Delphi DL-00183 manuale d’uso

Portable Oxygen Concentrator User Manual 12659da delphi POC covers 9/18/08 12:14 PM Page 1[...]

ii DL-00183 Rev . 3 Manufactured by: Delphi Medical Systems 5725 Delphi Drive T roy , Michigan 48098-2815 U.S.A. CUSTOMER SERVICE T el: [1] 888.526.1426 The information in this document is subject to change without notice. This document contains proprietary information that is protected by copyright. No part of this document may be reproduced in an[...]

Classification Th is equ ip me nt is li st ed wit h a na ti on al ly rec og ni ze d t est in g l ab or at or y an d cl as si fi ed wit h re sp ec t to ele ct ri c sh oc k, fir e, and me cha ni ca l h az ar ds in ac co rd an ce wit h th e fo ll ow in g st an da rd s:  • EN 606 01 -1 (19 90 ), Med ic al Ele ct ri ca lEq ui p[...]

i v DL-00096 Rev. 6 Explanation of Packaging and Labeling Symbols Caution, consultaccompanying documents Input 18VDC, 6.7A Output =90% ± 3% oxygen Serial number Catalog number U.S. federallaw restricts this device to sale by or on the order of a physician No smoking No o p e n[...]

v DL-00096 Rev. 7 Do notuse if packaging is damaged Handle with care Date ofmanufacture Manufacturer nameand address DL-00122 Re vision: 3 ECO 10180 Print Colors: Light Grey- Match GE Plast ics GY7D412 (Background), approx PMS427C Y ellow- PMS 123C (Symbol) Black- PMS Process Black (Symbol & Text) Red- PMS 485C [...]

v i DL-00096 Rev. 7 Introduction MANUAL VERSION Pl ea se ref ertoth isman ualfo rdet ai le din st ru ct io ns onwa rnin gs,pr ecau tion s, spe cif ica tio ns, andaddi tional  info rmat ion.Pri nte dinU.S. A. Electronic copiesof the current version of the Portable Oxygen Conc[...]

vii DL-00096 Rev. 7 INDICATIONS FOR USE The Porta bleOxyge n Con cen tra tor isinten dedtoprovi desuppl eme nta l oxy gen inahome,ins titut ion al, ortrave l envi ronmen t. INTENDED USE Th ePo rtab leOxy genCo ncen trat oris int en de dto del iver  con cent rate doxyg en [...]

viii DL-00096 Rev. 7 Warnings and Precautions WARNINGS OVERVIEW PRE CAUT ION: 1.  U.S.FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THEORDER OF A PHYSICIAN. 2.  ITIS RECOMMENDED AN ALTERNATE SOURCE OF OXYGEN BE AVAILABLEIN CASE OF POWER OUTAGE[...]

i x DL-00096 Rev. 7 PRE CAUT ION: 4.  IFYOU ARE UNABLE TO HEAR OR SEE ALARMS, DO NOTHAVE NORMAL TACTILESENSITIVITY, OR CANNOT COMMUNICATE DISCOM FORT,CONSUL T CLINICIAN BEFOREUSINGTHIS DEVICE . 5.  THISDEVICE IS NOT DESIGNED FOR USE WITH A[...]

x DL-00096 Rev. 7 PRE CAUT ION: 17. ALWAYS OPERATE DEVICE AT THE SETTING PRESCRIBED BY A CLINICIAN. DONOT ALTER THE SETTING UNLESS PRESCRIBED BY ACLINICIAN. 18. THIS DEVICE IS DESIGNED FOR USE BY ONE PATIENTAT A TIME. 19. THIS DEVICE MAY NOT?[...]

x i DL-00096 Rev. 7 Contents Classification ........................................................................................ iii Explanation ofPackaging and Labeling Symbols ................................. iv Introduction ........................................................................................[...]

xii DL-00096 Rev. 7 Device Disposal.................................................................................... 15 Alarm Indicators...................................................................................16  Alarms .............................................................................................[...]

Before You Get Started  A l w a y s i n s pe ct t he d ev ic e a n d it s ac ce ss or ie s fo r an y si gn o f da ma ge b ef or e us in g. Note: While box or packaging may exhibit some damage, e.g., tears or dents, the device may still be in a usable condition. If thedevice or any accessory?[...]

2 DL-00096 Rev. 7 Charging the Battery Pr io rto  usi ngthe  Por tab le Oxy ge nCo ncen trat orfor  the  fi rs tti me ,in stal lthe ba tt er yas  sho wninFi gure  1. The  bat tery  wil llat ch whe nfu llyse ated . Figure 1. PRE CAUT ION: ONL YCHAR GEBATTER Y INTH[...]

