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USER`S MANUAL - QuickMedical

1. test is accessible by the optional accessory software for displaying trends and other information It is not displayed in the Memory Review Mode 6 Additional information A reference PEF or FEV1 value is usually the best result you achieve when you are not having symptoms Reference PEF or FEV1 To turn ON the color zone indicator you or a healthcare professional must set a reference value see page 5 The following are color zone descriptions m Default Settings G Y R G Green test results over 80 of the set value Y Yellow test results between 50 80 of the set value R Red test results under 50 of the set value A Note If your test result falls in the Red Zone contact your physician immediately External settings by the optional accessory software program Toggle between displaying the color zone relative to the PEF or FEV1 reference Modify each color zone limits in 10 increments Q Factor Indicator Indicates to repeat the test since one or more of the following occurred A cough was detected The blow effort was too short The blow effort had a slow start The result was unnaturally low or high for your reference ay Downloading Data Purchase software at www quickmedical com plumondarydata The memory bank can be downloaded to a PC using the Cradle and the optional accessory software program 1 2 3 Place the PiKo 1 in the Cradle Open the Windows
2. ASINZS 4237 1994 EN60601 EN60601 1 1 EN60601 1 2 Type BF patient applied part Ordinary equipment not protected against harmful ingress of moisture Not suitable for use with flammable anesthetics Suitable for continuous operation 11 This symbol indicates Mechanical Feature Pike Peak Flow dardania Meters all instructions and warnings PEF v 7 Setting of Reference PEF v v This symbol indicates FEV v 4 that this Class equi Setting of Reference FEV v pment with measure Color Zone indicator v vt alee ment function compl Setting of Zones limits y Jes with the European Time Date Stamp V Union Medical Device Directive Memory of tests 4 a Nonvolaile memory P This symbol indicates Cough alert 7 K that this device provi Abnormal Blow alerts v esa certain level of Automatic Self Test F protection against electrical shock IR Communication to PC 4 Batteries included Optional Program lt Vv Amon Wi Universal unit forall ages v month Warranty Washable low cost v F Made in China v Available v Available in some U S A Patent 6 447 459 B1 lt software to download and trend test data In Europe 4 Hartforde Court John Tate Road Hertford Herts SG13 7NW UK BRACE 0086 ted ds ZAN Collins Morgan FERRARIS Cardio Espiat y F Pulmonary Data Services Inc a Ferraris CardioRespiratory company Authorized Distributor
3. QuickMedical Phone 425 831 5963 Fax 425 831 6032 Toll Free 888 345 4858 See the full line of Ferraris products at http quickmedical com pulmonarydata
4. QuickMedical is an authorized distributor for Piko1 Fax 425 831 6032 Toll Free 888 345 4858 http quickmedical com pulmunarydata USER S MANUAL PiKo 1 s J56 GEIE Pulmonary Data Services Inc a Ferraris CardioRespiratory company Morgan at FERRARIS Cardrorespirateary PiKo 1 User s Manual Intended Use The PiKo 1 measures the Peak Expiratory Flow PEF and the Forced Expiratory Volume in the first second of expiration FEV1 It displays the test results and also shows the respective color zone relative to the patient s PEF or FEV1 reference values In addition the blow quality is evaluated to notify the patient to repeat the test in case of a cough or any suspect blow The PiKo 1 is used for monitoring respiratory conditions such as COPD and Asthma PEF the fastest speed a person can blow air out of their lungs FEV1 the amount of air blown out in the first second of a forced exhalation Color Zones display the test results in a traffic light color format relative to the patient s reference PEF or FEV1 Q Factor Quality Factor notifies the patient to repeat the test in case of cough or any suspect blow _ Warnings Note Please read all the information in this manual before using the PiKo 1 The user should be under the care of a licensed healthcare professional Healthcare professionals may recommend the PiKo 1 as part of a disease management treatment plan
5. Regardless of displayed test results if signs or symptoms of chest tightness shortness of breath coughing or wheezing occur contact your healthcare professional immediately The Piko 1 is intended for use by a single person Follow instructions carefully to get a correct reading If you use the PiKo 1 above 1000 feet elevation 300m adjust your values by adding 1 5 To do this multiply the PEF amp FEV1 by 1 019 The Piko 1 is not designed or intended to be used as a primary diagnostic tool for asthma COPD or any other pulmonary disease pe PiKo 1 Description Removable Mouthpiece Vent holes Operate Button ColoredZones st Zone indicator Q Factor indicator Low battery indicator IR Communication window 9 PEF data LPM 10 PEF indicator 11 Memory counter 12 FEV1 indicator 12 13 FEV1 data Liters 14 Battery cover behind 13 Note The PEF data items 9 amp 10 and the FEV1 data items 12 amp 13 alternate at 2 second intervals Note The display turns blank if the operate button is not pressed for 3 minutes Upon pressing once the operate button the display will show the last test results Ec Perform Test If the display is blank press once the operate button The display will show the last test results 1 Stand up Hold the PiKo 1 in your j hand Do not cover the vent holes Oo 2 Bring the PiKo 1 up with the mouthpiece towards your mou
6. amage to the unit DO NOT immerse in water or use a dishwasher DO NOT use a high pressure water flow DO NOT use any sort of active solvent for cleaning DO NOT dry by heat hair dryer or a dishwasher DO NOT insert anything into the Vent Holes or the Mouthpiece opening Battery Replacement 1 Replace batteries when Low Battery indicator appears 2 Open the battery door using the special tool supplied with the PiKo 1 3 Use 2 type 357 Silver Oxide button cell batteries or eqv _9 Technical Specifications PEF Range 15 999 LPM 1 LPM resolution FEV1 Range 0 15 9 99 Liter 0 01 Liter resolution Accuracy PEF 5 or 10 LPM whichever is greater FEV 1 3 5 or 0 05 Liter whichever is greater Sensor Pressure flow sensor technology patented Memory 96 Tests containing PEF FEV1 Color Zone Quality Factor Time Date Stamp 15 min resolution Memory type Nonvolatile Color Zones 3 color Zones Green Yellow Red Reference values User settable for PEF or FEV1 Quality Factor Warning amp indicator for cough or abnormal blow Sounds 4 patterns for different indications and warnings Communication Bi Directional IR port RS232 format External settings Possible settings using the optional software Each Color Zone limits in 10 increments Select Color Zones to relate to PEF or FEV1 Battery 2 typ
