SenTec V-Sign System

Without disturbing
your patient's sleep
- continuous
tcPCO2 & SpO2
Noninvasive
ventilation and
oxygenation
monitoring
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Digital monitor for tcPCO2, SpO2, PR and HP monitoring (without activated PO2 channel)


The SenTec Digital Monitoring System (SDMS) provides continuous and noninvasive real.time monitoring of transcutaneous CO2 partial pressure (PCO2), functional oxygen saturation (SpO2), pulse rate (PR), pulsation index (PI) and heating power (HP) in adult and pediatric patients as well as for PCO2 and HP monitoring in neonatal patients in virtually and clinical settings.

Product Code: SDM

Sensor Options

  • OxiVenT™ Sensor (tcPCO2, tcPO2, SpO2, PR and RHP)
  • V-Sign™ Sensor (tcPCO2, SpO2, PR and RHP)

Features

  • For display of data measured with SenTec Sensors as specified in above pictures
  • Physical characteristics:
    • Weight: 2.3 kg (5.1 lbs) – including gas cylinder
    • Size: 10.2 cm x 27.0 cm x 23.0 cm (4.00’’ x 10.63’’ x 9.06’’)
    • Flip feet serving as carrying handle or to adjust angle for improved table-top viewing
    • Mountable on roll/infusion stands, wall mounts/railings, transport incubators, etc.
  • Interfaces:
    • Serial Output (RS-/EIA-232): Supported protocols: SenTecLink, Philips VueLink and/or Philips IntelliBridge, Spacelabs Flexport (no PO2 parameter), Serial Printer, TCB (TransCutaneous Basic Protocol to connect e.g. to Dräger Monitoring) and electronic medical device systems (e.g. Capsule)
    • LAN Port (UDP – RFC 768): Required for Remote Monitoring with V-CareNeT™
    • Analog output (0–1 V)
    • Nurse-call capability
  • TFT Color Display (LED backlight) -    Nonvolatile FLASH memory with capacity (monitoring data) of up to 227 hours (9.5 days)
  • Rechargeable, sealed LiIon Battery with capacity of up to 10 hours

Note

  • Above-mentioned features depend on Software Version of the «SDM-PO2» or «SDM»
  • Contact your SenTec representative for tcPO2 channel activation

V-Sign™ Sensor 2

Carbon dioxide tension and Pule oximetry sensor

  • Digital Sensor
  • Noninvasive and continuous measurement of tcPCO2, pulse oximetry (SpO2, PR), pulsation index and relative heating power (RHP)
  • Suitable for adult, pediatric, and neonatal* patients
  • Reusable, waterproof
  • To be attached to the patient with Multi-Site Attachment Ring (MAR) or Ear Clip
  • Includes 1 single Clothing Clip (SC-CC)
  • To be connected to the «SDM» with a «Digital Sensor Adapter Cable» (AC-XXX)

For a product demonstration, please contact your local SenTec Distributor.

 

* In neonatal patients, the use of the V-Sign™ Sensor is currently indicated for carbon dioxide tension monitoring only.

OxiVenT™ Sensor

Carbon dioxide tension oxygen tension and Pule oximetry sensor

  • Digital Sensor
  • Noninvasive and continuous measurement of tcPCO2, tcPO2, pulse oximetry (SpO2, PR), pulsation index and relative heating power (RHP)
  • Suitable for adult, pediatric, and neonatal* patients
  • Reusable, waterproof
  • To be attached to the patient with Multi-Site Attachment Ring (MAR) or Ear Clip
  • Includes 1 single Clothing Clip (SC-CC)
  • To be connected to the «SDM» with a «Digital Sensor Adapter Cable» (AC-XXX)

For a product demonstration, please contact your local SenTec Distributor.

 

* In neonatal patients, the use of the OxiVenT Sensor is currently indicated for carbon dioxide tension and oxygen tension monitoring only.
General Brochure

English

Neonatology

English

Anesthesiology

English

Chronic Respiratory Failure

English

Application Areas

The SenTec Digital Monitoring System is a safe, accurate and reliable way for continuous, noninvasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients and enables clinicians to better assess patient ventilation and oxygenation in virtually all clinical settings.

Please refer to following Application Areas for detailed information:

Always in Touch...The SDMS allows continuous monitoring of transcutaneous carbon dioxide tension (tcPCO2) and oxygen tensions (tcPO2) in neonates. Versatile sensor application (thorax, abdomen, back, low on forehead, inner or anterior aspect of tight) facilitates continuous measurement in virtually all clinical situations. 

