BioTrend™
0123
Oxygen Saturation and Hematocrit System
Iltmætnings- og hæmatokritsystem
Sauerstoffsättigungs-und Hämatokrit-Messsystem
Sistema de medición del hematocrito y de saturación de oxígeno
Système de mesure de la saturation en oxygène et de l’hématocrite
Sistema per saturazione di ossigeno ed ematocrito
Zuurstofsaturatie- en hematocrietsysteem
Syresaturations- och hematokritmätare
Operator and Reference Manual • Operatør- og referencehåndbog • Bedienungs- und
Referenzhandbuch • Manual del operador y de referencia • Manuel de référence et de l'utilisateur •
Manuale di riferimento per l'operatore • Gebruikers- en referentiehandleiding • Användar- och
referensmanual
Caution: Federal law (USA) restricts this device to sale by or
on the order of a physician.
The following list includes trademarks or registered trademarks of Medtronic in the United
States and possibly in other countries. All other trademarks are the property of their respective
owners.
Følgende liste indeholder varemærker eller registrerede varemærker tilhørende Medtronic i
USA og muligvis i andre lande. Alle andre varemærker tilhører de respektive ejere.
Die folgende Liste beinhaltet Marken oder eingetragene Marken von Medtronic in den USA
und möglicherweise in anderen Ländern. Alle anderen Marken sind Eigentum ihrer jeweiligen
Inhaber.
La siguiente lista incluye marcas comerciales o marcas registradas de Medtronic en los
Estados Unidos y posiblemente en otros países. Todas las marcas comerciales son
propiedad de sus propietarios respectivos.
La liste suivante inclut des marques commerciales ou des marques déposées de Medtronic
aux États-Unis et eventuellement dans d'autres pays. Toutes les autres marques
commerciales sont la propriété de leurs détenteurs respectifs.
L'elenco seguente include marchi di fabbrica o marchi registrati della Medtronic negli Stati
Uniti ed eventualmente in altri Paesi. Tutti gli altri marchi di fabbrica sono di proprietà dei
rispettivi proprietari.
In de onderstaande lijst staan de gedeponeerde of geregistreerde handelsmerken van
Medtronic in de Verenigde Staten en mogelijk in andere landen. Alle andere handelsmerken
zijn het eigendom van de desbetreffende eigenaar.
Följande lista innehåller varumärken eller registrerade varumärken som tillhör Medtronic i
USA och möjligen i andra länder. Alla övriga varumärken tillhör respektive innehavare.
BioTrend, Medtronic
Symbols on the product or packaging • Symboler på produktet eller emballagen •
Auf dem Produkt oder der Verpackung angebrachte Symbole • Símbolos que
aparecen en el producto o en el envase • Symboles figurant sur le produit ou
l’emballage • Simboli sul prodotto o sulla confezione • Symbolen op het product of
de verpakking • Symboler på produkt eller förpackning
Conformité Européenne (European Conformity). This symbol means that the
device fully complies with European Council Directive 93/42/EEC. •
Conformité Européenne (Europæisk standard). Dette symbol betyder, at
enheden fuldt ud overholder Det Europæiske Råds direktiv 93/42/EØF. •
Conformité Européenne (Europäische Konformität). Dieses Symbol besagt,
dass das Gerät allen Vorschriften der Richtlinie 93/42/EWG des Europäischen
Rates entspricht. • Conformité Européenne (Conformidad Europea). Este
símbolo indica que el dispositivo cumple totalmente la Directiva 93/42/CEE
del Consejo Europeo. • Conformité Européenne. Ce symbole signifie que
l’appareil est entièrement conforme à la Directive 93/42/CEE du Conseil
européen. • Conformité Européenne (Conformità europea). Questo simbolo
indica che il dispositivo è conforme alla Direttiva del Consiglio europeo
93/42/CEE. • Conformité Européenne (Europese Conformiteit). Dit symbool
betekent dat het product volledig voldoet aan de Europese Richtlijn
93/42/EEG. • Conformité Européenne (Europeisk standard). Denna symbol
betyder att enheten helt följer rådets direktiv 93/42/EEG.
For US audiences only • Gælder kun i USA • Gilt nur für Leser in den USA • Solo
aplicable en EE. UU. • Ne s’applique qu’aux États-Unis • Esclusivamente per
il mercato statunitense • Alleen van toepassing voor de VS • Gäller endast i
USA
Medical equipment with respect to electric shock, fire and mechanical hazards
only in accordance with UL60601-1:2006, CAN/CSA C22.2 No. 601.1 (2005),
ANSI/AAMI ES60601-1 (2005), CAN/CSA C22.2 No. 60601-1 (2008). 71NL. •
Medicinsk udstyr med hensyn til risiko for elektrisk stød, brandfare og
mekanisk skade kun i overensstemmelse med UL60601-1:2006, CAN/CSA
C22.2 No. 601.1 (2005), ANSI/AAMI ES60601-1 (2005), CAN/CSA C22.2 No.
60601-1 (2008). 71NL. • Medizinisches Gerät, erfüllt bezüglich Stromschlag,
Brandgefahr und mechanischer Gefahren die Anforderungen von
UL60601-1:2006, CAN/CSA C22.2 Nr. 601.1 (2005), ANSI/AAMI ES60601-1
(2005), CAN/CSA C22.2 Nr. 60601-1 (2008). 71NL. • Equipo médico
protegido únicamente frente a peligros mecánicos, de descargas eléctricas y
de incendio conforme a las normas UL60601-1:2006, CAN/CSA C22.2
N.º 601.1 (2005), ANSI/AAMI ES60601-1 (2005) y CAN/CSA C22.2
N.º 60601-1 (2008). 71NL. • Équipement médical en ce qui concerne les
risques de choc électrique, d’incendie et mécaniques uniquement en
conformité avec les normes UL 60601-1:2006, CAN/CSA C22.2 n° 601.1
(2005), ANSI/AAMI ES60601-1 (2005) et CAN/CSA C22.2 n° 60601-1 (2008).
