AirStrip Indications for Use

AirStrip Cardiology and AirStrip Patient Monitoring INDICATIONS FOR USE

Intended Use:

AirStrip is intended to allow clinicians to capture and display waveforms (such as ECG, SP02, ART), discrete parameters, patient demographics, alarms, and other information from medical devices on a mobile device (i.e. iOS or Android). This software is intended as a diagnostic aid to provide access for professional staff to view patient clinical data when the professional cannot observe the source system directly. AirStrip does not store Protected Healthcare Information on the mobile device accessing the data. Data available on the mobile device is in “near real time” and is displayed to show a full range of clinical data available, even when the data sources are obtained from different devices.

Indications for Use:

AirStrip gathers data from the medical devices that are connected to the patient. AirStrip is not directly connected to the individual, but to a networked medical device receiving data, and connects that data to individuals by medical record number or defined patient ID. AirStrip is intended to be used by clinicians for the following purposes:

• To visualize physiological data using a mobile device (cellular phone, tablet or other device) to assess clinical status of a patient when the source system cannot be observed directly by the clinician.
• To view the near real-time and historic waveforms.
• To view other near real-time patient data from a monitored system.
• To send electronic images of the cardiac rhythm to the medical record.

AirStrip is appropriate for use for in pediatric (0-21 years), adult and geriatric populations, as the networked medical devices AirStrip collects data from are already cleared for these populations. AirStrip software can display the following physiologic parameters and waveforms captured by other cleared medical devices:

• ECG Waveform
• Heart Rate
• Respiratory Rate
• Oxygen saturation
• Intracranial Pressure
• Central Venous Pressure
• Pulmonary Capillary Wedge
• Pressure
• Pulmonary Artery Pressure
• Cardiac Index
• Cardiac Output
• Temperature
• Temperature Source
• Bispectral index (BIS)
• Umbilical Artery
• Body Weight
• Systolic Blood Pressure- Invasive
• Mean Arterial Pressure-Invasive
• Diastolic Blood Pressure-Invasive
• Systolic Blood Pressure Cuff
• Mean Arterial Pressure Cuff
• Diastolic Blood Pressure Cuff
• Cerebral Perfusion Pressure
• Vasoactive Infusions
• Ventilators
• Allergies
• IV Fluid Delivery Rate
• IV Medication dose
• Pulse Rate
• Bispectral parameters
• Umbilical Vein
• Monitored Events
• Right Atrial Pressure
• Left Atrial Pressure
• Laboratory Data, including
• Blood Gas
• Chemistry
• Hematology
• Coagulation
• Hemodynamic calculated values
• Medications
• IV Volume infused
• ETCO2
• Fractional Inspired Concentration O2, CO2
• Case consumption liquid medications
• Case consumption respiratory gas

Contraindications:

AirStrip is not intended for use where cellular telephones or other wireless devices are prohibited.

Warning:

AirStrip requires an Internet or cellular connection to provide data.

Precautions:                                                                                                                                                 

AirStrip is an adjunct to care and not a replacement for direct viewing of the monitoring medical device(s).

AirStrip Obstetrics INDICATIONS FOR USE

Intended Use:

AirStrip is intended to allow Obstetricians to capture and display waveforms for the fetal heartbeat and maternal contractions to monitor the progress of labor and delivery in near real-time. This software is intended as a diagnostic aid to provide access to professional staff to patient clinical data when the professional cannot observe the patient directly or when a consult is required. AirStrip does not provide Protected Healthcare Information for storage on the mobile device accessing the data.

Indications for Use:

AirStrip gathers data from medical devices that are connected to and produce the patient data. AirStrip is not directly connected to the individual, but to the medical device receiving data, and connects that data to the individuals by medical record number or defined patient ID. AirStrip Obstetrics is intended to be used by clinicians for the following purposes:

• To more rapidly and thoroughly respond to a nurse call regarding fetal heart tracings or maternal contraction patterns by viewing near real-time waveforms using a mobile device when the data cannot be directly observed by the clinician.
• To review the current Labor and Delivery patient census list.
• To provide a request for remote consultation regarding fetal heart tracing via secure messaging.
• To remotely review other standard or near real-time numeric data from Labor and Delivery.

