section of this manual on page 3 or check the unit for bar code information Bar Code Label The bar code contains information about your Doppler When requesting service or parts please have this information available Serial Number MUNINN gt Part Number S H Seee AeneAAAee eBee Be08 81 1a e4 Description S A Date of Manufacture Carrying Cases Optional rugged aluminum cases with welded corners handle removable lid and room for accessories 800 is large enough to hold the Doppler a bottle of gel probe and battery charger 18 cm X 23 5 cm X 10 cm 7 25 in x 9 25 in x 4 in blue case Parks part 798 0016 02 901 will hold the Doppler a bottle of gel probe battery charger manometer and a few cuffs 21 6 cm X 28 9 cm X 11 4 cm 8 5 in x 11 375 in x 4 5 in white case Parks part 798 0018 05 Contact Information U LTRASO NIC Bop Flow DETECTOR Urasouno ae TEN SMISSION caf l i POA teceNt P PARKS Medical Electronics Inc PARKS Medical Electronics Inc Mailing Address PO Box 5669 Aloha OR 97006 USA Shipping Address 19460 SW Shaw
3. Active Medical Device In order to prevent electric shock the instrument utilizes a safety circuit that prevents it from operating while connected to a battery charger A Type B Applied Part All equipment that comes in contact with the patient complies with directives for the degree of protection against electric shock Acoustical Output Power The acoustical output power of this Doppler is within limits set by the European Union 2 811 B Ultrasonic Doppler Flow Detector Preface The Model 811 B kit e 811 B Doppler factory tuned to 8 2 MHz e Battery Charger with 24V 0 625A output and international socket adaptors for ac outlets e 8 2 MHz Pencil Probe or Flat Probe e Ultrasound Transmission Gel e 811 B Operating Service Manual This Doppler uses a rechargeable 12 volt 1 2 Ah sealed lead acid battery for its power source The Doppler is shipped ready to use with fully charged battery installed Safety This instrument is intended for use by health care professionals only The following symbols are used throughout this manual CAUTION Indicates a potentially hazardous situation that if not avoided could result in personal injury or damage to the instrument DANGEROUS VOLTAGE Indicates a potential electrical hazard that if not avoided could result in personal injury or damage to the instrument 0 AAN TYPE B APPLIED PART MEDICAL EQUIPMENT Type B Applied Part complies with degree of protection against electr
4. STERRAD 1008S sterilization procedures only PARKS pencil probes have been tested to a sterility assurance level SAL of 10 using STERRAD 100S sterilization procedures A copy of the sterility test report is available by calling us toll free at 1 800 547 6427 Do Not Autoclave the Probes Temperatures above 57 2 degrees Celsius 135 degrees Fahrenheit destroy the crystal activity and cause the covering over the individual cables and the outer sheath to shrink and crack With a raised temperature a severe loss of sensitivity will occur Autoclaving will void the probe s warranty 8 811 B Ultrasonic Doppler Flow Detector Operating Instructions A Please Read This Information contained in this manual is provided to help the user operate the instrument controls In no way must a diagnosis be made on the basis of information provided in the manual We provide procedures which we believe to be in current usage However the procedure to be used and the diagnosis of an individual patient must be determined by the attending physician from information in the scientific literature and from other medical sources PARKS Medical Electronics Inc 9 Operating Instructions Using the Probe Parks pencil probes are positioned differently than other Doppler probes because they are designed to detect blood flow in vessels that are too deep to feel The initial energy of the beam is only as wide as the crystals in the probe so yo
5. cuff or the beam will be off the artery when you deflate PARKS Medical Electronics Inc 13 Technical Information and Notes Specifications And Replacement Parts Doppler Height Width Depth Weight Battery Battery Charger Fuse Internal Speaker Headphones Tuning Probes Standard Pencil Probe Skinny Pencil Probe Adult Flat Probe Infant Flat Probe Ultrasonic Doppler Flow Detector Model 811 B 19 7 cm 7 76 in 13 6 cm 5 39 in 8 0 cm 3 27 in 1 34 kg 2 87 Ib with battery 12 V 1 2 Ah sealed lead acid rechargeable battery Fully charged at 14 5 V needs charging at 11 3 V fails at 10 V e Parks part 854 0017 01 or e Power Sonic Europe LTD part PS 1212 24V 0 625A output with international socket adaptors for ac outlets Parks part 984 0020 00R 16 VAC 250 mA charger may be used also 500mA 250 volt Slow Parks part 865 6002 00 Speaker disconnects when headphones are plugged in Acquire 32 ohm stereo headphones locally All 811 B Dopplers for the European Union are factory tuned to 8 2 MHz Order probes to match the 8 2 MHz frequency of the Doppler 9 5 mm 3 8 in diameter 6 35 mm 1 4 in diameter 15 9 mm x 19 mm 5 8 in x 3 4 in 12 7 mm x 15 9 mm 1 2 in x 5 8 in Probes are available with double shielded cable Replacement Probe Cable lengths Standard Cable Length Optional Cable Length Optional Cable Length Ultrasound Gel 0 25 Liter
