Sentec OxiVenT OV-N, OxiVenT OV-A, OxiVenT OV-P Directions For Use Manual
OxiVenT™ Sensor
REF OV-A/P/N
Carbon Dioxide Tension, Oxygen Tension and
Oxygen Saturation Sensor
Reusable / Nonsterile / Waterproof
Directions for Use
Introduction
SenTec’s OxiVenT™ Sensor is intended for continuous PCO2, PO2, SpO2/PR
monitoring.
The OxiVenT™ Sensor provides superior performance, is robust, reliable and
requires comparatively low maintenance. It combines within a patented digital
sensor design the optical components needed for 2-wavelength, reflectance
pulse oximetry with the components needed to measure PCO
Indications/Contraindications
The OxiVenT™ Sensor (REF OV-A/P/N) is indicated for use when continuous
non-invasive monitoring of carbon dioxide tension, oxygen tension, oxygen
saturation, and pulse rate are required for adult and pediatric patients. In
neonatal patients the use of the OxiVenT™ Sensor is indicated for carbon
dioxide tension and oxygen tension monitoring only. Oxygen tension monitoring
is contraindicated for patients under gas anesthesia. The OxiVenT™ Sensor
is for use only with SenTec instruments and instruments that contain SenTec
monitoring technology or are licenced to use SenTec sensors (SenTeccompatible instruments).
Instructions for use
Preparation - Membrane change
The membrane and the electrolyte of the OxiVenT™ Sensor must be changed
regularly. The monitor requests a membrane change if required. Additionally,
the membrane of the sensor must be changed if it is damaged, does not have
a tight fit, or if there is trapped air or dry electrolyte under the membrane. For
further information refer to the Instruction Manual for the SDMS, the Membrane
Changer Directions for Use for detailed membrane change instructions, and the
Technical Manual for the SDM or contact the manufacturer of the instrument.
Preparation - Calibration
The PCO2 segment and - less frequent - the PO2 segment of the OxiVenT™
Sensor must be calibrated regularly. Between monitoring it is recommended to
store the sensor in the docking station. This will ensure that the sensor is ready
for use, as the sensor will automatically be calibrated as needed. For further
information refer to the Instruction Manual for the SDMS and the Technical
Manual for the SDM or contact the manufacturer of the instrument.
Patient Application of the OxiVenT™ Sensor
The choice of the sensor attachment accessory depends on the patient’s age,
the parameters to be measured and the skin condition at the measurement
site. For additional information and detailed sensor application directions please
refer to the Instruction Manual for the SDMS or the Quick Reference Guide
of the SDMS or - in case of use with a SenTec-compatible instrument - to the
instrument’s manual or contact the manufacturer of the instrument.
and PO2.
2
Warning: The measurement of SpO2 and PR with SenTec TC Sensors is
only defined on sites specified by the manufacturer (refer to the instrument`s
manual). In order to avoid erroneous readings and false alarms of SpO2 and
PR, ensure that the appropriate patient type (Adult) is selected. Ensure to
disable the parameters SpO2/PR for sensor application on other measurement
sites.
Warning: The use of temperatures higher than 41°C requires special
attention to patients with susceptible skin, e.g. neonates, geriatric patients,
burn victims, patients with skin diseases.
CAUTION: A flat, well-perfused area of intact skin is needed (centrally
located sites are preferable). Avoid placement over large superficial veins or
areas of skin breakdown or edema.
Cleaning and Disinfection
CAUTION: The use of other cleaning and disinfection procedures oth-
er than those recommended here may result in permanent damage to the
sensor.
CAUTION: Do not remove the membrane of the sensor for cleaning
and disinfection.
CAUTION: Wiping and/or the application of mechanical force in general
can damage the sensor membrane or the sensor cable mechanically. Wipe the
sensor carefully and inspect the condition of the membrane and sensor cable
after cleaning and/or disinfection.
The OxiVenT™ Sensor must be cleaned before inserting it into the docking
station in order to remove any gel residues or other soils such as blood, protein,
or mucous that could contaminate the docking station, cause cross-infections
between different patients and/or gas leakage during calibration.
In order to remove all foreign substances, the sensor surface should be cleaned
prior to disinfection.
