Related Manuals for Sentec tcPCO2
Summary of Contents for Sentec tcPCO2
- Page 1 Instruction Manual For the Digital Monitoring System (Software version SMB SW-V08.02; MPB SW-V06.02)
- Page 2 SenTec Digital Monitoring System No ninvas ive Ve nt ilatio n and Oxygenation Moni to r ing [Sarah Miller] [John Smith]...
- Page 3 Trend Display Area Numerical Display Area Menu/Previous Level Button 39.4 AUDIO PAUSED/OFF Button PCO2 mmHg - 15 min 0 min AUDIO PAUSED/OFF Indicator (yellow LED) %SpO2 Door Handle 2.0 PI - 15 min 0 min Docking Station Door (colored dot in center of door indicates the SDM’s PO activation 12 sec...
- Page 4 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.
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Page 5: Table Of Contents
Contents Intended Use, Principles of Operation and Limitations .............. 5 Intended Use of the SenTec Digital Monitoring System (SDMS) ..................5 Transcutaneous PCO and PO ............................5 Pulse Oximetry .................................7 SenTec TC Sensors ................................9 The SenTec Digital Monitoring System (SDMS) ................ 10 Setting up the SDMS ......................... - Page 6 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 ....................................
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Page 7: Intended Use, Principles Of Operation And Limitations
Carbon dioxide (CO ) and Oxygen (O ) are gases that readily of the SenTec Digital Monitor (SDM), sensors and accessories diffuse through body and skin tissue and, therefore, can be (p. 10) – is indicated for continuous, noninvasive monitoring... - Page 8 Limitations of tcPCO and tcPO In newborns PO measured at the skin surface (PcO ) correlates with arterial PO (PaO ) almost in a one to one relationship at The following clinical situations or factors may limit the a sensor temperature of 43 to 44 °C, whereby the accuracy correlation between transcutaneous and arterial blood gas of PcO compared to PaO...
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Page 9: Pulse Oximetry
Pulse Oximetry When comparing PCO values displayed by the SDM with PaCO /PaO values obtained from arterial blood gas (ABG) Principles of Operations of Pulse Oximetry analysis, pay attention to the following points: The SDMS uses pulse oximetry to measure functional oxygen •... - Page 10 Limitations of Pulse Oximetry Note: The SDMS measures and displays functional oxygen saturation: the amount of oxygenated hemoglobin expressed The following clinical situations or factors may limit the as a percentage of the hemoglobin that can transport oxygen. correlation between functional oxygen saturation (SpO ) and The SDMS does not measure fractional saturation: oxygenated arterial oxygen saturation (SaO...
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Page 11: Sentec Tc Sensors
To achieve local arterialization of the skin tissue at the components needed for 2-wavelength, reflectance pulse measurement site, SenTec TC Sensors are operated at a oximetry with the components needed to measure PCO and –... -
Page 12: The Sentec Digital Monitoring System (Sdms)
SenTec Digital Monitor (SDM) conditions). Note: SDMs with firmware version SMB SW-V08.00/MPB SW- V06.00 or newer are available in a software-configuration Contact Gel (contact liquid for the application of SenTec TC without activated PO -option (SDM) and in a configuration with Sensors) - Page 13 Note: The SDMS Quick Reference Guide, the SDMS is provided in the respective Directions for Use. Detailed information on the SenTec Digital Monitor is provided in the Instruction Manual and various other manuals are Technical Manual for the SDM (HB-005752). Information on available for online viewing at www.sentec.com/ifu.
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Page 14: Setting Up The Sdms
AC power outlet. 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 Battery Operation of the SDM detailed description of the POST. -
Page 15: Installation Of The Gas Bottle (Service Gas-0812)
The Status Icon ‘Gas’ (p. 48) indicates the remaining capacity by pressing the two latches on the of the gas bottle in %. It is only displayed if a SenTec TC black plug to release the clamps (see Sensor is connected to the SDM and is in the Docking Station. -
Page 16: Connection Of A Sentec Tc Sensor
Connection of a SenTec TC Sensor If the sensor’s ‘Membrane Change Interval’ has elapsed (this usually applies to new sensors), the SDM will trigger Take a SenTec TC Sensor (V-Sign™ Sensor 2 or OxiVenT™ the message ‘Change sensor membrane’ upon insertion of Sensor). -
Page 17: Sensor Check, Sensor Calibration/Storage And Membrane Change
(including membrane, housing and cable) with 70% to the SDM. Instead, contact qualified service personnel or isopropanol or another approved cleaning agent (refer to your local SenTec representative regarding continued use or sensor’s Directions for Use). replacement of the sensor. -
Page 18: Sensor Calibration And Storage
CAUTION: Incorrect orientation Good to know! of the sensor in the Docking Station ‘Calibration Intervals’ for SenTec TC Sensors can last up to may cause damage to the sensor, the 12 hours. Once the ‘Calibration Interval’ has elapsed, sensor Docking Station, or parts thereof when calibration is recommended (message ‘Sensor calibration... -
Page 19: Changing The Sensor Membrane
(p. 17), it is recommended to store the sensor in the Docking Station at least for the duration indicated The membrane of a SenTec TC Sensor must be changed if the by the yellow information message ‘Recommended Sensor ‘Membrane Change Interval’ has elapsed. In this case, the SDM Stabilization [min]:’... - Page 20 Note: A Membrane Change Tutorial is available for Note: Neither touch nor hold the sensor cable while the sensor online viewing at www.sentec.com/tv/v0. is inside in the Membrane Changer nor pick up the Membrane Changer as this may lead to dislodging the sensor from the Membrane Changer.