71NL. • Dispositivo medico conforme unicamente alle normative
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UL60601-1:2006, CAN/CSA C22.2 n. 601.1 (2005), ANSI/AAMI ES60601-1
(2005) e CAN/CSA C22.2 n. 60601-1 (2008). 71NL riguardanti il rischio di
scosse elettriche, incendio e pericoli di natura meccanica. • Medische
apparatuur ten aanzien van elektrische schok, brand en mechanische
gevaren, uitsluitend volgens UL60601-1:2006, CAN/CSA C22.2
No. 601.1 (2005), ANSI/AAMI ES60601-1 (2005), CAN/CSA C22.2
No. 60601-1 (2008) 71NL. • Medicinsk utrustning som endast med avseende
på risken för elektrisk stöt, brandrisken och mekaniska risker överensstämmer
med UL60601-1:2006, CAN/CSA C22.2 nr 601.1 (2005), ANSI/AAMI
ES60601-1 (2005), CAN/CSA C22.2 nr 60601-1 (2008). 71NL.
Dangerous voltage • Farlig spænding • Gefährliche Spannung • Voltaje
peligroso • Tension dangereuse • Tensione pericolosa • Gevaarlijke spanning •
Farlig spänning
Danger: Risk of explosion if used in the presence of flammable anesthetics •
Fare: Risiko for eksplosion, hvis anvendt i nærheden af brændbare
anæstesimidler • Gefahrenhinweis: Explosionsgefahr bei Verwendung in
Gegenwart entflammbarer Anästhetika • Peligro: riesgo de explosión si se
utiliza en presencia de gases anestésicos inflamables • Danger : Risque
d’explosion en cas d’utilisation d’anesthésiques inflammables • Pericolo:
rischio di esplosione se utilizzato in presenza di sostanze anestetiche
infiammabili • Gevaarlijk: Explosiegevaar bij gebruik in de nabijheid van
ontvlambare anesthetica • Fara: Explosionsrisk vid användning nära
lättantändligt anestetikum
Consult instructions for use • Se brugsanvisningen • Gebrauchsanweisung
lesen • Consultar instrucciones de uso • Consulter le mode d’emploi •
Consultare le istruzioni per l’uso • Zie gebruiksaanwijzing • Läs
bruksanvisningen
Do not sterilize • Må ikke steriliseres • Nicht sterilisieren • No esterilizar • Ne
pas stériliser • Non sterilizzare • Niet steriliseren • Får inte steriliseras
Not MR safe • Ikke sikker ved MR-scanning • Nicht MRT-tauglich • No es
seguro para RM • Non compatible avec la RM • Non sicuro per la risonanza
magnetica (RM) • Niet MR-veilig • Ej MR-säker
Do not reuse • Må ikke genbruges • Nicht wiederverwenden • No reutilizar • Ne
pas réutiliser • Non riutilizzare • Niet opnieuw gebruiken • Får inte
återanvändas
Nonpyrogenic fluid path • Ikke-pyrogen væskebane • Pyrogenfreier
Flüssigkeitsweg • Vía de líquido apirógena • Trajet des fluides apyrogène •
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Percorso per il liquido apirogeno • Niet-pyrogeen vloeistoftraject • Pyrogenfri
vätskebana
Sterilized using ethylene oxide • Steriliseret med etylenoxid • Mit Ethylenoxid
sterilisiert • Esterilizado mediante óxido de etileno • Stérilisé à l’oxyde
d’éthylène • Sterilizzato a ossido di etilene • Gesteriliseerd met ethyleenoxide •
Steriliserad med etylenoxid
Alternating current • Vekselstrøm • Wechselspannung • Corriente alterna •
Courant alternatif • A corrente alternata • Wisselstroom • Växelström
On/Off • Tændt/Slukket • Ein/Aus • Encendido/Apagado • Marche/Arrêt •
On/Off • Aan/uit • På/Av
Standby • Standby • Bereitschaft • Espera • Veille • Standby • Stand-by •
Standby
Serial number • Serienummer • Seriennummer • Número de serie • Numéro de
série • Numero di serie • Serienummer • Serienummer
Communication port • Kommunikationsport • Kommunikationsschnittstelle •
Puerto de comunicaciones • Port de communication • Porta di comunicazione
• Communicatiepoort • Kommunikationsport
Date of manufacture • Fabrikationsdato • Herstellungsdatum • Fecha de
fabricación • Date de fabrication • Data di fabbricazione • Productiedatum •
Tillverkningsdatum
Manufacturer • Fabrikant • Hersteller • Fabricante • Fabricant • Fabbricante •
Fabrikant • Tillverkare
Manufacturing site • Fabrikationssted • Produktionsstätte • Lugar de
fabricación • Site de fabrication • Luogo di fabbricazione • Productieplaats •
Tillverkningsanläggning
Use-by date • Kan anvendes til og med • Verwendbar bis • Fecha de caducidad
• Date de péremption • Utilizzare entro • Uiterste gebruiksdatum •
Utgångsdatum
Catalog number • Katalognummer • Katalognummer • Número de catálogo •
Numéro de référence • Numero di catalogo • Catalogusnummer •
Katalognummer
Quantity • Antal • Menge • Cantidad • Quantité • Quantità • Aantal • Antal
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Do not subject to impact or rough handling • Må ikke udsættes for stød eller
hårdhændet håndtering • Vor Stößen, Schlägen und unsanfter Behandlung
schützen • No someter a impactos o manipulación brusca • Ne pas soumettre
à des chocs ou à une manipulation brutale • Non sottoporre a caduta o a
trattamento improprio • Voorzichtig behandelen • Får inte utsättas för stötar
eller ovarsam hantering
Do not place any object on this instrument • Undlad at anbringe nogen
genstand på dette instrument • Keine Objekte auf diesem Instrument ablegen •
No colocar ningún objeto sobre este instrumento • Ne poser aucun objet sur
l’appareil • Non collocare oggetti sopra il dispositivo • Niets boven op dit
instrument plaatsen • Placera inte något föremål på instrumentet
Nickel metal-hydride battery • Nikkel-metal-hydrid-batteri •
Nickel-Metallhydrid-Batterie • Batería de níquel-hidruro metálico • Pile au
nickel-métal-hydrure • Batterie all’idruro metallico di nichel •
Nikkel-metaalhydride batterij • Nickelmetallhydridbatteri
Temperature limitation • Temperaturbegrænsning • Temperaturbereich •
Limitación de la temperatura • Limite de température • Limiti di temperatura •
Temperatuurbereik • Temperaturbegränsning
Humidity limitation • Grænse for luftfugtighed • Luftfeuchtigkeitsbereich •
Limitación de la humedad • Limite d’humidité • Limiti di umidità •
Vochtigheidsbereik • Begränsning för luftfuktighet
Atmospheric pressure limitation • Grænse for atmosfærisk tryk •
Luftdruckbereich • Limitación de la presión atmosférica • Limite de pression
atmosphérique • Limiti della pressione atmosferica •
Atmosferische-drukbereik • Gräns för atmosfäriskt tryck
Lot number • Partinummer • Losnummer • Número de lote • Numéro de lot •
Numero di lotto • Partijnummer • Lotnummer
Type BF applied part • Type BF anvendt del • Anwendungsteil vom Typ BF •
Parte aplicable de tipo BF • Pièce appliquée de type BF • Parte applicata di tipo
BF • Toegepast onderdeel type BF • Applicerad del av typ BF
Do not dispose of this product in the unsorted municipal waste stream.
