Maxtec Handi+ Instructions For Use Manual Download Page 4

ENGLISH 

4

 

WWW .MAXTEC .COM  •  (800) 748-5355

3.0 OPERATING THE HANDI+

To Check the Oxygen Concentration of a Sample Gas:

1.  Maintain the Handi+ in an upright position such that you can read the product 

label.

2.  Place the Handi+ in the sample gas stream.

IMPORTANT:

 When using a standard "T" adapter, make sure that the sensor is mounted in the 

adapter with the flow diverter pointing down. Make sure that there is a tight fit between the 
flow diverter and the "T" adapter.

3.  Start the flow of the sample gas to the sensor. 
4.  Allow the oxygen sensor to remain in the flow of the sample gas until stable.
5.  If the Handi+ is not already turned on, do so now by pressing the analyzer ON 

button 

.

6.  Read the value displayed on the LCD.

NOTE:

 If the Handi+ is used to measure the oxygen concentration with equipment using a 

heated or humidified gas stream, it is recommended that the Handi+ be placed upstream of 
the heater and/or humidifier. For more information, refer to "Factors Influencing Calibration 
and Performance" below.

For hospital and home care a new calibration is required when:

 

The measured O2 percentage in 100% O2 is below 97.0% O2

 

The measured O2 percentage in 100% O2 is above 103.0% O2.

For ID testing (or optimum accuracy), a new calibration is required when:

7.  The measured O2 percentage in 100% O2 is below 99.0% O2.
8.  The measured O2 percentage in 100% O2 is above 101.0% O2.

4.0 FACTORS INFLUENCING 

ACCURATE READINGS

4.1 Elevation Changes

 

Changes in elevation result in a reading error of approximately 1% of reading per 
250 feet.

 

A change in altitude greater than 500 ft will require sensor recalibration.

 

This device does not automatically compensate for changes in barometric pressure 
or altitude. If the device is moved to a location of a different altitude, it must be 
recalibrated before use (see section 2.2).

4.2 Temperature Effects

The Handi+ will hold calibration and read correctly within ±3% when in thermal equilibrium 
within the operating temperature range. The device must be thermally stable when calibrated 
and allowed to thermally stabilize after experiencing temperature changes before readings 
are accurate. For these reasons, the following is recommended:

 

When used in a breathing circuit, place the sensor upstream of the heater.

 

For best results, perform the calibration procedure at a temperature close to the 
temperature where analysis will occur.

 

Allow adequate time for the sensor to equilibrate to a new ambient temperature.

4.3 Pressure Effect

Readings from the Handi+ are proportional to the partial pressure of oxygen. The partial pres-
sure is equal to the concentration times the absolute pressure. Thus the readings are pro-
portional to the concentration if the pressure is held constant. Flow rate of sample gas can 
affect pressure at the sensor in that back pressure at the sensing point may change. For these 
reasons, the following is recommended:

 

Calibrate the Handi+ at the same pressure as the sample gas.

 

If sample gases flow through tubing, use the same apparatus and flow rates when 
calibrating as when measuring.

 

The Handi+ oxygen sensor has been validated at pressures up to 2 atmospheres 
absolute. Calibration or operation above this pressure is beyond the intended use.

4.4 Humidity Effect

Humidity has no effect on the performance of the Handi+ other than diluting the gas, as long 
as there is no condensation. Depending on the humidity, the gas may be diluted by as much as 
4%, which proportionally reduces the oxygen concentration. The device responds to the actual 
oxygen concentration rather than the dry concentration. Environments where condensation 
may occur are to be avoided since condensate may obstruct passage of gas to the sensing 
surface, resulting in erroneous readings and slower response time.

For this reason, the following is recommended:

 

Avoid usage in environments greater than 95% relative humidity.

 

When used in a breathing circuit, place the sensor upstream of the humidifier.

5.0 CALIBRATION ERRORS AND 

ERROR CODES

The Handi+ analyzers have a self test feature built into the software to detect faulty calibra-
tions, oxygen sensor failures, and low operating voltage. These are listed below, and include 
possible actions to take, if an error code occurs. 

