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30 - HE

SE-DV64-HE

DEVILBISS לש ןרציה תרהצהו הייחנה

הרהזא

.םיפרוצמה םיכמסמב םיעיפומה )EMC( תיטנגמורטקלאה תומיאתה יטרפל םאתהב וליעפהלו וניקתהל שיו EMC-ל עגונב םידחוימ הנגה יעצמאל קוקז ילמשח יאופר דויצ

.יאופר ילמשח דויצ לע עיפשהל יושע דיינו לטלטמ RF תרושקת דויצ

.שמשי אוה הב הרוצתב ליגר לועפת אדוול ידכ תכרעמב וא דויצב תופצל שי ,הזכ בצמב םהב שומישב ךרוצ שי םאו רחא דויצ לעמ וא דיל תכרעמב וא דויצב שמתשהל ןיא

תביבס לוהינלו ,שומישה תביבס לש הקיטנגמורטקלאל תכרעמה וא דויצה תמאתה תעיבקל ינויח עדימ שמתשמל וא חוקלל תוקפסמ תורחא תויחנהו EMC-ה תואלבט

–

הרעה

.יאופר-וניאש ילמשח דויצל וא תורחא תוכרעמ וא דויצל עירפהל ילב םדיקפת תא עצבל תכרעמל וא ודיצל רשפאל תנמ לע תיטנגמורטקלאה שומישה

תוכרעמהו דויצה לכ תטילפ - ןרציה תרהצהו הייחנה

.וזכ הביבסב שמשי אוהש חיטבהל הז רישכמב שמתשמה וא חוקלה לע .ןלהל תטרופמה תיטנגמורטקלאה הביבסב שומישל דעוימ הז רישכמ

הטילפ תקידב

תומיאת

הייחנה - תיטנגמורטקלא הפיכא

RF תוטילפ

CISPR 11

2 הצובק

תא עצבל ידכ תיטנגמורטקלא היגרנא טולפל בייח DeVilbiss לש DV64-ו DV63 תרדסמ CPAP-ה

.ותביבסב אצמנה ילמשח דויצ לע עיפשהל יושע אוה .דעונ אוה הרובע היצקנופה

RF תוטילפ

CISPR 11

B הגרד

תוכלומו תורדושמ תוטילפ

תודסומ ללוכ ,תודסומה לכב שומישל םיאתמ DeVilbiss לש DV64-ו DV63 תרדסמ CPAP-ה רישכמ

.םירוגמ יניינבל תקפסמה ,ךומנ-חתמב למשח תקפסאל תירוביצה תשרל תורישי םירושקה ולאכו םייתיב

IEC 61000-3-2 תוינומרה

A הגרד

IEC 61000-3-3 בוהבה

םאות

תוניסח תקידב

IEC 60601 לש הקידב תמר

תומיאת תמר

הייחנה - תיטנגמורטקלא הביבס

)ESO( תיטטסורטקלא הקירפ

IEC 61000-4-2

עגמ ±8kV

ריווא ±15kV

עגמ ±8kV

ריווא ±15kV

תופצרה םא .הקימרק יחירא וא ןוטב ,ץעמ היושע תויהל הכירצ הפצרה

.30% תוחפל תויהל הכירצ תיסחיה תוקלה ,יטתניס רמוח תויושע

הצאה/ריהמ ילמשח רבעמ

IEC 61000-4-4

AC למשח תשרב ±2kV

תיב תביבס וא תירחסמ הביבס לש תוכיאב תויהל הכירצ למשחה תשר

תיסופיט םילוח

IEC 61000-4-5 הצאה

ישרפה ±1kV

ףתושמ ±2kV

ישרפה ±1kV

ףתושמ ±2kV

תיב תביבס וא תירחסמ הביבס לש תוכיאב תויהל הכירצ למשחה תשר

תיסופיט םילוח

תוקספה ,חתמ תוליפנ

יווק לע חתמ ייונישו תורצק

IEC למשחה תקפסא טלק

61000-4-11

רוזחמ 0.5 רובע 95%> לש הליפנ

םירוזחמ 5 רובע 60%> לש הליפנ

25 רובע 30%> לש הליפנ

םירוזחמ

תוינש 5 רובע 95%> לש הליפנ

רוזחמ 0.5 רובע 95%> לש הליפנ

םירוזחמ 5 רובע 60%> לש הליפנ

25 רובע 30%> לש הליפנ

םירוזחמ

תוינש 5 רובע 95%> לש הליפנ

תיב תביבס וא תירחסמ הביבס לש תוכיאב תויהל הכירצ למשחה תשר

םג תכשמתמ הלועפל קוקז רישכמב שמתשמה םא תיסופיט םילוח

למשח תקפסא תרזעב רישכמה תא ליעפהל ץלמומ ,למשח תוקספהב

.הללוס תרזעב וא תוקספהמ תלבוס הניאש

Содержание DV63 Standard Plus

Страница 1: ...LUE Positive Airway Pressure Device Instruction Guide EN RX ONLY Assembled in the USA Not manufactured with natural rubber latex DV63E DV64E series devices are CE0044 DV63A DV64A series devices are no...