Dispose of this product according to local regulations. See
http://recycling.Medtronic.com for instructions on proper disposal of this
product. • Produktet må ikke bortskaffes som usorteret husholdningsaffald.
Bortskaf dette produkt i overensstemmelse med lokale love og regler. Se
http://recycling.Medtronic.com for vejledning vedrørende korrekt
bortskaffelse af dette produkt. • Dieses Produkt darf nicht mit dem
Restmüll/Hausmüll entsorgt werden. Bei der Entsorgung dieses Produkts sind
6
die einschlägigen Vorschriften zu beachten. Anweisungen zur
ordnungsgemäßen Entsorgung dieses Produkts finden Sie unter
http://recycling.Medtronic.com. • No desechar este producto en los
contenedores para residuos municipales sin clasificar. Deseche este
producto de acuerdo con la normativa local. Consulte
http://recycling.Medtronic.com para obtener instrucciones acerca de la
correcta eliminación de este producto. • Ne pas mettre ce produit au rebut
dans une décharge municipale ne pratiquant pas le tri des déchets. Respecter
la réglementation locale en vigueur en la matière. Consulter le site Web
http://recycling.Medtronic.com pour obtenir des instructions sur la mise au
rebut correcte de ce produit. • Non eliminare questo prodotto insieme ai rifiuti
solidi urbani non differenziati. Attenersi alle normative in vigore per il corretto
smaltimento. Consultare la pagina http://recycling.Medtronic.com per le
istruzioni sullo smaltimento corretto del prodotto. • Niet met het gewone
huisvuil wegwerpen. Werp dit product weg volgens de lokale
afvalverwerkingsregels. Zie http://recycling.Medtronic.com voor instructies
voor de correcte afvoer van dit product. • Kassera inte produkten bland
osorterat kommunalt avfall. Kassera produkten enligt lokala föreskrifter.
Anvisningar om hur produkten ska kasseras finns på
http://recycling.Medtronic.com.
China RoHS Standard (SJ/T11364–2006) Electronic Information Products
Pollution Control Symbol. The number represents the years the device can be
used before it must be recycled (environmental protection use period). •
Symbol for kinesisk RoHS-standard (SJ/T11364–2006) om kontrol af
forurening forårsaget af EIP-produkter (Electronic Information Products).
Tallet angiver det antal år, hvori enheden kan anvendes, før den skal
genindvindes (miljømæssigt forsvarlig anvendelsesperiode). • China RoHS
Standard (SJ/T11364–2006) Electronic Information Products Pollution
Control Symbol. Die Zahl im Kreis gibt an, wie viele Jahre das Produkt
verwendet werden kann, bevor es der Wiederverwertung zuzuführen ist
(EPUP, Environmental Protection Use Period). • Símbolo para el control de la
contaminación causada por productos de información electrónica conforme a
la norma RoHS de China (SJ/T11364–2006). El número indica los años que se
puede utilizar el dispositivo antes de que se deba reciclar (período de
utilización no perjudicial para el medio ambiente). • Symbole de la norme
RoHS chinoise (SJ/T11364–2006) sur le contrôle de la pollution due aux
produits d’information électronique. Le chiffre correspond au nombre
d’années pendant lesquelles l’appareil peut être utilisé avant d’être recyclé
(période d’utilisation sans risque pour l’environnement). • Standard RoHS
della Repubblica Popolare Cinese (SJ/T11364-2006); contrassegno per il
controllo dell’inquinamento causato dai prodotti informatici elettronici. Il
numero riportato nel simbolo indica il periodo in anni in cui il dispositivo può
essere utilizzato prima dello smaltimento (periodo di utilizzo senza danni
ambientali correlati). • Chinese RoHS-logo bij richtlijn (SJ/T11364-2006)
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betreffende beperking van het gebruik van bepaalde gevaarlijke stoffen in
elektronische apparatuur. Het cijfer staat voor de tijdsduur dat het product
milieuveilig gebruikt kan worden. • China RoHS Standard (SJ/T11364-2006)
Symbol för Electronic Information Products Pollution Control
(EIP-föroreningskontroll). Siffran anger det antal år som enheten kan
användas innan den måste återvinnas (miljöskyddad vid användning fram till
angivet datum).