Important: The cleaning and disinfection solutions listed here have been
tested for their suitability for the OxiVenT
TM
Sensor. The below listed name brand
products for cleaning and disinfection may be substituted by other name brand
products of equivalent composition. However, as there are many factors (contact
time, force applied during wiping etc.) that can influence the functionality of the
sensor, it is the responsibility of the user to test the functionality of the sensor
after cleaning and/or disinfection. SenTec recommends using 70% Isopropanol.
Table 1: Low Level Disinfection
Brand name/
Cleaning procedure
manufacturer
WEBCOL Alcohol Prep
Pads (Kendal)
Isopropanol
Mikrozid (Schülke Mayr)
pre-soaked wipes;
25% Ethanol, 35%
Isopropanol
Kodan® forte
(Schülke&Mayr);
45,0 g 2-Propanol, 10,0 g
1-Propanol, 0,20 g Biphenyl-2-ol, 30% H2O2
Gigasept® AF
(Schülke&Mayr);
15 g Didecyldimethylammoniumchlorid,
10 g Phenoxypropanole,
6,9 g Aminoalkylglycine; 15
– 30% non-ionic tensides.
; 70%
Carefully wipe all SenTec TC Sensor surfaces and
the cable with alcohol wipes and allow to dry.
Carefully wipe all surfaces of the SenTec TC Sensor and the cable with wipes soaked Kodan forte.
Wait 5 min. Remove all Kodan forte residues using
70% Isopropanol. Allow to dry.
Carefully wipe all surfaces of the SenTec TC
Sensor and the cable with wipes soaked in 4 %
solution (e.g. 960 ml deionoized water plus 40
ml Gigasept AF). Note that the 4% dilution has a
shelf-life of 7 days. Wait 15 min.
Remove all Gigasept residues using 70% Isopropanol. Allow to dry.
Terralin Protect
(Schülke&Mayr)
22 g Quaternäre Ammoniumverbindungen, Benzyl-C12-16-alkyldimethyl-,
Chloride, 17 g 2-Phenoxyethanol, 0,9 g Aminoalkylglycine, 5 – 15% non-ionic
tensides.
Prevantics™ Device
Swab (PDI)
3.15% Chlorhexidine
Gluconate (w/v) and 70%
Isopropyl Alcohol (v/v)
Sanoclean AR (Sanosil);
1.5% Hydrogen Peroxide
(0.003% Silver)
Dismozon plus (Bode
Chemie);
Magnesium Monoperoxyphthalat 958 mg/g
Microbac Forte (Bode
Chemie);
20% Benzyl-C1218-alkyldimethylammoniumchloride; 5% N-(3Aminopropyl)-N-dodecylpropan-1,3-diamin
Super Sani Cloth (PDI);
0.25% n-alkyl dimethyl
ethylbenzyl ammonium
chlorides; 0.25% n-alkyl dimethyl benzyl ammonium
chlorides
CaviCide or CaviWipe
(METREX® RESEARCH
CORPORATION);
0.28% Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium
chloride; Isopropanol
Table 2: High Level Disinfection
Brand name/
manufacturer
Cidex OPA (J&J);
0.55%
ortho-Phthalaldehyde
Note: Requires pre-cleaning using an enzymatic
cleaner: ENZOL (J&J) or
Prolystica (Steris);
Subtilisin
Carefully wipe all SenTec TC surfaces and the
cable with wipes soaked in 2% solution (e.g. 980
ml deionoized water plus 20 ml Terralin Protect).
Wait 15 min.
Remove all Terralin residues using 70% Isopropanol. Allow to dry.
Carefully wipe all SenTec TC Sensor surfaces and
the cable with the pre-soaked PDI wipe for 5
seconds. Let dry for 5 seconds. Remove all PDI
residues using 70% Isopropanol. Allow to dry.
Carefully wipe all SenTec TC Sensor surfaces and
the cable with wipes soaked in Sanoclean AR
(note: the commercial solution is ready to use, no
further dilution required), Wait 15 minutes.
Remove all Sanoclean residues using 70% Isopropanol. Allow to dry.
Carefully wipe all SenTec TC Sensor surfaces and
the cable with wipes soaked in 3.6% solution (e.g.