- Page 21 Removing Sensor from Membrane Changer Keep the Membrane Changer horizontal while executing the following Press-and-Turn step 4 times: Press once again or lift the sensor to release and remove the sensor from a. Press down slowly but 1x press the Membrane Changer. firmly with palm of the hand 3 sec.
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Page 22: Patient Monitoring With The Sdms
Patient Monitoring with the SDMS Selection of Patient Type, Measurement Site, and Sensor Attachment Accessory Refer to the pictures below to select the patient type on the SDM, the measurement site and the sensor attachment accessory. Refer to the following page for additional (important) information. ‘Adult’... - Page 23 It is not recommended to use Note: To attach a SenTec TC Sensor with the Ear Clip (p. 27), the Contact Gel on patients who exhibit allergic reactions. the earlobe should be large enough to cover the entire sensor membrane (dark surface of the sensor).
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Page 24: Check Sdm Settings And System Readiness
Check SDM Settings and Note: Pressing the Enter Button (p. 42) while the ‘Ready System Readiness for use’ screen displays activates a ‘Quick Access Menu’ with the possibility to activate additional calibrations (p. 16), to Before initiating patient monitoring, ensure the current SDM access the sub-menu ‘Profiles’, or to activate the V-Check™... - Page 25 * ON and T = 44.5 °C in adults/T ≥ 43.5 °C in neonates Good to know! ** T < 44.5 °C in adults/< 43.5 °C in neonates Various profiles preconfigured by SenTec and tailored to V-Check™ Mode Indicator: If the V-Check™ Mode optimally fit the specific needs of varying clinical settings are (p.
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Page 26: Sensor Application Using A Multi-Site Attachment Ring/Easy
Sensor Application Using a Multi-Site Available Monitoring Time [hrs]: Indicates the time available for patient monitoring, i.e. the time interval after Attachment Ring/Easy removing the sensor from the Docking Station or applying the sensor to the patient until the selected ‘Site Time’ or - if According to the procedure described point by point below, is enabled - the ‘Calibration Interval’... - Page 27 4. Attach the ring to the measurement site. Verify that the skin under the adhesive Note: As contact liquid, you may use SenTec’s Contact Gel, is not wrinkled. Then press clean tap water, sterile water or sterile saline solution. gently on the retainer ring and...
- Page 28 9. Holding the sensor at its neck, properly to avoid entanglement approach the MAR from the flap side or strangulation and secure (a) or the MARe from any side (b) and it with a Clothing Clip to an first insert the nose of the sensor into appropriate site of the patient’s the retainer ring.
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Page 29: Sensor Application Using An Ear Clip
WARNING: Application of any pressure to the CAUTION: The SenTec Ear Clip (model EC-MI) is for measurement site (e.g. by using a pressure bandage) may single-use. Neither reattach used clips on the same nor on... - Page 30 Avoid contact with eyes and injured skin. Do not use on patients who exhibit allergic reactions. Use only Note: Always grab the sensor at its approved SenTec Contact Gel, clean tap water, sterile water neck to avoid pulling and tearing the or sterile saline solution.
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Page 31: Patient Monitoring
Patient Monitoring CAUTION: A good, hermetically sealed contact between ‘Sensor-On-Patient’ Detection the sensor and the skin is essential for TC monitoring! Once the sensor is correctly applied to the patient (see previ- WARNING: Ensure the sensor is applied correctly. ous sections), the SDM usually detects that the sensor was Incorrect application of the sensor can cause incorrect put on the patient and initiates monitoring for the enabled measurements. - Page 32 Once ‘Sensor-On-Patient’ is detected, the SDM initiates If the penetration of ambient air is of short duration only, monitoring and the enabled parameters stabilize. SpO and PR TC-readings will typically restabilize within a few minutes. usually stabilize within a few seconds, whereas PCO typically increases and PO typically decreases to reach a stabilized...