6. ensure that electrical components meet the company s standard of performance PARKS Medical Electronics Inc 21
7. or adult or infant flat probe The optional skinny pencil probe may also be ordered at additional cost The pencil probes are used for detecting blood flow and taking systolic blood pressure The flat probes are designed to be taped in place for repeated blood pressure measurements Each probe consists of two crystals one transmits ultrasound waves and one receives the reflected waves The probe s two connectors can be plugged into either of the two jacks The initial energy beam is as wide as the crystal The crystals are the parallel gold colored strips embedded in epoxy at the end of the probe Damage to either crystal will impair or prevent probe function The material covering the crystals can be damaged by ECG cream or paste abrasion soaking in alcohol or disinfectant and excessive heat You should use ultrasonic coupling gel between the tip of the probe and the skin The probe must match the tuned frequency of the Doppler This frequency is identified on the panel next to the jacks and on the label attached to the probe cable The frequency of this instrument is nominal 8 9 MHz 8 2 MHz for the European Union It is always best to have a spare probe Probes with double shielded cables can be ordered for use in areas with high interference Cable length 1 5 m 5 ft standard 2 1 m 7 ft and 3 0 m 10 ft cable lengths are available by special order Standard Pencil Probe Skinny Pencil Probe Diameter 9 5 mm 3 8 in Diameter 6 35
8. persists after these actions have been taken contact Parks Medical Electronics Inc Problem Situation Suggested Actions 1 0 Doppler unit 1 1 The power control knob Disconnect the battery charger doesn t turn on is on but the battery indicator Replace fuse lamp does not light up Replace battery if over three years old 1 2 The power control Listen with headphones knob is on and the battery If there is sound with the headphones but not indicator lamp lights up the speakers go to 3 2 1 2 0 Battery is not 2 1 Battery CHARGER Replace the battery charger charging lamp does not light up when Doppler is turned off and charger is connected 2 2 Battery CHARGER lamp See Routine Maintenance lights up when connected to Replace the battery charger with Doppler off Battery INDICATOR lamp blinks with Doppler on and charger disconnected after charging for at least 8 hours 3 0 Hard to hear 3 1 Too much noise 3 1 1 Prevent feedback screeching sound blood sounds e Keep the probe against the skin once gel is Poor signal to applied noise ratio Keep the probe out of line with the sound waves from the speaker e Keep probe cable from looping around and touching itself 3 1 2 Check for a noisy circuit Disconnect the probes and turn the Doppler unit on Turn the volume all the way up You should hear smooth white noise or hissing like the noise of wind or surf It may be loud but it must be smo
9. 0196 3 AL ASSY 011 8 CE 21728 S Fy N N Igi ULTRASONIC DOPPLER FLOW DETECTOR MODEL 811 B CE otez PARKS MEDICAL ELECTRONICS INC sal ALOHA OREGON U S A aa 1 PEA E eo 8 Seeecccee 7 1 Bar Code Label 5 Battery Charger Lamp Lists serial number SN part AT This lamp lights when the unit is charging description and date of manufacture 6 4 Battery Charger Jack 2 _A Battery Indicator Lamp The battery charger plugs into this jack This lamp lights when the unit is turned on The lamp blinks if the battery needs charging hy SE TIE ae pHOne VACK Headphones plug into this jack 3 Power Control Knob Turn knob to left to turn instrument off Turn knob to right to turn instrument on 4 Probe Jacks 9 2 Volume Control Knob This knob controls the speaker volume Turning the knob clockwise increases the volume counterclockwise decreases the volume 8 Internal Speaker Disconnects when headphones plugged in The probe cable plugs into these jacks Label next to jacks identifies tuned frequency Non operational symbols C Dra Type B Applied Part Date of Manufacture Do not dispose of in garbage o Recyclable C o197 Complies with EC Directives wil Manufactured by Parks Medical Electronics Inc SN Serial Number PARKS Medical Electronics Inc 5 Equipment Description Probes The Doppler comes equipped with either a standard pencil probe