E03: No valid calibration data available

Make sure unit has reached thermal equilibrium. Press and hold the Calibration Button 

 for 

three seconds to manually force a new calibration. 

E04: Battery below minimum operating voltage

Unit is at end of life, see "Product Disposal Instructions" for proper disposal.

CAL Err St: O2 Sensor reading not stable

Wait for displayed oxygen reading to stabilize when calibrating the device at 100% oxygen. 
Wait for unit to reach thermal equilibrium (Please note that this can take up to one half hour, 
if the device is stored in temperatures outside the specified operating temperature range). 

CAL Err lo: Sensor voltage too low

Press and hold the Calibration Button 

 for three seconds to manually force a new calibra-

tion. If unit repeats this error more than three times, contact Maxtex Customer Service for 
possible sensor replacement.

CAL Err hi: Sensor voltage too high

Press and hold the Calibration Button 

 for three seconds to manually force a new calibra-

tion. If unit repeats this error more than three times, contact Maxtec Customer Service for 
possible sensor replacement.

CAL Err Bat: Battery voltage too low to recalibrate

Unit is at end of life, see "Product Disposal Instructions" for proper disposal. 

6.0 CLEANING AND MAINTENANCE

When cleaning or disinfecting the Handi+, take appropriate care to prevent any solution from 
entering the analyzer.  

 

The Handi+ surface may be cleaned using a cloth moistened with 65% isopropyl 
alcohol/water solution or germicidal wipe.  

 

The Handi+ may be disinfected using standard topical disinfectants. 

 

The Handi+ is not intended for steam, ethylene oxide or radiation sterilization.

 

Store the Handi+ in a temperature similar to its ambient environment of daily use.

Summary of Contents for Handi+

Page 1: ...R218M12 REV L EN Instructions for Use 2 FR Instructions d utilisation 8 DE Bedienungsanleitung 14 NL Gebruiksaanwijzingen 20 IT Istruzioni per l uso 26 ES Instrucciones de uso 32 Handi M E D I C A L ...

Page 2: ...cluding electronics is not suit able for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrousoxide Onlythethreadedsensorface flowdiverter and T adaptermaybeallowed tocontactsuchagasmixture Thisdevicedoesnotcontainautomaticbarometricpressurecompensation DO NOT use near any type of flame or flammable explosive substances vapors or atmosphere NotforuseinanMRIenviro...

Page 3: ... calibration proce dure was performed or if the measurement value displayed is in question Calibrate the Handi to an oxygen source which has a traceable certificate and or USP certifi cation of either 20 9 oxygen as found in room air or 100 oxygen It is recommended that the oxygen source be documented at a pressure and flow similar to your clinical application NOTE Before beginning calibration the...

Page 4: ...commended Calibrate the Handi at the same pressure as the sample gas If sample gases flow through tubing use the same apparatus and flow rates when calibrating as when measuring The Handi oxygen sensor has been validated at pressures up to 2 atmospheres absolute Calibration or operation above this pressure is beyond the intended use 4 4 Humidity Effect Humidity has no effect on the performance of ...

Page 5: ...ne 6 2 Desflurane 15 2 Carbon Dioxide 10 2 Helium 70 2 8 0 HANDI SPARE PARTS AND ACCESSORIES 8 1 Standard Replacement Parts and Accessories PART NUMBER ITEM R218M12 Operation Manual Handi RP16P02 T Adapter R110P10 001 Flow Diverter Fitting R207P17 Barbed Adapter R100P92 002 Clear Tubing RP76P06 Lanyard R218P09 Handi Cover 9 0 FREQUENTLY ASKED QUESTIONS After I calibrate to 20 9 the display changes...

Page 6: ... supply network that supplies buildings used for domestic purposes NOTE The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals CISPR 11 class A If it is used in a residential environment for which CISPR 11 class B is normally required this equipment might not offer adequate protection to radio frequency communication services The user might need ...

