Sentec tcPCO2, tcPO2, SpO2 Instruction Manual

Instruction Manual
For the Digital Monitoring System
(Software version SMB SW-V08.02; MPB SW-V06.02)
SenTec Digital Monitoring System
Noninvasive Ventilation and Oxygenation Monitoring
19 20 21 22 23 24
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12 sec
100
70
75
25
- 15 min 0 min
- 15 min 0 min
0 min
39.4
50 30
PCO2
mmHg
84
140
50
PR
bpm
96
100
85
%SpO2
2.0 PI
100%
+
-
7.7h
AD
°C
42.0
RHP
0
[John Smith]
2014-04-28 15:28:31
1 2 3 4
5
6
7
8101213
14
11 9
1 Trend Display Area 2 Numerical Display Area 3 Menu/Previous Level Button 4 AUDIO PAUSED/OFF Button 5 AUDIO PAUSED/OFF Indicator (yellow LED) 6 Door Handle 7 Docking Station Door (colored dot in center
of door indicates the SDM’s PO
2
activation
status: blue if activated, orange otherwise)
8 Enter Button 9 Display Button 10 AC Power/Battery Indicator
(green/yellow LED)
11 UP/DOWN Buttons 12 ON/OFF Indicator (green LED) 13 Status Bar 14 Speaker (on the side) 15 Sensor Connection Port 16 Multipurpose l/O-Port
(Nurse Call & Analog Output)
17 Serial Data Port (RS-232) 18 Network Port (LAN) 19 Gas Bottle Slot 20 Fan 21 Equipotential Terminal Connector (ground) 22 Fuse Holder 23 AC Power Connector 24 ON/OFF Switch
C
L
A
S
S
I
F
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Warranty
The manufacturer warrants to the initial purchaser that each new component of the SenTec Digital Monitoring System will be free from defects in workmanship and materials. The manufacturer’s sole obligation under this warranty is to at its own choice repair or replace any component – for which the manufacturer acknowledges the warranty cover – with a replacement component.
Warranty Exclusions and System Performance
SenTec AG can neither guarantee or verify instrument performance characteristics nor accept warranty claims or product liability claims if the recommended procedures are not carried out, if the product has been subject to misuse, neglect or accident, if the product has been damaged by extraneous causes, if accessories other than those recommended by SenTec AG are used, if the warranty seal on the lower side of the monitor is broken, or if instrument repairs are not carried out by SenTec authorized service personnel.
CAUTION: Federal law (U.S.) restricts this device to sale by or on the order of a physician.
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
TM
, V-STATS™, V-CareNeT™, V-Check™, Staysite™, Illuminate Ventilation™ and Advancing Noninvasive Patient Monitoring™ are trademarks of SenTec AG / © 2018 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.
Patient Monitor IN ACCORDANCE WITH IEC 60601-1; ANSI/AAMI ES60601-1; CAN/CSA C22.2 No. 60601-1, IEC 60601-1-2, IEC 60601-2-23, ISO 80601-2-61
Manufacturer: SenTec AG, Ringstrasse 39, CH-4106 Therwil, Switzerland,
www.sentec.com
Page 3 . Contents
Contents
Intended Use, Principles of Operation and Limitations .............................................................. 5
Intended Use of the SenTec Digital Monitoring System (SDMS) ......................................................................................5
Transcutaneous PCO2 and PO
2
..........................................................................................................................................5
Pulse Oximetry .................................................................................................................................................................7
SenTec TC Sensors ...........................................................................................................................................................9
The SenTec Digital Monitoring System (SDMS) ........................................................................ 10
Setting up the SDMS ................................................................................................................. 12
Connect SDM to AC Power ............................................................................................................................................. 12
Battery Operation of the SDM ........................................................................................................................................ 12
Turning on the SDM ........................................................................................................................................................ 12
Installation of the Gas Bottle (Service Gas-0812) .......................................................................................................... 13
Connection/Disconnection of Digital Sensor Adapter Cable ........................................................................................... 13
Connection of a SenTec TC Sensor ................................................................................................................................. 14
Sensor Check, Sensor Calibration/Storage and Membrane Change ......................................... 15
Checking a SenTec TC Sensor ........................................................................................................................................15
Sensor Calibration and Storage ......................................................................................................................................16
Changing the Sensor Membrane .................................................................................................................................... 17
