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510(k) Data Aggregation
K Number
K183687Device Name
LifeWindow LW8 Lite
Manufacturer
Digicare Biomedical Technology, Inc.
Date Cleared
2019-09-25
(271 days)
Product Code
MWI, CCK, CCL, DQA, DRT, DSK, DXN, FLL
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
Digicare Biomedical Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LifeWindow™ LW8 Lite is a multi-parameter physiological patient monitor indicated for continuous measurement of the following parameters:
- · ECG waveforms from 3 or 5 lead measurements
- · Heart Rate (from ECG)
· Non-invasive blood pressure (NIBP) automatically measures systolic and diastolic pressure and pulse rate, while calculating mean arterial pressure (MAP). The equation used to calculate MAP provides an approximate value
- · End-tidal CO2 concentration (EtCO2) Mainstream or Sidestream
- · Inspired CO2 concentration (insCO2) Mainstream or Sidestream
- · Fractional Inspired Oxygen (FiO2)
- · Acoustic Respiration Rate (RRa)
- · Respiration Rate (from bioimpedance or EtCO2 measurement, or RRa)
- Two Temperature channels
- · Two Invasive Pressure channels (IP1, IP2)
- · Pulse Rate in BPM (from Pulse CO-Oximetry and/or NIBP)
· Pulse CO-Oximetry and pulse rate - the LifeWindow LW8 Lite Pulse CO-Oximeter functions and accessories incorporating Masimo technology are indicated for the continuous nomitoring of the following parameters during both no motion and motion conditions, and for patients who are well or poorly perfused:
- o Functional oxygen saturation of arterial hemoglobin (SpO2)
- o Carboxyhemoglobin saturation (SpCO)
- o Methemoglobin saturation (SpMet)
- o Total hemoglobin concentration (SpHb)
The defined patient population is adult through neonatal patients with appropriate accessories. The monitor displays a range of physiological waveforms and indices and provides alarms.
The LifeWindow™ LW8 Lite multi-parameter patient monitor may be used in hospital-type facilities, surgery centers, and emergency facilities. For professional use only. It is not intended for helicopter transport. hospital ambulance, or home use.
Device Description
The LifeWindow™ LW8 Lite Multi-Parameter Monitor is designed for the measurement and monitoring of multiple physiological parameters simultaneously in a single patient.
LifeWindow™ LW8 Lite Multi-Parameter Monitor is constructed with the following features:
- I Compact monitor design in a rugged aluminum chassis
- Integration of cleared vital signs modules
- 트 Patients from neonates through adults
- I High Definition 8.4" TFT screen with touch screen operation
- 트 Multi-channel vital signs trace display with variable sweep speeds
- I Hardcopy printing via an integrated strip chart or compatible printer
- 트 Waveforms sweep speeds from 6.25mm/s up to 50mm/s
- . Mainstream and sidestream Capnography options
- I Specification of cleared third-party patient-applied accessories
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