Safe Sensor Temperature Management

The digital V-Sign™ and OxiVent™ Sensors always stay in touch with your patient while safely measuring, supervising and controlling its temperature at the application site. The SenTec Digital Monitoring System allows a safe “plug and play” measurement with safety temperature management features: institution-restrictable sensor temperature, site inspection requests and – if missed – automatic sensor temperature reduction.

Gentle Sensor Application

You will always keep the sensor in touch with your patient, because the SenTec Digital Monitoring System provides you with a very gentle sensor application solution. The sophisticated sensor temperature management concept described above is one of these gentle sensor application features. For the most gentle sensor application to your patient, the SenTec's transcutaneous Sensor is extremely lightweight (less than 2,9 g), includes a highly-flexible cable, and keeps its full freedom of rotation if applied to the patient. Moreover, the neonatal attachment ring is devoted to the particular needs of neonatal skin: its design allows you a forceless sensor application and a smooth remove without damaging the sensitive skin when peeling off after monitoring. 

Reliable Measurement Performance 

Transcutaneous carbon dioxide tension values painlessly provide you with a precious estimate of arterial carbon dioxide tension levels. With the lowest technical drift of the currently available transcutaneous monitors, the digital V-Sign™ Sensor provides accurate transcutaneous carbon dioxide tension values even during long-term measurement [Storre 2010].  The OxiVenT™ Sensor measures PO2 optically with dynamic fluorescence quenching. This measurement principle is stable over time and therefore virtually drift free.

Convenient Operation 

“Always in touch with your patient” implies the possibility of up to 12 hours calibration free monitoring. Compared to spot check monitoring techniques, the continuous clinical information delivered by SenTec's transcutaneous sensor enables you to detect patient condition changes earlier and thus gives you more time to induce an optimized therapy according to your patient’s needs. Without the need of an additional calibration request, you can even disconnect the digital Sensor from the “Sensor Adapter Cable” within a disconnection time of up to 30 minutes. This allows you to examine, treat, or transport your neonatal patient with the convenience of extra mobility. This facilitates the operation of the measurement system especially around a neonatal incubator.

Clinical Application Examples

Safe Long-term Application in NICUToday’s gold standard to determine the arterial carbon dioxide tension in critically ill neonates is arterial blood gas analysis. This requires periodical arterial blood sampling with its drawbacks of invasiveness, risk of complications, procedure pitfalls, and iatrogenic anemia in neonatal patients. The SenTec Digital Monitoring System provides continuous, transcutaneous carbon dioxide and oxygen tension monitoring system, being safely applied to your neonatal patient. Application of the sensor is gentle, the sensor temperature management is extremely secure, and the operation is maximized for the neonatal patient and your convenience. The SenTec Digital Monitoring System’s long-term accuracy and applicability has been proven by Walsh et al. at the Children’s Hospital Vanderbilt, Nashville, TN, USA.  They tested the SenTec Digital Monitoring System on their smallest patients weighing between 1000 and 3400 grams. The measurement periods amounted up to 50 hours of tcPCO2 monitoring per sensor application site. The study affirmed the device’s safety (no adverse skin effects), and clinical relevant correlation of its tcPCO2 readings with arterial carbon dioxide tension [Walsh].
Neonatal Management Ventilation GuidanceDuring high frequency oscillation ventilation (HFOV) or non-invasive ventilation (NIV) procedure one cannot solely rely on common arterial carbon dioxide surrogate measurement techniques.  Rowley et al. tested if transcutaneous PCO2 measured with the SenTec Digital Monitoring System (SDMS) could reliably replace arterial blood gas analysis required during high frequency oscillation ventilation (HFOV) of neonatal patients. They determined a significant correlation between tcPCO2 measured with the SenTec Digital Monitoring System and arterial carbon dioxide in their neonatal patients with very low birth weight as well as in neonatal patients receiving vasopressors [Rowley]. The continuous tcPCO2 monitoring allows adjusting HFOV and may help to minimize sequela (i.e. intraventricular hemorrhage) resulting from wide arterial carbon dioxide tension swings [Rowley].  

Unrecognized respiratory depression on the General Care Floor (GCF), culminating in respiratory arrest, is occurring every day at hospitals across the world. A significant portion of these respiratory arrests occur in postoperative patients receiving opioid analgesics and sedatives, which contribute to respiratory depression [1]. Failure to recognize respiratory depression and institute timely resuscitation has led to cardiopulmonary arrest, resulting in anoxic brain injuries and deaths (only one in five patients suffering an in-hospital cardiac arrest survives to hospital discharge). While some patient populations - notably those patients with obstructive sleep apnea - appear to be at higher risk, it is important to emphasize that there is still a low but unpredictable incidence of life-threatening, opioid-induced respiratory depression in young healthy patients [2]. Moreover, life-threatening, opioid-induced respiratory depression also occurs with intermittent parenteral injections of opioid analgesics.