Authorized representative in the European community • Autoriseret
repræsentant i Det Europæiske Fællesskab • Autorisierter Repräsentant in der
Europäischen Gemeinschaft • Representante autorizado en la
Comunidad Europea • Représentant autorisé dans la Communauté
européenne • Rappresentante autorizzato nella Comunità europea •
Geautoriseerd vertegenwoordiger in de Europese gemeenschap •
Auktoriserad representant inom EG
Contains di(2-ethylhexyl)phthalate (DEHP) • Indeholder
di(2-ethylhexyl)phthalat (DEHP) • Enthält Bis(2-ethylhexyl)phthalat (DEHP) •
Contiene di(2-etilhexil)ftalato (DEHP) • Contient du di(2-éthylhexyl)phtalate
(DEHP) • Contiene di-2-etilesilftalato (DEHP) • Bevat di(2-ethylhexyl)ftalaat
(DEHP) • Innehåller di(2-etylhexyl)ftalat (DEHP)
Symbols on the device • Symboler på enheden • Symbole auf dem Gerät • Símbolos
que aparecen en el dispositivo • Symboles figurant sur l’appareil • Simboli presenti
sul dispositivo • Symbolen op het product • Symboler på enheten
Battery indicator • Batteriindikator • Batteriestatusanzeige • Indicador de
batería • Voyant de pile • Indicatore delle batterie • Batterij-indicator •
Batteriindikator
AC power indicator • Indikator for vekselstrøm • Stromversorgungsanzeige •
Indicador de alimentación de CA • Voyant d’alimentation CA • Indicatore
dell’alimentazione CA • Netspanningsindicator • Växelströmsindikator
Store • Gem • Speichern • Guardar • Mémoire • Salva • Opslaan • Spara
Recall • Hent • Abrufen • Recuperar • Rappel • Richiama • Opvragen • Hämta
Calibrate • Kalibrér • Kalibrieren • Calibrar • Calibrer • Calibra • Kalibreren •
Kalibrera
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Contents
1 Introduction ......................................................... 11
1.1 Description ........................................................ 11
1.2 Theory of operation ................................................. 12
1.3 Indications for use .................................................. 12
1.4 Contraindications ................................................... 13
1.5 Adverse effects ..................................................... 13
1.6 Warnings and precautions ............................................ 13
2 Device description and specifications ................................. 15
2.1 Front panel ......................................................... 15
2.2 Console ........................................................... 15
2.3 Technical specifications .............................................. 16
2.4 Electromagnetic emissions and immunity declarations ................... 17
3 Setup and operation ................................................. 20
3.1 Initial setup ......................................................... 20
3.2 Visual inspection .................................................... 20
3.3 Device setup ....................................................... 21
3.4 Device self-test ..................................................... 21
3.5 System setup ....................................................... 22
3.6 Calibration ......................................................... 22
3.7 Online operation .................................................... 24
3.8 Summary of system setup, calibration, and operation .................... 25
4 Results and adjustments ............................................. 26
4.1 Oxygen saturation results ............................................ 26
4.2 Hematocrit results ................................................... 26
4.3 Offset adjustment ................................................... 26
5 Troubleshooting ..................................................... 28
5.1 Alarms and warnings ................................................ 28
5.2 Troubleshooting guide ............................................... 28
6 Cleaning and maintenance ........................................... 30
6.1 Cleaning ........................................................... 30
6.2 Maintenance ....................................................... 30
9
English
6.3 Voltage identification ................................................ 31
6.4 Batteries ........................................................... 31
6.5 Instrument inspection ................................................ 31
7 Digital output ........................................................ 33
7.1 Connecting to the data acquisition device .............................. 33
7.2 Output format ...................................................... 33
7.3 Interface format ..................................................... 34
8 Warranties .......................................................... 35
8.1 Equipment limited warranty (US) ...................................... 35
8.2 Disclaimer of warranty (US) .......................................... 36
8.3 Equipment limited warranty (OUS) ..................................... 37
8.4 Disclaimer of warranty (OUS) ......................................... 38
English
10
1 Introduction
1.1 Description
The BioTrend oxygen saturation and hematocrit system is an online monitoring instrument
that combines both venous (SvO2) and arterial (SaO2) oxygen saturation measurement with
hematocrit (Hct) measurement. The BioTrend system consists of the BioTrend instrument, 2
sensor cables, and a power cord. The BioTrend system is designed to be used with the
tri-optic measurement cells (TMC), which are disposable components available separately
with a biocompatible coating or uncoated; contact a Medtronic representative for more
information.
Using fiber optic technology, the BioTrend system continuously measures the percentage of
oxygen saturation and hematocrit and displays the results on large, easy-to-read,
color-coded light-emitting diodes (LEDs). The display panel indicates operating status and
error messages, and provides a means for system calibration.
BioTrend sensor cables connect to the BioTrend instrument and the inline TMC to transmit
optical measurement signals. The TMC is a disposable device in the extracorporeal circuit
that provides a sealed interface between the blood pathway and the BioTrend sensor cable.
Refer to Section 3.5, “System setup”, page 22, for further information regarding the TMC.
The BioTrend sensor cables isolate the patient from the instrument electronics, providing
patient protection. The BioTrend instrument contains a built-in, rechargeable battery pack to
provide the battery power. Consequently, the BioTrend instrument can operate on AC or
battery power. A continuous, built-in self-check immediately alerts the operator to
equipment failure and displays a corresponding error code.
Figure 1. BioTrend instrument
11
English
1.2 Theory of operation
It has been established that blood oxygen saturation and hematocrit can be measured using
dual wavelength light reflectance techniques. The BioTrend system uses LEDs to generate
the wavelengths required for these measurements. The light is transmitted via the fiber optic
cables through the TMC wall to the blood. The light is reflected by the blood, generating an
optical signal proportional to the percent of oxygen saturation and hematocrit. The reflected
signal is returned to the instrument by the same fiber optic cable. This signal is then
converted to an electrical signal by a photosensitive transistor. To further improve the
accuracy and repeatability of the system, the reflected signal level of each light source has
a calibration factor determined during calibration. These resulting calibration factors are
used to correct each reflected signal prior to calculating oxygen saturation and hematocrit.
Oxygen saturation accuracy has been shown to have a dependency on the hematocrit.1 The
BioTrend system compensates for this effect in the calculation of oxygen saturation.
Therefore, the oxygen saturation equation contains a hematocrit value to increase the
accuracy of the oxygen saturation value.
% Oxygen saturation = Function (KV, RATIO, HCT)
●
KV is a calibration factor
●
RATIO is the ratio of IR:R
●
HCT is the hematocrit value
●
IR is the reflected infrared light wavelength signal
●
R is the reflected visible red light wavelength signal
Hematocrit is measured using reflected infrared light from formed particles in the blood. The
reflected infrared light will be proportional to the percent of red cells in the blood.
% Hematocrit = Function (IR)
The light source is preset to an intensity that is maintained by a servo control circuit in the
BioTrend instrument. The ambient light level at the TMC is monitored and subtracted from
these signals.
1.3 Indications for use
The BioTrend oxygen saturation and hematocrit system measures the percent of oxygen
saturation and hematocrit of the blood in the extracorporeal circuit. The extracorporeal circuit
is used for, but is not limited to, cardiopulmonary bypass, closed-chest support, and limb
perfusion.
1
Schmitt JM, Mihm FG, Meindl JD. New methods for whole blood oximetry. Ann Biomed Eng. 1986;14:35-52.
12English
1.4 Contraindications
The BioTrend oxygen saturation and hematocrit system is not intended to substitute for
regular patient observation and laboratory testing. Prior to any therapeutic treatment, the
oxygen saturation and hematocrit should be determined by laboratory methods. The
BioTrend system has not been tested for magnetic resonance imaging (MRI) compatibility
and should not be used in that environment.
1.5 Adverse effects
The following adverse effects are associated with the use of this device: abrasion, burn,
electrical shock, irritation, tingling, bruise, laceration, and fracture.