Patient Monitoring with the SDMS ............................................................................................ 20
Selection of Patient Type, Measurement Site, and Sensor Attachment Accessory ........................................................ 20
Check SDM Settings and System Readiness ................................................................................................................... 22
Sensor Application Using a Multi-Site Attachment Ring/Easy ......................................................................................... 24
Sensor Application Using an Ear Clip .............................................................................................................................. 27
Patient Monitoring ..........................................................................................................................................................29
Sensor Removal with Multi-Site Attachment Ring/Easy .................................................................................................. 38
Sensor Removal with Ear Clip ......................................................................................................................................... 40
Controls, Indicators and Alarms ................................................................................................ 42
Controls (Buttons) .......................................................................................................................................................... 42
LED Indicators ................................................................................................................................................................ 45
Auditory Indicators/Signals ............................................................................................................................................. 45
Alarms ............................................................................................................................................................................ 46
Status Bar with Status Icons and Status Messages ........................................................................................................ 48
Maintenance of the SDMS ......................................................................................................... 50
Routine Checks ............................................................................................................................................................... 50
Service ............................................................................................................................................................................ 51
Specifications of tcPCO2 , tcPO2 and Pulse Oximetry ................................................................ 52
Specifications of tcPCO2 and tcPO
2
................................................................................................................................. 52
Specifications of Pulse Oximetry ..................................................................................................................................... 53
Glossary of Symbols .................................................................................................................. 54
Page 5 . Intended Use, Principles of Operation and Limitations
Intended Use of the SenTec Digital Monitoring System (SDMS)
The SenTec Digital Monitoring System (SDMS) – consisting of the SenTec Digital Monitor (SDM), sensors and accessories (p. 10) – is indicated for continuous, noninvasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia. The SDMS is indicated for use in clinical and non-clinical settings such as hospitals, hospital-type facilities, intra-hospital transport environments, clinics, physician offices, ambulatory surgery centers and – if under clinical supervision – home environments. The SDMS is for prescription use only.
Note: The above phrasing corresponds to an abbreviated version of the SDMS’ Intended Use. Please refer to the current issue of the Technical Manual for the SDM (HB-005752) for the full phrasing of the SDMS’ Intended Use.
Intended Use, Principles of Operation and Limitations
Transcutaneous PCO2 and PO
2
Principles of Operations of tcPCO2 and tcPO
2
Carbon dioxide (CO2) and Oxygen (O2) are gases that readily diffuse through body and skin tissue and, therefore, can be measured by an adequate noninvasive sensor being applied at the skin surface. If the skin tissue beneath the sensor site is warmed up to a constant temperature local capillary blood flow increases, metabolism stabilizes, gas diffusion improves and, hence, reproducibility and accuracy of CO
2/O2
measurements at the skin surface improves. CO
2
tensions measured at the skin surface (PcCO2) are usually
consistently higher than arterial PCO
2
values (PaCO2) in patients
of all ages. It is therefore possible to estimate PaCO
2
from
the measured PcCO
2
using an adequate algorithm. TcPCO2
designates an estimate of PaCO
2
calculated from the measured
PcCO
2
with an algorithm developed by J.W. Severinghaus.
The ‘Severinghaus Equation’ first corrects PcCO
2
measured at the sensor temperature (T) to 37 °C by using an anaerobic temperature factor (A) and then subtracts an estimate of the local ‘Metabolic Offset’ (M).
Note: Hence, the tcPCO
2
values displayed by the SDM are corrected/normalized to 37 °C and provide an estimate of PaCO
2
at 37 °C. On the SDM and throughout this manual
(unless explicitly stated otherwise) ‘tcPCO
2
’ is displayed/
labeled as ‘PCO
2
’.
