Warning: The measurement of SpO
2
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 SpO
2
and PR,
ensure that the appropriate patient type (Adult) is selected. Ensure to disable
the parameters SpO
2
/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 other
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 V-Sign™ Sensor 2 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 should be cleaned prior
disinfection.
Important: The cleaning and disinfection solutions listed here have been tested
for their suitability for the V-Sign
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/
manufacturer
Cleaning procedure
WEBCOL Alcohol Prep
Pads (Kendal); 70%
Isopropanol
Carefully wipe all SenTec TC Sensor surfaces
and the cable with alcohol wipes and allow to
dry.
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
Carefully wipe all surfaces of the SenTec TC
Sensor and the cable with wipes soaked Kodan
forte. Wait 5 min. Remove all Kodan forte resi-
dues using 70% Isopropanol. Allow to dry.
Gigasept® AF
(Schülke&Mayr);
15 g Didecyldimethylammoni-
umchlorid,
10 g Phenoxypropanole, 6,9
g Aminoalkylglycine; 15 –
30% non-ionic tensides.
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% Iso-
propanol. Allow to dry.
V-Sign™ Sensor 2
REF VS-A/P/N
Carbon Dioxide Tension and
Oxygen Saturation Sensor
Reusable / Nonsterile / Waterproof
Directions for Use
Introduction
SenTec’s V-Sign™ Sensor 2 is intended for continuous PCO
2
, SpO
2
/PR monitoring.
The V-Sign™ Sensor 2 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
2
.
Indications/Contraindications
The V-Sign™ Sensor 2 (VS-A/P/N) is indicated for use when continuous non-
invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate
are required for adult and pediatric patients. In neonatal patients the use of the
V-Sign™ Sensor 2 is indicated for carbon dioxide tension monitoring only. The
V-Sign™ Sensor 2 is for use only with SenTec instruments and instruments that
contain SenTec monitoring technology or are licenced to use SenTec sensors
(SenTec-compatible instruments).
Instructions for use
Preparation - Membrane change
The membrane and the electrolyte of the V-Sign™ 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 SenTec Digital Monitoring
System (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 PCO
2
segment of the V-Sign™ Sensor 2 must be calibrated regularly. The
monitor requests a sensor calibration if required. 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 V-Sign™ 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.
Terralin Protect
(Schülke&Mayr)
22 g Quaternäre Ammonium-
verbindungen, Benzyl-C12-
16-alkyldimethyl-, Chloride,
17 g 2-Phenoxyethanol, 0,9 g
Aminoalkylglycine, 5 – 15%
non-ionic tensides.
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 Pro-
tect). Wait 15 min.
Remove all Terralin residues using 70% Isopro-
panol. Allow to dry.
Prevantics™ Device Swab
(PDI);
3.15% Chlorhexidine Gluco-
nate (w/v) and 70% Isopro-
pyl Alcohol (v/v)
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.
Sanoclean AR (Sanosil);
1.5% Hydrogen Peroxide
(0.003% Silver)
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% Iso-
propanol. Allow to dry.
Dismozon plus (Bode
Chemie);
Magnesium Monoper-
oxyphthalat 958 mg/g
Carefully wipe all SenTec TC Sensor surfaces
and the cable with wipes soaked in 3.6% solu-
tion (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% Iso-
propanol. Allow to dry.
Microbac Forte (Bode
Chemie);
20% Benzyl-C12-18-alkyldi-
methylammoniumchloride;
5% N-(3-Aminopropyl)-N-
dodecylpropan-1,3-diamin
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.
Super Sani Cloth (PDI);
0.25% n-alkyl dimethyl ethyl-
benzyl ammonium chlorides
0.25% n-alkyl dimethyl ben-
zyl ammonium chlorides
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% Isopropa-
nol. Allow to dry.
CAUTION: This cleang agent is potentially
aggressive to the skin. Thus, sensor membrane
must be changed after cleaning to ensure opti-
mal skin compatibility.
CaviCide or CaviWipe
(METREX® RESEARCH
CORPORATION)
0.28% Diisobutyl-phenoxye-
thoxyethyl dimethyl ben-
zyl ammonium chloride;
Isopropanol
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 opti-
mal skin compatibility.
Table 2: High Level Disinfection
Brand name/
manufacturer
Cleaning procedure
Cidex OPA (J&J) (*);
0.55% ortho-Phthalaldehyde
Note: Requires pre-cleaning
using an enzymatic cleaner:
ENZOL (J&J) or Prolystica
(Steris);
Subtilisin
First, remove debris using an enzymatic deter-
gent: 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 de-
ionized 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.
