Portable respiratory monitors

Capnostream™ 35 portable respiratory monitor

<p>The Capnostream™ 35 portable respiratory monitor provides continuous, noninvasive, and real-time respiratory status monitoring.</p>

Features

  • Combined with proprietary integrated algorithms, and alarm and data management, the monitor provides key insights for safe and effective care.
  • The monitor's portable, rugged, lightweight, ergonomic design helps facilitate moving a patient between hospital areas of care.
  • Proprietary Molecular Correlation Spectroscopy™ technology uses a CO2 specific infrared (IR) wavelength that is highly accurate and unaffected by the presence of other gases (e.g., O2, N2O, He or inhaled anesthetics.)2
  • Smart Capnography™ algorithms are engineered to alert clinicians to early indication of changes in respiratory status that may need intervention, while also reducing nonactionable alarms to help mitigate alarm fatigue.2
  • The Integrated Pulmonary Index™ algorithm combines four real-time measures — etCO2, SpO2, respiratory rate, and pulse rate — to provide an inclusive assessment of a patient’s respiratory status in a single number.
  • Connectivity to web-enabled devices on a secured hospital Wi-Fi network is offered for advanced data management and remote patient monitoring.

Flexible monitoring options so clinicians can choose what and how to monitor respiratory status

  • Access continuous, noninvasive, real-time respiratory status monitoring of etCO2 and capnography-derived respiration rate using a Microstream™ Advance filter line. The Nellcor™ respiratory rate sensor can also be used alone to measure SpO2, pulse rate and pulse oximetry-derived respiration rate (RRPleth).
  • Continuous monitoring of respiration rate, including pleth-based respiratory rate, offers an early indication of respiratory compromise compared to continuous SpO2 monitoring alone.3
  • In addition to having the option to measure pleth-based respiration rate, the Nellcor™ saturation pattern detection (SPD) algorithm identifies evolving SpO2 patterns in real-time, which can indicate repetitive reduction in airflow (RRia). One of the more well-known examples of RRiA is obstructive sleep apnea.

Frequently asked questions

Yes. Several published studies have shown a correlation between etCO2 and sepsis etCO2 and outcomes in asthmatic patients. The Capnostream™ 35 portable respiratory monitor was submitted to the FDA with the following data:

 

  • End-tidal carbon dioxide has been shown to be useful as a non-invasive, pre-hospital marker for suspected shock2,3 and sepsis.4
  • Pre-hospital end-tidal carbon dioxide has been shown to differentiate between cardiac and obstructive causes of dyspnea and to correlate with outcomes in adult asthmatic patients.5

 

Yes. The Capnostream™ 35 portable respiratory monitor is intended for use in emergency medical service applications, including ground and air transport. It is also intended for use in-hospital, across the continuum of care:

  • Resuscitation/crash cart
  • Procedural suites
  • General care floor
  • Emergency room
  • Intrahospital transport

Because of the monitor’s design, it is not indicated for home care use.

An advisory message, “battery low,“ appears when approximately 30 minutes of battery time remains.

Both batteries charge when the monitor is plugged in. Charging time takes up to five hours when the unit is plugged in and turned off, and takes up to eight hours when the monitor is plugged in and the unit is powered on.

The removable battery may also be charged with the battery charger accessory, available for purchase (SKU#: PM35CHG). When using the battery charger, the battery icon will show the approximate charge level.

Yes. The monitor can be upgraded for updates as new software, algorithms, parameters, and features become available.

The Capnostream™ 35 portable respiratory monitor's rugged, ergonomic design is engineered for demanding environments and challenges.

  • Portable design features include:
    • Lightweight (2.2 lbs.)
    • Internal and external battery for hot swappable battery capability
  • Durable and rugged design features include:
    • Shockproof to 1.25 meters
    • 4.3″ color sunlight-readable screen with multiple display views
    • Liquid and solid ingress protection (iP54)
  • Ease of use design features include:
    • Emergency medical mode (EMS): immediately initiates monitoring to eliminate additional steps
    • Data storage: USB/microSD card and/or transfer to other data systems
    • Nine screen layouts with optional parameter color change
    • Three levels of alarms and advisories (high priority alarms, medium priority alarms, and advisories), each defined by a set of audible and/or visual indications
    • Integrated Pulmonary Index™ algorithm, integrates four parameters (SpO2, etCO2, respiration rate, and pulse rate) into a single number, offering an indication overall respiratory status on a scale of 1–10

The calibration interval for the Capnostream™ 35 portable respiratory monitor is to initially calibrate after 1,200 operating hours, then once a year or after 4,000 operating hours, whichever comes first.