The Anesthesia Patient Safety Foundation (APSF) recently called for “zero tolerance” to patient harm due to postoperative opioids [2]. Among other and as previously stated by other standard bodies, APSF deems respiratory complications due to opioids to be preventable with better monitoring [1-5]. According to a "Closed Claims Analysis of Cases Involving Postoperative PCA and Neuraxial Narcotics” better monitoring could have prevented 73% of PCA related-cases and 56% of CNN related-cases [2]. Therefore, to advance safety of postoperative patients receiving opioid analgesics and sedatives APSF urges clinicians to continuously monitor ventilation (i.e. patient’s PCO2 levels) and oxygenation (pulse oximetry)  [2, 3]. Furthermore, considering lower staffing-to-patient ratios on the GCF - which typically preclude the level of direct surveillance – remote monitoring from a centralized station is essential and caregivers should be notified if adverse trends are observed that suggest hypoventilation [1, 2].

Monitoring patient ventilation and oxygenation on the general care floor 

  • Arterial blood sampling - being intermittent and invasive - is obviously impractical to assess patients ventilation and oxygenation status on the general care floor routinely. 
  • Pulse oximetry is an excellent means of continuously and noninvasively assessing patient oxygenation on the general care floor and helps avoid hypoxemia and tissue hypoxia. Furthermore, in patients who are breathing room air, pulse oximetry is – to a certain extent – an indirect indicator of hypoventilation. However, due to the physiology of the Hb-oxygen dissociation curve, pulse oximetry is NOT able to detect hypoventilation when supplemental oxygen is administered. In patients receiving supplemental oxygen and being monitored with pulse oximetry only, respiratory depression consequently may develop and deteriorate, remaining unnoticed until critical levels are reached.
  • Sidestream endtidal PCO2 (etCO2) monitoring is continuous and relatively easy to use and potentially can reflect patient ventilation. However, etCO2 strongly depends on the gas sampling quality and on a regular/full breathing cycle. Adequate tidal volumes are required to reflect alveolar PCO2 and shallow breathing may result in too low etCO2 readings. In patient’s with lung disease such as COPD or lung perfusion/ventilation mismatch the quality of etCO2 further may deteriorate. In spontaneously breathing patients, making up the majority of patients in postoperative general care floor settings, the quality of etCO2 therefore is poor.

Being continuous, noninvasive, and independent from the quality of the airway transcutaneous pCO2 (tcpCO2) monitoring is the way of accurate PaCO2 estimation overcoming the drawbacks of etCO2 and the invasiveness of ABG’s. Furthermore, continous tcPCO2 montoring unambiguously reflects hypoventilation irrespectively of supplemental oxygen being administered or not and thereby helps to enhance patient safety.

For continuous ventilation and oxygenation monitoring on the general care floor the SenTec Digital Monitoring System offers the following key features:

Reliable Measurement Performance

  • Unique in industry tcpCO2 artifact detection/rejection algorithm
  • Lowest technical drift of the currently available tcpCO2 monitors Storre 2010.
  • Combined tcpCO2/SpO2 monitoring being validated at a number of different measurement sites.
     

Remote Monitoring and secondary alarm suveillance

  • Remote Monitoring and secondary alarm surveillance with V-CareNeT™ System for up to 20 SenTec Digital Monitors (SDM). For each patient admitted to V-CareNeT™ system the central station on-line displays tcPCO2, SpO2, PR and alarms.
  • Setup of V-CareNeT™ is easy and only requires a conventional Ethernet network, at least one SDM, a PC serving as a central station with V-STATS™ installed and V-CareNeT™ Package activated.
     

Comprehensive Data Management

  • On-screen viewing and printing of graphical trends and statistical summary for selected measurement(s).
  • Memory capacity of up to 12 days monitoring time
  • V-STATS™ (PC software) enabling trend data download via the network for subsequent data analysis, reporting, and printing 

Safe Sensor Temperature Management

  • No burns due to sophisticated temperature management being optimized far above conventional standards of transcutaneous monitoring 