- Page 33 Preconfigured Measurement Screens Good to know! The SDM’s numeric values and online trends provide In order to reduce the number of ‘TC-Artifacts’, a good, continuous monitoring of the enabled parameters. Depending hermetically sealed contact between the sensor and the on the sensor type, the selected patient type and the enabled skin is essential.
- Page 34 Quality Indicators for Measurement Parameters ∆x-Values and Baseline Values The SDM continuously evaluates the quality of the measured Certain preconfigured measurement screens provide online parameters and the ∆x-values and baseline values derived trends with ∆x-values, baseline values and baselines for PCO thereof by assessing the severity of conditions presented to , SpO and/or RHP.
- Page 35 RHP Online Trends/Setting RHP Reference Example: ‘Baseline values for PCO ’ of ‘33.3 + 10.1 mmHg Once a SenTec TC Sensor is stabilized on the skin in an en- (00:12)’ indicate that the current PCO reading is 10.1 mmHg vironment with constant ambient temperature, the heating higher than the baseline of 33.3 mmHg which was set...
- Page 36 By using the menu-parameter ‘Heating Power Mode’ the op- corresponds to a RHP of 0 mW and reflects the RHP-reference erator can select between the display of the ‘Absolute Heating value. RHP values below/above the center-line correspond to Power’ (AHP), the ‘Relative Heating Power’ (RHP), or disable episodes during which the sensor required less/more power to the display of the heating power.
- Page 37 If the sensor is stabilized on the skin, the RHP-reference value Measurement Phase (default duration 2 minutes). If the can be set either a) by using the respective function in the V-Check™ Measurement is finished two short signal tones ‘Quick Access Menu’ that activates after pressing the Enter sound and the V-Check™...
- Page 38 ‘Severinghaus Correction’ is used, the ‘PCO In-vivo Correction’ offset is marked with an asterisk: e.g. ‘IC=x.xx*’.). To use V-Check™, select the SenTec-preconfigured SDM Profile V-CHECK as standard ‘SDM Profile’. This will set the WARNING: A ‘PCO sensor temperature to 43.5 °C, the ‘Site Time’ to 0.5 hours, In-Vivo Correction’...
- Page 39 By using V-CareNeT™, for example, remote monitoring and Note: To terminate the ‘Site time elapsed’ alarm, remove the secondary alarm surveillance of multiple SDMs connected to sensor from the patient and either press the Enter Button while the same network as the PC is possible. ‘Operator Events’, the message ‘Sensor off patient (8 )’...
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Page 40: Sensor Removal With Multi-Site Attachment Ring/Easy
Sensor Removal with 3. Clean the sensor with a swab wetted with 70% isopropanol to remove any Multi-Site Attachment Ring/Easy contact liquid residues or dirt (for other Remove the sensor from the patient when monitoring is approved cleaning agents refer to the completed or monitoring time has elapsed (message ‘Site time sensor’s Directions for Use). - Page 41 Sensor Removal without Reattachment to Same Note: Sensor calibration – if necessary – will start (message Site ‘Calibration in progress’). The message ‘Ready for use’ will display once calibration is finished. 1. Remove the sensor together with the Multi-Site Attachment Ring/Easy by carefully lifting the ring’s little tab 6.
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Page 42: Sensor Removal With Ear Clip
Sensor Removal with Ear Clip 3. Clean the sensor with a swab wetted with 70% isopropanol to remove any Remove the sensor from the patient when monitoring is contact liquid residues or dirt (for other completed or monitoring time has elapsed (message ‘Site time approved cleaning agents refer to the elapsed’... - Page 43 Sensor Removal without Reattachment to Same Note: Sensor calibration – if necessary – will start (message Earlobe ‘Calibration in progress’). The message ‘Ready for use’ will display once calibration is finished. 1. Open the clip’s jaws and remove it from the earlobe together with the sen- 6.
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Page 44: Controls, Indicators And Alarms
Controls, Indicators and Alarms Controls (Buttons) • to pause auditory alarm signals for 1 or 2 minutes (depending on respective menu setting) The ON/OFF switch is located on the rear panel of the SDM • to switch OFF auditory alarm signals permanently (by . - Page 45 must be confirmed by pressing the Enter Button to become effec- • Press to return to the main menu or to exit the tive (see example 2 below). To cancel changes/deactivate ‘editing menu. mode’ , use the Menu/Previous Level Button or the Display Button. Note: Changes made with the UP/Down Buttons immedi- ** will also reset the Site Timer ately become effective without confirmation for all parameters...