10. 811 B Ultrasonic Doppler Flow Detector Operating Service Manual ULTRASONIC DOPPLER FLOW DETECTOR MODEL 811 B CE ow PARKS MEDICAL ELECTRONICS wc tad ALOHA OREGON U S A l The 811 B Ultrasonic Doppler Flow Detector has clinical applications for vascular studies and detecting blood pressures The high frequency 8 2 MHz probe is used to detect blood flow for the measurement of systolic pressures at sites where a stethoscope cannot be used as well as pulses that are too faint for a stethoscope to detect reliably The sound of blood flow can be monitored during surgery with the 811 B This Doppler can be utilized in emergency vehicles emergency and recovery rooms intensive care units surgical wards veterinary urology pediatric and vascular clinics Read this manual prior to use Follow manufacturer s guidelines for safety and maintenance of equipment This instrument was manufactured to comply with all relevant national or international regulations and left the factory in safe condition In order to keep this instrument in a perfect and safe condition it is up to the user to observe all instructions and warnings included in this manual 811 B CEM 4 2 10 2010 PARKS Medical Electronics Inc 1 Preface Declaration Of Conformity tl Manufacturer f European Representative PARKS MEDICAL ELECTRONICS INC KARSCHNY MEDIZINTECHNIK 19460 SW Shaw Schallesbuchstr 3 Aloha OR 97007 D 65207 Wiesbaden U S A Germany
11. Aloha OR 97007 USA Phone 503 649 7007 1 800 547 6427 e mail Info parksmed com Fax 503 591 9753 Website www parksmed com 15 5 Ee 0 gt gt Technical Information and Notes Physiological Effects of Ultrasound Ultrasound Instrument Console and Transducer Assembly The biological effects of ultrasound on tissue appear to be threshold effects contrary to what is assumed for X ray When tissue is repeatedly exposed to ultrasound with rest intervals in between there will likely be no cumulative biological effect If a certain threshold has been passed biological effects may occur A temperature rise from 37 C to 41 C is permissible for extended periods whereas a temperature rise to 45 C may not be acceptable Implanted Devices Implanted devices such as cardiac pacemakers should be avoided due to the possibility of affecting their operation Some plastics used in replacement surgery may be affected by absorption of ultrasonic energy Metal implants can reflect ultrasound signals Studies Near Sensitive Tissues Extreme care should be taken when treating areas near any sensitive nervous tissue Extreme care should be taken when treating areas near the eye because of the risk of damage to the retina Environmental Hazards Battery and Instrument Batteries must be recycled or disposed of according to your local ordinances Do not dispose of old instruments or lead acid batteries in land fills
12. Please contact local authorities for recycling information Ultrasound Coupling Gel There are no potential environmental hazards from the gels recommended for use with the probes Radio Interference This instrument is intended for use by health care professionals only This instrument may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take precautionary measures such as reorienting or relocating equipment or shielding the location Warning The use of ACCESSORIES transducers and cables other than those specified with the exception of transducers and cables sold by the manufacturer of the EQUIPMENT as replacement parts for internal components may result in increased EMISSIONS or decreased IMMUNITY of the EQUIPMENT The following PARKS cable lengths are in compliance with the requirements of 36 201 and 36 202 of 60601 1 2 IEC 2001 E Standard Cable Length 1 5 m 60 in Maximum length 1 6 m 63 in Optional Cable Length 2 1 m 84 in Maximum length 2 6 m 85 in Optional Cable Length 3m 120 in Maximum length 3 07 m 1271 in PARKS probes are available with a shielded cable Static Portable and mobile radio frequency communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT This Doppler may experience a high pitched tone or buzzing noise from radio interference caused by a cell phone mobile service another Doppler electrocautery defective fluorescent
13. attery chargers are suspect e Try turning off lights and unplugging nearby devices Circuitry in cell phones and laptop computers can cause interference even when turned off 3 2 Weak signal 3 2 1 No sound or very little sound e If battery indicator lamp is blinking see 2 2 e Check headphone speaker connection 1 Listen with stereo headphones If there is sound in the headphones but not in the speaker the inside of the headphone jack is probably bent Unplug the headphones Remove the four screws on the outside corners of the front panel and gently remove the Doppler unit from the case Turn the volume control all the way up and squeeze the contacts on the inside of the headphone jack If you hear bursts of sound from the speaker bend the contacts to restore the connection 3 2 2 The speaker is loud but flow sounds are weak Check the frequency shown above the jack and the probe frequency to be certain they are the same If not obtain probe of matching frequency lf you have another Parks Doppler unit of the same frequency and a probe that works with it try the suspect probe on the good Doppler unit and the good probe on the suspect Doppler unit If the probe is suspect replace the probe If the Doppler unit is suspect call Parks technical support Probes fail more often than Doppler units If you do not have extra equipment to check against get a new probe If replacing the probe does not solve t