Convenient Operation

  • Just one sensor to simultaneously monitor tcpCO2 and SpO2, which can be applied to various measurement sites
    tcPCO2 monitoring unambiguously helps to detect hypoventilations that may be critically delayed or missed by SpO2 monitoring alone
  • Unique in industry SMART CALMEM function a) allowing to disconnect the digital V-Sign™ Sensor within a disconnection time of up to 30 minutes without an additional calibration request after reconnection and b) resulting in fewer calibration
  • Calibration interval of typically 12 hours allowing continuous monitoring of up to 12 hours
  • Membrane change interval of up to 42 days
  • Dedicated Parameters Setting for general care floor use (no auditory signals at the bed-side, display in sleep mode)
  • Various preconfigured, user-selectable measurement screens
  • Monitor mountable on roll/infusion stands, wall mounts/railings
  • Flip feet serving as carrying handle or to adjust angle for improved table top viewing

References

[1] Frank J. Overdyk, Postoperative Respiratory Depression and Opioids, Initiatives in Safe Patient Care, Initiatives.
[2] Weinger MB. Dangers of postoperative opioids: APSF workshop and white paper address prevention of postoperative respiratory complications. APSF Newsletter Winter 2006-2007; 21:61-67.
[3] Stoelting and Weinger MB. Dangers of Postoperative Opioids - Is there a Cure? APSF Newsletter Summer 2009; 24:25-26.
[4] JCAHO, Patient controlled analgesia by proxy, Sentinel Event Alert 33, December 20, 2004
[5] Practice Guidelines for the Perioperative Management of Patients with Obstructive Sleep Apnea, Anesthesiology 2006; 104:1081–93

In sleep diagnostics continuously monitoring the patient’s PCO2 levels without disturbing the patient’s sleep is important to assess nocturnal hypoventilation and to titrate noninvasive ventilation.

Arterial blood sampling is intermittent and invasive, hence, it can’t be done without disturbing the patient’s sleep.

Sidestream endtidal PCO2 (etCO2) monitoring is continuous and relatively easy to use. However, in addition to physiological factors such as “healthy lungs” and good lung perfusion/ventilation the quality of etCO2 strongly depends on the gas sampling quality and on a regular/full breathing cycle. In spontaneously breathing or mask ventilated patients, making up the majority of patients in sleep diagnostic settings, the quality of etCO2 therefore is poor.

Being continuous, noninvasive, and independent from the quality of the airway transcutaneous pCO2 (tcpCO2) monitoring is the way of accurate PaCO2 estimation overcoming the drawbacks of etCO2 and the invasiveness of ABG’s.

For sleep applications the SenTec Digital Monitoring System offers the following key features:

Reliable Measurement Performance

  • Lowest technical drift of the currently available tcpCO2 monitors Storre 2010.
  • Retrospective correction of residual drift with V-STATS™
  • PCO2 artifact detection/rejection algorithm

Safe Sensor Temperature Management

  • No burns due to sophisticated temperature management being optimized far above conventional standards of transcutaneous monitoring

Convenient Operation

  • Calibration interval of typically 12 hours
  • Membrane change interval of up to 42 days
  • Due to SMART CALMEM it is possible to disconnect the SenTec TC Sensors within a disconnection time of up to 30 minutes without an additional calibration request after reconnection.
  • Less calibrations required due to SMART CALMEM
  • Dedicated Parameters Setting for sleep diagnostics application (no auditory signals, no disturbing light from the display)

Comprehensive Data Management

  • Memory capacity of up to 12 days monitoring time
  • V-STATS™ (PC software) enabling trend data download for subsequent data analysis, reporting, and printing
  • Convenient trend data download via the network with V-CareNeT™ (incorporated in V-STATS™)
  • Parameter range for analog output (0-1V) of PCO2, SpO2, PR, Pleth selectable
  • Analog output connector with reinforced electrical insulation enabling straightforward interfacing with polygraphic and PSG systems without additional safety precautions

Anesthesiologists are often involved in management and treatment of clinical patients in almost every department of their hospital. They are challenged with an ambitious monitoring task of their patient in the different settings. The SenTec Digital Monitoring System (SDMS) is supporting Anesthesiologists in clinical situations, such as:

  • procedures involving special mechanical ventilation techniques (HFJV, HFO, One-Lung ventilation) or prolonged apneic phases (HFNC for apneic oxygenation/ventilation), monitored-anesthesia care / procedural sedation,
  • monitoring of adverse effects of pain medication, and surveillance in the post anesthesia care unit.

Operating room
In certain situations tcPCO2 monitoring provides better estimates of PaCO2 values in patients undergoing various surgical procedures (e.g. in thoracic anesthesia, anesthesia involving severely obese adults with ventilation/perfusion mismatch, and one-lung ventilation) than end tidal CO2 (ETCO2) monitoring.

TcPCO2 monitoring is also helpful during high frequency jet ventilation in e.g. upper airway laser surgery or trachea / lung surgical procedures. It is also used to control HFO or helps to guide the ventilation in one-lung ventilation procedures. During apneic phases TcPCO2 allows for continuous monitoring, especially when ETCO2 measurement is not possible e.g. during application of a high flow nasal cannula for surgical larynx or trachea procedures.