1.6 Warnings and precautions
Read all warnings, precautions, and instructions for use carefully prior to use. Failure to read
and follow all instructions, or failure to observe all stated warnings, could cause serious injury
or death to the patient.
1.6.1 Warnings
●
Possible explosion hazard - do not use in the presence of flammable anesthetics or other
explosive gases.
●
Do not autoclave, sterilize, or submerge the instrument in a liquid.
●
Do not autoclave, sterilize, or submerge the sensor cables in a liquid
●
Do not autoclave or resterilize a TMC. Do not reuse a TMC.
●
Do not kink or coil the sensor cables.
●
Do not touch the optical interfaces of the instrument, sensor cables, or TMC.
●
Do not drop the instrument.
●
Do not place any object on this instrument.
●
Do not attempt any repair of the instrument.
●
The BioTrend system is a Class 1 LED product.
●
To avoid the risk of electrical shock, this equipment must only be connected to a supply
mains with protective earth.
●
Do not modify this equipment.
●
The power cord may be used to disconnect the device from electrical power. Do not
position the device so that it is difficult to remove the power cord.
●
To avoid the risk of electric shock, do not touch the patient when installing or handling the
communication port cable.
●
Pole mounting requires a pole diameter of 1.91 cm to 5.08 cm (0.75 in to 2.0 in) to ensure
secure mounting.
Note: There is a risk that the pole may tip if the center of gravity is too high.
●
A safely mounted device should allow the pole to be tilted at least 10° without tipping.
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Note: Use caution when mounting the BioTrend to mobile poles or carts to avoid tipping
or falling.
1.6.2 Precautions
●
The BioTrend oxygen saturation and hematocrit system is an online monitoring
instrument that is not intended to substitute for regular patient observation and
laboratory testing. Prior to any therapeutic treatment, the oxygen saturation and
hematocrit should be determined by laboratory methods.
●
An electrical shock hazard exists when the instrument housing is open. Refer servicing
to a qualified Medtronic service representative.
●
Oxygen saturation levels are known to be affected by fetal hemoglobin. The effect of fetal
hemoglobin on the BioTrend system has not been quantified.
●
Use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous radiation exposure.
●
It is the responsibility of the user to dispose of the devices in accordance with local
regulations and hospital procedures.
●
If the battery pack used in this device is mistreated, it may present a risk of fire or
chemical burn. Do not disassemble the device, heat it above 149°F (65°C), or incinerate
it. Replace the battery pack only with Medtronic battery pack part number
M937866A001. Use of another battery may present a risk of fire or explosion.
●
The device should only be used in a hospital environment away from sources of
high-intensity electromagnetic disturbances, such as MRI devices.
●
Power cord and serial cable length must not exceed 3.45 m (136 in).
●
Use of this device with accessories, transducers, and cables other than those specified
or provided by the manufacturer of this device could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this device and result in improper
operation.
●
Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 in) to any part of the
device, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this device could result.
●
The emissions characteristics of this device 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 device might not offer adequate protection
to radio frequency communication services. The user might need to take mitigation
measures, such as relocating or reorienting the device.
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2 Device description and specifications
2.1 Front panel
The BioTrend instrument front panel display features large, colored LEDs and sealed
touch-sensitive buttons that are splash-proof to prevent possible fluid intrusion and provide
protection to interior electronics.
Figure 2. Front panel
1 Venous oxygen saturation value (SvO2) — Blue LED
2 Hematocrit value (Hct) — Yellow LED
3 Arterial oxygen saturation value (SaO2) — Red LED
4 Battery indicator — Glows green when running on battery power and turns red when the battery
is low. The BioTrend charges the internal battery when the device is plugged into an AC power
source.
5 AC power indicator — Glows green when the device is running on AC power and flashes green
when the battery is charging. It glows red to indicate the battery is out of the acceptable
temperature range and flashes red to indicate the battery is disconnected.
6 Up/down arrows — Press to adjust stored values.
7 Store indicator light — Glows when values have been stored.
8 STORE button — Press to store SvO2, Hct, and SaO2 values for later retrieval.
9 RECALL button — Press to recall previously stored values.
10 CALIBRATE button — Press to activate the system calibration during device setup.
2.2 Console
The sides and rear of the BioTrend instrument provide easy access to connections and
features required to operate the device. A door on the bottom of the device allows easy
access to remove and replace the rechargeable batteries. Removing the battery access
door does not expose the electronics.
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Figure 3. Rear and side view
1 Dust caps — Cover the arterial/venous connectors when not in use.
2 Arterial connector — Venous connector is on the opposite side.
3 Calibration port locking tabs
4 Calibration port
5 Pole clamp knob
6 Pole clamp — Fits poles from 1.91 to 5.08 cm (0.75 to 2.0 in) in diameter.
7 Power switch — Press once to turn the instrument from standby/Off to On. Press again to turn
the instrument to standby/Off. Battery will charge in either power state when plugged into an AC
power source.
8 Power cord inlet — Power cord is hospital-grade, right-angle, and detachable.
9 Communication port
2.3 Technical specifications
Oxygen saturation range 40% to 99%
Hematocrit operating range 16% to 38%
Display update 12 s
Power 100 to 240 VAC, 50 to 60 Hz, 13.2 W, 240 mA
Power cords 100/120 VAC: Length: 3-prong, hospital-grade connector (varies
by geography) must not exceed 3.45 m (11 ft 4 in).
220/230/240 VAC: Length 2.5 m (8 ft 2 in)
Battery life 6 hours
Batteries Rechargeable nickel-metal hydride battery pack
Battery recharge 24 hours to completely recharge when connected to an AC power
source
Fuses (F1, F2) 250 V, 2A time lag, breaking capacity 50 A @ 250 VAC
Standards safety IEC 60601-1 Type BF
Standards EMC IEC 60601-1-2
Vertical pole mount Accommodates pole diameters 1.91 cm to 5.08 cm (0.75 in to
2.0 in)
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Weight 5.9 kg (13 lb)
Size (w x h x d) 24.77 cm x 9.22 cm x 27.94 cm (9.75 in x 3.63 in x 11.00 in)
Environmental limits
Operating temperature 18°C to 33°C (64°F to 92°F)
Storage temperature -20°C to 65°C (-4°F to 149°F)
Operating humidity 10% to 90%, noncondensing
Storage humidity 5% to 95%, noncondensing
Operating pressure 73 kPa to 101 kPa
Storage pressure 73 kPa to 101 kPa
Classification (IEC 60601-1) Class I or internally powered
Type BF
Splash proof
Intermittent operation
Not anesthetic proof
LEDs Class 1 LED product per IEC 60825-1 (A2:2001)
Maximum power output: 390 µW
Pulse duration: 200 µs period, 50% duty cycle
2.4 Electromagnetic emissions and immunity declarations
IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard: Electromagnetic
disturbances – Requirements and tests – Class A, Group 1
Caution: The device should only be used in a hospital environment away from sources of
high-intensity electromagnetic disturbances, such as MRI devices.