Contraindications:

AirStrip Obstetrics is not intended for use anywhere cellular telephones or other wireless devices are prohibited.

Warnings:

AirStrip software requires an Internet connection to provide data. If an emergency response is requested by a nurse or an emergency response deemed necessary from reviewing the fetal heart rate tracing remotely, the physician should interrupt the session and proceed immediately to the hospital. Should the Internet signal be lost, if it is not restored in the standard time frame of approximately 15-20 seconds, then the clinician should proceed with standard care management protocol, which usually means discussing the last available data over the phone or going to the bedside to review the appropriate data.            

Precautions:

AirStrip is an adjunct to care not a replacement for direct viewing of the monitoring medical device(s) or patient interaction.

AirStrip Web Viewer INDICATIONS FOR USE

Intended Use:

AirStrip is intended to allow clinicians to capture and display waveforms (such as ECG, SP02, ART), discrete parameters, patient demographics, alarms, and other information from medical devices on a desktop device. This software is intended as a diagnostic aid to provide access for professional staff to view patient clinical data when the professional cannot observe the source system directly. AirStrip does not store Protected Healthcare Information on the device accessing the data. Data available on the web viewer is in “near real-time” and is displayed to show a full range of clinical data available, even when the data sources are obtained from different devices.

Indications for Use: 

AirStrip gathers data from the medical devices that are connected to the patient. AirStrip is not directly connected to the individual, but to a networked medical device receiving data, and connects that data to individuals by medical record number or defined patient ID. AirStrip is intended to be used by clinicians for the following purposes:

• To visualize physiological data using a web viewer to assess clinical status of a patient when the source system cannot be observed directly by the clinician.
• To view the near real-time and historic waveforms.
• To view other near real-time patient data from a monitored system.
• To send electronic images of the cardiac rhythm to the medical record.

AirStrip is appropriate for use for in pediatric (0-21 years), adult and geriatric populations, as the networked medical devices AirStrip collects data from are already cleared for these populations. AirStrip software can display the following physiologic parameters and waveforms captured by other cleared medical devices:

• ECG Waveform
• Heart Rate
• Respiratory Rate
• Oxygen saturation
• Intracranial Pressure
• Central Venous Pressure
• Pulmonary Capillary Wedge
• Pressure
• Pulmonary Artery Pressure
• Cardiac Index
• Cardiac Output
• Temperature
• Temperature Source
• Bispectral index (BIS)
• Umbilical Artery
• Body Weight
• Systolic Blood Pressure- Invasive
• Mean Arterial Pressure-Invasive
• Diastolic Blood Pressure-Invasive
• Systolic Blood Pressure Cuff
• Mean Arterial Pressure Cuff
• Diastolic Blood Pressure Cuff
• Cerebral Perfusion Pressure
• Vasoactive Infusions
• Ventilators
• Allergies
• IV Fluid Delivery Rate
• IV Medication dose
• Pulse Rate
• Bispectral parameters
• Umbilical Vein
• Monitored Events
• Right Atrial Pressure
• Left Atrial Pressure
• Laboratory Data, including
•  Blood Gas
•  Chemistry
•  Hematology
•  Coagulation
•  Hemodynamic calculated values
• Medications
• IV Volume infused
• ETCO2
• Fractional Inspired Concentration O2, CO2
• Case consumption liquid medications
• Case consumption respiratory gas

Contraindications:

None known.

Warning:

AirStrip requires an Internet connection to provide data.

Precautions:

AirStrip is an adjunct to care and not a replacement for direct viewing of the monitoring medical device(s).