In newborns PO2 measured at the skin surface (PcO2) correlates with arterial PO
2
(PaO2) almost in a one to one relationship at a sensor temperature of 43 to 44 °C, whereby the accuracy of PcO
2
compared to PaO2 is best up to PaO2 of 80 mmHg (10.67 kPa), above which it increasingly tends to read lower than PaO
2
(especially in adults). As target PaO2 levels in newborns are usually below 90 mmHg (12 kPa), a correction of PcO
2
values measured at a sensor temperature of 43 to
44 °C is normally not necessary. TcPO
2
designates an estimate
of PaO
2
and corresponds to the measured PcO2.
Note: On the SDM and throughout this manual (unless explicitly stated otherwise) ‘tcPO
2
’ is displayed/labeled as ‘PO2’.
Good to know!
Warming the skin tissue beneath the sensor to a constant temperature improves accuracy as it a) increases capillary blood flow/induces local arterialization, b) stabilizes metabolism, and c) improves gas diffusion through skin tissue. With increasing sensor temperature the application duration (‘Site Time’) must be evaluated carefully and adjusted accordingly to reduce the risk of burns. Special attention must be given to patients with sensitive skin at the sensor site (e.g. preterm or geriatric patients, burn victims, patients with skin diseases) and/or very low skin tissue perfusion beneath the sensor site (e.g. hypothermic patients, patients with vasoconstrictions, low blood pressure, or circulatory centralization (shock)).
Please refer to Technical Manual for the SDM (HB-005752) and the references cited therein for additional information on transcutaneous blood gas monitoring.
Limitations of tcPCO2 and tcPO
2
The following clinical situations or factors may limit the correlation between transcutaneous and arterial blood gas tensions:
• Hypo-perfused skin tissue beneath the sensor site due to low cardiac index, circulatory centralization (shock), hypothermia (e.g. during surgery), use of vasoactive drugs, arterial occlusive diseases, mechanical pressure exercised on measurement site, or inadequate (too low) sensor temperature.
• Arterio-venous shunts, e.g. ductus arteriosus (PO
2
specific).
• Hyperoxemia (PaO
2
> 100 mmHg (13.3 kPa)) (PO2 specific).
• Inadequate measurement site (placement over large superficial veins, on areas with skin edema (e.g. oedema neonatorum), skin breakdown, and other skin anomalies).
• Improper sensor application resulting in an inadequate, not hermetically sealed contact between the sensor surface and the patient’s skin causing the CO
2
and O2 gases diffusing out
of the skin to intermix with ambient air.
• Exposure of the sensor to high ambient light levels (PO
2
specific).
CAUTION: Compared to the corresponding arterial blood
gases PCO
2
readings are typically too high and PO2 readings
typically too low if the measurement site is hypo-perfused.
CAUTION: The SDMS is not a blood gas device. Keep the above mentioned limitations in mind when interpreting PCO
2
and PO2 values displayed by the SDM.
Page 7 . Intended Use, Principles of Operation and Limitations
When comparing PCO
2
/PO2 values displayed by the SDM with
PaCO
2
/PaO2 values obtained from arterial blood gas (ABG)
analysis, pay attention to the following points:
• Carefully draw and handle blood samples.
• Blood sampling should be performed in steady state conditions.
• The PaCO
2
/PaO2 value obtained from ABG analysis should be
compared to the SDM’s PCO
2
/PO2 reading at the time of blood
sampling.
• In patients with functional shunts, the sensor application site and the arterial sampling site should be on the same side of the shunt.
• If the menu-parameter ‘Severinghaus Correction Mode’ is set to ‘Auto’, the PCO
2
values displayed by the SDM are automatically corrected to 37 °C (regardless of the patient’s core temperature). When performing the ABG analysis, be sure to properly enter the patient’s core temperature into the blood gas analyzer. Use the blood gas analyzer’s ‘37 °C-PaCO
2
value to compare with the SDM’s PCO
2
value.