Caution: Power cord and serial cable length must not exceed 3.45 m (11 ft 4 in).
Caution: Use of this device with accessories, transducers, and cables other than those
specified or provided by the manufacturer of this device could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this device and result
in improper operation.
Caution: Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the
device, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this device could result.
Caution: The emissions characteristics of this device 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 device might not offer adequate protection to
radio frequency communication services. The user might need to take mitigation measures,
such as relocating or reorienting the device.
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Table 1. IEC 60601-1-2 table 4 – enclosure port
Phenomenon
Basic EMC standard
or test method
Electrostatic discharge IEC 61000-4-2 ±8 kV contact
Radiated RF EM fields IEC 61000-4-3 3 V/m
Proximity fields from RF wire-
IEC 61000-4-3 See IEC 60601-1-2 table 9 (Table 4)
less communications equipment
Rated power frequency mag-
IEC 61000-4-8 30 A/m
netic fields
Immunity test levels
Professional healthcare facility
environment
±2 kV, ±4 kV, ±8 kV, ±15 kV air
80 MHz – 2.7 GHz
80% AM at 1 kHz
50 Hz or 60 Hz
Table 2. IEC 60601-1-2 table 5 – input AC power port (1 of 2)
Phenomenon
Basic EMC standard
or test method
Electrical fast transients / bursts IEC 61000-4-4 ±2 kV
Surges, line-to-line IEC 61000-4-5 ±0.5 kV, ±1 kV
Surges, line-to-ground IEC 61000-4-5 ±0.5 kV, ±1 kV, ±2 kV
Conducted disturbances
IEC 61000-4-6 3 V
induced by RF fields
IEC 61000-4-11 0% UT; 0.5 cycle
Voltage dips
Voltage interruptions IEC 61000-4-11 0% UT; 250/300 cycle
a
Significant power loss may cause the device to shut off.
Immunity test levels
Professional healthcare facility
environment
100 kHz repetition frequency
0.15 MHz – 80 MHz
6 V in ISM bands between 0.15 MHz
and 80 MHz
80% AM at 1 kHz
At 0°, 45°, 90°, 135°, 180°, 225°, 270°
and 315°
0% UT; 1 cycle
and
70% UT; 25/30 cycles
Single phase: at 0°
a
Table 3. IEC 60601-1-2 table 8 – signal input/output parts port
Phenomenon
Basic EMC standard
or test method
Electrostatic discharge IEC 61000-4-2 ±8 kV contact
Electrical fast transients / bursts IEC 61000-4-4 ±2 kV
Immunity test levels
Professional healthcare facility
±2 kV, ±4 kV, ±8 kV, ±15 kV air
100 kHz repetition frequency
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environment
Table 3. IEC 60601-1-2 table 8 – signal input/output parts port (continued)
Phenomenon
Surges, line-to-ground IEC 61000-4-5 ±2 kV
Conducted disturbances
induced by RF fields
Basic EMC standard
or test method
IEC 61000-4-6 3 V
Immunity test levels
Professional healthcare facility
environment
0.15 MHz – 80 MHz
6 V in ISM bands between 0.15 MHz
and 80 MHz
80% AM at 1 kHz
Table 4. IEC 60601-1-2 table 9 – test specifications for enclosure port immunity to RF wireless communications equipment
Test fre-
quency
(MHz )
385 380–390 TETRA 400 Pulse modulation
450 430–470 GMRS 460,
710
780
810 800–960 GSM 800/900,
870
930
1 720 1 700–1 990 GSM 1800;
1 845
1 970
2 450 2 400–2 570 Bluetooth,
5 240 5 100–5 800 WLAN 802.11
5 500
5 785
Band
(MHz )
704–787
Service Modulation Maxi-
18 Hz
FM
FRS 460
LTE Band 13,
17
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25;
UMTS
WLAN
802.11 b/g/n,
RFID 2450,
LTE Band 7
a/n
±5 kHz deviation
1 kHz sine
Pulse modulation
217 Hz
Pulse modulation
18 Hz
Pulse modulation
217 Hz
Pulse modulation
217 Hz
Pulse modulation
217 Hz
Dis-
mum
power
(W )
1.8 0.3 27
2 0.3 28
0.2
2 0.3 28
2 0.3 28
2
0.2 0.3 9
tance
(m )
0.3 9745
0.3 28
Immun-
ity test
level
(V/m )
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3 Setup and operation
Each BioTrend system has been fully tested prior to shipment and should be used only in
accordance with the procedures detailed in this manual. The BioTrend instrument must be
used with Medtronic TMCs only. Any substitution will void performance claims and warranty.
3.1 Initial setup
The BioTrend instrument is packaged with 2 sheets containing stickers to customize the front
panel English text to a different language.
1. Wipe the area clean of any debris or dried fluids. See the cleaning instructions
(Section 6.1, “Cleaning”, page 30).
2. Select and peel the desired sticker.
3. Apply the sticker over the existing front panel text.
a. Align the sticker to the bottom and right edge of the front panel before applying.
b. Press down fully to prevent an uneven surface and to ensure that the sticker is firmly
attached to the front panel.
4. Retain the extra stickers if a different language is desired in the future.
Figure 4. Apply sticker
3.2 Visual inspection
1. Visually inspect the BioTrend instrument and sensor cables for external signs of
damage or wear before operation. The sensor cables can be used interchangeably on
either the venous or arterial connectors.
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2. Inspect the TMC sterile packaging before opening. If the sterile seal has been broken,
do not use. Follow the labeling on the TMC package.
3. Read and understand this manual completely before operating the BioTrend system.
3.3 Device setup
1. Mount the BioTrend instrument on a sturdy IV pole or pump console pole, using the
integrated pole clamp feature. The BioTrend instrument may also be placed on a sturdy
table or stand.
2. To operate on AC power, connect the power cord to the AC power inlet located on the
rear of the device. Connect the power cord to a grounded hospital-grade outlet.