EMS mode is the default mode for the Capnostream™ 35 portable respiratory monitor. EMS mode was developed specifically for emergency situations and/or resuscitation to bypass the start-up screen and immediately monitor the patient. In EMS mode, the Capnostream™ 35 portable respiratory monitor is immediately ready for monitoring when a CO2 sampling line and a SpO2 sensor are attached, and the monitor is powered on. The home screen appears immediately, eliminating additional steps.

Important note: In EMS mode, prior patient data will automatically be cleared when the monitor is powered on and begins monitoring a new patient.

To disable EMS mode as the default, please contact a Medtronic representative or the biomedical engineer for your institution.

Important note: Any institutional defaults that are set while the monitor is in EMS-enabled mode will remain relevant only as long as the monitor is in EMS mode. When EMS mode is disabled, defaults will be either factory defaults or institutional defaults (if previously set).

Likewise, if changes are made to defaults while EMS mode is disabled on the monitor, these changes will not be relevant in EMS mode. If desired, an institution can maintain two sets of institutional defaults: one for EMS mode and one for when EMS mode is disabled.

If the monitor is set to “disable EMS mode,“ every time the monitor is powered on, a message prompt to clear trend memory will be displayed. The user can press the enter button to continue monitoring the same patient. If a new patient will be monitored, and information regarding the previous patient should be cleared, select “yes” and press "enter.”

Yes, there is an option of placing the monitor in a separate standby mode parameter for capnography and for pulse oximetry. Once “parameter standby mode“ is enabled, it can be activated as required. The purpose of this option is so the monitor will alarm when a sampling line and/or sensor is disconnected from the monitor while still permitting the user to turn off this option.

Important note: In factory default, “parameter standby” mode is disabled.

When parameter standby mode is enabled, after a sampling line (FilterLine™ sampling line) has been connected and then removed from the monitor, the medium priority alarm, “filter disconnected,“ will sound.

Likewise, after a pulse oximetry sensor/extension cable has been connected and then disconnected from the monitor, a medium priority alarm, “SpO2 sensor disconnected“ will sound. The purpose of this alarm is to prevent unauthorized disconnection of a sampling line or SpO2 sensor from the monitor by a patient or a patient’s visitor.

Yes. The monitor can be connected wirelessly via the Vital Sync™ virtual patient monitoring platform, providing the flexibility to view patient information on any web-enabled device, EMR or clinical information system. In addition, patient data can be stored on a USB drive or microSD card and then transferred to other data systems.

Yes, the monitor can be connected to EMR via the Vital Sync™ virtual patient monitoring platform.

Important note: EMR systems vary, and customers should work directly with the EMR provider to determine connectivity requirements.

The monitor can export stored and current data to external devices, such as USB flash drives and microSD cards. Steps to download data are as follows:

  1. Click the menu button on the front panel of the monitor.
  2. Select “report”on the menu screen.
  3. Select “store report” on the report menu screen.
  4. Select the report you want to store.
  5. Choose the device on which you want to store the report.
  6. Select “save report” and then insert external drive.
  7. Press “next” to export the required data.

The Capnostream™ 35 portable respiratory monitor has a patient ID feature that enables the user to admit a new patient and avoid confusion.

Yes. You will need to use date and time on the trend data to determine appropriate patient identification.

Trends are automatically stored. The monitor stores the previous 48 hours of monitored data regardless of whether there is a period of time during which the monitor is turned off. Data is saved once per second, and real-time continuous CO2 waveform data is saved 20 times a second.

Trend data is displayed in two different formats — graphical and tabular. The graphical trend screen displays patient data over a longer time scale (1, 2, 4, 8, or 12 hours at a time), giving you the option to scroll through the data for patterns, specific events, or alarms. The tabular trend screen displays 1 sec, 5 sec, 15 sec, 30 sec, 1 min, 5 min, 15 min, 30 min, and 1 hour, offering you greater detail of patient respiratory status.