• Verify proper operation of the blood gas analyzer. Periodically compare the blood gas analyzer’s barometric pressure against a known calibrated reference barometer.
Pulse Oximetry
Principles of Operations of Pulse Oximetry
The SDMS uses pulse oximetry to measure functional oxygen saturation (SpO
2
) and pulse rate (PR). Pulse oximetry is based on two principles: firstly, oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophotometry) and secondly, the volume of arterial blood in tissue (and hence, light absorption by that blood) changes during the pulse (plethysmography).
Pulse oximeter sensors pass red and infrared light into a pulsating arteriolar vascular bed and measure changes in light absorption during the pulsatile cycle. Red and infrared low­voltage light-emitting diodes (LED) serve as light sources and a photodiode serves as photodetector. The software of a pulse oximeter uses the ratio of absorbed red to infrared light to calculate SpO
2
.
Pulse oximeters use the pulsatile nature of arterial blood flow to differentiate the oxygen saturation of hemoglobin in arterial blood from the one in venous blood or tissue. During systole, a new pulse of arterial blood enters the vascular bed: blood volume and light absorption increase. During diastole, blood volume and light absorption decrease. By focusing on the pulsatile light signals, effects of nonpulsatile absorbers such as tissue, bone and venous blood are eliminated.
Note: The SDMS measures and displays functional oxygen saturation: the amount of oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. The SDMS does not measure fractional saturation: oxygenated hemoglobin expressed as a percentage of all hemoglobin, in­cluding dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin.
Good to know!
Oxygen saturation measurement techniques – including pulse oximetry – are not able to detect hyperoxemia.
Due to the S-shape of the oxyhemoglobin dissociation curve (ODC) SpO
2
alone cannot reliably detect hypoventilation in
patients being administered with supplemental oxygen.
Limitations of Pulse Oximetry
The following clinical situations or factors may limit the correlation between functional oxygen saturation (SpO
2
) and
arterial oxygen saturation (SaO
2
) and may cause the loss of
the pulse signal:
• dysfunctional hemoglobins (COHb, MetHb)
• anemia
• intravascular dyes, such as indocyanine green or methylene blue
• low perfusion at the measurement site (e.g. caused by inflated blood pressure cuff, severe hypotension, vasoconstriction in response to hypothermia, medication, or a spell of Rynaud’s syndrome)
• venous pulsations (e.g. due to use of the forehead, cheek or earlobe as a measurement site on a patient in steep Trendelenburg position)
• certain cardiovascular pathologies
• skin pigmentation
• externally applied coloring agents (e.g. nail polish, dye, pigmented cream)
• prolonged and/or excessive patient movement
• exposure of the sensor to high ambient light levels
• defibrillation
Page 9 . Intended Use, Principles of Operation and Limitations
SenTec TC Sensors
SenTec TC Sensors provide superior performance, are robust, reliable and require comparatively low maintenance. They combine within a patented digital sensor design the optical components needed for 2-wavelength, reflectance pulse oximetry with the components needed to measure PCO
2
and –
in case of the OxiVenT™ Sensor only – PO
2
.
PO
2
(OxiVenT™ Sensor) is measured with dynamic fluorescence quenching, an oxygen sensing technology measuring the oxygen molecules present in the vicinity of a fluorescent dye being immobilized in a thin carrying layer incorporated within the sensor surface.
The PCO
2
measurement of SenTec TC Sensors (V-Sign™ Sensor 2, OxiVenT™ Sensor) is based on a Stow-Severinghaus type PCO
2
sensor, i.e. a thin electrolyte layer is confined to the sensor surface with a hydrophobic, CO
2
and O2 permeable membrane. Membrane and electrolyte must be exchanged every 28 to 42 days. With SenTec’s patented Membrane Changer the membrane and electrolyte can be changed with the ease of 4 identical Press-and-Turn steps in a highly reproducible manner (p. 17).