7. based optional accessory program and click the on screen Download button To start downloading press the Operate button The downloading progress will be indicated by C 5 J l the cycling segments on the display E Upon completion of the downloading the memory bank is cleared and the display turns to show the latest test results The optional software will show trends and other relevant information refer to the Manual of the optional program Note It is possible to interrupt the downloading process at any time by removing the PiKo 1 from the Cradle Sound Patterns Pressing Operate Button short beep Error During Initialization Long beep Blow Command Short beep Result within Green Zone No beep Result within Yellow Zone 2 short beep Result within Red Zone Long beep Any result containing Long beep Maintenance Note This product is NOT user serviceable Cleaning 1 Detach the mouthpiece by sliding it sideways 2 Wash the mouthpiece with a liquid dish soap in cold water rinse and dry thoroughly DO NOT use heat to dry 3 The PiKo can be cleaned as follows Rinse with low flow pressure water at room temperature Only the Head Section may be cleaned with a solution of 5 liquid dish soap in cold water followed by rinsing Hold the unit upside down and shake to remove the water Wipe exterior with a clean dry towel Air dry completely before further usage or storage 4 To avoid d
8. e 357 Silver Oxide button cells or equivalent Battery life 2 year based on average of 6 Tests day or 21 000 continuous Blows Dimensions 75 X 35 X 20 mm 3 X 1 3 X 0 8 inch Weight 35 gr 1 25 oz Back pressure 1 5 cm H2O L S 14 LPS or lower Operating Temp 10 to 38 C 50 to 100 F Storage Temp 20 to 60 C 4 to 140 F Humidity 0 100 relative humidity Barometric 550 to 780 mmHg Standard ATS1994 monitoring devices Compliance AS NZS 4237 1994 EN60601 EN60601 1 1 EN60601 1 2 Regulatory FDA 510 k for OTC CE 0086 Class with measurement function 10 Warranty Pulmonary Data Services Inc PDS warrants each hardware product it manufactures to be free from defects in material and workmanship Under this warranty PDS will repair or replace at its option any hardware product or part thereof within 6 months of purchase Examination of the product must disclose to PDS that the product is defective This warranty does not apply to any product or part that has been repaired or altered in any way that in PDS s judgement affects its durability or reliability or any product or part subjected to misuse negligence or accident THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES OF MERCHANTABILITY AND FITNESS A copy of the receipt must accompany a warranty claim If the product should become defective within the warranty period return to PDS at 908 Main Street Louisville CO 80027 USA Safety
9. old reference The display will return to the last test results The color zone and relative warning indicator in the memory review mode will reflect the new reference value The entire memory bank can be erased by setting the PEF reference to 10 or the FEV1 reference to 0 10 e The optional accessory software can be used to toggle between displaying the color zone relative to the PEF or FEV1 reference e The optional accessory software can be used to modify each color zone limits in 10 increments _5 Memory Review r 96 PEF amp FEV1 he warning The PiKo 1 memory bank can store the las tests Each memory location contains also indicators and a time date stamp of the tes To scroll through the memory bank follow hese steps 1 Press and hold the Operate button for 5 seconds The display will show the last test results containing the PEF FEV1 color zone and warning indicator It will also show the respective memory counter location 2 Release the button Each press of the button will now display the next oldest stored test 3 There are 2 ways to exit the Memory Review Mode Press the Operate button for 5 seconds or Avoid pressing the Operate button for 20 seconds The unit will then display the latest test result and will be ready for a new test Note The entire memory bank can be erased by setting the PEF reference to 010 or the FEV1 reference to 0 10 Note The time date stamp of each
10. th it 3 Press the operate button A short lt beep will confirm the action 4 Wait to hear the second beep The blow animation will indicate that the test can begin J 5 Inhale as fully as you can 6 Place the mouthpiece in your mouth and blow as hard as you can for several seconds T Your test results are displayed as soon as you complete the test 8 If a reference value was set a zone indicator will show your color zone 9 You may want to perform 3 Tests The PiKo 1 will select and save only the best results for any tests performed within 3 minutes _ A r E i he oa ae a F fF r E i ie Eo pi leif P 4 Setting Reference Values Setting a Reference PEF or FEV1 for color zone display 1 Press the Operate button quickly 4 times during 2 seconds The PEF or FEV1 indication will starts blinking The display will show the stored reference value 000 for first time setting 2 Release the button then each press will advance the display by 10 LPM for PEF or 0 10 Liter for FEV1 3 Hold the button for more than 5 seconds to save the desired reference value The PEF or FEV1 indicator will stop blinking and a beep will sound 4 The display will show briefly the new reference value and return to show the last test results Notes During the reference setting process if the button is not pressed within 5 seconds the unit will exit the Setting Mode without modifying the

USER`S MANUAL - QuickMedical

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