14. e Gel center of the vessel N e Search for the most present sound Skin Line NX e The Doppler sound for an artery is a hissing noise at systole e Background sounds are more or less continuous e If you do not hear any sounds move probe Flow Direction to a different location e Note that too much pressure on the skin can occlude an artery 4 Turn the volume up to near maximum to search for deep arteries small or obstructed arteries and veins e The Doppler sounds associated with low velocity blood flow have a very low pitch e The higher volume setting will also increase the transient background noise 5 Avoid unnecessary movement of the probe on the skin to minimize transient background noise Listen for best signal Ne Blood Vessel Positioning the Flat Probe 1 Position the flat probe over an artery with the crystals pointed antegrade 2 Secure the flat probe with a velcro strap or tape and anchor the cable at least one place distal to the probe Using the Probe Under Water The probe and cables can be fully immersed in water for vascular tests Be careful to keep the Doppler dry Liquids can seep into the instrument and short out electronic components Please pay special attention to the Electrical Safety page in this manual 10 811 B Ultrasonic Doppler Flow Detector Operating Instructions Headphones The speaker is disconnected when stereo headphones are plugged in You will always hea
15. ere and listen mae WPTLCCUCLCLEGS iiis Send the cable back to the factory for new plugs if the noise originates here Flex the cable near the crystals If the cable is noisy near the transducer replace probe It cannot be repaired Press gently on each crystal with your fingernail If a crackling or popping sound occurs replace probe The probe cannot be repaired 3 1 5 Check for electromagnetic interference Noise that is probably caused by an electromagnetic field a tone or whistle that does not change pitch a buzz or a hum a noise like a radio station a ticking sound that seems periodic Confirmation criteria The noise worsens when the probe is held or applied to the patient The noise disappears when the Doppler unit is used at another site Possibly if the noise lessens when the probe is disconnected PARKS Medical Electronics Inc 19 Maintenance amp Service Troubleshooting Guide This table lists common problems for the 811 B and suggestions for troubleshooting them If a problem persists after these actions have been taken contact Parks Medical Electronics Inc Problem Situation Suggested Actions continued continued continued 3 0 Hard to hear 3 1 Too much noise blood sounds Poor signal to noise ratio 3 1 5 Check for electromagnetic interference Identify and eliminate the source e If the noise is a buzz or hum the ballast in fluorescent lights motors and b
16. he problem contact Parks technical support 20 811 B Ultrasonic Doppler Flow Detector Replacing the Battery Maintenance amp Service This device uses a 12V 1 2 Ah sealed lead acid rechargeable battery for its power source Replace with Parks Part 854 0017 01 Caution Replace only with the same size sealed lead acid rechargeable battery The use of a larger battery could cause the terminals to come in contact with the circuit board or metal case Never allow battery terminals to come into contact with any metal part of the instrument This could result in fire or internal damage to the instrument To Replace the Battery 1 Be sure the instrument is turned off and the charger is disconnected Open the case by removing the four corner SCrews Carefully remove circuit board assembly from the case Locate the battery and note how the battery wires are connected For safety reasons disconnect the black battery wire first and then the red wire Wiggle and gently pull the connectors being careful not to break the insulation or short to ground The battery is mounted to the panel with adhesive Gently pry or cut the battery loose Replacing the Fuse If the Doppler will not turn on see Trouble Shooting Guide 1 1 and replacing the battery does not solve the problem the fuse may need to be replaced To Replace the Fuse oN gt T Technical Support and Service If following the troub
17. ic shock required by IEC 60601 1 Class lla Equipment This noninvasive ultrasound Doppler meets the safety requirements specified for a Class lla active medical device Acoustic Output Power is within limits set by the FDA and the European Union This device is intended for vascular studies It is not intended for obstetrical use Parks Medical Electronics Inc manufactures a complete line of obstetrical Dopplers Instrument Identification Information Write the information from your instrument bar code label here or on the parts page for reference when reordering parts or requesting technical support Serial Number gt o S Part Number Model gt gt gt S Date of Manufacture Date instrument purchased Customer Number PARKS Medical Electronics Inc 3 Preface Setting Up The Instrument 1 This instrument is shipped charged and ready to use 2 Place this instrument on a clean non conductive level surface e The instrument should not be placed near devices which may cause radio interference or grounding e The instrument should not come into contact with metal surfaces or other electronic devices 3 Plug the probe cable into the jacks The cable connectors can plug into either probe jack Remove the red protective cover from the probe tip prior to use 5 Use ultrasonic gel as a contact medium between the tip of the probe and the skin gt Warranty Parks Medical Electronics Inc wa