Calibration of the PCO
2
segment of SenTec TC Sensors is recommended every 6 to 12 hours and mandatory every 12 to 16 hours (p. 16). The PO
2
measurement of the OxiVenT™ Sensor is virtually drift free and, hence, calibration free. Nevertheless, the SDM, as a precaution, calibrates PO
2
during
each mandatory calibration and subsequently approximately once every 24 hours during one of the anyways ongoing PCO
2
calibrations.
To achieve local arterialization of the skin tissue at the measurement site, SenTec TC Sensors are operated at a constant sensor temperature of typically 41 °C in neonatal and 42 °C in adult/pediatric patients if PO
2
is disabled and – if PO2 is enabled – of typically 43 °C in neonatal and 44 °C in adult/ pediatric patients, respectively. Controls of sensor temperature and application duration are designed to meet all applicable standards. To guarantee safe operation, SenTec TC Sensors reliably supervise the sensor temperature with two independent circuits. Additionally, the SDM firmware redundantly controls the temperature of the connected sensor.
The SenTec Digital Monitoring System (SDMS)
The SenTec Digital Monitoring System (SDMS) comprises the following main components:
SenTec Digital Monitor (SDM) Note: SDMs with firmware version SMB SW-V08.00/MPB SW-
V06.00 or newer are available in a software-configuration without activated PO
2
-option (SDM) and in a configuration with
activated PO
2
-option (SDM-PO2). The respective configuration is indicated on the SDM’s ‘Power On Self Test’ Screen and on the second page of the menu ‘System Information’. Furthermore, the colored dot in the center of a SDM’s Docking Station Door
7
is orange, if PO2 is not activated, and blue, if
PO
2
is activated.
V-Sign™ Sensor 2 (for PCO
2
, SpO2/PR monitoring) or
OxiVenT™ Sensor (for PCO
2
, PO2, SpO2/PR monitoring) Note: Throughout this manual the notion ‘SenTec TC Sensor’ refers to SenTec sensors providing transcutaneous blood gas measurements (i.e. to the V-Sign™ Sensor 2 and the OxiVenT™ Sensor).
Digital Sensor Adapter Cable (to connect a SenTec TC Sensor to SDM)
Ear Clip and Multi-Site Attachment Rings (to attach SenTec TC Sensors to patients)
Staysite™ Adhesive (to improve attachment of Multi-Site Attachment Rings, e.g. in high humidity environments, for patients who perspire profusely and/or in challenging patient motion conditions).
Contact Gel (contact liquid for the application of SenTec TC Sensors)
Service Gas (to calibrate SenTec TC Sensors)
Membrane Changer (to change membrane and electrolyte
of SenTec TC Sensors)
V-STATS™ (PC based Trend Data Download/Analysis, Remote Monitoring, and Configuration Software for SenTec Digital Monitors)
SDMS Quick Reference Guide and SDMS Instruction Manual (the present document)
SDMS Manual CD (with the exception of the ‘Service and
Repair Manual for the SDMS’ all manuals and Directions for Use being related to the SDMS are provided on the Manual CD)
Note: The components listed above do not necessarily correspond to the scope of delivery. A complete list of available products including disposables and accessories is provided at
www.sentec.com/products.
Page 11 . The SenTec Digital Monitoring System (SDMS)
Additional information on SenTec TC Sensors, the Ear Clip, the Multi-Site Attachment Rings, the Staysite™ Adhesive, the Membrane Changer, and the Membrane Changer Inserts is provided in the respective Directions for Use. Detailed information on the SenTec Digital Monitor is provided in the Technical Manual for the SDM (HB-005752). Information on maintenance, service and repair procedures that do not require opening the cover of the SDM as well as on maintenance and service procedures for SenTec TC Sensors are provided in the SDMS Service Manual (HB-005615).
To ensure proper operation of the SDMS, precisely follow the instructions provided in this Instruction Manual step by step.
WARNING: The instructions given in the SDMS Quick Reference Guide, the SDMS Instruction Manual, the Technical Manual for the SDM, and on the SDMS Manual CD must be followed in order to ensure proper instrument performance and to avoid electrical hazards.