Страница 2: ...2 HE SE DV64 HE CPAP 0 45 1 2 5 1 5...

Страница 3: ...Code 11 HE SmartCode Rx 12 HE CPAP 12 HE Rx 12 HE 12 HE CPAP 12 HE SmartFlex Exhalation Relief Comfort 13 HE 13 HE 13 HE 14 HE 14 HE 14 HE 51 HE 15 HE 15 HE 15 HE 16 HE 16 HE Bluetooth 16 HE 16 HE 17...

Страница 4: ...V64 HE 21 RTCA DO 160 M Rx II DC DC C US TUV Rheinland C US BF EC REP 0044 MR IP21 EU EU 2012 19 CPAP CPAP SmartFlex CPAP CPAP 1 3 0 IEC 60601 1 cmH2O 8 CPAP CPAP CPAP CPAP DeVilbiss CPAP CPAP CPAP CP...

Страница 5: ...5 HE SE DV64 HE C 41 C 43 CPAP C 45 C 42 Encoder C 65 C 42 EMC EMC RF 104 F 40 C 104 F 40 C 109 F 43 C DeVilbiss USB DeVilbiss CPAP DeVilbiss DV6 DeVilbiss DC 10 psi 50 lpm CPAP...

Страница 6: ...6 HE SE DV64 HE OSA DeVilbiss IntelliPAP2 DeVilbiss BLUE 66 30 MR MR MR CPAP MR RFID CT CPAP CPAP 1 2 3 4 5 SD 6 7 8 CPAP 9 6 1 2 3 4 7 9 8 5...

Страница 7: ...7 HE SE DV64 HE SmartFlex Bluetooth USB...

Страница 8: ...8 HE SE DV64 HE LED 10 2 SD USB...

Страница 9: ...9 HE SE DV64 HE 1 5 4 2 SD 6 3...

Страница 10: ...10 HE SE DV64 HE 1 2 3 SmartCode Adherence Score...

Страница 11: ...11 HE SE DV64 HE SmartCode SmartCode Rx A Z 0 9 SmartCode 1 Rx 2 3 4 Smartcode www DeVilbissSmartCode com 1 SmartCode 2 1 3 7 30 90 SmartCode Rx SmartCode 5 6 2 046 SmartCode 5 6...

Страница 12: ...12 HE SE DV64 HE SmartFlex Pressure Relief Comfort FLX 1 SmartFlex 2 OFF 1 3 3 1 3 4 5 SmartFlex CPAP RX Rx CPAP SmartFlex SmartFlex 0 5 6 0 5 7 0 5 SmartFlex...

Страница 13: ...13 HE SE DV64 HE 1 2 3 45 0 5 4 1 2 5 1 5 CPAP 1 22 15 2 22 3 15 22 1 8 6 10 3 0 8 2 4 6 1 8 12 3 7...

Страница 14: ...14 HE SE DV64 HE 1 2 3 4 100 10 0 2 0 CPAP 1 2 0 0 100 1 2 3 4...

Страница 15: ...15 HE SE DV64 HE 1 2 1 24 12 12 24 1 2 3 4 5 0 0 CPAP...

Страница 16: ...16 HE SE DV64 HE 1 Bluetooth DV6WM 2 DV6WM DV6WM DeVilbiss Nonin WristOx2 Bluetooth 1 2 Bluetooth 3 CPAP Bluetooth Bluetooth Bluetooth Bluetooth Nonin WristOx2 1 2 1 CPAP 2 CPAP CPAP 3 CPAP...

Страница 17: ...17 HE SE DV64 HE 1 2 2 BIOS 1...

Страница 18: ...18 HE SE DV64 HE 1 50 35 2 10 SmartCode Rx SD SD SD SD SD SD SD SD 3 _____ SpO2 _____ _____ SpO2 _____ DV6WM 4 Krok X EOX E01 X E8X...

Страница 19: ...19 HE SE DV64 HE DEVILBISS SMARTLINK DeVilbiss SmartLink SmartLink SD SD SD 1 2 1 1 CPAP 2 SD...

Страница 20: ...60Hz 2987 425 hPa 700 hPa 1060 CPAP DC DC AC DV6EB Devilbiss 1 DC V DC 12 2 DC 3 DC AC AC DC 12V DC 4 220V 110V 400 200 100 CPAP CPAP PulseDose CPAP 3 5 3 5 CPAP cmH20 5 16 9 8 7 5 6 9 5 5 9 10 11 9...