18. leshooting guide does not correct problems you are experiencing with the Doppler call Parks Medical Electronics Inc for technical support Be sure the instrument is turned off Open the case by removing the four corner screws Carefully remove the circuit board assembly Refer to F1 on the Parts Location Diagram to find the location of the fuse or see accompanying photo Replace with a 500mA 250 volt slow fuse Parks part 865 6002 00 Carefully replace the circuit board assembly in the case Replace the four corner screws D _ _ 1 Position battery with a gs positive terminal next to front panel so both board with two strips of two layered double sided tape ie wire leads reach a battery terminals 3 Use single a F 2 Center and attach strip of tape paee P TA battery 1 8 from for padding Hi de EI S edge of circuit Attach tape to 1 wn battery but do not remove top plaid covering 7 Follow the instructions in the accompanying illustration to position and secure the new battery 8 Gently reconnect the red wire first and then the black wire Caution Failure to match wire and terminal colors will do permanent damage to the instrument 9 Carefully replace the circuit board assembly in the case 10 Replace the four corner screws Should this Doppler unit require technical service Parks recommends that the instrument be returned to the factory The manufacturer will
19. lighting or neon signs 16 811 B Ultrasonic Doppler Flow Detector Maintenance amp Service Routine Maintenance The Doppler unit does not require regularly scheduled maintenance The battery may need to be replaced every two or three years The probe jacks can wear out with extended use To Check the Battery 1 Determine how long at most the Doppler is kept on continuously 2 Recharge the battery for at least 8 hours 3 Connect a dry probe to the unit turn the unit on and turn the volume 2 3 of the way up 4 After one hour or twice the longest period of continuous use whichever is greater check the battery indicator lamp If the lamp is blinking replace the battery he Check the Probe Jacks Bend back the four sections of the ground flange of the plug of a defunct probe i a es 5 Insert the center pin of the plug into each probe jack 3 Ifthere is no friction or resistance replace the probe jack 4 If you do not have a defunct probe contact technical support 3 Tuning The Doppler unit is tuned by the manufacturer and the tuning of the circuit is very stable If sensitivity problems are suspected do not attempt to adjust the instrument contact your sales representative or Parks Medical Electronics Inc PARKS Medical Electronics Inc 17 Maintenance amp Service Troubleshooting Guide This table lists common problems for the 811 B and suggestions for troubleshooting them lf a problem
20. mm 1 4 in The smaller probe crystal of the optional Skinny Pencil Probe concentrates power to produce a beam with higher intensity than the standard probe It provides better resolution for small vessels Sy ail Infant Flat Probe Adult Flat Probe Size 12 7 mm X 15 9 mm 1 2 in X 5 8 in Size 15 9 mm X 19 mm 5 8 in X 3 4 in Crystals are set into the plastic so that a 10 mm wide ultrasound beam goes into the vessel at about 15 degrees from perpendicular Flat probes are easily taped into place for repeated measurements Battery Charger This Doppler is supplied with either a domestic or international battery charger e Domestic Units Output 24V 0 63A e International Units Output 24V 0 625A with international socket adaptors for ac outlets The charger plugs into the Doppler and must be connected to an electrical outlet The Doppler cannot be operated while it is connected to the battery charger This is a safety feature to prevent electric shock The charger cannot overcharge the battery 6 811 B Ultrasonic Doppler Flow Detector Operating Instructions 4 Electrical Safety A CAUTION This instrument is intended for use by health care professionals only Follow the instructions for the use of this equipment Misuse of this equipment and inappropriate electrical connections can create a shock hazard What may appear to be a simple connection to other equipment can put the patient and or the
