Riester ri-fox N User manual

OPERATOR’S MANUAL
Pulse Oximeter ri-fox N
ENGLISH

General Description
Oxygen Saturation is a very important parameter for the Respiratory Circulation
System. Many respiratory diseases can result in oxygen saturation being lowered in
human blood. Additionally, the following factors can reduce oxygen saturation: organ
dysfunction caused by anesthesia, intensive postoperative trauma, injuries caused by
some medical examinations. That situation might result in light-headedness, asthenia,
and vomiting. Therefore, it is very important to know the oxygen saturation of a patient
so that doctors can nd problems in a timely manner.
The fingertip pulse oximeter ri-fox N features small size, low power consumption,
convenient operation and portability. It is only necessary for a patient to put one of his
ngers into the ngertip photoelectric sensor for diagnosis, and a display screen will
show oxygen saturation. It has been proven in clinical experiments that it also features
high precision and repeatability.
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Product Operation Scope
Technical Specications
ri-fox N is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin
(SpO2) and pulse rate of adult and pediatric patients at home and hospital (including
clinical use in internal medicine/surgery, anesthesia, etc). The device is not intended for
continuous monitoring.
The ri-fox N requires no routine calibration or maintenance other than replacement of
batteries.
1. Display: LED
2. SpO2:
Measurement range: 70~100%
Accuracy: 70% ~ 100%, ±2%; <70% no denition
3. Pulse Rate:
Measure range: 30~235 bpm
Accuracy: 30~100bpm ±2bpm; 101~235bpm, ±2%
Pulse Intensity: Bar graph Indicator
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4. Power Requirements:
Two AAA alkaline Batteries
Power consumption: Less than 30mA
Low power indication:
Battery Life: Two AAA 1.5V, 800mAh alkaline batteries could be continuously
operated as long as 30 hours.
5. Dimension:
Length: 66mm
Width: 39mm
Height: 32mm
Weight: 34g (without batteries)
6. Environment Requirements:
Operation Temperature: 5°C~40°C
Storage Temperature: -20~55°C
Ambient Humidity: ≤80%, no condensation in operation;
≤93%, no condensation in storage
7. Measurement Performance in Low Perfusion Condition: The pulse wave is
available without failure when the simulation pulse wave amplitude is at 0.6% using
the test equipment (Biotek Index Pulse Oximeter Tester).
8. Interference Resistance Capacity against Ambient Light: Device works normally
when mixed noise produced by Biotek Index Pulse Oximeter Tester.
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1. Do not use the pulse oximeter in an MRI or CT environment
2. Do not use the pulse oximeter in situations where alarms are required. The device
has no alarms.
3. Explosion hazard: Do not use the pulse oximeter in an explosive atmosphere.
4. The pulse oximeter is intended only as an adjunct in patient assessment. It must be
used in conjunction with other methods of assessing clinical signs and symptoms.
5. Check the pulse oximeter sensor application site frequently to determine the
positioning of the sensor and circulation and skin sensitivity of the patient.
6. Before use, carefully read the manual.
7. ri-fox N has no SpO2alarms; it is not for continuous monitoring, as indicated by the
symbol.
8. Prolonged use or the patient’s condition may require changing the sensor site
periodically. Change sensor site and check skin integrity, circulatory status, and
correct alignment at least every 4 hours.
Precautions for use
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9. Inaccurate measurements may be caused by autoclaving, ethylene oxide sterilizing,
or immersing the sensors in liquid may cause inaccurate readings.
10. SpO2measurements may be adversely affected in the presence of high ambient
light. Shield the sensor area if necessary.
11. Excessive patient movement may cause inaccurate readings.
12. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter,
or intravascular line may cause inaccurate readings.
13. Fingernail polish or false ngernails may cause inaccurate SpO2readings.
Contraindication
14. Signicant levels of dysfunctional hemoglobins (such as carbonxy-hemoglobin or
methemoglobin) may cause inaccurate readings
15. Intravascular dyes such as indocyanine green or methylene blue may cause
inaccurate readings
16. Venous pulsations may cause inaccurate readings.
17. Hypotension, severe vasoconstriction, severe anemia or hypothermia may cause
inaccurate readings.