DL-00096 Rev. 7 3 Figure 2. Note: Ensu re power stat us icon (see Fig ure 6, page 5) indi cates powe r is conne cted. If not, che ck tha t cord is plu gged in com plete ly. (Se e “Trou blesh ootin g” on pag e 20 for mo re info rmati on.) Tomax imizebat terylife  andrun  time,  usewhi leconnec tedtoapower s[...]

4 DL-00096 Rev. 7 Display screen Features and Controls Figure 3. Figure 4. Power key – turns device on or off Previous/next key – changes setting Mode key – changes display information Alarm mute key – temporarily silences audible alarms or shows the last highest priority alarm Cannula port Green LED – indicates device is on Yellow LED ?[...]

5 DL-00096 Rev. 7 Figure 5. Input filter Battery Compressor filter Air intake Power status (battery) Power status (external) Figure 6. Setting Setting DL-00096 rev 7.indd 5 6/1/2009 4:48:30 PM[...]

6 DL-00096 Rev. 7 ACCESSORIES Ava riet yofacc esso ries  ca nen ha nc eth eport abil ityan duseo fth ePo rtab le Ox yg en Con cent rato r.Inad diti ontot he dev ic e, the  pac kage  con tain s ac ce ss or ie sto get  sta rted  and  in st ru ct io ns for  use .[...]

7 DL-00096 Rev. 7 Figure 7. Pull Cart Wh en usi ngthe  Por tabl eOxyg enCo nc en tr at or wit hapu llcar t,att acha nd se cu re the  con cent rato rwith  th est ra ps assh ownin  Fig ure8 .Th eha ndle  can be pul ledou tandad just edfo rco mf or t. Figur[...]

8 DL-00096 Rev. 7 Intentionally blank DL-00096 rev 7.indd 8 6/1/2009 4:48:31 PM[...]

9 Operating the Portable Oxygen Concentrator DL-00096 Rev. 7 Th ePo rtab leOxy genCo ncen trat oris des ig ne dfo rea seofus e,wit hall fu nc ti on sac ce ss ed thr ough  jus tafewk ey son the  con trol  pan el. Th ePo rtab leOxy genCo ncen trat orsh oul dbeca rr[...]

1 0 DL-00096 Rev. 7 To co nn ec tt hec an nu la to the pa ti en t, po si ti on th ec ann ul at ip si npa ti en t’ s no st ri lsa nd pas st ubi ng ov er bo th ea rs and un de rc hi n.F ol lo wm an uf ac tu re r’ s in st ru cti on s. Sl id ea da pt er up tu bin g?[...]

1 1 DL-00096 Rev. 7 Figure 11. Concentrator running on external power. RESPONDING TO ALARMS PRE CAUT ION: IF YOUARE UNABLE TO HEAR OR SEE ALARMS, DO NOT HAVE NORMAL TACTILESENSITIVITY, OR CANNOT COMMUNICATE DISCOM FORT,CONSUL T CLINICIAN BEFOREUSINGTHISDEVICE. Pr es si ngt h[...]

1 2 DL-00096 Rev. 7 Maintenance and Cleaning VERIFYING THE ALARM SYSTEM At sta rtup ,theLE Dssho uldl ig ht upan dbuzz ersho uldso undt ove ri fy op er at io n. BATTERY CARE Av oi dle ttin gbatt eryde plet e;ope rate  de vice  whe nconn ecte dtoAC pow er wh en ev er pos si b[...]

1 3 DL-00096 Rev. 7 ROUTINE MAINTENANCE WAR NING : DO NOT USE LUBRICANTS ON THIS DEVICE OR ANY OF ITS ACCESSORIES. PRE CAUT ION: R E P L A C E T H E C AN NU LA ON A R EG UL AR BA SI S. CH EC K W IT H C U S T O M E R S E R V I C E O R C LI NI CI AN TO DE TE RM IN E H OW OF TE N T HE C A N N U L A S H O U L D B E R EP LA CE D. De vi ce wil lind[...]

1 4 DL-00096 Rev. 7 PATIENT FILTER Th epa tien tfilt erisde sign edto tra pai rbor nepar ticu late s.Ift hed ev ic e in di ca te sth epa tien tfilt ersho uldbe  re plac ed,co ntac tCust omer  Se rv ic efo r re pl ac em en tfi lt er .Re plac eassho wninF ig ur [...]

1 5 DL-00096 Rev. 7 EXTERIOR CLEANING WAR NING : D O N OT SU BM ER GE TH IS DE VI CE IN LI QU ID . D O N O T E X P O S E T O W A T E R O R P RE CI PI TA TI ON . D O N OT EX PO SE TO DU ST Y C O ND I T I O N S. PRE CAUT ION: D O N OT US E C LE AN IN G A GE NT S O TH ER TH AN TH OS E S P E C I F I E D I N T H I S M A N U A L . A LL OW TH E C LE AN IN[...]