AirStrip Alarm Management

AirStrip Web Client with AirStrip Alarm Management (AAM) is intended to be used by clinicians for the following purposes:

• To view & respond to near real-time secondary alarms & alerts according to a hospital defined alarm escalation workflows on a mobile device or web client.
• To send secondary alarms on a pre-defined escalation workflow after triaging them using the primary system in a Centralized Telemetry Unit setting.
• To allow clinicians to manage secondary alarm transmission by triaging and responding to active events.
• To view historical data to determine event history, clinician response, and delivery statuses.
• To view near real-time and historic secondary alarm data from primary alarm systems, including medical devices.

Contraindications

Device shall not be used as a replacement for direct viewing of any of the primary monitoring devices from which it obtains its data.

AirStrip Insight

AirStrip Insight is a decision support device indicated for aggregating, displaying, and managing physiologic and other patient information. This information is generated by third party medical devices and patient information systems. The device performs automated calculations on patient data collected by third party devices based on approved clinical protocols at patient care facilities.

AirStrip Insight is intended for use by clinicians in healthcare facilities.

Contraindications

AirStrip Insight is not intended for use on mobile devices anywhere mobile devices are prohibited.

Precautions

1. AirStrip Insight is intended to be used by healthcare providers, including physicians, nurses, and respiratory therapists. People without medical training may not understand the information as presented and may not be using the device as intended.
2. AirStrip Insight is designed to be accessed from the following web browsers: Google Chrome (and Chromium). Other web browser access may lead to displaying a layout of the page content that is difficult to read, the application may remain in an “OFFLINE” state or the page may not be able to load (display any information) at all.
3. Electronic Medical Record Data Sources and Data Types must not be added or changed without involving AirStrip otherwise the information displayed may not be correct.

Warnings

1. Users are cautioned against accessing patient information not related to the care of the patient. This information is protected under the Health Insurance Portability and Accountability Act (HIPAA) and violation of the privacy laws may result in disciplinary action and / or fines.
2. AirStrip Insight should not be relied upon as a primary vital sign monitor. The device is used with the Electronic Medical Record system. The device is not connected directly to vital sign monitors and it is not a replacement for vital sign monitor displays. Not all information pertaining to a patient will appear in AirStrip Insight. It is advised that clinicians continue to review patient data from standard vitals monitoring devices and other primary data sources from the EMR for clinical decision making. AirStrip Insight can be used to assist in the decision-making process.
3. Since AirStrip Insight is not intended for primary patient monitoring, it does not provide audible alarms that are given by primary vital sign monitors.
4. AirStrip Insight is configured with your healthcare facility IT department during installation. Do not attempt to change the EMR system or patient information data sources as such changes may result in data loss or corruption. Contact AirStrip for set up of additional or new inputs.
5. Review AirStrip Insight for any technical messages that indicate that data is not updated (e.g., “service offline”, error messages, and other notes that would appear in the center of the screen). These error states must be resolved to continue monitoring the patient with AirStrip Insight. Please contact AirStrip for assistance.
6. Do not use AirStrip Insight if you do not understand the information displayed.
7. When viewing AirStrip Insight on a mobile device, ensure that the mobile device meets the minimum display resolution requirement of 640X480 pixels. Use of display devices with resolution lower than 640X480 pixels may lead to difficulty in recognizing AirStrip Insight displayed information.
8. If a mobile device on which AirStrip Insight is accessed to display patient information is lost, contact the IT department immediately to minimize possibility of unauthorized access and ensure that patient data remains secure. To further reduce unauthorized access to sensitive patient information, it is strongly recommended that all mobile devices maintain encryption of the device.

Notes

1. AirStrip does not supply display devices. Healthcare facility bedside displays, computers, and other devices can be used. Clinicians may also access AirStrip Insight from their own mobile phone or tablet devices with internet access (mobile data plan or other internet connection). Mobile phone offering is optional and limited to installations in the United States at this time.
2. To access AirStrip Insight via a supported internet browser, obtain a secured, authenticated access from the healthcare facility IT department.
3. AirStrip Insight is set up in accordance with your healthcare facility. When a healthcare facility implements a new care protocol through AirStrip Insight, the data will automatically be presented per the new protocol.
4. AirStrip Insight is a display-only device. It does not allow updating patient data vitals or entering any patient information.

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Page last updated 7.30.25.