Page 7: ...ons equipment including cables should be used no closer to any part of the equipment than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter as below Recommended sparation distance d 1 2 P d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 7 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmi...

Page 8: ...troniques n est pas adapté pour une utilisation en présence d un mélange d un anesthétique inflammable avec de l air ou de l oxygène ou d oxyde nitreux Seulelasurfacefiletéeducapteur ledérivateurdedébitetl adaptateurenTpeuvent êtreautorisésàentrerencontactavecuntelmélangegazeux Cet appareil ne contient pas de compensation automatique de pression atmosphérique NE PAS utiliser dans un environnement ...

Page 9: ...ge a été faite ou si la valeur de prise de mesure affichée est contestée CalibrerleHandi surunesourced oxygène quiauncertificattraçableet ouunecertification USP de 20 9 de teneur en oxygène comme l oxygène de l air ambiant ou de l oxygène pur 100 Il est préférable que la source d oxygène soit documentée pour une pression et un débit similaires à ceux de votre application clinique NOTE Avant de com...

Page 10: ...ndi à la même pression que le gaz d échantillon Si les gaz d échantillon sont débités à travers un tube utiliser le même appareillage et débits lors du calibrage que lors des lectures Le capteur d oxygène du Handi a été validé pour des pressions jusqu à 2 atmosphères absolues Le calibrage ou le fonctionnement au dessus de cette pression dépasse l étendue de l utilisation à laquelle il est destiné ...

Page 11: ...Sévoflurane 6 2 Désflurane 15 2 Dioxyde de carbone 10 2 Hélium 70 2 8 0 PIÈCES DE RECHANGES ET ACCESSOIRES HANDI 8 1 Pièces de rechanges et accessoires standard NUMÉRO DE PIÈCE ÉLÉMENT R218M12 Manuel d utilisation Handi RP16P02 Adaptateur en T R110P10 001 Connecteur d aiguilleur de débit R207P17 Adaptateur cannelé R100P92 002 Tube transparent RP76P06 Cordon R218P09 Couvercle du Handi 9 0 QUESTIONS...

Page 12: ...mestique et ceux directement raccordés au réseau d alimentation en électricité basse tension alimentant les bâtiments à usage domestique Émissions harmoniques IEC 61000 3 2 Classe A Fluctuations de tension scintillements IEC 61000 3 3 Conforme IMMUNITÉ ÉLECTROMAGNÉTIQUE Cet équipement est destiné à être utilisé dans l environnement électromagnétique spécifié ci dessous L utilisateur de cet équipem...

Page 13: ...équipement calculée à partir de l équation applicable à la fréquence de l émetteur comme indiqué ci dessous Distance de séparation recommandée RF transmise par conduction RF couplée aux lignes CEI 61000 4 6 150 kHz à 80 MHz hors des bandes ISMa 3 Vrms d 1 2 P RF par radiation IEC 61000 4 3 3 V m 80 MHz 2 5 GHz 3 V m d 1 2 P 80 MHz à 800 MHz d 2 3 P 800 MHz à 2 5 GHz où P correspond à la puissance ...

Page 14: ...elektronischen Bestandteile nicht für den Gebrauch mit brennbaren anästhetischen Gemischen an der Luft oder in Sauerstoff oder Stickoxyd geeignet Nur das Feingewinde der Sensoroberfläche das Regelventil und der T Adapter dürfenmitsolchenGasgemischeninKontaktkommen DiesesGerätenthältkeinenautomatischenLuftdruckregler NICHT IN der Nähe von offenem Feuer irgendwelcher Art oder brennbaren explosiven S...

Page 15: ...urde oder wenn der angezeigte Messwert fragwürdig ist Kalibrieren Sie das Handi auf eine Sauerstoffquelle die ein nachvollziehbares Zertifikat und oder eine USP Zertifizierung hat entweder mit 20 9 Sauerstoff wie ihn Raumluft aufweist oder mit 100 Sauerstoff Wir empfehlen dass die Sauerstoffquelle mit einem Druck und Fluss festgelegt wird die Ihrer klinischen Anwendung entsprechen HINWEIS Bevor Si...