18. Cardiac arrest or shock may cause inaccurate readings.
No side effects known
Follow local ordinances and recycling instructions regarding disposal or
recycling of the device and device components, including batteries.
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1. Easy to use.
2. Small in volume, light in weight.
3. Low power consumption.
4. Low voltage warning will be indicated in visual window when battery voltage is low.
5. The product will automatically be powered off when no signal is registered for longer
than 8 seconds.
1. Install two AAA batteries into the battery cassette, and then close its cover.
2. Open the clamp as shown in the picture below.
3. Insert one nger completely into the opening of the pulse oximeter.
4. Press the power switch once on the front panel.
5. The patient’s nger should remain still while the pulse oximeter is working.
6. Read corresponding data from display screen.
When you insert a nger into the Oximeter,
your nail surface must be upward.
Product specications
Operation Instructions
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The Pulse Bar graph displays the strength of the pulse rate signal. The height of the
bar graph shows the patient’s pulse strength.
1. Put the two AAA batteries into battery cassette in correct
polarities.
2. Press the button down along the arrow and push the
battery cover shown as below:
Brief Description of Front Panel
Battery Installation
Pulse Bar graph
Pulse low indicator
Oxygen Saturation
Pulse Rate
Press the button down!
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%SpO2
PR BPM

1. Replace batteries in time when low voltage lamp is lighted.
2. Clean surface of the ri-fox N before it is used in diagnosis for patients.
3. Remove batteries inside the battery cassette if the oximeter will not be used for a
long time.
4. It is best to preserve the product in a place where ambient temperature is –20~55°C
and humidity is <93%, no condensation.
5. It is recommended that the product should be kept in a dry environment anytime. A
wet ambient might affect its lifetime and even might damage the product.
6. Please follow the law of the local government to deal with used batteries.
1. The functional tester cannot be used to assess the accuracy of the oximeter.
2. The test method used to establish the SpO2accuracy is clinical testing. The
oximeters used to measure the arterial haemoglobin oxygen saturation levels are
compared to the levels determined from arterial blood sampling with a CO-oximeter.
3. Index 2 that is made by Biotek company is a function tester. Set Tech to 1, R curve
to 2, and then users can use this particular calibration curve to measure the
oximeter.
Maintenance and Storage
Calibrating the Oximeter
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EMC of this product complies with IEC60601-1-2 standard. Portable and mobile high
frequency appliances can influence medical electronic devices. Medical electronic
devices need special safety requirements concerning EMC. You may nd a detailed
description of the manufacturers EMC declaration at the end of this user manual.
The materials which the user can come into contact have no toxicity and no action on
tissues, comply with ISO10993-1, ISO10993-5 and ISO10993-10.
Declaration
Guidance and manufacture’s declaration – electromagnetic emissions-for all
EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
RF emissions
CISPR 11
RF emission
CISPR 11
Group 1
Class B
The ri-fox N uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
The ri-fox N is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Emission test Compliance Electromagnetic environment – guidance
The ri-fox N is intended for use in the electromagnetic environment specied below. The
customer or the user of the ri-fox N should assure that it is used in such and environment.
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Possible Problems and resolutions
SpO2or PR
can not be
shown normally
Problems Possible reason Solution
SpO2or PR is
shown unstably
The Oximeter
can not be
powered on
Indication
lamps are
suddenly off
“Error3”or
“Error4” is
displayed on
screen.
1.Finger is not plugged correctly
2.Patient’s Oxyhemoglobin value is
too low to be measured.
1.Finger might not be plugged
deeply enough.
2.Finger is trembling or patient’s
body is in movement status.
1.Power of batteries might be
inadequate or not be there at all.
2.Batteries might be installed
incorrectly.
3.The Oximeter might be damaged.
1.The product is automatically
powered off when no signal is
detected longer than 8 seconds
2. Lower power
1.Low power
2.Mechanical malfunction for
receive-emission tube
3. Amp circuit malfunction.
1. Retry by plugging the nger.
2. Try some more times, If you
can make sure about no problem
existing in the product. Please go
to a hospital for exact diagnosis.