Note: Statements in this manual are only applicable for SDMs with the software version indicated on the cover page.
Note: The SDMS Quick Reference Guide, the SDMS Instruction Manual and various other manuals are available for online viewing at www.sentec.com/ifu.
Note: SDMS related tutorials are available for online viewing at www.sentec.com/tv.
Setting up the SDMS
Connect SDM to AC Power
Plug the female connector of the power
cord into the AC power connector on the rear of the monitor
23
. Plug the male connector of the power cord into a properly grounded AC power outlet. Note: The SDM will automatically adapt to the applicable local voltage: 100 - 240V~ (50/60Hz).
Verify that the AC power/battery indicator
10
is lit. If the AC power/battery indicator is not lit, check the power cord, fuses, and the AC power outlet.
Battery Operation of the SDM
The SDM is equipped with a rechargeable internal Li-Ion battery that can be used to power the monitor during transport or when AC power is not available. The Status Icon ‘Battery’ (p. 48) indicates the remaining battery charge (%).
Good to know!
When using an SDM with a LED backlight display, a new, fully charged battery will provide up to 10 hours of monitoring time if Sleep Mode=OFF or Auto, and up to 12 hours of monitoring time if Sleep Mode=ON. It takes approximately 7 hours to fully charge a drained battery.
The AC Power/Battery Indicator 10 provides information on the charging status of the battery:
Green: SDM connected to AC power, battery fully charged Yellow: SDM connected to AC power, battery charging LED OFF: SDM not connected to AC power (i.e. powered by
internal battery)
Turning on the SDM
Turn on the SDM by pushing the ON/OFF Switch on the rear panel
24
. The SDM will automatically perform a ‘Power On Self Test’ (POST). Check the date/time settings of the SDM and adjust if necessary.
Note: If the POST fails, discontinue use of the SDM and contact qualified service personnel or your local SenTec representative. Refer to the Technical Manual for the SDM (HB-005752) for a detailed description of the POST.
ON/OFF
switch
Page 13 . Setting up the SDMS
Installation of the Gas Bottle (Service Gas-0812)
The gas bottle slot is located on the rear of the SDM 19.
Remove the old gas bottle by turning it counter-clockwise.
Insert the new gas bottle by turning it clockwise approx. 4.5 turns and thoroughly tighten it (without applying undue force).
CAUTION: Failure to properly insert the gas bottle may result in incorrect sensor calibrations and may cause increased gas consumption.
The Status Icon ‘Gas’ (p. 48) indicates the remaining capacity of the gas bottle in %. It is only displayed if a SenTec TC Sensor is connected to the SDM and is in the Docking Station.
WARNING: The Service Gas bottle is a pressurized container. Protect from sunlight and do not expose to temperatures exceeding 50 °C (122 °F). Do not pierce or burn, even after use. Do not spray on a naked flame or any incandescent material.
WARNING: Do not use expired gas bottles or gas bottles from manufacturers other than SenTec. The use of non-SenTec gas bottles may damage the Docking Station. Improper calibration gas mixtures will result in incorrect sensor calibrations and subsequently result in inaccurate PCO
2
and/or PO2 data.
Dispose of empty gas bottles according to local waste disposal regulations for aluminium containers.
Connection/Disconnection of Digital Sensor Adapter Cable
Connect the Digital Sensor Adapter Cable to the SDM. The con­nection is properly established when both clamps of the plug snap into place in the sensor connection port
15
.
Disconnect the cable from the SDM by pressing the two latches on the black plug to release the clamps (see picture) and pull to remove the cable.
Press
Connection of a SenTec TC Sensor
Take a SenTec TC Sensor (V-Sign™ Sensor 2 or OxiVenT™ Sensor).
Important: For PO
2
monitoring you must use an OxiVenT™
Sensor and an SDM with activated PO
2
-option.
Check the condition of the sensor membrane and the integrity of the sensor (p. 15). Change the membrane if necessary (p. 17). Do not use the sensor if any problems are noted.