Page 16: ...h die Leitungen fließen verwenden Sie denselben Apparat und dieselben Flussraten zur Kalibration und Messung Der Handi Sauerstoffsensor wurde bei Drücken bis zu 2 Atmosphären Absolutdruck validiert Kalibrierung oder Betrieb über diesem Druck geht über den Verwendungszweck hinaus 4 4 Auswirkungen der Luftfeuchtigkeit Solange keine Kondensation auftritt hat die Luftfeuchtigkeit keinen Einfluss auf d...

Page 17: ...uran 6 2 Desflurane 15 2 Kohlendioxid 10 2 Helium 70 2 8 0 ERSATZTEILE UND ZUBEHÖR FÜR HANDI 8 1 Standardersatzteile und Zubehör ERSATZTEILNUMMER ARTIKEL R218M12 Betriebsanleitung Handi RP16P02 T Adapter R110P10 001 Regelventilfitting R207P17 Adapter R100P92 002 Durchsichtige Leitungen RP76P06 Band R218P09 Handi Abdeckung 9 0 HÄUFIG GESTELLTE FRAGEN Die Anzeige verändert sich um 1 nachdem ich auf ...

Page 18: ...ungen die direkt an das öffentliche Niederspannungsnetz angeschlossen sind mit dem Gebäude für den Hausgebrauch versorgt werden Oberwellenemissionen IEC 61000 3 2 Klasse A Spannungsschwankungen Flicker IEC 61000 3 3 konform ELEKTROMAGNETISCHE STÖRFESTIGKEIT Dieses Gerät ist für die Verwendung in der unten spezifizierten elektromagnetischen Umgebung bestimmt Der Benutzer dieses Geräts sollte gewähr...

Page 19: ...z des Senders angewendet wird Empfohlener Abstand Leitungsgeb undene HF HF in Leitungen gekoppelt IEC 61000 4 6 150 kHz bis 80 MHz außerhalb ISM Bänder A 3 Vrms d 1 2 P Gestrahlte Hochfrequenz IEC 61000 4 3 3 V m 80 MHz 2 5 GHz 3 V m d 1 2 P 80 MHz bis 800 MHz d 2 3 P 800 MHz bis 2 5 GHz wobei P die maximale Ausgangsnennleistung des Senders in Watt W und d den empfohlenen Abstand in Metern m gemäß...

Page 20: ...tor ing werd bevonden is het toestel in zijn geheel inclusief elektronica niet geschikt voor het gebruik van een ontvlambare mengeling van verdovingsmiddel met lucht of zuurstof of lachgas Enkel het bedrade sensoroppervlak toevoerverdeler en T adapter mogen in contactkomenmetdergelijkgasmengsel Dittoestelbevatgeenautomatischeluchtdrukvereffening GEBRUIKHETtoestelniet in debuurtvanvlammenofontvlamb...

Page 21: ...gebruikerernietzekervaniswanneerdelaatstekalibrering procedure werd uitgevoerd of als de gemeten waarde in vraag wordt gesteld Stem de Handi op een zuurstofbron af die een na te gaan certificaat of US certificatie heeft van ofwel 20 9 zuurstof kamerlucht of 100 zuurstof Het wordt aanbevolen om een zuur stofbron te gebruiken met dezelfde druk en toevoer als uw klinische toepassing OPMERKING Alvoren...

Page 22: ...ebruik dan hetzelfde apparaat en stroomsnelheden zowel bij het kalibreren als meten De Handi zuurstofsensor kan druk tot 2 atmosfeer absoluut aan Kalibrering of gebruik boven deze druk behoort niet meer tot het bedoelde gebruik 4 4 Invloed door vochtigheid Luchtvochtigheid niet condenserende heeftgeenandereinvloedopdeprestatievandeHandi dan de verdunning van het gas op voorwaarde dat er geen conde...