1 6 DL-00096 Rev. 7 If the  Por tabl eOxyg enCon cen tr at ord et ec ts anal armco ndit ion,  itw il lin di - ca te the  ala rmvis uall yanda ud ib ly wit hi n10  sec onds .Ther earef ou rle ve ls of ala rms:  cri tica lhigh  pr io ri ty ,hi gh pri orit y,m[...]

1 7 DL-00096 Rev. 7 Alarm Message CheckVents LowBattery XX:Service!* *Value:21-50 Description Devi ceisunable  tomaint ain oxyg enpurity . Estimatedbattery life less than17 minutes. Servicerequired. Action Besure air inlet/outlet hasnot been blocked. If alarm persists, conta[...]

1 8 DL-00096 Rev. 7 Alarm Message ReplaceC-filtr ReplaceP-filtr WashI-filtr Replace batt XX:Service*  *Value: 71-99 Description Compressorfilter needs replacement. Patientfilter needs replacement. Inputfilter needs to be cleaned. Mainbattery has exceeded 300recharge cycles. Ser[...]

1 9 DL-00096 Rev. 7 Message Batterylow Fullycharged Checkingpower Nobattery BattLifeNN% Charging:NN% Charging RTXXXXX Breathrate XX Alarm cleared Description Estimatedbattery life less than17 minutes. The unit will also generate a high priority alarm as described above. Displayedas the [...]

2 0 DL-00096 Rev. 7 Problem System becomes inoperative Any alarm sound or either Batterynot charging   Possible Cause • Systemmay be disconnected from the powersource. • Systemmay be turned off. • Criticalhigh priority alarm hasoccurred. • See“Alarm Indica[...]

2 1 DL-00096 Rev. 7 Appendix 1: Technical Description Size: 7. 4” W x 4 .6 ”D x 11. 6” H (1 88 mm W x 11 7 mm D x2 95 mm H ) Unit weight: Le ss t ha n 10 lb s( wi th ou tc ar ry i ng ca se or ca rt ) Powe r requi rements : 1 00 - 2 40 V AC ( ±1 0 %) , 5[...]

2 2 DL-00096 Rev. 7 Appendix 2: Technical Information ELECTROMAGNETIC COMPATIBILITY (EMC) INFORMATION Me di ca lel ectr ical  equ ipme ntreq uire sspe ci al pre ca ut io ns reg ardi ng el ec tr om ag ne ti cco mpat ibil ity( EM C) .Po rtab lean dmo bile  ra diofr eque ncy( RF) co mm un ic at io ns [...]

2 3 DL-00096 Rev. 7 Immunity test Electrostatic discharge(ESD) IEC61000-4-2 Electricfast transient/burst IEC61000-4-4 Surge IEC61000-4-5 IEC 60601 test level ± 6kV contact ± 8kV air ± 2kV for power supply lines ± 1kV for input/output lines ± 1kV d i f f e r e n t i a l m o de ± ?[...]

2 4 DL-00096 Rev. 7 Immunity test Voltagedips, short interruptions, and voltagevariations on power supply input lines IEC61000-4-11 Powerfrequency (50/60Hz)magneti c field IEC61000-4-8 ConductedRF IEC61000-4-6 RadiatedRF IEC61000-4-3 IEC 60601 test level < 5 %U T ( >9 5 % di p i n[...]

2 5 DL-00096 Rev. 7 Rated maximum output power of transmitter (W) 0.01 0.1 1 10 100 15 0 k Hz to 80 MH z d= 1.2 √ P 0 . 12 0 . 38 1 . 2 3 . 8 1 2 Recommended separation distances between portable and mobile RF communications equipment and the Portable Oxygen Concentrator Th ePo rt abl eOx yg enC onc en tr at or isi nt en d[...]

Airline Travel Guidelines 2 6 DL-00096 Rev. 7 When travelingby air, it is recommended the guidelines listed below be followed: 1.  The  pat ient  mus tbeca pa bl eof  see ingth ealar mind ic at or lig ht s, hea ring th eva riou swarn ingal arms ,andt ak in g?[...]

Intentionally blank DL-00183 Rev . 3 27 12659da delphi POC covers 9/18/08 12:14 PM Page 3[...]

Delphi Medical Systems 5725 Delphi Drive T roy , Michigan 48098-2815 U.S.A. T el: [1] 888.526.1426 E-mail: medical@delphi.com www .delphimedical.com All trademarks are the property of their respective owners. © 2008 Delphi Corporation. All rights reserved. DL-00183 Rev . 3 12659da delphi POC covers 9/18/08 12:14 PM Page 4[...]