The monitor provides the opportunity to view or store various reports. Included are ventilation, desaturation, alarm review, case, and trend reports.

Smart alarm features are always activated on the Capnostream™ 35 portable respiratory monitor. These include:

  • Smart Alarm for Respiratory Analysis™ algorithm (SARA) is an embedded capnography alarm management technology, engineered to reduce 53% of clinically insignificant, unactionable nuisance alarms.6
  • SBD is a proprietary filter and pattern recognition algorithm that screens out low amplitude “non-breath” etCO2 excursions, helping to reduce the frequency of clinically insignificant respiratory rate alarms due to a patient snoring, talking, or crying.
  • Nellcor™ SatSeconds alarm management technology is designed to monitor both the degree and duration of desaturation as an index of desaturation severity. This may help distinguish significant clinical events from minor events and brief desaturations. This feature can be programmed for each patient.

Explain that the medication they will be given can make their breathing slow or shallow. Explain that a capnography monitor will alert clinicians to small changes in breathing before any problems can occur. Because the patient may be sedated, it is also important to educate family or friends who are present.

Let your patients and their family members know that alarms alert clinicians to a change in breathing. Explain that alarms can serve as a reminder to the patient to take a few deep breaths if they are awake.

Routine post-surgical activity, like sipping water or eating ice chips, does not interfere with monitoring.

Generally, patients will be monitored until the physician believes there is no longer a risk of slow or shallow breathing. This period depends on the type and duration of medication prescribed and the patient’s response to the medication.

Specifications

 

General characteristics
Unit dimensions 213 mm (h) x 137 mm (w) x 55 mm (d) [8.38 in (h) x 5.39 in (w) x 2.16 in (d)]
Unit weight 1 kg (2.2 lb)
Power supply
Input power 100–240 VAC, 50/60 Hz, ± 10%
Battery
Battery type Lithium ion
Battery pack nominal voltage and energy 7.2V; 18.72Wh
Battery operation 3 hours for removable battery pack; 20 minutes for internal battery pack
Battery charging time Up to 5 hours when the monitor is off and up to 8 hours when the monitor is on, for both batteries
Display
Screen 109 mm (4.3 in) color TFT display
Pixel pitch: 0.198 (horizontal) x 0.198 (vertical) mm
Active display area: 95.04 (horizontal) x 53.856 (vertical) mm
Resolution: 480 x 272 pixels
Viewing angle: (vertical) 125°
Viewing angle: (horizontal) 140°
Trace speed 3.0, 6.3, 12.5, and 25 mm/second
Waveform sampling rate 77.82 samples/second for SpO2 (fixed)
20 samples/second for capnography (fixed)
Trend storage 48 hours with 1 second resolution
Trend display Graphical display: 1 hour, 2 hour, 4 hour, 8 hour, 12 hour views
Tabular display intervals: 1 second, 5 seconds, 15 seconds, 30 seconds, 1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour
Algorithms
Integrated Pulmonary Index™ algorithm, Nellcor™ SatSeconds technology, Apnea-Sat Alert™ algorithm, Smart Alarm For Respiratory Analysis™ algorithm
Communication interface
Wi-Fi (Vital Sync™ virtual patient monitoring platform connectivity option) and file transfer via USB flash drive or microSD card
Microstream™ capnography
CO2 units mmHg or kPa or Vol%
CO2, etCO2 range 0–150 mmHg
CO2 waveform resolution 0.1 mmHg
etCO2 resolution 1 mmHg
CO2 accuracy 0–38 mmHg: ±2 mmHg
39–150 mmHg: ± (5% of reading + 0.08 for every 1 mmHg above 38 mmHg)
Respiration rate range 0–150 bpm
Respiration rate accuracy 0–70 bpm: ±1 bpm
71–120 bpm: ±2 bpm
121–150 bpm: ±3 bpm
CO2 alarms No breath, etCO2 High, etCO2 Low, RR High, RR Low, Integrated Pulmonary Index™ algorithm (IPI). IPI also requires pulse oximetry information.
Flow rate 50 (42.5 ≤ flow ≤ 65) mL/minute, flow measured by volume
Waveform sampling 20 samples/second
Response time 2.95 seconds (typical); with use with sampling lines with long tubing, ~5.0 seconds
Initialization time 40 seconds (typical
Calibration interval Initially calibrate after 1,200 operating hours, then once a year or after 4,000 operating hours, whichever comes first
Nellcor™ pulse oximetry
SpO2 measurement range 1 to 100%
SpO2 accuracy
Adult and pediatric mode
SpO2 range 70 to 100%
±2 digits over the range of 70 to 100% (when using the accessories defined in this document), including under low perfusion; with motion, ±3 digits; with low saturation (60 to 80%) ±3 digits
Infant/neonatal mode
SpO2 range 70 to 100%
±2% over the range of 70 to 100% (when using the accessories defined in the operator’s manual), with motion ±3%; with low saturation (60 to 80%) ±3%
Pulse rate range 20 to 250 bpm
Pulse rate values of < 20 bpm shall be displayed as zero bpm
Pulse rate values of > 250 bpm shall be displayed as 250 bpm
Pulse rate accuracy ±3 digits over the range of 20 to 250 bpm inclusive, including under low perfusion; with motion, 48 to 127 bpm ±5 digits
Alarms SpO2 High, SpO2 Low, PR High, PR Low
Nellcor™ SatSeconds alarm management range 10–100
Data output and connectivity
Data output Wi-Fi streaming data using Capnostream™ 20 bedside monitor protocol
USB streaming data using Capnostream™ 20p bedside monitor protocol
USB storage to flash memory devices
MicroSD card storage
Connectivity options Vital Sync™ virtual patient monitoring platform 
The monitor can connect to an internet network via a dedicated Ethernet cable
The monitor can communicate through serial interface via a dedicated serial cable
Cerner™* system