Page 23: ...thaan 5 2 Isofuraan 5 2 Enfluraan 5 2 Sevofluraan 6 2 Desfluraan 15 2 Kooldioxide 10 2 Helium 70 2 8 0 HANDI RESERVEONDERDELEN EN TOEBEHOREN 8 1 Standaard vervangonderdelen en toebehoren ONDERDEELNUMMER ONDERDEEL R218M12 Bedieningshandleiding Handi RP16P02 T adapter R110P10 001 Toevoerverderlerfitting R207P17 Adapter met weerhaken R100P92 002 Doorschijnend leidingstel RP76P06 Sleutelkoord R218P09 ...

Page 24: ...voor gebruik in alle instellingen uitgezonderd woonomgevingen en instellingen die rechtstreeks zijn aangesloten op openbare laagspanningsnetwerken voor gebouwen die worden gebruikt voor bewoning Harmonische straling IEC 61000 3 2 Klasse A Spanningsschommelingen flikkeringen IEC 61000 3 3 In overeenstemming ELEKTROMAGNETISCHE IMMUNITEIT Het apparaat is bedoeld om gebruikt te worden in de elektromag...

Page 25: ...nderdeel waaronder de kabels worden gebruikt dan de aanbevolen afstand die wordt berekend met de vergelijking voor de frequentie van de zender zoals hieronder aangegeven Aanbevolen scheidingsafstand Geleide RF rf gekoppeld in lijnen IEC 61000 4 6 150 kHz tot 80 MHz buiten ISM banden 3 Vrms d 1 2 P Uitgestraalde rf IEC 61000 4 3 3 V m 80 MHz 2 5 GHz 3 V m d 1 2 P 80 MHz tot 800 MHz d 2 3 P 800 MHz ...

Page 26: ...ilizzoinpresenzadimisceleanesteticheinfiammabiliconariaoconossigeno o ossido nitroso Solo il sensore il deviatore di flusso e l adattatore a T possono entrare in contattoconmisceledigas Ildispositivononcontieneunacompensazioneautomaticadellapressionebarometrica NON utilizzare vicino a qualsiasi tipo di sostanza infiammabile esplosiva vapori o atmosfera NON utilizzare in un ambiente MRI L usoimprop...

Page 27: ...tente non è sicuro di quando è stata ese guita l ultima calibratura o se è dubbio il valore di misurazione CalibrareHandi adunafontediossigeno cheabbiauncertificatotracciabilee ocertificazione USP di20 9 diossigeno comeinariaambientale o100 diossigeno Siconsigliachelafonte di ossigeno sia documentata ad una pressione e un flusso simile all applicazione clinica NOTA Prima di iniziare la calibratura...

Page 28: ... i gas di campionatura defluiscono nei tubi utilizzare lo stesso apparato e velocità di flusso della calibratura durante la misurazione Il sensore di ossigeno con analizzatore Handi è stato convalidato a pressioni fino 2 atmosfere assolute La calibratura o funzionamento al di sopra di questa pressione è al di fuori dell uso previsto 4 4 Effetto dell umidità L umidità ambientale non ha alcun effett...

Page 29: ...Desflurano 15 2 Diossido di carbonio 10 2 Elio 70 2 8 0 PEZZI DI RICAMBIO E ACCESSORI HANDI 8 1 Pezzi di ricambio e accessori standard NUMERO PARTE ARTICOLO R218M12 Manuale Operativo Handi RP16P02 Adattatore a T R110P10 001 Flusso Attrezzatura R207P17 Adattatore con filettatura R100P92 002 Tubo RP76P06 Cordoncino R218P09 Coperchio Handi 9 0 DOMANDE FREQUENTI Dopo una calibratura a 20 9 il display ...