Страница 21: ...21 HE SE DV64 HE 1 3 2 CPAP 1 CPAP CPAP cmH2O 8 CPAP CPAP lpm 10 psi 50...

Страница 22: ...DC DV6X 619 DC DC DV6X 619 DV51D 696 DV63D 613 AC DV51D 606 AC DV51D 609 DV6 Devilbiss DV6EB pk 4 DV51D 602 pk 4 DV51D 603 6 x 1 8 22 DV51D 629 6 x 1 8 15 DV61D 629 DV61D 604 DV63D 610 7353D 601 DV6H...

Страница 23: ...23 HE SE DV64 HE 2 AC AC 1 2 7 1...

Страница 24: ...24 HE SE DV64 HE 1 2 1 CPAP 6 10 30 1 2 2 3 10 1 4 5...

Страница 25: ...25 HE SE DV64 HE 10 6 3 0 10 30 0 3 6 CPAP 5 CPAP 6 PC WEEE EU 2012 19 X DV6 CPAP...

Страница 26: ...26 HE SE DV64 HE 1 1 DC 1 2 2 3 3 1 1 CPAP 1 2 2 3 3 4 Auto START 4 5 5 6 6 1 1 2 2 3 3 4 4...

Страница 27: ...27 HE SE DV64 HE 1 1 2 2 1 1 2 2 DeVilbiss DV6 1 1 1 1 2 2 1 1 2 2 3 3 4 4 5 5 1 1 CPAP 2 DeVilbiss DV6 2...

Страница 28: ...17 DC AC 65 25 10 cmH2O 20 3 F 104 C 41 F 40 C 5 93 15 2987 425 hPA 700 hPa 1060 F 158 C 13 F 70 C 25 93 15 cmH2O 30 dBA 26 6 ISO 17510 1 2007 dBA 34 6 LCD Bluetooth Bluetooth Bluetooth Bluetooth Blue...

Страница 29: ...k cmH2O I E 1 1 500 20 15 10 3 0 0 5 0 5 7 0 0 5 0 5 12 0 1 0 1 0 16 0 1 0 1 0 20 0 1 0 1 0 ISO 17510 1 2007 cmH2O 3 0 cmH2O 7 0 cmH2O 12 0 cmH2O 16 0 cmH2O 20 0 cmH2O 2 9 6 6 11 4 15 0 19 0 78 2 123...

Страница 30: ...ilbiss DV64 DV63 CPAP RF CISPR 11 B DeVilbiss DV64 DV63 CPAP IEC 61000 3 2 A IEC 61000 3 3 IEC 60601 ESO IEC 61000 4 2 8kV 15kV 8kV 15kV 30 IEC 61000 4 4 AC 2kV AC 2kV IEC 61000 4 5 1kV 2kV 1kV 2kV IE...

Страница 31: ...V1 3 Vrms ISM Vrms 6 RF D 0 4 P RF IEC 61000 4 3 V m 10 2 5 80 E1 10 V m 800 80 D 0 4 P 2 5 800 D 0 7 P D P E1 V1 P D W 800 80 1 2 RF RF W M 80 150 ISM D 0 4 P 800 80 D 0 4 P 2 5 800 D 0 7 P 0 01 0 04...

Страница 32: ...daily NOTE Use distilled water to avoid mineral deposit build up inside the chamber To Set Humidification Controls 1 Select Humidity 2 Choose humidity setting of OFF or 1 through 5 bars NOTE 5 bars i...

Страница 33: ...3 Humidity Settings EN 13 Tubing Settings EN 13 Master Volume Settings EN 14 Brightness Settings EN 14 Enable Menu EN 14 Clock Settings Menus EN 15 Clock Current Time EN 15 Format EN 15 Wake Up Alert...

Страница 34: ...o service your device will void the warranty Refer to International Standard IEC 60601 1 Ed 3 0 Amendment 1 for safety requirements applicable to Medical Electrical Systems Oxygen supports combustion...

Страница 35: ...operation place system on a flat sturdy level surface Do not place the device where it can be knocked onto the floor or where the power cord may create a trip hazard Never block air openings of the de...

Страница 36: ...in a Magnetic Resonance MR environment as it may cause unacceptable risk to the patient or damage to the CPAP or MR medical devices The device and accessories have not been evaluated for safety in an...

Страница 37: ...On and Setting Indicator only illuminated if optional humidifier is attached Idle Screen Blower Off Inset Status Icons Bluetooth Signal Indicator Wake Up Alert Indicator Oximeter Connected Indicator...

Страница 38: ...Ramp Rotary Knob Simple Press Turn opera tion Display returns to Idle Screen after 10 seconds without user action when in Main Menu returns to Main Menu after 2 minutes without user action when in any...