Note: Ensure that the outlet used is appropriate for the BioTrend instrument
(Section 6.3, “Voltage identification”, page 31).
3. For maximum battery operation, the BioTrend instrument should be connected to a
grounded AC power source for 24 hours prior to operation on battery.
Figure 5. Cable connections
1 Arterial or venous connector
2 Arterial or venous connector dust cap
3 Sensor cable plug
4 Sensor optical cable
5 Sensor cable dust cap
6 Sensor cable knob
7 Power cord inlet
3.4 Device self-test
1. When turned to On, the BioTrend instrument will automatically run a sequence of
diagnostic tests to determine the operational capabilities.
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2. All regions and segments of the display will be illuminated during the power-up period
for approximately 3 seconds. The battery indicator will change from red to green
halfway through the power-up sequence. If all regions and segments do not illuminate,
call a Medtronic service representative for assistance.
3. When the self-test is completed, the word “CAL” and the software revision (in this case,
2.0.0) will appear on the front panel display as follows:
This indicates that the operator may proceed.
3.5 System setup
1. Turn on the BioTrend instrument for a 20 min warmup period (note display as indicated
in Section 3.4, “Device self-test”, page 21 ).
2. Place 1 or 2 TMCs into the extracorporeal circuit using sterile technique. The venous
TMC should be placed in the venous line before the oxygenator and the arterial TMC
should be placed in the arterial line after the oxygenator. The TMC should be installed
into the extracorporeal circuit prior to priming.
Note: The TMC is provided with a protective label over the optical window. This label is
to protect the TMC window during installation into the extracorporeal circuit and should
be removed prior to the TMC being connected to the BioTrend sensor cable.
3. Remove the dust caps from the BioTrend instrument arterial and venous connectors.
4. Align the sensor cable plug with the slotted arterial or venous connector. Turn the plug
clockwise to lock it in place.
3.6 Calibration
Note: The system calibration must be performed every time a setup is initiated. To perform
subsequent calibrations, the instrument must be turned off, then back on.
Note: When using 2 BioTrend sensor cables, they must be calibrated simultaneously.
Note: Do not kink or disturb the BioTrend sensor cables during calibration.
1. Remove the sensor cable dust caps. Attach the sensor cable knobs to the calibration
ports to perform calibration. Align the slots on the knob with the calibration port locking
tabs (1 is larger than the other to ensure proper alignment). Press and rotate the knob
clockwise until it locks in place.
2. The display message will read “CAL” and the software revision (in this case, 2.0.0):
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3. Press and hold the CALIBRATE button until the display reads “CAL.”
This indicates that calibration is in process.
4. When the calibration is completed (using both sensor cables) the display message will
become:
Note: If only 1 VENOUS or ARTERIAL sensor cable is being used or if 1 sensor cable
fails to calibrate, the display message for that channel will become blank (example
using only the venous sensor cable):
Note: If both VENOUS and ARTERIAL channels fail to calibrate, the display message
will return to “CAL” and the software revision (in this case, 2.0.0):
Refer to Section 5.2, “Troubleshooting guide”, page 28 for possible causes of sensor
cable calibration problems.
Note: If calibration fails, reseat the sensor cables and cycle instrument power to
recalibrate.
5. The BioTrend instrument will automatically enter the run mode at the end of the
calibration mode. The displayed message will become dashed lines when entering the
run mode:
Note: Dashed lines will continue to be displayed until the sensor cables are connected
to the extracorporeal circuit, and blood is present in the circuit.
6. Disconnect the sensor cables from the calibration ports by turning the sensor cable
knob counterclockwise until disengaged.
Caution: Do not remove the sensor cables from the arterial/venous connectors without
recalibrating the instrument. This can lead to significant errors.
Note: Do not swap the sensor cables after calibration (always calibrate the arterial
connector with the arterial calibration port and apply the sensor cable to the arterial
line).
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3.7 Online operation
1. Remove the protective label from the TMCs. Ensure that the cell window is free from
defects and smudges. Replace the TMC if the cell window has defects. Clean the cell
window with a nonabrasive cloth if smudges are present.
2. Connect the venous sensor cable to the TMC in the venous line, and connect the
arterial sensor cable to the TMC in the arterial line. Align the slots on the sensor cable
to the locking tabs on the TMC and rotate the connector knob until it locks into position.
Caution: The system will operate effectively with only 1 TMC connected, but the dust
cap for the unconnected cable must be in place, either on the instrument (if no sensor
cable is attached) or on the end of the idle sensor cable (if it is attached to the
instrument).
3. If numbers are displayed on the unconnected saturation display, check the dust caps for
proper attachment.
Warning: Do not kink or coil the sensor cables after calibration as this can significantly
affect accuracy. For optimal accuracy, the bend radius of the optical cables should be
minimized and consistent with the relative position used during calibration.
4. After initiation of blood flow, allow the oxygen saturation and hematocrit readings to
stabilize for 30 s.
Caution: Invalid values may be displayed until blood and priming fluid are
homogenous.
Note: The display may show dashed lines until blood is flowing in the extracorporeal
circuit.
Note: When both arterial and venous sensor cables are used, the hematocrit reading
is taken from the arterial side.
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Figure 6. Tri-optic measurement cell and sensor cable
1 TMC
2 Sensor cable knob
3.8 Summary of system setup, calibration, and operation
1. Turn on the instrument and allow for a 20 min warm-up period.
2. Remove the dust caps from all of the sensor connections that will be used.
3. Insert the TMCs into the circuit.
4. Attach the sensor cable to the instrument.
5. Calibrate the instrument:
a. Connect the cables to the calibration ports.
b. Press and hold the CALIBRATE button to initiate the calibration process.
c. Remove the cables from the calibration ports.
6. Remove the protective labels from the TMCs.
7. Connect the cables to the TMCs in the circuit.
8. Allow readings to stabilize for 30 s after the start of blood flow.
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4 Results and adjustments
The BioTrend system is an online monitoring instrument and is not intended to substitute for
regular patient observation and laboratory testing. Prior to any therapeutic treatment, the
oxygen saturation and hematocrit should be determined by laboratory methods.
The BioTrend system performance ranges at nominal physiological conditions:
Oxygen saturation: 40% to 99%
Hematocrit: 16% to 38%
Note: When the instrument reaches the range limits, the display will flash these values.
4.1 Oxygen saturation results
The displayed SaO2 and SvO2 values will flash “40” or “99” if oxygen saturation falls outside
the range limits.