Page 30: ...è adatto per l uso in tutti i locali diversi da quelli domestici e quelli collegati direttamente alla rete elettrica pubblica a bassa tensione che alimenta edifici usati per scopi domestici Emissioni armoniche IEC 61000 3 2 Classe A Fluttuazioni di tensione Emissioni flicker IEC 61000 3 3 Conforme IMMUNITÀ ELETTROMAGNETICA Questo dispositivo è stato progettato per l uso negli ambienti elettromagne...

Page 31: ...abile alla frequenza del trasmettitore come illustrato di seguito Distanza di separazione raccomandata RF condotta rf accoppiata nelle linee IEC 61000 4 6 Da 150 kHz a 80 MHz fuori dalle bande ISM a 3 Vrms d 1 2 P RF irradiata IEC 61000 4 3 3 V m 80 MHz 2 5 GHz 3 V m d 1 2 P da 80 MHz a 800 MHz d 2 3 P da 800 MHz a 2 5 GHz Dove P è la potenza di uscita massima nominale del trasmettitore in watt W ...

Page 32: ...nterferenciasaceptables eldispositivoensutotalidad incluyendopar tes electrónicas no debe ser utilizado en presencia de mezclas anestésicas inflamables con aireuoxígenouóxidonitroso Sólolapartedelanteraenroscadadelsensor eldesviadorde flujoyeladaptadorenTpuedenentrarencontactoconesasmezclasdegases Eldispositivonotieneunacompensacióndepresiónbarométricaautomática NO lo utilice cerca de ningún tipo ...

Page 33: ... utilizando el producto cambia más de 150 metros Además es recomendable calibrar el dispositivo si el usuario no está seguro de cuándo se realizó la última calibración o del valor de la medición Calibre el Handi con una fuente de oxígeno que tenga un certificado atribuible o certificación USP o con 20 9 oxígeno como en el aire ambiental o 100 oxígeno Es recomendable que la fuentedeoxígenoestédocum...

Page 34: ... de un tubo utilice las mismas velocidades del aparato y del flujo cuando calibra y cuando mide El sensor de oxígeno del Handi ha sido validado a presiones de hasta 2 atmósferas absolutas La calibración o el funcionamiento por encima de esta presión no está dentro de la utilización para la cual se diseñó 4 4 Efectos de la humedad La humedad no tiene efecto alguno en el rendimiento del Handi aparte...

Page 35: ...rano 5 2 Sevoflurano 6 2 Desflurano 15 2 Dióxido de carbono 10 2 Helio 70 2 8 0 PARTES SUELTAS Y ACCESORIOS DEL HANDI 8 1 Partes de sustitución y accesorios estándar NÚMERO DE LA PARTE PARTE R218M12 Manual de funcionamiento Handi RP16P02 Adaptador en T R110P10 001 Toma del desviador de flujo R207P17 Adaptador con lengüetas R100P92 002 Tubo claro RP76P06 Cordón R218P09 Tapa del Handi 9 0 PREGUNTAS ...

Page 36: ...y en aquellos lugares directamente conectados con la red de alimentación de bajo voltaje pública que provee el suministro eléctrico a los edificios utilizados como vivienda Emisiones de armónicos IEC 61000 3 2 Clase A transitorios eléctricos rápidos en ráfagas IEC 61000 3 3 Conformidad INMUNIDAD ELECTROMAGNÉTICA Este aparato está indicado para utilizarse en el entorno electromagnético que se espec...

Page 37: ...ón aplicable a la frecuencia del transmisor indicada a continuación Distancia de separación recomendada RF conducida RF acoplada en líneas IEC 61000 4 6 150 kHz a 80 MHz fuera de bandas ISM 3 Vrms d 1 2 P RF emitida IEC 61000 4 3 3 V m 80 MHz 2 5 GHz 3 V m d 1 2 P 80 MHz a 800 MHz d 2 3 P 800 MHz a 2 5 GHz donde P es la potencia de salida máxima del transmisor en vatios W de acuerdo con el fabrica...

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Page 40: ...2305 South 1070 West Salt Lake City Utah 84119 800 748 5355 www maxtec com ...

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