21. n released just as with BP measurements using a stethoscope The systolic pressure is the sohygmomanometer reading when the Doppler detects the first flow sound as the cuff is deflated Patients with calcified arteries resulting from diabetic or renal disease processes can have falsely elevated blood pressures 12 811 B Ultrasonic Doppler Flow Detector Diagnostic Procedures Blood Pressure Measurements on Animals There are two primary sites for taking blood pressure measurements the limbs and the tail Which one you use depends on the animal and the conditions under which the measurements are taken There is also a matter of personal choice Most people use the pressure measurement as a reference point such as before during and after surgery Obtaining an absolute value is trickier because the accuracy of the measurement is dependent on the width of the cuff with respect to the cross sectional area of the limb or tail Anatomical hiding of the vessel may make it almost incompressible or compressible with difficulty making readings too high Vasoconstriction is of serious concern when measuring pressures on the tail of a rat The cuff width should be selected based on the limb size and should never be smaller than the diameter of the limb used but can be up to twice this diameter without affecting accuracy To figure diameter from circumference multiply the circumference by 3 Wherever you measure you should have the infla
22. operator at risk of electrical shock The following is a guide to avoiding common potential hazards It is not comprehensive Always seek the advice of a qualified bioengineer before making any electrical connections 1 Use caution when connecting the Doppler unit to other equipment Connecting the Doppler unit to a computer amplifier or intercom system can be extremely hazardous There is a shock hazard unless a medical grade isolation transformer is used The combined equipment must comply with medical systems standard 60601 1 1 for the safety of the patient and the operator Have a qualified technician or bioengineer review and approve any proposed connections Operate this instrument only with the prescribed battery as the power source This device cannot be used while connected to a charger This equipment is not intended to allow operation on a patient while being charged and any modification altering this will no longer comply with the tested requirements This safety feature provides protection from electrical shock Do not rewire or modify the battery charging circuitry in this Doppler unit The battery charger must comply with the relevant national requirements e g EN60601 1 1990 A1 1993 A2 1995 The battery charging input circuitry must not be modified or altered in the field Changing this safety feature would compromise safety and violate 21 cfr 898 12 Do not use this instrument in the presence of flammable gas o
23. oth If you hear crackling or sputtering the circuit is noisy Call Parks technical support 3 1 3 Check for a microphonic circuit 1 Tap or drum on panel and case with your fingers You should hear a dull thud 2 If you hear a ringing noise the circuit may be microphonic This makes it prone to scream whenever there is gel on the probe Call Parks technical support 18 811 B Ultrasonic Doppler Flow Detector Maintenance amp Service Troubleshooting Guide This table lists common problems for the 811 B and suggestions for troubleshooting them If a problem persists after these actions have been taken contact Parks Medical Electronics Inc Problem Situation Suggested Actions continued continued 3 0 Hard to 3 1 Too much noise 3 1 4 Check for noisy probe hear blood sounds Connect the probe to the Doppler unit turn Poor signal to the Doppler unit on and turn the volume up noise ratio Wiggle the probe plugs If you hear a crackling sound the connection is noisy Clean and dry the crystal end of the probe 4 Clean and tighten the probe plugs Wipe the pin in the center of the plug and the flange around it with contact cleaner or isopropyl alcohol Squeeze the flange with your fingers or gently with pliers Make the flange form a smaller circle so that it grips the jacks on the Doppler panel more tightly Check for noise again If there is still noise bend the cable h
24. pelepnole aso 0ue Telephone 49 6122 1 28 28 Fax 903 591 9753 Telefax 49 6122 1 29 80 Instrument Instrument Name MDD Class Doppler Type 811 B Vascular IIA Non directional We hereby declare under our sole responsibility that the above mentioned products meet the requirements of EC Directive 93 42 EEC as amended from time to time Parks Medical Electronics has a certified Quality Management system according to Annex Il Article 3 of the Directive through TUV Rheinland LGA Products GmbH The following standards have been applied to establish compliance EN60601 1 EN60601 1 2 EN60601 1 4 EN60601 1 6 EN60601 2 37 EN14971 EN10993 1 and EN980 Certification of our Quality System Certificate SX 60029163 0001 Dated 05 March 2010 Expires 04 March 2015 TUV Rheinland LGA Products GmbH Notification No 0197 Tillystrasse 2 90431 Nuremberg Germany Place Aloha OR 97007 Date 11 March 2010 Signature Af Ap Signature Ye z Eh Name A Afarin Name Loren Parks Title Quality Systems Administrator Title President Parks Medical Electronics Inc Parks Medical Electronics Inc Compliance C 0197 The CE marking certifies that this medical device has met European Union consumer safety health and environmental requirements The CE marking is an acronym for the French Conformit Europ enne Class lla This instrument uses a rechargeable battery as its power source and meets the safety requirements for a Class lla