Once sensor check/inspection of its membrane are completed successfully, connect the SenTec TC Sensor to the Digital Sensor Adapter Cable.
Thereafter, the SDM usually will display the message ‘Calibrate sensor’ (for exceptions see description of the feature SMART CALMEM, p. 17).
Insert the sensor into the Docking Station for sensor calibration (p. 16).
If the sensor’s ‘Membrane Change Interval’ has elapsed (this usually applies to new sensors), the SDM will trigger the message ‘Change sensor membrane’ upon insertion of the sensor into the Docking Station. In this case, you must change the sensor membrane (p. 17) before the SDM starts calibrating the sensor.
Note: If you have changed the sensor membrane just before connecting the sensor to the SDM, it won’t be necessary to change it once again. In this case, simply confirm the membrane change on the monitor (menu ‘Membrane Change’ ­only accessible if the sensor is outside the Docking Station).
Checking a SenTec TC Sensor
Check the condition of the sensor membrane and the integrity of the sensor before and after each use and after changing the membrane (p. 17)!
Ensure that the sensor is clean before visually checking it. If necessary, carefully wipe off any residue from the sensor’s surface (including membrane, housing and cable) with 70% isopropanol or another approved cleaning agent (refer to sensor’s Directions for Use).
a) 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.
Page 15 . Sensor Check, Sensor Calibration/Storage and Membrane Change
CAUTION: Do not touch the delicate optical/glass components embedded in the sensors surface should the membrane be missing.
b) Do not use the sensor if there is any visible damage to the sensor housing or cable, if the color of the ring around the glass electrode has a metallic luster (should be brown), or if the sensor’s red LED does not light when the sensor is connected to the SDM. Instead, contact qualified service personnel or your local SenTec representative regarding continued use or replacement of the sensor.
c) When operating with an OxiVenT™ Sensor, do not use the 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 with enabled PO
2
measurement function.
Sensor Check, Sensor Calibration/Storage and Membrane Change
CAUTION: Always clean the sensor before placing it in the Docking Station.
3. Hang the sensor into the holder in the inside of the door. Ensure that the sensor’s red light is visible.
CAUTION: Incorrect orientation of the sensor in the Docking Station may cause damage to the sensor, the Docking Station, or parts thereof when closing the Docking Station door.
4. Close the Docking Station Door. The SDM will check the sensor and – if necessary – start the sensor calibration (message ‘Calibration in progress’). The message ‘Ready for use’ will display once calibration is finished.
WARNING: Correct calibration requires the sensor to be properly positioned in the Docking Station Door and the Docking Station Door to be closed.
Note: If the sensor is stored in the Docking Station, additional sensor calibrations can be activated via a ‘Quick Access Menu’ (p. 42). If enabled, PO
2
is also calibrated during calibrations
that are activated with the menu-function ‘Calibrate sensor’.
Sensor Calibration and Storage
If a sensor calibration is mandatory, the SDM displays the message ‘Calibrate sensor’, a low priority alarm sounds and PCO
2
and PO2 are marked as ‘invalid’ (values replaced by ‘---’).
Good to know!
‘Calibration Intervals’ for SenTec TC Sensors can last up to 12 hours. Once the ‘Calibration Interval’ has elapsed, sensor calibration is recommended (message ‘Sensor calibration recommended’) and monitoring is possible for another 4 to 6 hours with PCO
2
marked as ‘questionable’ (p. 32). Thereafter, sensor calibration is mandatory. The SDM, as a precaution, calibrates PO
2
during each mandatory calibration and subsequently approximately once every 24 hours during one of the default PCO
2
calibrations.
To calibrate the sensor:
1. Open the Docking Station Door
7
by pulling the door
handle.
2. Check the gasket (arrow) in the Docking Station. If necessary, clean the Docking Station and gasket by using a cotton swab moistened with 70% isopropanol (for other approved cleaning agents refer to the Technical Manual for the SDM).
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