Ordering information

Item number Description Units per box
PM35MN02 Monitor with U.S. power cord 1
PM35CHGKIT Extra battery/charger kit 1
PM35BTY Spare battery 1
PM35CHG Battery charger 1
PM35PSP2 U.S. power supply cord 1
PM35CLP Monitor clamp and Vesa™ mounting adapter kit 1
PM35VAA Vesa™ mounting adapter 1
PM35MNF Clamp 1
10036074 Lantronix box pole clamp 1
PM35SGXMNT Lantronix box bracket 1
PM35ACETH USB to RS422 adapter cable 1
PM35ACRS422 USB to RS232 adapter cable 1
PM35ACRS232 USB to ethernet adapter cable 1

The Microstream™ capnography monitoring system should not be used as the sole basis for diagnosis or therapy and is intended only as an adjunct in patient assessment.

TM* Third-party brands are trademarks of their respective owners.

† Integrated Pulmonary Index® (IPI) measurement uses capnography derived respiratory rate.

‡ Pleth-based Nellcor™ respiration rate is not approved for use in EMS or intrahospital transport.

  1. Maddox RR, Williams CK, Oglesby H , Butler B, Colclasure B. Clinical experience with patient-controlled analgesia using continuous respiratory monitoring and a smart infusion system. Am J Health Syst Pharm. 2006;63(2):157-164.
  2. Kheng CP, Rahman NH. The use of end-tidal carbon dioxide monitoring in patients with hypotension in the emergency department. J Emerg Med. 2012;24;5(1):31.
  3. Caputo ND, Fraser RM, Paliga A, Matarlo J, Kanter M, Hosford K, Madlinger R. Nasal cannula end-tidal CO2 correlates with serum lactate levels and odds of operative intervention in penetrating trauma patients: a prospective cohort study. J Trauma Acute Care Surg. 2012;73(5):1202–7.
  4. Hunter CL, Silvestri S, Dean M, Falk JL, Papa L. End-tidal carbon dioxide is associated with mortality and lactate in patients with suspected sepsis. Am J Emerg Med. 2013;31(1):64–71.
  5. Nagurka R, Bechmann S, Gluckman W, Scott S, Compton S, Lamba S. Utility of initial prehospital End-tidal carbon dioxide measurements to predict poor outcomes in adult asthmatic patients. Prehosp Emerg Care. 2014;18(2):180–184.
  6. Internal test data on file.