1.Retry by plugging the nger.
2.Try not to move.
1.Please replace batteries
2.Please reinstall the batteries
3.Please contact with local customer
service centre.
1.Normal
2.Replace the batteries
1.Change batteries.
2.Please contact the local customer
service center.
3.Please contact the local customer
service center.
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Symbol Denitions
Symbol Denition
Type BF applied part
Attention, consult accompanying documents.
Oxygen saturation
Pulse rate (BPM)
Low power indication
NOT for continuous monitoring
Serial No.
Note:
The illustrations used in this manual may differ slightly from the appearance of
the actual product.
%SpO2
SN
PR BPM
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Disinfection
Warranty
Please use medical alcohol to clean the plastic material touching the nger inside of
the pulse oximeter, and clean the test sensor using alcohol before and after operation.
This product has been manufactured under the strictest quality standards and has
undergone a thorough nal quality check before leaving our factory. We are therefore
pleased to be able to provide a warranty of 30 months from the date of purchase on all
defects, which can veriably be shown to be due to material or manufacturing faults.
A warranty claim does not apply in the case of improper handling. All defective parts of
the product will be replaced or repaired free of charge within the warranty period. This
does not apply to wearing parts.
Please remember that all warranty claims have to be made during the warranty period.
We will, of course, be pleased to carry out checks or repairs after expiry of the warranty
period at a charge. You are also welcome to request a provisional cost estimate from
us free of charge. In case of a warranty claim or repair, please return the RIESTER
product to your dealer.
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Gebrauchsanweisung
ri-fox N Pulsoximeter
DEUTSCH

Allgemeine Beschreibung
Die Sauerstoffsättigung ist ein sehr wichtiger Parameter des Atmungs- und
Kreislauf-Systems. Viele Atemwegserkrankungen können zu einer Abnahme der
Sauerstoffsättigung des menschlichen Bluts führen. Darüber hinaus kann die
Sauerstoffsättigung durch folgende Faktoren reduziert sein: eine Organ-Dysfunktion
infolge von Anästhesie, ein postoperatives Trauma oder Verletzungen, die als Folge
einiger medizinischen Untersuchungen auftreten können. In solch einer Situation
kann es zu Benommenheit, Schwächeanfällen und Erbrechen kommen. Daher ist es
für Ärzte sehr wichtig, die Sauerstoffsättigung eines Patienten zu kennen, damit sie
eventuelle Probleme rechtzeitig erkennen können.
Das Finger-Pulsoximeter ri-fox N ist klein, mobil, hat einen geringen Energieverbrauch
und lässt sich leicht bedienen. Zur Diagnose muss der Patient lediglich einen
seiner Finger in den fotoelektrischen Fingerspitzen-Sensor stecken, und die
Sauerstoffsättigung wird auf dem Display angezeigt. Die hohe Präzision und
Reproduzierbarkeit der Messung mit dem Gerät wurde in klinischen Experimenten
nachgewiesen.
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Anwendungsbereich des Produkts
Technische Daten
Das ri-fox N Pulsoximeter ist ein tragbares, nicht invasives Gerät für die Vor-Ort-
Kontrolle der Sauerstoffsättigung des arteriellen Hämoglobins (SpO2) und der
Pulsrate bei erwachsenen und pädiatrischen Patienten; es ist für den Einsatz zu
Hause und im Krankenhaus geeignet (inklusive der klinischen Anwendung in der
Inneren Medizin, Chirurgie, Anästhesie etc.). Das Gerät ist nicht für die kontinuierliche
Patientenüberwachung vorgesehen.
Außer des Batterieaustauschs erfordert das ri-fox N Pulsoximeter im Routinebetrieb
keine Kalibrierung oder Wartung.
1. Display: LED
2. SpO2:
Messbereich: 70–100 %
Genauigkeit: ± 2 % (im Bereich 70–100 %); bei < 70 % nicht bestimmt
3. Pulsrate:
Messbereich: 30–235 min–1
Genauigkeit: ±2 min–1 im Bereich 30–100 min–1 bzw.