25. r high oxygen concentrations Do not position this instrument so that it comes in contact with metal surfaces cautery or other electronic equipment during use Burns can occur through the probe if the Doppler units metal case is inadvertently grounded when the electrocautery back plate is not connected properly To protect against this ensure that the cautery instrument s ground plate is on and only suspend the Doppler from an insulator if it is hung on an IV pole Inspect the probe covering for damage before each use Before using the probe inspect for any cracks or breaks in the protective epoxy covering Damage that could allow for ingress of conductive fluids such as acoustical coupling gel can create a shock or burn hazard if the Doppler unit s metal case is grounded and comes in contact with or is used with other electronic equipment This instrument should not be used with a defibrillator The probe can transmit an electric shock or cause burns when used with a defibrillator Parks assumes no responsibility for the misuse of this equipment PARKS Medical Electronics Inc 7 gt gt Operating Instructions Operating Conditions Ambient Temperature 10 C to 40 C e Relative Humidity 30 to 75 e Atmospheric Pressure 700 hPa to 1060 hPa e IPXO Rating Degree of protection against ingress of water none provided Environmental Conditions for Transport and Storage 601 1 e Ambient Temperature
26. r more through the headphones especially when checking weak flow or veins Shutting Down the Instrument After Use 1 Turn the volume control knob all the way down counterclockwise 2 Turn the instrument off 3 Wipe the gel off of the probe with a soft tissue Disconnect the probe from the Doppler unit only if it is to be sterilized Repeated insertion and removal of the plugs wears out the connectors and ultimately causes static If you remove a probe pull and twist the connector itself If you pull on the cable you can break internal wires 4 Connect the instrument to the battery charger 5 Disconnect battery charger and remove battery if equipment is not likely to be used for some time The Battery Low Battery A blinking battery indicator lamp warns that the battery needs to be charged The Doppler will continue to operate for a few hours if necessary after the light begins to flash but should be recharged as soon as possible Keep the VOLUME low or use headphones to get the maximum operating time from a weak battery Keep The Battery On Charge When Not In Use The battery is charged using an external battery charger The instrument should be put on the battery charger when not in use or after the last usage of the day The battery cannot be overcharged 1 Plug the connector of the battery charger into the battery charger jack on the front of the instrument 2 Plug the power cord of the charger into an ac outlet The bat
27. rrants this Doppler against defects in materials and workmanship for a period of one year probes for six months Parks will at its discretion replace or repair free of charge including labor all parts which prove to be defective and subject to such warranty This warranty does not apply to any instrument or probe not used according to instructions or damaged by abuse accident alteration misuse and or tampering The bar code label attached to the probes contain the part description the part number the date of manufacture and the serial number Removal of this label will void the probe s warranty Most problems can be taken care of by telephone You or your biomedical engineer should phone us before sending the instrument back for service Phone your sales representative or area distributor for instrument acquired outside of the U S A PARKS Medical Electronics Inc Mailing Address PO Box 5669 Aloha OR 97006 USA Shipping Address 19460 SW Shaw Aloha OR 97007 USA Phone 503 649 7007 1 800 547 6427 Fax 503 591 9753 e mail Info parksmed com Website www parksmed com Parks Medical Electronics Inc was established in 1961 as Parks Electronics Laboratory Parks was the second company in the world to make vascular Dopplers and is now the world s oldest maker of Dopplers 4 811 B Ultrasonic Doppler Flow Detector Equipment Description Front Panel POUT OONN OUA MOU MOOO MN IM 8118 130001994 3J
28. tery charger indicator lamp will light up to show that the Doppler battery is being charged The Doppler cannot be operated while the battery is being charged Only the charging circuit is active This is a Safety feature to protect both the patient and the operator from electric shock Battery Life Battery life between charges for a new battery will be more than 16 hours on a full charge The battery life will decrease as the battery ages or if it is not kept fully charged With normal service and care a battery can be expected to last two to three years Charging the Doppler in the Optional Carrying Case lf your Doppler came in the larger 800 or 901 carrying case Parks recommends that you keep the it on charge with the carrying case lid off The carrying case has slip hinges that allow for easy removal of the lid If you do not remove the lid during charging be sure the charger cord is in the small rubber grommeted half moon cutout before closing the lid of the carrying case This will prevent damage to the charger cord which might lead to electrical shock PARKS Medical Electronics Inc 11 Diagnostic Procedures Performing Diagnostic Procedures Follow the attending physician s and the institution s protocols for diagnostic procedures This section of the manual is provided only as a guide not to determine how a diagnosis is made This instrument has clinical applications for vascular studies both to detect blood flow and