36g of Dismozon granulate per liter of deionized
water). Note: The diluted solution has a shelf-life
of 8h. Wait 15 min.
Remove all Dismozon residues using 70% Isopropanol. Allow to dry.
Carefully wipe all SenTec TC surfaces and the
cable with wipes soaked in 2% solution (e.g. 980
ml deionoized water plus 20 ml Microbac Forte).
Wait 15 min.
Remove all Microbac Forte residues using 70%
Isopropanol. Allow to dry.
Carefully wipe all SenTec TC Sensor surfaces and
the cable with the pre-soaked PDI wipe. Wait 2
minutes.
Remove all PDI residues using 70% Isopropanol.
Allow to dry.
CAUTION: This cleang agent is potentially
aggressive to the skin. Thus, sensor membrane
must be changed after cleaning to ensure optimal
skin compatibility.
Spray CaviCide or CaviWipe directly onto the
sensor/cable surface. Allow surface to remain
visibly wet for 3 minutes. Remove all CaviCide or
CaviWipe residues using 70% Isopropanol. Allow
to dry.
CAUTION: This cleang agent is potentially
aggressive to the skin. Thus, sensor membrane
must be changed after cleaning to ensure optimal
skin compatibility.
Cleaning procedure
First, remove debris using an enzymatic detergent: Soak the Sensor and the desired length of
cable in enzymatic solution for 5 minutes. Rinse
the sensor and the cable briefly in deionized water. Blot dry carefully.
Soak the Sensor and the desired length of cable in
CIDEX OPA solution for 12 minutes.
Soak the SenTec TC Sensor and the desired length
of cable 3x for 2 minutes in sterile or deionized
water (renew after each soaking cycle).
Carefully wipe all surfaces of the SenTec TC Sensor and cable with 70% Isopropanol. Allow to dry.
CAUTION: Sensor membrane must be
changed after cleaning to ensure optimal sensor
monitoring performance.
Sani Cloth Bleach (PDI);
0123
Sodium Hypochloride
0.63%
Approx. 6000 ppm avail-
able free chlorine
Clorox Healthcare
Bleach Germicidal
Wipes;
5500 ppm Sodium
Hypochloride
Mikrozid® PAA wipes
(Schülke & Mayr);
0.07% Per-Acetic acid;
Hydrogen Peroxide, Acetic
acid
Visually verify that sensor membrane is intact.
Carefully wipe all SenTec TC Sensor surfaces and
the cable with the pre-soaked PDI wipe. Wait 4
minutes
Remove all PDI residues using 70% Isopropanol.
Allow to dry.
CAUTION: Do not use bleach cleaners on
sensor surfaces without or with defect membrane.
This may damage the PCO
CAUTION: Bleach is potentially aggressive
to the skin. Thus, sensor membrane must be
changed after cleaning to ensure optimal skin
compatibility.
Carefully wipe all SenTec TC Sensor surfaces and
the cable with the pre-soaked Mikrozid PAA wipes,
Wait 15 min. Remove all Mikrozid PAA residues
using 70% Isopropanol. Allow to dry.
unit.
2
Applying force, e.g. during wiping, can damage the sensor cable and sensor
membrane mechanically. After cleaning, verify that the membrane is not damaged and that there are no air bubbles between membrane and sensor surface.
The membrane ring must be securely seated on the sensor. In case of damages,
trapped air or loose fit the membrane must be changed. Do not use the sensor
if there is any visible damage.
Important: Always calibrate the sensor after cleaning and/or disinfection.
Note: For further information please refer to the Instruction Manual for the
SDMS or contact the manufacturer of the instrument.
Compatibility of OxiVenT™ Sensor with dierent
instruments
Before starting a measurement, please check the sensor’s compatibility with
the connected instrument. Conntection to SDM: The OxiVenTTM Sensor re-
quires firmware versions SMB V08.00 and MPB V06.00 or newer. The SMB and
MPB version of the monitor may be found in the SDM menu “System Information”. Please contact your local SenTec representative for firmware upgrade
information. Other SenTec-compatible instruments: Consult individual
manufacturers for compatibility of of particular instruments and sensor models.
