Fukuda Denshi DS-7000
Device Name:
Dynascope
Device Model:
DS-7000
Manufacturer:
Fukuda Denshi Co. Ltd., 2-23-5 Kita Ueno, Taito-Ku, Tokyo 110-0014, JAPAN.
Measuring functions:
Blood pressure, Arrhythmias, SpO2, Temperature, ECG, Respiration
Primary Client Use:
Intended for patient monitoring
Measurement Site:
BP: Upper Arm; SpO2: Finger
Measurement Occurrence:
BP & SpO2: Intermittent measurements at specified intervals or times
Availability:
Available Currently
Availability according to Countries or Regions:
Japan
Device Specifications:
Description:
The Fukuda Denshi DS-7000 is a patient monitor. Its blood pressure measurement technology has been proven to be accurate, with a 1-star Medaval rating and information regarding the accuracy of its oxygen saturation measurement technology does not appear to be available. Blood pressure measurements are taken from the upper arm and oxygen saturation measurements are taken from the finger. It is intended for bedside patient monitoring.
Assessment:
The technology used in the Fukuda Denshi DS-7000, to measure blood pressure, has passed in three clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications. There appears to be no peer-reviewed clinical validation information available on the technology used in the Fukuda Denshi DS-7000 to measure peripheral oxygen saturation.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | ★ Recommendation | Older clinical validation; older protocol; multiple clinical validations |
| BP | ESH (Europe) | Professional use for children | Published evidence |
| BP | Japanese Society of Hypertension | Professional use (Latest: 2016, 2018-2022) | Published evidence |
| BP | FDA (US) | 510(k) | 510(k) K083697,, K081891 |
Device Family:
Fukuda Denshi DS-7000J, Fukuda Denshi DS-7200J, Fukuda Denshi DS-8100J, Fukuda Denshi DS-8200J, Fukuda Denshi DS-8500J, Fukuda Denshi DSL-8001J, Fukuda Denshi DS-8007J, Fukuda Denshi DS-8400J, Fukuda Denshi DS-8005J, Fukuda Denshi FCL-2000J
Legend: J JHS Implied Equivalence
Legend: J JHS Implied Equivalence
Validation Publications:
Alpert BS, Blakely DW. Validation of the Fukuda Denshi DS-7000 patient monitor by AAMI standard testing. Blood Press Monit. 2009 Dec;14(6):274-6. doi: 10.1097/MBP.0b013e328332fd6d. PMID: 19923985.
BHS:1993 - Pass (A/A) In normal mode
BHS:1993 - Pass (A/A) In quick mode
SP10:2002 - Pass Adults and chlidren - In normal mode
SP10:2002 - Pass Adults and chlidren - In quick mode
SP10:2002 - Pass Infants (n=15), Neonates (n=18)