29. ting part of the cuff over the artery of interest Place the Doppler probe downstream from the cuff The Doppler sounds should be clear before the occlusion so that when blood does surge under the cuff you can hear it as a distinct change in the background noise If you move the probe off the vessel simply because you can not hold it steady you will get either nothing or a reading that is too low The manometer is read when blood flow is heard to return as the cuff is gradually deflated If this end point is not distinct you may be picking up flow from another vessel as well as the one of interest It is common to make more than one attempt to get a measurement Be sure to deflate the cuff completely between measurements Creating a reactive hyperemia from tissue anoxia can dilate the distal bed and make the end point more clear The School of Veterinary Medicine at Davis California was the first school to use the Doppler some 20 years ago Another active school is at the University of Florida Gainesville If you have a particular application you might want to contact them There are two types of probes to be used The most commonly used is the flat probe which can be affixed to the tail or leg with a Velcro band or non sticky first aid tape A pencil shaped probe is also available On humans the pencil probe is preferred for use on the limbs because you can push it in close to the vessel However it must be held on target while you inflate the
30. to measure blood pressures The Doppler is used to measure systolic pressures at sites where a stethoscope is not used as well as to detect blood pressures that are too low for a stethoscope to measure reliably Blood Pressure BP Measurement A Doppler can be used to make accurate systolic pressure measurements with greater sensitivity than a stethoscope A stethoscope is only used to take arm blood pressure but a Doppler can be used for both upper and lower extremity blood pressures The Doppler allows for the detection of low blood pressure in legs fingers and in animal legs and tails Measurements as low as 10 mm Hg have been documented Diastolic pressure can only be estimated not accurately measured by Doppler use To estimate diastolic pressure insert the probe under the lower edge of the BP cuff and listen for either the loss of sound as diastolic pressure passes or the return of the dicrotic notch which is the beginning of the cardiac cycle Measuring Systolic Pressure Because the sound quality is not as critical it Probe Crystals N is possible to align the pencil probe s crystals Gi perpendicular to the vessels to take blood pressures el BP Follow the operating instructions for positioning the pencil probe to optimize Doppler sounds Blood Vessel Accurate systolic measurements require a BP cuff width suitable to the limb being tested The cuff is inflated 20 30 mm Hg above estimated systolic pressure and the
31. u must always search the area of the vessel and tilt the probe to obtain best Doppler sounds Parks recommends that you practice searching for arteries six inches distal and proximal to the elbow 1 Inspect the probe for cleanliness and damage prior to each use See Electrical Safety 2 The probes require a conductive medium to maintain an interface between the skin and the probe for signal transmission Use only a coupling gel made for ultrasonic applications DO NOT use ECG cream or paste which may damage the probe covering 3 Invert the gel squeeze bottle and shake it downward to get the gel near the bottle opening Squeeze about 6mm inch of gel onto the tip of the probe making sure there are no air bubbles 4 Turn the volume control knob all the way down counterclockwise Turn the instrument on 6 Gradually turn up the volume clockwise A rumbling sound can be caused by the vibration of the gel from operator movement ah Positioning the Pencil Probe 1 Place the pencil probe over the approximate position Probe Crystals lt of the target vessel Align the probe s crystals parallel to the vessel for Blood ar lt Gel best artery vein separation 2 Tilt the back of the pencil probe to an angle of about 15 degrees from perpendicular making certain there is gel in the pathway between the probe and the skin and listen for the best signal Probe 3 Move the probe and the skin to try to find th
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