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Medtronic / Covidien Products / OEM Patient Monitoring Solutions / INVOS™ Cerebral Regional Oximetry External Interface OEM Solutions

Overview

Make INVOS™ cerebral/somatic oximetry your new monitoring modality

With the new INVOS™ regional oximetry strategic partner solution, adding noninvasive brain oxygenation and tissue perfusion patient monitoring to your portfolio is easy and efficient.

The new INVOS™ regional oximetry strategic partner solution is the first external fully-featured NIRS-based cerebral/somatic oximetry available for OEM integration.

Clinicians are increasingly adopting regional saturation monitoring for the early detection of cerebral hypoxia([FOOTNOTE=Vretzakis G, Georgopoulou S, Stamoulis K, et al. Cerebral oximetry in cardiac anesthesia. J Thorac Dis. 2014;6 Suppl 1:S60-69.],[ANCHOR=],[LINK=]) and to monitor changes in perfusion in neonates and infants. By integrating INVOS™ technology you can offer your customers the unique benefits of market-leading INVOS™ technology.

  • Clinical standard in regional oximetry
  • Evidenced-based claims for improved patient outcomes
  • Unique sensor designs optimized for adults, pediatric and infant/neonatal patients
  • An integrated solution with rSO2 data transfer and electronic medical record (EMR) connectivity
  • Patient-specific rSO2 baseline measurements, including calculation of area under the curve (AUC) and trend line averaging
  • USB functionality for rSO2 data offload and analysis

The INVOS™ technology difference

INVOS™ (IN VIVO OPTICAL SPECTROSCOPY) TECHNOLOGY FOR OEM MONITORING SOLUTIONS

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Product Features

Developed as a complete packaged OEM system, the INVOS™ Regional Oximetry Strategic Partner Solution includes:

  • INVOS™ monitor interface cable
  • INVOS™ preamplifier (s) – channel 1/2 ; optional channel 3/4
  • INVOS™ reusable cable sensors (two per preamplifier)
  • INVOS™ USB drive

The external cable design offers a simple technical integration without the mechanical space constraints of standard PCBA platform designs. And, the INVOS™ regional oximetry strategic partner solution provides the same full complement of features and functionality as the INVOS™ 5100c monitor, including:

  • EMR-compatible, seamless transmission of rSO2 data through networked monitoring platforms
  • USB port and USB exported data formats for data offload and management needs in STS reporting, as well as rSO2 and case analytics
  • Full parameter set of INVOS™ rSO2 values and clinical data including:
    • Regional saturation (rSO2) – per channel
    • Baseline – per channel
    • Trend average (60 minute average rSO2)
    • % change from baseline (% rSO2)
    • Signal strength indicator (SSI)
    • Area under the curve
  • Compatibility with all INVOS™ sensors – adult, pediatric and neonatal
  • INVOS™ OEM evaluation and development kits for rapid and efficient platform integration, scoping and execution
  • Backed by a global team of Medtronic OEM technical, clinical and marketing experts

HOW TO ORDER

For additional information or to place an order, call Customer Service at +44 (0) 19 2320 2504.

Output Parameters
The following information is provided to the patient monitor by the INVOS™ regional oximetry strategic partner solution, per channel:
Regional saturation (rSO2 ) 15 to 95
Baseline (BL) 15 to 95
Total average (six-minute average (rSO2 ) 15 to 95
Signal strength indicator 0 to 5
% change from the baseline (% ↑↓ (rSO2) -85 to 535%
Area under the curve (AUC) 0 to 99,999
Interface Specifications
Physical Connection – Connector/Receptacle
HyperGrip®* connector
(Part of INVOS™ monitor interface cable) Manufacturer P/N: HG2P14GY1204MRH, 12-pin barrel-style connector, yellow-colored strain relief, includes visual and mating keys
HyperGrip®* receptacle
(Recommended mating receptacle of host monitor/system) Manufacturer P/N: HG2 [E|C] 1 [0|1|4|5|6] GY1204FRANH
[E|C] Host designer to specify E = receptacle/panel
  C = receptacle/cable
[0|1|4|5|6] Host designer to specify 0-6 defines strain relief inner diameter options to accommodate outer diameter of OEM chosen cable (0 required for panel-mount receptacle)
HyperGrip® connectors and receptacles are Hypertac-brand products owned by Smiths Group. HyperGrip® P/Ns and product offering are subject to change.
Input Power Requirements
The INVOS™ regional oximetry strategic partner solution adheres to the power requirements of the USB 2.0 spec
Voltage Input +5VDC +/- 5%
Max Current Draw 500 mA
Supply Voltage Ripple <100 mV at all frequencies
Communication Requirements
Signal level RS-232
Rate 9,600 or 57,600 baud (selectable via select line)
Data 8 bit
Stop 1 bit
Parity No
Flow Control None

Data Exchange Summary

The INVOS™ regional oximetry strategic partner solution communicates with the host monitor through asynchronous serial communication (RS-232). The protocol is packet-oriented with binary data and ACK/NAK handshaking. Beyond the regular reporting to the host of the INVOS™ output parameters, in the data exchange the host can:

  • Retrieve hardware and software revision information for compatibility control
  • Configure INVOS™ device settings (baud rate, date format, etc.)
  • Configure INVOS™ case settings (alarm limits, case type, channel labels, etc.)
  • Report user-initiated clinical event markers for INVOS™ monitor interface cable recording, stored for reporting during USB data offload
  • Instruct the INVOS™ monitor interface cable to offload internally stored case data to a connected USB drive

 

®* is a registered trademark of its respective owner.

Environmental Specifications
Temperature Range
Operating 16 to 32° C (60 to 90° F)
Storage -20 to 70°C (-40 to 158°F)
Humidity
Operating 20 to 80% RH, noncondensing
Storage 10 to 95% RH, noncondensing
Altitude Range
Operating 0 to 3,048 m (0 to 10,000 ft)
Storage -500 to 4,600 m (-1,640 to 15,092 ft)

Safety Specifications

The INVOS™ regional oximetry strategic partner solution, a component to be integrated into and be part of an OEM partner’s system, has been designed to comply with the electrical safety requirements of IEC 60601-1 (both second and third editions). Compliance of the component was tested and proven by a third-party accredited test facility while integrated into a Medtronic-designed representative system. The test report may be obtained from Medtronic upon partner request.

The preamplifier of the INVOS™ regional oximetry strategic partner solution provides the required degree of patient isolation for a type BF applied part.

Compliance of the OEM partner’s system, including the integrated INVOS™ regional oximetry strategic partner solution, is the responsibility of the system provider.

Specifications

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Acute Care & Monitoring

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 INVOS™ Cerebral/Somatic Oximetry clinical education offerings

Engineered for ease of integration, the INVOS™ regional oximetry  strategic partner solution provides evaluation and development toolkits,  best practice user interface guides, global OEM technical and clinical  expertise, and dedicated OEM partner online and on site support. You also get the clinical education resources needed to train your  clinicians and teams on the applications and benefits of adopting INVOS™  regional saturation monitoring. Computer-based training modules on haemodynamics and applied learning with clinical case studies provide education about monitoring during adult cardiac surgery.

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