Each manufacturer of SenTec-compatible instruments is responsible for determining whether and under what conditions its instruments are compatible
for safe and effective use with each SenTec sensor model. This may include
different specifications and/or warnings, cautions, or contraindications. Refer to
the intrument’s manual or consult manufacturer for complete instructions for
use of this sensor with their SenTec-compatible instrument.
Accuracy
For accuracy specifications of the OxiVenT™ Sensor when used with SenTec
monitors refer to the Technical Specifications in the Technical Manual of the
SenTec Digital Monitor. For accuracy specifications of the OxiVenT™ Sensor
when used with SenTec-compatible instruments refer to the instrument`s
manual or contact the instrument manufacturer.
Usage time/ Life time
The Usage Time and Life Time of the OxiVenTTM Sensor are limited. The
available and used ‘Life Time’ (in days), ‘Usage Time’ (in hours), and ‘Warranty
Time’ (in days) are indicated in the menu of the monitor.
WARNINGS
• Sensors are designed for use with specific monitors. The user and/or operator
must verify the compatibility of the monitor, sensor, and cables before use or
patient injury may result.
• Failure to handle/apply the sensor properly may cause inaccurate
measurements.
• Keep the sensor (as well as any discarded parts) out of reach of children under
the age of 5 years. The sensor is small enough to be swallowed and may block
the trachea.
• Ensure that the sensor is physically intact, with no broken or damaged parts.
Discontinue use immediately if any defects are noted.
• Do not touch the sensor membrane with any sharp-edged objects or
your fingernails. Damage of the sensor membrane will cause inaccurate
measurements.
• Do not alter or modify the OxiVenT™ Sensor.
• To ensure accurate data verify that the sensing elements on the OxiVenT™
Sensor membrane-face are completely covered by the measurement site.
• Carefully route and fix sensor cables to reduce the possibility of patient
entanglement or strangulation.
• Do not use the OxiVenT™ Sensor during MRI scanning. Conducted current
may cause burns. Also, the OxiVenT™ Sensor may affect the MRI image, and
the MRI unit may affect the accuracy of oximetry measurements.
• The sensor can be kept on the patient during defibrillation, burns are possible
under very rare circumstances.
• Physically separate the sensor and cables from electro-surgical equipment
during electro-surgery. Do not place the sensor between cutting and counter
electrode.
• Any change in cutaneous PcCO
arterial PCO2/PO2, or due to a change in skin tissue blood flow beneath the
/PcO2 may be due to either a change in
2
sensor. Cutaneous PcCO2/PcO2 only reflects arterial PCO2/PcO2at relatively
high local blood flow.
• Do not expose the OxiVenT™ Sensor to strong ambient light such as direct
sunlight, surgical lamps, infrared warming lamps, and phototherapy lights
during clinical use. This may cause inaccurate measurements. In such cases,
cover the sensor with an opaque material.
• Excessive motion may compromise the performance of the OxiVenT™ Sensor.
• SpO
readings may be falsely low in the presence of tricuspid valve insufficiency
2
(mixture of arterial and venous values) due to retrograde venous pulsations.
• The pulsations from intra-aortic balloon support can be additive to the pulse
rate on the oximeter pulse rate display. Verify pulse rate against ECG heart
rate.
• Intravascular dyes may lead to inaccurate SpO
measurements.
2
• Elevated levels of Methemoglobin (MetHb) and/or Carboxyhemoglobin
(COHb) will lead to inaccurate SpO
measurements.
2
• Furthermore, the following situations may result in reduced accuracy of the
OxiVenT™ Sensor readings: dysfunctional hemoglobins, anemia, intravascular
dyes, low perfusion at the measurement site, venous pulsations, certain
cardiovascular pathologies, skin pigmentation, externally applied coloring
agents, prolonged and/or excessive patient movement, exposure of the
sensor to high ambient light levels, defibrillation.
• Ensure to select the upper alarm limit for PO
accord with accepted clinical standards. High oxygen levels may predispose a
and SpO2 carefully and in
2
premature infant to develop retinopathy.
• Always apply sensor on intact and closed skin sites. Pierced earlobes may
result in incorrect tcPCO
skin. Avoid placement over large superficial veins.
and/or tcPO2 measurements. Do not apply to injured
2
• After observation of any skin irritations, do not apply the OxiVenT™ Sensor
to the same measurement site. Unless the patient’s local skin perfusion and
physiological condition improved significantly do not apply the sensor to any
other measurement site.