±2 % im Bereich 101–235 min–1
Pulsintensität: Leuchtbalkenanzeige
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4. Energiebedarf:
zwei Alkali-Batterien, Typ AAA
Stromverbrauch: < 30 mA
Warnanzeige bei zu niedriger Spannung:
Batterie-Lebensdauer: Mit zwei AAA-Alkalibatterien (1,5 V; 800 mAh) kann das Gerät
bis zu 30 Stunden ohne Unterbrechung betrieben werden.
5. Abmessungen:
Länge: 66 mm
Breite: 39 mm
Höhe: 32 mm
Gewicht: 34 g (ohne Batterien)
6. Umgebungsbedingungen:
Betriebstemperatur: 5–40 °C
Lagerungstemperatur: –20 bis +55 °C
Luftfeuchtigkeit: ≤80 %, kondensationsfrei (im Betrieb);
≤93 %, kondensationsfrei (bei Lagerung)
7. Messleistung bei schwacher Durchblutung: Die Pulswelle wird störungsfrei
detektiert, wenn bei Verwendung des Testgeräts (Biotek Index Pulse Oximeter
Tester) die Amplitude der Simulations-Pulswelle 0,6 % beträgt.
8. Störsicherheit gegenüber Umgebungslicht: Das Gerät funktioniert bei Einwirkung
des vom Testgerät (Biotek Index Pulse Oximeter Tester) erzeugten Störsignals normal.
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Vorsichtshinweise für den Gebrauch
1. Das Pulsoximeter nicht im Bereich einer MRT- oder CT-Anlage verwenden.
2. Das Pulsoximeter nicht verwenden, wenn eine Alarmvorrichtung erforderlich ist. Das
Gerät hat keine Alarm-Funktion.
3. Explosionsgefahr: Das Pulsoximeter nicht in explosionsfähiger Atmosphäre
verwenden.
4. Das Pulsoximeter ist als Hilfsmittel bei der Beurteilung eines Patienten vorgesehen.
Es darf nur in Verbindung mit anderen Methoden zur Beurteilung klinischer Zeichen
und Symptome eingesetzt werden.
5. Überprüfen Sie häuger die Applikationsstelle des Pulsoximetersensors, um die
Sensorposition sowie Kreislauf und Hautempndlichkeit des Patienten zu
kontrollieren.
6. Lesen Sie die Bedienungsanleitung vor Gebrauch aufmerksam durch.
7. Das ri-fox N Pulsoximeter hat keine SpO2-Alarm-Funktion; es ist nicht für die
kontinuierliche Überwachung geeignet, wie durch das entsprechende Symbol
angezeigt.
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8. Bei längerem Gebrauch oder je nach Zustand des Patienten kann ein regelmäßiger
Wechsel der Sensor-Applikationsstelle erforderlich sein. Wechseln Sie spätestens
alle 4 Stunden die Applikationsstelle und kontrollieren Sie dabei die Unversehrtheit
der Haut, den Kreislauf und die korrekte Position des Sensors.
9. Ungenaue Messungen oder verfälschte Messwerte können durch Autoklavieren,
Sterilisieren mit Ethylenoxid oder Eintauchen der Sensoren in Flüssigkeiten
verursacht werden.
10. SpO2-Messungen können durch sehr helles Umgebungslicht ungünstig beeinusst
werden. Falls erforderlich, schirmen Sie den Sensorbereich ab.
11. Häuge Bewegungen des Patienten beeinträchtigen die Genauigkeit der Messung.
12. Platzierung eines Sensors an einer Extremität mit Blutdruck-Manschette, arteriellem
Katheter oder IV-Leitung kann zu ungenauen Messwerten führen.
13. Nagellack oder künstliche Fingernägel können ungenaue SpO2-Messungen
verursachen.
Kontraindikation
14. Signikant erhöhte Konzentration an dysfunktionalen Hämoglobinen (wie Carboxy-
oder Methämoglobin) können die Ursache für ungenaue Messwerte sein.
15. Intravaskuläre Farbstoffe wie Indocyanin-Grün oder Methylenblau können die
Messwerte ebenfalls verfälschen.
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