Страница 39: ...humidification option please refer to humidifier guide for device set up 5 Prepare mask and connect to tubing 4 Attach tubing to device 2 Insert power cord into back of device and wall outlet 6 Inser...

Страница 40: ...ngs are only adjustable by your provider Shown Hidden Indicates a feature that can be hidden by your provider If a feature is hidden you will not see it in your device Within menu select Back to retur...

Страница 41: ...y contain letters or numbers and knob may be turned either way to roll through 0 9 and A Z 1 Select SmartCode Rx to input code supplied by your provider 2 Highlight then turn knob to select first digi...

Страница 42: ...5 is the most When activated the SmartFlex pressure relief feature helps make it easier for you to exhale against your prescribed pressure by slightly lowering the pressure during exhalation If you e...

Страница 43: ...NOTE These settings must match the tubing you are using for pressure at the mask to be correct FEATURES AND SETTINGS CPAP Settings Menus Diameter 15mm 22 mm Length 1 8 m 6 1 8 m 6 2 4 m 8 3 0 m 10 3...

Страница 44: ...n Standby brightness Standby Brightness when no user activity idle Settings from 0 to Active must be equal to or lower than Active brightness Display and controls change to Standby brightness after 2...

Страница 45: ...me 4 Select Volume 5 Set Wake UP Alert Volume sound level 0 Off mute NOTE Wake Up Alert Volume is separate from Master Volume If provider hides clock wake up alert is hidden If clock is shown wake up...

Страница 46: ...and place probe on finger 2 Wait until your CPAP display shows the pop up message Oximeter Logging Started which means your CPAP is recording data from the oximeter NOTE If more than one person in th...

Страница 47: ...Device Info 2 Other Device information screen Other Device FEATURES AND SETTINGS Add Ons Allows you to see basic device information 2 Turn knob to scroll through Compliance Meter Serial Number Firmwa...

Страница 48: ...r When prescription change via SD Card fails Card Transfer Successful When valid SD Card inserted and data transfer complete Card Detected Ready for use When valid SD Card is inserted Firmware Update...

Страница 49: ...ard to collect data It should be installed during device set up and kept in device Your provider will instruct you on when to return the card 1 Insert card face up Press until it clicks into place 2 M...

Страница 50: ...not available when traveling by air or any time portability is desired Please refer to the guide included with your battery for details 2 Your device can be operated from a 12 V DC power source by us...

Страница 51: ...vice Never allow the oxygen source to run continuously while connected to the device if the device is not in use If the device is not being used turn off the oxygen flow CPAP pressure must be set high...

Страница 52: ...inlet filter 4 pk DV51D 602 Fine particle filter 4 pk DV51D 603 Air supply tubing 22 mm x 1 8 m 6 DV51D 629 15 mm x 1 8 m 6 DV61D 629 Air supply port cover DV61D 604 Carrying Case DV63D 610 Oxygen Ada...

Страница 53: ...will result in product damage If this occurs do not use the device Disconnect the power cord and contact your equipment provider for service NOTE Allow to dry completely before plugging into power sou...

Страница 54: ...fectant NOTE If a reduced drying time is desired connect the tubing to the CPAP device and allow air to circulate through the tubing until the tubing is completely dry Inspect the tubing to ensure tha...

Страница 55: ...can be used as secondary raw materials If you no longer need this packaging take it to your local recycling and waste disposal facility according to the applicable regulations for your location The e...

Страница 56: ...ing a full face mask that has an anti asphyxia valve 4 Auto START may not work because your exhaled breath escapes through the open valve Use the ON OFF button to start and stop the device 5 The air s...

Страница 57: ...perature fluctuates from higher to lower levels through the night 2 Increase room temperature Air from flow generator seems to be too warm 1 Air filters are dirty 1 Clean filters 2 Air inlet port is b...

Страница 58: ...reless Specifications This medical device contains a radio transmitter The Bluetooth radio integrated into this device is active when the Bluetooth icon on the LCD display is illuminated Bluetooth is...

Страница 59: ...4 15 0 19 0 Average flow at the patient connection port l min 78 2 123 5 166 8 157 7 138 0 Long Term Static Pressure Accuracy 0 5 cmH2O Additional Specifications Equipment classification with respect...

Страница 60: ...emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected RF Emissions CISPR 11 Class B Radiated and Conducted Emissions The DeVilbiss DV63 and...

Страница 61: ...equency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Recommended Separa...

Страница 62: ...Stra e 3 68309 Mannheim GERMANY 49 0 621 178 98 0 DeVilbiss Healthcare LLC 100 DeVilbiss Drive Somerset PA 15501 USA www DeVilbissHealthcare com 814 443 4881 800 338 1988 SE DV64 HE Rev A DeVilbiss H...

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DeVilbiss DV63 Standard Plus, Инструкция по эксплуатации

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