TcPCO2 doesn’t replace EtCO2 monitoring in the operation room (since EtCO2 immediately allows for detection of life-threatening situations), but TcPCO2 and EtCO2 monitoring are complementary measurements in many situations. TcPCO2 is a valuable addition to capnography in patients with an increased EtCO2/PaCO2 difference and in situations in which the continuous, noninvasive, and precise control of carbon dioxide level is required (e.g. one-lung ventilation).

The SDMS provides the anesthesiologist in the operating room a monitoring tool for estimating the patient's PaCO2 independent of the patient's lung ventilation/perfusion status in a fast, accurate and continuous way.

Procedural Sedation or MAC
Procedural sedation or monitored-anesthesia care (MAC) for diagnostic or therapeutic procedures with or without local anesthesia are often provided by the operator together with a trained nurse or in difficult cases an anesthesiologist is involved.

Procedural Sedation/MAC are indicated in e.g. the following diagnostic or therapeutic procedures: endoscopy, flexible fiberoptic laryngoscopy and bronchoscopy, cardiac catheterisation, electrical cardioversion, diagnostic imaging in children (MRI, CT), major dental procedures, extra-corporeal shock-wave lithotripsy, interventional radiology procedures, laceration repair in children, bone marrow aspiration, burn debridement/major abrasion cleaning (“road rash”), fracture reduction/dislocation reduction, thoracocentesis, thoracotomy/chest tube placement, central catheter placement.

Guidelines for sedation and/or analgesia by non-anaesthesiology doctors from the Section and Board of Anaesthesiology of the European Union of Medical Specialists recommend in terms of ventilation and oxygenation:

...monitoring should consist of a minimum of pulse oximetry and continuous visual observation of breathing and its frequency.

The American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists emphasizes:

...because ventilation and oxygenation are separate though related physiologic processes, monitoring oxygenation by pulse oximetry is not a substitute for monitoring ventilatory function.

The SDMS provides the medical doctors and nurses involved in procedural sedation settings with a single sensor application, which yields fast, accurate and continuous information about the ventilation (tcpCO2) and oxygenation (SpO2) status of their patients.

PACU
The Task Force on Postanesthetic Care of the American Society of Anesthesiologists report in their Practice Guidelines for Postanesthetic Care:

...It is recommended to assess airway patency, respiratory rate, and SpO2 during emergence and recovery and particular attention should be given to monitoring oxygenation and ventilation.

The detection of hypoventilation (induced by residual anesthetics, pain medication e.g. patient controlled analgesia (PAC) with e.g. opioids) by pulse oximetry alone will be impaired, if patients in the PACU receive supplemental oxygen therapy.

The SDMS helps the medical doctors in charge of the PACU to monitor their patients' ventilation and oxygenation status with one single sensor. Additionally with the V-CareNeT™ add-on package to the V-STATS™ Software, it is now possible to centrally monitor up to 20 SDMs connected to a standard Ethernet network on one PC-screen.

Publications for SenTec Digital Monitoring System

The SenTec Digital Monitoring System (SDMS) with the V-Sign™ Sensor is a safe, accurate and reliable way to track and monitor changes in arterial carbon dioxide, arterial oxygen saturation and pulse rate. Measuring tcPCO2 and SpO2 noninvasively, the V-Sign™ Sensor enables clinicians to better assess patient ventilation and oxygenation in virtually all clinical settings. There is a fast growing number of published clinical studies which were conducted to test and prove the usability, reliability and accuracy of the SDMS.

Click on the links below to view published clinical studies online, sorted by Application Areas:

Anaesthesia

ICU

Neonatology

Procedural Sedation

Pneumology

Sleep

Click on the links below to view published clinical studies online, sorted by other topics:

General

Validation /Accuracy

tcPCO2 vs EtCO2

Clinical Study Support
SenTec AG is interested to support clinical studies, which focus on or apply tcPCO2, tcpO2 and/or SpO2 monitoring in various application areas including but not limited to neonatology, sleep medicine, pneumology, home care, anesthesia, procedural sedation, or intensive care. Researchers planning to conduct clinical trials in one of our research focus areas are invited to send SenTec AG their study proposal. If SenTec decides to support the study SenTec typically offers to provide product training, to monitor the data quality during the study to avoid user errors, to provide data analysis support and to provide the necessary equipment to conduct the study.

Interested clinicians are invited to contact us for additional information. We’re looking forward to supporting your clinical study!