4.2 Hematocrit results
Hemodilution occurs when initiating an extracorporeal support circuit, which decreases the
hematocrit. This decrease in hematocrit will be proportional to the dilution ratio of the blood.
Caution: Prior to blood transfusion or other therapeutic treatments, the hematocrit should
be determined by laboratory methods.
Hematocrit should not decrease below accepted standards established by the institution.
Hct display values will flash at 12%, 13%, 14%, 15%, 16%, 38%, 39%, and 40%.
When the Hct range limits of 12% and 40% are exceeded, the front panel display will indicate
dashes:
4.3 Offset adjustment
Users should read and understand the Hct and SO2 correlation (described in this section)
completely before utilizing offset adjustment as this feature is timed to button activity.
Note: This is an optional feature. The BioTrend instrument allows the user to adjust none, 1,
or all of the displayed values. Normal operation of the BioTrend instrument is not dependent
on using this feature.
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Note: If using the offset feature, it is recommended that more than 1 lab sample be
considered when an adjustment is made.
1. Initiate the normal calibration procedure as described in Section 3.6, “Calibration”,
page 22.
2. The BioTrend system enters normal run mode.
3. Press the STORE button at the same time the sample is drawn and sent to lab. This
action stores all presently displayed values.
Note: The Store indicator light will illuminate indicating that a value has been stored.
4. SvO2, SaO2, and Hct will remain active, displaying current values.
5. Receive the sample results from the lab.
Hct correlation
6. Press the RECALL button 1 time to retrieve the stored Hct value.
7. Both of the SO2 displays will become blank, leaving only the Hct display visible.
8. Press the Up arrow to increase the Hct value or press the Down arrow to decrease the
Hct value to match the lab reference result.
SO2 correlation
9. Press the RECALL button again. The Hct and SaO2 displays will become blank, leaving
only the previously stored SvO2 value visible. The perfusionist can now increase or
decrease this value.
10. If the RECALL button is pressed a third time, the SvO2 and Hct displays will become
blank, leaving the previously stored SaO2 value visible. The perfusionist can now adjust
this value.
Note: After approximately 15 s of no button activity, the BioTrend instrument returns to
run mode and the Store light turns off. Values previously stored when the sample was
sent to the lab will no longer be available. Any adjustments made will be captured as the
instrument returns to the run mode.
Note: If there is no arterial (SaO2) side cable attached, pressing the RECALL button will
only cycle between the Hct and SvO2 displays. Conversely, if there is no venous (SvO2)
side cable attached, pressing the RECALL button will only cycle between the Hct and
SaO2 displays.
11. To return to run mode, wait 15 s. Pressing the RECALL button again will display the Hct
value again.
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5 Troubleshooting
5.1 Alarms and warnings
The alarms in the BioTrend instrument are visually displayed messages. The messages are
presented when conditions are detected that may affect the operation of the instrument.
Low battery
The battery indicator turns red when the battery is nearly depleted and approximately 30 min
remain before the system will stop operation. The actual time remaining will depend on the
condition and age of the batteries. Return the unit to AC power to discontinue the warning
and recharge the batteries.
Error codes
An error is indicated when the system detects an abnormal function that may compromise
the measured results. In these cases an alphanumeric error message will be shown in the
display area.
Warning: The instrument must be returned for repair when 1 of these error messages
occurs. Do not attempt any repair of the instrument.
Warning: Should the BioTrend instrument be dropped or otherwise damaged, it is important
to contact a Medtronic service representative immediately to return the instrument for
service.
Note: Record the alphanumeric error message and contact a Medtronic service
representative.
5.2 Troubleshooting guide
Note: When returning the BioTrend instrument to Service, the sensor cables must be
included to ensure proper diagnosis and repair.
Problem Cause Correction
Display not illuminated. Instrument power not turned on. Turn the power switch (located on
back of instrument) to the On
position.
Instrument turned On, but
display is not illuminated.
Instrument battery supply is discharged.
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Plug the power cord into the AC
outlet and charge the batteries.
Problem Cause Correction
Instrument will not calibrate. Calibration signal is outside of
acceptable limits.
Display shows “Err_ _” in
value windows.
Low Battery indicator Internal battery charge is deple-
Internal instrument failure. Return the instrument for repair.
ted.
1. Check the connections of
the sensor cable.
2. Hold 1 end of the sensor
cable toward light, observe
the other end of the cable for
light transmission through
all fibers.
3. Change or remount the
cable and attempt calibration again.
4. Contact a Medtronic service
representative.
Contact a Medtronic service representative.
Plug the power cord into a hospital-grade outlet.
Note: In all events, should the suggested correction not prove effective, contact a Medtronic
service representative for assistance.
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6 Cleaning and maintenance
Periodic maintenance is recommended to ensure accurate performance and reliability.
Note: Service on the BioTrend instrument, except for battery recharging or replacement,
should be referred to qualified Medtronic service personnel. Refer to the manual for
instructions regarding battery replacement.
6.1 Cleaning
The BioTrend instrument is designed to be spill resistant. If a spill should occur, follow the
cleaning guidelines below.
Warning: Do not sterilize the instrument or immerse it in fluids.
Caution: Do not use alcohol on the sensor cable ends (where the fiber ends are exposed).
●
Unplug the instrument before cleaning to avoid electrical shock.
●
Do not use chemical solvents such as methyl ethyl keone, alcohol, ether, acetone, or
acid-based solutions in or on any part of the instrument, as such solvents may be
destructive to the device and its internal components. Do not use abrasive cleaners or
cleaning solvents other than those recommended in this manual.
●
All external surfaces can be easily cleaned and disinfected for blood, saline, or other
spilled contaminants using normal medical equipment cleaners and disinfectants such
as bleach (5.25%) and hydrogen peroxide (3%).
●
Clean the instrument with a sponge or soft cloth moistened with water or a mild
detergent.
●
After the instrument is cleaned, wipe the unit with a cloth moistened with water to remove
any cleaning solution residue and then wipe the unit with a dry cloth.
6.2 Maintenance
All maintenance or service should be performed by a qualified Medtronic service
representative. Contact a local Medtronic representative for assistance.
Have a trained service person replace the battery.
Note: The dust covers should be kept attached to the instrument connectors and sensor
cable ends when not in use.
Important: When returning the BioTrend instrument for repair, the sensor cables must be
included to ensure proper diagnosis and repair.
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