• If PO
is enabled the recommended/ default application duration per
2
measurement site (site time) is 2 hours at temperature settings at 44 °C in
adults/ pediatrics and 43°C in neonates. If PO2 is disabled the recommended/
default site time is 8 hours at 42 °C in adults/ pediatrics and 41°C in neonates,
but longer site times are possible (up to 12 hours). Refer to the Technical
Manual for the SDM (when used with SenTec-compatible instruments refer to
the instrument`s manual) for further information. Exercise extreme caution
and assess the measurement site at least every 2 hours with poorly perfused
patients.
• For sensor temperatures higher than 44°C change the location of the sensor
every 4 hours to prevent skin burns.
• Regularly inspect the sensor. Do not use the sensor if there is any visible
damage to the sensor housing, sensor membrane, sensor cable or if the color
of the ring around the glass electrode has a metallic luster Change the sensor
membrane if it is damaged or missing, has a loose fit, or if there is trapped air
or dry electrolyte under the membrane.
• Do not use the OxiVenT
TM
Sensor if the off-centered, white, round spot on the
sensor surface is missing or is not illuminated in green-cyan color when the
OxiVenT™ Sensor is connected to the SDM.
• Check disposables monthly and replace any expired products.
• For additional warnings, cautions and/or contraindications when using
the OxiVenT™ Sensor with SenTec-compatible instruments, refer to the
instrument’s manual or contact the instrument manufacturer.
CAUTIONS
• Federal law (U.S.) restricts this device to sale by or on the order of a physician.
• WEEE Disposal: European consumers are obliged by law to dispose Waste
Electrical and Electronic Equipment (WEEE) according to the WEEE Directive:
1. All electrical and electronic waste must be stored, collected, treated, recycled
and disposed of separately from other waste. 2. Consumers are obliged by law
to return electrical and electronic devices at the end of their service lives to the
public collection points set up for this purpose or point of sale. Details to this
are defined by the national law of the respective country. Note: By recycling
materials or other forms of utilizing old devices, you are making an important
contribution to protecting our environment.
• Druing transport: store sensor with membrane and protected from light/
radiation.
• Do not clean the sensor in an ultrasonic cleaner.
• Do not immerse the connector of the sensor cable in any liquid solution.
• Do not sterilize any parts of the sensor by irradiation, steam, ethylene oxide,
plasma or autoclav method.
• Always clean the sensor surface before insertion into the docking station or
the Membrane Changer.
• Avoid bending and tearing the sensor cable or the application of any other
mechanical force (e.g. during cleaning), mechanical damage could result.
Warranty
To obtain information about a warranty (and warranty exclusions), if any, for this
product, contact SenTec AG, your local SenTec representative or the manufacturer
or the manufacturer’s local representative of the SenTec-compatible instrument.
Patents/Trademarks/Copyright
International Industrial Design No. DM/054179, Japanese Design No. 1137696, U.S. Design Patent
No. D483488. Canadian Patent No. 2466105, European Patent No. 1335666, German Patent No.
50111822.5-08, Spanish Patent No. 2278818, Hongkong Patent No. HK1059553, U.S. Patent No.
6760610. Chinese Patent No. ZL02829715.6, European Patent No. 1535055, German Patent No.
50213115.2, Spanish Patent No. 2316584, Indian Patent No. 201300, Japanese Patent No. 4344691,
U.S. Patent No. 7862698. SenTec™, V-Sign™, OxiVenT™, V-STATS™, V-CareNeT™, V-Check™,
Staysite™, Advancing Noninvasive Patient Monitoring™ and Illuminate Ventilation
of SenTec AG / © 2019 SenTec AG. All rights reserved. The contents of this document may not be
reproduced in any form or communicated to any third party without the prior written consent of
SenTec AG. While every effort is made to ensure the correctness of the information provided in this
document, SenTec AG assumes no responsibility for errors or omissions. This document is subject to
change without notice.
SenTec AG, Ringstrasse 39, CH-4106 Therwil, Switzerland
www.sentec.com
HB-007415-c Date of release: 03/2019
TM
are trademarks
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