- Page 46 Example 3: ‘Confirmation of Membrane Change’ • Press as many times as required to select the desired language. Note that changes do not become To reset the membrane timer after a successful membrane effective. change, the membrane change must be confirmed on the SDM •...
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Page 47: Led Indicators
Indicator • The ‘Ready for use’ Beep (short tone) sounds at the end of a successful calibration of a SenTec TC Sensor. This signal can • Green LED: Connected to AC power, battery fully only be switched ON/OFF by the institution; its volume is not charged adjustable. -
Page 48: Alarms
Alarms • The ‘Pulse Beep’ (short tone) sounds once for each pulse. Its automatic pitch modulation reflects changing SpO levels; use The SDM uses visual and auditory alarm signals to alert the the parameter ‘Pulse Beep’ to switch off/adjust the volume of user when a physiological measurement parameter (PCO , PO this signal. - Page 49 Visual Alarm Signals Auditory Alarm Signals The ‘Alarm Status Icon’ (p. 48) indicates the highest currently The SDM’s auditory alarm signals are priority encoded. A high active alarm priority. If a physiological parameter violates its priority alarm condition is indicated by a high-pitched fast alarm limits, the respective parameter and the ‘Alarm Status pulsing tone (two bursts of five short pulses repeated Icon’...
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Page 50: Status Bar With Status Icons And Status Messages
Note: The operating status of the SDM’s auditory alarm signals Status Bar with Status Icons and Status is visually indicated by the ‘AUDIO STATUS Icon’ (p. 48), Messages the ‘AUDIO PAUSED/AUDIO OFF Indicator’ (p. 45), and acoustically indicated by the ‘AUDIO OFF Reminder’. The Status Bar is located in the bottom of nearly all screens. - Page 51 The ‘Sensor Temperature’ Icon indicates the measured The Alarm Status Icon indicates the ranking of the sensor temperature (°C) and the current setting of SITE highest priority alarm condition (flashing white triangle with PROTECTION. A ‘red-blue rightward arrow with tip down’ curved line and exclamation mark on red background in a high priority alarm condition;...
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Page 52: Maintenance Of The Sdms
Routine Checks The following checks should be performed regularly: Note: Check the disposables monthly and replace any expired • Before and after every use check the SenTec TC Sensors products. (p. 15). • Weekly clean and disinfect SenTec TC Sensors and the Digital Sensor Adapter Cable. -
Page 53: Service
To perform a safety check and for service or repair, contact qualified service personnel or your local SenTec representative. Please note that repair and service procedures which require opening the cover of the SDM must be performed by SenTec authorized service personnel. WARNING: The cover should only be removed by SenTec authorized service personnel. -
Page 54: Specifications Of Tcpco
Specifications of tcPCO , tcPO and Pulse Oximetry Specifications of tcPCO and tcPO tcPCO tcPO Measurement range 0 – 200 mmHg (0 – 26.7 kPa) Measurement range 0 – 800 mmHg (0 – 106.7 kPa) Resolution 0.1 mmHg (0.01 kPa) below Resolution 1 mmHg (0.1 kPa) 100 mmHg (10 kPa) / 1 mmHg... -
Page 55: Specifications Of Pulse Oximetry
The indicated variation equals plus or minus one standard deviation (1SD), which encompasses 68% of the population. Note: A functional tester cannot be used to assess the SpO accuracy. Page 53 Specifications of tcPCO2 , tcPO2 and Pulse Oximetry... -
Page 56: Glossary Of Symbols
Glossary of Symbols Symbol Name Description of Symbol The table below summarizes symbols used on the SDMS Indicates a medical device that needs to be protected from Keep dry (including all its related parts), on the packaging and in the moisture. - Page 57 Symbol Name Description of Symbol Symbol Name Description of Symbol Equipoten- Indicates that the product Equipotential Terminal (ground) tiality complies with the requirements of the Medical Device Directive 93/42/EEC June 1993. CE Label Monitor ON If applicable, the 4-digit Notified (SDM rear Body number is added near or button)
- Page 58 Symbol Name Description of Symbol LED yellow: Auditory alarm signals paused for 1 or 2 minutes LED flashes yellow: Auditory alarm Audio signals permanently switched off Paused/ (activated by pressing ‘AUDIO Audio Off PAUSED/AUDIO OFF Button’ > 3 Indicator seconds) (On SDM front panel) LED off: Auditory alarm signals...
- Page 60 ADVANCING NONINVASIVE PATIENT MONITORING HB-005771-l ∙ Art. 100978 Date of release: 10/2018...
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